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Commentary

Lynch 'Em
Forbes, 6-18-07

Herper argues that the furor over Avandia is only a foretaste of "open–source" drug safety, where clinical trial data is posted on the web for any would–be crusader to analyze and criticize, in short, an invitation for a lynching."

Everyone—lawyer, doctor, think–tanker—wants a piece of the drug safety debate. The catalyst now is a piece of legislation in Congress that, post–Avandia, will establish a potentially dramatic remaking of drug regulation. Before Avandia it seemed that the drug industry was going to get a bill it could live with. The FDA would get new powers and industry would make some concessions. A grand reform that would result in much tougher scrutiny for drugs would be averted.

But Henry Waxman, the Democrat who runs the House committee that oversees the FDA, will hold hearings on June 6, determined to use the Avandia flap to put the FDA and drug manufacturers on the defensive. Now big pharma needs an antianxiety pill. It would be "wholly inappropriate" for Congress to change drug safety law over Avandia, says Ronald Krall, Glaxo's chief medical officer.

One change that seems inevitable is the creation of more Steven Nissens—that is, more outside scientists looking over the FDA's shoulder. A Senate–passed bill from Senators Edward Kennedy (D—Mass.) and Michael Enzi (R—Wyo.) seeks to force manufacturers to make all study results public. Nissen was able to do his Avandia analysis because Glaxo, in order to get then New York attorney general Eliot Spitzer off its back, agreed three years ago to put drug–trial results up for public viewing. The bill would put all drug firms in this boat.

Think of this as the open–source FDA. Already outsiders have pinpointed valid safety issues, such as Vioxx. But open source can be an invitation to a lynching. AstraZeneca (nyse: AZN – news – people)'s blockbuster cholesterol pill Crestor was originally maligned over kidney worries but has since been cleared. Expect "a free–for–all" as academic researchers get more access to data from companies and from electronic health records, says FDA Deputy Commissioner Janet Woodcock. "You could imagine tort lawyers running those analyses," she says.

The problem right now is that the FDA's credibility is at low–ebb. And this is not to say that drugs are any less safe than they were even a few years ago. But what has happened is that we have moved into a 24–hour media environment where scare sells and scientific discussion is pushed to the sidelines. Also, as medical science advances and more people find themselves taking medicines for chronic ailments, consumers are paying a lot more attention to headlines touting dangerous drug risks.

This is not to say that there aren't legitimate drug safety questions at stake surrounding Vioxx or Avandia, but that, in this environment, it very hard to ask the right questions that will improve public policy.



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