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What are the allegations against Dr. Wakefield?

16 Sep

Dr. Andrew Wakefield, not of Thoughtful House in the U.S., has recently been called before the General Medical Council for a “fitness to practice hearing”. The allegations stem from activities related to his research of about 10 years ago on children (many autistic).

I recently discussed two of incidents being investigated: a birthday party where blood was drawn from typically developing children (for controls) and activities related to his invention and the subsequent patent his hospital (the Royal Free) applied for. I found it interesting to see these layed out, so I decided to post them here for others to read as well.

These are allegations. The process has not concluded, nor has any decision been reached.

This is a short version. A detailed list (93 pages) can be found on Brian Deer’s website. Note that these 93 pages include allegations against Doctors Murch and Walker-Smith.

Dr Andrew WAKEFIELD GMC Reference number: 2733564

Professor John WALKER-SMITH GMC Reference number: 1700583

Professor Simon MURCH GMC Reference number: 2540201

The GMC’s statutory purpose is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine.

We investigate complaints about individual doctors in order to establish whether their fitness to practise is impaired and whether to remove or restrict a doctor’s registration.

The GMC does not regard its remit as extending to arbitrating between competing scientific theories generated in the course of medical research.

The following is a summary only of the allegations which will be made before the Panel at the forthcoming hearing.

The Panel will inquire into allegations of serious professional misconduct by Dr Wakefield, Professor Walker-Smith and Professor Murch, in relation to the conduct of a research study involving young children from 1996-98.

Dr Wakefield, Professor Walker-Smith and Professor Murch, were at the relevant times employed by the Royal Free Hospital School of Medicine with Honorary Clinical contracts at the Royal Free Hospital.

It is alleged that the three practitioners were named as Responsible Consultants on an application made to the Ethical Practices Committee of the Royal Free Hospital NHS Trust (“the ethics committee”) in 1996 to undertake a research study involving children who suffered from gastrointestinal symptoms and a rare behavioural condition called disintegrative disorder. The title of the study was “A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination”. The Panel will inquire into allegations that the three practitioners undertook research during the period 1996-98 without proper ethical approval, failed to conduct the research in accordance with the application submitted to the ethics committee, and failed to treat the children admitted into the study in accordance with the terms of the approval given by the ethics committee. For example, it will be alleged that some of the children did not qualify for the study on the basis of their behavioural symptoms.

It is further alleged that the three practitioners permitted a programme of investigations to be carried out on a number of children as part of the research study, some of which were not clinically indicated when the Ethics Committee had been assured that they were all clinically indicated. These investigations included colonoscopies and lumbar punctures. It is alleged that the performance of these investigations was contrary to the clinical interests of the children.

The research undertaken by the three practitioners was subsequently written up in a paper published in the Lancet in February 1998 entitled “Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis and Pervasive Developmental Disorder in Children” (“the Lancet paper”).

It is alleged that the three practitioners inaccurately stated in the Lancet paper that the investigations reported in it were approved by the ethics committee.

The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith acted dishonestly and irresponsibly in failing to disclose in the Lancet paper the method by which they recruited patients for inclusion in the research which resulted in a misleading description of the patient population in the Lancet paper. It is further alleged that Dr Wakefield gave a dishonest description of the patient population to the Medical Research Council.

The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith administered a purportedly therapeutic substance to a child for experimental reasons prior to obtaining information about the safety of the substance. It is alleged that such actions were irresponsible and contrary to the clinical interests of the child.

The Panel will inquire into allegations that Dr Wakefield was involved in advising solicitors acting for persons alleged to have suffered harm by the administration of the MMR vaccine. It is alleged that Dr Wakefield’s conduct in relation to research funds obtained from the Legal Aid Board (“LAB”) was dishonest and misleading. It will be alleged that Dr Wakefield ought to have disclosed his funding from the LAB to the Ethics Committee but did not.

The Panel will inquire into allegations that Dr Wakefield ordered investigations on some children as part of the research carried out at the Royal Free Hospital from 1996-98 without the requisite paediatric qualifications to do so and in contravention of his Honorary Consultant appointment.

The Panel will inquire into allegations that Dr Wakefield failed to disclose his involvement in the MMR litigation, his receipt of funding from the LAB and his involvement in a Patent relating to a new vaccine to the Editor of the Lancet which was contrary to his duties as a senior author of the Lancet paper.

The Panel will inquire into allegations that Dr Wakefield acted unethically and abused his position of trust as a medical practitioner by taking blood from children at a birthday party to use for research purposes without ethics committee approval, in an inappropriate social setting, and whilst offering financial inducement.

We cannot guarantee that all those wishing to attend the hearing will be able to do so, as seating is limited. If you plan to attend the hearing please email the GMC press office press@gmc-uk.org. In the event that we have to allocate seats those people who have notified the press office will be seated before others.
-Ends-

Greater detail can be found in this document, hosted on Brian Deer’s website. It is 93 pages of details of the allegations against Dr. Wakefield, Dr. Walker-Smith and Dr. Murch.

Dateline and Dr. Wakefield’s patent activities

16 Sep

In the recent Dateline NBC episode about Dr. Wakefield, Matt Lauer asked Dr. Wakefield about his patent activities.

As a bit of background: before Dr. Wakefield’s 1998 Lancet article was published, his hospital, the Royal Free, had submitted a patent application for an invention of Dr. Wakefield’s. The application was titled, “PHARMACEUTICAL COMPOSITION FOR TREATMENT OF IBD AND RBD”

IBD is “inflammatory bowel disease”
RBD is “regressive behavioural disease” “(also referred to as pervasive developmental disorder)”

(definitions taken from Dr. Wakefield’s Great Britain patent application 2,325,856)

As you might assume from the title, the patent has as a main thrust the idea that certain transfer factors could be used therapeutically. In other words, the main point appears to be to use this as a treatment. This does not exclude the fact that the patent also includes a claim for a classic, preventive vaccine.

The original patent application, filed June 6 1997 (before Dr. Wakefield’s first autism paper in The Lancet), is shown on Brian Deer’s website.

There are nine claims to the patent. Eight of which relate to the proposed treatment. Claim two, however, states:

The composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.

Prophylaxis, of course, meaning to prevent.

The existence of such a patent application raises the obvious question of conflict of interest. In other words, was there the possibility that Dr. Wakefield’s invention could result in royalty payments to Dr. Wakefield for a vaccine? Could he profit from what amounts to a single vaccine for measles (as opposed to the combination virus MMR vaccine)?

Dr. Wakefield in a previous statement (again hosted on Brian Deer’s website):

The reference to the possible use of TF [transfer factor] to protect children against measles infection – the thrust of the Sunday Times’ conspiracy theory – was put in as an afterthought in the patent. It was entirely speculative and never pursued in any shape, manner or form.

The provisional patent filing was entirely speculative and was for a possible therapy; as such, it had no bearing on the 1998 Lancet paper.

Note that Dr. Wakefield acknowledges that his invention was claimed to be able to protect against measles infection. As we will see below, this is in direct contrast to his statements on Dateline.

