Respectful Insolence

THE PAST IS PROLOGUE

Location: Central New Jersey, deep within the brick and steel of a secret pharma base.

Year: 1999.

A shadowy figure dressed in gray, bald, and stroking a white cat enters a nondescript room in the middle of which sits a massive conference table. More than a dozen men and women leap to their feet at attention and wait until the man pauses at the head of the table and then very deliberately sits in high-backed leather chair.

Shadowy figure: Have they arrived?

Lackey #1: Yes, Leader.

Shadowy figure: Let them wait a few minutes. First, we have pressing business. You have heard, no doubt, that Dr. Neal Halsey, who is head of the American Academy of Pediatrics’ vaccine advisory committee, has been agitating for the removal of thimerosal from childhood vaccines because they contain mercury. My informants in the CDC tell me that he will almost certainly succeed. Assuming he does succeed, this will seriously endanger the plans of SPECTREPHARM to continually increase the number of required vaccines, at which point we will start adding mind-control substances to them to make them willing and compliant servants. Thimerosal was utterly critical to the development of these drugs. Losing it from vaccines will set us back at least a decade. At least we still have Andrew Wakefield, who is doing far better than expected in casting fear on the MMR vaccine. We can afford to sacrifice one vaccine, but not all of them, and MMR is as good as any.

Lackey #2: Sir, our operatives have performed a time-modeling of the next ten years based on this new information regarding the removal of thimerosal. Evemn assuming that the last lots of thimerosal-containing vaccines are gone by the end of 2001, there will arise a subgroup within the anti-vaccine movement around 2004 to 2005 that will be utterly convinced that mercury in vaccines causes autism.

Shadowy figure (stroking cat, which purrs dutifully): They will be correct, of course. That is a side effect that allows the future mind control drug to be effective.

Lacky #2 (sweating): Er, hmmmm, yes sir. Our model predicts that by around 2007 or 2008 this subgroup of the anti-vaccine movement will fade to the point where even the main group promoting the concept that autism is a “misdiagnosis for mercury poisoning” will be backing away from such a specific hypothesis and promoting other, more vague and difficult-to-falsify ideas.

Shadowy figure (leans forward): Not good. It will take us a between one and two decades to develop our substitute for thimerosal-containing mind control vaccines. We want to keep their attention on thimerosal at least until 2010. 2015 would be better. We need a plan to keep the attention of American anti-vaccine groups focused on thimerosal while we develop our new vaccines.

Lackey #3: Well, we did implement our contingency plan in case thimerosal were ever banned. Two large studies will be started soon, one to compare whether thimerosal correlates with neuropsychiatric outcomes. We estimate that one will be released in 2006 or 2007. The second study will directly look at whether thimerosal is correlated with autism. We estimate that one to be released two to three years later. Our CDC operatives will guarantee, of course, that they both are negative but that they have just enough shortcomings for antivaccine groups to latch onto but not to invalidate their conclusions. This will allow them to attack these studies and fire up the base, so to speak, with the release of each new one. In the meantime, we will find flunkies in California to manipulate its database in order to produce additional studies.

Shadowy figure: Good, good! But we still need more! Which is why I want you to meet our newest deep cover operatives.

First, meet David Kirby. [A large oak door opens, and David Kirby walks in with a spotlight on him.] Currently, he is a freelance journalist writing sometimes for The New York Times, usually for the Travel and Leisure section. No one will ever suspect that he will produce a book in about five years that will blame thimerosal for an “autism epidemic.”

[Kirby takes his place standing at The Leader's side.]

Next, meet Dan Olmsted. He is currently a UPI editor, but in five years he will begin a series of articles blaming mercury in vaccines for autism. He will come up with bits of misinformation so outrageous that it’s hard for you and me to believe that anyone would take them seriously, but they will go on to become accepted lore in the anti-vaccine movement. One example will be the myth that the Amish don’t vaccinate and don’t get autism. (I thought of that one myself.) Later, he will go on to be the editor of the most notorious anti-vaccine website in existence.

[The Leader smiles. Olmsted, too, slowly walks over to take his place at The Leader's side.]

Finally, here is Mark Blaxill. He is currently a businessman, but he will come to work closely with Olmsted. In addition, he will help form another group to promote the idea that vaccines cause autism, and in a decade’s time or so he will team up with Olmsted to write a book, entitled Age of Autism. At a time when the idea that thimerosal causes autism is fading from the public consciousness, they will reignite the idea as we are in the final stages of finishing our mind control vaccines.

[Every man and woman sitting around the table rises and applauds.]

PROLOGUE: BAD LUCK AND BAD TIMING

Many are the times on this blog that I’ve characterized the notion that thimerosal in vaccines causes autism as a “scientifically discredited hypothesis.” And so it is. I like to characterize the notion that thimerosal-containing vaccines (TCVs) cause autism as the American version of the British myth, popularized by Andrew Wakefield and a sensationalistic British press, that the measles-mumps-rubella (MMR) vaccine causes autism and “autistic enterocolitis.”

Both notions were based on confusing correlation with causation, aided and abetted by some truly bad science, and both notions have been painfully difficult to dislodge. Indeed, in the case of Wakefield, only now that Wakefield was stripped of his license to practice in the U.K. by its General Medical Council, leading to The Lancet finally doing what it should have done six years ago and retracting Wakefield’s 1998 study that sparked the MMR frenzy in the U.K. and arguably kickstarted the modern anti-vaccine movement, do I sense that journalists are finally “getting” that science does not support the idea that the MMR vaccine causes autism. Andrew Wakefield may be trying to fight back with his book Callous Disregard after his disgrace was complete, basking in the glow of admiration of die-hard anti-vaccine groups, but, for now, at least, Wakefield and his MMR fear mongering are yesterday’s news, and that’s a very good thing indeed–at least for as long as it lasts.

