Andrew Wakefield: Difference between revisions
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Other concerns regarding Wakefield were that an extension of his project caused life-threatening complications in one child, who received substantial compensation in an out-of-court settlement.<ref>{{cite news |author=Ellis, Rachel |title=£500,000 for boy left fighting for life after being used as MMR guinea pig|url=http://www.dailymail.co.uk/health/article-500611/500-000-boy-left-fighting-life-used-MMR-guinea-pig.html |work=Daily Mail |date=10 December 2007 |accessdate=2009-03-29 | location=London| archiveurl= http://web.archive.org/web/20090213083219/http://www.dailymail.co.uk/health/article-500611/500-000-boy-left-fighting-life-used-MMR-guinea-pig.html| archivedate= 13 February 2009 <!--DASHBot-->| deadurl= no}}</ref> Wakefield's data were also questioned;<ref name="truth"/> a former graduate student, who appeared in Deer's programme, later testified that Wakefield ignored laboratory data which conflicted with his hypothesis. An independent investigation of a collaborating laboratory questioned the accuracy of the data underpinning Wakefield's claims.<ref name="newsweek">{{cite news |work=Newsweek | title = Anatomy of a Scare | date = 21 February 2009| accessdate = 2010-01-28| author= Begley, Sharon | url = http://www.newsweek.com/id/185853/page/1| archiveurl= http://web.archive.org/web/20100208135234/http://www.newsweek.com/id/185853/page/1| archivedate= 8 February 2010 <!--DASHBot-->| deadurl= no}}</ref> |
Other concerns regarding Wakefield were that an extension of his project caused life-threatening complications in one child, who received substantial compensation in an out-of-court settlement.<ref>{{cite news |author=Ellis, Rachel |title=£500,000 for boy left fighting for life after being used as MMR guinea pig|url=http://www.dailymail.co.uk/health/article-500611/500-000-boy-left-fighting-life-used-MMR-guinea-pig.html |work=Daily Mail |date=10 December 2007 |accessdate=2009-03-29 | location=London| archiveurl= http://web.archive.org/web/20090213083219/http://www.dailymail.co.uk/health/article-500611/500-000-boy-left-fighting-life-used-MMR-guinea-pig.html| archivedate= 13 February 2009 <!--DASHBot-->| deadurl= no}}</ref> Wakefield's data were also questioned;<ref name="truth"/> a former graduate student, who appeared in Deer's programme, later testified that Wakefield ignored laboratory data which conflicted with his hypothesis. An independent investigation of a collaborating laboratory questioned the accuracy of the data underpinning Wakefield's claims.<ref name="newsweek">{{cite news |work=Newsweek | title = Anatomy of a Scare | date = 21 February 2009| accessdate = 2010-01-28| author= Begley, Sharon | url = http://www.newsweek.com/id/185853/page/1| archiveurl= http://web.archive.org/web/20100208135234/http://www.newsweek.com/id/185853/page/1| archivedate= 8 February 2010 <!--DASHBot-->| deadurl= no}}</ref> |
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In June 2005, the [[BBC]] programme ''[[Horizon (BBC TV series)|Horizon]]'' reported on an unnamed and unpublished study of blood samples from a group of 100 autistic children and 200 children without autism. They reported finding 99% of the samples contained no trace of the measles virus, and the samples that did contain the virus were just as likely to be from non-autistic children, i.e. only three samples contained the measles virus, one from an autistic child and two from a |
In June 2005, the [[BBC]] programme ''[[Horizon (BBC TV series)|Horizon]]'' reported on an unnamed and unpublished study of blood samples from a group of 100 autistic children and 200 children without autism. They reported finding 99% of the samples contained no trace of the measles virus, and the samples that did contain the virus were just as likely to be from non-autistic children, i.e. only three samples contained the measles virus, one from an autistic child and two from a normal child. The study's authors found no evidence of any link between MMR and autism.<ref>{{cite news | title = Does the MMR Jab Cause Autism? The latest scientific evidence | publisher = BBC Horizon | url = http://www.bbc.co.uk/sn/tvradio/programmes/horizon/mmr_prog_summary.shtml | accessdate = 2007-08-10 }}</ref> |
