One of the favorite refrains of the mercury militia is that the mountains of scientific findings that undermine the thimerosal/vaccines and autism hypothesis are all fatally flawed by conflicts of interest with the pharmaceutical industry.
The National Autism Association is particularly aggressive with this canard. The organization smeared a recent study, which found no link between RhoGam and autism, as the “Best Science Drug Company Money Can Buy”
“This study is just another example of the pharmaceutical industry’s corruption of research to suit its own purposes,†according to National Autism Association president and parent Wendy Fournier. “They back the study designs that give the desired results of no harm.â€
In an Orwellian defense of discredited researcher Dr. Andrew Wakefield, NAA board member Scott Bono stated:
“Implicating the safety of vaccines such as MMR isn’t acceptable to drug companies or government officials who want to protect the vaccine program itself at the cost of the health of children.â€
The NAA conflict of interest smear campaign extended to the media during the recent Autism Omnibus trial when the organization was faced with a barrage of media reports reflecting the scientific consensus that there is no link between autism and thimerosal and/or vaccines. Dr. Nancy Snyderman of NBC News became enemy #1 when she suggested that financial gain was a motive for many of these lawsuits. NAA claimed she was acting as a shill for the pharmaceutical industry because of her long ago previous employment with Johnson and Johnson.
According to the NAA, even the government is under the influence of Big Pharma. In this NAA press release, Dr. Jay Lieberman, who presented safety data on thimerosal at a CDC meeting, is accused of “white washing†the data because of his work with various pharmaceutical companies.
“Dr. Lieberman has been a consultant to Merck, GlaxoSmithKline, and Sanofi-Pasteur and is on the speakers’ bureau for all three vaccine-makers, who have used, and currently use, thimerosal in their products. “We have been very concerned about Dr. Lieberman’s conflicts of interest,†commented Executive Director Rita Shreffler of NAA. Shreffler says that NAA requested that a counterpoint speaker without ties to drug companies be allowed to present current, peer-reviewed toxicological data and the request was denied. “ To leave this presentation in the hands of those who have profited from, and continue to use thimerosal in some of their products is consistent with the CDC’s history of concealing the consequences of injecting mercury into humans,†said Shreffler.”
Obviously, the NAA wants us to believe that conflict of interest is a driving force that prevents the public from learning “the truth†about thimerosal/vaccines and autism.
To extend their scenario to its logical conclusion means that pharmaceutical and academic scientists actively suppress or pervert relevant data in exchange for financial gain. The American Academy of Pediatrics is willing to harm the very population they serve in exchange for complimentary travel, meals and baubles. Government employees are forbidden to reveal “the truth” because political systems are corrupted and silenced by the pharmaceutical lobby. Media outlets throughout the world suppress a Pulitzer Prize worthy story in exchange for pharmaceutical advertising revenue. All told, hundreds of thousands of people are complicit and willing to endanger their families, friends and the public’s health in exchange for professional remuneration, campaign donations and advertising revenue.
Collectively, these accusations are absurd. But individually, they can help plant seeds of doubt in the uninformed or casual observer and obscure the overwhelming scientific evidence that undermines the thimerosal/vaccine hypothesis. This strategy is also effective as it posits the NAA as a referee of professional ethics. However, in truth the NAA is riddled with very real rather than imagined conflicts of interest.
Meet the NAA Litigants
Several NAA Board members, Rita Cave Shreffler, Claire Bothwell, Laura and Scott Bono, Rosemary Dubrowsky, Lori McIlwain, and Lyn Redwood are or were litigants in vaccine cases. Ms. Redwood is/was also suing Georgia Power claiming that the mercury they emitted to generate power contributed to their child’s autism. Dr. Jeffrey Bradstreet, the organization’s, medical advisor, witch DAN! doctor, resident exorcist, and would-be expert witness also has claims before the vaccine court.
The organization’s board members have fanned out to push their thimerosal/vaccine agenda to government and scientific organizations. They have testified on Capitol Hill, planned and participated in federal research meetings, and served as advisors for federally awarded grants. All the while these people are suing the federal government and pharmaceutical companies. Their lawsuits represent a clear conflict of interest where the policies they advocate have bearing on their lawsuits. This certainly does not pass the sniff test. Most taxpayers would be angry to learn that their government is in effect helping them in their lawsuits against the federal government. Although it is extremely unlikely that they will ever prevail, their advocacy risks sidetracking productive research in favor of chasing after evidence for a lawsuit.
Jeffrey Bradstreet Addresses the IACC
The Interagency Autism Coordinating Committee (IACC) directs federal funding decisions among the various federal agencies that have interest in autism. Top brass and scientists attend IACC meetings. Presenters at IACC meetings are high level government agency heads or accomplished scientists. However, in November 2006, Jeffrey Bradstreet was on the IACC agenda giving a talk entitled, “The Role of Environmental Factors in the Pathogenesis of Autism:Phenotypes, Lab Markers, Clinical Interventions and Suggested Areas for Researchâ€
The talk is a tour-de-force of junk science, skewed findings, lies, and damn lies. Every crappy paper ever smuggled into a medical journal on the imaginary association of thimerosal to autism is presented. And of course, at the end, Bradstreet has the audacity to suggest that NIH prioritize funding into biomarkers (read provoked urine tests for mercury) environmental toxins (read thimerosal) and DAN! Treatments (read chelation, HBOT, methyl-B12). He further suggests that this junk science be given program names within NIH and incorporated into existing Autism Centers of Excellence
Now, I would bet that the IACC members did their best to stifle laughter and not roll their eyes during his talk, but I’m not laughing. As someone concerned about autism, I’m brought to meltdown that Jeff Bradstreet, vaccine litigant and quack, was given a platform at the central seat of power in the U.S. for autism research funding. Why is the federal government encouraging a litigious fringe element? One has to wonder if the feds are aware of these conflicts.
Laura Bono and Lyn Redwood Plan IOM Meeting
In April, the prestigious Institute of Medicine held a scientific workshop Autism and the Environment. Laura Bono and Lyn Redwood were appointed to the planning committee for this meeting along with others in the mercury camp. Ms. Bono was given the floor to open the meeting where she excoriated the CDC for imagined failures and demanded that the federal government, “Grant money only to genetic vulnerability studies that have a clear environmental hypothesis.â€
How many litigants suing the federal government are given the opportunity to infleunce federal research dollars at a very high level scientific meeting? Most tax payers would find this arrangement perverse and question the appointment of people with such obvious conflicts of interest. Do you think Ms. Bono or Redwood revealed their conflicts to the IOM?
