As I’ve joked about before, I’m a bit like Dug the Dog from the movie Up whenever a squirrel goes by. In other words, I’m easily distracted by things that interest my primal urge to chase pseudoscience. I originally had a cancer-related topic in mind for this week’s foray into science-based medicine, but then on Friday our favorite group of antivaccine activists over at the antivaccine crank blog Age of Autism induced a squirrel to run in front of me, and the rest is history, at least for the moment. I’ll try to get back to my original topic either as a bonus post later this week or as next week’s post (unlike the topic of today’s post it’s not really particularly time sensitive). In the meantime, I’ll chase this squirrel. Sorry about that. But Dug’s gotta do what Dug’s gotta do. Besides, the topic I had in mind for this week is sufficiently complex that my ultimate post will probably end up being much better if I have a few more days to a week to think about it. At least, that’s what I keep telling myself.

If there’s one thing I’ve learned over the years opposing the antivaccine movement, it’s that these days its “Holy Grail” (well, a “holy grail”) is to have a “vaccinated versus unvaccinated” study performed, or, as it’s frequently abbreviated, a “vaxed verus unvaxed” study. The reason they want such a study so badly is not because they think there’s a scientific question that genuinely cries out for an answer. Rather, they believe it will confirm their fixed, unalterable belief that vaccines are the root of nearly all chronic health conditions children suffer today, particularly autism and autism spectrum disorders. In particular, they believe that a “vaxed versus unvaxed” study would demonstrate once and for all that vaccines are the cause of the “autism epidemic.” Hilariously, a few years back, the antivaccine group Generation Rescue tried to do such a study. It was more an utterly incompetently administered and analyzed telephone survey than anything else, and, ironically, its results actually were just as consistent with the conclusions that vaccines protect against autism as that they predispose to autism. And don’t even get me started on an even more hilariously incompetent vaxed versus unvaxed study by a German antivaccine homeopath (I know; “antivaccine homeopath” is redundant) that antivaccinationists were touting a while back. That took attempts to ape science to depressingly ridiculous extremes.

Meanwhile, other than incompetently performed studies by antivaccinationists (this one, for instance) many large, well-performed epidemiological studies have failed to find even the suggestion of a link between vaccines and autism or between mercury in the thimerosal preservative that used to be in childhood vaccines and autism, such that the Institute of Medicine reaffirmed this finding just this year. Yet, antivaccinationists remain undeterred. True, they seem to have accepted that their original Holy Grail, namely a prospective randomized, placebo-controlled trial in which one group is vaccinated and another is not, is considered highly unethical because it would intentionally leave one group of children unprotected against vaccine-preventable diseases. (I say “considered” because antivaccinationists are so convinced of the harm done by vaccines that they do not accept that a randomized controlled trial of vaccinated versus unvaccinated children would be unethical in the extreme.) Unfortunately, however, that doesn’t stop them from demanding other forms of vaxed versus unvaxed studies, even though such a study would be difficult, bias-prone, and unlikely to provide a definitive result, as I explained in detail before.

Well, they’re at it again. Antivaccinationists are trying to legislate where they have utterly failed to convince using science. It’s a standard tactic of cranks, but unfortunately there are nearly always credulous legislators who will be duped into going along or who are cranks themselves and therefore go along. Remember Dan Burton? He was antivaccine to the core and used his position as a Representative from Indiana to cause a lot of mischief with hearings on vaccines. Fortunately he’s retired now, but there are still Representatives who are either antivaccine themselves or easily duped into carrying antivaccinationist’s water.

Here’s what I mean. The other day, posted on the antivaccine crank blog, was a call for help by the antivaccine group SafeMinds to support a resolution by the House of Representatives, specifically HR 1757, The Vaccine Safety Study Act:

What is HR1757? – Also known as “The Vaccine Safety Study Act,” this bill, introduced by Rep. Bill Posey (R-FL) and Rep. Carolyn Maloney (D-NY), directs the National Institutes of Health to conduct a retrospective study of health outcomes, including autism, of vaccinated-versus-unvaccinated children, and to determine whether exposure to vaccines or vaccine components is associated with autism spectrum disorders, chronic illnesses, or other neurological conditions.

