Nine straw men.

I’m referring to an amazing post that appeared on the anti-vaccine crank blog Age of Autism over the weekend by contributing editor Julie Obradovic entitled The Difference Between You and Me. In this post, Julie describes not one difference, but nine differences, that she perceives between herself (and, apparently, by generalization other parents who have become believers in the myth that vaccines cause autism) and people like SBM contributors and (I hope) the vast majority of our readers, who support science-based medicine, understanding that correlation does not necessarily equal causation and that, most importantly, science not only does not support the belief that vaccines cause autism but provides us with copious evidence that there almost certainly no link between the two. Actually, there are more than nine differences, as Ms. Obradovic packs multiple apparently related differences around each of her nine “differences” and then complains that Alison Singer and, apparently by generalization the rest of us who support SBM and oppose the anti-vaccine movement, misrepresent the reasons why she and her merry band of anti-vaccine activists reject the science that has failed spectacularly to validate their deeply held belief that vaccines cause autism and all sorts of other health consequences. Her post ends up being a collection of straw men constructed to Burning Man size, each of which she then applies a flamethrower of burning nonsense to with self-righteous gusto.

Although no doubt Ms. Obradovic won’t see it that way, the reason I chose her article as an introduction for this post is not to pick on her (although if you look at her other posts on AoA, particularly her equally large city of straw men entitled How to Actually Save the Vaccine Program) she certainly deserves some picking on for her combination of pseudoscience, logical fallacies, and straw men). Rather, it’s because her collection of straw men are highly illustrative of what supporters of SBM have to deal with when dealing with pseudoscience and quackery. Ms. Obradovic’s “nine differences” may be all about vaccine-autism mythology and victimization that those mean and nasty scientists don’t take her beliefs seriously, but they could be about almost any form of non-science-based medicine. If you don’t believe me, do this simple thing. Wherever Ms. Obradovic writes “vaccines,” insert your favorite woo du jour and then channel the all-purpose quackery crank site Whale.to or NaturalNews.com. It doesn’t work for all of them (the part about the government “mandating” vaccines, for instance), but it works for enough of them to show my point.

Another reason why I’m going to discuss Ms. Obradovic’s collection of massive straw men peppered with other logical fallacies is that her attitude is not unique. What she writes demonstrates some key attitudes and belief systems towards science and points out many of the obstacles that those of us who try to promote science over pseudoscience, whatever the field, be it vaccines or any other area of quackery or pseudoscience, must address and overcome.

Straw men on flame with logical fallacies (apologies to Blue Öyster Cult)

Ms. Obradovic appears to be very incensed about a talk that Alison Singer, President of the Autism Science Foundation, arguably the only truly science-based autism charity in existence at the moment, and she uses a talk by Singer that was lambasted by Generation Rescue big macher J.B. Handley in three parts, as her jumping off point:

I am growing increasingly tired of the real reasons there is such controversy regarding vaccines and Autism being misconstrued to make me look pathetic. Alison Singer’s attempted explanation at Yale earlier this month (HERE) is a perfect example.

Contrary to what she suggests, our differences are not due to the internet. They are not due to desperation or the traumatization of having a child with Autism coupled with the need to blame someone. They are not due the media or the anti-establishment-toxic-earth movement. They are not due to the dismissive attitude of society and physicians who for years believed bad parenting was to blame. They are not due to an inability to simply accept clear science. They are not due to lack of an education or ability to think rationally. They are not due to being taken advantage of. They are not due to the cult of celebrity.

Wrong. Sorry. Not even close.

Actually, all of the above are excellent partial explanations for why parents like Ms. Obradovic refuse to accept science and continue to believe that vaccines cause autism. The reason Ms. Obradovic “looks pathetic” is not because some cabal of scientists are trying to make her look pathetic; it’s because she does an excellent job by herself of making pathetic arguments.

As I pointed out above, the rest of Ms. Obradovic’s post is structured as nine descriptions of what scientists and those of us who accept the science that doesn’t support her belief that vaccines cause autism believe, and her responding, “I don’t,” followed by a heapin’ helpin’ of what she does believe. Unlike Mark’s post, I’m not going to cover each and every one of these fallacies one by one in detail the way Mark did. I will note that upon rereading the post I just realized that Ms. Obradovic forgot a #3, disobeying the rule regarding the Holy Hand Grenade of Antioch: “Three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three.” Of course, Ms. Obradovic has two straw men #5; so it all evens out to nine straw men again.

So let’s start with straw man #1:

1. You believe the government (the Department of Health and Human Services) has the legally protected right to research, develop, patent, license, supervise, judge, approve, recommend, mandate, and profit from a product (vaccines) that they produce in partnership with a private entity (the pharmaceutical industry). You further believe they have the right to simultaneously oversee the quality, safety and efficacy of this product, and that they objectively do so. You even further believe that they have the right to fund and conduct studies used to defend their product and policy in a court that they serve as judge and jury over in the event you are harmed by it; and moreover, that if they do find in your favor, they have the right to award you compensation at their discretion using money that was secured by a tax you paid on the product when you purchased it and/or were mandated to use it. And finally, you believe this should be protected by law; that neither the government nor the private entity should be held criminally or financially responsible for negligence in the event it maims or kills you.

I don’t.

See what I mean? Straw man #1 is in reality several straw men prefaced by misrepresentation of Ms. Obradovic’s opinion as fact. The fct is that the government does by law have the power to fund the development of vaccines, purchase them for government-run vaccination programs, and recommend them. Note also how Ms. Obradovic is specifically castigating the federal government (DHHS is a federal, cabinet-level department) when in reality the federal government has relatively little power to mandate vaccines in the civilian sector. (If you don’t believe that, check out how few Americans were vaccinated against H1N1 last year despite a massive government effort to persuade Americans to be vaccinated). It is the state and local governments that set specific vaccine mandates required of children. True, they usually use the recommendations made by the CDC and AAP, but it is not primarily the federal government that “mandates” vaccines.

As for compensation, Ms. Obradovic is referring to the Vaccine Court. While it is true that the government requires that claims against vaccine manufacturers first be adjudicated through the Vaccine Court, as has been described on this blog and elsewhere, the Vaccine Court is actually a complainant-friendly venue, where the Daubert rule for scientific evidence is usually not enforced and it is not necessary to prove negligence. Moreover, for purposes of the Vaccine Court, there are a set of “table injuries,” which are in essence recognized potential complications from vaccines that are automatically compensable. These injuries are simply assumed to have been from vaccines, based on science documenting these as potential complications from vaccines. Also, unlike regular courts, the Vaccine Court will pay attorney’s fees and reasonable expenses even to losing petitioners. A petitioner need only demonstrate that the petition was filed in good faith and that there was a reasonable basis for the claim, the idea being to make it as easy as possible for ordinary citizens to seek compensation for vaccine injuries without incurring huge legal bills or being unable to find a lawyer to represent them on a contingency basis. Indeed, attorneys like Clifford Shoemaker have made quite the cottage industry of bringing claims before Vaccine Court, knowing that their expenses will be paid, win or lose. Finally, if an action fails in Vaccine Court, the parent is perfectly free to pursue it in the regular courts.

What straw man #1 reveals is that, like many supporters of pseudoscience and crankery, Ms. Obradovic views science and the government as being arrayed against her, all in cahoots with big pharma. Whatever the short comings and misbehavior of big pharma, some of which I’ve personally documented right here on this very blog, cranks like Ms. Obradovic go far beyond reasonable concerns about big pharma, as we will see.

On to straw man #2:

2. You believe the only protection the consumer needs to be afforded in the aforementioned situation is trust. People should simply trust that those given such enormous power and protection are honorable, ethical, and responsible human beings with families of their own who would never abuse it or put profit over safety primarily because they are smart, went to prestigious medical institutions, and are at the top of their field. You do trust them. And you trust that there are just too many of them involved to all be bad, somehow making the system safe from corruption based on numbers. This is the one point people rely on to debunk the “conspiracy theorists”.

I don’t.

First of all, trust is earned. So is respect. I don’t care what letters you have after your name. You’re smart? Great. So am I. I’m not impressed, nor am I intimidated. Smart doesn’t mean ethical. And some of the smartest people I know are also those with the least common sense.

Does this sound familiar? It’s very much the same anti-intellectual attitude that J.B. Handley once bragged about. Here’s a hint for Ms. Obradovic. Being “smart” isn’t what matters. “Common sense” isn’t what matters. Understanding and accepting the scientific method and how science works does. Ms. Obradovic honestly seems to believe that the reason the scientific community doesn’t accept her wild beliefs that vaccines cause autism is because of a lack of ethics, plus the government, big pharma, and scientists being all in some grand conspiracy, not because the scientific evidence doesn’t support her belief. Unlike the case for scientists, it never occurs to Ms. Obradovic that she might be wrong or that the reason her belief that vaccines cause autism are not taken seriously by scientists is because, well, she is wrong. But not just wrong, spectacularly and arrogantly wrong about the science. It is the the pure arrogance of ignorance, born of anti-intellectualism.

In brief, I’m not in the least bit impressed by Ms. Obradovic’s trumpeting of her being so “smart.” She has not earned respect in any scientific discussion–quite the contrary. She has proven time and time again that she does not know what she is talking about when it comes to science and that her emotion and distrust of science trump all. Contrary to Ms. Obradovic’s apparent belief that the science behind vaccines is rotten to the core, in actuality it is scientists, not misguided conspiracy mongers like Ms. Obradovic, who point out the shortcomings in the vaccine program.

Next, I’ll skip ahead a bit, because it’s a lot more of the same ranting about the government and the scientific community, and it can all be boiled down to straw man #5-1 (given that there are two straw men #5) anyway:

5. You believe the science funded and conducted by the DHHS, pharmaceutical companies, vaccine patent holders and government witnesses (there exists no widely accepted study without this level of participation and conflict) thus far on the potential role between vaccines and the onset of Autism Spectrum Disorder and other health outcomes (for which they will be held accountable) is objective and adequate as it stands right now in both quantity and quality to dismiss a link between the two.

I don’t.

There is not enough space in this article to explain why, but a detailed explanation can be found through the series of articles I wrote here at Age of Autism on the 14 Studies. I’ve read, analyzed and presented every single study multiple times. What you call clear science, I call crap. And no, I’m not willing to accept crap when it comes to my child.

The problem is, of course, that Ms. Obradovic doesn’t have the background to determine whether a scientific study is “crap” or well-designed, well-executed, and reliable. It is the arrogance of ignorance once again asserting itself. In addition, it is a straw man to claim that we supporters of SBM believe that the science “funded and conducted by the DHHS, pharmaceutical companies, vaccine patent holders and government witnesses” is adequate because there’s so much more than evidence funded by the U.S. government. There’s more to the world than just the United States, you know. There have been many studies not just in the U.S., but in several other countries, including Denmark, Canada, the U.K., Japan, Italy, and elsewhere that have failed to find a link between thimerosal in vaccines and autism or between vaccines and autism. Surely all these countries can’t be in on the conspiracy, can they? A much more accurate way of saying this, without the intentional use of the logical fallacy of poisoning the well, is that the totality of the scientific and clinical evidence, when taken as a whole, does not support a link between either thimerosal in vaccines and autism or between vaccines and autism. In contrast, by mentioning the execrable Fourteen Studies website, Ms. Obradovic demonstrates that what she views as “good science” is any science that reinforces her belief, no matter how biased it is or poorly designed and executed, as Steve Novella, Mark Crislip, and I have all demonstrated in our deconstructions of that particularly misinformation-packed Generation Rescue-sponsored propaganda effort. Let’s just put it this way. Anyone who doesn’t easily see through the distortions and misinformation in the Fourteen Studies website has forfeited any claim to an understanding of scientific studies adequate to make grandiose statements about the validity of existing science, such as what Ms. Obradovic makes in straw man #5-2:

5. You believe everything about Autism is a coincidence: the dramatic rise in incidence; the parallel increase in vaccinations given at the same time; the similarities to mercury poisoning; the ratio of boys to girls; the identification of this new disorder in 1943; the timing of the onset of symptoms; the anecdotal evidence of parents; the original CDC findings; the recovery of children who are treated medically; and more.

I don’t.

Science is rooted in observation, and yet, every observation here listed is casually tossed aside as a cosmic lining up of the stars. There is nothing scientific about calling all of this coincidence and explaining it away with unproven excuses (see your list in the second paragraph)…and crap.

This particular straw man demonstrates a misunderstanding of epidemiology so profound as to be beyond belief. In actuality, Ms. Obradovic’s “observations” are nothing more than the blatantly obvious confusing of correlation with causation. As has been pointed out time and time again, mercury poisoning and autism do not resemble each other that strongly. The “dramatic rise” in autism incidence can be largely (although it is unclear if it can be completely) explained by widening of the diagnostic criteria and diagnostic substitution. Also, an example I’ve used before is the Internet. The rise in Internet use beginning in the early 1990s very closely parallels the rise in autism diagnoses and autism prevalence. Surely, by Ms. Obradovic’s logic, the Internet should be just as plausible as a cause of autism as vaccines.

She’s also dead wrong that the hypothesis that vaccines cause autism has been “casually tossed aside” as coincidence. In fact, scientists have studied extensively vaccine safety, looking for a linkage between vaccines and autism, largely driven by the concerns of mothers like Ms. Obradovic. They haven’t found any. In fact, I can retort that one difference between someone like Ms. Obradovic and someone like me is that she doesn’t understand that correlation does not equal causation and that, when science has failed to find a linkage between two things, when that the most likely explanation for any linkage between the two is coincidence. It’s a really hard concept for most people to accept, particularly when they have an emotional investment in a claim of causation, but it’s true. Confusing correlation with causation, confirmation bias, and a number of other cognitive factors conspire to prevent people from easily accepting that sometimes bad things are a coincidence.

One excellent example came from an article about the H1N1 vaccine using the example of H1N1 vaccination and heart attacks.Given that there are this number of people having heart attacks each and every day, during the months when so many people were being vaccinated against H1N1, it was inevitable that there would be dozens, if not hundreds of coincidences a day in which something bad happens to a person after having the H1N1 vaccine. If you’re one of those people, it will seem all the world as though the vaccine caused the badness to happen. It’s not because these people are stupid or ignorant; it’s because, not knowing the expected rate of these coincidences, most people assume that the rate of coincidence is far lower than it truly is. They assume that the rate is close to zero, that such a coincidence would be rare, but that assumption is wrong when dealing with large numbers.

Yes, that’s one difference between Julie Obradovic and me. I understand that. She doesn’t. She thinks herself to be too “smart” ever to make the mistake of mistaking correlation for causation. One of my favorite movie quotes of all times comes from, of all places, a Dirty Harry movie, specifically, Magnum Force. In it, Dirty Harry Callahan says at one point, “A man’s got to know his limitations,” and at another point, “A good man always knows his limitations.” This applies to women as well as men, and Julie Obradovic doesn’t know her limitations with respect to science. From my perspctive, if Obradovic’s world view were more accurate than mine, if big pharma really did have the power to fake research findings all over the world, I’d have to wonder: Why bother to put all those alleged “toxins” in vaccines? Why not use homeopathic vaccines, something harmless but ineffective, and then make up evidence to make it look as though they work?

I think that, in the end, the difference between Ms. Obradovic and someone like me, a supporter of science-based medicine, is that there is evidence that, if produced, would change my mind about whether or not there is a link between vaccines and autism, and I know what that evidence would have to be right now. All it would take would be a couple of well-designed, well-executed, well-analyzed epidemiological studies showing a strong link between vaccines and autism. Produce those, and I would start to reconsider my position. Or, as Tim Minchin put it so brilliantly about homeopathy in his nine minute beat poem Storm (please be warned that Minchin is fond of the f-word):

Science adjusts its beliefs based on what’s observed
Faith is the denial of observation so that Belief can be preserved.
If you show me
That, say, homeopathy works,
Then I will change my mind
I’ll spin on a fucking dime
I’ll be embarrassed as hell,
But I will run through the streets yelling
It’s a miracle! Take physics and bin it!
Water has memory!
And while it’s memory of a long lost drop of onion juice is Infinite
It somehow forgets all the poo it’s had in it!

You show me that it works and how it works
And when I’ve recovered from the shock
I will take a compass and carve Fancy That! on the side of my cock.

The same goes for me and not just homeopathy, but the belief that vaccines cause autism. I’d be embarrassed as hell for having been wrong, and I might resist changing my mind for a while, but eventually science would win out, and I’d realign my beliefs to conform with science. I would, however, abstain from bringing any sharp instruments anywhere near my genitals, and I’m not sure if I’d go running through the streets yelling, “Vaccines cause autism!” I would, however, write about it right here on SBM, minus the use of the f-word. In contrast, there is clearly no evidence that will ever change Ms. Obradovic’s fanatical belief that vaccines cause autism. Just try asking her if you don’t believe me.

The question that remains is: Why do people like Julie Obradovic refuse to accept the science that shows that vaccines are safe and effective and that they are not associated with autism? I’ve already pointed out one reason: Failure to understand that correlation does not equal causation, coupled with failure to let go of a belief that isn’t supported by science. Obviously, though, that alone is not sufficient to explain the intensity of her reaction.

Next week (or the week after if something comes up that catches my fancy), I’ll consider mechanisms by which we protect irrational beliefs from science.

The anti-vaccine movement’s usual suspects haven’t been all over the mainstream media, as they usually are this time every year, often as early as April 1 or even March 31. In fact, over the last couple of years I had come to dread April 1, not because it’s April Fools’ Day (although the things that made me dread that particular day were often indistinguishable from an April Fools’ Day prank, so full of idiocy were they), but rather the expected carpet bombing of the media by the likes of Jenny McCarthy, J. B. Handley, and their ilk, some or all of whom would show up on various talk shows to spread their propaganda that vaccines cause autism. For instance, last year Jenny McCarthy and her former boyfriend Jim Carrey showed up on Larry King Live! with Dr. Jerry Kartzinel (her co-author on her latest book of autism quackery) and J. B. Handley, the last of whom even contributed a guest post on Larry King’s blog, in which he touted an incredibly bad, pseudoscientific “study” commissioned by Generation Rescue. The “study” (and calling it a “study” is way too generous) was no more than cherry-picked random bits of data twisted together into a pretzel of nonsense, as I described. Around the same time, Jenny McCarthy was interviewed by TIME Magazine, an interview in which she uttered these infamous words:

I do believe sadly it’s going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it’s their fucking fault that the diseases are coming back. They’re making a product that’s shit. If you give us a safe vaccine, we’ll use it. It shouldn’t be polio versus autism.

Soon after, Generation Rescue created a website called Fourteen Studies, which they promoted hither, thither, and yon. The idea of the website was to attack the main studies that failed to find a link between vaccines and autism and to promote the pseudoscientific studies that anti-vaccinationists like. In 2008, it was pretty much the same — well, worse, even. When she appeared on Larry King Live! with our old “friend,” anti-vaccine pediatrician to the stars, Dr. Jay Gordon, McCarthy shouted down real experts by yelling, “Bullshit!” (behavior trumpeted by Rachel Sklar of the Huffington Post).

This year? Oddly enough (and to me unexpectedly), there’s been almost nothing. J.B. Handley seems to be the man who wasn’t there. Well, not quite. It turns out that J. B. Handley has managed to get a little bit of fawning media attention, but just a little bit, in the form of an interview in The Bloomington Alternative entitled J. B. Handley: It’s unequivocal; vaccines hurt some kids. Apparently Mr. Handley has come down quite a bit in the world. Where’s his appearance with Jenny on Larry King Live! this year? Maybe it’s coming in the second half of the month. Or maybe the mainstream media, in the wake of the fall of Andrew Wakefield, have finally figured out how disreputable Generation Rescue is when it comes to vaccines. In the meantime Steven Higgs will have to do as a new mouthpiece for the anti-vaccine movement.

J.B. Handley: Anti-vaccine warrior that Steven Higgs loves

Regular readers of this blog will be able to spot the misinformation and anti-vaccine propaganda spewed by J.B. Handley in this article. There’s no doubt that Mr. Higgs is very impressed by J.B. from the very beginning of his article, which contains these characterizations of Mr. Handley:

• It’s not like Handley doesn’t understand the vitriol regularly aimed at him by what he routinely calls “the other side.” He is a pointed, straight-talking pain in their asses.
• McCarthy’s presence, Handley said, allows him to “hang out in the cheap seats and opine and write my own stuff and challenge people.” And in that regard, his style doesn’t earn him any props with the vaccines-are-sacrosanct crowd — the AAP, the pharmaceutical companies, and the government officials and researchers they financially support. He’s described their positions as “atomic stupidity” in articles he has written. Moron is a term he uses often, in print and in conversation.
• Even over the telephone from two-thirds of a continent away, J.B. Handley exudes a large personality and supreme confidence in his experiences and conclusions about his son’s autism.

“Atomic stupidity” describes a lot of what Mr. Handley says on a routine basis when it comes to vaccines and autism, although those of us who’ve butted heads with him in the past tend to refer to it as “burning stupid.” My sarcasm and intense dislike for Mr. Handley aside, given that most of the article consists of typical, run-of-the-mill Generation Rescue anti-vaccine nonsense that I and several of my co-bloggers have refuted time and time again, Mr. Higgs’ little opus might hardly have been worth my notice, much less blogging about, were it not for this passage, in which Higgs swallows whole J.B. Handley’s premature gloating about a post that Steve Novella wrote for SBM in February:

“Dr. Novella’s piece details a recent study published in the Journal of the American Academy of Child and Adolescent Psychiatry titled ‘A Prospective Study of the Emergence of Early Behavioral Signs of Autism’ that tried to figure out when signs of autism first emerge in babies,” Handley wrote. “Ironically, the study Novella references is quite supportive of the theory that autism is caused by the environment and most notably vaccines.”

The March 2010 study compared two groups of children, one at high risk for autism and one at low risk, and noted the onset of symptoms in children who developed autism. It found no difference in the frequency of visual contact, shared smiles and vocalizations at 6 months. The differences, however, “were significant by 12 months of age on most variables.”

In a blog post on the Web site Science-Based Medicine, Novella wrote, “What these results indicate is that clear signs of autism emerge between 6 and 12 months of age.”

Novella concluded that the study disproved a link between autism and vaccines. “Many children are diagnosed between the age of 2 and 3, during the height of the childhood vaccine schedule. This lends itself to the assumption of correlation and causation on the part of some parents.”

In an addendum to the blog, Novella acknowledged that he erred when he wrote that line, but he insisted, “Many parents blame their children’s autism on vaccines they received after the true onset of symptoms.”

While Handley didn’t comment on the addendum in his Age of Autism counterpost, he said the original line made him “shout and laugh at the same time.” Children have received 19 shots by 6 months — 52 percent of the total vaccination schedule — when the study says early symptoms of autism begin to appear.

Of course, Mr. Handley didn’t comment on (nor did Higgs link to) Steve’s followup post in his Age of Autism post, because Steve showed very clearly that Handley was, as usual, so wrong that he wasn’t even wrong. In essence, J.B. thought he had found a “gotcha” moment and that one erroneous statement that Steve made in his post was in fact an admission by mistake that the anti-vaccine movement is correct to point out a correlation between the peak ages of autistic regression and the height of the vaccine schedule. Steve admitted his error and then went on to describe clearly why his mistake was not evidence in favor of Mr. Handley’s position.

What was particularly interesting about Mr. Handley’s response was how much it showed that Mr. Handley has been changing his story and shifting the goalposts over the years. In particular, I noticed this paragraph in which J.B. stated:

More importantly, autism is not an event, it’s a process. It is exceptionally rare that I hear the story, “my son was 100% fine, and at 2 years old after one vaccine appointment he lost everything.” I have heard that story, but very rarely.

If Mr. Higgs had dug a little deeper, he might have realized that that’s exactly the sort of story I see time and time again presented by anti-vaccine believers, J.B. included, as “evidence” that vaccines cause autism.” Is this the same J.B. Handley who has touted at least since 2005 how common stories of children declining right after vaccines are? Let’s see, a couple of years ago he complained to the AAP:

Ms. Martin, let me give you a little insight into my world. If I wanted to find parents who had autistic children and who believed their child’s autism was impacted by vaccines, I wouldn’t need to email the nation’s pediatricians hoping I might find one or two. I could just open my window and yell, because these parents are everywhere in my neighborhood and town! Worse, our numbers continue to grow.

You see, not a day goes by without Generation Rescue receiving an email from a new parent who watched their child decline following a vaccination appointment with their pediatrician. While you search for the handful of parents with autistic children who may support immunizations, we can’t respond to emails fast enough from the thousands we hear from who feel vaccines contributed to their child’s autism.

“Not a day goes by …”? To me that sounded very much as though Handley was arguing that regression after vaccination is very common. Let’s look a bit more, say, from a post J.B. wrote before going on Larry King Live! last April:

Finally, we have tens of thousands of case reports of parents reporting that their child developmentally regressed, stopped talking, and was later diagnosed with autism after a vaccine appointment. The number of vaccines have risen along with autism rates, vaccines are known to cause brain damage, and parents report regression and later autism after getting them. Is it really so hard to believe we think vaccines are a trigger?

Wow. Tens of thousands of case reports! It appears to me that in his response to Steve there was more than a little bit of goalpost shifting. After all, the “stereotypical” (or “prototypical”) story of the anti-vaccine movement is of the child between the ages of 1 and 3 who is brought to the pediatrician, receives vaccines. Shortly thereafter, or so the anecdote goes, the child loses language and social skills and develops regressive autism. Never mind that, given the number of children who are vaccinated every year and the number of children who develop regressive autism, there are bound to be overlaps such that by random chance alone there will be many children who regress in reasonably close temporal proximity to vaccination. Never mind that no one has ever shown that this regression occurs more frequently in vaccinated children. Anecdotes like the ones J.B. was touting up until (apparently) now are the very “evidence” that the anti-vaccine movement uses to blame vaccination for autism. And, in all fairness, in a single child not studied in the context of populations, such an event can look all the world as though the vaccine caused the regression even when it did not. Even so, the point is that parents who believe vaccines caused their children’s autism don’t blame a process. They blame vaccines, often specific vaccines like the MMR.

In response to this article, I wrote Mr. Higgs an e-mail. I’ll admit that my tone was a bit peeved. However, it does bother me whenever a journalist give credence to the words of a man who, in addition to having a six or seven year history of spreading pseudoscience fueled by his unrelenting hostility towards vaccines, quite recently publicly gloated that he and his anti-vaccine movement were “early to middle stages of bringing the U.S. vaccine program to its knees.” My e-mail ultimately led to a three-way e-mail exchange between Mr. Higgs, Steve, and myself, and this led me to the definite conclusion that we have a budding Dan Olmsted on our hands.

Who is Dan Olmsted and why doesn’t any legitimate reporter want to be like him? Olmsted is currently the editor of Generation Rescue’s anti-vaccine propaganda blog Age of Autism. What people who haven’t been following this issue a long time is that Olmsted used to be an investigative reporter and senior editor for United Press International (UPI). Between January 2005 and July 2007, he wrote a series of “investigative” reports in a series that he called Age of Autism (his first installment predating the Age of Autism blog by nearly three years). In the series, he totally bought into vaccine-autism pseudoscience and presented the conspiracy theory through a combination of the same logical fallacies and bad science that undergirds the anti-vaccine movement, including confusing correlation with causation to blame thimerosal in vaccines or vaccines themselves for autism.

Olmsted’s most infamous gaffe was to be, as far as I can tell, the man who originated the myth that the Amish don’t vaccinate and that as a consequence they don’t get autism, a fallacy that Olmsted first reported in a two-part story entitled The Amish Anomaly (Part 2 here) and revisited time and time again. Of course, the Amish do vaccinate, and there are autistic Amish. In fact, Olmsted even missed a clinic in the heart of Amish country that treats autistic Amish children. Unfortunately, facts didn’t stand in the way of a good myth, which has only grown in the five years since Olmsted first imagined it.

Ultimately, Dan Olmsted left UPI (whether he resigned or was fired, only he and UPI know) and is now the editor of the anti-vaccine crank blog Age of Autism, where he can “report” to his heart’s content, free of any pesky concerns about editors insisting on actual facts and science. Steven Higgs looks as though he’s ready to join him.

An anti-vaccine reporter

Unfortunately, when it comes to autism and vaccines, it’s not that uncommon for reporters to fall for the myth. The reasons aren’t hard to understand. If there’s one way for a reporter to establish a name for himself, it’s to uncover a big story, the bigger the better. One category of story that is particularly seductive is the huge health scare, particularly if it’s something seemingly benign that is causing it.

Something like vaccines.

Higgs certainly isn’t the first. After all, David Kirby was seduced by the idea that mercury in the thimerosal preservative that used to be in vaccines was the cause of autism. After he published Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy in 2004, whatever remained of his journalistic career went into the crapper, leaving him to blog for The Huffington Post and, of course, Age of Autism. Then there’s a local connection, Steve Wilson, who up until recently was an investigative reporter for a local television station here in Detroit and who also bought into the myth that mercury in vaccines causes autism, a report that I duly criticized him for, even though I did it with some trepidation. My cancer center has a good relationship with the TV station that Wilson used to work for, and I was concerned that I would catch some flak for criticizing his report, which was nothing more than a rehash of the standard anti-vaccine mercury fear mongering. The sad thing is that Wilson did some absolutely outstanding work uncovering the malfeasance of our former mayor Kwame Kilpatrick. Unfortunately, his skepticism when it came to vaccines was in reality a pseudoskepticism, showing that even good investigative reporters can be crappy science and medical reporters.

Whether Higgs has any redeeming qualities in terms of investigative reporting skills, I don’t know. What I do know is that he has thoroughly drunk the Kool Aid, as demonstrated in spades in a story he published a month ago entitled Do Vaccines Cause Autism? In it, he tries to refute a contention by Dr. Phil Landrigan in a recent paper in which Dr. Landrigan stated bluntly (and correctly): “There is no credible evidence that vaccines cause autism.” In the article, Higgs repeated a number of common anti-vaccine tropes, tropes so common that I don’t feel obligated to answer them all, given that virtually all of them have been discussed before right here on this very blog. Some of them are talking points straight from Generation Rescue. For example:

• Higgs confuses correlation with causation when it comes to thimerosal. Unfortunately, there is a lot of evidence showing no correlation between thimerosal-containing vaccines and autism. The idea that thimerosal in vaccines cause autism is a failed hypothesis. It’s been tested scientifically and failed.
• Higgs buys the Generation Rescue line that nations with higher vaccination rates have higher autism rates and that vaccination does not correlate with lower childhood mortality. This is about as bogus a study as I can imagine, incompetently performed using cherry-picked data and not even peer-reviewed.
• Higgs cherry picks conclusions from a study of thimerosal-containing vaccines and neurodevelopmental disorders other than autism. That particular study produced results that were entirely consistent with random chance correlations from multiple comparisons. Indeed, if Higgs takes the negative correlations seriously, one wonders why he didn’t mention the positive correlations, where children receiving thimerosal-containing vaccines actually had better measurements of neurodevelopmental outcomes. In essence, Higgs cherry picks the bad results and ignores the good results when a careful reading of the study shows that, overall, the effects were consistent with random chance.

I could go on, citing more articles by Mr. Higgs and more refutations of the anti-vaccine talking points that he parrots, but I think you get the idea. If you don’t, I’ll cite Mr. Higgs’ own words:

I’ve spent most of the past 28 years journalistically investigating conflicts between environmental victims and experts in the relevant fields. And, I can say without qualification, the victims have been right and the experts wrong in every significant story I’ve covered. I can’t think of a single exception.

And with respect to vaccines and autism, I say again, without reservation, parents like J.B. Handley and grandparents like Dan Burton are right about vaccines and autism. The experts are wrong, and their behaviors — their vitriolic attacks upon those who disagree, their underhanded political tactics — suggest they know they were wrong.

Although Mr. Higgs denied this interpretation in his e-mails, both Steve and I interpreted this as an accusation of lying. Like Mr. Handley, Mr. Higgs seems incapable of considering the possibility that we have looked at the evidence and honestly come to a different conclusion. I don’t even think he realizes he is doing it, because he seemed surprised when we pointed out that this passage appears to be accusing us and every scientist who point out that science doesn’t support the idea that vaccines cause autism of not just being mistaken but dishonest. As for “vitriol,” I had to wonder if Mr. Higgs had actually seen some of J.B.’s antics, such as his misogynistic attacks on Amy Wallace, his attacks on Steve Novella, and, of course, me. Although J.B. was apparently not responsible for it, the most infamous of all was Generation Rescue’s portrayal on its propaganda blog Age of Autism of Steve Novella and Paul Offit, along with journalists Amy Wallace and Trine Tsouderos (both of whom had written exposes of the antivaccine movement in 2009) as baby-eating cannibals sitting down to a Thanksgiving feast of baby, an image so vile that it disgusted a fair number of Age of Autism’s regular readers and the criticism led to the image and post being thrown down the memory hole.

When it comes to vitriol, as “insolent” as I can be at times, Steve and I remain rank amateurs compared to the anti-vaccine movement, in particular J. B. Handley and his merry band of antivaccine propagandists at Age of Autism.

