Thursday, March 22, 2012

The Anti-Vaccine Crowd Shows They Are Anti-Informed Consent

"We want people to have informed choice when it comes to vaccines." These words, or at least something along these lines, are uttered by many anti-vaccine activists, like Barbara Loe Arthur (aka Barbara Loe Fisher) of the misnamed National Vaccine Information Center or the authors at Age of Autism. To hear them speak, you would imagine that they would be completely in favor of any efforts which strive to provide accurate, complete information to parents who are deciding whether or not to have their children vaccinated. Such efforts should be whole-heartedly embraced by these "pro-informed consent" warriors.

Just such an opportunity has arisen in California, with AB 2109. As I recently wrote, this bill would expand on California's philosophical exemptions regulations regarding immunization requirements for day care and school enrollment. If passed, parents seeking a philosophical exemption would need to obtain from a physician or other health care provider a signed statement that the doctor provided them with information on the benefits and risks of vaccines. Physicians are already required by Federal law to provide this information before administering a vaccine. This provision would provide an added opportunity for parents to receive sound information and advice regarding their children's vaccines.

Sounds like something Fisher and company would support, no? Surprisingly, no.

Well, I guess it isn't all that surprising. You see, Fisher and her organization, NVIC (who are described in her failed libel complaint [PDF] against Dr. Paul Offit, journalist Amy Wallace and publisher Condé Nast as advocating for "fully informed consent"), are vehemently opposed to the legislation. The NVIC, which is headquartered in Virginia, is urging its supporters to contact Assemblymembers to voice their opposition. They claim that parents' rights to "informed independent vaccination choices" are under attack with this legislation (which, remember, would be providing information to parents).

Some of the issues that Fisher finds objectionable I've already addressed in my previous post. For example, she claims that the bill forces parents to pay for "an expensive appointment at a medical doctor’s office". The bill requires no such thing. It merely states that parents need to submit with their request for exemption a signed statement from the physician that they provided the parents with information on the risks and benefits of vaccines. It does not specify how that information need be provided. The information could be provided over the phone and the signed form mailed. Hardly a costly burden. The bottom line, though, is that this claim is untrue. It is false. Go read the legislation yourself if you do not believe me.

She also suggests that it makes parents "jump through the bureaucratic hoops of obtaining yet additional new forms". Since the legislation has not yet been enacted, let alone passed the state Assembly, and we do not know precisely in what manner the forms will be provided, this objection seems rather premature. If the necessary forms are provided along with the exemption form, then there would not be any "hoops" to go through in acquiring it. Again, a groundless objection.

Her third objection is that parents would need to "find a health care provider actually willing to take the appointment and then sign the new forms within 6th [sic] months of starting school for the exemption to be valid". There is no reason to believe that physicians would not sign the form. "What will stop doctors from using this law to deny access to philosophical exemptions?" asks Fisher. I might similarly ask, what would stop physicians from using the medical exemption law to deny access to medical exemptions? Probably the fact that physicians want what is best for their patients and are not the vindictive, petty jerks that Fisher seems to think they are. If assuming that doctors are generally decent human beings is not enough, then there's always the threat of legal action, I suppose.

Ms. Fisher then provides a suggested course of action, with talking points including the previously mentioned untruth about forcing parents to make appointments with physicians. Here is where we really begin to see what she means by "informed consent". It appears that by "informed consent" what she really means is "informed with the information NVIC provides", which other writers have shown on numerous occasions omits important information and that the information they do provide is frequently presented in such a way as to exaggerate the risks of vaccines while downplaying their benefits and the risks of diseases.

