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Fiona Godlee of BMJ Responds to Wakefield Questions

Questions Below is a response that arrived in our comments from Fiona Godlee of the BMJ  to a post we ran last week titled, Email the BMJ Editor Asking These Questions RE: Andy Wakefield Editorial.

Fiona Godlee said:
Thank you for your emails. The BMJ stands by the article by Brian Deer and the linked editorial published on 5 January.[1] [2] The article, which was subjected to peer review and editorial checking, was based on enquiries carried out over some seven years, involving, among other things, interviews with parents of children enrolled in Andrew Wakefield's research. Four such parents are quoted in the article. As made clear in the article, the core data on which the findings were based were evidenced, except in the case of one child, by the transcript of a General Medical Council fitness to practise hearing which sat between July 2007 and May 2010. In your questions, you suggest that Andrew Wakefield did not have access to GP records and therefore could not be responsible for discrepancies between those records and what was published in the Lancet in February 1998.

The case we presented against Andrew Wakefield that the 1998 Lancet paper was intended to mislead is not critically reliant on GP records. It is primarily based on Royal Free hospital records, including histories taken by clinicians, and letters and other documents received at the Royal Free from GPs and consultants. We draw attention to the finding of the fitness to practise panel, on which we are entitled to rely, that "the 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 [Wakefield] 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." Contrary to other suggestions contained in your emails, we made no allegation of dishonesty against Andrew Wakefield's co-authors, or indeed against anybody else. As the GMC panel heard, it was Andrew Wakefield who wrote the Lancet paper, using data which he anonymised, with little oversight by other authors. We confirm that under the uniform requirements for manuscripts submitted to biomedical journals all authors should be in a position to speak to data, but the evidence is that in this case they were not. We are aware of recent claims made by Andrew Wakefield that "new documents have come to light" purportedly confirming his claims in the Lancet. The material he cites was presented to the GMC panel two and a half years ago. Andrew Wakefield was last year erased from the medical register and he has chosen not to appeal that decision. As indicated, the very many charges proven against him include dishonesty in his research. We are unaware of any peer reviewed paper replicating Andrew Wakefield's research or confirming his claims to have identified a new syndrome of regressive autism and inflammatory bowel disease associated with MMR vaccination. With respect to gastrointestinal issues, we draw attention to an authoritative consensus statement published last year by experienced specialists in this field [3] and particularly to statement 4: "The existence of a gastrointestinal disturbance specific to persons with ASDs (eg “autistic enterocolitis”) has not been established." With best wishes, Fiona Godlee, Editor in Chief, BMJ References 1. Deer B. How the case against the MMR vaccine was fixed. BMJ 2011; 342:c5347 doi: 10.1136/bmj.c5347 2. Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ 342:doi:10.1136/bmj.c7452 3. Buie P, Campbell DB, Fuchs GJ, et al. Evaluation, diagnosis, and treatment of gastrointestinal disorders in individuals with ASDs: a consensus statement. Pediatrics 2010;125;S1-S18.

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Angus Files


http://ehealthforum.com/blogs/fiddy/british-medical-journal-add-to-glaxo-s-woes-b50196.html

Health Blogs | Mental Health | Suicide

British Medical Journal Add to Glaxo's Woes


September 10th, 2015 by BOB FIDDAMAN

Hi
Had an email off the BMJ earlier this morning in regard to the infamous Paxil 329 study.

It's not looking good for GlaxoSmithKline, who are currently under investigation from the UK Serious Fraud Office for various bribery and corruption allegations and who are also facing a lawsuit in the UK regarding Paxil's (also known as Seroxat) propensity to cause severe withdrawal issues and dependency.


Hi

We have an important paper publishing in The BMJ next week that might be of interest.

Briefly, it's the first reanalysis of data from a widely used antidepressant drug trial that comes to a different conclusion about the drug's efficacy and safety in adolescents.

Accompanying articles highlight industry malpractice, hidden data allowing manufacturers, academics and clinicians to overstate the benefits and underplay the harms of treatment, regulatory failure, and inaction by the academic journals and institutions.

