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Joan
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Joan
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jabsadmin
1005 Posts |
Posted - 03/02/2010 : 16:13:30
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http://www.bmj.com/cgi/content/full/340/feb02_4/c644
BMJ
Published 2 February 2010, doi:10.1136/bmj.c644 Cite this as: BMJ 2010;340:c644
Observations
GMC Wakefield Verdict
Why did the Lancet take so long?
Trisha Greenhalgh, professor of primary health care, University College London
p.greenhalgh@pcps.ucl.ac.uk
The retraction of the infamous MMR paper may be overdue, but it is a good thing for science
On 28 February 1998 the Lancet published a study with the inauspicious title "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children."1 The paper has been much criticised, and the Lancet finally retracted it this week. But why did it all take so long?
The story is well known. Wakefield’s paper implied an association, later shown to be spurious, between gastrointestinal illness, the combined measles, mumps, and rubella (MMR) vaccine, and an autism-like disorder in a sample of 12 children. At a controversial press conference Wakefield appeared to conflate association with causation, and in the eyes of the tabloid press his tiny, skewed sample represented children in general. The immunisation record of then prime minister Tony Blair’s infant son became the most politically sensitive item of data held in the NHS. Private clinics enjoyed a brief boost to business by offering the three vaccines as separate, spaced injections as recommended by Wakefield. Measles returned—and did considerable damage.
On 18 February 2004 the investigative journalist Brian Deer complained to the Lancet that far from being "consecutive" referrals to the gastroenterology clinic, as claimed in the paper, several children in the sample had been referred to Wakefield by a medical negligence lawyer who sought grounds for pursuing a legal action on behalf of parents of allegedly vaccine damaged children. Deer claimed that Wakefield had not obtained ethics committee approval for invasive tests conducted on the children (including lumbar puncture and colonoscopy) and that the paper had been submitted under cover of ethics approval for a different study.
On 6 March 2004 the Lancet rejected Deer’s allegations relating to ethics approval and stated that "children reported in the 1998 Lancet paper were consecutively referred to the Royal Free [Hospital] and were not deliberately sought by the authors for inclusion in their study based on parents’ beliefs about an association between their child’s illness and the MMR vaccine."2 However, it agreed that funding from the Legal Aid Board for what it considered to be "parallel and related work" should have been declared as a conflict of interest (defined as: "Is there anything . . . that would embarrass you if it were to emerge after publication and you had not declared it?").
In the same issue 10 of the paper’s 13 authors published a "retraction of an interpretation."3 Despite this, two of those 10—Simon Murch and John Walker-Smith—joined Wakefield on the ropes in 2007 for what has already become the longest hearing by a fitness to practise panel in the history of the General Medical Council. In a judgment published last week the GMC declared that invasive investigations on children in the "Lancet 12" group were undertaken without proper ethics committee approval and without due regard to their clinical needs (www.gmc-uk.org/static/documents/content/Wakefield__Smith_Murch.pdf). Wakefield’s presentation of the referrals as consecutive and routine was deemed "dishonest" and "irresponsible" and was found to have "resulted in a misleading description of the patient population in the Lancet paper" (paragraph 32b, page 44).
An academic journal is not a collection of blank pages on to which authors inscribe important scientific facts as they discover them. Rather, science is made and shaped as authors consider the declared areas of interest, impact factors, and instructions for authors of candidate journals for their work and as the papers they submit clear the successive hurdles of eligibility screening, selection of peer reviewers, responding to reviewers’ comments, statistical approval, technical editing, and distribution of press releases. My own collection of rejection slips from journals with a high impact factor represents research that could have become important scientific facts but that turned out to be findings of marginal significance in publications to which neither politicians nor journalists subscribe.
A graph showing first a precipitous fall in immunisation rates in the United Kingdom and then a corresponding rise in the incidence of measles was later reproduced in the broadsheets (and in at least one GCSE biology syllabus) as an iconic symbol of bad science.
Leaving aside for a moment the questions of research ethics and fraudulent sampling claims raised by the GMC, there is an alternative interpretation of the same graph: that the acceptance for publication of some very preliminary laboratory findings by one of the world’s leading medical journals was, at the time that editorial decision was made, more a symptom than a cause of declining professional and public confidence in the MMR vaccine. But once the article appeared with the Lancet kitemark—cautious accompanying editorial notwithstanding4—the arguments were considered by many to be proved, and the ghastly social drama of the demon vaccine took on a life of its own.
In an ironic admission to the GMC panel (paragraph 30a, page 43) Wakefield disputed that the piece he submitted to the Lancet should be referred to as a "scientific" paper. And this week the Lancet stated that it had "become clear that several elements of the 1998 paper . . . are incorrect, contrary to the findings of an earlier investigation (Lancet 2004;363:824)," adding, "We fully retract this paper from the published record." Although the retraction seems overdue, it can only be a good thing for science.
Cite this as: BMJ 2010;340:c644
-------------------------------------------------------------------------------- See also Observations BMJ 2010;340:c672, doi:10.1136/bmj.c672; News BMJ 2010;340:c696, doi:10.1136/bmj.c696; Editorial BMJ 2010;340:c655, doi:10.1136/bmj.c655.