Ironically, as Ms. Bono issued her demand that genomics research be halted, a seminal genomics paper was published which found that genetic copy number variations account for a significant portion of autism. This paper was the basis for yet another seminal paper which advanced a new and compelling unified theory of sporadic and inherited autism.
If officials at the NIH were to heed Ms. Bono’s self-interested and uninformed diatribe, science would be losing out on major discoveries into the causes of autism. Ms. Bono is a marketing professional with absolutely no understanding of medical research. She has no business at such a meeting and it’s more than time that the NAA is left out in the cold. It is shameful that federal officials have given this litigous group a seat at such an infleuntial table.
Lyn Redwood Decides Funding for Federal Autism Grants
Speaking of seats at the table, Lyn Redwood was recently named to an advisory panel that will direct $7.5 million in funding for autism research through the U.S. Department of Defense (DoD). This panel will be responsible for selecting grants that will be funded. The NAA press release about the DoD autism program states, â€The DoD reached out to stakeholders in the autism community in an effort to identify under funded areas of investigation and solicit feedback regarding the most promising areas of research.â€
It is extremely troubling that the DoD reached out to a litigant suing the federal government and put them in a position to select federally funded research studies that have direct bearing on her lawsuit.
The overwhelming scientific data does not support any association between autism and thimerosal. Nonetheless, the NAA and like-minded organizations are working to fund research that will force a link. As you can imagine, the “scientists” who support the thimerosal/autism hypothesis are on the extreme fringe of research. They cannot meet the scientific rigor required for NIH funding and so they are desperate for other funding sources. Isn’t it convenient that Ms. Redwood became a panel member overseeing $7.5 million in autism research funding?
The DoD advisory panel conflict of interest policy clearly states that panel members are to divulge any and all conflicts of interest and recuse themselves from the grant selections or from the panel entirely.
Someone contacted the DoD about Ms. Redwood’s appointment as her involvement in litigation is an obvious conflict of interest. The news seemed to come as something of a surprise. A DoD representative responded that:
“The CDMRP take matters surrounding Conflicts of Interest (COI) very seriously and have had COI policies in place since the inception of our programs in 1992. As in other instances of potential COI as noted in our policy, the CDMRP will ensure that members of our 2007 Autism Spectrum Disorder Research Program Integration Panel (IP) are not claimants against the government before they participate in the review of proposals containing vaccine-related research. Our COI policy is attached. As you’ll note, IP members are expressly told that they “… will avoid any actions that might give the appearance that a conflict of interest exists or could reasonably be viewed as affecting objectivity in proposal review.” This means that IP members must either recuse themselves from reviews for which they have a COI or remove themselves from the panel altogether. We will ensure that this happens, and maintain the highest level of ethical accountability for our scientific processes, as the CDMRP has been doing for many years.â€
So once again, it seems an NAA board member failed to disclose a clear and concrete conflict of interest that should have precluded them from ever becoming a part of the DoD Autism panel.
You’d Think I Was Making All This Up
When I was younger, I was accussed of having an active imagination. In fact, I dreamed an entire television show while staring at a snow globe. But this is not fiction. It’s time the federal government put the mercury militia to the curb and drive off. If you agree, I suggest contacting IACC member agencies—especially the National Institute of Mental Health which oversees the IACC—and the DOD Autism Program to express your displeasure.
It’s time that other voices within the community be heard. Voices that are free of conflicts of interest.
Left Brain Right Brain 
That was awesome.
Excellent summary.
I think the word for what the mercury parent organizations have is “chutzpah.” Or maybe it’s “gall.”
The NAA are moving year after year towards full on anti-vax status. They need to step away from these sort of environments.
I’m astounded by this piece. Particularly the link leading to the Jeffrey Bradstreet claim in federal court.
I have an article downloaded from Bradstreet’s quacksite – which I printed in July 2004 – in which he states:
“I am not filing my son’s injury with VAERS or joining the autism/MMR class action lawsuit. Why? Because I do not want people to feel I am motivated by personal or family economic gains concerning our research and observations…”
And yet here you are pulling up a link to the federal register of May 2003 where his claim is logged.
I keep thinking I’m passed being shocked over these kinds of thing.
Indeed, very nice piece. Good job.
I hope the right people read this and act. An excellent piece of work.
Amazing. Troubling. Thoughtful.
I’m going to have the following needlepointed into a doiley and framed on my wall as it’s a thing of beauty:
“The talk is a tour-de-force of junk science, skewed findings, lies, and damn lies. Every crappy paper ever smuggled into a medical journal on the imaginary association of thimerosal to autism is presented.”
Do these people really think they can get away with these indiscretions and outright lies?
And I was at the IOM conference last spring… Ms. Bono, Redwood, and Blaxill play on emotion rather than fact and reason.
It’s actually easy to see why Insel et al. would attend “conferences” these people push: they’re pitiful in these privileged parents’ cries for mercy and someone who is dedicated to helping people will stop and pay some attention, even given the science-free, single-minded push to blame vaccines for what is likely a genetic issue.
I think the motivation of someone who heads the NIMH would be *fundraising* first. US funds do not go to science or reason at the moment, which is why someone would be tempted to entertain the drama kings and queens of “autism everyday”. For, after all, if it is not daily hell, why should any money be put into research?
To Tommy Rot Westphall
Your mistake for witch and dan seems bizarre.
Anyone can make errors; when Tommy comes up Rot seems to follow.
I am not sure what your qualifications are to deny that the most toxic non radioactive element is not a factor in death, autism and nearly every non infectious malady?
If you put the mercury vaccine in a swimming pool of water and got an analysis it would be illegal to drink.
The animals in the UK have been protected from mercury for 40 years from mercury because of its known harm.
Your most accurate statement was the allusion to genetics. Did you know that in addition to being quintessently toxic it is also a teratogen and could very well cause genetic changes in our children?
The facts above come from vaccine companies and makers of thimerosal to protect their workers. If they lied to them it would be the chemical industry itself that sued itself.
Why do you lie to those children dead or ill from toxins.