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The [[Institute of Medicine]] (IOM) of the [[United States National Academy of Sciences]],<ref>{{cite book | author = Immunization Safety Review Committee | title = Immunization Safety Review: Vaccines and Autism | year = 2004 | publisher = Institute of Medicine | accessdate = 2007-08-10 | isbn = 0-309-53275-2}}{{dead link|date=September 2011}}</ref> along with the [[Centers for Disease Control and Prevention|CDC]]<ref>{{cite web |url=http://www.cdc.gov/vaccinesafety/Vaccines/MMR/MMR.html |title= Measles, mumps, and rubella (MMR) vaccine |date=15 May 2010 |accessdate=2011-01-08 |publisher= Centers for Disease Control and Prevention}}</ref> and the UK [[National Health Service]],<ref>{{cite web |url=http://www.nhs.uk/Conditions/MMR/Pages/FAQs.aspx#autismrisk |accessdate=2011-01-08 |year=2009 |title= MMR – FAQs |publisher= National Health Service}}</ref> have found no link between vaccines and autism. Reviews in the medical literature have also found no link between the MMR vaccine and autism or with bowel disease, which Wakefield called "[[autistic enterocolitis]]."<ref>{{cite journal | author=Jefferson T, Price D, Demicheli V, Bianco E | title=Unintended events following immunization with MMR: a systematic review | journal=Vaccine | year=2003 | pages=3954–60 | volume=21 | issue=25–26 | pmid=12922131 | doi=10.1016/S0264-410X(03)00271-8}}</ref><ref>{{cite journal |author= Gerber JS, Offit PA |title= Vaccines and Autism: A Tale of Shifting Hypotheses |journal= Clin Infect Dis |volume=48 |issue=4 |pages=456–61 |year=2009 |pmid=19128068 |pmc= 2908388 |doi=10.1086/596476 |url=http://www.journals.uchicago.edu/doi/full/10.1086/596476 |laysummary=http://www.idsociety.org/Content.aspx?id=13336 |laysource=IDSA |laydate=2009-01-30}}{{dead link|date=September 2011}}</ref><ref>{{cite journal |author=Demicheli V, Rivetti A, Debalini MG, Di Pietrantonj C |title=Vaccines for measles, mumps and rubella in children |journal=Cochrane Database Syst Rev |volume=2 |pages=CD004407 |year=2012 |pmid=22336803 |doi=10.1002/14651858.CD004407.pub3}}</ref> |
The [[Institute of Medicine]] (IOM) of the [[United States National Academy of Sciences]],<ref>{{cite book | author = Immunization Safety Review Committee | title = Immunization Safety Review: Vaccines and Autism | year = 2004 | publisher = Institute of Medicine | accessdate = 2007-08-10 | isbn = 0-309-53275-2}}{{dead link|date=September 2011}}</ref> along with the [[Centers for Disease Control and Prevention|CDC]]<ref>{{cite web |url=http://www.cdc.gov/vaccinesafety/Vaccines/MMR/MMR.html |title= Measles, mumps, and rubella (MMR) vaccine |date=15 May 2010 |accessdate=2011-01-08 |publisher= Centers for Disease Control and Prevention}}</ref> and the UK [[National Health Service]],<ref>{{cite web |url=http://www.nhs.uk/Conditions/MMR/Pages/FAQs.aspx#autismrisk |accessdate=2011-01-08 |year=2009 |title= MMR – FAQs |publisher= National Health Service}}</ref> have found no link between vaccines and autism. Reviews in the medical literature have also found no link between the MMR vaccine and autism or with bowel disease, which Wakefield called "[[autistic enterocolitis]]."<ref>{{cite journal | author=Jefferson T, Price D, Demicheli V, Bianco E | title=Unintended events following immunization with MMR: a systematic review | journal=Vaccine | year=2003 | pages=3954–60 | volume=21 | issue=25–26 | pmid=12922131 | doi=10.1016/S0264-410X(03)00271-8}}</ref><ref>{{cite journal |author= Gerber JS, Offit PA |title= Vaccines and Autism: A Tale of Shifting Hypotheses |journal= Clin Infect Dis |volume=48 |issue=4 |pages=456–61 |year=2009 |pmid=19128068 |pmc= 2908388 |doi=10.1086/596476 |url=http://www.journals.uchicago.edu/doi/full/10.1086/596476 |laysummary=http://www.idsociety.org/Content.aspx?id=13336 |laysource=IDSA |laydate=2009-01-30}}{{dead link|date=September 2011}}</ref><ref>{{cite journal |author=Demicheli V, Rivetti A, Debalini MG, Di Pietrantonj C |title=Vaccines for measles, mumps and rubella in children |journal=Cochrane Database Syst Rev |volume=2 |pages=CD004407 |year=2012 |pmid=22336803 |doi=10.1002/14651858.CD004407.pub3}}</ref> |
Revision as of 21:54, 2 September 2013
Andrew Wakefield | |
---|---|
Born | 1957 (age 66–67) |
Nationality | British |
Education | King Edward's School, Bath |
Alma mater | St Mary's Hospital Medical School, London |
Occupation(s) | Former surgeon, researcher |
Known for | MMR vaccine controversy |
Andrew Jeremy Wakefield (born 1957) is a British former surgeon and medical researcher, known for his fraudulent 1998 research paper in support of the now-discredited claim that there is a link between the administration of the measles, mumps and rubella (MMR) vaccine, and the appearance of autism and bowel disease.[1][2][3]
Four years after the publication of the paper, other researchers' results had still failed to reproduce Wakefield's findings or confirm his hypothesis of a relation between childhood gastrointestinal disorders and autism.[4] A 2004 investigation by Sunday Times reporter Brian Deer identified undisclosed financial conflicts of interest on Wakefield's part,[5] and most of his co-authors then withdrew their support for the study's interpretations.[6] The British General Medical Council (GMC) conducted an inquiry into allegations of misconduct against Wakefield and two former colleagues.[7] The investigation centred on Deer's numerous findings, including one that autistic children were subjected to unnecessary invasive medical procedures,[8] such as colonoscopy and lumbar puncture, and that Wakefield acted without the required ethical approval from an institutional review board.
