Diabetes drug Avandia linked to higher mortality rates
The New York Times reported on November 25 that Harvard Medical School researchers mining Medicare data on 28,000 patients had concluded that patients taking Rosiglitazone (Avandia) to control diabetes were more likely to suffer fatal complications from congestive heart failure. They did NOT suffer more heart attacks or strokes, however, as previous stuidies had suggested. Investigators speculated that this complication may be disguised by fatal outcomes among a patient population whose average age was 78.
The elderly patients taking Actos (pioglitazone) suffered 15 percent fewer deaths than Avandia patients suffered, and the incidence of CHF among them was 13 percent lower. The president of the American Diabetes Association pointed out that this is about the tenth study showing a tie between Avandia and excess cardiovascular problems, but did not categorize the study as "proof" of the cause. The ADA still removed Avandia from its list of recommended treatments for Type 2 diabetes. The consumer group Public Citizen went a step further and sought to have the drug banned. Unfortunately, with the pharmaceutical industry's firm grip on the FDA approval process, this is unlikely to happen.
The maker of Avandia, Glaxo-Smith-Kline, disputes the Harvard conclusion that Avandia is associated with greater mortality, however, after the past few years' disclosures of drug company manipulation of research and bribery of researchers, manufacturer's credibility on these issues is severely tarnished. Since about half of the 28,000 people in the Harvard study were taking Avandia, it is obvious that GSK has enormous profits at risk. When there are ten studies, involving tens of thousands of patients , all showing that a comparable drug causes 3-15 percent fewer fatalities, an effective drug approval program would become involved to protect its citizens.