An ex-Senate investigator reveals how GlaxoSmithKline sought to conceal evidence linking its blockbuster diabetes drug to heart attacks.
Paul D. Thacker — Mother Jones
LAST THURSDAY, US and European regulators delivered a major blow to one of the world’s largest drug manufacturers, GlaxoSmithKline. The European Medicines Agency suspended sales of the pharma giant’s multibillion-dollar diabetes drug, Avandia, which has been linked to heart attacks and other cardiac problems, saying that its “benefits…no longer outweigh its risks.” The Food and Drug Administration severely restricted use of the drug to patients for whom there are no other options, stopping short of pulling Avandia off the market.
The fate of Avandia—which one FDA analysis blamed for causing some 83,000 heart attacks—is one part of the story. The other is about how for years GlaxoSmithKline (GSK) buried and downplayed questions about Avandia’s safety. As the lead investigator for Sen. Chuck Grassley (R-Iowa) on the Senate Finance Committee’s investigation into the drug, I spent three years probing Avandia. During that time, my colleagues and I combed through over 250,000 pages of internal GSK documents and interviewed dozens of witnesses and whistleblowers. What emerged was a troubling picture of a company that had placed corporate profits over patient safety. While suppressing inconvenient evidence about the risks of its top-selling drug, the company even began to develop another drug to treat the very side effect Avandia has been linked to.
Here’s what happened: As far back as 2000, GSK had evidence that Avandia causes the body to increase levels of a potentially deadly enzyme. The company’s own researchers have published studies connecting this enzyme to heart disease. But instead of informing patients and doctors, GSK patented a diagnostic test to detect the enzyme and began pouring millions into research to create a new blockbuster drug that would inhibit it, preventing heart attacks. Call it cross-product synergy.
GSK’s actions “reflect a consistent pattern of objectionable behavior,” says Steve Nissen, chairman of the cardiology department at the Cleveland Clinic and a drug safety champion. He adds: “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.”
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