References
Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998;351:637-41.[CrossRef][Web of Science][Medline] Horton R. The lessons of MMR. Lancet 2004;363:747-9.[CrossRef][Web of Science][Medline] Murch SH, Anthony A, Casson DH, Malik M, Berelowitz M, Dhillon AP, et al. Retraction of an interpretation. Lancet 2004;363:750.[CrossRef][Web of Science][Medline] Chen RT, DeStefano F. Vaccine adverse events: causal or coincidental? Lancet 1998;351:611-2.[CrossRef][Web of Science][Medline]
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jabsadmin
1005 Posts |
Posted - 03/02/2010 : 16:19:46
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http://www.bmj.com/cgi/eletters/340/feb02_4/c644
BMJ Rapid responses to OBSERVATIONS: Trisha Greenhalgh Why did the Lancet take so long? BMJ 2010; 340: c644
Rapid Responses published:
Statistical lessons to be learned as well S. Stanley Young (4 February 2010) Re: Statistical lessons to be learned as well John Stone (4 February 2010) Unfounded and unjust Mark Struthers (8 February 2010) Re: Re: Statistical lessons to be learned as well Peter J Flegg (8 February 2010) Judgement on what’s good for science? Mark Struthers (8 February 2010) Re: Re: Re: Statistical lessons to be learned as well John Stone (8 February 2010) The good, the bad and the ugly side of medical science Mark Struthers (8 February 2010) Evidence, statistical lessons and bias. Peter J Flegg (9 February 2010) The unexplained puzzle of the GMC verdict (and reponses to Peter Flegg) John Stone (10 February 2010) Trisha Greenhalgh: competing interests John Stone (24 February 2010) Research Michael l Boult (24 February 2010) Statistical lessons to be learned as well. Bill Welsh (26 February 2010) How Unfortunate! F. Edward Yazbak MD, FAAP (2 March 2010)
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Statistical lessons to be learned as well 4 February 2010 S. Stanley Young, Assistant Director of Bioinformatics National Institute of Statistical Sciences Send response to journal: Re: Statistical lessons to be learned as well
There has been and will be much examination and reconstruction of the circumstances in and around the Lancet paper of Wakefield. I add that there are statistical lessons to be learned as well. There were relatively few children in the two groups and though we can not count accurately from the paper, it has come out that there were a very large number of variables measured on each child, hundreds at least. With the large number of variables you will have small p-values, so their reported p-value of 0.003 is not unusual at all, even though it is likely to induce a “deer in the headlights” effect on most readers.
There is another statistical point. With the relatively small number of children in each group, the mean values for the groups will fluctuate widely. The resulting situation is that there will be small p-values with large estimated effects. It is doubtful that Lancet sent the paper to a real statistician, but a thinking statistician would not have passed the reported p-value in this paper.
Even after the authors did not divulge the biased sampling of the children, among other problems, could statistical problems have been identified? The editors and referees should have asked how many characteristics of the children were examined. A simple Bonferroni adjustment of the reported p-value would have given them serious pause. IF the data set had been public On Publication, knowledgeable readers could have made a strong case to kill the authors’claim. These statistical arguments are not meant to detract from the other objections to this paper, but to point to the general problems with small sample size/large number of variables observational studies.
Competing interests: None declared
*** Re: Statistical lessons to be learned as well 4 February 2010 John Stone, Contributing editor: Age of Autism London N22 Send response to journal: Re: Re: Statistical lessons to be learned as well
While I bow to S Stanley Young's superior statistical expertise I would point out that there is no control group in the so-called Lancet study [1]: and there was never any intention that a statistical inference could be drawn from it. It was published as an early report of 12 children with somewhat similar problems, seen in order of referral - a case series study [2] - even if some of the facts behind it stand officially disputed.
I think this illustrates the danger of paying too much attention to media or even professional reports, and jumping on bandwagon without looking where you are going.
[1] Wakefield et al, 'Ileal-lymphoid-nodular hyperplasia, non- specific colitis, and pervasive development disorder in children, THE LANCET, Vol 351, p.637-41, February 28, 1998 637
[2] Ben Goldacre, 'Don't dumb me down', Guardian 8 September 2005, http://www.guardian.co.uk/science/2005/sep/08/badscience.research
Competing interests: Autistic son
*** Unfounded and unjust 8 February 2010 Mark Struthers, GP and prison doctor Bedfordshire, mark.struthers@which.net Send response to journal: Re: Unfounded and unjust
I think it is now established that the study design was a small case series report and a perfectly good one, according to Dr Ben Goldacre. [1] But the Wakefield et al paper did not state a hypothesis, a flaw considered serious enough for Trisha Greenhalgh to invent one,
“The administration of MMR vaccine to infants increases their risk of developing (a) a particular pattern of inflammatory damage in the gastro- intestinal tract and (b) autism or an autism-like syndrome.” [2]
In her 2004 critical appraisal of the paper, Professor Greenhalgh then asks herself whether this design was an appropriate way to test the hypothesis. No, she says, “if the hypothesis was that there is a causal link between MMR and autism-bowel syndrome, this study design was incapable of proving that link one way or the other.” And the knowledge that case reports do only provide weak scientific evidence for such causal links, was probably why, in their paper, Wakefield et al stated,
“We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described.”
And why, in the last paragraph, they wrote,
“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.” [3]
[1] Ben Goldacre. Don't dumb me down. We laughed, we cried, we learned about statistics ... 8 September 2005. http://www.guardian.co.uk/science/2005/sep/08/badscience.research
[2] Professor Trisha Greenhalgh. Analysis of Wakefield MMR study asks why flaws weren't spotted by Lancet editors. April 2004. http://briandeer.com/mmr/lancet-greenhalgh.htm
[3] Early report. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. A J Wakefield, et al. THE LANCET • Vol 351 • February 28, 1998 637. http://www.theoneclickgroup.co.uk/documents/ME- CFS_docs/The%20Wakefield%20Paper,%20THE%20LANCET,%20Vol%20351,%20February%2028,%201998.pdf
Competing interests: None declared ***
Re: Re: Statistical lessons to be learned as well 8 February 2010 Peter J Flegg, Consultant Physician Blackpool, UK FY3 8NR Send response to journal: Re: Re: Re: Statistical lessons to be learned as well
The difficulty arises because Dr Wakefield himself drew the conclusion that vaccination was associated with enterocolitis/autism, and declared at a press conference that MMR might be causal. Yet we are now to believe that the publication was not meant to be a comparative study and represented merely a series of consecutively referred anecdotal problems. So on what possible evidence basis did Wakefield come to his bizarre conclusion?
We also now know that the cases were not actually consecutively referred through normal channels, and there was considerable deliberate selection bias in favour of children with autism in whom there was a specific concern about symptoms linked to vaccination. Whilst Wakefield might have been impressed by their clinical stories, he should have realised that this bias should have made him even more circumspect about drawing any conclusions about MMR's causal role.
Competing interests: None declared
*** Judgement on what’s good for science? 8 February 2010 Mark Struthers, GP and prison doctor Bedfordshire mark.struthers@which.net Send response to journal: Re: Judgement on what’s good for science?
