Editorial: More drug trouble

Saturday, May 26, 2007 | 7:10 a.m.

It appears the U.S. Food and Drug Administration may have known as early as 2002 that the popular diabetes drug Avandia carried a high risk of congestive heart failure among users.

But the public didn't know of the possibility of such risks until Monday, when The New England Journal of Medicine posted online a report that says an analysis of 42 smaller, short-term studies shows Avandia raised patient s' heart disease risk by 30 percent.

FDA officials on Monday acknowledged that Glaxo-SmithKline, which manufactures Avandia, notified the agency as far back as 2005 of studies showing the potential for the increased risk . But neither the drug company nor the FDA issued public warnings until The New England Journal published its analysis on Monday. The agency has since issued a "safety alert" that cites "potentially significant" risks of heart failure among Avandia users.

And, it gets worse.

A story by USA Today on Wednesday reports that the Public Citizen Health Research Group sent a letter this week to FDA Administrator Andrew von Eschenbach, accusing the agency of ignoring an internal 2002 memo in which agency staff recommended placing warning labels on Avandia and Actos, a drug in the same class, after reports of increased risk of congestive heart failure among patients.

The FDA required a warning on Avandia in April 2006, USA Today reports, but it came only after a study of patients who already had suffered heart failure was conducted.

Rep. Henry Waxman, D-Calif., has called for a congressional hearing June 6 to investigate the FDA's handling of Avandia. But it is uncertain whether the FDA would be willing to change. Two anti-inflammatory drugs, a painkiller and a cholesterol-busting drug have been yanked from the market or seriously questioned in recent years - in part because the FDA failed to press for adequate oversight of possible ill effects.

Last week the Senate passed legislation that would give the FDA added authority for oversight after new drugs hit the market. President Bush doesn't think the agency needs it - not surprising, because Bush has a history of handing the government's regulatory duties to the industries being regulated. And what good is added authority if, as has been alleged, the FDA ignores internal staff memos citing risks?

These are the kinds of questions for which Congress must demand answers. People who take prescription drugs are already sick. They have a right to expect that the drugs they are given will make them better, not worse.