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Senate Investigation of Avandia Shows Manufacturer Knew About Risks Years Ago

By February 23, 2010July 17th, 2019Dangerous Drugs

As a dangerous prescription drug attorney,I have paid close attention to the diabetes drug Avandia (rosiglitazone) ever since a 2007 study showed it increased risk of heart attacks substantially. That study, authored by Dr. Steven Nissen of the Cleveland Clinic and published in the New England Journal of Medicine, found that taking Avandia increased the risk of cardiac death by 64%. The study was particularly alarming because Avandia is taken by Type II diabetics, whose disease already puts them at high risk for heart problems. Among other things, this spurred a black box warning about heart failure and a Congressional investigation into allegations of unethical behavior by manufacturer GlaxoSmithKline. On Feb. 20, the Senate Finance Committee released the results of its investigation, and according to a Feb. 22 article from USA Today, the results are damning.
Most importantly, the Finance Committee found that GSK knew Avandia carried heart risks for several years before Nissen’s study. It accused GSK of trying to intimidate doctors who came to negative conclusions about the drug and minimizing or misrepresenting scientific evidence. It also said from U.S. Food and Drug Administration employees want the drug taken off the market. The FDA released a statement Monday telling patients not to quit taking Avandia without talking to their doctors, and announcing a panel meeting in July to discuss the results of a long-term, GSK-funded study of the cardiovascular risks of Avandia in Type II diabetics. The results are already in, but the agency said it needed more time to analyze them. An earlier panel voted 20-3 that Avandia does raise risk of heart attacks, but voted 22-1 to recommend keeping it on the market. It currently has sales of $1.19 billion in the United States.
Also on Feb. 22, the New York Times ran a related piece about a meeting between Nissen and GSK, just 11 days before Nissen’s study was published. Nissen legally audiotaped the meeting, concerned about intimidation by the company. He said executives made several false claims, including suggesting they had contradictory information that they could publish jointly with his study. According to the Congressional report, GSK already had the results of Nissen’s study, thanks to a journal reviewer who was also a consultant to the company. But it pretended it did not at the meeting. And even though GSK publicly criticized Nissen’s evidence and methodology, Congress found that GSK’s own scientists said Nissen’s work was sound.
We still don’t have the final results of the RECORD study, and the Times said its interim results were not conclusive. But as a pharmaceutical liability attorney, I don’t believe the public can trust a study funded by GSK. If the claims made by Congress and Nissen are true, GSK has repeatedly attempted to cover up, misrepresent or downplay scientific evidence that Avandia is dangerous, sometimes through intimidation. That behavior casts doubt on any conclusions reached by scientists on GSK’s payroll. Given that patients may risk death or lifelong heart problems from taking Avandia, the risk is just too great. If the existing evidence is not great enough to justify pulling Avandia from the market, as some regulators and safety groups want, the FDA should severely limit its use while it conducts a rigorous independent study.

Based in St. Louis, Carey, Danis & Lowe represents people around the United States who have been seriously injured by a dangerous prescription drug. That includes the hundreds of thousands of people who may have developed serious problems after taking Avandia, as well as their families. In addition to heart attacks, scientific evidence shows that Avandia can increase the risk of heart failure, liver failure and other serious problems. These are serious, lifelong medical conditions that can cause death and drastically reduce the patient’s quality of life. They can also be extremely expensive to treat. Our defective drug lawyershelp patients lay those costs at the feet of the organizations that caused them, and that failed to share vital safety information with patients and their doctors. In a lawsuit, patients and their families can penalize reckless, profit-driven companies and collect the money they need to pay for vital medical care.
If you or someone you love feel ill after taking Avandia or any other dangerous medication, Carey, Danis & Lowe can help. To set up a free, confidential evaluation of your case, please call us toll-free at 1-877-678-3400 or contact us through our Web site.