tag:blogger.com,1999:blog-36096839190997082262024-03-05T02:22:53.997-05:00Harpocrates SpeaksTodd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.comBlogger401125tag:blogger.com,1999:blog-3609683919099708226.post-34341709032262015562017-08-15T10:00:00.000-04:002017-08-15T11:19:53.126-04:00Dear FascistsI know I've been rather quiet, with no new posts in almost a year. Frankly, I got rather burned out dealing with the ignorance and vitriol of anti-vaccine activists. On top of that, there was the whole debacle in which a fascist cheetoh was elected president.<br />
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This is just going to be a brief post. It's not about vaccines or medicine. It's not about anti-vaxxers. It's just a simple post with a simple message. Warning, there will be some swearing, and if you find offense at anything I've written below, maybe take a moment to take a long, hard look at yourself.<br />
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If you are a white supremacist, if you are a white nationalist, if you are a "goose-stepping moron", hell, if you simply think that opposing fascism is a bad thing, kindly fuck off. You are not American, even though you may have been born here. You are not a patriot. Your views and beliefs are the antithesis of the ideals upon which this country was founded. You are clowns. You are toddlers throwing tantrums because people don't treat you like the center of the universe. You are lint-brained weasels (no offense to actual weasels, which are lovely, smart animals) ignorant of your own ignorance. When you die, you will become meal for worms, and the world will go on about its ways without you, just as it does for all of us, whether we're white, black, brown, female, or male.<br />
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Go ahead and shout. I will stand up for your right to spew your counterfactual verbal diarrhea without the government interfering, so long as it does not incite others to violent action. You have that right. And I support it. But I will also stand up for the right of everyone else to shout you down, to take away your platforms, to ridicule you, to mock you as the rotten, festering turds you are. They are not violating your 1st Amendment rights. They aren't the government. So when they rightfully silence your hatred, do not complain that your rights are being violated. If you do, then you show that you don't give one flying fuck about the Constitution. But we already knew that.<br />
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So again, fascists, you blithering, shit-brained pustules, you abortive cankerous toads, you Nazis, and I do mean this most sincerely, kindly...fuck...off.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.comtag:blogger.com,1999:blog-3609683919099708226.post-90849494677458320892016-09-19T08:00:00.000-04:002016-09-19T08:00:03.000-04:00Happy Talk Like a Pirate Day!Arrr. Ahoy there, mateys! It be <a href="http://talklikeapirate.com/wordpress/" target="_blank">Talk Like a Pirate Day</a>. Time t' hoist the jolie rouge. Avast, ye wee creepies, for ye'll have no quarter.<br />
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(This also be me four hundredth post, for those what're keepin' count.)Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com3tag:blogger.com,1999:blog-3609683919099708226.post-30251756108697907572016-09-15T02:00:00.000-04:002019-05-09T07:33:36.975-04:00Influenza Vaccine Has Been Studied in Pregnant Women<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
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Summer is very nearly over in the Northern hemisphere. Fall and winter creep ever closer. As the temperatures drop, we begin to think about pulling out our warmer clothes. We shake out our jackets. Those with oil heat make sure their tanks are filled. Others stock up on firewood. The really forward thinking might ensure that their shovels are in decent shape for any snow that may be coming their way.<br />
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We're also heading into flu season. Influenza rears its ugly head from fall, through winter, and into early spring. It's one of those diseases that people tend to <a href="http://www.isg.org.au/index.php/about-influenza/myths-and-misconceptions/" target="_blank">underestimate</a> and have a lot of <a href="http://www.cdc.gov/flu/about/qa/misconceptions.htm" target="_blank">misconceptions</a> about. A lot of illnesses people think are the flu are actually different illnesses caused by bacteria, parasites, or different viruses. A lot of people think that it is a fairly benign disease, even though it kills thousands of people in the U.S. every year, and hundreds of thousands worldwide. Then there are the myths about the flu vaccine. Probably the most common mistaken belief is that the vaccine can give you the flu, <a href="http://www.harpocratesspeaks.com/2013/11/an-honest-flu-ad.html" target="_blank">even though</a> <a href="http://www.harpocratesspeaks.com/2013/11/nvic-know-omissions-part-2.html" target="_blank">it can't</a>. The available vaccines use either inactivated virus or a severely weakened form of the virus, neither of which will give you the flu.<br />
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Suffice it to say, there is a lot of misinformation out there about the flu and the flu vaccine. But there is one population that is more seriously affected, both by the disease itself and by the myths: pregnant women.<br />
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Pregnant women are considered a vulnerable population, that is, a group that may be prone to greater risks. There's a greater risk of complications following infection. They may be prone to exploitation. Their fetuses may suffer from exposure to disease, drugs or medications, or environmental contaminants. In research involving pregnant women, a <i>lot</i> of additional measures must be taken to ensure the safety of pregnant women. The greater the uncertainty around an experimental drug, device, or procedure, the more difficult it is to convince an institutional review board to allow the study in pregnant women. This is especially true with products that are not targeted specifically at pregnant women, but rather at a very broad population that may incidentally include women who are pregnant or who may become pregnant.<br />
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Like vaccines.<br />
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I'll get back to testing vaccines in pregnant women later. First, let's see how all of this comes together: influenza misinformation, pregnant women, and vaccines. A pretty common myth promoted by those who oppose vaccines is that the flu vaccine has never been tested in pregnant women (or some variant of that argument). For reference, they will point to the vaccine package inserts.<br />
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For example, the anti-vaccine site <a href="https://webcache.googleusercontent.com/search?q=cache:oner0RjcAUEJ:https://healthimpactnews.com/2013/flu-vaccines-not-tested-on-pregnant-women/+&cd=1&hl=en&ct=clnk&gl=us" target="_blank">Health Impact News asks</a>:<br />
<blockquote>
Do doctors and nurses who administer the flu vaccine to pregnant women
warn them that these vaccines have not been tested on pregnant women?</blockquote>
They include a link to the insert for one of the flu vaccines out there, <a href="http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM305089.pdf" target="_blank">Fluzone</a>, and quote from it:<br />
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Safety and effectiveness of Fluzone has not been established in pregnant women.</blockquote>
Similarly, Dr. Joe Mercola <a href="http://webcache.googleusercontent.com/search?q=cache:CyUzBcZ4398J:articles.mercola.com/sites/articles/archive/2010/06/08/should-pregnant-women-avoid-all-vaccines.aspx+&cd=3&hl=en&ct=clnk&gl=us" rel="nofollow" target="_blank">wrote in 2010</a>:<br />
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<span id="ctl00_bcr_lblDrComments">As I've reported in previous articles, this vaccine has NEVER been tested in pregnant women – until now.</span></blockquote>
Interestingly, while Mercola is aghast that the flu vaccine has never (in his mind) been tested in pregnant women, he also stated that he did not think that pharmaceutical products should <i>ever</i> be tested in pregnant women. I guess he thinks that pregnant women should just not receive anything, ever, even if there is potential that it might help them or improve their chances for having a healthy child. I wonder if that includes all of those supplements that he sells?<br />
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At any rate, the mistake that they, and those who repeat their misinformation, make is that they look to the vaccine package insert as the be-all, end-all of scientific information on the vaccine. They use it as if it were a complete and 100% accurate summation of all that is known about the vaccine. It isn't. Either they misunderstand the role of package inserts, or they know that they are misrepresenting it yet mislead their followers anyway.<br />
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A package insert is, first and foremost, a <a href="http://www.harpocratesspeaks.com/2014/09/package-inserts-understanding-what-they.html" target="_blank">legal document</a>. It instructs physicians on how to prescribe and administer the product, as well as listing adverse reactions, whether they are actually caused by the product or not. It includes information from studies that the <i>manufacturer</i> has conducted, the indications that they have sought and gained FDA marketing approval for, and it <i>might</i> include a smattering of information from other studies. Generally speaking, though, package inserts do not include information on off-label uses of the product. Off-label use includes using the product for any indication, dosing schedule, age range, or population for which the manufacturer has not received FDA approval. The package insert will reflect that, saying, for example, that the product has not been studied in pregnant women.<br />
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That does not mean, though, that <i>no one</i> has studied the vaccine in pregnant women. We know that the flu vaccine can help reduce the risk of getting the flu (the actual flu - influenza - not the queasy stomach you got from norovirus or something else). And, yes, how effective it is varies from year to year, but it always provides more protection than not getting the vaccine at all; even when it doesn't prevent infection, it can often lessen the severity of illness. Although there has not been a great deal of study on the effects of influenza infection in pregnant women, we do know that there is some increased risk of adverse pregnancy and fetal outcomes. If the vaccine can reduce the risk of influenza infection and severity of infection, and we know that pregnant women are at greater risk of adverse outcomes if they get infected with the influenza virus, then we should figure out if the vaccine is safe for pregnant women to receive.<br />
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Fortunately, unlike anti-vaccine activists who only complain about vaccines, the scientific community actually looks into questions like this. Researchers from around the world <i>have</i> studied vaccines in pregnant women. There have been retrospective studies, prospective studies. Some studies were case-control studies. Others were cohort studies. Some looked at seasonal flu vaccines. A lot have looked at the A/H1N1 pandemic influenza vaccine. With adjuvants? Check. Without adjuvants? Check. Randomized controlled trials? There have been a couple of those, too. There have been systematic reviews, too, combining multiple studies to gain greater power to detect possible problems. And, yes, the U.S. Centers for Disease Control and Prevention, which recommends that pregnant women get the annual flu vaccine, <a href="https://www.cdc.gov/flu/highrisk/qa_vacpregnant.htm" target="_blank">have also studied, and continue to monitor, the flu vaccine in pregnant women</a>.<br />
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What have we discovered? There do not appear to be any increased risks of adverse pregnancy outcomes, adverse fetal outcomes, nor adverse infant outcomes. It even looks as though getting a flu vaccine will <i>improve</i> outcomes. Pregnant women who receive the flu vaccine have a lower risk of having a miscarriage, for example. The antibodies that pregnant women produce as a result of vaccination are also passed on to the infant, protecting them for several months, until they are able to mount their own defense against infection. <br />
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For those who follow the actual facts about vaccines, this should come as no surprise. However, it is a fairly pernicious myth that just won't die. <a href="http://www.redwineandapplesauce.com/2014/01/08/the-real-story-on-the-flu-vaccine-during-pregnancy/" target="_blank">Tara Haelle wrote about it in 2014</a>, listing a number of studies that had been done.<br />
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If all of these studies have been done, and we know that the vaccines are safe for pregnant women to get, why don't the manufacturers add pregnant women to their package inserts?<br />
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In order to do so, manufacturers would have to conduct clinical trials to study their vaccines in pregnant women. That is a very, very expensive endeavor. As mentioned before, they would have to get ethics approval before they could begin such a study. That would be rather difficult. On the one hand, it involves testing a product in a vulnerable population. On the other, we already have evidence that the vaccine is safe and provides a benefit to pregnant women, so giving it to one group and giving a placebo to the other would violate the research principle of <a href="http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/#xbenefit" target="_blank">beneficence</a>. If we know that the product is beneficial and that not giving it leaves one at increased risk, we cannot ethically give it to one group but withhold it from another.<br />
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There also is no incentive for a manufacturer to undertake a clinical trial. Remember, the purpose of a manufacturer undertaking a clinical trial is to gain FDA approval to actively market their product for the indication and population(s) in the trial. The flu vaccine is already widely used by pregnant women. There is already a large body of evidence supporting its safe use in pregnant women, allowing physicians to be confident that they are helping to protect their patients. Undertaking clinical trials would be a major expense for vaccine makers with little to no return on investment.<br />
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Finally, let's suppose that a manufacturer did undertake a clinical trial for their flu vaccine in pregnant women. They receive ethical approval. They decide that there is some financial benefit to investing in the trial. Would it alter any of the claims of the anti-vaccine community? Probably not. They would only accept the results if they were negative. Any positive result would very likely be swept under the rug with accusations that "of <i>course</i> it was positive; Big Pharma<sup>TM</sup> needs their money."<br />
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One ironic aspect of all this is that there is some evidence that <a href="http://www.ncbi.nlm.nih.gov/pubmed/23147969" target="_blank">influenza infection during pregnancy <i>might</i> increase risk of autism spectrum disorder</a>. Granted, the evidence is weak at present, and we cannot conclude that there is a causal association. As I mentioned before, there hasn't been a lot of research into the effects of influenza infection, so we don't have a solid grasp on what risks influenza infection poses for pregnant women and their fetuses. It is definitely worth further research, and if this suggestion of a link turns out to be true, then anti-vaccine activists are arguing against something that could help reduce the risk of autism, much as they do for the MMR; congenital rubella syndrome, which results from infection with rubella while pregnant, is one of the known causes of ASDs.<br />
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At the end of the day, the next time you hear someone claim that the flu vaccine has <i>never</i> been tested in pregnant women, you can be sure that they have either been lied to, misunderstand package inserts, or perhaps they are just outright lying. They might try to claim that there have been no clinical trials or randomized, placebo-controlled trials, but that's not true either. Flu vaccines <i>have</i> been studied in pregnant women. Flu vaccines <i>have</i> been found to be safe for pregnant women to receive, and that they even have benefits to the newborn.<br />
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Here is an annotated list of reviews and studies looking at the flu vaccine in pregnant women that you can use to help dispel that myth. I've also included a handful of studies that examined the risks of influenza infection during pregnancy. This list is not exhaustive, by any means, and there continue to be new studies looking at this question.<br />
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<u><b>Reviews</b></u></div>
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Bednarczyk RA, Adjaye-Gbewonyo D, & Omer SB. (2012). <a _blank="" href="http://www.ncbi.nlm.nih.gov/pubmed/22920058" target="_blank">Safety of influenza immunization during pregnancy for the fetus and the neonate</a>. <i>American Journal of Obstetrics and Gynecology, 207</i>(3 Suppl):S38-S46. - Review. "There is a long history of research findings that highlight the safety of vaccinating pregnant women. This review summarizes nearly 40 years of research on influenza vaccination of pregnant women and the lack of association with adverse fetal or neonatal outcomes."<br />
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Fell DB, Platt RW, Lanes A, Wilson K, Kaufman JS, Basso O, & Buckeridge D. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25040307" target="_blank">Fetal death and preterm birth associated with maternal influenza vaccination: systematic review</a>. <i>BJOG, 122</i>(1):
17-26. - Systematic review. "Most studies reported no association
between fetal death or preterm birth and influenza vaccination during
pregnancy. Although several reported risk reductions, results may be
biased by methodological shortcomings of observational studies of
influenza vaccine effectiveness."<br />
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Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, & Cox NJ. (2007). <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5606a1.htm" target="_blank">Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007</a>. <i>MMWR Recomm Rep 2007</i> (56):1–54 - Review. "[O]ne study of approximately 2,000 pregnant women who received TIV during pregnancy demonstrated no adverse fetal effects and no adverse effects during infancy or early childhood (<i>326</i>). A matched case-control study of 252 pregnant women who received TIV within the 6 months before delivery determined no adverse events after vaccination among pregnant women and no difference in pregnancy outcomes compared with 826 pregnant women who were not vaccinated (<i>152</i>). During 2000--2003, an estimated 2 million pregnant women were vaccinated, and only 20 adverse events among women who received TIV were reported to VAERS during this time, including nine injection-site reactions and eight systemic reactions (e.g., fever, headache, and myalgias). In addition, three miscarriages were reported, but these were not known to be causally related to vaccination (<i>327</i>). Similar results have been reported in several smaller studies (<i>151,153,328</i>)."<br />
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Glezen WP & Alpers M. (1999). <a href="http://www.ncbi.nlm.nih.gov/pubmed/10064230" target="_blank">Maternal immunization</a>. <i>Clinical Infectious Diseases, 28</i>(2):219-224. - Review. Mentions the Collaborative Perinatal Project, conducted by the National Institute of Neurological and Communicative Disorders and Stroke. This project followed pregnant women and their offspring until 7 years of age, recording exposures during pregnancy (including influenza and poliovirus immunizations), labor and delivery events, and child malformations, hearing impairment, and learning disabilities. "[I]mmunizing agents as a group gave no evidence of being associated with the principal outcomes of the study."<br />
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Kharbanda EO, Vazquez-Benitez G, Shi WX, Lipkind H, Naleway A, Molitor B, Kuckler L, Olsen A, & Nordin JD. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22920059" target="_blank">Assessing the safety of influenza immunization during pregnancy: the Vaccine Safety Datalink</a>. <i>American Journal of Obstetrics and Gynecology, 207</i>(3 Suppl): S47-S51. - Review. "We describe ongoing analyses of influenza vaccine safety during pregnancy within the Vaccine Safety Datalink that includes the evaluation of acute events, adverse pregnancy and birth outcomes, and congenital anomalies."<br />
Khromava A, Cohen CJ, Mazur M, Kanesa-thasan N, Crucitti A, Seifert H. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22920060" target="_blank">Manufacturers' postmarketing safety surveillance of influenza vaccine exposure in pregnancy</a>. <i>American Journal of Obstetrics and Gynecology, 207</i>(3 Suppl): S52-S56. Review. "This article reviews some of the pregnancy registries that have been established for US-licensed vaccines, which includes influenza vaccines, and other postlicensure safety surveillance efforts for monitoring safety in vaccinated pregnant women."<br />
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Loubet P, Kerneis S, Anselem O, Tsatsaris V, Goffinet F, & Launay O. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25363497" target="_blank">Should expectant mothers be vaccinated against flu? A safety review</a>. <i>Expert Opinion on Drug Safety, 13</i>(12): 1709-1720. - Review. "Available data suggest no evidence of an increased risk for any adverse event for both mothers and fetuses after vaccination against flu during pregnancy."<br />
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Mak TK, Mangtani P, Leese J, Watson JM, & Pfeifer D. (2008). <a href="http://www.ncbi.nlm.nih.gov/pubmed/18156088" target="_blank">Influenza vaccination in pregnancy: current evidence and selected national policies</a>. <i>Lancet Infectious Diseases, 8</i>(1):44-52. - Review. "No serious adverse effects of influenza immunisation in pregnancy have been reported in the few published studies on vaccine safety. There are, however, limited data on safety in the first trimester. Furthermore, the risk from infection and hence the assumed benefit of vaccination in the first trimester are unclear."<br />
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McMillan M, Porritt K, Kralik D, Costi L, & Marshall H. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25758932" target="_blank">Influenza
vaccination during pregnancy: a systematic review of fetal death,
spontaneous abortion, and congenital malformation safety outcomes</a>. <i>Vaccine, 33</i>(18):
2108-2117. - Systematic review. "Results do not indicate that maternal
influenza vaccination is associated with an increased risk of fetal
death, spontaneous abortion, or congenital malformations."<br />
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Michiels B, Govaerts F, Remmen R, Vermeire E, & Coenen S. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21840359" target="_blank">A systematic review of the evidence on the effectiveness and risks of inactivated influenza vaccines in different target groups</a>. <i>Vaccine, 29</i>(49): 9159-9170. - Systematic review. "The vaccination of pregnant women might be beneficial for their newborns."<br />
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Moro PL, Tepper NK, Grohskopf LA, Vellozzi C, & Broder K. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23002972" target="_blank">Safety of seasonal influenza and influenza A (H1N1) 2009 monovalent vaccines in pregnancy</a>. <i>Expert Review of Vaccines, 11</i>(8): 911-921. - Review. "Studies conducted before 2009 did not identify any safety concerns after trivalent inactivated influenza vaccine in mothers or their infants. During the 2009-2010 influenza A (H1N1) influenza vaccination program, several monitoring systems were established or enhanced to assess whether adverse events were associated with H1N1 2009 monovalent vaccines (2009 H1N1 influenza vaccines). Data from these systems did not identify any safety concerns in pregnant women who received 2009 H1N1 influenza vaccines or their infants. Although live attenuated influenza vaccines are not recommended in pregnant women, a small number of studies have not shown any safety concern among pregnant women or their infants who were inadvertently exposed to these vaccines."<br />
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Naleway AL, Irving SA, Henninger ML, Li DK, Shifflett P, Ball S, Williams JL, Cragan J, Gee J, & Thompson MG; Vaccine Safety Datalink and Pregnancy and Influenza Project. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24742490" target="_blank">Safety of influenza vaccination during pregnancy: a review of subsequent maternal obstetric events and findings from two recent cohort studies</a>. <i>Vaccine, 32</i>(6):3122-3127. - Review. "No associations between inactivated influenza vaccination and gestational diabetes, gestational hypertension, preeclampsia/eclampsia, or chorioamnionitis were observed in either cohort. When considered as a whole, these studies should further reassure women and clinicians that influenza vaccination during pregnancy is safe for mothers."<br />
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Ortiz JR, Englund JA, & Neuzil KM. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21550377" target="_blank">Influenza vaccine for pregnant women in resource-constrained countries: a review of the evidence to inform policy decisions</a>. <i>Vaccine, 29</i>(27): 4439-4452. - Review. "The excellent safety profile and reliable immunogenicity of inactivated influenza vaccine support WHO recommendations that pregnant women be vaccinated to decrease complications of influenza disease during pregnancy." Includes table of studies summarizing designs and outcomes of studies in pregnant women and newborns.<br />
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Polyzos KA, Konstantelias AA, Pitsa CE, & Falagas ME. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/26444106" target="_blank">Maternal influenza vaccination and risk for congenital malformations: a systematic review and meta-analysis</a>. <i>Obstetrics and Gynecology, 126</i>(5):
1075-1084. - Systematic review. "This systematic review did not
indicate an increased risk for congenital anomalies after maternal
influenza immunization adding to the evidence base on the safety of
influenza vaccination in pregnancy."<br />
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Tamma PD, Ault KA, del Rio C, Steinhoff MC, Halsey NA, & Omer SB. (2009). <a href="http://www.ncbi.nlm.nih.gov/pubmed/19850275" target="_blank">Safety of influenza vaccination during pregnancy</a>. <i>American Journal of Obstetrics and Gynecology, 201</i>(6): 547-552. - Review. "Inactivated influenza vaccine can be safely and effectively administered during any trimester of pregnancy. No study to date has demonstrated an increased risk of either maternal complications or untoward fetal outcomes associated with inactivated influenza vaccination. In addition, no scientific evidence exists that thimerosal-containing vaccines are a cause of adverse events among children born to women who received influenza vaccine during pregnancy. Immunization of the mother reduces 1 potential source of viral exposure to the infant, and immunization of other family members will decrease other potential sources. Health care workers caring for pregnant females can play a pivotal role in helping to protect women and newborns from this vaccine-preventable disease and should anticipate questions that expecting mothers may have regarding vaccine safety."<br />
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<div style="text-align: center;">
<b><u>Studies</u></b></div>
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Abzug MJ, Nachman SA, Muresan P, Handelsman E, Watts DH, Fenton T, Heckman B, Petzold E, Weinberg A, & Levin MJ; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1086 Protocol Team. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23378284" target="_blank">Safety and immunogenicity of 2009 pH1N1 vaccination in HIV-infected pregnant women</a>. <i>Clinical Infectious Diseases, 56</i>(10): 1488-1497. - Prospective study. "Two 30-mcg doses were moderately immunogenic in HIV-infected pregnant women. No concerning vaccine-related safety signals were observed. Seroprotection persisted in most women postpartum. Efficient transplacental antibody transfer occurred, but seroprotection in infants waned rapidly. Vaccination to protect HIV-infected pregnant women and their newborns from new influenza strains is feasible, but more immunogenic platforms should be evaluated."<br />
<br />
Beau AB, Hurault-Delarue C, Vidal S, Guitard C, Vayssière C, Petiot D, Montastruc JL, Damase-Michel C, & Lacroix I. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24486369" target="_blank">Pandemic A/H1N1 influenza vaccination during pregnancy: a comparative study using the EFEMERIS database</a>. <i>Vaccine, 32</i>(11): 1254-1258. - Prospective cohort study. "There was no significant association between adverse pregnancy outcomes and vaccination with a non-adjuvanted A/H1N1 vaccine during pregnancy."<br />
<br />
Bratton KN, Wardle MT, Orenstein WA, & Omer SB. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25409473" target="_blank">Maternal influenza immunization and birth outcomes of stillbirth and spontaneous abortion: a systematic review and meta-analysis</a>. <i>Clinical Infectious Diseases, 60</i>(5): e11-19. - Systematic review. "Women in the influenza vaccine group had a lower likelihood of stillbirth (relative risk [RR], 0.73; 95% confidence interval [CI], .55–.96); this association was similar when restricted to the H1N1pdm09 vaccine (RR, 0.69; 95% CI, .53–.90). The pooled estimate for spontaneous abortion was not significant (RR, 0.91; 95% CI, .68–1.22). These analyses add to the evidence base for the safety of influenza vaccination in pregnancy."<br />
<br />
Candela S, Pergolizzi S, Ragni P, Cavuto S, Nobilio L, Di Mario S, Dragosevic V, Groth N, & Magrini N; SaFoH1N1 working group. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22766247" target="_blank">An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one</a>. <i>Vaccine, 31</i>(10): 1431-1437. - Prospective surveillance study. "No cases of clinically relevant AEs, SAEs, or AESI were observed within a six-week period of vaccine administration. In accordance with existing clinical and post-marketing safety data, the results of this active surveillance study demonstrate a good safety profile for the MF59-adjuvanted A/H1N1 vaccine, Focetria, within the general population."<br />
<br />
Chambers CD, Johnson D, Xu R, Luo Y, Louik C, Mitchell AA, Schatz M, & Jones KL; OTIS Collaborative Research Group. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24016809" target="_blank">Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants</a>. <i>Vaccine, 31</i>(44): 5026-5032. - Prospective cohort study. "For the 2009-12 influenza seasons combined, we found no meaningful evidence of increased RR or HR for major birth defects, spontaneous abortion, or small for gestational age infants. There was some evidence of an increased HR for preterm delivery following pH1N1-influenza vaccine exposure; however the decrease in gestational age on average was approximately three days."<br />
<br />
Chambers CD, Johnson DL, Xu R, Luo YJ, Louik C, Mitchell AA, Schatz M, & Jones KL; OTIS Collaborative Research Group. (2016). <a href="http://www.ncbi.nlm.nih.gov/pubmed/27449682" target="_blank">Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS</a>. <i>Vaccine, 34</i>(37): 4443-4449- Prospective cohort study. "Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine."<br />
<br />
Chavant F, Ingrand I, Jonville-Bera AP, Plazanet C, Gras-Champel V, Lagarce L, Zenut M, Disson-Dautriche A, Logerot S, Auffret M, Coubret-Dumas A, Bruel ML, Boyer M, Bos-Thompson MA, Veyrac G, Carlier P, Beyens MN, Lates S, Damase-Michel C, Castot A, Kreft-Jaïs C, & Pérault-Pochat MC. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23516007" target="_blank">The PREGVAXGRIP study: a cohort study to assess foetal and neonatal consequences of in utero exposure to vaccination against A(H1N1)v2009 influenza</a>. <i>Drug Safety, 36</i>(6): 455-465. - Prospective cohort study. "This study suggests that exposure to the A(H1N1)v2009 pandemic influenza vaccine during pregnancy does not increase the risk of adverse pregnancy outcomes. However, because of the relatively small number of women exposed during the first trimester, other studies are needed to exclude an increased risk of malformation."<br />
<br />
Choe YJ, Cho H, Song KM, Kim JH, Han OP, Kwon YH, Bae GR, Lee HJ, & Lee JK. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21788704" target="_blank">Active surveillance of adverse events following immunization against pandemic influenza A (H1N1) in Korea</a>. <i>Japanese Journal of Infectious Diseases, 64</i>(4): 297-303. - Survey. "The non-adjuvanted vaccine was found to be safe for pregnant women, as suggested by other studies (25,26)."<br />
<br />
Cleary BJ, Rice Ú, Eogan M, Metwally N, & McAuliffe F. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24793932" target="_blank">2009 A/H1N1 influenza vaccination in pregnancy: uptake and pregnancy outcomes - a historical cohort study</a>. <i>European Journal of Obstetrics, Gynecology, and Reproductive Biology, 178</i>: 163-168. - Retrospective cohort study. "There was no association between vaccination during pregnancy and adverse pregnancy outcomes. Women who were vaccinated were less likely to have a preterm delivery than unvaccinated women."<br />
<br />
Conlin AM, Bukowinski AT, Sevick CJ, DeScisciolo C, & Crum-Cianflone NF. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23635612" target="_blank">Safety of the pandemic H1N1 influenza vaccine among pregnant U.S. military women and their newborns</a>. <i>Obstetrics and Gynecology, 121</i>(3): 511-518. - Retrospective cohort study. "No adverse pregnancy or newborn health outcomes associated with pandemic H1N1 vaccination during pregnancy were noted among our cohort. These findings should be used to encourage increased vaccine coverage among pregnant women."<br />
<br />
Deinard AS & Ogburn P Jr. (1981). <a href="http://www.ncbi.nlm.nih.gov/pubmed/7246624" target="_blank">A/NJ/8/76 influenza vaccination program: effects on maternal health and pregnancy outcome</a>. <i>American Journal of Obstetrics and Gynecology, 140</i>(3): 240-245. - Prospective case-control study. "This longitudinal, prospective study demonstrated no association between
immunization with InfA/NJ and maternal, perinatal, or infant
complications. No teratogenicity was demonstrated, and the two groups of
infants did not differ in physical or neurological assessments at birth
and at 8 weeks of life."<br />
<br />
de Vries L, van Hunsel F, Cuppers-Maarschalkerweerd B, van Puijenbroek E, & van Grootheest K. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24706475" target="_blank">Adjuvanted A/H1N1 (2009) influenza vaccination during pregnancy: description of a prospective cohort and spontaneously reported pregnancy-related adverse reactions in the Netherlands</a>. <i>Birth Defects Research. Part A, Clinical and Molecular Teratology, 100</i>(10):731-738. - Prospective cohort study. "Compared with the background rate, no increased risk of spontaneous abortions or congenital malformations was observed. There were three spontaneous abortions among 23 first trimester exposures. In the cohort of 281 pregnancies with known outcomes, three major malformations were observed after exposure at any time during pregnancy. In these cases exposure occurred once periconceptional, and twice in the second trimester. Furthermore, no increased risk of adverse pregnancy outcomes or neonatal problems were observed. The spontaneously reported pregnancy-related adverse events showed no unexpected pattern."<br />
<br />
Dodds L, Macdonald N, Scott J, Spencer A, Allen VM, & McNeil S. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22947404" target="_blank">The association between influenza vaccine in pregnancy and adverse neonatal outcomes</a>. <i>Journal of Obstetrics and Gynaecology Canada, 34</i>(8): 714-720. - Prospective cohort study. "The results of our study showed consistent improvement after maternal influenza vaccination (or a trend towards improvement) in newborn outcomes for all five outcomes analyzed. Newborns whose mother had received the influenza vaccine during pregnancy had significantly lower rates of low birth weight and SGA."<br />
<br />
Fabiani M, Bella A, Rota MC, Clagnan E, Gallo T, D'Amato M, Pezzotti P, Ferrara L, Demicheli V, Martinelli D, Prato R, & Rizzo C. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25820060" target="_blank">A/H1N1 pandemic influenza vaccination: a retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy</a>. <i>Vaccine, 33</i>(19): 2240-2247. - Retrospective cohort study. "We did not observe any statistically significant association between the A/H1N1 pandemic influenza vaccination and different maternal outcomes (hospital admissions for influenza, pneumonia, hypertension, eclampsia, diabetes, thyroid disease, and anaemia), fetal outcomes (fetal death after the 22nd gestational week) and neonatal outcomes (pre-term birth, low birth weight, low 5-min Apgar score, and congenital malformations)."<br />
<br />
Fell DB, Sprague AE, Liu N, Yasseen AS 3rd, Wen SW, Smith G, & Walker MC; Better Outcomes Registry & Network (BORN) Ontario. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22515877" target="_blank">H1N1 influenza vaccination during pregnancy and fetal and neonatal outcomes</a>. <i>American Journal of Public Health, 102</i>(6): e33-40. - Cohort study. "Our results suggest that second- or third-trimester H1N1 vaccination was associated with improved fetal and neonatal outcomes during the recent pandemic. Our findings need to be confirmed in future studies with designs that can better overcome concerns regarding biased estimates of vaccine efficacy."<br />
Fisher BM, Van Bockern J, Hart J, Lynch AM, Winn VD, Gibbs RS, & Weinberg A. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22457731" target="_blank">Pandemic influenza A H1N1 2009 infection versus vaccination: a cohort study comparing immune responses in pregnancy</a>. <i>PLoS One, 7</i>(3):e33048. - Cohort study. "Vaccination against pH1N1 confers a similar HAI antibody response as compared to pH1N1 infection during pregnancy, both in quantity and quality. Illness or vaccination during pregnancy confers passive immunity to the newborn."<br />
<br />
Heikkinen T, Young J, van Beek E, Franke H, Verstraeten T, Weil JG, & Della Cioppa G. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22939717" target="_blank">Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study</a>. <i>American Journal of Obstetrics and Gynecology, 207</i>(3): 177.e1-8. - Cohort study. "No maternal deaths or abortions occurred among the vaccinated women. No differences between the vaccinated and unvaccinated cohorts were observed for gestational diabetes, preeclampsia, stillbirth, low birthweight, neonatal deaths, or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard, 0.69; 95% confidence interval, 0.51-0.92). No differences were observed in rates of congenital malformations after vaccination in the first (2.1%), second (2.7%), or third (2.1%) trimesters."<br />
<br />
Heinonen OP, Shapiro S, Monson RR, Hartz SC, Rosenberg L, & Slone D. (1973). <a href="http://www.ncbi.nlm.nih.gov/pubmed/4359832" target="_blank">Immunization during pregnancy against poliomyelitis and influenza in relation to childhood malignancy</a>. <i>International Journal of Epidemiology, 2</i>(3):
229-235. - Case-control study. Part of the Collaborative Perinatal
Project. Included 2,291 women who were immunized with influenza
vaccine while pregnant. "There was no evidence of an excess of
malignancies in children exposed <i>in utero</i> to attenuated live polio vaccine, to influenza vaccine, or to spontaneous viral infections." <br />
<br />
Horiya M, Hisano M, Iwasaki Y, Hanaoka M, Watanabe N, Ito Y, Kojima J, Sago H, Murashima A, Kato T, & Yamaguchi K. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21934453" target="_blank">Efficacy of double vaccination with the 2009 pandemic influenza A (H1N1) vaccine during pregnancy</a>. <i>Obstetrics and Gynecology, 118</i>(4): 887-894. - Cohort study. "The overall incidence of adverse reactions was low, less than 10% for all adverse reactions except for redness, because the vaccine is a split vaccine containing no adjuvant. In participants who received double 2009 H1N1 vaccination during pregnancy, adverse reactions were not markedly augmented or attenuated by the second vaccination. Moreover, early delivery or abortion, malformation, and birth weight were not significantly affected. Nonetheless, the sample size was insufficient to fully evaluate the safety of the vaccine; additional information from larger studies is needed to determine this."<br />
<br />
Huang WT, Chen WC, Teng HJ, Huang WI, Huang YW, Hsu CW, & Chuang JH. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21850250" target="_blank">Adverse events following pandemic A (H1N1) 2009 monovalent vaccines in pregnant women--Taiwan, November 2009-August 2010</a>. <i>PLoS One, 6</i>(8): e.23049. - Surveillance study. "The passive surveillance provided rapid initial assessment of adverse events after 2009 H1N1 vaccination among pregnant women. Its findings were reassuring for the safety of 2009 H1N1 vaccines in pregnancy."<br />
<br />
Irving SA, Kieke BA, Donahue JG, Mascola MA, Baggs J, DeStefano F, Cheetham TC, Jackson LA, Naleway AL, Glanz JM, Nordin JD, & Belongia EA; Vaccine Safety Datalink. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23262941" target="_blank">Trivalent inactivated influenza vaccine and spontaneous abortion</a>. <i>Obstetrics and Gynecology, 121</i>(1): 159-165. - Case-control study. "There was no statistically significant increase in the risk of pregnancy loss in the 4 weeks after seasonal inactivated influenza vaccination."<br />
<br />
Jackson LA, Patel SM, Swamy GK, Frey SE, Creech CB, Munoz FM, Artal R, Keitel WA, Noah DL, Petrie CR, Wolff M, & Edwards KM. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21849282" target="_blank">Immunogenicity of an inactivated monovalent 2009 H1N1 influenza vaccine in pregnant women</a>. <i>The Journal of Infectious Diseases, 204</i>(6): 854-863. - Prospective clinical trial. "Eighteen SAEs were reported for 15 women, and 24 SAEs were reported for 20 infants; all were considered to be unrelated to the vaccine, and the frequency of events was generally balanced across study groups, with 9 of the 15 maternal SAEs and 13 of the 20 infant SAEs reported in the 25-mcg dose group."<br />
<br />
Källén B & Olausson PO. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22901103" target="_blank">Vaccination against H1N1 influenza with Pandemrix(®) during pregnancy and delivery outcome: a Swedish register study</a>. <i>BJOG, 119</i>(13): 1583-1590. - Cohort study. "A total of 18 612 vaccinated women having 18 844 infants were studied. The risk for stillbirth, preterm birth and low birthweight was lower than in the comparison groups whereas the risk for small for gestational age and a congenital malformation (after vaccination during the first trimester) did not differ from the comparison groups."<br />
<br />
Kharbanda EO, Vazquez-Benitez G, Lipkind H, Naleway A, Lee G, & Nordin JD; Vaccine Safety Datalink Team. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23921876" target="_blank">Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events</a>. <i>Obstetrics and Gynecology, 122</i>(3): 659-667. - Cohort study. "Our cohort included 74,292 vaccinated females matched on age, site, and pregnancy start date with 144,597 unvaccinated females. We did not observe increased risks within 42 days of vaccination for hyperemesis, chronic hypertension, gestational hypertension, gestational diabetes, proteinuria, or urinary tract infection. Using a risk window from vaccination through pregnancy end, we did not observe increased risks after vaccination for proteinuria, urinary tract infection, gestational hypertension, preeclampsia or eclampsia, chorioamnionitis, puerperal infection, venous complications, pulmonary embolism, or peripartum cardiomyopathy."<br />
<br />
