Do Over
Fombonne, Lord, Leventhal vs. Children with Autism

The GMC and the MMR case: 162-95 is the key

Queen Victoria dining By John Stone

In order to convict all three doctors in the GMC  hearing the panel  had to dissemble in front of the press and public, maintaining that  the generic ethical permission granted to Andrew Wakefield’s colleague Prof John Walker-Smith to retain biopsy samples for scientific use (given the reference by the Royal Free ethics committee of 162-95) was a “project”. Their ruling read out to the assembled media on 28 January stated:

“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.”

Calling 162-95 a “project”  enabled the panel to avoid explaining before the public that Walker-Smith was acting inside his ethical remit as the most senior clinician in the field, or to avoid having to give any reasoning behind their decision that this ethical permission did not pertain in this instance. The GMC panel were required to come to a view on the basis of the highest standard of proof in English law (“beyond reasonable doubt”) and yet their decision effectively changed the rules on the basis of which Prof Walker-Smith and his colleague Prof Simon Murch had made their clinical decisions  13 or 14 years after the event.



The chairman of the GMC panel, Surendra Kumar, which has also branded Andrew Wakefield as “dishonest” failed to disclose on his own behalf, that he owned shares in MMR manufacturer GlaxoSmithKline or that he sat on two medicine licensing authority committees  (HERE). Kumar was appointed in succession to Prof Denis McDevitt who was forced to withdraw following press enquiries regarding his presence on a government committee  in 1988 which had passed the controversial mumps ‘Urabe strain’ MMR vaccine, Pluserix, as safe in 1988 (HERE). Kumar also presently sits on the British Medical Association ethics committee (HERE )

This is just the culmination of a 6 year long prejudicial exercise. Writing in 2004, the Lancet’s editor Richard Horton, recalled a meeting he had with a senior GMC officer following the weekend in which he and journalist Brian Deer made their original allegations against Wakefield, in which they discussed how to bring about a prosecution (HERE):

"Indeed, the GMC seemed non-plussed by Reid's [John Reid, the Health Secretary] intervention. The best their spokeswoman could say was: 'We are concerned by these allegations and will be looking at what action, if any, may be necessary.' In truth, they  (the GMC)  had not a clue where to begin. At a dinner I attended on 23 February (2004), one medical regulator and I discussed the Wakefield case. He seemed unsure of how the Council could play a useful part in resolving the confusion. As we talked over coffee while the other dinner guests were departing, he scribbled down some possible lines of investigation, and passed me his card, suggesting that I contact him directly if anything sprang to mind. He seemed keen to pursue Wakefield, especially given ministerial interest.
Here was professionally led regulation of doctors in action - notes exchanged over liqueurs in a beautifully panelled room of one of medicine's most venerable institutions.”

This parody of legal process did not stop the GMC also putting Horton on the stand three years later to testify against Wakefield. 
 
John Stone is UK Contributing Editor for Age of Autism.
 
 

Comments

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Carol

You could argue that even if Brian Deer was aware of 162-95 in February 2004 when he confronted Simon Murch, Deer might have thought it was irrelevant. You could argue that except that from Dr. Murch's description below, it seems like Deer allowed Murch to look only at the first page of 172-96--and that only briefly--while Deer asserted that 172-96, without a doubt, was the ethical approval alluded to in the Lancet paper. That's seems like an effort to confuse and bamboozle Murch (and others present). Presenting Murch with the texts of both approvals might have jogged his memory so he didn't do that. Why else would Deer have denied himself the pleasure of leisurely rubbing Murch's nose in 172-96?

Carol

From _Callous Disregard_: "Documents recently released under the Freedom of Information Act (FOIA) reveal that the complainant, journalist Brian Deer, knew in [January] 2004 that the research biopsies had EC [Ethics Committee] approval as part of 162-95."

So when Deer accused Dr. Murch in February 2004, ten years after events, of using a backdated ethical approval, Deer disclosed the existence of both 162-95 and 172-96 because that would be the ethical way to proceed, right? Except that it looks like Deer didn't:


Q [by Hopkins at the GMC] During the course of that meeting with Brian Deer did he show you any documents?

A [by Murch] Yes, he did.

Q Did those documents include the 172/96 documentation---

A Yes.

Q ---or some of it anyway?

A Yes. I, to my recollection, did not get to read it in full. It was rather shoved under my nose and I was shown the front page.

Q Do you recall the gist of the allegations as you understood them?

A Probably. The difficulty is that in a lengthy, hostile and adversarial meeting it is difficult to remember specifics. I think overall in essence the journalist was alleging that the 172/96 document had been knowingly and fraudulently put in, in an attempt to provide some form of cover for a legal fishing expedition, in other words, that the aim had been to provide ammunition for a legal hearing rather than being primarily a clinical event; furthermore, it was obvious that these cases did not have disintegrative disorder, and this was, I believe, known to us; the motives were financial, and that it was effectively an improper abuse of clinical process. I think it was just such a hostile and difficult meeting it is very difficult to remember with clarity.

---------

Q Do you now believe that any of The Lancet 12 were being been investigated under 172/96?

A I do not, because we see, in their case notes, admittedly these are case notes that had been pulled apart for repeated photocopying, and we have seen pages out of order, but we do see that there has been entry into the case notes of the 162/95 consent forms and we have not uncovered the consent forms for 172/96.

