Left Brain/Right Brain

Why Do Scientists Commit Fraud?

2010-02-09T04:55:56Z

It is a favorite assumption of the anti-vaccine movement that any opposition to their views is motivated by “pharma” dollars. In comments about Wakefield, I have observed a similar pattern in assumptions about his motivations. For example, a comment on “The Duty to Censor Wakefield” says in part, “He was angling to make money from a new vaccine, not helping autistic kids. Autism was the gambit he planned to use to achieve his monetary goal. He continues to use and abuse autistic kids and their parents in order to make money at thoughtful house performing (among other things) heavy metal chelations on kids. “ I do not believe that his is the case. I find this line of argument uncomfortably like an echo of anti-vaccine propaganda. Far more importantly, it has long been my observation that, in cases of fraud by a professional scientist, personal financial gain is consistently unsatisfactory as an explanation of motive, and I have gone on record arguing this at “evil possum”.

To start, some definitions are in order. The breadth of the field of scientific fraud will vary greatly depending on what is accepted as “scientific”. It is my preference, for purposes of discussion, to look only at work by credentialed scientists, and mainly at examples in professional journals. It is my observation that this will generally exclude the cases where financial motive is most obvious: The likes of PT Barnum, Lysenko and “Doctor” Hulda Clark and obviously had gained a great deal of income from their schemes, but they were strictly amateurs. I suspect this is because those who only care about making money don’t have the talent or patience to earn credentials, and, unfortunately, prove perfectly capable of success without them. When a “pro” is involved, I find far more subtle explanations are in order. I offer as examples the following notorious cases:

Charles Dawson- While the name is not familiar, this man is by strong consensus the creator of the most notorious hoax of modern science, “Piltdown Man”, and dozens of wholly obscure hoaxes. Dawson does not entirely satisfy the description of “professional”, but by the standards of the time his wealth and education as the son of a successful attorney were enough to win acceptance as a peer in the circles of science. With regard to his motive, it has been taken nearly as a given that any financial gain from his hoaxes was too small to provide a plausible motive. His investments in the Piltdown hoax in particular were quite extraordinary: He not only fabricated the two “Piltdown Man” skulls, but an entire assemblage of faked or planted artifacts and animal remains; on top of that, he took the risk of leading two other scientists through the staged site. The time, labor, materials and risks involved are completely out of proportion to any reward he could have anticipated. All serious discussion has focused instead on an argued desire for social recognition (consistent with clinical narcissism), with admittance to the Royal Society and knighthood being offered as his ultimate objectives. However, this may be overestimating his desire for personal attention. In the Piltdown affair in particular, he effectively gave others the chance to take credit for his “discovery”. I suspect that Dawson was less like a narcissist than a sociopath on the lines of Shakespeare’s Iago: Content to appear to be only a humble subordinate, but maneuvering his superiors toward humiliating themselves.

Paul Kammerer- Kammerer’s claim to infamy is (apart from Lysenko’s politically driven revival) the last serious and seriously noticed defense of Lamarckism. He reported that, when the “midwife toad” was forced to mate in water instead of on land, they developed “nuptial pads” for breeding in the new environment that were passed on to resulting progeny. In 1926, critics examining his specimens found evidence that their toes had been treated with ink, and so argued that the “pads” did not exist and that Kammerer had intentionally faked them. Relatively soon afterward, Kammerer killed himself. Historians of science have been relatively lenient with Kammerer. By the most benign interpretations, the nuptial pads reported may have existed in fact, and the ink could have been added (not necessarily by Kammerer) simply to make the pads more visible. My take on the matter is that, while Kammerer probably believed the pads to be real, he was aware of the use of ink and knew perfectly well that his peers would find this action unacceptable if it was discovered. His final act belies any desire for monetary gain. (Of course, the commercial potential of a novel method of breeding toads would appear limited in any event!) It would appear that it was instead the judgments of his peers that mattered most to him. It could paradoxically have been this very preoccupation with honor and fear of criticism and rejection that made the use of ink to better reveal the pads seem acceptable in the first place.

Cyril Burt- Burt was a psychologist whose claims about heredity and IQ aroused suspicion, particularly after two studies published in 1955 and 1966 reported identical correlation coefficients despite allegedly much larger samples. Soon after his death, critics openly argued that his final research was fraudulent. Further reconsideration has refuted or challenged the harshest charges against him (particularly the proposal that two “assistants” were wholly fictitious). However, there can be little doubt that he did, at a minimum, consciously manipulate the linear regression of his data in the last of the disputed studies. Perhaps more than in any other cases here, Burt’s actions cannot be accounted for by anything as simple or “logical” as monetary gain: By ca. 1966, he was probably well aware that he would be dead (of cancer) within a few years, leaving him no opportunity to enjoy money or any other personal reward. The standard appraisal is that his slide into fraud was a result of his mental state declining along with his health. He may also have felt (when sufficiently lucid) a need to make a final achievement to secure a legacy beyond his own lifetime.

Cecil Jacobson- If there is any case of a true pro exposed as a con man out for nothing but money, it is this man, “winner” of an IgNobel prize. He began his career as a pioneer in amniocentesis, but a long string of shortlived hospital positions, he went into business for himself by founding a fertility clinic”. He came up with an exceptionally cruel con: He injected women with a hormone called Human Chorionic Gonadrophin, whose sole effect was to cause false positives on pregnancy tests. Of course, he did this at well above cost, and he also strongly discouraged patients from seeing their regular gynecologists and obstetricians. Jacobson was greedy, no doubt, but another aspect of his con presents an even more sordid picture: He performed artificial insemination, supposedly using “samples” from carefully selected donors, but the sole donor was in fact himself. (His wife went on record saying recipients were “lucky”.) Hence, it is credible to infer that he was not interested just in money, but in the even more fundamental drive to reproduce, quite possibly with a generous helping of misogyny to boot.

