The end could be drawing near for GlaxoSmithKline's multi-billion dollar diabetes drug Avandia, if two U.S. Food and Drug Administration reviewers are successful in their bid to have the drug pulled from the market because of its link to heart problems.
The recommendations were released as part of a report from the Senate Finance Committee on the controversial drug.
While Avandia, known in medical circles as rosiglitazone, works as well as its competitor pioglitazone (Actos), the report concluded, use of the drug is responsible for a "substantial excess number" of heart attacks and heart failure cases that would not have occurred if patients were taking Actos instead.
"Rosiglitazone should be removed from the market," concluded Dr. David Graham and Dr. Kate Gelperin, both epidemiologists with the FDA.
In a statement released Monday, the FDA recommended despite the report that patients currently taking Avandia continue doing so unless their doctor tells them otherwise.
Graham, who has developed a reputation as a safety crusader and whistle blower critical of the agency's postmarket drug safety monitoring record, also raised early concerns about the anti-inflammatory drug Vioxx, which was subsequently removed from the market.
The fear that Avandia could be linked to an increased risk of heart attack and heart failure is not a new one. In 2007, then-president of the American College of Cardiology Dr. Steven Nissen raised the alarm when his analysis revealed that those taking the drug experienced a 43 percent higher risk of heart attacks and a 64 percent increased risk of dying from heart disease.
But the call for the drug's demise comes as Graham and Gelperin say that Avandia is responsible for about 500 additional heart attacks and 300 additional cases of heart failure each month than would occur if Actos were used exclusively.
Perhaps more troubling, committee chairman Max Baucus of Montana and ranking Republican Sen. Charles Grassley of Iowa suggest in the Senate Finance Committee report that GSK was aware of the cardiac risks associated with Avandia years before the evidence became public.
The drugmaker should have warned patients and the FDA about its concerns, but instead "intimidated independent physicians, focused on strategies to minimize findings that rosiglitazone may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk," the senators wrote in a letter to FDA Commissioner Margaret Hamburg.
In a response published on its Web site, GSK rejected the report, which it said is inconsistent with "rigorous scientific evidence supporting the safety of the drug."
And in response to the charge that the company sought to intimidate doctors to tamp down warnings over the drug's risks, GSK spokeswoman Nancy Pekarek said, "We certainly don't condone any effort to silence scientific debate, but we will certainly correct inaccuracies if there is something said about our product that is inaccurate."
Still, in some ways the debate could be a moot point. Primary care doctors contacted by ABC News overwhelmingly said they already eschew the drug in favor of other options.