Speaking of Racketeer Influenced and Corrupt Organizations, GlaxoSmithKline wants to protect its drug profits at the expense of hundreds of deaths a year.
Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.
The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.
The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.
[Click to continue reading Diabetes Drug Avandia Harms the Heart, Studies Find – NYTimes.com]
GSK is more interested in resurrecting their cash cow:
Driven in part by a multimillion-dollar advertising campaign, sales [of Avandia] were $3.2 billion in 2006
despite the US Senate suggesting the process itself was/is flawed:
In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked “what steps the F.D.A. has taken to protect patients in the TIDE trial” and said the trial’s patients had never been told about the concerns raised by the agency’s own safety officers.
Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.
“It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,” Mr. Grassley said. “The Avandia case may be the most alarming example of the problem with this setup.”
The question of when and how to communicate possible drug risks has long bedeviled drug makers and regulators. Hints are common that drugs may cause injuries; thousands of drug injury reports pour into the Food and Drug Administration every week. For example, Avandia ranked first among all prescribed drugs in the number of serious, disabling and fatal problems — including 304 deaths — reported to the agency in the third quarter of 2009, according to an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group.
The Senate investigation — the result of years of digging through more than 250,000 internal company documents — concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.
Don’t forget that the FDA’s coziness with the pharmaceutical corporations is part of the problem too. Unless there are some drastic structural changes in the FDA, these sorts of issues are going to come up repeatedly.