Carol

I should mention, of course, that Justice Mitting having ruled that the procedures done on the Lancet children were justified by clinical need, it doesn't much matter whether 162-95 or 172-96 was in effect at the time, as long as some ethics committee approval was in force to cover the research elements, i.e., the two research biopsies.

What does matter is if Deer didn't disclose the existence of 162-95 to the GMC. That's evidence of motivation.

Carol

I'm sure you're right because the existence of 162-95 provided a simple explanation for the many absurdities arising from trying to fit the Lancet children into 172-96. 172-96 talked about disintegrative disorder, not autism; it talked about measles/rubella vaccination, not MMR. The Lancet children all had signed consent forms for 162-95, not 172-96, in their files. I don't think that 172-96 had even been approved at the time the Lancet children were treated. That should have been a clue. Instead the GMC acted like Percy and Nelson in "The Amazing Hat Mystery."

One can see why Deer would want to keep the existence of 162-95 quiet.

John Stone

Hi Carol,

I doubt whether Deer ever included information about 162-95 in his complaints about the three doctors to the GMC. As my article above shows it was an important part of the defence of all three (even though the prosecution apparently knew nothing of it), and which the GMC panel chose to disregard as evidence (without reasoning). It is a matter of history that in the appeal of Prof John Walker-Smith the High Court judge, Mr Justice Mitting, upheld the defence, and could not detect any reasoning behind the panel decision (as I had pointed out two years before - even shouting out at the hearing when Kumar delivered this specious nonsense). Deer poked fun at this incident in Gorski's blog a little while later, and particularly my swift exit after it (in order to avoid being man-handled by security btw).

John

Carol

If I read this before in _Callous Disregard_, I didn't appreciate its significance:


"There were no ethical violations in relation to the investigation and reporting of The Lancet 12. No child was subjected to any invasive test for the purpose of research. The GMC prosecution rested on the claim that The Lancet children were part of research project 172-96. It appears to have concealed EC 162-95 research approval for biopsies, and, for the first time, attempted to second-guess the judgment of eminent clinicians about what investigations were clinically indicated to diagnose and treat desperately ill children....

Documents recently released under the Freedom of Information Act (FOIA) reveal that the complainant, journalist Brian Deer, knew in 2004 that the research biopsies had EC [Ethics Committee] approval as part of 162-95. This was disclosed to him in January 2004 through his FOIA request to the Strategic Health Authority that has responsibility for the Royal Free Hospital.

You may think it strange that although this document was clearly relevant to the conduct of research on biopsies taken from children under the care of Professor Walker-Smith, the GMC appeared to know nothing of it. Presumably Deer disclosed this document to the GMC, otherwise he would have risked exposure as a fraud for withholding key evidence following any serious initial investigation by GMC staff. It was not included in the documents upon which the GMC relied in formulating their original charges against the doctors that had been supplied by Deer with his complaint. Nor was it ever disclosed in the documents supplied to the defendants by the GMC, including all of the unused material that the GMC is obliged to disclose...."

Jenny Allan

As I have stated before, the GMC have not yet 'struck off' Dr Wakefield or his colleagues Profs Murch and Walker Smith, although the concensus of opinion amongst their supporters is that this will happen.

The GMC will almost certainly attempt to 'sneak' this decision through whilst the attentions of the press and public are diverted by other, more newsworthy, events. In the UK we have an election coming up and my 'bet' is that this is when their pronouncements will be made.

We must all be vigilant and be prepared to make a great deal of outraged fuss, if any or all of these excellent doctors are struck off the medical register as a result of these trumped up spurious charges against them.

Sylvia

Thats Queen Victoria at Winsdor Castle in the picture, circa 1895.

angus files

Reid and Weep

http://www.sourcewatch.org/index.php?title=John_Reid

Anne

Would love to see some kind of fair "documentary" featuring this whole travesty of a GMC hearing. Would be great to see/hear Dr. Wakefield tell his side of the story. He's so credible. If no media outlets will air it, post it on the Internet. Anyone know of anything in the works?

Gatogorra

It is possible to put applause in this box. Just turn the volume down.
http://www.youtube.com/watch?v=tvlXrkziqlk&feature=related

Saving a sample was a "project" in itself? That might require more sound effects-- I just don't want to be that rude.

Is there any way to find out what drugs or devices Kumar approved in his time on committees? It might be very interesting.

Thank you, John, as always. I'm no longer shocked by any of this but that's just the numbing effects of prolonged exposure to insanity.

John Stone

Thanks Martin - we'll all get there together.

What a wonderful image Kim has found for us today.

Martin Walker

Its such a shame that I can't put applause in this box - no doubt that will come. Until then I can only say that unless the earth is flat, two and two make five and the earth is actually the centre of the universe, science, reason and most of all justice will prevail, we will win and your writing and research will have contributed to this. Keep it up John.

Natasa

I loved the photo, so fitting! Old Boys sheming, plotting behind the scenes to preserve their bastions of power and profit.

Two words come to mind: French and Revolution. Or the other hand the more civilised combination of Tar and Feathers would do.

I hope I live long enough to witness a symbolic version of one or the other falling on heads of those weasels.

Jake Crosby

And the press totally bought it, too. Shame on them.

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