A closed mind

In my correspondence with Mr. Higgs, to which Steve Novella contributed, I came to the distinct impression that Mr. Higgs had come to view himself as a crusader and, based on his experience, has simplified environmental issues to viewing that experts are always wrong. His experience with previous environmental catastrophes and the reactions of companies responsible for them have led him to the point where he cannot imagine even the possibility that the claim that thimerosal in vaccines causes autism can possibly be wrong or that the experts who point out that science doesn’t support such a link might actually be correct this time. That’s how anti-expert and anti-intellectual Mr. Higgs has he become. Indeed, Steve Novella even called Higgs out on his anti-intellectualism, and, incredibly, Higgs’ response was that had lived in a college town for many years around intellectuals and therefore couldn’t possibly be anti-science or anti-intellectual.

But he is. His writings leave no doubt of that.

As a final example, I will mention two things Higgs cited. First, he cited this video as “the most persuasive evidence I have found thus far,” the one moment in time when he came to believe that vaccine cause autism:

Yes, that’s Bernadine Healy, former director of the NIH, and Mr. Higgs is quite enamored with her. Unfortunately, in recent years, she’s been flirting with the anti-vaccine movement, blaming the American Academy of Pediatrics, the CDC, and other health organizations and “just asking questions” about whether there is a connection between vaccines and autism. She’s also been promoting the idea of a “vaccinated versus unvaccinated” study, apparently not realizing the inherent difficulties involved in such a study. In essence, Dr. Healy, despite her previous position as NIH director (a position she was arguably unqualified for), is not an authority on vaccines. In fact, if you want an idea of how far down the rabbit hole of anti-vaccine lunacy Dr. Healy’s gone, consider that she was named as Age of Autism’s Person of the Year for 2008. If there’s one virtually completely reliable indication that a scientist or physician is well on the way to becoming an antivaccine crank (or has already become one), it’s being named Person of the Year by Age of Autism. It’s like the Nobel Prize, Oscars, Pulitzer Prizes, and Congressional Medal of Freedom for antivaccine crankery and autism quackery all rolled into one.

Finally, Mr. Higgs cited an article entitled Educating the Ohio Valley’s special kids. The interesting thing is that nothing in this article mentions vaccines as a cause of autism. Rather, the entire focus of the article appears to be on mercury and industrial pollution, the argument being that it is that that is correlated with the steadily increasing special education rolls in Evansville, IN. However, in his penultimate e-mail to me, Higgs cited this article and the leveling off of special ed enrollment in 2007 and 2008 as potential evidence for the thimerosal hypothesis, given that thimerosal was removed from most childhood vaccines by early 2002 and a 3 to 5 year delay would be expected after that happened before autism diagnoses would fall if thimerosal-containing vaccines were etiologically linked with autism. In his e-mail, Higgs asked, “I understand that two years does not constitute a long-term trend, but what other constant do you think every child in Indiana may have experienced in 2002 and 2003, other than vaccines?” Of course, as has been found in several studies in multiple locations and countries, there has been no convincing evidence of a leveling off or decrease in autism diagnoses five years after thimerosal was removed from vaccines in various countries, and there has been no convincing evidence of a leveling off or decrease in autism in California. The idea that thimerosal in vaccines causes autism led to a testable hypothesis. Every time this hypothesis has been tested, it has failed.

Curious about Mr. Higgs’ graph, I decided to look at the numbers anyway. In this task I was assisted by some blog buddies of mine, including Liz Ditz, who pointed out that a large number of factors could account for such an increase in special ed numbers and a leveling off in 2007, including the starting of campaigns to identify learning disabilities and their eventual leveling off and the effect of funding incentives on special ed enrollment. Multiple people pointed out to me that this leveling off of special ed cases appears to be occurring among all age cohorts. If thimerosal had anything to do with a leveling off in special ed case loads, it should have a far more profound effect in the youngest groups. It didn’t.

Meanwhile, Joseph was kind enough to provide me with a spreadsheet based on actual data, with special education counts for Indiana coming from here and whole-population enrollment counts coming from the National Center for Education Statistics here. He produced for me four graphs.

The first graph shows all disabilities for children aged 6 to 21:

Not much of a change over the period covered, is there? Next, we have a graph of all disabilities in the age group that would be most likely to be affected; that is, if thimerosal had anything to do with developmental disabilities requiring special ed:

Then we have a the same graph for the age group between ages 12 and 17.

Note how it looks very similar to the graph for ages 3-5. If thimerosal had anything to do with diagnoses leading to enrollment in special ed programs, you would expect to see a huge difference between the 3-5 year age cohort and the teenage cohort.

Finally, let’s look at the graph for diagnoses of autism at age 6:

Nope. No sign of a decrease in autism diagnoses in 2006 or later, which is what would be expected if thimerosal, which was removed from most childhood vaccines in late 2001, were a major etiological factor in autism. We can conclude from these graphs that Mr. Higgs is either very naive when it comes to data analysis or he saw what he wanted to see and stopped looking. His rush to judgment also belies one of his claims in his e-mails, namely that the science and epidemiology aren’t that hard to understand or do. That is, of course, just plain wrong. They are hard to understand and even harder to do. If they weren’t, then anyone could do them. Unintentionally, Mr. Higgs demonstrated himself that something that looks simple is not, and his looking at it simply led him to make an obvious rookie mistake that led him to the wrong conclusion.

Another Dan Olmsted?

Although admittedly I started out trying to address Mr. Higgs with a bit more “insolence” than might have been advisable, I had a hard time restraining myself, given his swallowing of everything that J. B. Handley lays down and his falling for everything Handley says about Dr. Novella. In any case, I tried to be less “insolent” as the correspondence continued. It nonetheless became clear in our correspondence that Mr. Higgs is a true believer, who really does think that Andrew Wakefield has been unjustly abused by the medical establishement and, amazingly, that J. B. Handley knows what he is talking about. I tried to plant a seed by providing him with a number of links, both from SBM and elsewhere, that refuted key points of the anti-vaccine movement. He said point blank that he wasn’t going to read them, at least at first. Also, in his responses he pointedly called me “Mr.” Gorski, even though after the first e-mail he clearly must have known I am a physician, an intentional bit of disrespect that amuses me far more than offends me, given how often I’ve seen anti-vaccine advocates and alt-med practitioners use it against me. In that, if anything, Mr. Higgs appears less polite than the journalist whose path he seems to be following, Dan Olmsted, or maybe David Kirby, given his fawning three part series interviewing Kirby.

But why?

In Mr. Higgs’ case, I rather suspect that it is really a case of being a true believer. According to him, every environmental health threat he’s seen was accompanied by industry denials and coverups. That may well be true. However, that history has apparently led Mr. Higgs to be so distrustful of what the government and medical authorities say, so suspicious of what “experts” say, that he can’t even consider the possibility that, in the case of vaccines, the experts are actually correct. There is no link between vaccines and autism that science has been able to detect. As passionate as Mr. Higgs may be about environmental pollution, he is, quite simply, on the wrong side of this particular issue and well on the way to becoming another Dan Olmsted supporting the quackery that is DAN!.

Indiana deserves better.

ADDENDUM: Steve Novella has also blogged about this, and he has shown that I might be wrong. It’s not Dan Olmsted whom Mr. Higgs is emulating. It’s Robert F. Kennedy, Jr.

Unfortunately for them, their rhetoric and activities betray them. For one thing, the anti-vaccine movement is not monolithic. There are indeed anti-vaccine zealots who are not afraid to admit that they are against vaccines. Many of them showed up to Jenny McCarthy’s Green Our Vaccines march on Washington two years ago with signs bearing slogans such as “Danger: Child Vaccine (Toxic Waste)”; “We found the weapons of mass destruction”; “Stop poisoning our children”; and, of course, “No forced vaccination! Not in America!” In the run-up to that march, I lurked on several anti-vaccine discussion forums, and I saw first hand how the organizers of the march were trying to keep people with these signs in line and less visible, not so much because they don’t agree with them but because they promoted the “wrong” message. In this, they remind me of political parties trying to rein in their most radical elements.

Among these groups, Generation Rescue has supplanted the former most influential anti-vaccine group, the National Vaccine Information Center (NVIC). It has achieved this largely through somehow attracting a scientifically ignorant washed-up model, actress, and comedienne named Jenny McCarthy who, most recently before having a son diagnosed as being on the autistic spectrum had been promoting “Indigo Child” woo on her IndigoMoms.com website, complete with a “quantum prayer wheel” invented by William Nelson, inventor of the quackalicious EPFX-SCIO. Back in 2007, just prior to the release of her first autism book, Louder Than Words: A Mothers’ Journey in Healing Autism, McCarthy’s “indigo” website disappeared from the web in a futile attempt to send it down the memory hole, but thankfully The Wayback Machine knows all. In any case, thanks to Jenny McCarthy and, at least as much to her boyfriend, the massively more famous Jim Carrey, Generation Rescue has been tranformed from an ignored fringe anti-vaccine group to a famous and influential fringe anti-vaccine group with all sorts of ins among the Hollywood elite, just as it’s been tranformed from just Generation Rescue to Jenny McCarthy and Jim Carrey’s Autism Organization – Generation Rescue.

Its increasing fame and influence notwithstanding, Generation Rescue has been playing the “pro-safe vaccine” game for at least five years now. Indeed, J.B. Handley himself, founder of Generation Rescue, wrote just last year:

I have vaccinated my children. I encourage others to vaccinate. But when I question vaccine safety, or rather the lack thereof, I’m called “anti-vax” by people like you.

Tell me, how am I anti-vaccine? How am I endangering other people by encouraging them to read up on vaccine injuries. How am I endangering them by giving them as much information as possible in the hopes that their children will not have the same reaction as my son?

Of course, in the five years since I first learned of J.B. Handley, during which time I’ve been following his exploits, I have never once heard him say or seen him write anything that encouraged parents to vaccinate, that expressed anything other than regret or anger at having vaccinated his children and, apparently in his view, caused their autism, or that said anything good about vaccines at all. Quite the contrary, in fact. Last year, for example, J.B. Handley began April, which is Autism Awareness Month, by releasing a truly incompetent attempt at a “study” and then launching Generation Rescue’s deceptive Fourteen Studies website. All the while, I have seen J.B. paint himself as a guardian or watchdog of vaccine safety time and time again, while using familiar denialist tactics of sowing fear and doubt; misinterpreting, cherrypicking, or misrepresenting existing science; highlighting bogus science like that of Andrew Wakefield and Mark and David Geier; and demonizing his opponents, the last of which he is particularly talented at.

Consistent with this, it would appear that J.B has finally let his “I’m not anti-vaccine” mask drop. Last week, Handley laid down an unusually candid bit of his typical braggadocio about a recent study that appeared in the journal Pediatrics about parental attitudes towards vaccination. Tellingly, he entitled it Tinderbox: U.S. Vaccine Fears up 700% in 7 years, in which he gloated about having been responsible for the increasing mistrust of vaccines among parents. Since Handley prominently mentions yours truly, I felt that a bit of a friendly rejoinder was in order.

J.B. Handley starts off his post by boasting:

With less than a half-dozen full-time activists, annual budgets of six figures or less, and umpteen thousand courageous, undaunted, and selfless volunteer parents, our community, held together with duct tape and bailing wire, is in the early to middle stages of bringing the U.S. vaccine program to its knees.

Cue the “Star Wars” music, with a rag-tag band of rebels fighting off an evil galactic empire. Citing the study (Freed et al), which found that 25% of parents surveyed believe that vaccines “can cause autism in healthy children” and that 60% of mothers agree or strongly agree that “I am concerned about serious adverse effects of vaccines,” Handley then gloats by congratulating his people:

Community, prepare to take a bow, America is listening.

I can’t help but make three points here. First, I’m not sure why anyone would want to “take a bow” for spreading misinformation based on ignorance, outright pseudoscience, and paranoid conspiracy theories about vaccines because it has started to have some traction among the public. In my book, that’s nothing to be proud of at all. Second, if J. B. Handley is “not anti-vaccine,” why on earth would he think it’s a good thing that, if the study he cites first is to be believed, parents are becoming more afraid of vaccines, so much so that he blusters and brags about his “success” in his typical fashion? J.B. clearly believes he and his ilk are the responsible for a huge increase in fear and doubt about vaccines and goes so far as to take the credit for it in the name of the “autism community” and lays out his anti-vaccine belief very clearly in a typically testosterone-laced style. Third, although the survey does raise some cause for concern, it is not as bad for supporters of science-based medicine and good for the anti-vaccine movement as Handley tries to paint it. Before I get to explaining why, let’s first note the full reason that Handley is gloating:

Taking a very different approach from the average journalist, I started doing some of my own research, and came across this study, Parental Vaccine Safety Concerns, Results from the National Immunization Survey, 2001-2002.

I was floored.

I remember 2001-2002. My son was born in 2002. I’d barely heard of autism. I’d heard the faintest whispers about vaccines causing autism, but wrote it off as hippy-conspiracy stuff. Not surprisingly, the 2001-2002 report, unlike the 2009 report, does not even mention the word “autism.”

And, in 2001-2002, what percent of parents expressed any concerns about the safety of vaccines? Seven. 7%. Less than 10. Five plus two. A full 93% of parents said vaccines were “completely safe.” In fact, the 2001-2002 study was exceptionally proud of the “low prevalence of vaccine safety concerns.”

What a difference seven years has made. Folks, the U.S. vaccine program literally has its hair on fire. 56% of parents today are concerned about the serious adverse effects of vaccines, and 60% of moms. 56% of parents is an 8-fold, or 700% increase from 2001-2002.

That’s right. J.B. Handley is taking credit on behalf of the movement he leads for cranking up hysteria about vaccines, concluding, “Parents, you can now take a bow. It’s way worse than we thought.”

Well, yes and no. You’ll see why this is a typical bit of J.B. Handley hyperbole in a minute. On the other hand, it is very difficult to argue that fear and loathing of vaccines haven’t increased during the last decade or so. This increase in mistrust of vaccines is particularly evident in the United Kingdom, where Andrew Wakefield’s shoddy, trial lawyer-purchased, incompetent, and possibly even fraudulent 1998 Lancet study linking the MMR vaccine to bowel problems in children, coupled with the aid of the credulous media, both witting and unwitting, has driven down MMR uptake in the U.K. to far below the level necessary for herd immunity. This decline in MMR uptake rates has predictably resulted in measles incidence skyrocketing over the last decade to the point where it has become endemic again. Although it took 12 years, the results of Wakefield’s malfeasance finally came home to roost last month, when, in rapid succession, Wakefield was found guilty of research misconduct by the U.K. General Medical Council, saw his Lancet paper retracted by The Lancet’s editors, saw his infamous “monkey study” withdrawn by NeuroToxicology, and was then forced to resign from Thoughtful House by its board of directors, led, ironically enough, by Jane Johnson, heiress to the Johnson & Johnson pharmaceutical fortune. If 2009 was a bad year for the anti-vaccine movement in many ways, 2010 looks to be potentially as bad, starting with the latest ruling from the Vaccine Court against the second batch of test cases, one year after the first batch also failed.

All of the above developments, and more, have led the anti-vaccine movement in general and J.B. Handley in particular to lash out, and I see this latest bit of braggadocio as part of that lashing out. I was particularly amused by this passage:

Referring again to the 2009 Pediatrics report that “current public health education campaigns on this issue have not been effective,” I am pleased to lay the blame for that on four people: Dr. Paul Offit, Dr. David Gorski, Amanda Peet, and Ms. Alison Singer. The data clearly shows that the efforts of these four to stem the tide of public opinion away from vaccines has been a miserable failure.

I must say, there’s nothing like being mentioned in the same sentence with Dr. Paul Offit, Alison Singer, and Amanda Peet as defenders of the vaccination program to give a nice little boost to one’s ego! And J.B. even called me “Dr.,” something he often apparently intentionally avoids doing! Seriously, I’m profoundly honored that in J.B.’s mind I deserve to be viewed as being on the same level. Think about it. Here I am, an itty-bitty blogger. Well, not exactly itty-bitty. This blog has a healthy and respectable traffic, as does my other, more infamous blog, so much so that to my shock when I traveled to St. Louis a couple of weeks ago the Skeptical Society of St. Louis thought enough of me to arrange an impromptu get together on short notice at a local bar. Even so, to compare my feeble efforts to combat the anti-vaccine movement to those of Paul Offit, who has been a vaccine researcher for decades and made real scientific and medical contributions to eliminating infectious disease, is ridiculous. To compare me to Amanda Peet, who has many orders of magnitude more name recognition that I have, either under my real name or my more infamous pseudonym, does seem a stretch, as does comparing me to Alison Singer, who was forced out of Autism Speaks because she doesn’t share the belief that vaccines cause autism and ended up forming a new autism charity called the Autism Science Foundation. Unrealistic or not, ridiculous or not, being considered to be on par with such people puts me in very good company indeed, although, in the words of Wayne and Garth from a couple of decades ago, “I’m not worthy, I’m not worthy!”

In comparison, all I’ve done is to have been a persistent thorn in J.B. Handley’s side through my blogging for the last five years about the vaccine pseudoscience promoted by Generation Rescue (and later Age of Autism), written one relatively popular blog, edited another popular group blog, and participated in a panel discussion about the anti-vaccine movement at TAM7 last year. All of these are worthy activities, but I can only conclude that it is a measure of J.B.’s fixation with me that he would be deluded enough to include me in such a list. Whatever influence I’ve garnered through my personal blog and, with the help of my cobloggers,though SBM is on the order of several thousand readers. That influence is not even close to being of the same order of magnitude as that of the mainstream media or of someone like Jim Carrey or Jenny McCarthy, which makes “blaming” me for whatever failure there has been in combatting the tide of misinformation spread by various anti-vaccine organizations rather silly. I also wonder why J.B. didn’t also target Steve Novella, who’s done at least as much, if not more, than I, as he’s done in the past.

Perhaps this is why:

Did Hollywood cast this guy as a villain? He’s perfect! Of course, Offit found Amanda Peet, who let the world know we were all parasites (anyone hear from her lately?). Go online to get the other side, and your likely to find Dr. Gorski’s blog, where a dozen anonymous commentators echo Dr. Gorski’s venomous invective – just the thing to build trust with a new mommy! The newest entrant, Ms. Peet’s replacement, is Ms. Singer, who looks like she stepped out of the morgue to take each interview and tell everyone that vaccines are safe and we all barely exist. Keep talking, Ms. Singer, keep Paul Offit on your board, and keep publicizing the “National Immunizations Conference” on your “autism science” website.

I’ll admit that my other persona is a tad more–shall we say?–blunt (insolent, even!) than I am when I write for SBM, but to hear J.B. complain about “venomous invective” nuked my irony meter. Generation Rescue and its propaganda arm Age of Autism specialize in “venomous invective,” particularly against Paul Offit and anyone else who opposes its anti-vaccine agenda. After all, this is the same man who launched personal attacks on Steve Novella that can only be viewed as more than venomous. This is the same man whose misogynistic attacks on Amy Wallace, a journalist who wrote an excellent article on the anti-vaccine movement, made him infamous throughout the science-based blogosphere. This is the same man who periodically blasts away at me^1,2,3 whenever I get under his skin too much. This the same man whose blog posted a Photoshopped picture of Steve Novella, Amy Wallace, Paul Offit, and Trine Tsouderos sitting around the table for a Thanksgiving feast, the main course of which was a baby, as shown by this screenshot taken from my computer around the time the post showed up:

That was so over-the-top that even AoA ended up deleting it after a firestorm of criticism. I can’t compete with venom like that even if I wanted to, and I don’t want to.

But let’s get to the study touted by Handley. It did indeed show that 25% of parents polled think that vaccines can cause autism in healthy children, a disturbingly high rate, but, quite honestly, much lower than I feared it would be when I first heard about the story. However, what Handley neglects to mention is that, despite the 54% of parents expressing concern about serious adverse events due to vaccines, 90% of parents agreed that “getting vaccines is a good way to protect my child(ren) from disease” and that 88% agreed that “generally I do what my doctor recommends about vaccines for my child(ren).” These responses suggest that, although more than half of parents express concern about adverse events, most of these same parents don’t find the worries they have about vaccines compelling enough to refuse vaccination. In other words, they have heard about the concerns, most likely thanks to anti-vaccine groups and activists like Generation Rescue and J.B. Handley, but the concerns haven’t “stuck” enough to make them refuse vaccination. Unfortunately, J.B. Handley and his ilk are certainly doing their best to change that.

More disturbing is the finding that nearly 1 in 8 parents have refused certain vaccines for their children, with newer vaccines being more likely to be refused than older vaccines. This figure suggests to me that the “too many too soon” propaganda of Generation Rescue and others, and the “alternative vaccination schedules” touted by people like Drs. Bob Sears and Jay Gordon may be gaining traction. How much of that can be attributed to the propaganda of the anti-vaccine movement is impossible to say for sure, but certainly other factors are at play, including a general trend of questioning medicine more, along with the rise of the Internet, which has allowed people with no particular expertise in a topic to attend “Google U.” and conclude that they know more about a topic than researchers who have studied an issue all of their lives. While it’s true that science does advance and scientific consensuses do change, they do so through data, experimentation, and clinical research, not through conspiracy theories and misrepresentation of science. Moreover, changing public opinion has nothing to do with the validity of a position. Many more people believe in ghosts than in the scientifically discredited idea that vaccines cause autism. That does not mean ghosts exist.

In the end, I have to wonder whether the anti-vaccine movement has reached its high water mark in terms of public influence and J.B.’s gloating is a tad premature. After all, the last year or so has been very bad for him and his organization. Before 2009 started, study after study have failed to find a link between vaccines and autism or thimerosal and autism, many of which we’ve collected right here. In February 2009, strong evidence showing that Andrew Wakefield had committed scientific fraud came to light, and that was followed by a ruling against the first three Autism Omnibus test cases. A series of excellent reports by Trine Tsouderos and Pat Callahan of the Chicago Tribune demonstrated the depths of autism quackery driven largely by anti-vaccine ideas, while exposes of the anti-vaccine movement came fast and furious from Chris Mooney for DISCOVER (Why Does the Vaccine/Autism Controversy Live On?) and Amy Wallace for WIRED (An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All), leading to the aforementioned misogynistic attacks against Amy Wallace and a recent hilarious invocation of the “pharma shill” gambit against Chris Mooney. Since 2010 began, not only has Andrew Wakefield been completely discredited that he was forced to resign from Thoughtful House, but the Vaccine Court ruled against the second set of test cases. Meanwhile, later this year Paul Offit is scheduled to release a book about the anti-vaccine movement that paints it in a very unfavorable light. Increasingly, people are (correctly, in my estimation) viewing Jenny McCarthy as a dangerous loon abusing her celebrity.

I’ve been very critical of the AAP and CDC before. I and many others have been sounding the alarm against the anti-vaccine movement for at least five years now, and the AAP and CDC remained tone deaf to the growing vaccine denialism movement fronted by J.B. Handley and, since 2007, Jenny McCarthy and Jim Carrey. To me, it seemed that it wasn’t until 2009 (2008, to be generous) that health authorities in the U.S. seemed to wake up to the threat. So, since 2002, the anti-vaccine movement had the playing field to itself by and large. Now it does not. I may be the eternal optimist in this (either that, or I’m bipolar, cycling between extremes of pessimism and optimism), but for the first time since 2005, the year I first started paying attention to vaccine issues in a big way, I sense a positive shift in the national zeitgeist against the anti-vaccine movement. That’s one reason why I consider it important to mention two things. First, the questionnaires for this survey were administered in January 2009. Second, I’ve sensed this change most strongly beginning in late 2008/early 2009, and accelerating in early 2010, meaning that this survey could indeed represent the high water mark of mistrust of vaccines. I also note that the spectacular flameout of Andrew Wakefield in January and February, in particular as evidenced by the retraction of his 1998 Lancet paper, has seriously hurt the anti-vaccine movement, and don’t think they aren’t feeling it.

I do have to thank Mr. Handley though. His article did do more for my already inflated ego than anything since finding out at TAM7 that I’m not just an itty-bitty blogger anymore. I also thank him for laying it on the line: The goal of the anti-vaccine movement is to spread fear and doubt about vaccines among parents, to “bring the U.S. vaccine program to its knees,” as J.B. so aptly put it. Now that we know that, we know that, for all the disclaimers of “I’m not anti-vaccine” notwithstanding, J.B. Handley and Generation Rescue are anti-vaccine to the core.

ADDENDUM:

I can’t resist pointing out a perfect case of crank magneticism by an AoA commenter who left a doozy of a comment after the post above that amused me greatly:

First off Keebler count me in the quarter that denies the 18th century evolution theory that even the theorist decried before his death as he turned to God. His theory was just a 4 centuries removed from the 14th century world is flat group.

Also count me in the group that says global warming is Horse Sh– and the students paper it is based on, the emails that exposed the conspiracy of lies and the revelation that Al Gore used photos from a Hollyweird movie did not have anything to do with my firm conclusion. Anybody who is even remotely aware of the weather man/woman and the accuracy of their predictions clearly knows that the weather cannot be accurately predicted from Monday to Wednesday with any consistency therefore to take the word of these same people that the planet will be warmed significantly from CO2 from SUV’S and cars is beyond laughable. As any grade schooler can tell you the earth has more water than land, almost 72%, and the greatest emission of green house gases is from the ocean, God sort of planned it that way and you can take for granted that he is a wee bit smarter than you are ok genius.

Also Keebler the hysteria from people like you screaming that the glaciers are melting and that this will cause floods all over the world is nothing short of histrionics spawned by true ignorance, you see according to Archimedes principal, another high school physics tid bit, when an object displaces water, like ice does, even if it melts the water level does not rise because of the volume displaced by the ice is equal to it’s volume when melted.

By the way, water is the ONLY substance that when solid is less dense than when it is a liquid. If this were not true then the plants in the bottom of lakes, rivers and oceans in cold areas would die and not make oxygen and the fish would die and then we would eventually die. Again God planned it that way and when you know everything because you actually created everything it works really well.

Finally the vaccine scam will come to an end. Physicians and surgeons everywhere outside of pediatrics and psychiatry are telling people not to vaccinate. I stand straight up and tall and look parents in the eye and tell them not to vaccinate and give them my card and tell them to tell their pediatrician to call me if he has the guts to.

Evolution denial, anthropogenic global warming denial, and vaccine denial, all in one comment! Truly, we have the crank trifecta!

Less amusing is this:

After this scam comes to an end, and it most certainly will come to an end because ALL SCAMS COME TO AN END. I personally am hoping it is through mob violence so I can get my licks in. I am going to have all of these ass wipe fraudulent studies along with the pictures of the authors printed on toilette paper of my choice, with raised lettering( so it catches more fecal material when I clean myself) on double ply paper because I want to be real comfortable when these “peer reviewed” articles and their authors from Pediatrics, Elsevier the CDC and the New England journal of Medicine do their real job. I am certain they will be great at it and that this is what their true purpose in life is.

When J.B. talks about “venomous invective,” perhaps he should look at his own blog. Nowhere do I ever advocate (or even just hope for) “mob violence.”

None of this mattered. Andrew Wakefield still enjoys a cult of personality among the anti-vaccine crowd that no revelation seems able to dislodge, even the revelation that at the time he was both in the pay of trial lawyers and working on his study, Andrew Wakefield was also applying for a patent for a rival measles vaccine. Indeed, the anti-vaccine propaganda blog Age of Autism bestowed upon him last year its “Galileo Award” as the “persecuted” scientist supposedly fighting for truth, justice, and anti-vaccinationism against the pharma-funded or brainwashed minions of the “Church of the Immaculate Vaccination.” In the meantime, MMR uptake rates in the U.K. have plummeted over the last decade, far below the level needed for herd immunity, to the point where, last year the Health Protection Agency declared measles to be once again endemic in the U.K., 14 years after the local transmission of measles had been halted.

Since Wakefield’s study was released, a number of studies have shown that there is no epidemiologically detectable link between vaccination with MMR and autism, including one by a researcher who once appeared to be a believer in the idea that vaccines are somehow linked with autism, Mady Hornig. Hornig actually tried very hard to replicate Wakefield’s 1998 Lancet study, only this time with more children, and she found no link between MMR and autism using methodology similar to Wakefield’s. None of these studies has had any effect on the anti-vaccine movement, except to motivate them to circle the wagons even more, as J.B. Handley of Generation Rescue did when he launched a website called Fourteen Studies, whose purposes are to launch fallacious and pseudoscientific attacks on studies failing to find a link between vaccines and autism (often involving accusations of being a “pharma shill”), to promote the lousy science that gives the appearance of supporting the hypothesis that there is a link between the MMR vaccine and autism, and then slime anyone who points out how deceptive their attacks were.

Now, yet another study has been released studying whether there is a link between MMR vaccination and autism. Yet another study has failed to find a link between MMR vaccination and autism. Yet another study is all set to be attacked by Generation Rescue and the anti-vaccine movement. The sad and sordid history of reactions of the anti-vaccine movement to studies that do not support its belief in the unsinkable rubber duck of a myth that vaccines cause autism. This study was published online in The Pediatric Infectious Disease Journal by a group from Department of Epidemiology and Preventive Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland (a Polish group, my people!) and entitled Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study. It’s yet another nail in the coffin of the myth that the MMR causes or contributes to autism. Indeed, this study not only shows that MMR vaccination is not associated with autism but that it may even be protective against autism. True, for reasons I will discuss shortly, I doubt that that latter interpretation is true, but there’s no doubt that this study is powerful evidence against the view that there is an association between MMR and autism. Unfortunately, I fear that all the nails in my local Home Depot would not be enough to keep the zombie of this pseudoscience from rising from its grave yet again.

Here’s the abstract of the paper:

OBJECTIVE: The first objective of the study was to determine whether there is a relationship between the measles-mumps-rubella (MMR) vaccination and autism in children. The second objective was to examine whether the risk of autism differs between use of MMR and the single measles vaccine.

DESIGN: Case-control study.

STUDY POPULATION: The 96 cases with childhood or atypical autism, aged 2 to 15, were included into the study group. Controls consisted of 192 children individually matched to cases by year of birth, sex, and general practitioners.

METHODS: Data on autism diagnosis and vaccination history were from physicians. Data on the other probable autism risk factors were collected from mothers. Logistic conditional regression was used to assess the risk of autism resulting from vaccination. Assessment was made for children vaccinated (1) Before diagnosis of autism, and (2) Before first symptoms of autism onset. Odds ratios were adjusted to mother’s age, medication during pregnancy, gestation time, perinatal injury and Apgar score.

RESULTS: For children vaccinated before diagnosis, autism risk was lower in children vaccinated with MMR than in the nonvaccinated (OR: 0.17, 95% CI: 0.06-0.52) as well as to vaccinated with single measles vaccine (OR: 0.44, 95% CI: 0.22-0.91). The risk for vaccinated versus nonvaccinated (independent of vaccine type) was 0.28 (95% CI: 0.10-0.76). The risk connected with being vaccinated before onset of first symptoms was significantly lower only for MMR versus single vaccine (OR: 0.47, 95% CI: 0.22-0.99).

CONCLUSIONS: The study provides evidence against the association of autism with either MMR or a single measles vaccine.

Indeed it does. It’s worth talking a bit about the methodology of the study. First of all, this is a case control study, which means that it’s retrospective and therefore not randomized. On the other hand, it was a case control study by Sir Richard Doll that was the first outside of Nazi Germany (whose scientists, oddly enough, had found evidence linking smoking to lung cancer more than two decades before the Surgeon General issued his report in 1964) to find an association between tobacco smoking and lung cancer, a finding that was subsequently followed up in cohort studies and found to be valid. Be that as it may, case control studies, instead of prospectively following a population over time, study a population of patients who already have a disease or condition and then try to identify factors associated with the development of that condition. Basically, this involves picking a control population that is equivalent to the study population, and this is how the investigators did it:

Subjects were identified using general practitioner records in the Lesser Poland (Małopolska) Voivodeship in Poland. The sample population of this study included children aged 2 to 15 years diagnosed with childhood or atypical autism, classified according to ICD 10-criteria as F84.0 or F84.1, respectively. Every diagnosis of autism was made by child psychiatrist. Dates of these diagnoses were recorded in general practitioners files. Cases with uncertain diagnosis of autism, secondary to disease state or trauma, were excluded. Two controls were selected for each affected child, individually matched by year of birth, gender, and physician’s practice. The first 2 children visited the physician after the time of the autistic child visit who met entry criteria served as controls.

This is a reasonable strategy to use to pick the control group, as it means that the children would be coming from the same pediatric practices as the autistic children and would be about as comparable as it is possible to make them in this sort of trial design. Another strength of this study is that it used physician reporting for vaccination history and the age at which each autistic child was first diagnosed, rather than relying on parents’ reporting, which is prone to serious confirmation bias. True, the parents were also asked when they first suspected their child’s symptoms might be related to autism, and their knowledge and beliefs regarding the cause of autism, but vaccination was not mentioned in order to avoid biasing the parents’ answers. Cases of autism were then analyzed and considered to have been vaccinated if they received the MMR prior to the onset of autistic symptoms. Controls were considered vaccinated if they had received the MMR before the age of onset of their matched case controls. Finally, the authors corrected for other potential risk factors for autism, including mother’s age, education, gestation time, medications during pregnancy perinatal injury, and the APGAR score of the child at birth. Those that appeared significant in univariate analyses were then subjected to multivariate analysis.