Launay O, Krivine A, Charlier C, Truster V, Tsatsaris V, Lepercq J, Ville Y, Avenell C, Andrieu T, Rozenberg F, Artiguebielle F, Tréluyer JM, & Goffinet F; Inserm COFLUPREG Study Group. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23300637" target="_blank">Low rate of pandemic A/H1N1 2009 influenza infection and lack of severe complication of vaccination in pregnant women: a prospective cohort study</a>. <i>PLoS One, 7</i>(12): e52303. - Prospective cohort study. "Despite low vaccine coverage, incidence of pandemic flu was low in this cohort of pregnant women.No effect on pregnancy and delivery outcomes was evidenced after vaccination."<br />
<br />
Lim SH, Lee JH, Kim BC, Jung SU, Park YB, & Lee CS. (2010). <a href="http://www.ncbi.nlm.nih.gov/pubmed/20832495" target="_blank">Adverse reaction of influenza A (H1N1) 2009 virus vaccination in pregnant women and its effect on newborns</a>. <i>Vaccine, 28</i>(47): 7455-7456. - Survey. "This study was focused on the safety of pregnant women who were vaccinated for pandemic (H1N1) 2009 virus, since very little such studies have been done to the best of our knowledge. In our study, various adverse reactions developed after vaccination, but the symptoms were mild and resolved within several days without requiring any treatment or hospitalization."<br />
<br />
Lin TH, Lin SY, Lin CH, Lin RI, Lin HC, Chiu TH, Cheng PJ, & Lee CN. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22342546" target="_blank">AdimFlu-S(®) influenza A (H1N1) vaccine during pregnancy: the Taiwanese Pharmacovigilance Survey</a>. <i>Vaccine, 30</i>(16): 2671-2675. - Retrospective cohort study. "During the observation period of each cohort, four subjects (2.0%) in the exposed group experienced vaccine-related adverse events that were mild in severity. A total of 17 women (8.6%) in the vaccine exposed group and 40 women (20.2%) in the unexposed group underwent at least one adverse effect during their pregnancy. A total of 72 infants (35.6%) in the exposed group and 101 infants (49%) in the unexposed group had at least one adverse event within 8 weeks after they were born (p < 0.05). The adverse events experienced by the women and their infants were not increased when the vaccine was administered during the first trimester. There were no significant differences between these two groups with regard to preterm delivery rate and stillbirth rate."<br />
<br />
Louik C, Ahrens K, Kerr S, Pyo J, Chambers C, Jones KL, Schatz M, & Mitchell AA. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24016804" target="_blank">Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: exposure prevalence, preterm delivery, and specific birth defects</a>. <i>Vaccine, 31</i>(44): 5033-5040. - Prospective cohort study. "Among women exposed to pH1N1 vaccine, we found a decreased risk for PTD in the 2010-2011 season; risk was increased in 2009-2010, particularly following exposure in the first trimester, though the decrease in gestational length was less than 2 days. For specific major defects, we found no meaningful evidence of increased risk for specific congenital malformations following pH1N1 influenza vaccinations in the 2009-2010 and 2010-2011 seasons."<br />
<br />
Louik C, Kerr S, Van Bennekom CM, Chambers C, Jones KL, Schatz M, & Mitchell AA. (2016). <a href="http://www.ncbi.nlm.nih.gov/pubmed/27452865" target="_blank">Safety of the 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Preterm delivery and specific malformations, a study from the case-control arm of VAMPSS</a>. <i>Vaccine, 34</i>(37): 4450-4459. - Prospective case-control study. "For PTD (1803 fullterm deliveries, 107 PTD for all seasons combined), an elevated adjusted risk was observed for only the 2nd trimester of the 2011-12 season (HR=2.60, 95% CI 1.21, 5.61) - a reduction in gestational length of < 2 days. For the 42 specific defects or categories of defects (2866 cases, 1411 controls for all seasons combined) most adjusted risks were close to 1.0; the highest was 2.38 for omphalocele and the lowest was 0.50 for atrioventricular canal defects. None had lower confidence bounds >1.0. For each season separately, only one elevated OR had a lower 95% CI >1.0: omphalocele in 2011-12 (OR=5.19, 95% CI 1.44, 18.7)."<br />
<br />
Ludvigsson JF, Ström P, Lundholm C, Cnattingius S, Ekbom A, Örtqvist Å, Feltelius N, Granath F, & Stephansson O. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/26572546" target="_blank">Maternal vaccination against H1N1 influenza and offspring mortality: population based cohort study and sibling design</a>. <i>BMJ, 351</i>: h5585. - Prospective, population-based cohort study. "H1N1 vaccination during pregnancy is not associated with adverse fetal outcome or offspring mortality, including when familial factors are taken into account."<br />
<br />
Ludvigsson JF, Zugna D, Cnattingius S, Richiardi L, Ekbom A, Örtqvist Å, Persson I, & Stephansson O. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23715672" target="_blank">Influenza H1N1 vaccination and adverse pregnancy outcome</a>. <i>European Journal of Epidemiology, 28</i>(7): 579-588. - Retrospective cohort study. "H1N1 vaccination during pregnancy, using an AS03-adjuvanted vaccine, does not appear to adversely influence offspring risks of LBW, preterm birth, SGA, or low Apgar score. Our results suggest that this vaccine is safe for the offspring when used in different stages of pregnancy."<br />
<br />
Ma F, Zhang L, Jiang R, Zhang J, Wang H, Gao X, Li X, & Liu Y. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24990911" target="_blank">Prospective cohort study of the safety of an influenza A(H1N1) vaccine in pregnant Chinese women</a>. <i>Clinical and Vaccine Immunology, 21</i>(9): 1282-1287. - Prospective cohort study. "From these results, we conclude that the influenza A(H1N1) vaccine is safe for pregnant women and has no observed adverse effects on fetal growth."<br />
<br />
Madhi SA, Cutland CL, Kuwanda L, Winberg A, Hugo A, Jones S, Adrian PV, van Niekerk N, Treurnicht F, Ortiz JR, Venter M, Violari A, Neuzil KM, Simões EA, Klugman KP, Nunes MC, & Maternal Flu Trial (Matflu) Team. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25184864" target="_blank">Influenza vaccination of pregnant women and protection of their infants</a>. <i>The New England Journal of Medicine, 371</i>(10): 918-931. - Randomized, saline-placebo-controlled trial. "Injection-site reactions (mainly mild to moderate) were more frequent among IIV3 recipients than among placebo recipients in both cohorts, but there were no other significant differences in solicited reactions between the two study groups in either cohort. Data on serious adverse events in both cohorts, including infant and maternal deaths and hospitalizations, are shown in Tables S11 to S23 in the <a href="http://www.nejm.org/doi/suppl/10.1056/NEJMoa1401480/suppl_file/nejmoa1401480_appendix.pdf" target="_blank">Supplementary Appendix</a>. There were no significant between-group differences with regard to rates of miscarriage, stillbirth, or premature birth or birth weight in the HIV-uninfected cohort (<a href="http://www.nejm.org/action/showImage?doi=10.1056%2FNEJMoa1401480&iid=t01" target="_blank">Table 1</a>, and Table S11 in the <a href="http://www.nejm.org/doi/suppl/10.1056/NEJMoa1401480/suppl_file/nejmoa1401480_appendix.pdf" target="_blank">Supplementary Appendix</a>) and in the HIV-infected cohort (<a href="http://www.nejm.org/action/showImage?doi=10.1056%2FNEJMoa1401480&iid=t02" target="_blank">Table 2</a>)." Also notes protection against influenza of mothers <i>and</i> their infants versus placebo controls.<br />
<br />
Moro PL, Broder K, Zheteyeva Y, Revzina N, Tepper N, Kissin D, Barash F, Arana J, Brantley MD, Ding H, Singleton JA, Walton K, Haber P, Lewis P, Yue X, Destefano F, & Vellozzi C. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21861964" target="_blank">Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System</a>. <i>American Journal of Obstetrics and Gynecology, 205</i>(5): 473.e1-9. - Surveillance study. "Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes."<br />
Moro PL, Broder K, Zheteyeva Y, Walton K, Rohan P, Sutherland A, Guh A, Haber P, Destefano F, & Vellozzi C. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/20965490" target="_blank">Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009</a>. <i>American Journal of Obstetrics and Gynecology, 204</i>(2): 146.e1-7. - Surveillance study. "No unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of TIV or LAIV."<br />
<br />
Moro PL, Museru OI, Broder K, Cragan J, Zheteyeva Y, Tepper N, Revzina N, Lewis P, Arana J, Barash F, Kissin D, & Vellozzi C. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24201689" target="_blank">Safety of influenza A (H1N1) 2009 live attenuated monovalent vaccine in pregnant women</a>. <i>Obstetrics and Gynecology, 122</i>(6):1271-1278. - Retrospective surveillance study. "Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified."<br />
<br />
Munoz FM, Greisinger AJ, Wehmanen OA, Mouzoon ME, Hoyle JC, Smith FA, & Glezen WP. (2005). <a href="http://www.ncbi.nlm.nih.gov/pubmed/15846187" target="_blank">Safety of influenza vaccination during pregnancy</a>. <i>American Journal of Obstetrics and Gynecology, 192</i>(4):1098-1106. - Cohort study. "Among 7183 eligible mother-infant pairs, only 252 pregnant women (3.5%) received the influenza vaccine...No serious adverse events occurred within 42 days of vaccination, and there was no difference between the groups in the outcomes of pregnancy (including cesarean delivery and premature delivery) and infant medical conditions from birth to 6 months of age. CONCLUSION: Influenza vaccine that was administered in the second or third trimester of gestation was safe in this study population."<br />
<br />
Nordin JD, Kharbanda EO, Benitez GV, Nichol K, Lipkind H, Naleway A, Lee GM, Hambidge S, Shi W, & Olsen A. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23635613" target="_blank">Maternal safety of trivalent inactivated influenza vaccine in pregnant women</a>. <i>Obstetrics and Gynecology, 121</i>(3): 519-525. - Retrospective cohort study. "Receipt of trivalent inactivated influenza vaccine during pregnancy was not associated with increased risk of adverse events in the 42 days after vaccination, supporting its safety for the mother."<br />
<br />
Nordin JD, Kharbanda EO, Vazquez-Benitez G, Lipkind H, Lee GM, & Naleway AL. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25045808" target="_blank">Monovalent H1N1 influenza vaccine safety in pregnant women, risks for acute adverse events</a>. <i>Vaccine, 32</i>(39): 4985-4992. - Cohort study. "In this large cohort of pregnant women no acute safety signals were identified within 6 weeks of receipt of MIV."<br />
<br />
Nordin JD, Kharbanda EO, Vazquez Benitez G, Lipkind H, Vellozzi C, & Destefano F; Vaccine Safety Datalink. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24582484" target="_blank">Maternal influenza vaccine and risks for preterm or small for gestational age birth</a>. <i>Journal of Pediatrics, 164</i>(5): 1051-1057. - Retrospective cohort study. "Receipt of trivalent inactivated influenza vaccine during pregnancy was not associated with increased or decreased risk of preterm or SGA birth. These findings support the safety of vaccinating pregnant women against influenza during the first, second, and third trimesters, and suggest that a nonspecific protective effect of the influenza vaccine for these outcomes does not exist."<br />
<br />
Ohfuji S, Fukushima W, Deguchi M, Kawabata K, Yoshida H, Hatayama H, Maeda A, & Hirota Y. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21459817" target="_blank">Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine among pregnant women: lowered antibody response by prior seasonal vaccination</a>. <i>The Journal of Infectious Diseases, 203</i>(9): 1301-1308. - Prospective cohort study. "No severe adverse events occurred among pregnant women and their fetuses throughout the study period. One fetal death was reported on the day after vaccination; however, a pathologic diagnosis indicated that the fetal death had occurred >=7 days before the H1N1 vaccination. Therefore, the fetal death was unrelated to the vaccination. Previous studies about the reactogenicity of seasonal influenza vaccine also reported no severe adverse events among fetuses and infants"<br />
<br />
Omer SB, Goodman D, Steinhoff MC, Rochat R, Klugman KP, Stoll BJ, & Ramakrishnan U. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21655318" target="_blank">Maternal influenza immunization and reduced likelihood of prematurity and small for gestational age births: a retrospective cohort study</a>. <i>PLoS Medicine, 8</i>(5): e.1000441. - Retrospective cohort study. "This study demonstrates an association between immunization with the inactivated influenza vaccine during pregnancy and reduced likelihood of prematurity during local, regional, and widespread influenza activity periods. However, no associations were found for the pre-influenza activity period. Moreover, during the period of widespread influenza activity there was an association between maternal receipt of influenza vaccine and reduced likelihood of SGA birth."<br />
<br />
Omon E, Damase-Michel C, Hurault-Delarue C, Lacroix I, Montastruc JL, Oustric S, & Escourrou B. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22036887" target="_blank">Non-adjuvanted 2009 influenza A (H1N1)v vaccine in pregnant women: the results of a French prospective descriptive study</a>. <i>Vaccine, 29</i>(52): 9649-9654. - Prospective cohort study. "569 pregnant women were monitored until delivery. Compared with the general population, the risks of maternal conditions, malformations and neonatal conditions were not statistically different."<br />
<br />
Oppermann M, Fritzsche J, Weber-Schoendorfer C, Keller-Stanislawski B, Allignol A, Meister R, & Schaefer C. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22564554" target="_blank">A(H1N1)v2009: a controlled observational prospective cohort study on vaccine safety in pregnancy</a>. <i>Vaccine, 30</i>(30): 4445-4452. - Prospective cohort study. "Pregnancy outcome of 323 women immunized with adjuvanted or non-adjuvanted A(H1N1)v2009 influenza vaccines from 2009-09-28 to 2010-03-31 were compared to 1329 control subjects. The risk for spontaneous abortions (HR 0.89; 95% CI 0.36-2.19) and the rate of major malformations (all trimesters: OR 0.87; 95% CI 0.38-1.77; preconception and first trimester exposure: OR 0.79; 95% CI 0.13-2.64) did not vary between the two cohorts. Furthermore, there was no increase in preeclampsia, prematurity, and intrauterine growth retardation in the vaccinated cohort."<br />
<br />
Pasternak B, Svanström H, Mølgaard-Nielsen D, Krause TG, Emborg HD, Melbye M, & Hviid A. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22782418" target="_blank">Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy</a>. <i>JAMA, 308</i>(2): 165-174. - Cohort study. "In this Danish cohort, exposure to an adjuvanted influenza A(H1N1)pdm09 vaccine during pregnancy was not associated with a significantly increased risk of major birth defects, preterm birth, or fetal growth restriction."<br />
<br />
Pasternak B, Svanström H, Mølgaard-Nielsen D, Krause TG, Emborg HD, Melbye M, Hviid A. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22551713" target="_blank">Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark</a>. <i>BMJ, 344</i>:e2794. - Cohort study. "This large cohort study found no evidence of an increased risk of fetal death associated with exposure to an adjuvanted pandemic A/H1N1 2009 influenza vaccine during pregnancy."<br />
<br />
Poehling KA, Szilagyi PG, Staat MA, Snively BM, Payne DC, Bridges CB, Chu SY, Light LS, Prill MM, Finelli L, Griffin MR, & Edwards KM; New Vaccine Surveillance Network. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21492825" target="_blank">Impact of maternal immunization on influenza hospitalizations in infants</a>. <i>American Journal of Obstetrics and Gynecology, 204</i>(6 Suppl 1): S141-148. - Case control study. "Our results indicate that hospitalized infants whose mothers received influenza vaccine during pregnancy were 45% to 48% less likely to have laboratory-confirmed influenza during their first influenza season compared with infants of unvaccinated mothers. Adding history of influenza-like illness during pregnancy to the analyses had little impact on the odds ratio for having an influenza-positive, hospitalized infant. Given that infants < 6 months of age have the highest hospitalization rate among all children2–6 and that the vaccine is not licensed for that age group,16 these data support that infants born to vaccinated mothers benefit from the transfer of maternally derived antibodies."<br />
<br />
Regan AK, de Klerk N, Moore HC, Omer SB, Shellam G, & Effler PV. (2016). <a href="http://www.ncbi.nlm.nih.gov/pubmed/27314823" target="_blank">Effect of maternal influenza vaccination on hospitalization for respiratory infections in newborns: a retrospective cohort study</a>. <i>The Pediatric Infectious Disease Journal</i>. Epub ahead of print. - Retrospective cohort study. "3,169 infants were maternally vaccinated and 27,859 were unvaccinated; 732 hospitalizations were identified, 528 (69%) of which were for bronchiolitis. There were 21.9 hospitalizations per 100,000 person days among maternally vaccinated infants, and 30.2 hospitalizations per 100,000 person days among unvaccinated infants. Maternally vaccinated infants were 25% less likely to be hospitalized for an acute respiratory illness during influenza season compared with unvaccinated infants (aHR: 0.75, 95% CI: 0.56-0.99, p=0.04). Vaccinations administered in the third trimester were associated with a 33% reduction in the risk of newborn hospitalization (aHR: 0.67, 95% CI: 0.47-0.95, p=0.03). No such reduction was identified for vaccinations administered earlier in pregnancy."<br />
Regan AK, Moore HC, de Klerk N, Omer SB, Shellam G, Mak DB, & Effler PV. (2016). <a href="http://www.ncbi.nlm.nih.gov/pubmed/27033634" target="_blank">Seasonal trivalent influenza vaccination during pregnancy and the incidence of stillbirth: population-based retrospective cohort study</a>. <i>Clinical Infectious Diseases, 62</i>(10): 1221-1227. - Retrospective cohort study. "Mothers who received seasonal TIV during pregnancy were significantly less likely to experience stillbirth compared with unvaccinated mothers. These results support the safety of seasonal influenza immunization during pregnancy and suggest a protective effect."<br />
<br />
Regan AK, Tracey L, Blyth CC, Mak DB, Richmond PC, Shellam G, Talbot C, & Effler PV. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25880741" target="_blank">A prospective cohort study comparing the reactogenicity of trivalent influenza vaccine in pregnant and non-pregnant women</a>. <i>BMC Pregnancy and Childbirth, 15</i>: 61. - Prospective cohort study. "No other significant differences in reported symptoms were observed. No serious vaccine-associated adverse events were reported, and less than 2% of each group sought medical advice for a reaction. CONCLUSIONS: We found no evidence suggesting pregnant women are more likely to report adverse events following influenza vaccination when compared to non-pregnant female HCWs of similar age, and in some cases, pregnant women reported significantly fewer adverse events. These results further support the safety of TIV administered in pregnant women."<br />
<br />
Richards JL, Hansen C, Bredfeldt C, Bednarczyk RA, Steinhoff MC, Adjaye-Gbewonyo D, Ault K, Gallagher M, Orenstein W, Davis RL, & Omer SB. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23378281" target="_blank">Neonatal outcomes after antenatal influenza immunization during the 2009 H1N1 influenza pandemic: impact on preterm birth, birth weight, and small for gestational age birth</a>. <i>Clinical Infectious Diseases, 56</i>(9): 1216-1222. - Retrospective cohort study. "Pregnant women who received H1N1 influenza vaccine were less likely to give birth preterm, and gave birth to heavier infants. The findings support US vaccine policy choices to prioritize pregnant women during the 2009 influenza A (H1N1) pandemic."<br />
<br />
Ropero-Álvarez AM, Whittembury A, Bravo-Alcántara P, Kurtis HJ, Danovaro-Holliday MC, & Velandia-González M. (2015). <a href="http://www.sciencedirect.com/science/article/pii/S0264410X14014601" target="_blank">Events supposedly attributable to vaccination or immunization during pandemic influenza A (H1N1) vaccination campaigns in Latin America and the Caribbean</a>. <i>Vaccine, 33</i>(1): 187-192. - "The rate of serious ESAVI reported in LAC (6.91 per million doses) was significantly lower than the rate reported in Europe (38.2 per million doses) and slightly lower than in the United States (8.8 per million doses) and China (7.9 per million doses), where ESAVI notification was also through passive surveillance systems [19], [20] and [21]."<br />
<br />
Rubinstein F, Micone P, Bonotti A, Wainer V, Schwarcz A, Augustovski F, Pichon Riviere A, & Karolinski A; EVA Study Research Group Estudio Embarazo y Vacuna Antigripal. (2013). <a href="http://www.ncbi.nlm.nih.gov/pubmed/23381200" target="_blank">Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicentre study</a>. <i>BMJ, 346</i>:f393. - Prospective cohort study. "This study showed that adjuvanted MF59 H1N1 vaccination during pregnancy did not result in an increased risk of adverse maternal or perinatal events in a large sample of women. In fact, vaccination was associated with a lower risk of events, both in the overall study population and in the different subgroups in the sensitivity analysis."<br />
<br />
Sheffield JS, Greer LG, Rogers VL, Roberts SW, Lytle H, McIntire DD, & Wendel GD Jr. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22914461" target="_blank">Effect of influenza vaccination in the first trimester of pregnancy</a>. <i>Obstetrics and Gynecology, 120</i>(3): 532-537. - Retrospective cohort study. "Neonates born to mothers receiving the vaccine in any trimester did not have an increase in major malformations regardless of trimester of vaccination (2% regardless of vaccination group, P=.9). Stillbirth (0.3% compared with 0.6%, P=.006), neonatal death (0.2% compared with 0.4%, P=.01), and premature delivery (5% compared with 6%, P=.004) were significantly decreased in the vaccinated group."<br />
<br />
Steinhoff MC, Omer SB, Roy E, El Arifeen S, Raqib R, Dodd C, Breiman RF, & Zaman K. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/22353593" target="_blank">Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial</a>. <i>CMAJ, 184</i>(6): 645-653. - Randomized, controlled trial. "During the period with circulating influenza virus, maternal immunization during pregnancy was associated with a lower proportion of infants who were small for gestational age and an increase in mean birth weight. These data need confirmation but suggest that prevention of influenza infection in pregnancy can influence intrauterine growth."<br />
<br />
Sumaya CV & Gibbs RS. (1979). <a href="http://www.ncbi.nlm.nih.gov/pubmed/479636" target="_blank">Immunization of pregnant women with influenza A/New Jersey/76 virus vaccine: reactogenicity and immunogenicity in mother and infant</a>. <i>Journal of Infectious Diseases, 140</i>(2): 141-146. - "In this study, 56 women received inactivated influenza A/New Jersey/76 virus vaccine during the second and third trimesters of pregnancy. No significant immediate reactions or increased fetal complications were associated with administration of the vaccine."<br />
<br />
Tavares F, Nazareth I, Monegal JS, Kolte I, Verstraeten T, & Bauchau V. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21596080" target="_blank">Pregnancy and safety outcomes in women vaccinated with an AS03-adjuvanted split virion H1N1 (2009) pandemic influenza vaccine during pregnancy: a prospective cohort study</a>. <i>Vaccine, 29</i>(37): 6358-6365. - Prospective cohort study. "The adverse events reported were consistent with the events anticipated to be reported by this study population. No adverse events of special interest were reported. The results of this analysis suggest that exposure to the AS03 adjuvanted H1N1 (2009) vaccine during pregnancy does not increase the risk of adverse pregnancy outcomes including spontaneous abortion, congenital anomalies, preterm delivery, low birth weight neonates, or maternal complications. Although limited in size, the fully prospective nature of the safety follow-up of these women vaccinated during pregnancy is unique and offers an important degree of reassurance for the use of the AS03 adjuvanted H1N1 (2009) vaccine in this high risk group for H1N1 infection."<br />
<br />
Thompson MG, Li DK, Shifflett P, Sokolow LZ, Ferber JR, Kurosky S, Bozeman S, Reynolds SB, Odouli R, Henninger ML, Kauffman TL, Avalos LA, Ball S, Williams JL, Irving SA, Shay DK, & Naleway AL; Pregnancy and Influenza Project Workgroup. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24280090" target="_blank">Effectiveness of seasonal trivalent influenza vaccine for preventing influenza virus illness among pregnant women: a population-based case-control study during the 2010-2011 and 2011-2012 influenza seasons</a>. <i>Clinical Infectious Diseases, 58</i>(4):449-457. - Case-control study. "Influenza vaccination reduced the risk of ARI associated with laboratory-confirmed influenza among pregnant women by about one-half, similar to VE observed among all adults during these seasons."<br />
<br />
Toback SL, Beigi R, Tennis P, Sifakis F, Calingaert B, & Ambrose CS. (2012). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21672166%3Cbr%3E" target="_blank">Maternal outcomes among pregnant women receiving live attenuated influenza vaccine</a>. <i>Influenza and Other Respiratory Viruses, 6</i>(1): 44-51. - Cohort study. "In this cohort, there was no evidence of significant maternal adverse outcomes after receipt of LAIV. These data may offer some reassurance to providers and pregnant women in the event of inadvertent LAIV administration, but do not support the routine use of LAIV in pregnant women."<br />
<br />
Trotta F, Da Cas R, Spila Alegiani S, Gramegna M, Venegoni M, Zocchetti C, & Traversa G. (2014). <a href="http://www.ncbi.nlm.nih.gov/pubmed/24874845" target="_blank">Evaluation of safety of A/H1N1 pandemic vaccination during pregnancy: cohort study</a>. <i>BMJ, 348</i>. - Cohort study. "No increased risk of either fetal or birth outcomes was seen following vaccination, whereas a limited increase in the prevalence of gestational diabetes and eclampsia was observed."<br />
<br />
Wortman AC, Casey BM, McIntire DD, & Sheffield JS. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25607230" target="_blank">Association of influenza vaccination on decreased stillbirth rate</a>. <i>American Journal of Perinatology, 32</i>(6): 571-576 - Retrospective cohort study. "During the study period, 8,690 pregnant women received the seasonal influenza vaccine antepartum and delivered at our institution. Thirty of these births were complicated by stillbirth as compared with 436 stillbirths in the 76,153 women not vaccinated (0.35 vs. 0.57%, p = 0.006). No association was identified between assigned causes of stillbirth when comparing vaccinated and nonvaccinated women."<br />
<br />
Yeager DP, Toy EC, & Baker B 3rd. (1999). <a href="http://www.ncbi.nlm.nih.gov/pubmed/10586981" target="_blank">Influenza vaccination in pregnancy</a>. <i>American Journal of Perinatology, 16</i>(6): 283-286. - "A total of 448 eligible pregnant women were offered the influenza vaccine at routine prenatal visits. Vaccinated women were interviewed at their subsequent visit regarding adverse effects and attitudes toward future vaccination. Of the 448 women studied, 319 (71.2%) accepted the vaccine. There was no difference in acceptance rates between English- and Spanish-speaking women. Mild adverse reactions were experienced by 5.3%...The influenza vaccine is readily accepted by pregnant women, and is infrequently associated with mild side effects."<br />
<br />
Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E, Omer S, Shahid N, Breiman RF, & Steinhoff MC. (2008). <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa0708630" target="_blank">Effectiveness of maternal influenza immunization in mothers and infants</a>. <i>The New England Journal of Medicine, 359</i>(15): 1555-1564. - Randomized controlled trial. "A total of 340 women in the third trimester of pregnancy who met the inclusion criteria agreed to participate in the study. The mothers and infants in the two study groups were similar in both demographic and other characteristics (Table 1). Minor local and systemic side effects that occurred during the first 7 days after immunization were similar in the two groups of mothers except for local pain, which was more frequent among the mothers who received pneumococcal vaccine. The difference in the rate of severe adverse events between the two groups was not significant (for details, see the <a href="http://www.nejm.org/doi/suppl/10.1056/NEJMoa0708630/suppl_file/nejm_zaman_1555sa1.pdf" target="_blank">Supplementary Appendix</a>)."<br />
<br />
<div style="text-align: center;">
<b><u>Risks of Influenza During Pregnancy</u></b></div>
<br />
Centers for Disease Control and Prevention. (2011). <a href="http://www.ncbi.nlm.nih.gov/pubmed/21900872" target="_blank">Maternal and infant outcomes among severely ill pregnant and postpartum women with 2009 pandemic influenza A (H1N1)--United States, April 2009-August 2010</a>. <i>MMWR: Morbidity and Mortality Weekly Report, 60</i>(35): 1193-1196. - Case review. "This report summarizes the results of that analysis, which found that, among 347 severely ill pregnant women, 75 died from 2009 H1N1, and 272 were admitted to an intensive-care unit (ICU) and survived. Women who survived received antiviral treatment sooner after symptom onset than women who died. Pregnant women with severe influenza who delivered during their influenza hospitalization were more likely to deliver preterm and low birth weight infants than those in the general U.S. population; infants born after their mother's influenza hospitalization discharge were more likely to be small for gestational age."<br />
<br />
Gruslin A, Steben M, Halperin S, Money DM, Yudin MH, Boucher M, Cormier B, Ogilvie G, Paquet C, Steenbeek A, Van Eyk N, van Schalkwyk J, & Wong T. (2009). <a href="http://www.ncbi.nlm.nih.gov/pubmed/19175969" target="_blank">Immunization in pregnancy</a>. <i>Journal of Obstetrics and Gynaecology Canada, 30</i>(12):1149-1154. - Review of literature. "Pregnancy is associated with significant cardiovascular and respiratory demands, as evidenced by increases in stroke volume, heart rate, and oxygen consumption. This is high-lighted in a 1998 study, which reported that the need for hospitalization was four times greater in pregnant than non-pregnant women with influenza...Pregnant women should be offered the influenza vaccine when pregnant during the influenza season." Also notes that maternal antibodies to influenza vaccine are passed on to the child following birth, thus protecting the infant until their immune system is more developed.<br />
<br />
MacDonald NE, McNeil S, Allen VM, Scott J, & Dodds L. (2004). <a href="http://www.ncbi.nlm.nih.gov/pubmed/15605434" target="_blank">Influenza vaccine programs and pregnancy: a need for more evidence</a>. <i>Journal of Obstetrics and Gynaecology Canada, 26</i>(11):961-963 - Commentary. "This commentary provides an overview of maternal morbidity in pandemic and nonpandemic influenza seasons as well as a list of research questions whose answers are needed for evidence-based public health policy in this area." Includes a brief discussion of schizophrenia risk in infants of mothers who were infected with influenza during the first trimester.<br />
<br />
Rothberg MB, Haessler SD, & Brown RB. (2008). <a href="http://www.ncbi.nlm.nih.gov/pubmed/18374680" target="_blank">Complications of viral influenza</a>. <i>American Journal of Medicine, 121</i>(4):258-264. - "Other groups at risk for influenza complications include those who are pregnant or immune suppressed. Compared with non-pregnant women, both high and low-risk pregnant women—especially during the third trimester—have more cardio-pulmonary events during influenza season...Psychiatric complications after influenza infection are considered controversial. Several studies note increased rates of schizophrenia in offspring of women who developed influenza during the second trimester of pregnancy, implying fetal developmental brain abnormalities. This was especially related to the influenza epidemic of 1957 but has been associated with other influenza seasons.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com4tag:blogger.com,1999:blog-3609683919099708226.post-42955633359704845702016-08-25T03:00:00.000-04:002016-09-07T16:38:03.655-04:00Colorado's Non-Medical Vaccine Exemption Form Ruffles Anti-Vaccine Feathers<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3ABdCuryvZiELmGASHegt5Z-hhuoSze9EtCFV162dJltAhLTp3O6syCkAxt4mKO9wkAtIGKcZMJ-0BZeCsd1XYElXTHhki6odyJ0MJct1hMme0MZCpn-auzUTw_-Cpu7yNBNeDsFxfg2k/s1600/Back+to+School+Immunizations+-+Happy+Kid.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3ABdCuryvZiELmGASHegt5Z-hhuoSze9EtCFV162dJltAhLTp3O6syCkAxt4mKO9wkAtIGKcZMJ-0BZeCsd1XYElXTHhki6odyJ0MJct1hMme0MZCpn-auzUTw_-Cpu7yNBNeDsFxfg2k/s1600/Back+to+School+Immunizations+-+Happy+Kid.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Back to school time. Show your child you care about their health.<br />
Image Source: <a href="http://sflcn.com/free-back-to-school-immunizations-at-the-florida-department-of-health-in-miami-dade-county/" target="_blank">South Florida Caribbean News</a></td></tr>
</tbody></table>
<i>Note: see update at the end of the article.</i><br />
<i> </i> <br />
School is nearing (or already upon us) in many states. Parents are out buying notebooks, pens and pencils, folders, and new clothes for their children to make sure they're ready for the first day. It's also the time when many parents need to make sure that their children are up to date on their vaccinations in order to attend school. Naturally, this is also a time that anti-vaccine activists absolutely hate, especially in states where public health officials have taken efforts to ensure parents are better informed about vaccines and the diseases they prevent, as well as making opting out of vaccinations closer to the same burden that exists for those who choose to protect their children from diseases.<br />
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One of the latest battlegrounds is Colorado. Anti-vaccine activists and organizations, like the National Vaccine Information Center, are really upset with Colorado. Nothing has changed with regard to the law in that state, though. Non-medical exemptions haven't been removed, like they have in California. Parents aren't required to sit through an educational session on the benefits and risks of vaccines and the diseases they prevent. All that changed is this year's vaccine exemption form and the rules around its use.<br />
<a name='more'></a><br />
First, let's back up a little bit. In 2015, Colorado's Board of Health revised the Infant Immunization Program and Immunization of Students Attending School rule (<a href="http://www.sos.state.co.us/CCR/6%20CCR%201009-2.pdf?ruleVersionId=6808&fileName=6" target="_blank">6 CCR 1009-2</a>). Previously, parents who wanted to opt out of immunizing their children, whether for religious or personal belief reasons, could submit an exemption form once and be done with it. The revised rules require submission of the non-medical exemption form every year (or more frequently for infants in day care). By contrast, medical exemptions, both under the old rules and the new ones, only need to be submitted once.<br />
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Naturally, that rankles those opposed to vaccines. When I initially gave this some thought, I have to admit I actually agreed (to a slight degree) that that portion of the new rules could be overly burdensome for non-medical exemptions, if we compare the overall burden among those who do and do not vaccinate. I also thought that the medical exemptions process is too lax, compared to vaccinating or eschewing vaccines for personal reasons. However, after talking it over with a friend, I've changed my mind. I don't believe that annual submissions of the exemption form are overly burdensome. Those who choose to protect their children from preventable diseases must take time out of work and/or school to go to the doctor's office, wait, be seen, then travel back home. Likewise, those who need a medical exemption must also go to their doctor to get it signed. By contrast, those who opt out of vaccination for non-medical reasons, merely have to complete and submit the exemption form online or print it and send it with their child to school. An argument might be made that submitting the form every year is overkill and that a laxer schedule would suffice. At the bare minimum, if we wish to be equatable, exemptions, whether medical or non-medical, should be submitted at the same schedule as vaccinations are recommended, as well as when a child changes schools, if not more frequently. All that said, under Colorado state law, the department has the authority to require exemptions be submitted at any interval they choose.<br />
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The revised rules also approved a new online <a href="https://docs.google.com/presentation/d/1T_j7H3g5CTvK0dIqvHZreXmrnHYTC7WCGYu9Plhvwvg/pub?start=true&loop=false&delayms=60000#slide=id.p3" target="_blank">educational module</a>, as required by 2014's <a href="https://www.colorado.gov/pacific/sites/default/files/Imm_HB1288.pdf" target="_blank">House Bill 14-1288</a>. That bill required the Board of Health to make available "evidence-based research, resources and information from credible scientific and public health organizations". The module includes a lot of links to additional information, though some of the slides are a bit difficult to read due to small font sizes.<br />
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Those two aspects of the new rules aren't really what has the anti-vaccine community in an uproar. Certainly, they don't like the frequency of submitting non-medical exemption forms, but there is something new this year that really has them upset.<br />
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For 2016, the Board of Health revised the non-medical exemption form to include attestations that the parent understands the risks of not vaccinating. For example, for each vaccine being declined, the form requires them to note that they understand that:<br />
<blockquote>
My child/I may be at increased risk of developing [disease(s)] if exposed to [this disease/these diseases].</blockquote>
Pretty straightforward and in line with reality. If a vaccine is declined, the child may be at increased risk of getting the disease if exposed. This is supported by studies such as "<a href="http://www.ncbi.nlm.nih.gov/pubmed/19482753" target="_blank">Parental refusal
of pertussis vaccination is associated with an increased risk of
pertussis infection in children</a>" (Glanz et al., <i>Pediatrics</i>, 2009). We've also seen an example of this in the United Kingdom; when MMR uptake plummeted following Andrew Wakefield's (who calls the vaccination program a "<a href="https://leftbrainrightbrain.co.uk/2016/08/19/andrew-wakefield-hes-not-anti-vaccine-he-just-thinks-this-is-a-deliberate-eugenics-program-a-deliberate-population-control-program/" target="_blank">deliberate eugenics program</a>") <a href="http://www.harpocratesspeaks.com/2014/05/beware-wakefraud.html" target="_blank">fraudulent paper</a>, measles, which had been eliminated in the country, came roaring back. Each vaccine entry also describes the disease and includes a link to the corresponding Vaccine Information Sheet. But still, that's not the really big thing that has the anti-vaccine groups riled up.<br />
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Instead, it's the following statement on the form:<br />
<blockquote>
Failure to follow the advice of a physician, registered nurse, physician’s assistant, or public health official who has recommended vaccines may endanger my child’s/my health or life and others who come into contact with my child/me.</blockquote>
Most news stories talking about this have only provided that statement in isolation. Here it is in context:<br />
<blockquote>
I am the parent/guardian of the above-named student or am the student himself/herself (emancipated or over 18 years of age) and have a religious or personal belief that is opposed to vaccines. By signing this form, I am declining the vaccine(s) required for school entry for my child/myself, as initialed above, and understand the following:<br />
<ul>
<li>My child/I may not be able to attend child care or school during a disease outbreak. </li>
</ul>
</blockquote>
<blockquote>
<ul>
<li>Some vaccine-preventable diseases are common in other countries and my child/I could easily get one of these diseases while traveling or from a traveler. </li>
</ul>
</blockquote>
<blockquote>
<ul>
<li>Failure to follow the advice of a physician, registered nurse, physician’s assistant, or public health official who has recommended vaccines may endanger my child’s/my health or life and others who come into contact with my child/me. </li>
</ul>
</blockquote>
<blockquote>
<ul>
<li>I may change my mind at any time and accept vaccination(s) for my child/myself in the future. </li>
</ul>
</blockquote>
<blockquote>
<ul>
<li>I can review evidence-based vaccine information at www.colorado.gov/cdphe/immunization-education, or www.ImmunizeforGood.com to learn about the benefits and risks of vaccines and the diseases they prevent. </li>
</ul>
</blockquote>
<blockquote>
<ul>
<li>I can contact the Colorado Immunization Information System (CIIS) at www.ColoradoIIS.com or my health care provider to locate my child’s/my immunization record.<sup>3</sup></li>
</ul>
The information I have provided on this form is complete and accurate. I acknowledge that I have read this document in its entirety and fully understand it.</blockquote>
There are two primary arguments that I've seen against the offending statement: conflict with beliefs and violation of free speech.<br />
<br />
<u><b>Belief vs. Facts</b></u><br />
<br />
Many of the news stories (e.g., <a href="http://www.thedenverchannel.com/news/local-news/concerned-parents-seek-to-change-wording-of-colorados-non-medical-vaccine-exemption-form" target="_blank">Concerned parents seek to change wording of Colorado's non-medical vaccine exemption form</a>, <i>The Denver Channel</i>) have some parent comment along the lines of, "I don't believe this to be true". Some also suggest that parents are interpreting this as stating that they <i>are</i>, rather than <i>might be</i>, putting their children's health at risk.<br />
<br />
Unfortunately for those parents, reality doesn't particularly care what they do or do not believe. The plain facts, backed up by many studies from various sources around the world, are that vaccines prevent infection and/or transmission of the diseases they protect against, and that those who are not vaccinated are at a greater risk of infection than those who are vaccinated. These parents might also believe that the Earth is flat, that the moon landing was a hoax, that man-made climate change is not occurring, or that not washing their t-shirt will help their favorite sports team win. But simply believing something to be true does not change reality to fit your beliefs. The Earth is round (well, <a href="http://www.scientificamerican.com/article/earth-is-not-round/" target="_blank">an oblate spheroid</a>), we actually did <a href="http://www.slate.com/blogs/bad_astronomy/2011/02/15/moon_hoax_10.html" target="_blank">land people on the moon</a>, <a href="http://climate.nasa.gov/scientific-consensus/" target="_blank">man-made climate change is happening</a>, and that t-shirt is just getting dirty and smelly without bestowing any magical good luck on your team.<br />
<br />
<u><b>Violating Free Speech</b></u><br />
<br />
The other argument, being promoted by anti-vaccination organizations like the National Vaccine Information Center (which changed their page on Colorado's exemptions sometime between <a href="https://web.archive.org/web/20160525031353/http://www.nvic.org/Vaccine-Laws/state-vaccine-requirements/colorado.aspx" target="_blank">May 25, 2016</a> and <a href="https://web.archive.org/web/20160824161243/http://www.nvic.org/Vaccine-Laws/state-vaccine-requirements/colorado.aspx" target="_blank">August 24, 2016</a>, urging readers to consult a lawyer), is that the statement amounts to "compelled speech" and is thus a violation of the 1st Amendment. (A nice article on compelled speech can be found <a href="https://www.law.upenn.edu/live/files/1566-keighley15upajconstl5392012pdf" target="_blank">here</a>.<br />
<br />
Before I go further, let me note that I am not a lawyer and am not offering legal advice. I would, however, like to talk about how I interpret the legal aspects at play. I invite lawyers with relevant expertise to correct any errors that I make.<br />
<br />