Currently before the US House Committee on Energy and Commerce, the bill, if implemented, “should bring an answer to this decades-long question,” Rep. Posey stated on the House floor.

No. It. Won’t. It would be expensive, and it would be highly unlikely to provide an answer, for the reasons I pointed out before. Moreover, contrary to the claims in the SafeMinds press release reposted by AoA, there is no compelling scientific rationale for such a study. There are no preclinical data or epidemiological observations that would mandate (or even justify) such a study from a scientific standpoint. Before such a study would be mandated, there would have to be strong evidence of a problem with vaccine safety or indication that vaccines cause autism and chronic health problems. There is no such indication. Fevered dreams of antivaccinationists don’t count.

SafeMinds cites “findings” discovered through a Freedom of Information Act (FOIA) request claiming that “risks of autism, ADD, sleep disorders and speech/language delay were consistently elevated in the more exposed group: Increased autism risk in one-month-old infants with the highest exposures ranged from 7.6 to 11.4 times higher than zero-exposure infants.” No links are provided, but my best guess is that SafeMinds is referring to Verstraeten et al., which is a very old gambit on the part of the antivaccine movement that has no validity but is frequently used to try to provide the impression of a conspiracy and government cover-up. There wasn’t. It’s Simpsonwood all over again, eight years later. Safeminds then cites another study that claims that unvaccinated children had significantly lower emergency room visits. The implication is that unvaccinated children are healthier, but, as has been pointed out before, despite what Brian Hooker says, the study shows nothing of the sort. Indeed, let’s look at what the investigators themselves said about this result:

These results suggest inherent health care–seeking behavioral differences between the 2 groups of parents. For example, published survey data31-32 have shown that parents who choose not to have their children vaccinated are less likely to trust health care professionals and more likely to use complementary/alternative medicine providers than are parents who have their children fully vaccinated. It is therefore possible that parents who delay or refuse immunizations are less likely to use the traditional health care system when their children contract minor acute illnesses but will seek medical care when their children become seriously ill. Such differences could create a selection bias in studies that attempt to examine the risk of potential adverse events following vaccination.

Emphasis mine. There was nothing in the study that claimed to show that unvaccinated children use the ER less because they are healthier.

So what about the bill itself? The introduction and background (called the “Findings”) in HR 1757 start out paying lip service to the importance of vaccines and then move on to a whole bunch of antivaccine tropes before getting to the “meat” of the bill. The bill itself is sponsored by Rep. Bill Posey (R-FL), who appears to be vying for Dan Burton’s position as the most antivaccine member of Congress, so much so that he even participated in a “Congressional panel” at this year’s antivaccine quackfest Autism One in May, following in the footsteps of prior years’ Autism One quackfests.

But what about the bill’s co-sponsor, Rep. Carolyn Maloney (D-NY)? Well, it turns out that she’s very much into antivaccine pseudoscience as well. A quick Google search of her name plus the term “vaccines” brings up a plethora of embarrassment (from a scientific viewpoint that is), much of it right on her very own website. For instance, here she touts Dan Olmsted’s incompetent and incomplete series of news stories claiming that the Amish don’t vaccinate and don’t get autism from back when he was actually a reporter (they do, and they do; it’s a myth that they don’t). She has also been known to grill CDC officials about vaccines, as shown in this YouTube video:

The above video comes from a hearing held by by the House Oversight and Government Reform Committee, chaired by Rep. Darrell Issa (R-CA). One notes that Darrell Issa is not exactly known for being a fan of science. Besides being an anthropogenic global climate change denialist, he’s prone to meddling in peer review and trying to micromanage the National Science Foundation. He’s also at the very least sympathetic to antivaccine views, holding a hearing about the “autism epidemic” and “environmental causes” (translation: it’s the vaccines) last November, a month before Rep. Dan Burton (R-IN) retired. Dan Burton, the chair of the same committee in the 1990s and into the 2000s, used it for no end of antivaccine legislative mischief when he was in control, and Darrell Issa appears to be taking up the antivaccine mantle left behind now that Burton has retired.