In 2003, Richard Horton, editor of the Lancet, wrote these words about the 1998 Wakefield et al paper,
"The MMR vaccine paper was published not because peer review indicated that the findings were true - peer review can never prove truth, only indicate acceptability to a few experts, as was indeed the case with Wakefield’s findings - but because the issue raised was so important for public health and so in need of urgent verification that not to publish with appropriate caveats would, in my view, have been an outrageous act of censorship." [1]
And even Ben Goldacre, in 2005, said that he thought "the paper always was and still remains a perfectly good small case series report." [2]
And yet in 2010, Trisha Greenhalgh, professor of primary health care at UCL, believes that the recent retraction of the peer reviewed paper, published in 1998, "can only be a good thing for science."
Why? Professor Greenhalgh doesn't provide a credible explanation.
However, it is more than obvious that that what has happened to Andrew Wakefield will have taught scientists that it's safer not to rock the boat. Many doctors will be scared to speak for fear that what happened to Andrew Wakefield could happen to them. Can this state of affairs really be good for science? Andrew Wakefield doesn't think so, and I, for one, would strongly agree with him. [3] Over to you, Professor Greenhalgh.
[1] Richard Horton glorifies Wakefield, with "no regrets" over discredited MMR paper. Richard Horton, Second Opinion, Granta Books, 2003 http://briandeer.com/mmr/horton-wakefield.htm
[2] Ben Goldacre. Don't dumb me down. We laughed, we cried, we learned about statistics ... The Guardian, 8 September 2005. http://www.guardian.co.uk/science/2005/sep/08/badscience.research
[3] Sally Beck. Judgement day for MMR rebel: an investigation that has blighted doctor's life for 12 years finally approaches conclusion. Daily Mail, 23 January 2010. http://www.dailymail.co.uk/news/article-1245518/Judgement-day-MMR-rebel- investigation-blighted-doctors-life-12-years-finally-approaches- conclusion.html
Competing interests: None declared ***
Re: Re: Re: Statistical lessons to be learned as well 8 February 2010 John Stone, Contributing editor: Age of Autism London N22 Send response to journal: Re: Re: Re: Re: Statistical lessons to be learned as well
I do not see how Peter Flegg can hope to recuperate the ill-informed remarks of S Stanley Young. I could only conclude that Young had not even seen the paper he was criticising since it referred to "two groups" when there was only ever one.
This was not a statistical paper. I note Flegg's extreme and unscientific bias against the possibility that MMR or measles vaccination could be implicated in autism/Pervasive Development Disorder or bowel disease. On what principle would even a single child be denied investigation if their medical history indicated it?
Regardless of what the GMC panel claim to have found it is beyond credibility that a doctor of Prof Walker-Smith's experience and seniority would have ordered invasive tests on children with no symptoms. I note that that the histopathology results were positive for inflammation in 11 out of 12 cases. Perhaps, if we are to have a real doctors' purge the GMC ought to go after the signatory histopathologists now?
And, I don't know what conclusions we can draw about referral - is Flegg suggesting that there ought to have been other children that he knows about included in the sequence, and on what basis? It was never supposed to be a random group.
Competing interests: Autistic son ***
The good, the bad and the ugly side of medical science 8 February 2010 Mark Struthers, GP and prison doctor Bedfordshire mark.struthers@which.net Send response to journal: Re: The good, the bad and the ugly side of medical science
Dr Ben Goldacre, sometime correspondent for the BMJ and author of the ‘Bad Science’ column in Guardian once wrote,
"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." [1]
While acknowledging that the case series provides weak scientific evidence, Professor Greenhalgh, in her widely acclaimed book on the basics of evidence-based medicine, gives a good example of the case report providing an early warning of vital importance to science and public health,
“A doctor notices that two babies born in his hospital have absent limbs (phocomelia). Both mothers had taken a new drug (thalidomide) in early pregnancy. The doctor wishes to alert his colleagues worldwide to the possibility of drug-related damage as quickly as possible.” [2] Professor Greenhalgh goes on to say that “anyone who thinks ‘quick and dirty’ case reports are never scientifically justified should remember this example.” I am therefore somewhat surprised that Professor Trisha Greenhalgh should have considered the retraction of a perfectly good small case series report a good thing for science.
[1] Ben Goldacre. Don't dumb me down. We laughed, we cried, we learned about statistics ... 8 September 2005. http://www.guardian.co.uk/science/2005/sep/08/badscience.research
[2] Trisha Greenhalgh. How to Read a Paper. BMJ Publications, Third edition 2006 Sections 3.7 & 3.8, Pages 52-53.
Competing interests: None declared
*** Evidence, statistical lessons and bias. 9 February 2010 Peter J Flegg, Consultant Physician Blackpool, FY3 8NR Send response to journal: Re: Evidence, statistical lessons and bias.
John Stone has plainly failed to understand my point, so I will try again:
He and others are at great pains to point out that Andrew Wakefield’s Lancet study is merely a small, hypothesis-generating series of illustrative cases. This being so, what on earth was the evidence for Dr Wakefield’s claims following its publication that MMR vaccine should be avoided? An answer to this question would be appreciated.
Mr Stone seems particularly churlish when he accuses Stanley Young of being “ill informed” about statistics when he discusses the relevance of statistical differences between 2 groups of study subjects and of not reading the Lancet paper. It actually appears to be Mr Stone who has not read the paper, for in the “Laboratory tests” section it clearly refers to the statistical differences in laboratory biomarkers including urinary methylmalonic-acid levels between a study group of 8 children and a group of age-matched controls. Clearly these are 2 different groups, and they are what Stanley Young was referring to.
It is worth emphasising that the cases were not “consecutively referred” through normal channels, but the majority were specifically referred to the Royal Free either at the behest of Wakefield himself after parents had contacted him directly or because of their involvement in vaccine damage litigation. This means the study subjects were massively affected by selection bias towards children whose symptoms were allegedly due to MMR vaccine. This should have made Dr Wakefield extremely circumspect in drawing any causal inferences about the vaccine’s role.
I note that in 8 of the cases symptoms were allegedly temporally related to MMR vaccine, and in one case to natural measles infection. Unlike Stanley Young (and like Mr Stone) I am no statistician, but I wouldn’t mind knowing the statistical odds of Dr Wakefield encountering a case of measles-linked as opposed to vaccine-linked autism when in 1996 there were only 112 cases of measles documented nationally(1), yet there would have been approximately 570,000 thousand MMR vaccines administered (92% of 620,000 infants).
