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 Pharmaceuticals drug Actos).

Interestingly, there was fairly sparse media coverage 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 FDALegislativeWatch discussed this recent step as “an interim [emphasis added] step in [FDA’s] ongoing review of thiazolidinedione cardiac safety.” 

The FDA’s deliberate moves (with these multiple “interim” steps) are to be commended.  However, I think ultimately – as predicted by this blog –Avandia will end up being taken off (or disappear) from the market.

Role of Patient Choice

While one of main points of this blog 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 – namely 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. This holds true 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.

Ogan Gurel, MD MPhil
gurel@aesisgroup.com
http://blog.aesisgroup.com/

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