If it isn’t thimerosal to blame then perhaps you could enlighten me as to what kills children in 6 hours inividually or in groups when they are fit and well before just having a mercury vaccine.
I have studied this toxin and others for a long time and when people ignore their effects they have to ignore their effects.
John Fryer M Sc B Sc Advanced Analytical Chemist
Way to go Tommy! Your first blog post and you got a live one – ad hominems, appeals to authority, (his own) and a complete lack of data. I am impressed.
Thanks for taking the time to read this long piece. Also, thanks to kev for inviting me to contribute to his blog.
Thanks to John Fryer for his incoherence.
John Fryer said:
If you put the mercury vaccine in a swimming pool of water and got an analysis it would be illegal to drink.
Let’s see. Consider a pool of 350,000 liters of water. Let’s assume the water is completely clean to start with, for argument’s sake. That’s approximately 350,000 Kg of water, 350,000,000 grams or 350,000,000,000,000 micrograms of water. You add 25 microgams of mercury to that and you get 0.00007 parts per billion (ppb) mercury.
It’s completely within EPA recommendations.
Besides, even if the recommendations are exceeded, I don’t think it would be illegal to drink.
So, John Fryer, besides ad-hominem, completely false statements, and unsubstantiated inuendo, what can you offer?
Jon Fryer,
a good list of the classic red herrings. The question is not whether mercury is toxic above a certain dose, the question is whether it causes autism At least, that is the question here.
If you want to debate mercury toxicity on its own, there are probably blogs out there.
When you do, first check the LD50’s for mercury and arsenic. Then correct your statement about mercury being the most non-radio-active element.
Matt
I’d just like to praise the commenter’s above me for apparently being able to extract meaning from the word salad John Fryer just sicked up. Well done.
“Then correct your statement about mercury being the most non-radio-active element.”
Should read
Then correct your statement about mercury being the most toxic non-radio-active element.
“If you put the mercury vaccine in a swimming pool of water and got an analysis it would be illegal to drink.”
How do these people find us?
John Freyer states:
“If it isn’t thimerosal to blame then perhaps you could enlighten me as to what kills children in 6 hours inividually [sic] or in groups when they are fit and well before just having a mercury vaccine.”
I would have assumed that Mr. Freyer had a source for this information, if his next sentence wasn’t:
“I have studied this toxin and others for a long time and when people ignore their effects they have to ignore their effects.”
This makes so little sense that it had to come from a post-modern “lit-crit” professor. Either that, or Mr. Freyer needs to avoid posting ‘blog comments when he has had too much to drink.
Indeed, if there were documented cases of children dying “…inividually [sic] or in groups when they are fit and well before just having a mercury vaccine.”, I would be very interested in the cause.
Absent the reports of such deaths (which I imagine Mr. Freyer will not be able to produce, having left them in his other pants), it is nothing more than idle chatter.
It doesn’t even rise to the level of rumor.
Prometheus
Kevin,
You are absolutely right that it is completely hypocritical of these people to break the COI rules.
But you don’t have to embelish your argument by pretending that COI in industry funded studies doesn’t exist. In fact, that same conflict of interest probably precludes every pharmaceutical (or Pharma investor) from sitting on the same commitee.
Did you actually read the details of the RhoGham study you quoted the critical review from? It definately reeked of bad industry funded science.
Kevin didn’t write this entry. I did.
Medical research operates with a clear and codified system to disclose COI. You can bet that every scientist on the DoD Autism panel adhered to the COI policy by disclosing their funding sources and affiliations. Lyn Redwood, on the other hand, appears to have failed to adhere to DoD’s COI policies.
The RhoGam study is an example of the integrity of the COI system. The study authors clearly divulged their funding sources, including J&J. The paper was peer-reviewed with that disclosure and found worthy. How exactly does it reek of bad industry funded science? Anyone without an axe to grind would see that J&J acted as a good corporate citizen to support research that was motivated by public concern. Do you really think they somehow manipulated the data?
Every scientific talk I have ever attended, the investigator lists his/her COI in the slides. The conference program also lists the COI. Jeffrey Bradstreet has published studies and given talks where he failed to disclose his COI. Moreover, according to Brian Deer, he appears to have deceived the public by claiming he is not a litigant, when he clearly is a litigant.
COI does not preclude someone from sitting on a review committee or participating in a meeting. However, if you fail to disclose your COI, then you are operating in a dishonest manner that prevents science from operating in the brightest light possible.
From this:
http://www.bmj.com/cgi/eletters/321/7269/1091
It says “John Fryer, early retired scientist”
(which somewhat answers Brian Deer’s question, Mr. Fryer spends his retirement looking for platforms to state his opinions)
Mr. Fryer, it looks like you have not worked in actual science for quite a while. I have also not worked in my previous profession for quite a while (structural engineering)… but I know enough to look up relevant facts before making statements. I also have gladly accepted corrections.
I would suggest you take the information in the replies given to your message and look up the relevant chemistry facts. The next time you post an opinion, please post the evidence and data that supports your statement.
Just a reminder on the NAA… If you look at the archives on this blog (I’m sticking to only one URL these days), you will see that they accused a researcher Paul Shattuck of accepting money from Merck! Unfortunately, it was not the pharmaceutical company! It was the John Merck Fund, an organization that supports research in developmental disabilities.
It is nice to see that not only are they bad at research, but they are hypocrits.
Very thought provoking blog post Tommy Westphall.
Sorry that I mistook your name Tommy — reading too many posts.
A couple things: The guidelines do appear to allow someone to sit on the committee as long as they recuse themselves from a review of the studies that they have a direct COI with. Are you aware of which reviews she recused herself from? If her court case is specifically related to Thimerosal, she could technically sit on reviews of research related to other environmental items.
Similarly, your accusation against Bradstreet would also preclude any Pharma funded scientist, CDC, IOM or Government scientist from making a presentation to the IACC. Did you check all of the other presenters as well?
As for Brian Deer’s accusation of misleading the public? Please spare me the dramatics. A post on a blog can hardly be considered misleading the public.
How about comparing a blog entry to looking at the official press release about that Rho Gam study you reference. Please note that there is no mention of conflict of interest at all. So much for the integrity of the COI system as one has to read the report (not widely distributed to the public) to find the funding source.
http://munews.missouri.edu/NewsBureauSingleNews.cfm?newsid=15185
Even worse, if you actually get to read the study and it lists the funding sources, it does not make any mention that this study is directly relevant to litigation involving the funding party (as a defendant). This undisclosed revelation is very ironic given the context in which you raised this study in your article.