There we have it: Four of the most notorious cases of fraud and misconduct in the last century, and the most obvious common denominator is the absence of monetary gain as primary motive. So why did they do it? Psychopathology undoubtedly plays a major role, with narcissistic and/or sociopathic tendencies offering an especially potent motivation. Stress related to career is also a possible trigger, in forms as varied as Jacobson’s failed potential and Cyril Burt’s terminal illness. What may be the most conspicuous common denominator is every appearance of sincere belief in whatever their fraud is supposed to “prove”, as is thought of Burt and arguable for Kammerer. This misguided zeal to convince others of their belief is likely to be rooted in a lack of emotional stability, which leads them to “overinvest” in a particular idea. I believe, returning to the case at hand, that any of these factors could have been at least as significant an influence on Wakefield as the prospect of profit.

Finally, there is an unasked question here: Why do people so readily assume money as a motive of fraud? I think this is, in large part, because greed supplies a rational motive for evil, and makes the evil less threatening to a sense of order in nature and society. On consideration, it may also play off a notion of the scientist as somehow more logical and less emotional than ordinary people. In these terms, there is kind of back-handed idealization in assuming money as motive for scientific fraud: It can be inferred as a subtext that scientists could only be swayed by a temptation as concrete and quantifiable as the data they collect for a living. The reality is that scientists are subject to mental and emotional problems, just like anyone else. For the purposes of detecting and even preventing fraud, looking for psychological warning signs is more useful than looking at numbers in bank accounts.

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Wakefield’s research: from The Lancet to Medical Veritas?

2010-02-09T00:31:25Z

The Lancet is one of the medical community’s premier journals. As such, tetting a paper into such a journal is a big accomplishment for any medical researcher. When Dr. Andrew Wakefield chose to submit his 1998 study to The Lancet, it is likely he wanted to put it in as high a profile journal as possible. One can speculate how the Andrew Wakefield of 1998 would have viewed publishing his work in Medical Veritas, a newer journal which, well, is not generally highly regarded. Somehow, this observer thinks Dr. Wakefield would not have welcomed a suggestion to submit to Medical Veritas had it existed at the time.

Frequent readers to LeftBrainRightBrain, or most places autism is discussed for that matter, will know that Dr. Wakefield’s study has been retracted by the editors at The Lancet.

Frequent readers here may be also familiar with the magazine, Medical Veritas as it has been the home for a number of questionable autism/vaccine articles. If you aren’t familiar with Medical Veritas, let’s just say that Medical Veritas is not in the same league as the Lancet, to put it mildly.

Why bring these two very disparate journals into this blog post? Well, Medical Veritas has offered to republish Dr. Wakefield’s study:

So with zero confidence in The Lancet, Dr. Horton, those paying his salary, and those criticizing him for his actions, Medical Veritas editors are inviting Dr. Wakefield to re-publish his controversial paper in their next issue.

Wow. What a strange move, and on so many fronts. The most obvious being—what sort of standards does Medical Veritas show when it is willing to publish a paper that has been found to be so fatally flawed? It is really hard to consider that this offer was serious. The Royal Free Hospital, Dr. Wakefield’s employer, assigned the copyright to his paper to The Lancet. The study, even retracted, likely remains the property of The Lancet. Also, it isn’t Dr. Wakefield’s right to decide for his coauthors whether to submit to another journal.

The strangeness goes on and on. Let me just pick out one more oddity of this offer by “the editors” of Medical Veritas. Dr. Wakefield is one of the editors. Yes, one read is that Dr. Wakefield has basically invited himself to reprint “his” paper in Medical Veritas.

Just when you thought the story of the Wakefied/Lancet paper couldn’t get stranger.

The Duty To Censor Wakefield

2010-02-07T00:11:19Z

Letter to Neurotoxicology

The GMC’s ruling against Wakefield was followed in record time (in fact, preceded by) a publicity stunt of a complaint to the GMC about his trial. But, it seems that this is not the only stunt he is pulling. Today, Jim Carrey and Jenny McCarthy issued a statement announcing, “Dr. Andrew Wakefield is being discredited to prevent an historic study from being published that for the first time looks at vaccinated versus unvaccinated…” And what is this study? Why, the “monkey study” inexplicably accepted by Neurotoxicology!

That this is “new” is news to me and everyone tracking the anti-vaccine movement. It is widely believed that the “study” began as an abstract in 2008, which Wakefield et. al. expanded into the present “study” simply by adding “control” animals after the fact. Wakefield heavily publicized the paper as soon as it appeared on Neurotoxicology’s website on Oct. 2, 2009. This ensured that it came to the prompt attention of critics, who quickly established that it was grossly flawed and probably fraudulent. Thus, the supposed “historic study” that Wakefield’s enemies have supposedly conspired to discredit has in fact been available for more than four months, and for most of that time has been criticized in the harshest terms by virtually everyone to give it any attention outside of the circle of Wakefield’s followers.

I took action of my own way back on November 13 when I sent this message to the Neurotoxicology editor:

“It has been reported that your journal has or will soon publish a paper cowritten by Andrew Wakefield, against whom there are well-substantiated charges of fraud. If so, you have breached professional ethics, and unless you retract immediately, I feel it is the duty of all professionals to boycott your magazine and all others in the Elsevier line. I would welcome any explanations or clarifications you have to offer.”