There are plenty of examples of this in their call to arms, for example this:
Bill supporters claim that vaccines are safe. The reality is there is real risk. The Vaccine Injury Compensation Program was established by Congress in 1986 to protect vaccine manufacturers and doctors from liability for vaccine injuries and death. As of Jan. 3, 2012, there have been 14,073 claims filed for vaccine injury and 1077 death claims. The total dollar amount of vaccine injury and death awards granted and paid to families of vaccine victims by our government is $2,366,649,931.96.
Yes, vaccines are safe (insofar as anything in life can be said to be safe). Yes, there are risks, but the risks from vaccines are much smaller and less likely than complications from the diseases they prevent. Regarding the VICP, Ms. Fisher leaves out quite a lot of additional information. For example, she helped to establish it. It was also established to make it easier for those injured by vaccines to be compensated for it by paying for legal costs regardless of the outcome of the claim, eliminating the Daubert Standard for scientific validity, and doing away with the need for claimants to prove that the manufacturer was negligent, among other legal obstacles present in the tort system. She also fails to specify just how many of those claims have actually been causally connected and which were coincidental. Not all claims made are for injuries that actually stem from a vaccine. Fisher's statements are similar to those who cite VAERS figures, neglecting to mention that those figures also include claims like this:
VAERS ID 209245-1: "This subject is a three month old female, who suffered a fatal head injury while enrolled in a comparative post marketing safety study of Daptacel (diptheria and tetanus toxoids and acellular pertussis vaccine absorbed) administered with other recommended vaccines according to the US standard of care. The subject received one dose of study vaccine: the last dose prior to the event was given on 01/14/2003. The subject ""expired instantly due to blunt head injuries in motor vehicle accident described as ""auto vs. fixed object, ejected,"" 18 days post immunization and expired the same day. No other information was reported. Death Certificate has been received. Autopsy has been performed but report not yet received. The event of fatal head injury was reported by the investigator as unrelated to the study product. The autopsy report states accident automobile, death. Follow up on 09/30/2003: ""Autopsy Report received by medical affairs on 09/16/2003. This three-month-old female is a victim of an apparent accidental death. ""Auto (passenger) vs. F/O, rollover, ejected"". The base portion of the car seat strapped in the center of the back seat. The car seat carrier was facing rear, however it was behind the passengers seat of the vehicle (not locked in the base) with the seat belts in use. The car seat canopy was found with the descedent. She was about 100 feet north of the vehicle, face down with her head against a rock. There was a blanket covering her. Death is probably instant and is clearly from crushing blunt injuries to the head. Other injuries also listed in the autopsy report include a crushed head and multiple severe abrasions and probable compressed chest event due to collapsed lungs and areas of hemorrhagic discoloration on lungs. This can happen in infants without fractures of the ribs, etc. Other injuries included fracture of the left femur as well as crushed and avulsed toes of the right foot. There was no signs of internal torso injuries except for the lungs. No further information is anticipate"
The final bit of misleading is in the numbers she cites. Checking the link she provides (http://www.hrsa.gov/vaccinecompensation/statisticsreports.html#Claims), we find that of the ~14,000 claims that were filed, ~8,500 were dismissed, meaning that the claimants failed to show, even by the lowers standards of the vaccine court, that a vaccine was responsible for the injury. Out of the millions of doses of vaccines that have been administered since the Vaccine Injury Compensation Program began in 1988, less than 3,000 claims have been filed and compensated. From 1953-1963 (before the MMR vaccine was approved), the U.S. saw an average of 450 deaths from measles alone each year, or roughly 4,500 deaths from a single disease in a single decade. That does not include other complications, like hospitalization, blindness, deafness, brain damage and so forth. Compare that to the around 3,000 injury claims (which includes all injuries) over just shy of a quarter century. Is there room to make vaccines safer? Yes. Should manufacturers be working toward that? Yes. But Fisher and her ilk do not reasonably argue for improved safety, instead opting to exaggerate and spin.

The objections to AB 2109 of Barbara Loe Fisher, NVIC and other anti-vaccine activists give the lie to their claims that they are pro-informed consent. Unfortunately, there are quite a few parents who may believe the propaganda produced by these organizations. Please stand up for public health and true informed consent. If you are in California, contact your Assemblymembers to voice your support for the bill.

19 comments:

  1. I was in a discussion with Dr Bob Sears on FB about this bill today. He also raised the issue that what is a parent to do if they cannot find a physician to sign the form (which I agree is higly unlikely). But I think instead of dismissing this possibility, we should be trying to find out if there is some scope in the legislation for this possiblity.
    I suggested that there should be an exemption by way of a notarised statement if a parent were to find themselves in that situation.

