Mistakes Were Made - Carol Tavris [24]
If most of the scientists funded by industry are not consciously cheating, what is causing the funding bias? Clinical trials of new drugs are complicated by many factors, including length of treatment, severity of the patients’ disease, side effects, dosage of new drug, and variability in the patients being treated. The interpretation of results is rarely clear and unambiguous; that is why all scientific studies require replication and refinement and why most findings are open to legitimate differences of interpretation. If you are an impartial scientist and your research turns up an ambiguous but worrisome finding about your new drug, perhaps what seems like a slightly increased risk of heart attack or stroke, you might say, “This is troubling; let’s investigate further. Is this increased risk a fluke, was it due to the drug, or were the patients unusually vulnerable?”
However, if you are motivated to show that your new drug is effective and better than older drugs, you will be inclined to downplay your misgivings and resolve the ambiguity in the company’s favor. “It’s nothing. There’s no need to look further.” “Those patients were already quite sick, anyway.” “Let’s assume the drug is safe until proven otherwise.” This was the reasoning of the Merck-funded investigators who had been studying the company’s multibillion-dollar painkiller drug Vioxx before evidence of the drug’s risks was produced by independent scientists.16
You will also be motivated to seek only confirming evidence for your hypothesis and your sponsor’s wishes. In 1998, a team of scientists reported in the distinguished medical journal the Lancet that they had found a positive correlation between autism and childhood vaccines. Naturally, this study generated enormous alarm among parents and caused many to stop vaccinating their children. Six years later, ten of the thirteen scientists involved in this study retracted that particular result and revealed that the lead author, Andrew Wakefield, had had a conflict of interest he had failed to disclose to the journal: He was conducting research on behalf of lawyers representing parents of autistic children. Wakefield had been paid more than $800,000 to determine whether there were grounds for pursuing legal action, and he gave the study’s “yes” answer to the lawyers before publication. “We judge that all this information would have been material to our decision-making about the paper’s suitability, credibility, and validity for publication,” wrote Richard Horton, editor of the Lancet.17
Wakefield, however, did not sign the retraction and could not see a problem. “Conflict of interest,” he wrote in his defense, “is created when involvement in one project potentially could, or actively does, interfere with the objective and dispassionate assessment of the processes or outcomes of another project. We cannot accept that the knowledge that affected children were later to pursue litigation, following their clinical referral and investigation, influenced the content or tone of [our earlier] paper….We emphasise that this was not a scientific paper but a clinical report.”18 Oh. It wasn’t a scientific paper, anyway.
Of course we do not know Andrew Wakefield’s real motives or thoughts about his research. But we suspect that he, like Stanley Berent in our opening story, convinced himself that he was acting honorably, that he was doing good work, and that he was uninfluenced by having been paid $800,000 by the lawyers. Unlike truly independent scientists, however, he had no incentive to look for disconfirming evidence of a correlation between vaccines and autism, and every incentive to overlook other explanations. In fact, five major studies have found no causal relationship between autism and the preservative in the vaccines (which was discontinued in 2001, with no attendant decrease in autism rates). The correlation is coincidental, a result of the fact that