U.K. General Medical Council Rules Wakefield & Co. "Dishonest," "Irresponsible" · 2010-01-28 15:25

Today, the General Medical Council (GMC), which registers doctors to practice medicine in the U.K., issued a decision in its inquiry into the professional conduct of Dr. Andrew Wakefield and his colleagues Dr. John Walker-Smith, and Dr. Simon Murch, co-authors of a study which concluded that a causal connection exists between the measles-mumps-rubella vaccine and autism.

The GMC determined that the three doctors failed to act in the best interests of the autistic children under their care, that Dr. Wakefield was dishonest, misleading and irresponsible in his descriptions of research, and that the findings of the investigation “would not be insufficient to support a finding of serious professional misconduct” against all three doctors.

The study at the center of the inquiry was published in The Lancet in 1998. Six years later, ten of its thirteen co-authors retracted their conclusions in that study.

Further background can be found on the website of journalist Brian Deer, whose in-depth investigation of Wakefield and his research alleged numerous irregularities — including his failure to disclose his role in litigation against vaccine manufacturers, failure to disclose pending vaccine patents, performance of needless, invasive medical procedures on autistic children, and misrepresentation of data — and ultimately led to the disciplinary hearings.

On 7 April 2010, the GMC Disciplinary Panel will consider whether the conduct described in the decision warrants professional sanctions, including revocation of Dr. Wakefield’s, Dr. Walker-Smith’s or Dr. Murch’s license to practice medicine in the U.K. Dr. Wakefield now resides in Texas, and although not licensed to practice medicine in the United States, is the Executive Director of Thoughtful House, which provides medical care to autistic children.

The following passages are excerpted from the GMC decision.


On the responsibilities of a physician/researcher:

[A]mongst the responsibilities of a Responsible Consultant, is the requirement to conduct research within ethical constraints, and report it responsibly, accurately and fairly. At no stage should a doctor take any action that is contrary to the clinical interests of the patient involved.

On Dr. Wakefield’s, Dr. Walker-Smith’s and Dr. Murch’s authorization of hospital admission and medical procedures on children for whom they were not clinically indicated, and commencement of research for which no ethical approval had been obtained:

Child 1 underwent a colonoscopy, MRI scan of his brain, an EEG and a variety of blood and urine tests. These were some of the investigations listed in the programme of the project. He was further admitted on 23 October 1996 for further investigations regarding the “etiology of the autism”, again for no obvious clinical gastro-intestinal reasons. During this admission, Child 1 underwent a barium meal and follow-through and a lumbar puncture. These were also the investigations listed in the programme of the project. The Panel has concluded that Child 1 underwent a programme of investigations for research purposes and for which there was no Ethics Committee approval. (p. 16)

You [Dr. Murch] attempted to carry out a colonoscopy on Child 1 when such an investigation was not clinically indicated… You wrote in your colonoscopy report dated 22 July 1996 that the child’s history is “disintegrative disorder” and noted that the letter to the child’s GP from Professor Walker-Smith concluded the child had features of toddler’s diarrhoea. The Panel concluded that these were not clinical indications to undergo a colonoscopy… You attempted to carry out a colonoscopy on Child 1 when such an investigation was not clinically indicated. (pp. 120, 125)

[T]here is no evidence in Child 3’s clinical notes to indicate that a lumbar puncture was required. Experts on both sides… both considered that such a test was not clinically indicated… The Panel is persuaded by the letters written by [Dr. Walker-Smith] at the time, to Child 3’s paediatric neurologist, his school doctor and his GP, that you did conclude there was no evidence of bowel inflammation on routine blood results but nevertheless you decided to admit Child 3. In particular, the Panel noted the wording of the letter dated 18 July 1996 to the paediatric neurologist: “…the initial blood screens for bowel inflammation were negative, however Dr Wakefield is of the opinion that subtle changes in relation to inflammation may be present… and we have arranged (Child 3’s) admission”. (p. 68)

The Panel is satisfied that… you [Dr. Wakefield] exposed Child 4 to an unnecessary test. (p. 24)

You [Dr. Wakefield] ordered the neurophysiological investigations [on Child 7] without having requisite paediatric qualifications and writing an incorrect diagnosis on the investigation form. (p. 40)

Child 8 was admitted to the Royal Free Hospital on 19 January 1997, without prior outpatient assessment. (p. 37)

