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Wakefield denied the charges. On 27 March 2008, Wakefield began his defence in the hearing.<ref>BBC [http://news.bbc.co.uk/1/hi/health/7314144.stm MMR doctor to begin his defence] 27 March 2008</ref>
Wakefield denied the charges. On 27 March 2008, Wakefield began his defence in the hearing.<ref>BBC [http://news.bbc.co.uk/1/hi/health/7314144.stm MMR doctor to begin his defence] 27 March 2008</ref>


On 28 January 2010, the GMC ruled that Wakefield "failed in his duties as a responsible consultant",<ref name="YEP GMC result"/> acted against the interests of his patients,<ref name="YEP GMC result"/> and "dishonestly and irresponsibly" in his controversial research.<ref name="BBC GMC result"/> Wakefield is likely to have to wait several more months to learn of any disciplinary actions to be taken by the GMC.<ref>[http://www.channel4.com/news/articles/science_technology/gmc+mmr+doctor+aposabused+position+of+trustapos/3519237 "GMC: MMR doctor 'abused position of trust'"], ''[[Channel 4 News]]'', 28 January 2010</ref> The entire text of the findings of the [[General Medical Council|GMC]] are available online.<ref name="GMC"> http://www.scribd.com/doc/25983372/FACTS-WWSM-280110-Final-Complete-Corrected</ref>
On 28 January 2010, the GMC ruled that Wakefield "failed in his duties as a responsible consultant",<ref name="YEP GMC result"/> acted against the interests of his patients,<ref name="YEP GMC result"/> and "dishonestly and irresponsibly" in his controversial research.<ref name="BBC GMC result"/> Wakefield is likely to have to wait several more months to learn of any disciplinary actions to be taken by the GMC.<ref>[http://www.channel4.com/news/articles/science_technology/gmc+mmr+doctor+aposabused+position+of+trustapos/3519237 "GMC: MMR doctor 'abused position of trust'"], ''[[Channel 4 News]]'', 28 January 2010</ref> The entire text of the findings of the [[General Medical Council|GMC]] is available online.<ref name="GMC"> http://www.scribd.com/doc/25983372/FACTS-WWSM-280110-Final-Complete-Corrected</ref>


==Data fixing allegations==
==Data fixing allegations==

Revision as of 13:21, 8 February 2010

Andrew Wakefield
Born
1957
Occupation
Physician

Andrew Wakefield (born 1957) is a British-born physician best known for his discredited work regarding the MMR vaccine and its possible connection with pervasive developmental disorder, in particular autism.[1] Wakefield was the lead author of a 1998 study, published in The Lancet, which reported bowel symptoms in twelve children diagnosed with autism spectrum disorders, to which the authors suggested a possible link with the MMR vaccine, though stating "We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described".[2] In a press conference held in conjunction with the publication, Wakefield recommended separating the components of the injections by at least a year. Wakefield's publication, and the resulting media coverage, were linked to a steep decline in vaccination rates in the United Kingdom[3] and a steep rise in confirmed cases of measles, with two child fatalities, as well as others seriously ill on ventilators.[4]

Subsequent investigation failed to confirm or reproduce Wakefield's findings.[5] The interpretation section of the 1998 paper was subsequently retracted by ten of the paper's thirteen authors.[6] An investigation by the Sunday Times raised allegations of unreported conflict of interest and scientific misconduct against Wakefield, leading the editor of The Lancet to state that the 1998 paper would not have been published had he known about the "fatal" conflicts of interest.[7]

In March 2004, the British General Medical Council (GMC) announced it was launching an inquiry into the allegations of misconduct against Wakefield and two former colleagues.[8] The investigation centered on claims brought forth by journalist Brian Deer that autistic and neurotypical children may have been subjected to unnecessary medical procedures,[9] including one colonoscopy that caused life-threatening complications.[10] Wakefield's data were also questioned;[4] a former graduate student testified that Wakefield ignored laboratory data which conflicted with his hypothesis, and an independent investigation of a collaborating laboratory questioned the accuracy of the data underpinning Wakefield's claims.[11]