I received this message in reply:

“As Editor of Neurotoxicology this is to inform you that the referenced manuscript has been subjected to rigorous independent peer review according to our journal standards. If you have issues with the science in the paper please submit them to me as a Letter to the Editor which will undergo peer review and will be subject to publication if deemed acceptable.”

Let’s take a look at what the editor claims. According to online records, the submitted manuscript was submitted 16 June and accepted on September 17, pretty much exactly 3 months. On reviewing the records for 17 other articles, I found only 4 that went from being received to being accepted in equal or better time. Hence, not only did a reasonably reputable journal accept a manuscript which, as far as I’m concerned, should not have been read further than Wakefield’s name, the staff did so in what appears to be significantly less time than average. Based on this, I judge it probable that it was accepted through the undue influence of Wakefield upon one or more of the editorial staff. (I have seen a “suspect” named, but don’t remember whom and don’t care to look it up again just to repeat it here.) Thus, not only is it likely that the paper is fraudulent, even its acceptance may be fraudulent.

On the other hand, it can be said in the journal’s defense that the paper has not exactly been published. Each submission goes through three phases: “uncorrected proof”, “corrected proof” and “accepted manuscript”. As far as I can determine, it has still not advanced beyond “corrected proof”. And note, that more than four and a half moths have passed since “acceptance”- about half again as what it took the magazine to accept. I suspect that this has resulted from greater scrutiny from management, and possibly from Wakefield stalling on “revisions”. So, the scientific community might not yet be forced to boycott Neurotoxicology into the dark ages.

After receiving the reply from the editor to my email, I sent a letter (made available at the time at evilpossum.weebly.com) further outlining my views:

I am not interested in rebutting this paper. (Others have already done that quite convincingly.) I do not care if what I have to say is published. But I am deeply concerned that any professional journal would even consider publishing a paper by Andrew Wakefield. Brian Deer, Steve Bustin and Nick Chadwick among others have made serious charges of fraud against Wakefield, with regard to his 1998 paper alleging a connection between autism and MMR, backed by a great weight of evidence. These involve not just misreporting of data, but misleading statements to parents about the medical condition of their children, the injury of at least one child during an unnecessary colonoscopy, and the use of fabricated data to further frivolous litigation. At the present time, Wakefield is the subject of ongoing disciplinary proceedings in the UK. In light of these well-substantiated charges, there is only one appropriate response: Do not publish any work to which he has contributed. This is the traditional penalty of fraud, and any exception undermines the credibility and ethical standards of your journal and the scientific community as a whole. The most appropriate action at this point is to retract the paper, and investigate whether one or more members of the editorial staff acted inappropriately in allowing the paper to be published.

Furthermore, I would like to draw your attention to the use Wakefield is making of the paper. The paper specifically alleges developmental delays due to vaccines containing mercury, which advances the claims that autism is caused by vaccination and/or other forms of mercury exposure and that chelation is an appropriate treatment for autism. While your journal has done nothing more than accept a corrected proof for peer review, it is already being independently cited and circulated by Wakefield and others who support these claims as a “published” study supporting these opinions. Wakefield himself has a clear interest in advancing a particular conclusion on this issue, as his organization Thoughtful House performs chelation as a treatment for autism.

Finally, in deciding whether Wakefield should be represented in your journal, a current court action associated with Thoughtful House deserves attention. Juli Martinez is currently seeking to prevent her ex-husband from having their son receive chelation therapy from Thoughtful House. While Thoughtful House policies specify that IV chelation requires approval from both parents, the child’s father is seeking a court ruling to waive this requirement. Juli Martinez believes that Thoughtful House is providing significant support to her husband’s court action. If she is correct, then Wakefield and/or associates are seeking to circumvent rules they themselves put in place. Ms. Martinez also maintains that previous Thoughtful House treatments of her son have not only failed to help but led to significant deterioration in his condition. I am a member of a group supporting Juli Martinez in her effort to prevent the use of chelation on her son, and counter the aggressive promotion of this dangerous and useless therapy by Wakefield and others.

David N. Brown

(Bachelor of Science, Geology)

I will add a little more as a postscript. As I said in the letter it is “tradition” that once fraud by a researcher is proved, his work is never used again. This is quite independent of formal disciplinary processes; indeed it might be compared to “vigilante justice”. There are times when this seems regrettable, as in the case of Paul Kammerer, who committed suicide when it was found that his specimens had been doctored with ink. But Wakefield has given us no cause for mercy or even pity. The evidence that he personally and knowingly fabricated “data” is among the strongest I have seen. Kammerer shot himself over charges less serious and well-substantiated! Yet, Wakefield has not only declined to die, but refused to confess his fraud, retract his claims or make any other admission of error or wrongdoing on his own part. He has shown no remorse, nor even the candor of a criminal who boasts about what he got away with. That is why reputable scientific publications have been censoring him for years, and why we should if necessary censor those who persist in allowing him to speak.

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Letter to Jim Moody: Halt libels against GMC witness!

2010-02-06T23:43:30Z

In my fiction, I have come up with the following line as a motto for a group of elite, heavily armored soldiers: “The best way to stop a bullet is to shoot the other man first.” It is more or less in this spirit that I am seeking to refute swiftly a publicized “complaint” by Wakefield to the GMC alleging “false testimony” in the trial which lead to multiple findings of serious misconduct. While there is no chance of this wretched, overlong document being taken seriously by the GMC, and good reason to doubt whether it was even intended as such, it offers a very convenient vehicle for pro-Wakefield and anti-vaccine propaganda. (Though so far, it seems to have received attention only from AoA.) I have covered this in two essays at my own blog, one of which deals solely with claims about Michael Rutter. Building on the latter, I composed this email to Jim Moody, a Washington attorney holding high positions in SafeMinds and NAA, about an AoA post and videotaped press release publicizing the “complaint”, outlining the extent to which his actions toward Rutter alone constitute outright misconduct. I await his response with great interest!

