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Andrew Wakefield

Andrew Wakefield

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Andrew Wakefield is a British former surgeon and medical researcher, known as an advocate for the discredited claim
MMR vaccine controversy
The MMR vaccine controversy was a case of scientific misconduct which triggered a health scare. It followed the publication in 1998 of a paper in the medical journal The Lancet which presented apparent evidence that autism spectrum disorders could be caused by the MMR vaccine, an immunization...

 that there is a link between the measles, mumps and rubella (MMR) vaccine
MMR vaccine
The MMR vaccine is an immunization shot against measles, mumps, and rubella . It was first developed by Maurice Hilleman while at Merck in the late 1960s....

, autism
Autism
Autism is a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior. These signs all begin before a child is three years old. Autism affects information processing in the brain by altering how nerve cells and their...

 and bowel disease, and for his fraudulent 1998 research paper in support of that claim.

Four years after the publication of the study, the findings of other researchers had still failed to confirm or reproduce
Reproducibility
Reproducibility is the ability of an experiment or study to be accurately reproduced, or replicated, by someone else working independently...

 Wakefield's hypothesis of a relation between childhood gastrointestinal disorders and autism. A 2004 investigation by Sunday Times reporter Brian Deer
Brian Deer
Brian Deer is a British investigative reporter, best known for inquiries into the drug industry, medicine and social issues for the Sunday Times of London.- Career :...

 identified undisclosed financial conflicts of interest
Conflict of interest
A conflict of interest occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other....

 on Wakefield's part, and most of his coauthors then withdrew their support for the study's interpretations. The British General Medical Council
General Medical Council
The General Medical Council registers and regulates doctors practising in the United Kingdom. It has the power to revoke or restrict a doctor's registration if it deems them unfit to practise...

 (GMC) conducted an inquiry into allegations of misconduct
Scientific misconduct
Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in professional scientific research. A Lancet review on Handling of Scientific Misconduct in Scandinavian countries provides the following sample definitions: *Danish definition: "Intention or...

 against Wakefield and two former colleagues. The investigation centred on Deer's numerous findings, including one that autistic children were subjected to unnecessary invasive medical procedures, such as colonoscopy
Colonoscopy
Colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a CCD camera or a fiber optic camera on a flexible tube passed through the anus. It may provide a visual diagnosis and grants the opportunity for biopsy or removal of suspected...

 and lumbar puncture
Lumbar puncture
A lumbar puncture is a diagnostic and at times therapeutic procedure that is performed in order to collect a sample of cerebrospinal fluid for biochemical, microbiological, and cytological analysis, or very rarely as a treatment to relieve increased intracranial pressure.-Indications:The...

, and that Wakefield acted without the required ethical approval from an institutional review board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

.

On 28 January 2010, a five-member statutory tribunal of the GMC found some three dozen charges proved, including four counts of dishonesty and 12 counts involving the abuse of developmentally challenged children. 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. 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. Wakefield was struck off the Medical Register in May 2010, with a statement identifying dishonest falsification in the Lancet research, and is barred from practising medicine in the UK.

In January 2011, an editorial accompanying an article by Brian Deer in BMJ
BMJ
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...

identified Wakefield's work as an "elaborate fraud". In a follow-up article,

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". However, by that time, 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
Measles
Measles, also known as rubeola or morbilli, is an infection of the respiratory system caused by a virus, specifically a paramyxovirus of the genus Morbillivirus. Morbilliviruses, like other paramyxoviruses, are enveloped, single-stranded, negative-sense RNA viruses...

 cases, resulting in serious illness and fatalities.

Wakefield has continued to defend his research and conclusions, saying there was no fraud, hoax or profit motive. BMJ stands by its story.

Personal life and career


Wakefield was born in 1957;
his father was a neurologist and his mother was a general practitioner. After leaving the independent King Edward's School, Bath
King Edward's School, Bath
King Edward's School , Bath, Somerset, England is an independent school providing education for 950 pupils aged 3 to 18.The school is a member of The Headmasters' and Headmistresses' Conference....