Wakefield's hearing began in July 2007.[12] On January 28, 2010, the General Medical Council ruled that Wakefield "failed in his duties as a responsible consultant", acted against the interests of his patients, and acted "dishonestly and irresponsibly" in his controversial research.[13][14][15]

Wakefield is currently the Executive Director[16] at the Thoughtful House, a centre for autistic children in Texas, where he earns a reported £175,000 (278,880 U.S. dollars) a year.[17] Wakefield does not have a medical license in the United States[18][19] and is currently unlicensed in the UK.[20]

On February 2, 2010, The Lancet retracted his 1998 publication, noting elements of the manuscript had been falsified.[21]

Career

Wakefield qualified as a doctor in 1981 and, at the time of his MMR research study, was Senior Lecturer and Honorary Consultant in Experimental Gasteroentology at the Royal Free Hospital School of Medicine (from 2008 UCL Medical School) and, from 1997, he was Reader in Experimental Gasteroenterology.[22] He resigned in 2001.[23] In 1995, while conducting research into Crohn's disease, he was approached by Rosemary Kessick, the parent of an autistic child seeking help with her son's bowel problems and autism.[24] Kessick ran a group, Allergy Induced Autism,[25] which focused on the effects of diet on autistic children's behavior.

In November 2001 Wakefield became a fellow of the Royal College of Pathologists in recognition of his research publications. He is currently unlicensed in the UK as a physician.[20]

As of 2010, Wakefield serves as the Executive Director of Thoughtful House Center for Children in Austin, Texas, USA.[16]

MMR controversy

In February 1998 a paper written by Wakefield and 12 other doctors about 12 autism spectrum children was published in the Lancet.[2] Although the paper stressed no causal connection had been proven, Wakefield called for suspension of the triple MMR vaccine until more research could be done, at a press conference and in a video news release issued by the hospital.[26]

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." He suggested parents should opt for single jabs against measles, mumps and rubella, separated by gaps of one year.

The paper described what its authors suggested was a possible new syndrome, raising the possibility of a link between a novel form of bowel disease, autism, and the MMR vaccine. In prefacing the study's findings, the authors noted parents of eight of the twelve children reported the onset of behavioral problems within two weeks of MMR vaccination. In the published Lancet summary, 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." 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.[27] 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 vaccine and children who did not receive the MMR vaccine after it was stopped from being administered to children in 1993.[28]

The controversy escalated as the UK government declined to introduce single-jab alternatives (which would have required licenced products to become available), based on the contention most closely associated with Dr David Salisbury, Deputy Chief Medical Officer, that the risk of prolonging the period before children were immunised against all three diseases was greater than any credible risk of harm from combining them. Single vaccines, spaced a year apart, expose children to greater risk of infection, as well as additional distress and expense, and no evidence had been produced upon which to adopt such a policy. Again no studies on this protocol were done or are planned.

In December 2001, Wakefield resigned from the Royal Free Hospital, saying, "I have been asked to go because my research results are unpopular."[23] 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."[29]

Aftermath of initial controversy

Wakefield has continued conducting clinical research in the US, joining American researcher Jeff Bradstreet to conduct further studies on the possible relationship between the MMR vaccine and autism.

Controversy resurfaces

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 Lancet study 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 into what happened to their normally developing children who regressed into autism.[30] Previously, in October 2003, the board had cut off public funding for the litigation against MMR manufacturers.[31] Following an investigation of The Sunday Times allegations by the UK General Medical Council, Wakefield was charged with serious professional misconduct, including dishonesty. As the only medical doctor studying regressive autism in children, he was asked to testify.[32] The GMC opened the hearings in the summer of 2007 but, after the prosecution case was presented, suspended the proceedings and defense presentation until March, 2008.