On 28 January 2010, a five-member statutory tribunal of the GMC found three dozen charges proved, including four counts of dishonesty and 12 counts involving the abuse of developmentally challenged children.[9] The panel ruled that Wakefield had "failed in his duties as a responsible consultant", acted both against the interests of his patients, and "dishonestly and irresponsibly" in his published research.[10][11][12] The Lancet immediately and fully retracted his 1998 publication on the basis of the GMC’s findings, noting that elements of the manuscript had been falsified.[13] Wakefield was struck off the Medical Register in May 2010, with a statement identifying dishonest falsification in The Lancet research,[14] and is barred from practicing medicine in the UK.[15]
In January 2011, an editorial accompanying an article by Brian Deer in BMJ identified Wakefield's work as an "elaborate fraud".[1][16][17] In a follow-up article,[18] Deer said that Wakefield had planned to launch a venture on the back of an MMR vaccination scare that would profit from new medical tests and "litigation driven testing".[19] In November 2011, yet another report in BMJ[20] revealed original raw data indicating that, contrary to Wakefield's claims in The Lancet, children in his research did not have inflammatory bowel disease.[21][22]
Wakefield's study and public recommendations against the use of the combined MMR vaccine were linked to a steep decline in vaccination rates in the United Kingdom and a corresponding rise in measles cases, resulting in serious illness and fatalities.[23][24][25] Wakefield has continued to defend his research and conclusions, saying there was no fraud, hoax or profit motive.[26][27]
Personal life and career
Wakefield was born in 1957;[28][29] his father was a neurologist and his mother was a general practitioner.[30] After leaving the independent King Edward's School, Bath,[31] Wakefield studied medicine at St Mary's Hospital Medical School[30] (now Imperial College School of Medicine), fully qualifying in 1981. He became a fellow of the Royal College of Surgeons in 1985.[29] At the University of Toronto from 1986 to 1989, he was part of a team that studied tissue rejection problems with small intestine transplantation, using animal models.[32][33] He continued his studies of small intestine transplantation under a Wellcome Trust travelling fellowship at University of Toronto in Canada.[29]
Back in the UK, he worked on the liver transplant programme at the Royal Free Hospital in London.[29] In 1995, while conducting research into Crohn's disease, he was approached by Rosemary Kessick, the parent of an autistic child, who was seeking help with her son's bowel problems and autism; Kessick ran a group called Allergy Induced Autism.[34] In 1996, Wakefield turned his attention to researching possible connections between the MMR vaccine and autism.[29] At the time of his MMR research study, Wakefield was senior lecturer and honorary consultant in experimental gastroenterology at the Royal Free Hospital School of Medicine (from 2008 UCL Medical School). He resigned in 2001,[35] by "mutual agreement and was made a fellow of the Royal College of Pathologists",[36] and moved to the US in 2001[37] or 2004,[36] both dates according to The Times. One report noted he was asked to leave Royal Free Hospital in 2004 after he did not fulfill a request to duplicate the findings in his controversial The Lancet paper.[38]
Wakefield subsequently helped establish and served as the executive director of Thoughtful House Center for Children, a center for the study of autism in Austin, Texas where, according to The Times, he "continued to promote the theory of a link between the MMR vaccine and autism, despite admitting it was 'not proved'."[36] He resigned from Thoughtful House in February 2010, after the British General Medical Council found that he had been "dishonest and irresponsible" in conducting his earlier autism research in England.[32][39] The Times reported in May 2010 that he was a medical advisor for Visceral, a UK charity that "researches bowel disease and developmental disorders".[36]
Wakefield is no longer licensed in the UK as a physician,[15] and is not licensed in the US.[40] As of January 2011, he lives in the US where he has a following including celebrity Jenny McCarthy[41] who wrote the foreword for Wakefield's autobiography, Callous Disregard, and believes her son's autism is due to vaccines.[25] According to Deer, as of 2011, he lives near Austin with his wife, Carmel, and four children.[32]
In 2011, Wakefield was at the top of the list of the worst doctors of 2011 in Medscape's list of "Physicians of the Year: Best and Worst".[42] In January 2012, TIME Magazine named Wakefield in a list of "Great Science Frauds".[3]
MMR controversy
On 28 February 1998, a paper written by Wakefield and twelve other authors about twelve autistic children was published in The Lancet.[43] In it, the authors claimed to have identified a new syndrome which they called autistic enterocolitis, raising the possibility of a link between a novel form of bowel disease, autism, and the MMR vaccine. The authors noted that the parents of eight of the twelve children linked what were described as "behavioural symptoms" with MMR, and reported that the onset of these symptoms began within two weeks of MMR vaccination.[43] In the published The Lancet summary, known as the "interpretation", the authors wrote:
- "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."[43]
These possible triggers were reported to be MMR in eight cases, and measles infection in one. The paper was instantly controversial, leading to widespread publicity in the UK and the convening of a special panel of the UK's Medical Research Council the following month.[44] One study done based in Japan found that there was no causal relationship between the MMR vaccine and autism in groups of children given the triple MMR vaccine and children who received individual measles, mumps and rubella vaccinations. The MMR was replaced with individual vaccinations in 1993.[45]
Although the paper said that no causal connection had been proven, and before it was published, Wakefield made statements at a press conference and in a video news release issued by the hospital, calling for suspension of the triple MMR vaccine until more research could be done.[46] The press conference was later criticized as 'science by press conference'.[47] According to BBC News, it was this press conference, rather than the paper in The Lancet, that fueled the MMR vaccination scare.[48] According to the BBC, "He told journalists it was a 'moral issue' and he could no longer support the continued use of the three-in-one jab for measles, mumps and rubella. 'Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people,' Dr Wakefield said at the time."[48] He said, "If you give three viruses together, three live viruses, then you potentially increase the risk of an adverse event occurring, particularly when one of those viruses influences the immune system in the way that measles does."[46] He suggested parents should opt for single jabs against measles, mumps and rubella, separated by gaps of one year.
In December 2001, Wakefield resigned from the Royal Free Hospital, saying, "I have been asked to go because my research results are unpopular."[35] The medical school said that he had left "by mutual agreement." In February 2002, Wakefield stated, "What precipitated this crisis was the removal of the single vaccine, the removal of choice, and that is what has caused the furore—because the doctors, the gurus, are treating the public as though they are some kind of moronic mass who cannot make an informed decision for themselves."[49]
Aftermath of initial controversy
Wakefield continued conducting clinical research in the United States after leaving the Royal Free Hospital in December 2001. He joined a controversial American researcher, Jeffrey Bradstreet, at the International Child Development Resource Center, to conduct further studies on the possible relationship between the MMR vaccine and autism.[50]
In 2004, Wakefield started work at the Thoughtful House research center in Austin, Texas.[51] Wakefield served as Executive Director of Thoughtful House until February 2010, when he resigned in the wake of findings against him by the British General Medical Council.[39][52]
In February 2004, controversy resurfaced when Wakefield was accused of a conflict of interest. The Sunday Times reported that some of the parents of the 12 children in the study in The Lancet were recruited via a UK lawyer preparing a lawsuit against MMR manufacturers, and that the Royal Free Hospital had received £55,000 from the UK's Legal Aid Board (now the Legal Services Commission) to pay for the research.[53] Previously, in October 2003, the board had cut off public funding for the litigation against MMR manufacturers.[54] Following an investigation of The Sunday Times allegations by the UK General Medical Council, Wakefield was charged with serious professional misconduct, including dishonesty.[55] In December 2006, the Sunday Times further reported that in addition to the money they gave the Royal Free Hospital, the lawyers responsible for the MMR lawsuit had paid Wakefield personally more than £400,000, which he had not previously disclosed.[56]
Twenty-four hours before the 2004 Sunday Times report, The Lancet responded to the investigation in a public statement, describing Wakefield's research as "fatally flawed". The Lancet's editor said he believed the paper would have been rejected as biased if the peer reviewers had been aware of Wakefield's conflict of interest.[57] Ten of Wakefield's twelve co-authors of the paper in The Lancet later published a retraction of an interpretation:[58] The section of the paper retracted read as follows:
- "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."
