One of the interesting revelations from the Avandia debacle this week is that Steve Nissen, whose piece in The New England Journal of Medicine about the drug’s heart risks triggered the controversy, found the clinical trial data on Glaxo’s own web site.

The posting was the result of a deal with the New York attorney general, who filed a lawsuit against Glaxo for failing to disclose clinical trial data for its Paxil antidepressant, which was linked to suicidal behavior. So Glaxo agreed to post trial results of its drugs.

As it turns out, the first posting Glaxo made involved the same 65 Avandia studies that Nissen analyzed. “It was a treasure trove,” the Cleveland Clinic cardiologist tells The New York Times.

Not surprisingly, Glaxo is none too happy. Ron Krall, Glaxo’s chief medical officer for Glaxo says the drugmaker recognized that controversy could ensue by creating the database. Others may analyze the data differently than the company.

“We are committed to the principle of transparency,” Krall tells the Times. “But we knew that when starting this, by putting the data in the public, many things could happen, some of which could be trouble.”

The episode underscores the intensity of the controversy over disclosing clinical trial results. Congress is considering legislation to require drugmakers to post the data. There’s also debate about whether the info should be designed primarily for scientists or the general public.

“I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” says Steve Galson, the director of the FDA’s Center for Drug Evaluation and Research.

Deborah Zarin, the director of ClinicalTrials.gov, tells the paper there’s been “significant discussion” among experts over the last year about the issue, and that most people involved appear to agree that data is best understood by experts.

Maybe. But already the move toward disclosure has had a positive affect - the Avandia episode illustrates the importance of making data available. Not everyone is a Steve Nissen. And certainly not everyone will agree with him or others who attempt the same feat. Clearly, though, the public is better off if there’s an opportunity to better understand the drugs it takes.

And so if drugmakers really want to avoid ‘trouble’ - and instill confidence in their ability and willingness to develop, test and market safe medicines - they should be required to post results. They’re free to disagree with an analysis. Debate is, in fact, healthy. But if they’re truly confident of the integrity of their work, they should have nothing to hide.

Further reading…
The New York Times (registration required);
National Conference of State Legislatures list of states with bills about trial disclosure.

[tags]Avandia, Clinical Trials, GlaxoSmithKline[/tags]