In December 2006, the Sunday Times further reported that in addition to the money given to the Royal Free Hospital, Wakefield had also been personally paid £400,000 which had not been previously disclosed by the lawyers responsible for the MMR lawsuit.[33]

Retraction of an interpretation

Twenty-four hours before the Sunday Times report, the Lancet responded to the investigation in a public statement, describing Wakefield's research as "fatally flawed," an allegation he has denied. The Lancet's editor said the paper would have been rejected as biased if the peer reviewers had been aware of Wakefield's conflict of interest.[7]

Ten of Wakefield's twelve co-authors of the Lancet paper later published a retraction of an interpretation:[34] 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:[34]

"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."[35]

In November 2004, Channel 4 broadcast a one-hour investigation by reporter Brian Deer, which alleged that before the Lancet paper was published, Wakefield had filed a patent application[36] for a single measles vaccine, and that his laboratory had failed to find measles virus in the children.[37] In November 2005, the scope of the allegations facing Wakefield, which he denies, were set out in a High Court judgment.[38] In December 2006, the Legal Services Commission revealed that it had paid £435,643 in fees to Wakefield[39]—payments which The Sunday Times reported had begun two years before the Lancet paper.[33]

In January 2007 Wakefield dropped his action against Channel 4 rather than have it come to court, and was required to pay all their legal costs.[40]

In June 2005 the BBC program Horizon reported on an unpublished study examining blood samples from a group of one hundred autistic children and two hundred children without autism. They report 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. The study's authors found no evidence of any link between MMR and autism.[41] The BBC program also included interviews with Harvard pediatric gastroenterologist Timothy Buie, who stated that he did not believe any new bowel syndrome had been found in autistic children, and leading autism expert Lorna Wing, who said that she had seen no change in the presentation of developmental disorders in recent years.

The Institutes of Medicine (IOM),[42] along with the CDC, NIH, and Food and Drug Administration (and their British counterparts) continue to deny that any link has been found between vaccines and autism. While a number of epidemiological studies have concluded there is no evidence of any link between MMR and autism or bowel disease, Wakefield and his collaborator Carol Stott contend one of these studies supports his thesis.[43]

Inconsistencies have been found between the autism onset dates claimed in the Lancet study and the medical records of the children concerned.[4]

In the aftermath of the Wakefield affair, data suggest that UK vaccination rates have begun to rise again.[44]

On February 2, 2010 the Lancet formally retracted Wakefield's 1998 paper.[45][46] 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".[21]

Professional misconduct charges

A 2007 hearing with the General Medical Council examined charges of professional misconduct against Wakefield and two colleagues involved in the Lancet paper.[47][48] The charges included:

  • He was being paid to conduct the study by solicitors representing parents who believed their children had been harmed by MMR, and failed to disclose this in his application to the Ethical Practices Sub-Committee of the Royal Free Hampstead NHS Trust.[22]
  • He ordered investigations "without the requisite paediatric qualifications".
  • Acting "dishonestly and irresponsibly" in failing to disclose how patients were recruited for the study, and that some were paid to take part.
  • Performing colonoscopies, colon biopsies and lumbar punctures ("spinal taps") on his research subjects without proper approval and contrary to the children's clinical interests, when these diagnostic tests were not indicated by the children's symptoms or medical history.
  • Conducting the study on a basis which was not approved by the hospital's ethics committee.
  • Purchasing blood samples - for £5 each - from children present at his son's birthday party, as described by Wakefield himself in a videotaped public conference.

Wakefield denied the charges. On 27 March 2008, Wakefield began his defence in the hearing.[49]

On 28 January 2010, the GMC ruled that Wakefield "failed in his duties as a responsible consultant",[13] acted against the interests of his patients,[13] and "dishonestly and irresponsibly" in his controversial research.[14] Wakefield is likely to have to wait several more months to learn of any disciplinary actions to be taken by the GMC.[50] The entire text of the findings of the GMC is available online.[22]

Data fixing 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", citing evidence obtained by the newspaper from medical records and interviews with witnesses, and supported by evidence presented to the GMC. The newspaper went on to state that the rates of inoculation fell from 92% (very slightly below measles herd immunity) to below 80% after the publication of Wakefield's study, and that confirmed cases of measles in England and Wales have risen from 56 in 1998 to 1348 in 2008, with two child fatalities, as well as others seriously ill on ventilators.[4]