    I also suggested that it would be counter intuitive for the govt to stop children from attending school when it is legally compulsory to do so. When I said that the aim of the legislation was to try and increase vaccination rates by providing an opportunity for parents to have a discussion with a doctor about the issue and what is wrong with that - all of my comments were deleted and I was blocked from commenting further.
    I am an Australian, so this legislation is not relevant to me but I think you guys in California should be trying to to ensure that there is an escape clause for parents who CLAIM to not be able to find a doctor to sing the form.
    I believe that falsifying a Notarised Statement is the same as falsifying a Statutory Declaration in Australia is considered to be perjury.
    Oh yeah and if anyone would like to comment on Dr Bob's page here is the link http://www.facebook.com/?ref=tn_tnmn#!/pages/Dr-Bob-Sears/116317855073374

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  2. May NVIC have the same success they had in Washington State: none.

    Perhaps because the state had already spent plenty of public money dealing with disease outbreaks, like the one where all eight children in one family caught measles with three being hospitalized. California has spent enough on outbreak control with its limited budget. And there are memories of just a couple of decades ago:

    Pediatric hospital admissions for measles. Lessons from the 1990 epidemic.
    West J Med. 1996 Jul-Aug;165(1-2):20-5.

    And, no, there should not be an escape clause for those who claim to not find a doctor to sign the form. That makes it as easy as the philosophical exemption is now.

    Also, if you read the cited paper about the 1990 epidemic, you will read "Hospital costs amounted to $18 million, two thirds of which was paid for by Medi-Cal." Medi-Cal is medical insurance for those with low income. So having low income should not be an excuse, and for obvious reason, neither should having too high an income to qualify for Medi-Cal.

    And there are plenty of schooling opportunities for those who opt out. There is both homeschooling and private schools, like Waldorf. If one does not like either of those options, then gather together with other families who dislike public health and create your own school.

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  3. Earlier this year, I ran the numbers on awards in the National Vaccine Injury Compensation program:

    http://lizditz.typepad.com/i_speak_of_dreams/2012/01/oh-no-the-us-has-paid-out-2-billion-in-vaccine-injury-compensation-that-must-mean-vaccines-are-dange.html

    "I estimate that there have been more than 1.8 billion doses of vaccines administered to children six and under since the program began. The average ratio of vaccine awards per million doses of vaccines is...1.3. By my estimation, the awards amount to about $0.99 cents for every vaccine administered."

    One of my commenters pointed out that of the 2,932 cases compensated, 1,266 were for the whole-cell pertussis vaccine formulation, which is no longer used. So the numbers are even smaller.

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  4. @mochuck

    There is the possibility that there might be some physicians who refuse to sign the form, but I think it will be extremely rare, rather than a more frequent occurrence as Dr. Sears seems to suggest. There is also the possibility of physicians who sign the form without providing any information, or only minimal/erroneous information, such as Dr. Sears or Dr. Jay Gordon.

    Adding a notarization requirement would protect parents from physicians who go against the spirit of the legislation and refuse to sign the form. It would also minimize the risk of forgeries or slacker physicians. However, it would definitely add an additional financial burden to parents, since notaries public must be paid for their services.

    There are some legitimate criticisms to be made regarding this bill, but none have been made by the anti-vaccine activists.

    I'm not particularly surprised that Dr. Sears deleted your comments. Like most of the folks associated with the anti-vaccine movement, they hate legitimate, reasoned criticism and facts, since they cannot argue against them. Instead, they opt for the silencing of dissenting voices and, as Orac calls it, "mis-informed consent".

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  5. Speaking of numbers:

    AB 2109 would take effect in 2013. Entering kindergarteners would have been born in 2007; there were about 566,000 kids born in that year. According to The Bay Citizen, the average Personal Belief Exemptions sought are 2.28% of kindergarten enrollment.That’s about 13,000 in the whole state — hardly a huge burden to the state or to pediatricians/family practice doctors.