The money tables are Table 3 and Table 4:

What’s surprising about these results is that the multivariate analysis found a relative risk (RR) of autism for children vaccinated with any vaccine before the onset of autistic symptoms of 0.65 and 0.28 for children vaccinated before their “official” diagnosis of autism. When looking at the single vaccine for measles or the trivalent MMR vaccine, both appeared to be protective against autism, but the MMR appeared to be considerably more protective than the single shot measles vaccine. (This comparison could be made because the Polish national health service only covered the single dose measles vaccine and not the MMR until 2004, meaning that before 2004 parents who wanted the MMR vaccine had to pay extra.) Indeed, this study evne found that for children vaccinated with MMR before their diagnosis of autism the RR = 0.17, suggesting a six-fold decreased risk of autism in children vaccinated with MMR!

Is this really true? Is MMR vaccination really that protective against autism? Probably not. An effect of that magnitude would very likely been picked up in one or more of the large population-based studies that failed to find a correlation between vaccines and autism. There is also one shortcoming in this study is that it only looked at autistism and not other pervasive developmental disorders; however there is ample other evidence that MMR is not associated with PDDs other than autism, and the original claim of the anti-vaccine movement was that MMR causes autism. So how to explain such a result? One possibility is simply random chance, given that the sample size, although reasonable, is not that large. Another possibility is that there is a confounder that wasn’t adequately controlled for. Whatever the case, here’s one thing to remember about retrospective studies in general. They often find associations that later turn out not to hold up under study using prospective studies or randomized trials or, alternatively, turn out to be much weaker than the retrospective study showed. They do not so often find a result that is exactly the opposite of hypothesis tested for. In other words, when such a study is used to look for a positive association between a factor and a specific condition or disease, it is quite uncommon to find a negative association, particularly one this strong. One possible reason for this seeming protective effect observed was discussed by the authors:

The decreased risk of autism among vaccinated children may be due to some other confounding factors in their health status. For example, healthcare workers or parents may have noticed signs of developmental delay or disease before the actual autism diagnosis and for this reason have avoided vaccination.

I have speculated before that a study of “vaccinated” versus “unvaccinated” children could be similarly confounded by parents who have one autistic child, become convinced that vaccines caused it, and therefore don’t vaccinated subsequent children that they might have. The main point to remember is that, even though this study is not compelling evidence that MMR is protective against autism, at the very least, the Polish study is strong evidence against a positive correlation between vaccination with MMR or single vaccination against measles and the development of autism. It is yet another pebble in the mountain of evidence that vaccination with MMR is not associated with autism or “autistic enterocolitis.”

It’ll be fun to see how long it is before Handley adds this study to his “Fourteen Studies” website and renames it “Fifteen Studies.” Of course, at the rate studies failing to support Generation Rescue’s cultish clinging to the unsinkable rubber duck of a belief that vaccines cause autism, Handley will have to rename his site every few months at least, and either I or one of my partners in crime here at SBM will have to slap down yet another scientifically ignorant attempt at discrediting each new study.

On and on it goes. Meanwhile, autistic children pay the price for quackery related to anti-vaccine beliefs, and normal children face the resurgence of vaccine-preventable diseases, thanks to the efforts of anti-vaccine cranks like J.B. Handley, Jenny McCarthy, Jim Carrey, Barbara Loe Fisher, and the rest of the vaccine denialists.

It was a thing of beauty. There was no false “balance” that puts cranks pushing dangerous pseudoscience on the same plane as real scientists like Paul Offit. There was even a section calling out purveyors of vaccine misinformation. Several luminaries of the the anti-vaccine movement were there, including ones discussed frequently on this blog, like Jenny McCarthy and Jim Carrey, and Robert F. Kennedy, Jr. But that wasn’t all! There was even a section on how to debunk anti-vaccine canards. What more could an advocate of science-based medicine ask for?

When I first read Wallace’s article, I knew she was going to be in for a rough time. The anti-vaccine movement doesn’t take kindly to criticism. Indeed, I even warned the publicist who had e-mailed a bunch of bloggers, including me, about the article that I hoped she was ready for a “shitstorm” (the exact word I used). After all, I’ve been the target of J.B. Handley’s wrath on more than one occasion. He’s particularly fond of trying to poison my Google reputation when I annoy him sufficiently, and one time either he or someone inspired by one of his attacks on me actually e-mailed my cancer center director a link to his screed. In fact, it wouldn’t surprise me if J.B. posts another similar smear after this post.

In any case, the publicist said she and Wallace were ready. Well, as an interview on NPR with Wallace has shown, the “shitstorm” has arrived, and it is just as disgusting and vile as the term implies, complete with misogyny and sexism. Fellow SBM blogger David Kroll pointed out how effective Wallace’s article was, and now a list of attacks on Wallace has been compiled from Wallace’s Twitter feed:

I’ve been called stupid, greedy, a whore, a prostitute, and a “fking lib.” I’ve been called the author of “heinous tripe.”

J.B. Handley, the founder of Generation Rescue, the anti-vaccine group that actress Jenny McCarthy helps promote, sent an essay title” “Paul Offit Rapes (intellectually) Amy Wallace and Wired Magazine.” In it, he implied that Offit had slipped me a date rape drug. “The roofie cocktails at Paul Offit’s house must be damn good,” he wrote. Later, he sent a revised version that omitted rape and replaced it with the image of me drinking Offit’s Kool-aid. That one was later posted at the anti-vaccine blog Age of Autism. You can read that blog here

Stay classy, J.B. Stay classy.

That’s exactly the behavior from Mr. Handley that we’ve come to know and despise. Indeed, J.B. recently smeared our very own Steve Novella. This is the sort of behavior that we expect from the anti-vaccine movement:

I’ve been told I’ll think differently “if you live to grow up.” I’ve been warned that “this article will haunt you for a long time.” Just now, I got an email so sexually explicit that I can’t paraphrase it here. Except to say it contained the c-word and a reference to dead fish.

I’ve already discussed how Paul Offit has suffered from attempted intimidation and death threats from the anti-vaccine movement. In this, the anti-vaccine is very much like the Animal Liberation Front or other animal rights groups, wielding intimidation to keep scientists from speaking out. Their level of understanding science is about at the same level, as well. But it’s not just Paul Offit. I’m currently reading Michael Specter’s new book Denialism: How Irrational Thinking Hinders Scientific Progress, Harms the Planet, and Threatens Our Lives. (Why is it that books like this always require such a long and unwieldy subtitle? Heck, even Suzanne Somers’ book is called Knockout: Interviews with Doctors Who Are Curing Cancer–And How to Prevent Getting It in the First Place. Word to publishers: Stop it! But I digress.) In Denialism, Specter includes a solid chapter about the anti-vaccine movement, Vaccines and the Great Denial, and in that chapter he describes how Marie McCormick, who led the Institute of Medicine panel that produced a seminal report in 2004 scientifically exonerating vaccines as a cause of autism suffered from similar harassment. She now has a guard posted near her office.

It’s the M.O. of the anti-vaccine movement. Unable to win on science, they try to win through intimidation and smears. As a result, scientists are reluctant to go into autism research, because they quite understandably don’t want the hassle of dealing with the attacks. Ditto vaccine science. After all, all one has to do is to look at the examples of Paul Offit and Marie McCormick to understand why public health officials shy away from getting involved and especially from speaking out in defense of science and against fear mongering. The same is also true of journalists. Indeed, the reaction of the anti-vaccine movement to Wallace’s piece makes me wonder if part of the reason for so much of the false balance and the apparent reluctance of journalists to call out Jenny McCarthy and put her on the spot in an interview has anything to do with the fear. It’s a possibility.

I do have to admit that I was quite amused by J.B.’s attack on Wallace in the anti-vaccine crank blog Age of Autism, though. It was full of whining and bits that show such a complete lack of self-awareness on J.B.’s part that it was truly hilarious to behold. Here is a sampling:

• “Ms. Wallace appears to have gone exclusively to Google University to research her feeble attempt at describing a very complex topic.” I just about spit out my coffee all over my lovely MacBook Pro when I read this. Given that the “spokesperson” for Generation Rescue, Jenny McCarthy, is perhaps the best known user and abuser of the University of Google, a use and abuse that have led her to make gut-bustingly funny manglings of science like this, J.B.’s statement took my irony meter and fried that sucker into a puddle of molten metal and rubber, and even that was quivering in fear of another assault.
• “I grow so weary of pointing out the same logical fallacies, misstatements, and outright factual errors that many journalists make when covering this debate, it’s going to be a struggle for my stamina to analyze her tripe in detail.” This is one of the rare areas where I’m in agreement with J.B., just not in the way he thinks. In fact, I think I’ve used that very sentence, or a variation thereof, when beginning more than one post about some nonsense published on J.B.’s anti-vaccine blog Age of Autism, because I do get tired of pointing out the same logical fallacies, misstatements, and outright factual errors that each and every blogger at AoA–nay, every anti-vaccine zealot I’ve ever encountered!–routinely parrots. J.B. is no exception; in fact, he spews more than usual, for instance his monumentally not-even-wrong project “Fourteen Studies.” But I keep doing it, because, well, it’s become my duty. In fact, I’m going to have to exercise some of that patience and stamina right here because J.B once again serves up a huge heapin’ helpin’ of logical fallacies, misstatements, and outright factual errors. As usual.
• “The main targets of our movement are the CDC, AAP, and vaccine makers. Offit is an annoying sideshow, nothing more. He’s annoying because of articles like yours. He didn’t cause my son’s autism, and he has nothing to do with my son’s recovery.” For Dr. Offit’s supposedly being someone that J.B. doesn’t consider very important, who is an “annoying sideshow,” J.B.’s blog and organization sure do expend a lot of verbiage attacking him. In fact, a quick Google search for “Paul Offit” in the domain ageofautism.com pulled up over 1,000 hits. Just this week, J.B. launched a hilariously off-base attack entitled Dr. Paul Offit, The Autism Expert. Doesn’t See Patients with Autism? So hilariously self-unaware was J.B. in that post that earlier this week I seriously thought of doing a parody of it substituting Andrew Wakefield for Paul Offit. After all, Wakefield doesn’t see children with autism either. He’s been a “researcher” (and a truly incompetent, compromised, and likely fraudulent one at that) ever since he finished his training. These days, Wakefield lends his anti-vaccine cred to Thoughtful House, where he can’t see patients because of that pesky problem of having decided to flee the consequences of his large part in the promotion of the myth that the MMR vaccine causes autism, resulting in a plunge in vaccination rates and the resurgence of measles in the U.K. over the last decade, and not having a medical license. Sadly, other things got in my way. Or maybe not so sadly. I’m better at humor and sarcasm than parody.
• “Offit actually has proven to be quite helpful – he’s the poster boy for the other side, which means his faults become the other side’s faults.” Project much, J.B.? Actually, it’s J.B. and his ilk who try to make Offit the poster boy for all the imagined and exaggerated faults fo the “other side.” Besides, every conspiracy movement needs a villain. For 9/11 Truther’s it’s the U.S. government (and sometimes the Mossad). For creationists, it’s Richard Dawkins. For the anti-vaccine movement, it’s Paul Offit, for much the same reason that Richard Dawkins is made into the villain by creationists and fundamentalists. They both dare to speak out against popular pseudoscience and don’t back down.

In his post, it’s also hard not to point out that J.B. does inadvertently demonstrate why any reasonable person should consider him anti-vaccine:

Why are you boring readers with misguided psychobabble? You could have used this time to read some of the science on our side of the fence which is also peer-reviewed! Clean water, toilets, and refrigerators eradicated disease, or at least 98% of it, I’ll give vaccines credit for the final 2% — and a whole lotta’ autism, allergies, and other demylenating illnesses.

Wow. Just wow. I’d really like to see what “peer-reviewed” evidence from “his side” that J.B. has that shows that it was not vaccines but rather clean water, toilets, and refrigerators that eradicated “98%” of infectious disease or that vaccines cause a “whole lotta autism allergies, and other demyelinating diseases.” Here’s hint one for J.B.: Peer-reviewed doesn’t mean it’s necessarily good research. It’s a minimum standard, and the “research” that J.B. cites has, without an exception that I’ve ever seen, been uniformly awful. (Monkey business, anyone?) As I pointed out with the most recent assault on science by the anti-vaccine movement, namely the execrable monkey study being touted as evidence that thimerosal in the hepatitis B vaccine causes “neurological damage” (an anti-vaccine code word in its “research” for “autism”), peer reviewers are routinely mislead by various studies by anti-vaccine cranks because they don’t know the subtext for these studies.

Here’s another thing that J.B.’s comment makes me wonder about. He gets very indignant when he is called anti-vaccine. He inevitably whines that he is not “anti-vaccine” but “pro-safe vaccine” or some variant thereof. I have to wonder, though. If J.B. really thinks that vaccines are only responsible for a mere 2% of the elimination of infectious disease–I mean, really, really believes it right down to the depths of his soul–why doesn’t he just come right out and admit that he’s anti-vaccine? After all, if he believes that vaccines cause an “epidemic” of autism, demyelinating diseases, and allergies, all for the benefit of a mere 2% when it comes to infectious diseases, then why not just say he is against vaccines because they don’t do any good and do a lot of harm? That’s what he just said, and I have no reason to believe he’s lying. Let’s put it this way. If I believed as J.B. apparently does, if I believed that vaccines were responsible for at most 2% of the elimination of infectious diseases and at the same time caused an “epidemic” of autism, demyelinating diseases, and other severe consequences, you can bet that I’d come out and say I was against vaccination. It would be a reasonable stance based on unreasonable beliefs about the dangers of vaccines. But I don’t believe anything of the sort. The scientific evidence simply doesn’t support J.B.’s assertions. I also suspect that, deep down J.B. doesn’t entirely believe these things either. If he truly does believe that vaccines do so little good and cause so much harm, his self-delusion would have to exceed even his obnoxiousness. Maybe it does.

After all, the evidence that vaccines played a major role in the elimination of diseases is incontrovertible. Smallpox was not eliminated by better sanitation and refrigeration. It was eliminated by a vaccine. The incidence of measles didn’t plunge dramatically primarily because of better sanitation or refrigeration; it plunged because of the introduction of an effective vaccine. (Unfortunately, this progress is being endangered by the misinformation being spread by the likes of J.B. Handley and the pseudoscience of quacks like Andrew Wakefield.) The incidence of invasive Haemophilus influenzae type B (Hib) disease didn’t plunge in the early 1990s because of better sanitation or refrigeration. Sanitation and refrigeration were just fine in the late 1980s. The incidence of severe Hib plunged because of a vaccine–indeed, to the point where younger pediatricians have never even seen a case of HiB. This is a good thing, although I’m not so sure J.B. would agree. Either that, or he’d try to claim that it wasn’t the vaccine, which is nonsense.

J.B. also can’t stand strong, principled disagreement with him. Like all people, he doesn’t like to be told he is wrong. The difference is that he reacts to criticism by attacking the person doing the criticism, not by refuting him with evidence. That’s because he can’t use evidence; his position is unsupportable by science. J.B. also has a huge amount of what appears to me to be a mixture of envy and contempt for the scientists who tell him he doesn’t know what he’s talking about. Indeed, this is what he’s written:

I’m not intellectually intimidated by any of these jokers. Their degrees mean zippo to me, because I knew plenty of knuckleheads in college who went on to be doctors, and they’re still knuckleheads (I also knew plenty of great, smart guys who went on to be doctors and they’re still great, smart guys).

I chose a different path and went into the business world. In the business world, having a degree from a great college or business school gets you your first job, and not much else. There are plenty of Harvard Business School grads who have bankrupted companies and gone to jail, and plenty of high school drop-outs who are multi-millionaires. Brains and street-smarts win, not degrees, arrogance, or entitlement.

In other words, as I said before, to J.B., it’s all about “elitism.” He honestly seems to believe that the reason the scientific community doesn’t accept his wild beliefs that vaccines cause autism is because of elitism and groupthink, not because the scientific evidence doesn’t support that belief. Unlike the case for scientists, it never occurs to him that maybe–just maybe–he might be wrong. It never occurs to him that the reason he is viewed with such disdain among scientists is because, well, he is wrong. But not just wrong, spectacularly, dangerously, and arrogantly wrong about the science. Truly, he is full of the arrogance of ignorance, and thinks that his success in the business world (or, as he puts it, his “brains and street smarts”) means that he can figure vaccines out. He can’t. Brains and street smarts count for little in science without a background understanding of science and acceptance of the scientific method, neither of which J.B. has.

One thing Amy Wallace gets completely right is described in her interview with NPR :

Wallace calls part of the discourse that has followed her article “a bullying tactic.” She points to JB Handley, founder of Generation Rescue — which contends that too many vaccines are given too soon and blames autism on vaccines — for many attacks against her in the blogosphere. She says such tactics dissuade many scientists from taking a stand in the debate. It is important to speak out against those tactics, she says, adding that she has been commenting regularly about the issue on Twitter.

Indeed it is important to stand up to bullies, and Wallace has done just that.

At this stage, I have to wonder if the anti-vaccine movement is becoming its own worst enemy. As the science keeps marching in that shows no connection between vaccines and autism and lends no support to the concept that vaccines are ineffective and dangerous promoted by the anti-vaccine movement, groups like Generation Rescue are becoming more shrill and even more quacktastic than ever. In doing so, they further marginalize themselves. Quite correctly, their behavior leads reasonable and scientific people to dismiss them more and more. Unfortunately, when that happens, all that leaves is abuse and bullying as tactics to intimidate those who speak out against them.

Indeed, just the other day, the anti-vaccine crank groups the National Vaccine Information Center (NVIC), Talk About Curing Autism (TACA), and the anti-vaccine crank blog Age of Autism posted a call for the elimination of hepatitis B vaccination for newborns:

Washington, DC – National Vaccine Information Center and Talk About Curing Autism are calling on President Obama to order the immediate suspension of the Centers for Disease Control and Prevention recommendation of the birth dose of the Hepatitis B vaccine after two recent studies linking the Hepatitis B vaccine to functional brain damage in U.S. male newborns and infant primates.  In a related development today, the United States Department of Health and Human Services, including the Health Resources and Services Administration and Centers for Disease Control and Prevention,  announced that 1 in every 91 children are now diagnosed with an autism spectrum disorder as reported in the November 2009 issue of Pediatrics. Previous data released by the CDC indicated a prevalence of 1 in every 150 children affected by the disorder.

Note how AoA not-so-subtly interposed the latest information about autism prevalence with its call to eliminate the birth dose of the hepatitis B vaccine. Very clever. By doing so, it linked the two in readers’ minds, as if one had something to do with the other. There’s no good scientific evidence that the hepatitis B vaccine has anything to do with the “autism epidemic.” Meanwhile, David Kirby is up to his usual nonsense, and the resident anti-vaccine propagandist at CBS News, Sharyl Attkisson, who has been known to feed Age of Autism information on at least one occasion in the past, served up this credulous, noncritical interview with Andrew Wakefield:

The quantity of misinformation in that single six minute video is far beyond the scope of this article. Were I to start dissecting it, I would not have time to do what the purpose of this article was intended to do: To deal with the study Wakefield is hawking. That’s why I leave the dissection of this pièce de résistance of disingenuousness and misinformation as an exercise for SBM readers–after reading the rest of this post, of course. Trust me, it will help you.

At the heart of this latest propaganda onslaught by the anti-vaccine movement are two studies, one a restrospective study in humans and the other a study in monkeys, both of which the anti-vaccine movement is promoting as slam dunk evidence that the hepatitis B vaccine is causing all sorts of horrific problems. Taking both of them on in one post is too much, even for my logorrheic tendencies. So I’ll deal first with Wakefield’s monkey study and then, either later this week or sometime next week, hopefully discuss the human study.

The reason I start with the monkey study is because, so confident are the anti-vaccinationists of the study that they’ve placed the accepted manuscript on the Thoughtful House website (PDF). The study has also been posted on the anti-vaccine blog Age of Autism (PDF). That means that you can read it for yourself. (Thanks, Age of Autism and Thoughtful House! You made my work much easier!)

Wakefield’s study is entitled Delayed Acquisition of Neonatal Reflexes in newborn Primates receiving A Thimerosal-containing Hepatitis B Vaccine: Influence of gestational age and Birth weight. It was performed and written by a cast of characters that we’ve met before, including the crank who launched thousands of cases of MMR in the U.K. through his shoddy science, being in the pocket of trial lawyers, and possibly even scientific fraud. Then there’s also Laura Hewitson. We’ve seen her before as the author of a couple of abstracts that I dissected in gory detail last year. Suffice it to say that, not only was the science shoddy, but massive conflicts of interest were not disclosed. The only difference this time around is that the conflicts of interest were disclosed.

In fact, let’s look at the conflicts of interest first, using the statement straight from the manuscript:

Prior to 2005, CS and AJW acted as paid experts in MMR-related litigation on behalf of the plaintiff. LH has a child who is a petitioner in the National Vaccine Injury Compensation Program. For this reason, LH was not involved in any data collection or statistical analyses to preclude the possibility of a perceived conflict of interest.

It’s hard for me not to retort that LH (Laura Hewitson) is the first author of the paper! She designed and coordinated the study, as the manuscript itself states here:

LH and AJW designed the study but were not involved in data collection and statistical analysis. LH was also responsible for coordinating all aspects of the study.

One wonders how a researcher can be “responsible for coordinating all aspects of the study” if that researcher is not involved in data collection and analysis, one does. Hewitson is also the corresponding author, which presumably means that she wrote the manuscript, or most of the manuscript. Contrary to Blaxill’s hilariously disingenuous claim, there is not just the appearance of a conflict of interest; there is a conflict of interest, a massive conflict of interest. The same is the case with Andrew Wakefield, who not only was in pocket of trial lawyers when he did the work that led to his infamous 1998 Lancet paper that started the MMR scare in the U.K. but was recently revealed to have almost certainly falsified data. Wakefield, of all people, has a lot to gain if there were any work that supported his belief that vaccines cause autism. In fact, if I were to use the same criteria that Age of Autism did when it automatically labeled any study with any pharmaceutical company underwriting whatsoever as hopelessly biased in its Fourteen Studies website, I could stop right here and dismiss Wakefield’s current monkey study as so hopelessly the result of a conflict of interest that I don’t even need to analyze it.

Fortunately, unlike the anti-vaccine propagandists responsible for Generation Rescue, the Age of Autism, and Fourteen Studies, that’s not how I roll. I did, however, have a hearty laugh at AoA’s attempt to justify the blatant conflict of interest thusly:

One likely tactic of critics of the study will include attempts to nullify the evidence based on the alleged bias of those involved. For one, the study is privately funded and acknowledges some well known autism advocates as financial contributors. These include the Johnson family (Jane Johnson is co-author of Changing the Course of Autism, a member of the Board of Directors of Thoughtful House and Director of Defeat Autism Now!), SafeMinds, the Autism Research Institute and Elizabeth Birt. Although all of these groups make clear their research interest is vaccine safety, they are frequently attacked for being “anti-vaccine”, an epithet that will almost certainly be hurled again here.

If the shoe fits…

After all, Thoughtful House is the place where Andrew Wakefield plies his pseudoscience on autistic children; Defeat Autism Now! is a cesspit of autism pseudoscience and quackery largely based on the discredited idea that vaccines cause autism, as are the Autism Research Institute and SafeMinds.

Even more amusing was this:

The most aggressive attacks, however, will likely be reserved for the study authors. The basis of these attacks is best anticipated by the following conflict of interest disclosure in the published paper. “Prior to 2005, [Carol Stott] and [Andrew Wakefield] acted as paid experts in MMR-related litigation on behalf of the plaintiff. [Laura Hewitson] has a child who is a petitioner in the National Vaccine Injury Compensation Program. For this reason, [Hewitson] was not involved in any data collection or statistical analyses to preclude the possibility of a perceived conflict of interest.”

Isn’t the hypocrisy breathtaking? To me, it’s truly astounding! The anti-vaccine movement in general and AoA in particular go out of their way to attack any investigator who does a vaccine study that fails to find a link between vaccines and autism or other neurodevelopmental outcomes. Inevitably, they use any hint of research funding, past or present, by pharmaceutical companies to paint the investigators as hopelessly biased. They relentlessly attack, for example, Paul Offit as the Dark Lord of Vaccination–Satan Incarnate with syringes!–because he invented an effective vaccine and made money selling it to a pharmaceutical company (along with his university, it should be added). In Fourteen Studies, AoA and Generation Rescue slimed every investigator who received a penny of money from a pharmaceutical company. In fact, Generation Rescue defined conflicts of interest this way:

We considered a scientist employed by a vaccine maker or a study sponsored by a vaccine maker to have the highest degree of conflict, with a public health organization (like the CDC) to be the second-worst.

Based on some of the things that Generation Rescue said about those “Fourteen Studies,” it also appeared to define the mere fact of being funded through grants from the CDC, NIH, American Academy of Pediatrics, or even the Canadian Institutes for Health Research as being a hopeless conflict of interest. Scientists who have had NIH grants (such as myself) or grants from any of these other organizations know just how ridiculous considering that particular funding source to be a horrific conflict of interest is. The bottom line is obvious. It’s a conflict of interest only if Generation Rescue says it is. Accepting funding from a pharmaceutical company? It’s a conflict of interest. No doubt about it. Real researchers would define it so. But there’s more to a conflict of interest than just where one’s research funding comes from or what companies one might work for. Not to Mark Blaxill. To Mark Blaxill and the Age of Autism, being one of the complainants in the Autism Omnibus and being funded by organizations whose purpose is to demonstrate that vaccines somehow cause autism and other neurodevelopmental problems poses no problems with regards to being a conflict of interest. None at all. Neither is Andrew Wakefield’s history of being in the pocket of trial lawyers at the time he did his “research” (and I do use the term loosely) that led to his infamous 1998 Lancet paper.

In fact, it’s not only a non-issue, it’s a sign of virtue to have accepted funds from anti-vaccine groups like SafeMinds. That’s because anti-vaccine advocates like Blaxill see themselves on the side of angels and think that they could never, ever have their objectivity affected by the funding source, having an autistic child, or being part of any legal action seeking compensation for “vaccine injury,” which, by the way, would definitely be helped by apparent scientific evidence showing that vaccines can cause autism or other neurodevelopmental disorders. One notes that one of the things the previous monkey study published as an abstract by Hewitson and Wakefield got dinged for in the blogosphere was that no conflicts of interest were reported. Poor Mark seems really peeved at the criticism Hewitson justly received for that little ethical lapse last year.

On to the study. The first thing I always try to figure out whenever reading any study is a simple question: What is the hypothesis being tested? A good study explicitly states its hypotheses in no uncertain terms. Not this one. This is the closest I could find to the study hypothesis:

Here we examine, in a prospective, controlled, observer-blinded study, the development of neonatal reflexes in infant rhesus macaques after a single dose of Th-containing HB vaccine given within 24 hours of birth, following the US childhood immunization schedule (1991-1999). The rhesus macaque is used in preclinical vaccine neurotoxicity testing and displays complex early neurobehavioral and developmental processes that are well characterized (reviewed by [7]).

Of course, to anyone who’s been involved in dealing with the anti-vaccine movement, one thing that’s very clear is that the subtext behind this is the unsinkable rubber duck of a belief among the anti-vaccine movement that, somehow, someway, either vaccines or mercury in vaccines causes autism. An inconvenient fact is that there has been no thimerosal in early childhood vaccines other than the flu vaccine since late 2001, but that doesn’t stop the anti-vaccine movement. I suspect that the reviewers of this article were probably blissfully ignorant of this context and concentrated solely on the methodology. Had they known, no doubt they would have asked some uncomfortable questions in their reviews. Of course, they would have no way of knowing that this study is in fact more of a propaganda tool than anything else. One thing that needs to be emphasized is that there really is no good primate model of autism, at least not that I’m aware of. That’s why Hewitson and Wakefield resorted to looking at infant reflexes, even though it’s not even clear whether these reflexes are in the least bit relevant to humans. Several readers have informed me that the primitive reflexes studied by Wakefield and Hewitson in this study are present at birth in humans.

Another question that needs to be asked. Why did the investigators look at thimerosal-containing hepatitis B vaccination? There’s no thimerosal in the hepatitis B vaccine anymore and hasn’t been since 2001. In fact, if you read the methods section of the paper, you’ll see that Hewitson et al added thimerosal to Recombivax HB (Merck) in order to recreate that thimerosal feeling from the 1990s. Why on earth would they do something like that? Especially since the authors state in the conclusion that the study design “was not able to determine whether it was the vaccine per se, the exposure to thimerosal, or a combination of both, that caused these effects”? I will suggest a possible reason before the end of this discussion.

Before I get to the effects Wakefield and Hewitson supposedly observed, let’s just consider something else. When I read this study, there was something that set my skeptical antennae twitching fiercely. Remember the abstracts I discussed last year? Let’s take a trip down memory lane and read what I wrote back then:

What first leaps to mind in looking at the study is that there are 13 monkeys in the “vaccine” group and only three in the control group. No explanation is given for why there are such unequal numbers. Similarly, there is no mention of how the monkeys were assigned to one group or the other (randomization, anyone?), whether the experimenters were blinded to experimental group and which shots were vaccine or placebo, whether the monkeys were weight- and age-matched, or any of a number of other controls that careful researchers would do. Right off the bat, from the small numbers (particularly with only three monkeys in the control group), I can say that the study almost certainly doesn’t have the statistical power to find much of anything with confidence.

Now, let’s look at how many monkeys in this study: Thirteen receiving the hepatitis B vaccine plus added thimerosal. Doesn’t that seem rather–shall we say?–coincidental, convenient, even? There were also three animals receiving no injection and four receiving a saline placebo. Sound familiar? It should. There were three controls receiving no injection and four receiving saline placebo. Why do I bring this up? Remember, the abstract from last year described the monkeys as undergoing the “entire vaccination schedule” (actually, a version of the entire U.S. vaccination schedule, with the vaccination doses moved closer together to try to make the times the monkeys received various vaccines supposedly equivalent to the same physiological and developmental age when humans receive the same vaccines in the vaccination schedule). The inevitable consequence of this, of course, is that the monkeys received a lot of vaccines in a much shorter time period than human babies do. Remember how, as a result, the results of these abstracts were were portrayed as showing that vaccinated monkeys “exhibited autism-like symptoms”:

The first research project to examine effects of the total vaccine load received by children in the 1990s has found autism-like signs and symptoms in infant monkeys vaccinated the same way. The study’s principal investigator, Laura Hewitson from the University of Pittsburgh, reports developmental delays, behavior problems and brain changes in macaque monkeys that mimic “certain neurological abnormalities of autism.”

The findings are being reported Friday and Saturday at a major international autism conference in London.

Although couched in scientific language, Hewitson’s findings are explosive. They suggest, for the first time, that our closest animal cousins develop characteristics of autism when subjected to the same immunizations – such as the MMR shot — and vaccine formulations – such as the mercury preservative thimerosal — that American children received when autism diagnoses exploded in the 1990s.

Is it just me, or does this latest study strike you as being merely a subset of a study that’s already done? Given the similarity of the description of the study described in the manuscript, in which hepatitis B vaccine was even spiked with thimerosal in order to mimick the vaccine schedule of the 1990s (given that hepatitis B vaccine no longer containes thimerosal) and the previously reported abstract, in which the entire vaccine schedule of the 1990s was supposedly mimicked, it does make me wonder. Could it be that the results being reported derived from observations made on the same monkeys used to generate the IMFAR results? In other words, could it be that the investigators gave the monkeys the hepatitis B vaccine after birth, tested their various reflexes early in their lives (only for the first 14 days), and then continued with their “simulated” vaccination schedule in order to produce the rest of the observations reported last year? Inquiring minds want to know! After all, the current study only goes out for two weeks; it would be easy to continue the rest of the simulated vaccination schedule after that and then make measurements on the same monkeys.

Indeed, one wonders if, stung by the criticisms of inadequate controls, the investigators added additional controls and kept the same group of 13 monkeys as the “vaccinated group.” Maybe they didn’t, but the similarity between the numbers of monkeys used in the studies described in the IMFAR abstracts last year and the numbers of monkeys used in this study sure do raise an eyebrow, don’t they? So does this part of the methods section:

Animals were allocated to either the vaccinated (exposed) or saline/no injection (unexposed) groups 19 on a semi-random basis in order to complete peer groups for later social testing [7] such that each 20 peer group contained animals from either the unexposed or exposed study groups. Once a new peer 21 group was started, new animals were assigned to this group until it consisted of 3 or 4 infants, the 22 ages of which were less than 4 weeks apart from their peers.

My first thought was: What’s with this “semi-random basis” stuff? Why not on a random basis? Being a little bit “not random” is like being a little bit pregnant, if you know what I mean. In other words, when investigators start adding nonrandom selection to a protocol, it’s not random anymore. That much should be obvious. And when the selection of animals is no longer random, then that calls the whole study into question. It sounds to me as though Hewitson and Wakefield designed the experiment (or let the experiment unfold) so that all members of a given peer group received the same treatment; i.e., they all got Th-HepB (HepB vaccine with thimerosal added), they all got saline, or they all got no injection. If so, that’s certainly consistent with my speculation that there were some animals added at the end of the experiment. If my interpretation (i.e., that more animals were added later as controls), it strikes me as odd. Why on earth would Hewitson and Wakefield choose that design? Why not include at least one saline or no-injection animal in each peer group? With the apparent design for this experiment, there’s no way to discriminate between possible vaccine-related effects and uncontrolled time-related confounders, given that some monkeys under this design must have been analyzed in a noncontemporaneous fashion.

