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Tuesday, July 13, 2010

FDA Begins Review of Potentially Dangerous Drug Avandia

After publication of scathing criticism of a major trial supporting Avandia's safety, the FDA will today begin its safety review on the potentially dangerous drug, whose generic name is rosiglitazone. For years, Avandia manufacturer GlaxoSmithKline (GSK) has been using studies it financed to say the drug poses no additional risk of negative cardiovascular outcomes, while others said the drug was dangerous. Now major criticism of GSK's flagship study and the revelation of previously hidden studies lead to questions whether the company has been cooking the books all along to protect this lucrative drug whose sales peaked at $3.2 billion in 2006.

The last time the FDA reviewed the drug was in 2007, shortly after the release of a metastudy by Cincinnati researcher Dr. Steven E. Nissen which showed the drug resulted in a 42% increase in heart attack risk, a 50% increase in congestive heart failure risk, and a 64% increase in the risk of sudden cardiac death. However, the FDA concluded that the drug should stay on the market despite its risks, a decision that led many to criticize the FDA and conclude that officials responsible for approving a drug (who often had strong ties to the industry) had too much power over officials responsible for reviewing ongoing safety of a drug.

Now, there is even more reason to question that decision. In February, the US Senate Committee on Finance issued a scathing report at the conclusion of a two-year investigation, saying that GSK knew the risks of Avandia and tried to conceal them by manipulating data and intimidating scientists. It has also been shown that 87% of those who wrote favorably about Avandia had potential conflicts of interest with (i.e. received money from) GSK. This week, we also learned that an FDA scientist has found several irregularities after closely examining the files of GSK's flagship study RECORD (Rosiglitazone Evaluated for Cardiovascular outcomes in ORal agent combination therapy for type 2 Diabetes). And as early as 1999, GSK (then SmithKline Beecham) hid evidence that Avandia increased cardiovascular risks.

On Friday, an FDA scientist said he found that several instances of apparent serious heart problems that were not included in the tally of adverse events in the RECORD study. The scientist said he found a dozen such instances, and notes that that is a very large number for a cursory review of 549 patient records (about 12% of the total patients enrolled in the study). Overall, he found problems with 16% of the records for patients taking Avandia and 9% of the records of patients in the control group. Overall these "problems" favored Avandia by a ratio of 4:1. In other words, more than 10% of records reviewed had "problems" that favored Avandia.

Equally damning is the revelation of an early study that GSK hid from the FDA and doctors. In 1999, SmithKline Beecham (later GSK) began a study to determine whether Avandia was safer for the heart than Actos, a competing diabetes drug. The result gave clear signs that Avandia might actually be dangerous to the heart. These results were never published, and a senior official later wrote in an email, "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." And so the results remained hidden for 11 years, while millions of prescriptions were written for this dangerous drug.

This may be one of the worst cases of pharmaceutical companies concealing information about dangerous drugs to protect profits, but it is not by far the only case. If you or a loved one has suffered serious injury after taking Avandia or another dangerous drug, filing a pharmaceutical injury lawsuit can not only help you receive compensation, but reduce the profits of companies that engage in these deceptive practices and show other companies that endangering the public is an unprofitable practice. The product liability lawyers of The Cochran Firm stand ready to help you fight unconscionable practices by these corporate giants. Please contact us today for a free initial consultation.


posted by Benjamin A. Irwin at 10:47 AM

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