Andrew Wakefield

Andrew Wakefield (born 1956 in the United Kingdom) is a Canadian trained surgeon and the lead author of a controversial 1998 research study, published in The Lancet, which reported bowel symptoms in a selected sample of twelve children with autism spectrum disorders and other disabilities, and alleged a possible connection with MMR vaccination.^[1] Citing safety concerns, in a press conference held in conjunction with the release of the report, Wakefield recommended separating the components of the injections by at least a year. The recommendation, along with widespread media coverage of Wakefield's claims, was responsible for a decrease in immunisation rates in the UK.^[2] The section of the paper setting out its conclusions was subsequently retracted by ten of the paper's thirteen authors.^[3]

Following the controversy, in March 2004 the GMC announced it was launching an inquiry into allegations of serious professional misconduct against Wakefield and two former colleagues,^[4] It centred on claims that autistic and neurotypical children were subjected to unnecessary colon biopsies and lumbar punctures, two of which caused serious complication requiring hospitalization. Additionally, Wakefield is accused of suppressing and falsifying data based on the testimony of Dr. Stephen Bustin and Dr. Nicholas Chadwick during the Autism Omnibus vaccine hearing in June of 2007. However, some of the children's parents are understood to have staunchly defended the doctors' actions, praising them as the first to take their concerns seriously. Wakefield's hearing began on July 16, 2007.^[5]

Wakefield has since claimed in several journals, including the Journal of Clinical Immunology, to have discovered a new disease, unlike other childhood intestinal disorders, known as autistic enterocolitis. However, he has not shown any evidence that this disease exists, and his claim is not recognized by the scientific community^[6] Since arriving in the United States in the wake of the MMR vaccine controversy, over which he is accused of scientific misconduct, Wakefield has continued his research at the Thoughtful House, a centre for autistic children in Texas.^[7]

In May 2006 one of Wakefield's colleagues from Thoughtful House presented preliminary research in Montreal, Canada, that he said supported Wakefield's findings with what was described as fresh evidence of the presence of the vaccine strain of the measles virus in the guts of autistic children.^[8] Stephen Walker, of the Wake Forest University School of Medicine, North Carolina, however, warned against making any such connection.^[9]

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Early career

Andrew Wakefield, MB BS FRCS FRCPath, is an academic gastroenterologist. He graduated in Medicine from St. Mary’s Hospital (now part of Imperial College), part of the University of London, in 1981, and pursued a career in gastrointestinal surgery, pursuing an interest in inflammatory bowel disease. He became a Fellow of the Royal College of Surgeons in 1985, and in 1996 he was awarded a Wellcome Trust Traveling Fellowship to study animal small intestinal transplantation in Toronto, Canada.

Discoveries made during his time in Canada led him to pursue the scientific investigation of inflammatory bowel disease. In 1998, he and his colleagues at the Royal Free Hospital reported what he claimed to be a novel inflammatory bowel disease in children with developmental disorders such as autism; which he later called autistic enterocolitis. He left the Royal Free School of Medicine in 2001, after refusing financial support from his employer, University College London, to verify his hypothesis in a large cohort of children. He is involved in scientific collaborations in the U.S and Europe. The main focus of Dr. Wakefield’s research is an investigation of the immunologic, metabolic, and pathologic changes occurring in inflammatory bowel diseases such as autistic enterocolitis, links between intestinal disease and neurologic injury in children, and the potential relationship of these conditions to environmental causes, such as childhood vaccines.

During the course of his work on childhood developmental disorders, Dr. Wakefield said he became increasingly convinced of the need for a research-oriented, integrated bio-medical and educational approach to these disorders in order to translate clinical benefits for affected children into measurable developmental progress; this is the driving aim of Thoughtful House. Dr. Wakefield has published 132 original scientific articles, book chapters and invited scientific commentaries and was awarded the Fellowship of the Royal College of Pathologists in 2001. He is medical advisor to the United Kingdom charity, Visceral, and sits on the board of the U.S. charity, Medical Interventions for Autism.