The retraction stated:[58]
- "We wish to make it clear that in this paper no causal link was established between (the) 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."[59]
Wakefield v Channel 4 and others
In November 2004, Channel 4 broadcast a one-hour Dispatches investigation by reporter Brian Deer; the Toronto Star said Deer had "produced documentary evidence that Wakefield applied for a patent on a single-jab measles vaccine before his campaign against the MMR vaccine, raising questions about his motives".[32][60][61]
In addition to Wakefield's unpublished initial patent submission,[60] Deer released a copy of the published patent application.[62] At page 1, the first paragraph of this stated:
- "The present invention relates to a new vaccine/immunisation for the prevention and/or prophylaxis against measles virus infection and to a pharmaceutical or therapeutic composition for the treatment of IBD (Inflammatory Bowel Disease); particularly Crohn's Disease and Ulcerative Colitis and regressive behavioural disease (RBD) (also referred to as "Pervasive Developmental Disorder)."
Before describing the research in Wakefield's 1998 paper in The Lancet, at the same page this patent explicitly states that the use of the MMR vaccine causes autism:
- "It has now also been shown that use of the MMR vaccine (which is taken to include live attenuated measles vaccine virus, measles virus, mumps vaccine virus and rubella vaccine virus, and wild strains of the aforementioned viruses) results in ileal lymphoid nodular hyperplasia, chronic colitis and pervasive developmental disorder including autism (RBD), in some infants."
According to Deer, a letter from Wakefield's lawyers to him dated 31 Jan 2005 said: "Dr Wakefield did not plan a rival vaccine."[60]
In the Dispatches programme, Deer also revealed that Nicholas Chadwick, a researcher working under Wakefield's supervision in the Royal Free medical school, had failed to find measles virus in the children reported on in The Lancet.[63]
In January 2005, Wakefield initiated libel proceedings against Channel 4, the independent production company Twenty Twenty and Brian Deer. At the same time, Wakefield issued libel proceedings against The Sunday Times, and against Deer personally over his website briandeer.com.[64] Within weeks of issuing his claims, however, Wakefield sought to have the action frozen until after the conclusion of General Medical Council proceedings against him. Fighting back, Channel 4 and Deer obtained a High Court order compelling Wakefield to continue with his action, or discontinue it. After a hearing in court on 27 and 28 October 2005, Mr Justice David Eady ruled against a Stay of proceedings, stating:
- "It thus appears that the Claimant wishes to use the existence of the libel proceedings for public relations purposes, and to deter other critics, while at the same time isolating himself from the “downside” of such litigation, in having to answer a substantial defence of justification."
He also said in his judgment:
- "I am quite satisfied, therefore, that the Claimant wished to extract whatever advantage he could from the existence of the proceedings while not wishing to progress them or to give the Defendants an opportunity of meeting the claims."[65]
The judgment identified Channel 4's "very lengthy extracts" regarding Wakefield, where Deer's allegations are that he had:[65]
- i) Spread fear that the MMR vaccine might lead to autism, even though he knew that his own laboratory had carried out tests whose results dramatically contradicted his claims in that the measles virus had not been found in a single one of the children concerned in his study and he knew or ought to have known that there was absolutely no basis at all for his belief that the MMR should be broken up into single vaccines.
- (ii) In spreading such fear, acted dishonestly and for mercenary motives in that, although he improperly failed to disclose the fact, he planned a rival vaccine and products (such as a diagnostic kit based on his theory) that could have made his fortune.
- (iii) Gravely abused the children under his care by unethically carrying out extensive invasive procedures (on occasions requiring three people to hold a child down), thereby driving nurses to leave and causing his medical colleagues serious concern and unhappiness.
- (iv) Improperly and/or dishonestly failed to disclose to his colleagues and to the public at large that his research on autistic children had begun with a contract with solicitors which were trying to sue the manufacturers of the MMR vaccine.
- (v) Improperly and/or dishonestly lent his reputation to the International Child Development Resource Centre which promoted to very vulnerable parents expensive products for whose efficacy (as he knew or should have known) there was no scientific evidence.
Mr Justice Eady's ruling states that "...the views or conclusions of the GMC disciplinary body would not, so far as I can tell, be relevant or admissible...", that Channel 4's allegations "...go to undermine fundamentally the Claimant's professional integrity and honesty..." and that "It cannot seriously be suggested that priority should be given to GMC proceedings for the resolution of issues...".