The questions of why there are two control groups and why the randomization scheme was such that each member of a peer group got the same treatment becomes especially suspicious to me because in their analyses, Hewitson and Wakefield pool the four monkeys receiving the saline control with the three receiving no injection for purposes of calculating means. Could it be that the investigators simply added a few monkeys after the experiment had already been started (or even after the original 16 monkeys had already undergone the entire “vaccination schedule”)? Again, inquiring minds want to know! Could it be that, in order to beef up their apparent statistical power to detect differences in these various reflexes, some additional monkeys had to be added? Or was this done in response to reviewers’ concerns? If that’s the case, then when were these additional monkeys studied? How long after the original group? Mark Blaxill brags that the person who measured the monkeys’ reflexes was trained by an expert until her results had a high concordance with those of experts, but if there were a several month delay between when she measured the first group of monkeys and then the additional controls, it’s not too hard to imagine that she got better and thus more able to detect subtle differences in the reflexes. If conditions under which the monkeys were raised change, then the same sort of time-dependent confounders could be at work here. I’d really like to see when each monkey was born and what the time to criterion was for each monkey. In other words, I’d like to see at least some of the raw data.

The similarities between the designs of the studies described in the IMFAR abstracts last year and this study sure make me wonder if perhaps Hewitson and Wakefield are perhaps “minimizing” the use of animals. Of course, minimizing the use of animals, particularly primates, in research is normally a good thing, but if that’s what they’re doing, why not report the entire study? After all, in the video above, Wakefield admits that this study is part of an ongoing study of the “vaccine schedule.” However, if you go back to look at the IMFAR abstracts that I discussed last year, you’ll see that it was stated that the monkeys were killed between 12-15 months and tissues examined at necropsy. In other words, Hewitson and Wakefield were done with those animals over a year ago! Given that, why not just report the whole study instead of this little piece of it, which must have been done at least two or three years ago? Are they planning on having data from this study come out in little dribs and drabs. In other words, are they planning on publishing several papers, each consisting of what we call an “MPU” or “minimal publishable unit,” derived from part of the same study?

Whatever the case, in this particular MPU, what did Hewitson and Wakefield find? Not much, actually, the triumphant crowing of Mark Blaxill at AoA notwithstanding. Basically, Hewitson and Wakefield reported that three of thirteen infant reflexes were delayed in their appearance. Specifically the root reflex was delayed by one day; the suck reflex by nearly two days, and the snout reflex, also by nearly two days. Because they mixed thimerosal into the hepatitis B vaccine and didn’t have a control group with thimerosal-free hepatitis B vaccine, Hewitson and Wakefield couldn’t even hazard a guess whether the effects observed, even if significant, were due to the vaccine or the thimerosal or both.

There also appeared to be a confounding factor in that monkeys with lower gestational age (GA). For example, the authors state:

In general,as GA increased animals reached criterion earlier whereas animals of lower GA were relatively delayed. This effect was only significant when exposure was taken into account.

I really have to wonder whether in a larger group of completely unvaccinated monkeys the correlation between the delay in appearance of these reflexes with decreased gestational age would reach significance, no hepatitis B vaccination necessary. The authors try to spin their results as suggesting that lower GA monkeys are more susceptible to whatever effect it is they think they’re seeing due to Th-HepB, but their arguments are not very convincing–about as convincing as their data, actually, as in not very. In addition, given such small numbers, I always wonder about the validity of carrying out any sort of multivariate analysis. Another point to consider, in this paper these reflexes are ranked from 0 (absent) to 3 (the highest possible score). The time to criterion was defined as the time to reach the highest possible score. Again, given the small numbers and the correlation between gestational age and reaching these milestones, I really have to question whether the results in this study, despite being apparently statistically significant if you pool the two control groups, are really behaviorally or biologically significant. If there’s one thing my mentors always taught me, it’s that statistically significant doesn’t necessarily mean significant. This is particularly true, since it is not reported whether these delays are prolonged or whether the baby monkeys recover. Finally, there is the question of whether the authors bothered to correct for multiple comparisons. Whenever a large number of comparisons are made, by random chance alone the odds of seeing a “positive” or a correlation between a marker and what is being studied increases. The problem is that, the larger the number of comparisons, the larger the chance that any “hit” observed is a false positive. In the case of multiple comparisons, a statistical adjustment needs to be made to correct for the effect of multiple comparisons. In other words, if the authors didn’t correct for multiple comparisons, it’s quite possible–likely, even–that their observed “positives” are in fact false positives.

Personally, I’m not all that impressed. One reason is that, even if the study shows what the authors claim it shows, so what? Wakefield and Hewitson haven’t shown evidence of long-lasting neurological impact, and they certainly haven’t shown any evidence that the hepatitis B vaccine causes autism, even though you know that’s the subtext of what they are arguing. Moreover, the numbers are really small. I look at monkey studies in much the same way that I look at clinical trials. If a study is worth doing prospectively, it’s worth doing with enough subjects at the outset to provide sufficient power to guarantee that there is a high likelihood that the question being asked will be answered. If an investigator can’t provide enough subjects, then he shouldn’t do the study

Another reason I have a problem with this study is that no statistical justification is given for pooling the no vaccine group with the saline placebo group. Whenever I see pooling of groups like this, I become very suspicious of a post hoc combining of data, which is always dicey. Indeed, a good rule of thumb is that it’s usually at least a little bit questionable to combine groups like this for purposes of statistical analysis unless this pooling was part of the study design from the beginning, in which case it is still somewhat dicey but not as bad. Presumably the reason why two control groups were used was to determine if simply the pain of giving a saline injection may have had any affects on the time to criterion for these neurodevelopmental parameters. That’s a scientifically legitimate reason to have two control groups (although one certainly does wonder why they didn’t have a control group receiving thimerosal-free hepatitis B vaccine). But, again, it really makes me wonder whether the investigators pooled the data, apparently post hoc. The only reason to do such a post hoc pooling is to convert three groups to two groups and to add statistical power to the control group. You can be quite confident that, had there been a statistically significant difference between the “vaccinated” group and the saline placebo group and between the “vaccinated” group and the uninjected group, Hewitson and Wakefield would not have pooled the data. In fact, I almost guarantee it. After all, why do something that will lead to scientists questioning the validity of your study’s statistical analysis if you don’t have to? In the case that there were in fact statistically significant differences between each of the control groups compared to the “vaccinated” group, you can be quite certain that the results would have been reported–shall we say?–unmassaged by the pooling of the two control groups.

It’s also rather instructive to look at the original IMFAR abstract, which reported:

Kaplan-Meier survival analyses revealed significant differences between exposed and unexposed animals, with delayed acquisition of root, suck, clasp hand, and clasp foot reflexes. Interaction models examined possible relationships between time-to-acquisition of reflexes, exposure, [3C]DPN binding, and volume. Statistically significant interactions between exposure and time-to-acquisition of reflex on overall levels of binding at T1 and T2 were observed for all 18 reflexes. For all but one (snout), this involved a mean increase in time-to-acquisition of the reflex for exposed animals.

It’s interesting to note that they looked at 18 reflexes then but only reported 13 now. Why did they drop five between then and now? There were more “significant” differences in time to criterion in the “old” study described in the IMFAR abstract, and only two of the reflexes appeared to be consistent between the two studies. Again, I have to ask: Is the experiment reported in this paper a true repeat of the studies in the IMFAR abstracts, or is it simply an “extended” version of the prior study? I think you know which one I suspect. In fact, Wakefield all but admitted it in the interview in the video above.

I also think that this study was a horrible waste of primates, and I can’t believe the University of Pittsburgh’s IACUC was thinking when it approved this study. Maybe it’s because, as Mark Blaxill was so happy to inform us, the University of Pittsburgh primate facility is relatively new, and Pitt’s IACUC was not experienced in evaluating primate protocols at the time these experiments were being proposed.

Finally, on a different note, I wonder about the ostensible justification for this study:

Since Th[imerosal]-containing vaccines, including the neonatal HB vaccine, continue to be used routinely in developing countries [3], continued safety testing is important, particularly for premature and low-birth-weight neonates.

If the authors are so concerned with vaccine reactions and autism in developing countries, then why on earth did they try to mimic the U.S. vaccination schedule? Why did they use monovalent hepatitis B vaccine, when few countries other than the U.S. do? Most developing countries use a tetravalent, pentavalent, or hexavalent vaccine containing multiple other antigens, such as diphtheria, tetanus, pertussis, IPV, Hib, and HepB antigens. The hepatitis B vaccine, if given at all, usually isn’t given until at least six weeks of age as part of existing vaccine programs. So, when you come right down to it, this study isn’t even studying what it claims to be looking at or following the rationale that its authors claim as the reason for the study! If it were, it would not be following the U.S. vaccination schedule. In reality, it looks very much as though this study is custom-designed to sow doubt and fear about the birth dose of hepatitis B vaccine in the United States. That, and it’s almost certainly going to be used as ammunition for legal action and lawsuits. Just wait.

It also may be another objective here. I note that anti-vaccine groups like TACA funded this study, which certainly cost at least $100,000 to do, most likely considerably more than that. Anti-vaccine groups would not have invested so much money if they didn’t expect a payoff. Here’s what I think might be going on. Like all good denialists, anti-vaccine groups and their toady scientists (like Wakefield) want material to sow doubt about the science they deny, in this case, the safety and efficacy of childhood vaccines. Small preliminary studies in general have a fairly high likelihood of producing false “positive” results (i.e., showing a correlation where a larger, better designed study would find none); so funding such studies is likely to produce at least some apparent “hits,” such as this this study by Hewitson and Wakefield. Because such studies are small and preliminary, they can’t really settle anything, and the anti-vaccine movement knows it. So anti-vaccine groups like TACA and Generation Rescue will use the results of these small studies as justifications for claiming that there is doubt over whether vaccines are safe and, most importantly, that more money is needed to do more and bigger studies. They’ll then get such larger studies funded through the NIH or through the efforts of anti-vaccine sympathizers like Representative Dan Burton. In the meantime, they’ll point to the very existence of such NIH-funded studies as further “evidence” that there is still a scientific controversy over whether vaccines cause autism and milk them for all they’re worth until the larger studies come back negative, as they almost always do.

It’s a very hard strategy to counter, and, unfortunately, it just might work.

However, there is one other consequence of the antivaccine movement, however, and it is at least as important as the public health implications of the potential dimunition of herd immunity caused by the fear mongering of groups like Generation Rescue. That consequence is the cottage industry of “biomedical” treatments to which desperate parents subject their children. Gluten-free diets, chelation therapy (which has caused deaths), hyperbaric oxygen chambers (a recent story described a child getting severely burned when one of these caught fire), autistic children have been subjected to it all. But of all the biomedical woo to which autistic children have been subjected, one form of woo stands out as being particularly heinous. Indeed, I agree with our fearless leader Steve in characterizing it as an “atrocity.”

I’m referring to Mark and David Geier’s favored “treatment” for autistic children, namely a drug called Lupron.

THE LUPRON PROTOCOL

I first became interested in Mark and David Geier around four years ago, around the same time I first became aware of and interested in the antivaccine movement.Dr. Mark Geier is a physician but has no expertise in pediatrics, endocrinology, vaccines, or autism. His son only has a bachelor’s degree in biology; yet he assists his father in his “research” and in essence helps him treat patients, despite his lack of medical training. Together, they are the Batman and Robin of autism woo (the 1960s camp version, not the updated Dark Knight version) going into battle against autism, which–surprise! surprise!–they blame on vaccines. But not just any vaccines. Oh, no. Batman and Robin–excuse me, Mark and David–were there at ground zero of the formation of the mercury militia. Together, they were at the forefront of promoting the now scientifically discredited concept that mercury in the thimerosal preservative that was in childhood vaccines until the end of 2001 causes autism and published many dubious papers arguing that mercury in vaccines caused autism.

Not that the Geiers didn’t put their own personal spin on things. Not at all. In fact, around four years ago, they conjured up a “hypothesis” (my fingers seized up as I typed that, not wanting to dignify their idiotic idea with such a scientific term) that testosterone somehow bound to mercury, making it harder to chelate. They even claimed that testosterone binds to mercury, leading to a complex that can’t pass the blood-brain barrier and keeps mercury in the body, a complex that the quackery known as chelation therapy won’t chelate (more on that later). They claimed that autistic children were really undergoing premature puberty and had too much testosterone, which was binding to mercury and somehow enhancing its toxicity. So what was their solution?

In essence, chemical castration using a powerful anti-sex hormone drug called Lupron.

The Geiers even called it their “Lupron protocol,” and a disturbing number of parents not only fell for this disturbing abuse of autistic children, but they even paid big bucks for it. Even after the revelations of what the Geiers did, I could never figure out, though, since 2006, more than three years ago, is just how. How did they manage to keep subjecting children to a treatment with science so bad that it doesn’t even qualify as junk science? And why didn’t the mainstream media ever notice, even though a small cadre of skeptical bloggers wrote about it repeatedly?

I don’t know, but I do know that finally a major newspaper noticed the Geiers, who operate a makeshift laboratory in the basement of Dr. Geier’s house, complete with a tissue culture hood. Yesterday, the Chicago Tribune ran companion stories entitled ‘Miracle drug’ called junk science and Physician team’s crusade shows cracks.

All I can say is that it’s about time.

I first learned about the Geiers’ Lupron protocol (to my horror) back in Februrary 2006, when I first read blogger Kathleen Seidel’s account of their activities. Somehow, some way, the Geiers have managed to inject autistic children with a powerful drug that suppresses sex hormone production for over three years now. How did this all get started? First, let me explain what Lupron is.

Lupron is the trade name for a drug called leuprolide acetate, a synthetic analog of a hormone known as gonadotropin releasing hormone (GnRH, a.k.a. LH-RH). After causing an initial stimulation of gonadotropin receptors by binding to them, chronic administration of Lupron inhibits gonadotropin secretion, specifically leutenizing hormone (LH) and follicle stimulating hormone (FSH). The end result is the inhibition of the synthesis of steroid hormones in the testes in men and in the ovaries in women. In men, testosterone and androgen levels fall to castrate levels, and in women estrogens are reduced to postmenopausal levels.

This is a drug that doesn’t have very many uses. Perhaps the most common use is in men with metastatic prostate cancer, because prostate cancer is an androgen-dependent tumor. Back when I was a surgical resident, such patients were treated with surgical castration. These days, they are usually put on Lupron or a similar GnRH agonist, and this treatment works quite well to suppress the growth of prostate cancer for a while. Such tumors will inevitably develop androgen-independent growth and become resistant to hormonal suppression with Lupron, but in the meantime chemical castration with Lupron can provide excellent palliation. Another use for Lupron is in women with estrogen-dependent conditions, such as endometriosis and uterine fibroids. One troubling side effect of its use in women is the onset of menopausal symptoms, often quite severe, a problem that sometimes causes women to stop taking it. The other major use of Lupron is during cycles of in vitro fertilization, in which it is used to suppress ovarian function completely in order to allow complete control of hormone levels and ovarian follicle development through the use of hormone injections. Without Lupron or similar drugs, it is very difficult to get multiple ovarian follicles to develop and mature at the same time, allowing the harvest of many eggs.

But we’re not talking about adults here. We’re talking about children. Are there any medically accepted uses of Lupron in children? Yes, but only one: Precocious puberty. Precocious puberty is defined as the onset of secondary sexual characteristics before 8 years old in girls and 9 years old in boys. It can be the result of tumors, central nervous system injury, or congenital anomalies. The package insert for Lupron emphasizes that children should not be treated with Lupron unless they meet the following criteria:

1. Onset of secondary sexual characteristics before age 8 in females and age 9 in males.
2. The clinical diagnosis must be confirmed by a pubertal response to GnRH (adequate secretion of LH in response to a challenge with injected GnRH) and bone age advanced at least one year beyond chronological age.
3. Baseline evaluation has to include: Height and weight measurements; sex steroid levels; adrenal steroid level to rule out congenital adrenal hyperplasia; beta-chorionic gonadotropin (beta-HCG) to rule out a beta-HCG-secreting tumor; pelvic and adrenal ultrasound to rule out a steroid-secreting tumor; and a CT of the head to rule out an intracranial tumor.

Also, precocious puberty is a rare condition. Autism is not. Not that that that stops the Geiers. In any case, in my book, if you’re going to give a potent drug like Lupron to children, a drug that can almost completely shut down the synthesis of both male and female steroid hormones, you’d better have damned good evidence that it’s likely to help to make it worth the risk.

So did the Geiers have good evidence three or four years ago, when they first started pumping autistic children full of Lupron? Take a guess. As pointed out by Kathleen Seidel, the Geiers seemed quite excited about manipulating testosterone levels and were recruiting children for a “clinical trial,” having presented their concept in 2005 at the Autism One conference in Chicago. Prior to that, they had published their idea in a medical journal known as Medical Hypotheses, giving it the patina of respectability. The problem is, Medical Hypotheses is a fringe journal that is not well respected. For one thing, it’s not peer-reviewed. The other reason that it exists to publish “radical” ideas that “conflict with current theory and practice.” Such a speculative journal may serve a useful purpose in the publishing world, but citing speculative articles published in it is not exactly good evidence for anything, other than that

Not surprisingly, the paper was a mess, full of unsupported speculation. Its first flaw was apparent right from the beginning. First, the Geiers implicitly assumed that mercury is the cause of autism and that chelation is the cure. As evidence, they cited the usual suspects, such as the Hornig “rain mouse” study; the Redwood et al study using a model to predict the hair level of mercury due to vaccines (while ignoring the Pichichero et al, which actually measured the levels and showed that mercury levels in infants given thimerosal-containing vaccines according to a standard schedule had blood levels well within what is considered safe); papers studying cultured cells treated with ridiculously high concentrations of thimerosal, concentrations unattainable in humans; and the infamous Boyd Haley study that showed lower levels of mercury in the hair of autistic babies compared to normals, leading him to speculate without evidence that autistics do not secrete mercury as well, leading it to accumulate in the brain. They also cited the Bradstreet article that looked at mercury levels excreted in response to a “challenge” with the chelating agent DMSA and supposedly found that autistic children secrete more mercury than nonautistic children. The problem was, Bradstreet used a nonstandard method of normalizing their mercury concentrations in the urine, didn’t measure total mercury excretion, not to mention that they didn’t match the ages of their groups very well. Worse, their data was so full of scatter that it’s hard to tell how they made any conclusions. (Not surprisingly, this article was published in the Journal of American Physicians and Surgeons, a really crappy journal that’s chock full of antivaccination rhetoric, antifluoridation articles, and an article defending Alan Yurko, an antivaccination activist who was tried for shaking a baby to death but got off by claiming it was the result of vaccines causing encephalitis. Many of the rest of the articles cited had been written by the Geiers themselves, and they ignored important studies that cast serious doubt on any link between mercury and autism. Worse, through it all, the Geiers stated as fact that chelation therapy is effective, when there is in fact no credible evidence suggesting that it is.

As I’ve mentioned before, however, the new twist that the Geiers placed on their mercury madness is the concept that testosterone somehow increases the toxicity of mercury. The way the Geiers came to this concept is rather roundabout. First they cite a paper suggesting that there are increased markers of increased oxidative stress in autistic patients. (To me this begs the question of why there was so much focus on mercury rather than abnormalities in oxidative metabolism in autism. Since then, there has been a lot of such work that has been used to justify all manner of antioxidants and other dietary manipulations. But I digress.) They also presented a paper in which the investigators treated cultured neuroblastoma and glioblastoma tumor cells with high concentrations of thimerosal and show that pretreatment with glutathione (an antioxidant) is protective against thimerosal toxicity. However, the authors themselves state:

Acute high dose exposures to Thimerosal (mmol/L) in cultured cells were used to study mechanistic aspects of Thimerosal toxicity and not intended to mimic exposures of developing brain cells in vivo to Thimerosal in vaccines (nmol/kg).

Little details like that never stopped the Geiers from representing the study as strong “evidence” that defects in oxidative metabolism potentiate thimerosal toxicity as a cause of autism. At best the study shows that very high concentrations of thimerosal are toxic to brain cancer cells and that glutathione can protect these cells.

So how did the Geiers link oxidative metabolism defects observed in some autistics, testosterone, and mercury? Well, if you’re the Geiers, it’s easy. You wave your hands and point out that one of the one enzyme (hydroxysteroid transferase) that modifies a testosterone precursor DHEA to DHEA-S (a sulfate group added) requires glutathione and is inhibited by mercury. Of course the Geiers cite a 30-year old paper and don’t even use the name of the enzyme that I find in the more recent literature, namely DHEA sulfotransferase. In any case, DHEA is the main precursor to androgens like testosterone, and DHEA sulfotransferase adds a sulfate group to it, “shuttling” DHEA away from the pathway to make testosterone by turning it into DHEA-S. DHEA-S is thought to be a “storage” form of DHEA, and DHEA and DHEA-S are freely interconverable. If something prevents DHEA from being converted to DHEA-S, there’s more precursor for testosterone synthesis. Elevated DHEA and DHEA-S levels have been implicated in polycystic ovary syndrome.

This all sounds well and good, but there was no good evidence then that any of this, at least as explained by the Geiers, has anything to do with the pathogenesis of autism, nor is there any evidence now that it does. The abnormalities in oxidative metabolism observed in some autistics may be a cause of autism or they may simply be a consequence of other genetic abnormalities that are responsible for autism. It is not yet possible to know their significance with the current state of our data, but that hasn’t stopped the Geiers from mining this rich vein for pesudoscientific justifications for their Lupron protocol over the last four years.

But if you really want to know how risibly bad the Geiers’ understanding of biochemistry is, consider the “testosterone sheet” nonsense they laid down three years ago, when they were quoted as saying that mercury binds to testosterone and forms “sheets” in the brain, leading to a complex that can’t pass the blood-brain barrier and keeps mercury in the body. This is indeed nonsense on many levels. Besides the fact that there is no persuasive evidence that mercury causes autism in the first place, there is even less evidence that testosterone in any way prevents the elimination of mercury from the body. I can’t help but note that the claim that testosterone binds mercury and prevents it from being excreted was not in the Medical Hypotheses paper, suggesting that it was too far out even for that far out journal. Instead, the Geiers included large figures showing complex pathways of steroid biosynthesis and wildly speculated that the combination of testosterone and decreased glutathione might inhibit the activity of DHEA sulfotransferase. Thus even if mercury were the cause of autism, there would be no biochemical justification for the shotgun approach of using Lupron to suppress steroid hormone synthesis in boys. Remember, Lupron doesn’t just suppress testosterone production; it suppresses both the androgenic and estrogenic pathways.

The Geiers have also liked to cite a paper they published in Hormone Research. The Chicago Tribune article quite nicely pointed out what garbage it was:

To support their theory that a link exists between testosterone, mercury and autism, the Geiers often cite their own paper published in the journal Hormone Research. Their report describes symptoms and lab results for 16 autistic children ages 3 to 10 and finds nearly all have high testosterone.

Experts who read the paper said it is deeply flawed and its conclusions are baseless.

The blood tests the Geiers use as proof of excessive testosterone don’t show that at all, and other data they cite mean nothing, said Paul Kaplowitz, chief of endocrinology at Children’s National Medical Center in Washington, D.C., and an expert on precocious puberty. They also leave out test results that could help show whether the children are in early puberty, he added.

Looking at the tests, Kaplowitz said he asks himself: “Is Dr. Geier just misinformed and he hasn’t studied endocrinology, or is he trying to mislead?”

Another deconstruction of the paper can be found here.

Once again, if you’re going to propose doing something as radical as shutting down steroid hormone synthesis in children, you’d better have damned good evidence to justify it, and the Geiers didn’t then and don’t now. The best piece of clinical evidence that suppressing testosterone might help autistic boys they can muster is a case report in which a 24-year old autistic man exhibiting severe frequent inappropriate sexual behavior who frequently masturbated in public and became sexually aroused around young children was placed on Lupron. Surprise, surprise! His inappropriate sexual behavior decreased markedly. Chemical castration will do that. This case report said nothing about what treating children with Lupron would do. (It also raised some seriously touchy ethical questions.)

It isn’t that there hasn’t been at least some evidence suggesting that abnormal testosterone levels might have something to do autism. Certainly, the high proponderance of males with autism alone could suggest such a linkage. There’s just one problem. Nearly all of the evidence supporting such this link has correlated high levels of prenatal exposure of the fetus to testosterone with autism and autism spectrum disorders. The main proponent of this hypothesis is Simon Baron-Cohen, who has published several papers finding correlations between elevated fetal testosterone and empathy, decreased quality of social relations, gender-typed play, and autism. This has led to Baron-Cohen’s concept that autism is due to an “extreme male brain.” This is a controversial concept in the autism research community, and I can see why. Personally, I found the evidence supporting this concept to be a somwhat shaky after reading several papers describing it. Even so, the concept is probably worth further study. Of course, none of Baron-Cohen’s data provides any real support for the Geiers’ concept that lowering testosterone will help autistics. Nearly all of the evidence implicating testosterone in autism pathogenesis come from correlations with prenatal testosterone levels and markers for high prenatal levels of testosterone. Presumably, treating children several years after birthwould be too late; the brain has already been largely shaped by the prenatal testosterone.

THE CHICAGO TRIBUNE NOTICES THE GEIERS

I had first got wind through some of my online sources that the Tribune might be doing a story on the Geiers a couple of weeks ago. I was skeptical, but apparently the inciting event was the yearly autism quackfest known as Autism One held in Chicago every Memorial Day week. Mark and David Geier be spoke there this year, as they have most years in the recent past. For those not familiar with Autism One, it’s best described as an autism Quackapalooza. Chelation, hyperbaric oxygen, “biomedical” interventions, gluten-free diets, every form of autism woo and quackery that you can imagine is there, all under one roof. But, above, all there is the antivaccine movement. As long as it’s antivaccine, it’s all good, and every luminary of the antivaccine movement, including most of the crew of Age of Autism will be there, probably Tweeting and blogging away. Heck, Jenny McCarthy herself was the keynote speaker in 2009, just as she was in 2008.

Moreover, quackfest that Autism One is, the organizers don’t in the least like skeptics or those who don’t buy into the claim that vaccines cause autism to be there. They don’t like it at all. Indeed, one such skeptical blogger, despite remaining polite but firm in his questions, was expelled last year on a trumped up excuse. Indeed, the irony of the timing, so hot on the heels of Ben Stein’s anti-evolution documentary Expelled!, was not lost on those of us who have corresponded with this particular blogger. This time around, not surprisingly Autism One organizers took measures to prevent skeptics from infiltrating and most especially to prevent anyone not associated with Autism One from videotaping or recording, but what are they going to do if the Trib decides to send reporters?

Be that as it may, I like the chorus of strongly condemning quotes from real scientists studying autism:

Four of the world’s top pediatric endocrinologists told the Tribune that the Lupron protocol is baseless, supported only by junk science. More than two dozen prominent endocrinologists dismissed the treatment earlier this year in a paper published online by the journal Pediatrics.

Simon Baron-Cohen, a professor of developmental psychopathology at the University of Cambridge in England and director of the Autism Research Center in Cambridge, said it is irresponsible to treat autistic children with Lupron.

“The idea of using it with vulnerable children with autism, who do not have a life-threatening disease and pose no danger to anyone, without a careful trial to determine the unwanted side effects or indeed any benefits, fills me with horror,” he said.

Experts in childhood hormones warn that Lupron can disrupt normal development, interfering with natural puberty and potentially putting children’s heart and bones at risk. The treatment also means subjecting children to daily injections, including painful shots deep into muscle every other week.

And:

Specialists in autism, hormones and pharmacology who are familiar with the Geiers’ protocol said it cannot work as they suggest.

“In terms of science, there is nothing suggesting the most basic elements of what they are talking about,” said Tom Owley, director of the Neurodevelopmental Pharmacology Clinic at the University of Illinois at Chicago and a specialist in the treatment of autistic children with medicine. “That there are high levels of mercury in autism — not proven! That they have precocious puberty — not proven!”

I shared Dr. Baron-Cohen’s horror three years ago. So did Kathleen Seidel. So did a number of other bloggers. I didn’t really know, though, just how much money this protocol sucks out of desperate and gullible parents. I knew Lupron is an expensive drug and that insurance won’t pay for it for autism. That’s exactly why, as Kathleen put it, the Geiers found a way to label virtually every child they used the drug on as having “precocious puberty,” even though by definition any girl older than 8 or boy older than 9 cannot have precocious puberty. That doesn’t stop the Geiers from this:

To treat an autistic child, the Geiers order $12,000 in lab tests, more than 50 in all. Some measure hormone levels. If at least one testosterone-related level falls outside the lab’s reference range, the Geiers consider beginning injections of Lupron. The daily dose is 10 times the amount American doctors use to treat precocious puberty.

By lowering testosterone, the Geiers said, the drug eliminates unwanted testosterone-related behaviors, such as aggression and masturbation. They recommend starting kids on Lupron as young as possible and say some may need the drug through the age of puberty and into adulthood.

The cost of the Lupron therapy is $5,000 to $6,000 a month, which health plans cover, Mark Geier said. However, two families told the Tribune that they had trouble getting insurance to pay for the treatment.

This is big bucks. Seriously big bucks. It’s also possibly insurance fraud, because the Geiers claim precocious puberty but in fact are using Lupron to treat autism. Indeed, the way the Geiers do their testing is all but guaranteed to produce in most children the “desired” diagnosis. The reason has to do with multiple lab values. The “normal” range of lab values, by definition, is designed so that 95% of “normal” patients will fall within that range. That means, for any “normal” child and any single given laboratory test, there is by random chance alone a 5% chance that his or her lab value will fall outside the “normal” range. 5% of 50 tests would mean that the average child would be likely to have 2.5 (or, given that these are whole numbers) between 2-3 lab values that fall outside the normal range. And–presto!–that will mean that they have “precocious puberty” and need the Geiers’ Lupron protocol. It’s all bogus (word choice intentional)

In fact, it’s so bad that the antivaccine propaganda blog Age of Autism actually–to my shock!–allowed a post that was critical of the Lupron protocol:

It is of great concern that studies on testosterone and autism are being misinterpreted, leading to the use of therapies aimed at disturbing steroid hormone production in individuals with autism. Currently, many autistic children may be being treated, without proof of safety and scientific and medical evidence of benefit, with a view to reducing their hormonal secretion of testosterone (Lupron Therapy, Spironolactone). The rationale behind advocating these therapies appears to be based on a misunderstanding of autistic behaviours and without systematic laboratory evidence of abnormal testosterone levels.

Word to Mark and David Geier: When the antivaccine cranks at Age of Autism starts attacking you (even if they don’t do it by name and they draft an outsider to write the post), your credibility is seriously shot. So how do the Geiers defend themselves against all these scientists criticizing them? You guessed it! A panoply of the usual excuses used by purveyors of pseudoscience:

• Don’t knock it till you’ve tried it: Mark Geier responded that these are “opinions by people who don’t know what they are talking about,” saying the pediatric endocrinologists interviewed by the Tribune don’t treat autistic children and have not tried the Lupron treatment.
• Misrepresenting the work of real scientists: David Geier said prominent scientists support their work and gave as an example Baron-Cohen, the autism expert who told the Tribune that the Geiers’ Lupron treatment filled him with horror.
• Conspiracy theories: The Geiers also say mainstream medicine condemns them because of their vocal stance that pediatricians, health officials and drug companies are covering up the link between vaccines and autism. “Nobody likes a whistle-blower,” Mark Geier said in an interview.
• The pharma gambit: The Geiers are not dissuaded by the criticism. Mark Geier said the courts are biased against him and that the medical establishment is more concerned about preserving drug companies’ profits than about protecting children. “There’s no question this will turn out to be true,” Mark Geier said in an interview, referring to the vaccine-autism connection.

And, most despicable of all, the Geiers demonize the very autistic teens upon whom they are plying their quackery:

“With masturbating there is a degree of normal, and then there is autism. Parents will say: ‘He will hump pillows, he will hump your leg,’ ” David Geier told doctors at Eisenstein’s office. He made similar statements on the same visit to about 60 parents of autistic children.

In an autistic teenager, high testosterone will lead to dangerous aggression, Mark Geier said, mentioning an autistic Ohio teen accused of killing his mother. “They are incredibly strong. They can hurt you,” he said. “You have to respect that these kids are on massive testosterone.”

Autistic children with high testosterone are heading down an ominous path, the Geiers said, and likely will end up hooked on psychiatric drugs, institutionalized or jailed.

This is nonsense. Even worse, it’s pernicious nonsense. Unfortunately, it’s exactly the same sort of pernicious nonsense they’ve been pushing since four years ago, when they published their “case report” of the autistic child whose inappropriate sexual behavior abated after he was dosed with Lupron.

Of course, the parents of Geiers’ patients are largely self-selected to believe the woo and have a serious incentive, after sinking thousands of dollars into it, to believe it’s working. And they do provide testomonials, a couple of which were included in the Trib story. It wouldn’t even surprise me if some of them are true. If you shut down a child or teen’s testosterone production, they will likely become more docile and have a decreased sex drive. That doesn’t mean the drug is doing anything at all for the teen’s autistic symptoms or to improve their neurocognitive functioning. Indeed, it could be doing great harm to the child. While Lupron may not be too risky for prepubertal children, giving it to teens can “put puberty on hold,” as one scientist put it, calling it “chemical castration”:

Said Kaplowitz: “You can lower sex drive, yes, but are you going to do that for every autistic [teenage] boy, do a medical castration? … For a year? For their lives?”

Neither Eisenstein nor the Geiers dispute that what they are doing amounts to chemical castration.

