Avandia Defects Could be Responsible for 83,000 Excess Heart AttacksJan 10, 2008 | Parker Waichman LLP
Avandia could have been responsible for an additional 83,000 heart attacks. That stunning number comes from an Avandia analysis performed by Food & Drug Administration (FDA) scientists presented at a July 2007 safety panel meeting. The Avandia heart attack analysis is included in a report released in November by the Senate Finance Committee entitled “The Intimidation of Dr. John Buse and the Diabetes Drug Avandia.”
Avandia’s heart attack link came to light when an analysis of 42 clinical trails published by the Cleveland Clinic in May showed that patients taking the drug had a 43% higher risk of having a heart attack. Late last year, the FDA announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks. However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues, and have called on GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market.
The Avandia debacle has shed a great deal of light on the uncomfortable relationship between the FDA and drug makers like Glaxo. At July Senate hearings on Avandia, it was revealed that Glaxo had informed the FDA of a study it had conducted that produced results similar to the Cleveland Clinic study. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues. The FDA also spent months negotiating with Glaxo over Avandia’s black box heart attack warning, and some consumer advocates argue that the warning is too weak as a result.
Now it appears Glaxo might have tried intimidation to silence one Avandia critic. Dr Buse is an expert in diabetes with extensive research experience in the thiazolidinedione class of drugs that includes Avandia. In 1999, Dr. Buse began expressing concerns about the cardiovascular risks of Avandia. Earlier this summer, the Senate committee heard testimony from Dr. Buse, who said he felt pressured by the drug’s maker, SmithKlineBeecham (now part of GlaxoSmithKline) to sign a clarifying statement drafted by the company that downplayed his concerns. During his testimony, Dr. Buse described name-calling and what he said was the veiled threat of a lawsuit by a high-ranking drug company executive after he had criticized Avandia at a medical meeting. Dr. Buse also testified that Glaxo complained about him to his supervisors at the University of North Carolina.
Now, the Senate Committee has implicated two high-ranking Glaxo executives in the intimidation campaign against Dr. Buse. The report alleges that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved in the intimidation. Dr. Buse had also named Yamada in testimony to the Senate committee. The report cites several emails as evidence of this intimidation, including one that says in part “ …write him a firm letter that would warn him about doing this again…with the punishment being that we will complain up his academic line and to the CME granting bodies that accredit his activities….The question comes up as to whether you think this is a sensible strategy in the future (we don’t really do too much work at UNC to make any threats).”
According to the Senate Committee report, if Glaxo had considered Avandia’s increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr Buse, “instead of trying to smother an independent medical opinion,” some 83,000 Avandia heart attacks may have been avoided.
Despite the evidence of intimidation included in the Senate Committee report, Glaxo insists the allegations are false.