So, now the verdict is out, what does it actually say?
Background:
As we all know, Wakefield and his colleagues published a case series on autistic children in the Lancet back in 1998. The paper itself was not particularly remarkable and scientifically was rather substandard and barely of publishable merit. However it did mention a possible link between MMR vaccination and autistic enterocolitis, something Wakefield went on to suggest this in much stronger terms in media interviews, implying causality. The rest is history.
The media and antivaccination groups hyped up non-existent evidence, putting the frighteners up parents, about 20% of whom didn’t give their kids MMR, which dropped vaccination uptake levels to under 80% . There was a resurgence of measles, which became endemic in the UK and in 2008 there were over 1300 cases. Two children have died in the last 5 years, and vaccination levels still remain below that necessary to ensure adequate herd immunity against measles (95%). There have also been numerous significant mumps outbreaks.
Wakefield was reported to the GMC, not for implying a link, but for reasons of professional misconduct that came to light from his work which led to the publication of the article. After 18 months taking evidence and deliberating, the GMC’s has decided Wakefield acted unethically and dishonestly and had failed in his duties as a responsible consultant.
The GMC statement says many things, and starts by asserting its position regarding ethical research:
“In coming to its findings the Panel has considered the concept of research ethics and research governance. It accepted the expert evidence in this case as to the principles guiding such ethics, in particular that contained 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.”
Financial shenanigans:
In 1996 Wakefield acted in an advisory capacity to a solicitor (Barr) involved in vaccine damage litigation concerning what type of research would be required to establish a vaccine had caused injury. Wakefield provided the Barr with proposals for a study which he hoped would receive legal aid funding to the tune of £57,750. It was entitled: “Proposed Clinical and Scientific Study of a new syndrome: disintegrative disorder and enteritis following measles and measles/rubella vaccination.”
The Legal Aid Board agreed to provide £50,000 of funding.
Yet most of the investigations proposed and costed were subsequently done within the NHS, and Wakefield’s conduct was found to be “dishonest”, “misleading” and he was “in breach of his duty” to use funds as stated and to account for those funds.
Research and Ethics Committee approval:
Wakefield’s research project went ahead. The project title was: “A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination”. Ethical submissions were made to the appropriate committees and reassurances given that children would only have investigations that were clinically indicated, and not because they were part of the trial protocol. (In fact at that time 5 children had already been seen in the unit and had the investigations performed). The investigations included MRI brain scans, lumbar punctures, EEGs, colonoscopies and bowel biopsies (sometimes these required general anaesthesia). The children were ostensibly “consecutively referred” to his unit for clinical reasons.
The GMC found that Wakefield’s involvement with MMR litigation (through Barrs solicitors) had “ethical implications and should have been disclosed” and that he should have revealed the funding he was getting from the Legal Aid Board.
The Children:
The 12 children who were the subject of the Lancet paper were looked at in depth, and the GMC took them on a case by case basis. I won’t go through each case, since much repetition is involved, but the final conclusions were that Wakefield had “caused children to undergo a programme of investigations for research purposes without having Ethics Committee approval for such research” (in other words the invasive investigation performed on many children were not clinically indicated and constituted no part of any approved study).
Wakefield had “ordered investigations “without having the requisite paediatric qualifications to do so” and his “conduct [was] contrary to the clinical interests” of the children (in other words many of the procedures were not clinically indicated, and he ordered them to be done purely for research purposes).
Some children required general anaesthetics for tests to be done, and in one case I note that Professor Walker-Smith (Wakefield’s co-defendant) had specifically advised that the child be “not for MRI or LP”, yet these procedures were still performed at Wakefield’s behest.
I also note that Wakefield’s contract with the Royal Free as an Honorary Consultant stipulated that he should have no clinical involvement in the management of patients, yet that was something he quite clearly did.
(Imagine a doctor subjecting your own child to a battery of completely unnecessary, clinically inappropriate and potentially dangerous invasive investigations, without any ethical approval and sometimes having them put under a general anaesthetic to do so, just to get “evidence” for the doctor’s pet research study he is being paid to do. It quite beggars belief that the parents of the study children are so supportive of Wakefield, and says much for his charisma).