Speaking about one teen he put on the drug, Mark Geier said: “I wasn’t worried about whether he would have children when he is 25 years old. If you want to call it a nasty name, call it chemical castration. If you want to call it something nice, say you are lowering testosterone.”

Karl Rove would be proud of Dr. Geier.

In a companion article, another aspect of the Lupron protocol is deconstructed:

Abbott Laboratories, which sells Lupron in the U.S., once applied for a patent with the Geiers through a now-defunct joint venture with another drug company, yet never pursued work with them. A spokeswoman for the North Chicago-based company said there was no scientific evidence to justify further research.

When a pharmaceutical company decides it isn’t interested in pursuing a potentially lucrative new indication for one of its drugs, you know you’re deep into pseudoscience. I will say, though, that Abbott Laboratories should be ashamed of itself. Until now, it has been winking and nodding at the use its product is being put to, even though its scientists know there is no scientific justification for it. Of course, the Geiers had already tried to patent their Lupron protocol once, because, of course, they’re doing this all out of the goodness of their hearts.

Not:

The Geiers’ first Lupron patient, a Virginia boy with severe autism who is now 13, started the treatment about four years ago. Since then, the Geiers have opened eight clinics in six states, including one in Springfield and their arrangement with Eisenstein, which he described as a “franchise” of sorts.

“We plan to open everywhere,” Mark Geier said in February at Eisenstein’s office. “I am going to treat as many as I can.”

Some of the Geiers’ clinics are headed by doctors; a psychiatrist runs the Springfield clinic. But that is not always the case. The clinic in Indianapolis is run by an X-ray technologist who has an autistic child.

In Washington state, the head is a health advocate and documentary filmmaker.

I can’t help but ask: How do the Geiers get away with it? These people whom they’ve hired to run their other clinics are not physicians. They are clearly practicing medicine without a license!

WHAT THE TRIBUNE MISSED

There were only two deficiencies in these articles. The first one almost goes without saying in stories of this type. There was too much of the usual “tell both sides” journalistic construction, in which testimonials were given far more weight than they deserved and the Geiers were extensively quoted. I’ve given up expecting anything other than that from journalists. The other deficiency is that there was no mention of how the Geiers played fast and loose with human research protections in order to ply their quackery. There was no report at all of this in the Trib’s article.

What do I mean? In essence, the Geiers formed their own Institutional Review Board (IRB) to review their own studies and thereby get around federal regulations over human subjects research. The IRB is usually reported as being from an entity formed by the Geiers listed as The Institute for Chronic Illnesses. As Kathleen Seidel first reported, it’s an elusive institute whose address is the same as that of Dr. Mark Geier’s home residence. (It also has a lovely tennis court.) But, elusive or not, The Institute for Chronic Illnesses does have its own IRB, and that IRB is actually registered with the federal government. Leave it to Kathleen’s tenacity to track down through a Freedom of Information Act request some information on this particular IRB. What she found is very disturbing indeed.

In order for you to understand why what Kathleen discovered is so disturbing, a word is in order about just what an IRB is and does (or should be and is supposed to do). I’ve written about the international treaties and U.S. law regulating human subjects before, but not in detail about what IRBs are and do. After the horrors of Nazi medical experimentation and the abuses during the Tuskegee syphilis study right here in the good ol’ USA, it was clear that rules were needed to protect human research subjects from such abuses. A historic document in the development of such rules in the U.S. was the Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research finalized on April 18, 1979. This report identifies three essential and fundamental ethical principles for human subject research (respect for persons, beneficence, and justice) that form the basis of all Department of Health and Human Services human subject protection regulations to this day. It is essential reading for anyone doing human subject research in this country. In 1991, these regulations were codified into what is now known as The Common Rule. All institutions doing federally funded research are required to adhere to The Common Rule. Moreover, some states, such as Maryland (where the Geiers have their businesses) require that all human research, regardless of funding source, must conform to the Common Rule.

A key aspect of The Common Rule is the IRB. The IRB is in essence a committee that oversees all human subject research for an institution and makes sure that the studies are ethical in design and that they conform to all federal regulations. Basically, IRBs are charged with weighing the risks and benefits of proposed human subject research and making sure that (1) the risks are minimized and that the risk:benefit ratio is very favorable; (2) to minimize any pain or suffering that might come about because of the experimental therapy; and (3) to make sure that researchers obtain truly informed consent. Once a study is in progress, regular reports must be made to the IRB, which can shut down any study in its institution if it has concerns about patient welfare. Indeed, the IRB at my particular institution is like a bulldog; it’s utterly ruthless in how it deals with researchers. The same is the case at most institutions that receive significant federal funding, and these are the criteria for approving a study:

(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by 46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

It sounds pretty clear-cut. And, from discussing studies with members of different IRBs, I know that good IRBs take the above guidelines very seriously, almost always erring on the side of being more protective of human subjects. (If you’re interested in learning more about federal human subject research guidelines, check out this course.) Now here’s where it gets even more interesting. The membership of an IRB must be at least five persons according to these guidelines:

a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

Well, guess who was on the IRB of the Institute for Chronic Illnesses at the time of their seminal “studies” on testosterone and autism (and, as far as I know, are still on the ICI IRB)? If you’ve clicked on the link to Kathleen’s article you already know, but for those who haven’t done so yet (or who don’t believe in clicking on links), now’s a good time to do so:

Mark Geier, Chair
Affiliated Scientist; MD, PhD; Genetics

David Geier
Affiliated Scientist; BA; Biochemistry

Lisa Sykes
Unaffiliated Non-Scientist; MA; Clergy (Rev. Sykes is a Richmond, Virginia Methodist minister, anti-thimerosal activist, and mother of a participant in Dr. Geier’s study. The clinical data for Patient #1 in the Hormone Research article is identical to data from her son’s medical records, which were displayed at the 2005 and 2006 Autism One conferences.)

Kelly Kerns
Unaffiliated Scientist; RDH; Dentistry (Mrs. Kerns is a Lenexa, Kansas dental hygienist, anti-thimerosal activist, and petitioner in vaccine injury complaints for each of her three autistic children.)

John Young
Unaffiliated Scientist; MD; OB-GYN, Genetics (Dr. Young is Dr. Geier’s business partner in Genetic Consultants of Maryland and Genetic Consultants of Virginia; he, Dr. Geier and various business entities were codefendants in a 1994 medical malpractice lawsuit.)

Anne Geier
Affiliated Scientist; BS; Educator (Mrs. Geier is wife of Dr. Mark Geier and mother of David Geier. She is a ranking member of the U.S. Tennis Association.)

Clifford Shoemaker
Affiliated Non-Scientist; JD; Legal (Mr. Shoemaker is a vaccine injury lawyer, a member of the Vaccine Injury Alliance, and a member of the Omnibus Autism Proceeding Petitioners’ Steering Committee. Dr. Geier has testified on behalf of his clients in Price v. Wyeth et al, Platt v. HHS, Jenkins v. HHS, Lewis v. HHS, Raj vs. HHS, Jefferies v. HHS, and other cases.)

Notice how conveniently every single member of this IRB was either one of the Geiers, an anti-thimerosal activist, a Geier associate, or a lawyer suing on behalf of “vaccine-injured” clients. Anyone want to make a bet about how closely they adhere to the guidelines for human research listed above? It almost doesn’t matter anyway because, as Kathleen pointed out, besides the fact that none of the members of this IRB has any expertise in endocrinology, Mark and David Geier would not be eligible to debate or vote on their own protocols anyway; having them on the IRB is utterly unethical and almost certainly illegal. Ditto Anne Geier, who wouldn’t be eligible to vote because of her relationship to Mark and David, and Lisa Sykes, who wouldn’t be eligible to vote if her child is to be a subject in the research protocol being reviewed. And does anyone really think that any of the other members of this particular IRB has research subject protection as his or her overriding concern?

But it didn’t end there. If the FOIA information that Kathleen has obtained is complete, then it looks as though the research reported under the auspices of this IRB was done before the IRB of The Institute for Chronic Illnesses was even registered with the federal government. It is hard not to strongly suspect that the Geiers were told by someone while submitting their paper that human subjects research had to be approved by an IRB and that no reputable journal would publish such research without a statement to the effect that the research encompassed in the manuscript had been approved by an IRB.

CONCLUSION

After having watched with frustration for over three years how the Geiers have managed not only to continue to subject autistic children to, in essence, chemical castration and have large numbers of parents sufficiently desperate or sufficiently believing in “alternative” medicine that they are willing to pay the Geiers big bucks to submit their children to their “protocol,” I am gratified that the Chicago Tribune did this investigation and wrote this study. True, the reporters didn’t uncover the chicanery the Geiers have been demonstrating for years with the dubious IRB, and I can’t help but be a bit disturbed at this because, as a clinical researcher, I try very hard to hew to the rules and law governing human subjects research and conduct such research ethically.

The Geiers’ saga, in fact, demonstrates a number of things. First, there is the utter lack of medical ethics that would allow them to inject autistic children with a powerful anti-androgen and anti-estrogen drug based on a concept as easy to demonstrate to be without scientific foundation as mercury being bound up in “testosterone sheets.” But more importantly, there is the issue of how on earth our laws and regulations could be so lax that the Geiers could get around them by creating a dubious “Institute,” creating an equally dubious IRB, and then stacking that IRB with true believers and cronies, among them the principal investigator of all of the Geiers’ “studies,” Dr. Mark Geier himself.

The price of antivaccine lunacy is steep and getting steeper. In addition to decreasing herd immunity and endangering those who do not subscribe to their toxic mix of paranoid conspiracy theories and pseudoscience, antivaccine zealots like the Geiers have managed to make a mockery of our system of human subjects protection. Above, all, however, autistic children pay the price for the current antivaccine madness sweeping through our country.

I just hope that the media will increasingly notice. Shining the light of day on this quackery and egregious flouting of human subjects protections is the only chance these children have to be spared from such atrocities.

ANTI-VACCINE LUNACY AT THE HUFFINGTON POST

My disdain for The Huffington Post’s treatment of medical science goes way, way back–all the way back to its very beginnings. As I mentioned before, a mere two or three weeks after Arianna Huffington’s little vanity project hit the blogosphere, I noticed a very disturbing trend in its content. That trend was a strong undercurrent of antivaccination blogging. At the time, a “friend” of mine pointed out how Santa Monica pediatrician to the stars and “vaccine skeptic” Dr. Jay Gordon (whom both Steve and I have discussed) had found a home there, along with David Kirby, author of the mercury militia Bible Evidence of Harm (and who has been a regular punching bag of mine for at least four years, and deservedly so), and Janet Grilo.

This was right from the beginning.

These anti-vaccine “luminaries” were soon joined by Robert F. Kennedy, Jr (whose anti-vaccine activism I have discussed before) and more recently by Deirdre Imus, the driving force ramping up the antivaccinationist mercury militia proclivities of her husband, aging shock jock Don Imus. (Indeed, if Jenny McCarthy didn’t exist, Deirdre Imus would get my vote for the antvaccine zealot who routinely says the most astoundingly ignorant things about science.) Although we don’t hear much from Grilo or Gordon anymore, other than an occasional specious analogy between tobacco companies and the pro-vaccine stance of the CDC and AAP or nonsense about Tamiflu, unfortunately we do hear from Kirby, Imus, and Kennedy on a fairly regular basis, all on The Huffington Post, with one of the few voices of reason when it comes to vaccines being Arthur Allen, author of Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver. Unfortunately, Allen has not posted to HuffPo in a long time. Given this history, it’s not for naught that on occasion I’ve referred to The Huffington Post “Arianna’s Home for Happy Antivaccinationists” and noted that it’s been seriously questioned whether it could ever do a real science section.

Meanwhile, while anti-vaccine “luminaries” such as David Kirby and RFK, Jr. regularly delivered the anti-vaccine propaganda on HuffPo, former Media & Special Projects Editor of The Huffington Post, Rachel Sklar was quite impressed with McCarthy’s antics on CNN back in April 2008, when McCarthy shouted down pediatricians and scientists who tried to refute her scientific ignorance. Since then, she has e-mailed me to argue that she is not “anti-vaccine,” and I will take her at her word, but she sure could have fooled me with her breathless praise of Jenny McCarthy’s boorishness last April on Larry King Live. Soon after, Alison Rose Levy joined her. In recent days, I’ve learned that Levy also happens to be a booster of other forms of unscientific medicine and was recently very impressed with the testimony of Dean Ornish, Andrew Weil, Mehmet Oz, and Mark Hyman, at the Institute of Medicine that I discussed earlier this year, arguing that their talks were nothing more than the same old pseudoscientific justifications for “integrating” pseudoscience and faith-based medicine with science-based medicine. Indeed, of late, HuffPo even invited a managing editor of the antivaccine propaganda blog Age of Autism, namely Kim Stagliano, to blog for it. It doesn’t get more anti-vaccine than that–one of the “editors” of the most prominent anti-vaccine blog promoting the scientifically discredited idea that vaccines somehow cause autism.

Finally, just a little more than a week ago, surprising me, given that I had been waiting for Jenny McCarthy to make an appearance as a blogger on HuffPo, her much more famous boyfriend, Jim Carrey, started blogging for HuffPo with an incredibly inane bit of anti-vaccine propaganda entitled The Judgment on Vaccines Is In??? In it, Carrey regurgitated all manner of anti-vaccine talking points, including the “toxins” gambit (apparently Dr. Jay never warned Carrey just how much it reveals Carrey’s ignorance to use the “formaldehyde” or “antifreeze” in vaccines gambit); parroted the intellectually dishonest Generation Rescue “study” that tries to correlate the vaccine schedules of various nations with their autism prevalences (which I discussed here) and its equally intellectually dishonest “Fourteen Studies” website (discussed by Steve, leading to an all-out personal attack on him by J.B. Handley; Mark; and, of course, me). Suffice it to say, the intellectual incompetence on display by Carrey was very reminiscent of at least one of characters he used to play on In Living Color back in the 1990s. The post even had a similar structure to one of his old sketches.

There is little doubt that the blogging culture of HuffPo is steeped in anti-vaccine pseudoscience. If that were all that’s wrong with HuffPo, it would be bad enough. But it’s not. This year, HuffPo blogging has taken a turn for the worse. For HuffPo, this year is the year of the quack.

2009: THE EMERGENCE OF RANK QUACKERY IN THE HUFFINGTON POST

HuffPo has been home to more than just anti-vaccine propaganda over the years. Perhaps the most famous example is the regular appearance of that maven of “quantum” healing pseudoscience, Deepak Chopra (whose IntentBlog often crossposts the same nonsense), who of late has become a point man in the battle to coopt President Obama’s plans for health care reform in order to insert unscientific ‘alternative medicine” under the guise of “wellness” and “prevention.” On the HuffPo, he has laid down all sorts of nonsense about dualism, “intelligent design” creationism, universal consciousness, and “quantum” healing. All of this is standard fare for Chopra, and, for the most part, that’s as far as HuffPo went into dubious medical science outside of vaccines. Indeed, before 2009 advocacy of rank quackery not related to vaccines in the HuffPo has been relatively slight.

In 2009, that changed. Big time. Enter licensed acupuncturist, certified clinical nutritionist, and a homeopath (not to mention HuffPo’s new “Wellness Editor”). Here is how she is described in her bio:

She has a Master’s Degree in Traditional Chinese Medicine and a Doctorate in Homeopathic Medicine. She is the founder and Medical Director of the Santa Monica Wellness Center and the author of the best-selling, award-winning The Detox Solution: The Missing Link to Radiant Health, Abundant Energy, Ideal Weight, and Peace of Mind. You can learn more at TheDetoxSolution.com.

On HuffPo, Patricia Fitzgerald has recommended a “spring cleaning” for your liver for “detox” and praised Jenny McCarthy and her promotion of “biomedical” quackery for autism. I can’t help but speculate that in this case, the correlation between Fitzgerald’s arrival and the major uptick in the number of posts touting unproven and pseudoscientific medical practices on HuffPo may well equal causation, even though Fitzgerald appears to be relatively careful not to go too far off the deep end in terms of the health care practices she advocates on HuffPo. She, at least, is apparently smart enough to qualify them and stick mostly with diet and exercise as her cure-all.

Ramping up the woo a bit more into Deepak Chopra territory is Srinivasan Pillay, “certified master coach, psychiatrist, brain imaging researcher and speaker,” whatever that means (other than psychiatrist). As Peter Lipson has pointed out, his “brain imaging” publications in PubMed are pretty darned sparse, mostly functional MRI studies, which are very difficult to do correctly in order to obtain any correlations or useful data. If his HuffPo presence is any indication, I hate to think what he’s doing with that fMRI machine. His first major “contribution” was an article entitled The Science of Distant Healing, in which he purports to present the “scientific evidence” for distant healing. Distant healing, for those who may not be aware, is the magical belief that just by sending one’s “intent” or wishes to a distant person one can actually heal that person or send one’s “intent” to him or her. I say “magical” belief because there really isn’t any other word to describe it. There’s no scientific or physical mechanism by which it can occur, at least none that scientists have yet been able to find. His followup post, with Pillay seemingly irked at all the criticism he received for his distant healing article, was aptly entitled Why Rational Thinking Is Not All It’s Cracked Up to Be. In it, he concludes that, because humans are irrational, science can never be rational, never realizing that the scientific method itself is a system designed to minimize the effects of human cognitive biases and shortcomings on the observation of nature. Steve Novella had some real fun with the nonsense in this post, and I can’t say that I blame him.

Still, like Fitzgerald, Dr. Pillay is relatively careful to stay in the rather mystical quantum world of Deepak Chopra and not to directly advocate anything clearly dangerous. The same cannot be said of other bloggers, as not long after Fitzgerald’s arrival a new quackery apologist lit up HuffPo with some of the most outrageously dangerous quackery I’ve seen in a long time.

I’m referring to Kim Evans, “author of Cleaning Up! and the creator of The Cleaning Up! Cleanse, a powerful body cleanse that addresses deep levels of toxicity throughout the body and a common fungal problem, candida overgrowth.” She goes on to describe herself in her bio:

Kim believes that toxicity in the body is at the root of most all disease and impacts us in ways spiritually that perhaps defies current spiritual understanding. She also believes that most disease can be permanently removed from the body with deep body cleansing, upgrading your on-going diet and consciously avoiding common toxicity sources.

Kim has spent thousands of hours researching, studying, cleansing and experimenting with different cleansing techniques and has eliminated more than a dozen problems in her own body – including several problems that medical doctors had no solutions for. She’s given people information that when they applied it, eliminated their health problems and had medical doctors adding years to their life expectancy – in addition to asking what they were doing so they could pass the information along to their patients because they had “never seen anything like it.”

Regular readers of this blog can predict the sorts of nonsense that Ms. Evans has been laying down about “detox” and colon and liver “cleanses.” And lay it down she has, claiming that “detox” can get rid of fungal infections which, she claims that 90% of us have. Of course, 90% of us do have candida albicans growing on or in our body somewhere, but in the presence of a competent immune system, it doesn’t cause any problems. That’s not what Kim Evans is saying. She’s claiming that 90% of us have “overgrowth” or are infected with candida.

Steve has already discussed Kim Evans’ quackery advocacy twice, pointing out that her claim that antibiotics cause cancer and that fungus is cancer is rank quackery and that her defensiveness over the criticism that she is promoting pseudoscience is, in fact, an excellent example of how pseudoscientists think, rife with logical fallacies, postmodernist nonsense and tu quoque, as did a certain “friend” of mine. However, because I’m a surgical oncologist, I can’t help but briefly discuss one aspect of Kim Evan’s world view that disturbs me greatly. Specifically, it’s her belief that Dr. Tullio Simoncini is correct about cancer.

DANGEROUS CANCER QUACKERY

So who is Dr. Simoncini? He’s an Italian physician who claims to be an oncologist, whose claim to fame is the invention of the quackery–yes, quackery–that claims that cancer is in reality a fungus and that all cancer can be treated and cured with sodium bicarbonate. Here is a video in which Simoncini describes how he came to this conclusion as he hawkshis book Cancer Is A Fungus, makes the argument that fungus is the One True Cause of Cancer and that the medical establishment is Too Deluded or Too Blind to realize it:

Worse, Simoncini proposes a treatment that, even if cancer were a fungus, is completely implausible and wouldn’t work. Indeed, we don’t treat fungal infections that way even when we are treating a clearly diagnosed fungal infection. You can get an idea of just how quacktastic this video is by listening to Dr. Simoncini opine in the first couple of minutes of the vide that whenever he sees a cancerous tumor in the body, the lumps are “always white.” He emphasizes this amazing observation several times, so apparently important is it. Yes, that was the observation that supposedly led him to his idea (I refuse to dignify it with the term “hypothesis”) that tumors are in fact due to fungus. In response, the host gushes about how brilliant that is and how obvious it is. Just crush up a mushroom! Of course, it would be a major blow to Dr. Simoncini’s idea, would it not, if not all mushrooms are white. Truly, Dr. Simonici has demonstrated the the ultimate in taking a flawed observation and running with it straight off the cliff, as this description of his book shows:

The book “Cancer is a fungus” describes how a fungous infection always forms the basis of every neoplastic formation, and this formation tries to spread within the whole organism without stopping.

I also have to wonder what kind of oncologist Simoncini is if that’s all he’s seen. From my experience as a surgeon, it’s trivial for me to tell you that not all tumors are white. Many are, but a lot of them are brownish-colored, tan, or even greenish-colored. (Uh-oh, better not let Dr. Simoncini know that; that’s fungus color we’re talking!) And what about leukemias and other blood cancers? Dr. Simoncini then shows a bronchoscopy and thoracoscopy demonstrating white tumors. I’m supposed to be impressed by this? He also argues that in reality cancer is due to “excess acidity” that allows the fungus free rein.

So what is the answer, according to Dr. Simoncini? Baking soda. Yes, baking soda, a.k.a. sodium bicarbonate. Dr. Simoncini injects sodium bicarbonate into tumors and claims to be able to cure any cancer using these injections. One thought that immediately comes to mind whenever I see a claim like this is: If Dr. Simoncini can actually do what he claims he can do, where are his publications? Where is his Nobel Prize? To be able to cure cancer by something as simple as injections of sodium bicarbonate directly into tumors would be such an incredible breakthrough that there’s no way it could be kept quiet. Yet somehow only Dr. Simoncini knows this remedy, which is not only physiologically incredibly implausible and isn’t even used to treat real, biopsy- or culture-proven fungal infections but has no evidence to support it. There’s a whole culture of acid-base quackery that I’ve been meaning to write about in more detail, and Dr. Simoncini would be right up there among its chief “practitioners.”

Not surprisingly, Dr. Simoncini has been a focus of attention for the Italian health authorities.All I could find was this thread on the JREF forums. According to various commenters, not only was Dr. Simoncini expelled from the Italian Medical Order (Ordine dei Medici e Chirurghi) but he was condemned in the first degree by an Italian court for cheating and homicide. Here’s one report from a woman by the ‘nym of JennyJo:

I live in the Netherlands.

Last year, tullio simoncini was giving his treatments with sodium bicarbonate in a private clinic for alternative ‘medicine’ in Bilthoven in the Netherlands.

October 2007, a woman with curable breast cancer, who was afraid of operation and chemo therapy, came into contact with simoncini and was treated by him. He injected large doses of baking soda into her breast.

On the fourth day of the therapy, the woman became very ill and was transported to a university hospital in Amsterdam, where she died the following day.

The matter is since under investigation by the Dutch Justice Department. Simoncini denies he ever treated the woman, although various staff members have seen him administering injections. The clinic maintains the woman died of dehydration (sic).

More application of science to Dr. Simoncini’s quackery can be found at Cancer Is Not A Fungus and, of course, the Quackwatch affiliate Cancer Treatment Watch. There’s just so much wrong with Simoncini’s ideas that at some point I may well jump into the ring myself with a more detailed explanation of just what is so wrong and why. Suffice it to say Dr. Simoncini is without a doubt the very picture of a quack. Also suffice it to say that Kim Evans believes in Simoncini’s quackery and views him as “persecuted,” as this comment by her reveals:

Tullio Simoncini, yes, he had his license revoked, and there are reasons for that. In modern medicine today, medical doctors must practice standard accepted procedures, and if not, their license is in jeopardy. Let’s be clear, Dr. Simoncini was not going the standard and accepted chemo and radiation route. He found something far more effective and posed no harm to the patient. But because it was outside standard practice, he had his license revoked. Unfortunately, vitamin and herbal therapies also fall outside standard accepted practice, and are not often taught in medical school, as this community seems to think that only drugs are effective and little else plays a role in the body.

There are plenty of videos on the net if you care to watch Dr. Simoncini pour an alkaline solution of baking soda and water as close to a tumor as possible, and have the tumor disappear, often in a matter of days. While I grant that it is possible that Dr. Simoncini could be wrong about the cause of the tumor (I don’t believe he is, but for arguments sake, I’ll allow that possibility), I find it hard to believe that after graduating from oncology school he doesn’t know what a tumor looks like. Or that the videos showing the tumors being eliminated were somehow not eliminated or not tumors to begin with. So, even if the cause was incorrect, the fact that these tumors are being quickly eliminated seems pretty straight forward.

To Evans, Simoncini is a persecuted martyr for the One True Cause of Cancer who’s being attacked because he’s supposedly better at curing cancer than “”outside of standard practice.” Never mind that it has zero physiological plausibility, relies on a model of cancer causation that is trivial to demonstrate to be utterly incorrect, and has zero evidence other than the lowest quality testimonials to support it. Never mind that it’s never been convincingly demonstrated that injecting anything into a large, established tumor will cure it, much less solutions of baking soda. Never mind that Simoncini has been directly linked to the deaths of patients from his quackery. Again, if Simoncini could really do what he claims and demonstrate it to accepted scientific standards, the Nobel Prize is his. I suspect, however, that the Nobel committee won’t be considering him any time soon.

This is the sort of irresponsible promotion of outright quackery that HuffPo permits within its pages, but it doesn’t end even there.

SWINE FLU QUACKERY AT HUFFPO

Given the recent scare over the likelihood of a swine flu pandemic, the quackery level has ramped up even more at HuffPo, led by (who else?) Kim Evans, who penned a post called Swine Flu: Protect Yourself and Loved Ones. In this post, Evans is more than willing to recommend her detox quackery to protect against swine flu:

Cleansing involves changing your internal environment and specifically, removing a bunch of the stored waste that most people have trapped in their bodies. Most estimates are that the average person has ten or more pounds of stored waste just in their colon, and I’d argue far more throughout their body. In any case, many people have found that disease disappears when this waste is gone, and that when the body is clean it’s much more difficult for new problems, like viruses, to take hold in the first place. And it’s my understanding that many people who took regular enemas instead of vaccines during the 1918 pandemic made it out on the other side as well.

That’s right. Evans is recommending enemas and “detox” quackery to protect yourself against the swine flu. I can tell you one thing; this woman is utterly ignorant of history.There was no vaccine against influenza during the 1918 influenza pandemic. In fact, influenza vaccines were only developed widely available during World War II, where they were used to protect our soldiers. After the war, development of the vaccine continued. Moreover, there are not–I repeat, not–ten or twenty pounds of “stored waste” in the colon that are making people sick, and it especially isn’t feces in your colon that gives you the flu. Any surgeon who’s ever operated on the colon regularly (as I used to do until I subspecialized) or gastroenterologist who does endoscopy knows this to by a myth, but it’s the basis of so much enema quackery, as is the belief that the liver needs “help” dealing with these unnamed “toxins” through purging and enemas. Indeed, this obsession with “toxins” and poo caking the inside of the colon is nothing more than the alt-med version of the religious belief that one is “unclean” and desperately needs “purification” in order to achieve righteousness but all the enemas in the world won’t purify believers in this woo. They always think they are “toxic.”

Next up is Matthew Stein, who wrote a post entitled When a Superbug Strikes Close to Home, How Will You Deal With it? (also published in a patently unreadable form on Stein’s own website). After a whole lot of fear-mongering over “superbugs” and swine flu, Stein presents his answer:

The good news is that there are many alternative medicines, herbs, and treatments that can be quite effective in the fight against a wide variety of viruses and antibiotic-resistant bacteria, to which mainstream high-tech Western medicine has little or nothing to offer. The bad news is that 99 percent of the doctors in our hospitals are not trained in these alternatives, and don’t have a clue about what to do when their pharmaceutical high-tech medicines fail to heal. If you wait until a pandemic starts, you will have only a slim chance for locating an available health practitioner familiar with alternative herbs, medicines, and methods. In the words of Robert Saum, PhD, the typical attitude amongst most of his medical colleagues in this country is, “If I didn’t learn it in medical school, it can’t be true.”

That’s right, according to Matthew Stein, there are all of those “natural cures ‘they’ don’t want you to know about” for all those nasty, horrible, resistant bacteria. And, of course, those nasty, close-minded “allopathic” physicians are too clueless or prejudiced against them to learn about them or offer them to you. Even better, they will heal when the products of big pharma fail. So says Stein, who even claims that homeopathy could be an answer, citing an article Could Homeopathy Prevent a Pandemic?:

Do we have alternatives? During Spanish flu pandemic of 1918, which killed up to 50 million people worldwide, homeopathic physicians in the U.S. reported very low mortality rates among their patients, while flu patients treated by conventional physicians faced mortality rates of around 30 percent. W.A. Dewey, MD, gathered data from homeopathic physicians treating flu patients around the country in 1918 and published his findings in the Journal of the American Institute of Homeopathy in 1920. Homeopathic physicians in Philadelphia, for example, reported a mortality rate of just over one percent for the more than 26,000 flu patients they treated during the pandemic.

Today, a number of homeopathic remedies for the flu are available, including oscillo, or oscillococcinum, which has been shown to shorten the duration of symptoms when taken within 48 hours of onset. Homeopaths have been given this remedy since 1925. Interestingly, it’s made from the heart and liver of ducks, which carry flu viruses in their digestive tracts.

“Based on clinical studies, homeopathy produces some of the fastest results in relieving flu symptoms,” says Dana Ullman, MPH, the author of nine books on homeopathic medicine.

Anyone who’s been a regular here for a while probably remembers Dana Ullman, the homeopath who seems to have a lot of time on his hands to Google himself for new mentions on blogs and then infest blogs that criticize him and homeopathy. I have little doubt that he will show up here. If you want the best deconstruction of Ullman’s nonsense, check out the new Internet law that my coblogger Kimball Atwood laid down about him:

In any discussion involving science or medicine, being Dana Ullman loses you the argument immediately…and gets you laughed out of the room.

How true. Moreover, Stein’s falling for the same old claims by homeopaths that somehow patients treated with homeopathy only suffered a 1% mortality compared to conventional physicians, whose patients supposedly suffered a 30% mortality. As co-blogger David Kroll pointed out a couple of years back, these are the same sorts of nonsense claims that were trotted out during the avian flu scare. Of course there’s a big problem here. No doubt homeopaths reported low mortality, but was there any objective evidence that they actually observed such low mortality in their patients? What about selection bias, where the less severely ill patients chose real medicine instead of homeopathy? How do we know that patients who got sicker under the homeopaths’ care didn’t go to real physicians or die without being followed up? Do we know that the homeopaths’ patients were comparable to the patients treated by “conventional” medicine? We don’t. Finally, if the peer review of the Journal of the American Institute of Homeopathy is anything like the peer review of homeopathy journals in 2009, I don’t have high hopes that Dewey’s article was subjected to anything resembling rigorous peer review. That hasn’t stopped it from being trotted out in the intervening 90 years since the Spanish flu pandemic by homeopaths every time a flu pandemic or flu scare comes up. Truly, it is a zombie study that just won’t die, and a HuffPo blogger is promoting it.

But that’s not all Stein is promoting. He’s also promoting something called the Beck protocol, which consists of:

1. Blood electrification
2. Colloidal silver
3. Magnetic pulsing
4. Ozonated water

The Beck protocol could take up an entire post on its own, and perhaps someday I will write one. In fact, each of the four elements of the Beck protocol could be the topic of its very own post, and perhaps I should do a four-parter. However, in the meantime, regular readers should recognize that each of these four elements is quackery. But even that level of quackery isn’t enough for Stein. He finishes with a list of a veritable panoply of herbalism, supplements, and other dubious remedies to “protect yourself” against the swine flu.

Most recently, another HuffPo blogger, Lisa Sharkey, opined in a post entitled What Most Doctors Won’t Tell You About Preparing for the Swine Flu:

What can I do to keep my family safe? How can I boost our immune systems now and what complementary medicines can I begin taking immediately, regardless if I ever come in contact with the dreaded Swine Flu?

You know what sort of answers are coming, I bet. That’s right: Supplements, herbalism, homeopathy, reflexology, tapping, this post is a veritable cornucopia of quackery for swine flu, with Sharkey touting it all as “immune-boosting.”

She even prefaced her post with the typical “dodge the FDA” disclaimer:

Author’s note: This swine flu story on alternative and complementary medicine is not meant to replace anything you hear from you doctor, the WHO or the CDC, but is meant to show you some natural ways to enhance your overall wellness in addition to any medication you may need either to prevent or treat the flu.

Very appropriate, I would say. Too bad the rest of HuffPo’s health bloggers don’t add the same disclaimer to their posts.

WHY IS HEALTH PSEUDOSCIENCE SO INGRAINED AT THE HUFFINGTON POST?

