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FDA issues a "black box" warning for Avandia - A Balancing Act Between Safety and Choice
Thu, 08/23/2007 - 11:26 — Zangani
By Ogan Gurel MD. You can email Dr. Gurel at gurel@aesisgroup.com and view his blog at http://blog.aesisgroup.com/.
The Avandia controversy has been a whirlwind but the outcome continues inexorably in favor of drug safety as consistently suggested by this blog. Last week, the FDA issued a “black box” warning for Avandia as well as other thiazolidinedione type drugs (such as the Takeda drug Actos).
Interestingly, there was fairly sparse media converage of the event. The Associated Press took it up but it didn’t appear in most of the major newspapers – perhaps because most writers and pundits consider the topic a dead horse at this point. Indeed FDA Legislative Watch.com discussed this recent step as “an interim [emphasis added] step in [FDA’s] ongoing review of thiazolidinedione cardiac safety.”
I think that the FDA’s deliberate moves (with multiple “interim” steps) are to be commended. However, I think ultimately – as predicted by this blog – that Avandia will end up being taken off (or disappear) from the market.
While one of my major points over the past year has been the growing importance of safety in drug development and approval, it would appear that the main argument for keeping Avandia on the market is actually another topic which I have commented on – that of patient choice. See: “What Patients Want: A Story of Choice, Trials, Evidence-Based Medicine” Basically patients deserve (and want) the opportunity for choice which holds not just for diabetic medications but with medical care in general.
The FDA then is carefully balancing the values of choice and safety and while the topic seems to have receded from the headlines, these issues will not go away. It’ll be interesting to see how things play out.
Dr. Ogan Gurel is chairman of the Aesis Group which provides consulting services in the life sciences and healthcare sectors to clients that have included biopharma/medtech companies, hospitals & health systems, private equity firms, venture capital groups and hedge funds. Presently, he is also a Board Director at FireFly Medical and Chief Medical Officer at BlueBob Analytics. As a healthcare technology expert and futurist, he has been a frequent conference speaker worldwide, addressing the issue of emerging technologies and their impact on the future of healthcare with particular focus on convergent medical technologies including medical nanotechnology. Ogan’s commentaries have been published in prominent publications, including the Wall Street Journal and he is a regular columnist for Midwestbusiness.com, a juror for the 2007/2008 Medical Design Excellence Awards and an Adjunct Associate Professor of bioengineering at the University of Illinois at Chicago. Ogan’s scientific work has been published in the peer-reviewed literature and has received numerous awards; he has taught at several universities including the Columbia University College of Physicians & Surgeons, Roosevelt University, Princeton University and Harvard Medical School. For a more complete bio, you can download a PDF or click here. You can email Ogan by clicking here and view his blog at http://blog.aesisgroup.com/.
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