When Blumsohn sat down with Barton at the company's Surrey headquarters in late July, he says he spotted something peculiar. In one critical graph showing how Actonel affects fracture rates, Blumsohn noticed that 40 percent of the patient data was missing. Inclusion of the data, he thought, would have disproved P&G's "key message" about Actonel's effectiveness in reducing bone fractures. Several months later, Blumsohn recorded a meeting in which Barton expressed concern that if P&G included the missing 40 percent of the data, Merck would exploit the results. "Because that is contradicting our original manuscript," he said. "I just know what Merck are like. I think they are going to use it."
P&G denies that it skewed data to achieve desired results, saying that Blumsohn "was given access to all of the data related to his research." But the company's previous written statements seem to contradict this assertion. When Blumsohn's lawyer filed a formal data request on his behalf, P&G responded: "It is not the standard practice of P&G to allow unlimited access to raw data from clinical trials to individual investigators, as these data are proprietary."
In November, Blumsohn won a few concessions. He says P&G agreed to remove the graph he'd objected to from an oral presentation and to delete some text from a paper appearing in his name. But P&G's educational materials and other writings continued to make assertions about Actonel's effectiveness, which Blumsohn believed the data he'd seen did not support.
Increasingly, Blumsohn felt he was doing battle not only with P&G but with his university. Shortly after Blumsohn complained about the apparent manipulation of his Actonel data, he recorded a conversation in which Eastell warned, "The only thing we have to watch all the time is our relationship with P&G." The P&G money "is a good source of income, we have got to really watch it."
Over the next 22 months, Blumsohn wrote formal complaint letters to various Sheffield officials. The university didn't investigate his claims, according to an article in the British Times Higher Education Supplement. In July, Blumsohn announced that he would go public with his concerns. Sheffield suspended him in September, citing, among other things, his "refusal to comply with a reasonable management instruction by briefing journalists." Sheffield then offered him the $300,000. Sheffield states that it repeatedly asked Blumsohn to provide evidence supporting his allegations and urged him to bring that evidence "through the proper channels." The university says legal negotiations were initiated "at Blumsohn's request" and "undertaken in good faith by the University."
Universities have long accepted funding from pharmaceutical companies to conduct clinical drug trials. But in the past, their professors insisted on running those trials independently of the sponsor. As the Blumsohn case makes clear, this arm's-length relationship appears to be breaking down. Earlier this month, the Wall Street Journal reported on the growing willingness of some academics to sign their names—and lend their prestige—to articles and editorials penned by drug-company ghostwriters. In addition to the Vioxx episode, recent reports indicate that published academic studies related to the drugs Celebrex, Paxil, and Zoloft appear to have been skewed when their authors permitted the suppression of negative results.
The British Parliament has promised to investigate Blumsohn's allegations. And in January, medical journal editors will be gathering once again to discuss what can be done to restore the integrity of the research they publish. One idea that's been floated in the United States is a new arm of the National Institutes of Health that could serve as a repository for complete clinical trial data while also monitoring trials and verifying the accuracy of published results. Whatever the solution, something needs to be done soon. Scholarly independence has already taken too many hits.
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