Seeing the pervasiveness of anti-vaccine views, New Age mysticism and pseudoscience à la Deepak Chopra, and, most recently, outright quackery at HuffPo, one is left to ask: Why? Why is health pseudoscience and even outright quackery so pervasive at HuffPo? Why is it that (as I have been told) so many commenters who try to counter this nonsense find that their comments are “moderated” (a.k.a. censored), as I myself have experienced when trying to counter anti-vaccine posts I’ve seen on HuffPo. Why is it that a woman who so profusely praised President Barack Obama in an editorial about his first 100 days for reversing the Bush Administration stand on embryonic stem cell research, runs such a site so full of quackery? Huffington in particular praised Obama’s statement that it is “about ensuring that scientific data is never distorted or concealed to serve a political agenda, and that we make scientific decisions based on facts, not ideology.” I agree. It’s a fine sentiment, long overdue after the Bush administration. Too bad Arianna Huffington doesn’t apply President Obama’s sentiment to her own blog and kick out the quacks and pseudoscientists.

But then the question is, once again, why? Why doesn’t Huffington kick out the quacks? Part of the answer, at least, is suggested in an article in The New Yorker that appeared about her last fall entitled The Oracle: The Many Lives of Arianna Huffington, in particular these excerpts:

During a student-group fair, Huffington toured the chambers of the university’s debating society. Since girlhood, she had possessed a spiritual impulse, studying Hinduism and fasting on the name day of the Virgin Mary.

Huffington’s business and spiritual pursuits merge in her interest in human-potential movements, the sorts of popular groundswell that, as she once wrote, will provide us, in “a new age that is being born,” with “an opening for great possibilities of new being, for a breakthrough in our evolution.”

Over the years, Huffington has been touchier about her relationship with John-Roger, the baby-faced spiritual leader of M.S.I.A., who was born Roger Delano Hinkins in Rains, Utah, in 1934, and, in 1963, rechristened himself upon his emergence from a nine-day coma induced by kidney-stone surgery. In an investigation published in the Los Angeles Times in 1988, the reporters Bob Sipchen and David Johnston linked John-Roger—whose students believe that he has unique access to a power called Mystical Traveler Consciousness—to financial and sexual improprieties. (John-Roger stated, through a spokesman, that the allegations “remain as untrue today as when they were first published.”) His views on the body are certainly unusual: In “Sex, Spirit & You,” he writes, “When a woman has a history of blocking her creative flow and shutting off this area of expression by pushing the energy back down into the creative center, she may develop many problems related to her menstrual flow.”

The couple eventually embarked on a period of metaphysical inquiry that alienated some of their friends and colleagues as much as it entertained the press. Christopher Hitchens wrote, “Let the record show that in October 1979. . . Bernard Levin achieved the total state of self-absorption towards which he had been moving for so long. The venue was the Café Royal: amid incense and vaguely Oriental music, flanked by his companion, Levin rose and told a large invited audience how they could be ‘changed,’ by investing £150 in a 50-hour ‘Insight training.’ ” (Insight was founded by the spiritual leader John-Roger, with whom Huffington has remained affiliated. Huffington denies that incense and Oriental music played a role in the event.) When Levin died, in 2004, his obituary in the Times noted that Huffington’s “interest in mystic cults . . . was to lead him into one of the more embarrassing episodes of his journalism—his hyperbolic praise through a number of columns of the self-promoting guru, Bhagwan Shree Rajneesh.”

Christopher Hitchens, even when I don’t agree with him (which is fairly frequently on political topics), always has a way with words. And, most impressively, there is this descriptoin of Arianna Huffington:

Through all her incarnations, Huffington’s interest in mass movements, human potential, and the improvability of man has been as consistent as her suspicion of pharmacology, utilitarianism, and Skinner boxes. Her own life may be her greatest project.

In five decades of self-improvement, she has tried fire-walking, list-making, journal-keeping, mercury detoxification, homeopathy, chiropractic, infrared saunas, microdermabrasion, est, and—she writes in her 2006 book, “On Becoming Fearless”—“the Beverly Hills diet, the all-brown-rice diet, the grapefruit diet, the cabbage soup diet, the no carbs, no fat, indeed no calories diet.” Her daily regimen includes yoga, meditation, and prayer.

In other words, in this article, at least, Arianna Huffington comes across as a credulous New Age believer, flitting from one woo to the next, one quackery to the next, with no apparent understanding of why they are woo and quackery. Anyone who can embrace homeopathy uncritically is not someone who runs her life from a science-based perspective, all of her praise of President Obama’s sentiments about science and all of her claims not to be a relativist described in the New Yorker article notwithstanding. It is thus not surprising that her political blog would reflect this. However, until recently HuffPo’s bad medical science was primarily limited to its support of anti-vaccine bloggers such as David Kirby, Kim Stagliano, Robert F. Kennedy, Jr., and, most recently, Jim Carrey. Recently, however, HuffPo’s promotion of pseudoscience has accelerated.

WHAT TO DO?

In the wake of the recent surge in quackery promotion on HuffPo, there has been a debate in the blogsophere over what, if anything, can be done. My co-blogger Peter Lipson has described the promotion of quackery on HuffPo as a “dangerous assault on medicine” and suggested a “Vendetta!” of sorts, in reality a letter-writing campaign in which writers are urged to present “specific examples of their malfeasance, and asking them to consider altering their editorial policy on health issues, for the sake of morality, health, and humanity.”

Although I understand the sentiment, sadly, I don’t think that it will do that much good, unless it somehow impacts HuffPo’s bottom line in terms of the page views that determine advertising rates. The antivaccine nonsense, for example, has been very deeply ingrained in HuffPo blogging culture from the very beginning. I highly doubt, for instance, that Arianna would ever kick Robert F. Kennedy, Jr. off of HuffPo or allow any of her editors to do so. He’s just too high profile a liberal voice. Similarly, given how the influx of outright quackery has coincided with the tenure of the new “wellness editor,” I highly doubt that, short of removing her, any level of complaints will dislodge the quacks. I’d love to be wrong, but I fear I’m not, which is why I don’t think it’s a bad idea at least to try to deluge the editors with complaints about the recent spike in quackery blogging on HuffPo, the most irresponsible and utterly opportunistic of which are the claims by various charlatans that homeopathy or “detox” regimens can somehow protect you from the swine flu or that “cancer is a fungus” and sodium bicarbonate can cure it.

Janet Stemwedel, who blogs at Adventures in Ethics and Science, echoes a question I’ve been asking myself for a while now, namely whether to engage with The Huffington Post:

Should scientists and physicians try to do something about this?

Sure, blogular dissections of problematic HuffPo posts count as responses, and I know a great deal of work goes into countering flaky reasoning with logic while preventing one’s own head from exploding. But it’s not clear how many of the responses to HuffPo posts arguing that enemas and prayers will be sufficient to protect us from swine flu are getting to the large HuffPo audience.

Hypothetically, if HuffPo invited a scientist or physician to write an article, would it be a good idea or a bad idea to accept the offer? Would it help the HuffPo readers? Would it hurt the scientist or physician?

I don’t know the answer to that one. On the one hand, any respectable physician or medical scientists who blogs about health on HuffPo runs the risk of taint by association, along with a deluge of HuffPo CAM aficianados shouting “pharma shill” in the comments. Moreover, such a person risks being coopted by HuffPo’s editors as “evidence” that HuffPo does provide an outlet for science-based blogging about health. On the other hand, HuffPo has a very large readership, far larger than even the most popular of science bloggers. Granted, it’s the front page political blogs that drive most of the traffic, and it’s unclear how much traffic that the many dozens, if not hundreds, of other blogs on HuffPo actually garner. Still, there’s no doubt that, if it continues on its current path, HuffPo may someday rival Whale.to, Mercola.com, and NaturalNews.com. Should medical scientists try to stop that by “joining up,” so to speak? And what would be the price? More importantly, would joining up be more effective in muting the cheerleading for quackery on HuffPo than remaining outside and ruthlessly criticizing and mocking examples of it? Should we try to “fight from the inside” or “attack from the rear”?

Again, I don’t know the answer to this question. However, this question is somewhat more than hypothetical, which is why I need to contemplate it further. In either case, something needs to be done to counter HuffPo’s war on medical science.

Second, in the interest of openness and transparency, I will state my conflicts of interest up front: none. I have not talked to a drug rep in at least 20 years. Outside of a trip to San Francisco as a fellow, paid for by the company who was funding a drug study my boss was participating in, I have accepted no gifts or money of any kind from big (or little) pharma since I was a medical student. Nothing. I don’t even eat the pizza at conferences (1).

Third, I am a hospital based adult Infectious Disease doctor. I make zero money from vaccines. In fact, I only make money if people get sick with infections. For my bottom line, giving vaccines to prevent disease is counter productive to my bottom line.

Why 14 studies?

Fouteen Studies is child (8) of Generation Rescue, one of the autism organizations that, among other things, promotes a link between vaccines and autism. The web site opens with Amanda Peet, my favorite actress (2), who generated a brouhaha when she suggested that vaccines were safe. As the top of the home page of fourteenstudies.org quotes:

“Fourteen studies have been conducted (both here in the US and abroad), and these tests are reproducible; no matter where they are administered, or who is funding them, the conclusion is the same: there is no association between autism and vaccines.”

Fourteen Studies refers to Ms. Peet as “Spokesperson for Sanofi Aventis, a vaccine manufacturer.” They imply she is a shill for big pharma. As best I can tell she is a spokesman for Vaccinateyourbaby.org, a site by Every Child by Two.

Every Child By Two (ECBT) was founded by former First Lady Rosalynn Carter and former First Lady of Arkansas Betty Bumpers in 1991 as a result of the measles epidemic that killed nearly 150 people.

I am convinced. Whenever I think of Rosalyn Carter, I think evil incarnate. Don’t you?

Ms. Peet is a spokesman for Vaccinate Your Baby, which gets support from the vaccine maker sanofi pasteur.

Every Child By Two’s Vaccinate Your Baby campaign is made possible through an unrestricted, educational grant from sanofi pasteur (9).

However:

Amanda Peet is generously volunteering her time to support this cause and does not receive compensation for her time and effort.

Anyone besides me think this is cheesy? But this site is more about implying financial impropriety and bias, than evaluation of science. Anyone mind if I continue the theme of being a financial shill?

The papers discussed at Fourteen Studies like the Vaccinateyourbaby.org website, have some openness and transparency. Both at least let you know where the funding comes from (4).

Generation Rescue, like the Age of Autism website, is rife with advertisements yet nowhere can I find a statement of any financial conflicts of interest they might have. It is a small thing, but in the interest of openness and transparency, it would be nice to know how much they take in from advertisements, on line sales and speaking fees. Generation Rescue is a tax exempt charity, but I cannot find their financial statement on line. It would help put their position into context, at least as far as financial bias goes. Maybe its nothing.  Maybe it is a dollar a year, like what Apple pays Steve Jobs. Jobs appears to be doing OK. Maybe they make a good living from the proceeds.

Fourteen Studies often in its criticisms links to other sites that also do not mention any potential financial conflicts of interest. Which they probably don’t have. We all blog out of the intrinsic goodness of out hearts, after all. But when someone asks “Amanda Peet, How Much Are They Paying You?” on a web page with 12 sponsors and advertisers of autism treatments, the moral high ground slumps into the Marianas Trench.

(A later in the day addendum.  I found the 990’s. The founders of GR are paid nothing.  They spend the 400K a year they take in mostly on market research and advertising. No research. A breakdown of the source of income is not available).

What they do at the Fourteen Studies is rate each study (and there are more than 14 studies) with the following criteria, each worth up to 10 points: “Asked the Right Question,” “Conflict of Interest,” “Ability to Generalize,” and “Post-Publication Criticism.” 40 points would be the highest possible score. The highest score two studies received was a 5. Several received negative numbers suggesting either that those doing the scoring either did not know how to apply their own criteria, do not know how to correctly add together 4 positive numbers, or that the whole scoring system is bogus.

They say “We ranked all of the studies on a forty point scale.” Who the ‘we’ is who are doing the scoring is not mentioned. In each of the studies evaluated on the website, you know who did the work. Not fourteen studies. Transparency and accountability do not appear to be the strong suit of this site.

The first click to take you to the 14 studies gives a list of the studies and the only flaw they mention is the conflict of interest in each study. I have written before on this blog about the perils of funding and the results of clinical trials. It is not a trivial issue, but is, in and of itself, not a reason to dismiss a study. In the end the study has to rise and fall on the merits of its science and its reproducibility. Key concept. Reproducibility. The more a study is reproduced, the more reliable its underlying premise and the results.

The page does give the impression that there is a widespread, well funded, conspiracy between researchers, industry and government to suppress the truth about the side effects of vaccines.

Which is not true. As we all know that the REAL widespread, well funded, conspiracy between researchers, industry and government is suppress the truth about the Kennedy assassination. And man made global warming. And the Trilateral Commission. And the Holocaust. And UFO’s. And Big Foot. And Homeopathy. And Fluoridation. And the Loch Ness Monster. And and and and…

High quality studies take time and money to complete and are not easy to do. Someone has to do them, and the only people with the resources to fund biomedical research are the government and industry. Funding bias is a two edged sword, so if we look at the studies in peer reviewed, high impact journals funded by Generation Rescue we find, well, I can’t find any published studies Generation Rescue has funded. But if they do fund a published study that shows a link between autism and vaccines, by their own standards it will be suspect. Unless they are good guys, and so, as good guys, are resistant to funding bias. Of course, everyone thinks they are the good guy. Except me. I am totally prone to be influenced (1).

There is a page on the website called “Our Studies,” but they are not “their studies” because Generation Rescue is responsible for the studies, but because they support Generation Rescue’s position. That is the approach of Fourteen Studies: A good study is one that supports a vaccine/autism connection and a bad study is on that contradicts the connection. If, in the end, reality does not support your position and you do not change your opinion based on reality, then all you are left with is being a crank. I suspect that Generation Rescue is destined for crankdom.

None of “their studies”, save the Lancet MMR article by Wakefield, are high impact journals. Two studies were funded by Cure Autism Now Foundation. Does that invalidate them? Two are partially funded by the NIH? I thought the government were the Bad Guys. One (besides Wakefield’s) is by researchers who testify as experts on the damage caused by vaccines. Many do not mention conflicts of interest at all. Thanks to an apparent disregard for copyright/intellectual property (5), you can download all the references yourself from the fourteen studies website. Not that I would encourage you to do that. I got my copies through my hospital’s library.

In residency (and sometime beyond if you practice in a teaching hospital as I do) you have to suffer though, I mean, participate in Journal Club. In Journal Club an article is chosen and then carefully analyzed line by line. You look carefully for the strengths and weaknesses of the paper to learn how to read a paper critically. The one take home from years of participating in Journal Club is that all studies have flaws. All of them. Our studies and their studies are have flaws and bias. That is why most studies need to be repeated and all studies need to be taken in context. Clinical trials are messy and an individual study is rarely definitive.

Lets do a modified Journal Club with the 14 (actually 19) studies. These are all downloadable from Fourteen Studies, again, not that I suggest you violate copyright laws.

1) “Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Database”
Pediatrics, Thomas Verstraeten, MD (November 2003)
They gave it a 3. Their main issue with the paper was the politics and bias behind it. What about the science?

In this study they looked at HMO records of 124,170 infants for associations between neurodevelopemental disorders and thimerosal exposure. They then reevaluated the same disorders on another 16,717 children in another HMO. They found different associations between neurodevelopemental disorders and thimerosal exposures at the two HMO’s. And when it came to autism and attention deficit disorder, there were no increased risks that they could determine.

The discussion is a sober and reasonable evaluation of the potential confounding issues in the study that make it difficult to make a definitive statement that thimerosal does not cause autism. It is also one of those studies that makes your brain hurt trying to wrap your brain around it. In the conclusion they say “Although the lack of consistency between the 2 phases argues against a thimerosal effect, we believe that additional investigation is required.” It is typical of the calm, considered discussions found in all fourteen studies of the limitations of the study in question.

It is an article that demonstrates how difficult it is to tease out risk from a single exposure in a large population using epidemiology studies. The website suggests what is needed is a study that compares autism rates in vaccinated vrs unvaccinated children. Given the benefits of vaccines, such a study could never be ethically done. To deliberately randomize children to not getting vaccines would be immoral to do and impossible to get past an IRB.

That study will be possible in the future, thanks to the anti-vaccine and alternative vaccine schedule proponents. We will be able to compare disease, death and autism rates in vaccinated and unvaccinated populations. I predict that the unvaccinated group may have a slightly higher autism rate. If autism is mostly genetic, families where vaccines are not given due to prior autism cases will have more cases of autism when compared to vaccinated groups.

Where fourteen studies sees ethical malfeasance, I see a typical epidemiologic study. Messy, but helpful. It is one brick in the wall.

2) “Thimerosal and the Occurrence of Autism: Negative Ecological Evidence from Danish Population-Based Data”
Pediatrics, Kreesten M. Madsen, MD (September 2003)
According to fourteen studies, who gave it a 1, “Written by a Danish vaccine company, the study made a mockery of the data, a problem the authors themselves warned of. And, the CDC engineered the entire study. This one goes beyond useless, it was fraudulent to run the numbers this way, and they knew it.”

In this study they look at autism rates in Denmark during the use of thimerosal and after it was removed from the vaccines. The rates of autism diagnosis were stable during the thimerosal era and increased once thimerosal was removed. Suggesting that thimerosal is not associated with the development of autism (and maybe protective? (6)).

The mockery and fraud? I can’t mockery or fraud in the study. They recognise the confounding factors that both the criteria for diagnosis and the ability to find cases changed during the study period and may be a confounding variable.

I thought a nice study, and, for a retrospective epidemiologic study, fairly clean.

3) “Continuing Increases in Autism Reported to California’s Developmental Services System”
Archives of General Psychiatry, Robert Schechter, MD (January 2008) They gave it a 1.

“The entire study is based on the false premise that children’s vaccines no longer contain mercury. ” Not true. The premise was that mercury exposure declined over time.

This study looked at the prevalence of autism from 1995 to 2007. From 1999 to 2001, when most of the thimerosal was removed from the vaccine schedule, From 1995 to 2007 autism rates rose. Again, demonstrating that thimerosol is protective?

Another relatively clean and compelling epidemiologic study. The “Bad” studies that show an no association between vaccines and autism are all messy, as life is messy. They are several logs better than “Our” studies. The best study, a randomized, prospective, blinded trial can never ethically be done.

4) “Neuropsychological Performance 10 Years After Immunization in Infancy With Thimerosal-Containing Vaccines” Pediatrics, Alberto Eugenio Tozzi, Patrizia Bisiacchi (February 2009). A negative 2. It is concerning that the those at Fourteen studies can take a 0 to 10 scale and, after adding 4 positive numbers, get a negative number. Next thing you know, they will say a study that demonstrates no association between a vaccine and autism actually shows such an association (11). They gave it a negative two due to “such extreme fraud”

In medicine, there is a dose response curve. More drug, more effect, less drug, less effect. The assumption, reasonable outside of the world of homeopathy, is that if groups of kids who get less thimerosal (62.5 mcg) are compared to kids who had more thimerosal, (137.5 mcg), there should be a less toxicity in the group that received less thimerosal.

Not so in this study. There was (mostly) no difference in the two groups.

“Nearly 70% of the invited subjects participated in the neuropsychological assessment (N = 1403). Among the 24 neuropsychological outcomes that were evaluated, only 2 were significantly associated with thimerosal exposure. Girls with higher thimerosal intake had lower mean scores in the finger-tapping test with the dominant hand and in the Boston Naming Test.”

And the association could have been due to chance as often happens in studies that look at multiple endpoints. Natural noise in biologic outcomes results in the occasional outlier looking significant. It is why studies need to be reproduced.

The Italians had only one autism case in the study, so, while interesting on the potential for other neurotoxicities from thimerosal, it does not directly address the issue of autism. But extreme fraud? Nope. I can’t find any. I half expect Fourteen studies to say “The CDC is infested with Vaccinationists. I have here in my hand a list of 205—a list of names that were made known to the Secretary of Health as being members of the Vaccinationist Party and who nevertheless are still working and shaping policy in the CDC (9).”

5) “Autism and Thimerosal-Containing Vaccines: Lack of Consistent Evidence for an Association”
American Journal of Preventive Medicine, Paul Stehr-Green, DrPh, MPH (August 2003). A zero score.

In this study they “compared the prevalence/incidence of autism in California, Sweden, and Denmark with average exposures to Thimerosal- containing vaccines.”
They found that as the use of thimerosal declined, the rates of autism rose in all three areas. The Swedes have much less autism than the US, whether real or diagnosed, I cannot say, but the results are as compelling as epidemiologic data gets. And there is a pattern in the studies.

6) “Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association” Pediatrics, John Heron and Nick Andrews, PhD (September 2004). This study received a -4, the worst score and worst addition in the group. Why the low score?

They looked at 14,000 kids, when they received a vaccine, then calculated the amount of thimerosal they received, and were “compared with a number of measures of childhood cognitive and behavioral development covering the period from 6 to 91 months of age.” They did not specifically look at autism.

Annoying for Fourteen studies, and perhaps the real reason it received a -4, is the explicitly stated result that the exposure of thimerosal was beneficial:

“Contrary to expectation, it was common for the unadjusted results to suggest a beneficial effect of thimerosal exposure. For example, exposure at 3 months was inversely associated with hyperactivity and conduct problems at 47 months; motor development at 6 months and at 30 months; difficulties with sounds at 81 months; and speech therapy, special needs, and “statementing” at 91 months.”

So mercury is good for you? I doubt it. It demonstrates the difficulties in retrospective epidemiologic studies, that occasionally the data has what are probably not real results. To be believed, it need to be reproduced.
How about adverse effects from thimerosall? No.

“We could find no convincing evidence that early exposure to thimerosal had any deleterious effect on neurologic or psychological outcome when given according to an accelerated schedule.”

Anyone besides me noticing a pattern here? Epidemiologic studies, all coming at a problem from a different angle, all with the same result. Of course, the same result is what you would expect from a high level conspiracy.

7) “Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years”
New England Journal of Medicine, Thompson WW et al. (September 27, 2007). Highest score with a 5 out of 40. No one, not even Fourteen studies, would dis the NEJM. It is not that different from study 4 that received a -2.

They looked at “1047 children between the ages of 7 and 10 years and administered standardized tests assessing 42 neuropsychological outcomes. (We did not assess autism-spectrum disorders) ” and how much thimerosal they received in vaccines. They found that mercury exposure in vaccines was probably not a neurotoxin.

“The weight of the evidence in this study does not support a causal association between early exposure to mercury from thimerosal containing vaccines and immune globulins administered prenatally or during infancy and neuropsychological functioning at the age of 7 to 10 years. The overall pattern of results suggests that the significant associations may have been chance findings stemming from the large number of statistical tests that we performed. “

“Association Between Thimerosal-Containing Vaccine and Autism”
Journal of the American Medical Association, Anders Hviid, MSc (October 2003). A score of 1.

The study looked at all children born in Denmark from 1990 and 1996 and found no difference in the rates of autism in kids vaccinated with vaccines that contained thimerosal and those that were vaccinated with vaccines that did not contain thimerosal.

As best they could tell, no relation between thimerosal and autism. They also found that as the use of thimerosal declined, the rates of autism increased.

The data was reanalyzed by Safe Minds on the assumption that cases of autism were lost and if that was factored in, autism rates declined when thimerosal was removed. The authors disagreed with this approach, and, in an exchange in the letters sections of JAMA (curiously not mentioned at 14 studies) said they checked with the source of the data, that the numbers used were not prevalence measurements, and that cases were not lost, invalidating the analysis of Safe Minds (3).

9) “Mercury concentrations and metabolism in infants receiving vaccines containing thimerosal: A descriptive study”
The Lancet, Michael Pichichero, MD (November 2002). Rated zero.

An interesting study that looked at mercury levels in children who received thimerosal containing vaccines and compared it to mercury blood levels in children who received thimerosal free vaccines. The mercury in the blood of the vaccine children was about twice that of controls, but well with in what is considered safe. And 12 of the samples in the vaccine group had no detectable mercury. It does not address the issue as to whether near homeopathic blood levels of mercury are associated with autism, but is an interesting basic science. I would, as mentioned above, expect a dose response effect of mercury and, if the levels after vaccine are low to undetectable after vaccine, I would be skeptical, on the basis of basic pharmakotoxicity, that mercury is a cause of autism.

Fourteen studies take? “One of the sillier studies ever performed, and the lead author is a vaccine patent-holder, no less. Absurd that this study appears on lists of studies exploring the relationship of vaccines to autism, as it doesn’t even address the topic. More absurd is the author’s complete misunderstanding of how mercury is excreted from the body.”

I can’t see why this is silly. If you are to understand how ethylmercury is toxic, in part you need to understand its pharmakokinetics, how it is excreted and where it goes in the body. Which is what this study investigated and reported.  Based on the critics, I imagine they would only be satisfied if brain biopsies were done to measure mercury level in the CNS.  If you think the return of polio is ok, probably a brain biopsy would not be so bad (12).

10)  “Thimerosal and Autism?” Pediatrics, Karen Nelson, MD (March 2003). Rated zero.

A nice review that concludes, based on 60, yes 60 (when I count postive numbers, I get a postive number), which, in my world of numbers, is greater than 14, papers that there is no link between thimerosal and autism.

11) “Lack of Association Between Rh Status, Rh Immune Globulin in Pregnancy and Autism”
American Journal of Medical Genetics, Judith H. Miles and T. Nicole Takahashi (May 2007). Another zero.

Looks at whether Rh Immune Globulin, which contains thimerosal, is associated with autism. It isn’t. While not a vaccine, it is a mercury exposure, and does concern the issue as to whether or not thimerosal is toxic.

That’s the 11 articles that address thimerosal and autism. A very compelling series of articles that, when taken as a whole, are convincing that there is no relation between mercury and autism. I had read the articles piecemeal before, but, like evolution, when read in total, are an excellent argument that thimerosal is not associated with autism.

Lets move on to the 7 articles concerning MMR and autism

Wakefield had a study published in Lancet titled ” Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children,” that has had some issues.

This study demonstrated that “Onset of behavioral symptoms [autism] was associated, by the parents, with measles, mumps, and rubella vaccination [MMR] in eight of the 12 children, with measles infection in one child, and otitis media in another…We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.”

The response of fourteen studies is that “This relatively straightforward conclusion, that the MMR may in fact be related to autism, set off a worldwide controversy and a mini-industry of bogus scientific reports trying to refute the idea that MMR and autism are related. You will see many of the studies below.”

If true, the Wakefield needs to be reproduced, if not true, that also needs to be determined. The first study that looked at high dose steroids and sepsis showed benefit. Multiple subsequent studies (or should I say a mini-industry of bogus scientific reports trying to refute the idea that steroids were helpful) showed harm and no benefit. A typical and annoying feature of the medical literature is differing results. It is why it is important to consider both biologic plausibility and the results of the preponderance of studies.

The following studies, unlike the Wakefield study, are bogus. Hm.

12) “Lack of Association Between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study”
PLoS One, Mady Hornig, Thomas Briese T, et al. (September 2008). Rated 1.

The secret to believable medical information is reproducibility. Cold fusion died because no one can reproduce it. So an association between MMR and autism will have to be reproduced to be compelling.

They tried, in part, to repeat the Wakefield study, They did not get the same results. “However, it made one critical distinction from the Wakefield approach: it didn’t recruit for the subset of children with autism who regressed after MMR vaccination.” Evidently, neither did Wakefield.

“The sample was an age-matched group of US children undergoing clinically-indicated ileocolonoscopy. Ileal and cecal tissues from 25 children with autism and GI disturbances and 13 children with GI disturbances alone (controls) were evaluated by real-time reverse transcription (RT)-PCR for presence of MV RNA in three laboratories blinded to diagnosis, including one wherein the original findings suggesting a link between MV and ASD were reported. The temporal order of onset of GI episodes and autism relative to timing of MMR administration was examined. We found no differences between case and control groups in the presence of MV RNA in ileum and cecum. Results were consistent across the three laboratory sites. GI symptom and autism onset were unrelated to MMR timing.”

This study had the advantage over the Wakefield study in that the data was not made up or falsified.

13) “MMR Vaccination and Pervasive Developmental Disorders: A Case-Control Study” The Lancet, Liam Smeeth, MRCGP, Eric Fombonne, MD (September 11, 2004). Rated a 2.

In medicine, if you want to see if there is a risk of disease in a population, you do a case control study. The two groups differ in (hopefully) one variable. In this study they compared “1294 cases and 4469 controls were included. 1010 cases (78·1%) had MMR vaccination recorded before diagnosis, compared with 3671 controls (82·1%) before the age at which their matched case was diagnosed.”

They could find no association between the MMR and autism. Fourteen studies argues that the MMR causes regression of autism, which was not the point of the study, and therefore the study is no good because it looked at the ‘wrong’ question. It is an easy and typical criticism throughout Fourteen studies: the study looked for and found no association using a given methodology. The study is no good because it didn’t look at the information Fourteen studies thought it should. Given that most studies try for a narrow focus, there will always be a component not evaluated. A common straw man argument throughout the website.

Within the context of the study, it is reasonable to conclude that the MMR is not associated with developing autism.

14) “Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunizations”
Pediatrics, Eric Fombonne, MD (July 2006). Another issue with addition, it is rated -2.

The negative number may come from the finding that “The prevalence of pervasive developmental disorder in thimerosal free birth cohorts was significantly higher than that in thimerosal-exposed cohorts (82.7 of 10 000 vs 59.5 of 10 000).” Curious we now have several studies that showed thimerosal to be protective. Ouch.

To add insult to injury, they also found

“Pervasive developmental disorder rates significantly increased when measles-mumps-rubella vaccination uptake rates significantly decreased. In addition, pervasive developmental disorder prevalence increased at the same rate before and after the introduction in 1996 of the second measles-mumps-rubella dose, suggesting no increased risk of pervasive developmental disorder associated with a 2–measles-mumps-rubella dosing schedule before age 2 years.”

Now I feel like Truedeau. The vaccination information THEY don’t you to know: MMR and thimerosal are protective for developing autism.

They derived this information looking at 27,000 kids, 180 of whom had a pervasive developmental disorder, including autism and comparing rates of autism (which went up) with thimerosal and MMR use (both of which went down).

15) “No Evidence for a New Variant of Measles-Mumps-Rubella-Induced Autism”
Pediatrics, Eric Fombonne, FRCPsych (October 2001). A one rating.

Their insightful analysis of the article starts “What is it with Eric Fombonne and Pediatrics? ” I do not think they approve of Fombonne. Next they will accuse him for something he didn’t do (11).  Not a sign of compelling science analysis and they do not give a reason for the 1 rating, the link takes one to another site for analysis. Suggesting again a mini-industry of bogus scientific ratings trying to refute the idea that MMR and autism are not related.

This study, with small numbers, compared 96 children with MMR and autism to data from other studies of children with autism before and after an MMR. Not the most compelling of methodological design (more cases are always better, especially if looking for very rare events) and looked to support 6 hypothesis:

“1. Childhood disintegrative disorder might have become more frequent;
2. The mean and distribution of age at which parents become concerned has changed and is closer to the mean immunization age than in children who were not exposed to MMR;
3. Regression in the development of children with autism has become more common;
4. The age of onset of symptoms for autistic children with regression clusters around the immunization date and is different from that of autistic children without regression;
5. Children with regressive autism may have distinct symptom and severity profiles; and
6. Regressive autism is associated with gastrointestinal symptoms, and children with regressive autism may exhibit increased frequency of inflammatory bowel disorders. “

Their data comparisons did not support any of the above. Not the most convincing data set, but in the context of the above studies, ok conclusions.

16) “No effect of MMR withdrawal on the incidence of autism: a total population study”
Journal of Child Psychology and Psychiatry, Hideo Honda, Michael Rutter. A five.

Highest score in the group. Why?

“We gave this study our highest score because it appears to actually show that MMR contributes to higher autism rates.”
The key phrase in the whole site. Data that supports their position is good, data that doesn’t is bad. What makes a study good is not its methodology or its rigor, but if it supports vaccines casing autism. Bass Ackwards thinking.
The position that vaccines cause autism is determined, then you look for data that supports the position. When you read the studies, they do not support the position that the MMR is associated with autism.

It is doubly odd in that the paper’s conclusion is that

“The MMR vaccination rate in the city of Yokohama declined significantly in the birth cohorts of years 1988 through 1992, and not a single vaccination was administered in 1993 or thereafter. In contrast, cumulative incidence of ASD up to age seven increased significantly in the birth cohorts of years 1988 through 1996 and most notably rose dramatically beginning with the birth cohort of 1993.”
Remember reference 4? Foreshadowing.

In Yokohama they gave ZERO MMR’s after 1993. Zip. The result?

Kind of hard to argue that MMR leads to autism when autism rates continue to increase after no more MMR is given. One explanation link as to why black is really white leads to ‘404 not found error,’ the other links to a web page where, as best I can gather, they argue that the MMR withdrawal lead to a decrease in autism because there was actually an increase in autism due to increase in the use of Japanese encephalitis and single measles vaccines. Which demonstrates that the increased autism rates that followed MMR removal were a decline in autism rates. I may have that wrong. Read it and let me know. Maybe the 404 site explained it better.

17) “Measles Vaccination and Antibody Response in Autism Spectrum Disorders”
Archives of Disease in Childhood, Gillian Baird (February 2008). Rated a one, they must have become distracted in the MMR section as they do not give a breakdown of how the score was derived for the last five studies.

