New calls for old drug data in the U.K. have experts second-guessing big drug-safety scandals. If scientists and regulators had had access to every bit of data on Vioxx from the get-go, for instance, would heart attacks and strokes have been averted? Ditto Avandia? "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent," one expert told the Associated Press.
These questions are arising in the wake of a British investigation into GlaxoSmithKline and its antidepressant Seroxat. The government concluded that GSK withheld information on the med's suicide risk for teens, but could not prosecute because withholding that data wasn't illegal under British law because Seroxat wasn't approved for use in kids, just adults. (GSK maintains that it didn't withhold info, anyway.) Officials say they intend to strengthen legislation governing clinical trial info by year's end.
The worry is that safety risks aren't being reported by drugmakers until they absolutely have to. "It would be unwise to assume that this particular case was anomalous," a journal editor said. But other observers emphasized the fact that some side effects aren't known until a drug hits the market and is administered to millions of people instead of a few thousand as in a clinical trial.
- read the story in the International Herald Tribune