See also

References

  1. ^ Rose, David (2010-02-03). "Lancet journal retracts Andrew Wakefield MMR scare paper". Times Online. Archived from the original on 2010-02-03.
  2. ^ a b Wakefield AJ, Murch SH, Anthony A; et al. (1998). "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children". Lancet. 351 (9103): 637–41. doi:10.1016/S0140-6736(97)11096-0. PMID 9500320. Retrieved 2006-07-01. {{cite journal}}: Explicit use of et al. in: |author= (help)CS1 maint: multiple names: authors list (link)
  3. ^ Ross, Emma (2003-10-31). "Brit Parents Wary Of Vaccine". Associated Press. Retrieved 2007-08-10.
  4. ^ a b c d "Hidden records show MMR truth". London: Sunday Times. 2009-02-19.
  5. ^ 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. PMC 119436. PMID 12193358. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  6. ^ McKee, Maggie (2004-03-04). "Controversial MMR and autism study retracted". New Scientist. Retrieved 2007-08-10.
  7. ^ a b "Lead researcher defends MMR study". BBC News. 2004-02-22. Retrieved 2007-08-10.
  8. ^ "MMR doctor 'to face GMC charges'". BBC News. 2006-06-12. Retrieved 2007-08-10.
  9. ^ MP raises new allegations against Andrew Wakefield. Annabel Ferriman. BMJ. 2004 March 27; 328(7442): 726.
  10. ^ Ellis, Rachel (2007-12-10). "£500,000 for boy left fighting for life after being used as MMR guinea pig". Daily Mail. Retrieved 2009-03-29.
  11. ^ Begley, Sharon (February 21, 2009). "Anatomy of a Scare". Newsweek. Retrieved January 28, 2010.
  12. ^ "Dr Andrew Wakefield, Professor John Walker-Smith, Professor Simon Murch" (Press release). General Medical Council Press Office. Retrieved 2007-11-10.
  13. ^ a b c "MMR-row doctor failed in his duties". Yorkshire Evening Post. January 28, 2010. Retrieved January 28, 2010.
  14. ^ a b "MMR scare doctor 'acted unethically', panel finds". BBC News. January 28, 2010. Retrieved January 28, 2010.
  15. ^ "Andrew Wakefield found 'irresponsible' by GMC over MMR vaccine scare", guardian.co.uk, 28 January 2010
  16. ^ a b Andrew Wakefield is the Executive Director...
  17. ^ ‘Callous, unethical and dishonest’: Dr Andrew Wakefield - London Times
  18. ^ Journal retracts study that linked autism to vaccine (Austin American-Statesman)
  19. ^ Leader of Austin autism center gets British reprimand (Austin American-Statesman)
  20. ^ a b GMC doctor's register
  21. ^ a b The Editors of The Lancet (2 February 2010). "Retraction—Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children". {{cite news}}: |author= has generic name (help)
  22. ^ a b c http://www.scribd.com/doc/25983372/FACTS-WWSM-280110-Final-Complete-Corrected
  23. ^ a b Fraser, Lorraine (2001-12-02). "Anti-MMR doctor is forced out". The Daily Telegraph. Retrieved 2009-03-29.
  24. ^ Grania Langdon-Down (1996-11-27). "Law: A shot in the dark; The complications from vaccine damage seem to multiply in the courtroom" (Reprint). The Independent. p. 25. Retrieved 2007-08-10.
  25. ^ Home page. Autism Medical. Retrieved on 2007-11-10.
  26. ^ "Interview: Dr Andrew Wakefield, research team leader, Royal Free Hospital School of Medicine". Brian Deer. 1998-02-04. Retrieved 2007-08-10.
  27. ^ "Wakefield misled top UK medical research hearing over where he got MMR children (MRC documents)". Brian Deer. 1998-03-23. Retrieved 2007-08-10.
