Some doctors and many unlucky diabetes patients are wondering what the U.S. Food and Drug Administration (FDA) was thinking when it decided to allow the drug Avandia (generic name rosiglitazone) to continue to be sold in the United States. According to an article in the British newspaper The Independent, last week the European Medicines Agency recommended that Avandia be banned from sale in Europe because scientific research confirmed that the drug is linked to an increased risk of heart attacks.
In the United States, however, the FDA acknowledged the link between heart attacks and Avandia, but decided to allow the drug to continue to be prescribed…but only for people whose diabetes cannot be controlled by other medications. In addition, the manufacturer, GlaxoSmithKline (GSK), must provide greater details about the potential risks, in language that is unequivocal.
Avandia was created to help people with type 2 diabetes to control their blood glucose levels by increasing sensitivity to their own natural insulin levels. It was a very successful drug…if you measure success in financial terms. In 2006, global sales of medicines containing Avandia reached $3.2 billion, making it the world’s best-selling diabetes drug.
But in 2007, The New England Journal of Medicine published research showing that people who took Avandia had an increased risk of heart attacks. Since then, additional studies confirmed that Avandia works as intended, but that its side effects can be deadly. According to an article published in February in the New York Times (“Research Ties Diabetes Drug to Heart Woes”), government reports estimated that:
…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 because Avandia can hurt the heart.
That’s an astonishing 6,000 heart attacks every year that could have been prevented if the patients had simply taken a different diabetes medication.
But pharmaceutical companies can be persistent and persuasive. Sometimes frighteningly so. A bipartisan Senate investigation published earlier this year said that GSK failed to warn patients that Avandia might kill them.
“Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.
Mr. Baucus said of the report, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.” [from The New York TImes, February 19, 2010 article]
In June 2010, an article from the prestigious Journal of the American Medical Association concluded that Avandia increased the risk of stroke, heart failure, and all-cause mortality. The conclusion of the study’s lead researcher, Dr. David Graham, was that the drug should be removed from the market. (Oh, and by the way, Dr. Graham works for the Center for Drug Evaluation and Research, which is part of the FDA.)
Where We Are Today
So…banned in Europe, restricted (but not banned) in the United States, and thousands of innocent people hurt or even killed by Avandia side effects. And what does GSK have to say?
All medicines have risks as well as benefits which need to be evaluated in the context of the diseases that they aim to treat. It’s the regulators’ responsibility to review these risks and benefits and to come to a decision as to which medicines should be available for physicians to prescribe for their patients. We recognise that this is an important and at times, difficult job. [from a video transcript of GSK’s Chief Medical Officer, Dr. Ellen Strahlman]
Well, that’s true. But the job drug regulation becomes increasing difficult if a pharmaceutical company attempts to hide or downplay known risks. And who among us would willingly take a medication if we knew that it could potentially kill us? I wouldn’t.
We all weigh risks and benefits daily, but it is a tragedy to be harmed by a medication known to be dangerous, especially if those dangers aren’t clearly, completely, and loudly disclosed. The drug injury lawyers of HensonFuerst continue to look into all research about Avandia. We will use this and other scientific information to protect our clients, and to help them get compensation for their damages.
I’ve asked the question before, but I’ll ask it again: What will it take for the FDA to value public protection over “big pharma” influence?
If you believe you or someone you love have been harmed by the drug Avandia and have questions about your legal options, please contact the attorneys of HensonFuerst. We are available 24 hours a day, 7 days a week, every day of the year at 1-800-4LAW-MED. If you prefer to submit an online request for an immediate evaluation of your case, visit our website at https://www.hensonfuerst.com. There, you’ll also find additional information about your legal options for injuries from taking medications.
Remember, you’re not alone. We’re here for you. If you have questions, HensonFuerst Attorneys have answers.
RESOURCES FOR MORE INFORMATION
The New England Journal of Medicine article. “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” June 14, 2007.
New York Times article. “Research Ties Diabetes Drug to Heart Woes,” by Gardiner Harris. February 19, 2010.
Journal of the American Medical Association. Early release article, posted June 28, 2010. JAMA. 2010;304(4):(doi:10.1001/jama.2010.920).
New Study Slams Avandia. HensonFuerst blog from June 28, 2010
The Independent. “GSK’s Avandia Banned in Europe on Heart Worries,” by Alistair Dawber, September 24, 2010.