Wednesday July 14, 2010
According to the New York Times' live blogging from the F.D.A. hearing on Avandia, the votes are in and it's not looking good for GlaxoSmithKline.
Of the 33 members of the committee, only three voted in favor of keeping Avandia on the market as is. Seven advocated adding more warnings on the drug; ten votes went to restricting its sale or making significant revisions to the label, and twelve committee members voted to take Avandia off the market altogether. The F.D.A. will make a final decision "at a later date."
Tuesday July 13, 2010
A New York Times article published today makes the scandalous revelation that SmithKline Beecham (now called GlaxoSmithKline) conducted a study on its new diabetes drug, Avandia, in 1999, and has been working to hide the findings from the public for the past 11 years.
The 1999 study found that Avandia was not only no more effective than its competitor, Actos, but also that it presented more risks of heart attack and stroke. The Times published the following excerpt from an email written in 2001 by SmithKline executive Dr. Martin I. Freed:
"This was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK."
To make matters worse, it seems that Dr. John Jenkins, head of the F.D.A.'s office of new drugs, has been rooting for Avandia, speaking out against taking it off the market, and "disciplining" an employee who recommended that the health warnings be strengthened for Avandia.
Tuesday June 29, 2010
We've known since 2007 that Avandia, once the world's most popular diabetes drug, may increase risk of stroke and heart attack. Two new studies further confirm the suspicions raised three years ago. The FDA plans to meet in July to finally decide whether or not to take Avandia off the market.
The larger of the two studies, commissioned by the FDA and published in the Journal of the American Medical Association, followed 230,000 Medicare patients who were taking either Avandia or a comparable drug called Actos. The results, study leader Dr. David Graham told NPR, indicate a frightening probability: "If you treated 60 people for a year with Avandia," he says, "you would cause one extra case of heart attack, stroke, heart failure or death compared to if you had treated 60 patients with Actos." By the same token, Graham says, approximately 100,000 Americans have likely died or had strokes, heart attacks or heart failure as a result of taking Avandia since it went on the market in 1999.
A meta-analysis of dozens of studies that came out in 2007 found the same results as these most recent studies, yet the FDA's Drug Safety Oversight Board voted 8-7 to keep Avandia on the market. What do you think? Has the FDA failed to learn the lesson posed by the Vioxx scandal in 2004? Or are they right to proceed with caution before pulling a product from the market?
Tuesday June 22, 2010
A new game on Facebook challenges you to improve your diet and lifestyle with your virtual friends as witnesses (and hopefully supporters). HealthSeeker, developed by Diabetes Hands Foundation and Joslin Diabetes Center, involves things called "Missions" and "Action Steps," which you must complete in order to advance in the game and ultimately achieve several "Lifestyle Goals," like eating more healthily, reaching a particular weight, reducing blood sugar levels and improving heart health. Players report on their progress and receive points, badges and awards for their hard work. The game can be found at www.healthseekergame.org.
What do you think? Does HealthSeeker seem like a legitimately helpful way to improve your habits and manage your health, or is it just yet another way to reveal too much personal information on Facebook? Share your thoughts below.