Law firm Kaplan Fox & Kilsheimer LLP, who holds the drawstring to the dragnet, claims in the suit that the drugs increased the risk of heart attacks and that the company officials had made false statements. The suit claims that pooled—or meta-analysis—data record that Avandia increased the risk of a heart attack. The law firm alleged that the Food and Drug Administration (FDA) was informed of the preliminary results of Glaxo's analysis as long ago as September 2005. The FDA was again approached with updated information in August 2006. However, the results never saw the daylight.
Avandia's effects occupied column space for the second time in a span of 15 days in The New England Journal of Medicine when on May 21, top U.S. cardiologist Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, first posted a study about Avandia's potential to induce heart attacks. After conducting 42 small, short-term studies, Nissen pooled the results to conclude that Avandia raised hospitalization risks for blocked coronary arteries by about 40%.
Now, since Glaxo publicly disclosed its own meta-analysis after Nissen published his own meta-analysis in the same magazine, the drug maker finds its cookie crumbling. Looking at the plummeting sales and prescriptions, worried investors are at tether's end anticipating that it might result in their having to bear the burden if Avandia, Glaxo's second-biggest seller, tumbles. Avandia alone accrued $3.2 billion in 2006, while Glaxo drugs in sum generated nearly $6 billion in sales in the same year. Decision Resources shared the investors' fears stating that the FDA's decision to add a warming label about cardiovascular risk to patients on the packages of Avandia and Takeda's Actos will cause the drugs' dominance to recede in the market in favor of similar agents in second-line diabetes therapy.
So even though Glaxo is putting up a brave front and disputing Nissen's conclusion, industry analysts fear Glaxo may also face the wrath of product-liability lawsuits from patients sometime in the future. And in the meantime, the market roads for Glaxo appear to be too slippery and pothole-riddled.
