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Thursday, June 07, 2007

Acting on Actos....

At yesterday's House hearings on the ongoing "Avandia affair", the FDA commisisoner announced that stronger warning labels had been ordered for Avandia (see yesterday's post) and Actos (generically, pioglitazone). These are two of three drugs under the class of thiazolidinediones (we are really now regretting falling asleep in our high school chemistry class), the third being troglitazone which was taken off the market in 2000 for its link to increased risk of hepatitis.

Hmmmm. While I was rather gleeful that I had not really been taking Avandia all that long, I had been on Actos for quite awhile prior to the switch to Byetta (again, more on that later) and it was a bit of a surprise to hear that they are concerned enough about Actos to order the enhanced warnings as well.

As I recalled, back when it was first put on my list of medications, the studies were indicating that Actos actually reduced the risk of heart attacks -- and I believe that was the motivation for my GP prescribing it since I had already been through a cardio event. Looking it up on the web, I found that early study highlighted in a number of news stories -- back in 2005.

But in the interim, another meta-analysis of several studies was published indicating otherwise -- this time concluding that Actos may not only be riskier than the 2005 study indicated and may not be that effective in achieving the kind of blood glucose control that it was designed for. My sense is that the combination of the Avandia scandal and the relatively close "family" relationship between Actos and Avandia led them to extend the cautionary warnings to Actos.

I am typically pretty skeptical about administrative reforms promoted by members of Congress whenever something like this FDA story breaks - usually they are mere symbolic gestures that prove costly and unwise in the long term regardless of the impression they give that the problems are being solved. But watching this all play out at the FDA, I am now sympathetic to the idea (currently on the table in Congress) to create and/or empower a separate entity to deal with drug safety while leaving drug approval to the FDA. The mixture of the functional roles within the FDA clearly raises issues of accountability in the truest sense of that term, for there are distinct and contrasting interests to be served within this regulatory process.

Putting the two (approval and safety) in the same agency under one commissioner makes sense only to the extent that there is an agreement upfront as to which trumps the other. Up until this Avandia episode (and there have been others that have come to the surface), the recent "agreement" gave priority to the approval process over safety concerns. This is probably an artifact of both a move from the right to deregulate and pressure from the left to speed up the approval process in light of the HIV/AIDS epidemic. The resulting state of affairs altered a more cautious "safety first" perspective fostered by the infamous Thalidomide tragedy of the late 1950s and the congressional hearings and legislation that followed.

With that in mind, and given the uncertainties of any one specific study as well as the power of the pharmaceutical industry, it may be best to spin off the safety unit into an autonomous agency where the sense of administrative responsibility is clearer and less subject to overrulings and reprimands for doing their job. It is interesting that the folks heading the agency do not regard it as a structural issues, but rather one of improving communication with the public. Either they don't get it or I don't get it.....




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