Other proceedings continued for two years, but in December 2006, Deer reported figures obtained from the Legal Services Commission showing that it had paid £435,643 in undisclosed fees to Wakefield for him to build a case against the MMR vaccine,[66] payments which The Sunday Times reported had begun two years before the paper in The Lancet.[56]
Within days of Deer's report, Wakefield dropped all his libel actions[67] and was required to pay all the defendants' legal costs.[68][69]
Other concerns
Other concerns regarding Wakefield were that an extension of his project caused life-threatening complications in one child, who received substantial compensation in an out-of-court settlement.[70] Wakefield's data were also questioned;[24] a former graduate student, who appeared in Deer's programme, later testified that Wakefield ignored laboratory data which conflicted with his hypothesis. An independent investigation of a collaborating laboratory questioned the accuracy of the data underpinning Wakefield's claims.[71]
In June 2005, the BBC programme Horizon reported on an unnamed and unpublished study of blood samples from a group of 100 autistic children and 200 children without autism. They reported finding 99% of the samples contained no trace of the measles virus, and the samples that did contain the virus were just as likely to be from non-autistic children, i.e. only three samples contained the measles virus, one from an autistic child and two from a normal child. The study's authors found no evidence of any link between MMR and autism.[72]
The Institute of Medicine (IOM) of the United States National Academy of Sciences,[73] along with the CDC[74] and the UK National Health Service,[75] have found no link between vaccines and autism. Reviews in the medical literature have also found no link between the MMR vaccine and autism or with bowel disease, which Wakefield called "autistic enterocolitis."[76][77][78]
General Medical Council hearings
Between July 2007 and May 2010, a 217-day "fitness to practise" hearing of the UK General Medical Council examined charges of professional misconduct against Wakefield and two colleagues involved in the paper in The Lancet .[79][80] The charges included that he:
- "Was being paid to conduct the study by solicitors representing parents who believed their children had been harmed by MMR".[79]
- Ordered investigations "without the requisite paediatric qualifications" including colonoscopies, colon biopsies and lumbar punctures ("spinal taps") on his research subjects without the approval of his department's ethics board and contrary to the children's clinical interests,[79] when these diagnostic tests were not indicated by the children's symptoms or medical history.
- "Act[ed] 'dishonestly and irresponsibly' in failing to disclose ... how patients were recruited for the study".[79]
- "Conduct[ed] the study on a basis which was not approved by the hospital's ethics committee."[79]
- Purchased blood samples—for £5 each—from children present at his son's birthday party, which Wakefield joked about in a later presentation.[79]
Wakefield denied the charges;[81] on 28 January 2010, the GMC ruled against Wakefield on all issues, stating that he had "failed in his duties as a responsible consultant",[10] acted against the interests of his patients,[10] and "dishonestly and irresponsibly" in his controversial research.[11] On 24 May 2010 he was struck off the United Kingdom medical register. It was the harshest sanction that the GMC could impose, and effectively ended his career as a doctor. In announcing the ruling, the GMC said that Wakefield had "brought the medical profession into disrepute," and no sanction short of erasing his name from the register was appropriate for the "serious and wide-ranging findings" of misconduct.[15][82] On the same day, Wakefield's autobiography, Callous Disregard was published. It argued that he had been unfairly treated by the medical and scientific establishment.[83]
Fraud and conflict of interest allegations
In February 2009, The Sunday Times reported that a further investigation by the newspaper had revealed that Wakefield "changed and misreported results in his research, creating the appearance of a possible link with autism",[84] citing evidence obtained by the newspaper from medical records and interviews with witnesses, and supported by evidence presented to the GMC.
In April 2010, Deer expanded on laboratory aspects of his findings in a report in the BMJ, recounting how normal clinical histopathology results (obtained from the Royal Free hospital) had been subjected to wholesale changes, from normal to abnormal, in the medical school and published in The Lancet.[85] On 2 January 2011, Deer provided two tables comparing the data on the twelve children, showing the original hospital data and the data with the wholesale changes as used in the 1998 The Lancet article.[86]
On 5 January 2011, BMJ published an article by Brian Deer entitled "How the case against the MMR vaccine was fixed".[87] Deer, funded by The Sunday Times of London and Channel 4 television network, said that, based on examination of the medical records of the 12 children in the original study, his research had found:[87]
- "The paper in The Lancet was a case series of 12 child patients; it reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event.” But in fact:
- "Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism;
- "Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns;
- "Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination;
- "In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”;
- "The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link;
- "Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation."[87]
In an accompanying editorial, BMJ editors said:
Clear evidence of falsification of data should now close the door on this damaging vaccine scare ... Who perpetrated this fraud? There is no doubt that it was Wakefield. Is it possible that he was wrong, but not dishonest: that he was so incompetent that he was unable to fairly describe the project, or to report even one of the 12 children's cases accurately? No. A great deal of thought and effort must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction; misreporting was gross. Moreover, although the scale of the GMC's 217 day hearing precluded additional charges focused directly on the fraud, the panel found him guilty of dishonesty concerning the study's admissions criteria, its funding by the Legal Aid Board, and his statements about it afterwards.[1]
In a BMJ follow-up article on 11 January 2011,[18] Deer said that based upon documents he obtained under Freedom of information legislation,[88] Wakefield—in partnership with the father of one of the boys in the study—had planned to launch a venture on the back of an MMR vaccination scare that would profit from new medical tests and "litigation driven testing".[19][60] The Washington Post reported that Deer said that Wakefield predicted he "could make more than $43 million a year from diagnostic kits" for the new condition, autistic enterocolitis.[88] According to Deer's report in BMJ, the ventures, Immunospecifics Biotechnologies Ltd and Carmel Healthcare Ltd—named after Wakefield’s wife—failed after Wakefield's superiors at University College London's medical school gave him a two-page letter that said:
"We remain concerned about a possible serious conflict of interest between your academic employment by UCL, and your involvement with Carmel ... This concern arose originally because the company's business plan appears to depend on premature, scientifically unjustified publication of results, which do not conform to the rigorous academic and scientific standards that are generally expected."[18]