Perhaps it is the fall of Andy Wakefield that has led to an apparent resurgence of the concept that mercury in TCVs somehow causes autism, after having faded into the background after the CDC and AAP recommended that thimerosal be removed from all childhood vaccines in 1999 and the last TCV having expired towards the end of 2001. After all, if the hypothesis that TCVs cause autism had been correct, we should have expected to see a marked decrease in the incidence of autism and autism spectrum disorders (ASDs) within about 5 years of 2002, given that the vast majority of cases of ASDs are diagnosed between the ages of 2 and 5. We have not, and, even though its adherents have kept moving the goalposts back regarding the date that we should start to see a leveling off and drop in the incidence of ASDs, starting with 2005, then 2007, and now, apparently, 2011 (which is only less than four months away, by the way), even Jenny McCarthy’s anti-vaccine organization originally founded by J.B. Handley and his wife, namely Generation Rescue, began demphasizing mercury in 2007, after having stated flatly on its website that autism is a “misdiagnosis for mercury poisoning” for so long. Since then, “too many, too soon” has been the favored propaganda talking point.

Of course, not every crank is ready to abandon the myth that TCVs cause autism. Indeed, tomorrow two mercury militia “heavy hitters” and bloggers for the anti-vaccine propaganda blog Age of Autism, Mark Blaxill and Dan Olmsted, will be releasing a book entitled Age of Autism: Mercury, Medicine, and a Manmade Epidemic. It amuses me that the official release of the release of the not-so-dynamic duo of the mercury militia’s book actually will one day after a study that is arguably the last nail in the coffin of the very dead hypothesis that TCVs cause autism was released. Either the great pharma conspiracy is far more conniving and effective than even J.B. Handley thinks, or Blaxill and Olmsted’s luck is just that bad. As I anticipate the conspiracy mongering posts about this bad timing aside, let’s just take a look at this last coffin nail, which is a study by Price et al that was released today in the journal Pediatrics entitled Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism.

SPINNING THOMPSON ET AL

The first thing you need to know about this study is that it is the long-awaited follow-up to a study by Thompson et al published in The New England Journal of Medicine in 2007, which I’ve discussed before. Thompson et al was a study that examined in a rigorous fashion whether there is a correlation between TCVs and adverse neuropsychological outcomes other than autism and ASDs. Basically, this was a case-control study of over 1,000 children tested for 42 different neuropsychological outcomes other than autism and ASDs in which children were subjected to various neuropsychological tests and the results correlated to exposure to TCVs during the neonatal period (days 0 to 28) and the first seven months of life. The results were a classic example of in essence random noise. There were a few neuropsychological measures in which lower scores correlated with TCV exposure, and there were a few neurodevelopmental measures in which higher scores correlated with TCV exposure. However, the detected associations were small and almost equally divided between positive and negative effects; in other words, nothing more than would be expected from random noise in the data.

One aspect of this study that was depressing and amusing at the same time was that the input of anti-vaccine–excuse me, “pro-safe vaccine”–groups was solicited during the design of the study. Indeed, Sallie Bernard, president of SafeMinds, was a consultant to the investigators of Thompson et al and participated in the design of the case-control study, despite the fact that she has no relevant background in science, statistics, or clinical trial design! Yes, in the ultimate case of trying to appease those who cannot be appeased and indulging Ms. Bernard’s arrogance of ignorance, apparently the CDC and the Vaccine Safety Datalink (VSD) team decided to “reach” out to their foes. The result? Sallie Bernard saw the writing on the wall, namely that the study was not showing what she wanted it to show, dropped out of the study, and started attacking it immediately, even jumping the gun on the article embargo in order to post her sour grapes all over the Internet. Interverbal aptly criticized Bernard for this:

Even before this study was released yesterday, there was publicized dissent from advocates from the idea of a mercury etiology of neuropsychological harm. One of them came from a well known advocate, Sallie Bernard, who was invited to be a collaborator in this study. It seems that she was involved in the planning of this study, but the lead author indicated that she withdrew her support after the results began to be circulated.

That is not how science works. If you have a problem with a study design then you dissent before you begin collecting data.

As Joseph aptly put it, sour grapes. As the final draft circulated, Bernard read it and didn’t like what the results showed. She even went so far as to write a letter to the NEJM listing her complaints, to which the Thompson et al responded, skewering all of her objections quite ably. Bernard’s behavior with respect to her involvement in Thompson et al is one reason why I have come to the conclusion that attempting to “build bridges” to the leaders of the anti-vaccine movement is a fruitless and pointless exercise. That is not to say that we shouldn’t try to build bridges to parents who express fears over vaccines because they’ve heard the message of anti-vaccine leaders like Bernard, but trying to convert or coopt high profile anti-vaccine activists like Bernard is a waste of effort.

The other common reaction of the anti-vaccine movement to this study was to cherry pick all the negative outcomes and ignore all the positive outcomes. Steve Novella caught opportunistic anti-vaccine propagandist David Kirby doing just that at the time of the study. Sadly, this dishonesty continues even today. Indeed, just last week I called out Mark Blaxill himself for promoting the very same misinterpretation of Thompson et al just last week. Spin and misinformation promoted by the anti-vaccine movement never truly dies. Once a line of attack is developed, no matter how many times it is soundly refuted by science, it inevitably rises again, much like the zombies in any number of movies that I’ve enjoyed through the years. What that means is that defenders of science-based medicine, in order to outrun the zombies when they inevitably rise again, need to do their cardio.

ONE MORE TIME: MERCURY IN VACCINES DOESN’T CAUSE AUTISM

When Thompson et al was published three years ago, the authors pointed out that they intentionally did not include autism and ASDs as studied outcomes and that these outcomes would be the topic of a subsequent paper. Price et al is that paper. What one also needs to understand about Price et al and Thompson et al is that these were studies suggested at the time that the CDC and AAP first decided on the precautionary principle to recommend the removal of thimerosal from all childhood vaccines. That it took until 2007 to publish Thompson et al and until now to publish Price et al just goes to show how difficult and time-consuming epidemiological research can be. Finally, given that the data sources and methodology were in essence the same for each of the two studies, we can expect that the anti-vaccine movement will use the same spin and misinformation about Price et al as it did for Thompson et al in order to attack it.