The Panel concluded that subjecting the child [Child JS] to a colonoscopy was not clinically indicated as his main presentation was behavioural difficulties and you [Dr. Walker-Smith] accepted his GI symptoms were “rather minor… In your evidence to the Panel you accepted that you did “lower the threshold” in relation to this child… The Panel concluded that these findings, which include those of your irresponsible conduct and not acting in the child’s best clinical interests in several instances, would not be insufficient to support a finding of serious professional misconduct. (p. 111)

On Dr. Wakefield’s taking of blood samples from guests at his son’s birthday party:

On a date unknown prior to 20 March 1999 at your son’s birthday party you… caused blood to be taken from a group of children to use for research purposes… [Y]ou showed a callous disregard for the distress and pain that you knew or ought to have known the children involved might suffer.. The Panel is satisfied by your evidence that the children were “paid for their discomfort”, which it concluded was evidence of a callous disregard. (54-55)

On Dr. Walker-Smith’s “parent-driven” testing and treatment recommendations:

The Panel was satisfied on the basis of your letter to his GP dated 21 June 1996, where you stated “…if (child 1’s mother) feels that is appropriate we could consider performing endoscopy and further assessments…” The Panel concluded that your reliance on her views that there was a link between autism and immunisation and bowel inflammation was inappropriate. (p. 67)

On Dr. Wakefield’s assertion that the definition of “conflict of interest” changed after publication of the Lancet study:

The Panel is satisfied that the concept of a conflict of interest, and the extension of this to the perception of a conflict of interest, was known in the scientific community in 1997. At that time the Lancet and other organisations had published guidance on the requirement for authors for recognising and declaring financial and other conflicts of interests, as well as the importance of declaring “potential”, “perceived” or “apparent” conflicts of interest. The Panel therefore rejects the proposition put forward by your Counsel that third party perceived conflicts of interest did not fall within the relevant definition at the time. (p. 44)

On Dr. Wakefield’s failure to disclose relevant information about the purpose and subjects of the Lancet study:

[T]he project reported in the Lancet paper was established with the purpose to investigate a postulated new syndrome and yet the Lancet paper did not describe this fact at all. Because you drafted and wrote the final version of the paper, and omitted correct information about the purpose of the study or the patient population, the Panel is satisfied that your conduct was irresponsible and dishonest. (p. 45)

On Dr. Wakefield’s assertion that his autistic subjects were “routine referrals” for whom invasive testing was medically indicated:

Having regard to its findings in relation to Child 1, 9, 5 and 10, namely that these children were admitted to undergo a programme of investigations for research purposes, and that they all lacked a history of gastrointestinal symptoms, the Panel is satisfied that these referrals did not constitute routine referrals to the gastroenterology department… In reaching its decision, the Panel concluded that your description of the referral process as “routine”, when it was not, was irresponsible and misleading and contrary to your duty as a senior author. (p. 46)

On Dr. Wakefield’s response to allegations of selection bias:

The Panel is persuaded by all the correspondence in the Lancet Journal volume 351 dated 2 May 1998 regarding a suggestion by correspondents to the Lancet that there was a biased selection of patients in the Lancet Paper of 28 February 1998, of which you were one of the senior authors. The Panel has found that your [published response] does not respond fully and accurately to the queries made by correspondents to the Lancet. The Panel is satisfied that the statement you made would be considered by ordinary standards of reasonable and honest people to be dishonest. Additionally, you knew that this statement omitted necessary and relevant information, such as the active role you played in the referral process, and the fact that the referral letters in four cases made no mention of any gastrointestinal symptoms and the fact that the investigations had been carried out… for research purposes. Therefore, the Panel is satisfied that your conduct in this regard was dishonest and irresponsible. (p. 47)

On Dr. Wakefield’s failure to disclose conflicts of interest to the editors of the Lancet:

…[T]he Panel is satisfied that your conduct in failing to disclose your involvement in the MMR litigation, your receipt of funding for part of [your research] from the Legal Aid Board and your involvement in the Patent, constituted disclosable interests. Your failure to disclose these to the Editor of The Lancet was contrary to your duties as a senior author of the Lancet paper. (p. 50)

On the administration of an unlicensed drug to a study subject:

The Panel noted that Child 10’s deterioration was not assessed by any clinician prior to being administered Transfer Factor. Therefore the Panel has concluded that Child 10 was given Transfer Factor for experimental reasons… Furthermore, an essential requirement of a doctor is to share information with colleagues in the ways that best serve patients’ interests. The Panel has noted the evidence that Child 10’s GP did not have any knowledge of any prescription of Transfer Factor other than that contained in a letter from the community paediatrician. The Panel is satisfied that you [Dr. Wakefield] did not inform the GP or arrange for someone else to do so. (pp. 52-53)