Before we delve into that, I must strongly disagree with Dr. Wakefield as to whether this had bearing on the 1998 Lancet article. Part of the patent application clearly claims the use of the invention as a vaccine. Whether the invention was speculative or that the main use was as a therapy is immaterial. The appearance of a financial conflict of interest should have been reported to The Lancet, the referees, and to the press, in my opinion.

In his statement, Dr. Wakefield goes on to say:

It constituted no potential conflict until the patent was awarded.

Again, I strongly disagree. If the patent was a potential conflict of interest, so was the application. Both are a potential to profit.

Also, if the patent itself is a potential for profit, how can one justify the previous argument that the application was not a conflict since it was merely “for a possible therapy”? Again, if the language of the patent was a potential conflict due to the inclusion of the vaccine, the application was a potential conflict as well.

So, after that long introduction, what did Dr. Wakefield have to say to Matt Lauer?

Dr. Wakefield is back to denying that the invention was for a vaccine to prevent measles and is claiming it as merely a therapeutic agent.

But as we have already seen above, this is not what the patent states. This isn’t even consistent with Dr. Wakfield’s own previous comments.

Here is the section where Matt Lauer of Dateline interviewed Brian Deer on the topic:

First impression: Matt Lauer’s team messed up with the statement that the vaccine was “for the elimination of MMR”. I heard that statement as though the purpose of the Wakefield vaccine was to eliminate the MMR as a vaccine. The wording of the first sentence of the patent application is:

The present invention relates to a new vaccine for the elimination of MMR and measles virus and to a pharmaceutical composition…

I read this as the vaccine for the elimination of the MMR viruses from someone with a persistent infection of one or more of measles/mumps/rubella, not as for the elimination of the MMR vaccine itself.

It is not well worded.

The statement from the patent application that most clearly shows that it covers the invention as a vaccine is claim 2. It is short, clear and direct to the point.

The composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.

This is what Dateline should have used, in my opinion.

I think the segment below clearly shows that part of the intention of the invention was as a vaccine for the prevention of measles which is purported to be safer.

fragment of Dr. Wakefield's original patent application

fragment of Dr. Wakefield's original patent application

Back to the interview, I think that Mr. Deer makes a key point in stressing that the patent application discussed the invention as a “safer” vaccine. This makes it more clearly a possible contender to replace the MMR vaccine as a product.

Brian Deer notes on his website:

A letter from his lawyers dated Jan 31 2005 said: “Dr Wakefield did not plan a rival vaccine.”

It is very difficult to ascertain intentions. At a very real level, what Dr. Wakefield planned is immaterial. The fact of the matter is that there was a possibility (however remote) that Dr. Wakefield could profit if the combination MMR vaccine were removed. The appearance (at least) of a potential conflict of interest was there and should have been disclosed in the paper and press conference, in my opinion.

The information I would like to see on this would be Dr. Wakefield’s lab books (or notes, as the case may be). In particular, he is reported to have applied his “transfer factor” on at least one child. Were there any tests performed (say, measles titers?) that could have been used to justify development as a vaccine? For example, measles titers?

It is also worth noting that as far as I can see, all of the patents on this potential vaccine have been abandoned. In other words, Dr. Wakefield and/or the Royal Free Hospital do not appear to have continuing financial interests in the proposed measles vaccine, or the IBD/autism therapy.

As a final word–I find it interesting that in one of the patents Dr. Wakefield states that that the autism prevalence is about 1%. This from a document dated 1998, 10 years ago. So much for that epidemic, eh?

Section of GB patent 2,325,856

Section of GB patent 2,325,856

The Wakefield birthday party blood draw story

15 Sep

One of the strangest parts of the story of Dr. Wakefield’s research is the birthday party where blood was drawn from his child’s friends who were given five pounds each.

Dateline NBC included this in their recent story, A Dose of Controversy. Here are two clips from that show, spliced together:

The first thing that struck me was the explanation of the money. If I understand Dr. Wakefield correctly, he didn’t “pay” the children, they were “rewarded” at the end of the party. That makes it a different situation “in ethical terms”.

I’d like to have one of the kids at the party explain the ethical differences, as I am confused.

I guess if the kids gave the blood of their own free will, and only later the were “rewarded”…they didn’t know they would get money…in that case the money wasn’t an incentive or a coercion? Is that what is being said?

If so,I am further confused by this quote attributed to Dr. Wakefield:

Again for those who’ve heard the story, you can put your hands over and you can take time out here, but this is again my son’s birthday party, 32 healthy controls. And you line them up – with parental informed consent, of course. They all get paid £5, which doesn’t translate into many dollars I’m afraid.

So, were they were paid? I thought we just heard that they were “rewarded”, which is different in an ethical sense.

And, what about that “at the end of the party” statement? Again, a quote attributed to Dr. Wakefield:

“One child, who’s my son’s best friend, Ollie, he put his arm out, very bold, had the tourniquet put on, and then went very pale and sort of … wait till next year. He was nine at the time, and his four year old sister came up, stuck her arm out, had the blood taken, took her five pounds and went off.

Is it important that the children were rewarded at the end of the party? My guess is that makes it less of a coercion. But, that little girl got her money right away, didn’t she?

I guess if she was the last child to have blood drawn, and this was the end of the party, this could fit in with Dr. Wakefield’s description of “end of the party.” Possible, I guess, but that is not how I saw this playing out when I first read that quote.

Sorry to switch back on you, but I am still trying to reconcile “reward” vs payment. Consider this statement attributed to Dr. Wakefield:

“And (NAME) burst into tears. Ruined his birthday party. But people said to me, Andrew, look, you know, you can’t do this, people, children won’t come back to you. [laughter]. I said you’re wrong, I said: ‘Listen, we live in a market economy. Next year they’ll want ten pounds!'”

I am having trouble figuring out how to reconcile “rewards” with “a market economy” and the children wanting a higher amount the next time.

I gather that at least part of the problem Dr. Wakefield is facing is that blood is not bought or sold in the UK (at least, there is a statement to this effect on Brian Deer’s website). As a U.S. citizen, I am used to the idea that blood is bought and sold. Paying people for blood is still a bit strange to me, but not unheard of. But from my perspective, I would have greater respect for Dr. Wakefield if he had just said (assuming it is true) that he had made a mistake.

Just in case Dr. Wakefield’s comments in print seem a bit too surreal to be true, Here is a video with a bit more of Dr. Wakefield discussing the birthday party:

note–I made a number of clarifications after this post was published.

The National Autism Association’s embarrassing spitefulness

14 Sep

In a recent Dateline episode about Dr. Andrew Wakefield, Matt Lauer stated that to some groups Dr. Paul Offit is “public enemy number one”.

As if to prove Matt Lauer right, the National Autism Association launched an attack on Dr. Offit for his appearance on Dateline. They did this through a press release, Offit’s Failure to Disclose Jeopardizes Swine Flu Vaccine Program.