Basically, Price et al is a similar sort of case-control study. A case control study is a type of retrospective trial in which subjects with a certain condition (cases) are matched as closely as possible with subjects without the condition under study (controls), and the two groups compared to look for factors that correlate with the condition. That’s how Thompson et al was performed, and that’s how Price et al was also performed. Being retrospective, such a study can never be as rigorous as a randomized controlled trial or a prospective cohort study. However, given that thimerosal has already been removed from all infant vaccines other than the flu vaccine (and there is a thimerosal-free alternative) and, more importantly, that it would be unethical to conduct a randomized double blind, placebo-controlled clinical trial, this sort of trial is the best evidence that we will be able to come up with.

Basically, the final two groups that were studied consisted of 256 children with ASD and 752 matched controls. One very interesting aspect that looks as though it were almost certainly placed into the experimental design based on concerns of anti-vaccine advocates like Sallie Bernard is a group of children who underwent regression. Basically, the study examined whether there was a correlation between ASD and TCV exposure. It also examined two subsets of ASD, autistic dsorder (AD) and ASD with regression, looking for any indication whether TCVs were associated with any of them. Regression was defined as:

the subset of case-children with ASD who reported loss of previously acquired language skills after acquisition.

Also, when adding up total thimerosal exposure, the investigators also included any thimerosal exposure that might have come prenatally from maternal receipt of flu vaccines during pregnancy, as well as immunoglobulins, tetanus toxoids, and diphtheria-tetanus. In other words, investigators tried to factor in all the various ideas for how TCVs might contribute to autism when designing this study.

So what did the investigators find? I think you probably know the answer to that question. They found nothing. Nada. Zip. There wasn’t even a hint of a correlation between TCV exposure and either ASD, AD, or ASD with regression:

There were no findings of increased risk for any of the 3 ASD outcomes. The adjusted odds ratios (95% confidence intervals) for ASD associated with a 2-SD increase in ethylmercury exposure were 1.12 (0.83-1.51) for prenatal exposure, 0.88 (0.62-1.26) for exposure from birth to 1 month, 0.60 (0.36-0.99) for exposure from birth to 7 months, and 0.60 (0.32- 0.97) for exposure from birth to 20 months.

The last result is a bit of an anomaly in that it implies that exposure to TCVs from birth to 1 month and birth to 7 months actually protects against ASD. The authors quite rightly comment on this result thusly:

In the covariate adjusted models, we found that an increase in ethylmercury exposure in 2 of the 4 exposure time periods evaluated was associated with decreased risk of each of the 3 ASD outcomes. We are not aware of a biological mechanism that would lead to this result.

Of course, two of the most likely explanations for such a paradoxical result would be either that parents of cases, given the genetic component of ASD, might have older children who have already developed ASDs. If these parents have imbibed the anti-vaccine propaganda that is so prevalent, they might be less likely to vaccinate their children according to the recommended schedule. The authors looked for such a correlation between older siblings with ASD and TCV exposure levels and found none. They also asked whether parents of children in the case group may have suspected that their children had an ASD and been influenced in their choice of vaccines by that knowledge, but none of the case children had been diagnosed by 7 months and only a few had been diagnosed by 20 months, which were the two time periods for which cumulative thimerosal exposure was calculated. In light of this, I would tend to interpret this seemingly paradoxical result as meaning, in essence, that there really isn’t even a whiff of a hint of a difference between the two groups.

This study had an additional strength as well, namely that the case and control populations were collected from three managed care organizations (MCOs) that participate in the VSD. Consequently, because of the detailed records maintained by these MCOs, investigators were able to develop a detailed and accurate estimate of total thimerosal exposure from the computerized databases maintained by the MCOs as well as the medical records of the cases, controls, all supplemented by standardized interviews with the parents. In addition, outcomes were measured in clinical settings using standardized assessment tools. In Price et al, the most up-to-date standardized assessment tools used to diagnose ASDs were used to identify cases. In addition, in order to make sure that the controls did not include children with undiagnosed ASD, which would tend to decrease any apparent differences between the groups, controls the lifetime form of the Social Communication Questionnaire was administered as part of the interview with each mother for children who had indications of any neurodevelopmental difficulties. Several children were excluded from the control group in this manner. Finally, the detailed medical records and databases maintained by the MCOs allowed for the detailed determination of and control for many potential confounders. All of these are strengths that were shared with Thompson et al.

So is this study the “last nail in the coffin” of the hypothesis that TCVs cause or contribute to ASDs? Scientifically, I would argue that it’s close, if not actually the final nail. After all, there have been multiple large, well-designed epidemiological studies of varying designs, all of which have come to the same conclusion: There is no detectable correlation between exposure to mercury in vaccines and ASDs. As far as case-control studies go, Price et al is quite good, but it is a retrospective study and the possibility of undetected biases or unidentified confounders can never be completely excluded. Also, it shares one other weakness with Thompson et al, namely a relatively low response rate of around 30%. However, as the authors pointed out in their response to Sallie Bernard, that participation rate was actually higher than predicted as the study was being designed, and it was accounted for in incredible detail in the technical description of how the study was set up.

Even though Price et al provides yet another bit of powerful evidence that, as far as science can tell, mercury in vaccines is not a cause of ASDs, I am under no illusion that this study will put this issue to bed once and for all. After all, if Blaxill and Olmsted are still publishing books based on Olmsted’s laughably poorly researched series Age of Autism. Let’s also not forget that Sallie Bernard was an external consultant for Price et al, as well. No doubt she will make her displeasure known soon, and no doubt it will consist of the same already refuted criticisms that she leveled at Thompson et al.

I can think of one criticism of this study that the anti-vaccine movement will level at it. In the methods, the authors state:

Children were excluded if they had the following medical conditions with known links to ASD traits: fragile X syndrome; tuberous sclerosis; Rett syndrome; congenital rubella syndrome; or Angelman syndrome.