They looked at antibody to measles as a result of MMR in autism cases and controls and found no correlation. This one study adds little to the data. It supports the lack of correlation between MMR and autism, but the last study is far more compelling.

18) “Neurologic Disorders After Measles-Mumps-Rubella Vaccination”
Pediatrics, Annamari Makela, MD (November 2002). Another zero without reason.
This study looked at 535, 544 children for neurologic events after MMR. It was more to look at encephalitis and meningitis, which were not increased as a result of the vaccine. Autism was not also seen, but, as legitimately pointed out (the one and only legitimate sentence in the whole web site) “it used “hospitalizations” as a criteria for finding children with autism.” Not a good way to find autism cases, I agree.

The last paper in the group,
Association of Autistic Spectrum Disorder and the Measles, Mumps, and Rubella Vaccine”
Archives of Pediatrics & Adolescent Medicine, Eric Fombonne, FRCPsych (July 2003) is a structured review of 28 papers that fails to demonstrate a relationship between the MMR and autism.

This is really odd. Their ‘headline’ is “Fombonne again.”
But the authors of this reference are Kumanan Wilson, MD, MSc, FRCP(C); Ed Mills, DPH; Cory Ross, MSc, DPH, CHE; Jessie McGowan BMus, MLIS; Alex Jadad MD, DPhil, FRCP(C). I cut and pasted it from the reference.

For posterity’s sake, here is a screenshot before they change it:

Are they even reading the damn articles?
The full title of the article is “Association of Autistic Spectrum Disorder and the Measles, Mumps, and Rubella Vaccine
A Systematic Review of Current Epidemiological Evidence.”

The key words, left out by Fourteen studies, are ” Systematic review.” For those who do not have to read the medical literature (bold added by me),

“Systematic reviews are scientific investigations in themselves, with pre-planned methods and an assembly of original studies as their “subjects.” They synthesize the results of multiple primary investigations by using strategies that limit bias and random error. These strategies include a comprehensive search of all potentially relevant articles and the use of explicit, reproducible criteria in the selection of articles for review. Primary research designs and study characteristics are appraised, data are synthesized, and results are interpreted.”

“A systematic review involves the application of scientific strategies, in ways that limit bias, to the assembly, critical appraisal, and synthesis of all relevant studies that address a specific clinical question. (7)”

A well done Systematic review is more that a review, it is a valuable, if less than perfect, way to evaluate a literature that tries to correct for bias and for variation in study methodologies.

Finally, if you want another excellent (free) review, try Vaccines and Autism: A Tale of Shifting Hypothesis.

I read over 100 or so journal articles a month just for my Infectious Disease podcast. Plus those I read for patient care, for general interest, for the blogs. They are of variable quality, from the ground breaking to the incomprehensible. The ‘bad’ references on the fourteen studies site are by and large pretty good, especially given the methodologic, logistic and ethical problems in doing large epidemiologic studies.

In medicine, as in all of science, no single study is definitive. Epidemiologic studies in medicine are particularly messy, and researchers never do a perfect study. I am always impressed with the ingenuity and hard work on the part of epidemiologists to get good information out of complicated and incomplete data sets. You have to read all the studies in context of biologic plausibility, the flaws in a given study, reproducibility, and, yes, the financial bias of the researcher.

I would like to thank the Fourteen studies for their website. Anyone who takes the time to read all the articles will come away convinced of the safety of both thimerosal and the MMR vaccine, especially in contrast to the quality of ‘our’ studies that purport a causation. The moving target of the cause of autism appears to be shifting to aluminum and too much too soon. I’m skeptical on biologic plausibility grounds. I am as certain as I can be (i.e. I am one, preferable more, high quality studies in a high impact journal from changing my mind) that the vaccines, both separately and together, are many logs safer than the diseases they prevent.

Now I get to read the other blog entries on the topic. About time.

========

References

*I love the movie 28 Days Later and its sequel. Something about fast, mindless, infected zombies running amok, producing more mindless zombies with the resultant body count appeals to me. I didn’t care for Shawn of the Dead, which didn’t work as either a comedy or a zombie movie for me. But do read World War Z if you are a zombie fan.

(1) Not that I do not want to sell my soul. I do. I just set the price higher than most want to pay.

(2) In the spirit of transparency, I will admit she isn’t. A review of the Internet Movie Database suggests I have never seen her perform, but most movies I see are with my 11 year old and are animated.

(3) JAMA letters Vol 291, No 2, page 181

(4) Not enough for my taste, but I am a crank on the topic. I think everyone should have to list, in dollar amounts, all direct and indirect (travel, food etc) support they receive if they give CME accredited lectures or publish in journals

(5) I can’t download the Lancet references with paying first. I doubt the publishers will complain as it would look like they are in cahoots with Big Pharma to suppress information.

(6) I don’t really think that. It is what the data would suggest, but I can’t really see the plausibility.

(7) http://www.annals.org/cgi/content/full/126/5/376

(8) A child evidently vaccinated against reality.

(9) They do not capitalize their title, very hip edgy. For a drug company. To be really Web 2.0 it needs a random capital and a vowel removal: snoFi psTeur.

(10) Modified from Joseph McCarthy, US Senator.

(11) A literary device called foreshadowing.

(12) “I do believe sadly it’s going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it’s their f___ing fault that the diseases are coming back. They’re making a product that’s s___. If you give us a safe vaccine, we’ll use it. It shouldn’t be polio versus autism.” http://www.time.com/time/health/article/0,8599,1888718,00.html

In this case, however, I feel some explanation is in order because I feel a bit responsible for having brought J.B.’s wrath down upon Steve. First, a little history (albeit recent history) is in order. As I described in detail last week and the week before, Generation Rescue, with Jenny McCarthy and Jim Carrey at the fore, sometimes with J.B. himself, has mounted an impressive anti-vaccine propaganda effort. It started with a media tour promoting her most recent paean to anti-vaccine pseudoscience and autism quackery written with “co-author” Dr. Jerry Kartzinel. The book is entitled Healing and Preventing Autism: A Complete Guide, and three weeks ago Jenny McCarthy and her boyfriend Jim Carrey showed up on Larry King Live to tout a truly incompetent and intellectually dishonest “study” that purported to find that U.S. children are the “most highly vaccinated children in the world” and that that’s correlated with our higher autism rates. I would have none of it. Next, Generation Rescue introduced its equally intellectually dishonest “Fourteen Studies” website, which launched dubious attacks from pseudoexperts on fourteen of the major studies that failed to find a correlation between vaccines and autism or thimerosal-containing vaccines and autism. I wrote a lengthy post for SBM describing the utter intellectual and scientific bankruptcy of the entire enterprise.

Now, to go back a little further, J.B. and I have a bit of a history dating all the way back to when I first became interested in the antivaccine movement in 2005. This history, however, had played out entirely on my other blog, where as many readers here know, I blog under a pseudonym. Handley consistently thought that by “outing” me (as cranks as varied as antivaccinationists and creationists had done before) he would somehow frighten me into silence. My persistence over four years shows how well that worked. In any case, we at SBM had discussed divvying up both the studies that Generation Rescue hated (the fourteen studies) and the highly dubious studies they liked, several of which I’ve discussed in detail, showing why they were so bad. As a part of this, Steve did a followup post on one specific study, the one that is often referred to in the literature as the “Danish study,” that failed to find a correlation between mercury in vaccines and autism. Characteristically, Steve did an excellent job.

Here’s where the story gets interesting. One week after I posted my deconstruction of J.B. Handley’s “Fourteen Studies,” I reposted a modified version of the same post on my other blog. I explicitly did this as an experiment whose hypothesis was that J.B. would only attack my pseudonymous persona and would not attack me under my own name, because doing so would rob him of his ability to whine about my blogging under a pseudonym. Never mind that my pseudonym is perhaps the worst-kept secret in the medical/scientific blogosphere. (It also didn’t hurt that I was away at the AACR Meeting in Denver and needed some easy material because I didn’t have time to blog.) As predicted, J.B. didn’t bite at the first version. Also as predicted, he did show up in the other version, saying:

What the hell is wrong with your brain? Why is this such a hard concept for you to grasp? How did you get to be so stupid?

To which I replied:

As I predicted when I posted this, JB was a no show elsewhere but a show here. I wonder why. I also wonder why he didn’t also show up at Steve Novella’s takedown or the takedown published by a “friend” of the blog a week ago.

Thank you, JB, for confirming my hypothesis, though. I do appreciate it, and you are always welcome to comment here and on my “friend’s” blog.

The next day, J.B. Handley launched a nasty personal attack on Steve on Age of Autism, the antivaccine propaganda blog, which appears to be a wholly owned subsidiary of Generation Rescue where J.B., along with his merry band of antivaccine zealots including David Kirby, Dan Olmsted, Kim Stagliano, and others, regularly blogs.

Now do you see why I feel a bit responsible? I suspect that my amused tweaking of J.B. led to his shifting his frustration to Steve, who is far nicer and more civil than I usually am when dealing with nonsense on the order of what Age of Autism and Generation Rescue regularly serve up.

Certainly, though, I’m not worried that Steve couldn’t handle himself against a booster of pseudoscience like J.B. Steve was more than able to write a devastating response to J.B.’s attack that eviscerated his every point, and I can’t wait to see what the skeptical rogues on The Skeptics’ Guide to the Universe will say about this. However, having had a bit more–shall we say?–history with J.B., certain aspects of his attack caught my attention.

First, this:

I don’t know Dr. Novella and I certainly having nothing against him personally, but I was stunned by the utter lack of knowledge and critical thinking that went into his critique of our new site.

I find it amusing that apparently J.B. doesn’t read his own blog because last July Age of Autism published a response by Hannah Poling’s father Dr. Jon Poling to Steve’s discussion of the Hannah Poling case, to which Steve responded. It was actually a pretty big deal. Here’s a little hint to J.B. that I learned long ago blogging: Search your own blog for any person or topic you’re thinking of writing about to make see if you’ve addressed the topic or person before, and, if you did, what you or your coblogger said. Most amusing about this misstep, J.B.’s self-absorption is showing. Apparently if he hasn’t heard of someone (or has but forgot about him), that person is insignificant. Be that as it may, this passage, more than any other, boils down J.B.’s mindset. It’s pathognomonic of him and explain much about why he hates us “pointy-headed” scientists so much:

I’m not intellectually intimidated by any of these jokers. Their degrees mean zippo to me, because I knew plenty of knuckleheads in college who went on to be doctors, and they’re still knuckleheads (I also knew plenty of great, smart guys who went on to be doctors and they’re still great, smart guys).
�
I chose a different path and went into the business world. In the business world, having a degree from a great college or business school gets you your first job, and not much else. There are plenty of Harvard Business School grads who have bankrupted companies and gone to jail, and plenty of high school drop-outs who are multi-millionaires. Brains and street-smarts win, not degrees, arrogance, or entitlement.

In other words, to J.B., it’s all about “elitism.” He honestly seems to believe that the reason the scientific community doesn’t accept his wild beliefs that vaccines cause autism is because of elitism and groupthink, not because the scientific evidence doesn’t support that belief. Unlike the case for scientists, it never occurs to him that he might be wrong or that the reason he is viewed with such disdain among scientists is because, well, he is wrong. But not just wrong, spectacularly and arrogantly wrong about the science. As both Steve and I have pointed out, it is the arrogance of ignorance.

J.B. also clearly doesn’t understand the nature of academic medicine and science. He seems to think it’s some sort of cushy ivory tower where a Ph.D. guarantees one a career. He’s so wrong on this one that he is, as they say, “not even wrong.” However, as I am in a benevolent mood, I’ll educate J.B. a bit on what it takes to be a academic faculty at a major university. First off, a Ph.D. (or an M.D.) doesn’t guarantee anything. Making a parallel to the business world, sure, it helps to have a Ph.D. from a good school. It’ll help to get a good postdoctoral position. However, once you’re in your postdoc, no one really gives a rodent’s posterior where you went to school, and, if you’re an M.D., once you’re in your residency, no one cares anymore where you graduated from medical school. They really don’t. All they care about is how well you do where you are now.

In fact, science is every bit as Darwinian a career as business, with the exception that the rewards are not financial, nor is a scientists’s worth measured by money, which appears to be the be-all and end-all for how J.B. views success, given his remark about millionaires. After fighting to get into a good Ph.D. program, a freshly minted scientist needs to fight to get a good postdoc. Once there, he has to produce. He has to demonstrate his worth by doing good science and publishing in good journals. Then, because obtaining an entry-level faculty position has become intensely competitive, a new Ph.D. often needs to do two or even three two- to three-year postdocs in order to amass enough of a track record to entice a university to take a chance on him with a lab and a startup package. Finally, once a new scientist has a faculty position, he has in general around three or four years to obtain independent research funding to cover at least 50% of his salary as a condition of tenure, or he will be fired and have to start all over again looking for a new faculty position, which will be harder to find after having failed to gain tenure at one institution. Worse, over the last few years, getting that initial grant has become harder than ever. In the past, scientists who failed to gain tenure often ended up working for pharma, but in the current climate pharma has been downsizing. There now exists an underclass of underemployed Ph.D. scientists, who may be poorly paid adjunct professors with no hope of any permanent work.

So let’s see: Get funded in three or four years or get fired to face a highly uncertain fate. That sounds pretty hardcore to me. I will admit that it’s easier for academic physicians in that they can always return to practicing medicine if they fail, but will no longer have a lab. I will grant that, once a scientist obtains tenure, things are easier in that he can’t be easily fired, but, trust me, if a scientist doesn’t produce and loses funding, he will find himself in a world of hurt. Schools have ways of making such faculty’s lives so miserable that they end up quitting.

J.B. also doesn’t understand the culture of science at the faculty level, either. Once someone becomes a full scientist and obtains an academic position, no one cares where he or she went to school, where he did his postdoc, or where he did his residency. Really. No one does. All they care about is whether that person does good science, publishes good science, and can get his or her science funded. In this, science and medicine are a lot like the business world that J.B. waxes so rhapsodic about. J.B. is also wrong to think that “street smarts” should win in science. They don’t necessarily, because what matters is doing good science. The scientific method is a systematized method of minimizing human bias and error, whereas “street smarts” are, all too often, all about hunches. Hunches can be valuable in science, but only as a first step. If a hunch isn’t supported by scientific evidence, it is worthless, and scientists will discard it. It may not happen as fast as we like; it may be messier than we like; but eventually it will happen. That’s the difference between scientists and J.B. Handley. No matter how cherished our hunches are, we do consider the possibility that they may be wrong, and eventually we can be persuaded that they are wrong if the evidence is strong enough. Indeed, this is perhaps the most ignorant thing J.B. said in his attack:

I have been astonished by the culture of arrogance and elitism that medical schools appear to breed in their doctors and scientists. The culture tends to produce an “us vs. them” mentality, where doctors collectively back each other up on controversial issues, typically without understanding the issue for themselves.

J.B. really hasn’t seen how cut-throat scientific arguments can be. Moreover, science actually does reward overthrowing the existing paradigm. Look at the list of Nobel Prize winners. You won’t find anyone there who won that prize because he or she simply confirmed pre-existing scientific dogma. Believe me, if a scientists provided compelling scientific evidence that vaccines or mercury in vaccines do cause autism and could show how they do it, that scientist would be instantly famous and a serious contender for a Nobel Prize. In any case, clearly the accusation of “arrogance” against J.B. really stings him. However, what else should we call it when someone, without any knowledge or training, blithely rejects the findings of science and labels them all a vast conspiracy to “hide the truth”? Or when someone thinks his “street smarts” trumps the accumulated knowledge of science thus far? Arrogance doesn’t begin to describe such an attitude, and only a lack of understanding of science could have produced this comment:

On of the most fascinating aspects of the autism epidemic is how the mainstream health community seems to get away with a stunning paradox: they are so damn smart that they are certain as to what doesn’t cause autism, but they haven’t a clue as to what does. How can that be? Why aren’t the smarts being applied to finding the cause?

This is nothing more than the classic logical fallacy of an appeal to ignorance. In other words, to J.B. because scientists don’t really know what does cause autism, then his pet view that vaccines cause autism must be plausible.

After my having dealt with J.B. online on and off for four years, one thing that’s become clear to me is that he does not understand science. He thinks he does, but he does not. He has made up his mind about vaccines and autism and is not open to evidence falsifying his belief. That is inimical to the culture of science, which is always testing scientific dogma versus reality and discarding what doesn’t line up with the evidence. With few exceptions, even the most dogmatic of scientists can be persuaded if the evidence is strong enough. In contrast, Mr. Handley clearly views science as a tool to support his conclusions and an enemy when it does not. Moreover, viewing the vaccine-autism pseudoscience through the prism of a businessman’s viewpoint, rather than a scientist’s viewpoint, to him it’s a propaganda battle to win, not a scientific question to answer. Like any good businessman, he has a product to sell, and sell it he does, using all the tools of Madison Avenue pitch men at his disposal. It doesn’t matter to him if the product is a lemon; he needs to sell it.

Moreover, the entire culture at the Age of Autism is an increasingly paranoid echo chamber. Just look at some of the comments there:

Dr. Novella buries his nose in literature, but he fails to recognize the political backstories that skewed the studies. And he hasn’t had face time — or G.I. time — with any kids on the autism spectrum. His selective ignorance is not only arrogant, it’s life-threatening. (Nancy Hokkanen)

Novella is part of the HealthFraud crowd, started by Barrett who was the cover for the AMA when its dirty tricks dept had to go underground.

To see what sort of operation is going on it would help to study the COINTRELPRO operation of the FBI.

His comment “including the Centers for Disease Control, the American Academy of Pediatrics, The American Medical Association, the Institute of Medicine, and the March of Dimes.”

is just the old authority ploy, or ‘lying with the truth’. Blair was the master, of course. (john)

And, my favorite:

Novella, I believe, is one of the members of the “Quackwatch,” along with Gorski (aka Orac, aka Dirtbag, aka whoever knows how many other aliases he hides behind), Probert (aka TheProbe, aka Freespeaker), Kevin Leitch, and numerous others. I find it deliciously ironic that they claim to be a group of people concerned about quackery in all of its forms (and, they even have the cute little “superhero” names to prove it), and they are the biggest quacks of them all! (Craig Willoughby, who has abandoned any prior pretense of rationality.)

I love the adoration of my fans, much as, I suspect, Steve does. Word to Craig: I don’t have any other aliases than the two you know about. I’m also terribly, terribly hurt that you consider me a “dirtbag.”

I presented these examples to show just how inimical to science the entire Age of Autism crew is. If science doesn’t jibe with their beliefs, then everyone who criticizes them is part of some huge conspiracy by The Man (in the form of the CDC, AAP, big pharma, and the government) to suppress The Truth. Personally, I often joke that I wish there were such a conspiracy, because I want in on some of that filthy big pharma lucre for doing what I would do anyway: Writing about pseudoscience and quackery. Maybe I could even quit my day job and sit around in my shorts all day blogging. Alas, it is not to be, and I have to blog in my spare time.

In the end, I feel rather sorry for J.B. Sure, he’s rich. Sure, he gets to pal around with celebrities these days. However, he labors under the delusion that vaccines caused his child’s autism and that various forms of “biomedical therapy” (a.k.a. autism quackery) will cure it. He may never believe me when I say this, but it would actually be fantastic if scientists could find so obvious and simple a cause of autism as vaccines; if that were the case, doctors could change their practice to correct the problem. That’s what we do when we find out that a treatment is causing harm. Moreover, if all the dubious “biomedical” interventions actually worked, it would mean that scientists would have a huge leg up in figuring out what the cause of autism is; they do not, and so scientists do not, and doctors still have only limited options of relatively weak efficacy for treating autistic children. Worse, J.B. is in the position to do so much good for autistic children, but instead he chooses to use his wealth and business savvy to promote pseudoscience that is not just harmful to autistic children, but potentially harmful to all children through its discouragement of vaccination and the increasing risk of outbreaks of vaccine-preventable diseases that follow from his antivaccine activism.

But more telling is J.B. reaction to criticism. In the case of Steve he relies primarily on ad hominems and distortions. In the case of me, he’s utterly ignored my criticisms of his “Fourteen Studies” website, at least not those written under my own name. Whether it’s because he doesn’t want to give me the satisfaction of responding or because he’s embarrassed at realizing that he’s behaved exactly as I had publicly predicted, I don’t know. In any case, rather than addressing actual substantive criticisms, he routinely chooses to lash out at critics when they score direct hits on his nonsense, digging any dirt he can at the University of Google and slinging the mud far and wide. That should tell you all you need to know.

On that anti-vaccine propaganda site J.B. Handley begins his introduction with this logical fallacy:

Of all the remarkable frauds that will one day surround the autism epidemic, perhaps one of the most galling is the simple statement that the “science has spoken” and “vaccines don’t cause autism.” Anytime a public health official or other talking head states this, you can be assured that one of two things is true: they have never read the studies they are talking about, or they are lying through their teeth.

Of course this is  a false dichotomy, or forced choice.  I personally know of many people, including myself and David, who have both read all the studies and are telling the truth about our opinions that they do not support a link between autism and vaccines. It seems to be inconceivable to Mr. Handley that an informed professional could honestly disagree with his opinions – such is the nature of fanaticism.

It is also remarkable that Handley himself quotes many professional, expert, and advisory bodies who also have read the studies and concluded that they overwhelmingly support the conclusion of a lack of correlation between vaccines and autism – including the Centers for Disease Control, the American Academy of Pediatrics, The American Medical Association, the Institute of Medicine, and the March of Dimes. Handley casually and self-servingly assumes that all of the professionals in these organizations are incompetent or they are lying.

And keep in mind what it would mean to lie on this issue – Handley believes that many doctors who have chosen the career path of public health are deliberately condemning millions of children to autism simply to avoid admitting past error, because they cannot face the horrible truth, or to receive their Big Pharma kickbacks. It’s no wonder their rhetoric often becomes hysterical – they really believe this is going on. For some reason it is easier for them to believe this astounding horrible claim than even consider the possibility that perhaps they have misinterpreted the science and that trained experts who have dedicated their lives to understanding the science may know better. This is what we call the “arrogance of ignorance.”

I wish to add that there are also many scientist and physician bloggers who have also taken the time to analyze the data and agree with the consensus opinion of no link. We have no dog in this hunt. David and I, for example, do not prescribe vaccines in our practice, we do not work for pharmaceutical companies, we are not involved in litigation – we have none of the conflicts of interest typically cited to discredit otherwise valid studies or opinions. Our only personal stake in this issue, as science bloggers, is our reputations, which are based upon honest and transparent analysis. We have nothing to gain and everything to lose if we are dishonest or sloppy on this issue.

You also cannot legitimately argue, as many often attempt to, that we are just protecting the status quo or that we are doing this as a favor to our colleagues. We have taken up the task of criticising our colleagues and the status quo whenever we feel it is appropriate. We are in the business of ruffling feathers. Our only stake is in defending something we firmly believe in – science-based medicine.

But the anti-vaccine fanatics simply assume we must be hiding some conflict of interest, or that we are simply incapable of seeing the Truth. That is the paranoid behavior of a cult.

With David’s post for background on the methods used, I will add to his analysis one more of the studies in question.

Madsen 2003 Danish Study

Madsen et al evaluated autism rates in Denmark from 1971 – 2000. From 1961 – 1970 children received 400 micrograms of thimerosal. From 1971-1992 they received 250 micrograms of thimerosal. After 1992 all thimerosal was removed from childhood vaccines in Denmark. The study identified 962 children with autism over this period. They found that from 1970 to 1990 there was no change in the incidence of autism. After 1990 autism rates began to increase, which was attributed to expanding diagnosis and surveillance. These numbers generally match the experience in other Western nations.

The authors conclude that there was no association in their study between thimerosal dose and autism rates.  This is the same as the experience so far in the US – thimerosal was removed by 2002 and yet autism rates continued to rise without a blip.

The “fourteen studies” site gives this study a score of 1 on their rigged scale. There main criticism is that in 1994 outpatient records were used in addition to inpatient records to assess autism incidence. By itself this is a legitimate criticism, but it does no invalidate the study as they suggest. This is a potential weakness of retrospective studies – researchers are somewhat dependent on the consistency of methods used over the years in study. The authors of this study were completely up front about the changing methods over time and the potential impact on their data.

But anti-vaccine critics miss a couple of very important points. First, if thimerosal were a significant contributor to autism rates then we would expect (as with all toxins) a dose response effect. In 1970 the dose of thimerosal in the Danish vaccine schedule was reduced from 400 to 250 micrograms. This did not result in a decrease in autism rates 3-7 years later as one would predict from the thimerosal hypothesis. Autism rates were stable during this time, and there are no concerns about altering methods of diagnosis or counting during this time.

Second – Madsen and his co-authors were well aware of the effects of altering counting methods in their study. Therefore they did the following:

In additional analyses we examined data using inpatients only. This was done to elucidate the contribution of the outpatient registration to the change in incidence. The same trend with an increase in the incidence rates from 1990 until the end of the study period was see.

So they did a reasonable assessment of the effect of adding outpatient to inpatient records on their data by looking at the inpatient data alone, and they found the same trend.  This completely invalidates the criticism of this study by the anti-vaccine crowd, which is premised on the fact that the increasing rates of autism after 1990 were due to the addition of outpatient records.

The bottom line is that this study shows no correlation between changing doses of thimerosal and autism rates. It does reveal an increase in autism rates beginning in the early 1990s resulting from expanded diagnosis and surveillance. It is interesting that the anti-vaccine critics use that very fact to argue that this study is not valid. Yet otherwise they deny that increasing autism rates are due to these factors because it is their claim that the increase in autism rates were due to vaccines. They therefore directly contradict themselves.

In addition to a lack of correlation between thimerosal and autism, this study supports the conclusion that the rise of autism rates in the 1990s and beyond are due to changes in the definition of autism and efforts to make the diagnosis in the population. That is the common element between Denmark and the US. Exposure to thimerosal and the vaccine schedule differed between these two countries, and yet autism rates were similar. Thimerosal and vaccines are not the common element in the rise of autism diagnoses – definition and surveillance are. So this data becomes much more powerful evidence against a link between autism and vaccines when it is considered in the context of US data.

The “fourteen studies” website declares:

Where is the truth? Like everything else in life, the devil is in the details.

It is indeed.

The reason is that, in retrospect, I now realize that the Jenny and Jim antivaccine propaganda tour was clearly merely phase I of Generation Rescue’s April public relations offensive. In rapid succession last week, courtesy of J.B. Handley, the founder of Generation Rescue, who in order to have a couple of famous faces fronting his organization has allowed himself to be displaced, so that Generation Rescue has now been “reborn” as Jenny McCarthy and Jim Carrey’s Autism Organization (the better to capitalize on her D-list celebrity yoked to Jim Carrey’s formerly A-list (but rapidly plunging) celebrity), announced Generation Rescue’s latest initiative in a post on its antivaccine blog Age of Autism entitled Fourteen Studies? Only if you never read them.:

For me, it all started when Amanda Peet said the following in her “apology” to calling parents parasites:

“Fourteen studies have been conducted (both here in the US and abroad), and these tests are reproducible; no matter where they are administered, or who is funding them, the conclusion is the same: there is no association between autism and vaccines.”

And, don’t think Amanda Peet is alone, the mantra comes fast and furious from all sides…

These comments were driving me nuts. I’d read a majority of the studies they were referring to, I knew how bad they were, and I also knew that most journalists couldn’t even find the studies being referred to, because most weren’t even on the web!!

Several hundred hours of work later, Generation Rescue is pleased to introduce a website with a very simple purpose: to tell the truth. You will find every study in its entirety and a whole lot more right here:

www.fourteenstudies.org

Before I dive in, let me just point out right here and right now that J.B. Handley wouldn’t be able to recognize good science if it bit him on the posterior. Ditto bad science, because he simply does not have an understanding of the scientific method or the methodology involved that would allow him to distinguish good from bad science. His well-known arrogance of ignorance leads him to be very confident that he knows as much or more than the pointy-headed scientists, whom he clearly despises and for whom he clearly has little but contempt, and can thus judge the quality of complicated epidemiology and basic science, but he clearly does not. That’s why Mr. Handley’s claim that he recognized these studies to be bad science by reading them made me chuckle heartily. After all, Mr. Handley’s proven time and time again that he doesn’t understand science, the scientific method, or epidemiology, and I find the picture that pops into my mind of Mr. Handley poring over epidemiological and scientific studies, carefully making note of the methodology and picking out the flaws almost as outlandish as Jenny McCarthy’s transformation from an “Indigo Mom” to a “warrior mom” for autistic children. That’s because J.B. also understands nothing about clinical trials and especially the ethics of clinical trials, one particularly egregious example of which I should someday post about. Be that as it may, right off the bat, I knew that this “Fourteen Studies” initiative was likely to be more of the same. The claim that it took “several hundred hours of work” is probably true, but, given the results, but it clearly wasn’t time and money well spent, at least on an intellectual level. Whether it was time and money well spent in terms of producing effective propaganda remains to be seen.

Taking a general view of the Fourteen Studies, I note that it’s divided broadly into what I can’t help but refer to “studies antivaccinationists hate” (because they are for the most part large, well-designed epidemiological studies that found no association between thimerosal and autism or vaccines and autism) and “studies antivaccinationists like.” Of this latter category, the studies listed that I recognize include some small preliminary studies (which are more prone to false positives), more than a fair amount of cluelessness (the Generation Rescue “vaxed versus antivaxed” phone survey, which I’ll discuss more later), the incompetent (pretty much anything by Andrew Wakefield or Mark and David Geier), or execrable (anything published in the vanity Medical Hypotheses, which discourages the publication of data and will publish virtually article as long as it presents a provocative and speculative hypothesis, making it a “what if?” speculative journal and not a serious research journal , or the crank journal, the Journal of American Physicians and Surgeons (JPANDS), whose penchant for antivaccine pseudoscience I’ve discussed in depth before on this very blog). Heavy hitters in the world of vaccine or autism science, these are not. (Hint: If you want to be taken seriously in the world of medical science, don’t cite JPANDS. Really. Don’t. Doing so is a deal breaker. Also, citing articles from Medical Hypotheses as though they were evidence of anything other than the author’s speculative flights of scientific fancy shows more cluelessness than anything else.)

I also recognize that a lot of these criticisms are the same old dubious, exaggerated, and/or fallacious criticisms of these studies that have been floating around in antivaccine circles for a long time. I recognize them because I have read nearly all of these articles myself, both the ones Generation Rescue likes and the ones it doesn’t like, over the years, and I have seen these “criticism” True, I’m more familiar with some of these studies than others, but in fact I have even blogged about some of them, here and elsewhere. (I will link to such posts where appropriate.) In essence, what I plan to do is to set the stage by discussing the overall intellectual dishonesty that underpins Fourteen Studies and then take a few (I hope) well-chosen examples to illustrate this intellectual dishonesty. Over the coming days, it is my hope that some of my fellow SBM bloggers will take on other examples, explaining the fallacies behind the “critiques” and why the “studies antivaccinationists like” are, by and large, not very good and/or do not show what antivaccinationists think they show.

We do this because we realize that the Fourteen Studies website is going to metastasize all over the web. That is clearly Mr. Handley’s intent; he saw what he feared to be an effective public relations gambit from scientists and physicians, and he couldn’t let that go unanswered. To him, it’s not about the science, but winning the P.R. war. That’s why we know that antivaccinists will be referring journalists to it, if they have not already begun to do so. We also predict that antivaccine parents will be planting printouts of it in front of their pediatricians in order to try to persuade them that the evidence base supporting the consensus that vaccines do not cause autism is hopelessly corrupt and weak. We realize that this is exactly the purpose of Generation Rescue’s new website, which is why we believe that there should be as many rebuttals on the web to which people can be referred as possible. In fact, it is my hope that our readers will help us out by deconstructing some of the studies in the comments, and that readers who happen to be bloggers will join in this effort by applying some evidence-based criticism to the site. Unfortunately, here at SBM can’t afford to spend the hundreds of hours that Generation Rescue spent on this website in order to counter the misinformation there. We do not have the time, nor do we have the money to pay someone to do it, as Generation Rescue apparently does.

“RANKING” CRITERIA THAT GUARANTEE THE OUTCOME

First, let’s take a look at how Generation Rescue “ranks” these 14 studies. This alone should show you more than anything else why this site is propaganda, not science. Whoever put it together first ranked the studies on a scale of 40 points, made up of four 10-point subscales. The first of these subscales is described thusly:

Asked the Right Question (0-10 points):
Did the study actually contemplate the real world example of a parent vaccinating their child with 5 or more vaccines and then seeing a regression into autism afterward? Did it contemplate something close to that which could be helpful and generalized? A perfect question received a 10, a study that didn’t even contemplate the question at hand received a zero.