To me it would seem that having natural measles appeared to be a far, far riskier prospect than having an MMR vaccine, so I am surprised that Dr Wakefield didn’t alert people to this finding when he spoke at his press conference after the release of his Lancet study, and that he didn’t take the opportunity to reinforce the importance of MMR vaccination.
(1) http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1195733833790
Competing interests: None declared ***
The unexplained puzzle of the GMC verdict (and reponses to Peter Flegg) 10 February 2010 John Stone, Contributing editor: Age of Autism London N22 Send response to journal: Re: The unexplained puzzle of the GMC verdict (and reponses to Peter Flegg)
The panel stated in the short version of their findings on fact read out to journalists at the GMC last month [1]:
“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.”
However, it is my understanding that 162-95 was not a "project" in any normal sense but the ethical approval granted Prof Walker-Smith on his arrival at the Royal Free Hospital in September 1995 - as probably the most senior figure in British paediatric gastroenterology - to retain biopsy samples from colonoscopies for research purposes. If this is the case it would seem a basic criticism of the panel, that in reaching their view, they did not explain why this ethical permission did not obtain in this instance. We are also confronted by the oddity that the panel having concluded that the study was in fact project 172-96 then found the three doctors to be in breach of its terms at every twist and turn, instead of drawing the more obvious inference that it wasn't 172-96 at all, but an "early report" as stated. (And this, incidentally, is why several of us think that Ben Goldacre had it right in the first place.)
It is still baffling what is at stake over referral. It is common experience that when getting a specialist referral from a GP the patient is asked to which hospital they would like to be referred - an elective aspect is inherent in the system, as is reputation - and in this instance this was no ordinary department, so it is not clear what anyone would expect: it wasn't supposed to be "a scientific sample" or a statistical measure of anything, which is why I cannot make any sense of S Stanley Young's comment [2]. You do no not need to be a senior statistician to conclude that the group in the paper have little or no statistical significance, but this does not tell you why or how they are ill, and doesn't answer the parents' legitimate concern about adverse vaccine reactions and their sequelae. Nor could epidemiology tell you anything certain about that.
It seems to me that with Peter Flegg's [3] response, as so often with vaccination, ethics are being turned upside down. The instant position of those confronted with reports of adverse drug reactions is not to record them, or investigate but simply to retreat behind denial - which is what Andrew Wakefield conspicuously didn't do.
So we move to the next stage, which is that the doctor who did express concern about the safety of a vaccine and took parents on trust is as a matter of policy turned into a public enemy - and eventually a gigantic fishing expedition is mounted to see whether anything can be found against him. And all the time no parent has ever complained!
What we get is neither the practice of ethics or science but the exercise of social repression. Nothing ensures the unsafety of the system more certainly than the refusal to investigate sympathetically adverse reports - and why should a single child be denied investigation if their medical history indicates it? This is something that Flegg does not seem to be able to explain. Meanwhile, we get the resort to statistics which cannot show that it hasn't happened in individual instances, and probably also don't show that it hasn't happened en masse [4, 5]. Accompanied by total lack of curiousity as to why autism incidence figures continue to spin out of control (at the last count 1 in 64)[6].
I think it should remembered in fairness that Andrew Wakefield supported the then vaccine programme in 1998, endorsing the use of single vaccines, and the government promptly polarised the issue by making them unavailable. Also, I believe Flegg is being naieve in contrasting confirmed cases of measles in 1996, when there was probably only limited laboratory testing capacity and nothing like the active monitoring, with the present time.
About the GMC there is a huge problem of transparency - they publish the allegations and the findings but nothing in between. If you actually want to find out what the defence case was from the official transcript it will cost you upwards of £100,000 [7].
[1] Findings of Fact - Summary. General Medical Council, 28 January 2010. http://www.theoneclickgroup.co.uk/documents/vaccines/GMC%2C%20Findings%20Of%20Fact%20Summary2.pdf
[2] S Stanley Young, 'Statistical lessons to be learned as well' BMJ Rapid Responses 4 February 2010, http://www.bmj.com/cgi/eletters/340/feb02_4/c644#230877
[3] Peter Flegg, 'Evidence, statistical lessons, and bias' BMJ Rapid Responses 9 February 2010, http://www.bmj.com/cgi/eletters/340/feb02_4/c644#231116
[4] Demicheli V, Jefferson T, Rivetti A and Price D, 'Vaccines for Measles, Mumps and Rubella in Children', The Cochrane Library, Wiley 2005, http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/frame.html
[5] John Stone, 'Re: Evidence is not bullying', http://www.bmj.com/cgi/eletters/339/sep09_1/b3658#220537
[6] Baron-Cohen et al, 'Prevalence of autism-spectrum conditions: UK school-based population study', Br J Psychiatry. 2009 Jun;194(6):500- 9,http://www.ncbi.nlm.nih.gov/pubmed/19478287
[7] GMC Publication Scheme, http://www.gmc- uk.org/publications/right_to_know/publications_scheme.asp
Competing interests: Autistic son
*** Trisha Greenhalgh: competing interests 24 February 2010 John Stone, Contributing editor: Age of Autism London N22 Send response to journal: Re: Trisha Greenhalgh: competing interests
Prof Greenhalgh [1] does not disclose any competing interests. She has, however, contributed a controversial article [2,3] attacking the 1998 paper [4] to journalist Brian Deer's website. Although not disclosed here by Greenhalgh or in the accompanying article by Deer [5], Deer was named as a complainant against Andrew Wakefield in the High Court by Mr Justice Eady, who stated [6]:
"Well before the programme was broadcast [Mr Deer] had made a complaint to the GMC about the Claimant. His communications were made on 25 February, 12 March and 1 July 2004. In due course, on 27 August of the same year, the GMC sent the Claimant a letter notifying him of the information against him."