Bernard complained that low birth weight children were excluded from Thompson et al (and presumably also from this study), not understanding that the reason for excluding low birthweight children was obvious: Such children are more likely to have neurodevelopmental problems completely independent from any external cause, such as thimerosal. Including preemies and lower birth weight children would only contribute to the background noise and make finding true associations more difficult. Or perhaps she did understand that and picking up false positives from random noise is what she hoped to see. Be that as it may, the same reasons apply for excluding children with medical conditions with known links to ASD traits. Including them would have added random noise to the current study. Anti-vaccine zealots will no doubt claim that the CDC intentionally excluded them because they are more “vulnerable” to “vaccine injury,” but there is no convincing evidence that this is so, and making such a claim is a shifting of the goalposts from the original claim that autism is a “misdiagnosis for mercury poisoning.” Such a hypothesis will probably eventually have to be studied, but it is a relatively implausible hypothesis given the weight of existing evidence. I also wonder if anti-vaccine activists realize just how much of a shrinking of their hypothesis it is to narrow it down to saying that vaccines cause autism only in children with these conditions. Particularly ironic is congenital rubella syndrome, given that maternal rubella during pregnancy is one of the few known external contributors to the development of autism.

In the end, it is always frustrating to watch how studies like Thompson et al and Price et al are spun by antivaccinationists. Epidemiology is like that, though. It’s virtually impossible to conduct a case-control study like this without there being significant shortcomings in it. The reason is that, unlike a bench experiment, the investigators can never control all the variables. Trade-offs are inevitable, and rarely are there adequate resources to assure sample sizes large enough to be completely bullet-proof or to be able to account for every single potentially confounding variable.

However, if there’s one rule in science-based medicine, it’s that no one study is ever sufficient to confirm or rule out correlations between undesirable outcomes and various exposures. However, as the weight of several studies starts to bear down on the problem, the preponderance of evidence must at some point be acknowledged, because we do not have unlimited resources to keep doing studies to answer the same question over and over and over again and every repeated study uses resources that could be used to study other potential causes and treatments for autism. Price et al happens to be one large and convincing chunk of that evidence, but it is not the only one. It builds on multiple other studies and it fits into the confluence of evidence strongly refuting the hypothesis that mercury in vaccines is a cause of autism.

EPILOGUE

Scene: The same shadowy room. The Leader sits at the head of the same table, looking a decade older, petting a different cat.

Time: September 13, 2010.

Leader: Who is responsible for this? Who allowed the release of Price et al to occur on the day before Blaxill and Olmsted’s book came out? Who? This confluence is too close! It endangers all my plans!

Lackey #1 (cowering): Sir, we could not help it! That’s how the publication schedules fell out!

Leader: What do I pay our lackeys over at Pediatrics for, anyway? Surely they could have delayed publication or accelerated it! What about Price, Thompson, and the rest of those twits at the CDC and the VSD? They were supposed to have wrapped this study up a year after Thompson et al was published! Late 2008 or early 2009 would have been perfect! Not now!

Lackey #1 (very frightened, and very tentative): Sir, if I may suggest something.

Leader (stops raging): It had better be good. Your life depends on it.

Lackey #1 (swallowing hard): Well, sir. We could always feed into the anti-vaccine groups’ paranoia. Rather than a screw-up, we can plant the idea that this was an intentional plot to discredit Blaxill and Olmsted. We could put the word out on the street that our operatives made sure that Price et al was published the day before Age of Autism was to be released. It was all a big pharma plot. Trust me, that will be the attack anti-vaccine groups will make.

Leader (pausing and thinking, stroking his chin): You may continue to live. For now.

TO BE CONTINUED….

EPILOGUE #2:

Leader (cackling): It’s working! It’s working!

[Fade.]

TO BE CONTINUED….AGAIN

Comments

  1. #1 NZ Sceptic
    September 13, 2010

    As far as I can make out, Wakefield’s book didn’t exactly set the best-seller charts on fire and I doubt The Collected Fairy Tales of Olmstead and Blaxill will either!

  2. #2 dt
    September 13, 2010

    I look forward to finding it placed on the store bookshelves in the section marked “Childrens’ fairy tales”.

  3. #3 SteveF
    September 13, 2010

    An epic; one of your best I reckon Orac.

  4. #4 Paul
    September 13, 2010

    I would say this is more than a nail in the coffin of the hypothesis that autism is mainly or substantially caused by TCVs. I would say that it constitutes a few spadefuls of earth and a eulogy as well. The hypothesis that a very few especially vulnerable children might have been affected by TCVs remains but seems extremely unlikely.

    Meanwhile, there’s currently a small flurry in the UK news about homeopathic “vaccines” after a BBC investigation. Mercury-free vaccines are one thing, but vaccine-free vaccines?

  5. #5 Grant
    September 13, 2010

    NZ Skeptic,

    If you care to assist, you could hop around to sciblogs.co.nz We’ve a local anti-vaccine promoter to deal with closer to home… (Sigh)

    Paul,

    I’ve heard of ‘homeopathic vaccines’ before, but your description of them as ‘vaccine-free vaccines’ is hilarious :-) Seriously though, that’s right up there with offering homeopathic remedies as treatment for AIDS.

    Speaking for myself, I hope to be writing more about the likes of the recent PLoS paper on the genome-wide search for parent-of-origin effects in autism. It’s painful to have be defensive and there are interesting new starts on the genetics over the last year or so.

  6. #6 superdave
    September 13, 2010

    Sometimes the arguments proposed by the age of autism people are so nonsensical that it actually takes a few tries to understand their point. The argument that not enough preemies and high risk infants were looked at in this study was one such example. People on the AOA boards were flabbergasted that the study didn’t include people known to be at risk for autism and considered this to be stacking the deck against autism. That conclusion is so stupid, so full of hubris, and so ignorant, it made me feel more sympathy for how these people have been mislead than anything else.

  7. #7 laura
    September 13, 2010

    orac–awesome!

  8. #8 René Najera
    September 13, 2010

    I’m probably going to get kicked out of the bookstore (at best) or arrested (at worst), but I’m going to get all the copies of the book and walk them over to the fiction section.
    I’d burn their books (outdoors and in a controlled fashion), but that’s become too passe.