I am very concerned at Andrew Wakefield’s “complaint” against the GMC, and am posting these concerns. On examining just the “counts” against Michael Rutter, I have easily established that multiple statements are either unproven or provably false:

1. The allegation that Rutter has served “ as a paid expert witness for the vaccine industry” cannot be supported even from the text of the complaint, which mentions only ”UK MMR litigation funded by the Legal Aid Board… and for the U.S. Government “.

2. A claim from Jake Crosby at AoA that “LAB funding was petitioned to Rutter by lawyers for pharma” is supported by no apparent evidence, and counterintuitive given that Rutter’s publications were repeatedly cited by Wakefield and others arguing FOR an MMR/autism link. Even if Crosby’s allegation can be verified, which will require a document from a pharmaceutical representative which requests him by name, the fact can still be established that Rutter’s involvement was approved by the LAB, the same agency which paid Wakefield for services, and that he was never directly paid by or eligible for payment from a vaccine manufacturer.

3. A list of “experts’ fees and expenses” for the LAB MMR litigation does not include Rutter, thus there is no evidence that he was paid for his involvement in MMR litigation (by his own account consisting of an imcomplete report).

4. In at least one of the papers in which it is claimed COI was undisclosed, “No Effect of MMR Withdrawal on the Incidence of Autism: A Total Population study”, the allegation is supported by no evidence that has been made available. Since no statement either reporting or denying COI is present in the published paper, it must have been present only in “page 1 of the submitted manuscript”, which the complaint neither offers as evidence nor even claims first-hand knowledge of.

By supporting this complaint, you are guilty of LIBEL against Dr. Rutter (among others). If you do not voluntarily retract your statements, two lines of recourse are at the disposal of Rutter and other concerned parties. One (barring a problem of jurisdiction) is a lawsuit. The other is to file a complaint against you with the Washington Bar Association. You have fair warning.

David N. Brown

Jim Carrey Jenny McCarthy Definitely not anti-vaccine

2010-02-06T10:12:51Z

In the recent statement released by Jim Carrey and Jenny McCarthy regarding Andrew Wakefield, the twosome made a number of references that clear up once and for all how they feel about vaccines. Because as we all know they’re not anti-vaccine.

Dr. Andrew Wakefield is being discredited to prevent an historic study from being published that for the first time looks at vaccinated versus unvaccinated primates and compares health outcomes, with potentially devastating consequences for vaccine makers…

Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers…

The retraction from The Lancet was a response to a ruling from England’s General Medical Council, a kangaroo court where public health officials in the pocket of vaccine makers…

The fallout from the study for vaccine makers and public health officials could be severe. Having denied the
possibility of the vaccine-autism connection for so long while profiting immensely from a recent boom in vaccine sales around the world, it’s no surprise that they would seek to repress this important work.

No, definitely not anti-vaccine.

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Is Wakefield being shut up, or are Jenny and Jim trying to get publicity for his research?

2010-02-06T00:55:25Z

In a public statement, Jenny McCarthy and Jim Carrey claim that “Dr. Andrew Wakefield is being discredited to prevent an historic study from being published”. Readers of LeftBrainRightBrain are already well aware that Dr. Andrew Wakefield was recently found to be “dishonest” and to have acted in a manner against the clinical interests of the children who were his research subjects. This recent statement is in support of the now discredited doctor.

Or, is it? A cynical mind might consider that this is a public relations ploy to get Dr. Wakefield’s current research in front of the media. His last paper was much hyped by Jenny McCarthy’s organization, but got little if any actual press coverage. But now, with the media focused on Dr. Wakefield, what better time to promote his research in hopes of getting some play in the media?

Ms. McCarthy and Mr. Carrey are prominent members of Generation Rescue (“Jenny McCarthy and Jim Carrey’s Autism Organization”) and have posted their statement on the Generation Rescue website with the full version on the blog sponsored by Generation Rescue, the Age of Autism.

This reader is somewhat amazed at the language used and the ignorance of the history of the General Medical Counsel proceeding that Ms. McCarthy and Mr. Carrey have shown.

The language puts the team well into the world conspiracy-theory:

It is our most sincere belief that Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers reporting on the retraction of a paper published in The Lancet in 1998 by Dr. Wakefield and his colleagues

We are to believe that the news reporting on the retraction of the paper in The Lancet is orchestrated by vaccine manufacturers. That’s worth considering a moment—two actors, people who depend on their public image for their livelihood—are claiming that the reporting on a major news event is “engineered by vaccine manufacturers”.

The fact is that Dr. Wakefield thrust himself into the limelight with a press conference to publicize the paper. This and the fact that he has kept himself in the public’s eye for 12 years appears to have been lost on the McCarthy/Carrey team. After over a decade of promoting his research well beyond its importance or scientific merit, of course the media would take to the story that Dr. Wakefield had been found guilty of misconduct and that his paper had been retracted.

If there is any doubt as the conspiracy-theory theme of the statement, phrases like “Kangaroo court” and “in the pocket of vaccine makers” should put that to rest:

The retraction from The Lancet was a response to a ruling from England’s General Medical Council, a kangaroo court where public health officials in the pocket of vaccine makers served as judge and jury.

The article goes on:

Despite rampant misreporting, Dr. Wakefield’s original paper regarding 12 children with severe bowel disease and autism never rendered any judgment whatsoever on whether or not vaccines cause autism, and The Lancet’s retraction gets us no closer to understanding this complex issue.

