Glaxo Denies Concealing Avandia Heart Problems

GlaxoSmithKline PLC has released a 30-page rebuttal to a U.S. Senate report that accused the company of intentionally trying to conceal potential heart problems with Avandia, a diabetes treatment that used to be a blockbuster drug for the pharmaceutical company.

The British drug maker released a “white paper” on Wednesday, arguing that the Senate Finance Committee’s Avandia report “does not present an accurate, balanced, or complete view of the currently available information on Avandia.”

Avandia (rosiglitazone) is a thiazolidinedione agent, a class of drugs approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years over concerns about the risk of Avandia heart problems.

In May 2007, a meta-analysis of 42 different clinical trials published in the New England Journal of Medicine suggested that users face an increased risk of a heart attack from Avandia. The FDA has since added a black box heart attack warning to Avandia, and some experts have estimated that the diabetes drug could have caused as many as 100,000 heart attacks since it was first introduced.

The Senate report, which was released last weekend, indicates that the pharmaceutical company was not only aware of the dangers of Avandia and chose to ignore them, but also suggests that the company attempted to conceal the risk of heart problems prior to release of this study by directing attention away from the drug’s pitfalls. The report says that the company intimidated physicians and worked to suppress and minimize findings that highlighted Avandia heart problems. The report also blasts the FDA for ignoring recommendations of drug safety reviewers who called for an Avandia recall as early as 2007.

Glaxo’s rebuttal claims that the Senate committee staff cherry-picked data, taking it out of context and not accurately reporting the results of other clinical trials in an effort to misconstrue the side effects of Avandia.

Since the Senate report’s release, GlaxoSmithKline has come under increased pressure to issue a recall of Avandia. Earlier this week U.S. Representative Rosa DeLauro called for the FDA to remove Avandia from the market. DeLauro is the chair of the subcommittee on agriculture for the House Appropriations Committee, which controls the FDA’s funding.

The Glaxo response argues that the company kept the FDA continually abreast of safety information on potential problems with Avandia, and notes that an FDA committee looked at numerous clinical trials before determining that Avandia should be left on the market. The company says that a number of other clinical trials do not show an increased risk of heart attack from taking the drug, but accuses the Senate of leaving that information out of its report.

GlaxoSmithKline PLC currently faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania, where the first trials are expected to begin later this year.