Quoth the Institute of Medicine: The current vaccine schedule is safe and effective. Quoth antivaccinationists: Gahhhh!

I sense another disturbance in the antivaccine Force.

Yes, I realize that it was just a couple of days ago that I sensed a previous disturbance rippling through the antivaccine Force. That’s when antivaccinationists brought David Kirby out of mothballs from whatever journalistic slime pit he’s currently residing in to use every trick at his disposal to convince you that somehow the government has compensated two families of children for vaccine-induced autism when in fact he’s playing the same game he’s always played: Claiming that if any child who’s ever been compensated by the National Vaccine Injury Compensation Program (VICP) who at some point developed any syndrome resembling autism or autism spectrum disorders it means that vaccines caused the autism. It’s such a transparent ploy that Kirby’s used so often that it only induced ennui.

However, for some reason (probably because I only check out the antivaccine propaganda blog Age of Autism every now and then for yucks), I missed a post there by our old pal J.B. Handley pimping donations about a highly dubious study for which Generation Rescue is raising money. I blogged about this study a couple of months ago. Basically, it’s a study that’s the holy grail of the antivaccine movement, a study known colloquially as a “vaxed-unvaxed” study. Basically, it’s the sort of study that antivaccinationists clamor for as a second choice. While most (but not all) antivaccinationists grudgingly accept that a prospective randomized study comparing vaccinated and unvaccinated children would be completely unethical, they are so convinced that vaccines are pure evil that they want to compare vaccinated versus unvaccinated populations for health outcomes, expecting to find enormous differences, with vaccinated children being all autistic and riddled with chronic diseases like asthma. Or something. For some reason, the investigators doing this study claim they need $500,000. To do what, I can’t figure out, given that this “study” appears to be little more than an Internet survey examining home schooled children, who of course represent a highly unrepresentative population to be studying. Its principal investigator is Anthony R. Mawson, M.A., Dr.P.H., who is an admirer of Andrew Wakefield and clearly has antivaccine tendencies.

Then, a few days ago, J.B. Handley repeated his call for money for these science-challenged antivaccine investigators. He framed it as a a “Q & A” session about the study by Suzanne Humphries, which is not a good choice if you want to convince anyone that the study is anything other than an antivaccine study, given that Humphries is known for referring to vaccines as “disease matter.” Particularly interesting is this bit:

Q: So if they need Internal Review Board approval, does this mean that there could be other sources of funding? $500,000 is a lot to come up from the grassroots. There needs to be a benefactor or some other creative financing.

A: IRB approval for the study was obtained at Jackson State University, where the study is based, in 2011. Approval was renewed for Year 2 a few months ago. There is no other current funding for the study. The pilot study was funded by Generation Rescue, whose support was financial. They are totally uninvolved in study design and analysis.

It’s pretty sad when someone like Humphries or Handley apparently doesn’t know that it’s Institutional Review Board approval, not Internal Review Board approval, but it’s about par for the course for these people. Be that as it may, one wonders what sort of IRB they have at Jackson State University or what they were smoking there to approve such a dubious study like this. Be that as it may, Handley showing up again made me wonder what’s going on. Frequently, the antivaccine movement knows about things that are about to happen before I do because, well, they spend incredible amounts of time and effort finding these things out, and I have a job and a life. In any case, it didn’t take long for me to find out what probably provoked this (besides, of course, Generation Rescue’s only having raised $30,000 out of the needed additional $400,000). Just yesterday, a very telling screed appeared from our old friend Dan Olmsted about the recently released Institute of Medicine report on vaccines, Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies.

Olmsted begins, predictably enough, with a whine:

It isn’t worth spending much time and energy to take on the new Institute of Medicine report on vaccine safety concerns– bought and paid for by the Department of Health and Human Services — except to note that as the Feds continue trying to bottle up the truth about the autism epidemic, it keeps leaking out everywhere else. The Vaccine Court rulings this week, uncovered by the outstanding reporting of David Kirby and validated over and over by the Unanswered Questions report of EBCALA, are far more important in the long run than the dying yelps of the medical-industrial complex.

