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. This trend began when news broke that the drug, which has been a big money maker for GlaxoSmithKline, may increase the risk of heart trouble.The data supporting the claim was gathered by the AP from the US Food and Drug Administration. Whoever wrote this article makes a point of noting that the figures were obtained with the backing of the Freedom of Information Act, although the report does not say the FDA resisted handing the information out. 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 AP says that several experts consulted for the article agree that doctors are probably attributing patients' heart problems to the drug, whereas before they likely would not have made the connection. The report also touches on the problem that's at the heart of the Avandia story: the dire need for reform of the FDA. Right now, there is no organized governmental oversight of drug safety once a drug is on the market and all reporting of side effects is voluntary. No one is driving the bus, basically. Click here to read more.
Don't know about the Avandia scandal? Want to read more on the background to this story? Click here for just one of a gazillion news stories published recently on Avandia and the FDA.
1. doctors are probably attributing patients' heart problems to the drug, whereas before they likely would not have made the connection.
What an indictment of our vaunted medical professionals. Until someone made an irrefutable connection between drug-adverse event, I imagine many doctors scratched their heads in consternation, never making the connection between drug administration and dangerous outcome. When will some highly-intelligent, humanitarian doctor, willing to think “outside the box” give some credence to the almost-two-decades of adverse events reported by “stupid, non-compliant diabetics” and make the connection that the DRUG—not the patient—is a REAL (not imagined) cause of dangerous/deadly outcomes.
For almost two decades, doctors who treat diabetes have allowed necessary tools to be withdrawn from diabetics (i.e. natural animal insulins). By their silence, they have allowed Lilly, Novo and Aventis to dictate how diabetics will be treated . . . and the treatment has become standardized across the population to include ONLY synthetic insulins and analogs.
The profession as a whole holds themselves out as highly-trained, intellectually superior beings who spent fortunes in their quest to serve humanity. It appears they are no less subject to ‘herd mentality’ than the dirty-masses they treat. Someday, some keen observer will recognize that anecdotal reports from patients do indeed have more than a speck of truth; after all, a diabetic lives with his disease 24/7/365. Who can better evaluate an ‘abnormal’ response? Unfortunately, diabetics (and the doctors who treat them) oftentimes have NO BASIS FOR COMPARISON since a previous ‘generation’ of doctors chose to “go along to get along” rather than to advocate for freedom of choice for necessary tools to treat this ugly disease.
Posted at 9:04AM on Jul 13th 2007 by Melody