WebMD reported on Deer's BMJ report, saying that the $43 million predicted yearly profits would come from marketing kits for "diagnosing patients with autism" and that "the initial market for the diagnostic will be litigation-driven testing of patients with AE [autistic enterocolitis, an unproven condition concocted by Wakefield] from both the UK and the US".[89] According to WebMD, the BMJ article also claimed that Carmel Healthcare Ltd would succeed in marketing products and developing a replacement vaccine if "public confidence in the MMR vaccine was damaged".[89]
In October 2012, research published in PNAS, the Proceedings of the National Academy of Sciences, identified Wakefield's 1998 paper as the most cited retracted scientific paper, with 758 citations, and gave the "reason for retraction" as "fraud".[2]
Journal retractions
On 2 February 2010, The Lancet formally retracted Wakefield's 1998 paper.[90][91] The retraction states that "the claims in the original paper that children were 'consecutively referred' and that investigations were 'approved' by the local ethics committee have been proven to be false".[13]
The following day the editor of a specialist journal, Neurotoxicology, withdrew another Wakefield paper that was in press. The article, which concerned research on monkeys, had already been published online and sought to implicate vaccines in autism.[92]
In May 2010, The American Journal of Gastroenterology retracted a paper of Wakefield's that used data from the 12 patients of the article in The Lancet.[93]
On 5 January 2011, BMJ editors recommended that Wakefield's other publications should be scrutinized and retracted if need be.[41]
Wakefield response
As of January 2011, Wakefield has continued to maintain his innocence. In a press release, he stated,
I want to make one thing crystal clear for the record—my research and the serious medical problems found in those children were not a hoax and there was no fraud whatsoever. Nor did I seek to profit from our findings. ... despite media reports to the contrary, the results of my research have been duplicated in five other countries ... I continue to fully support more independent research to determine if environmental triggers, including vaccines, are causing autism and other developmental problems. ... Since the Lancet [sic] paper, I have lost my job, my career and my country. To claim that my motivation was profit is patently untrue. I will not be deterred—this issue is far too important.[26]
In an internet radio interview, Wakefield said the BMJ series "was utter nonsense" and denied "that he used the cases of the 12 children in his study to promote his business venture".[19] Although Deer is funded by The Sunday Times and Channel 4, he has filed financial disclosure forms and denies receiving any funding from the pharmaceutical industry, which Wakefield says is paying him.[19] According to CNN, Wakefield said the patent he held was for "an 'over-the-counter nutritional supplement' that boosts the immune system".[19] WebMD reported that Wakefield said he was the victim of "a ruthless, pragmatic attempt to crush any attempt to investigate valid vaccine safety concerns".[89]
Wakefield claims that Deer is a "hit man who was brought in to take [him] down" and that other scientists have simply taken Deer at his word. While on Anderson Cooper 360°, claiming he had not read the BMJ articles yet, he denied their validity and denied that Deer had interviewed the families of the children in the study. He also urged viewers to read his book, Callous Disregard, which he claimed would explain why he was being targeted, to which Anderson Cooper replied: "But, sir, if you're lying, then your book is also a lie. If your study is a lie, your book is a lie."[38][94]
Wakefield would later imply that there is a conspiracy by public health officials and pharmaceutical companies to discredit him, including suggesting they pay bloggers to post rumors about him on websites or that they artificially inflated reports of deaths from measles.[38]
Deer counter-response
Deer responded to Wakefield's charge by challenging Wakefield to sue him for libel:
If it is true that Andrew Wakefield is not guilty as charged, he has the remedy of bringing a libel action against myself, the Sunday Times of London, against the medical journal here, and he would be the richest man in America.[95]
He also noted that Wakefield has previously sued him and lost.[65][95] In January 2012 Wakefield filed a defamation lawsuit in Texas state court against Deer, Fiona Godlee and the BMJ for false accusations of fraud, seeking a jury trial in Travis County. The lawsuit said Wakefield is a resident of Austin.[96][97] The suit cited the "Texas Long-Arm Statute" as justification for the venue. The journal said that it stood by the writings and would "defend the claim vigorously."[98][99] On 3 August 2012, Judge Amy Meachum, in the 201st Texas district court, dismissed Wakefield's suit.[100][101][102]
On 5 April 2011, Deer was named the UK's specialist journalist of the year in the British Press Awards, organised by the Society of Editors. The judges said that his investigation of Wakefield was a "tremendous righting of a wrong".[103]
Epidemics and effects
Physicians, medical journals, and editors[104][105][106][107][108] have made statements tying Wakefield's fraudulent actions to various epidemics and deaths.[109] Michael J. Smith, a professor of pediatrics at the University of Louisville, an "infectious diseases expert who has studied the autism controversy's effect on immunization rates", said, "Clearly, the results of this [Wakefield] study have had repercussions."[110][111]
The Associated Press said:
- "Immunization rates in Britain dropped from 92 percent to 73 percent, and were as low as 50 percent in some parts of London. The effect was not nearly as dramatic in the United States, but researchers have estimated that as many as 125,000 US children born in the late 1990s did not get the MMR vaccine because of the Wakefield splash."[110]
ABC News Channel WWAY3 said:
- "Since Dr. Andrew Wakefield's study was released in 1998, many parents have been convinced the measles, mumps and rubella vaccine could lead to autism. But that study may have done more harm than good. According to the Centers for Disease Control and Prevention, in the United States, more cases of measles were reported in 2008 than any year since 1997. More than 90 percent of those infected had not been vaccinated, or their vaccination status was not known."[109]
Paul Hébert, editor-in-chief of the Canadian Medical Association Journal (CMAJ) said:
- "There has been a huge impact from the Wakefield fiasco ... This spawned a whole anti-vaccine movement. Great Britain has seen measles outbreaks. It probably resulted in a lot of deaths."[32]
A profile in a New York Times Magazine article noted:
- "Andrew Wakefield has become one of the most reviled doctors of his generation, blamed directly and indirectly, depending on the accuser, for irresponsibly starting a panic with tragic repercussions: vaccination rates so low that childhood diseases once all but eradicated here—whooping cough and measles, among them—have re-emerged, endangering young lives."[38]
Journalist Brian Deer called for criminal charges to be brought against Wakefield.[95]
J. B. Handley of the autism and anti-vaccine advocacy group Generation Rescue noted, "To our community, Andrew Wakefield is Nelson Mandela and Jesus Christ rolled up into one."[38] Wakefield has a fundraising group dedicated to supporting his litigation.[112][113]
On 1 April, 2011, the James Randi Educational Foundation awarded Wakefield the Pigasus Award for "refusal to face reality".[114]
A 2011 journal article described the vaccine-autism connection as "the most damaging medical hoax of the last 100 years".[115]
Selected publications
- Books
- Wakefield, Andrew J (24 May 2010). Callous Disregard: Autism and Vaccines: The Truth Behind a Tragedy. Skyhorse Publishing. ISBN 1-61608-169-4.