See what I mean? This is, of course, not the “right question” at all, other than in the minds of antivaccinationists who have already made up their minds about the answer. This is, in essence, an appeal to anecdotal evidence (”contemplate the real world example”) framed in the most “dramatic” way possible, full of inflammatory language about “five or more vaccines.” The right question is, rather, whether or not there is an association or correlation between autism and vaccination. Also, note how vague and subjective this scale is. What determines how close to the “right” question a hypothesis will be ranked, apparently, is whether it sounds good to the Generation Rescue antivaccinationist who ranked it. Certainly there do not appear to be anything resembling objective criteria, which are essential for any sort of scale like this. I also note with some amusement that one of the studies included as “Our Studies” on this website, namely a 2006 study by Raymond Palmer looking at whether proximity to coal-fueled power plants is associated with increased prevalence of autism, would get a zero on this scale, as it didn’t even look at vaccines at all! It was also a really crappy study, as I discussed extensively a few months ago during a deconstruction of Palmer’s followup study. At least Generation Rescue could have cited Palmer’s 2008 followup study instead, which, while not very good at all, was at least not as spectacularly awful as his 2006 study, which didn’t even bother to try to control for some very obvious confounders. Apparently asking the “right” question doesn’t really matter to Generation Rescue if J.B. Handley likes the answer.

Next, Generation Rescue lists:

Conflict of Interest (0-10 points):
We considered a scientist employed by a vaccine maker or a study sponsored by a vaccine maker to have the highest degree of conflict, with a public health organization (like the CDC) to be the second-worst. A conflict free study would receive a 10, a study rife with conflicts as low as zero.

This one really annoyed me, because I’ve discussed on at least a couple of occasions how rife with conflicts of interest are many of the “studies” used by antivaccine advocates to support their point of view. For example, the grossly incompetent “study” by Generation Rescue that I discussed last week and that is featured on Fourteen Studies was commissioned and performed by an organization whose raison d’être is to convince lawmakers and the public that vaccines cause autism and that “biomedical treatments” targeted at “vaccine injury” can cure autism. If that’s not a conflict of interest, I don’t know what is. The same is true of an awful study of vaccination in monkeys by Laura Hewitson (which I blogged about several months ago and that Generation Rescue widely promoted, but apparently decided to leave off of its latest propaganda initiative even though it would get a 10 out of 10 on “asking the right question” by Generation Rescue’s definition. (Maybe the criticisms stung.) After all, Laura Hewitson is not only married to antivaccine hero Andrew Wakefield’s IT director but she and her husband are complainants in the Autism Omnibus proceedings, which led me and others to wonder at the time if their “monkey study” was in fact done explicitly to provide more ammunition for the test cases under consideration by the Vaccine Court at the time.

Finally, let’s not forget Mark and David Geier, both of whom have much invested in the concept that mercury in vaccines causes autism and advocate, in essence, chemical castration with Lupron as a “treatment” for autism to help “free” the mercury from testosterone and allow it to be chelated more effectively. In fact, they took conflicts of interest to whole new levels undreamt of by even the most cynical, greedy, and amoral big pharma executive when they specially created an IRB and stacked it with their cronies in order to approve “studies” of their Lupron therapy. Any of their studies would get a zero on this the conflict of interest scale. Heck, they’d get negative scores! And all of this doesn’t even count Andrew Wakefield, who was shown by Brian Deer not only to have been an incompetent scientists, but in the pocket of trial lawyers suing vaccine manufacturers for “vaccine injury.” Worse, these are undisclosed conflicts of interest, whereas any conflict of interest listed in the “fourteen studies” was disclosed right there on the manuscript. In marked contrast, it took Brian Deer years to dig up Andrew Wakefield’s blatant conflicts of interest; Kathleen Seidel’s digging to unearth the Geiers’ abuse of the IRB process; and the digging of several bloggers to figure out Laura Hewitson’s undisclosed conflict of interest in being a plaintiff in the Autism Omnibus. If there’s one rule of thumb in medical research, it’s that undisclosed conflicts of interest correctly raise far more suspicion of bias than disclosed ones do.

Cleverly, Generation Rescue disingenuously inoculates itself from charges of picking studies with huge conflicts of interest by narrowly defining a conflict of interest the way that it wants to: As an investigator’s only being affiliated with a vaccine maker or the CDC. (Because, you know, antivaccine warriors can’t possibly ever have a conflict of interest.) Then, to guarantee that every study that it doesn’t like has an irretrievable “conflict of interest,” even if there is no pharmaceutical company connection, Generation Rescue appears to consider the mere fact of the lead investigator working for the NIH to be a severe conflict of interest. That is what is listed as the sole conflict of interest for Dr. Karen Nelson, who wrote a review article on thimerosal and autism. If that’s not enough to guarantee a “conflict of interest” for all of these “fourteen studies,” Generation Rescue also appears to define the mere fact of being funded through grants from the CDC, NIH, American Academy of Pediatrics, or the Canadian Institutes for Health Research. Scientists who have had NIH grants (such as myself) or grants from any of these other organizations know just how ridiculous considering that funding source to be a horrific conflict of interest is. After all, such grants are in general competitive grants awarded after rigorous peer review, and the NIH, for example, exercises almost no control over how researchers funded through it do their work, other than enforcing federal regulations on animal and human subjects welfare by refusing to disburse funds until the appropriate approvals are in place.

Next up, Generation Rescue ranks the ability to generalize and post-publication criticism:

Ability to Generalize (0-10 points):
This was a measure of the robustness, replicability, and usefulness of the study. Where possible, we looked to experts to help us gauge this ranking. The more robust, replicable, and broadly applicable, the higher the score.

Post-Publication Criticism (0-10 points):
Was the study widely accepted in the scientific community, or was it the subject of extreme criticisms from many sources? The closer to widely accepted, the closer to 10 points.

One wonders why Generation Rescue didn’t always look to experts to gauge this ranking. After all, neither J.B. Handley, Jenny McCarthy, nor Jim Carrey are scientists. In fact, they have shown time and time again that they are clueless about science. Any conclusion by them or the other antivaccine warriors at Generation Rescue on the generalizability of a study would be highly suspect even giving them every benefit of the doubt. As part of this propaganda effort, forget it. Also, one can’t help but note that the “experts” Generation Rescue does find happen to be antivaccinationists like Boyd Haley, the former chairman of the Department of Chemistry at the University of Kentucky whose academic career imploded as a result of his having delved too deeply for too long into mercury and vaccines pseudoscience (as well as “toxic teeth” amalgam pseudoscience), or Mark Geier, whose protocol that uses Lupron to treat autism is, in my considered opinion, dangerous quackery. In other cases, the “experts” are nothing more than some of J.B. Handley’s fellow antivaccine activists with no special scientific or medical training: Sallie Bernard of SafeMinds or Deirdre Imus–or even J.B. Handley himself. Such are Generation Rescue’s “experts”! Clearly, the talent pool of “experts” at Generation Rescue is not particularly deep. One wonders why Generation Rescue didn’t draft Jim Carrey or Jenny McCarthy to do a critique of one of these articles.

Also, it’s extremely disingenuous of Generation Rescue to rank these studies on “post-publication criticism” because it is the antivaccine movement, including Generation Rescue, that accounted for the vast majority of criticisms of these articles (most were not particularly controversial among scientists). Indeed, the antivaccine movement encouraged criticism at every turn. In most cases, Generation Rescue is conflating criticisms based on ideology with scientific criticisms, which is how they keep the vaccine/autism manufactroversy alive. One can’t help but note again that, if post publication criticism were a major criterion by which Generation Rescue’s favored studies should be judged, Andrew Wakefield’s 1998 Lancet study was disavowed by 10 of its original 13 authors and ultimately utterly repudiated by the scientific community–and deservedly so! Yet there it is on the “Our Studies” page of Fourteen Studies. Apparently only criticism by the antivaccine movement counts as a negative to Generation Rescue. Criticism by scientists? Apparently not so much.

ON TO SOME OF THE “FOURTEEN STUDIES”

Mady Hornig’s 2008 study

Even though it was obvious from the start that this website is every bit as much propaganda as the Green Our Vaccines rally in Washington, DC last year, still I wanted to see what Generation Rescue said about some of the studies. So I picked a few that I am quite familiar with. First, off, I noticed that Mady Hornig’s study from last fall that tried to replicate Andrew Wakefield’s original Lancet study that implicated the MMR vaccine in the pathogenesis of “regressive” autism and enterocolitis. You might remember this one too. You might also recognize that all Generation Rescue did was to regurgitate old attacks by Andrew Wakefield, SafeMinds, and the National Autism Association on it. You may also recall that I blogged about this study shortly after it was published and showed you why these criticisms were, scientifically speaking, a load of horse hockey. Suffice it to say, they have not aged well.

The 2009 Italian study

Another study included on the list is an Italian study that came out this year by Tozzi et al, which was published in the February issue of Pediatrics and entitled Neuropsychological Performance 10 Years After Immunization in Infancy With Thimerosal-Containing Vaccines. The study was done in Italy, and one of its great advantages is that the amount of thimerosal to which the infants were exposed was actually known, unlike many epidemiological studies, where sometimes the dose of thimerosal (and therefore mercury) has to be estimated or inferred from the vaccine schedule at the time.

The reason is that the children studied were children who had taken part in a randomized study of two different diptheria-tetanus-acellular-pertuss (DTaP) vaccines, one that contained thimerosal and one that did not:

In 1992-1993, 15,601 healthy, 2-month-old infants were enrolled in the Italian Trial on Pertussis Vaccines. 18-20 In this trial, infants were selected from the general population in 4 of Italy’s 20 regions (Fig 1) and were assigned randomly to receive, under double-blind conditions, 3 doses of 1 of 4 vaccines, 2 of which were DTaP vaccines from 2 different manufacturers. One DTaP vaccine contained 50 μ g of thimerosal (or 25 μ g of ethylmercury) per dose, and the other was thimerosal-free (2-phenoxyethanol was used as preservative). The 3 doses of DTaP vaccine were administered at 2, 4, and 6 months of age. To comply with Italy’s vaccination schedule, all children also received 3 doses of hepatitis B virus vaccine (child formulation), each of which contained 25 μ g of thimerosal (or 12.5 μg of ethylmercury), at 2, 4, and 12 months of age, and a fourth dose of diphtheriatetanus vaccine, which contained 50 μg of thimerosal (or 25 g of ethylmercury), at 11 months of age…Therefore, in the first 12 months of life, the cumulative intake of ethylmercury, the mercury metabolite of thimerosal, was 137.5 μg for the children who were assigned randomly to receive the DTaP vaccine that contained thimerosal (”higher intake group”) and 62.5 μ g for those who received the thimerosal- free DTaP vaccine (”lower intake group”).

Ten years later, the children from this study living in the Veneto Region were studied. 1,403 children (697 belonging to the high thimerosal group and 706 belonging to the low thimerosal group) were recruited and subjected to a battery of eleven neurodevelopmental tests that produced a total of 24 neuropsychological outcomes to assess their development. The results were unsurprising and very much like the results of a study of thimerosal-containing vaccines as a risk factor for neurodevelopmental disorders other than autism that was published a year and a half ago. Most outcome measures showed no difference between the low and high thimerosal group, and the ones that did were small and entirely compatible with random chance due to multiple comparisons.

I knew at the time exactly what antivaccine activists would probably say when and if they get around to attacking this study, and, in fact, that’s basically the criticism on Fourteen Studies. (Most depressingly, Generation Rescue even reprints J.B. Handley’s scientifically illiterate criticism of the study.) In any case, the main criticism is that there was not a control group receiving no thimerosal. True enough. The authors themselves make that very point. However, if thimerosal in vaccines were associated with autism, one would not expect that it would be different than any other toxin associated with an abnormality, disease, or condition in that it would be expected that the chance of autism or neurodevelopmental disorders would increase with increasing dose.

The second argument that I thought advocates would try to make but that Generation Rescue actually did not make is that the dose-response curve for mercury and autism has a plateau, and that plateau is below 62.5 μg, hence the lack of difference between the two groups. There’s just one problem with that argument. An exposure to 62.5 μg, to which the low exposure group was exposed, corresponds to roughly the total dose of mercury in thimerosal to which American infants were exposed in 1989–before the alleged “autism epidemic.” Even if mercury does indeed cause autism and there is indeed a plateau in the dose-response below a dose of 62.5 μg, that would not be consistent with the antivaxers’ other pet claim, that an autism epidemic started in the 1990s because of the increasing amount of thimerosal exposure due to vaccines. That couldn’t have happened if a dose of thimerosal less than 62.5 μg maxed out the risk of autism, because 62.5 μg below the baseline exposure before the alleged “autism epidemic” started. The two claims (that of an autism epidemic in the 1990s due to increasing amounts of thimerosal in vaccines versus that of an effect that maxes out before a 62.5 μg cumulative dose of mercury from thimerosal) are mutually contradictory. I suppose antivaccinationists could postulate a threshold effect that doesn’t occur until a dose above 137.5 μg. Unfortunately for them, then they would have the problem of how long they ranted that any mercury was toxic and any mercury was unacceptable, not to mention the–shall we say?–inconvenient epidemiological evidence that autism rates did not plummet back to 1980s levels after 2001, which was when thimerosal was removed from most childhood vaccines and mercury exposure from vaccines plummeted to well under 62.5 μg.

Finally, the most ironic thing about this study is the question of why autism prevalence was so low among the Italian population studied. Of course, as Generation Rescue points out, all of the subjects received at least 62.5 μg mercury from their vaccines; so by antivaccinationist logic there should have been a much larger prevalence of autism, particularly among the Italian children who received 137.5 μg mercury. There wasn’t. The prevalence was much lower than in the U.S., which also rather undermines the claims Generation Rescue made in its recent “vaccines by nation” nonsense. So much for “mercury poisoning,” at least in this case.

The 2008 Schechter study

Antivaccinationists really, really hate this study because it looked at a very specific prediction that naturally follows from the hypothesis that mercury in the thimerosal preservative in vaccines was a major cause of the “autism epidemic.” I say “was” because by early 2002, thimerosal had been removed from the vast majority of vaccines, and this allows the testing of the hypothesis. Specifically, the prediction is that, if thimerosal in vaccines was indeed a major cause of autism, autism incidence should have plummeted within a few years after it was removed. This study showed that there is no evidence that the apparent rise in autism is even plateauing yet in California. In a truly fun bit of additional irony, this study even uses the California Department of Developmental Services (CDDS) database, to which David Kirby has often referred as a good way of looking at whether autism rates have started falling since thimerosal was removed from most vaccines. He has also since been moving the goalposts as to when he would expect autism rates to begin falling if the thimerosal hypthesis is true, going first from 2005 to 2007 and, most recently, to 2011.

In order to ask the question of whether autism rates had declined, Schechter and Grether examined data for clients with active status reported from January 1, 1995 to March 31, 2007. Using careful statistical analyses, they used two approaches to measure the occurrence of ASD during this period. The second approach, in which ASD prevalence was determined in the 3 to 5 year old cohort, is perhaps the most informative. It shows a continuing increase in autism prevalence without even a blip or decrease in the rate of increase after 2002. Indeed, showing the skill of some bloggers to analyze the same data, the money figure in the paper (Figure 3) looks almost exactly the same as the graph prepared in early 2007, a continually increasing curve since 1995. This result is not only consistent with multiple other published and unpublished studies, including the famous (or, if you’re an antivaccinationist, infamous) Danish and Canadian studies, but it is about as unambiguous evidence as can be obtained from a database like the CDDS database. Indeed, despite the known limitations of the use of this database, it is an excellent example of proponents of a “mercury injury” hypothesis of autism being “hoisted by their own petard,” so to speak. Even more amusingly, one of the criticisms of the study was written by Deirdre Imus, who has been known to regularly lay down some of the more–shall we say?–easily refuted antivaccinationist canards, all cloaked in “concern for the children,” is one of the “experts” refuting this study, while Boyd Haley wrote a long rant that is mostly a non sequitur.

The complaints about this study from antivaccinationists can be boiled down to one: That mercury hasn’t been completely eliminated from childhood vaccines. In other words, even though mercury has been removed from all mandated childhood vaccines other than the flu vaccine (and there are thimerosal-free versions of the flu vaccine available), leaving only trace thimerosal in the current set of vaccines, according to antivaccinationists that’s not enough. To them, mercury is just that toxic, and even the trace levels left in the vaccines are enough to keep the “autism epidemic” moving in a steadily upward direction. This is an utterly fallacious criticism for exactly the same reasons the criticisms of the Italian study listed above are similarly fallacious. Once again, remember that the “mercury hypothesis” states that an “autism epidemic” began in the late 1980s/early 1990s after the government expanded the number of mandated vaccines containing thimerosal. A consequence of that claim is that we should expect late 1980s/early 1990s levels of autism to be associated with a certain dose of mercury in vaccines, which, as you remember, was approximately 60-75 μg in 1989–by antivaccinationist Mark Blaxill’s own estimates! With now thimerosal removed from all vaccines save the flu vaccine (which many children still don’t get anyway), all that is present in the total vaccine dose received by children is a level of mercury less than what children received in 1989. So, in the world of antivaccinationists, lowering the level of total mercury received in vaccines by children to a level lower than what children received 20 years ago (before the “autism epidemic”) is still too toxic. (Consistency has never been the antivaccine movement’s strong suit.) Unfortunately, by the antivaccinationists’ own arguments, if the graph that Mark Blaxill likes to show represents not just correlation but causation, the dose-response curve for mercury must be such that the level in 1989 resulted in a relatively low level of autism; therefore, lowering it to levels below those seen in 1989 should result in a dramatic decrease in autism rates–again, using the mercury militia’s own numbers.

It didn’t. Stick a fork in the mercury-thimerosal-autism hypothesis. It’s quite done.

Thompson et al, 2007

This study did not specifically look at autism, but was the first publication of a larger study looking at neurodevelopmental outcomes after vaccination using data from the Vaccine Safety Datalink (VSD) database, a massive database overseen by the CDC and maintained through several large HMOs that collects data on vaccination outcomes. The first publication, Thompson et al, looked at whether there were adverse neurodevelopmental outcomes other than autism that could be identified as being correlated with thimerosal-containing vaccines. A second study looking specifically at autism using the VSD is in the works.

The authors found weak associations between thimerosal and developmental outcomes that were most consistent with being due to chance. It is true that there were some negative correlations found that achieved statistical significance. However, when running 42 tests, it would be shocking if there were not a few anomalous associations. What makes the study authors confident that the findings are anomalous is that they were divided roughly equally in both directions, good and bad. It is true that there were some negative correlations found that achieved statistical significance. When running 42 tests, it would be shocking if there were not a few anomalous findings. What makes the study authors fairly confident that the findings are anomalous is that they were divided roughly equally in both directions, good and bad. Consequently, if antivaccinationists are going to insist that the correlation, for example, with increasing mercury exposure and poorer performance on the GFTA-2 measure of speech articulation test is real and due to likely causation, then it must also accept the findings of a beneficial association between mercury and identification of letters and numbers on the WJ-III test, as there is no scientific reason to reject it. Even Autism Speaks, one of the “guest commentators” in Fourteen Studies, concedes this but tries to latch onto these few findings as being somehow significant.

Another important aspect of this study is that Sallie Bernard of SafeMinds, was a panelist on the consulting board that helped design this study. She pulled out when the results weren’t what she had been hoping for and has been criticizing the study ever since, up to and including being one of the “guest commenters” on this article for Generation Rescue. Her complaint is the most ridiculous of all, specifically that the study

comprised children who were least likely to exhibit neuropsychological impairments. Specifically, children with congenital problems, those from multiple births, those of low birth weight, and those not living with their biological mother were excluded. The sample was skewed toward higher socioeconomic status and maternal education — factors that are associated with lower rates of neurobehavioral problems and higher intervention rates and that were not measured.

Ms. Bernard is too scientifically illiterate to realize that that’s because the hypothesis being studied was that mercury in vaccines is associated with neurodevelopmental problems in normal children. Remember, in virtually all of the testimonials about regressions after vaccines, parents insist that their child was absolutely, positively normal before those horrible pediatricians pumped them full of those nasty, toxic, autism-causing vaccines. In fact, this study was looking at exactly the “right question.” Also (and arguably more importantly for the study design) children with congenital problems and of multiple births or of low birth weight have a higher baseline level of neurodevelopmental problems. Including such children would have (1) made it difficult to determine whether thimerosal actually was associated with neurodevelopmental difficulties because the effect size could well be dwarfed by the baseline levels of neurodevelopmental disorders in this population and (2) introduced confounders that would have been very difficult to control for in the final statistical analysis.

In any case, Ms. Bernard is being intellectually dishonest to an extreme. She participated in the design of the study but never criticized its design until after its results contradicted her expectations. Does anyone think she would have had a problem with this study if it had come back less resoundingly negative, with even a bit of wiggle room? Such is the intellectual dishonesty of the antivaccine movement and a major reason why it was always a bad idea for the government to include antivaccinationists in the the decision-making process about anything in the name of “inclusion” and the hopes that if they had a stake in the outcome they would be more constructive. The government hoped to shut up antivaccinationists by including them on such panels; it should have realized that they would turn on the government as soon as it didn’t get its way or as soon as scientific studies in whose design they participated failed to yield the results craved by the antivaccine movement.

AN EXAMPLE OF “GOOD” VACCINE STUDIES, ACCORDING TO GENERATION RESCUE

Before I conclude, I was curious to note what Generation Rescue apparently considers to be “good” studies. I already mentioned some of the awful studies, such as those by Andrew Wakefield or Mark and David Geier, that Generation Rescue likes. One study from 2009 included on the list is one I haven’t seen before, and I may well write about it on its own, as it makes a provocative but, in my opinion, ultimately highly doubtful conclusion.

One constant refrain of antivaccinationists is that there should be a study of “unvaccinated” versus “vaccinated” children. Never mind that they never quite state the hypothesis that such a study would study and sometimes even suggest utterly unethical studies, such as a randomized double-blind, placebo-controlled study. Such a study, although methodologically rigorous, would be completely unethical because it would leave the control group unprotected against vaccine-preventable diseases. Nonetheless, that doesn’t stop Generation Rescue from listing as number two its utterly risible and badly executed telephone study from 2007.

Kevin Leitch did an excellent job of deconstructing the numerical shenanigans in the poll that lead GR to boldly claim things like:

All vaccinated boys, compared to unvaccinated boys:

• Vaccinated boys were 155% more likely to have a neurological disorder (RR 2.55)
• Vaccinated boys were 224% more likely to have ADHD (RR 3.24)
• Vaccinated boys were 61% more likely to have autism (RR 1.61)

Older vaccinated boys, ages 11-17 (about half the boys surveyed), compared to older unvaccinated boys:

• Vaccinated boys were 158% more likely to have a neurological disorder (RR 2.58)
• Vaccinated boys were 317% more likely to have ADHD (RR 4.17)
• Vaccinated boys were 112% more likely to have autism (RR 2.12)

(Note: RR means “relative risk,” which in this poll is the ratio of the percentage of the condition of interest in the group of interest to the percentage found in the control population, in this case the allegedly “completely” unvaccinated.)

I’m not going to go over the same ground that Kevin Leitch so ably covered when the poll first came out, specifically the numbers. Kevin did a good job with the details showing that the “finding” are not nearly as impressive as they are represented to be. Particularly amusing is the observation that, for several of the groups, the “partially vaccinated” (whatever that means; it’s not defined) had apparently higher numbers of parents reporting autism or ASD but with parents of fully vaccinated children reporting numbers the same or lower than the unvaccinated, leading him to drolly observe:

There’s no getting away from this. This is a disaster for Generation Rescue and the whole ‘vaccines cause autism’ debacle. Generation Rescue’s data indicates that you are ’safer’ from autism if you fully vaccinate than partially vaccinate. It also indicates that across the spectrum of autism, you are only 1% more likely to be autistic if you have had any sort of vaccination as oppose to no vaccinations at all – and thats only if you are male. If you are a girl you chances of being on the spectrum are less if you have been vaccinated! Across both boys and girls, your chances of being on the spectrum are less if you have received all vaccinations.

Of course, what the results actually suggest is a reporting bias in the phone survey in which parents whose children developed autism or an ASD and who believed vaccines might have been responsible stopped vaccinating, thus falling into the “partially vaccinated” group. Kevin’s also kindly converted the locked PDF with the raw data supplied by J. B. Handley into an Excel spreadsheet that allows more easy analysis of the figures. Some commenters ran some statistical tests on the raw data for various groups. Not surprisingly, the results were not statistically significant in nearly all cases. I looked at a few groups myself and did a few chi squared tests, and I failed to find any statistically significant differences either. I will admit that I did this only to sample the data; I have better things to do with my time than an exhaustive analysis.

Given that background, I’d like to step back a bit and look at the big picture. This phone poll is fatally flawed as a medical study for several reasons. First, note how there are now more diagnoses being looked at. Given Generation Rescue’s previous concentration on autism almost exclusively, I found it striking that ADD and ADHD were in the mix. In one row, ADD, ADHD, autism, and ASDs were all combined into one group, even though there is no etiological or logical reason to do so. Generation Rescue refers to this as “neurologic” diagnoses, but then why did the survey limit itself to just the above? After all, mental retardation is a neurological diagnosis. Seizure disorders are neurological diagnoses. It makes very little sense.

In reality, the whole enterprise was nothing more than one huge case of doing multiple comparisons and seeing if anything shakes out. Remember, at the 95% confidence level there’s still a 5% chance that any seemingly “positive” result that is found is in reality due to chance alone. The more groups looked at and compared, the more chances of a spurious result that isn’t “real.” There are statistical methods for controlling for multiple comparisons, but there’s no evidence that I can find that they were done for this poll. My best guess is that this survey was nothing more than a sloppily conducted fishing expedition where they didn’t even bother to control for multiple comparisons. Moreover, doing what is in essence subgroup analysis is dubious when only around 6% of the children (a reassuring figure, actually) were totally unvaccinated, as it makes the numbers of unvaccinated in many of the subgroups too small to be statistically useful (not that that stopped Generation Rescue from slicing and dicing the group any which way it could to extract more probably spurious “correlations”). I’m not even entirely convinced that the 991 unvaccinated children supposedly identified by this poll represent a big enough sample. Moreover, the poll concludes that there is no increased risk of autism or other ASDs in girls due to vaccination, which makes me wonder if J. B. will change his tune and urge girls, at least, to be vaccinated.

Another problem with the poll is how the vaccinated group was divided into “partially vaccinated” versus “fully vaccinated.” For one thing, the definition of “fully vaccinated” would not be the same in all age groups, given that the recommended vaccination schedule changes periodically based on new recommendations from the CDC and the American Academy of Pediatrics. Second, “partially vaccinated” would encompass a huge range of possibilities, from children who only received one or two recommended vaccinations to those who received all but one. It’s an almost meaningless distinction, particularly in a phone survey. The only sort of study for which separating the vaccinated into two groups like that might be useful is one in which investigators can review the vaccination records of the subjects polled and know who got exactly what vaccines. No doubt J. B. was hoping to find some sort of dose-response curve, with increasing levels of neurologic diagnoses as one goes from unvaccinated, to partially vaccinated, to fully vaccinated. That makes it all the more hilarious that the results show in many groups equal percentages of diagnoses in the unvaccinated and fully vaccinated groups, with the peak percentages reported being in the partially vaccinated group and suggests that the real comparison that should have been made was one that wasn’t: between the completely unvaccinated and patients who had gotten any vaccines (partially vaccinated + fully vaccinated). Of course, again, this also suggests a reporting bias, where parents who think their children’s problems stem from vaccines stop vaccinating. Or it could just be spurious. What it does suggest is that there is a serious problem with the poll.

The biggest problem, however, that makes me doubt this survey is the questionnaire and how the study was conducted. J. B. makes a big deal about how their methodology “mirrored” the methodology that the CDC used to establish estimates of autism prevalence. The two are only superficially comparable. The CDC used very simple methodology:

The surveys were independently conducted but both were conducted during the same time period, 2003 to 2004. Both were based on a nationally representative sample of non-institutionalized U.S. children and in both surveys parents or guardians of the sampled children were asked about a range of different health issues.

Autism prevalence was estimated from the question asking parents if they were ever told by a doctor, or other health care providers, that their child had autism.

Leaving aside that Generation Rescue doesn’t describe how their sample was chosen, what measures were taken to make sure it was representative, and what the response rate was, compare this to the questionnaire that Generation Rescue tried to get parents to answer. Here’s a sample:

5) If this child has ever been diagnosed with asthma, juvenile diabetes, autism, Asperger’s Syndrome, ADD, ADHD, or PDD-NOS, press 1 (continue to next Q)
Otherwise, press 2 (skpt to closing language “B”)

6.) OK, then, let’s go through each condition one at a time.
Has this child been diagnosed…
With Asthma?
Yes, press 1
No, 2
Not sure? 3

7.) With Juvenile Diabetes?
Yes, press 1
No, 2
Not sure? 3.

8.) With Autism?
Yes, press 1
No, 2
Not sure? 3.

9.) With Asperger’s?
Yes, press 1
No, 2
Not sure? 3.

10.) With ADD?
Yes, press 1
No, 2
Not sure? 3.

11.) With ADHD?
Yes, press 1
No, 2
Not sure? 3.

12.) With PDD-NOS?
Yes, press 1
No, 2
Not sure? 3.

PDD-NOS? How many parents know what PDD-NOS is? (It’s pervasive developmental disorder, not otherwise specified, by the way.) I didn’t know what a PDD-NOS was until I became interested in the vaccine-autism hysteria. The only parents who are going to know what that is are the ones whose child has a diagnosis. Heck, even though most parents know what autism is, a lot of parents don’t know what Asperger’s is unless their child has it.

Moreover, the CDC study produced estimates of autism prevalence that were consistent with previous studies. In contrast, J. B.’s survey produced estimates of autism and ASDs of 3% in the aggregated data. That’s 1 in 33, approximately 5 times more prevalent than the usually cited estimate of 1 in 166 or 1 in 150. This, too, suggests reporting bias, where parents who have a child with autism or an ASD will be more likely to complete this survey. Moreover, SurveyUSA is known for asking very concise questions that have been known in the past to produce divergent results using automated telephone polls, which have a number of problems, not the least of which is a much lower response rate than traditional polls. Again, the issue of reporting bias comes up. That’s not to say that it’s not possible to do accurate polls with automated technology, but asking about health problems is difficult, leading me to take any such poll done looking for correlations between vaccines and anything with a huge grain of salt. Moreover, no evidence about response rates or how many parents responded “not sure” for each question is presented, nor is any evidence to show that the sample chosen is representative. In any case, Prometheus has done an excellent job discussing how a true “vaccinated versus unvaccinated” study could be done with both a reasonable degree of scientific rigor and ethically as well. Unfortunately, it would take a minimum of 20,000 children:

A study of autistic children in the 3 – 6 year age range would need over 683,000 children in each group to detect a 10% difference in vaccination level. It would need nearly 22,000 in each group to detect a 50% difference. With a predicted number of 110,000 autistic children in that age range, that is a sizeable fraction of all autistic children.

A more manageable study – one with 10,000 children in each arm (which is still a HUGE study!) – would only be able to tell the difference between the national average of 0.3% unvaccinated in the non-autistic group and 0.1% unvaccinated in the autistic group (at the specified levels of confidence). If the difference is smaller than that, the results would be considered negative (i.e. that there is no effect of vaccination). For reference, a study with 1,000 children in each arm would show statistical significance (at our specified level of confidence) only when the autistic group was below 0.01% unvaccinated or above 1.7% unvaccinated.

Of course, we wouldn’t have to just look at unvaccinated vs fully vaccinated with this study, which is a large part of its superiority. We could look at a dose response of vaccination - to see if it really is “too many” – as well as the age at youngest vaccination – to see if it really is “too soon”. In fact, a few studies have already looked at those issues and found that there is no difference between the autistic and non-autistic groups. I suspect this is the reason the folks pushing to “put on a study” want to look at vaccinated vs unvaccinated – they hope that the numbers will be different (or, at least, not as definitive) the other way round.

This would, of course, be a massively expensive study to do as well and would funnel more research money to dubious studies of highly unlikely hypotheses.

CONCLUSION

Given that Generation Rescue paid $200,000 to do its poll, if I were J.B., I’d be asking for my money back. On the other hand, compared to how much money Generation Rescue is raking in hand over fist, thanks to Jenny McCarthy, who’s been hitting the pro wrestling circuit, doing celebrity poker events with Lance Armstrong, holding fundraisers with Hugh Hefner and Britney Spears and making numerous appearances to raise money for Generation Rescue, I’m guessing that these days $200,000 is pocket change. Moreover, only J.B. knows how much money was spent on the Fourteen Studies website, but I’m guessing it was quite a bit. The slickness of the website, coupled with all the TV appearances, and celebrity fundraisers, all of which coopt the message of “autism awareness” and conflate it with the antivaccine activist agenda, bespeak large amounts of money flowing into the antivaccine propaganda effort. Wouldn’t it be wonderful if Generation Rescue actually spent its money on real research, instead of propaganda like the Fourteen Studies website?

Don’t hold your breath waiting for that to happen.

That’s because, unfortunately, it’s not about science, evidence, or reason to Generation Rescue. It never has been; it is not now; and it never will be. No, it’s all about winning, which means that the evidence showing that vaccines are not associated with autism must be attacked, because the AAP, CDC, and Paul Offit are the “bad guys.” That’s why this Fourteen Studies website is nothing more than pure propaganda; indeed, it’s every bit as much propaganda as Jenny and Jim’s media tour to promote McCarthy’s latest paean to antivaccine pseudoscience and autism quackery or the “Green Our Vaccines” march last spring. I also note that there are far more than “14 studies” showing no association between vaccines and autism. Indeed, Mady Hornig cited twenty just looking at MMR and autism alone. That defenders of vaccines have chosen “fourteen studies” as a talking point was not a good idea; it was a strategy that made a website like Fourteen Studies possible. That, alas, was a failing of scientists as communicators.