Three of the authors are based at the University of Adelaide.

Dr Fiona Godlee, The BMJ Editor-in-Chief says this reanalysis "sets the record straight" and "shows that the public and clinicians do not have the unbiased information they need to make informed decisions."

And she calls for legislation to ensure that the results of all clinical trials are made fully available for legitimate independent third party scrutiny.

We are planning a telephone briefing with the authors and Dr Godlee at 15:00 hrs UK BST / 23:30 hrs ACST on Mon 14 September to talk through the findings and their implications ahead of publication.

BMJ.

More info on the reanalysis of 329 can be found here.


Bob Fiddaman.

Read more: British Medical Journal Add to Glaxo's Woes by Fiddy http://ehealthforum.com/blogs/fiddy/british-medical-journal-add-to-glaxo-s-woes-b50196.html#ixzz3lTFGPMMg
Follow us: @ehealthforums on Twitter

MMR RIP

John Stone

FIREWORKS IN BMJ RAPID RESPONSES TONIGHT

Letters from Ed Yazbak, Prof Christoper A Shaw, John R Smith, and Alex Snelgrove. This is surely material that BMJ were sitting on and didn't dare post.

http://www.bmj.com/content/342/bmj.c7452/reply#bmj_el_248996

Garbo

Proving once more "There are none so blind than those who will not see. The most deluded people are those who choose to ignore what they already know." She's deluded, that's for certain.

Jen

Wow, just got my alumni magazine from U. Of Guelph and in it is an article called, "There's a Complex Eco-system Inside your Gut." The topic of autism comes up. ..."Even less likely might be the notion of GI doctors talking to neurologists....Allen-Vercoe is now looking at possible connections between gut microbes and nervous disorder, specifically autism.... bacteria produce all kinds of toxic products, says PhD student, Mike Toh...effects of adding say, hormones or antibiotics... is investigating diet-disease connections with autism researchers at U. Of Western Ontario and witty microbiologists at U. Of California, Los Angeles. "It's a meeting of the minds between developmental biology and microbiology."
I guess Fiona Godlee isn't meeting with any minds.

Jenny

I would love to see an independent film re-enacting Dr. Wakefield's trial. But I would add a brightly colored in-scene narrator in front of the other characters, who would be frozen in time at critical junctures while the narrator explains along the way everything that the public didn't know about the antagonists, i.e. conflicts of interest, and what the misinformation is about that spews out of their mouths. The Lancet children and their families WOULD be included, interviewed by the narrator periodically throughout . . .

AutismGrandma

Re: Post by John Stone: "I note that when Dr Godlee was appointed to her role as editor of BMJ she had just delivered a presentation on a national platform how to manage public opinion over vaccines."

Leave it to you John to dig up the dirty laundry. We can always count on you to make those "conflict of interest" links. For some reason I find it more shocking when females engage in this coverup regarding so many thousands of children suffering from MMR induced bowel disease. I wonder if Fiona is a mother; thank God she is not my grandson's mother, but if she were, at least she would see first hand the suffering caused by vaccine induced bowel disease and then maybe she would have some maternal compassion. Otherwise she just appears to be a conniving selfish bitch.

Carol

You know, I don't think Godlee is quite telling the truth when she says that she's making no allegations of dishonesty against anyone other than Andrew Wakefield. Doesn't Brian Deer make it pretty clear that many of the parents invented stories of their children's post-MMR regressions to cash in?

In any case, if their children are misrepresented in the Lancet paper and they haven't said anything, that would make them complicit with Andrew Wakefield. I don't think Deer is claiming that the *parents* didn't know which kid was which in the study. According to Deer, it's only Wakefield's pathetic co-authors who didn't have a clue.

The Mikado

Of course, Dr Godlee wouldn't be posting on AoA unless she was under pressure. Fascinating to note that she has already apparently erased her own name from the medical register and so presumably cannot face a disciplinary hearing. On the other hand Dr Marcovitch may be faced with the unappealing prospect of cutting his own head off.

