Monday, March 8, 2010

Olmstead's Dishonest Essay: Wakefield Inquisition Case Series Insanity

The panel deciding Wakefield's Fitness to Practice   a UK medical doctor defined dishonesty (FTP page 48) as conduct that "would be considered by ordinary standards of reasonable and honest people to be dishonest."  By that standard, Dan Olmsted, author of  The Wakefield Inquisition Case Series Insanity March 5, 2010 is dishonest.  It cannot be ignorance because Olmstead criticizes those writing about the Lancet's complete retraction of Wakefield's 1998 paper who are not  "familiar with three things: Wakefield’s original paper; the General Medical Council ruling from the week before that found his ethical behavior “dishonest,” and The Lancet retraction of the paper itself that quickly followed."

Here is the statement from the Lancet:
Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation [the farcical investigation by the Lancet in 2004]. In particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record." 
Like Olmstead, this essay does not discuss the ethics issues except to note that Bill Long has been having second thoughts regarding Wakefield's ethics.


Olmstead's essay shows that the statement that the children were consecutively referred is factually correct.  However, that is not an answer to the question with which Olmstead begins: "What, exactly, did Dr. Andrew Wakefield do wrong?"  Olmstead then romps for hundreds of words in a series of straw man and red herring arguments.  Olmstead implicitly argues that Wakefield has done nothing wrong. Why? Because if you look at the words closely enough and squint your eyes, they are pedantically true. An interesting idea, but Wakefield himself disagrees.  He admitted (stipulated)

 "..[As] one of the senior authors of the Lancet paper, you knew or ought to have known the importance of
accurately and honestly describing the patient population." (FTP page 43)
Wakefield's fitness to practice is being called into question because of concerns that he may have "behaved dishonestly, fraudulently or in a way designed to mislead or harm others."  Doctors are required to behave better than the man in the street or the proverbial used car salesman,  The panel defined dishonest as conduct that "would be considered by ordinary standards of reasonable and honest people to be dishonest." (FTP page 48)  Additionally, it must be judged, beyond a reasonable doubt, to be "intentional and deliberate." (FTP page 106)   How strong was the evidence against Wakefield?   Very strong, because for an allegation to be proved against Wakefield, the panel had to be convinced beyond a reasonable doubt. (FTP page 2)


Medical Research  Is Defined by the Intention of  the Doctor to Generalize Knowledge
Before going further, it is necessary to dispose of a falsehood.  For years, Wakefield and his supporters have argued that clinically indicated medical procedures and tests were not medical research.  They say the only bit of the Lancet paper that was research was doing additional laboratory studies and that was covered by Waker-Smith's permission from the Ethics Committee to take additional biopsies from any colonoscopy and use them for unspecified research purposes (162-95).  So the Ethics Committee approval in January 1997 wasn't for medical research that became the Lancet paper, it was for something else. The panel explicitly rejected the 162-95 argument.

Medical research is identified by the intent of the doctor to create new, generalizable information. The classic example is systematically studying patients to gather new information and perhaps publish it or present it. Sound familiar?  That was what Wakefield, Walker-Smith and Murch were planning and undertook. These were medical academics, they write papers and presentations. What they were doing was medical research. It did not matter if the tests and procedures were routine and clinically indicated. The  generalizable information gathered by Wakefield, Walker-Smith and Murch was presented in the 1998 paper.   It does not matter if the paper is a case-study or a randomized drug trial. Why base the definition on intent?  Because it identifies when a conflict of interest can arise between the obligation of a doctor to treat the patient and the obligation to gather and produce information for the paper or presentation.

Obviously, the 12 children were seen at the Royal Free hospital as part of a systematic program to develop new knowledge.

Olmstead is correct when he says that a case study with 12 children is perfectly acceptable medical research, that controls are not  needed,  that randomization is not necessary and the subjects can be selected by the researcher. Members of the media and others who thought otherwise were wrong.  But it is a red herring because the Ethics Committee approved the research project without controls and this was not an issue before the GMC panel.  Wakefield can select the children for his study however he wants, he just has to include accurate information explaining the selection process in the paper. Below you can see why Wakefield didn't want to be honest.