The primary argument made by objectors to the form's language is that the 1st Amendment protects not only the right to speak what is in our minds, but also the right to <i>not</i> speak what is <i>not</i> in our minds. The origins of the compelled speech doctrine go back to the 1940s in a case where students were forced to recite the Pledge of Allegiance (<a href="https://en.wikipedia.org/wiki/West_Virginia_State_Board_of_Education_v._Barnette" target="_blank"><i>West Virginia State Board of Education v. Barnette</i></a>). Those who failed would be expelled, and their parents faced potential legal charges. In that case, the courts ruled that individuals could not be compelled to express a belief or ideology that they did not hold or that conflicted with their beliefs.<br />
<br />
Further cases have made further distinctions about when the state can and cannot compel certain kinds of speech. For example, the state cannot compel politicians to speak only the truth when they're on the campaign trail. The state <i>can</i> compel a company to disclose information that helps to inform the consuming public (e.g., calorie counts in restaurants, cancer risks on tobacco products, etc.). The compelled speech, though, must be uncontroversially factual in nature, must provide information and needs to serve a compelling state interest. Importantly, the language cannot be "normative", that is, telling consumers what they should or should not do, rather than just providing information to make an informed choice. For example, the state could compel a restaurant to disclose that a sandwich has 800 calories, but it could not compel the restaurant to issue a statement that consumers should not eat the sandwich if they're overweight, even though the end result and goal are the same: to get people to make healthier eating decisions.<br />
<br />
Opponents of the form's language argue that by signing it, they are being forced to state that they <i>are</i> placing their children in harm's way, when, in fact, they believe that they are doing what is best for their children. For example, the Home School Legal Defense Association (as a brief aside, the exemptions forms are <i>not</i> required for parents who home school their children) <a href="https://contentsharing.net/actions/email_web_version.cfm?message_id=13379542&&user_id=HSLDA" rel="nofollow" target="_blank">writes</a> (emphasis added)<br />
<blockquote>
<span class="c1">First is the requirement that parents affirm that by
exempting their child from immunizations they <u><b>are</b></u> endangering the life
and health of that child. We understand that, for some, this statement
is a viewpoint at odds with their personal and/or religious beliefs.</span></blockquote>
I'm not certain how compelling this argument would be. First, in virtually every argument against the form I've seen, it is assumed that parents are being forced to admit that they are, unequivocally, putting their children at risk. However, that is not what the form says. At every point in the form where the risks of not vaccinating are mentioned, the form uses the word "may", implying that while there could be an increased risk of harm, it is not a certainty. It does not say that the child <i>will</i> get the disease, nor that failure to follow a physician's advice <i>will</i> endanger the child's health; it is merely the expression of the possibility that this <i>could</i> happen.<br />
<br />
Second, the government of Colorado has a rather compelling interest, that is, ensuring that parents are informed and understand the ramifications of their decision. Along these lines, the form informs parents of the risks posed by the diseases and by not vaccinating. It includes links to additional information. It requires that parents acknowledge that they <i>understand</i> the information provided to them and what effects their choices might have. It does <i>not</i> require them to profess belief in that information, nor does it require them to reject their own beliefs. Parents are still free to believe and to express the belief that they are doing what they think is best for their child, whether that stems from simple unease about the vaccines or from a belief that vaccines are part of some conspiracy to kill or control the populace. Parents are not being asked to set aside their own ideology and accept some other ideology with which they disagree.<br />
<br />
Interestingly, despite outcries that the form's language is unacceptable, I've yet to see any suggestions as to what should be used instead. My guess is that opponents would prefer the language to simply be removed entirely. If the form did not include statements about the factual risks of not vaccinating, the state would not be performing its charge to adequately inform parents.<br />
<br />
One fundamental aspect of this issue, of course, is that while the government has more leeway to compel speech when it is commercial in nature, there is no commercial speech in this instance. That could make it more difficult for the Board of Health and the Colorado Department of Public Health and Environment to defend the form. If the department does not change the language (and perhaps even if it did), I foresee this going to court. The outcome would largely depend on the judge and how well the state presents their arguments.<br />
<br />
<u><b>Conclusion</b></u><br />
<br />
To sum up, the non-medical exemption form makes several factual statements regarding the risks of the diseases and the risks of not vaccinating against those diseases. Those who do not vaccinate are, on average, at an increased risk of infection compared to those who do vaccinate. Similar to how school tests gauge whether students understand the material they were taught, but do not require them to accept that material as true, the form requires parents to affirm that they <i>understand</i> these facts, regardless of whether or not they accept them as true. It does not require them to state that they believe they <i>are</i> endangering their children's health. Parents are still free to believe that they are doing what they think is best for their children, and they are free to express that belief to others.<br />
<br />
The Colorado Department of Public Health and Environment could be proactive and change the language to something like:<br />
<blockquote>
The scientific literature suggests that my child/I may be at increased risk...</blockquote>
and<br />
<blockquote>
The scientific literature suggests that failure to follow the advice of a physician...</blockquote>
These minor changes would make the forms more belief- or ideology-neutral. However, I don't see any language discussing the risks of not vaccinating being acceptable to those who are opposed to vaccinations. Those who reject vaccines on ideological grounds tend to believe that vaccines do not work to prevent disease and that the risks of vaccines are much greater than they really are.<br />
<br />
<b>[<i>Updated 9/7/16:</i></b><i> As of September 1, 2016, the Colorado Department of Public Health and Environment has updated the non-medical exemption form. The form no longer contains "I/my child" language that anti-vaccine activists found so objectionable. Gone, too, is the "Failure to follow the advice of a physician...may endanger my/my child's health" language. It does, however, still note that unvaccinated children may be at increased risk of developing the disease prevented by the declined vaccine, and notes that children with exemptions may be kept out of child care/school in the event of an outbreak.</i><b>]</b> Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com5tag:blogger.com,1999:blog-3609683919099708226.post-15466720124498636872016-07-25T03:00:00.000-04:002016-07-25T14:12:29.002-04:00Cinema Libre's Philippe Diaz Tries to Bully "Vaxxed" Critic into Silence<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhn_Ro42yqFrAIsB6JxkXoWoBUJ4zSbMBFQn6vhqpz7CYMk3BQ8pFL_v_ua0yFGFe1hB1KWCIBxHcn834gHYkHdAcSCTUneo5iSqlaKzMoL4v0MuyB18q8UGf8HXXY1wrfdqQoq9PDs14FA/s1600/Philippe+Diaz.jpg" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhn_Ro42yqFrAIsB6JxkXoWoBUJ4zSbMBFQn6vhqpz7CYMk3BQ8pFL_v_ua0yFGFe1hB1KWCIBxHcn834gHYkHdAcSCTUneo5iSqlaKzMoL4v0MuyB18q8UGf8HXXY1wrfdqQoq9PDs14FA/s1600/Philippe+Diaz.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Cinema Libre Founder and CEO, Philippe Diaz<br />
Source: <a href="http://cinemalibrestudio.com/about-philippe-diaz.html" rel="nofollow" target="_blank">Cinema Libre Studio</a></td></tr>
</tbody></table>
<span style="font-size: small;">Apparently, Philippe Diaz, <a href="http://cinemalibrestudio.com/about-philippe-diaz.html" target="_blank">founder, president, and CEO of Cinema Libre Studio</a>, is a litigious bully.</span><br />
<span style="font-size: small;"><br /></span>
<span style="font-size: small;">But, I'm getting ahead of myself. Let me back up and start by introducing you to Fiona O'Leary. Fiona is the mother of five children, living with her husband in Ireland. Two of her children are autistic, as is Fiona herself. Several years ago, she became an outspoken advocate for autistic rights, campaigning against quack autism treatments like MMS, chelation, GcMAF, and so on. Last year, she was featured in an Irish documentary called <a href="https://www.youtube.com/watch?v=_8LbfYAphF8&app=desktop" target="_blank"><i>Bleach Cult</i></a>, which detailed the bleach treatment known as MMS, a protocol created by ex-Scientologist Jim Humble. She also worked with the Illinois attorney general to shut down MMS promoter Kelli Rivera. In April 2015, Fiona and her husband, Tim, founded the charity <a href="http://autisticrightstogether.ie/" target="_blank">Autistic Rights Together</a>, an organization of autistic and non-autistic individuals dedicated to promoting the rights and respect for children, teens, and adults on the autism spectrum.</span><br />
<span style="font-size: small;"><br /></span>
<span style="font-size: small;">On July 19, Fiona started a <a href="https://www.change.org/p/ken-paxton-texas-attorney-general-stop-vaxxed-and-their-reckless-campaign?recruiter=49447223&utm_source=share_petition&utm_medium=facebook&utm_campaign=share_for_starters_page&utm_term=des-lg-no_src-no_msg&recuruit_context=fb_share_mention_control" target="_blank">Change.org petition</a> to stop the film <i>Vaxxed</i> and its production team (Andrew Wakefield, Del Bigtree, and Polley Tommey) from spreading its anti-vaccine message (e.g., stating that <a href="https://www.youtube.com/watch?v=zBL-NIoe84w" target="_blank">there is no safe vaccine</a>) in the state of Texas, and possibly beyond. The petition notes how the film and its production team are spreading misinformation about vaccines and autism around the country, particularly during the Q&A sessions after some of the screenings. Examples include <a href="https://www.youtube.com/watch?v=GvDIS8nAc4M" target="_blank">Polly Tommey telling people that pediatricians are dangerous and should be avoided</a>, Tommey saying that she <a href="https://www.youtube.com/watch?time_continue=1&v=X6GOWDaDyyc" target="_blank">would never judge parents who murder their autistic children</a>, and Bigtree's <a href="https://www.youtube.com/watch?v=ZaR81c9bscA" target="_blank">urging of anti-vaccine activists to exercise their second amendment right to bear arms</a> in their fight against vaccinations. Fiona also notes Bigtree's comments <a href="https://www.youtube.com/watch?v=KM0juxy5mEI" target="_blank">comparing autistic individuals to chimps and dogs</a>, as well as how the supporters of <i>Vaxxed</i> ridicule autistic individuals who protest the film.</span><br />
<span style="font-size: small;"><br /></span>
<span style="font-size: small;">This is where we get back to Philippe Diaz and Cinema Libre's threats. On July 21, he sent a letter on the studio's letterhead to Mrs. O'Leary threatening her with legal action.</span><br />
<a name='more'></a><br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgU8b4AkzxttikZ4MW5j7xQzyT148ruwyZfCB9VjHnNeOxA9LED3hCMr9CRihPjrfn9RHVtDvmVsxjQOfCVh21dl1qXWj-aWKBb7KatNBRnwcWXy7MHePQocNSYMFyt7fEeiPrsxanL4jW5/s1600/Diaz+to+O%2527Leary+-+Threat+of+Legal+Action.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgU8b4AkzxttikZ4MW5j7xQzyT148ruwyZfCB9VjHnNeOxA9LED3hCMr9CRihPjrfn9RHVtDvmVsxjQOfCVh21dl1qXWj-aWKBb7KatNBRnwcWXy7MHePQocNSYMFyt7fEeiPrsxanL4jW5/s400/Diaz+to+O%2527Leary+-+Threat+of+Legal+Action.jpg" width="307" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Mr. Diaz threatens legal action against Fiona O'Leary<br />
Click to enlarge.</td></tr>
</tbody></table>
<div class="separator" style="clear: both; text-align: center;">
</div>
Fiona shared this letter on <a href="https://www.facebook.com/photo.php?fbid=10210370694091586&set=a.3951344429929.245687.1469686336&type=3&theater" target="_blank">her Facebook page</a>. Both <a href="https://www.facebook.com/fiona.oleary.5/videos/10210377016329638/?permPage=1" target="_blank">she</a> and <a href="https://www.youtube.com/watch?v=76x8y5viNxg&feature=youtu.be&a" target="_blank">her husband</a> have posted video responses to the letter.<br />
<br />
Diaz, in my opinion, has made some very significant errors. First, he picked a target that is a very outspoken advocate for autism rights, one who would have no qualms going public about this threat. Second, I don't think he took into account the widespread support that Fiona has from other members of the scientific and autistic communities. There have already been several posts written about Cinema Libre's actions, including posts by <a href="https://reasonablehank.com/2016/07/22/vaxxed-anti-vaccine-film-distributor-threatens-autism-rights-advocate/" target="_blank">Reasonable Hank</a> and <a href="http://autisticatedalmayne.com/autism/vaxxed-threaten-to-sue-autistic-advocate-for-petition/" target="_blank">Emma Delayne</a>. More are almost certain to surface.<br />
<br />
There is also the question of <i>why</i> Diaz targeted Fiona. <a href="http://lizditz.typepad.com/i_speak_of_dreams/2016/04/running-list-of-reviews-of-andrew-wakefields-film-vaxxed-.html" target="_blank">Numerous people have pointed out the falsehoods</a> and lack of ethics in the movie <i>Vaxxed</i>, as well as calling out Wakefield, Bigtree, and Tommey for their often inflammatory and incorrect statements about vaccines and autism. Yet none of those individuals have received letters threatening them with legal action. Even another filmmaker, Todd Drezner, has <a href="http://www.thinkingautismguide.com/2016/03/todd-drezners-open-letter-to-cinema.html" target="_blank">spoken out against <i>Vaxxed</i></a>. This is significant, considering Drezners' film, <a href="http://lovinglamppostsmovie.com/" target="_blank"><i>Loving Lampposts</i></a>, was also distributed by Cinema Libre. Regarding the studio's latest actions, <a href="https://www.facebook.com/lbrb.sullivan/posts/1233318466718960?comment_id=1233330100051130&comment_tracking=%7B%22tn%22%3A%22R1%22%7D&pnref=story" target="_blank">Drezner notes</a>:<br />
<blockquote>
<span data-ft="{"tn":"K"}"><span class="UFICommentBody">Cinema
Libre distributes my documentary, which calls Wakefield's research
fraudulent. Therefore, CLS should sue itself for defamation.</span></span></blockquote>
Perhaps Fiona was targeted because not only has she pointed out the dangerous statements of Del Bigtree, Polly Tommey, and the movie <i>Vaxxed</i>, but she has also urged others to take action to stop them. That threatens not only the production team's pocketbooks, but Cinema Libre's income, as well. Perhaps Diaz thought Fiona would be an easy target, that she would pull her petition and cower in silence, rather than face the threat of a lawsuit.<br />
<br />
Speaking from experience, this letter seems more likely to just be posturing and bluff, rather than a real threat. You see, several years ago, I was also on the receiving end of a <a href="http://www.harpocratesspeaks.com/2012/01/defending-fearful-magic.html" target="_blank">threatened defamation lawsuit</a>. There are several aspects of the letter that suggest it is more bluster than true threat.<br />
<br />
First, as with the note that I got in 2012, there is no mention of specific statements considered to be defamatory. Rule #1 if you're going to accuse someone of defamation: make sure you state explicitly what they said that is defamatory. In order to prove libel/slander, you have to <a href="http://www.citmedialaw.org/legal-guide/california-defamation-law" target="_blank">show</a> that the comment was a:<br />
<ol>
<li>publication of a statement of fact</li>
<li>that is false,</li>
<li>unprivileged,</li>
<li>has a natural tendency to injure or which causes "special damage," and</li>
<li>the defendant's fault in publishing the statement amounted to at least negligence.</li>
</ol>
Expressions of opinion fail the first point. You can't simply say, "Everything that you've said is libelous". If it were that simple, then absolutely no one would even bother to write a negative review of a film (or anything else).<br />
<br />
Another tell that Diaz likely won't follow through on his threat is that he demands that Fiona not make <i>any</i> further statements about <i>Vaxxed</i>, Cinema Libre Studio, Wakefield, Bigtree, Tommey, Autism Media Channel, or anyone else associated with AMC. Talk about a suppression of speech rights. Which is rather ironic, considering how Andrew Wakefield and Del Bigtree <a href="https://s-media-cache-ak0.pinimg.com/736x/9d/43/c6/9d43c6fcc19b69731a4409c42f6f6b6a.jpg" target="_blank">posed next to a large display quoting Frederick Douglass on free speech</a>:<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEimm991NN_wQTiqKr_TpZdoLT6I9QhwWW6ZYJLYyS3w-lVdmMRNuVGZO8cxA7I_yPMTOWi9OzkF3V0ppRIRUfI20L1WEfej6PqK4vJGsz2cC9Uc7FV-SDnBU8PNQmL2nFGE5ta6uGxhZpLB/s1600/Wakefield+and+Bigtree+-+Free+Speech.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="395" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEimm991NN_wQTiqKr_TpZdoLT6I9QhwWW6ZYJLYyS3w-lVdmMRNuVGZO8cxA7I_yPMTOWi9OzkF3V0ppRIRUfI20L1WEfej6PqK4vJGsz2cC9Uc7FV-SDnBU8PNQmL2nFGE5ta6uGxhZpLB/s400/Wakefield+and+Bigtree+-+Free+Speech.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Wakefield and Bigtree support free speech, but only if it agrees with them.</td></tr>
</tbody></table>
Not only can Diaz and company not sue for statements of opinion, they also cannot sue (and hope to prevail) for statements that are factually true. Fiona has recounted what Bigtree and Tommey have said, themselves, with links to video of them saying those very things. I can't imagine how Diaz hopes to win should he bring suit.<br />
<br />
Finally, letters claiming real defamation, which request that <i>specific</i> offending statements be removed, and which threaten legal action for noncompliance are generally written, or at least reviewed by, a lawyer <i>before</i> being sent to the offending party. Diaz chose to write the letter and send it to his lawyer, Jay Statman, at the same time that he sent it to O'Leary. Any good lawyer would have advised against sending such a vacuous demand if they had any intention of following through in court.<br />
<br />
All that really remains are questions that arise should Diaz foolishly follow through.<br />
<br />
First, where would he file suit? Since Fiona's petition is specific to Texas, and that is where Wakefield resides, that seems the most logical location. Texas is also home to <a href="https://mycpa.cpa.state.tx.us/coa/servlet/cpa.app.coa.CoaGetTp?Pg=tpid&Search_Nm=autism%20media%20channel%20&Button=search&Search_ID=32043336927" target="_blank">Autism Media Channel</a>, Wakefield's and Tommey's media company. However, Texas has a <a href="https://slappedintexas.com/primer/" target="_blank">rather strong anti-SLAPP law</a>. He could file in California, since that's the home of Cinema Libre. California also has some reasonable <a href="http://www.casp.net/california-anti-slapp-first-amendment-law-resources/statutes/" target="_blank">anti-SLAPP laws</a>. Since anti-SLAPP laws generally allow for the defendant to reclaim legal fees if they win, he might try to bring suit in a state without such a law.<br />
<br />
Whatever state he chooses, though, Diaz would also have to prove that Fiona acted with <a _blank="" href="http://www.lectlaw.com/def2/m006.htm" target="_blank">actual malice</a>, since the plaintiffs would be public figures and this is a matter of public interest. In other words, not only does he have to prove that the statements were false, but he would also have to prove that Fiona <i>knew</i> they were false beforehand or recklessly did not care whether or not they were false. That sets a rather high bar for him to overcome.<br />
<br />
Because of the legal hurdles in the U.S., Diaz might try to bring his case in Ireland, where Fiona resides. Irish law requires the defendant to <a href="http://www.lawyer.ie/defamation/" target="_blank">prove that the statement is true</a>, since alleged defamatory comments are presumed to be defamatory unless otherwise proved. That seems a rather expensive proposition, since he would need to find a lawyer there, as well as pay for travel costs to get there. Given how long court cases can drag on, that could run up a rather large bill.<br />
<br />
Another question that comes to mind is whether this is actually Diaz's idea at all or if he was prompted by Wakefield or Bigtree. It certainly sounds like something that Wakefield would do, since he has tried to sue people for libel several times before in attempts to silence them, and <a href="https://violentmetaphors.com/2014/09/20/andrew-wakefield-loses-again-in-court-what-happened/" target="_blank">he failed each time</a>. In fact, in Wakefield's first failed libel case against British journalist Brian Deer, the presiding justice, The Honorable David Eady, <a href="http://briandeer.com/wakefield/eady-judgment.htm" target="_blank">described Wakefield using the proceedings</a> as:<br />
<blockquote>
a weapon in his attempts to close down discussion and debate over an important public issue.</blockquote>
Finally, there's the little matter of discovery. This cannot go well for Philippe Diaz, Andrew Wakefield, Del Bigtree, or Polly Tommey. I can envision them feverishly deleting emails and texts to hide anything that they may have said about Fiona O'Leary that could jeopardize their case or give her more fuel in her fight against their message.<br />
<br />
I've written to Mr. Diaz asking for some clarification on his letter. We'll see if he responds or remains quiet. <br />
<br />
In the end, I applaud Fiona O'Leary for standing up to Andrew Wakefield, Del Bigtree, Polly Tommey, and the movie <i>Vaxxed</i>. While they do have the right to say (almost) anything they want, they are not free from criticism, nor are they free from the consequences of what they say. The message that they are spreading is dangerous to public health, generally, and more specifically to the health of children across the world. Fiona is calling for the Texas attorney general to investigate them and determine whether their comments and message represent a public threat. If you support this, consider <a href="https://www.change.org/p/ken-paxton-texas-attorney-general-stop-vaxxed-and-their-reckless-campaign?recruiter=49447223&utm_source=share_petition&utm_medium=facebook&utm_campaign=share_for_starters_page&utm_term=des-lg-no_src-no_msg&recuruit_context=fb_share_mention_control" target="_blank">adding your name to her petition</a>. Remember, while they are guaranteed the right to not have their speech suppressed by the government, they are <i>not</i> guaranteed a platform for that speech.<br />
<br />
Furthermore, if you oppose using libel laws to bully critics into silence, particularly Cinema Libre's attempts to bully Fiona O'Leary, an autistic woman and advocate for autism rights, into complete silence with regard to <i>Vaxxed</i> and its production team, consider adding your name to Kevin Jenco's <a href="https://www.change.org/p/american-society-of-cinematographers-blacklist-cinema-libre-studio-for-threatening-over-vaxxed-criticism?recruiter=574234493&utm_source=share_petition&utm_medium=twitter&utm_campaign=share_twitter_responsive" target="_blank">petition to several motion picture organizations</a>, asking them to cease doing business with Cinema Libre unless the studio retracts their threat and issues an apology. Jenco makes three demands in his petition:<br />
<ol>
<li>That all members of the motion picture community refuse to do business
with Cinema Libre until they retract their threat and issue an apology.</li>
<li>That the Motion Picture Association of America issue a condemnation
of Cinema Libre.</li>
<li>That theater groups across the country refuse to show <i>Vaxxed</i>.</li>
</ol>
<b>[<i>Edited to add (7/25/16):</i></b><i> I meant to include a brief statement about Jenco's petition. He describes Cinema Libre as "a studio that cranks out innumerable cheap films and documentaries of dubious quality". I do not share that opinion of the studio as a whole. Yes, </i>Vaxxed<i> fits that description, but </i>Loving Lampposts<i>, mentioned earlier, does not.</i><b>]</b><br />
<b> </b> <br />
I also encourage readers to speak up and voice their own opinions on Cinema Libre and Philippe Diaz's actions. Mr. Diaz wants criticism shut down. Shine a light on this. Amplify the story of what he, Wakefield, Bigtree, and Polley are doing. Show them to be the bullies they are and refuse to be quiet.<br />
<br />
Using the threat of a defamation suit to bully your critics into silence simply because you don't like what they have to say or because it paints you in an unflattering light not only abuses the legal system, it chills public discourse. Those who shake their sabers and threaten to bring such a frivolous lawsuit ought to be ashamed. After all, as Wakefield and Bigtree know, "to suppress free speech is a double wrong".<br />
<br />
<b>[<i>Edited to Add</i></b><i> <b>(7/25/16):</b> It looks like someone in the anti-vaccine community doesn't like the idea of Fiona O'Leary speaking her mind or advocating for the rights of autistic people. They have started a <a href="https://www.change.org/p/donald-macintosh-stop-unqualified-advocates-in-ireland-0942bc88-7772-4295-9887-ef02bc25439f" rel="nofollow" target="_blank">petition</a> asking the Irish government to regulate the term "advocate".</i><b>]</b> <br />
<ol>
</ol>
Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com10tag:blogger.com,1999:blog-3609683919099708226.post-86560162142032957622016-06-22T02:00:00.000-04:002016-06-22T08:03:44.656-04:00Vaxxed's Polly Tommey and Del Bigtree Support Parents Convicted of Medical Neglect<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgeh0FaA7sTf8of2dzAHpgTgYjeCbHln4BkJQiOTey9dfwsVeUlGzGYiVUIC4Rt4EWXd2LIJNi9wmWPJAU2m3tIkIyLf_pIyi5l5lXB0xpCfDu67A4QqMU2SOgquZD4HJwjRBMoso6WoDJT/s1600/Ezekiel+Stephan.jpg" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="213" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgeh0FaA7sTf8of2dzAHpgTgYjeCbHln4BkJQiOTey9dfwsVeUlGzGYiVUIC4Rt4EWXd2LIJNi9wmWPJAU2m3tIkIyLf_pIyi5l5lXB0xpCfDu67A4QqMU2SOgquZD4HJwjRBMoso6WoDJT/s320/Ezekiel+Stephan.jpg" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Photo: Facebook/<a href="https://www.facebook.com/PrayersForEzekiel/" rel="nofollow" target="_blank">Prayers for Ezekiel</a></td></tr>
</tbody></table>
When two people become parents, they take on a responsibility to care for and do what is best for their children. It is, by no means, an easy task. There are no handbooks, no guidelines that describe in detail what parents should do in every given situation. Parents make mistakes sometimes, even though they may mean well. Generally, those mistakes are minor, and the incident passes on without lasting impact. Sometimes, they make a bad call that results in something more serious. Again, they may have meant well, and they may have acted as any reasonable person would have done. Hopefully, they learn from their mistake and move on. These types of mistakes can, for the most part, be forgiven. Parents are granted a great deal of latitude in how to raise their children.<br />
<br />
But sometimes, sometimes they make an error that is so egregious, so far beyond what any rational, reasonable person would do, that they end up inflicting unforgivable harm upon their children. They stumble into the realm of <a href="http://www.harpocratesspeaks.com/2016/04/medical-child-abuse-overview-part-1.html" target="_blank">medical neglect</a> and <a href="http://www.harpocratesspeaks.com/2016/04/medical-child-abuse-overview-part-2.html" target="_blank">child abuse</a>. They may still believe that they are not doing anything wrong, that they actually are doing what is best for their child. But those beliefs, nonetheless, result in serious, or even fatal, harm.<br />
<br />
Such is the case of David Robert Stephan and his wife, Collet Dawn Stephan, whose negligence resulted in the death of their 18-month-old son, Ezekiel.<br />
<a name='more'></a><br />
You can readily find numerous <a href="https://www.google.com/search?q=ezekiel+stephan&ie=utf-8&oe=utf-8#q=ezekiel+stephan&tbm=nws" target="_blank">news reports</a> and <a href="https://www.sciencebasedmedicine.org/ezekiel-stephan-another-pediatric-death-by-world-view/" target="_blank">blog posts</a> about it. There are also the findings of fact from the case (<a href="http://www.canlii.org/en/ab/abqb/doc/2016/2016abqb319/2016abqb319.html" target="_blank">R v Stephan, 2016 ABQB 319 (CanLII)</a>). The short version is that Ezekiel fell ill on February 27, 2012. Despite worrying symptoms like difficulty breathing, his parents did not take him to a medical professional for examination. Instead, they called a nurse friend and discussed his symptoms over the phone, deciding it was just croup. They gave him water and maple syrup using an eye dropper to increase his fluid intake, along with various supplements.<br />
<br />
He continued to have difficulty breathing for nearly a week, and then his symptoms started growing worse. They gave him "apple cider vinegar, onion powder,
ginger root, garlic, hot peppers, and horseradish root", but over the next couple of days he started to develop stiffness to the point that his back started to arch. They did not take Ezekiel to a doctor.<br />
<br />
They called their nurse friend, who came to their house to examine Ezekiel. She wasn't sure of the issue, but suspected it might be meningitis. She recommended they take Ezekiel to a doctor. Ms. Stephan looked up meningitis on the internet and decided to play-act being a doctor, deciding, in her complete lack of medical training, that Ezekiel must have viral meningitis (note that online medical sources generally <a href="http://www.webmd.com/children/vaccines/tc/meningitis-when-to-call-a-doctor" target="_blank">recommend calling a doctor if meningitis is suspected</a>). David and Collet decided to treat him with more supplements. They did not take Ezekiel to a doctor.<br />
<br />
On March 13, two weeks after first falling ill, the Stephans drove into Lethbridge to sign some purchase documents, taking Ezekiel with them. He was too stiff to sit comfortably in his car seat, so they made up a bed for him in the back of their SUV. They called a naturopath for recommendations to boost Ezekiel's immune system. The receptionist told them to take him to a doctor, but they said they had a nurse friend looking in on him. They dealt with their lawyer, stopped by the naturopath's office to buy a "natural remedy", and then went shopping at Superstore. Superstore has a walk-in clinic attached to it, but they didn't take Ezekiel in. Instead, they headed home with Ezekiel once again lying in the back of the SUV, too stiff to sit in his car seat. They still did not take Ezekiel to a doctor.<br />
<br />
I'll quote this next part straight from the findings of fact in the case:<br />
<blockquote>
[27] Mr. Stephan noticed that Ezekiel began to experience irregular breathing, and shortly after Ms. Stephan returned from her meeting, around 9 pm, Ezekiel stopped breathing. Mr. Stephan called his father, and then called 911. Ms. Stephan patted Ezekiel’s back and he started breathing but stopped again shortly after. Ms. Stephan gave Ezekiel a few rescue breaths and he started breathing again.<br />
<br />
[28] Mr. Stephan told the 911 operator that an ambulance did not need to be dispatched because Ezekiel was breathing again and they would drive him to the hospital. About 20 minutes later the family left in their vehicle for the Cardston hospital. Ezekiel stopped breathing again and Ms. Stephen performed CPR in the vehicle for a considerable time while Mr. Stephan drove and called 911. The family met the ambulance a few kilometers from Cardston where the ambulance attendants took over Ezekiel’s care. By then Ezekiel was blue.<br />
<br />
[29] When the emergency responders took over Ezekiel’s care he had no pulse or blood pressure, his heart rate was 0, he was not breathing, his respiratory rate was 0, and his Glasgow Coma Scale (GCS) score was 3, the lowest score possible. The GCS gives an indication of the level of consciousness. He had no eye opening, muscle movement or verbal response. The doctors described this state as being dead.</blockquote>
Despite Ezekiel's signs indicating that he was dead by the time the emergency responders arrived, they did not give up on him. They took over CPR and tried to establish an airway, but were unable to for about 8 minutes. Once they reached the hospital, they saw Ezekiel's chest rise and fall. Doctors took over, continuing CPR and giving him intravenous medications and fluids. After about 30 minutes, his heart started beating again. He was ultimately transported to the pediatric intensive care unit at the Alberta Children's Hospital in Calgary. He did not regain consciousness. Two different neurologists examined him on the mornings of March 15 and 16, both determining that he was brain dead. David and Collet Stephan kept him on life support for two more days despite Ezekiel's continued lack of neurological function.<br />
<br />
David Robert Stephan and Collet Dawn Stephan were <a href="http://www.cbc.ca/news/canada/calgary/meningitis-trial-verdict-1.3552941" target="_blank">found guilty of failing to provide the necessaries of life</a> on April 26, 2016.<br />
<br />
Not once since their son died have the Stephans acknowledged that they did anything wrong. Instead, they blame the emergency responders for not having the appropriately sized tube to intubate Ezekiel.<br />
<br />
The Facebook page Prayer for Ezekiel has posted comments contesting the facts of the case. For example, they posted a portion of a transcript of one of the 911 calls, claiming that Ms. Stephan was able to get air into Ezekiel and that he was breathing again. Yet the transcript shows that <a href="https://www.facebook.com/PrayersForEzekiel/posts/1226640500679866?comment_id=1226642617346321&comment_tracking=%7B%22tn%22%3A%22R9%22%7D" rel="nofollow" target="_blank">Ezekiel was <i>not</i> breathing</a>:<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjRsOZ918CHr0wrMXhUynQA4d9OfRDhutjy1lyOplfsKI24V5p8TTUsFCqDa8buhnCvAL5fMs38bF_Ub-49y8lBhw5FfJwKqok_O6EfrmFqKnpnBumMT1WKJ1COFLKwUXvW5Ba5w9RAjdlo/s1600/911+Call+-+Ezekiel+was+not+breathing.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="307" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjRsOZ918CHr0wrMXhUynQA4d9OfRDhutjy1lyOplfsKI24V5p8TTUsFCqDa8buhnCvAL5fMs38bF_Ub-49y8lBhw5FfJwKqok_O6EfrmFqKnpnBumMT1WKJ1COFLKwUXvW5Ba5w9RAjdlo/s400/911+Call+-+Ezekiel+was+not+breathing.png" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Photo: Facebook/<a href="https://www.facebook.com/PrayersForEzekiel/posts/1226640500679866?comment_id=1226642617346321&comment_tracking=%7B%22tn%22%3A%22R9%22%7D" rel="nofollow" target="_blank">Prayers for Ezekiel</a> (Click to enlarge)<br />
Note the faded portions where Collet says he was not breathing.</td></tr>
</tbody></table>
<a href="https://www.facebook.com/david.stephan.568/posts/10156529198400722" rel="nofollow" target="_blank">The Stephans have also claimed</a> that the case is really an attempt by the government to set a legal precedent to hold non-vaccinating parents criminally liable if the child falls ill:<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJI2FxpWFLBPdDLWd2Frp5kryC0AqARZFVamhjxCin7fSCTxTq06vPLQ2wEbZfjYLdqeKitwA_-5hrIq1YfE66lKzJBW_BEYH4gqSKfJozsIlDpJoCh-KcUqPZf5Gyo9nwNYSUxVl-dV45/s1600/David+Stephan+-+Conspiracy+Against+Us.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJI2FxpWFLBPdDLWd2Frp5kryC0AqARZFVamhjxCin7fSCTxTq06vPLQ2wEbZfjYLdqeKitwA_-5hrIq1YfE66lKzJBW_BEYH4gqSKfJozsIlDpJoCh-KcUqPZf5Gyo9nwNYSUxVl-dV45/s320/David+Stephan+-+Conspiracy+Against+Us.png" width="117" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Source: Facebook/<a href="https://www.facebook.com/david.stephan.568/posts/10156529198400722" target="_blank">David Stephan</a> (Click to enlarge)</td></tr>
</tbody></table>
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</div>
The autopsy report, which <a href="https://www.facebook.com/PrayersForEzekiel/photos/p.1226640787346504/1226640787346504/?type=3&theater" rel="nofollow" target="_blank">Prayers for Ezekiel claims was falsified</a>, notes that Ezekiel's death was likely caused by the bacterium <i>Haemophilus influenzae</i>:<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgBvEelFe77kdJmdixoXD1n1pwmbwcJWyvk1C06bd0TL6yECSmjQuNg8W_bJcK0ndG7vVv7ShubSs92bID8_Qw1OGqVJ5F_i4OBIXfKGKSG5YCdw5M4BLqrq5U-4NnKThBSorNcf3RALwIu/s1600/Ezekiel+Stephan+Autopsy+Report.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgBvEelFe77kdJmdixoXD1n1pwmbwcJWyvk1C06bd0TL6yECSmjQuNg8W_bJcK0ndG7vVv7ShubSs92bID8_Qw1OGqVJ5F_i4OBIXfKGKSG5YCdw5M4BLqrq5U-4NnKThBSorNcf3RALwIu/s320/Ezekiel+Stephan+Autopsy+Report.jpg" width="248" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Photo: Facebook/<a href="https://www.facebook.com/PrayersForEzekiel/photos/p.1226640787346504/1226640787346504/?type=3&theater" rel="nofollow" target="_blank">Prayers for Ezekiel</a> (Click to enlarge)</td></tr>
</tbody></table>
<i>Haemophilus influenzae</i> type b can be prevented by immunization, but it is unclear from the autopsy report which serotype of <i>Haemophilus influenzae</i> Ezekiel had. Yet this case is not about whether Mr. and Mrs. Stephan were negligent in not vaccinating their son. Rather, the case is about their not seeking appropriate medical attention to treat Ezekiel's illness, which ultimately killed him. There were multiple points when his parents ought to have recognized that he needed proper professional medical care. The vaccine issue is a distraction from the fact that, whether or not David and Collet thought they were doing the right thing, their actions (or rather, inaction) killed their son.<br />
<br />
But the vaccination issue has garnered support for the Stephans. The <a href="https://reasonablehank.com/2016/06/21/vaxxed-documentary-team-rallies-behind-actual-child-killers/" target="_blank">anti-vaccine community</a> is <a href="http://jezebel.com/vaxxed-filmmakers-support-parents-convicted-of-letting-1782353108" target="_blank">rallying behind them</a>. Del Bigtree, producer of the anti-vaccine film <i>Vaxxed</i>, posted a brief interview with David and Collet on <a href="https://www.facebook.com/del.bigtree/videos/10153531538035964/" rel="nofollow" target="_blank">Facebook</a>:<br />
<div style="text-align: center;">
<br /></div>
<div style="text-align: center;">
<iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/CwC_WhKS40s" width="420"></iframe><br /></div>
<br />
The primary concern appears to be with what this case has meant for David and Collet and other parents who choose to eschew proper medical attention for their sick children, rather than concern for the children themselves. Reasonable people, like the jury who convicted the Stephans, recognize that what they did is reprehensible. Reasonable people focus on the kids. The Stephans, Polly Tommey, Del Bigtree, and the like seem to care more for the parents that neglect and abuse their children.<br />
This is an attitude that is, sadly, quite common among those who opt for so-callled "alternative medicine". <a href="http://www.harpocratesspeaks.com/2015/07/who-chooses-parents-vs-childrens-rights.html" target="_blank">Children have rights</a>. They <a href="http://scienceblogs.com/insolence/2013/10/29/children-are-not-their-parents-property/" target="_blank">are not the property of their parents</a>. While parents have the right to make medical decisions for their children, <a href="http://www.harpocratesspeaks.com/2014/03/the-case-of-justina-pelletier-calls-for.html" target="_blank">those rights</a> <a href="http://www.harpocratesspeaks.com/2014/02/mississippi-parent-group-working-to.html" target="_blank">are not absolute</a>. What is truly disturbing is how the anti-vaccine community tends to rally behind parents that harm their own children. Anti-vaccine groups like the <a href="https://twitter.com/nvicloedown/status/473894608590864384" rel="nofollow" target="_blank">National Vaccine Information Center</a> and the <a href="https://reasonablehank.com/2014/05/26/meryl-dorey-again-repeats-vaccines-cause-shaken-baby-syndrome-lie-at-queensland-expo/" target="_blank">Australian Vaccination-Skeptics Network</a> try to excuse child abusers by <a href="https://www.sciencebasedmedicine.org/the-antivaccine-lie-that-just-wont-die-shaken-baby-syndrome-is-really-due-to-vaccine-injury/" target="_blank">claiming that shaken baby syndrome is actually vaccine injury</a>, and that the abusers were wrongfully accused. They sympathize with and excuse <a href="https://leftbrainrightbrain.co.uk/2013/08/31/whitewashing-the-brutal-murder-of-alex-spourdalakis/" target="_blank">parents who kill</a> <a href="http://www.harpocratesspeaks.com/2013/09/cbs-sympathizes-with-murderers.html" target="_blank">their autistic children</a>. And when a <a href="http://www.sciencealert.com/this-12-year-old-just-trolled-anti-vaccers-in-the-most-brilliant-way" target="_blank">child artfully takes down</a> the anti-vaccine movement, <a href="https://epidemiological.net/2016/06/05/the-fear-a-12-year-old-mexican-can-raise/" target="_blank">they respond</a> by <a href="https://www.sciencebasedmedicine.org/how-low-antivaccine-warriors-will-go-attacking-a-12-year-old-and-abusing-facebook-harassment-reporting-algorithms/" target="_blank">trying to intimidate</a> and <a href="http://jezebel.com/anti-vax-activists-are-trying-to-dox-a-12-year-old-budd-1781097185" target="_blank">dox him</a> (<a href="https://www.facebook.com/ScienceMarco/posts/235384123512781" target="_blank">try being the operative word</a>).<br />
<br />
For all that the anti-vaccine movement claims to be about the kids, they really only care for themselves, for their ideology. Will any of them have the courage to stand up and denounce those who harm their children?<br />
<br />
<b>Addendum:</b> <br />
As an additional resource, there is a blog that has put up transcripts of the <a href="http://stephanmeningitis.blogspot.com/" target="_blank">police interviews</a> with David and Collet. The interviews were originally released by <a href="http://www.cbc.ca/news/canada/calgary/stephan-david-collet-lethbridge-meningitis-police-interview-toddler-death-1.3537887" target="_blank">CBC News</a>. Note that despite what Mr. Stephan claims in the interview with Polly Tommey and Del Bigtree, Mrs. Stephan admits that Ezekiel was too stiff to sit in his car seat. The interviews also reveal that his symptoms ought to have raised concern and cued his parents to take him to a doctor.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com8tag:blogger.com,1999:blog-3609683919099708226.post-30036200970530364682016-06-01T03:00:00.000-04:002016-06-01T03:00:00.981-04:00Measles Doesn't Kill, Except When It Does<div class="separator" style="clear: both; text-align: center;">
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There are quite a number of things that people take for granted today, regarding their health, at least in developed nations, like the United States. The majority of the population doesn't think much about the possibility of starving or being malnourished. If we suffer an injury, we can find treatment at a nearby pharmacy or convenience store. For something more serious, medical care is generally not too far away along roads that are kept in good repair. The same thing if we get sick.<br />
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There are diseases that we may never see in our lives, anymore, thanks in large part to vaccines. While these diseases may ravage poorer countries that lack the resources and infrastructure to provide a high level of immunization, such as <a href="http://outbreaknewstoday.com/philippines-measles-outbreak-2014-58010-cases-110-deaths-31292/" target="_blank">the Philippines</a>, those who live in affluent countries seldom see diseases that were once a common occurrence, let alone deaths from those diseases. This leads to a measure of complacency. Those of us who suffered through vaccine-preventable diseases all too easily think that it was nothing. After all, we made it. We forget, however, those who weren't so lucky, those who are no longer here to tell their story. So it is that we think of diseases like measles as no big deal. We think that it's only dangerous for people "over there".<br />
<br />
Unfortunately, measles does not care what we think. It doesn't recognize borders. It doesn't care if you're from the United States, Germany, the Philippines, Pakistan, Nigeria, Brazil. It will infect wherever it can. And it will kill without a care about who you are or what you believe.<br />
<a name='more'></a><br />
