• Time, Thursday, August 12, 2010 10:41 AM

Massimo Calabresi, Alice Park and Susan Weill detail how GlaxoSmithKline outmaneuvered Food and Drug Administration officials to keep the diabetes drug Avandia on the market despite research that showed the drug was linked to a 43% increase in heart attacks. The persuasion was worth billions of dollars to GSK, they write, but also may have put millions of patients at risk.

Scientists and policymakers who follow drug approval and safety monitoring process tell the reporters that what happened with GSK is "disturbingly common." Critics charge that the drug-approval process is too easy for pharmaceutical companies to game because the agency relies on the drug companies themselves to perform all pre-market safety testing. It also relies on industry "user fees" for 65% of its budget for post-market monitoring of the drugs it approves.

"The FDA's relationship with the drug industry [is] too cozy," says Sen. Chuck Grassley, R-Iowa.

Meanwhile, deputy FDA commissioner Dr. Joshua Sharfstein tells Time that the agency is investigating whether GSK broke the law by failing to fully inform the agency of Avandia's heart risks. GSK insists the drug is safe and it offers multiple studies that are inconclusive or show no increase in heart risk for Avandia. "GSK continues to stand behind Avandia," says spokesman Kevin Colgan. "The facts will support our position."

Read the whole story at Time »