Since 2003 Greenhalgh has benefitted from more than £1.4m in research grants from the Department of Health [7]. When Deer's original allegations were published in the Sunday Times in February 2004 he was supported by the then Prime Minister, Tony Blair, who told ITV :
"There is absolutely no evidence to support this link between MMR and autism. If there was, I can assure you that any government would be looking at it and trying to act on it. I hope, now that people see that the situation is somewhat different to what they were led to believe, they will have the triple jab because it is important to do it."
and by Chief Medical Officer, Sir Liam Donaldson, who told the BBC :
"I don't think that spin and science mix. If they are mixed, it is a very unfavourable position for children's health. Now a darker side of this work has shown through, with the ethical conduct of the research and this is something that has to be looked at."
and Jeremy Laurance reported in the Independent [9]:
"At the Department of Health, which has striven for the past six years to bolster public confidence in the vaccine, joy is unconfined at the discrediting of Andrew Wakefield, as the researcher responsible for the scare."
Meanwhile, Health Secretary John Reid asked the GMC to investigate [10].
I express concern that conflicts that go up to the highest ranks of government are still conflicts, that the government itself is not a disinterested player, and has not behaved like one. At the same time Prof Greenhalgh's research has benefitted hansomely from its largesse. I believe there should be an inquiry.
[1] Trisha Greenhalgh, Why did the Lancet take so long? BMJ 2010; 340: c644
[2] Professor Trisha Greenhalgh. Analysis of Wakefield MMR study asks why flaws weren't spotted by Lancet editors. April 2004. http://briandeer.com/mmr/lancet-greenhalgh.htm
[3] Mark Struthers, 'Unfonded and Unjust' BMJ Rapid Responses 8 February 2010 http://www.bmj.com/cgi/eletters/340/feb02_4/c644#230993
[4] Wakefield et al, 'Ileal-lymphoid-nodular hyperplasia, non- specific colitis, and pervasive development disorder in children, THE LANCET, Vol 351, p.637-41, February 28, 1998 637
[5] Brian Deer,'Reflections on Investigating Wakefield' Published 2 February 2010, doi:10.1136/bmj.c672
[6] Melanie Phillips, 'A deer in the headlights', The Spectator 16 February 2009, http://www.spectator.co.uk/melaniephillips/3362116/a-deer- in-the-headlights.thtml
[7] Profile: Prof Trisha Greenhalgh: Funding Received: http://myprofile.cos.com/P243302GRa
James Meikle, 'Claim that MMR work mixed science and spin', Guardian 24 February 2004, http://www.guardian.co.uk/uk/2004/feb/24/science.sciencenews
[9] Jeremy Laurance, 'Ministers temper their triumphalism but delight spreads at Whitehall', 24 February 2004, http://www.independent.co.uk/news/uk/politics/ministers-temper-their- triumphalism-but-delight-spreads-at-whitehall-571091.html
[10] BBC NEWS, Top doctor wades into MMR debate', http://news.bbc.co.uk/1/hi/health/3512195.stm
Competing interests: Autistic Son Research 24 February 2010
***
Michael l Boult, semi-retired and carer BH24 3DZ Send response to journal: Re: Research
My response is to all who are not parents or relatives of a child who regressed after the MMR vaccination,to all the experts and doctors who deny the possibility, who are so critical that it becomes suspicious-my gp believed and sent yellow card,let me ask why no reseach,only foreign quoted studies basically statistics have been in the media? can anyone dispute over a million parents? whose fear and worry over the years has been ignored or browbeaten by the status quo? NO. Mr clegg tut tut.
Competing interests: Regressed Autistic daughter
*** Statistical lessons to be learned as well. 26 February 2010 Bill Welsh, President Autism Treatment Trust, Edinburgh. EH3 7BJ Send response to journal: Re: Statistical lessons to be learned as well.
With regard to Stanley Young’s observation that “there were relatively few children” and Professor Greenhalgh’s “his tiny skewed sample” it is important to remember that there was an addendum to the 1998 paper. The report in the Lancet was on the FIRST 12 children. The addendum to the paper says:
''Up to Jan 28, a further 40 patients have been assessed; 39 with the syndrome'.(1)
Hundreds more followed.
Perhaps this also goes some way to answering Peter Flegg’s point regarding evidence.
(1) Wakefield et al, 'Ileal-lymphoid-nodular hyperplasia, non- specific colitis, and pervasive development disorder in children, THE LANCET, Vol 351, p.637-41, February 28, 1998 641. Addendum: Up to Jan 28, a further 40 patients have been assessed; 39 with the syndrome.
Competing interests: Grandfather to an autistic boy.
Editorial note: Reposted 26 February 2010.
***
How Unfortunate! 2 March 2010 F. Edward Yazbak MD, FAAP, Pediatrician Falmouth, Massachusetts 02540 Send response to journal: Re: How Unfortunate!
The question is really not "What took the Lancet so long?" The question is: “Why did the GMC take so long and spend all this money and effort without interviewing all available parents and grandparents of the children who supposedly were tortured and traumatized at the GI unit at the Royal Free Hospital?"
Take me for example. I am the grandfather of one of those children. I am a pediatrician, a former assistant clinical director of a teaching hospital and a former director of pediatrics in a community hospital. I know and understand “Quality of Care” inside out: I taught it to residents and required it from staff.
I certainly can state without hesitation that we were always treated with utmost courtesy and that our boy received outstanding care at the Royal Free. Thanks to Professor Murch, who was his doctor, the awful GI difficulties subsided gradually and never recurred. Sometimes Professor Walker Smith would see him in coverage and help us immensely. Both gentlemen were at all times caring, kind, courteous and as everyone knows most knowledgeable.
I also met Dr. Wakefield at the time and was thoroughly impressed with his on-going research and his prior achievements. I have yet to find a single valid reason for his persecution.
Our family was simply jubilant when our big boy was accepted in the “study” and we can attest that all his testing was justified, fully and clearly explained and expertly carried out. He was never hurt or injured in any way. In fact he looked forward to his trips to Hampstead.
If after all this time we were asked to summarize in one word our Royal Free experience that word would be “SPECTACULAR”.
Now if I had to describe in one word my perception of the GMC hearings, that word would have to be “OUTRAGEOUS”.
What is happening to Professor Walker-Smith, Professor Simon Murch and Dr. Andrew Wakefield, three dedicated and wonderful physicians is unjust, unfair and unforgivable.