It is not uncommon to hear someone on the internet claim that measles isn't dangerous. They will say that <a href="https://twitter.com/justin_kanew/status/734850463678369792" target="_blank">we haven't had any recent measles deaths</a> in the U.S. They might argue that the last measles death was in 2003, even though a woman <a href="http://www.doh.wa.gov/Newsroom/2015NewsReleases/15119WAMeaslesRelatedDeath" target="_blank">died in 2015</a> due to measles pneumonia. They may try to convince others that the lack of measles deaths is because the disease has become less serious on its own, and that vaccines have nothing to do with it. Often, they will <a href="http://www.harpocratesspeaks.com/2014/06/pre-vaccine-declines-in-measles.html" target="_blank">trot out a graph</a> that shows how measles mortality was decreasing before the vaccine was introduced. Sometimes they'll try to claim that mortality (dying from a disease) is just an extreme version of morbidity (getting sick with a disease), perhaps like a doctor who has lost his license <a href="http://scienceblogs.com/insolence/2016/05/31/andrew-wakefield-claims-natural-herd-immunity-is-better-than-anything-vaccines-can-do-never-mind-all-that-suffering/" target="_blank">recently said</a>:<br />
<blockquote>
As a consequence of natural Herd Immunity, in the developed world
measles mortality had fallen by 99.6% before measles vaccines were
introduced. A fall in morbidity will have paralleled the fall in
mortality (mortality is the extreme of morbidity).</blockquote>
What they do not note, however, is that the mortality rate never dropped below about <a href="http://www.cdc.gov/measles/about/complications.html" target="_blank">1-2 per 1,000 cases</a> to <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC81137/" target="_blank">1 per 3,000 cases</a>, nor do they note that the <a href="http://www.harpocratesspeaks.com/2014/06/pre-vaccine-declines-in-measles.html" target="_blank">total number of cases (morbidity) didn't drop</a> until the vaccine was introduced. They will also generally not mention that the "no deaths since 2003" figure represents only <i>lab-confirmed</i> measles deaths. That figure leaves out deaths due to measles that were diagnosed clinically, but did not meet the CDC criteria for lab confirmation. Nor does the figure include deaths due to <a href="https://www.nlm.nih.gov/medlineplus/ency/article/001419.htm" target="_blank">subacute sclerosing panencephalitis</a> (SSPE), a rare, universally fatal, complication of measles.<br />
<br />
Before we get into all of those other deaths, let's take a look at just the lab-confirmed measles deaths. We have <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5331a3.htm" target="_blank">two in 2003</a> and one in 2015. From 2003-2015, there were 1,846 cases of measles in the U.S., giving us a mortality rate of about 1.6 deaths for every 1,000 cases. This doesn't differ much from the mortality rate around the time the vaccine was introduced. The picture changes, somewhat, when we include data from death certificates.<br />
<br />
The <a href="http://www.cdc.gov/nchs/nvss/" target="_blank">National Vital Statistics System</a> provides a wealth of additional information on births and deaths in this country. Accessed via the CDC's WONDER database, anyone can look up data on the underlying cause of death, with the caveat that the recorded cause of death reflects the physician's best clinical judgment. It can then be grouped by a variety of criteria, letting users slice and dice things to a great level of detail. We could see how many people died of a particular disease or disease complication, what year they died, what the age distribution was, and so forth.<br />
<br />
Once we delve into these death records, we see that there have been more deaths than just the three noted above. For the same 2003-2015 period, NVSS shows 9 deaths from measles with or without complications (it only shows 1 for 2003; this may be because the other death was reported using a non-measles ICD code). There were also 20 deaths due to SSPE in the same period. In fact, if we look at the entire span covered by ICD-10 codes (<a href="http://wonder.cdc.gov/ucd-icd10.html" target="_blank">1999-2014</a>), we get a much grimmer view of this easily preventable disease:<br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg1YDDARf1vZhLlRRLMm5x-Ib1c3lPlCtF7t7Qvj5ZpLRGnfXfkeu5-y3hAvsjD_b8x69Vdwv5vh7yPFiOu9RW0QmNl4kORXRgAFYtyFPGqOgvwICElmblmDiJ5wYtpwWmnCGZNvaCRqCJe/s1600/Measles+Deaths+1999-2014.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="365" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg1YDDARf1vZhLlRRLMm5x-Ib1c3lPlCtF7t7Qvj5ZpLRGnfXfkeu5-y3hAvsjD_b8x69Vdwv5vh7yPFiOu9RW0QmNl4kORXRgAFYtyFPGqOgvwICElmblmDiJ5wYtpwWmnCGZNvaCRqCJe/s400/Measles+Deaths+1999-2014.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Click to enlarge.<br />
Source: <a href="http://wonder.cdc.gov/ucd-icd10.html" target="_blank">CDC WONDER Database, Detailed Mortality</a></td></tr>
</tbody></table>
For the last seventeen years, there have been 51 deaths due to measles and its complications (49 reported to the NVSS plus 1 additional death each in 2003 and 2015 confirmed by CDC). Let's put that into perspective against the number of measles cases overall for those same years:<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbwCaoC315JSiV2wMKOdkO8fos9AL0PiTLByVNZP435W5729CQoc9T3ztQM8OdmpB1hDijcIHHPph2XGJK0RrZJCQIftlOYrwQAdgkM_2AJxGSbtzC8ugn5SaFrLTrMRCtk0Qi-LM9XF3R/s1600/Measles+Cases+and+Deaths+1999-2015.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="353" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbwCaoC315JSiV2wMKOdkO8fos9AL0PiTLByVNZP435W5729CQoc9T3ztQM8OdmpB1hDijcIHHPph2XGJK0RrZJCQIftlOYrwQAdgkM_2AJxGSbtzC8ugn5SaFrLTrMRCtk0Qi-LM9XF3R/s400/Measles+Cases+and+Deaths+1999-2015.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Note: The 2003 total only includes data from NVSS. <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5331a3.htm" target="_blank"><br />CDC confirms there were two deaths that year</a>.</td></tr>
</tbody></table>
This should begin to illustrate the toll that measles takes on people, even those living in affluent countries. And remember, this is only looking at <i>deaths</i> from measles. The virus can also cause a number of non-fatal, but still serious complications, such as encephalitis (resulting in deafness or intellectual disability), ear infections (resulting in hearing loss), and pneumonia. Around <a href="http://www.nhs.uk/conditions/vaccinations/pages/measles-outbreak-advice.aspx" target="_blank">1 in 10 kids need to be hospitalized due to measles</a>, though, again, certain doctors who value stories over facts may try to claim that those are <a href="http://www.harpocratesspeaks.com/2011/03/soft-hospitalizations-in-minnesota.html" target="_blank">"soft hospitalizations"</a>. Furthermore, measles can make its victims <a href="http://science.sciencemag.org/content/348/6235/694.abstract" target="_blank">susceptible to other diseases (even ones they've had before) for up to 2-3 years</a>.<br />
<br />
The next time you see or hear someone saying that measles "isn't that bad", remind them that it still <a href="http://www.harpocratesspeaks.com/2014/05/anti-vaxers-and-math-dont-mix.html" target="_blank">kills a fair number of those it infects</a>, even in the United States. Show them these numbers. Remind them that it does more than kill. It also disables. It makes them more vulnerable to other diseases. Even those who are not permanently injured can still spend time in the hospital receiving supportive care. And if they advocate getting immunity "the natural way" (i.e., by suffering through an infection), possibly even recommending hosting a measles tea, do your best to steer them away from such <a href="http://www.harpocratesspeaks.com/2014/06/orgies-of-death-dangerous-tradition-of.html" target="_blank">orgies of death</a>. They can achieve immunity without the disease, and without being medically negligent, thanks to vaccinations.<br />
________________________________________<br />
References:<br />
<ul>
<li>Centers for Disease Control and Prevention. (2015). <a href="http://www.cdc.gov/measles/about/complications.html" target="_blank">Complications of measles</a>. Retrieved June 30, 2016 from <a href="http://www.cdc.gov/measles/about/complications.html" target="_blank">http://www.cdc.gov/measles/about/complications.html</a> </li>
<li>Centers for Disease Control and Prevention WONDER Database. <a href="http://wonder.cdc.gov/cmf-icd9.html" target="_blank">Compressed mortality,
1979-1998</a>. National Vital Statistics System. </li>
<li>Centers for Disease Control and Prevention WONDER Database. <a href="http://wonder.cdc.gov/ucd-icd10.html" target="_blank">Detailed mortality, 1994-2014</a>. National Vital Statistics System.</li>
<li>Centers for Disease Control and Prevention. (2004). <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5331a3.htm" target="_blank">Epidemiology of measles -- United States, 2001-2013</a>. <i>Morbidity and Mortality Weekly Report</i>. Retrieved June 30, 2016 from <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5331a3.htm" target="_blank">http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5331a3.htm</a> </li>
<li>Centers for Disease Control and Prevention. (2009). <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5653a1.htm" target="_blank">Summary of notifiable infectious diseases and conditions - United States, 2007</a>. Retrieved June 30, 2016 from <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5653a1.htm" target="_blank">http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5653a1.htm</a> </li>
<li>Centers for Disease Control and Prevention. (2015). <a href="http://www.doh.wa.gov/Newsroom/2015NewsReleases/15119WAMeaslesRelatedDeath" target="_blank">Summary of notifiable infectious diseases and conditions - United States, 2013</a>. Retrieved June 30, 2016 from <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6253a1.htm" target="_blank">http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6253a1.htm</a> </li>
<li>Herriman, R. (2015). <a href="http://outbreaknewstoday.com/philippines-measles-outbreak-2014-58010-cases-110-deaths-31292/" target="_blank">Philippines measles outbreak 2014: 58,010 cases, 110 deaths</a>. <i>Outbreak News Today</i>. Retrieved June 30, 2016 from <a href="http://outbreaknewstoday.com/philippines-measles-outbreak-2014-58010-cases-110-deaths-31292/" target="_blank">http://outbreaknewstoday.com/philippines-measles-outbreak-2014-58010-cases-110-deaths-31292/</a> </li>
<li>Mina, MJ, Mercalf, CJE, de Swart, RL, Osterhaus, ADME, & Grenfell, BT. (2015). <a href="http://science.sciencemag.org/content/348/6235/694.abstract" target="_blank">Long-term measles-induced immunomodulation increases overall childhood infectious disease mortality</a>. <i>Science, 348</i>(6235), 694-699.</li>
<li>NHS. (2015). <a href="http://www.nhs.uk/conditions/vaccinations/pages/measles-outbreak-advice.aspx" target="_blank">Measles outbreak: what to do</a>. Retrieved June 31, 2016 from <a href="http://www.nhs.uk/conditions/vaccinations/pages/measles-outbreak-advice.aspx" target="_blank">http://www.nhs.uk/conditions/vaccinations/pages/measles-outbreak-advice.aspx</a> </li>
<li>Shapiro, H & Weir, E. (2001). <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC81137/" target="_blank">Measles in your office</a>. <i>Canadian Medical Association Journal, 164</i>(11), 1614. </li>
<li>U.S. National Library of Medicine. (2014). <a href="https://www.nlm.nih.gov/medlineplus/ency/article/001419.htm" target="_blank">Subacute sclerosing panencephalitis</a>. Retrieved June 30, 2016 from <a href="https://www.nlm.nih.gov/medlineplus/ency/article/001419.htm" target="_blank">https://www.nlm.nih.gov/medlineplus/ency/article/001419.htm</a> </li>
<li>Washington State Department of Health (2015). <a href="http://www.doh.wa.gov/Newsroom/2015NewsReleases/15119WAMeaslesRelatedDeath" target="_blank">Measles led to death of Clallam Co. woman; first in a dozen years</a>. Retrieved June 30, 2016 from <a href="http://www.doh.wa.gov/Newsroom/2015NewsReleases/15119WAMeaslesRelatedDeath" target="_blank">http://www.doh.wa.gov/Newsroom/2015NewsReleases/15119WAMeaslesRelatedDeath</a></li>
</ul>
Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com2tag:blogger.com,1999:blog-3609683919099708226.post-40115239708327298862016-05-23T03:00:00.000-04:002016-05-24T22:09:52.267-04:00The NECSS of Thought and Reality - Year 6May 13-15 marked the eighth annual <a href="http://necss.org/" target="_blank">Northeast Conference on Science and Skepticism</a> (NECSS). This was the sixth time I've attended, though I almost skipped this year (more on that later). For those who have never attended, NECSS is a joint effort by the <a href="http://nycskeptics.org/" target="_blank">New York City Skeptics</a> and <a href="http://www.theness.com/" target="_blank">The New England Skeptical Society</a>. The conference, once more held at the Fashion Institute of Technology, fills three days of science, critical thinking, and education for attendees on a wide range of subjects. Some topics are geared toward the general public, while some sessions are more introspective, looking at the skeptical community itself. If you weren't able to make it, don't worry; videos from the conference will be posted on the <a href="https://www.youtube.com/user/NECSSConference" target="_blank">NECSS YouTube channel</a>. You can also get a taste of previous years' conferences from my reviews of <a href="http://www.harpocratesspeaks.com/2011/04/necss-of-thought-and-reality.html" target="_blank">2011</a>, <a href="http://www.harpocratesspeaks.com/2012/05/necss-of-thought-and-reality-year-2.html" target="_blank">2012</a>, 2013 (<a href="http://www.harpocratesspeaks.com/2013/04/the-necss-of-thought-and-reality-year-3.html" target="_blank">part 1</a> and <a href="http://www.harpocratesspeaks.com/2013/05/the-necss-of-thought-and-reality-year-3.html" target="blank">part 2</a>), 2014 (<a href="http://www.harpocratesspeaks.com/2014/04/the-necss-of-thought-and-reality-year-4.html" target="_blank">part 1</a> and <a href="http://www.harpocratesspeaks.com/2014/04/the-necss-of-thought-and-reality-year-4_23.html" target="_blank">part 2</a>), and 2015 (<a href="http://www.harpocratesspeaks.com/2015/04/necss-year-5-part-1.html" target="_blank">part 1</a>, life unfortunately intervened, so I never got around to writing up days 2 and 3).<br />
<br />
As always, I like to take this time to summarize what skepticism means, at least to me. Many people have a caricature image of skepticism in their minds as people who simply reject things out of hand, arguing against things simply for the sake of disagreeing. Contrarian would be a better word to describe that. Skepticism, on the other hand, doesn't have to do with <i>what</i> you think, or just dismissing things that you don't agree with. It is <i>how</i> one approaches the world. Skepticism involves questioning claims and investigating evidence to see where it leads, always open to the possibility that what we may have thought was true is actually wrong. When we read something on the internet, whether it's the latest celebrity gossip or questions on the nature of the universe, we use skepticism to evaluate the claims and weigh the quality of the evidence. Skepticism isn't just critically examining others' claims, though. It's also taking a critical look at our own beliefs, and a willingness to change our beliefs to match the evidence, rather than trying to fit reality to our beliefs. As for the skeptical community, we're just normal people from all backgrounds. It's the <i>way</i> that we examine the world around us that brings us together.<br />
<br />
Now that that's out of the way, how was this year's conference?<br />
<a name='more'></a><br />
<u><b>Day 1 - Science-Based Medicine</b></u><br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgUtb5Mz1RjfvAJ1ku_8S7Ssk8tGrMtVXZCu3i3DYo7cQKjbX97aw2PUn5FuDDFO1YjDtY5qTJxAYagkIsj6c_mi6bIq4-hWUrhq_xW0bLrkDhC1OlXjJdiwPYBbC3eIWUjXH6d3FaioCDp/s1600/NECSS+Day+1.jpg" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="243" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgUtb5Mz1RjfvAJ1ku_8S7Ssk8tGrMtVXZCu3i3DYo7cQKjbX97aw2PUn5FuDDFO1YjDtY5qTJxAYagkIsj6c_mi6bIq4-hWUrhq_xW0bLrkDhC1OlXjJdiwPYBbC3eIWUjXH6d3FaioCDp/s320/NECSS+Day+1.jpg" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Harriet Hall, Grant Ritchey, Scott Gavura, Jann Bellamy,<br />
John Snyder, Saul Hymes, Clay Jones, Steve Novella,<br />
Panel, and SBM Q&A</td></tr>
</tbody></table>
As with last year, Friday was a full day devoted to science-based medicine. While last year's talks took a more introductory tack, this year focused on slightly more advanced topics. <a href="http://www.skepdoc.info/index.html" target="_blank">Dr. Harriet Hall</a> opened the morning and her talk on functional medicine with a tribute to one of the original authors at the <a href="https://www.sciencebasedmedicine.org/" target="_blank">Science-Based Medicine Blog</a>, <a href="https://www.sciencebasedmedicine.org/emeritus/wallace-sampson-md-assistant-editor/" target="_blank">Dr. Wallace "Wally" Sampson</a>, who passed away last year. Dr. Hall recounted how Wally described functional medicine (FM) as IBTHOOM (It Beats The Hell Out Of Me), since even the promoters of functional medicine have such a vague definition that could describe conventional medicine just as well. The main difference, according to Dr. Hall, is that FM incorporates quackery and real medicine, though its practitioners often claim that diet alone is enough to treat disease, while also arguing that "normal" is not enough; we must strive to go beyond normal.<br />
<br />
<a href="http://necss.org/speakers/grant-ritchey/" target="_blank">Dr. Grant Ritchey</a>, one of the hosts of the <a href="http://www.prismpodcast.com/" target="_blank">The Prism</a> podcast, then took us into the world of dental quackery, from amalgam fillings and fluoride myths to other fringe practices, like "toxic" root canals, acupuncture to treat dental issues, and <a href="https://www.sciencebasedmedicine.org/oil-pulling-your-leg/" target="_blank">oil pulling</a>. One of the more amusing examples he shared was cranial osteopathy. Practitioners claim they can treat dental issues by shifting the bones of the skull, when they really just move the soft tissue around. If the bones of the skull really were being shifted around, the patient would suffer severe trauma, since the bones are a) fused together quite strongly and b) interlocked by many intricate turns along the edges.<br />
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Demonstration of cranial osteopathy. Practitioner claims he is moving the skull bones.</div>
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Staff in Dr. Ritchey's office, with no training, show it's just the soft tissue moving.</div>
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One of the more interesting talks of the morning came from pharmacist <a href="https://www.sciencebasedmedicine.org/contributors/scott-gavura-bscphm-mba-rph/" target="_blank">Scott Gavura</a>, discussing dietary supplements. Talks on dietary supplements usually go into the questions of safety and efficacy of these products. What made Gavura's talk different was that he went into the pharmacokinetics of herbs, vitamins, and other supplements, that is, how the body absorbs, distributes, metabolizes, and eliminates (ADME) substances. Some supplements, like curcumin (from turmeric), are poorly absorbed and rapidly eliminated, while others, like St. John's Wort, can interact with other drugs, resulting in lower efficacy or increased risk of adverse events.<br />
<br />
Attorney <a href="https://www.sciencebasedmedicine.org/contributors/jann-bellamy-jd/" target="_blank">Jann Bellamy</a> took the legal side of dietary supplements, discussing the legislative and cultural history of supplement regulation. The current state of regulation is largely due to lobbying efforts by supplement manufacturers, coupled with <a href="https://www.youtube.com/watch?v=IV2olDA0w8U" target="_blank">propaganda commercials</a> starring big names like Mel Gibson.<br />
<br />
After lunch, emcee Jamy Ian Swiss did his usual schtick of doing a magic trick to welcome people back for the afternoon sessions. Surprisingly, it was the only magic he did during the conference, but still felt a bit old. I've mentioned before that the conference could use someone different to serve as emcee.<br />
<br />
At any rate, the first talk of the afternoon was <a href="https://www.sciencebasedmedicine.org/contributors/john-m-snyder-md/" target="_blank">Dr. John Snyder</a>. Dr. Snyder covered the risks of mixing quackery with pediatric care, citing examples from Northampton Wellness Associates (NWA), a Complementary and Alternative Medicine clinic near his practice. A common feature of these cases are a staggering battery of lab tests on these children that are not indicated by any clinical features. Treatment frequently involved supplements (sold by NWA), as well as real drugs to treat nonexistent illnesses. Dr. Snyder's overall style was especially engaging, using humor to keep the audience engaged.<br />
<br />
Pediatric infectious disease doctor, <a href="http://necss.org/speakers/saul-hymes/" target="_blank">Dr. Saul Hymes</a>, then led us into the world of Lyme disease. This talk held particular interest for me, considering my own <a href="http://www.harpocratesspeaks.com/2013/10/b-lyme-y.html" target="_blank">brush with the disease</a>. Dr. Hymes taught us about how the disease is diagnosed, what it does to the body, and the controversy around post-treatment Lyme disease (not to be confused with the fictitious disorder called Chronic Lyme Disease).<br />
<br />
Pediatrician <a href="http://necss.org/speakers/clay-jones/" target="_blank">Dr. Clay Jones</a> gave an overview of infant chiropractic, highlighting how unscrupulous chiropractors use fear to scare parents into getting their children's spines manipulated. As with Dr. Snyder's examples, Dr. Jones explained how chiropractors attempt to treat self-limiting conditions and non-existent illnesses by manipulating the spine and supposedly the skull (recall the severe head trauma I mentioned earlier). While most infant chiropractic involves gentle, rather than high-velocity/low-amplitude, movements, he did share one particularly frightening video of Ian Rossborough, an Australian chiropractor, cracking a premature infant's spine:<br />
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<iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/MDgSpDSGgoo" width="560"></iframe><br />
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You can read a more in-depth discussion of <a href="https://www.sciencebasedmedicine.org/the-crack-heard-round-the-world/" target="_blank">The Crack Heard Round the World</a> over at Science-Based Medicine.<br />
<br />
Finally, <a href="http://www.theskepticsguide.org/about/steven-novella" target="_blank">Dr. Steven Novella</a> wrapped up the individual talks with an introduction to Bayesian statistics. He emphasized how much of medical science relies too heavily on p-values, ignoring the prior plausibility of the hypothesis. While a Frequentist approach to research tends to examine hypotheses in somewhat of a vacuum, a Bayesian approach looks at the hypothesis in the context of what we already know (i.e., prior plausibility) and modifies the prior plausibility based on the results of the research.<br />
<br />
The day closed with a panel discussion on whether doctors should "fire" patients who refuse to vaccinate their kids, and a Q&A for all of the SBM speakers. Some highlights coming out of this are that doctors probably should not fire patients, but rather try to educate them. We also got ideas for how to advocate for science-based medicine (Dr. Snyder mentioned that his waiting room has a laminated flipboard of reliable web sites), how to respond to "it worked for me" (acknowledge that you're happy they're better, but also ask why they think it worked), and what the ideal regulation is for supplements. And last of all, we learned that parents who fall for quackery, even if they mean well, can unfortunately open themselves up to accusations, and even convictions for, <a href="http://www.harpocratesspeaks.com/2016/04/medical-child-abuse-overview-part-1.html" target="_blank">medical child abuse</a>.<br />
<br />
An added bonus on Friday night was the Skeptical Extravaganza of Special Significance, hosted by the crew of the Skeptics' Guide to the Universe, with emcee George Hrab and special guest Bill Nye. This was a fun, relatively loose sort of variety show culminating in an audience vs. SGU trivia contest. While is found <a href="http://www.harpocratesspeaks.com/2015/04/necss-year-5-part-1.html" target="_blank">last year's</a> extravaganza to have a better pace and energy, it was still a fun way to end the day.<br />
<br />
<u><b>Day 2 - Thinking, Memory, Advocacy, SGU, Diversity, and Positive Skepticism</b></u><br />
<br />
<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi89XBSkq8uPD-nGQ6BI6sRkUw_0UegIHD1dMmlgAHixQlmSQgjhIQ4mur8KHRPtWPd9cyoCeFiqpkwMAVQ8ygCe1LGghV0fIi0wRAqt_xtYcL4SUOKxWFx5t-hMzL4-N1y9LpA7Q2LQiM0/s1600/NECSS+Day+2.jpg" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="183" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi89XBSkq8uPD-nGQ6BI6sRkUw_0UegIHD1dMmlgAHixQlmSQgjhIQ4mur8KHRPtWPd9cyoCeFiqpkwMAVQ8ygCe1LGghV0fIi0wRAqt_xtYcL4SUOKxWFx5t-hMzL4-N1y9LpA7Q2LQiM0/s320/NECSS+Day+2.jpg" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Deborah Berebichez, Shari Berkowitz, Bill Nye, SGU<br />
SGU, Panel, and Richard Wiseman</td></tr>
</tbody></table>
The next morning, I headed a couple blocks down to the Malibu Diner at 163 W. 23rd St. for some breakfast. I've eaten here pretty much every year the conference has been held at FIT. The food is good, service is fast, and the staff are incredibly nice. Every time I've been in there, they welcome the regulars, including several different blind customers.<br />
<br />
<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi52RgRE-G8zkS2NSDbi3RIu8Ijs6kQSYMYyhsxocAmgi8RnjG9Hl7keGO-RGXH3QDvzgDBdNdK-dMqsBgosiURB8GXP0NTw4cJ0DrxNhJPLS27sSmMm6N4HWUr83Yvpl7QkgrMIGEDSrtF/s1600/Outrageous+Thinking.JPG" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="260" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi52RgRE-G8zkS2NSDbi3RIu8Ijs6kQSYMYyhsxocAmgi8RnjG9Hl7keGO-RGXH3QDvzgDBdNdK-dMqsBgosiURB8GXP0NTw4cJ0DrxNhJPLS27sSmMm6N4HWUr83Yvpl7QkgrMIGEDSrtF/s320/Outrageous+Thinking.JPG" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Dr. Berebichez gives examples of reasonable/outrageous<br />
and true/false ideas. (Click to Enlarge)</td></tr>
</tbody></table>
After breakfast, it was back to FIT to hear <a href="http://www.sciencewithdebbie.com/" target="_blank">Dr. Deborah Berebichez</a>,
physicist and STEM advocate. She spoke on how ideas can be basically
approximated in terms of reasonable or outrageous, true or false. Washing hands to prevent disease is reasonable and true, while the idea that vaccines cause autism is outrageous and false. But where an idea falls into the grid can change over time, as new evidence surfaces. The idea that vaccines cause autism was, at one time, a reasonable, though false, idea. Hand-washing to prevent disease was once outrageous, though true. Reasonable but false and outrageous but true areas challenge our skeptical outlook.<br />
<br />
Next up, <a href="http://necss.org/speakers/shari-berkowitz/" target="_blank">Dr. Shari Berkowitz</a> discussed the fallibility of memory and how the judicial system lacks sufficient scientific inquiry. She noted how memories can change and how people can be made to remember events that never happened, whether by suggestion or by the person telling a lie enough times that they eventually believe it to be true. This can cause trouble in the courts, since witnesses may implicate the wrong individual, and innocent suspects may even confess to a crime they did not commit. Dr. Berkowitz calls for scientists to educate the courts, and reminds us to look at <i>all</i> of the evidence, how reliable and accurate it is, and whether the source of the evidence is independent.<br />
<br />
Last year's keynote speaker, <a href="http://billnye.com/#home" target="_blank">Bill Nye</a>, returned this year to talk about science advocacy and an upcoming documentary about him titled <i>Change the World</i>. Although science denialists have been very successful, Nye urges us to remain optimistic and be confident that we can overcome the denialists and make a positive change in the world. As Nye said, "Now I'm talking to adults, and I'm not mincing words."<br />
<br />
After lunch, the crew of the <a href="http://www.theskepticsguide.org/" target="_blank">Skeptics' Guide to the Universe</a> had their live NECSS show that serves as a tribute to <a href="http://theness.com/neurologicablog/index.php/perry-deangelis-8221963-8192007/" target="_blank">Perry DeAngelis</a>, one of the co-founders of the New England Skeptical Society.<br />
<br />
Then it was on to a panel featuring Dr. Berebichez, <a href="http://www.cnn.com/profiles/rachel-crane-profile" target="_blank">Rachel Crane</a>, and <a href="http://necss.org/speakers/hussein-jirdeh/" target="_blank">Dr. Hussein Jirdeh</a>, moderated by <a href="http://necss.org/speakers/jennifer-lopez/" target="_blank">Jennifer Lopez</a>. Though listed as being about diversity in science and space exploration, the panel focused mainly on diversity in <a href="http://www.ed.gov/stem" target="_blank">STEM</a> in general. There are still a lot of barriers to gender and racial minorities, which is unfortunate, since creativity and innovation thrive when people from many different backgrounds are involved. Students need to be able to see themselves in science advocates and educators. Much of what was discussed we've heard before, which highlights why this is such an important topic, and how we still have a good fight ahead of us to increase diversity in science.<br />
<br />
The afternoon presentations ended with this year's keynote speaker, <a href="https://richardwiseman.wordpress.com/" target="_blank">Prof. Richard Wiseman</a>. This was truly a treat, as Prof. Wiseman is an amazing speaker and entertainer. With a blend of magic, humor, and science, he showed us how our brains make shortcuts, seeing or hearing what isn't there. We essentially trick ourselves. It's very easy for us to get bogged down in countering misinformation, falling into a negative approach. Prof. Wiseman reminds us that we can be positive, and that science and skepticism are amazing ways to reach youth.<br />
<br />
He followed his talk with a "show without a performer", titled <i>Experimental</i>. The audience essentially drives the show by making choices at several points. It combines psychology, magic, and whimsy. There was so much in this show that words can't do it justice. Suffice to say that it engaged everyone in the audience and had us laughing together.<br />
<br />
After the conference, the <a href="https://www.secular.org/" target="_blank">Secular Coalition for America</a> sponsored a free reception for all NECSS attendees. Normally, the conference holds a fundraising reception to help defray costs and fund future conferences as an opportunity to meet and talk with the presenters. While it was welcome that this year's reception was free (including a free drink ticket for each attendee), it really amounted to Drinking Skeptically with an added lobbying rally thrown in. It was still a fun evening, including some science/skepticism-themed trivia. I used the opportunity to hang out with some friends and make some new ones.<br />
<br />
<u><b>Day 3 - Introspection, Con Men, Climate Change, ISS, Rationally Speaking, and Free Speech</b></u><br />
<br />
<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiJS1FLKTWOZEjvBTcq61sroWWw5egggxQ86pafBW30COjZQmRq7vGu7Rj5DjO9dHuGjTkPxp20C9s_DIxsLgKpvNilcy1GMPXNZ-132Llg2YDUk2BPN9zUgnF0iaaf0NQpAMg9An2IuaAd/s1600/NECSS+Day+3.jpg" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="265" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiJS1FLKTWOZEjvBTcq61sroWWw5egggxQ86pafBW30COjZQmRq7vGu7Rj5DjO9dHuGjTkPxp20C9s_DIxsLgKpvNilcy1GMPXNZ-132Llg2YDUk2BPN9zUgnF0iaaf0NQpAMg9An2IuaAd/s320/NECSS+Day+3.jpg" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Yvette d'Entremont, Maria Konnikova, Michael Mann<br />
Jennifer Lopez, Rationally Speaking, and Panel</td></tr>
</tbody></table>
Yvette d'Entremont, aka <a href="http://www.scibabe.com/" target="_blank">SciBabe</a>, opened the last day of NECSS with primer on some of the mistakes that skeptics, including herself, make. People who have been in the skeptical community for a long time likely knew most of what she discussed, but hers was a good introduction for those who are relatively new to skeptical activism. It's very easy to fall into a sort of cult of personality, launching <i>ad hominems</i> at writers we don't like rather than addressing their content. We also need to be wary of going from skepticism to cynicism, avoiding confirmation bias, argument from authority, and not doing our research.<br />
<br />
<a href="http://www.mariakonnikova.com/" target="_blank">Maria Konnikova</a> then took us into the world of the confidence man, using the example of <a href="https://en.wikipedia.org/wiki/Ferdinand_Waldo_Demara" target="_blank">Ferdinand Waldo Demara</a>, a man who successfully conned people, even when they knew he had lied to them. He exemplifies the features of a successful con artist: psychopathy, narcissism, and Machiavellianism. These traits allow the con artist to coldly analyze others, giving them the appearance of being a good listener; justify his actions; and manipulate people into thinking that it was their own idea to take whatever action benefits the con artist. Konnikova was the only speaker that did not use slides, engaging the audience only through powerful storytelling and a tone of voice that made you sit up and listen.<br />
<br />
Climatologist <a href="http://www.meteo.psu.edu/holocene/public_html/Mann/index.php" target="_blank">Dr. Michael Mann</a> spoke about his upcoming book, <a href="http://www.meteo.psu.edu/holocene/public_html/Mann/books/madhouse/index.php" target="_blank"><i>The Madhouse Effect</i></a>. Dr. Mann teams up with political cartoonist <a href="https://www.washingtonpost.com/people/tom-toles" target="_blank">Tom Toles</a> to tackle climate change denialism through satirical cartoons. He showed a number of cartoons illustrating various points that hit home against those who question the role of humans in global climate change. Unfortunately, the images were often too small to read from further away than the first several rows of the auditorium. Nonetheless, <i>The Madhouse Effect</i> looks like it can be an effective tool to address deniers' claims...if only they would read it.<br />
<br />
The last speaker before lunch was <a href="http://necss.org/speakers/jennifer-lopez/" target="_blank">Jennifer Lopez</a>, Commercial Innovation Technology Development Lead at the <a href="http://www.iss-casis.org/" target="_blank">Center for the Advancement of Science in Space</a> (CASIS). Lopez noted that the International Space Station is a <a href="http://www.spacestationresearch.com/" target="_blank">national laboratory</a> open to researchers. "We have a framework for discovery," she said. The ISS allows for experiments in microgravity that cannot be done on Earth.<br />
<br />
<a href="http://necss.org/speakers/julia-galef/" target="_blank">Julia Galef</a> next hosted <a href="http://rationallyspeakingpodcast.org/" target="_blank">Rationally Speaking</a>, with guest bioethicist <a href="http://www.jacobmappel.com/" target="_blank">Jacob Appel</a>.<br />
<br />
The podcast was followed by a panel on free speech, social justice, and political correctness. Moderated by <a href="http://necss.org/speakers/brian-wecht/" target="_blank">Brian Wecht</a>, the panel featured <a href="http://necss.org/speakers/heather-berlin/" target="_blank">Dr. Heather Berlin</a>, <a href="https://www.thefire.org/resources/speakers-bureau/will-creeley/" target="_blank">Will Creeley</a>, Yvette d'Entremont, and Julia Galef. A good portion of the discussion focused on sensitivities vs. free speech, and that while a person may have the right to say whatever they wish, they do not have a right to a platform from which to speak. Absolute free speech is a fiction. The panel came about as a result of what happened with Richard Dawkins. You can read about the background <a href="http://theness.com/neurologicablog/index.php/necss-and-richard-dawkins/" target="_blank">here</a>.<br />
<br />
In my intro, I mentioned how I had nearly skipped attending this year's NECSS. That was due to their invitation to Richard Dawkins. However, it wasn't because of the video that Dawkins shared, but because of his long history of denigrating others and consistently failing to take responsibility for his words, choosing instead to dig himself deeper. I recognize that he has done a great deal to advance critical thinking, particularly in the field of evolution vs. creationism. However, he too frequently allows his ideology to drive his speech, doing more to divide the skeptical movement than to bring it together. Unfortunately, other than just a couple of passing comments, the panel did not address this at all. It would have been a far more interesting and worthwhile discussion if they had.<br />
<br />
I had to leave after the panel, so I did not see the final two talks of the conference, from <a href="http://www.thegreatcourses.com/professors/john-mcwhorter/" target="_blank">Dr. John McWhorter</a>, speaking on the disappearance of languages, and journalist <a href="http://www.johnhorgan.org/" rel="nofollow" target="_blank">John Horgan</a>, on "hard" vs. "soft" targets of skepticism. Horgan did, however, <a href="http://blogs.scientificamerican.com/cross-check/dear-skeptics-bash-homeopathy-and-bigfoot-less-mammograms-and-war-more/" target="_blank">publish his talk</a> on Scientific American's website. Horgan's talk created a bit of a stir, garnering critical posts from <a href="http://theness.com/neurologicablog/index.php/john-horgan-is-skeptical-of-skeptics/" target="_blank">Dr. Steven Novella</a>, <a href="http://scienceblogs.com/insolence/2016/05/18/john-horgan-is-skeptical-of-skeptics-or-homeopathy-and-bigfoot-versus-the-quest-for-world-peace/" target="_blank">Orac</a>, and <a href="http://www.skeptic.com/insight/bigfoot-versus-the-quest-for-world-peace/" target="_blank">Daniel Loxton</a>, and a supportive post from <a href="http://freethoughtblogs.com/pharyngula/2016/05/18/skepticism-will-not-fix-its-problems-by-denying-their-existence/" target="_blank">PZ Myers</a>. Horgan <a href="http://blogs.scientificamerican.com/cross-check/my-response-to-responses-to-my-critique-of-skepticism/" target="_blank">penned a reply</a> to these responses in which he essentially claimed victory. His original talk had a grain of a point: skeptics should question not only those with whom they disagree, but also those with whom they agree. Unfortunately, he proceeded to stray from that point to attack strawmen. His rebuttal, likewise, boils down to an admission that he was doing little more than trolling skeptics for a reaction, rather than making a substantive point.<br />
<br />
Other than the couple of less-than-ideal presentations, I only have two other critiques. First, the conference could do with a new emcee. While Swiss may do an adequate job for newcomers, he feels a bit too predictable and lackluster. Second, raising the house lights could encourage greater audience engagement, particularly during panel discussions. At one point, an audience member asked for the house lights to be brought up, but was overruled by Swiss. Another journalist present also mentioned that the lack of house lights made taking notes very difficult, a feeling I share. Even one of the speakers was taken aback at stepping onto the stage and seeing only black. Even raising the house lights to half could help alleviate these issues and encourage greater audience engagement.<br />
<br />
Overall, my criticism aside, this year's NECSS hosted some excellent speakers. As always, it was a great opportunity to learn new things,
meet new people, and reconnect with friends. Keep an eye on the <a href="https://www.youtube.com/user/NECSSConference" target="_blank">NECSS YouTube channel</a> for videos from the conference.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh5ZqWXmNmGuBtx-xf-P0KUfd0AOEIqs-9nYREueoYnI-8mxlvmHohdawHyexFR7_SPOf9XKXrPBWEYcaPhdDLoPHmqWjTiWAPSIFU2uEdcgybtfRvfRMUuHzIAZ_zgwJEakG5WAE4P8BcB/s1600/NECSS+Staff+and+Volunteers.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh5ZqWXmNmGuBtx-xf-P0KUfd0AOEIqs-9nYREueoYnI-8mxlvmHohdawHyexFR7_SPOf9XKXrPBWEYcaPhdDLoPHmqWjTiWAPSIFU2uEdcgybtfRvfRMUuHzIAZ_zgwJEakG5WAE4P8BcB/s1600/NECSS+Staff+and+Volunteers.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">The amazing staff and volunteers that make NECSS a success.</td></tr>
</tbody></table>
Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com0tag:blogger.com,1999:blog-3609683919099708226.post-32811681517213751002016-04-14T02:00:00.000-04:002016-06-08T08:17:00.747-04:00Medical Child Abuse, An Overview - Part 2<i>This post originally appeared at </i><a href="http://thescientificparent.org/medical-child-abuse-part-two/" target="_blank">The Scientific Parent</a> <i>blog on 4/13/16</i>. <br />
<br />
Medical child abuse can be thought of as the flip side of medical
neglect; instead of failing to get real medical treatment a child needs,
a child’s caregiver seeks out medical treatment that the child does not
need, and which may in fact be harmful. While I addressed that in depth
in my <a href="http://www.harpocratesspeaks.com/2016/04/medical-child-abuse-overview-part-1.html" target="_blank">last post</a>, today, I discuss the complications to this discovery
process. What about rare diseases? How can physicians tell the
difference? In this post, I address rare diseases, regulations, and
mandated reporting issues.<br />
<a name='more'></a><br />
<u><b>Medical Child Abuse or Rare Disease?</b></u><br />
<br />
While
some cases of medical child abuse may be easier to identify (such as
when the caregiver tampers with medical equipment), there may be
considerable difficulty differentiating between fabricated illness and a
rare disease. Rare or emerging diseases may not have clear, objective
tests to diagnose them, or the tests may not yet be sufficiently robust
for accurate diagnosis. Doctors may lack the expertise to identify a
rare disease, as well, and may suspect abuse where there is none; the
child may actually be sick because of the disease.<br />
<br />
There
are several features that have been identified for medical child abuse
that are also seen in parents of children with legitimate, if rare,
diseases:<br />
<ul>
<li>They often seek multiple doctors</li>
<li>They may be well-versed in medical terminology</li>
<li>They may seek to raise funds and/or sympathy from others</li>
<li>They may be particularly assertive in asking for more extensive testing</li>
<li>They insist on remaining with their child as much as possible</li>
</ul>
How is a doctor to differentiate between a devoted, loving, and
fierce advocate for their child and a parent who is harming their child
by seeking out unnecessary medical treatment?<br />
<br />
It creates a very
dangerous line for the health care worker to walk. If they fail to
recognize the rare disease and incorrectly report abuse, the child may
continue to suffer or deteriorate from lack of treatment, and the family
member may face significant social and legal harm. If the health care
worker fails to recognize abuse, they may not only contribute to further
unwittingly harming the child, but once released to the caregiver, they
are at risk for <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1029641/pdf/archdisch00560-0005.pdf" target="_blank">continued abuse</a>.<br />
<br />
Unfortunately,
the lack of knowledge of rare diseases can not only make it hard for
parents to find adequate help for their child, but it can also provide a
ripe landscape for medical child abuse. The caregiver may gain a great
deal of knowledge about a rare disease (e.g., mitochondrial disorder)
and fabricate or induce symptoms in their child to simulate that
disease. Without proper expertise, physicians may not notice
discrepancies between the symptoms as reported by the caregiver and the
known symptoms and presentation of the disease.<br />
<br />
These
challenges highlight the importance for doctors and nurses to have clear
and open communication with each other, as well as for doctors to
review medical notes from previous physicians rather than relying solely
on the caregiver's account of prior care. Getting as complete and
accurate a picture is vital to properly diagnosing the cause of the
child's symptoms, and to determine whether it is a real disease or fabricated.<br />
<br />
<u><b>Mandated Reporting</b></u><br />
<br />
All
50 states require, by law, certain classes of individuals to report
suspected cases of child abuse to state officials. Mandatory reporters
include <a href="https://www.childwelfare.gov/pubPDFs/manda.pdf#page=1&view=Professionals%20Required%20to%20Report" target="_blank">doctors, nurses, and other health care workers</a>. It is a duty that <a href="http://www.chadhayesmd.com/medical-child-abuse-is-a-problem-not-a-panic/" target="_blank">they take very seriously</a>.
