The U.K. medical journal the Lancet has taken the unusual step of withdrawing an article it published—a study of 12 children with behavioral disorders that developed following administration of vaccines or the onset of measles or otitis media.
“Following the judgment of the U.K. General Medical Council [GMC] Fitness to Practise Panel on Jan. 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation,” the Lancet editors said in a Feb. 2 statement. “In particular, 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. Therefore we fully retract this paper from the published record.”
The Wakefield study involved 12 children described in the journal as having been “consecutively referred” to the pediatric gastroenterology department at the Royal Free Hospital and School of Medicine in London (Lancet 1998;351:637-41). All had a history of a pervasive developmental disorder with loss of acquired skills. They also had intestinal symptoms, including diarrhea, abdominal pain, bloating, and food intolerance. “Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent,” the authors wrote.
The researchers took histories, including details of immunizations and exposure to infectious diseases as well as developmental histories. They also performed a battery of tests, including colonoscopy with multiple biopsies, cerebral MRI, and EEG. On endoscopy, they said the “most striking and consistent feature” was lymphoid nodular hyperplasia of the terminal ileum in 10 subjects.
Behavioral diagnoses for the children included autism (9), possible postviral or vaccinal encephalitis (2), and disintegrative psychosis (1). I
In eight children, parents or physicians linked the onset of behavioral problems to receiving the mumps, measles, and rubella vaccination. Five children had immediate adverse vaccine reactions including rash, fever, delirium, and in three cases, convulsions. One subject had received monovalent measles vaccine at 15 months, after which his development slowed. He later received a dose of the mumps, measles, and rubella vaccine at age 4 years 5 months, a day after which his mother described “striking deterioration in his behavior that she did link with the immunization,” the researchers noted.
The researchers noted that “intestinal and behavioral pathologies may have occurred together by chance, reflecting a selection bias in a self-referred group; however, the uniformity of the intestinal pathological changes and the fact that previous studies have found intestinal dysfunction in children with autistic spectrum disorders suggests that the connection is real and reflects a unique disease process.”
They added that their study “did not prove an association between measles, mumps, and rubella vaccine and the syndrome described.”
According to its report, the panel found that in 1996, Dr. Wakefield was involved in advising Richard Barr, an attorney acting on behalf of people alleged to have suffered harm caused by the administration of the measles, mumps, and rubella (MMR) vaccine, “as to the research that would be required to establish that the vaccine was causing injury.”The panel found that “[Dr. Wakefield's] involvement in the MMR litigation … had ethical implications and should have been disclosed.”oimilarly, it found that Dr. Wakefield should have disclosed that he received 50,000 pounds ($78,000) in funding for the study from the Legal Aid Board—from a grant that Mr. Barr applied for. In helping Mr. Barr apply for the money, Dr. Wakefield did not disclose to the Legal Aid Board that some of the items that money was being requested for, such as MRI studies, were already being paid for by Britain's National Health Service, the board found.
Regarding the Lancet paper, the panel found that Dr. Wakefield's describing the referral process as “routine” when some of the patients were actually specifically selected for the study “was irresponsible and misleading and contrary to [his] duty as a senior author.” The panel also noted that four of the children in the study lacked a history of gastrointestinal symptoms, thereby making them unlikely “routine referrals”to the hospital's gastroenterology department, and that Dr. Wakefield should have disclosed to the Lancet that, in 1997, he filed for a patent on a new MMR vaccine.
The panel also noted that Dr. Wakefield paid some children who were guests at his son's birthday party 5 pounds ($8) to have their blood taken as part of the study; it noted that this showed “a callous disregard for the distress and pain that [Dr. Wakefield] knew or ought to have known the children involved might suffer.”
Does the Lancet's withdrawal of the paper help vaccination advocates? “I think the retraction is far too little far too late,” Dr. Paul Offit, ok chief of the division of infectious diseases and the director of the Vaccine Education Center at the Children's Hospital of Philadelphia, okid in an interview. “The Lancet published a hypothesis that was unsupported and has since been disproven by careful scientific study. But there is no undoing the harm of that original paper. Many parents abandoned the MMR vaccine. As a consequence, hundreds of children were hospitalized and four were killed by measles. This retraction will do nothing to change that.”
The Lancet and this news organization are both owned by Elsevier.
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