The Lancet Paper:
The project’s findings were published in the Lancet. The GMC say the paper did not state the children were part of a research project to investigate bowel disorders after vaccination, and there was a “misleading description of the patient population”. (How misleading is clear from Brian Deer’s revelations that go far beyond what the GMC’s remit was).
So despite Wakefield’s claim that the children were routine referrals, this was clearly not so, and four children were referred through other routes (presumably expressly to provide substance for the vaccination link to autistic enterocolitis). The GMC stated that the description of referrals was both “irresponsible” and “misleading”.
At this point the GMC panel discussed other statements made by Wakefield relating to the Lancet paper. Wakefield, responding to claims that there was selection bias in the recruitment of his cases, wrote to the Lancet in May 98 to dispute their suggestions. The GMC say that his statement at that time was “dishonest and irresponsible” and that Wakefield “knew the statement [he made] omitted necessary and relevant information”. A similar story unfolded regarding claims made by Wakefield at a Medical Research Council meeting in March 98 regarding the patients in the Lancet paper. (Put simply, Wakefield was dishonest, he knew he was being dishonest, and he was repeatedly dishonest).
Wakefield also failed to disclose to the Lancet that he was:
- Involved with MMR litigation
- In receipt of funding from the Legal Aid Board (similarly so)
- Involved with the “patent” – this being the submission for a new vaccine patent.
These constitute massive unstated conflicts of interest which were not disclosed to the Editor of the Lancet at the time of publication.
Transfer Factor.
This is a little vignette I was previously only vaguely aware of. It seems that there was another research project ongoing at the same time as Wakefield’s main protocol. Wakefield had proposed to set up a company called “Immunospecifics Biotechnologies Ltd” which was to produce and sell a substance called Transfer Factor, reputed to treat autistic enteropathy and also to act as a “vaccine alternative”. The proposed CEO of the Company was the father of one of the research children (Child 10) and Wakefield and this man were to share equity in the company. Wakefield and Walker-Smith applied to the Royal Free Research and Ethics Committee to conduct this research study, and Child 10 was started on Transfer Factor.
The GMC found that Wakefield “inappropriately caused Child 10 to be administered Transfer Factor” for experimental reasons. This was “contrary to the clinical interests of child 10” and was an “abuse of [Wakefield’s] position of trust as a medical practitioner”.
(These actions sound very bizarre – set up a company to sell a dubious product, and experiment on a child with it to get some data? This seems more akin to what someone like the Geiers would do, rather than a bona fide medical researcher.)
Birthday Party.
As everyone will know, Wakefield boasted about paying children attending his son’s birthday party to give control blood samples for his project. Two of them fainted.
The GMC state this conduct took place without ethical approval and with disregard for the distress and pain it might cause. The GMC panel regarded evidence that the children “were paid for their discomfort” as evidence of a callous disregard for their welfare, and say Wakefield “brought the medical profession into disrepute”.
Well there you have it.
I haven’t gone into details about the findings on Murch or Walker-Smith.
I think that’s quite enough for now.
This is a guest post by British doctor DeeTee.
This sort of crass statement makes me weep tears of despair.
http://www.badscience.net/forum/viewtopic.php?f=3&t=14401&start=100#p299178
Boo, hoo, blubber ....
Congrats on a nice job translating / summarizing the rather indigestible 150-odd pages of the GMC report.
Many of the (mostly raving anti-MMR) commenters on the various newspaper articles seem to have missed that the hearing was not directly about the correctness of Wakefield's work. It was about the things he and the others had done to get the data they based the theory on, and how that squared with medical and research ethics.
In a way I am least surprised at the findings regarding Wakefield; given all the revelations about his scientific data-torturing, the GMC finding him "dishonest" is no great surprise, and the other findings were well-trailed by Brian Deer. I am astonished, though, by the extent to which Walker-Smith and Murch seem to have been involved. I was particularly struck by the bit on p 107-111 about Walker-Smith having a couple of goes at talking a reluctant community paediatrician into allowing "child JS" to be put through the test protocol - especially the bit about how W-S initially accepted the other doctor's reluctance, but then went back for another go after Wakefield had nagged W-S that they needed the child for the study. All rather icky.