This is a very strange statement to have made by representatives of Generation Rescue. Generation Rescue states on their own website, in reference to Dr. Wakefield’s paper in The Lancet, “”This study demonstrates that the MMR vaccine triggered autistic behaviors and inflammatory bowel disease in autistic children”.

Much more to the point, the press release for Dr. Wakefield’s press conference on the release of his study in The Lancet states that “Their [Wakefield et. al] paper, to be published in The Lancet 28 February, suggests that the onset of behavioural symptoms was associated with MMR vaccination”

If the defense now is that there is a difference between “proven” and “associated with” in the minds of the public, the importance of that is lost on me. Dr. Wakefield himself put the idea in the public’s mind that the MMR was causing autism.

In a video interview about his 1998 study, Dr. Wakefield stated that the link was not proven. However, he went on to claim that the “risk of this particular syndrome developing is related to the combine vaccine”:

Again, this was very contentious and you would not get consensus from all members of the group on this, but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines.

If there is rampant misreporting of the notion that Dr. Wakefield’s study in The Lancet promoted the idea that vaccines cause autism, then it is the fault of Jenny and Jim’s own organization, together with Dr. Wakefield himself.

Much of the trouble resulting from Dr. Wakefield’s work (and by that I mean trouble caused to the world and the autism communities in particular, not trouble to Dr. Wakefield), stems from Dr. Wakefield overplaying the importance or the quality of his research. Even had the study been done as claimed in the publication, it was not a very strong study. It has been reported that four referees recommended rejecting the paper before publication. I don’t know the policy at The Lancet, but often 2 or 3 referees total are used to screen a paper for a journal.

Those who forget history are doomed to repeat it. In this case, overplaying the importance of research well beyond its scientific merit. In their statement, Jenny McCarthy and Jim Carrey promote Dr. Wakefield’s ongoing research as though it is so earth shattering that it must be stopped at all costs. They discuss a series of studies Dr. Wakefield’s new group is undertaking. This research has been discussed by Medical Researcher David Gorski in an article Monkey business in autism research.

We are to believe that there is a media campaign afoot to keep Dr. Wakefield from making his new research public. In the internet age, there is no way to keep information from the public. Dr. Wakefield and his colleagues are even editors of a new pseudo-journal for autism research.

At no point to Ms. McCarthy and Mr. Carrey address the ethical violations that Dr. Wakefield was found guilty of. No mention of whether it is appropriate for medical researchers to perform invasive procedures on disabled children when there is no clinical reason to do so.

In other words, Ms. McCarthy and Mr. Carrey never actually defend Dr. Wakefield for his actions. They never address the serious ethical lapses found proved by the General Medical Counsel.

I am left thinking that this is in reality a pre-release promotional event to get press coverage for Dr. Wakefield’s upcoming paper. The study is “on the brink” of being published. In other words, it is likely already in-press. The faux outrage that his work is being suppressed in light of this is painful to read.

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U.S. Government Committee recomends increased research into the needs of autistic adults

2010-02-05T05:58:35Z

The Interagency Autism Coordinating Committee is a group representing government agencies that research autism and some segments of the autism community. It was reenacted as a result of the Combating Autism Act. The main product, if you will, of the IACC is the Strategic Plan, which lays out a suggested framework for the U.S. government’s autism research activities.

The main section of the Plan is divided into seven sections, framed around questions. I think it unfortunate that the questions are voiced as though they are posed by a parent. Be that as it may, here are the sections/questions:

1. When Should I Be Concerned?
2. How Can I Understand What Is Happening?
3. What Caused This To Happen And Can This Be Prevented?
4. Which Treatments And Interventions Will Help?
5. Where Can I Turn For Services?
6. What Does The Future Hold?
7. What other Infrastructure and Surveillance Needs Must be Met?

It is my belief, and that of many others, that the most important section is number 6: what does the future hold? This section covers research into understanding autistic adults. This is an area that has been woefully neglected in my opinion.

The goals below have a projected total budget of over US$50 million. I’d like to see a lot more. I’d like to see it now. But this is a good step forward.

Short-Term Objectives

1. New objective
Launch at least two studies to assess and characterize variation in the quality of life for adults on the ASD spectrum as it relates to characteristics of the service delivery system (e.g., safety, integrated employment, post-secondary educational opportunities, community inclusion, self-determination, relationships, and access to health services and community-based services) and determine best practices by 2012. IACC Recommended Budget: $5,000,000 over 3 years.
2. New objective
Evaluate at least one model, at the state and local level, in which existing programs to assist people with disabilities (e.g., Social Security Administration, Rehabilitation Services Administration) meet the needs of transitioning youth and adults with ASD by 2013. IACC Recommended Budget: $5,000,000 over 3 years.
3. New objective
Develop one method to identify adults across the ASD spectrum who may not be diagnosed, or are misdiagnosed, to support service linkage, better understand prevalence, track outcomes, with consideration of ethical issues (insurance, employment, stigma) by 2015. IACC Recommended Budget: $8,400,000 over 5 years.
4. New objective
Conduct at least one study to measure and improve the quality of life-long supports being delivered in community settings to adults across the spectrum with ASD through provision of specialized training for direct care staff, parents, and legal guardians, including assessment and development of ASD-specific training, if necessary, by 2015. IACC Recommended Budget: $7,500,000 over 5 years.