In other words, the fact that vaccines are the main driver of the autism epidemic, validated every day by families across the county and now in the world, is far more important than the ginned-up claim by the special interests that they don’t cause autism, or autoimmune disorders, or asthma, or ADHD, or juvenile diabetes, and etcetera and etcetera and etcetera.

It’s the same ol’, same ol’. The IOM is a pharma shill; vaccines are the cause of autism and all sorts of horrible diseases; and, of course, only Dan Olmsted, David Kirby, and their fellow antivaccine travelers know the truth. Of course, that EBCALA report referred to by Olmsted was in itself unauthorized human subjects research—and incompetently done research, to boot.

In fact, the report is nothing unexpected. The IOM, while acknowledging that

The committee acknowledges the evidence that reducing vaccine coverage is associated with increases in vaccine-preventable disease and found only ad hoc, inconsistent, and anecdotal evidence to imply that the recommended immunization schedule is not safe. Furthermore, existing systems for the detection of adverse events provide confidence that the existing childhood immunization schedule is safe, and the committee recognizes that the federal government invests considerable resources to ensure vaccine safety. Nevertheless, some stakeholders have suggested that further work is warranted, such as a comparison of vaccinated children with unvaccinated children or children receiving immunizations on alternative immunization schedules.

Ad hoc, inconsistent, and anecdotal evidence is exactly the sort of evidence that the antivaccine movement relies on is, of course, because it doesn’t have any epidemiological evidence or scientific evidence worth bothering with. Its evidence comes from at best low quality, uncontrolled or poorly controlled studies, and studies done by antivaccine investigators like Mark and David Geier, Christopher Shaw, or Andrew Wakefield. In any case, the report goes on to point out that doing a prospective randomized trial of vaccinated versus unvaccinated children would be completely unethical and:

[T]he committee concludes that a randomized controlled trial comparing the recommended schedule with any alternative schedule would be unethical and infeasible and could increase the risk of vaccine-preventable diseases in individuals and in the community.

While I don’t necessarily completely agree that testing alternative vaccination schedules would be inherently unethical, depending on the precise parameters of the schedule being tested (after all, we do that in essence when we add new vaccines to the existing vaccination schedule and it probably wouldn’t be unethical to test schedules in which certain vaccines are moved up or extra doses are added), I agree completely that a prospective randomized “vaxed versus unvaxed” study would indeed be completely unethical. Moreover, even though a study testing various “alternative” vaccine schedules might be ethically acceptable, depending upon the specific schedules being tested, absent compelling evidence of harm from the existing vaccine schedule, there is no scientific rationale to do such studies. (Hint to antivaccinationists: Just because you want one is not a scientific rationale.) Given that such a study would be very expensive and that the end result of “spreading out” the vaccine schedule would result in more visits and more time for children to be unprotected against vaccine-preventable diseases, such a study would be a waste of time and money.

In fact, for the benefit of antivaccine activists who might read this, I’ll explain why a randomized study comparing unvaccinated children versus vaccinated children or alternative vaccine schedules in which children are left undervaccinated too long would be completely unethical no matter what you believe. If vaccines are not dangerous and do not cause autism, as science shows and I accept, and the current vaccine schedule is safe and effective then doing a “vaxed versus unvaxed” study in which one group is randomized to receive no vaccines or a schedule that unnecessarily spreads out vaccines is completely unethical because the unvaccinated (or undervaccinated group) would be knowingly and intentionally left unprotected from vaccine-preventable diseases. Now, even if vaccines did cause autism and were a major cause of sudden infant death syndrome, asthma, and all the other diseases that antivaccinationists try to pin on vaccines, and there was compelling evidence to suggest that this was true, then the study would still be of questionable ethics, because the vaccinated group would then be knowingly placed into a group that would be likely to be harmed by the vaccination schedule. In this latter case, if there were truly evidence of harm, then decisions would likely have to be made on the basis of what that evidence is, what the specific harms suspected are, all balanced against the known harm that would come from cutting back on the vaccine schedule. None of this is to say that a randomized controlled trial of different vaccine schedules would always be unethical. The principle of clinical equipoise holds, after all. However, the classic “vaxed versus untaxed” randomized study some of the more clueless antivaccine activists want would indeed be unethical under pretty much any imaginable circumstance.

