Responding to that skepticism, Drazen has urged doctors to overcome their doubts and to “believe the data,” as he put it in a recent editorial.
“Some people thought I was a little naive” for saying that, Drazen said. But he said he is convinced that most researchers are on the same mission he has for the journal — to find the truth and help patients.
“This is a business built on people telling the truth,” he said.
But Drazen said he has no illusions about what the demand for profits can do to pure motives. He noted that the stakes are highest for patients.
“I lie awake at night because I know somebody somewhere is trying to pull a fast one on me,” he said. “Have we plugged every leak?”
He pauses and shrugs:
“We don’t know. But we think we get most of them.”
Risks vs. benefits
The outlines of the Avandia case — in which the drug’s dangers had been recognized within the company long before the FDA pulled it from retail shelves — are well known.
But the way that company officials employed academics — and the prestige of the nation’s top journal — to promote the idea that the drug was safe has received little public scrutiny, and a full account offers a window into the corporate decisions underlying today’s drug research.
Interviews, FDA documents and e-mails released by a Senate investigation indicate that GlaxoSmithKline withheld key information from the academic researchers it had selected to do the work; decided against conducting a proposed trial, because it might have shown unflattering side effects; and published the results of an unfinished trial even though they were inconclusive and served to do little but obscure the signs of danger that had arisen.
The company says it acted properly throughout.
“We firmly believe we acted responsibly in conducting the clinical trial program, in marketing the medicine, in monitoring its safety once it was approved for use and in updating information in the medicine’s labeling as new information became available,” the company said in a statement.
From nearly the beginning, Glaxo scientists confronted signs of potential heart dangers in Avandia. In 2000, about a year after the drug’s approval, a small internal study suggested that Avandia might raise “bad” cholesterol levels more than a competitor.
The company considered sponsoring a full-blown trial to weigh the issue, but before it did, scientists conducted a “risk/benefit” analysis — not to calculate the risks and benefits of the drug to patients but to see whether a full-blown trial could harm the drug’s reputation.