They are dedicated to ensuring the well-being of their patients, first
and foremost, and the stakes are very high. Incorrectly diagnosing
medical child abuse holds the potential to cause serious emotional and
psychological trauma to the child, or, in the other direction, it may
lead to continued abuse from the child's caregiver, and possibly even
death. Furthermore, if a clinician or other health care worker reports medical child abuse, whether they are
right or wrong, they put themselves and the hospital in the legal
crosshairs of the family. It is not a diagnosis to make lightly.<br />
<br />
There
are no objective standards by which a report must be made, and when a
report must be made can vary between states. Most, however, require the
reporter to make a report when they suspect or reasonably believe that a
child is being abused. They must make a judgment call based on the
evidence they have at their disposal.<br />
<br />
<u><b>The Focus is the Child</b></u><br />
<br />
Remember, though, that the focus of medical child abuse, or caregiver-fabricated illness in a child, is the <i>child</i>
and the alleged abuse's effect upon them. Do the caregiver's actions result in the
child being harmed by inappropriate or unnecessary medical tests and
treatments? It does not matter what the caregiver's intentions or
motivations are.<br />
<br />
They may be doing it for attention themselves, to paint
themselves as a martyr.<br />
<br />
They may be doing it out of malice toward the
child.<br />
<br />
Or, they may excessively worry about inconsequential health
issues in the child, such as a cough or minor rash, or make up symptoms
in order to get medical treatment they think their child needs; while
their intentions maybe good, their actions ultimately result in the harm
of the child.<br />
<br />
<b>The first step is to stop the harm to
the child.</b> That will almost certainly require that the child be
separated from the caregiver, and possibly other colluding family
members, for some period of time. [<b><i>Edited to add: </i></b><i>please note that this is specifically in reference to </i>treating<i> medical child abuse, i.e., once the diagnosis has been made and other causes, such as rare diseases, have been ruled out.</i>] Treatment may include medical care to
correct any damage done by previous treatment, as well as psychological
care to address any mental harm that resulted from the abuse. It will
also include therapy for the caregiver and other family members, to help
them identify and be aware of abusive behaviors. This is the step where
understanding the caregiver's motivation can be most helpful, since <a href="http://pediatrics.aappublications.org/content/132/3/590.long" target="_blank">it can help clarify what course of treatment is required</a>.
Ideally, the child will eventually be reunited with their caregiver,
though this is not always possible. Some caregivers may never admit that
they are responsible, or they may not develop the skills to recognize
and manage their own needs to avoid future abuse.<br />
<br />
<u><b>Responding to Medical Child Abuse Allegations in the Media</b></u> <br />
<br />
When
you read about a case involving an allegation of medical child abuse,
understand that you need to approach it with a great deal of nuance and
caution. It is an almost certain guarantee that you will not have all of
the relevant facts available to you.<br />
<br />
While the family is free to say
whatever they like about the case, the medical providers are restricted
by Federal law from discussing the details.<br />
<br />
It is easy to react without
thinking and cast blame on the doctors, especially when details are
scarce or only come from one side of the issue. We see an emotionally
distraught parent asking us for sympathy, and we want to comfort them.
We understand how it would feel to have our children taken away from us.
We want to believe that parents would never do anything to hurt their
children, but it does happen. That emotional parent may truly be upset
and want their child back, yet still be the cause of their child's
illness and harm. The pleas may be a facade, designed to evoke sympathy
and attention for the caregiver, rather than an actual attempt to help
the child.<br />
<br />
Above all, remember that we all, parents and
health care providers alike, want what is best for the child. Take
steps to learn more about medical child abuse and the signs to look for.
It may just save a child's life.<br />
______________________________<br />
<b>References and Additional Reading</b><br />
<ul>
<li>Bools CN, Neale BA, & Meadow SR. (1993). <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1029641/pdf/archdisch00560-0005.pdf" target="_blank">Follow up of victims of fabricated illness (Munchausen syndrome by proxy)</a>. <i>Archives of Disease in Childhood, 69</i>.</li>
<li>Burton MC, Warren MB, Lapid MI, & Bostwick JM. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25274180" target="_blank">Munchausen syndrome by adult proxy: a review of the literature</a>. <i>Journal of Hospital Medicine, 10</i>(1).</li>
<li>Child Welfare Information Gateway. (2014). <a href="https://www.childwelfare.gov/topics/systemwide/laws-policies/statutes/manda/" target="_blank">Mandatory
reporters of child abuse and neglect</a>. United States Department of Health
and Human Services. </li>
<li>Flaherty EG, MacMillan HL, & Committee on Child Abuse and Neglect. (2013). <a href="http://pediatrics.aappublications.org/content/132/3/590.long" target="_blank">Caregiver-fabricated
illness in a child: a manifestation of child maltreatment</a>.<i> Pediatrics</i>, <i>132</i>(3).</li>
<li>Harpocrates Speaks. (2014). <a href="http://www.harpocratesspeaks.com/2014/03/the-case-of-justina-pelletier-calls-for.html" target="_blank">The case of Justina Pelletier calls for nuance and moderation</a>.</li>
<li>Harpocrates Speaks. (2014). <a href="http://www.harpocratesspeaks.com/2014/07/case-of-justina-pelletier-spawns.html" target="_blank">Case of Justina Pelletier spawns dubious legislation</a>. </li>
<li>Harpocrates Speaks. (2016). <a href="http://www.harpocratesspeaks.com/2016/03/Case-of-Justina-Pelletier-Still-Calls-for-Nuance.html" target="_blank">The case of Justina Pelletier still requires nuance</a>. </li>
<li>Harpocrates Speaks. (2014). <a href="http://www.harpocratesspeaks.com/2014/03/justina-pelletier-to-remain-in.html" target="_blank">Justina Pelletier to remain in Massachusetts DCF custody</a>. </li>
<li>Hayes C. (2015). <a href="http://www.chadhayesmd.com/medical-child-abuse-is-a-problem-not-a-panic/" target="_blank">Medical child abuse is a problem, not a panic</a>. <i>Demystifying Pediatrics</i>. (web site)</li>
<li>Koetting C. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25900681" target="_blank">Caregiver-fabricted illness in a child</a>. <i>Journal of Forensic Nursing, 11</i>(2).</li>
<li>Rabbone I, Galderisi A, Tinti D, Ignaccolo MG, Barbetti F, & Cerutti F. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/26438710" target="_blank">Case report: when an induced illness looks like a rare disease</a>. <i>Pediatrics, 136</i>(5). </li>
<li>Roesler TA & Jenny C. (2008). <i><a href="http://ebooks.aappublications.org/content/medical-child-abuse" target="_blank">Medical child abuse: Beyond Munchausen syndrome by proxy</a></i>. American Academy of Pediatrics.</li>
<li>Yalndağ-Öztürk N, Erkek N, & Şirinoğlu MB. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25856657" target="_blank">Think again: first do no harm: a case of Munchausen syndrome by proxy</a>. <i>Pediatric Emergency Care, 31</i>(10). </li>
</ul>
Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com0tag:blogger.com,1999:blog-3609683919099708226.post-50450995938469666102016-04-13T02:00:00.000-04:002016-04-13T02:00:10.906-04:00Medical Child Abuse, An Overview - Part 1<i>This post originally appeared at </i><a href="http://thescientificparent.org/medical-child-abuse/" target="_blank">The Scientific Parent</a> <i>blog on 4/12/16</i>.<br />
<br />
Recently, I wrote about the case of Justina Pelletier, whose parents are <a href="http://www.harpocratesspeaks.com/2016/03/Case-of-Justina-Pelletier-Still-Calls-for-Nuance.html" target="_blank">suing Boston Children's Hospital</a> for negligence after the hospital rejected Justina's diagnosis of mitochondrial disorder in favor of somatoform disorder. The hospital staff further suspected medical child abuse, which they reported to Massachusetts Department of Children and Families. I won't go into the details of Justina's case. If you're interested, you can read my <a href="http://www.harpocratesspeaks.com/2014/03/the-case-of-justina-pelletier-calls-for.html" target="_blank">original post</a> on the subject, my <a href="http://www.harpocratesspeaks.com/2014/03/justina-pelletier-to-remain-in.html" target="_blank">follow-up post</a>, or my post on the <a href="http://www.harpocratesspeaks.com/2014/07/case-of-justina-pelletier-spawns.html" target="_blank">dubious legislation</a> that her case spawned.<br />
<br />
Instead, I want to focus on medical child abuse here - what it is, and the difficulties and nuances involved with it. Many parents or other caregivers, and even many health care providers, may not know much about what constitutes medical child abuse. This article will, hopefully, serve as a general introduction and jumping off point for further discussion.<br />
<a name='more'></a><br />
<u><b>What is Medical Child Abuse?</b></u><br />
<br />
Medical child abuse can be thought of as the flip side of medical neglect; instead of failing to get real medical treatment a child needs, the caregiver seeks out medical treatment that the child does not need, and which may in fact be harmful.<br />
<br />
"Medical child abuse" is a relatively new term, <a href="http://ebooks.aappublications.org/content/medical-child-abuse" target="_blank">coined in 2009 by Drs. Thomas Roesler and Carole Jenny</a>. Their intent was to replace the use of Munchausen Syndrome by Proxy (MSbP) to focus more on the effects on the child, rather than on a diagnosis of the caregiver. MSbP occurs when a caregiver, particularly a parent, fabricates or induces illness in a person under their care in order to garner attention for themselves.<br />
<br />
Medical child abuse (MCA), on the other hand, focuses on the effects on the child, rather than on the intention of the caregiver. MCA is <a href="http://pediatrics.aappublications.org/content/132/3/590.long" target="_blank">one of a number of names</a>, including "factitious disorder by proxy", "child abuse in the medical setting", and "caregiver-fabricated illness in a child", that attempt to describe the same thing: abuse of a child by a caregiver through the fabrication or induction of illness, regardless of the intent of the caregiver (though identifying the intention may assist with treatment). Although most cases of MCA involve the mother, perpetrators may be fathers, grandparents, older siblings, or anyone else in a position to fabricate or induce an illness in the child.<br />
<br />
Cases of medical child abuse often involve a variety of organ systems (gastrointestinal, cardiovascular, neurological, etc.). Symptoms may fluctuate, though they typically occur in the presence of the caregiver, or the caregiver is the only one who witnesses the episode. The perpetrator of the abuse will often "doctor shop" or seek numerous opinions and interventions for the child's condition. Occasionally, the victim of the abuse may even collude with their abuser to fabricate their own illness.<br />
<br />
Thankfully, the reported <a href="http://pediatrics.aappublications.org/content/132/3/590.long" target="_blank">incidence is low</a>, at around 0.5 to 2.0 cases per <a href="http://pediatrics.aappublications.org/content/132/3/590.long" target="_blank">100,000 children under 16 years of age</a>, though it is also believed to be under-reported, due in part to the difficulty in identifying the abuse.<br />
<br />
The goal in identifying medical child abuse is to stop current harm to the child, as well as to prevent future harm. But diagnosing MCA can be incredibly difficult. The relationship between a parent and their child's doctors is built on trust. Doctors trust that their patients and families will give them an accurate account of the signs and symptoms experienced, as well as anything that might have contributed to the illness described.<br />
<br />
When a child is the victim of MCA, however, the caregiver might make up the symptoms, or they might take actions that cause the symptoms - for example by <a href="http://www.ncbi.nlm.nih.gov/pubmed/25900681" target="_blank">poisoning</a> or suffocating the child. The caregiver's actions then lead to tests or treatments that not only are unnecessary, but may be invasive or have increased risk for the child. When those tests or treatments have no effect on the child's apparent illness, it can lead to further tests and treatments that cause further harm to the child. That may be one of the first clues that more is going on than the parent is saying.<br />
<br />
Flaherty and MacMillan (2013) identified several <a href="http://pediatrics.aappublications.org/content/132/3/590.long" target="_blank">indicators of possible fabricated illness in a child</a>:<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhTG7epY5mR9_ipkRhFuuGjCYXpkh8F8Z9SgYm6jXreHwxqtct_38j9NxrYCyxEezGHlDtEHxGlx-jtMyQHIgVKlHIWk9atTc5m0Av89n5X0UVdvfPLLgvNaJynzy1cEAgV5MIOf5UgyFUa/s1600/Indicators+of+Possible+Fabricated+Illness+in+a+Child+-+Flaherty+et+al.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="214" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhTG7epY5mR9_ipkRhFuuGjCYXpkh8F8Z9SgYm6jXreHwxqtct_38j9NxrYCyxEezGHlDtEHxGlx-jtMyQHIgVKlHIWk9atTc5m0Av89n5X0UVdvfPLLgvNaJynzy1cEAgV5MIOf5UgyFUa/s400/Indicators+of+Possible+Fabricated+Illness+in+a+Child+-+Flaherty+et+al.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Click to enlarge.<br />
Source: <a href="http://pediatrics.aappublications.org/content/132/3/590.long" target="_blank">Flaherty and MacMillan, 2013</a>.</td></tr>
</tbody></table>
A child's alleged symptoms may be inconsistent with objective tests, they may only occur in the presence of the caregiver, or they may be unusually resistant to treatment. The clinical history may also have numerous inconsistencies. Additionally, the caregiver's own behavior may hold clues: their reactions may not match the severity or seriousness of the situation, they may not be relieved when they're told the child is improving, and they may insist on invasive procedures, even if there's no medical indication for them. These points are congruent with a pattern where caregivers may also seek out multiple different doctors or specialists to pursue additional treatments and procedures.<br />
<br />
<u><b>Difficulties in Diagnosis and Reporting</b></u><br />
<br />
As mentioned above, diagnosing medical child abuse can be very difficult. When the caregiver exaggerates or makes up the symptoms, they may not be present when the doctor examines the child. Symptoms may be nonspecific, leading the doctor to suspect a more common ailment. Even when the symptoms do not match normal physiology, the physician may suspect a rare disorder, rather than maltreatment. There may even be some real underlying medical illness that, combined with the fabricated symptoms, confound an accurate diagnosis. Compounding the problems with identifying medical child abuse, treating physicians may not communicate with previous doctors to discuss the case and obtain additional details.<br />
<br />
Even in cases where medical child abuse is suspected, where there are clues, doctors may still not report it. They may feel that there is insufficient evidence to support their report. Occasionally, they may have previous experiences with child protective services that deter them from reporting, such as when CPS has not taken action to protect a child.<br />
<br />
Reporting is also not without legal risk to the doctor, who could be subject to a lawsuit. Or the physician may avoid reporting because of the harm that an incorrect report could cause to the child and their family. Often, the only way to make a firm diagnosis of medical child abuse is to catch the caregiver in the act (for example, using covert video surveillance) or separating the caregiver from the child to see if symptoms improve in the absence of the suspected caregiver.<br />
<br />
Each of those options, however, carry their own problems. Not every health care setting is equipped to conduct video surveillance, let alone the ethical questions that arise from using it. And separation from the caregiver may erode the trust relationship with the health care provider.<br />
<br />
Then there are the rare diseases. How can physicians tell the difference? Tomorrow, I'll address rare diseases, regulations, and mandated reporting issues.<br />
______________________________<br />
<b>References and Additional Reading</b><br />
<ul>
<li>Bools CN, Neale BA, & Meadow SR. (1993). <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1029641/pdf/archdisch00560-0005.pdf" target="_blank">Follow up of victims of fabricated illness (Munchausen syndrome by proxy)</a>. <i>Archives of Disease in Childhood, 69</i>.</li>
<li>Burton MC, Warren MB, Lapid MI, & Bostwick JM. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25274180" target="_blank">Munchausen syndrome by adult proxy: a review of the literature</a>. <i>Journal of Hospital Medicine, 10</i>(1).</li>
<li>Child Welfare Information Gateway. (2014). <a href="https://www.childwelfare.gov/topics/systemwide/laws-policies/statutes/manda/" target="_blank">Mandatory
reporters of child abuse and neglect</a>. United States Department of Health
and Human Services. </li>
<li>Flaherty EG, MacMillan HL, & Committee on Child Abuse and Neglect. (2013). <a href="http://pediatrics.aappublications.org/content/132/3/590.long" target="_blank">Caregiver-fabricated
illness in a child: a manifestation of child maltreatment</a>.<i> Pediatrics</i>, <i>132</i>(3).</li>
<li>Harpocrates Speaks. (2014). <a href="http://www.harpocratesspeaks.com/2014/03/the-case-of-justina-pelletier-calls-for.html" target="_blank">The case of Justina Pelletier calls for nuance and moderation</a>.</li>
<li>Harpocrates Speaks. (2014). <a href="http://www.harpocratesspeaks.com/2014/07/case-of-justina-pelletier-spawns.html" target="_blank">Case of Justina Pelletier spawns dubious legislation</a>. </li>
<li>Harpocrates Speaks. (2016). <a href="http://www.harpocratesspeaks.com/2016/03/Case-of-Justina-Pelletier-Still-Calls-for-Nuance.html" target="_blank">The case of Justina Pelletier still requires nuance</a>. </li>
<li>Harpocrates Speaks. (2014). <a href="http://www.harpocratesspeaks.com/2014/03/justina-pelletier-to-remain-in.html" target="_blank">Justina Pelletier to remain in Massachusetts DCF custody</a>. </li>
<li>Hayes C. (2015). <a href="http://www.chadhayesmd.com/medical-child-abuse-is-a-problem-not-a-panic/" target="_blank">Medical child abuse is a problem, not a panic</a>. <i>Demystifying Pediatrics</i>. (web site)</li>
<li>Koetting C. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25900681" target="_blank">Caregiver-fabricted illness in a child</a>. <i>Journal of Forensic Nursing, 11</i>(2).</li>
<li>Rabbone I, Galderisi A, Tinti D, Ignaccolo MG, Barbetti F, & Cerutti F. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/26438710" target="_blank">Case report: when an induced illness looks like a rare disease</a>. <i>Pediatrics, 136</i>(5). </li>
<li>Roesler TA & Jenny C. (2008). <i><a href="http://ebooks.aappublications.org/content/medical-child-abuse" target="_blank">Medical child abuse: Beyond Munchausen syndrome by proxy</a></i>. American Academy of Pediatrics.</li>
<li>Yalndağ-Öztürk N, Erkek N, & Şirinoğlu MB. (2015). <a href="http://www.ncbi.nlm.nih.gov/pubmed/25856657" target="_blank">Think again: first do no harm: a case of Munchausen syndrome by proxy</a>. <i>Pediatric Emergency Care, 31</i>(10). </li>
</ul>
Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com0tag:blogger.com,1999:blog-3609683919099708226.post-78522726935355749662016-04-04T09:00:00.000-04:002019-10-22T08:12:50.417-04:00Wakefield's "Vaxxed" Demands Less Safety<div class="separator" style="clear: both; text-align: center;">
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiIiNFGsgsZ6Xkn0VCXJ0iJY0TfeKLw5jeQSsuiJ-3fn8z75-4vS8LhxuadHAhyphenhyphen9yOxq06RtgRwYL7el-WnNaqTHxfEurJDCGuNOgw1f49O2TN0E10om14rR1FCvFpbJVxFHby3Zc_XhH3N/s1600/Vaxxed+Movie.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiIiNFGsgsZ6Xkn0VCXJ0iJY0TfeKLw5jeQSsuiJ-3fn8z75-4vS8LhxuadHAhyphenhyphen9yOxq06RtgRwYL7el-WnNaqTHxfEurJDCGuNOgw1f49O2TN0E10om14rR1FCvFpbJVxFHby3Zc_XhH3N/s1600/Vaxxed+Movie.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">"This is not an anti-vaccine movie. We're just going to use ominous imagery to make people scared of vaccines."<br />
- Del Bigtree, Vaxxed Producer [My paraphrase.]</td></tr>
</tbody></table>
This past weekend, Andrew Wakefield's factitious documentary <i>Vaxxed: From Cover-Up to Catastrophe</i> premiered in New York City at the Angelika Film Center, after being dropped from the TriBeCa Film Festival. A number of reporters and skeptics attended the film, <a href="https://storify.com/lizditz/critical-views-of-vaxxed-the-movie-premiering-toda" target="_blank">live-tweeting the experience</a> and writing up reviews of the movie afterward. You can read reviews at <i><a href="http://www.hollywoodreporter.com/review/vaxxed-cover-up-catastrophe-film-879960" target="_blank">The Hollywood Reporter</a></i>, <i><a href="https://www.statnews.com/2016/04/01/vaxxed-autism-movie-review/" target="_blank">STAT News</a></i>, <i><a href="http://www.theguardian.com/film/2016/apr/02/vaxxed-film-scientist-interview-vaccines-autism" target="_blank">The Guardian</a></i>, <i><a href="http://www.thedailybeast.com/articles/2016/04/01/i-watched-the-anti-vaxx-doc-booted-from-tribeca-film-festival-and-it-was-insane.html" target="_blank">The Daily Beast</a></i>, <i><a href="http://www.indiewire.com/article/vaxxed-from-cover-up-to-catastrophe-is-designed-to-trick-you-review-20160401" target="_blank">Indiewire</a></i>, and others. The central story of the film, such as it is, is William Thompson and the CDC. For background on the saga, please read <a href="http://www.harpocratesspeaks.com/2014/09/mmr-cdc-and-brian-hooker-media-guide.html" target="_blank">this reference guide</a>. (As an aside, even though the impetus behind the film is William Thompson, the CDC researcher does not appear anywhere in the film. Instead, the audience is left with only recorded phone calls between Thompson and Brian Hooker. The transcripts were released last year in a book, which was discussed <a href="https://www.sciencebasedmedicine.org/vaccine-whistleblower-bj-hooker-and-william-thompson-try-to-talk-about-epidemiology/" target="_blank">here</a>, <a blank="" href="https://www.sciencebasedmedicine.org/vaccine-whistleblower-an-antivaccine-expose-full-of-sound-and-fury-signifying-nothing/" target="">here</a>, and <a href="https://www.sciencebasedmedicine.org/review-of-vaccine-whistleblower-a-legal-perspective/" target="_blank">here</a>.) The movie alleges that the CDC covered up evidence that vaccines cause autism. However, according to William Thompson's own documents, which <a href="http://leftbrainrightbrain.co.uk/2016/01/04/the-william-thompson-documents-theres-no-whistle-to-blow/" target="_blank">Matt Carey has kindly made publicly available at his blog Left Brain Right Brain</a>, there was no cover up. <br />
<br />
I have yet to see the film, so I will leave you to read those other reviews. Instead, I wanted to focus on a list of "demands" at the end of the film, helpfully <a href="https://twitter.com/mrjamesmaskell/status/716105645166972928" target="_blank">posted by a Wakefield supporter on Twitter</a>. The four demands would do little to help children or people with autism and would instead run counter to what the anti-vaccine community wants.<br />
<a name='more'></a><br />
<div class="separator" style="clear: both; text-align: center;">
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhjqPxPfo1_2u1UHPPikijjK_V4aKJ-CMgI_LkktJBUFUPSQ5Q14chbt_foxh5nJbn72TeyHJDlnz45Gt-oIDJExMezLTEB2JSPep1vDpmJeq5vihLtJacMhseCt7mxvN7Egq1Eptf2o1n0/s1600/Vaxxed+Movie+Ending+Demands.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhjqPxPfo1_2u1UHPPikijjK_V4aKJ-CMgI_LkktJBUFUPSQ5Q14chbt_foxh5nJbn72TeyHJDlnz45Gt-oIDJExMezLTEB2JSPep1vDpmJeq5vihLtJacMhseCt7mxvN7Egq1Eptf2o1n0/s1600/Vaxxed+Movie+Ending+Demands.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Wakefield's "demands", which wouldn't do anyone any good.</td></tr>
</tbody></table>
<i>Vaxxed</i> ends with four demands:<br />
<ol>
<li>That Congress subpoena Dr. William Thompson and investigate the CDC fraud.</li>
<li>That Congress repeal the <i>1986 National Childhood Vaccine Injury Act</i> and hold manufacturers liable for injury caused by their vaccines.</li>
<li>That the single measles, mumps, and rubella vaccines be made available immediately.</li>
<li>That all vaccines be classified as pharmaceutical drugs and tested accordingly.</li>
</ol>
As I said, if these demands came to fruition, they would not help the anti-vaccine movement at all and would be bad for everyone all around. Very simply, they are, at best, misguided and designed to appeal to people's emotions, rather than good sense.<br />
<br />
<u><b>Subpoena Thompson and Investigate CDC Fraud</b></u><br />
<br />
The first of Wakefield's demands echoes something that the anti-vaccine community has been clamoring for since William Thompson was first outed by Andrew Wakefield and Brian Hooker as the CDC whistleblower two years ago. Since then, there have been a couple of speeches by Representative Bill Posey that have essentially fizzled. Congress doesn't seem all that interested in taking any action, and rightly so, considering there is no evidence of fraud. At most, this would be a waste of taxpayer money and Congressional time that could be better spent on more important things. As noted before, Thompson's own documents show that there was <a href="http://scienceblogs.com/insolence/2016/01/05/the-cdc-whistleblower-documents-a-whole-lot-of-nothing-and-no-conspiracy-to-hide-an-mmr-autism-link/" target="_blank">no coverup or research misconduct</a>, nor did Thompson ever claim the CDC committed fraud. That allegation is something that originated in the fevered minds of the anti-vaccine movement.<br />
<br />
<u><b>Repeal the National Childhood Vaccine Injury Act</b></u><br />
<br />
The second demand would be a very bad idea. The National Childhood Vaccine Injury Act (NCVIA) of 1986 (<a href="http://uscode.house.gov/view.xhtml?path=/prelim@title42/chapter6A/subchapter19&edition=prelim" target="_blank">42 USC 300aa-10 and on</a>) established the <a href="http://www.hrsa.gov/vaccinecompensation/" target="_blank">National Vaccine Injury Compensation Program</a> (VICP), which ensures that those who are actually injured by a vaccine can receive compensation from the Federal government. The program is <a href="http://www.harpocratesspeaks.com/2014/05/who-pays-for-vicp.html" target="_blank">funded by a tax paid by vaccine manufacturers</a> for every vaccine they sell. The act was created through a joint effort by the Federal government, parents, and vaccine manufacturers as a no-fault system that aimed to provide families with a more rapid process than the civil courts, more generous legal standards, and less financial burden. The program also protects manufacturers from lawsuits based on design defect claims (i.e., that the very design of the vaccine is bad and irreparably dangerous), some of which had no merit, and which threatened to drive companies to abandon vaccines altogether before the passage of the act. A common misunderstanding is that the VICP shields manufacturers from <i>all</i> liability; <a href="http://www.harpocratesspeaks.com/2013/02/liar-liar-pants-on-fire.html" target="_blank">it does not</a>. They are still subject to manufacturing and labeling defect claims in the civil court.<br />
<br />
The following table summarizes some of the differences between a case that goes through VICP and a case that goes through the civil courts. A more detailed explanation of the difference can be found <a href="http://www.skepticalraptor.com/skepticalraptorblog.php/national-vaccine-injury-compensation-program-facts/" target="_blank">here</a>.<br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFIL1IJV1S4psJHjqwH5-DjFHQI4useK-meDD2mAxNUQoPBvcMOetXfzDcOyeumCCmugx5-Mp2QKj7yLy1B83Ugztzo5NeNeXYiDJ3kkIUmYrIaMb5li9ekdpoFLR6FdNRclNEWCxlJeFX/s1600/VICP+versus+Civil+Court.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFIL1IJV1S4psJHjqwH5-DjFHQI4useK-meDD2mAxNUQoPBvcMOetXfzDcOyeumCCmugx5-Mp2QKj7yLy1B83Ugztzo5NeNeXYiDJ3kkIUmYrIaMb5li9ekdpoFLR6FdNRclNEWCxlJeFX/s1600/VICP+versus+Civil+Court.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Overall, VICP is more generous to claimants than the civil court system.</td></tr>
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The biggest points to note are that in the civil court, plaintiffs must meet a higher burden of proof that the vaccine caused the injury. They must show that the vaccine's design was defective, that the defect caused the injury, that the risk of the vaccine is greater than the utility of it, and they must provide scientific evidence, subject to the <a href="https://www.law.cornell.edu/wex/daubert_standard" target="_blank">Daubert Standard</a>, to support their claim. By contrast, in VICP, they do not need to show that the vaccine was defective, and in many cases they need not even provide any evidence that the vaccine <i>can</i> cause the injury claimed. All they need to do is show that the injury either meets the requirements for a table injury or that there is a plausible mechanism and timing by which the vaccine <i>might</i> cause such an injury (the <a href="http://caselaw.findlaw.com/us-federal-circuit/1108450.html" target="_blank">Althen Standard</a> for causation, i.e., a medical theory causally connecting the vaccine and injury, a logical sequence of cause and effect, and a reasonable temporal relationship between the vaccination and the injury). In other words, the plaintiff would have a much harder time proving their case in civil court than in VICP.<br />
<br />
Then there is the financial burden. The civil court favors those who have more money in a few different ways. First there's the process of discovery, which is allowed (and required) in civil court, but may be optionally allowed in VICP. While discovery may allow the plaintiff to find information that may help their case, the party with more money (i.e., the vaccine companies) could draw this process out, costing the plaintiff more money and delaying resolution of their case. Second, lawsuits cost a lot of money in general. There are attorneys' fees, expert witness fees, and so on. Under VICP, whether the claimant wins or loses their case, their legal costs (within reason) are covered and paid for by the program. In civil court, they would need to foot the bill themselves. That could bankrupt a family who may already be dealing with expensive medical bills.<br />
<br />
At the end of the day, while repealing the NCVIA would potentially allow manufacturers to be "punished", the reality is that families who are actually harmed by vaccines would be the ones that would lose out. And as much as anti-vaccine activists and their followers complain about the VICP, they would have a much more difficult time of things in civil court.<br />
<br />
<u><b>Make Single Measles, Mumps, and Rubella Vaccines Available</b></u><br />
<br />
For some reason, anti-vaccine activists do not like combination vaccines, like the MMR vaccine, despite there being no evidence that there is any difference in safety between the combination vaccine and single vaccines. Furthermore, splitting the MMR out into separate single vaccines would go against the anti-vaccine mantra that there are <a href="http://www.harpocratesspeaks.com/2016/01/69-doses-of-vaccines.html" target="_blank">too many vaccines</a> that kids get. Currently with the MMR combined vaccine, children get two injections (one at 12-15 months and one at 4-6 years) of the 0.5 mL vaccine, for a total of 1.0 mL. If the vaccine is split into single vaccines, children would get triple the injections (6 separate punctures) and triple the excipients (all the stuff in the vaccine beside the antigens), for a total of 3.0 mL of vaccines. Two doses of vaccines with the current vaccine, or six doses if this demand is granted. Given how anti-vaccine activists complain about so-called "toxins" in vaccines, it is surprising that they would be arguing for more.<br />
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There is also the questions of timing, cost, and completion. While single vaccines would allow parents to spread the MMR series out into six different injections instead of two, they would still likely need to get those in the same timeframe as the combined vaccine in order for their child to be protected from the diseases. That would lead to more visits to the doctor, resulting in more copays. The single vaccines would also cost more than the combined MMR, since they require triple the ingredients. They would also place increased burden on the doctor's office, as doctors would need to triple the space allotted to measles, mumps, and rubella vaccine storage. The increased costs of the vaccines and the cost of storage would drive up medical prices charged by doctors and, consequently, insurance prices. Finally, it's reasonable to question whether parents would complete the vaccinations, since there will be a greater burden on them to take time off of work to do so. That leaves the kids at increased risk of infection from these diseases.<br />
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As a brief aside, it should also be noted that <a href="http://briandeer.com/wakefield/vaccine-patent.htm" target="_blank">Andrew Wakefield holds a patent for a single measles vaccine</a>. As far as I'm aware, this single measles vaccine of Wakefield's has not undergone clinical trials to determine safety or efficacy, nor has it received regulatory approval. I wonder if these facts were disclosed in the film, since Wakefield would stand to make money if the combined MMR were abandoned in favor of single vaccines.<br />
<br />
<u><b>Classify Vaccines as Drugs and Regulate Accordingly</b></u><br />
<br />
This demand is, perhaps, the least informed of the bunch. Vaccines are classified as both <a href="https://www.fda.gov/industry/regulated-products/human-drugs#drug" target="_blank">drugs</a> <i>and</i> <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm" target="_blank">biological products</a>, medical products that are derived from living organisms. Like other drugs, biologics are intended to treat diseases (or in the case of vaccines, to prevent or mitigate them), and they are, technically, a subtype of drug. Because of the <a href="https://www.bio.org/articles/how-do-drugs-and-biologics-differ" target="_blank">differences between non-biological drugs and biological drugs</a> (for simplicity, from here on, I'm going to use "drug" to refer to non-biological drugs), the regulations between a product defined as a "drug" and one defined as a "biologic" also differ slightly. For instance, unlike most drugs, biologics are required to be manufactured under <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm" target="_blank">aseptic conditions from start to finish</a> to avoid microbial contamination by things like bacteria or fungi. The regulations for drugs are found at <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=b94d709a4993c87172b9a7d4abc5e7d3&mc=true&tpl=/ecfrbrowse/Title21/21cfrv4_02.tpl#0" target="_blank">21 CFR 200-299</a> and <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=ed2972565ea5fe912c6a97d2f215107d&mc=true&tpl=/ecfrbrowse/Title21/21cfrv5_02.tpl#0" target="_blank">21 CFR 300-499</a>, and biologic-specific regulations are found at <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=ed2972565ea5fe912c6a97d2f215107d&mc=true&tpl=/ecfrbrowse/Title21/21cfrv7_02.tpl#0" target="_blank">21 CFR 600-680</a><br />
<br />
From the very beginning of manufacturing, vaccines (and biologics in general) must follow very tight production controls. Even a minor change in the process can result in significant changes in the final product. By contrast, a drug can be manufactured using a variety of different methods without significant differences in the final product. This allows the drug manufacturer to change production methods at any time down the line without creating a therapeutically different product. This also allows for generics to be made using different methods. So while a drug manufacturer could make minor changes to the manufacturing process without having to conduct additional clinical trials to show that the finished product has an equivalent safety and efficacy profile to the previous version, the only way for a vaccine maker to get approval for any changes would be to conduct additional clinical trials comparing the new vaccine to the previous version, since they are, in effect, producing a completely new product. From the manufacturing standpoint, then, regulating vaccines as drugs would end up making vaccines less, not more, safe.<br />
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Vaccines have to go through all of the normal steps that drugs have to go through to be approved. Both new vaccines and new drugs must first be tested <i>in vitro</i> and in animal studies before clinical trials can begin in humans. Both require submission of an Investigational New Drug application. Both require phase I studies in humans to determine initial safety. Both require phase II studies to gather additional safety data, start to gather efficacy data, and to work on proper dosage. Both require larger phase III trials to continue gathering safety and efficacy data and to solidify the dosage and administration. New vaccines and new drugs are both required to follow Good Manufacturing Practices and Good Clinical Practices during all phases of development (from animal testing through post-marketing). But because of the nature of how vaccines are used, because they are given to healthy people to prevent disease, they must meet a <a href="http://www.hhs.gov/asl/testify/2007/04/t20070418c.html" target="_blank">stricter balance between risk and benefit</a>, where even rare adverse reactions must be very carefully considered. Furthermore, vaccine manufacturers are often required to conduct phase IV (post-market) clinical trials for new vaccines to continue gathering more safety data.<br />
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Once vaccines are approved, there is another difference between how they are regulated versus how a drug is regulated. If an adverse event occurs after administration of a drug, only the manufacturer is required to report it to FDA. Healthcare professionals and patients are optional reporters. For vaccines, however, in addition to the manufacturer, <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5201a1.htm" target="_blank">healthcare providers are also required to report adverse events</a> to the Department of Health and Human Services. That requirement was put in place by the National Childhood Vaccine Injury Act of 1986 (another reason why demand #2 is ill-advised).<br />
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The bottom line, though, is that vaccines <i>are</i> regulated as drugs already, because biologics <i>are</i> a subtype of drug. There are just some minor differences due to the nature of biologic vs. non-biologic drugs, and some of the regulations for biologics are more stringent than if they were subject only to the non-biologic drug regulations. The result is that if Wakefield's demand #4 were granted, and vaccines were regulated as non-biologic drugs instead of biologics, vaccine safety would <i>decrease</i>.<br />
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<u><b>Conclusion</b></u><br />
<br />
While the demands at the end of <i>Vaxxed</i> appeal to the viewers' emotions, and, on the surface, seem reasonable, once we take a closer look at the details, it should be readily apparent that matters would become <i>worse</i> rather than better. But perhaps that is the goal. Make vaccines less tenable so that the argument to get rid of vaccines altogether seems reasonable and is more likely to come to pass. Unfortunately, public health would suffer. We would see more disease, more permanent disabilities, and more death. Those who suffer real vaccine injuries would have a more difficult time getting compensation. But how many people who see this film will have the knowledge to get past the surface veneer, the seemingly reasonable sheen that hides the darker and more dangerous outcome? My guess is very few.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com7tag:blogger.com,1999:blog-3609683919099708226.post-30713425685479840112016-03-03T10:00:00.000-05:002016-09-19T16:44:21.144-04:00The Case of Justina Pelletier Still Requires NuanceIt's not all that regular that I venture away from the topic of vaccines. I should do it more frequently (and there is one topic I really want to write about if I find the time), but for the most part, I stick to immunizations and the anti-vaccine movement. Now and then, though, I do venture onto other, rather more nuanced subjects. There are certain areas of medicine and ethics that are far less clear cut than whether or not vaccines are safe and effective. For instance, what happens when parents and doctors disagree about a treatment plan for a child? What rights to the parents retain? Can there be questions about who is acting in the best interests of the child? Can a <a href="http://www.harpocratesspeaks.com/2015/07/who-chooses-parents-vs-childrens-rights.html" target="_blank">parent's wishes trump their child's preferences</a>? <br />
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Two years ago, I wrote about the rather <a href="http://www.harpocratesspeaks.com/2014/03/the-case-of-justina-pelletier-calls-for.html" target="_blank">complex case of Justina Pelletier</a> (please read that post for a more detailed discussion of the case at the time). This was a case involving a teenage girl caught between two competing, and controversial, clinical diagnoses: <a href="http://www.ncbi.nlm.nih.gov/books/NBK1224/" target="_blank">mitochondrial disorder</a> and <a href="http://emedicine.medscape.com/article/918628-overview" target="_blank">somatoform disorder</a>. Her story is back in the news, but before I dive into the new developments, some background is in store.<br />
<a name='more'></a><br />
<b><u>The Background</u></b> <br />
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Connecticut teenager Justina Pelletier had been born prematurely and had a <a href="https://www.bostonglobe.com/metro/2013/12/15/justina/vnwzbbNdiodSD7WDTh6xZI/story.html" target="_blank">history</a> of gastrointestinal issues and learning difficulties. After years of being sick off and on, she developed stomach cramps and blockages. Exploratory surgery revealed cartilage wrapped around part of her colon. Despite its removal, along with the removal of her appendix, she did not get better. In 2011 her care was transferred to gastroenterologist Dr. Alejandro Flores, and the following year she had another, relatively new, procedure called a <a href="http://www.hopkinsmedicine.org/healthlibrary/test_procedures/gastroenterology/cecostomy_135,17/" target="_blank">cecostomy</a> performed to install a button port through which doctors could administer drugs that would force her colon to flush itself out. She was then diagnosed in January of 2012 by a Tufts physician, Dr. Mark Korson, as having mitochondrial disorder, a rare and very difficult to diagnose disorder. Dr. Korson's diagnosis consisted of cataloging Justina's symptoms, rather than performing diagnostic lab tests, and he admits that <a href="https://www.bostonglobe.com/metro/2013/12/15/justina/vnwzbbNdiodSD7WDTh6xZI/story.html" target="_blank">he could not be 100% certain of his diagnosis</a> (<i>Boston Globe</i>, Dec. 15, 2013). Then in February 2013, she <a href="http://abcnews.go.com/Health/advocates-fight-teen-justin-pelletier-held-state-pysch/story?id=22312907" target="_blank">fell ill with influenza</a>. She began to have <a href="http://www.bostonglobe.com/metro/2013/12/15/justina/vnwzbbNdiodSD7WDTh6xZI/story.html" target="_blank">difficulty walking</a> and wasn't eating. Dr. Korson advised her parents, Lou and Linda Pelletier, to take her to Dr. Flores, who had transferred to Boston Children's Hospital. And so they had her taken by ambulance from Connecticut to Boston.<br />
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The physicians on shift (<a href="https://www.bostonglobe.com/metro/2013/12/15/justina/vnwzbbNdiodSD7WDTh6xZI/story.html" target="_blank">Dr. Flores was not on call</a> that day) in the BCH emergency department began to care for her, asking Justina's parents about her medical history. Dr. Jurriaan Peters, the neurologist on call in the ED that saw her, had his doubts about the mitochondrial disorder diagnosis. He noted that a muscle biopsy (a common test to try to diagnose a mito disorder) had never been done and that her metabolic workup did not show anything unusual. He called in psychologist Dr. Simona Bujoreanu, who observed that Justina's symptoms grew worse when her mother, Linda, was around. This led Dr. Bujoreanu to suspect somatoform disorder. Somatic illnesses manifest as physical symptoms without any physical cause, being psychological in origin. Justina's parents rejected the psychological diagnosis and insisted that Justina continue being treated for mito disorder.<br />
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The resulting conflict between the Pelletiers and the BCH doctors resulted in a suspicion that Justina was the victim of <a href="http://emedicine.medscape.com/article/295258-overview#a0101" target="_blank">medical child abuse</a>, a term that has come to replace Munchausen Syndrome by Proxy. Basically, BCH believed that Justina was being inappropriately treated for an illness she did not have, and that the treatment was thus putting her at unjustified risk. The case was reported to the Massachusetts Department of Children and Families, who agreed with the BCH doctors and had Justina admitted to the hospital's pediatric psychiatric unit. And, <a href="https://www.bostonglobe.com/metro/2014/06/17/judge-orders-custody-justina-pelletier-returned-parents/mDWtuGURNawSuObO0pDX4J/story.html" target="_blank">this wasn't the first time a DCF complaint was made against Lou and Linda Pelletier</a>, as a complaint had been filed against them in Connecticut in 2011.<br />
