Question: How can BP begin to restore its reputation going forward?

UNPROFESSIONAL CONDUCT

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 last decade 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 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 8 of the children associated the behavioral problems with the administration of the MMR vaccine. While the paper clearly stated that apparently enough to set off a media storm. Parents began to question the composition of the vaccination itself (specifi cally the thimerosal compound), and the justifi cation 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 Wakefi eld'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 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 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 appears unrepentant, arguing that the conflicts of interest did not discredit the research in the original Lancet paper. He also points 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. Wakefield remains a popular advocate with parents who are convinced that there is a link between MMR and autism.