Undisclosed Conflicts of Interest in Vaccine Research

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.

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.

This all brings us to a study that was originally published as an uncorrected proof in the journal Vaccine, and later withdrawn by the journal: Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus  (HPV) vaccine Gardasil, by Rotem Inbar, Ronen Weiss, Lucija Tomljenovic, Maria-Teresa Arango, Yael Deri, Christopher A. Shaw, Joab Chapman, Miri Blank, and Yehuda Shoenfeld.

69 Doses and Matters of Trust

The other day, I wrote about the incorrect claim that there are 69 doses of vaccine on the U.S. recommended childhood immunization schedule. That claim has morphed into 71 (or 72 [Edited to Add (2/24/15): apparently, anti-vaccine groups are now dishonestly claiming 74!]) 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.

So what's behind the misunderstanding? What point was I trying to make?

The Precautionary Principle to an Absurd Degree

Every 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?

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 Daily Mail, apparently in an attempt to scare people about vaccines.

Despite the Mail being known for rather sub-par reporting and being prone to sensationalism, I gave the story a look. The title says a fair bit, "Paramedics called to secondary school as pupils fall ill and collapse after being given their vaccinations".

69 Doses...or Is It 53? Or Even Fewer?

Please note additional edits to this article, particularly those added after 2/3/16, with the publication of the new 2016 recommended schedule.
 
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.

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 my post about package inserts to suggest that they are evidence that vaccines cause harm. Now, vaccine package inserts do list adverse reactions (i.e., something known to be caused by the product) discovered during clinical trials. They also include adverse events (i.e., something that occurs after using the product, but may or may not actually be caused 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 "Any. And every" bit listed in Section 6.

Click to enlarge.

But it wasn't his misuse of my post that really grabbed my attention and prompted this post. Rather, it was his claim that he has "read and studied the 69 vaccines package inserts in the Feds recommended list":

Click to enlarge.

Sixty-nine package inserts? Really? Where did he get this number?

Locked in Ignorance

The 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 here. 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.

Here are a few resources for your reference as you read through this.

• MMR, the CDC and Brian Hooker: A Guide for Parents and the Media 
• Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan atlanta (Original study from DeStefano et al.) 
• A look at the analysis plan for DeStefano’s MMR study: no evidence of fraud (includes a link to the 2001 Draft Analysis Plan) 
• Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data (Brian Hooker's retracted study)

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.

What 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 "goating". 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.

And for that, he was doxed.

Donald Trump's "Massive" Vaccines

This will be a very brief post. As I was reading Orac's post about Donald Trump's anti-vaccine musings, 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.

At any rate, I put this image together to illustrate what I think is going on in Trump's mind. Enjoy.

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?

Ethan Posard's The Shots Book

Be a community immunity superhero!

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 vaccine preventable disease wanted posters. I've also written other posts for past Vaccine Awareness Weeks that could fit in well with NIAM, too, like the myth that if vaccines work, then it doesn't matter if you vaccinate your kid or not. 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.

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 The Shots Book: A Little Brother's Superhero Tale, 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?

Ethan is the younger brother of Camille Posard, one of the talented young high schoolers who wrote and produced the film Invisible Threat, which I discussed last year. 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.

Are You Weird? Not on the Internet! #NeverWeird

Nothing weird or dorky to see here.

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 Star Trek. 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.

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.

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 Felicia Day's new book, You're Never Weird on the Internet (almost).

Who Chooses? Parents' vs. Children's Rights

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 it actually does matter to others if you vaccinate your child, how anti-vaccine people want to change legislation, or how they oppose what they see as government interference), as well as my discussion about a case involving controversy over competing diagnoses. Others have also written 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?

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.