Theodora Trudorn

I would give her my personal medical history, but that would be considered "anecdotal" and therefore I don't count! Of course! I guess I should know that by now, huh? *sarcasm* All I know is that after 26 years of suffering on this earth I DESERVE SOME ANSWERS!! PARENTS DESERVE ANSWERS!! After all the money spent, study after study, from the 1940's to this current day, we are no further along that we ever were. And those like me, we merely have Aspergers, we don't count after all, even though our numbers continue to grow too, and thousands of us fall through the cracks and stay behind closed doors everyday with parents wondering what will happen to us when they die. I guess their anecdotes and histories don't count either. Of course not!! How many will have to go through this before WE STOP BEING JUST ANECDOTES TO THESE EFFIN PEOPLE AND WE START TO ACTUALLY MATTER!!!!! Sorry folks, I'm a bit angry. Angry that the few brave souls who dare ask questions get crucified, of being told than me and my like don't count and don't matter. *sighs*

GH

The inability of Wakefield to appeal is the worst news I have heard since Insel withdrew the research funding two years ago; an exoneration would have shown the world exactly what has been happening. It may also explain the timing of the latest round of Deerism, in that it let the editors of the BMJ know they can not be held accountable no matter how untruthful the allegations they publish may be.

I once heard a farmer who was fighting Monsato describe the scales of justice as 'tipping in the direction of who could pile the most money'.

John Stone

Godlee has now posted a version of her response in BMJ Rapid Responses without the document - with its 9 questions - to which she was replying. Oh dear!

http://www.bmj.com/content/342/bmj.c7452/reply#bmj_el_249550

Carol

Godlee writes, "Contrary to other suggestions contained in your emails, we made no allegation of dishonesty against Andrew Wakefield's co-authors, or indeed against anybody else. As the GMC panel heard, it was Andrew Wakefield who wrote the Lancet paper, using data which he anonymised, with little oversight by other authors."

It appears she's saying that Wakefield took bits of information about certain of the Lancet children and swapped them around without the other authors noticing because they didn't know who was who. To what end?

For the record, Wakefield has said that all the authors knew who was who at the time of publication.

John Stone

GH

Unfortunately, insurance would not cover Andy's appeal. The appeal by John Walker-Smith goes ahead.

Jake Crosby

"The material he cites was presented to the GMC panel two and a half years ago. Andrew Wakefield was last year erased from the medical register and he has chosen not to appeal that decision."

Erased by a panel chaired by a GlaxoSmithKline stockholder, a conflict Marcovitch never stepped up to stop apparently because he's on the take, too. According to the BMJ, if Andrew Wakefield isn't going to invest time and money he doesn't have only to face the possibility of being shafted by the UK legal system again, he MUST by guilty!

"...or confirming his claims to have identified a new syndrome of regressive autism and inflammatory bowel disease associated with MMR vaccination."

Except that Andrew Wakefield never claimed to have identified a "new syndrome" in the Lancet paper, he merely hypothesized ones. The clinical findings in that paper following examinations of autistic children with bowel disease were replicated in five countries around the world.

Erik Nanstiel

I'd like to include Andy's rebuttal video, recently uploaded to YouTube.

http://www.youtube.com/watch?v=N3fxHvvibsU

GH

'Andrew Wakefield was last year erased from the medical register and he has chosen not to appeal that decision.'

A few months ago Dr. Wakefield was talking about his upcoming appeal, does anyone know what if anything has changed? My understanding was that his insurance would cover the legal costs (I think I read that here).

Katie Wright

I would invite Ms. Finona Godlee to go to simply go to pub med and type autism and gastrointestinal disease and learn about the plethora of recent research on this subject. It absolutely HAS been established that upwards of 50% of the ASD population suffers from GI problems. Ms. Godless alleges this is normal? I don't have GI disease, no one except Christian does in my entire family- this so often the case. I would feel confident in estimating that no more than 5-10% of the population has serious GI problems.

Ms. Godlee please elaborate on why you believe the % of GI disease among ASD and the non population is the same?