The press release has the header: “Doctor Who Made Millions Off MMR Manufacturer Does Not Tell Public of His Financial Relationship during NBC Dateline Broadcast”

The NAA state further,

Dr. Paul Offit of Children’s Hospital of Philadelphia (CHOP), who was interviewed for a Dateline NBC television special, failed to tell millions of viewers that while he was promoting MMR as safe he had also made tens of millions of dollars from selling another vaccine patent to Merck, which is the manufacturer of MMR.

Let’s take a look at what was actually said, shall we?

Matt Lauer states (about 1:45 into the video clip), “Dr. Offit is a target. Not just for supporting vaccine safety, but because he himself made millions of dollars for inventing a vaccine.”

Quite frankly, the NAA is lying. Matt Lauer knew that Dr. Offit invented a vaccine and made money from his vaccine and Matt Lauer informed his audience of this. My guess if pressed the NAA will likely hide behind the Merck connection. Yeah. Like Matt Lauer and his producer didn’t know that RotaTeq is sold by Merck. (if so, that Merck logo on the RotaTeq box should have been a big clue, don’t you think?)

A minor point: Dr. Offit did not sell a vaccine patent to Merck. He assigned the rights to his invention the Children’s Hospital of Philadelphia (CHOP), a standard arrangement for an academic or industry employee. CHOP then applied for and was granted patents. CHOP (not Dr. Offit) licensed the patent to Merck, and then sold the license rights to a third party for a lump sum. Out of that sum, CHOP payed Dr. Offit, Dr. Plotkin and Dr. Clark.

The NAA press release further states:

According to CHOP documents, Offit’s share of a royalty sale for the Rotateq vaccine to Merck is a minimum of $29 million and may approach $50 million.

This is wrong. This is wrong on two counts. First, there are no CHOP documents which state that Dr. Offit’s share of the sale of the patent rights for $29 to $50M. There can’t be documents that say this because Dr. Offit’s share was about 1/10 of this amount.

How did the NAA get such incorrect information? There is a blog post, written by Dan Olmsted and Mark Blaxill which estimates this based on information they gleaned from the CHOP website. Their misinformation has been spread far since that post.

The only problem is, Dan Olmsted and Mark Blaxill were wrong. They made some big (and easily avoided) mistakes.

First mistake is that they used the incorrect Patent and Intellectual Property Policy in their calculation. That agreement wasn’t in effect when Dr. Offit and his co-inventors invented what became RotaTeq. Even Misters Blaxill and Olmsted acknowledged this in their post.

The old inventor agreement (easily found on the CHOP website) states:

payment to inventors was based on gross income, with 50 percent distribution on the first $250,000, 30 percent on the next $250,000, 15 percent on the next $4.5 million and 10 percent on the remainder.

The bulk of the payout was 10% of net income. Not 30% as Misters Blaxill and Olmsted assumed.

The second mistake is that Misters Olmsted and Blaxill neglected the fact that Dr. Offit shared the CHOP payment with his co-inventors, Dr. Stanley Plotkin and Dr. Fred Clark.

Mister Blaxill has stated in the comments to his post that Clark and Plotkin were not faculty of CHOP, but, instead were at Wistar. Again, one can easily confirm that they were faculty at CHOP with a simple google search. The CHOP research timeline states,

Drs. H. Fred Clark, Stanley Plotkin and Paul Offit develop a rotavirus vaccine for infantile gastroenteritis.

CHOP’s 2006 annual report (also easily found) states:

As part of its distinguished legacy of developing vaccines to improve the lives of children, Children’s Hospital investigators Paul Offit, M.D., chief, Division of Infectious Diseases; H Fred Clark, D.V.M., Ph.D.; Stanley Plotkin, M.D.; and The Wistar Institute developed RotaTeq®, the oral rotavirus vaccine that was licensed and further developed by Merck & Co. Inc.

Dr. Plotkin is the former chief of infectious diseases at CHOP, and Dr. Clark was a research professor of Pediatrics at CHOP. Both easily confirmed through the CHOP website.

It is unequivocal that CHOP considered Dr. Clark and Dr. Plotkin to be a part of the CHOP team. The Intellectual property policy (and all standard IP policies) divide the inventors’ share amongst all inventors.

Sorry to go into such detail, but I can not figure out why Misters Blaxill and Olmsted have not corrected their mistake. One commenter to their blog pointed out that Doctors Clark and Plotkin were CHOP faculty, only to have Mr. Blaxill respond that “…Offit would have received the entirety of the CHOP inventor’s share”. I’d be interested what Mr. Blaxill based that statement upon.

CHOP is reported to have sold their rights to RotaTeq for $182M. Using the correct information, this leads to an estimated payout of about $6M. (Note, Mr. Blaxill and Mr. Olmsted report that the net income to CHOP was $153M. This would lead to about $5M payment for each inventor).

Using the correct CHOP policy, one can calculate (based on $182M):

Inventor share
50% of first $250k is $125,000
30% of the next $250k is $75,000
15% of the next $4.5M is is $675,000
10% of the remainder ($176,750,000) is $17,675,000

Total inventor share $18,550,000
This is split amongst the three inventors, leading to:
each inventor getting $6,183,333

I have confirmed that this is is an accurate estimate with Dr. Offit.

I post this calculation not as an estimate, but as a demonstration that the accurate amount could have been calculated by Misters Olmsted and Blaxill with publicly available information at the time they did their blog post Misters Blaxill and Olmsted took great efforts to find information about the inventor policies at multiple other institutions–much more effort than was required to find the accurate information on CHOP’s own website.

$6M is a lot of money, don’t get me wrong. Dr. Offit has acknowledged this in his statements. But, it is much lower than the estimate that Mark Blaxill and Dan Olmsted have publicized. The honorable thing for these two gentlemen to do now is to correct their mistake.

The real honorable thing to do is to not only correct their error, but to correct the error wherever it has propagated.

What is more important than the amount of the sale is the fact that CHOP sold its interest in the patent. Why is that important? Because that means that the amount of money CHOP can make from this patent will be unaffected by just about anything Dr. Offit does or say.

But, I’ve strayed a bit on this post, away from the NAA. The source of the misinformation is the Age of Autism blog and Misters Blaxill and Olmsted. Perhaps the NAA could use the argument that they didn’t create the misinformation, they were just passing it along? Except that the NAA sponsors the Age of Autism blog.

Back to the rest of the press release. It is an amazing piece of work. I found it especially odd when the NAA interview themselves and make it sound like news. They don’t try to hide it, they give quotes from Wendy Founier and Jim Moody…and then list themselves as the contact people for the press release.

They also interview Dr. Wakefield, who calls Dr. Offit “disingenuous” at the beginning of the paragraph, and finishes the paragraph showing concern for how people like Dr. Offit might impact the integrity of the swine flu vaccine.

Anyone detect the irony there? Dr. Wakefield (and the NAA) are so concerned about the swine flu vaccine program that they worry about Dr. Offit impacting the integrity of the program?

Talk about disingenuous.

The press release repeats one of the stranger of the accusations against Dr. Offit–the claim that he does not treat patients with autism:

Beyond Offit’s financial conflicts, autism advocates are also dismayed about the physician’s credibility on speaking about autism in general, as he does not treat patients with autism.

