Several days ago, Senate Finance Committee Chairman Max Baucus and Senator Charles Grassley (democrat and republican, respectively) have added fuel to the massive fire brewing over the Avandia diabetes drug scandal. The Senators sent a letter to the FDA, the government agency responsible for approving new drugs, that alleged complicity on the part of the FDA to sweep possible side-effects under the rug in order to assure approval for Avandia’s maker, industry stalwart GlaxoSmithKline.
The Diabetes blog has been following this controversy closely over the past few months. They revealed some details of the contents of the allegation made by the senators. Allegedly, “a former FDA primary reviewer for Avandia was removed from her/his work on the drug after voicing safety concerns,” the article also noted that, “The unnamed scientist believed the evidence for risk of congestive heart failure was strong enough for a “black box” warning on Avandia.”
Obviously, GSK thought that a black box warning would inhibit sales of their precious new diabetes drug and they used their insidious tentacles to get inside the FDA and have the offending analyst removed. Literally, the results of the study were not to the liking of a private corporation, so they used their influence to have that person’s expert opinion silenced. Is this part of the FDA’s mandate?
A study from the New England Journal of Medicine confirms that a patient taking Avandia (the fancy corporate name for rosiglitazone) has just increased their risk of heart attack by a full 43%.
An older post from the Diabetes Blog noted some extremely troubling statistics in terms of reported side-effects from Avandia patients. “According to a new Associated Press (AP) feature, federal regulators have experienced a dramatic surge in reports of Avandia-related side effects. In fact, they say they are receiving triple the number of reports just in the last month.”
While an exponential increase in reported side effects is troubling, the post goes on to note some even more depressing news.
The key finding: in the thirty-five days before the Avandia story broke in the media, only five heart attacks were reported as side effects involving rosiglitazone. Rosiglitazone is the active ingredient in Avandia and its little cousin Avandamet, which combines that drug with metformin. Yet in the thirty-five days following the revelation, that number soared to ninety. The AP also says reports of heart-related hospitalizations increased dramatically.
The author of the Diabetes Blog Post is adamant that all of this complicity leads us to one inevitable conclusion- we must dramatically reform the FDA. In its current form, it serves as a conduit for big pharma to get their new products through the government hurdles as easily as possible. The Avandia scandal serves as concrete proof that the FDA now places American corporate health before the health of the public that they are sworn to protect.
At the very least, the scandal has hit GSK in the pocketbook. Simon Margolis, MD wrote a post in the Yahoo Health News Blog that mentioned many doctors are now turning away from Avandia because they don’t want their diabetic patients to wind up as heart patients in the near future. Margolis quotes Dr. David Nathan from the Diabetes Center at Massachusetts General Hospital saying “Physicians may find it difficult to explain to their patients why they are starting treatment with a potentially dangerous drug when other choices with longer and better safety records are available.”