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Thus began a lengthy and contentious battle between Justina's family, the hospital, and DCF. Most media outlets and social media sided with the parents, using a lot of emotive language. There was a public outcry against the hospital, which remained silent about any details of Justina's care due to patient privacy laws. All that was really available was the narrative told by Justina's parents. Rather than waste more space on the background, I urge you to pause to go read my <a href="http://www.harpocratesspeaks.com/2014/03/the-case-of-justina-pelletier-calls-for.html" target="_blank">previous post</a> about this, as well as the <a href="http://www.harpocratesspeaks.com/2014/03/justina-pelletier-to-remain-in.html" target="_blank">follow-up post</a> I wrote. Suffice to say, there was a lot of jumping to conclusions and going beyond the available facts. So much so that two Federal legislators introduced some rather <a href="http://www.harpocratesspeaks.com/2014/07/case-of-justina-pelletier-spawns.html" target="_blank">dubious legislation</a>.<br />
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<b><u>New Developments</u></b><br />
<br />
Fast forward a bit. Justina was returned to her home in 2014 by the same judge that had originally ruled that she should remain in DCF custody. A few months after returning home, <a href="https://www.bostonglobe.com/metro/2014/12/07/difficult-return-hospital-for-justina-pelletier/u4JXzmt5YsmWhYk95za2aK/story.html" target="_blank">she was admitted to Yale-New Haven Children's Hospital</a> for GI problems. Despite tests and treatment, she did not improve and was transferred to Children's Hospital of Philadelphia. According to the Facebook page A Miracle for Justina, run by Justina's sister Jennifer, Justina <a href="https://www.facebook.com/permalink.php?story_fbid=597065377097385&id=253343311469595" rel="nofollow" target="_blank">underwent a surgical procedure</a> to treat her continuing GI issues, and was <a href="https://www.facebook.com/permalink.php?story_fbid=671279113009344&id=253343311469595" rel="nofollow" target="_blank">in the hospital again in September</a>. As with media coverage during the lengthy custody battle, there are a lot of implications that her health issues are the result of Boston Children's treatment of Justina, though there is no clear evidence that this is the case, nor do her gastrointestinal health issues predating BCH receive much, if any, mention.<br />
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What brought this story to my attention again, however, is the recent announcement that the Pelletiers are <a href="http://www.foxnews.com/us/2016/02/25/justina-pelletiers-family-to-sue-boston-hospital-after-long-custody-fight.html" target="_blank">suing</a> Boston Children's Hospital, as well as four of its doctors (Jurriaan Peters, Simona Bujoreanu, Alice Newton, and Colleen Ryan), for <a href="https://www.bostonglobe.com/metro/2016/02/25/parents-justina-pelletier-sue-boston-children-hospital-for-negligence/jCrlgTQBVikJtokEnlFBmN/story.html" target="_blank">gross negligence and civil rights violations</a>. According to the <a href="http://www.masscourts.org/eservices/home.page.6" target="_blank">Massachusetts Trial Court Electronic Case Access</a>, the suit was filed on February 11, 2016 in the Suffolk County Civil Court division of the Superior Court. The family is suing for unspecified monetary damages. According to Lou Pelletier, in his <a href="http://www.myfoxboston.com/news/family-of-justina-pelletier-announces-lawsuit-against-boston-childrens-hospital/112745822" target="_blank">public statement</a> on the case:<br />
<blockquote>
"This is not about revenge. This is about making people accountable and making the medical community think twice before they take actions that can do damage to a child and a family that can be irreversible."</blockquote>
Justina, who also appeared at the announcement, stated that the hospital treated her "badly". In an <a href="http://www.courant.com/news/connecticut/hc-foxct-exclusive-interview-with-justina-pelletier-20140618-embeddedvideo.html" target="_blank">interview with FOXCT reporter Beau Berman</a> (starting about 5:20 in the video), Justina describes what sounds like physical therapy, which could be exhausting and aversive, even if medically necessary.<br />
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There are a couple of things that I feel must be pointed out, since they are details that bear on this whole story and have not been widely reported. First off, although Justina was treated at Boston Children's Hospital for a very (very) long period, that decision was made by the Massachusetts Department of Children and Families, not by the hospital. DCF ordered her to remain at BCH to be treated in the psychiatric unit. Furthermore, there were early efforts by MA DCF to <a href="http://c.o0bg.com/rw/Boston/2011-2020/2014/03/25/BostonGlobe.com/HealthScience/Graphics/SCAN.pdf" target="_blank">move Justina from BCH back to Connecticut</a>, but they were unable to do so in part because of Lou Pelletier's threats to sue a program just twenty minutes from their house if Justina was placed there:<br />
<blockquote>
There were efforts by the MA DCF early into this case to place Justina in a program located approximately twenty minutes from her home in Connecticut. The program was identified as an appropriate placement to meet Justina's needs and would have been able to provide services for the parents. Unfortunately, the Connecticut program declined to accept Justina because Mr. Pelletier told the program he would sue the program if Justina was placed there. This program continues to decline to accept Justina. Other programs refused to accept Justina due to concerns of litigation by Justina's parents and the confidentiality of other clients.</blockquote>
Efforts to get Justina out of the hospital were plagued by programs declining to accept her due to fear of legal action, as well as media exposure of other patients, since the Pelletiers were very, very active in getting television coverage.<br />
<br />
We also have to take Justina's own recollections of her time at BCH with a grain of salt. Memory is notoriously fickle and subject to alteration; it isn't a DVD that you can just cue up and replay. As more and more time passes, and the story gets retold, it will change. Add in the fact that Justina clearly loves her parents, that they and the rest of her family speak very negatively about BCH, that her family appears to have a good bit of influence on her, and top it off with continued media exposure, and, sadly, her memories can get recast in a more and more negative light, and the possibility of false memories rises. We need objective records to know what actually took place.<br />
<br />
There were also some new details mentioned in the <i><a href="https://www.bostonglobe.com/metro/2016/02/25/parents-justina-pelletier-sue-boston-children-hospital-for-negligence/jCrlgTQBVikJtokEnlFBmN/story.html" target="_blank">Boston Globe</a></i> article that caught my curiosity. That article mentions that last year, the Pelletiers filed for bankruptcy, that their house faced foreclosure, and that they were able to settle their mortgage payments with money from A Miracle for Justina, a non-profit fund set up by Justina's sister, Jennifer. The implication is that the encounter with Boston Children's Hospital, and the ensuing custody battle, led to the Pelletiers' financial straights, and that if this ordeal had not occurred, they would not have had to file for bankruptcy or faced foreclosure.<br />
<br />
Before I get into the bankruptcy claim, there is one small matter that I feel should be pointed out regarding A Miracle for Justina. I haven't been able to find it registered anywhere. In Connecticut, a non-profit <a href="https://www.cga.ct.gov/2011/pub/chap419d.htm" target="_blank">does not have to register</a> if it is expected to raise less than $50,000 per year (CT State Statutes, Chapter 419d, Sec. 21a-190d(6)). Without any public listing, I don't know for certain if they filed for 501(c)3 status, though they do <a href="https://www.facebook.com/A-Miracle-for-Justina-253343311469595/info?tab=page_info" target="_blank">represent it as a non-profit fund</a>. However, the purpose of a non-profit is to support or advance the public good, <a href="https://www.irs.gov/Charities-&-Non-Profits/Charitable-Organizations/Exemption-Requirements-Section-501%28c%29%283%29-Organizations" target="_blank">not to benefit an individual</a>, particularly one associated with the non-profit. If A Miracle for Justina has been granted tax-exempt status, then using the money from that fund to pay the Pelletiers' mortgage debt is not legally allowed and would be subject to rather significant excise tax.<br />
<br />
At any rate, I looked for court documents relating to a bankruptcy filing and found that Lou and Linda Pelletier did, indeed, file for Chapter 13 bankruptcy in 2015. I also found that they filed for bankruptcy in 2014 (Chapter 7) and 2012 (Chapter 13). There were also a few of collections cases that went against them in 2008 and 2011, as well as foreclosure proceedings in 2008 (withdrawn by the plaintiff in 2015) and in 2011, which may be the one mentioned in the <i>Globe</i> article, as it is still open.<br />
<br />
With these added details, it's clear that their financial difficulties predate their encounter with Boston Children's Hospital by several years, though certainly the fight did not help their financial situation. It also seems that their use of money from A Miracle for Justina may hamper their bankruptcy filing. One document from that case alleges that the fund (which the Chapter 13 Standing Trustee calls a charity) has brought in more than $50,000 per year and is thus not properly registered. The document goes on to allege that reliance on the charity to make payments does not comply with state bankruptcy statutes.<br />
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I bring all of this up because, although Mr. Pelletier says that this is not about revenge, that it's about making the medical community think twice, there is definitely a financial incentive to suing the hospital. The potential financial gain to be had and the debts that they face must factor into their decision to sue and how they frame the events, even if they may not be consciously aware. It is not clear whether their difficulties stem from Justina's history of health issues or due to other factors, and frankly, it doesn't particularly matter. But discussions of the lawsuit should go forward with an awareness of all of the factors that may play a role upon it.<br />
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There is no doubt that this entire episode has been a very trying experience for Justina and her family. I do sympathize with her and hope for the best outcome for her health and growth. Yet at the same time, I cannot be certain of the Pelletiers' version of events. The hospital is barred from discussing Justina's care, so the only side of the story we hear comes from her family. They adamantly <a href="https://www.bostonglobe.com/metro/2014/06/18/justina-pelletier-returns-her-family-home-connecticut-ending-medical-and-legal-odyssey/ON7QhGURgprYZoVS7uuxeL/story.html" target="_blank">reject the idea that her symptoms may be psychiatric in origin</a>:<br />
<blockquote>
Linda and Lou Pelletier remain adamant Justina’s ailments have always been physical, not psychiatric.</blockquote>
Even before BCH, Tufts doctors suggested that her problems may have a <a href="http://www.bostonglobe.com/metro/2013/12/15/justina/vnwzbbNdiodSD7WDTh6xZI/story.html" target="_blank">mental health</a> component, but her parents did not accept it then, either. And their reluctance to even consider a psychiatric diagnosis gives me pause. Does it stem from some sort of stigma against psychiatric issues? A diagnosis of somatoform disorder does not mean that Justina is "crazy" or that she's "making it up". The symptoms of somatoform disorder are very real and can be very distressing. They are most definitely physical, even if their cause is psychiatric. If there <i>is</i> a psychiatric aspect to her symptoms, their reluctance to accept that can only harm her, which brings us back to what started all of this.<br />
<br />
The lawsuit against Boston Children's Hospital could go one of several different ways. The court could find that BCH was at fault, and that the Pelletiers are due damages that might help with their financial situation, as well as pay for the care that Justina obviously still needs. Or the court could find that BCH acted within the standards of accepted medical practice. The court could find that in some aspects BCH handled things improperly, but that the Pelletiers <i>also</i>
bear responsibility for how things went. They may also find that the
fault could lie with DCF, who is not included in the case. If the case follows any of those outcomes adverse to the Pelletiers, then they will have wasted a lot of money and time, not to mention the stress that a trial will cause Justina herself. That stress could adversely affect her health. There is a lot of risk in this for Justina, with any possible beneficial outcome rather uncertain. And if the case goes against the Pelletiers, I'm fairly confident that they will not change their mind at all. It seems that they are firm in their conviction that BCH is at fault for Justina's problems and that they will not accept any psychiatric component to her illness (though part of the agreement when she was released from DCF custody included <a href="https://www.bostonglobe.com/metro/2014/06/17/judge-orders-custody-justina-pelletier-returned-parents/mDWtuGURNawSuObO0pDX4J/story.html" target="_blank">therapy</a> for her and her parents). Even if the case does go in their favor, it is far from clear whether it will elucidate which diagnosis was the correct one. <br />
<br />
At this point, I can only hope that this trial runs its course quickly and that it does not cause additional distress for Justina, though it may be years before a final judgment is handed down. I also hope that it brings to light objective facts regarding her treatment at Boston Children's Hospital. They may corroborate the Pelletiers' account, or they may contradict their version, and I am fine with either outcome, because at least then we will know the truth. But at the end of the day, my top concern and hope for all of this is that Justina, a medically fragile individual, gets the best and most appropriate care that she needs to thrive. Whether that care aligns with her parents' beliefs or not, I sincerely hope that she gets it.<br />
_____________________________<br />
<b>Additional Reading and References Used</b><br />
<br />
<u>The Background</u><br />
<ul>
<li>ABC News - <a href="http://abcnews.go.com/Health/advocates-fight-teen-justin-pelletier-held-state-pysch/story?id=22312907" target="_blank">Advocates Fight for Justina Pelletier, Teen Held by State in Psych Ward</a></li>
<li>Boston.com - <a href="http://www.boston.com/lifestyle/health/blogs/white-coat-notes/2014/02/26/child-year-long-custody-case-won-moved-foster-care-north-shore/jWLWZA6a6IEm8oGJTiiuxK/blog.html" target="_blank">Justina Pelletier, child in year-long custody case won't be moved out of Framingham facility</a></li>
<li><i>Boston Globe</i> - <a href="http://www.bostonglobe.com/metro/2013/12/15/justina/vnwzbbNdiodSD7WDTh6xZI/story.html" target="_blank">The Justina Pelletier Case: A medical collision with a child in the middle (part 1)</a> </li>
<li><i>Boston Globe</i> - <a href="http://www.bostonglobe.com/metro/2013/12/16/month-medical-ordeal-conclusion-still-uncertain/Y7qvYTGsq8QklkxUZvuUgP/story.html?s_campaign=sm_tw" target="_blank">The Justina Pelletier Case: Frustration on all fronts in struggle over child’s future (part 2)</a></li>
<li><i>Boston Globe</i> - <a href="https://www.bostonglobe.com/metro/2014/06/17/judge-orders-custody-justina-pelletier-returned-parents/mDWtuGURNawSuObO0pDX4J/story.html" target="_blank">Justina Pelletier heads home after judge ends state custody</a></li>
<li><i>Boston Globe</i> - <a href="http://www.bostonglobe.com/metro/2014/02/28/state-agency-says-actively-working-return-justina-pelletier-connecticut/pfqMBiVwmoylAYsWYVI2YL/story.html" target="_blank">Mass. agency works to return teen to Connecticut</a> </li>
<li>FoxCT - <a href="http://fox61.com/2014/02/26/mass-representatives-ask-dcf-to-release-justina-pellitier/" rel="nofollow" target="_blank">Mass. Representatives Ask DCF To Release Justina Pelletier</a> </li>
<li>Harpocrates Speaks - <a href="http://www.harpocratesspeaks.com/2014/03/the-case-of-justina-pelletier-calls-for.html" target="_blank">The Case of Justina Pelletier Calls for Nuance and Moderation</a></li>
<li>Harpocrates Speaks - <a href="http://www.harpocratesspeaks.com/2014/07/case-of-justina-pelletier-spawns.html" target="_blank">Case of Justina Pelletier Spawns Dubious Legislation</a> </li>
<li>Harpocrates Speaks - <a href="http://www.harpocratesspeaks.com/2014/03/justina-pelletier-to-remain-in.html" target="_blank">Justina Pelletier to Remain in Massachusetts DCF Custody</a> </li>
<li><i>Hartford Courant</i> - <a href="http://articles.courant.com/2014-03-27/health/hc-ctdcf-pelletier-0328-20140327_1_connecticut-dcf-lou-pelletier-justina-pelletier" target="_blank">DCF Defends Actions in Pelletier Custody Case</a></li>
<li><i>Hartford Courant</i> - <a href="http://www.courant.com/news/connecticut/hc-foxct-exclusive-interview-with-justina-pelletier-20140618-embeddedvideo.html" target="_blank">FOXCT Exclusive Interview With Justina Pelletier</a> </li>
<li><a href="https://actright.com/petition/72" rel="nofollow" target="_blank">Justice for Justina</a> (petition)</li>
<li><a href="https://www.facebook.com/events/1424295344483403" rel="nofollow" target="_blank">Justina Pelletier Prayer Vigil and Witness</a> (March 1st vigil held outside Wayside Youth and Family Support) </li>
<li><i>MetroWest Daily News</i> - <a href="http://www.metrowestdailynews.com/article/20140301/NEWS/140309693/?tag=1" target="_blank">State authority questioned at vigil for Conn. teen</a></li>
<li>Patrick F. Chinnery - <i>GeneReviews</i>: <a href="http://www.ncbi.nlm.nih.gov/books/NBK1224/" target="_blank">Mitochondrial
Disorders Overview</a></li>
<li>Suffolk County Juvenile Court - <a href="http://c.o0bg.com/rw/Boston/2011-2020/2014/03/25/BostonGlobe.com/HealthScience/Graphics/SCAN.pdf" target="_blank">Care and Protection of Justina Pelletier</a> </li>
<li>Women of Grace - <a href="http://www.womenofgrace.com/blog/?p=28140" rel="nofollow" target="_blank">Outrage Grows Over Justina Pelletier Case</a></li>
</ul>
<u>New Developments</u><br />
<ul>
<li>A Miracle for Justina (Facebook) - <a href="https://www.facebook.com/permalink.php?story_fbid=597065377097385&id=253343311469595" rel="nofollow" target="_blank">April 4, 2015 Post</a></li>
<li>A Miracle for Justina (Facebook) - <a href="https://www.facebook.com/permalink.php?story_fbid=671279113009344&id=253343311469595" rel="nofollow" target="_blank">September 29, 2015 Post</a> </li>
<li>ABC News - <a href="http://abcnews.go.com/Health/justina-pelletier-spends-fathers-day-home-amid-custody/story?id=24155485" target="_blank">Justina Pelletier Spends Father's Day at Home Amid Custody Battle</a> </li>
<li><i>Boston Globe</i> - <a href="https://www.bostonglobe.com/metro/2014/06/18/justina-pelletier-returns-her-family-home-connecticut-ending-medical-and-legal-odyssey/ON7QhGURgprYZoVS7uuxeL/story.html" target="_blank">After 16-month battle, Justina Pelletier returned home</a></li>
<li><i>Boston Globe</i> - <a href="https://www.bostonglobe.com/metro/2014/12/07/difficult-return-hospital-for-justina-pelletier/u4JXzmt5YsmWhYk95za2aK/story.html" target="_blank">A
difficult return to hospital for Justina Pelletier</a></li>
<li><i>Boston Globe</i> - <a href="https://www.bostonglobe.com/metro/2016/02/25/parents-justina-pelletier-sue-boston-children-hospital-for-negligence/jCrlgTQBVikJtokEnlFBmN/story.html" target="_blank">Parents of Justina Pelletier sue Boston Children's Hospital for negligence</a> </li>
<li>Fox61 - <a href="http://fox61.com/2015/02/15/justina-pelletier-facing-more-medical-problems/" rel="nofollow" target="_blank">Justina Pelletier facing more medical problems</a></li>
<li>Fox News - <a href="http://www.myfoxboston.com/news/family-of-justina-pelletier-announces-lawsuit-against-boston-childrens-hospital/112745822" target="_blank">Family of Justina Pelletier announces lawsuit against Boston Children's Hospital</a> </li>
<li>Fox News - <a href="http://www.foxnews.com/us/2016/02/25/justina-pelletiers-family-to-sue-boston-hospital-after-long-custody-fight.html" target="_blank">Justina Pelletier's family to sue Boston hospital after long custody fight</a> </li>
</ul>
<ul>
</ul>
Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com107tag:blogger.com,1999:blog-3609683919099708226.post-63334483533290825402016-02-18T04:00:00.000-05:002016-09-11T21:59:53.967-04:00Undisclosed Conflicts of Interest in Vaccine Research<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg8ObhJSMDGmbG6LtqQAFevk9CD5oxGHcJCz2pOF57XI-RdGVAWYI0sEDcm7rGHt9Li91c-DIU44Wswu_fLx0wgbIK9jzM4R6qpqPP2xz4yfkvcSMSCQlHiwsXI5pAum7DqepMmDnLlsA_C/s1600/Conflict+of+Interest.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg8ObhJSMDGmbG6LtqQAFevk9CD5oxGHcJCz2pOF57XI-RdGVAWYI0sEDcm7rGHt9Li91c-DIU44Wswu_fLx0wgbIK9jzM4R6qpqPP2xz4yfkvcSMSCQlHiwsXI5pAum7DqepMmDnLlsA_C/s1600/Conflict+of+Interest.png" /></a></div>
Conflicts of interest (COIs) are very important considerations in research. The most obvious COIs are financial; the researcher may receive financial gain for one result versus another, or they will at least avoid losing current or future income if they get a specific result. But COIs could also be non-financial. Perhaps they have family or close friends that would prefer one outcome versus another. Or they might hold a volunteer position of authority in the sponsor's organization. Whatever form they take, COIs may not necessarily invalidate a study, they hold the potential to influence scientists' behavior during a study, their analysis of the data, and the conclusions they draw from their research. Sometimes, the researcher may not even be fully aware of the influence of their COIs on their work. Blinding can help reduce the influence of conflicts of interest, but any COIs must be disclosed so that anyone who reads the study can think about how they may have influenced the study design, the methods, the analysis, and the conclusions.<br />
<br />
When it comes to published research, most journals require authors to disclose both financial and personal relationships with other organizations or people that could bias their study. Failure to disclose COIs can be grounds for refusal of a manuscript or retraction of a paper that has already been published. It can really damage the researcher's reputation, but it can also harm the reputation of the journal.<br />
<br />
This all brings us to a study that was originally published as an uncorrected proof in the journal <i>Vaccine</i>, and later withdrawn by the journal: <a href="http://www.ncbi.nlm.nih.gov/pubmed/26778424" target="_blank">Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil</a>, by Rotem Inbar, Ronen Weiss, Lucija Tomljenovic, Maria-Teresa Arango, Yael Deri, Christopher A. Shaw, Joab Chapman, Miri Blank, and Yehuda Shoenfeld.<br />
<a name='more'></a><br />
I was fortunate enough to get a copy of the full paper. I'm not going to go into any of the <a href="http://scienceblogs.com/insolence/2016/02/17/no-gardasil-does-not-cause-behavioral-problems/" target="_blank">numerous flaws</a> in this study, as that has already been done (far more ably) by <a href="http://www.skepticalraptor.com/skepticalraptorblog.php/gardasil-causes-behavioral-issues-more-myth-debunking/" target="_blank">others</a>. Instead, I want to focus on the conflicts of interest. Here is the entirety of the statement from the paper:<br />
<blockquote>
Yehuda Shoenfeld has acted as a consultant for the no-fault U.S. National Vaccine Injury Compensation Program. L.T. has served as an expert witness in cases involving adverse reactions following qHPV vaccine administration. The other co-authors declare nocompeting interests.</blockquote>
Here are some COIs that are missing from that statement. While Lucija Tomljenovic declares her having served as an expert witness in cases involving HPV vaccine, Dr. Christopher Shaw does not declare that he has also been an expert in a case involving Gardasil. In 2012, Dr. Shaw gave <a href="http://www.odt.co.nz/news/national/220882/biological-plausibility-vaccine-caused-death" target="_blank">expert evidence</a> for a coroner's inquest into the death of a young woman named Jasmine Renata. He was sent samples of her brain tissue for testing, ultimately claiming that he found aluminum and HPV in her brain, though reports do not state how he got his results. (The coroner ultimately failed to find a connection between her death and Gardasil.) Dr. Shaw should have declared his past involvement as an expert in a case involving alleged injury from Gardasil.<br />
<br />
That's not the only undisclosed COI, though. Dr. Shaw is also the <a href="http://www.cmsri.org/about/sab/" rel="nofollow" target="_blank">chair of the Scientific Advisory Board</a> for the <a href="http://www.cmsri.org/about/background/" target="_blank">Children's Medical Safety Research Institute</a> (CMSRI). What, you might ask, is CMSRI? It is a registered 501(c)3 charity whose primary activity is to "Address eroding public confidence in national vaccine policies" (from the <a href="http://www.guidestar.org/FinDocuments/2013/463/208/2013-463208360-0a732a96-9.pdf" target="_blank">2013 form 990</a> for the Children's Medical Safety Research Institute Endowment Fund, accessed via Guidestar). The organization also <a href="http://www.cmsri.org/about/background/" rel="nofollow" target="_blank">seems to view</a> vaccine-induced brain injury and immune dysfunction as established fact, with a focus on the "toxic potential" of vaccines. CMSRI was founded by Albert and Lisa Claire Dwoskin, who also sit on the <a href="http://www.cmsri.org/about/governing-board/" rel="nofollow" target="_blank">governing board</a>. The Dwoskins funded this particular study via their family foundation:<br />
<blockquote>
<b>Funding</b><br />
<br />
This work was supported by the grants from the Dwoskin Foundation Ltd.</blockquote>
Dr. Shaw has a professional relationship with the funding sponsor of this study, yet this does not appear in the conflict of interest statement, nor in the author information. Nor is Dr. Shaw the only author involved in this study with such a connection to CMSRI. The corresponding author, Dr. Yehuda Shoenfeld, is <a href="http://www.cmsri.org/about/sab/" target="_blank">also on the Scientific Advisory Board of CMSRI</a>.<br />
<br />
I've written a bit about the Dwoskins <a href="http://www.harpocratesspeaks.com/2013/08/a-snapshot-of-deep-pockets-of-anti.html" target="_blank">few years ago</a>, pointing out that despite their objections that they are not anti-vaccine but rather "vaccine safety advocates", their words suggest otherwise. As <a href="https://web.archive.org/web/20110606043826/http://www.foxbusiness.com/on-air/stossel/blog/2010/10/30/holocaust-of-poison" target="_blank">Claire Dwoskin wrote to John Stossel</a> following a segment he did on vaccines (emphasis added):<br />
<blockquote>
I just saw the show and am so sorry to hear that other than what Chris
had to say, not a word of truth was spoken by Stossel or Offitt. What a
travesty – I hope someday he will recognize the error of his ways and
realize the fear and damage that he is contributing to by allowing
falsehoods to rule the air. At least his daughter is alive, smiling,
educated and enjoying life. That cannot be said for the hundreds of
thousands of vaccine injured children in the US. What his daughter went
through is NOTHING compared to what the families of autistic children go
through every day of their lives. No disease can match this record of
human devastation. <b>Vaccines are a holocaust of poison on our children’s
brains and immune systems.</b> Shame on you all.</blockquote>
We have an anti-vaccine sponsor for this study, conducted, in part, by two board members of an organization formed, funded, and directed by the anti-vaccine sponsor. This sponsor also happens to be one of the primary sources of funding for Dr. Shaw's vaccine research activities overall. Yet neither author thought they ought to disclose this connection. This is reminiscent of Mark and David Geier <a href="https://web.archive.org/web/20070104192033/http://neurodiversity.com/weblog/article/98/an-elusive-institute-significant-misrepresentations-mark-geier-david-geier-the-evolution-of-the-lupron-protocol-part-two" target="_blank">forming their own Institutional Review Board</a>, stacked with their family and business partners, to approve their own research.<br />
<br />
Despite the flaws in the study that I linked to above, and despite the failure to disclose competing interests that could bias or influence the study (in violation of <a href="https://www.elsevier.com/__data/assets/pdf_file/0010/92476/ETHICS_COI02.pdf" target="_blank">Elsevier's conflict of interest policy</a>), Dr. Shaw <a href="http://www.metronews.ca/news/vancouver/2016/02/16/ubc-prof-defends-study-linking-vaccine-and-behaviour-changes.html" target="_blank">stands behind the study</a> and seems shocked and perplexed that it was withdrawn.<br />
<br />
As I mentioned at the beginning of this article, conflicts of interest do not necessarily invalidate a study, but they do give reason to view the study with an extra measure of scrutiny. When the authors fail to disclose their COIs, it does not speak well for the authors, the reviewers, or the journal, and it casts further doubt on the conclusions drawn in the study. The irony in all of this is that anti-vaccine activists are very quick to claim that research in support of vaccines is horribly biased due to real, but disclosed, COIs or due to COIs that only exist in their imaginations, yet here we have real conflicts of interest on the part of anti-vaccine authors that they failed to disclose.<br />
<br />
This represents a significant lapse in research ethics. Even if there were no methodological or statistical flaws in this study, there are still grounds for the journal to withdraw the paper.<br />
<br />
<b>[<i>Edited to Add (2/24/16):</i></b><i> The journal has put up the following statement regarding this paper:</i><br />
<i></i><br />
<blockquote>
</blockquote>
<i>
</i>This article has been withdrawn at the request of the Editor-in-Chief
due to serious concerns regarding the scientific soundness of the
article. Review by the Editor-in-Chief and evaluation by outside
experts, confirmed that the methodology is seriously flawed, and the
claims that the article makes are unjustified. As an international
peer-reviewed journal we believe it is our duty to withdraw the article
from further circulation, and to notify the community of this issue.<i></i><br />
<br />
<i>In other words, the article no longer exists. (h/t to Skeptical Raptor for the update)</i><b>]</b><i> </i><br />
<br />
<b>[<i>Edited to Add (9/11/16):</i></b><i> The paper was submitted to and published by </i><a href="http://www.ncbi.nlm.nih.gov/pubmed/27421722" target="_blank">Immunologic Research<i></i></a>, with reportedly altered statistics, but the same data. Likewise, the Conflict of Interest and Funding statements remain unaltered. Unfortunately, the original <br />
Vaccine<i> paper is no longer available to compare the details of the statistics and data.</i><b>]</b> Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com2tag:blogger.com,1999:blog-3609683919099708226.post-9740548621543905162016-02-16T11:00:00.000-05:002016-02-24T19:22:18.904-05:0069 Doses and Matters of TrustThe other day, I wrote about the incorrect claim that there are <a href="http://www.harpocratesspeaks.com/2016/01/69-doses-of-vaccines.html" target="_blank">69 doses</a> of vaccine on the U.S. recommended childhood immunization schedule. That claim has morphed into 71 (or 72 <b>[<i>Edited to Add (2/24/15):</i></b><i> apparently, anti-vaccine groups are now dishonestly claiming </i>74<i>!</i><b>]</b>) doses since the publication of the 2016 schedule, which added the Meningococcal B vaccine for at-risk individuals, as well as those for who would like to get the vaccine and their doctor agrees it is indicated. The MenB vaccine has not yet been added as recommended for all individuals. At any rate, I had hoped that my post might help those repeating the "69 doses" claim realize that they were mistaken and misled by whomever they heard the claim from (e.g., @VaxCalc has been quite busy on Twitter, spouting out that claim on an almost daily basis, despite being told that it is incorrect). I've share the post with a number of people on Twitter that have repeated the claim. As yet, I have not had a single person admit that the claim is wrong. Mostly, they try to come back with rationalizations, which really misses the point of my post.<br />
<br />
So what's behind the misunderstanding? What point was I trying to make?<br />
<a name='more'></a><br />
First, let me address where I think the misunderstanding originates. There are two terms for which it is vital that we have a clear understanding and definition, so that we all use the same meanings for word. I've written before about how some anti-vaccine activists like to <a href="http://www.harpocratesspeaks.com/2015/04/beware-humpty-dumptys.html" target="_blank">redefine words to fit their message</a>. This is another situation where I think that is happening. With that in mind, let's take a look at these words:<br />
<ul>
<li>Dose - in medicine, a dose is simply a specific quantity of medicine to be taken at one time. In the context of vaccines, a dose of vaccine is one administration of the vaccine. Which brings us to the next term.</li>
<li>Vaccine - a vaccine is a preventative medical treatment consisting of one or more types of viral or bacterial antigens, as well as the diluent, or vehicle. The diluent is all of the non-therapeutic "stuff" in the vaccine: water, stabilizers, adjuvants, manufacturing residuals, and so on. For example, the Hepatitis B vaccine contains HepB surface antigens, an aluminum adjuvant, the liquid vehicle, etc. for a total dose of 0.5mL. Similarly, the DTaP vaccine contains diphtheria antigens, tetanus antigens, pertussis antigens, an adjuvant, liquid vehicle, and so on for a total dose of, again, 0.5mL.</li>
</ul>
One dose of vaccine means (for injected vaccines) a single injection of 0.5mL. A shot of the Hep B vaccine is one dose. A shot of the DTaP vaccine is also one dose. A shot of DTaP-HepB-IPV (diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated polio) is one dose.<br />
<br />
Where is the misunderstanding? For that, let's look at the originator (or at least, one of the main promoters) of this false claim, the National Vaccine Information Center (NVIC). They created a poster specifically for this claim, reproduced here:<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgAaru8ia43XKFopPC9x9neWhZBlMY-jjxzRNpotARr_-YW4UjDKh8ujFHU8GDwpRHmqwHb6f_shjJM0POsKhxc-xMgtnFyGIbnBxAbAkJG_jmogljdyki5IIyOPDZKgwZKRRDk-6s0Zmab/s1600/NVIC+-+69+Doses+by+Age+18.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="258" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgAaru8ia43XKFopPC9x9neWhZBlMY-jjxzRNpotARr_-YW4UjDKh8ujFHU8GDwpRHmqwHb6f_shjJM0POsKhxc-xMgtnFyGIbnBxAbAkJG_jmogljdyki5IIyOPDZKgwZKRRDk-6s0Zmab/s400/NVIC+-+69+Doses+by+Age+18.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Click to enlarge.</td></tr>
</tbody></table>
Another variation on this is this meme:<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgAhZRNSEJTD6v2_RflpY9uZmVUUBBEaaiUuSQ0SMmIVEhrK8u8aECochtW6yxnyYQipERoJC9P4V38M1gnexBfDUKZpme6lxtdwDnchG0P57A0Sq9ZghE0imhmBZbiSZ93-QcI8mDx420i/s1600/1983-2016-70-doses.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="640" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgAhZRNSEJTD6v2_RflpY9uZmVUUBBEaaiUuSQ0SMmIVEhrK8u8aECochtW6yxnyYQipERoJC9P4V38M1gnexBfDUKZpme6lxtdwDnchG0P57A0Sq9ZghE0imhmBZbiSZ93-QcI8mDx420i/s640/1983-2016-70-doses.jpg" width="492" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Click to enlarge.</td></tr>
</tbody></table>
<br />
NVIC misleads people with this poster by stating that, for example, DTaP vaccine is actually three separate vaccines, simply because it contains antigens for three different diseases, while ignoring that fact that the total number of antigens in the schedule has gone down dramatically, as I showed in my other post. But at the same time, they note that a vaccine has all of these other allegedly "bad" ingredients. In other words, they imply that your child will get three separate injections of 0.5mL, three separate needle sticks every time they go in for their DTaP or Tdap boosters. The same thing with MMR. But <a href="http://www.harpocratesspeaks.com/2016/01/69-doses-of-vaccines.html" target="_blank">as I noted in my previous post</a>, the total number of doses of vaccines is significantly lower than NVIC would have you believe. It is even lower if one opts for combination vaccines, like the DTaP-HepB-IPV vaccine.<br />
<br />
But what's the point? Why does it matter if it's 69 doses of vaccine, 53 doses, or only 46 doses? First off, that is, at minimum, a difference of 16 injections. NVIC is inflating the number of needle sticks by anywhere from 16 to 23 shots! I am all for reducing the number of times kids need to get a shot. Getting a shot hurts. We can do things to help reduce that pain (e.g., distracting the child, getting them to relax, etc.), but there's always going to be some discomfort. It can also be an emotionally distressing event if the child is afraid of needles. Use combination vaccines where there are safe and effective options. What NVIC is doing here is frightening parents by suggesting that their children will have more needle sticks and more trauma than they really will.<br />
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The other point that I want people to get is this: the "69 doses" claim is wrong, and very easily shown to be so. Whether NVIC and the others who actively promote this claim to their followers are doing so out of simple misunderstanding or are deliberately lying in order to advance their anti-vaccine message is largely irrelevant. What matters is that they are wrong about this. And if they are wrong about something as simple as how many doses are in the vaccine schedule, what else are they wrong about? Are there other claims they make that are based on misunderstanding or outright lies? If they so easily make a mistake about the number of doses in the vaccine schedule, how much easier is it for them to be wrong about more complex issues?Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com8tag:blogger.com,1999:blog-3609683919099708226.post-16132484686894438042016-02-01T00:00:00.000-05:002016-02-01T00:00:00.731-05:00The Precautionary Principle to an Absurd DegreeEvery now and then, we hear about some event in the news. Sometimes it can cause unjustified panic, like when people in the U.S. started panicking about Ebola virus, despite the risk to the average American being next to nothing. Other times, it can cause realistic concern, such as we see among the people of Flint, Michigan, or among members of communities where there are disease outbreaks. Reactions to these events run the gamut from the rational to the irrational and absurd. There is always an emotional component, but how much we let our emotions or our reason dictate our responses influences where we fall on the spectrum. Do we panic? Are we reasonable? Callous? Compassionate?<br />
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I was reminded of this today through an interaction with someone on Twitter (which lately seems to be a rather fertile spot for blog material). Self-described libertarian and stay-at-home dad, @CalypsoWaxed linked to a story in the <i>Daily Mail</i>, apparently in an attempt to scare people about vaccines.<br />
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Despite the <i>Mail</i> being known for rather sub-par reporting and being prone to sensationalism, I gave the story a look. The title says a fair bit, "<a href="http://www.dailymail.co.uk/news/article-3419025/Paramedics-called-vaccinated-pupils-Northampton-School-Boys-faint.html" rel="nofollow" target="_blank">Paramedics called to secondary school as pupils fall ill and collapse after being given their vaccinations</a>".<br />
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Basically, the article in the <i>Mail</i> states that 10 to 15 boys in year 10 at <a href="http://www.nsb.northants.sch.uk/" target="_blank">Northampton School for Boys</a> fainted on Tuesday after receiving their vaccinations. Which vaccines were administered is not reported, but we have a second-hand quote that "several different vaccines were being administered". The <i>Mail</i> also reports that the immunizations were stopped as a precaution and the incident is being investigated. While all of the boys recovered and are doing well, the school's nursing team also sent notes home letting parents know that while they do not expect anyone else to fall ill, they should seek medical advice if their kids feel dizzy, nauseated, develop a rash or have difficulty breathing (signs of an allergic reaction).<br />
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A bit more detail was available from <i>The Sun</i>, which ran with the rather more sensationalistic "<a href="http://www.thesun.co.uk/sol/homepage/news/6889652/Horror-as-up-to-15-kids-COLLAPSE-after-having-jabs-at-school.html" target="_blank">Warning [originally "Horror"] as up to 15 kids COLLAPSE [<i>sic</i>] and one rushed to A&E after 'duff jabs' at school</a>". According to <i>The Sun</i>, as well as <a href="http://www.harpocratesspeaks.com/2016/01/69-doses-of-vaccines.html" target="_blank"><i>The Mirror</i></a>, the boys were given a meningitis vaccine. None of the news articles note how many boys in total received the vaccine, only that ten to fifteen fainted, with one of those being taken to hospital as a precaution. Both <i>The Sun</i> and <i>The Mirror</i> report that all of the boys are now well and doing fine.<br />
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At this point, the cause is unknown, but there are some possibilities. First, as the mother quoted in all of the articles guesses, it's possible that that particular batch of vaccine was bad. A batch of vaccine can be bad in a couple different ways. First, it could have been stored improperly (e.g., outside of the recommended temperature range). If the vaccines were single-use vials or prefilled syringes, though, this would have more likely meant that the vaccine would be ineffective, not that it would cause more adverse reactions. The second way it could be bad is if it were contaminated with some other substance. For multi-dose vials stored improperly, this could be bacterial or fungal growth. For single-dose vials, it could mean lack of sterility during production, or the accidental introduction of other substances into the finished product. A bad batch, however, seems unlikely. Fungal contamination would generally not produce such sudden and mild symptoms as fainting. Likewise, contamination with other substances would likely take much longer to produce symptoms, with severity ranging from mild to serious. Finally, we don't know how many boys received the vaccines in total, but if there were a lot, then we would have seen reactions in the majority, if not all. The reports, as well as the letter sent home to the parents suggests that the 10-15 boys affected were in the minority.<br />
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Another potential cause of the boys' fainting is <a href="http://www.mayoclinic.org/diseases-conditions/vasovagal-syncope/basics/definition/con-20026900" target="_blank">vasovagal syncope</a>. This is essentially a fear-response (though it can have other causes), in which your heart rate slows and the blood vessels in your legs widen, resulting in lower blood pressure and, consequently, less blood to your brain. Less blood to the brain leads to fainting. This type of response can have feelings of unease before the fainting, such as nausea, dizziness, and so on. Fainting before or after vaccination is a fairly common occurrence among teens, and the U.S. CDC notes that they have <a href="http://www.cdc.gov/vaccinesafety/concerns/fainting.html" target="_blank">received reports of fainting</a> following all three of the vaccines given to teens: HPV (human papillomavirus), MCV4 (meningococcal), and Tdap (tetanus, diphtheria, and acellular pertussis). Both of the meningococcal vaccines <a href="http://www.nhs.uk/conditions/vaccinations/pages/men-acwy-vaccine.aspx" target="_blank">used in the U.K.</a>, <a href="https://www.medicines.org.uk/emc/PIL.26513.latest.pdf" target="_blank">Nimenrix</a> (PDF) and <a href="https://www.medicines.org.uk/emc/PIL.27358.latest.pdf" target="_blank">Menveo</a> (PDF) also warn that fainting can occur following vaccination. Vasovagal syncope is most likely the result of the vaccination process itself, rather than any ingredient of the vaccine. It's the fear or pain of the needle stick that triggers the response. This seems like the most probably explanation for what happened during the immunization program at the Northampton School for Boys.<br />
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However, until the investigation is completed, we can't know what the cause was. I mentioned this, and the possibilities, to Calypso, which prompted him to note what I surmise was the point of his linking to the story:<br />