I also fundamentally disagree with your assertion that there is integrity of the COI system as it exists today. There are numerous studies that have investigated this problem, but this study summarizes the problem pretty thoroughly:
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0040019
Of even more interest in this case, is that the juristiction where this study found rampant undisclosed conflict of interest in medical studies is where many of the Thimerosal epidemiology studies were done (in Denmark). The real kicker is that the statistician is often the ghost writer supplied by Pharma, and arguably will define the outcome of the results.
I’m guessing you didn’t actually read the Rho Gam study, because supporting your argument with the statement that it was peer reviewed and published does not even come close to guaranteeing good science as you should well know. It is well known that a vast percentage of published conclusions turn out to be wrong and peer review is hardly a guarantee for good science. It certainly helps weed out bad science, but does not guarantee good science.
From a letter in the medical journal of Australia: http://www.mja.com.au/public/issues/172_04_210200/horton/horton.html
“First, how can two (reasonably) well-regarded organisations peer review the same work — Ewen and Pusztai’s research on the effects of feeding genetically modified potatoes to rats — and yet come to such radically opposite conclusions about its validity, as did the Royal Society and The Lancet? All six Royal Society reviewers pronounced the research “flawed”, while five out of six of The Lancet’s reviewers judged that Ewen and Pusztai’s work should be published.6 Peer review as a reliable technique for assessing the validity of scientific data is surely discredited.”
“The mistake, of course, is to have thought that peer review was any more than a crude means of discovering the acceptability — not the validity — of a new finding. Editors and scientists alike insist on the pivotal importance of peer review. We portray peer review to the public as a quasi-sacred process that helps to make science our most objective truth teller. But we know that the system of peer review is biased, unjust, unaccountable, incomplete, easily fixed, often insulting, usually ignorant, occasionally foolish, and frequently wrong. A recent editorial in Nature was right to conclude that an over-reliance on peer-reviewed publication “has disadvantages that should be countered by adequate provision of time and resources for independent assessment and, in the midst of controversies, publicly funded agencies providing comprehensive, reliable and prompt complementary information”
From the NYTimes: http://www.nytimes.com/2006/05/02/health/02docs.html?ex=1190174400&en=4ffe131a6f88768f&ei=5070
“That message, however, has created a widespread misimpression that passing peer review is the scientific equivalent of the Good Housekeeping seal of approval.
Virtually every major scientific and medical journal has been humbled recently by publishing findings that are later discredited. The flurry of episodes has led many people to ask why authors, editors and independent expert reviewers all failed to detect the problems before publication.”
…
“However, even the system’s most ardent supporters acknowledge that peer review does not eliminate mediocre and inferior papers and has never passed the very test for which it is used. Studies have found that journals publish findings based on sloppy statistics. If peer review were a drug, it would never be marketed, say critics, including journal editors.”
Now that we discarded the peer review = good science fantasy, let me summarize my issues with the study:
* The study has a fundamental flaw in that it does not account for any subsequent Thimerosal exposure through childhood vaccines in the study group which could easily have hidden any effect the inital fetal exposure might have had
* The Study has a small study group and a very small and strange control group
* The study makes wide ranging conclusions that can’t be supported by the study design, and their reaching assumptions aren’t supported by any evidence
* The study authors appear to have a bias, illustrated clearly in their discussion section and lack of credible supporting references and notable exclusions of references not supporting their view
* The study was funded by a the RhoGam manufacturer currently defending itself in court for this specific product
Like I said, your article was good, but you should have left out the reference to the Rho Gam study (or maybe read the study more carefully before holding it up as an example), because the accusations against it ring quite true from what I read.
Schwartz,
NAA tried to tar and feather the Miles study as being flawed by COI. They accuse them of outright fraud! However, the Miles paper doesn’t have any COI problems. Nada. None. They declared their funding source and further stated, “Neither funding source was involved in the design and conduct of the study, collection, management, analysis or interpretation of the data, preparation, review, or approval of the manuscript.”
It obviously wasn’t ghost authored as you seem to allege in the link you provide to the PLoS article. So where exactly is the problem? Do you think that industry has no right to investigate and assure the safety of their products when concerns have been raised? If they don’t provide funding for an independent investigation, who will? Is it the obligation of taxpayers to provide funding for every medical product where safety concerns arise?
The scientific validity of the Miles study is peripheral to my larger consideration of the NAA smear campaign (remember they are accusing Miles et al of fraud). However, your critique of the study is questionable.
How would subsequent thimerosal-containing vaccinations in the study group mask the initial fetal exposure? How is this a fundamental flaw?
The study authors admit that the primary limitation is their study size. However, given the frequency of Rh incompatibility and autism, by nature this is a small study. Nonetheless, it is still the largest sample to date and they used accepted statistical methods to produce their findings.
What is strange about the comparison group of families with a Down syndrome child? This population was free of ascertainment bias and their medical records were available. What’s not to love?
Also, you claim the authors failed to include references that don’t support their view. I’m not sure that you read the paper as they discuss Geier, Wakefield, Hornig, Safe Minds, Rimland, and Holmes are all given their space.
Yes, COI and peer-review, like all human enterprises, are subject to manipulation. People abuse what are clear and codified systems that depend on personal integrity. That was the point of my blog piece.
However, despite problems with peer review, the scientific truth eventually prevails. For example, compare the Miles study to that which embodies all that is really wrong with peer-review: http://tinyurl.com/2nlp5z
Test
Tommy,
You won’t see me defending any poorly written peer reviewed study regardless of the position it takes on the matter. I was never claiming that only pro-Thimerosal studies were guilty of bad science. What I was pointing out, was that the example you were holding up as a smear campaign, appears to be quite justified. I was also pointing out that you initially defended the study by pointing out that it was published and peer reviewed. I think we can agree that arguments along those lines are pointless and contribute nothing to the debate.
My inclusion of the ghost authoring was not intended to implicate the Miles study, but was a general argument against your statement: “The RhoGam study is an example of the integrity of the COI system.” You implied that the current COI system is full of integrity, and the study I quoted shows that the system itself is sorely lacking and is not full of integrity as you implied. The procedures do not exist to identify ghost writers, and we don’t actually know if the Miles study employed them or not because the general practise is not to include them.