What did Wakefield do Wrong?

Before the formal allegations were issued against Wakefield, he had the opportunity to admit to certain allegations. In legal language, this is a stipulation.   On page 43, Wakefield admitted that:

"The Lancet paper purported to identify associated gastrointestinal disease and developmental regression in a group of previously normal children which was generally associated in time with possible environmental triggers which were identified by their parents in eight cases with the child’s MMR vaccination You  [Wakefield] knew or ought to have known that your reporting in the Lancet paper of a temporal link between the syndrome you described and the MMR vaccination [would have] .. "major public health implications" and "would attract intense public and media interest."


"..[As] one of the senior authors of the Lancet paper, you knew or ought to have known the importance of
accurately and honestly describing the patient population."
Wakefield didn't admit but it was found proved that Wakefield "had a duty to ensure that the factual information in the paper and provided by you in response to queries about it was true and accurate."  Part of the evidence for this finding was: "In evidence, you accepted that when providing information in response to queries about the contents of the paper you had a duty to ensure that such information was true and accurate."   page 44

Did not state that this was a research project

32.  a.   You failed to state in the Lancet paper that the children whose referral and histories you described were part of a research study project, the purpose of which was to investigate a postulated new syndrome comprising gastrointestinal symptoms and disintegrative disorder following vaccination.  Found proved on the basis that the children who were described in the paper were admitted under a programme of investigations for Project 172-96  for research purposes.  page 44


b.  Your conduct as set out at paragraph 32.a. was dishonest, irresponsible and "resulted in a misleading description of the patient population in the Lancet paper " page 44  

The Children were not routine referrals to Department of Paediatric Gastroenterology

The Lancet paper stated that the children who were the subject of the paper were
 “consecutively referred to the department of paediatric gastroenterology with a history of a pervasive developmental disorder with loss of acquired skills and intestinal symptoms (diarrhoea, abdominal pain, bloating and food intolerance)” and subsequently described them as a “self referred” group,  page 45


You knew or ought to have known that such a description implied,  a routine referral to the gastroenterology department in relation to symptoms which included gastrointestinal symptoms and a routine process in which the investigators had playedno active part;Found proved  page 45

The GMC panel found, beyond a reasonable doubt, that because
  • 34a. Child 1, Child 5, Child 9 and Child 10 were not routine referrals to the department of paediatric gastroenterology.
  • 34b  Child 2, Child 9, Child 5 and Child12 "included active involvement in the referral process by you.",  page 46
the statement that the 12 children were "consecutively referred to the department of paediatric gastroenterology" and "self referred"  was irresponsible, misleading and and contrary to Wakefield's duty to be accurate.

 "."[Wakefield wrote] in the Lancet volume 351 dated 2 May 1998, in response to the suggestion of previous correspondents that there was biased selection of patients in the Lancet article, [stating] that the children had all been referred through the normal channels (e.g. from general practitioner, child psychiatrist or community paediatrician) on the merits of their symptoms page" page 47

On 23 March 1998 at a scientific meeting at the Medical Research Council convened to examine the evidence relating to measles or measles vaccine and chronic intestinal inflammation, you [Wakefiield] were asked about the issue of bias in generating the series of cases including the twelve children in the Lancet paper and you stated that all patients reviewed so far had come through General Practitioners or paediatricians by “the standard route” page 48


The GMC panel found, beyond a reasonable doubt, that in "the circumstances set out in paragraphs 32.a., 34.a. and 34.b." Wakefield's conduct in responding to the letter to the Lancet and at the scientific meeting was dishonest, misleading and contrary to his duty to be accurate"  page 47-4

Judging the Lancet Retraction

With this background from the decision of the GMC panel, now look again 2010 restraction statement of  The Lancet.
In particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false.
Is the Lancet statement slightly cryptic?  Yes.  Is it correct?  Yes, when you understand it is shorthand for  "While that statement that  children were consecutively referred may be pedantically correct, it was dishonest, misleading and  contrary to the authors' obligation to be accurate."