, Wakefield studied medicine at St Mary's Hospital Medical School
St Mary's Hospital Medical School
St Mary's is the youngest of the constituent schools of Imperial College, London, founded in 1854 as part of the new hospital in Paddington. During its existence in the 1980s and 90s, it was the most popular medical school in the country, with an application to place ratio of 27:1 in 1996.St Mary's...

 (now Imperial College School of Medicine), fully qualifying in 1981. He became a fellow of the Royal College of Surgeons in 1985. At the University of Toronto
University of Toronto
The University of Toronto is a public research university in Toronto, Ontario, Canada, situated on the grounds that surround Queen's Park. It was founded by royal charter in 1827 as King's College, the first institution of higher learning in Upper Canada...

 (U of T) from 1986 to 1989, he was part of a team that studied tissue rejection problems with small intestine
Small intestine
The small intestine is the part of the gastrointestinal tract following the stomach and followed by the large intestine, and is where much of the digestion and absorption of food takes place. In invertebrates such as worms, the terms "gastrointestinal tract" and "large intestine" are often used to...

 transplantation, using animal models. He continued his studies of small intestine transplantation under a Wellcome Trust
Wellcome Trust
The Wellcome Trust was established in 1936 as an independent charity funding research to improve human and animal health. With an endowment of around £13.9 billion, it is the United Kingdom's largest non-governmental source of funds for biomedical research...

 traveling fellowship at U of T in Canada.

Back in the UK, he worked on the liver transplant programme at the Royal Free Hospital
Royal Free Hospital
The Royal Free Hospital is a major teaching hospital in Hampstead, London, England and part of the Royal Free Hampstead NHS Trust....

 in London. In 1995, while conducting research into Crohn's disease
Crohn's disease
Crohn's disease, also known as regional enteritis, is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract from mouth to anus, causing a wide variety of symptoms...

, 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. In 1996, Wakefield turned his attention to researching the connection between the MMR vaccine and autism. At the time of his MMR research study, Wakefield was senior lecturer and honorary consultant in experimental gastroenterology
Gastroenterology
Gastroenterology is the branch of medicine whereby the digestive system and its disorders are studied. The name is a combination of three Ancient Greek words gaster , enteron , and logos...

 at the Royal Free Hospital School of Medicine (from 2008 UCL Medical School). He resigned in 2001, by "mutual agreement and was made a fellow of the Royal College of Pathologists", and moved to the US in 2001 or 2004, both dates according to 'The Times
The Times
The Times is a British daily national newspaper, first published in London in 1785 under the title The Daily Universal Register . The Times and its sister paper The Sunday Times are published by Times Newspapers Limited, a subsidiary since 1981 of News International...

'. 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 Lancet paper.

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
Austin, Texas
Austin is the capital city of the U.S. state of :Texas and the seat of Travis County. Located in Central Texas on the eastern edge of the American Southwest, it is the fourth-largest city in Texas and the 14th most populous city in the United States. It was the third-fastest-growing large city in...

 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'." He resigned from Thoughtful House in February 2010, after the British General Medical Council
General Medical Council
The General Medical Council registers and regulates doctors practising in the United Kingdom. It has the power to revoke or restrict a doctor's registration if it deems them unfit to practise...

 found that he had been "dishonest and irresponsible" in conducting his earlier autism research in England. The Times reported in May 2010 that he was a medical advisor for Visceral, a UK charity that "researches bowel disease and developmental disorders".

Wakefield is no longer licensed in the UK as a physician, and is not licensed in the US. As of January 2011, he lives in the US where he has a following including celebrities like Jenny McCarthy
Jenny McCarthy
Jennifer Ann "Jenny" McCarthy is an American model, comedian, actress, author, activist, and game show host. She began her career in 1993 as a nude model for Playboy magazine and was later named their Playmate of the Year. McCarthy then parlayed her Playboy fame into a successful television and...

 who wrote the foreword for Wakefield's autobiography, Callous Disregard, and believes her son's autism is due to vaccines. According to Deer, as of 2011, he lives near Austin with his wife, Carmel, and four children.