The Panel is persuaded that Child 10 was administered Transfer Factor by the weekly diary card completed by his mother, submitted to the Royal Free Hospital in January 1998 which states, “over Christmas and New Year we felt very optimistic about the apparent effect of Transfer Factor… is it possible that the dose now needs to be increased?”. The Panel concluded that you [Dr. Murch] caused the child to be administered with Transfer Factor on the basis of the letter of 23 July 1997 that you and Dr Wakefield wrote to the Dispensary Manager. You informed her that “we would like to start Child 10 …on measles-specific Transfer Factor and we are prepared to take full responsibility for the outcome of this treatment. The supplies of the drug are presently in our hands (Dr Wakefield).” … The Panel is persuaded that this was experimental treatment and not given for clinical reasons, because you had not seen or assessed the child before causing him to be administered with the unlicensed drug and you stated “we do not know whether the treatment will work” in your letter to the Dispensary manager of the pharmacy, dated 23 July 1997, jointly signed by you and Dr Wakefield. (p. 100)

Conclusion re Dr. Wakefield:

The Panel concluded that these findings, which include those of dishonesty and misleading conduct, would not be insufficient to support a finding of serious professional misconduct. (p. 55)

Conclusion re Dr. Walker-Smith:

The Panel concluded that these findings, which include those of your irresponsible conduct and not acting in the child’s best clinical interests in several instances, would not be insufficient to support a finding of serious professional misconduct. (p. 111)

Conclusion re Dr. Murch:

The Panel concluded that these findings, which included Dr. Murch failing in his duty as a responsible consultant and in some cases, not acting in the best clinical interests of the children, would not be insufficient to support a finding of serious professional misconduct.

Comments


  1. Thank you for doing this part, Kathleen.

    I’m doing my usual roundup

    Andrew Wakefield: Dishonesty, Misleading Conduct, and Serious Professional Misconduct: Blog Posts Approving of Verdict; Blog Posts Critical of Verdict.

    — Liz Ditz    2010-01-28 16:50    #

  2. Now would be a good time for Keith Olbermann to apologize to Bryan Deer.

    — _Arthur    2010-01-28 17:19    #

  3. I'll say. Although I used to Olbermann's rants, I don't think I've even listened to one since his totally opportunistic, ignorant and unwarranted slam on Brian Deer.

    — Kathleen Seidel    2010-01-28 20:23    #

  4. THANK YOU for this summary of the GMC’s roasting of Wakefield. I don’t think we’ll be disappointed with the conclusions of the disciplinary panel.

    I was unaware of Olbermann’s slamming of Deer, I like him otherwise. He did an excellent full hour rant about Health Care just before New Years. But I like Rachel Maddow better.

    — Clay    2010-01-29 15:03    #

  5. There has been a theme lately that Dr Wakefield has not been discredited.

    Well, arguably that was true. Up until now it was only his research that was discredited. Now the man also is discredited.

    I hope this gives the media the information they need to stop consulting him and his followers for “balance”.

    — Sullivan    2010-02-01 18:17    #

  6. The Lancet officially withdrew the article based on the study today.

    “The medical journal which originally published the discredited research linking autism and MMR has now issued a full retraction of the paper.

    The Lancet said it now accepted claims made by the researchers were “false”.”

    - BBC News Online

    — Moonwolf    2010-02-02 18:47    #

  7. And roundup #2, on the retraction.

    http://lizditz.typepad.com/i_speak_of_dreams/2010/02/on-the-lancets-retraction-of-wakefields-1998-paper-alleging-a-connection-between-the-mmr-vaccine-and.html

    As with the first roundup, the range of responses gives me hope that the anti-vaccination, “autism can be cured” movement is becoming marginalized.

    — Liz Ditz    2010-02-04 13:23    #

  8. I presume that most of you will now be aware that another Wakefield paper has been pulled (see link on my name).

    Liz, regards your lists, I’ve written a couple of “reports” on this, but they’re really only “heads’ up” new reports. I’m pro-retraction, of course!

    — Grant    2010-02-14 04:29    #

  9. While it would be nice to find a definitive cause and cure for autism, we certainly need to be ware that medical charlatans exist too and can mislead people. This whole sorry affair has not advanced our civilization one iota.

    — Karl    2010-03-24 07:03    #