Intended for healthcare professionals

Editor's Choice

A tale of two vaccines

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4152 (Published 04 October 2018) Cite this as: BMJ 2018;363:k4152

Re: A tale of two vaccines and the "spectre of Andrew Wakefield"

The "spectre of Andrew Wakefield" certainly should not be allowed to deflect from this important issue [1,2].

I wrote to this journal in February 2010 explaining why the GMC findings against Royal Free doctors were defective [3], and no one challenged me. The Wakefield Lancet paper had nothing to do with the Legal Aid Board commissioned protocol; investigations were carried out according to clinical need; the order of referral was a red-herring - all of which anticipated the views of the High Court judge, Sir John Mitting, when exonerating the senior clinician and senior author of the paper, Prof John Walker-Smith, two years later [4]. Mitting dismissed the central contention the of the GMC prosecution that the authors of the paper were executing the Legal Aid Board sponsored protocol (172/96):

“Its conclusion that Professor Walker-Smith was guilty of serious professional misconduct in relation to the Lancet children was in part founded upon its conclusion that the investigations into them were carried out pursuant to Project 172-96. The only explanation given for that conclusion is that it was reached ‘in the light of all the available evidence’. On any view, that was an inadequate explanation of the finding. As it may also have been reached upon the basis of two fundamental errors – that Professor Walker-Smith's intention was irrelevant and that it was not necessary to determine whether he had lied to the Ethics Committee, it is a determination which cannot stand ….” [para 20]

The case that Walker-Smith was undertaking research was dismissed:

“..their case was that he was in fact undertaking research, which required Ethics Committee approval, without realising that he was doing so. This is an untenable proposition, as the analysis of the letter of 11th November 1996 above demonstrates. In consequence, not only was the panel invited by the GMC not to determine Professor Walker-Smith’s intention, it was also invited not to determine his truthfulness in his dealings with the Ethics Committee.” [Par. 18]

“It is in its findings on the clinical issues in the individual cases of the Lancet children that the most numerous and significant inadequacies and errors in the determination of the panel occur. In no individual case in which the panel made a finding adverse to Professor Walker-Smith did it address the expert evidence led for him, except to misstate it. The issues to which this evidence went were of fundamental importance to the case against him. Universal inadequacies and some errors in the panel's determination accordingly go to the heart of the case. They are not curable. Unless the remainder of the panel's findings justify its conclusion that Professor Walker-Smith was guilty of serious professional misconduct, its determination cannot stand.”

Mitting rejects the idea that there was any misrepresentation over referrals:

“This paper does not bear the meaning put upon it by the panel. The phrase “consecutively referred” means no more than that the children were referred successively, rather than as a single batch, to the Department of Paediatric Gastroenterology. The words did not imply routine referral.”[par. 157]

Finally, Mitting states:

“For the reasons given above, both on general issues and the Lancet paper and in relation to individual children, the panel's overall conclusion that Professor Walker-Smith was guilty of serious professional misconduct was flawed, in two respects: inadequate and superficial reasoning and, in a number of instances, a wrong conclusion….The panel's determination cannot stand. I therefore quash it. Miss Glynn, on the basis of sensible instructions, does not invite me to remit it to a fresh Fitness to Practice panel for redetermination. The end result is that the finding of serious professional misconduct and the sanction of erasure are both quashed.” [para.186-7]

It remains concerning that the chairman (Surendra Kumar) of the fitness to practice panel in the case against the three Royal Free doctors sat on two MHRA committees and owned shares in GSK [5].

All this time Cochrane has been far from clear about MMR, finding safety studies in successive reviews (2003, 2005, 2012) to be "largely inadequate" [6]. Nor do we seem to be able to rely on the MHRA and the EMA to guard the public's safety - either with sufficient rigour or with sufficient distance from the industry.

[1] Fiona Godlee, "A tale of two vaccines", BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4152 (Published 04 October 2018)

[2] Philip Bryan, June Raine, Ian Hudson, 'MHRA response to BMJ Editor’s Choice – ‘A tale of two vaccines’', r 2018, 18, https://www.bmj.com/content/363/bmj.k4152/rr-11

[3] John Stone, "The unexplained puzzle of the GMC verdict (and responses to Peter Flegg) 10 February 2010, https://www.bmj.com/rapid-response/2011/11/02/unexplained-puzzle-gmc-ver...

[4] In the High Court between Prof Walker-Smith and and the General Medical Council, http://www.bailii.org/cgi-bin/markup.cgi?doc=/ew/cases/EWHC/Admin/2012/5...

[5] John Stone, 'Re: Financial conflicts -shock horror', 22 October 2008, https://www.bmj.com/rapid-response/2011/11/02/re-financial-conflicts-sho...

[6] John Stone, 'Response to David Oliver II (Risks of Vaccines)', 28 August 2018, https://www.bmj.com/content/362/bmj.k3596/rr-11

Competing interests: No competing interests

22 October 2018
John Stone
UK Editor
AgeofAutism.com
London N22