A recent study that concluded the diabetes drug Avandia causes serious increased cardiac risk came about because of an unusual transparency in the drug industry, one that has sparked debate about how such information is used.
At issue is a study released last week showing Avandia, which is used by 1 million people in this country, increased the risk of heart attack by 43 percent and cardiac-related death by 64 percent.
The study was done by Dr. Steven Nissen, who used what is known as a “meta analysis.” To reach their conclusions, he and colleagues analyzed 42 previously conducted clinical trials involving 28,000 patients.
Nissen had found the results of the prior studies on a website that the makers of Avandia – GlaxoSmithKline – had been required to post as part of a settlement of a lawsuit filed by the state of New York over Paxil, another Glaxo drug.
The New England Journal of Medicine rushed publication of Nissen’s study, which was released on the Web last Monday. Glaxo has disagreed with the conclusions.
And while some said the resulting warning underscored the need for widespread posting of drug trial results, others questioned its usefulness, fearing such availability could confuse doctors and patients.
“I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” Dr. Steven Galson, director of the FDA’s Center of Drug Evaluation and Research, told The New York Times.
Congress also has set its sights on the issue and is considering passing a measure requiring such disclosure of clinical trials. Furthermore, the Senate earlier this month passed a bill that would require the FDA to monitor the entire life cycle of a drug, including side effects, and not just the approval process.
There is a public appetite for more information about the efficacy of prescription drugs and their side effects.
Late last week it was revealed that as early as 2000, the FDA had known about concerns about Avandia’s heart risks. The revelation prompted lawmakers to act. Rep. Henry Waxman, a California Democrat who chairs the Committee on Oversight and Government Reform, said he had opened an investigation into Avandia and planned to call Glaxo officials before Congress.
There are many questions to be answered about the most effective way to collect and deliver information about prescription drugs. But patients and their doctors have a right to the best data available so they can make wise health care choices.
