FDA gets grilled over Avandia 'failure'

NEW YORK (CNNMoney.com) -- FDA commissioner Andrew von Eschenbach took a tongue-lashing from members of Congress over the way his agency handled Avandia, the diabetes drug from GlaxoSmithKline that has come under scrutiny for alleged heart attack risks.

Rep. Henry Waxman (D-California), chairman of the Committee on Oversight and Government Reform, called the Food and Drug Administration's role in monitoring Avandia's safety after it went on the market "a major failure of our system."

"The FDA never required the manufacturer to [conduct] a thorough post-market study of Avandia's heart risks," said Waxman, at a congressional hearing on Wednesday. The hearing was scheduled as a result of a recent report in The New England Journal of Medicine that linked Avandia to increased risk of heart attacks.

The FDA typically requires safety studies on drugs after they are approved for the market. These postmarket studies tend to focus on large patient populations over long periods of time. They're considered important because some safety risks don't manifest themselves until years of use by millions of patients.

Von Eschenbach testified at the congressional hearing that his agency did in fact conduct "rigorous post-marketing surveillance" of Avandia's safety and effectiveness, after he and other agency members approved the drug in 1999.

But the FDA's "phase 4" study, called Adopt, "was not specifically designed for heart attacks in and of itself," he said.

Waxman balanced his criticism by noting that the extent of Avandia's heart attack risks are not fully understood.

"Sounding a false alarm about the drug has the potential to cause harm to patients," said Waxman, who has been heavily involved in Big Pharma legislation for the bulk of his career, having spearheaded the current regulatory system for generic drugs back in 1983.

Avandia is GlaxoSmithKline's second-biggest seller, exceeding $3 billion in 2006 sales. The blockbuster pill controls blood-sugar levels in diabetics. This is considered a lucrative area of health care because, according to the American Diabetes Association, there are more than 20 million diabetics in the United States.

The New England Journal of Medicine published a report on May 21 from Steven Nissen, the Cleveland Clinic's outspoken chief cardiologist whose studies and comments are closely watched by doctors, politicians and investors. In this article, Nissen said that Avandia increased heart attack risk by 43 percent.

Glaxo's (down $0.44 to $51.46, Charts) stock price plunged 8 percent on May 21, after the NEJM published the story. Glaxo's stock slipped another 1 percent on Wednesday.

Dr. Nissen, who also testified before Congress, said that heart disease was a leading problem for diabetics and that a diabetes drug that increases heart attack risk was a "potentially important public health concern."

The FDA issued a safety warning about Avandia after Nissen published his article on on May 21 and said that the drug causes a "potentially significant" increase in risk of heart attacks and death. But many representatives wanted to know why the FDA didn't take more action earlier.

Testimony grew heated at times, with Congress members accusing von Eschenbach of dodging questions, presenting insufficient data and burying warnings. At one point, von Eschenbach said he needed more staffers to analyze health risks in drugs that have already been approved.

But skeptics of Nissen's article point to the fact that his study was a meta-analysis examining data from 42 previous studies rather than direct research in its own right. Some Congress members said that the study might be alarmist.

Indeed, there were representatives who attacked Nissen for publishing the report, which drove down Glaxo's stock. Nissen replied that he had an "absolute moral and ethical obligation" to publish the study.

Nissen also said that the best way to determine accurately Avandia's cardiovascular safety was to conduct a large, seven-year study comparing the Glaxo drug to other diabetes drugs.

GlaxoSmithKline, a British drugmaker, disputed the findings of Nissen's article and said that other studies show different results.

Dr. Moncef Slaoui, chairman of research and development for Glaxo, also testified on Wednesday but was spared the hostility that Congress unleashed on Nissen and Eschenbach.

Slaoui said that Avandia's heart attack risks were comparable to the drug's competitors, and he accused a recent NEJM editorial of "cherry pick[ing] data points."

Dr. Raymond Woosley, chief executive of The Critical Path, a company that helps the FDA establish an efficient way of reviewing drug safety, didn't watch the congressional hearing but said he was "surprised they didn't treat the industry person the same way they treat others."

Woosley said the politicians might have reserved their ire for Nissen because he based his article on a meta-analysis.

"I can't believe the NEJM published it," said Woosley. "It's not the kind of science that should change practice. That's why some people took shots at him on the Hill."

Avandia's bad news could benefit competitors, according to analysts. As a result of this controversy, Avandia could lose sales to other to diabetes drugs like Januvia from Merck (Charts, Fortune 500), Actos from Takeda Pharmaceuticals and Byetta from Eli Lilly & Co. (Charts, Fortune 500) and Amylin (Charts).