Again, you admonished Bradstreet for being misleading the public, but the official Miles press release (which is the only public information available unless you pay for the journal) has no mention of conflict of interest. And I fully agree with your statement: “COI does not preclude someone from sitting on a review committee or participating in a meeting [or funding a study]. However, if you fail to disclose your COI, then you are operating in a dishonest manner that prevents science from operating in the brightest light possible.” The Miles study did not state the conflict of interest in their public press release AND they were not fully forthcoming about the litigation in the actual study. You seem to be applying two standards here.
I’ll comment more fully on the study now:
—
Analysis of the Study Data and Methodology
One acknowledged weakness of the study is the small sample size both in the study group, and especially in the control groups. The choice of control group is very interesting as the primary control group was mothers with children diagnosed with de novo chromozone disorders. They did this to remove the bias of people who were directed to the clinic itself. The result is that the control group was very small. The other control groups used had enough variances to the study group (different gender, ethnicity etc) so the focus of the control group was the small one. Although it is a strange control group, the only real issue I can raise is that it’s small.
Again, due to the size, there were two data points that did not support the conclusion, and the explanations were weak as well:
“Though comparisons between the telephone report only group and the control populations did not generate statistically significant differences, we consider this data biased by the exclusion of 25 mothers (27.5%) who did not know their blood type. Women who have undergone a pregnancy are more likely to remember their blood type if they tested Rhbecause of the ensuing discussions of Rh incompatibility that only occur with the Rh- mothers. This will bias recall studies toward a greater percentage of Rh- mothers.”
This is pure conjecture, not supported by any reference or evidence, and I would argue inaccurate. I would agree that the discussions around RH incompatibility that occur with RH- mothers probably occured, but I’ll bet they won’t remember the details of whether they were RH- or RH+, and probably don’t understand the details of why they were really getting the shot. I will speak from personal experience here. I would argue that many of the attempted interjections during pregnancy are not fully explained, and rarely questioned by the mother.
—
Methodology Issues
Since Autism and Autism Disorders are not diagnosed until an older age, all of these children could very well (and most likely were) be exposed to significant levels of Thimerosal after they were born in the form of vaccines. If the level of Mercury exposure for these children is X at age A and Y at age B etc… then the vaccine dosage could easily have triggered the onset of Autism, hiding any effect that the RhoGam Thimerosal might have had.
This study did not take into account ANY information regarding childhood vaccinations and thus can’t account for this possible confounding factor.
—
Issues in the background section
My next issue in the study is the following statement:
“The vast majority of studies have indicated no association between thimerosal containing vaccines and autism… ”
And it goes on to reference a number of studies. I noticed a strange resemblance between the studies reviewed by the Cochrane report about MMR and Autism, and the list provided here, including a familiar set of Authors (all of which produced studies that the Cochrane group rejected as not contributing to the evidence).
Of the 11 references they provided for their statement, 6 (> 50%) don’t even study a link between Thimerosal and Autism, they refer to MMR and Autism. This is the type of mistake I expect from high school students. To make matters even worse for the authors, most of those MMR studies had been rejected by the Cochrane report as non-credible. Of the remaining, 5 references, all of them have flaws (not fatal in all cases mind you) and can hardly be considered “strong” evidence. Right now, the credibility of the researchers is damaged and their bias is quite exposed.
—
Other Errors or Evidence of Bias
“Acting on these concerns, the FDA conducted a review of thimerosal in childhood vaccines and though they found no evidence of harm, noted that some low birth weight infants could have been exposed to cumulative levels of mercury during the first 6 months of life which exceed EPA recommended guidelines for safe intake of methylmercury [Ball et al., [2001]].”
They do not reference any data around the FDA review, nor do they back up their statement with evidence that “no evidence of harm” was found. This appears to me to be a glaring ommission and again indicates bias.
“By 2002, all routinely recommended early childhood vaccines were thimerosal free.”
Again, this is a just incorrect. The hepatitus B vaccines which is currently recommended in early childhood by the CDC Recommended Immunization Schedules for Persons Aged 0–18 Years (http://www.cdc.gov/Nip/recs/child-schedule.htm#printable) contain Thimerosal, as does the Flu vaccines, and some of the variants on the DTaP-HepB-IPV and DTaP vaccines. (http://www.fda.gov/cber/vaccine/thimerosal.htm#tox)
—
Conclusion is Wide Reaching and Incorrect, Press release is Egregious
Let’s review the conclusion:
“These findings support the consensus that exposure to ethylmercury in thimerosal is not the cause of the increased prevalence of autism. These data are important not only for parents in this country but also for the international health community where thimerosal continues to be used to preserve multi-dose vials which in turn makes vaccines affordable.”
1) There is no consensus on this topic, they even admit that in their discussion section. The majority of the studies they provide as references to support this in the discussion don’t even test for Thimerosal. The majority of the rest can be be deemed non-credible or flawed.
2) The link to vaccines is completely unjustified. To quote from their introduction:
“To address the question of whether thimerosal exposure causes autism, we investigated thimerosal exposure during pregnancies which resulted in the birth of a child subsequently diagnosed with autism. Rh negative (Rh-) women are routinely treated with Rh immune globulin (RhIg) at 28 weeks gestation and earlier if bleeding or other symptoms indicate mixing of potentially Rh+ fetal blood in the mother’s circulation. Since most RhIg manufactured in this country contained thimerosal until 2001, and since young fetal brains are more susceptible to neurotoxic effects, we hypothesized that if thimerosal were associated with the development of autism, we would find a higher proportion of Rh- mothers of children with autism, born before 2002. To test this hypothesis, we assessed Rh status and ante partum thimerosal exposure of mothers and children who came to a statewide, dedicated autism clinic.”
First, we’ll note, that none of these steps or assumptions are backed up by any references at all, so we can guess that they are basing their wide conclusion about vaccines, on the following string of logic:
* Thimerosal causes damages to young developing Fetus’ and Children equally
* The fetal exposure to Thimerosal from Rho Gam in dosage and timing is similar in effect to a vaccinated child’s exposure to Thimerosal.
They provide no evidence at all to support these two assumptions.
Even worse for the study is the lack of any ability to deal with the confounding factor of Thimerosal exposure of the children from the vaccines themselves. Since they don’t provide (and didn’t get) any vaccination information, we pretty much have to assume that the children in the sample groups all received their childhood vaccines.