Unless the NAA wants to state that autistics in Philadelphia do not get infectious diseases, it is pretty certain that Dr. Offit has treated a number of autistics in his long career.

To cap this all off, the Age of Autism blog, sponsored by the NAA, ran a post advertising the NAA press release. However, instead of calling it what it is, a press release, they framed it as being “reported by Reuters”.

Yeah. They tried to make it sound like news reporting by a major outlet rather than a press release.

Even their own readership balked at that and they had to change the title. No apology, though. Just an acknowledgment and a claim that it wasn’t “an intentional attempt to mislead“. If you go over to Age of Autism to check, you’ll have to do some searching as they didn’t correct the post but, rather, buried it in the comments.

The NAA press release was a cheap swipe at Dr. Offit and it is as transparent as it was childish. It is an embarrassment to the autism communities.

As an appendix, I add the following information:

The Countering Age of Autism blog posted a comment by Dr. Offit. Also on Countering, frequent commenter to this blog, David N. Brown, wrote an excellent deconstruction of the NAA press release.

David N. Brown also took on the task of informing Mr. Blaxill of his error in the comments to Mr. Blaxill’s Age of Autism blog post. Mr. Blaxill responded with:

David Brown, please read the article before making incorrect statements. The payment to CHOP was $182 million (Wistar received a separate and earlier $45 million dollar payment). From this, Offit would have received the entirety of the CHOP inventor’s share. Benchmarks show the inventor’s distribution can range from 15-35% of royalty income, with the current CHOP policy set at 30% (a share we didn’t feature in our calculations because it is a new standard and may not have been the relevant one for Offit’s distribution). In other words, our estimate is conservative and uses a percentage that is at the very low end of the relevant range.

I informed Mr. Blaxill and Mr. Olmsted ahead of publishing this post of this information, specifically that (a) Dr. Offit did not receive the entirety of the CHOP payout and that (b) their calculation of the CHOP inventors’ share was incorrect and not even a conservative estimate. I included links they could use to confirm the information. I encouraged them to make the correction. Mr. Blaxill and Mr. Olmsted have declined.

Andrew Wakefield gives NBC “talking points”

11 Sep

Dr. Wakefield “took issue” with a recent Dateline episode discussing him and his work. Thoughtful House (his clinic) has offered Dateline some talking points to, I gather, give “the full story” that Dateline supposedly missed.

Since there is next to zero chance that Dateline will act on them, I thought I would take a look at the talking points:

A. There has been extensive replication of the finding of bowel disease in children with autism (ASD) from five different countries. These findings have been published in peer-reviewed journals or presented at scientific meetings. It is therefore incorrect and misleading of Matt Lauer to have stated that every aspect of my original hypothesis has been disproved. On the contrary, the main findings of the original Lancet paper, that is, bowel disease in autistic children, has been repeatedly confirmed. This obvious inaccuracy requires clarification by NBC.

One of my many failings is that I am a sloppy writer and, yet, I key in on imprecise language in the work of others. Case in point:

“On the contrary, the main findings of the original Lancet paper, that is, bowel disease in autistic children, has been repeatedly confirmed. ”

“…the main point of the Lancet paper, bowel disease in autistic children…”

Very imprecise. What about bowel disease in autistic children is the finding of the Lancet article that Dr. Wakefield wants us to know? The statement is so vague that all we are left with is the fact that some autistic children have bowel disease.

This is misdirection on Dr. Wakefield’s part. It isn’t even good misdirection. The Dateline story wasn’t “the career of Andrew Wakefield, what he got right and wrong”. It was about the assertions that MMR cause autism.

Dr. Wakefield makes it appear that this statement was Matt Lauer’s. It is a fine point, but Matt Lauer didn’t state that “…every aspect of my original hypothesis has been disproved”. The statement was from the American Academy of Pediatrics, which Matt Lauer quoted with attribution.

It’s worth recalling what the Lancet paper stated. The concluding paragraph of the 1998 Lancet article was:

We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunisation. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.

Had Dr. Wakefield himself distanced himself from the MMR-causation theory in the last 10 years, even a little, I’d think it reasonable for him to emphasize the the idea that he brought to light GI disturbances in autistic kids. But he hasn’t. It isn’t what the Dateline story was about.

The big question, if he thought this was important, why didn’t Dr. Wakefield himself emphasize that in the interview?

Dr. Wakefield’s second point:

B. The shortcomings and the flaws of the studies quoted by Dr. Offit, claiming to disprove an association between vaccines and autism, were not discussed in the program. In my interview with Mr. Lauer I took as an example a paper from Dr. DeStefano from the CDC claiming to exonerate MMR that actually showed that a younger age of vaccination with MMR is associated with a greater risk of autism. This study confirms the association and has been falsely portrayed as vindicating the vaccine. This should have been included in order to provide balance to the program.

Can someone tell me what DeStefano paper and what analysis he is talking about?

C. Reference was made to an autistic child in the vaccine court whose claim for MMR damage was overturned by the judge. No reference was made to the successful vaccine court case on behalf of the child Bailey Banks, coming just one week after the unsuccessful claim described by Mr. Lauer, in which the judge ruled that MMR vaccine can cause autism. Therefore, in the view of vaccine court, it is not a question of whether or not MMR can cause autism, but rather how many children are affected.

The case referred to in the Dateline episode was that of Michelle Cedillo. Her’s was the first “test case” to be heard by the Autism Omnibus Proceeding.

Her case was first heard by a “special master”, who denied compensation. The case then was appealed, and the judge didn’t “overturn” anything. The judge upheld the original decision.

The Bailey Banks case is one that gets debated a lot on the net. Rather than go into that again, let’s ask: how does this relate to Dr. Wakefield’s research? Perhaps I missed it as I did some very quick searches, but I didn’t find anything in the Bailey Banks decision that had anything to do with digestion/inflamation/enterocolitis/constipation/diarrhea… I think you get the idea–the case has nothing to do with Dr. Wakefield’s ideas about autism and the gut.

I.e. Wakefield’s point C is another diversionary tactic.

D. There was a complete absence of comment on the lack of any adequate safety studies of childhood vaccines and the vaccine schedule in particular. There was no mention of the admission by vaccine regulators that there is no data on the long-term safety of vaccines, the chronic disease burden caused by vaccines, and the likely potentially harmful interactions between various vaccines in the routine schedule.

Have you heard the phrase “diversionary tactic” too often yet? What does any of this have to do with whether Dr. Wakefield’s research? This is a favored diversion in online discussions of vaccines/autism. When people run out of real ammunition (and they do quickly), switch to trying to debate general safety of vaccines–and it almost worked. Instead of addressing some of your comments, I’ll move on to your fifth point:

E. Undue credibility was given to Brian Deer, a discredited freelancejournalist, whose false reporting has caused so much misunderstanding and damage to children through the misrepresentation of the doctors and parents who were seeking answers to the vaccine-autism question. Deer has repeatedly misled the public and the medical profession and has been unable to respond to clear evidence of his false reporting in the Sunday Times through the UK’s Press Complaints Commission.