Competing interests: Grandfather of a child with regressive autism
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Seonaid
United Kingdom
1174 Posts |
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Govna
43 Posts |
Posted - 03/05/2010 : 10:10:13
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http://www.rescuepost.com/files/100120---gmc---first-amended-complaint-1.pdf
The whole document is 89 pages long, excerts below:
FIRST AMENDED COMPLAINT (Breach of duty of honesty and candor; False Testimony; Misuse of Professional Position, Failure to Disclose Conflicting Interest, False Expert Testimony)
'All truth passes through three stages. First, it is ridiculed, second it is violently opposed, and third, it is accepted as self-evident.' - Arthur Schopenhauer
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Rosemary
United Kingdom
2025 Posts |
Posted - 03/05/2010 : 21:20:38
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How Unfortunate and Short Sighted. 3 March 2010 Michael D Innis, Send response to journal: Re: Re: How Unfortunate and Short Sighted.
Editor,
What Wakefield and his collaegues showed was "urinary methylmalonic acid was significantly raised in all eight children who were tested compared with age matched controls".
Methylmalonic acid is a neurotoxin and it "may contribute to neuronal injury in human conditions in which it accumulates". [1]
Instead of discrediting his work researchers should be concerned with reducing the toxic effect of methylmalonic acid following MMR vaccination.
Reference
1. Narasimhan P, Sklar R, Murrell M, Swanson RA,Sharp FR. Methylmalonyl-CoA Mustase Induction by Cerbral Ischemia and Neurotoxicity of the Mitochrondrial Toxin Methylmalonic Acid. Journal of Neuroscience;1996: vol16; pp7336-7346
Competing interests: None declared http://www.bmj.com/cgi/eletters/340/feb02_4/c644#232203 |
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Rosemary
United Kingdom
2025 Posts |
Posted - 03/05/2010 : 21:25:31
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Did retracting the paper matter? 4 March 2010 F. Edward Yazbak, Pediatrician Falmouth, Massacusetts 02540 Send response to journal: Re: Did retracting the paper matter?
It is clear that many were pleased when the Lancet retracted “the paper”. The question is: Did that accomplish much? Did it change the fact that "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children" are related? Did it wipe out the brilliant observation by the GI team at the Royal Free that a gut- brain connection existed? The answer is obviously NO.
Dr. Wakefield, Professor Simon Murch and others elaborated further on the autism-related gastro-intestinal findings when they published a review article in 2002, titled “The concept of entero-colonic encephalopathy, autism and opioid receptor ligands”. The authors proposed that it was plausible that exogenous, gut-derived neurotoxins entered the systemic circulation “during a critical window of vulnerability”, damaged the central nervous system and caused autism.
They also mentioned that the gut-brain axis is central to certain encephalopathies and that opioid peptides may mediate some aspects of autism. Most importantly, they gave hope to the rapidly increasing population of parents with affected children by pointing out that modification of the diet was likely to reduce the toxicity of certain opioids and improve symptoms.
Obviously Wakefield’s opponents were not too happy. They went on discrediting his theory that the brain injury and deficits in regressive autism were related to very specific GI findings and they claimed that his findings had not been reproduced by others, when indeed they were in multiple centers in the U.S. They also never mentioned how effective the gluten-free and casein-free diets were in improving symptoms in many affected children.
In late 2009, just when the GMC was getting ready to reveal its “verdict”, a team from Norway published an important and very carefully conducted study. At any other time, the reported findings would have and should have caused world-wide interest. They did not, probably because they would have vindicated Wakefield and shown that the GMC was “on a collision course with reality” as a good friend put it.
In a review article titled "The possibility and probability of a gut- to-brain connection in autism" and published in the Annals of Clinical Psychiatry, Reichelt and Knivsberg reported that “In autistic syndromes, we can show marked increases in UV 215-absorbing material eluting after hippuric acid that are mostly peptides. We also show highly significant decreases after introducing a gluten- and casein-free diet with a duration of more than 1 year. We refer to previously published studies showing improvement in children on this diet who were followed for 4 years and a pairwise matched, randomly assigned study with highly significant changes.”
The authors added that the literature now showed abundant data pointing to the importance of a gut-to-brain connection in autism and concluded: “An effect of diet on excreted compounds and behavior has been found. A gut-to-brain axis is both possible and probable.”
The Lancet paper didn’t matter after all!
Competing interests: Grandfather of a child with regressive autism http://www.bmj.com/cgi/eletters/340/feb02_4/c644#232203 |
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Rosemary
United Kingdom
2025 Posts |
Posted - 03/10/2010 : 19:33:09
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http://www.bmj.com/cgi/eletters?lookup=by_date&days=4#232512
Why did the Lancet take so long? Response to Mr. Deer’s remarks 9 March 2010 F. Edward YAZBAK, Pediatrician Falmouth, Massachusetts 02540 Send response to journal: Re: Response to Mr. Deer’s remarks
Mr. Deer is absolutely correct: My grandson was not one of the 12 children enrolled in the original Wakefield study that was published in the Lancet in February 1998. If he had been, I would have certainly mentioned that among my competing interests for the last 10 years. Had Mr. Deer written earlier, I would have made that clear.
It almost seems that Mr. Deer is less upset about what I wrote than about the fact that some web site somewhere had picked it up. I certainly have no idea where my remarks were circulated and by whom and I have no control of that.
In any case: If anyone else misunderstood my statement (s), I sincerely apologize for the confusion. No deceit was ever intended!
I must say that I am troubled that Mr. Deer was able to obtain the names and family backgrounds of the 12 original study patients. I am also surprised that he finds it fair to censor my defense of Dr. Wakefield after he subjected him to public flagellation for so long. Maybe it is time for Mr. Deer to take a deep breath and relax.
From everything I have read, it seems clear that the accusatory claims related to pain, suffering and unwarranted risky investigations that were discussed in the last few years were not limited to those original twelve children. They certainly seemed to be about the many others who were later seen and “studied” for autistic entero-colitis at the Royal Free GI unit and whose cases were reported in subsequent publications and presentations. When I mentioned “all available parents and grandparents of the children…” I certainly had in mind those hundreds of parents and grandparents that were never interviewed by the GMC committee. Whether they were inside the hall or on the sidewalk, outside of London or outside of the United Kingdom, many of them would have been elated to testify. It is regrettable that they were not allowed to.