"All rather icky."
OMG, you really are a dreadful drip, Droopy Draust!
Excellent summary, thank you.
One of my blogging habits is to collate pro and con posts on a particular issue.
One reason to do is that each blog has its own set of commenters and often the comments reveal aspects of the issue previously not considered elsewhere.
Today's issue is the UK's General Medical Council's ruling on Andrew Wakefield.
The list can be found at
http://lizditz.typepad.com/i_speak_of_dreams/2010/01/andrew-wakefield-dishonesty-misleading-conduct-and-serious-professional-misconduct.html
It will be interesting to see the blog responses over the next few days. Currently the "Andy Wakefield is a hero of science and will be vindicated" posts stand at 18; the "GMC findings are correct. Good science is eventually self-correcting" posts stand at 63.
Utter garbage!
You don't have to read this 'British doctor's' blog post - and I certainly didn't waste my time - to know that it's a screed of appalling nonsense.
The laid back, scientific (teehee) proprieter of this arrogant little corner of the blogosphere was noted recently to have written the following breathtaking homily,
"Without wanting to sound arrogant about it, if you're used to reading scientific papers, or if you just know a little bit about how to do a science experiment you can spot the awful flaws in Wakefield's 'study' pretty much at a glance. I mean, it's basic stuff - cherry-picked participants, no coherent hypothesis presented to test, inadequate controls and sample size and so on. In many ways, I believe the then Editor of the Lancet has a hell of a lot to answer for, allowing such drivel to be published."
Mr MJ Robbins (DipLaySci) may be interested in the drivel the Editor of the Lancet (then and now) has written in support of a convicted medical miscreant (aka dodgy doctor and titled professor).
http://www.bmj.com/cgi/eletters/331/7508/66-a#112701
Just a little bit icky, eh, droopy draust?
PS. But Sir Richard (aka Biggus Dickus) also wrote this piece in praise of Andrew Wakefield.
http://briandeer.com/mmr/horton-wakefield.htm
Cyber, perhaps it would be advisable to check who has authored comments/posts as well as reading them first before you open your mouth. It would save you putting your foot in it.
Foot in what, DeeTee? Advisable? What are you trying to say, Dr Cryptic?
Mr Robbins is being uncharacteristically coy: when is Martin going to come clean and explain his comments to the Goldacre groupies?
http://www.badscience.net/forum/viewtopic.php?f=3&t=14401&start=100#p299178
Cybertiddles, you misquote Robbins. He said: "I believe the then Editor of the Lancet has a hell of a lot to answer for, allowing such drivel to be published." Please don't mislead.
I agree with Robbins - the article should never have been published..
Now correct me if I am wrong, but are you calling for a Nurenberg-type punishment for those who lied to the GMC panel? Like Wakefield, for instance??? Or has he borrowed Tony's teflon coating as far as you antivaxxers are concerned?
Cybertigger:
I'm a little lost - what exactly am I supposed to be explaining? The comment I post is pretty self-explanatory. Wakefield's study was poor, I don't believe it should have been published in the state it was in. Hence my comment...
Martin is the editor of layscience.net.
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Mr Robbins clearly needs some help.
Keywords and phrases: Early report, Case series, The Case report or case series are "immediately understandable by non academic clinicians and the lay public" - but obviously not understood by lay - and bad - scientists like Mr Robbins and Dr DeeTee.
Homework. Trisha Greenhalgh. How to read a paper: the basics of evidence-based medicine. Start on section 3.7, page 52.
PS. Do you need a link to Wakefield et al's 1998, peer reviewed, case series report, in the Lancet?
Nurnberg-type punishment? Where did I say anything about Nuremburg, Dr DeeTee?
PS. I think it would be very mean of you to expect Andrew Wakefield to share a cell at The Hague with the likes of Biggus Dickus and Professor Sir David Salisbury. Very mean!
