Oct 1, 2010: GlaxoSmithKline Under Fire Over Avandia

GlaxoSmithKline, pharmaceutical giant and maker of the controversial diabetes medication, Avandia, is under fire once again. In addition to being severely restricted in the US by the Food and Drug Administration and for undergoing a suspension by the European Medicines Agency, a potential precursor to a ban there, Glaxo is being accused of putting money over patient health, reported Mother Jones.

Following a recent panel review, Avandia's risks were found to outweigh its benefits after long being linked to heart attack, stroke, and death. As a matter-of-fact, one agency review indicated that Avandia was the cause of an unbelievable 83,000 heat attacks, noted Mother Jones.

The drug maker is being blamed for minimizing "questions about Avandia's safety," said the lead investigator for a probe conducted by Senator Chuck Grassley (Republican-Iowa) of the Senate Finance Committee. The investigator reviewed hundreds of thousands of internal Glaxo documents, interviewing an array of whistleblowers and witnesses.

The investigator discussed a company that hid critical facts about its medication's dangerous complications, saying that in 2000, Glaxo knew about Avandia's causing the body to increase an enzyme described as "potentially deadly," noting that researchers at Glaxo published studies that linked the possibly fatal enzyme to heart disease, Mother Jones reported. The Senate Finance Committee concluded that, "the totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public," quoted Mother Jones. Instead of issuing warnings to physicians and patients, Glaxo focused on developing a diagnostic test to locate and inhibit the enzyme's adverse reactions, noted Mother Jones.

According to Steve Nissen, chairman of cardiology at the Cleveland Clinic, Glaxo's responses "reflect a consistent pattern of objectionable behavior.... Whenever the company developed evidence of harm from Avandia, they actively sought to conceal this information from physicians and patients. This pattern of deceit has resulted in serious injury or death in 50,000 to 200,000 patients," quoted Mother Jones.

In the face of tens to hundreds of thousands of links to fatalities and serious illnesses, black box warnings, accusations of cover-ups and placing profits over patients, Glaxo maintains patients are its number one priority. "Avandia is an important treatment for patients with type 2 diabetes," said Glaxo yesterday in a press release that quoted its chief medical officer, Ellen Strahlman, as saying, "Our primary concern continues to be patients with type 2 diabetes."

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