When we took our boy to the Royal Free, we wanted to find out what was wrong with him. We just could not see him suffer and cry all day anymore. It was our understanding that while many children with autism and GI problems were being treated at the unit, only few could be fully investigated because of a multitude of reasons. We were therefore most elated when my grandson was selected. That is what I meant when I mentioned the “study”. We still count our blessings that my daughter and her family were living in London at the time.
It is no secret that I have been and will always be a supporter of Dr. Wakefield. Yet, I would point out that I did not submit a single rapid response to the BMJ in nearly two years and that I did not criticize the GMC ethics hearings while they were going on. Dr. Wakefield’s attackers on the other hand never hesitated to publish defamatory remarks about him throughout that same period of time.
Mr. Deer is fortunate not to have a child, a relative or a friend with regressive autism. We were not so lucky and when we were down and out, we received comfort and extra good care from three wonderful physicians who unfortunately are still being subjected to a living hell.
Competing interests: Grandfather of a boy with regressive autism
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Rosemary
United Kingdom
2025 Posts |
Posted - 03/10/2010 : 19:36:12
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Why did the Lancet take so long? Brian Deer's viewing of medical files. 9 March 2010 Hilary Butler, freelance journalist home 2121 New Zealand. Send response to journal: Re: Brian Deer's viewing of medical files.
Dear Sir,
There are several UK medical studies relating to vaccines where I suspect that the authors are up to no good, so I would like unrestrained access to all key documents to see if I can confirm my suspicions, but can't quite work out how to do this.
Could Brian Deer please let the BMJ know the means by which UK legislation allows free lance (or any other) journalists, to view original research files, and compare them with Royal Free (or any other hospital or private practice) medical files of children with full identities available, all test results available, without parental consent; the studies' authors consent; privacy restraints or hospital ethics committee approval?
Could Brian Deer also let the BMJ know the means by which a freelance journalist initiates proceedings with the GMC? As he so graphically stated on Radio New Zealand, (1) such fraudulent behaviour is but the tip of medical fraud iceberg.
Sincerely,
Hilary Butler.
(1) http://www.radionz.co.nz/audio/national/ntn/2010/02/11/feature_guest_- _brian_deer
Competing interests: None declared Also additional responses http://www.bmj.com/cgi/eletters?lookup=by_date&days=4#232512 |
Edited by - Rosemary on 03/11/2010 16:39:18 |
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Seonaid
United Kingdom
1174 Posts |
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jabsadmin
1005 Posts |
Posted - 03/11/2010 : 16:58:59
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http://www.bmj.com/cgi/eletters?lookup=by_date&days=4#232530
Why did the Lancet take so long? Patient Confidentiality 10 March 2010 John A. Dodge, Hon. Professor of Child Health University of Wales Swansea
Send response to journal: Re: Patient Confidentiality Like Hilary Butler, I was surprised that the journalist Brian Deer apparently holds names and addresses of autistic patients, as well as the details of their clinical histories.
As the former director of a national disease registry, I am well aware of the difficulty bona fide medical researchers often encounter, and of the great lengths to which hospitals and Trusts go to ensure confidentiality, and where possible anonymity, for patients before they will release any information, for fear of violating the Data Protection Act.
It is particularly surprising that a journalist for a lay newspaper under orders to find a big story (Mr Deer's own words) could persuade a respected teaching hospital to give him such data. Did the request go to the research ethics committee? Did he obtain written consent from the parents? Was he not given instructions to destroy all information which could possibly identify individuals as soon as he had extracted what he needed, in which case he should no longer hold names and addresses?
Remembering the threat of litigation if journalists should try to reveal the immunisation status of the child of the then Prime Minister, I can only conclude that Mr Deer either covered his back and went through the correct procedures, or else that he assumed that the parents would have no appetite, or money, to take him, his newspaper or the hospital Trust to court for violating their privacy. I await his clarification with interest.
Competing interests: Occasional frustration at inability to obtain information from medical records for epidemiological research |
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Seonaid
United Kingdom
1174 Posts |
Posted - 03/11/2010 : 18:33:30
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Well, well, well: Wakefield questions
http://www.vueweekly.com/article.php?id=14512
It turns out I didn't get an inch past the shoreline when I dipped my toes into the Andrew Wakefield Lancet paper retraction story a few weeks ago, so I decided to revisit it. To give the man at the centre of the controversy the opportunity to respond to media statements being made about his ethics and integrity, I contacted him.
To recap, The Lancet retracted Wakefield's 1998 paper suggesting a potential link between the measles, mumps, rubella (MMR) vaccine and the bowel disorders he was seeing in his autistic patients. Journalists and medical professionals alike have been cheering ever since: the so-called hoax and vaccine conspiracy theory has been exposed, and we can now apparently relax in the safety of the MMR vaccine.
I asked Wakefield if it was true that he'd been paid over 400 000 pounds by trial lawyers working to prove the vaccine unsafe. "I worked as a medical expert for nine years on the MMR litigation," he wrote in an email. "When the case folded because Legal Aid was withdrawn, the lawyers refused to pay what was owed and the costs judge took a lot of the fees back from the various experts. What I did earn was donated to an initiative to build a new centre for gastroenterology care and research at the Royal Free [in London]. Unfortunately I was forced out and it never got built." Not a single penny of Legal Aid Board (LAB) money was spent on the Lancet paper. A LAB grant was provided for a separate viral detection study, but the Lancet paper had been submitted for publication before the LAB grant was even available.
What about allegations that Wakefield had been working for a company making a rival vaccine? He was involved in developing a nutritional immune stimulant they hoped would clear up chronic vaccine-induced measles infection. But this, he says, "could in no way have competed with a live viral vaccine and was not intended for that purpose. The patent was owned by the medical school and not by me. It was never progressed." The charge that Wakefield is responsible for new outbreaks of measles, mumps and rubella is, to my mind, absurd. Parents have become wary of vaccines, true, but this, it seems to me, is the doing of vaccines, not of Dr Wakefield.
Further, outbreaks among the vaccinated happen all the time—77 percent of those affected in the recent New York and New Jersey outbreak were immunized. And though the outbreaks in England and Wales have reportedly occurred mostly in unvaccinated children, the question we ought to be asking is whether we need to fear measles as much as we do. United States mortality statistics indicate that the mortality rate—13.3 per 100 000 in 1900 and 0.2 by 1945—was negligible by 1963 when the vaccine was introduced.