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<a href="https://twitter.com/CalypsoWaxed/status/693181147887566849" target="_blank">He wrote</a>, "Exactly. We don't know if the vaccines are bad until they have already been administered. By then, its [<i>sic</i>] too late." His argument boils down to this: If we don't know that X is bad until it's too late, we should avoid X. It is a simplistic viewpoint that ignores much of what we <i>do</i> know. What were to happen if we applied this to other areas of our lives? For instance, we don't know if the batch of food we're eating is bad until it's too late. Does that mean we should avoid food? Certainly not. Because we also know that the alternative (starving) is rather bad. We also know that, generally speaking, quality control around food is pretty good, such that the risk of having a bad outcome is relatively low. The same is true for vaccines. The alternative to vaccination is getting the disease the vaccine prevents, which can be quite bad, especially in the case of bacterial meningitis. We also know that vaccines are generally safe. They are extensively tested before they're approved, and they are subject to quite strict quality controls, as well as additional post-market surveillance and testing. Then there are the precautions taken while administering vaccines, which certainly are not present when consuming food. You have medical staff right there in case something bad does happen. If there is an unexpected allergic reaction to the vaccine, there is usually ready access to epinephrine to treat it. We tell parents and patient about what to keep an eye out for following vaccination to ensure prompt treatment, as well. And, in the U.S., at least, if a patient does suffer a rare adverse reaction, we have a system in place for compensation. Try finding that if Billy turns out to be severely allergic to the spinach you just gave him.<br />
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While this isn't a perfect analogy, it does serve to illustrate the absurd degree to which CalypsoWaxed stretched the precautionary principle. In part, I suspect that, at least in regard to vaccines, he engages in the <a href="https://en.wikipedia.org/wiki/Nirvana_fallacy" target="_blank">Nirvana fallacy</a>. He seems to think that since vaccines are not 100% perfectly safe, that because there is <i>some</i> risk of harm, however small, that they are therefore unreasonably risky and should be avoided. While not uncommon, this is a simplistic and incorrect view of reality. As with all things in life, we have to look at all of the risks <i>and</i> all of the benefits, choosing those things which, to the best of our ability, we can determine to be more beneficial than harmful. Nothing is 100% safe. We always weigh the risks and the benefits. When it comes to vaccines, we have to choose between the benefits (immunity without suffering the disease) and risks (mostly mild and temporary, but, yes, with very rare but serious reactions) of the vaccine, versus the risks of the diseases prevented, which are orders of magnitude more likely than the risks of the vaccines.<br />
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The precautionary principle can be useful, and indeed, the school nursing staff in Northampton applied it appropriately. But it can also be taken to absurd extremes, as demonstrated by CalypsoWaxed. These situations call for nuance and measured examination, not the broad brushstrokes so enamored of fearmongers.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com2tag:blogger.com,1999:blog-3609683919099708226.post-29581816208153119872016-01-18T00:00:00.000-05:002016-02-16T11:03:27.194-05:0069 Doses...or Is It 53? Or Even Fewer?<i>Please note additional edits to this article, particularly those added after 2/3/16, with the publication of the new 2016 recommended schedule.</i><br />
<i> </i> <br />
My deepest apologies to my readers for this rather long spell without any new posts. Work and real life both got rather too busy for me, and I just did not have the time or energy to write. It certainly isn't for a lack of topics. I have a couple that I would really like to get to, including at least one request. But to get back into the swing of things, I thought I'd start with something pretty easy.<br />
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The other day, I got into a discussion on Twitter with a naturopath by the name of Stephen M. Gibson. He caught my eye because he appeared to be using <a href="http://www.harpocratesspeaks.com/2014/09/package-inserts-understanding-what-they.html" target="_blank">my post about package inserts</a> to suggest that they are evidence that vaccines cause harm. Now, vaccine package inserts <i>do</i> list <a href="https://en.wikipedia.org/wiki/Adverse_drug_reaction" target="_blank">adverse reactions</a> (i.e., something known to be caused by the product) discovered during clinical trials. They also include <a href="https://en.wikipedia.org/wiki/Adverse_event" target="_blank">adverse events</a> (i.e., something that occurs <i>after</i> using the product, but may or may not actually be <i>caused</i> by it) reported to the manufacturer after it has been put on the market. I tried to get Mr. Gibson to let me know which specific injuries he was concerned about. The best I got was him referring to Section 6 of the inserts (which, again, includes reports of things that are not necessarily caused by the vaccine) and that he's opposed to "<a href="https://twitter.com/TryNaturopathy/status/687453982843887616" target="_blank">Any. And every</a>" bit listed in Section 6.<br />
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But it wasn't his misuse of my post that really grabbed my attention and prompted this post. Rather, it was <a href="https://twitter.com/TryNaturopathy/status/687452649843736576" target="_blank">his claim</a> that he has "read and studied the 69 vaccines package inserts in the Feds recommended list":<br />
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Sixty-nine package inserts? Really? Where did he get this number?<br />
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As of this writing, the FDA lists <a href="http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm" target="_blank">81 vaccines</a> approved for us in the U.S. Now, that list includes vaccines that are no longer used (e.g., smallpox), as well as vaccines that are not on the recommended schedule (e.g., BCG, rabies, yellow fever). There are also multiple brands of vaccine (e.g., Fluarix and Fluvirin) that cover the same disease but are made by different manufacturers. Eliminating the obsolete vaccines, the ones not on the schedule, and the multiple variations of the same vaccine, the number is way below Gibson's claim of 69, meaning his claim that he read 69 package inserts is wrong.<br />
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Well, maybe his grammar is just bad and he missed an apostrophe, as in, "the 69 vaccines' package inserts". Since he mentioned the recommended list, I went to the CDC's <a href="http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf" target="_blank">2015 Combined Recommended Immunization Schedule for Persons Aged 0 through 18 Years</a> (PDF). At most, there are 13 vaccines recommended for the average child, which protect against 16 different diseases:<br />
<ul>
<li>Hepatitis B (HepB)</li>
<li>Rotavirus (RV)</li>
<li>Diphtheria, Tetanus, and acellular Pertussis (DTaP)</li>
<li>Tetanus, Diphtheria, and acellular Pertussis (Tdap)</li>
<li><i>Haemophilus influenzae</i> type b (Hib)</li>
<li>Pneumococcal Conjugate (PCV)</li>
<li>Inactivated Poliovirus(IPV)</li>
<li>Influenza (Flu)</li>
<li>Measles, Mumps, Rubella (MMR)</li>
<li>Varicella (VAR)</li>
<li>Hepatitis A (HepA)</li>
<li>Human Papillomavirus (HPV)</li>
<li>Meningococcal (Men)</li>
</ul>
Maybe he meant the number of doses of those 13 vaccines? Let's see...nope, there are only 53 doses [<i><b>Edited to Add (2/3/16):</b> (or 52, depending on the rotavirus vaccine used)</i>]:<br />
<ul>
<li>3 doses of Hepatitis B (HepB)</li>
<li>3 doses of Rotavirus (RV) [<b><i>Edited to Add (2/3/16): </i></b><i>if RotaTeq used, 2 doses if Rotarix used</i>]</li>
<li>5 doses of Diphtheria, Tetanus, and acellular Pertussis (DTaP)</li>
<li>1 dose of Tetanus, Diphtheria, and acellular Pertussis (Tdap)</li>
<li>3 doses of <i>Haemophilus influenzae</i> type b (Hib)</li>
<li>4 doses of Pneumococcal Conjugate (PCV)</li>
<li>4 doses of Inactivated Poliovirus(IPV)</li>
<li>19 doses of Influenza (Flu)</li>
<li>2 doses of Measles, Mumps, Rubella (MMR)</li>
<li>2 doses of Varicella (VAR)</li>
<li>2 doses of Hepatitis A (HepA)</li>
<li>3 doses of Human Papillomavirus (HPV)</li>
<li>2 doses of Meningococcal (Men)</li>
</ul>
I even tweeted at him how I came up with the total number of doses (though I incorrectly listed 3 doses of Men at the time). Note that this list includes all of the boosters, despite his erroneous admonishment that I should include boosters. (As an aside, it should be noted that not all of these are required for school enrollment, so the number that kids have to get for school is even lower.)<br />
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Since I had shown the math that I used to arrive at my total number of doses, I asked Mr. Gibson to do the same. All he did was send me links to the recommended schedule I already referenced and an <a href="http://www.cdc.gov/vaccines/schedules/easy-to-read/" target="_blank">easy-to-read version</a> of the same thing, which also adds up to 53 doses.<br />
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So where was he getting this mysterious figure of 69 doses by age 18? Where else but the anti-vaccine organization known as the <a href="http://www.harpocratesspeaks.com/search/label/NVIC" target="_blank">National Vaccine Information Center</a>. Specifically, he referenced a poster titled <a href="https://www.nvic.org/CMSTemplates/NVIC/pdf/49-Doses-PosterB.pdf" rel="nofollow" target="_blank">49 DOSES OF 14 VACCINES BEFORE AGE 6? 69 DOSES OF 16 VACCINES BY AGE 18?</a> (PDF, all-caps in the original). Here's a screen shot for your reference so you don't have to click through to their site:<br />
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<tr><td class="tr-caption" style="text-align: center;">Click to enlarge and find the dishonesty.</td></tr>
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Take a look at that list and see if you can spot the dishonest tactic that the NVIC is using. Yes, they break out the DTaP, Tdap, and MMR vaccines into separate, individual doses. NVIC is adding 16 doses to the list.<br />
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Why is this dishonest? Well, when looking at the antigens alone, yes, there are 69 doses of <i>antigen</i> that a child receives. [<i><b>Edited to Add (1/21/16):</b> It should be noted that the <a href="http://www.ncbi.nlm.nih.gov/books/NBK220494/" target="_blank">overall antigen load in the vaccination schedule has been </a></i>decreasing<i>, even though the number of vaccines has increased, over the past 50 years.</i><br />
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<br />
<i>But as you can see, even going by antigens, the NVIC list is still misleading.</i>]<br />
<br />
But their poster implies that it's 69 doses of the complete vaccine (i.e., antigens plus all of the other stuff like stabilizers, liquid vehicle, etc.), especially given their footnote about vaccine ingredients. That's not the case. Let's look at it this way. There is a stand alone measles vaccine (e.g., India's <a href="http://www.seruminstitute.com/content/products/product_mvac.htm" target="_blank">M-Vac</a>), but it isn't used in the U.S. M-Vac is given in a 0.5mL dose. In the U.S., the MMR vaccine is also a single 0.5mL dose, not a 1.5mL dose. You can see, then, why listing measles, mumps, and rubella out separately misleads people, and why the claim of 69 doses by age 18 is false.<br />
<br />
And even 53 doses is a bit high. There are newer combination vaccines that mean even fewer injections. For example, <a href="http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM241874.pdf" target="_blank">Pediarix</a> (PDF), given in a 3-dose series, combines the DTaP, HepB and IPV vaccines into one, meaning 6 fewer doses (3 doses of HepB and 3 doses of IPV), bringing the total doses a child receives down to 47. Or there's <a href="http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109810.pdf" target="_blank">Pentacel</a> (PDF), which is given in a 4-dose series and combines DTaP, Hib, and IPV. Using that would eliminate 7 doses from the total (3 doses of Hib and 4 doses of IPV), bringing the maximum doses received down to 46.<br />
<br />
The next time you see someone claim that kids get 69 doses of vaccines by the time they're 18 years old, you can rest assured that they have either not done the math, simply taking the word of others for granted; misunderstood what they were counting; or they are lying. I'd recommend being charitable and assuming that they either haven't done the legwork to count things up or they simply misunderstood. But then, I tend to assume the best of people.<br />
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[<i><b>Edited to Add (1/22/16):</b> Mr. Gibson wasn't the only one parroting the 69 doses claim on Twitter. @VaxCalc did as well, posting <a href="https://twitter.com/VaxCalc/status/690273707382685696" target="_blank">this image</a>:</i><br />
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<i>When I asked if they thought each time a child got a DTaP they got a 1.5mL dose, they <a href="https://twitter.com/VaxCalc/status/690512243868459010" target="_blank">responded</a>, "Stick to "dose" as used in CDC schedule. Stop trying to obfuscate simple fact of 69 doses of 16 vaccines #Astroturf". Notice that the CDC schedule in VaxCalc's own image notes "1st Dose", "2nd Dose", etc., which adds up to 53, not 69.</i><br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjmEaFKB1Rs7JPpDFxFH1y3t6ruo97hk1va_sKoqXC6V6UnmMgGBsQcTmVbyc3c8fs17mbMgJnsa5o2T-seBVmAshX4CZl9wXn-YnA2HLfsHyW_FtZOZUdk_mGDMWITC0vzbJgishU0aTNt/s1600/Twitter+-+VaxCalc+Misleads+-+Defitinion+of+Dose.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="210" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjmEaFKB1Rs7JPpDFxFH1y3t6ruo97hk1va_sKoqXC6V6UnmMgGBsQcTmVbyc3c8fs17mbMgJnsa5o2T-seBVmAshX4CZl9wXn-YnA2HLfsHyW_FtZOZUdk_mGDMWITC0vzbJgishU0aTNt/s320/Twitter+-+VaxCalc+Misleads+-+Defitinion+of+Dose.jpg" width="320" /></a></td></tr>
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<i>I do enjoy the irony of VaxCalc misleading by muddying the definition of "dose" while accusing me of obfuscation. Oh, and their apparent belief that "<a href="https://en.wikipedia.org/wiki/Astroturfing" target="_blank">astroturf</a>" just means "someone I disagree with saying saomething I don't understand".</i>]<br />
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[<i><b>Edited to Add (2/3/16):</b> With the publication of the 2016 updated vaccination schedule, anti-vaccine folks are now claiming 71 doses or even 72 doses of vaccine. This is because the CDC has added the recently approved Meningococcal B vaccine to the schedule. However, what they do not note is that currently, the MenB vaccine is included only for those not at high risk, subject to individual clinical decision making, as well as for certain high-risk groups. It is not part of the standard recommendations for all children.</i>]<br />
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I've written a follow-up to this post that I hope clears up some things. You can read it <a href="http://www.harpocratesspeaks.com/2016/02/69-doses-and-matters-of-trust.html" target="_blank">here</a>. Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com16tag:blogger.com,1999:blog-3609683919099708226.post-53718956268787268962015-11-17T12:30:00.001-05:002016-01-26T12:50:29.584-05:00Locked in IgnoranceThe other day, I got into a discussion with someone calling for Congressional hearings on the DeStefano 2004 study that is the latest to-do in anti-vaccine circles. I won't go into the background; you can read about it <a href="http://www.harpocratesspeaks.com/2014/09/mmr-cdc-and-brian-hooker-media-guide.html" target="_blank">here</a>. Instead, I'll just present the Storify curation of tweets. My interlocutor just didn't understand what she had read. There is nothing wrong with that. We all have areas in which we lack the requisite knowledge to fully grasp the subject. The real trick is figuring out where we are ignorant and put in the effort to learn and grow. I'm presenting the whole conversation here in the hopes that others might learn from it. It's a bit long, but it gives a good pictures of how our preconceptions can lock us into a state of ignorance.<br />
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Here are a few resources for your reference as you read through this. <br />
<ul>
<li><a href="http://www.harpocratesspeaks.com/2014/09/mmr-cdc-and-brian-hooker-media-guide.html" target="_blank">MMR, the CDC and Brian Hooker: A Guide for Parents and the Media</a> </li>
<li><a href="http://www.ncbi.nlm.nih.gov/pubmed/14754936" target="_blank">Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan atlanta</a> (Original study from DeStefano et al.) </li>
<li><a href="http://leftbrainrightbrain.co.uk/2014/10/16/a-look-at-the-analysis-plan-for-destefanos-mmr-study-no-evidence-of-fraud/" target="_blank">A look at the analysis plan for DeStefano’s MMR study: no evidence of fraud</a> (includes a link to the 2001 Draft Analysis Plan) </li>
<li><a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4128611/" target="_blank">Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data</a> (Brian Hooker's retracted study)</li>
</ul>
Ignorance is not bad, unless we make no effort to overcome it.
Being wrong is not bad, unless we do not accept that we are wrong. <br />
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Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com3tag:blogger.com,1999:blog-3609683919099708226.post-19977377850982574472015-09-16T00:00:00.000-04:002015-09-16T12:25:41.806-04:00What does the dox say?The other day, a friend of mine wrote a blog post about how an anti-vaccine Facebook page was taken over by someone who worked their way up to admin privileges, locked out all of the other admins, and then started posting goat memes, a practice known as "<a href="http://www.urbandictionary.com/define.php?term=goating" target="_blank">goating</a>". My friend had been invited to take part, but by the time he took a look, the goating was well underway. All he did was write up a blog post describing what had happened, mentioned in passing that he had enjoyed watching events unfold, and giving a history of how goating started.<br />
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And for that, he was <a href="https://en.wikipedia.org/wiki/Doxing" target="_blank">doxed</a>.<br />
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I mentioned <a href="https://en.wikipedia.org/wiki/Doxing" target="_blank">doxing</a> a couple of weeks ago in <a href="http://www.harpocratesspeaks.com/2015/08/Youre-never-weird-on-the-internet.html" target="_blank">my review of Felicia Day</a>'s new book, <i><a href="http://feliciadaybook.com/" target="_blank">You're Never Weird on the Internet (almost)</a></i>. Day had been doxed by members of <a href="https://en.wikipedia.org/wiki/Gamergate_controversy" target="_blank">#GamerGate</a> after she wrote a post describing how the whole #GamerGate phenomenon had made her afraid and cautious. The point of her post was just to illustrate how the actions of a few were creating a rift among the gaming community. She was trying to bring gamers back together to celebrate what all of them love: games. And for that, those handful of malcontents posted her personal information in an attempt to silence her.<br />
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[<b>Editorial note:</b> Apparently, that last sentence was missed by some people, so I feel like I need to clarify some things. 1) I am not saying that all of #GamerGate engages in doxing or other bad behavior. Just like every community has its bad seeds, the people who doxed Day are a subgroup and may or may not be representative of the larger group. I'm relating a single incident. 2) This is a minor point that I made in passing. I'll be taking a close look at comments that focus on this, rather than the larger issue I'm addressing: namely, the doxing of people with the intent to silence them or cause them distress. You want to talk about GG? There are plenty of other places on the intranet for that. This post isn't one of them. So, please, keep your comments on topic.]<br />
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Similarly, that's what happened with my friend, René. He is an epidemiologist who happens to have a personal blog, <a href="http://epidemiological.net/blog/" target="_blank">Epidemiological</a>, where he writes about things that interest him. That mostly has to do with public health. It's a topic he's so passionate about that he's not content simply working in the field, but pretty much lives and breathes public health. He cares a great deal about his fellow human beings and wants to make sure that everyone has the best chance to live their lives to the fullest.<br />
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So what happened?<br />
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The first thing is that his registrar messed up, big time. He had requested that his personal information be kept private, but the registrar claimed they had a technical issue that revealed his info. Although they fixed the problem, it was already too late. Anyone that did a WhoIs search for his domain had been able to find his name, address, and phone number.<br />
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Phillip Brandon Holmes did just that:<br />
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<tr><td class="tr-caption" style="text-align: center;">Doxing: the way of the coward.</td></tr>
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But Mr. Holmes wasn't content to post only Ren's home address and phone number, he also posted his cell number, defending his decision to do so even after it was pointed out to him that Ren wasn't involved in the takeover of the Facebook page:<br />
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Others also took the information that Mr. Holmes provided and spread it on Facebook. Just like with Felicia Day, the intention behind doxing Ren was to silence him, to send the message that people know his information and can make his life difficult. That alone is bad enough, but it seems Mr. Holmes was not content with simply doxing Ren.<br />
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As Ren described to me, he received a phone call on his cell phone. He Googled the number and guess whose name should come up? Phillip Brandon Holmes. Here's how Ren describes that call:<br />
<blockquote>
"I had just finished talking to my wife when the phone rings. It’s him. He asked if I was looking for him. If you see the post he’s now deleted, he claims that someone from my area code called him, so he called me. Frankly, I don’t know how he got my cellphone number, but I’ve put it out there a couple of times. (LinkedIn?) Anyway, he tells me that he’s not afraid of me, blah, blah, blah. He then says that he’s from Texas, as if that’s supposed to scare me. I told him, “Good. I’m from El Paso.” He was quiet for a few seconds and then raised his voice, yelling at me that he was in Dallas and that I’d be — in his words — “spitting out buckshot” if I went looking for him. (Why would I do that? Who willingly goes to Dallas for anything?) He then cursed at me a few times. I tried to be calm and reason with him, but he wasn’t having any of it. He then hung up the phone. I promptly blocked his number. I hope he has a nice life."</blockquote>
That's not the only harassment Ren endured, either. Another anonymous person emailed Ren's dean to complain about him, stating that he was harassing others and violating his own <a href="http://epidemiological.net/comments-and-privacy-policy/" target="_blank">privacy policy</a>, both false claims. This person asked that Ren be disciplined.<br />
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Fortunately, Ren's dean supported my friend for several important reasons. First off, Ren was writing as a private individual, on his own blog, where he makes clear that "any and all opinions here are solely those of the author and not
necessarily those of his friends, employers, relatives, schools, etc." His post had nothing to do with his university. Second, as a doctoral student, he has <a href="https://en.wikipedia.org/wiki/Academic_freedom" target="_blank">academic freedom</a> to pursue and share ideas, even if they may be inconvenient to others. Finally, there's the fact that his university honors his right to free speech, which allows him to express his opinions on anti-vaccine tactics and to criticize their actions.<br />
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This isn't the first time that Ren has been harassed by those who disagree with him. Back in 2011, he was the target of <a href="http://lizditz.typepad.com/i_speak_of_dreams/2011/08/keeping-up-with-epigate.html" target="_blank">another person</a> who doxed him and emailed his employers. In that instance, the person emailed almost everyone at Ren's work. Someone higher up the chain forced him to pull the plug on his blogging, and he was, for a time, silenced.<br />
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Doxing is a despicable act. The fellow from 2011, Mr. Holmes, and every other person who posted Ren's personal info all have some things in common. None of them have cogent, logical arguments to present. None of them value critical inquiry. And all of them are cowards. Gutless bullies to the last. What this tactic says is, "I'm not going to bother arguing the facts. I'm not going to bother politely asking you to make corrections or remove errors. No. If you you write something I don't like, I'm going to make your life hell." The sad thing is that, depending on the target, it can work.<br />
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Ren's been through this before, and, because he is so passionate about public health, I'm sure that he will go through this again. Although he took down the post that prompted these latest attacks, Ren won't stay quiet. He will continue to educate people and write about vaccines, infectious diseases, outbreaks, and, yes, anti-vaccine activists. He's fortunate, now, to have a position where he does have the freedom to express his opinions.<br />
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I'd just like to end with what I feel I shouldn't have to say. This is my personal blog. I don't write as a representative of anyone other than myself. If you have a problem with anything I've written, take it up with me. If you can present valid arguments, I'm more than happy to change my opinion and post corrections. I'll also note that the images I used were posted publicly, though they have since been removed from Facebook.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com7tag:blogger.com,1999:blog-3609683919099708226.post-57137402009520352112015-09-15T09:10:00.001-04:002015-09-15T09:10:16.146-04:00Donald Trump's "Massive" VaccinesThis will be a very brief post. As I was reading Orac's post about <a href="http://scienceblogs.com/insolence/2015/09/15/the-long-sordid-antivaccine-history-of-donald-trump/" target="_blank">Donald Trump's anti-vaccine musings</a>, one thing kept jumping out at me. Trump kept talking about "massive shots" that kids get, going so far as to say that "tiny children are not horses". I get the impression that Trump has either never seen an actual vaccine syringe or he is so terrified of needles that when he did see one, his interpretation of reality was so warped he imagined it to be some huge monstrosity.<br />
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At any rate, I put this image together to illustrate what I think is going on in Trump's mind. Enjoy.<br />
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Oh, and as a side note, do you know how hard it is to find images of doctors practicing good hand hygiene by wearing gloves while administering a vaccine?Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com3tag:blogger.com,1999:blog-3609683919099708226.post-66013484586131294672015-08-28T09:00:00.000-04:002015-08-28T09:00:05.119-04:00Ethan Posard's The Shots Book<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
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<tr><td class="tr-caption" style="text-align: center;">Be a community immunity superhero!</td></tr>
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I meant to do this post at the beginning of the month. I really did. But life finds ways of interfering. In case you didn't know, August is National Immunization Awareness Month. I've posted stuff for NIAM before, like my lineup of <a href="http://www.harpocratesspeaks.com/2012/08/complete-vpd-wanted-poster-lineup.html" target="_blank">vaccine preventable disease wanted posters</a>. I've also written other posts for past Vaccine Awareness Weeks that could fit in well with NIAM, too, like the <a href="http://www.harpocratesspeaks.com/2011/12/vaccine-awareness-week-if-vaccines-work.html" target="_blank">myth that if vaccines work, then it doesn't matter if you vaccinate your kid or not</a>. Some years, though, I've let August slip past without writing anything specifically for NIAM, even though I have written posts with some vaccination issue as the main topic.<br />
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Not this year. I could write about outbreaks of diseases or the activities of the anti-vaccine movement, but I'd rather keep things nice and positive, at least for now. In July, I received a review copy of <a href="http://theshotsbook.com/" target="_blank"><i>The Shots Book: A Little Brother's Superhero Tale</i></a>, by Ethan Posard. Rather than publishing a post about the book right away, I wanted to hold off until Immunization Awareness Month. Then, as sometimes happens, life decided to muck up my good intentions and delay me for a while. Better late than never, right?<br />
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Ethan is the younger brother of Camille Posard, one of the talented young high schoolers who wrote and produced the film <a href="http://www.chstvfilms.org/" target="_blank"><i>Invisible Threat</i></a>, which I discussed <a href="http://www.harpocratesspeaks.com/2014/05/the-visible-attacks-on-invisible-threat.html" target="_blank">last year</a>. Although the film was met with exceptionally harsh criticism from the anti-vaccine movement (without their even having viewed the documentary), the teens who produced it proudly stood up to the bullies that tried to silence them and shut down screenings. One portion of the film follows Ethan as he goes in for one of his scheduled shots, and it's that experience with both the shot and the film that inspired him to write this book.<br />
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<i>The Shots Book</i> is based on Ethan's real experiences learning about vaccines and vaccine preventable diseases. Like the teens who produced <i>Invisible Threat</i>, it was the experience with his dog, Roxy, that really drove home the importance of vaccinations and <a href="http://www.niaid.nih.gov/topics/pages/communityimmunity.aspx" target="_blank">community immunity</a> (aka herd immunity). The book begins with Ethan wondering why he needs to get a shot if he does all the other stuff to stay healthy: eating right, exercising, washing his hands, and covering his coughs and sneezes with his arm. He and his family did the same for their puppy Roxy. Unfortunately, she still got very sick from what the vet suspected was parvovirus, a deadly doggy disease that happens to be preventable with a vaccine. Roxy hadn't been vaccinated yet because she was too young, so she depended on older dogs around her being immunized to keep her safe.<br />
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Roxy fortunately got better, and when she was old enough, she got her parvovirus vaccine, which protects not only her, but other young puppies around her. Roxy became part of the community immunity that prevents spreading of diseases. That's a lesson that Ethan took into his own life. He was able to see in Roxy why vaccines are important and what can happen when vaccination rates drop. Adding to the personal importance for him was the fact that his aunt was pregnant with twins.<br />
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Ethan describes how vaccines work, but since this is a kids' book, he uses analogies to simplify things and make them easier to understand. Rather than going on about the innate and adaptive immune systems, TH1 cells, macrophages, cytokines, and so on, he talks about them in concepts that younger kids can understand: superpowers and force fields. He also gives some tips on how to approach getting a shot, like trying not to worry, not looking at the shot, and working with your parents to pick out some treats to help celebrate your bravery in becoming a community immunity superhero.<br />
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<i>The Shots Book</i> is a really nice little book by a kid for kids. While there may be a few big words, the text is easy enough for elementary school kids to understand. The fun and engaging illustrations, for which he did the rough sketches, do a great job supporting the book's messages. But the best part of this book is that for every one you buy, Ethan will donate another copy to a Children's Hospital.<br />
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You can follow Ethan on Twitter (<a href="https://twitter.com/IAmTheHerd" target="_blank">@IAmTheHerd</a>), get updates on <a href="https://www.facebook.com/TheShotsBook" target="_blank">Facebook</a>, and buy a copy of the book at <a href="http://theshotsbook.com/" target="_blank">theshotsbook.com</a>. The book is available in both English and Spanish. Help spread the word, get vaccinated, and proudly say, <a href="https://twitter.com/hashtag/iamtheherd" target="_blank">#IAmTheHerd</a>.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com0tag:blogger.com,1999:blog-3609683919099708226.post-22947839676702344572015-08-26T22:00:00.000-04:002015-08-26T22:00:00.142-04:00Are You Weird? Not on the Internet! #NeverWeird<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgulVMV4Bg9AKBAODfZTA_Vk9kXjROxnu_4E_8m_8uBC5TckOsTq6P8V1ZpBvzS8hM2DMM0AgECikM02vvSlyrz48fB9KSzzW5ofDOqKe0Dlgsy2qP-mm7UP8uJ8nf697S-EcYsdbLTvc8U/s1600/Youre+Never+Weird+on+the+Internet+-+almost.jpg" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="259" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgulVMV4Bg9AKBAODfZTA_Vk9kXjROxnu_4E_8m_8uBC5TckOsTq6P8V1ZpBvzS8hM2DMM0AgECikM02vvSlyrz48fB9KSzzW5ofDOqKe0Dlgsy2qP-mm7UP8uJ8nf697S-EcYsdbLTvc8U/s320/Youre+Never+Weird+on+the+Internet+-+almost.jpg" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Nothing weird or dorky to see here.</td></tr>
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Ever feel like you don't quite belong? That something you do, or something you're interested in sets you apart from other people, but not necessarily in a positive way? I've certainly felt that way. I geek out about something or make some dorky joke and just get blank stares, or people suddenly find something intensely interesting somewhere else. Before sci-fi and fantasy were considered acceptable fare by the general public, I was into dragons and magic. I liked <i>Star Trek</i>. Hours ticked by while I played games on my computer. And role-playing games? When, where, and what type of character is needed? Don't play? I'll show you the ropes. Online role-playing games? Woot! I spent a number of years playing a MUD (multi-user dungeon, basically a text-based online game) originally named "F-----" (sorry, gotta avoid infringing on a trademark owned by some ocean-adjacent spellcasters). Eventually, I moved on to be a builder, creating large portions of the world. When the trademark owners decided they wanted to get in on this whole online gaming thing, giving an ultimatum to the owner of the MUD to buy a license or shut down, I spent a hectic several days converting the entire world to remove any trademarked words and change descriptions. I spent hours every day playing, building, and running quests. After a few years, the game took a hiatus. Although I helped start it up again, I realized that it took over too much of my life and that I had to give it up. I scaled way back, ultimately quitting the game.<br />
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But no matter how geeky my interests, I still held back a little bit so I could "fit in" (sorta) with "regular" people (not to mention my fear of getting sucked into something that would eat up all of my free [and not-so-free] time). And because of that, I wasn't quite geeky enough for the geeks. The really hard core gamers? I might as well have had three heads when I showed any lack of knowledge about the latest game. I'm weird. And I'm proud of that.<br />
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The internet, however, is something of an equalizer. No matter what your interests, no matter how odd your sense of humor, you will find a community online that accepts you and welcomes you for who you are. Online, you never have to worry about being "weird". That's one of the big messages in <a href="http://feliciaday.com/" target="_blank">Felicia Day</a>'s new book, <a href="http://feliciadaybook.com/" target="_blank"><i>You're Never Weird on the Internet (almost)</i></a>.<br />
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If you're into geek culture, you probably know who Felicia Day is. If not, I'll give a little background. You might know her from several acting roles, including <a href="http://buffy.wikia.com/wiki/Violet" target="_blank">Vi</a> (one of the potential slayers) in the TV series <i>Buffy the Vampire Slayer</i>; Penny in <a href="http://drhorrible.com/" target="_blank"><i>Dr. Horrible's Sing-Along Blog</i></a>; Charlie on the show <a href="http://www.cwtv.com/shows/supernatural/the-hunter-games/?play=daff09dc-0fe1-44b4-a1ee-b8ced8974e79" target="_blank"><i>Supernatural</i></a>; and Holly Marten on Syfy's <a href="http://www.syfy.com/eureka" target="_blank"><i>Eureka</i></a>. But what she's probably best known for are her web series <a href="http://watchtheguild.com/" target="_blank"><i>The Guild</i></a> and her multimedia production company and YouTube channel <a href="http://geekandsundry.com/" target="_blank">Geek & Sundry</a>. An avid gamer, Day has become something of a geek icon.<br />
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<i>Never Weird</i> is Day's memoir. She writes about her, uh, rather unconventional upbringing. Day was home schooled, but not, she writes, for religious reasons. She was home schooled for hippie reasons, but not "<i>full </i>hippie...[m]ore hippie adjacent". She didn't have a set curriculum and never actually received a high school degree. Instead, she grew up with a variety of lessons, like violin (from the age of 2<span class="st">½)</span>, ballet, water color, cross-stitch, martial arts. Basically, whatever was on offer at the local community college. Oh, and math. Her grandfather was a physicist, and there was a big drive to impress him talking about things like the Pythagorean theorem. She also spent a lot of time with computers. Her family was an early adopter of the whole online thing, and Day found a home in games like <a href="https://en.wikipedia.org/wiki/Ultima_%28series%29" target="_blank"><i>Ultima</i></a> and their online forums. She went on to get a full scholarship to university at 16 years old (despite having no GED) and graduated (with a 4.0) with degrees in violin and math.<br />
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While an interesting read, the story of what has made Day "weird" isn't the best part of her book. The truly striking parts come toward the end, where she writes about her adult life (so far) and the lessons that came out of her experiences. After college, she moved to Los Angeles to pursue her dream of being an actor. Day shares how video games helped her cope with the harsh realities of L.A. In real life, she appeared in commercials (the prop to the product "star") and in the same "quirky secretary" type of roles over and over. But online, she was a powerful warlock. She had friends. She fit in. She was important. Yet, like any addiction, it consumed her life. She kept putting off her idea of writing a TV pilot. She neglected her friends and family. She let her auditioning slide.<br />
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But eventually, a small group of friends helped motivate her to get going on her script. The result was <i>The Guild</i>, which drew heavily on her experiences. It's also what shot her to geeky stardom. Day started appearing at conventions. And toward the last few seasons of <i>The Guild</i>, she started working on her company, Geek & Sundry. That's also the time she sank into depression.<br />
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While it may seem counter-intuitive, Day's success was part of the problem. The series was so popular that she didn't feel that she could deliver anything as good, that her efforts would be a failure destined to disappoint her fans. Add on the fact that something that had been such a big part of her life for the past several years was coming to an end, and starting her own company, the stress overwhelmed her. Day speaks candidly about her battle with depression and anxiety (at one point, she mentioned that if she'd been an animal in a former life, she would have been a <a href="https://en.wikipedia.org/wiki/Dik-dik" target="_blank">dik-dik</a>), and about how she didn't really realize she had a problem. She thought she could deal with things on her own. A big problem with depression is that your own brain works against you, driving you further and further down and away from those who could really help you. There is help, as Day discovered. She also learned that she had a thyroid problem that contributed to both her depression and some of her physical health problems she had been experiencing. Hopefully her book can help others struggling with depression realize there is help out there, as well as raise awareness about thyroid and mental health issues.<br />
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But depression and how to deal with it aren't the only lessons in <i>Never Weird</i>. Day also writes about the negative side of the internet. One of the things that I've experienced in writing about vaccines is the vitriol and personal attacks from those who disagree with me. I've had it relatively easy, only getting unimaginative insults, but friends of mine have been harassed at work, <a href="https://en.wikipedia.org/wiki/Doxing" target="_blank">doxed</a>, and otherwise personally targeted in attempts to silence them. The gaming world isn't free of such behavior, either. Some of you may have heard of <a href="https://en.wikipedia.org/wiki/Gamergate_controversy" target="_blank">#GamerGate</a>. Briefly, this is something that started with a guy posting a lot of personal information about his girlfriend, a game designer, after they broke up, in an attempt to destroy her reputation and cause her as much pain as possible. From there, #GamerGate expanded into a misogynistic, anti-feminist cultural movement, where doxing and rape and death threats aimed at critics of #GamerGate became something of a norm.<br />
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For a long time, Felicia Day remained silent about #GamerGate because she had seen what happened to those who spoke out, particularly women. And having had issues with stalkers in the past, Day feared what would happen if she said anything. She eventually did speak out, however, in a post titled "<a href="http://feliciaday.com/blog/crossing-the-street/" target="_blank">Crossing the Street</a>". The goal of the post was to highlight how #GamerGate and the fear that group generated was driving a wedge between gamers. It was meant to try to bring gamers back together as a community of people who all loved games. Day posted it right before she had to leave for filming. Within a few hours, she got a phone call from her friend, Wil Wheaton. An actual phone call, rather than a text or email, was unusual. He told her she needed to shut down commenting on the post right away. Instead of drawing support, the comments were filled with #GamerGate supporters posting Day's home address. She also became the target of a barrage of insulting and sexist comments on Facebook, Twitter, YouTube, pretty much anywhere there is an online presence.<br />
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Speaking out online takes courage. It can be very hard to do what you know is right, to fight back against the wrongs being done, especially when doing so will very likely draw personal attacks and underhanded, unethical tactics like doxing. It's one reason that I write pseudonymously, to allow me to speak out while protecting those who are close to me. Day knew what could happen to her if she said anything even remotely critical about #GamerGate, yet she still spoke out. As she writes in <i>Never Weird</i>:<br />
<blockquote>
"So if my speaking up made one person feel like they belong or prevented one person from stifling their own voice, then it was absolutely worth it.<br />
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Because if you can't be your own weird self on the internet, where can you be? And what would be the point?"</blockquote>
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I thoroughly enjoyed reading <i>You're Never Weird on the Internet (almost)</i>. Even if you don't know much about Felicia Day, the book is a must-read, especially if you are young. Teens have a lot of stuff going on as they try to define themselves and "fit in". Maybe this book can help them be comfortable just being their own weird selves, knowing that there is always a community that will accept and support them. Day's personality shines through, making for a fun and entertaining read with some very powerful lessons. If possible, try to get the book from a small, local bookseller. But if you can't find it locally, maybe <a href="http://feliciadaybook.com/" target="_blank">Felicia can help</a> you find it online. And you can keep up by following the hashtag <a href="https://twitter.com/hashtag/neverweird" target="_blank">#NeverWeird</a> on Twitter.<br />