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  6. I don't know why Dr. Bob Sears and Dr. Jay Gordon are so freaked out by the law. They are (in)famous as real medical doctors who reject actual vaccine science, so this law will bring them more business. They could rake in lots of cash by "claiming" they explained the required information to parents, and then signing the exemption form.

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  7. The law in WA state is different from what is proposed in CA. "Physicians (M.D.), physician assistants (P.A.), osteopaths (D.O.), naturopaths (N.D.), and advanced registered nurse practitioners (A.R.N.P.) who are currently licensed in Washington are authorized to sign the exemption form or write a letter."

    http://www.doh.wa.gov/cfh/immunize/schools/exemption-FAQ.htm#require

    In contrast, the proposed CA law will only allow medical doctors to sign the papers.

    So, even though I am usually vehemently in favor of vaccinations, I actually agree with NVIC on this issue. This law is not going to lead to more children being vaccinated. It is going to lead to more parents hiding their children from the system to keep them unvaccinated.

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  8. Chris, Dr Bob Sears is pro vax as is the rest of his family practice. If you would actually read his book, you would know that.


    If CA wants to increase the vax rate, they need to do more public education on the fallacies of the antivax movement.

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  9. @kathy

    Both bills (CA and WA) restrict who can sign the form to licensed "health care practitioners". The difference is in how that term is defined, legally. Washington has passed legislation that includes naturopaths. I feel that this makes the Washington legislation nearly meaningless, since naturopaths are among those who spread misinformation about vaccines.

    California includes physicians, surgeons, physician assistants and nurse practitioners. So, it is not restricted solely to medical doctors.

    Regarding Dr. Sears, he is not exactly a proponent of vaccination, since he exaggerates the risks of vaccines, downplays some of the risks of diseases and irresponsibly recommends a vaccination schedule which increases the risk that a child will be infected with a disease.

    I do agree, though, that public education and a more proactive approach to anti-vaccine misinformation is needed from public health workers. AB 2109 may not be the best legislation, but it is a step in the right direction.

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  10. Why should I waste my time on Sears book when this is much shorter?

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  11. I see that Orac also thinks like I did above ("They could rake in lots of cash by "claiming" they explained the required information to parents, and then signing the exemption form."). He included that thought in his article: California Bill AB 2109: Real informed consent versus antivaccine misinformed consent.

    Chemmomo adds in Comment #47 about Sears citing costs: "Coming from a man who advocates spacing out vaccinations into separate office visits? For which his patients will (based on my own experience) get charged separately! What a hypocrite!"

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  12. If I am remembering correctly, neither Dr. Bob or Dr. Jay accept insurance. You pay up front and file with the insurance company on your own.

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  13. @ Todd - you say that Dr. Sears downplays some of the risks of diseases, yet don't some people downplay the risk of vaccines? There is a risk, children do die from them, and become injured by them. Billions in awards have been paid to those that have truly been injured by them. IF it were your child who received a vaccine injury, I seriously doubt you would just shrug your shoulders and say, "I did what I had to do for the greater good, little Mary, it is okay that you are brain damaged or disabled for the rest of your life, good luck with that."

    I can say I would be DEVASTATED to have had a choice and made the wrong one for my child.

    Have you heard of the SV40 virus which continued to be distributed although there was science backing up the fact that it causes cancer, binds and mutates with human DNA, and our government kept on giving it to over 98 million Americans? Did you know that same SV40 virus is found in 60% of certain types of cancer tumors? Did you know they did a study that shows that vaccinated B cells divide into abnormal daughter cells. B Cells cause certain types of childhood leukemia that is higher than ever.

    The anti-vax camp is asking for INDEPENDENT studies. You know, ones NOT funded by Big Pharma through the government. If lobbyists can get to our politicians which is pretty much a known fact, and be bought off. Why wouldn't 'government officials' in places like the FDA and CDC be able to be bought off by these same corporations? That is why the anti-vax camp asks for independent studies where an unvaccinated population is actually compared to a vaccinated population. Were you aware that there has never been a study conducted in this way? They don't use the placebo effect, like in almost ALL other hypotheses, concerning vaccinations. They compare one dose or one kind against another. How is that a fairly accurate, meaningful study? And when independent doctors DO speak up (yes, there are many, even neurosurgeons) they are made out to be villians and 'quacks'.