Ms. Godlee needs to familiarize herself with the research. The consensus statement certainly said that a disproportionate amount of ASD children have GI problems and need treatment. That is not controversial and not even in debate among the best researchers and clinicians. The sad fact is the due to efforts by Ms. Godleee and others attempting to minimize or dismiss this disorder too many children are living in pain.

Unlike Mr. Deer and Ms. Godlee children like mine can no longer speak. Have Godlee or Deer spent 1 day with an ASD child w/ GI disease? Ms. Godlee you have a responsibility to learn about this condition, talk to clinicians and parents- not just oddball reporters and academics.

Jen

Godlee invites me to complain to the PCC cos she can't see what else i could possibly want, she won't be retracting Deer, etc.
The PCC's code of conduct has been breached by Brian Deer / Fiona Godlee - clauses 1, 2, and 4, IMHO. I'm raising a complaint now.

Deborah Nash

Obviously, what Fiona is saying in the first few lines of her reply, is that they looked at what Mr Deer had reported over 7 years, so, nothing independent or new was ever going to be published in the BMJ. That must lead to the question - what was the ulterior motive behind repeating Deer's work?

Media Scholar

So why not ask the BMJ how one proves vaccine injury in the current politicized main-steam medical environment?

Why not ask Royal Free if they can produce a single document of vaccine injured individuals that have been aided in their legal fight against the vaccine manufacturing drug companies.

Why not ask all the so called medical periodicals how can they dare prevent their advertisers from over-lording themselves in editorial control thus inflicting their "modern" anti-litigation bloc form of "research" on their editors?

Jen

i am complaining to the GMC again, and am still waiting for Fiona to get back to me. I phoned up - which probably makes me annoying, but i dont care.

John Stone

How extraordinary is this? Dr Godlee, who will not post comments and questions relating to Brian Deer's data in her own journal, now feels forced to come out and defend herself in the most legalistic terms on Age of Autism.

Fundamental to her problems are the erroneous claims made about the alteration of the GP record. If the claims printed in the journal were not germane to accusations of fraud why then did they appear? It now appears that Godlee's defence is not based on "fresh" claims (or rather Mr Deer's warmed-up claims from a Sunday Times article published exactly two years ago and re-published as peer-review research) but only on what the GMC has already found. So, apparently she has had to concede that the new research is really what we in the UK call "nonsense on stilts", and she has been unable to defend it her own columns.

Her claim that the research in the Lancet paper has not been replicated seems to based on obsessive literalism: she ignores the fact that there is by now a huge body of literature which shows that the doctors were engaged in a real rather than fabricated branch of enquiry. It is certainly possible to say that unidentical papers do not have identical findings, but the problems of the children were real and responsible medical practice would look at the matter without prejudice, and also be prepared to look at the problem of whether in some instances the patients' conditions were triggered by vaccines. To rule this out as an area of enquiry on the basis of institutional expedience has nothing to do with the good practice of science, and certainly will not re-assure parents. I note that when Dr Godlee was appointed to her role as editor of BMJ she had just delivered a presentation on a national platform how to manage public opinion over vaccines.

Of course, Andrew Wakefield's ability to defend himself in the courts is limited by his financial resources (and he has a family). The financial resources of the pharmaceutical industry are on the other hand bottomless. Manifestly, the chairman of the panel that tried the the three doctors was in breach of the Nolan rules on public standards. He failed to disclose ahead of the hearing that he sat on two licensing authority committees and owned shares in an MMR defendant company, GSK. After the hearing he further blotted his copybook by inappropriately leading a debate at the British Medical Association calling for MMR to be made compulsory in the United Kingdom. As we know Dr Kumar replaced Prof McDevitt, who had to stand down because he had sat on the Committee on Safety in Medicines when the original Pluserix MMR vaccine was cleared for use in the United Kingdom (and later had to be withdrawn). It seems highly irregular that Dr Marcovitch, who is present chair of GMC panels should also be party to Mr Deer and BMJ's raft of allegations, and perhaps he would be fulfilling his role more credibly if he were belatedly to look into these other matters.