  28. ^ Honda H, Shimizu Y, Rutter M ' No effect of MMR withdrawal on the incidence of autism: a total population study (2005). J Child Psychol Psychiatry. 46 (6): 572–9. doi:[https://doi.org/JCPP1425%20%5Bpii%5D%0A10.1111%2Fj.1469-7610.2005.01425.x JCPP1425 [pii] 10.1111/j.1469-7610.2005.01425.x]. PMID 15877763 http://www.ncbi.nlm.nih.gov/pubmed/15877763?dopt=Citation. Retrieved 2009-11-10. {{cite journal}}: Check |doi= value (help); Missing or empty |title= (help); line feed character in |doi= at position 15 (help)CS1 maint: multiple names: authors list (link)
  29. ^ Andrew Wakefield (2002-02-10). "Why I owe it to parents to question triple vaccine". Sunday Herald. Retrieved 2007-08-10.
  30. ^ Brian Deer (2004-02-22). "Revealed: MMR Research Scandal" (Reprint). The Sunday Times (London). Retrieved 2007-08-10.
  31. ^ "Taxpayer cash for MMR action is stopped after £15m that stoked fear was spent". Brian Deer. Retrieved 2007-08-10.
  32. ^ Brian Deer (2005-09-11). "MMR Scare Doctor Faces List of Charges". The Sunday Times (London). Retrieved 2009-03-29.
  33. ^ a b Brian Deer (2006-12-31). "MMR doctor given legal aid thousands". London: Times Online. Retrieved 2007-08-10. {{cite news}}: External link in |publisher= (help)
  34. ^ a b Murch SH, Anthony A, Casson DH; et al. (2004). "Retraction of an interpretation". Lancet. 363 (9411): 750. doi:10.1016/S0140-6736(04)15715-2. PMID 15016483. {{cite journal}}: Explicit use of et al. in: |author= (help)CS1 maint: multiple names: authors list (link)
  35. ^ Emma Ross (2004-03-03). "Scientists retract interpretation of research linking vaccine with autism" (Reprint). Associated Press. Retrieved 2007-08-10.
  36. ^ "Revealed: the first Wakefield MMR patent claim describes "safer measles vaccine"". Brian Deer. Retrieved 2007-08-10.
  37. ^ "Molecular testing in Wakefield's own lab rebutted the basis for his attack on MMR". Brian Deer. Retrieved 2007-08-10.
  38. ^ "Approved Judgment in the case of Andrew Wakefield vs. Channel Four Television Corporation, Twenty Twenty Productions Ltd., and Brian Deer". British and Irish Legal Information Institute. 2005-11-04. Retrieved 2007-08-10.
  39. ^ "Revealed: undisclosed payments to Andrew Wakefield at the heart of vaccine alarm". Brian Deer. Retrieved 2007-08-10.
  40. ^ "MMR Doc drops libel case versus Channel Four".
  41. ^ "Does the MMR Jab Cause Autism? The latest scientific evidence". BBC Horizon. Retrieved 2007-08-10. {{cite news}}: External link in |publisher= (help)
  42. ^ Immunization Safety Review Committee (2004), Immunization Safety Review: Vaccines and Autism, Institute of Medicine, retrieved 2007-08-10
  43. ^ "Japanese study is the strongest evidence yet for a link between MMR and autism" (Press release). Wakefield AJ, Stott CM. 2005. Retrieved 2008-01-22.
  44. ^ "Rise in MMR vaccine uptake rate". BBC News. 2005-11-22. Retrieved 2007-08-10.
  45. ^ Vaccine-Autism Study Is Retracted. New York Times, February 2, 2010. Accessed February 3, 2010
  46. ^ Medical journal retracts study linking autism to vaccine. CNN, February 2, 2010. Accessed February 3, 2010
  47. ^ "MMR scare doctor 'paid children'". BBC News. 2007-07-16. Retrieved 2007-08-10.
  48. ^ General Medical Council Press Office (2007-10-08). "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 2007-10-27.
  49. ^ BBC MMR doctor to begin his defence 27 March 2008
  50. ^ "GMC: MMR doctor 'abused position of trust'", Channel 4 News, 28 January 2010