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Oh, and Felicia, if you read this, I'd love to share a game or game story with you someday. Contact info's over there on the right.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com0tag:blogger.com,1999:blog-3609683919099708226.post-85557303852556483202015-07-16T09:00:00.000-04:002015-07-16T09:00:04.018-04:00Who Chooses? Parents' vs. Children's Rights<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgP2S8FeWPN9HfqbLvwCkPGA5PcUUFIdsITjBrfvvXmLUqecTW8CTfDx8V8_cyF1QnTo5jq1SFgF3J03vlKV7IRe529wEDoTuFe-4osjNnSaHECwZGVLtKzVTy9pXl1ntD4oKoP4Y_t_zKB/s1600/I_have_a_voice.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgP2S8FeWPN9HfqbLvwCkPGA5PcUUFIdsITjBrfvvXmLUqecTW8CTfDx8V8_cyF1QnTo5jq1SFgF3J03vlKV7IRe529wEDoTuFe-4osjNnSaHECwZGVLtKzVTy9pXl1ntD4oKoP4Y_t_zKB/s1600/I_have_a_voice.jpg" /></a></div>
There's a topic that I've touched on a few times over the years here, but I've never really delved into it. It's something that comes up pretty frequently in discussions of children's health, particularly when talking about vaccines or so-called alternative medicine. It's even something that arises around issues of which real treatment a child should receive. I've mentioned it in passing in posts about vaccines (e.g., when talking about why <a href="http://www.harpocratesspeaks.com/2011/12/vaccine-awareness-week-if-vaccines-work.html" target="_blank">it actually does matter</a> to others if you vaccinate your child, how <a href="http://www.harpocratesspeaks.com/2014/02/mississippi-parent-group-working-to.html" target="_blank">anti-vaccine people want to change legislation</a>, or how they oppose what they see as <a href="http://www.harpocratesspeaks.com/2015/02/is-govt-taking-away-peoples-beliefs.html" target="_blank">government interference</a>), as well as my discussion about a case involving <a href="http://www.harpocratesspeaks.com/2014/03/the-case-of-justina-pelletier-calls-for.html" target="_blank">controversy over competing diagnoses</a>. <a href="http://scienceblogs.com/insolence/2013/10/29/children-are-not-their-parents-property/" target="_blank">Others</a> have <a href="http://scienceblogs.com/insolence/2014/01/28/once-again-caring-more-about-parental-rights-than-the-rights-of-the-child-being-subjected-to-quackery/" target="_blank">also written</a> about it in the context of cancer treatment. A common element in all of these topics is autonomy: the right to make decisions about one's own healthcare. More specifically, do parents own their children? Do parents have the freedom and the right to do with their children as they please? Or are parents merely guardians and stewards for their children until they are mature enough to make decisions on their own? Where do parental rights end and the child's rights begin?<br />
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Recently, this notion came up again in response to a post on Reddit, in which a mother, who is opposed to vaccines and did not vaccinate any of her children, relates how she discovered her eldest daughter got herself vaccinated in secret, much to the mother's chagrin. She asks if she can take any legal action.<br />
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The <a href="http://archive.is/kupY5" target="_blank">July 8, 2015 post</a> to the legal advice subreddit was eventually removed, but not before garnering a robust response. Many comments were along the lines of praising the daughter for taking her health into her own hands. Others heaped insult onto the parents for not protecting their children. And quite a few pointed out that given the girl's age (16 years), she is fully entitled to make her own health care decisions without her parents' consent.<br />
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Here's the original comment, before it was removed:<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjFQ8nKc6mA91QuU3edTfQaZPUPkCwRjOxekRpCcqRg88p7fYP6qfo5xwScJArN8mMY7kJv3mtmWuYc0AjiwBcVu-XpB8UGRiBPZEotC-FxsscFf-vkJ9W4KXAYu0hPnPRCzfhAF10OGpJM/s1600/Reddit+-+Daughter+Vaccinated+Herself+-+Can+I+Sue.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjFQ8nKc6mA91QuU3edTfQaZPUPkCwRjOxekRpCcqRg88p7fYP6qfo5xwScJArN8mMY7kJv3mtmWuYc0AjiwBcVu-XpB8UGRiBPZEotC-FxsscFf-vkJ9W4KXAYu0hPnPRCzfhAF10OGpJM/s1600/Reddit+-+Daughter+Vaccinated+Herself+-+Can+I+Sue.jpg" /></a></div>
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The text reads:<br />
<blockquote>
None of my children are vaccinated. Totally by accident I came to find
out that my oldest daughter has been fully vaccinated (Tetanus,
diphtheria, pertussis, polio, measles, mumps, rubella, hep a and b,
menengitis a and b and hpv) without mine or my husband's knowledge or
consent. In Ontario we have socialized medicine and publicly funded
vaccines. She admitted she went to clinics run for school aged children
run by our local health public health unit to get her shots and also got
a few at a local walk in clinic that are not yet publicly funded paid
for with her babysitting money. When I called public health and the
clinic to complain they both said that because she is age 16 they cannot
release any information to me - and I'm her mother! My husband and are
livid that she was vaccinated without our consent. What kind of action
can we take against public health and the clinic for vaccinating a child
without parental consent? Do we have a case for a lawsuit?</blockquote>
For those who support vaccines, it's a great story: a teenage act of rebellion where the teen is the smart one, taking her health into her own hands. There is some question as to whether this story is actually true or not. There are details that cast doubt on it, such as the idea of the girl paying for any of the vaccines with her babysitting money. Canada has universal healthcare, which covers all routine vaccinations. While some private clinics would charge for a vaccine, they are uncommon, and many of the nurses and doctors staffing a walk-in clinic are <a href="http://www.ontario.ca/page/walk-clinics" target="_blank">still covered by the Ontario Health Insurance Plan</a>. There's also the username of the poster: "momquestionthrowaway". And then the whole story seems too absurd and outlandish to be real. None of this means it did not happen, but there are reasons to doubt and no means of verifying the elements of the story.<br />
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But what about the essence of the post? Whether the story is true or not, it brings up an important question: do the parents have a right to their daughter's medical records? Do they have a right to legal action against the clinics for vaccinating their daughter without <i>their</i> consent? Do the parents' rights supersede their daughter's right to privacy and autonomy over her own healthcare?<br />
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Capacity to consent is, in many locations, not so much a matter of ability as it is of arbitrary age cut-offs set by law. For instance, in the United States, as far as the law is concerned, you are incapable of safely operating a car unsupervised until you are 16. Likewise, you can't consent to working conditions or contracts until you're at least 16, and in some cases not until you are 18. Only when you reach 18 are you considered an adult, capable of making your own decisions and even altering how our country functions (via voting). But you cannot make decisions, legally, about drinking alcoholic beverages until you are 21 years old, despite the fact that, in all other regards, you are legally an adult. Then there are the varying ages allowed by the states for possession and unsupervised operation of a firearm. For example, while Federal law limits the sale of firearms by a licensed dealer to only those aged 21 or older, <a href="http://codes.lp.findlaw.com/mtcode/45/8/3/45-8-344" target="_blank">Montana state law</a> allows anyone at least 14 years old to possess and use a rifle without adult supervision.<br />
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As far as the legal question in the Reddit story goes, per <a href="http://www.ontario.ca/laws/statute/96h02#BK1" target="_blank">Ontario law</a>, anyone who is at least 16 years old has guaranteed medical autonomy, barring any conditions or disorders that impair their decision-making capacity. That means that as soon as a child turns 16, they can make their own medical decisions and their medical records are a private matter between the child and their doctor. The mother in the story has no legal right to view her daughter's records nor to take action against the clinics or the provincial Department of Public Health for complying with her daughter's wishes.<br />
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But what if she were 15 years old? Would her parents have a right then? Not necessarily. While Ontario law guarantees autonomy once a person reaches 16 years of age, the province is <a href="http://www.royalcollege.ca/portal/page/portal/rc/common/documents/bioethics/section1/case_1_5_2_e.html" target="_blank">one of several</a> that recognizes that the ability to make medical decisions for oneself is not a simple matter of age. They employ a "mature minor" standard in that there is no statutory minimum age required for a child to consent to medical treatment on their own. If, in the physician's judgment, the child understands the nature and consequences of their decision, then they are capable of making the choice for themselves, without any other input from the parents. Before her parents would be able to obtain the medical records relating to her autonomous decision or to take action against the clinics, her parents would need to challenge her capacity as a mature minor in court. In short, they would need to demonstrate that she did not understand the nature or consequences of her decision and that she is therefore unfit to make her own medical decisions.<br />
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I'm admittedly simplifying the issues somewhat for purposes of this post; there are nuances to the law and its interpretation and enforcement. But at least from a legal viewpoint in Ontario, parents do not have an automatic right to dictate what medical procedures their children do and do not get.<br />
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But what about the ethical angle? Regardless of what the law says, should a parent have unfettered control over their child's healthcare decisions? Should a child be considered completely autonomous and allowed to make decisions without the consent of their parents? I'm sure that there are some parents who would answer "yes" to the first question and "definitely not" to the second. Conversely, there are some children who would answer just the opposite. From an ethical perspective, the answer to both questions would tend toward "no", though more realistically, the answer is, "it depends".<br />
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<a href="https://www.mja.com.au/journal/2004/180/7/youth-health-research-ethics-time-mature-minor-clause" target="_blank">Some research</a> notes that adolescents are capable of making informed medical decisions by the time they are 14 years old. They are mature enough to understand the magnitude of their decisions. <a href="http://www.ncbi.nlm.nih.gov/pubmed/23615057" target="_blank">Other research</a> argues that people are not fully cognitively developed until they are 21 years old. Obviously, there is variation from individual to individual, and from situation to situation. A child may be capable of an informed medical choice at a young age, where they are free of peer (or parental) influence and the consequences are limited in severity. The same child may be incapable of making a medical decision for themselves when they are under the strong influence of friends or their parents, or where the outcomes are of such a great magnitude that the child is incapable of fully understanding.<br />
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Whether a child is mature enough to make their own medical decisions, whether to accept or refuse treatment, depends on the child and the situation. However, if the child can demonstrate that they understand, that they truly comprehend their situation and the options available, then from an ethical standpoint, they ought to be able to give or refuse consent, without the intervention of their parents. They are individuals in their own right, and as such are deserving of respect as an individual. They are not objects owned by their parents. They are not chattel for the parents to do with as they please. They are individual human beings.<br />
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In an ideal world, parents and their children would make medical decisions together, and when the child is mature enough, whether as early as 14 or not until they are legally adults at 18, decision making moves into their hands. But no matter what age a child begins deciding for themselves, the parent does not have an absolute right over their child. When it comes to medical decisions, the parent has an obligation to do what is in the best interests of their child, even if that decisions is at odds with the parent's wishes, as is the case with vaccines and parents opposed to vaccination. Likewise, within the parent-child-doctor relationship, the doctor's duty is to the child, not to the parents.<br />
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It may be difficult for parents to accept that their children are growing up, that their kids do not need them anymore. And it can be even harder for some parents to view their children as individuals capable of making their own decisions rather than property, to put aside their own desires and beliefs in deference to what is objectively best for their child. Unfortunately, there is no hard and fast rule, no clear cutoff point at which we can say, "This person is now capable of making informed medical decisions on their own." It is a complex issue that is very situation-dependent. But at the very least, we can respect that parents do not own their children, no matter what <a href="http://scienceblogs.com/insolence/2015/02/03/is-republican-party-becoming-antivaccine-party/" target="_blank">misguided Kentucky politicians</a> might say.<br />
<br />
Parents are not free to do with their children as they please, because children are not property. They are not owned. Children have rights, too. That includes the right to protect themselves when their parents fail to do so.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com1tag:blogger.com,1999:blog-3609683919099708226.post-85795084881429726872015-07-02T00:01:00.000-04:002015-07-02T18:34:12.911-04:00Jim Carrey's The Bad Tweet<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh5T3-vH2PlT_ToN2Td5M_2btLLW5-CepBp-8odxIWQLGfnhMcS2ceq_hTU5Y_TQtC-oXQHaAx4JwhbBlmTbLkoQXPAcR2JHtfw9Lms0-nb0D4DR-3SAz1elLVAPkO5rGMc8r597V7xvGwr/s1600/Jim+Carrey+-+Liar+Liar.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh5T3-vH2PlT_ToN2Td5M_2btLLW5-CepBp-8odxIWQLGfnhMcS2ceq_hTU5Y_TQtC-oXQHaAx4JwhbBlmTbLkoQXPAcR2JHtfw9Lms0-nb0D4DR-3SAz1elLVAPkO5rGMc8r597V7xvGwr/s1600/Jim+Carrey+-+Liar+Liar.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Did you learn nothing from this movie, Jim?</td></tr>
</tbody></table>
<b>[<i>Update 7/2/15 at 6:30pm:</i></b><i> Jim Carrey has removed the tweets mentioned below and replaced them with text-only tweets. He has not tweeted any apologies.</i><b>]</b><br />
<b> </b> <br />
Oh, Jim Carrey. Not content to be a fool on screen, you decide to (continue) to be a fool on Twitter. After the passage and signing of California's <a href="https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160SB277" target="_blank">SB277</a>, a new law that removes non-medical exemptions to school immunization requirements, <a href="http://www.slate.com/blogs/bad_astronomy/2015/07/01/jim_carrey_anti_vax_is_as_anti_vax_does.html" target="_blank">Carrey went on a bit of a rant</a> on Twitter, declaring the law fascist (<a href="http://www.nbcnews.com/health/health-news/commentary-why-jim-carrey-wrong-about-vaccines-n385321" target="_blank">it's not</a>), playing the Pharma Shill Gambit, the <a href="http://www.harpocratesspeaks.com/search/label/toxin%20gambit" target="_blank">toxin gambit</a>, and, like so many other anti-vaccine activists, declaring he's <a href="http://www.harpocratesspeaks.com/2010/11/vaccine-awareness-week-im-not-anti-vax.html" target="_blank">not anti-vaccine</a>. In short, he's just following the anti-vaccine handbook. But he wasn't content to keep it to just being mildly unhinged. But I'll get to that in a bit.<br />
<br />
I first became aware of <a href="http://blogs.discovermagazine.com/badastronomy/2009/04/23/jim-carrey-loves-the-pro-disease-movement/#.VZSArkaH3B8" target="_blank">Carrey's anti-vaccine nonsense</a> back in 2009, when Carrey was with anti-vaccine spokesperson Jenny McCarthy. For a while, Phil Plait, aka the Bad Astronomer, had occasionally written about the anti-vaccine movement. Like clockwork, anti-vaccine activists would show up in the comments spouting the same tired tropes over and over. It prompted me to write up a summary addressing the <a href="http://antiantivax.flurf.net/" target="_blank">more common myths around vaccines</a>. It's helped some learn the truth and facts about vaccines and exposed many of the lies told about them.<br />
<br />
Apparently Jim Carrey didn't bother reading it, or, if he did, he didn't learn a thing. So what has he done this time around that went beyond merely making a fool of himself and showed that he is an opportunistic and insensitive ass that doesn't really care about those affected by autism?<br />
<a name='more'></a><br />
In his crusade to villify vaccines and scare parents away from protecting their children, he posted a series of photos, railing about "toxins" in vaccines. He suggests that the photos show what the future may hold for California, now that SB277 is law. For instance, there's <a href="https://twitter.com/JimCarrey/status/616277959972753409" target="_blank">this tweet</a>:<br />
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<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgKFmmzWfIn-0zFyRoFog8m7Lp4TeGyy4iCAmONcnvUmFxioFaghlRTmIZ0aE2Dp087W_ntOTAhdzxwg13qJpVP-CHD45791JJ8IcHUU_2Jmcklg-ER7t1JBmUbepgAzZTNBZnSrokYyPNA/s1600/Twitter+-+Jim+Carrey+uses+Shutterstock+tantrum+photo+to+promote+anti-vaccine.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="394" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgKFmmzWfIn-0zFyRoFog8m7Lp4TeGyy4iCAmONcnvUmFxioFaghlRTmIZ0aE2Dp087W_ntOTAhdzxwg13qJpVP-CHD45791JJ8IcHUU_2Jmcklg-ER7t1JBmUbepgAzZTNBZnSrokYyPNA/s400/Twitter+-+Jim+Carrey+uses+Shutterstock+tantrum+photo+to+promote+anti-vaccine.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">BECAUSE ALL CAPS MAKES IT REASONABLE!</td></tr>
</tbody></table>
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The tweet reads, "TOXIN FREE VACCINES, A REASONABLE REQUEST!" (all caps in the original), with a link to a PDF advertising <a href="https://www.sciencebasedmedicine.org/five-years-on-bill-maher-is-still-an-antivaccine-crank-and-proves-it-yet-again/" target="_blank">Robert F. Kennedy Jr.'s</a> <a href="http://www.donotlink.com/robertfkennedyjr.com/docs/Skyhorse_USA_Today_Final_colorNZ.pdf" target="_blank">book on thimerosal</a>.<br />
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Then there's <a href="https://twitter.com/JimCarrey/status/616290384096813056" target="_blank">this tweet</a>:<br />
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<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi9KF9Mc9WXKsly_BohViKTXnSaqc8-KVUuLlmap1-2frvrqnhBlT7D8fmX26I_gvCfmNQtOxwwAeVRFBTqS2K-l2CsV9ESmLNlEvKF2-vsinM3jF6Y8UqMop5pJOpSKiesrvh004bZNc3z/s1600/Twitter+-+Jim+Carrey+uses+another+stock+photo+to+promote+anti-vaccination.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi9KF9Mc9WXKsly_BohViKTXnSaqc8-KVUuLlmap1-2frvrqnhBlT7D8fmX26I_gvCfmNQtOxwwAeVRFBTqS2K-l2CsV9ESmLNlEvKF2-vsinM3jF6Y8UqMop5pJOpSKiesrvh004bZNc3z/s1600/Twitter+-+Jim+Carrey+uses+another+stock+photo+to+promote+anti-vaccination.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Again, SHOUTING makes you sound more reasonable.</td></tr>
</tbody></table>
Similar to his other tweet, the text reads, "This could be the face of California's future. TOXIN FREE VACCINES, A REASONABLE REQUEST!". And once again, he includes a link to the advertisement for Kennedy's book.<br />
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And then there's <a href="https://twitter.com/JimCarrey/status/616282382958661632" target="_blank">this tweet</a>:<br />
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<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXetGMd46_S1EW6WJ3hEICgIZdq77h17dnb160zMxJ9vx6Achm-IunIf4G79SEHp2xuQR1BVlPKfWlb8XHskOrVuvkpSPrYc-b4jWLvkgZ2NUMEedUYZqVNiaDXQ8pd0obsAiyv9b2at-3/s1600/Twitter+-+Jim+Carrey+uses+picture+of+child+w+TSC+to+promote+anti-vaccination.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXetGMd46_S1EW6WJ3hEICgIZdq77h17dnb160zMxJ9vx6Achm-IunIf4G79SEHp2xuQR1BVlPKfWlb8XHskOrVuvkpSPrYc-b4jWLvkgZ2NUMEedUYZqVNiaDXQ8pd0obsAiyv9b2at-3/s400/Twitter+-+Jim+Carrey+uses+picture+of+child+w+TSC+to+promote+anti-vaccination.jpg" width="378" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Maybe a trillion dollars would also buy a therapist for Jim.</td></tr>
</tbody></table>
This one doesn't include a link, but there's still some shouting about being reasonable, as he writes, "A trillion dollars buys a lot of expert opinions. Will it buy you? TOXIN FREE VACCINES, A REASONABLE REQUEST!". <b>[<i>Edited to add:</i></b><i> As I was writing this, it appears that a complaint was lodged to Twitter and the photo was removed at the request of the copyright holder.</i><b>]</b><br />
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The theme running through these three tweets is that the photos, according to Carrey's insinuation, are all of children that are "vaccine damaged". The motive is pretty plain: scare people away from vaccines. Make them think that this could be what happens to <i>your</i> child if you vaccinate them.<br />
<br />
There's just one problem. None of the photos have anything to do with vaccines.<br />
<br />
That first photo? It's from <a href="http://www.shutterstock.com/pic.mhtml?id=49401919" target="_blank">Shutterstock</a>, copyrighted by Pixel Memoirs, and has been used in numerous places around the web:<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlNCe15TxUk8oEtr6fM6pgcO7QSrWxt1gPIhI5yxa32WcQ6sWO_2u7ZGKv6BrjbEZwe2KjYllFy4IUa3Mv5tG6xo1QUmeU3mYz2NVx4pjYYuz6YmIw9hQ3n1vO9QXeERTYpvDhmxNiJO9_/s1600/Shutterstock+Photo.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="257" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlNCe15TxUk8oEtr6fM6pgcO7QSrWxt1gPIhI5yxa32WcQ6sWO_2u7ZGKv6BrjbEZwe2KjYllFy4IUa3Mv5tG6xo1QUmeU3mYz2NVx4pjYYuz6YmIw9hQ3n1vO9QXeERTYpvDhmxNiJO9_/s400/Shutterstock+Photo.jpg" width="400" /></a></div>
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The second photo is apparently another stock photo that's been in use since <a href="http://webcache.googleusercontent.com/search?q=cache:vlMKEw8lZ9UJ:madmenmedia.blogspot.com/2009/10/im-pc-microsoft-vs-apple-but-who-is.html+&cd=1&hl=en&ct=clnk&gl=us" target="_blank">at least 2009</a>. It, too, is all over the internet, used in various stories, many having to do with frustration or parenting:<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhGfmvp7ENctVhpuQtXkMXTZNgo98o3XYc-PE47Cb4-fh5vbNlKdUX06_Vkx6iY-OmFmKfAzXgtCNVuXHEEfuSkC1dKyKljQZuD4tBW31omOWTFvfOUtSUAhZhb_6rGx1Byf7ODlrqbC2Pj/s1600/Frustrated+Kid.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="340" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhGfmvp7ENctVhpuQtXkMXTZNgo98o3XYc-PE47Cb4-fh5vbNlKdUX06_Vkx6iY-OmFmKfAzXgtCNVuXHEEfuSkC1dKyKljQZuD4tBW31omOWTFvfOUtSUAhZhb_6rGx1Byf7ODlrqbC2Pj/s400/Frustrated+Kid.jpg" width="400" /></a></div>
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Then there's the third photo. That one's not a stock photo. It's a still from a <a href="https://www.youtube.com/watch?v=bR7hcocpXBc" target="_blank">video segment</a> used in <a href="http://www.kptv.com/story/20660400/medical-marijuana-used-to-manage-autism" target="_blank">news stories</a> about a boy named Alex Echols, who has <a href="http://www.ninds.nih.gov/disorders/tuberous_sclerosis/detail_tuberous_sclerosis.htm" target="_blank">tuberous sclerosis complex</a> (TSC). I was alerted to Jim Carrey's tweet by Alex's aunt, <a href="https://twitter.com/SCeWelch/status/616345278975725568" target="_blank">Elizabeth Welch</a>, who was justifiably upset with Carrey's cynical exploitation of the picture of Alex during one of his TSC episodes. TSC is a genetic disorder caused by mutations in at least one of two genes (TSC1, TSC2). It leads to tissue growths in various organs of the body, but most commonly the brain and kidneys. Symptoms can include seizures, cognitive impairment, and behavioral problems. It is also one of the known causes of autism spectrum disorder. Alex, indeed, has also been diagnosed with autism.<br />
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And just like the pictures exploited by Jim Carrey to promote his anti-vaccine message, Alex's TSC has nothing to do with vaccines. Tuberous sclerosis isn't caused by immunizations. He was <a href="http://www.alexneedshelp.com/about-alex#.VZSkEEaH3B8" target="_blank">diagnosed when he was only six weeks old</a> in 2001. He has rather severe self-injurious behaviors. It is so bad, in fact, that his parents are not able to provide the care he needs to prevent serious injury. They made the very difficult decision to place him in a home. According to Ms. Welch, the original video from which the photo is drawn was made to raise awareness of tuberous sclerosis. Yet here Carrey used it out of context to promote his own message.<br />
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Jim Carrey owes this family a huge apology for exploiting their child by using his image without their permission to promote his anti-vaccine agenda. Carrey has shown that he is an incredibly insensitive and callous ass with no care about how his actions will affect others.<br />
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<i>There is also an <a href="http://www.buzzfeed.com/virginiahughes/jim-carrey-tweeted-this-kids-photo" target="_blank">article about this on BuzzFeed</a> by Virginia Hughes.</i> Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com4tag:blogger.com,1999:blog-3609683919099708226.post-81244605995825155282015-07-01T05:00:00.000-04:002015-07-01T10:16:31.835-04:00SB277 Signed! Congratulations, California!<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEivR9XvRz2eKHPmwy_ZjC24_rp3spZ6zV6yQ9xOf3IPWh-rvClLNjEo9XpbzqkmcUf5LiDJ4L3FYBYlE2dU8B-jnj_WqcuIrS8okwcbNWg8fitj8d4q9cQoHRB8B23Lr-LcCgO3lNihnQir/s1600/Cute+Baby.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEivR9XvRz2eKHPmwy_ZjC24_rp3spZ6zV6yQ9xOf3IPWh-rvClLNjEo9XpbzqkmcUf5LiDJ4L3FYBYlE2dU8B-jnj_WqcuIrS8okwcbNWg8fitj8d4q9cQoHRB8B23Lr-LcCgO3lNihnQir/s1600/Cute+Baby.jpg" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">June 30, 2015 - A happy day for California children!</td></tr>
</tbody></table>
This is just a very brief post to celebrate the triumph of science and public health over the fear and lies of the anti-vaccine movement. On June 30, 2015, Gov. Jerry Brown signed <a href="https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201520160SB277" target="_blank">SB277</a> into law. <a href="http://www.harpocratesspeaks.com/2015/06/SB277-Opposition-Smokescreen-of-Parental-Choice.html" target="_blank">As I mentioned briefly before</a>, SB277 ensures that only medical exemptions will be allowed for school immunization requirements. California has joined Mississippi and West Virginia as the only three states in the country that put children's health above misguided personal and superstitious beliefs.<br />
<br />
In his <a href="http://gov.ca.gov/docs/SB_277_Signing_Message.pdf" target="_blank">signing statement</a> (PDF), Gov. Brown noted the importance of vaccines and the science that supports their use:<br />
<blockquote>
The science is clear that vaccines dramatically protect children against a number of infectious and dangerous diseases. While it's true that no medical intervention is without risk, the evidence shows that immunization powerfully benefits and protects the community...<br />
<br />
...Thus, SB277, while requiring that school children be vaccinated, explicitly provides an exception when a physician believes that circumstances - in the judgement and sound discretion of the physician - so warrant.</blockquote>
My thanks go out to Senators Pan and Allen for shepherding this bill through the California legislature, to all of the senators and assembly members who voted for this bill, the parents and activists who supported their efforts, and Gov. Brown for signing it. You have all done an amazing thing to protect the health of California's most vulnerable population.<br />
<a name='more'></a><br />
<b>[<i>Edited to Add:</i></b><i> While this bill will, in the long run, help to protect California children from infectious disease outbreaks, we won't see an effect immediately. The way the bill is worded, any personal belief exemption for a child filed before January 1, 2016 will be honored until the child reaches the next grade span, i.e.:</i><br />
<ol>
<li><i>Birth to preschool;</i></li>
<li><i>Kindergarten to 6th grade; and</i></li>
<li><i>7th-12th grade</i></li>
</ol>
<i>This means that it could be as late as 2021 or 2022 before we see the full impact of this new law, in terms of increasing vaccination uptake among schoolchildren.</i><br />
<br />
<i>During this period, we may also start to see an increase in medical exemptions being filed, primarily by anti-vaccine-sympathetic doctors like Dr. Bob Sears and Dr. Jay Gordon. Hopefully, the state medical board will keep tabs on this to ensure that only valid medical exemptions are being filed.</i><b>]</b><i> </i>Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com0tag:blogger.com,1999:blog-3609683919099708226.post-70254057055991607942015-06-22T07:00:00.000-04:002015-06-23T09:18:25.012-04:00SB277 Opposition: The Smokescreen of Parental Choice<div class="separator" style="clear: both; text-align: center;">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgC9YCpqQVqwM8JeyVFoyf1S8MqMJV4nVnb-f25IEfYtseWnH0XjwSQlZ7vLyUfrC8MykU1IHjSALeXtW1FKEppw24zrUeKVihDUnPqBYBuAh-NfWo9hmqgO5O5R5vW5SnaGBqMuKT30kGN/s1600/Free+to+Choose.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="225" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgC9YCpqQVqwM8JeyVFoyf1S8MqMJV4nVnb-f25IEfYtseWnH0XjwSQlZ7vLyUfrC8MykU1IHjSALeXtW1FKEppw24zrUeKVihDUnPqBYBuAh-NfWo9hmqgO5O5R5vW5SnaGBqMuKT30kGN/s400/Free+to+Choose.jpg" width="400" /></a></div>
Humans love to have choices. From early on in our childhood, we like to be able to choose what we want to do. Play with this toy or that one. Eat this food or that. And we don't like having limitations placed on our choices, especially if it involves doing something we don't want to do. Our parents try to teach us that while we are able to choose, sometimes our choices have strings attached. "You need to finish your vegetables if you want dessert." We're given the power to choose what to do: eat the veggies so we can have dessert, or choose not to eat the veggies and miss out on dessert. We might not like the options, we might wish we could choose the dessert without any other limits on our choice, but we have to deal with the reality. Depending on our maturity, we may throw a tantrum when we don't get what we want, when there is even the most minor constraint on our choices.<br />
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By the time most people are adults, they're mature enough to realize that every choice we make has some sort of consequences. They may occur prior to getting what we want, or they might follow it; they may be good consequences, or they may be bad. Then there are those who never seem to reach that maturity. They're stuck in the childish dream of wanting their choices to be free from any limitations, unable to accept that their choices may have consequences or that there may be some manner of prerequisite before they can have their choice fulfilled.<br />
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We can see this in action in the anti-vaccine movement, in particular as they fight against a bill in California (<a href="https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160SB277" target="_blank">SB277</a>).<br />
<a name='more'></a><br />
Introduced by Senators Richard Pan and Benjamin Allen, SB277 would eliminate all non-medical exemptions to school vaccination requirements for students enrolling in a public or private school. Any parent who wishes to skip a vaccine for non-medical reasons would have to enroll their child in a home-based private school or arrange for an independent study program outside of classroom-based instruction. The bill went through three committees in the state Senate (Health, Education, and Judiciary) before being passed by the full Senate. Then it went to the state Assembly, where it passed the Health Committee and is currently in the full Assembly for a vote. If it passes and is signed into law, which is looking likely, California would join West Virginia and Mississippi as the only states that value children's health enough to allow only medical exemptions to school immunizations.<br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGkUOstRBe2-rIKQ6Z36msYhpWzH76wbIpH-z392H6DBpxZgwHCU26T7RRjUArct39jA_adlcsLcRMJXLQZ2e_lnqftqMJUACrNqwVdlRZuJMybNJ__IZ7-4LOVQxZAdOzLzTbS9nix8Xg/s1600/Anti-SB277+Hitler+Pan.jpg" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGkUOstRBe2-rIKQ6Z36msYhpWzH76wbIpH-z392H6DBpxZgwHCU26T7RRjUArct39jA_adlcsLcRMJXLQZ2e_lnqftqMJUACrNqwVdlRZuJMybNJ__IZ7-4LOVQxZAdOzLzTbS9nix8Xg/s200/Anti-SB277+Hitler+Pan.jpg" width="200" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">No hyperbole here. Move along.</td></tr>
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So what arguments have opponents been using to fight this bill? There's the usual rhetoric: calling anyone who supports it a Big Pharma shill, comparing Sen. Pan to Hitler, claiming that our public vaccination programs are like the Holocaust, and so on. But the central argument around which they have rallied and allied themselves to Libertarians, far-right Republicans, the Nation of Islam, and Scientologists is "freedom of choice". They argue that SB277 removes their parental choice about which medical treatments and interventions to give their children.<br />
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<u><b>Removing parental choice</b></u><br />
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The biggest flaw with their argument is that SB277 does not remove their choice to vaccinate or not vaccinate their children. What it does do, however, is force them to accept responsibility for their decision. Parents are free to choose not to vaccinate their children, leaving them susceptible to infectious diseases, but that choice comes with the consequence of having to home-school their child. Vaccination is like a serving of spinach that must be eaten before getting dessert (public/private school). Like the spinach, the vaccines improve a child's health by decreasing their risk of becoming infected with a bacterial or viral disease. There are some risks associated with spinach (choking, contamination with listeria or salmonella), but the benefits outweigh the risks. Likewise, vaccines carry risks such as severe allergic reactions or other very rare serious reactions, but on balance, the benefits outweigh the risks.<br />
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I posed the following question to several anti-SB277 folks on Twitter: if I, as a parent, want to strap a bomb to my child, should my child be allowed entry into the school? It's an extreme and unlikely example, but it highlights that parental choice is not 100% free. <b>[<i>Edited to Add (6/23/15):</i></b><i> Just to clarify, I'm not equating vaccinated or unvaccinated children to bombs or terrorists. I chose this scenario because it </i>is<i> extreme and people will more readily have a very clear "yes" or "no" answer to it. The bomb in this scenario is simply a bomb, not an analogy or metaphor for vaccination status.</i><b>]</b> Only one individual actually answered my question, saying that no, my child should not be allowed in. When I argued that not allowing my child in violated my parental rights, they admitted that in situations where others would be put at risk of harm or that would create false fears, parental choice should not be honored. In my scenario, I could choose to follow through on my choice to strap a bomb to my child, but I'd have to find some other way to ensure their education.<br />
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When I pressed further, asking if it was the school's decision to not allow medical exemptions, my interlocutor said that was fine. For them, when it really came down to it, it really wasn't about choice. That was just a smokescreen. It was really about the government taking an action to protect its citizens from infectious diseases. Had all of the schools, public and private, in California initiated this on their own, then, if this person is to be believed, there would be no protest. Yet they also complained about physicians choosing, on their own, to exclude non-vaccinating families from their practices, so their claimed acceptance of private measures being enacted rings hollow.<br />
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<u><b>Where there's risk, there must be choice</b></u><br />
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Anti-SB277 activists (many of whom oppose the bill despite being from outside of California) have come up with the slogan, "Where there's risk, there must be choice". Part of this argument, as we've seen, is based on a false premise: namely that parental choice is being removed. They also argue, however, that because vaccines do carry risks, they should have the option to choose whether or not to vaccinated their children and <i>still</i> be allowed to enroll them in a public or private school.<br />
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But it really isn't about the risk itself. There are far greater risks that they take every day when sending their child to school, which they probably don't even think about. For example, in the state of California, <a href="http://www.kidsdata.org/topic/71/bullying-and-harassment-at-school/summary" target="_blank">1 in 3 children are victims of bullying</a>. Bullying not only affects the victim's performance in school, but can have <a href="http://www.violencepreventionworks.org/public/bullying_effects.page" target="_blank">significant health effects</a>, some of which can <a href="http://archpsyc.jamanetwork.com/article.aspx?articleid=1654916" target="_blank">last into adulthood</a>. Effects can be psychological or physical, <a href="http://www.ncbi.nlm.nih.gov/pubmed/23764670" target="_blank">sometimes even fatal</a>. Although treating the effects of bullying after the fact is an option, it is often impossible to prevent, other than by avoidance.<br />
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Then there is getting to school. If the child walks, they risk injury by tripping or slipping or being struck by a vehicle. There's a risk of abduction or targeting by drug dealers. If they take the bus, there's a risk of getting into an accident. Likewise with cars, which brings up another government mandate that carries risk: seat belts.<br />
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A seat belt is intended to reduce the risk of injury in an accident. And it does. But it also carries a risk of injury caused by the seat belt itself. This can include minor effects, like bruising, to more serious effects, like laceration or damage to internal organs. And even though a seat belt may operate exactly as properly designed, such injuries can be <a href="http://www.researchgate.net/publication/11412674_Fatal_childhood_vascular_injuries_associated_with_seat_belt_use" target="_blank">potentially fatal</a>. And yet the government mandates seat belt use in passenger vehicles, and no one protests. That is because, despite the risks posed by the seat belt operating precisely as designed, it reduces overall risk of serious or fatal injury to both the user and other passengers. People can choose to wear or not wear a seat belt (or choose to vaccinate or not), but they risk being fined if caught (or not being allowed into a school), not to mention the increased risk of injury if in an accident (or exposed to a disease).<br />
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<u><b>Not choice, but fear and selfishness</b></u><br />
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The opposition to SB277, then, isn't driven by valid questions around choice. Parents can choose whatever they wish to do, but their choice drives the available options. Choice is just a tool around which to frame the issue. It gives people something to latch onto in the name of "freedom" or "fairness". But the real basis of the opposition is about fear and selfishness.<br />
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The core contingent of anti-SB277 activists fear vaccines, thinking that they cause autism, among other alleged maladies. That risk, to them, is greater than what they see as minimal risks from "<a href="http://scienceblogs.com/insolence/2015/01/22/the-past-and-present-rebuke-antivaccinationists-who-claim-measles-is-benign/" target="_blank">benign</a>" childhood illnesses that they view as completely harmless. They go so far as to encourage <a href="http://www.harpocratesspeaks.com/2014/06/orgies-of-death-dangerous-tradition-of.html" target="_blank">pox parties and measles teas</a> (or, as Prof. R. Tanner Hewlett and Dr. Austin Threlfall Nankivell put it in 1921, an "<a href="https://books.google.com/books?id=scpxdi0h-o4C&focus=searchwithinvolume&q=orgy" target="_blank">orgy of death</a>") rather than getting immunized, forgetting <a href="http://www.harpocratesspeaks.com/2012/01/lesson-from-history.html" target="_blank">lessons from history</a> of what happens when immunization rates drop.<br />
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That fear drives them to compare vaccination to the Holocaust, themselves the equivalent of <a href="http://www.forbes.com/sites/tarahaelle/2015/06/18/california-doctor-invokes-holocaust-analogy-compares-non-vaccinating-parents-to-jews/" target="_blank">persecuted Jews</a>. To them, autism is the same as being rounded up in concentration camps and exterminated. It is a disgusting comparison that demeans survivors of the Holocaust and their families, as well as autistics themselves.<br />
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Yet just as with the "parental choice" argument, their fear is based on a false premise. There is no evidence that vaccines cause autism, and even if they did in some tiny percentage of individuals, a living autistic child is better than a dead child. But to them, it is reversed; autism is worse than death. Perhaps that is why so many bend over backwards to <a href="http://paulacdurbinwestbyautisticblog.blogspot.com/2014/05/murder-of-autistics-excuses-excuses.html" target="_blank">excuse the murder of autistics</a>. In the world of the anti-vaccine movement, autism is so feared that they <a href="http://leftbrainrightbrain.co.uk/2013/08/31/whitewashing-the-brutal-murder-of-alex-spourdalakis/" target="_blank">whitewash brutal murders</a>, blaming everyone but the murderer for the death.<br />
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There is also an egotism associated with their opposition. What matters is <i>their</i> choice. <i>They</i> know better than all of the doctors and researchers who have dedicated their lives to improving children's health. <i>They</i> are smart enough to see the conspiracy that us <a href="https://xkcd.com/1013/" target="_blank">sheeple</a> are apparently too blind to see. They attempt to justify it by arguing that, <a href="http://www.harpocratesspeaks.com/2011/12/vaccine-awareness-week-if-vaccines-work.html" target="_blank">if vaccines work, why does it matter what they do</a>? This is nothing more than the <a href="https://en.wikipedia.org/wiki/Nirvana_fallacy" target="_blank">Nirvana fallacy</a> in action. It ignores the fact that for a small percentage of individuals, some vaccines will not produce immunity. Worse, and where the selfishness really shines through, is that their argument ignores those who, for medical reasons, cannot be immunized.<br />
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Vaccination has a very low level of risk for real injuries, but autism is not one of them. The real risks, though, are vastly outweighed by the benefits conveyed. Vaccines reduce the risk of infection from multiple diseases, and consequently the much greater risks of complications from illness. There is even evidence that <a href="http://www.nlm.nih.gov/medlineplus/news/fullstory_152420.html" target="_blank">immunization may protect against more than just the disease vaccinated against</a>. When the facts and science are accounted for, there is no sound reason to skip vaccination. Time after time, we see how forgoing vaccines leads to outbreaks that affect far more than just the unvaccinated individual. And we have seen how, left to their own devices, the fearful few put the greater community around them at risk.<br />
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SB277 aims to protect the citizens of California by increasing vaccine uptake among schoolchildren, the ones most prone to infection and the ones most likely to spread the disease in an outbreak. Those who oppose it are putting not only their own children at increased risk, but their communities, as well, not to mention visitors to their state, as evidence by the measles outbreak at Disneyland that spread to several other states and countries. They couch their opposition in terms of freedom of choice, but it's a false and dishonest argument. Even they must admit that parental or personal choice is not sacred and inviolate. There are reasonable limits placed on them. They can choose to drink and drive, but they face consequences. They can choose to beat their children, but they face consequences. They can choose to not vaccinate their child, but they face consequences.<br />
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For the people of California, I sincerely hope that SB277 passes, and they become one of the top three states with the lowest rates of preventable diseases. Don't let fear, masquerading as choice, put children at risk.Todd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.com2