MMR controversy


On 28 February 1998, a paper written by Wakefield and twelve other authors about twelve autistic
Autism spectrum
The term "autism spectrum" is often used to describe disorders that are currently classified as pervasive developmental disorders. Pervasive developmental disorders include autism, Asperger syndrome, Childhood disintegrative disorder, Rett syndrome and Pervasive Developmental Disorder Not Otherwise...

 children was published in The Lancet. In it, the authors claimed to have identified a new syndrome
Syndrome
In medicine and psychology, a syndrome is the association of several clinically recognizable features, signs , symptoms , phenomena or characteristics that often occur together, so that the presence of one or more features alerts the physician to the possible presence of the others...

 which they called autistic enterocolitis
Autistic enterocolitis
"Autistic enterocolitis" is a controversial term first used by discredited British gastroenterologist Andrew Wakefield to describe a number of common clinical symptoms and signs which he contends are distinctive to autism...

, raising the possibility of a link between a novel form of bowel disease, autism, and the MMR vaccine. In the study's "findings", the authors noted that the parents of eight of the twelve children linked what were described as "behavioural symptoms" with MMR, and in its "results" reported that the onset of these symptoms began within two weeks of MMR vaccination. In the published 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."


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
Medical Research Council (UK)
The Medical Research Council is a publicly-funded agency responsible for co-ordinating and funding medical research in the United Kingdom. It is one of seven Research Councils in the UK and is answerable to, although politically independent from, the Department for Business, Innovation and Skills...

 the following month. 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.

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. The press conference was later criticized as 'science by press conference
Science by press conference
The term science by press conference is a phrase referring to scientists who put an unusual focus on publicizing results of research in the media. The term is usually used disparagingly...

'. According to BBC News, it was this press conference, rather than the Lancet paper, that fueled the MMR vaccination scare. 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." 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.
In December 2001, Wakefield resigned from the Royal Free Hospital, saying, "I have been asked to go because my research results are unpopular." 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."

Aftermath of initial controversy


Wakefield continued conducting clinical research in the US after leaving the Royal Free Hospital
Royal Free Hospital
The Royal Free Hospital is a major teaching hospital in Hampstead, London, England and part of the Royal Free Hampstead NHS Trust....

 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.

In 2004, Wakefield started work at the Thoughtful House research center in Austin, Texas. 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
General Medical Council
The General Medical Council registers and regulates doctors practising in the United Kingdom. It has the power to revoke or restrict a doctor's registration if it deems them unfit to practise...

.

In February 2004, controversy resurfaced when Wakefield was accused of a conflict of interest. The Sunday Times
The Sunday Times (UK)
The Sunday Times is a Sunday broadsheet newspaper, distributed in the United Kingdom. The Sunday Times is published by Times Newspapers Ltd, a subsidiary of News International, which is in turn owned by News Corporation. Times Newspapers also owns The Times, but the two papers were founded...

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
Legal Services Commission
The Legal Services Commission is an executive non-departmental public body of the Ministry of Justice that is responsible for the operational administration of legal aid in England and Wales.-Overview:...

) to pay for the research. Previously, in October 2003, the board had cut off public funding for the litigation against MMR manufacturers. Following an investigation of The Sunday Times allegations by the UK General Medical Council, Wakefield was charged with serious professional misconduct, including dishonesty. 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.

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. Ten of Wakefield's twelve co-authors of the Lancet paper later published a retraction of an interpretation: 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:
"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."

Wakefield v Channel 4 and others


In November 2004, Channel 4
Channel 4
Channel 4 is a British public-service television broadcaster which began working on 2 November 1982. Although largely commercially self-funded, it is ultimately publicly owned; originally a subsidiary of the Independent Broadcasting Authority , the station is now owned and operated by the Channel...

 broadcast a one-hour Dispatches
Dispatches (TV series)
Dispatches is the British television current affairs documentary series on Channel 4, first transmitted in 1987. The programme covers issues about British society, politics, health, religion, international current affairs and the environment, usually featuring a mole in an organisation.-Awards:*...

investigation by reporter Brian Deer
Brian Deer
Brian Deer is a British investigative reporter, best known for inquiries into the drug industry, medicine and social issues for the Sunday Times of London.- Career :...

; 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".