Long-Term Objectives

1. New objective
Develop at least two individualized community-based interventions that improve quality of life or health outcomes for the spectrum of adults with ASD by 2015. IACC Recommended Budget: $12,900,000 over 5 years.
2. New objective
Conduct one study that builds on carefully characterized cohorts of children and youth with ASD to determine how interventions, services, and supports delivered during childhood impact adult health and quality of life outcomes by 2015. IACC Recommended Budget: $5,000,000 over 5 years.
3. New objective
Conduct comparative effectiveness research that includes a cost-effectiveness component to examine community-based interventions, services and supports to improve health outcomes and quality of life for adults on the ASD spectrum over age 21 by 2018. IACC Recommended Budget: $6,000,000 over 5 years.
4. New objective
Conduct implementation research to test the results from comparative effectiveness research in real-world settings including a cost-effectiveness component to improve health outcomes and quality of life for adults on the ASD spectrum over age 21 by 2023. IACC Recommended Budget: $4,000,000 over 5 years.

IACC calls for $175 million in autism and the environment research

2010-02-05T05:00:00Z

The Interagency Autism Coordinating Committee has posted the revised Strategic Plan. I blogged it recently here on LeftBrainRightBrain. I made a note of the large commitment to environmental causation research. I thought it worthwhile to highlight that section, since this is the cause of so much criticism of the IACC.

Strangely, the criticism doesn’t come from those who are supposedly “It’s all genetic” types. No, the “it’s all environmental” groups seem to be very loud in complaining that all the research funding is going into genetics.

The Plan is divided by a number of questions. Research into causation is listed in Question 3: “What Caused This To Happen And Can This Be Prevented?”

Under that category, there are seven projects on environmental or gene-environment research. Seven out of 10 projects. The estimated budget for all these projects? $175,900,000.

In other words, 70% of the projects and, if I did my math right, nearly 70% of the funding for causation is estimated to be going to environment and gene-environment projects.

This would seem like a great victory for those who have lobbied for more environmental research. I have yet to see anyone from that group even mention the new Strategic Plan, much less the large commitment to environmental research. Where are the statements from SafeMinds (who have a very vocal member who sits on the IACC proper and another who is on a working group)? How about Generation Rescue? The National Autism Association?

In my opinion, these groups really don’t care much about environmental causation unless it is either mercury or vaccines. Hey, I could be wrong. Let’s see if they surprise me with some acknowledgment of this effort by the US Government.

Here are the objectives if you would like to read for yourself.

Short-Term Objectives

1. Coordinate and implement the inclusion of approximately 20,000 subjects for genome-wide association studies, as well as a sample of 1,200 for sequencing studies to examine more than 50 candidate genes by 2011. Studies should investigate factors contributing to phenotypic variation across individuals that share an identified genetic variant and stratify subjects according to behavioral, cognitive, and clinical features. IACC Recommended Budget: $43,700,000 over 4 years.
2. Within the highest priority categories of exposures for ASD, identify and standardize at least three measures for identifying markers of environmental exposure in biospecimens by 2011. IACC Recommended Budget: $3,500,000 over 3 years.
3. Initiate efforts to expand existing large case-control and other studies to enhance capabilities for targeted gene – environment research by 2011. IACC Recommended Budget: $27,800,000 over 5 years.
4. Enhance existing case-control studies to enroll racially and ethnically diverse populations affected by ASD by 2011. IACC Recommended Budget: $3,300,000 over 5 years.
5. New objective
Support at least two studies to determine if there are subpopulations that are more susceptible to environmental exposures (e.g., immune challenges related to infections, vaccinations, or underlying autoimmune problems) by 2012. IACC Recommended Budget: $8,000,000 over 2 years.
6. New objective
Initiate studies on at least 10 environmental factors identified in the recommendations from the 2007 IOM report “Autism and the Environment: Challenges and Opportunities for Research” as potential causes of ASD by 2012. Estimated cost $56,000,000 over 2 years.

Long-Term Objectives

1. Conduct a multi-site study of the subsequent pregnancies of 1,000 women with a child with ASD to assess the impact of environmental factors in a period most relevant to the progression of ASD by 2014. IACC Recommended Budget: $11,100,000 over 5 years.
2. Identify genetic risk factors in at least 50% of people with ASD by 2014. IACC Recommended Budget: $33,900,000 over 6 years.
3. Determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development by 2015. IACC Recommended Budget: $25,100,000 over 7 years.
4. Support ancillary studies within one or more large-scale, population-based surveillance and epidemiological studies, including U.S. populations, to collect data on environmental factors during preconception, and during prenatal and early postnatal development, as well as genetic data, that could be pooled (as needed), to analyze targets for potential gene/environment interactions by 2015. IACC Recommended Budget: $44,400,000 over 5 years.

Read more: http://leftbrainrightbrain.co.uk/2010/02/iacc-strategic-plan-is-up/#ixzz0edI3Pe8h

Wakefield, O’Leary and Bustin

2010-02-05T08:05:13Z

Below is an old post from 2007 when the Omnibus hearings were in full swing. It goes through the testimony of Professor Stephen Bustin and why it was so deadly to the MMR hypothesis. I thought now might be an ideal time to republish it.

On Day 8 of the Autism Omnibus proceedings, the MMR section of the hypothesis under examination (that thiomersal and MMR together cause autism) was examined. Just to briefly generalise about the MMR hypothesis –
It was hypothesised that measles virus (MV) from the MMR was travelling from the injection site, to the gut and then to the brain where it either a) causes autism or b) in conjunction with thiomersal causes autism. Wakefield claims to have found MV in the gut of several kids. Krigsman claimed to have replicated this work. They both used the lab of one Professor John O’Leary (Unigenetics IIRC) in Ireland.

