Diabetic Drug Avandia Tagged as a Heart Danger
The New York Times published a story on February 19th about the dangers of Avandia, an enormously popular – and profitable – diabetes medication produced by GlaxoSmithKline. The report was authored by two FDA researchers and declares in straightforward English that “Rosiglitazone [Avandia] should be removed from the market.” Language that definitive is rare from the FDA; the reason for such direct comment is that the report is an internal document, one of dozens that have debated the dangers of Avandia over the past seven years.
The drug is known to increase the danger of heart attacks in diabetics, who are prone to heart problems anyway. Avandia was linked to 304 deaths in the third quarter of 2009 alone. According to one FDA report, “…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…”
Debate but No Decision from the FDA
A public news story about these internal FDA research reports reflects the long and controversial history of debate over Avandia and the threat it poses to diabetics who use it. It also reflects the frustration of some of the FDA’s research staff, as similar reports have been issued in the past but the FDA has chosen to leave the medication on the market. Also in play is an unusual Senate investigation into the drug and its manufacturer – the Senate report is scheduled for release on February 20th. Among its conclusions: that GlaxoSmithKline (GSK) has failed to warn users of the medication about its potential dangers.
The debate on Avandia goes back to at least 2003, when the manufacturer concluded a study that showed diabetics who took Avandia had far more heart problems than those who used an alternative medication. In 2006 at the insistence of European regulators GSK conducted and concluded a “meta-study” showing that Avandia increased the risks of serious heart problems by nearly a third. In 2007 the FDA issued a warning about the drug, but stopped short of recall – choosing to leave it on the market.
Questionable Company Research
While sales have dropped as the result of multiple studies and public commentary over the drug’s dangerous side effects, GSK continues to sell the product and market it aggressively. As the result of continuing pressure the company has launched yet another study that is currently recruiting diabetic participants, although some within the FDA have characterized the study’s methodology as “unethical and exploitative.” The test is expected to take a decade or so, with completion expected in 2020. However the patent on Avandia expires in 2012, meaning the drug will no longer be the exclusive profit center that rang up $3.2 billion in sales in 2006 alone.
The reports of heart problems associated with Avandia have been rampant over the years, while GSK and the FDA have kicked the issue back and forth. If you are a diabetic who has taken Avandia and suffered heart problems, contact an attorney about your rights to compensation. GlaxoSmithKline will be spending years in court over their insistence in keeping Avandia on the market.