None of this stops Olmsted from laying down swaths of flaming antivaccine stupid:

So, it’s prospectively unethical. OK, then what about a study of people who are already unvaccinated — you know, the Amish, homeschoolers, the HomeFirst practice in Chicago? Chiropractors, Christian Scientists, Bushmen, Waldorfers, Spenglerians, Hippie-Dippies (not my term!) in Ashland.

No way. The report says: “Some people have suggested comparing vaccinated children with children in “naturally occurring” populations of unimmunized individuals, such as certain religious communities. With less than 1 percent of the American population refusing all immunizations, however, it would be very difficult to recruit enough willing unvaccinated participants, the committee concluded. It can take tens of thousands of study participants to discover uncommon health problems. Moreover, these populations tend to be much less diverse ethnically, racially, socio-economically, and genetically than the general population, and because such factors can influence health, it would be difficult to determine if differences between the study groups are the result of vaccines or these other factors. The costs of conducting this kind of study or a randomized controlled trial likely would be prohibitive.”

The IOM, as it turns out, is completely correct about this. I’ve explained exactly why multiple times before, remarking that it’s so cute when anti-vaxers try to discuss epidemiology. Actually, it’s not cute, but it is ignorant. As I pointed out, even if a researcher could sign up 10% of the entire estimated number of unvaccinated children in the U.S., then the smallest difference in autism prevalence that could be detected would be around a 70% increase in autism prevalence. The reason for this is that there are only estimated to be 50,000 total completely unvaccinated children between 3 and 6 in the entire country. This study would cost millions of dollars to do, as well. If we were to do a more conventional study (say, 5,000 matched controls and 500 unvaccinated children), we might be able to detect a seven-fold increase in the prevalence of autism, but only if we accept a beta error (the chance of erroneously saying there is no difference when there is a difference) of 50%. Check out Prometheus’s post and my old post for the full details.

So the IOM is correct about this, and Dan Olmsted doesn’t know what he’s talking about when he rants and raves and insinuates dogmatism and conspiracy while dismissing scientists’ objections to “vaxed versus unvaxed” studies of the type advocated by epidemiology-challenged antivaccine activists as the “Epistemological Obscenity.” (So what else is new?) Of course, “Epistemological Obscenity” is a pithy phrase that makes Olmsted sound pithy and profound, but in reality his post and those of antivaccinationists about such “vaxed versus unvaxed” studies are the real Epistemological Obscenities because in them true ignorance about the validity and limits of human knowledge is not just demonstrated, but flaunted proudly, as demonstrated by Olmsted when he compares the simple analyses of ethics, statistical power, cost, and practicality that lead scientists to dismiss him to “some mad extrapolation of Heisenberg’s Uncertainty Principle to the macro-atomic level” when it is anything but that. Thinking himself more knowledgeable about vaccines, autism, and biology than scientists who have spent their entire careers studying these issues, Olmsted doesn’t even realize or accept that scientists and physicians are correct when they point out that one of studies that he so fervently wants (a prospective randomized trial) is completely unethical, and that his grudgingly suggested fallback (an epidemiological study of vaxed versus unvaxed children) is highly unlikely to give them the answer that they crave. This is not surprising, given that antivaccinationists like Olmsted seem to think that an incompetently performed phone survey or an Internet survey by a German homeopath named Andreas Bachmair that was even more incompetently performed (but that they tout anyway) represents good science.

Of course, ultimately I suspect that’s the point. They already “know” vaccines cause autism, SIDS, asthma, and many other problems, and no study, no matter how convincingly negative, will ever change their minds.