At the age of 14 months old, most children in North America and Europe receive a triple vaccination against three diseases: measles, mumps, and rubella (also known as German measles). Abbreviated as MMR, the vaccination has come under increased scrutiny over the past two decades for concerns over a potential link between MMR and autism (a neural disorder affecting behavioral and cognitive skills). Concerned parents have become vocal advocates on both sides of the argument. On one side, parents of autistic children believe that MMR, or specifically the preservative agent thimerosal (a mercury-containing chemical compound), causes significant intestinal problems and behavioral changes shortly after administration of the vaccination. On the other side of the debate, parents are concerned that a choice not to vaccinate exposes children to diseases that have long been controlled in our population. This debate over a connection between MMR and autism began in earnest in 1998 after the publication in the British medical journal The Lancet of a research paper by Dr. Andrew Wakefield of the Royal Free Hospital in London. The paper proposed a new syndrome with two conditions: chronic intestinal disease and the loss of behavioral skills that had already been acquired as part of normal child development. Out of 12 cases in the paper, parents of eight of the children associated the behavioral problems with the administration of the MMR vaccine. While the paper clearly stated that no association between the MMR and the condition had been proved, the implication was there, and that was apparently enough to set off a media storm. Parents began to question the composition of the vaccination itself (specifically the thimerosal compound), and the justification for administration of all three vaccines in one dose at such a young age. Inevitably, many parents started to choose not to vaccinate their children. In Britain, 91 percent of age-eligible children were vaccinated in 1998. By 2004 that number had fallen to 80 percent which, doctors warned, was far below the 90 percent rate needed to keep the diseases under control. Despite reassurances from the Medical Research Council in Britain and the U.S. Institute of Medicine that there was no evidence of a link between MMR and autism, emotions continued to escalate. Even study data from Finland (1.8 million children over a 14-year period) and Denmark (537,303 children) showing no evidence of a connection failed to have a calming effect, and Wakefield’s reputation as a parent advocate continued to grow, even though his study had included only 12 cases. However, in 2004, a four-month investigation by Brian Deer, a journalist at England’s Sunday Times newspaper, revealed information that brought Wakefield’s work into serious question: • While actively warning parents to avoid MMR as the senior author on the Lancet paper, Wakefield failed to disclose that a follow-up study was funded by a legal aid group helping parents who believed that their children had been harmed by the MMR vaccines. Wakefield received £55,000 ($90,000) from the group but did not disclose the relationship with his coauthors of the paper or with editors at The Lancet. • In addition, Wakefield’s support for three separate vaccinations, rather than the triple MMR (which he believed could be overloading children’s immune systems), included an experimental product under development by a company in which he had a financial interest. This information prompted a partial retraction of the 1998 paper by The Lancet on grounds of “a fatal conflict of interest.” In addition, persistent media scrutiny of Prime Minister Tony Blair’s decision not to reveal whether or not his son Leo had received the MMR vaccination kept the story alive in the British press. In 2006 the death of a 13-year-old boy who had not received the MMR, the first person in Britain in 14 years to die from measles, prompted calls for a full investigation from the General Medical Council (GMC). After a two-and-a-half year investigation (the longest medical misconduct case in the GMC’s 147-year history), at a cost of over £1 million ($1.6 million), the GMC removed Wakefield’s license to practice medicine. Evidence for the decision included the conflicts of interest discovered by the Sunday Times investigation and other concerns: • Wakefield was working at the Royal Free Hospital as a gastroenterologist at the time of the studies, which, the GMC found, did not give him the ethical approval or medical permission to conduct tests outside of his approved area, including brain scans, spinal taps (lumbar punctures), and colonoscopies. • While conducting his follow-up study, Wakefield was found to have acted unprofessionally after taking blood samples from children of fellow medical professionals at his son’s birthday party in return for payments of £5. Despite losing his license to practice medicine, Wakefield continued to remain unrepentant, despite being named one of Time magazine’s top 10 “Science Frauds” in 2012. He continued to argue that the conflicts of interest did not discredit the research in the original Lancet paper. He also pointed out that the GMC ruling was based not on the conclusions he made but for the way in which those conclusions were reached. The Lancet, in response to the GMC ruling, fully retracted the paper from the journal, effectively erasing it from public record. In January 2011, the British Medical Journal (BMJ) published an article by Brian Deer, titled “Secrets of the MMR Scare: How the Case against the MMR Vaccine Was Fixed,” along with an editorial by BMJ Editor-in-Chief Fiona Godlee. The damage to Wakefield’s reputation by an assessment from the BMJ that his work was “an elaborate fraud” was increased even further by a follow-up BMJ article in November 2011 claiming that several of the children in his study didn’t have the inflammatory bowel disease that he claimed. Wakefield responded with a lawsuit filed in a Texas circuit court in January 2012, suing the BMJ for defamation. The lawsuit and subsequent appeal motion were both denied on the grounds that the articles in question did not concern Texas or any activities that occurred in Texas. Wakefield remains a popular advocate with parents who are convinced that there is a link between MMR and autism. In a February 2015 Newsweek magazine interview in which an earlier measles outbreak that began at Disneyland in December 2014 was referenced, Wakefield adamantly defended his views: “The responsibility lies squarely on the shoulders of those that have been involved in vaccine policymaking, which is totally inadequate and bordering on dangerous . . . the government has only themselves to blame.” When asked to comment on plummeting vaccination rates and the fact that there were more cases of measles in the United States in January 2015 than in all of 2012, Wakefield remained dismissive of any responsibility: “The people who put the blame on me are really just displacing their inadequacy on others.”

QUESTION

1. What were the perceived conflicts of interest in Wakefield’s research activities?

2. If Wakefield had disclosed the source of the funding of his study and his interest in the experimental vaccine, would that have added credibility to his campaign against MMR? Why or why not?

3. Why did Wakefield lose his license to practice medicine?

4. The GMC found that Wakefield brought his profession into disrepute with his conduct. What could he have done differently to share his concerns about MMR?