Journal Retracts Controversial Study Linking MMR Vaccine, Autism

The Lancet's Decision Could Ease Parental Resistance to Vaccination

February 10, 2010 04:05 pm David Mitchell

The Lancet has fully retracted the 1998 study(www.thelancet.com) (free registration is required to view the full text of the article) that linked autism to the measles, mumps and rubella, or MMR, vaccine after an independent panel recently concluded that the study was flawed and its lead author's conduct was "dishonest, irresponsible and misleading."

The Lancet's editors said it has become clear that several elements of the original paper by Andrew Wakefield, M.D., and his co-authors are "incorrect" and "contrary to the findings of an earlier investigation."

Jonathan Temte, M.D., Ph.D., a professor in the department of family medicine at the University of Wisconsin School of Medicine and Public Health, Madison, and a member of the CDC's Advisory Committee on Immunization Practices, said the retraction should help reassure physicians who have concerns about purported, but unsubstantiated, links between vaccines and neurodevelopmental disorders.

"In the world of academic medicine, this is a rare and incredibly severe sanction," Temte told AAFP News Now. "The Lancet has, basically, removed this contribution from existence based on well-documented lapses in acceptable scientific conduct."

Temte said "extensive and well-done studies" that followed Wakefield's paper have found no link between vaccines and autism. However, he acknowledged that many parents who have been influenced by Wakefield's study are unlikely to be swayed by the retraction.

"This may be seen as a production of the medical-industrial complex," he said, "thus missing the larger issue of the significant and lingering consequences of poorly conducted research."

Alison Singer, president and co-founder of the Autism Science Foundation, was more optimistic that the retraction, which received widespread media coverage in the United States and abroad, will make a difference.

"I hope this is the point where more parents accept what the science is telling us," she said. "The science is clear on MMR and autism. Now that The Lancet paper has been retracted, parents won't have an unfounded fear based on that study."

Singer said medical journals must take responsibility for reviewing studies because parents make decisions based on what is published.

"It's a big responsibility," she said. "They need to make sure that these studies have the weight of evidence behind them because people will act based on what they publish. In this case, children died because of what was published."

Wakefield's study reported on 12 children with gastrointestinal symptoms who were diagnosed with autism spectrum disorders, and it linked the children's health problems to the MMR vaccine.

Despite the fact that 10 of Wakefield's co-authors later renounced the study -- and numerous studies that followed found no links between autism and vaccines -- many parents in the United States and abroad have avoided vaccinating their children based on the Wakefield study.

The United States and other countries have seen outbreaks of measles and mumps in recent years.

The United Kingdom's General Medical Council, or GMC, announced in 2004 that it was launching an investigation into the allegations of misconduct against Wakefield and two of his former colleagues. A hearing, which began in July 2007 and lasted more than two years, concluded Jan. 28.

In a strongly worded 143-page report, the GMC -- which regulates physicians in the United Kingdom -- determined that Wakefield had committed numerous ethical violations, among them

  • that Wakefield, who was working as a gastroenterologist at London's Royal Free Hospital at the time of the study, did not have the ethical approval or qualifications to oversee the research;
  • that although his contract prohibited him from involvement in patient care, Wakefield subjected children to invasive and unjustified procedures, including lumbar punctures and colonoscopies;
  • that Wakefield was found guilty of failing to disclose conflicts of interest, including receiving funding from lawyers who represented the parents of autistic children and failing to disclose that he held a patent for a single-entity measles vaccine, which he advocated be used in place of MMR vaccine;
  • that Wakefield misrepresented cases as routine referrals when he actually used a biased selection process; and
  • that Wakefield paid children at his son's birthday party for blood samples to be used as a control group in his study, thus demonstrating "callous disregard for the distress and pain" of the children involved and abusing his "position of trust" as a physician.

In April, the GMC will deliberate whether Wakefield and two of his former colleagues committed "serious professional misconduct" and whether sanctions should be imposed on their medical registrations in the United Kingdom. For Wakefield, however, such a sanction may be moot: He now is a founder and executive director of Thoughtful House Center for Children in Austin, Texas.

According to the Thoughtful House Web site(www.thoughtfulhouse.org), the organization's mission is "to advance the treatment and understanding of development disorders through medical care, education and research."


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