Nice slam, there, Dr. Wakefield. Given the sloppy nature of your previous comments, I am impressed that you pulled this together so well.

You make it seem like it is accepted that Brian Deer is “discredited”. I guess if you don’t get out of Thoughtful House or autism-parent conventions, you might think that.

The “unable to respond…” bit is pretty classic. The Press Complaints Commission isn’t hearing the complaint until after your own GMC hearing, correct? So, I guess he has been unable to respond at the PCC. But, did that really stop him from responding? I seem to recall a pretty sharp worded response that Orac hosted on Respectful Insolence.

Didn’t you, Dr. Wakefield, bring that complaint to the PCC? If so, nice job leaving out the fact. It would come across quite differently had you stated: “…and has yet been unable to respond to clear my claims of his false reporting in the Sunday Times through the UK’s Press Complaints Commission.”

F. It was not disclosed that I have repeatedly invited Dr. Offit to take part in public debate on the safety of MMR vaccine and the false and misleading claims that he has made in the media and his book. He has refused to accept this invitation and has continued to hide from an open and honest debate.

Why would NBC waste time on this? Was it pertinent to the discussion? Answer: no.

I think they did you a favor by not mentioning it. No one looks good with the “So and So won’t debate me” argument. They just don’t. The “please debate me” argument is a staple of the crank. I doubt you wish to appear to be in that category, do you?

Academics “debate” in the literature, not on some stage. If you want to debate Dr. Offit, come up with some good research. Publish it.

Alternatively, if you want to see how a Wakefield/Offit debate comes out, read “autism’s false prophets”. If that is “hiding”, he hasn’t done a very good job of it.

G. NBC alluded briefly to the fact that Richard Horton, editor of The Lancet, was informed of my participation as a medical expert in the MMR litigation almost one year before publication of the Lancet paper in 1998. NBC failed to clarify that when Horton was challenged to respond to the fact that when he so enthusiastically denounced me and the paper in 2004 the Lancet staff was already fully aware of the facts and at that time did not consider them to be relevant. Horton refused to be interviewed by NBC and the interview segment shown was from 2004. This refusal is in sharp contrast to his willingness to denounce me in the media in 2004. NBC also failed to mention that in the light of these facts Horton has been reported to UK’s General Medical Council on an allegation of perjury.

Even if true, this is just more diversions. If you thought it important enough to fax all this information to the Lancet, why didn’t you include a conflict of interest statement in the article itself? The referees would have appreciated that, I believe. Was there any mention of potential conflicts of interest in your cover letter to The Lancet when you submitted the paper? Or in the cover letter for your acceptance? All of those were places where you should have made such statements.

H. It was unfortunate that NBC, having stated their determination to resist external pressure to distort the balance of the program, yielded to such pressure from the American Academy of Pediatrics, allowing them the final word in the program while denying representation from the National Autism Association who put forward to NBC a rational and well reasoned call for further science to resolve this very real issue.

I’m sorry, but are you seriously putting he “National Autism Association” on equal footing with the American Academy of Pediatrics? How many members does the NAA have? (a lot less than the AAP) What is the name of their journal (they don’t have one) What is the impact factor of their journal? (Pediatrics is a very well respected journal).

Given the NAA’s recent childish antics with their attempted slime job against Dr. Offit (which you, Dr. Wakefield, participated in), I think that Dateline has been proven correct for not airing their comments.

I. Dr. Offit cited a large population study of autism and MMR from Denmark in support of his claim to ‘certainty that there is no link.’ This study was so flawed that it was rejected from consideration by the gold standard scientific review by the highly influential Cochrane Collaboration. Dr. Offitt, who is not an epidemiologist, was clearly at a loss to understand the study’s fatal flaws.

“Dr. Offitt, who is not an epidemiologist…” What’s up with that comment? I’m sorry, is Dr. Wakefield an epidemiologist? Answer: no. Do you have to be an epidemiologist to understand the study or it’s strengths or flaws? No.

What fatal flaws is Dr. Wakefield referring to? The big Danish study was by Madsen, et al.. The Cochrane Review lists this study as one of the “cohort studies included in the review”. Not “rejected from consideration”.

That aside, I have the Cochrane Review “Vaccines for measles, mumps and rubella in children (Review)” open. The version I have open is noted: “This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2009, Issue 3”, so I think it is the most recent.

I guess if the Cochrane review is “highly influential” and the “gold standard” it would make sense to see what they think of the autism/MMR hypothesis, eh? The review states:

No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found.

Was this because they didn’t know about Dr. Wakefield’s work? Hardly. Four of Dr. Wakefield’s papers were listed. All were listed in the “excluded studies” section.

So where does this leave us? We have, what, nine talking points which are mostly diversions or misrepresentations. Anyone wonder why I don’t think Matt Lauer will be responding to these soon?

Dr. Bernadine Healy talks about vaccines and autism…or does she?

1 Sep

Vaccines and autism: publicity of the topic just got a “shot in the arm” this weekend with a story on Dateline. As part of the story, Dr. Bernadine Healy was interviewed.

Dr. Healy has called for more research into the proposed vaccine-autism link. She has some good credentials (former head of the National Institutes of Health)

Take a look at what she had to say.

I really want people to actually watch her before reading my opinions. I’m very interested in what other people see, untainted by my opinion.

Did you watch? OK, go ahead.

My view: She sounds like a politician on a stump speech. She makes her “constituency” think that she made a commitment when, in fact, she never does.

“…in the area of autism, and in the area of vaccines, there are many many questions that need to be answered and they need a broad base of science.”

Does she ever say, “we need to research vaccines as a cause of autism”? No. She doesn’t. She mentions autism and she mentions vaccines, but doesn’t really put them together.

Another statement, in talking about vaccine safety:

“…it is about understanding if something is happening that we need to address in a small subset”

Her words are very imprecise, letting the reader interpret as he/she will.

“small subset”. Some will hear that and think, “children with autism, that’s the small subset” and the “take away” message will be, “she supports the idea of vaccines causing an epidemic of autism”. It’s possible that “small subset” means a small subset of autistics. In other words, she might be accepting the data that shows vaccines haven’t caused an epidemic of autism. It’s possible that “small subset” is the very small subset of people who are injured by vaccines, some of whom are autistic and some of whom are not. In which case, what she said isn’t controversial at all.

We just can’t tell what she meant from what she said.

And, yet, many would could come away thinking that her statement supports their side.

Perfect politician speak. Very reminiscent of the style Sentator McCain used in his comments courting the autism vote in the last U.S. presidential election.

Dr. Healy has not always been so cautious with her words. When she first appeared on the autism scene, she made accusations against the Institute of Medicine. She also made statements about young children having no risk for Hepatitis B, questioning the need for that vaccine. There are more examples, but these two serve the point: when we make specific statements, we run the risk of being wrong.

The rest of the interview was mostly “mom and apple pie” statements about good communication with parents, pediatricians and the American Academy of Pediatrics.