If Thimerosal exposure WAS the cause of the autism — remember, both the RH- and RH+ children would have been exposed equally to Thimerosal through vaccines and the vulnerable period of exposure is during the infant years or they were genetically predisposed to react to Mercury — then we would see exactly the results they found.
So we would expect the results they found if:
* Thimerosal did not cause the autism OR
* Thimerosal did cause the autism
AND
* The incremental RhoGam thimerosal exposure was not enough increased exposure to cause any additional cases of Autism.
If it turns out that there is a genetic predisposition to Mercury toxicity in certain children, then the RhoGam exposure could be expected to cause the same rate of damage as the Thimerosal found in vaccines.
They also strongly imply that Thimerosal from Rho Gam is safe, and therefore it is also safe in vaccines, yet they provide no evidence that the timing of exposure and the levels of exposure between the fetus and child were equivalent and therefore their conclusions are based purely on conjecture. That is hardly scientific.
I also notice that you do not address the extensive Safeminds writeup on the same study which accompanies their claims of bias and conflict of interest. It appears as though you are cherry picking in this instance.
The Safeminds press release alleges tha same outright fraud as the NAA. Neither group has a shrerd of credibility. It’s a ridiculous smear campaign. You and they can pick apart the study all day long. But their central claim is that the investigators committed scientific fraud at the behest of a pharmaceutical company. Do you buy this?
Tommy,
They wrote an extensive detailed report that is linked on their site to an 18 page PDF. It outlines specific arguments that are not related to their claim of conflict of interest.
Their conclusion in summary:
“The Miles & Takahashi conclusions are questionable based on research quality issues. Recalculation of the data
shows an increased risk of autism from Rh immune globulin. Definitive conclusions await higher quality studies. ”
That doesn’t sound like their issues center around conflict of interest at all. In fact, I would also judge that the accusations of COI derive from the poor quality of the research in the report itself.
You’ll note that my analysis was independently done (I’m not a researcher) and arrived at different issues with the same study.
I have yet to see any actual analysis done by any supporter of the study including yourself to address any of the well documented SPECIFIC issues with the study.
Your own writing at this point is sounding quite guilty of what you are accusing the others of doing. Making accusations without properly reading the information, and making blanket accusations like “Neither group has a shred of credibility” or “you can pick apart the study all day long” does not help your cause. You asked for specifics, they have been amply provided and you choose to ignore them or apply the blanket accusation of conspiracy theorists.
Do I buy this? I will look at the facts:
* I consider the methodology fundamentally flawed because it can’t answer the question they are asking.
* There is a documented critical analysis which points to problems in the statistical analysis itself.
* The funding source has a direct conflict of interest which was not at all disclosed in the press release and was not fully disclosed in the study itself.
* The concluding statements were invalid based on the flawed methodology within the study scope itself. Even more eggregious is the expanded conclusions based on no evidence whatsoever, and propagated by a misleading press release.
None of the accusations I have seen levelled against this study appear baseless based on a specific analysis of the facts, critical reviews, or evidence provided. Your accusations in this particular instance are based on a lot weaker evidence and a lot of anecdote.
If you want to continue to hold the Miles study up as an example of good science and the integrity of COI then I think you’ve made a very poor choice based on the available evidence. As a result are doing a disservice to the studies that are actually worth the paper they’re printed on.
I repeat my question. They have leveled fraud accusations at the study authors. Do you agree?
Tommy,
I did not accuse the study authors of fraud (nor am I now), and I didn’t see you present any evidence of anyone leveling fraud accusations against the authors of this study.
““This study is just another example of the pharmaceutical industry’s corruption of research to suit its own purposes,—
The author clearly accuses the Pharma industry of corrupting research, not falsifying it. I didn’t see anyone –including my own analysis — accusing anyone of falsifying information. The study authors are accused of publishing poor science and this accusation is supported by a significant amount of real evidence.
““They back the study designs that give the desired results of no harm.—
Again, as my analysis shows, their study design is flawed and does not (and could not) support the conclusions they published from what I can tell. The study and it’s design were backed by a Pharma company that had a keen interest in seeing the exact flawed result that was published. Although I level no specific accusation, the author of the quote above has provided some evidence to support their statement with this particular study.
There are many studies — and I’m not going to bother referencing them because you’re clearly not interested in debating any specific points or altering your opinion in the face of real evidence — that clearly show a tendency for industry funded studies to reach conclusions favourable to the funding industry.
It appears that you are the one making false accusations in the face of conflicting evidence. I am just pointing out the bad science and supporting it with evidence and the people you quoted above appeared to be doing the same (at least the safeminds people were).
Do you continue to insist that this study was accurate and represents good science?
Tommy,
I don’t understand why you insist on defending this study. Is it so surprising that some Pharma supported research (or research supporting your position) may have been guilty of bias or bad science?
Certainly there exists bad and biased science on the other side of the thimerosal argument as well. I just think that your choice of an example study (Miles) being undeservedly smeared was a poor one, and that despite your dislike of the people you’re writing about, they may actually get something right once in a while.
The Miles example is the embodiment of the NAA SOP. They are alleging fraud. That is a very serious and unfounded charge. It has nothing to do with peer-review or the merits of a published study.
Tommy,
So you admit that the study was based on poor science then?
It absolutely has everything to do with the merits of this particular study because you are using it as an exmample to support your own allegations of slander — unfounded accusations of fraud.
Given the following:
* nature of the poor science,
* the direction of bias in the writeup,
* the egregious conclusions unsupported by evidence
* the lack of disclosure in the public press release and in the study of a key conflict of interest
The authors and study funders have certainly given the impression of bias and conflict of interest and thus the quotes you provided by the NAA about this particular study are not unfounded, and they did not allege fraud, only corrupted science.
It doesn’t really matter what the NAA SOP is in this particular instance as long as they’re right.
You may have a perfectly valid case that they have incorrectly smeared other valid studies, but we’re discussing this particular study because you used it as an example.
Your article has aptly demonstrated the hypocracy of the situation — regarding conflicts of interest in the committee seats — no doubt about that.
Moving on to the general statements by the NAA, there are studies that support the hypothesis that industry funded studies more often conclude positive results in the interests of the industry, so this type of general allegation is actually supported by evidence.
