Experts Reports from Omnibus Autism Proceeding

I've been interested in the experts reports at the Omnibus Autism Proceeding.  I thought they hadn't been made public. I was wrong, at least as far as the defendant's expert reports were concerned. Go to

Thanks to a 2009 posting at  Left Brain Right Brain for this information.

Of Course The Vaccine Matters - Fluzone - High Dose

It has been long overdue for me to post my correspondence with the authors of the truly ignorant  article in The Atlantic Monthly's November 2009 issue and my letters to the editor and publisher of the magazine.  The Atlantic Monthly acknowledged receipt of my letters and email correspondence and invited me to write a letter to the editor which I declined.

I've kept putting it off.  It will probably be another week or so before I finally do it.

In the meantime, one of my predictions to the editor of the Atlantic Monthly has come true.  You see, the authors went on and on about how flu vaccine didn't work in the elderly --- but didn't realize or didn't report that new vaccines that were much more effective were likely  to be available in the near future.  I mean, why get upset about a problem that may have a near term solution?

 Here's what I wrote on this issue in my November 10th letter to the editor.

Game Over for Wakefield at the Start of the GMC Hearing

--some modifications made March 27, 2010--
  Dr. Pegg's testimony  hasn't gotten enough attention.  Dr. Pegg was the chairman of the Ethics Committee at the Royal Free Hospital from 1995.

Jim Moody, the US attorney for a number of vaccines cause autism groups who supported Wakefield wrote a complaint to the UK medical authority, the GMC, making accusations against five doctors who gave testimony against Wakefield.  He did not understand why he
shouldn't mention Dr. Pegg. Because it was through his ridiculous complaint against Dr. Pegg that the fanciful two studies theory really comes apart.

Moody first sets out Wakefield's defense:

 "...[Dr.Pegg] falsely claimed that the investigation of the 12 children reported in the Paper did not have the approval of the Ethics Committee.  In fact, the children were investigated according to their clinical need and not as part of a follow-on program of scientific and clinical investigation approved by the Committee on December 18, 1996.  The one “research” aspect relevant to these children (collection of additional biopsies during colonoscopy and biopsy analysis for research purposes) had, in fact, been granted routine generic approval by the Committee on September 5, 1995 (project 162-95)."  

.  I've discussed that before.

Much of the hearing was decided when Dr. Pegg finished testified.  The key to understanding the GMC decision are a few words by Dr. Pegg, reported, probably by accident, by Martin Walker.

Walker wrote the following:

A second key matter on which the defence was eager for commitment from Dr Pegg was whether a ‘case study’ - that is a clinical report of one or more similar cases – did or did not need ethical committee approval. On this matter, Pegg was hardly helpful to anyone. If the doctor concerned knew from the beginning of a case that he was going to write it up, then he needed ethical approval. If he did not initially intend writing up the case but did anyway, then he didn’t.[emphasis added]  This was a ridiculous explanation and one suspects it was made up on the hoof. What he probably meant to say, was that if individual children were examined for the sake of a scientific study then the doctor concerned needed ethical committee approval. If, however, all the children were seen on the basis of clinical need and at some point a number of the cases were written up, no ethical committee approval was needed.

Actually, Dr. Pegg said exactly what he meant to say. The standard way of determining if it is research is to look to the intent.

Why Clinically Indicated Treatment Can Still Be Research

 This blog entry is incorrect because it ignores that the only issue that matters was whether the 3 doctors intended to create some new generatized knowledge.   The concept of 'clinically indicated' has nothing to do with  the determination of what is and what is not medical research.


See:http://vaccineswork.blogspot.com/2010/02/game-over-for-wakefield-at-start-of-gmc.html


The rules for medical research are not based on what parents or patients want. Many people with diseases and conditions would gladly take part in medical research if they could. But that, for reasons you can look up, doesn't govern what can be done in medical research. The BMC panel sets out the rules that apply to children in one sentence. "in the guidance of the British Paediatric Association in relation to children (RCP, 1990) that if research is of no therapeutic benefit then it can be of no more than minimal risk." Anything beyond a simple blood test isn't going to qualify.

So what is research:

"The distinction between medical research and innovative medical practice derives from the intent. In medical practice the sole intention is to benefit the individual patient consulting the clinician, not to gain knowledge of general benefit, though such knowledge may emerge from the clinical experience gained. In medical research the primary intention is to advance knowledge so that patients in general may benefit: the individual patient may or may not benefit directly." 
An August 1996 explanation

This document goes into greater detail and makes clear that "clinically indicated" does not mean that the practice or practices aren't research. http://www.sahealthinfo.org/ethics/ethicspolicy.htm

The program that the children underwent was designed to advance knowledge so that patients in general may benefit-- they were looking for a new bowel condition by examining a series of children. That is research. That needs explicit ethics committee approval even if it is, in the minds of the doctors, clinically indicated.

There was only one ethics committee approval for the program they were carrying out on children. That was 172-96. The panel found that all the children in The Lancet study were part of a research project.

The Value of Censorship

The anti-vaccination movement seek to censor those who disagree with them, by arguing that it is wrong to criticize  parents who say vaccines damaged their child.

What is wrong with doing that? Those parents don't mind criticizing anyone who disagrees with their views, including parents who do vaccinate their children.

The reason anti-vaccination hate to see the parents criticized is because the believe the parents story (Jenny McCarthy's favorite reason) is central to the success of their movement.