She also talks about vaccines and how there are “questions that must be addressed”. See what I mean about how that sounds like a politician? What questions must be addressed? The listener is likely to fill in the blank and feel that Dr. Healy made a statement supporting, say, questions about vaccines potentially causing autism.

Contrast Dr. Healy’s non-statements to the statement by the American Academy of Pediatrics on the Dateline website.

August 2009

Statement from the American Academy of Pediatrics to “Dateline”

The immunization schedule is considered the ideal schedule for healthy children. It is designed to stimulate children’s immune systems so they will not suffer illness, disability and death from vaccine-preventable diseases. The recommended immunization schedule is based on the latest scientific research. There is no scientific evidence to support the safety or effectiveness of alternative schedules. Delaying vaccines leaves babies unprotected when they are most vulnerable to vaccine-preventable diseases such as hepatitis B (a liver infection), rotavirus (severe diarrheal disease), whooping cough and bacterial meningitis.

Autism is a devastating, poorly understood neurodevelopmental condition. It is upsetting for families not to know what caused their child’s autism. The American Academy of Pediatrics (AAP) supports additional research to investigate genetic and environmental factors that may affect the developing brain. While it is likely that there are many environmental factors that influence the development of autism, vaccines are not the cause of autism. We know this because many careful and repeated studies show no link between vaccines and autism. Specifically, numerous studies have refuted Andrew Wakefield’s theory that MMR vaccine is linked to bowel disorders and autism. Every aspect of Dr. Wakefield’s theory has been disproven.

The AAP wants parents to have complete, science-based information so they can make the best decision for their child about immunization. The AAP urges parents who have questions about vaccines to talk to their pediatrician. For more information, visit www.aap.org.

See the difference between Dr. Healy’s interview and the AAP statement? The AAP said something concrete. They said that Wakefield’s theory has been disproven. They say that they support additional research into genetic and environmental factors.

Having done so, the AAP will almost certainly have their message picked apart and misinterpreted.

For example, one common attack I would expect to see is “if they don’t know what causes autism, how can they say that vaccines didn’t cause an autism epidemic?” This comes up enough that I have a handy counterexample: I, for one, feel safe in not applying research funding into the “refrigerator mother” theory, even though we don’t know what causes autism. I will go out on a limb and state that it is likely that most autism parents and autistics would agree with me on that. See, one can reject some ideas even without a complete understanding of autism.

What I really expect is for some people to jump on the “environmental factors” statement by the AAP. David Kirby, for one, has made a mini-career out of collecting such statements. Each time it is evidence of a “new” position on the possibility of environmental causes of autism by one group or another, Mr. Kirby jumps on it and adds it to his list.

I guess this hasn’t happened with this statement by the AAP because because this isn’t a new position. For example, this past May they stated, “A complex collection of variables, both genetic and environmental, have been associated with the development of autism spectrum disorders (ASD).”. This statement is a part of the FAQ (frequently asked questions) on the AAP autism website.

I was amazed then that Mr. Kirby didn’t extrapolate wildly on the “environmental” statements by the AAP.He tends to leave it implied that anyone who accepts “environmental causes” of autism is referring to events that happen to young children and not, as is most often the case in the studied environmental risk factors, prenatal events. Mr. Kirby tends to imply that anyone who agrees that there are environmental risk factors likely supports his contention that mercury causes autism.

In other words, he tends to claim support for his ideas even where there is none.

But, enough about Mr. Kirby. At least he sometimes makes definitive statements. Yes, he likes to hide behind the cloak of “what if” statements that are supposed to be “sparking a national debate”. But, he can and does occasionally make hard statements, unlike Dr. Healy in her interview.


The CDC also submitted a statement to Dateline. It too has concrete statements:

August 26, 2009

NBC News
30 Rockefeller Plaza
Suite 325W-1
NY, NY 10112

CDC Statement on Vaccine Safety, Thimerosal and Autism

At the Centers for Disease Control and Prevention we understand that autism and autism spectrum disorders place a heavy burden on many families.

Despite compelling scientific evidence against a link between vaccines and autism, some parents wonder if vaccines could have caused their children to develop autism. The suggestion that MMR (Measles, Mumps and Rubella) vaccine could be related to autism was initially raised in a 1998 article by Andrew Wakefield and colleagues. Several subsequent studies by independent researchers, however, have not found an association. A study that included the same laboratory that was involved in Wakefield’s original studies was not able to replicate the original findings. Concerns have been raised about possible biases in the study by Wakefield, and 10 of the coauthors of the 1998 article have published a formal retraction of the article’s conclusions. A review by the Institute of Medicine in 2004 concluded that the evidence indicates that MMR vaccine does not cause autism.

In early 2000, concerns were raised that thimerosal, a mercury-based preservative that had been used in some childhood vaccines, could cause autism. Numerous studies have found no association between thimerosal exposure and autism. Since thimerosal was removed from all U.S. childhood vaccines by 2002 (with the exception of the flu vaccine), we have not seen a decline in children being identified with autism, indicating that thimerosal is unlikely to be related to autism.

The CDC supports research to better understand the causes of autism and to develop more effective treatments. Early intervention is critical and research is our best hope for understanding the causes of autism. Through collaborations with partners in government, research centers, and the public, CDC is focusing on three areas: 1) understanding the frequency and trends of autism spectrum disorders, 2) advancing research in the search for causes and 3) improving early detection and diagnosis.

CDC places a high priority on vaccine safety and the integrity and credibility of our vaccine safety research. CDC, along with other federal agencies, is committed to assuring the safety of vaccines through rigorous pre-licensure trials and post-licensure monitoring. This commitment not only stems from our scientific and medical dedication, it is also personal–for most of us who work at CDC are also parents and grandparents. We too, are concerned about the health and safety of children.

Frank Destefano, M.D., M.P.H. Edwin Trevathan, M.D., M.P.H.
Director Director

Immunization Safety Office, CDC National Center on Birth Defects
& Developmental Disabilities, CDC

Again, unlike Dr. Healy, the CDC makes definitive statements. On statement I am surprised I haven’t read people pointing out the “burden” statement.

I also am surprised I haven’t heard people jump on some other statements. Specifically, “understanding the frequency and trends of autism spectrum disorders”. That’s a perfect opening for people to claim that the CDC believes there could be a vaccine-caused epidemic of autism.

Most people tend to just equate the idea of the autism rate increasing with vaccines and or mercury. So, if anyone were to say, “so-and-so thinks the autism rate may be increasing”, they usually are trying to imply, “so-and-so thinks that vaccines cause autism”.

Well, guess what, the CDC does think it is possible that the autism rate is increasing. That’s why they are monitoring the autism rate.

But, bringing this back to Dr. Healy. I am on the one hand pleased that she didn’t make her false statements about the IOM or other unfounded comments. On the other hand, I would hope that if MSNBC thought it valuable to interview her, they would have found it valuable to get her to actually say something concrete.

It is interesting to look at the blog post on the Age of Autism blog about this. They show the video, with no commentary other than the title: “Dr. Bernadine Healy Implies Hubris on Part of Docs Who Deny Vaccine Autism Possibility”.

