Top Diabetes Doc: Drugmaker Threatened Me

The controversy surrounding GlaxoSmithKline's diabetes drug Avandia grew Wednesday as a medical expert told Congress that executives threatened to sue when he first raised questions in 1999 about the treatment's safety.

That testimony, coupled with a recent medical journal analysis highlighting the heart attack risks associated with Avandia, prompted some Democratic lawmakers to rebuke the Food and Drug Administration for failing to protect consumers, and to call for stricter industry regulation.

"Despite additional warnings from outside experts, despite the millions of patients who rely on Avandia to control their blood sugar, and despite the potential risks involved, FDA never required the manufacturer to conduct a thorough post-market study of its heart risks," Rep. Henry Waxman, D-Calif., said.

Waxman, who chairs the House Committee on Oversight and Government Reform, called Wednesday's hearing after an analysis that appeared last month in the New England Journal of Medicine concluded Avandia could raise patients' risk of heart attack by more than 40 percent.

GlaxoSmithKline calls the whole controversy overblown, reports CBS News correspondent Wyatt Andrews. CEO Jean Pierre Garnier acknowledged the need for more studies, but described Avandia as safe.

"In other words, with Avandia, the risk of a heart attack is very infrequent and not necessarily any more than other similar medicines."

Glaxo argues that its own patient studies are a more reliable measure of the drug's safety, although outside experts say the company's results are inconclusive.

Dr. John Buse told lawmakers that after he drew attention in 1999 to heart problems among some patients using Avandia, SmithKline Beecham, which later combined with GlaxoWellcome, warned him that some executives wanted to hold him accountable for a $4 billion drop in the company's stock.

In a letter to SmithKline distributed at the hearing, Buse wrote: "Please call off the dogs. I cannot remain civilized much longer under this kind of heat."

Buse, who is head of endocrinology at the University of North Carolina and is set to become president of the American Diabetes Association, said he eventually signed a clarifying statement with the company that was used to ease concerns from investors. But one year later, Buse sent a letter to the FDA raising the same concerns.

FDA Commissioner Andrew von Eschenbach told Congress his agency is still reviewing dozens of often contradictory studies and analyses on the drug's effects on diabetics. FDA has scheduled a July 30 meeting to have a group of outside experts look at the data.

Von Eschenbach revealed that FDA is ordering Glaxo and rival Eli Lilly to add black box warnings to their diabetes drugs Avandia and Actos, strengthening existing warnings about heart failure, a condition where the heart does not adequately pump blood. The issue is separate from the trend toward heart attacks highlighted in the New England Journal of Medicine.

The problem came to light two weeks ago, when the journal published a study by Dr. Steven Nissen of the Cleveland Clinic that showed pooled results of 42 studies suggesting that Avandia raised the risk of heart attacks by 43 percent and possibly heart-related deaths.

"What patients need to know is there is some evidence of cardiovascular harm from Avandia — but there is not any reason to panic," Nissen told WebMD last month.

More than 6 million people worldwide have taken Avandia or a related drug, Avandamet, since it came on the market in 1999. Glaxo reported total U.S. sales of $2.2 billion for the drug last year.

Avandia's label (.pdf) already warns about possible heart failure and other heart problems when taken with insulin. The drug also raises LDL, or bad cholesterol, and can cause fluid retention and weight gain.

For its part, Glaxo released the most recent results from a large-scale study of Avandia ahead of the hearing. The study compares Avandia with two other diabetes pills in nearly 4,500 people around the world. Drug maker GlaxoSmithKline PLC released results of the first few years of the six-year study showing similar rates of heart-related deaths and hospitalizations among those on Avandia versus those on the other drugs.

The Senate recently passed a version of a bill that makes major changes to FDA's drug safety system. Companion legislation has not yet appeared in the House. Waxman and other leading Democrats said they favor legislation that would give FDA more power to require companies to conduct drug safety studies.

Shares of GlaxoSmithKline fell 44 cents to $51.46 Wednesday on the New York Stock Exchange.