In addition to Wakefield's unpublished initial patent submission, Deer released a copy of the published patent application. 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 Lancet paper, at the same page this patent explicitly states that the MMR vaccine causes autism:
"It has now also been shown that use of the MMR vaccine (which is taken to include live attentuated 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."

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.

In January 2005, Wakefield initiated libel proceedings against Channel 4, the independent production company Twenty Twenty
Twenty Twenty
Twenty Twenty is a British independent television production company which joined the Shed Media Group in September 2007. The company produces documentaries, current affairs, drama, living history, and children's television.-Current productions:...

 and Brian Deer. At the same time, Wakefield issued libel proceedings against The Sunday Times, and against Deer personally over his website briandeer.com. 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
David Eady
Sir David Eady , styled The Hon. Mr Justice Eady, in legal writing Eady J, is a High Court judge in England and Wales. As a judge he is known for having presided over many high-profile libel and privacy cases....

 ruled against a Stay of proceedings
Stay of proceedings
A stay of proceedings is a ruling by the court in civil and criminal procedure, halting further legal process in a trial. The court can subsequently lift the stay and resume proceedings. However, a stay is sometimes used as a device to postpone proceedings indefinitely.-United Kingdom:In United...

, stating:
"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."


The judgment identified Channel 4's "very lengthy extracts" regarding Wakefield, where Deer's allegations are that he had:
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.

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.
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.
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.
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.

In addition the 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, payments which The Sunday Times reported had begun two years before the Lancet paper.

Within days of Deer's report, Wakefield dropped all his libel actions and was required to pay all the defendants' legal costs.

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. Wakefield's data were also questioned; 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.

In June 2005, the BBC
BBC
The British Broadcasting Corporation is a British public service broadcaster. Its headquarters is at Broadcasting House in the City of Westminster, London. It is the largest broadcaster in the world, with about 23,000 staff...

 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 neuro-typical child. The study's authors found no evidence of any link between MMR and autism.

The Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...

 (IOM) of the United States National Academy of Sciences
United States National Academy of Sciences
The National Academy of Sciences is a corporation in the United States whose members serve pro bono as "advisers to the nation on science, engineering, and medicine." As a national academy, new members of the organization are elected annually by current members, based on their distinguished and...

, along with the CDC
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...

 and the UK National Health Service
National Health Service
The National Health Service is the shared name of three of the four publicly funded healthcare systems in the United Kingdom. They provide a comprehensive range of health services, the vast majority of which are free at the point of use to residents of the United Kingdom...

, 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
Autistic enterocolitis
"Autistic enterocolitis" is a controversial term first used by discredited British gastroenterologist Andrew Wakefield to describe a number of common clinical symptoms and signs which he contends are distinctive to autism...

."

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
Medical ethics
Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...

 against Wakefield and two colleagues involved in the Lancet paper. 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".
  • Ordered investigations "without the requisite paediatric qualifications" including colonoscopies
    Colonoscopy
    Colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a CCD camera or a fiber optic camera on a flexible tube passed through the anus. It may provide a visual diagnosis and grants the opportunity for biopsy or removal of suspected...

    , colon biopsies and lumbar puncture
    Lumbar puncture
    A lumbar puncture is a diagnostic and at times therapeutic procedure that is performed in order to collect a sample of cerebrospinal fluid for biochemical, microbiological, and cytological analysis, or very rarely as a treatment to relieve increased intracranial pressure.-Indications:The...

    s ("spinal taps") on his research subjects without the approval of his department's ethics board
    Institutional review board
    An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

     and contrary to the children's clinical interests, 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".
  • "Conduct[ed] the study on a basis which was not approved by the hospital's ethics committee."
  • Purchased blood samples - for £5 each - from children present at his son's birthday party, which Wakefield joked about in a later presentation.


Wakefield denied the charges; on 28 January 2010, the GMC ruled against Wakefield on all issues, stating that he had "failed in his duties as a responsible consultant", acted against the interests of his patients, and "dishonestly and irresponsibly" in his controversial research. On 24 May 2010 he was struck off the United Kingdom medical register; co-author John Walker-Smith was also struck from the medical register, while junior author Simon Murch was cleared. 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. John Walker-Smith is appealing the decision.