Even they couldn’t pull a concrete conclusion out of this interview. The strongest statement they are left with is “implies hubris”.

If AoA can’t spin this interview into a strong statement, it’s pretty clearly a fairly empty interview.

Autism Omnibus: Hazelhurst appeal denied

29 Jul

The Autism Omnibus Proceedings is, for better or worse, one of the big stories in the world of autism news. Hearings have been held, using the best science and arguments that could be brought to bear. The two theories were (1) does MMR cause autism and (2) does thimerosal cause autism.

Each theory was tested using three “test cases”. Essentially, three trials for each theory, each discussing an individual child plus arguments on “general causation”.

So far, the decisions are only in on the MMR question. The answers were clear and decisive: “this is not a close case”.

The Omnibus decisions are not the end of the vaccine/autism lawsuits. Not by a longshot. The first step was an appeal, and the first appeal has been decided.

Here is the conclusion of the Judge who heard the appeal for the Hazelhurst case:

In hearing this appeal, the court is not without sympathy for Yates, the Hazlehursts, and the other children and families dealing with autism and autism spectrum disorders. And this court, like the special master, acknowledges both the burdens many of these families have faced and the tremendous love and support they have shown their children. The facts, however, do not support petitioners’ appeal and we have no choice but to deny their motion. Accordingly, for the reasons set forth above, the special master’s decision of February 12, 2009, is AFFIRMED.

I.e. the appeal failed. The decision stands. The Court holds that MMR does not cause autism.

The judge’s decision in the appeal gives a good summary of the original case. If you want to read about the Hazelhurst case, it would be the first place I would send you.

From the appeals judge’s ruling, here are the two “cardinal” flaws in the petitioner’s case:

1) First, the special master explained that petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus rather than on the characteristics of vaccine-strain measles, despite the fact that the measles vaccine is distinguishable from the wild-type measles virus in several key respects.

2) Second, the special master observed that petitioners’ experts further based their opinions on studies (detecting the presence of the measles virus in the gut tissue of autistic children) that the special master found to be unreliable.

The special master considered the presence of the measles virus in the gut to be the “linchpin” of the petitioner’s case. In other words, they needed to show reliable data or studies demonstrating that the virus was still in the tissues of the children long after the vaccination.
The two studies they had to rely on were (a) that by Dr. Wakefield’s team and (b) an unpublished study by Dr. Stephen Walker, presented as a poster at the 2006 IMFAR conference. Well, the Wakefield study was pretty well discredited, and the Walker study was never published.

In the appeal, the Hazelhurst’s lawyer argued that the testimony of Dr. Stephen Bustin should not have been considered. Amongst the arguments were that some of the information was submitted at the last minute.

No arguments were made that Dr. Bustin was wrong in his analysis of the O’Leary laboratory. That was one of those strange moments in law–no one challenged Dr. Bustin on being right. The judge hearing the appeal noted that the rules for the Vaccine Court are different from a typical court of law. Specifially, the rules are designed specifically to allow more information in to inform the Special Master. The judge further noted that under the typical rules of evidence, the Walker study would never be admitted anyway.

If you haven’t read about Dr. Bustin’s testimony, you should consider it now. Dr. Bustin basically discredited the entire “persistent measles in the gut” idea by showing that the O’Leary laboratory that made tests had serious methodological flaws and, basically, couldn’t make the tests at all.

The Hazelhurst’s lawyer then argued that the Special Master failed to include all the relevant evidence., In specific, that the Walker study wasn’t given due weight.

Again, one of those strange moments in law. The laywers moved directly from trying to get the Special Master to exclude evidence that was clearly relevant, to claiming that the Special Master had to include all relevant evidence. I guess that’s why I am not a lawyer. I couldn’t pull that off with a straight face.

As it turns out, even the witness for the Hazelhurts’ side stated that the Walker study wasn’t reliable:

Respondent additionally notes that Dr. Hepner herself acknowledged that the preliminary data from the study was “not useful at this time” (Cedillo Tr. at 682), declined to draw any conclusions about the biological significance of the Walker group’s findings (Cedillo Tr. at 682), and identified what respondent describes as several significant drawbacks to the study, including that the experiments had not been “blinded”28 and had lacked negative controls.

So, it is rather moot as to whether the Walker study was considered, since it doesn’t really provide substantial evidence to support the MMR theory.

The third main argument used in the appeal was that the Special Master failed to decide on a “critical issue”. Namely, whether regressive autism exists as a separate phenotype.

The Special Master wrote in his decision, and the appeals judge agreed: since the decision held that MMR doesn’t cause autism, there was no point in deciding on the question of regressive autism as a separate phenotype.

Given that the expert testimony was against this idea, it is probably better for the petetioners that this question was left unanswered.

The main result is, of course, the original decision was upheld. Looking forward, it doesn’t look good for the MMR theory to win in civil litigation from my perspective. The Bustin testimony is very damning to the little evidence there is, and that will be allowed in a civil case. The Walker study, however, will almost certainly not be allowed as it is unpublished and has severe limitation

Autism and Gastrointestinal symptoms: two new studies

28 Jul

Autism and poop. You hear those two words in the same sentence a lot on the net. People have been asking for studies on whether autistics have a higher incidence of gastrointestinal (GI) problems for a long time. Well, two papers came out in the last week with answers…and many parents are not happy.

The two papers are:


The early stool patterns of young children with autistic spectrum disorder

by B Sandhu, C Steer, J Golding, A Emond of the University of Bristol

and

Incidence of Gastrointestinal Symptoms in Children With Autism: A
Population-Based Study

by Samar H. Ibrahim of the Mayo Clinic.

The Bristol group’s study came out last week. Given that the Mayo Clinic study was on the way, I figured I’d wait and blog them both at the same time. Actually, I considered not blogging them at all. These papers are more nails in the coffin for Andrew Wakefield’s hypothesis that MMR causes “autistic enterocolitis” and the belief by many that this drove much of the “autism epidemic”. But, tired as that story is, the question of whether autistics have GI problems at a higher rate is important and worth discussing.

The Bristol study has free pdf access. Not so the Mayo Clinic study: abstract only, but I have a copy. Rather than go through the studies in detail (if you are that interested you will likely read the paper for yourself), let’s just look at the results and conclusions sections of the abstracts:

Bristol group:

Results: Comparison of the ASD and control group during the first 3.5 years of life showed no major differences in stool colour or consistency, or in frequency of diarrhoea, constipation, bloody stools or abdominal pain. The ASD children had similar stool frequency up to 18 months, but there was a trend for ASD children to pass more stools at 30 months (OR 3.73, 95% CI 1.11 to 12.6; p=0.004) and at 42 months (OR 6.46, 95% CI 1.83 to 22.7; p,0.001), although only three children passed more than 4 stools/day. Repeating the analysis on only those cases diagnosed as having classical childhood autism resulted in very similar findings.