  9. #9 MI Dawn
    September 13, 2010

    @Rene Najera: as much as I agree with you about the fictional status of the book, please take pity on the poor employees who have to move the books back and not do it.

    However, I see nothing wrong in placing a piece of paper that says that the book is a work of fiction inside the cover…

  10. #10 stripey_cat
    September 13, 2010

    Brilliant.

    The point in the last paragraph of the serious bit about limited resources always upsets me a lot. It’s heartbreaking that these people (many of whom have family members with autism) are lobbying to, in fact, set back research that might help their relatives, or at least help prevent future cases.

  11. #11 K0ilar
    September 13, 2010

    …And now I just crave to see Dr Jays comment on that… Does he still think he “saw” 1 in 100-200 children develop autism after vaccination? Although I know the answer already, he probably does…

  12. #12 desiree
    September 13, 2010

    what of that persistent, albeit weak, protective effect of thimerosal-containing vaccines against autism? i remember it cropping up in earlier research too (and a brief mention and dismissal in autism’s false prophets). has the effect popped up often enough to warrant real consideration? or was it just a few times in more than a dozen studies, thereby not consistent enough to likely be real?

  13. #13 Denice Walter
    September 13, 2010

    It’s fabulous!!!!!( in more ways than one)! Seriously, I have been thinking recently that “one of us” ( but emphatically, not me ) should create a tongue-in-cheek blog where ” pharma shills”,” black ops”, and other nefarious beings could “confess” their “crimes against humanity”, explain the inner workings( and pay scales) of the various matrices to which they’ve “sold their souls”, and publicly re-iterate the “secret histories” of the “Organization”, the “Man”, the “Pharma-Industrial Complex”, and the NWO of Medicine. Thus, woo-dependent conspiracy-mongers would have continous internet “validation” ( of course ,our tales would be *somewhat* – I’m being kind- more sophisticated than is the usual dreck) for their wildest dreams and most unspeakable fears.

  14. #14 Calli Arcale
    September 13, 2010

    desiree, the only example of a protective affect of vaccines against autism that I recall was from Generation Rescue’s phone survey, which was deeply ironic. The methodology was so poor it’s hard to draw conclusions, but one of the likely confounders is that families who would talk to GR and who have an autistic child are less likely to vaccinate subsequent children, and if you have one child with autism, you have a higher risk of additional children with autism, as established in multiple other studies. So, by this reasoning, thimerosal would have had nothing to do with it, and it’s more of a sampling bias than a genuinely protective effect.

    I see no plausibility for thimerosal being protective against autism. Then again, in a very large population, vaccination — not thimerosal per se — would be mildly protective, by reducing incidence of encephalitis and prenatal rubella. Note, however, that the rubella protection doesn’t involve thimerosal and never has; MMR is a live vaccine.

  15. #15 MI Dawn
    September 13, 2010

    @desiree: you recall correctly; for some of the measures the researchers found a “weak” link with TCV being protective (or, to be more precise, the children who received TCV performed better on some of the measures – and worse on some of the other measures). However, the level of positive/negative in this study and the Thompson study, the only 2 (IIRC) that found this, was only at the level of “noise” and may not be a valid measure, since the variances were within the normal deviations.

    Perhaps someone with better statistical knowledge can answer more fully, but I think from what I have read, the sampling groups would need to be much larger to determine if the level was “noise” or actual positive/negative trend.

  16. #16 Pablo
    September 13, 2010

    the only example of a protective affect of vaccines against autism that I recall was from Generation Rescue’s phone survey, which was deeply ironic

    I know there have been others, including this one, because I have gotten into pissing matches with you folks here over the topic.

    I absolutely and vehemently disagree with the approach of “even though the study shows a protective effect, we won’t conclude there is one and will say that it has no effect.” That is very bad data manipulation.

    So, by this reasoning, thimerosal would have had nothing to do with it, and it’s more of a sampling bias than a genuinely protective effect

    This is a bad move that completely destroys the credibility of the study. Fortunately, the authors don’t go there like you did.

    The reason it is a bad move is the following:

    You have conceded that the study suffers from sampling bias.

    If I were an anti-vaxxer, I would see that as your acknowledgment that the study cannot be considered reliable.

    Yes, I know, every study has the potential of sampling bias. But in those cases, the bias is generally unrecognized and its effects are unknown.

    In this case, you have not only asserted that there is a significant sample bias, you have also asserted that this sample bias must be in a specific direction AND to a specific extent.

    Think about that last one for a bit. You assert there is a sampling bias that changes the autism effect from 1.0 to 0.6, and hence, there is really no effect. However, that assumes your conclusion. If the sample bias is that big, why do you say the ratio would be 1.0 without it? How can you rule out the possibility that it would be 1.2?

    Why is a factor of 1.6 (1/.6) due to sample bias acceptable, but a factor of 2 is not?

    Given the magnitude of the sample bias you are proposing, you are not justified in saying that it is masking no effect to make it look like a real effect. It could just as easily be masking a a real effect in the other direction to make it look like thimerasol is protective.

    Yes, sample bias is always a concern. However, if a sample bias cannot be identified, you cannot justify saying that a) it must exist, and b) it must have exactly this effect just based on how far the results deviate from “what you expect.”

    I think it’s time to make the statement: not only do the scientific studies show thimerasol does not cause autism, it appears to have a preventative role. This result is actually consistent with those from previous studies, although at least one of them has questionable methodology. If you dispute these conclusions, you need an explanation. A REAL explanation for why this is observed, and not brush it off with “it’s possible.” What is wrong with the sample?

    The authors of the paper certainly considered it, so it’s not like it’s obvious.

    Is there a reason to think the data are biased aside from “it didn’t give the result we expected”?

  17. #17 Coryat
    September 13, 2010

    Orac you fool! The dear leader will have you liquidated for exposing the details of our secret meetings! You may try to run, but there is nowhere that the icy fist of SPECTREPHARM may not snatch you from.