In any case, Maloney begins by complimenting Dan Burton for “doing such a fine job” back in the day. She then demands to know why autism prevalence has gone from 1 in 10,000 to 1 in 88, dismissively saying that she “doesn’t want to hear that we have better detection” and claiming that detection would not account for a jump from 1 in 10,000 to 1 in 88. That is, of course, a straw man argument. As I’ve pointed out many times, screening programs, broadening of diagnostic criteria, diagnostic substitution, and better detection can easily account for huge increases in the prevalence of a condition. My favorite example is ductal carcinoma in situ, whose incidence increased 16-fold in 30 years just because of mammographic screening. Other examples include hypertension and hypercholesterolemia. In reality, the prevalence of autism is probably not higher (or at least nowhere as much higher as the antivaccine movement would like you to believe) than 30 years ago. When careful studies are done, it is found that autism prevalence is the same now as it was then. So, right off the bat, we know that Maloney doesn’t want to hear the science-based answer, namely that diagnostic substitution, broadening of the diagnostic criteria, and more intensive screening programs have led to a massive increase in autism prevalence without a real, biological increase. She’s convinced that the vaccine program or some other environmental factor is causing an “autism epidemic,” and she falls for the “too many too soon” trope beloved antivaccinationists. Unfortunately, Colleen Boyle, the hapless CDC official who had to answer, appears completely unprepared for the hectoring about vaccinations to which Maloney subjects her.

I also learned that Rep. Maloney marched with Jenny McCarthy in her infamously pointless antivaccine Green Our Vaccines rally in 2008. I think that says it all about Rep. Maloney. Well, maybe not all. Her performance in last year’s hearing shows that she values anecdote above scientific evidence; she attacks straw men explanations for the increase in autism prevalence (i.e., that it’s just better detection, when it’s a combination of factors); she makes spurious and downright dumb analogies between vaccine manufacturers and tobacco companies; and she’s just plain scientifically ignorant. In other words, she fits the very picture of being antivaccine. The video above demonstrates it beyond debate. Sadly, she is not alone among our legislators.

Rep. Maloney’s clearly the Democratic counterpart to the Republican antivaccine fringe represented by Rep. Posey and former Rep. Dan Burton and has been pushing the dubious vaxed versus unvaxed study resolution for a long time. Indeed, she’s been doing this for years. I do give her some credit for making at least one change from previous versions of the bill, namely pointing out that “Nothing in this Act shall be construed to authorize the conduct or support of any study in which an individual or population is encouraged or incentivized to remain unvaccinated.” One also notes a quack-friendly clause that “To facilitate further research by the Secretary or others, the Secretary shall ensure the preservation of all data, including all data sets, collected or used for purposes of the study under this section.” One wonders whom the “others” are, one does. Does anyone want to take any bets that this clause is designed to make sure that antivaccine groups like SafeMinds have access to the complete data set of such a study to use and abuse for their ideological purposes? One wonders who provides her with these anecdotes, one does. Could it be SafeMinds, The Canary Party, and Age of Autism? Sure, it could.

But what about this time around? Amusingly (if you can ignore the waste of taxpayer money and the antivaccine impetus behind HR 1757), the bill itself demands that the each investigator of the required study:

  1. is objective;
  2. is qualified to carry out such study, as evidenced by training experiences and demonstrated skill;
  3. is not currently employed by any Federal, State, or local public health agency;
  4. is not currently a member of a board, committee, or other entity responsible for formulating immunization policy on behalf of any Federal, State, or local public health agency or any component thereof;
  5. has no history of a strong position on the thimerosal or vaccine safety controversy; and
  6. is not currently an employee of, or otherwise directly or indirectly receiving funds from, a pharmaceutical company or the Centers for Disease Control.

One notes that requirements #3 through #6 pretty much destroy any chance the NIH have of being able to find an investigator who meets requirement #2. As an aside, it’s also amusing to note a reaction to HR 1757 from our old buddy, now the antivaccine Robin to the crazed “health freedom” Batman (Patrick “Tim” Bolen) after having been the Boy Blunder at the antivaccine crank blog Age of Autism before he betrayed AoA and SafeMinds, Jake Crosby, who rants No More Federal Research Fraud – OPPOSE HR1757! His reason for opposing HR 1757 (other than because SafeMinds and AoA are for it)? Because he doesn’t trust the NIH:

In other words, this bill aims to mandate the National Institutes of Health (NIH) to conduct a vaccinated vs. unvaccinated study of autism and other disorders before the NIH and other federal agencies are forced to clean up their act and stop engaging in the institutional research misconduct that causes the vaccine-autism cover-up to persist. Although the initiatives of congressional representatives like Bill Posey and Carolyn Maloney to investigate malfeasance by government agencies should be commended, HR1757 only helps to legitimize and facilitate federal research misconduct by agencies like NIH, while distracting from efforts to expose government corruption. Autism Investigated supports vaccinated versus unvaccinated research conducted by independent researchers at academic institutions, but not conducted by federal agencies that merely pursue predetermined results. NIH is one of those agencies.