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", 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
BMJ
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...

, recounting how normal clinical histopathology
Histopathology
Histopathology refers to the microscopic examination of tissue in order to study the manifestations of disease...

 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. 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 Lancet article.

On 5 January 2011, BMJ published an article by Brian Deer entitled "How the case against the MMR vaccine was fixed". 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:
"The Lancet paper 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."


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.


In a BMJ follow-up article on 11 January 2011, Deer said that based upon documents he obtained under Freedom of information legislation
Freedom of information legislation
Freedom of information legislation comprises laws that guarantee access to data held by the state. They establish a "right-to-know" legal process by which requests may be made for government-held information, to be received freely or at minimal cost, barring standard exceptions...

, 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". 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
Autistic enterocolitis
"Autistic enterocolitis" is a controversial term first used by discredited British gastroenterologist Andrew Wakefield to describe a number of common clinical symptoms and signs which he contends are distinctive to autism...

. 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."


WebMD
WebMD
WebMD is an American corporation which provides health information services. It was founded in 1996 by Jim Clark and Pavan Nigam as Healthscape, later Healtheon, and then acquired WebMD in 1999 to form Healtheon/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". 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".

Journal retractions


On 2 February 2010, The Lancet formally retracted Wakefield's 1998 paper. 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".

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.

In May 2010, The American Journal of Gastroenterology
The American Journal of Gastroenterology
The American Journal of Gastroenterology is a medical journal published for the American College of Gastroenterology by the Nature Publishing Group....

retracted a paper of Wakefield's that used data from the 12 patients of the Lancet article.

On 5 January 2011, BMJ editors recommended that Wakefield's other publications should be scrutinized and retracted if need be.

Wakefield response


As of January 2011, Wakefield has continued to maintain his innocence. He said:
"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 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."


According to BMJ, he says "he never claimed that the children had regressive autism, nor that he said they were previously normal. He never misreported or changed any findings in the study, and never patented a measles vaccine. None of the children were [attorney] Barr's clients before referral to the hospital, and he never received huge payments from the lawyer. There were no conflicts of interest. He is the victim of a conspiracy. He never linked autism with MMR."

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". 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, who Wakefield says is paying him. According to CNN, Wakefield said the patent he held was for "an 'over-the-counter nutritional supplement' that boosts the immune system". WebMD reported that Wakefield said he was the victim of "a ruthless, pragmatic attempt to crush any attempt to investigate valid vaccine safety concerns".

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°
Anderson Cooper 360°
Anderson Cooper 360° is a one-hour television news show on CNN, hosted by the American journalist Anderson Cooper. It is also broadcast around the world on CNN International....

, claiming he hadn't 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
Anderson Cooper
Anderson Hays Cooper is an American journalist, author, and television personality. He is the primary anchor of the CNN news show Anderson Cooper 360°. The program is normally broadcast live from a New York City studio; however, Cooper often broadcasts live on location for breaking news stories...

 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."

Wakefield would later imply that there is a conspiracy
Cabal
A cabal is a group of people united in some close design together, usually to promote their private views and/or interests in a church, state, or other community, often by intrigue...

 by public health
Public health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population 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.

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."

He also noted that Wakefield has previously sued him and lost.

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".

Epidemics and effects


Physicians, medical journals, and editors have made statements tying Wakefield's fraudulent actions to various epidemics and deaths. Michael J. Smith, a professor of pediatrics at the University of Louisville
University of Louisville
The University of Louisville is a public university in Louisville, Kentucky. When founded in 1798, it was the first city-owned public university in the United States and one of the first universities chartered west of the Allegheny Mountains. The university is mandated by the Kentucky General...

, 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."

The Associated Press
Associated Press
The Associated Press is an American news agency. The AP is a cooperative owned by its contributing newspapers, radio and television stations in the United States, which both contribute stories to the AP and use material written by its staff journalists...

 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."


ABC News
ABC News
ABC News is the news gathering and broadcasting division of American broadcast television network ABC, a subsidiary of The Walt Disney Company...

 Channel WWAY3 said:
"Since Dr. Andrew Wakefield's study was released in 1998, many parents have been convinced the measels, 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
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...