  18. #18 Pablo
    September 13, 2010

    Perhaps someone with better statistical knowledge can answer more fully, but I think from what I have read, the sampling groups would need to be much larger to determine if the level was “noise” or actual positive/negative trend.

    This is possible, but I would also note that it is very different from Calli’s explanation.

  19. #19 Mu
    September 13, 2010

    Going over the attendance lists for the various meetings trying to find the leak of his top secret information, shadowy leader realized only one man had been present for all of them: lackey #48, also known ans cat-litter-guy. Agonizing between the satisfaction to personally choke the life from the traitor and having to clean out the litter box, he decided a stern warning was appropriate. But, just to be safe, he also made an anonymous donation to the SEED network, to be traced back in time of need as proof for the existence of evil pharma shills.

  20. #20 cat-litter-guy
    September 13, 2010

    @Mu

    You have no proof.

  21. #21 Calli Arcale
    September 13, 2010

    Pablo, do you think I’m somehow supporting Generation Rescue’s phone survey? I’m not. Or are you? Now I’m confused.

    I don’t think it should even be dignified with the term “study”. As I said (and as Orac said at the time when he wrote on it), it was deeply ironic that GR went to some effort to do what they felt constituted a scientific study of vaccines and autism, comparing a vaccinated and unvaccinated cohort, and ended up with data that actually suggested a protective effect from vaccines. Of course, the “study” was garbage anyway.

    This is a bad move that completely destroys the credibility of the study. Fortunately, the authors don’t go there like you did.

    You say that like the “study” had any credibility in the first place. Dude, it was a *phone survey* by Generation freakin’ Rescue. Why would you want to defend it?

    If I were an anti-vaxxer, I would see that as your acknowledgment that the study cannot be considered reliable.

    Well, that is basically what I meant by it. The survey is garbage. I’m not really conceding that it’s unreliable. I’m outright saying it, and it’s been said many times before.

    Is there a reason to think the data are biased aside from “it didn’t give the result we expected”?

    Um, yeah, there is. The children who were unvaccinated were not put in that group by chance; they were unvaccinated because their parents believed that vaccines cause autism. You seriously don’t think that might have any affect on the results?

    Pablo, are you doing a Poe here? Are you seriously suggesting that Generation Rescue did good science?

  22. #22 Kristen
    September 13, 2010

    Callie,
    I could be wrong but I think Pablo was referring to (possibly?) other studies that came up with the appearance of a TCV protective effect. I didn’t get the impression at all that he was arguing that the GR survey should have any kind of credibility.

    He was simply stating (in my estimation) that one cannot say there is or is not a protective effect without more research. It (posible protective effect from TCV) should not be discounted because it was an unexpected result.

    I suppose, if I am reasoning correctly, this effect is discounted because:

    We are not aware of a biological mechanism that would lead to this result.

    This is very open-ended. “We are not aware of” is not the same as ‘there is none’.

    Whether this will be an anti-vax argument or not, I don’t know. I doubt they will go there simply because it looks bad for them. I know if I heard this or that study said ‘this vaccine protects against autism’ I wouldn’t care if it wasn’t plausible (back when I was wondering about vaccines) it would give me pause. The anti-vaxers would be better off leaving that part out.

    Just my 2¢.

  23. #23 Charles
    September 13, 2010

    If I didn’t already believe that vaccines’ mercury content was harmless, this would not be convincing evidence. The Pharma companies are not unbiased witnesses. They have a clear axe to grind.

    As it is, however, while they caused me to re-evaluate my position, they didn’t change it. There’s enough evidence from not obviously biased sources.

    I do, however, think that trusting a vaccine vendor to be honest about the defects in his merchandise is rather like trusting a used car salesman to be honest about the defects in *his* merchandise…with the difference that it’s easier to nail a used car salesman for fraud.

    P.S.: There have been repeated revelations about suppressed studies showing injurious, or even life-threatening, defects in drugs that pharma companies had up for approval. The only penalties I’ve heard of was occasionally an approval was revoked, and a monetary judgment against the company. If a person did something equivalent they’d be looking at over a decade in prison…and so should the responsible parties in this kind of fraud. Since that doesn’t happen, the decision to consider it just a part of “the cost of doing business” is reinforced.

    Did you hear about the Elseivier journal that was published with all reviews written by staff of one of the pharma companies? (Or maybe just most.) I forget some of the details, I think subscriptions were limited, but it was considered a refereed journal and the articles were cited by other articles in other journals. Quite an extensive piece of deceit, though I’m not sure any laws were broken. I only read a summary in the popular press, but I’m sure you have access to a more detailed account.

  24. #24 sheldon101
    September 13, 2010

    Slight Correction – Expiry Dates 2002
    ————
    There’s a slight error. Orac writes: “[Even] assuming that the last lots of thimerosal-containing vaccines are gone by the end of 2001.”

    The relevant date is the expiry date. Some thimerosal as a preservative vaccines had expiry dates in 2002. That’s from page 3 of an FDA letter that discusses the vaccines one by one.
    https://docs.google.com/fileview?id=0B7TTKX7laEzvY2M0ZDY4NjQtZjY0NC00MGJjLWExZGUtNTg1NjQ0OWJmOTRh&hl=en

    This letter is a great resource to respond to claims that vaccines with thimerosal as a preservative (except for the flu) were on the market later.

  25. #25 Dangerous Bacon
    September 13, 2010

    What is most upsetting* about this latest study is that it has become obvious that the old “mercury militia” designation for the common run of antivaxers is ready for the dustbin (diminishing mercury diehards not withstanding).

    What will take its place? The Aluminum Army? The Formaldehyde Force? Or even the Cytokine Cowboys? None has the same ring to it.

    I suppose it doesn’t matter, as long as we remember that It’s Gotta Be The Vaccines. The details are irrelevant.

    *apart from reminding us of the time and effort spent on debunking claims of a vaccine-autism connection, which could have been funneled into uncovering real causes and prevention/treatment.