Olmstead writes;
So, again, what exactly did Wakefield do wrong? We fail to see a problem here. The paper as published meets every test of transparency we can imagine – including the comment that the self-referrals by the parents raised the risk of a chance pattern. To reel in horror 12 years later over a non-randomized, cherry-picked, biased report that might have been due to chance – well, it makes you want to puke.

Olmstead makes me want to puke. 

Olmstead writes :
The Lancet’s retraction and the media’s reporting thus convinced everyone that, entirely aside from the alleged ethical wrongs, the science underlying the report was fatally flawed. If only the report had been a book, we could burn it.

An Honest Paper

If Wakefield had authored an honest paper, he would not be about to lose his medical license in the UK.  Here is what an honest paper should have stated:

Aims

" A New Paediatric Syndrome: Enteritis and Disintegrative Disorder Following Measles/Rubella Vaccination We [Wakefield, Walker-Smith and Murch tested] the hypothesis that in genetically susceptible children [page 2], measles vaccination is associated with persistent enteric (and possibly CNS) infection, enteritis and malabsorption of vitamin B12.  In the rapidly myellinating brain, which is particularly susceptible to vitamin B12 deficiency, the latter predisposes to encephalopathy...

Material and Methods

Children, referred either by their GP, or via the vitamin B12 unit at the Chelsea and Westminster Hospital, who manifest disintegrative disorder and symptoms and signs of intestinal disease will be admitted to Malcolm ward for a period of one week."

We included in the paper children:
  • who did not have Measles/Reubella vaccination.  All children had MMR vaccination.
  • who have ASD symptoms  (or something similar) but not necessarily Disintegrative Disorder
  • who are part of, or are interested in a lawsuit against MMR vaccine makers,
  • have parents who (8 of 12)   state their child was normal before the  MMR vaccination
  • have GI complaints but may not meet the standard for having a colonoscopy
  • were not to be enrolled in the study as they had been tested prior to December 18, 1996 (page 9)
  • cut off the number at 12, even though children were continuing to be seen prior to publications and the results weren't as strong. See here and here
  • we have nothing to say about genetically sensitive childre even though it was part of our objectives
We put them through an intensive series of tests, including a colonoscopy and for some a lumbar puncture. Using blood, intestinal biopsies and spinal tap fluid, we looked  for measles vaccine virus RNA.  We report that measles vaccine virus RNA has not been found in biopsies, spinal tap fluid or blood.  Select item QQ from here for affidavit.  Nick Chadwick testimony is here.

We found  Ileal-lymphoid-nodular hyperplasia in many of the children.  We note that LNH is considered to be non-pathalogical and found in many children undergoing colonoscopies who are constipated.

If Wakefield had written an honest paper, he would not have faced an FTP hearing for allegations regarding the Lancet paper. However, the Lancet would not have published the paper.  And the rate of MMR vaccination would not have dropped and children would not have died in the UK and Ireland.

 And Dan Olmsted would not have written a dishonest essay.

8 comments:

  1. Sheldon is a dumb piece of dog shit.

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  2. You'll only get abuse for this. Pointing to factual material only every produces this response from the Wakefield crowd.

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  3. Last time I got very interested in a topic on the internet, I got a lovely email telling me, that come the revolution I would be hung as a traitor to the Constitution of the United States of America. I explained why that couldn't happen, legally, as I wasn't a citizen of the United States of America.

    I thought it was funny. Years later, the email writer died in shootout with police.

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  4. Possibly the best written piece I have read on this.I don't recall Wakefield ever mentioning anything about B12 malabsorption.Could you show me where?

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  5. The source is in the paragraph. It is the protocol and pro forma submission to the Ethics Committee dated August 6 1996. http://briandeer.com/mmr/royal-free-11.htm The date is shown as 6/8/96. But this is British and the date format is d/m/y.

    The quotes come from the second page of the protocol.

    ReplyDelete