So, on Day 8 of these proceedings Stephen Bustin came to the stand. Bustin is possibly the world expert on the techniques used in the O’Leary lab that he claimed led to identifying MV in autistic kids gut and brain. The technique is called PCR. Not only does Bustin use PCR every day, he has 14 papers in the peer reviewed literature on PCR, over 8 book chapters and is personally the author of the A to Z of Quantitative PCR. which is considered ‘the bible’ of PCR. One of his papers has been cited over 1,000 times. Another has been cited over 500 times. He both organises and speaks at international PCR conferences (1934 – 37).

Basically, when it comes to PCR - this is the guy.

The first part of Bustin’s testimony concentrated on an explanation of PCR techniques and how these techniques were employed in a key study relied upon the week previous to make the MMR/Cedillo case: Uhlmann 2002. This paper describes the exact process that Unigentics lab used to carry out their PCR work .

This is a mind bogglingly techie area so I’m going to try and stick to laypersons terms. Basically, the Uhlmann study is badly flawed. The key issues related to controls. Uhlmann (and a subsequent, as yet unpublished Walker poster presentation) didn’t use any.

a positive control is an essential control that tells you whether your assay is working, so what you would do is you would take the target that you’re interested in detecting and put it into a test tube and use your assay to detect it. If you don’t detect it, you know there’s a problem with your assay because it’s a positive control. If you do detect it, you know your assay is working. If you do this consistently each time, you know how efficient your assay is from day to day.

The positive control is simply something that tells you that your assay is okay.

Q And a negative control?
A A negative control is something very crucial. There you leave out your target, so if you don’t detect it then that means that there’s no amplification, which is what you want. If you do detect a positive in a negative control then you know there’s a problem with your assay because it should not be there, and you always get suspicious of any assay that gives you a positive result in a negative control.

So, back to Uhlmann:

Q And did Uhlmann provide the information necessary to establish whether these controls were working as expected?
A No. One of the surprising aspects of this paper is they give you very little information about how the assay was performed, about what the results actually were, and it really does not let you evaluate at all how reliable and consistent the results are.

Q Is there any discussion in Uhlmann about contamination?
A No.

Q Is this important?
A It is essential because obviously if you are trying to detect a very low copy number target and there is contamination around, and if you do not know whether there’s contamination around, then you can’t rely on your assay.

......

Q Now, did Uhlmann discuss how the RNA was handled?
A No. As I think I said one of the things about this paper is that it’s fairly unique in my experience, and it’s given no information at all about what actually was done. It actually tells you in outline what they did, where they got their samples from and that they prepared RNA, but it gives you no information whatsoever about, for example, the quality of the RNA the quantity of the RNA and how the different RNAs were extracted from different samples which they refer to.

Without being sure of how RNA is handled, it is impossible to rule out contaminants. i.e. that the samples are contaminated. And there’s more:

Q Did you also identify a mismatch between the measles virus sequences listed in the paper and the probes?
A Yes. This is, again, well, it suggests that there’s a problem with the probe design.

Q Now, regarding consistency and reproducibility did Uhlmann provide any data regarding amplification sensitivity or efficiency?
A No. I need to come back to what I’ve been saying several times now. There’s this lack of information that doesn’t allow you to evaluate this paper properly in terms of its validity.

And specifically regarding the Walker poster presentation:

....Now, as I tried to point out today I think virtually every expert in this case has referred to controls are essential. You always want controls of your samples. There’s no controls on this. So even though this is a poster presentation at the very least there should be a negative control on there to show that the PCR in the negative control hasn’t worked.

We don’t have that information. So this immediately invalidates these results because we can’t now say whether these are genuine or not because there’s no negative control there. So that’s a real problem….

Q Unless these issues are resolved would you have confidence at least in what’s been presented from the Walker lab?
A I can’t have any confidence because there’s actually no results I can evaluate without referring to a negative or a positive control, and these don’t give them to me.

So basically, Mr PCR - the guy who literally wrote the book on PCR - thinks these two things – the Uhlmann paper and the Walker poster presentation – are essentially useless.

Lets also not forget that these two items describe the exact methodology that Unigentics – O’Leary’s lab – used to state that Wakefields/Krigsmans and a multitude of private cases had MV in their samples.

Oh yeah – and as for the old crapola about the two clinical studies done thus far not repudiating Wakefield et al because the look at blood, not gut, Bustin states emphatically:

this is not an assay that is at its limits so this should be easily detectible, and it also means that if you’ve got that much measles virus in a gut sample it probably is in other cells as well and you should be able to detect it, for example, in blood.

In blood.

Turning to Unigenetics itself, as part of the failed UK litigation against MMR, Bustin was asked to look at the lab and samples that the Unigentics team had worked on. For this work he put in an astonishing 1,500 hours of work.

Now, Professor O’Leary’s own controls tell us that this should have been shifted upwards because this is much poorer quality RNA. The evidence from his own data is completely clear. There’s no such shift. This must mean that whatever this is is a contaminant that has been introduced after the sample has been formalin-fixed.

So by definition this cannot be part of the original biopsy because if it had been it will have shifted upwards.

Ouch. But the next one is a body blow to the entire MMR hypothesis.

...if you have a reference gene in that sample that is a cellular reference gene you should detect it if the RNA is of good quality.

If you don’t detect it there’s something wrong with the RNA. As Professor O’Leary’s SOP states, if we can’t detect the GAPDH we shouldn’t use the sample for analysis, which makes perfect sense.

Now, it happens that Professor O’Leary did use those samples for his analysis, and that’s why I was able to then hopefully identify what the contaminant is.