{{cite book}}
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- Journals
- Withdrawn: Hewitson L, Houser LA, Stott C, Sackett G, Tomko JL, Atwood D, Blue L, White ER, Wakefield AJ (2009). "WITHDRAWN: Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight". Neurotoxicology. doi:10.1016/j.neuro.2009.09.008. PMID 19800915.
{{cite journal}}
: Unknown parameter|month=
ignored (help)CS1 maint: multiple names: authors list (link) - Retracted:Wakefield AJ, Anthony A, Murch SH, Thomson M, Montgomery SM, Davies S, O'Leary JJ, Berelowitz M, Walker-Smith JA (2000). "Enterocolitis in children with developmental disorders". Am. J. Gastroenterol. 95 (9): 2285–95. doi:10.1111/j.1572-0241.2000.03248.x. PMID 11007230.
{{cite journal}}
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ignored (help)CS1 maint: multiple names: authors list (link) (Retracted)- Retraction: Wakefield AJ, Anthony A, Murch SH, Thomson M, Montgomery SM, Davies S, O'Leary JJ, Berelowitz M, Walker-Smith JA (2010). "Retraction: Enterocolitis in Children With Developmental Disorders". The American Journal of Gastroenterology. 105 (5): 1214. doi:10.1038/ajg.2010.149.
{{cite journal}}
: CS1 maint: multiple names: authors list (link)
- Retraction: Wakefield AJ, Anthony A, Murch SH, Thomson M, Montgomery SM, Davies S, O'Leary JJ, Berelowitz M, Walker-Smith JA (2010). "Retraction: Enterocolitis in Children With Developmental Disorders". The American Journal of Gastroenterology. 105 (5): 1214. doi:10.1038/ajg.2010.149.
- Retracted: Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, Berelowitz M, Dhillon AP, Thomson MA, Harvey P, Valentine A, Davies SE, Walker-Smith JA (1998). "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children". The Lancet. 351 (9103): 637–41. doi:10.1016/S0140-6736(97)11096-0. PMID 9500320.
{{cite journal}}
: CS1 maint: multiple names: authors list (link) (Retracted)- Retraction: The Editors Of The Lancet (2010). "Retraction – Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children". The Lancet. 375 (9713): 445. doi:10.1016/S0140-6736(10)60175-4. PMID 20137807.
{{cite journal}}
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- Retraction: The Editors Of The Lancet (2010). "Retraction – Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children". The Lancet. 375 (9713): 445. doi:10.1016/S0140-6736(10)60175-4. PMID 20137807.
- Wakefield AJ, Ekbom A, Dhillon AP, Pittilo RM, Pounder RE (1995). "Crohn's disease: pathogenesis and persistent measles virus infection". Gastroenterology. 108 (3): 911–6. doi:10.1016/0016-5085(95)90467-0. PMID 7875495.
{{cite journal}}
: Unknown parameter|month=
ignored (help)CS1 maint: multiple names: authors list (link) - Wakefield AJ, Pittilo RM, Sim R, Cosby SL, Stephenson JR, Dhillon AP, Pounder RE (1993). "Evidence of persistent measles virus infection in Crohn's disease". J. Med. Virol. 39 (4): 345–53. doi:10.1002/jmv.1890390415. PMID 8492105.
{{cite journal}}
: Unknown parameter|month=
ignored (help)CS1 maint: multiple names: authors list (link) - Wakefield AJ; Sankey EA; Dhillon AP; et al. (1991). "Granulomatous vasculitis in Crohn's disease". Gastroenterology. 100 (5 Pt 1): 1279–87. PMID 2013373.
{{cite journal}}
: Unknown parameter|author-separator=
ignored (help); Unknown parameter|month=
ignored (help) - Wakefield AJ, Sawyerr AM, Dhillon AP, Pittilo RM, Rowles PM, Lewis AA, Pounder RE (1989). "Pathogenesis of Crohn's disease: multifocal gastrointestinal infarction". The Lancet. 2 (8671): 1057–62. PMID 2572794.
{{cite journal}}
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See also
References
- ^ a b c Godlee F, Smith J, Marcovitch H (2011). "Wakefield's article linking MMR vaccine and autism was fraudulent". BMJ. 342: c7452. doi:10.1136/bmj.c7452. PMID 21209060.
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{{cite journal}}
: Invalid|display-authors=3
(help); Unknown parameter|author-separator=
ignored (help); Unknown parameter|month=
ignored (help) - ^ a b "Great Science Frauds". TIME Magazine, 13 January 2012
- ^ Black C, Kaye JA, Jick H (2002). "Relation of childhood gastrointestinal disorders to autism: nested case-control study using data from the UK General Practice Research Database". BMJ. 325 (7361): 419–21. doi:10.1136/bmj.325.7361.419. PMC 119436. PMID 12193358.
