In a front-page story, the New York Times reported, “Hundreds of people taking Avandia [rosiglitazone], a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports.”
A Senate Finance Committee review cites internal FDA documents that highlight a dispute among regulators that “has been brewing for years but has been brought to a head by disagreement over a new clinical trial.”
The Wall Street Journal reports that the Senate committee concluded that Glaxo was aware of the risks, but minimized the issue and attempted to suppress concerned physicians.
The FDA’s documents also indicate that agency scientists said the drug should be pulled from the market in 2008, but FDA chiefs rejected the recommendations.
Now, agency commissioner Margaret Hamburg is expected to meet “with FDA scientists and outside experts to gain a full understanding … of all of the data and issues involved,” a spokeswoman said.
The AP reported that the Senate committee is asking the FDA “why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.”
Glaxo agreed to an FDA request for “a six-year study between its drug and” the Pfizer diabetes drug Actos [pioglitazone] “to give a definitive picture of Avandia’s safety.”
But, the FDA’s internal documents showed that “safety officers … said that a medical trial comparing Avandia with Actos that was being planned would be ‘unethical and exploitive’ because it would expose patients to unwarranted risks,” Bloomberg News reported.
Sens. Max Baucus (D-MT) and Charles Grassley (R-IA) sent a letter to Hamburg “asking what steps the agency was taking to protect patients in the … trial and demanded a response to their concerns by March 4.”
CNN reported, “The Senate committee investigation stems from concerns that Avandia and other high-profile drugs put ‘public safety at risk because the FDA has been too cozy with drugmakers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks,’ the report states.”
So, what am I telling my Avandia patients?
Well, I’m not sure it’s wise to condone politicians trying to practice medicine, but this report is disturbing to me. Therefore, I’m telling my Avandia patients this: since there are data indicating a potential risk with Avandia, and since we have medications (like Actos) that may work as well and not have these side effects, I think it’s reasonable to switch until the dust settles.
But, if you’re on Avandia, do NOT stop the medication until you’ve had a face-to-face meeting with your healthcare professional to talk about your individual options — and the costs, risks, and benefits of each option.