Deer Brian's spirit is mean ... and everywhere about us ...
http://www.timesonline.co.uk/tol/news/uk/health/article7009882.ece
I thought Mr Robbins was a devoted disciple of Ben Goldacre. But Mr Robbins has not been listening to the God of Bad-Science and as a consequence his understanding of good-science remains pathetically minimal.
http://www.guardian.co.uk/science/2005/sep/08/badscience.research
"Now, even though popular belief in the MMR scare is - perhaps - starting to fade, popular understanding of it remains minimal: people periodically come up to me and say, isn't it funny how that Wakefield MMR paper turned out to be Bad Science after all? And I say: no. The paper always was and still remains a perfectly good small case series report, but it was systematically misrepresented as being more than that, by media that are incapable of interpreting and reporting scientific data."
Come in Mr Robbins, you've been rumbled.
Cyber, your distasteful comments about Nuremberg were removed, and quite rightly so.
Meanwhile, back in the land of reality, The Lancet has finally formally retracted the Wakefield paper:
http://download.thelancet.com/flatcontentassets/pdfs/S0140673610601754.pdf
Trisha Greenhalgh wonders why it took so long:
http://www.bmj.com/cgi/content/extract/340/feb02_4/c644
Other commentary in the BMJ:
http://www.bmj.com/cgi/content/extract/340/feb02_4/c696
http://www.bmj.com/cgi/content/extract/340/feb02_4/c655
http://www.bmj.com/cgi/content/extract/340/feb02_4/c672
Yes, Dr DeeTee, I'd noticed the ugly flotilla of vultures circling the BMJ in search of carrion. I dare say you will soon be making comment in similar unpleasant fashion. Of course, you have the same self satisfied style as Deer Brian.
A flotilla of vultures??
Having looked afresh at the BMJ, I must say you are correct for once Cyber, with your comments about circling vultures.
I see all the usual antivaccination terriers have made it into the Rapid Response section. The flecks of spittle and bile being disgorged through cyberspace are so vitriolic they are dissolving my monitor screen.
I see Mr Robbins, esteemed editor of layscience.net, has made himself scarce. TeeHee!
"It wasn't really the study itself, but the press conference etc., that was the problem. Ironically, the GMC verdict isn't really anything to do with the credibility of the research (but at this stage i suppose it was all they had)."
http://www.badscience.net/forum/viewtopic.php?f=3&t=14578#p301954
Read it while you can: I feel sure that Mojo's posting will be deleted. TeeHee.
How interesting that Nuremberg gets a mention. Perhaps we should remember it was there that the first set of international guidelines for ethical clinical trials was published following the trials. The same international guidelines that Dr (soon to be mr) Wakefield drove a horse and cart through when he started his abuse of children for their parents, and his own financial gain.
Dr DeeTee has failed to share with Doc Martin and other assorted Lay Scientists the latest word according to Doc Horton of the Lancet. Enjoy!
http://www.onthemedia.org/transcripts/2010/02/05/01
Enjoy particularly the words of some of the commentators - particualry Aravinda and Michael Fransom. And I thought all Amerikans were gullible fools - how wrong I was!
Is he on something? Here it is we see Dr DeeTee wandering foolishly about again,
http://www.badscience.net/forum/viewtopic.php?f=3&t=14649#p303433
... along with some other familiar jokers,
"Well there's a toss up here. On the one hand, the whole point of peer review is to put useful information into the public domain for other scientists to then scrutinize. On the other hand, Wakefield's paper was poor in quality, on a critical public health topic, and submitted to a high-profile journal. For me, a high impact journal should not be publishing highly speculative results on a key public health issue without considerably weight behind them."
Stuck up stuff like this you really can't make up!
So what are the implications of these findings on the Lancet? Perhaps, a silly question relative to the death and suffering in the wake of this 1998 publication. I live in the US and am not aware of news relative to the fall out on the status of this journal. Mistakes are made, we are fallible after all. But there clearly seems to be malice on Wakefield's part. But lack of proper peer review, in my mind, makes the Lancet culpable as well.
BigDick Horton is as scientifically confused as Mr Robbins, but then Mr Robbins is a zillion light years away from being editor of the Lancet.
http://www.huffingtonpost.com/sally-beck/richard-horton-waffles-on_b_460...
Oh dear, oh dear, oh dearie me!
Cyber,
I think you make considerably more sense when you post under your "ugur" sock puppet.
Could you stick to that one in future, please?
Wot r u on about, Dt? Dt, wot r u on?