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- ^ McKee, Maggie (4 March 2004). "Controversial MMR and autism study retracted". New Scientist. Archived from the original on 13 August 2007. Retrieved 10 August 2007.
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- ^ Deer B (2011). "Pathology reports solve 'new bowel disease' riddle". BMJ. 343: 984. doi:10.1136/bmj.d6823. PMID 22077090.
- ^ Geboes K (2011). "Commentary: I see no convincing evidence of 'enterocolitis,' 'colitis,' or a 'unique disease process'". BMJ. 343: 990. doi:10.1136/bmj.d6985. PMID 22077092.
- ^ Bjarnason I (2011). "Commentary: We came to an overwhelming and uniform opinion that these reports do not show colitis". BMJ. 343: 990. doi:10.1136/bmj.d6985. PMID 22077091.
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- ^ Silverman RE; Cohen Z; Craig M; et al. (1989). "Monocyte/macrophage procoagulant activity as a measure of immune responsiveness in Lewis and brown Norway inbred rats. Discordance with lymphocyte proliferative assays". Transplantation. 47 (3): 542–8. doi:10.1097/00007890-198903000-00028. PMID 2522255.
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ignored (|url-status=
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- ^ "UK Patent Application GB 2 325 856 A" (PDF).
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suggested) (help) - ^ General Medical Council Press Office (8 October 2007). "Dr Andrew Wakefield, Professor John Walker-Smith, Professor Simon Murch: Fitness to Practise Hearings" (Press release). General Medical Council press office. Archived from the original on 27 October 2007.
- ^ "MMR doctor to begin his defence". BBC News. 27 March 2008. Retrieved 5 January 2011.
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{{cite news}}
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suggested) (help) - ^ Wakefield, Andrew J (24 May 2010). Callous Disregard. Skyhorse Publishing. ISBN 1-61608-169-4.
- ^ Deer Brian (8 February 2009). "MMR doctor Andrew Wakefield fixed data on autism". The Sunday Times. London. Archived from the original on 8 February 2009. Retrieved 9 February 2009.
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ignored (|url-status=
suggested) (help) - ^ Deer B (15 April 2010). "Wakefield's "autistic enterocolitis" under the microscope". BMJ. 340: c1127. doi:10.1136/bmj.c1127. PMID 20395277.
- ^ "MMR & Autism: Fixing a Link", Tables prepared by Brian Deer as a supplement to his peer reviewed report "How the case against the MMR vaccine was fixed", published in the BMJ in January 2011 (BMJ 2011;342:c5347). alt source (archive (at anchor #T1))
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ignored (|url-status=
suggested) (help) - ^ "Medical journal retracts study linking autism to vaccine". CNN. 2 February 2010. Retrieved 2 February 2010.
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ignored (help); Unknown parameter|month=
ignored (help) - ^ Wakefield AJ; Anthony A; Murch SH; et al. (2010). "Retraction: Enterocolitis in Children With Developmental Disorders". The American Journal of Gastroenterology. 105 (5): 1214. doi:10.1038/ajg.2010.149.
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ignored (help) - ^ Anderson Cooper (interviewer), Andrew Wakefield (interviewee) (6 January 2011). Autism-vaccine study author defends work. CNN.
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(help) - ^ "Doctor who did autism research in Austin sues medical journal, writers (Austin American-Statesman, Jan. 6, 2012)". Statesman.com. Retrieved 26 April 2013.
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has generic name (help) - ^ Ian Sample, science correspondent. "Andrew Wakefield sues BMJ for claiming MMR study was fraudulent (The Guardian, 5 January 2012)". Guardian. Retrieved 26 April 2013.
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ignored (help) - ^ Deer, Brian (6 January 2011). "Brian Deer: Piltdown medicine: The missing link between MMR and autism". BMJ Group Blogs. Retrieved 8 January 2011.
- ^ "Link between MMR Vaccines and Autism conclusively broken". IB Times. 7 January 2011. Retrieved 8 January 2011.
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{{cite journal}}
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ignored (help)CS1 maint: multiple names: authors list (link) - ^ "Dr. Wakefield Justice Fund". Retrieved 24 December 2012.
- ^ "You're Invited: Long Beach California Fundraising Event for Dr. Andrew Wakefield Legal Defense Fund – AGE OF AUTISM". Retrieved 24 December 2012.
- ^ Crabtree, Sadie (1 April 2011). "The 5 Worst Promoters of Nonsense" (Press release). James Randi Educational Foundation. Retrieved 6 April 2011.
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External links
- Deer, B. (2011). "The Lancet's two days to bury bad news". BMJ. 342: c7001. doi:10.1136/bmj.c7001. PMID 21245118.
- Kumar, S; Dean, S; Golding, W; Moodley, P; Webster, S (2007, corrected 2010). "Findings of the GMC Fitness to Practice Panel".
{{cite journal}}
: Check date values in:|date=
(help); Cite journal requires|journal=
(help) - Opel, D. J.; Diekema, D. S.; Marcuse, E. K. (2011). "Assuring research integrity in the wake of Wakefield". BMJ. 342: d2. doi:10.1136/bmj.d2. PMID 21245120.
- Alaszewski, A. (2011). "How campaigners and the media push bad science". BMJ. 342: d236. doi:10.1136/bmj.d236.
- Godlee, F. (2011). "Institutional and editorial misconduct in the MMR scare". BMJ. 342: d378. doi:10.1136/bmj.d378.
- "The Vaccine War" – PBS FRONTLINE documentary, 27 April 2010
- "Lessons from the MMR Scare" by Fiona Godlee, presentation 6 September 2011 at the Fogarty International Center, National Institutes of Health
- Use dmy dates from October 2012
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