Jen

I got sent the same email today - word for flaming word verbatim. She did not address my complaint, only copy and pasted this to me.

i have replied, asking her to address my original two complaints - lets see if she does.

[huge eyeroll]

just noticed her email footer has her phone number and that of her PA on it...

Twyla

Fiona Godlee, editor in chief, Jane Smith, deputy editor, and Harvey Marcovitch, associate editor, nicely summarize their outlook, motivations, and objectives when they begin their article with the statement that:
“Clear evidence of falsification of data should now close the door on this damaging vaccine scare.”
http://www.bmj.com/content/342/bmj.c7452

Even if everything they said about Dr. Wakefield were true, how could this close the door on the thousands of reports of vaccine induced autism and bowel disease, and the biological science on vaccine injuries such as encephalitis, and accepted cases such as that of Bailey Banks?

Then they describe John Deer quite accurately as:
“one man, standing outside medicine and science”.
Yes indeed, a totally unqualified reporter with no scientific or medical credentials, voicing opinions which should carry absolutely no weight.

A couple of interesting "rapid response" comments posted in reply to BMJ articles:

Analysis of Deer's tabled data
John P Heptonstall, Director of TCM Acupuncture & Moxibustion Clinic
Leeds LS27 8EG
Published 8 January 2011
http://www.bmj.com/content/342/bmj.c7452/reply#bmj_el_247507

Wakefield's article linking MMR vaccine and autism was fraudulent
John R Smith, Special Education
DET
“To my mind the following studies do represent just such a link and perhaps the tool of epidemiology was the wrong instrument to precisely uncover that association."
Published 11 January 2011
http://www.bmj.com/content/342/bmj.c7452/reply#bmj_el_247437

It's quite odd that we keep hearing that Wakefield's twelve coauthors signed the paper without knowing what it was going to say, and without bothering to verify any of the information in it, and that 10 of them retracted the paper. It's hard to believe that anyone would be willing to put their name on a published paper without knowing what it would say. And actually the 10 co-authors only retracted the "interpretation", not the data or other findings. They said:

“The main thrust of this paper was the first description
of an unexpected intestinal lesion in the children reported.
Further evidence has been forthcoming in studies from
the Royal Free Centre for Paediatric Gastroenterology
and other groups to support and extend these findings.
While much uncertainty remains about the nature of these
changes, we believe it important that such work
continues, as autistic children can potentially be helped by
recognition and treatment of gastrointestinal problems.

“We wish to make it clear that in this paper no causal
link was established between MMR vaccine and autism as
the data were insufficient. However, the possibility of such
a link was raised and consequent events have had major
implications for public health. In view of this, we consider
now is the appropriate time that we should together
formally retract the interpretation placed upon these
findings in the paper, according to precedent.”

The "Interpretation" in the paper merely said:
"Interpretation: We identified associated gastrointestinal
disease and developmental regression in a group of
previously normal children, which was generally associated
in time with possible environmental triggers."
http://www.lifehealthchoices.com/images/lancetwakefield.pdf

Of course, the paper also said, "We investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder... Onset of behavioural symptoms was associated, by the parents, with measles, mumps, and rubella vaccination in eight of the 12 children, with measles infection in one child, and otitis media in another... We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue... We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunisation. Further investigations are needed to examine this syndrome and its possible relation to this vaccine."

Such mild language! Wouldn't someone engaged in fraud proclaim more sweeping conclusions rather than simply calling for more research?

SaraD

Main Entry: Fiona Godlee
Part of Speech: noun
Definition: person who tells falsehood
Synonyms: cheat, con artist, deceiver, deluder, dissimulator, equivocator, fabler, fabricator, fabulist, false witness, falsifier, fibber, maligner, misleader, perjurer, phony, prevaricator, promoter, storyteller, trickster

Anne McElroy Dachel

The real story of the Lancet children is on this video:

Selective Hearing, Brian Deer and the GMC, Dr Andrew Wakefield Autism MMR Film Favorite
http://www.viddler.com/explore/ziggy/videos/1/

Anne Dachel
Age of Autism

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