Some Avandia Researchers Had Ties to Glaxo

The controversial diabetes drug, <"">Avandia (rosiglitazone), has been the subject of lawsuits and a Senate probe, as we have long been writing. Now, Business Week is reporting that according to HealthDay News, a new analysis on Glaxo’s Avandia has found many financial links between study researchers—specifically those who submitted positive Avandia results— and pharmaceutical companies. Avandia treats type 2 diabetes and has been linked to heart attacks and heart failure.

HealthDay News points out that it remains unclear if drug maker payments are fully linked to the so-called “supportive” research; however, the review pointed out that a massive 94-percent of the researchers authoring positive study results on Avandia were paid by drug companies.

The researchers looked at over 200 studies and wrote that “there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies,” quoted HealthDay News. According to the review, 45-percent of the study authors had financial conflicts of interest, with about 25-percent of those not having disclosed that information, according to the Mayo Clinic researchers, wrote HealthDay News. The review was published online March 19 in BMJ.

Avandia has been the subject of safety concerns for several years. In November 2007, a black box warning—the Food & Drug Administration (FDA’s) strongest safety warning—detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. The black box was added after the Cleveland Clinic published a meta-analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack.

Meanwhile, last month, the FDA announced it was looking at information regarding Avandia’s risks for heart attack and heart failure to determine if the medication should be removed from the market, wrote HealthDay News. The FDA is scheduling a public meeting on the information in July.

Liability for Avandia lawsuits could total as much as $6 billion, according to a UBS analyst. GlaxoSmithKline, the maker of Avandia, faces more than 13,000 U.S. lawsuits over the controversial diabetes drug.

Last month, the Senate Finance Committee released a report detailing its two-year Avandia investigation. According to the report, in July 2007, the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. Two FDA doctors wrote in an October 2008 memo that Avandia should be removed from the market because it poses serious heart-related dangers to patients, the report said. The Senate report also claimed that Glaxo tried to undermine criticism of the drug. The report drew on 250,000 pages of documents, including emails from GlaxoSmithKline officials and interviews with Glaxo and FDA officials, and anonymous whistleblowers. Since the release of the Senate report, calls have increased for the FDA to pull Avandia off the market.

In a UBS note just made public, the brokerage said Glaxo’s Avandia lawsuit liability was in the range of $1 billion to $6 billion. Avandia lawsuits allege that GlaxoSmithKline failed to adequately warn users about the increased risk of serious and potentially life-threatening injuries, such as heart attack, stroke, congestive heart failure, liver failure, bone fractures, macular edema (vision loss), and death. Federal Avandia lawsuits have been consolidated for pretrial proceedings in an MDL, or multidistrict litigation, in the U.S. District Court for the Eastern District of Pennsylvania. The first bellwether, or test trials, in that litigation are expected to begin in June.

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