By Amanda Dolan for Diabetes1
Popular Type 2 diabetes drug Avandia is being investigated by the FDA as a possible cause of thousands of heart attacks. The drug, supplied by prominent pharmaceutical company GlaxoSmithKline, is an oral medicine that aims to help the body control blood sugar levels by making body cells more sensitive to insulin. Avandia contains rosiglitazone maleate, which is the component thought to cause heart failure and heart attacks. In response to the recent senate report about the link between heart failure and Avandia , the FDA is investigating the controversial medicine. Currently the FDA is formulating a formal opinion on whether or not rosiglitazone should be removed from the market.
The senate report criticizes the FDA’s role in the final decisions of this drug as the FDA was the one who put the drug on the market in the first place. The conflict of interest there has set off alarms for the senate who hopes to start a new sect of the FDA for judging drugs already on the market. In their report, the senate calls for efforts by both the FDA and Congress toward the establishment of “independence for post-market surveillance” which could be made possible by the creation of a new department of the FDA. The senate is using the Avandia case as a main proponent for change calling this issue “a matter of sound science and public safety.”
These recent reports and accusations came to light over the weekend, though a spokesperson for Senator Grassley says that the senate’s report was ready before this and claims the press release was not in response to the New York Times story on Friday. The senate report contains over 250,000 pages of documents from the FDA, GSK, and other research institutes. Investigators spoke with “numerous people at GSK and the FDA and anonymous whistleblowers.” The report says that GSK knew about the myocardial infarction risks of rosiglitazone for “several years” before the 2007 paper in the New England Journal of Medicine, which was the first to raise concerns. The report also alleges that the company failed to warn patients and the FDA about these risks and that GSK also has attempted to discredit any research that portrays rosiglitazone negatively. In addition, the senate claims that GSK intimidated physicians and did its best to “downplay findings that competing agent pioglitazone might reduce cardiovascular risks.” The senators also asked the Food and Drug Administration to describe what steps their agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue—given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, “unethical and exploitative” of patients. Yet the lack of action on the part of the FDA indicates what the senate has deemed being “too cozy with drug makers” and being “regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.”
In the third quarter of 2009 alone, about 300 deaths were linked to rosiglitazone—though the FDA has yet to come to a decision about whether Avandia should still remain an option for patients. Some agency members believe a safer alternative is already available for patients while others are unconvinced that the link to heart failure is justified scientifically and should stop Avandia from being offered as an option. Drug manufacturer GSK has come out with a quick rebuttal, holding fast to their claim that “the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events.”
Back when the controversy started a few years ago in 2007, the FDA looked into these claims and ruled that “Avandia remain available to patients for the treatment of Type 2 diabetes.” Since then, GSK reports now that there have been “seven large, prospective, randomized, clinical trials” that have sound results . GSK goes on to say that, “none of these randomized clinical trials, which remain the gold standard for evaluating scientific and medical questions, show a statistically significant association between rosiglitazone and myocardial infarction (heart attack) or other ischemic cardiovascular events.” The GSK press release explains that the 164 clinical trials were comprehensive and found no link between heart problems and the drug. The company also notes that the safety of Avandia is being assessed now with another clinical trial TIDE mandated by the FDA. The senate has asked the FDA why the TIDE trials continue when a few years ago a “safety officer wrote that because of cardiovascular concerns with Avandia “the safety of the study itself cannot be assured, and is not acceptable.””
In response to these newly resurface claims, GSK has published all of the clinical trials, meta-analyses, and observational studies on their website “for all to see” because “GSK does not condone any effort to silence scientific debate” and upon any and all accusations, “GSK corrects inaccuracies and misstatements.”
The senate’s allegations stand and as Senator Baucus says, “Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust. We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines.” A decision will be made by the FDA soon.
As always, if you (or someone you know) is taking Avandia or another prescription medication—please do not hesitate to speak directly with your doctor if you have any questions or concerns.