Conclusions: During the first 42 months of life, ASD children had a stool pattern that was very similar to that of other children, apart from a slight increase in stool frequency at 30 and 42 months. There were no symptoms to support the hypothesis that ASD children had enterocolitis.

Mayo Clinic:

RESULTS: Subjects were followed to median ages of 18.2 (case subjects) and 18.7 (control subjects) years. Significant differences between autism case and control subjects were identified in the cumulative incidence of constipation (33.9% vs 17.6%) and feeding issues/food selectivity (24.5% vs 16.1). No significant associations were found between autism case status and overall incidence of gastrointestinal symptoms or any other gastrointestinal symptom category.

CONCLUSIONS: As constipation and feeding issues/food selectivity often have a behavioral etiology, data suggest that a neurobehavioral rather than a primary organic gastrointestinal etiology may account for the higher incidence of these gastrointestinal symptoms in children with autism.

Or, to put in a single sentence: there is no evidence that children with autism have GI problems at a greater rate than the general public.

How about repeating that with emphasis: there is no evidence that children with autism have GI problems at a greater rate than the general public. They are not saying that there are no children with autism and GI issues. Quite the contrary. You wouldn’t know that to read some comments on the internet about these studies.

I’m a little surprised by these results. No, I don’t think that Wakefield was right. But, I wouldn’t be surprised if children with autism have other medical concerns at higher rates. Also, there were two abstracts from IMFAR 2008 that stuck in the back of my mind.

In the first, a team from the University of Connecticut presented a study suggesting that GI issues may be more common in children with children with ASD’s (but at a similar rate to children with other developmental delays).

No evidence for higher rates of gastrointestinal problems in young children with ASDs versus those with other developmental delays

Conclusions: In this sample of young community-based children with ASDs and other developmental delays, no significant group differences in parentally reported feeding problems and gastrointestinal symptoms were found at age two or at age four. Most published research has been conducted at specialty GI or DD/ASD clinics with older children. The results of this study suggest that their findings may not be applicable to young children or to children evaluated in community settings. While GI problems may be increased in children with developmental disorders, we found no evidence that they were specific to autism spectrum disorders.

The second abstract (which later became a paper that was discussed on this blog): David Mandell’s group presented a paper suggesting that a significant fraction of adults hospitalized with schizophrenia diagnoses might actually have autism:

Evidence of autism in a psychiatrically hospitalized sample

Their IMFAR presentation (and later published paper) showed an increased number of GI problems in their adult group. 36% of their adults had GI problems vs. 23% of the general psychiatric hospital population.

Unfortunately, these latest studies are getting the usual “online-autism-parents” community welcome. It follows the same pattern as vaccine/autism research:

a) Ask for studies to be done
b) Studies are done
c) Disagree with the data
d) try to slime the authors

Is it a surprise to anyone that some researchers have opted out of working on autism?

(note: minor edits were made shortly after publishing this article)

Brian Deer talks back to Andrew Wakefield

7 Jul

I was copied in to the following:

Date: Mon, 06 Jul 2009 18:12:00 +0100
To: “Joanna Bower”
From: Brian Deer
Cc: Thoughtful House

Ms Joanne Bower,
RadcliffesLeBrasseur LLP

Dear Ms Bower,

Your client, Dr Andrew Wakefield, has published, and caused to be published, on his website, thoughtfulhouse.org, and on other sites, false claims that the Press Complaints Commission has issued an “interim order” concerning my investigation into his conduct. Dr Wakefield claims that The Sunday Times has been ordered by the PCC to remove my stories about him from its website.

I understand that the PCC has written to your client to point out that these claims are untrue. In fact, all of my stories concerning him are available at the Times Online website.

thoughtfulhouse.org is unquestionably controlled by Dr Wakefield, and his publication there has caused similar untruths to be published on websites either directly controlled for his interests, such as cryshame.org, which, as you may know was set up by Mrs Isabella Thomas, the parent of two of the children anonymised in the now-infamous Lancet MMR paper, or indirectly controlled for his interests, such as ageofautism.com, operated to promote and profit from concern over children’s vaccines.

It is, of course, nothing new for Dr Wakefield to mislead the public, and especially the parents of autistic children. He has faced the longest ever proceedings before a General Medical Council fitness to practise panel, following the GMC’s reinvestigation of my journalism. In due course, I’d expect he will face a hearing of the PCC, covering much of the same ground on a significantly different evidential base.

However, you may feel it advisable to explain to your client that either he accepts the untruth of his latest claims and takes them down, or he maintains them in publication, in which case his conduct would not merely be wrong, but would be dishonest.

With best wishes,

Brian Deer

http://briandeer.com

Wakefield’s false claims backfire

6 Jul

Last week Andrew Wakefield announced to the world that the Press Complaints Commission (PCC) had ordered the Sunday Times to take down some articles about him from its website. Wakefield suggested that this was a tacit admission by the Times that its story was inaccurate and this message was dutifully repeated by Age of Autism and the rest of Wakefield’s online supporters.

As I reported previously, the PCC is waiting on the final outcome of the GMC disciplinary hearing against Wakefield before conducting its own inquiry over the articles and felt it would be fairer all round if the material was temporarily removed from the Times website. The Times agreed and removed the articles as a courtesy to the PCC. The Times was not impressed by Wakefield’s ungracious response and as a result the material is now back on their website.

This is not the first time that Wakefield’s actions have backfired on him. Four years ago he tried to sue Channel 4 and Brian Deer for libel over a documentary, MMR: What they didn’t tell you, that contained damaging revelations about Wakefield’s role in the MMR scare. As with his current complaint to the PCC and his recent press release, Wakefield’s action in bringing the case seems to have been motivated by a desire to please his loyal supporters rather than a serious attempt to settle the issue. Unusually for a litigant, Wakefield showed a marked reluctance to clear his name in court, seeking to delay the hearings for two years. When the court decided that Deer and his legal team were entitled to see the unredacted medical records of the children who were the subjects of Wakefield’s original Lancet paper Wakefield withdrew the action and agreed to pay costs to Brian Deer.

It is ironic that without the libel action by Wakefield it is unlikely that Deer would have been granted access to the medical records. And without the records he would not have sat through months of the GMC and so written the story that Wakefield is now complaining about.

According to Brian Deer (private communication, quoted with permission)

There’s also the irony that it was Wakefield who in February 2004 called for a GMC investigation into my allegations that he had a conflict of interest over his research for lawyers, and no proper ethical cover, prompting me to hand over all my materials to the GMC’s lawyers, producing the longest doctor’s discplinary hearing ever.

I understand that the Press Complaints Commission has written to Dr Wakefield about the claims on his website, and he’s now in a tricky position. Either he admits that was he says is untrue, and takes down his claims, or he leaves them up in circumstances which would then be both dishonest and actionable.

I expect Wakefield to withdraw his complaint to the PCC once the GMC deliver their verdict. He will claim that it is impossible for him to get a fair hearing in the UK. It may suit him to continue to play the martyr from his self-imposed exile in America while enjoying the adulation that befits a “brave maverick doctor.” But he is and will remain the author of his own misfortune.

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