, 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."


Paul Hébert
Paul Hébert
Paul Hébert, OC, CQ is a French Canadian actor. He was awarded the Officer of the Order of Canada on June 29, 1987 for his services to French Canadian entertainment and was made a Knight of the National Order of Quebec in 1994...

, editor-in-chief of the Canadian Medical Association Journal
Canadian Medical Association Journal
The Canadian Medical Association Journal is a general medical journal that is published biweekly by the Canadian Medical Association . It covers research and ideas aimed at improving health for people in Canada and globally. CMAJ publishes original clinical research, analyses and reviews, news,...

(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."


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."


Journalist Brian Deer
Brian Deer
Brian Deer is a British investigative reporter, best known for inquiries into the drug industry, medicine and social issues for the Sunday Times of London.- Career :...

 called for criminal charges to be brought against Wakefield.

Despite the allegations of misconduct and fraud, Wakefield continues to rely on the monetary and emotional support of fans who continue to support him. J. B. Handley of the autism and anti-vaccine advocacy group Generation Rescue
Generation Rescue
Generation Rescue is a nonprofit organization that advocates the view that autism and related disorders are primarily caused by environmental factors, particularly vaccines. These claims are biologically implausible and lack convincing scientific evidence...

 noted, "To our community, Andrew Wakefield is Nelson Mandela
Nelson Mandela
Nelson Rolihlahla Mandela served as President of South Africa from 1994 to 1999, and was the first South African president to be elected in a fully representative democratic election. Before his presidency, Mandela was an anti-apartheid activist, and the leader of Umkhonto we Sizwe, the armed wing...

 and Jesus Christ rolled up into one."

On April 1, 2011, the James Randi Educational Foundation
James Randi Educational Foundation
The James Randi Educational Foundation is a non-profit organization founded in 1996 by magician and skeptic James Randi. The JREF's mission includes educating the public and the media on the dangers of accepting unproven claims, and to support research into paranormal claims in controlled...

 awarded Wakefield the Pigasus Award
Pigasus Award
The Pigasus Award is the name of an annual tongue-in-cheek honor recognized by noted skeptic James Randi. The awards seek to expose parapsychological, paranormal or psychic frauds that Randi has noted over the previous year...

 for "refusal to face reality".

Selected publications


Books
Journals
  • Withdrawn:
  • Retracted:
  • Retracted:


External links

  • "Secrets of the MMR scare: The Lancet’s two days to bury bad news" - Brian Deer
    Brian Deer
    Brian Deer is a British investigative reporter, best known for inquiries into the drug industry, medicine and social issues for the Sunday Times of London.- Career :...

    , BMJ
    BMJ
    BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...

    18 January 2011; 342:c7001 doi: 10.1136/bmj.c7001
  • "Assuring research integrity in the wake of Wakefield" - DJ Opel, DS Diekema, EK Marcuse, BMJ
    BMJ
    BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...

    18 January 2011; 342:d2 doi: 10.1136/bmj.d2
  • "How campaigners and the media push bad science" - Andy Alaszewski, BMJ
    BMJ
    BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...

    18 January 2011; 342:d236 doi: 10.1136/bmj.d236
  • "Institutional and editorial misconduct in the MMR scare" - Fiona Godlee
    Fiona Godlee
    Fiona Godlee has been editor in chief of the BMJ since 2005; she is the first female editor appointed in the journal's history.-Career:...

    , editor, BMJ
    BMJ
    BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...

    19 January 2011; 342:d378 doi: 10.1136/bmj.d378
  • "The Vaccine War" - PBS
    Public Broadcasting Service
    The Public Broadcasting Service is an American non-profit public broadcasting television network with 354 member TV stations in the United States which hold collective ownership. Its headquarters is in Arlington, Virginia....

    FRONTLINE documentary, 27 April 2010
  • "Lessons from the MMR Scare" by Fiona Godlee
    Fiona Godlee
    Fiona Godlee has been editor in chief of the BMJ since 2005; she is the first female editor appointed in the journal's history.-Career:...

    , presentation September 6, 2011 at the Fogarty International Center, National Institutes of Health
    National Institutes of Health
    The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...