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.^[10] Kessick ran a group, Allergy Induced Autism,^[11] focused on the effects of diet of autistic children's behavior. Wakefield subsequently began the controversial Lancet study that ultimately included 12 children, including Kessick's son.

As of 2007, Wakefield is the Executive Director of Thoughtful House Center for Children.^[12]

MMR controversy

Main article: MMR vaccine controversy

In February 1998 a paper written by Wakefield and 12 other doctors about 12 autism spectrum children was published in the Lancet.^[1] Although the paper stressed no causal connection had been proven, Wakefield called for suspension of the triple MMR vaccine at a press conference and in a video news release issued by the hospital.^[13]

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.^[14]

Publicity for Wakefield's warnings caused a drop in the number of children receiving MMR, as had been predicted in a letter to the government by Wakefield's chief at the hospital.^[15] 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, clearly 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.

In November 2001 Wakefield became a fellow of the Royal College of Pathologists in recognition of his research publications.

In December 2001, Wakefield resigned from the Royal Free Hospital, saying, "I have been asked to go because my research results are unpopular."^{[citation needed]} The medical school said that he had left "by mutual agreement."^{[citation needed]} 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 furor - 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."^[16]

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.

Meanwhile, many parents with autistic children have come forward to tell of children who appeared to be developing normally, until shortly after administration of MMR but whose development then regressed, with many reported to also have digestive problems and food intolerances.^{[citation needed]} Some parents have criticized Wakefield's warnings about the potential adverse effects of the MMR, contending they were made to feel guilty for having had their child vaccinated.^{[citation needed]} Wakefield's medical critics say the temporal association between vaccination and the appearance of developmental disorders is inevitable, rather than demonstrating causation, since autism is commonly first revealed early in the second year of life, when MMR vaccination is routine.^{[citation needed]}

The "novel bowel syndrome" claimed by Wakefield has also been criticised, since the key symptom had been recognised for many years as a common finding in children without developmental disorders.^[17]

Controversy resurfaces

In February of 2004, controversy resurfaced when Wakefield was accused of a conflict of interest. The London Sunday Times reported that some of the parents of the 12 children in the Lancet study were recruited via a UK attorney 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.^[18] Previously, in October 2003, the board had cut off public funding for the litigation against MMR manufacturers.^[19] Following an investigation of The Sunday Times allegations by the UK General Medical Council, Wakefield was charged with serious professional misconduct, including dishonesty.^[20] 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 of 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 attorneys responsible for the MMR lawsuit.^[21]

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.^[22] The Lancet's editor said he would not have published the study if he had known of the legal involvement in the research.^{[citation needed]}

Ten of Wakefield's twelve co-authors of the Lancet paper later published a retraction of an interpretation:^[23] 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:^[23]

"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."^[24]

In November, 2004, the UK's Channel 4 Television broadcast a one-hour investigation by reporter Brian Deer, which alleged that before the Lancet paper was published, Wakefield had filed a patent application^[25] for a single measles vaccine, and that his laboratory had failed to find measles virus in the children.^[26] In November 2005, the scope of the allegations facing Wakefield, which he denies, were set out in a High Court judgment.^[27] In December 2006, the Legal Services Commission revealed that it had paid £435,643 in fees to Wakefield^[28]—payments which The Sunday Times reported had begun two years before the Lancet paper.^[21]

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.^[29] 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),^[30] 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 contends some of the data supports his thesis.^[31]

In the aftermath of the Wakefield affair, data suggest that UK vaccination rates have begun to rise.^[32]

Professional misconduct charges

A 2007 hearing with the General Medical Council is examining charges of professional misconduct against Wakefield and two colleagues involved in the Lancet paper.^[33][34]The charges include:

• 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 IRB.
• 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 denies the charges.

See also

• List of vaccine topics

References