Poor Jake. Back when he was in high school and maybe even college I could (sort of) forgive such ignorance, but he’s a graduate student now. Unfortunately, it’s now utterly clear that he is utterly clueless about how the NIH works, which could be a real problem for him if he ever becomes an epidemiologist and wants to apply for research funding. Note that HR 1757 says that the NIH “shall conduct or support” such a study. That means the NIH, if so instructed, could simply issue an RFA (request for applications) for a grant to do a vaxed versus unvaxed study. In fact, that is almost certainly what would happen if this unscientific bill passed; the NIH almost certainly wouldn’t do the study itself; it’s not really well set up to do such a study, but, more importantly, by the very language of the bill it couldn’t. Indeed, perhaps the most amusing part of Jake’s tirade is the lack of insight into this very point. He clearly didn’t even bother to read the bill. Note the clause listed above that the investigators can’t be “currently employed by any Federal, State, or local public health agency.” Here’s a hint for Jake: The NIH is a federal agency. Seriously, I think that Jake’s just phoning it in these days.

I rather suspect that antivaccinationists are so deluded that they don’t realize that this bill actually is against their interests. What do I mean? Easy? Look at criteria #1, 2, and 5 required of any investigators recruited to do such a study. The bill states that any such investigator must (1) be objective; (2) be qualified; and (3) have “no history of a strong position on the thimerosal or vaccine safety controversy.” These three criteria alone completely rule out any investigator that would be acceptable to SafeMinds, as none of their favored investigators fit any of them! I’m also going to emulate Matt Carey the next time I see an antivaccine study and ask if the investigators have a history of a strong position on the thimerosal or vaccine safety controversy. I presume that I can just dismiss studies based on this reason alone; after all fair’s fair. That’s often the main reason why antivaccine groups dismiss the plethora of studies failing to find a link between vaccines and autism.

No, I’m all about the science; so I couldn’t do that.

Antivaccinationists have been trying to legislate science for a very long time now, and Rep. Maloney is just ignorant or antivaccine enough to be willing to be their contact person. Meanwhile, Bill Posey seems to be relatively new at the antivaccine game, but he’s clearly up and coming, and, given that the House is currently controlled by the Republican Party, he’s more likely to do more damage in the short term because he’s part of the majority party. Either way, although I realize that this bill has little chance of passing and that the lack of appropriations for the study suggest that even Reps. Maloney and Posey know it, skeptics and supporters of science-based medicine should still fight fire with fire, I say. I’m willing to bet that there are a lot more science-based people out there than antivaccinationists; so I’ll finish echoing exactly what AoA said. Only, do it from the science-based perspective and use the same tactics to oppose HR 1757:

  • First identify your own Representative in the House by clicking here:
  • Call and schedule a meeting at their district office and urge them or their staff to sign on to this absolutely critical bill.
  • If they will not commit, indicate you will call back in one week to check on progress and check with Rep. Posey’s office to confirm their commitment to co-sponsor.
  • After Labor Day confirm everything has happened and thank them for their support.
  • Also, let SafeMinds know! Answer the few simple questions on our online survey at:

At the very least, write letters to your Representatives, real letters on real paper, and to Bill Posey and Carolyn Maloney as well. (E-mails are easier to ignore.) I plan on doing that much at least, even though I’m not a big fan of my current Representative (to say the least). I realize that HR 1757 is a resolution, and I realize that it probably doesn’t have a lot of support. I also realize that it appears to be stuck in committee. Let’s do our best to keep it that way. Never underestimate the antivaccine movement.

Finally, I’m serious about that last bullet point. After all, we’d like SafeMinds to know that they’ve inspired us to stand up for science, wouldn’t we?

Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.