It is very difficult to prove slander or fraud in science, so you have to be extremely specific in providing examples of wrongdoing. For you to attack general statements like theirs with your own general statements or with poor examples, makes your case as weak as theirs and they will always be able to provide actual evidence to support their general statements — as you practically did by raising the issue of the Miles study.
General allegations against the CDC are also very hard to argue against, because there is lots of official documentation widely available that can be used to illustrate financial conflict of interest, questionable science, and safety especially when it comes to the topic of mercury or Thimerosal.
Tommy,
Please don’t mistake my position with being a conspiracy theorist. I recognize that the CDC and other government or industry organizations are subject to the same benefits and flaws of any government or industry organization — easily subject to financial influence in a percentage of cases.
That is why it is imperative to inspect every piece of evidence with a skeptical eye. That includes data coming from industry, peer reviewed journals, government, or Autism associations fighting the government and industry.
Certainly there exists bad and biased science on the other side of the thimerosal argument as well.
It’s one thing if a study has confounds, flaws and biases. I’d say that most if not all case-control and ecological type studies potentially have this. It’s always possible to consider a new confound. For example, did the authors of the pesticide study consider if the women working in the farms were related? Did the authors of the TV study consider availability of specialists in areas with high population density as a confound?
That’s why such studies generally need replication that tries to control for all the possible confounds one can think of. And that’s how scientific knowledge advances.
It’s quite another matter when a study is plagiarized from another, for example; or when a graph skips a 4 year range as if it didn’t exist; etc.
So let’s not pretend there’s equivalence in both sides of the scientific argument here. (I find this insulting, actually).
Schwartz,
So I’ll ask one last time, do you think the Miles study was fradulant?
One can criticize published findings forever and a day. But NAA alleges fraud. Read the quotes from the NAA press release.
“Besides extensive design flaws, the analysis uncovered MANIPULATION of the study sample, so that earlier data revealing a positive autism-RhIg association was CONCEALED.”
“This study is just another example of the pharmaceutical industry’s CORRUPTION of research to suit its own purposes.”
The NAA and Safe Minds are fortunate not to have been sued by Uni. of Missouri.
Joseph,
If a study has a methodological flaw that is fundamental to being unable to reach a conclusion, then there isn’t much point in doing the study is there? Let alone wasting big Pharma’s hard eared profits.
The methodology was only one of several flaws that were well articulated and published.
“It’s one thing if a study has confounds, flaws and biases. I’d say that most if not all case-control and ecological type studies potentially have this. It’s always possible to consider a new confound. For example, did the authors of the pesticide study consider if the women working in the farms were related? Did the authors of the TV study consider availability of specialists in areas with high population density as a confound?”
But why are we discussing general topics here? If you want to support this study, please discuss the specific points raised and come right out and state that you think it’s good science. It would help if you could provide evidence to debate the numerous specific problems raised.
I am not debating the merits of the anti-Thimerosal studies here because as I’ve already stated there are several examples of bad science in that group as well. You didn’t have to go and find them for me, I’ve read them as well. I’m really not sure where you read in any of my posts that I either support the Thimerosal/Autism hypothesis or that I support any of those studies.
I also don’t understand why you are insulted. My point here was quite simple: An example was given of a study that was accused of corrupted science and conflict of interest. The evidence provided justifies both of those claims. The study had an undisclosed conflict of interest, and evidence was presented that the science was bad. How much simpler does it get?
Arguing that other studies are just as bad has nothing to do with the poor example given in the article, or my position on this study.
Save your arguments for someone willing to support bad science in the face of credible evidence. That wouldn’t be me.
Tommy,
Fraud is the word you are using. I stated pretty clearly above which you must have missed because you insist on repeating the question.
“I did not accuse the study authors of fraud (nor am I now)”
I’ll state it again. I did not accuse the study authors of fraud and I am not accusing the study authors of fraud.
I am asserting that the study authors produced a flawed study, and they stated conclusions that were not supported by any credible evidence. I am also asserting that they failed to disclose any conflict of interest in their press release, and they failed to mention a key conflict of interest in the study text.
I am glad that you have now provided more quotes from the NAA and the new addition is an accusation of manipulation of data. I’m not a lawyer but I’m pretty sure this doesn’t qualify as criminal fraud but that doesn’t really matter here.
You’ll note that Safeminds provides very detailed evidence of the accusation of data manipulation:
“The study sample was altered and not just added to during implementation.
Mothers and children who were part of the initial case and control samples in
2005 were no longer part of the final study, suggesting manipulation of the
study protocol in violation of standard research practice.”
The extensive paper goes on to detail the specific cases that were ommited from the final study results. I will note, that I did not read in the study a decision to remove specific cases partway through the study.
These are not my accusations, as I was not privy to the original data. However, the authors that you are quoting (NAA, Safeminds) have provided evidence for thei position. If you wish to debate the merits of their claims, I suggest you provide evidence to support your position.
From my objective position they have made claims against the authors and supported them with evidence and analysis.
They made claims of scientific fraud. That is why they were included in my piece.
By the definition of scientific fraud (not criminal fraud), the claims of data manipulation could be interpreted that way. However, safeminds provided evidence to support their position and you did not.
One of the key premises behind Kevin’s philosophy is to base your judgements on actual evidence and critical thinking. In this example, you have failed to provide any to support or evidence of your position that their allegations were untrue.
It appears that you fell into the trap of assuming that a peer-reviewed study published in a journal you trust must mean that the science is good and that they declared all their conflicts of interest. You should be careful to critically read the studies you plan to use as examples, regardless of where they are published or whether they are peer reviewed or not.
Schwartz,
How long will it take you to understand that the scientific merits of the Miles study are not the issue? Scientists regularly debate the quality of a study. It’s a sport.
NAA alleges fraud without an iota of proof. Where is the evidence that they intentionally concealed and manipulated data? It’s preposterous.
The Miles example emobodies all that is problematic with NAA.
Tommy,
They provided data to back up the allegation of data manipulation based on two published analysis by the authors themselves — did you still not read the safeminds report. I even quoted the relevent summary above. That would be the evidence to back the claim of data manipulation.
I have not seen you or the study authors defend against that evidence or provide any contrary evidence.
Help me understand how the merits of the study are not important, when one aspect of the complaint that you specifically quoted was an accusation of corrupted science? Drawing conclusions not supported by evidence sounds exactly like corrupted science to me.