For the record, my criticism is that the parents have nothing to say. At best, they accurately observed a change of behavior after vaccination. That's all. Separately, they have to decide the meaning to give to the observations. Some parents choose to blame vaccination, others do not.

Misleading Research at Autism Insights

Misleading at Best
-----------------------
Autism Insights under a Editorial banner published Is There a Relationship Between Autisism and Gastrointestinal Disease?   This is research, not an editorial and the answer from the research presented is no.  Autism Insights is Wakefield's own peer-reviewed journal.

But that isn't what the abstract says:
--abstract start--
Abstract: Is gastrointestinal disease more prevalent in children with autism? There are arguments favoring both sides of the controversy. We present data collected from the medical history of a recent Autistic Genetic Resource Exchange (AGRE) database of autistic children and their siblings, demonstrating that autistic children may be significantly more susceptible to overall GI disease, as well as chronic diarrhea and constipation specifically [emphasis added]. Many autistic children have GI disease, however, whether this disease is significantly increased in children with autism is still being debated
-- abstract end--

Obviously, this is research. There is no IRB (Ethics) statement, which is surprising.  The first author A. J. Russo is, just like Krigsman with his paper, on the editorial board of Autism Insights. Except that Russo is editor-in-chief.

The paper is based on a download of the AGRE database and compared autistic children and their non-autistic siblings for reports of GI symptoms.  STOP.  As anyone who has followed the Wakefield follies should know, GI symptoms are not GI disease. The relevant diseases causing causing chronic diarrhea or constipation are the Inflammatory Bowel Diseases (IBD) namely Crohn's disease, ulcerative colitis and perhaps Irritable Bowel Syndrome (IBS - described in error as Inflammatory Bowel Syndrome).  Chronic diarrhea or constipation are not GI diseases.  To be kind, we'll add in any reports of autistic enterocolitis, the disease invented by Wakefield and refuted by experts.

A quick look at the chart shows:  0 cases of IBD in either group. No cases of autistic enterocolitis reported. And no significant difference in IBS. So to the question, Is There a Relationship Between Autisism and Gastrointestinal Disease?  The answer to the question asked by the title is, NO, at least by this research paper.

But now we see some fancy footwork.  Because the chart and the abstract move from  GI disease to comparing GI disease plus chronic diarrhea and constipation compared to non-autistic sibling controls. And find autistic children have a significantly higher percentage of chronic diarrhea and constipation.  That is no surprise.

If anything, this paper rejects Wakefield and Krigsman's views. It support the view of experts that children with ASD do not have higher rates of GI diseases. 

Wakefield, Walker-Smith and Murch Will Be Erased from the Register

I predict all three will be struck off (no longer able to practice in the UK).  It hasn't been obvious because the panel never provided an overview.  Here's a really short succinct version.

Even though the 1998 Lancet paper states, "Up to January 28 [1998], a further 40 patients have been assessed; 39 with the syndrome." , the charges against the three doctors are limited to the 12 children discussed in the paper.

This is a conspiracy by three doctors with teaching appointments at one of our medical schools. They planned and carried out from the the spring of 1996 into 1997 (for the 12 children)  a research project on children in distress that required the children to undergo a  week or more intensive "high risk" procedures and tests that they knew, for most of the children, were not  clinically indicated and which were of no therapeutic benefit to the children. This conspiracy required them to repeatedly lie to their colleagues and the governing Ethics Committee.

This was a terrible violation of the children and goes  basic ethical standards for any research on patients, let alone children in distress.  When it is done by three doctors who taught students in a medical school it is especially horrendous.

The General Medical Council which currently (2010) governs UK doctors, has written a number of ethics guidance documents. The guidelines for research document is dated 2002.

The GMC used a three step process; an investigative process, a fact finding process and a sanctions (sentencing) process. For Sanctions Information start here and select  Indicative Sanctions Guidance for the Fitness to Practise Panel April 2009and read Erasure starting on page 22.

All three should be easily erased from the register.

Minor modifications and clarifications April 1, 2010.

162-95 In One Paragraph OR Sinking The Conspiracy

 
162-95 Explained in one Paragraph or
Sinking The Three Doctors
-----------------------------------

 This blog entry is incorrect because it ignores that the only issue that matters was whether the 3 doctors intended to create some new generatized knowledge.   The concept of 'clinically indicated' has nothing to do with  the determination of what is and what is not medical research.   162-95 was never relevant at all to the determination of what was research.



See:http://vaccineswork.blogspot.com/2010/02/game-over-for-wakefield-at-start-of-gmc.html
The GMC panel, which didn't provide a decent overview, at least said the following on page 3.

"The Panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet 12 children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95. In the light of all the available evidence, the Panel rejected this proposition. "

ONE PARAGRAPH
At the time, gastroenterologists at teaching hospitals such as The Royal Free often took extra biopsies (tiny bites) for research purposes from the intestines of patients they did colonoscopies on.  You didn't need Ethics Committee approval.  And you may not have needed permission from the patient or parent.  Professor Walker-Smith moves from St.Barts hospital to the Royal Free in 1995. In August, he writes the Ethics Committee asking  if he can follow his practice at St. Barts of  taking 2 extra biopsies for  "various research" purposes. He includes a copy of the information sheet sheet he gives to patients. Two weeks later, the Chairman of the Committee writes back and says that's fine, go ahead now, we'll formally approve it our next meeting. And if you need to write us again about this, please  include the identification  number 162-95.

THE LONGER VERSION

Dr. Bill Long agrees that if the doctors can't rely on 162-95, the case against them is much stronger.