To summarise: O’Leary’s RNA was poor quality. There is no reference gene. There is something wrong with the RNA. O’Learys lab SOP (Standard Operating Procedure) states that in the events of this happening, they shouldn’t use the sample for analysis. But they did use it. They used contaminated RNA for their analysis. And Bustin has identified exactly what the contaminant was.

But first, what is definitely not ?

If you detect a target that is apparently measles virus in the absence of an RT [like this one] step by definition it can’t be measles virus because it has to be DNA [measles virus does not exist as a DNA molecule]. It’s a very simple concept. At least it is to me. It’s not to everyone else.

Whatever it is that O’Learys lab is picking up in their lab tests, it cannot possibly be Measles virus. No RT step was taken:

What I immediately observed was that they had forgotten to do the RT step

No RT step means it’s DNA. Measles virus does not exist as a DNA molecule. That’s simple medical fact. Bustin later summed up:

So all of this evidence suggests very, very strongly that what they are detecting is DNA and not RNA. Because measles virus doesn’t exist as a DNA molecule in nature, they cannot be detecting measles virus RNA. They are detecting a contaminant. All of the additional evidence, from the nonreproducibility by Professor Cotter of the same samples that Unigenetics analyzed to the analysis of the data where there are discordant positives, where the negatives came up positive, suggests very, very strongly to me that there is a lot of contamination in the laboratory, which is not unusual, but they have not handled it very well in how they have troubleshot their problems.

So I have very little doubt that what they are detecting is a DNA contaminant and not measles virus, and I do not believe there is any measles virus in any of the cases they have looked at.

And just as an added kick in the teeth:

Q Now, we know that cerebral spinal fluid samples were sent from Dr. Bradstreet to Unigenetics for testing. Do the same concerns you’ve outlined here apply to that testing?
A Yes. Exactly the same concerns would apply to that.

This testimony exposes the MMR hypothesis as totally dead in the water. What a waste of time, money and health.

Elsewhere

Arthur Allen in the Huffington Post
Autism Diva

More on autism “clusters”

2010-02-04T05:50:36Z

There are regions of California where the autism “rate” is much higher than in other regions. If you are a regular reader of this blog, you are likely thinking “repeat!” Yes, between Kev and myself and even the Evil Possum himself, David N. Brown, we have about 10 posts about the GMC ruling on Andrew Wakefield and the retraction of his article in The Lancet. Now another “autism cluster” post?

Only a month ago I blogged “Autism Clusters Found: areas with high incidence of autistic children“, discussing a paper by Dr. Hertz-Picciotto at the U.C. Davis MIND Institute. Well, it turns out that another “cluster” paper has been published. This article, The spatial structure of autism in California 1993-2001, is by Prof. Bearman’s group at Columbia. This is the same group that recently published Diagnostic change and the increased prevalence of autism

Here’s the abstract:

The spatial structure of autism in California, 1993-2001.

Mazumdar S, King M, Liu KY, Zerubavel N, Bearman P.

Institute for Social and Economic Research and Policy Columbia University, New York, NY, USA.

This article identifies significant high-risk clusters of autism based on residence at birth in California for children born from 1993 to 2001. These clusters are geographically stable. Children born in a primary cluster are at four times greater risk for autism than children living in other parts of the state. This is comparable to the difference between males and females and twice the risk estimated for maternal age over 40. In every year roughly 3% of the new caseload of autism in California arises from the primary cluster we identify-a small zone 20km by 50km. We identify a set of secondary clusters that support the existence of the primary clusters. The identification of robust spatial clusters indicates that autism does not arise from a global treatment and indicates that important drivers of increased autism prevalence are located at the local level

They used data from the California Department of Developmental Services (CDDS). This dataset has been discussed a lot online. While the work of Dr. Bearman’s group and Dr. Hertz-Picciotto’s group are both much more rigorous than the simple comparisons done by myself and others, there are severe limitations in using CDDS data. The CDDS does not make an effort to seek out all autistics, for one thing. There are variations by Regional Center in identification and services for disabled Californians.

That said, Prof. Bearman’s group found a large “cluster”. If a child was born in this region, he/she is about 4 times more likely to be listed by the CDDS with the label of autism than if he/she were born in the rest of California.

The cluster is in the Los Angeles area. (map was taken from the Wall Street Journal’s story, L.A. Confidential: Seeking Reasons for Autism’s Rise)

Prof. Bearman’s group checked that the cluster was stable over time and found that there was a region with the high administrative prevalence existed for 5 or more years. That is one good check that this is a “real” cluster and not a statistical artifact.

The Wall Street Journal quotes Prof. Bearman:

Dr. Bearman says he believes social influences are the leading cause for the high autism rates in Los Angeles, although the researchers continue to examine environmental issues.

Other studies have shown that older parents run a greater risk of having an autistic child. But when the Columbia researchers adjusted the Los Angeles cluster to factor out parental age, the higher levels remained. Dr. Bearman says he believes the high levels will also remain after the data are adjusted for education levels, socio-economic status and other demographic characteristics in future studies.

You may recall that the MIND Institute study found multiple “clusters”, using different criteria.

There is a cluster roughly centered on Hollywood in those maps, consistent with the newer Columbia study. (as an aside, the closeup map from the MIND Institute press release doesn’t look like the same region to me.)

It seems reasonable to assume that both groups were looking for clusters in a search for a possible “hot spot” of some environmental trigger for autism. Instead, Bearman’s group indicates “social issues” and Hertz-Picciotto’s group found parental education and proximity to autism treatment centers were linked to the “clusters”.

Both groups are to be commended, in my view. They are looking for some answers on causation. They are working with data that are much less than high quality, and they are dealing with shifting awareness and societal influences which could cloud any trends that may or may not exist.

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