|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 05-23-2007
Lawyers forecast a flood of Avandia litigation
There is one certainty in the ongoing debate surrounding a potential increase in heart disease risk for patients taking GlaxoSmithKline's diabetes medicine Avandia: No matter what the science says, lawsuits will pile up against the company in short orderand perhaps siphon billions of dollars away from drug research into years of costly litigation.
GlaxoSmithKline is expected to be hit with a wave of lawsuits from users of the diabetes drug Avandia, plaintiff's lawyers said on Wednesday.
For drug makers, a downside to full disclosure
File this story under "damned if you do, damned if you don't." Even as companies comply with demands from Congress and the media to put ever more clinical trial data into public repositories on the Web, they expose themselves to lawsuits and accusations of hiding safety data. The problem is that safety signals that come from the meta–analyses of many different clinical trials—many of them small and of uncertain clinical value—are very much open to interpretation and debate.
In the meantime, as the scientific evaluation around the data proceeds slowly, patients are frightened and lawsuits proliferate. Until the FDA, industry, and academics agree on the basic parameters for analyzing data under these circumstances, at least as much confusion will be generated by transparency as information of real value.
When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs.
Avandia concerns reopen a wider debate
This article, from the Wall Street Journal, reports that Avandia's class of drugs, called peroxisome proliferated–activated receptors or PPARS, have a long track record of both extraordinary promise and safety problems. Companies are working hard to maximize the benefit of PPAR drugs while minimizing the risks; hopefully, the backlash against Avandia will not shelve promising research in this area.
"It is a challenging class of drugs," said Robert Meyer, who heads the Food and Drug Administration office that oversees diabetes medications. "These are drugs with many effects and many targets" in the body.
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