Doctor Says Avandia Maker Intimidated Him

"Although Avandia has been on the market for eight years and has been used by millions of Americans, the post-market studies have not been done to say conclusively whether Avandia increases or decreases the risks of heart attacks. That's a major failure of our system," Waxman said.

FDA Commissioner Andrew C. von Eschenbach revealed that agency decided on May 23 to call for much stronger label warnings about the risks of congestive heart failure in patients taking Avandia and a similar drug called Actos.

But von Eschenbach said the agency is still analyzing conflicting data about whether Avandia increases the risk of heart attack.

"Up until this point in time we have not had sufficient data that we can rely upon to make a decision," he said.

The agency has scheduled a July 30 meeting of outside experts to evaluate Avandia and similar drugs, he said.

Yesterday's hearing was marked by tense exchanges between Waxman and several Republican committee members, who questioned whether the safety concerns and hearing were politically motivated.

"This does look like in fact it was a political concoction to go after a company, and I object to that," said Rep. Darrell Issa (R-Calif.), charging that the hearing was "politicizing science."

Issa and several other members aggressively questioned Steven E. Nissen of the Cleveland Clinic, whose analysis prompted the hearing, about why he contacted members of Congress before he contacted the FDA.

Nissen said he had approached several lawmakers in the hope that they would help him get access to data for his study.

"This is about patients, it's not about politics," Nissen said.

Waxman and other committee members said the episode provides support for legislation that would give the FDA more power to ensure drug safety.

"FDA needs the will, the resources and the authority to be a more effective watchdog of drug safety," he said.

Sen. Charles E. Grassley (R-Iowa), meanwhile, sent a letter to the FDA asking for an investigation into why an agency scientist was reprimanded for agreeing with a recommendation that stronger warnings were needed for Avandia.

"The Avandia case has opened a new round of questions about the way the FDA monitors drug risks and decides whether to let the public know about emerging risks," he said.