    Do you remember when smoking was considered to be safe? Until people pushed and pushed and pushed for INDEPENDENT studies not funded by the tobacco company.

    I believe we are all entitled to our own opinion. I don't think people should be looked upon badly one way or the other. I think that each side has valid points, but just beating one another up over opinions, is quite UnAmerican. Just because people like myself believe in natural immunity does not mean our children shouldn't have access to education. Perhaps the government should set up unvaccinated/vaccinated schools to accommodate everyone's beliefs until it can be proven why 1 in 65 boys get autism and the trend is GROWING along with the rate of vaccination.

    I am 37 and I did not go to school with ONE kid with autism, and my grade school was K-8. I also live in San Diego County, so it isn't exactly in an underpopulated area. Something is going on with our kids, and many (including doctors) believe it is in the ever-increasing vaccine schedule. Shooting a baby up at a day old with a Hepatitis B vaccine in my opinion is not a responsible medical choice.

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  14. @Unknown

    It seems you have been misled. Where to begin...

    While I'm sure they are out there, I have yet to see vaccine proponents downplay the risks of vaccines. They all pretty readily acknowledge the risks and put them into the context of the real world. Yes, bad things can happen, but they are exceedingly rare. Out of the millions (possibly billions) of doses of vaccines that have been administered since the creation of the VICP, a total of 2,957 cases have been compensated. As I mentioned in my post, compare that to the number of children who died from diseases, then think of how many more were permanently injured by those same diseases. Yes, it is horrible that bad things happen due to vaccines, and we should always strive to make them better, but not vaccinating is not the answer. If a child is injured, even devastatingly, of course we mourn, but we continue to love and support and give that child the absolute best we can give to make sure they reach their potential.

    Regarding SV40, you seem to be somewhat misinformed. First off, you make it sound as if the contaminated vaccines were given to 98 million Americans even after it was discovered. That is not true. The polio vaccine in question was administered from 1955 to 1963. SV40 was not discovered until 1960, and it wasn't until later than that that it was discovered that some (not all) of the polio vaccines were contaminated. When this was discovered, production of the vaccine was halted and measures put in place to screen for SV40 so that no future lots would be contaminated. Second, while SV40 has been found in some cancers, no causal link has been found, despite numerous studies looking for that evidence. SV40 has also been found in subjects who never received contaminated vaccines.

    You want independent studies? Go peruse PubMed, because there are a ton out there. There are plenty of studies that have absolutely zero funding from industry, both in the U.S. and in foreign countries. If you haven't seen any, then you haven't exactly been looking very hard.

    You want vaccinated vs. unvaccinated? Retrospective studies of that have been done (see http://www.aerzteblatt.de/pdf.asp?id=80869 and a review of the study at http://photoninthedarkness.com/?p=211). If you want a prospective study of vaccinated vs. unvaccinated, then I suggest you read my series on the ethics involved in such a study. Part 1 is at http://silencedbyageofautism.blogspot.com/2011/03/vaccinated-vs-unvaccinated-rct-overview.html.

    Regarding placebo controls, again, you have been misled. Take a look at the package inserts for some of the vaccines or, again, visit PubMed. You will find that there have been studies comparing a vaccine against either a saline placebo (to see whether the vaccine as a whole poses a greater risk than placebo) or an antigen-free control (all the regular ingredients except the antigens to see whether the antigen causes an increased risk beyond the normal components of a vaccine). This is a criticism that many anti-vaccine activists like to tout, but it is, quite simply, wrong and easily shown to be wrong. There is more that can be said on study design and comparators, but I don't want to make this response too long.

    You have also, apparently, been misinformed regarding smoking. The scientific community knew (or suspected) that tobacco smoke caused an increased risk of cancer. There was a minority of industry-paid researchers and PR flacks pumping out the erroneous message that smoking was harmless. The same situation applies to vaccines: the scientific community knows that vaccines are relatively safe and that their risks are far outweighed by their benefits, while a small minority of ideologically driven researchers pump out flawed research and propaganda to scare people, such as yourself, away from vaccines.