  26. #26 Enkidu
    September 13, 2010

    @Dangerous Bacon: Let’s just call them the Toxin Avengers so we don’t have to come up with a new name every couple of years. :)

  27. #27 JoeB
    September 13, 2010

    The other time I remember seeing a protective effect in a Autism-Vaccine study was (I think) MMR in Poland. Along with the possible sampling biases I remember seeing speculation about the protective effect being vaguely plausible due to the known, but rare, neurological complications of measles.

    Did that makes sense then, and could it be at work here too?

  28. #28 Prometheus
    September 13, 2010

    After reading Pablo’s comment, I realised that the study did not compare the number of vaccines the two groups had received. While it is reasonable to assume that greater exposure to thimerosal is equivalent to more vaccines, I would feel more confident if they had given us that data.

    However, one possible sociological explanation for the association between autism and lower thimerosal dose may be that the autism group included more children who had not received the usual schedule of vaccinations (sometimes described as the “Too many, too soon” regimen). The reason for this may have been a history of autism in older siblings, which led the parents to – erroneously – think that it would be safer to not vaccinate subsequent children.

    Since autism is – according to available data – a genetic disorder, not giving vaccinations would not be expected to reduce the risk of autism in siblings. In this case, the lower thimerosal doses in the autism group may be a surrogate variable for siblings with ASD.

    Prometheus

  29. #29 Militant Agnostic
    September 13, 2010

    Charles @23

    Did you hear about the Elseivier journal that was published with all reviews written by staff of one of the pharma companies? (Or maybe just most.)

    Yup – Orac blogged about it here more than once (including last week) – it is still in the Recent Posts list

    http://scienceblogs.com/insolence/2010/09/threats_to_science-based_medicine_pharma_1.php

    Lord Draconis was not pleased.

  30. #30 desiree
    September 13, 2010

    pablo, i get your point. orac says in this post that the authors checked the 2 most likely causes of sample bias (parents not vaccinating the younger siblings of autistic kids, and parents not vaccinating because they suspect or have gotten an autism diagnosis), and the biases weren’t there. so if the groups are really that well matched, is it time to consider that thimerosal might really be protective? 60% seems like a pretty big reduction to me, i know if thimerosal appeared to increase autism by 60%, people would be going nuts. and just because we don’t understand why, doesn’t mean it’s not impossible, right? or, is there some kind of guideline for considering this kind of currently implausible phenomenon–like, showing up in 10% of studies is probably meaningless, but showing up in 35% is interesting. or whatever.

    i donated my copy of autism’s false prophets to my local library so i can’t check that part i’m thinking of, where dr. offit mentions the protective effect (a move i’m rather proud of, as it’s been checked out a dozen or so times this year.)

  31. #31 Composer99
    September 13, 2010

    Zombieland references == full of win.

  32. #32 Liz Ditz
    September 13, 2010

    The paper is being discussed at several sites. As usual, I’m keeping a list.

    http://lizditz.typepad.com/i_speak_of_dreams/2010/09/important-new-paper-again-maybe-finally-no-link-between-vaccination-and-thimerosal-in-vaccines-not-c.html

    Don’t miss Prometheus’ post — top flight as always.

  33. #33 Sullivan
    September 13, 2010

    “After reading Pablo’s comment, I realised that the study did not compare the number of vaccines the two groups had received.”

    Prometheus–

    They did. Check the technical reports. Total number of vaccines received is the same amongst groups.

    Check page 82 of volume 2 of the Technical Report.

    http://abtassociates.com/reports/Aut_Tech_Report_Vol2_090310.pdf

  34. #34 Orac
    September 13, 2010

    After reading Pablo’s comment, I realised that the study did not compare the number of vaccines the two groups had received. While it is reasonable to assume that greater exposure to thimerosal is equivalent to more vaccines, I would feel more confident if they had given us that data.

    However, one possible sociological explanation for the association between autism and lower thimerosal dose may be that the autism group included more children who had not received the usual schedule of vaccinations (sometimes described as the “Too many, too soon” regimen). The reason for this may have been a history of autism in older siblings, which led the parents to – erroneously – think that it would be safer to not vaccinate subsequent children.

    Actually, they did control for at least the number of children with siblings with ASD. It’s mentioned in the Discussion section of the paper and in the technical report. I also mentioned it in my writeup.

  35. #35 NZ Sceptic
    September 13, 2010

    #5 – Don’t worry Grant, I’m there already with EA firmly in my sights!!

  36. #36 Roger Kulp
    September 13, 2010

    So is this study the “last nail in the coffin” of the hypothesis that TCVs cause or contribute to ASDs?

    We all know the answer to that.

    Grant@ #5.I just read the Parent-of-Origin study

    http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0012513

    Anybody with an autism diagnosis,who has had any genetic studies done,even for “unrelated” congenital medical problems,should find it very interesting.I’m hoping some blogger will break it down further,for the less scientifically literate among us.

  37. #37 concerned citizen
    September 13, 2010

    anyone read Tim Bolen’s latest article “Is Terry Polevoy the Information Source for Doctor ‘ s Data?…” http://www.bolenreport.com/feature_articles/Doctor's-Data-v-Barrett/Terry-polevoy-working-with-doctor's-data.htm

    what do you think?

  38. #38 A Nonny Moose
    September 13, 2010

    Upcoming AoA headline: “ORAC ADMITS PHARMA CONSPIRACY REGARDING VACCINES AND AUTISM!”

  39. #39 wfjag
    September 13, 2010

    “Shadowy figure: Good, good! But we still need more! Which is why I want you to meet our newest deep cover operatives.”

    But the Shadowy Figure, with his black mask and cape, has still out-foxed you Orac. You totally missed the False Flag Authors, those who wrote articles supposedly questioning the idea that Mercury Causes Autism and were then sued:

    Kathleen Seidel, who in February 2008 in her blog Neurodiversity wrote about the then pending suit Sykes v. Seidel. All of her records, including the actual identities of persons posting comments on her blog were subpoena by Darth Shoemaker. After this generated articles written to present both sides of the issue, the subpoena was conveniently quashed. http://www.citmedialaw.org/threats/sykes-v-seidel
    [And, you thought it was quashed because it had no merit. Que evil laughter].

