As Drug Industry’s Influence Over Research Grows, So Does the Potential for Bias
For drugmaker GlaxoSmithKline, the 17-page article in the New England Journal of Medicine represented a coup.
The 2006 report described a trial that compared three diabetes drugs and concluded that Avandia, the company’s new drug, performed best.
“We now have clear evidence from a large international study that the initial use of [Avandia] is more effective than standard therapies,” a senior vice president of GlaxoSmithKline, Lawson Macartney, said in a news release.
What only careful readers of the article would have gleaned is the extent of the financial connections between the drugmaker and the research. The trial had been funded by GlaxoSmithKline, and each of the 11 authors had received money from the company. Four were employees and held company stock. The other seven were academic experts who had received grants or consultant fees from the firm.
Whether these ties altered the report on Avandia may be impossible for readers to know. But while sorting through the data from more than 4,000 patients, the investigators missed hints of a danger that, when fully realized four years later, would lead to Avandia’s virtual disappearance from the United States:
The drug raised the risk of heart attacks.
“If you looked closely at the data that was out there, you could see warning signs,” said Steven E. Nissen, a Cleveland Clinic cardiologist who issued one of the earliest warnings about the drug. “But they were overlooked.”
A Food and Drug Administration scientist later estimated that the drug had been associated with 83,000 heart attacks and deaths.
Arguably the most prestigious medical journal in the world, the New England Journal of Medicine regularly features articles over which pharmaceutical companies and their employees can exert significant influence.