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  15. Yes, we are entitled to our own opinions, but we are not entitled to our own facts. And there is nothing unamerican about "beating one another up over opinions". Vigorous debate and free speech are quite American. If you wish to rebuke those who would silence people's opinions, then I suggest you take aim at people like the editors at Age of Autism, who regularly prevent dissenting opinions from ever appearing in their comments.

    The idea of separate vaccinated and unvaccinated schools, quite frankly, scares the crap out of me, though probably not for the reasons you might think. Setting up such schools establishes pockets where there is zero immunity. In other words, it sets up prime spots for really bad disease outbreaks. As it is, there are already small pockets of vaccine refusal that lead to costly (both in dollars and in health) outbreaks. Just take a look at the measles outbreaks in Indiana and Minnesota the past couple years. Such schools would be a public health nightmare and would be a horrible disservice to the children we all want to protect.

    When I was growing up, my high school (4 grades) had well over a thousand students. I never saw any kids with autism, either. But then, I didn't hang around the special ed classrooms, nor did I visit the mental institutions where the more severe cases were placed. Since the early 1990s (especially following the movies Rain Man and What's Eating Gilbert Grape), awareness of autism has grown and efforts at early intervention and increased pushes for mainstreaming have meant that more and more children with autism are in public schools, rather than in residential programs or centers geared specifically toward treating and educating children with autism. So while you might think that you did not go to school with even a single kid with autism, there probably were some in your school, even if they were higher functioning or misdiagnosed with some other disorder.

    My advice to you is to stop getting your misinformation from people like Bob Sears and places like Age of Autism, NVIC, SafeMinds and the like. They distort and misrepresent the science, sometimes even going so far as to outright lie, in order to advance their anti-vaccine agenda. Stick to the science. Look at the original sources (don't even take my word for it - click the links I provide and do your own research) and you'll be much better served. Wading through the literature can be very hard, but when you put the effort into it, you will find that the reality is not what the anti-vaccine crowd makes it out to be.

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  16. ToddW, there are already "separate vaccinated vs unvaccinated" schools. Just look up the PBE rates for Waldorf schools, some of which are public, "Waldorf inspired" charter schools.

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  17. @Liz Ditz

    Yeah, I forgot about the Waldorf schools. Lovely little cess pits of disease that they are. We definitely do not need any more like them.

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  18. 2 things: 1st: If certain kids are immunized then they are immune to the unImmunized, right? 2nd, what is a booster? Assuming you answered correctly, (a booster is given to "kick an immunization" back in, so...) technically, the immunized are running around unimmunized for Who Knows How Long, huh? Just sayin...

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  19. @Heather Wahlquist

    Your first premise oversimplifies things a bit. Most of those who are vaccinated are immune to the virus or bacteria against which they were immunized. For a small percentage (depending on the vaccine), the vaccine won't take, so they are effectively unimmunized. Your premise also ignores those who are unable to be immunized due to medical contraindications. For a more in depth discussion of this, read my post If Vaccines Work...

    A booster is typically a vaccine that "boosts" the immune system by presenting another challenge, in essence, reminding the body about some virus or bacteria. Not all vaccines require a booster to maintain immunity. For example, MMR provides, as best as we can tell, lifelong immunity to measles. The pertussis vaccine wanes over time, just like the real disease, so a booster is needed to keep people immune.

    The key point of vaccination is to reduce the risk of infection and make it more difficult for viruses and bacteria to find hosts and spread. The alternative (no vaccinations) means more hosts and more opportunities for outbreaks and epidemics. We have seen this in spades with measles. In those places where immunization levels fall, there are outbreaks. In England, for example, measles used to be eliminated. Falls in vaccination rates, though, led to the disease becoming endemic again, meaning that it is able to sustain itself within the population, rather than only occurring due to imported cases.

    Hope that clears up some of your questions.

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