Unless you’re withdrawing that specifc accusation against the people you quoted, then the merits of the study are part of the issue being discussed. As I stated early, the quotes you have provided in your article have made the issue relevant in this discussion — this was exactly my initial point to you. I liked your article, it just loses credibility as soon as you defended the specific allegations about that study.
— As an aside, does it not seem ironic to you that you’re saying that even if the study is based on bad science, it’s still unacceptable for anyone to point that out publically? Or are only the Thimerosal supporters allowed to mock and publically point out bad science? —
I would also advise that if you’re making allegations of libel that you actually read the full backup material and evidence provided by the authors of the people you quoted.
It is pretty simple: They have provided credible evidence and analysis to backup their statements. You have not yet provided ANY evidence to refute their information.
Schwartz,
You want to believe that seasoned investigators committed scientific fraud.
Be my guest.
Tommy,
I’m basing my opinion on the evidence provided.
It looks to me that you’re the one applying “beliefs” to your argument based on the reputation of peer-review even in the face of conflicting evidence.
There isn’t a shred of evidence of fraud. Data sets on posters often get refined for entirely valid reasons.
It is absurd to believe they presented a poster that found an association and then concealed the data to negate the finding.
Safeminds and NAA have no standing in this. They are not scientists. They hold Geier up as the more definitive result.
You’ve been drinking too much thimerosal.
Tommy,
Why do you (and others) insist on comparing this to other studies? When did this argument ever touch a Grier study?
Again, your evidence appears to be limited to your belief “[that] it is absurd to believe…”. We’re trying to critically review evidence, not your personal beliefs based on reputation.
Please provide the data points you BELIEVE were presented in the poster compared to the final study so we can evaluate your evidence. The accusing party has done exactly that.
Most doctors wouldn’t drink Thimerosal, and even if you wanted to drink some to make a point, it wouldn’t really apply to this argument.
The argument touched on Geier because Safe Minds uses it in their critique you seem to think has validity.
My evidence is the same as yours. There is no evidence of fraud.
I don’t believe for a second that a senior investigator who is an MD PhD, dept. chair with an endowed chair conceals data to arrive at a fraudulant conclusion. There’s nothing to gain and everything to lose. It’s a prime example of why I wrote the article. When someone finds evidence contrary to their pet hypothesis, Safe Minds and NAA allege fraud and COI.
I’m done here.
Tommy,
If your final argument resorts to defence based on reputation and “why would someone” or “I can’t believe” statements, then you’re right, we can’t engage in any further logical debate.
But I did read your post, and decided to look up more information about the lead author and her reputation out of interest.
This particular study deviates from the type of research she normally does because it ventures into the area of pharmaceuticals. She has interests in Autism and genetic syndrom diagnosis and the majority of her published studies fall within that realm.
“Dr. Miles research interests are the delineation of the clinical and genetic heterogeneity within the autism behavioral diagnosis and how this information can be used to improve diagnosis, find specific genetic and epigenetic causes and to direct treatment choices which will improve outcomes.”
Her personal intersts would explain the blatent source of bias illustrated in the discussion sections of the study and the unsubstantiated conclusions. Perhaps the poor study design, lack of medical rigour around dosages and exposure could also be explained by her lack of expertise in that type of Pharmaceutical related study. It is interesting to note that the study was published in the American Journal of Medical Genetics — and a quick scan of their articles shows that a Pharma based study is unusual for that journal as well — but would be a natural place for her to publish. In fact, all of her previous studies except one were published in that journal.
As you correctly stated, data can be removed from a study for numerous reasons, and one could easily suggest that her personal bias influenced the decisions around those data points (not an allegation of fraud, just bad science).
Given the grey area between data manipulation and statistics, I don’t see how the allegations leveled by the NAA and safeminds would translate into strong support for accusations of scientific fraud. Her reputation is well established in the areas of Autistic Genetics, so one could easily blame lack of expertise in this area as an excuse for the pitiful science that was published. She really has little to lose if the data provided by safeminds is accurate.
However, your statement of calling her a seasoned investigator no longer rings as true. She may be a seasoned investigator, but this study was outside of the area of her expertise, and it shows in the study itself.
What really happened?
1) She’s just a bad scientist
2) The funding source biased the study
3) Her personal beliefs biased the study
Her reputation will not be severely damaged even if she did manipulate the data for financial reasons. (please note, that is not my position).
She was also a paid consultant involved in litigation for the industry funding soure of the study which was not noted anywhere as a conflict of interst.
So you see, there are plausible explanations for the unprovable questions you asked.
I’ll leave you with a question: Why would safeminds publish precise data outlining the manipulation they discussed if it were fabricated?
That would definitely leave them open to a lawsuit. It would also be very easy for the authors to refute as a simple statement supported by their presentation would clear up the allegations very quickly. Neither has transpired, which just supports the likelihood that the safeminds analysis is correct.
So on the quote by the NAA and safeminds:
1) They were 100% right on the conflict of interest allegation
2) They appear to be right that the data was manipulated
3) NAA alleges that the reasons for the manipulation were for financial reasons, which can’t be proven or disproven.
Her severe conflict of interest certainly invites questions about #3 (which is why the DOD has such strict guidelines around COI), but again, her person bias could equally play into the equation.
From a purely objective perspective the NAA is batting 2/3 and in your defence, their allegations of financial influence on the data manipulation are virtually impossible to prove or disprove and not an allegation I would make.
However, it’s not the outrageous claims of slam dunk you alleged in your article, nor is it outside the realm of possibility given the current published facts.
One last thing I missed earlier that I find objectionable is the following statement published by yourself:
“Safeminds and NAA have no standing in this. They are not scientists. They hold Geier up as the more definitive result.”
So I guess that most of the non-scientists on this site (even possibly you) have no standing in the overall debate because they’re not designated as scientists? That’s truley laughable. The whole idea around published studies and reviews is that everyone can analyze the data and judge the science based on the merits of the science, not the author.
As for referencing Geier: I have no illusions of their past reputation, nor do I support the science of some of their past work. However, I have not read the study referenced by Safeminds, — to be truthful, there were more than enough ample examples of poor science already, the reference was not required to show the bad science in the Miles study — and thus I can’t pass judgement on it.
I am curious if you approached it with the same objectivity.