What Wakefield did is publish a case study of a group of patients in which he'd identified a common thread. These kinds of studies often lead to new hypotheses. This is how science is supposed to work. The feeling of the parents of the children involved in the study and the many who have since been helped by Dr Wakefield's work is that he was being a responsible physician in pursuing the cause of his patients' illness.
But industry has a habit of quashing science that may not be good for business. Follow the links: The Lancet is published by Reed Elsevier. The CEO of Reed Elsevier during the time period in question was Sir Crispin Davis, who was also a non-executive director of GlaxoSmithKlein, one of three defendant drug companies in the MMR controversy.
We all know that money is power, and that money wins legal battles, and that the pharmaceutical industry has money like no other. As Noam Chomsky would say, it takes effort not to see what's happening. This is not conspiracy theory. Wakefield has been singled out for the purpose of discouraging other doctors willing to listen to their patients and do the relevant research even when it challenges vaccine dogma. His career and reputation have been severely harmed as a result of putting his patients ahead of his own protection.
But Wakefield views that as trivial compared to what has been lost to the children. In his mind, they are the real victims.
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Rosemary
United Kingdom
2025 Posts |
Posted - 03/16/2010 : 14:19:45
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http://www.ageofautism.com/2010/03/brian-deer-blunders-in-british-medical-journal-.html#more
Brian Deer Blunders in British Medical Journal By John Stone
A blunder by Sunday Times journalist Brian Deer has left him exposed in the columns of British Medical Journal on-line, leaving open the question of how he could have legally obtained information on the background to cases in the disputed Lancet study including the identities of the patients and their families (HERE: http://www.bmj.com/cgi/eletters/340/feb02_4/c644).
Deer had intervened in continuing correspondence following ‘the findings of fact’ in the General Medical Council case against Andrew Wakefield, John Walker-Smith and Simon Murch, and the Lancet’s decision to retract the 1998 paper. Misunderstanding a claim by distinguished US paediatrician and autism/vaccine campaigner, Ed Yazbak, that his grandson was one of the Royal Free cases, Deer wrote:
“I know the names and family backgrounds of all 12 of the children enrolled in the study, including the child enrolled from the United States. I don't believe that Dr Yazbak has a family relationship with any of them.”
In fact, Yazbak had never intended to imply that his grandson was one of the original 12, only that he had been a patient at the Royal Free and had been included in ongoing research into autism, gut disease and MMR at the hospital.
The issue of Deer’s access to confidential patient material had arisen before - both in relation to articles in the Sunday Times and to posts on his website - but there had never been opportunity to question him about it in a public forum before. Deer was immediately embarrassed by a mild mannered response from Yazbak, pointing out the misunderstanding, but asking how he came by such information, and a more caustic one by well-known New Zealand vaccine campaigner, Hilary Butler.
Yazbak rejoindered:
“ It almost seems that Mr. Deer is less upset about what I wrote than about the fact that some web site somewhere had picked it up. I certainly have no idea where my remarks were circulated and by whom and I have no control of that.
“In any case: If anyone else misunderstood my statement (s), I sincerely apologize for the confusion. No deceit was ever intended! I must say that I am troubled that Mr. Deer was able to obtain the names and family backgrounds of the 12 original study patients.
“I am also surprised that he finds it fair to censor my defense of Dr. Wakefield after he subjected him to public flagellation for so long. Maybe it is time for Mr. Deer to take a deep breath and relax. “ While Butler wrote:
“There are several UK medical studies relating to vaccines where I suspect that the authors are up to no good, so I would like unrestrained access to all key documents to see if I can confirm my suspicions, but can't quite work out how to do this.
“Could Brian Deer please let the BMJ know the means by which UK legislation allows free lance (or any other) journalists, to view original research files, and compare them with Royal Free (or any other hospital or private practice) medical files of children with full identities available, all test results available, without parental consent; the studies' authors consent; privacy restraints or hospital ethics committee approval?”
But worse was to come for Deer when the following day he was further challenged by senior British doctor, Prof John Dodge – who is Honorary Professor of Child Health at Swansea, Emeritus Professor of Child Health at Belfast, and has a remarkable string of letters after his name (CBE, MD, FRCP, FRCP(Edin), FRCPI, FRCPCH, DCH):
“Like Hilary Butler, I was surprised that the journalist Brian Deer apparently holds names and addresses of autistic patients, as well as the details of their clinical histories.
“As the former director of a national disease registry, I am well aware of the difficulty bona fide medical researchers often encounter, and of the great lengths to which hospitals and Trusts go to ensure confidentiality, and where possible anonymity, for patients before they will release any information, for fear of violating the Data Protection Act.
“It is particularly surprising that a journalist for a lay newspaper under orders to find a big story (Mr Deer's own words) could persuade a respected teaching hospital to give him such data. Did the request go to the research ethics committee? Did he obtain written consent from the parents? Was he not given instructions to destroy all information which could possibly identify individuals as soon as he had extracted what he needed, in which case he should no longer hold names and addresses?
“Remembering the threat of litigation if journalists should try to reveal the immunisation status of the child of the then Prime Minister, I can only conclude that Mr Deer either covered his back and went through the correct procedures, or else that he assumed that the parents would have no appetite, or money, to take him, his newspaper or the hospital Trust to court for violating their privacy. I await his clarification with interest.
“Competing interests: Occasional frustration at inability to obtain information from medical records for epidemiological research”
It is also a remarkable aspect of this story that despite the ethically questionable nature of these activities Deer’s work continues to receive the support not only of the government and the National Health Service, but collaborators such as Prof Greenhalgh and Dr Evan Harris MP. Some of these bodies and personages ought to start considering their position in relation to this affair.
As to Deer, he remains silent...
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Govna
43 Posts |
Posted - 03/17/2010 : 12:11:58
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http://www.rescuepost.com/files/100120---gmc---first-amended-complaint-1.pdf
FIRST AMENDED COMPLAINT (Breach of duty of honesty and candor; False Testimony; Misuse of Professional Position, Failure to Disclose Conflicting Interest, False Expert Testimony)...................
'All truth passes through three stages. First, it is ridiculed, second it is violently opposed, and third, it is accepted as self-evident.' - Arthur Schopenhauer
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