    Then, Amy Wallace published “An Epidemic of Fear: One Man’s Battle Against the Anti-vaccine Movement ” Wired Magazine (Oct. 19, 2009) and was sued 2 months later for libel by Barbara Loe. After generating sufficient articles written to present both sides of the issue, the suit was conveniently dismissed. Covering Vaccines, By Amy Wallace, Reporting on Health (August 30, 2010) http://www.reportingonhealth.org/resources/lessons/covering-vaccines [And, you thought it was dismissed because it completely lacked factual or legal merit. Que heavy breathing by the person wearing black mask with grill that looks like it was salvaged from a 57 DeSoto.]

    And, then the best of the False Flag operations, Simon Singh’s comments about chiropractic — including much more than dismissing claims that it can be used to treat autism, and questioning whether it can be use to treat anything that can possibly be treated with drugs and his refusal to apologize. This lead to the libel suit by the British Chiropractic Association. Author Simon Singh Puts Up a Fight in the War on Science, by Robert Capps, Wired Magazine (August 30, 2010) http://www.wired.com/magazine/2010/08/mf_qa_singh/ [Listen closely to the Figure dressed in black -- "Orac, Orac, I am your father. Paul Offit-wan lied to you. Join with me and we can defeat the Emperor and rule Big Pharma."]

  40. #40 MikeMa
    September 13, 2010

    @Mouse,

    ORAC ADMITS PHARMA CONSPIRACY…

    Really? Will they use all caps? Will it mean anything in the reality based world?

  41. #41 Joseph
    September 13, 2010

    Really? Will they use all caps?

    Of course they will. They are cranks, aren’t they?

  42. #42 Lackey #93
    September 13, 2010

    That’s it! I’ve had it with SPECTREPHARM. I still haven’t gotten any Shill cheques. I don’t get invited to no secret meetings. It’s like I don’t even exist at all!

    Well now I’m going to go where the money is and write an anti-vaxx novel. So there!

  43. #43 Antiquated Tory
    September 13, 2010

    Big Pharma needs to slip some Super-Gullible into their compounds.

  44. #44 RJ
    September 13, 2010

    Uh…the story is up at HuffPo. Get ready for the bat-shit alarm to go off.

  45. #45 Calli Arcale
    September 13, 2010

    I think this is what I get for posting while multitasking on a particularly insane day at work. I didn’t read all the way through Orac’s article. I need thirty lashes with a wet noodle. And possibly a stiff drink; it’s been a day.

  46. #46 A Nonny Moose
    September 13, 2010

    Really? Will they use all caps? Will it mean anything in the reality based world?

    I’ve actually never been able to go to AOA, because I can’t stomach the BS they spew. I just assumed, that like any good crackpot website, they’d use all caps.

  47. #47 MikeMa
    September 13, 2010

    @Mouse,
    Good guess on the CAPS.

    As RJ reported, HuffPo’s Living section has a link to the Yahoo ‘No link found between vaccine mercury and autism’ article and the comments are, in large part, insane.

  48. #48 Grant
    September 13, 2010

    Roger Kulp wrote “I’m hoping some blogger will break it down further,for the less scientifically literate among us.”

    I’m going to have (another) look at it tonight to see if it looks suitable to write up. (My blog is linked on my name.)

  49. #49 The Gregarious Misanthrope
    September 14, 2010

    @Lackey #93

    Your ‘nym answers your own question: Lackey. Dude, you need to upgrade to Minion. That’s when the bacon (dangerous and otherwise) really starts to roll in.

  50. #50 Minion #93
    September 14, 2010

    Wait…there’s bacon?
    *holds out plate*

  51. #51 Kristen
    September 14, 2010

    Mikema,

    Will it mean anything in the reality based world?

    Wait, did they say something that made sense? It would be news to me.

    …the comments are, in large part, insane.

    My hat goes off to anyone who can read those comments. I can’t get past four or five without getting to the point where I am unsure if I should cry or scream.

    BTW Orac, you don’t disappoint.

  52. #52 Roger Kulp
    September 14, 2010

    On the other hand,the fun may be just beginning.If recent posts at Autism-Mercury are any indication,they are starting to float the idea autism is caused by get ready for it… chemtrails.

  53. #53 The Gregarious Misanthrope
    September 15, 2010

    Oh, I’d love to get into a chemtrails discussion. There is so much burning stupid there, and so easy to debunk.

  54. #54 Grant
    September 15, 2010

    Roger Kulp (and anyone else who is curious!):

    I’ve written up something about the parent-of-origin effect paper, linked on my name below. (Not the greatest piece in the world, but better than nothing, perhaps?)

  55. #55 jen
    September 16, 2010

    too bad the study is an obvious piece of statistical crap. See the AoA article (from Safeminds)as to why.

  56. #56 Science Mom
    September 16, 2010

    too bad the study is an obvious piece of statistical crap. See the AoA article (from Safeminds)as to why.

    Wow, jen is regurgitating vomitus from her favourite crank site without nary an original insight. I’m shocked I tell you.

    jen, the obvious part is not obvious to me, perhaps you would be so kind as to explain anything that the Price et al. didn’t. It’s okay to use big words too.

  57. #57 ebohlman
    September 16, 2010

    Maybe they’ll start blaming hydromagnetic fields next.

  58. #58 KD
    September 17, 2010

    I find it astounding that the same folks who will look for any flaws in the large-scale, well-designed studies were so very willing to accept the results of the completely flawed, biased, miniscule study in the first place!! (I know it’s political, but I cannot resist – similar to people who will accept a clearly forged birth certificate (with the wrong country name) of a certain politician as being more reliable than the empirical, concurrent evidence (birth announcement, state records) and testimony of people who have no reason to lie (being of the opposite political persuasion)). Makes one very sad…

  59. #59 Militant Agnostic
    September 18, 2010

    Ebohlman @57 – that Irish Times article you linked to was some first class blarney. I wonder if anyone took it seriously.

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