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Wednesday, June 06, 2007

Glaxo's pain, my gain....

The postings on this blog have typically been mostly about my obsession with two things -- accountability and life in general (that pretty much covers it, I guess).

Well, as it happens this AM's New York Times has a story that brings together both my personal and scholarly obsessions.

The story is about various issues surrounding testing for the drug Avandia, a medication prescribed for folks like me with Type 2 diabetes.

At the heart of the controversy (no pun intended) is the online publication on May 21 of a metaanalysis study indicating Avandia (generically rosiglitazone) was associated with a 43% increase in the risk of heart attacks by its users in the study groups (that is, their "risk ratio" as study participants was 1.43). This generated all sorts of reactions. The FDA issued a warning and had to respond to many questions about what it knew, when it knew it, and why it did not take action earlier. Many of the reported several million who take the drug were told to consult their physicians (that certainly must have tied up the phone lines) and there were reports that a good many of those patients involved in an ongoing study being conducted by Avandia's manufacturer, GlaxoSmithKline (GSK), were withdrawing. Of course a congressional hearing was called for today (not the first time for the FDA), and that has brought the controversy up a level or two....

In addition to posting all sorts of information on its Avandia web site and elsewhere, GSK took out large adverts in major papers on Tuesday expressing its confidence in Avandia and its commitment to the safety of the drug, and later in the day a preliminary analysis of the ongoing study was published online which highlighted that (thus far) fewer people in the Avandia group had died from cardiovascular problems than among the non-Avandia taking group (btw, they were on a regimen of other medications).

According to the Times article, the New England Journal of Medicine published three "editorials" (here and here and here) along with this more favorable piece, one noting that the number of cardiovascular events (not merely deaths) was actually slightly more among the Avandia group. (It is noted that none of the numbers rise to the level of statistical significance and thus nothing is proven one way or the other to this point; the study -- if they can keep folks from fleeing -- still has another year to go...).

Adding fuel to the controversy is the claim by an FDA supervisor (noted in the Times article) that she was overruled and rebuked for issuing a recommendation last year that the warning label on Avandia ought to be strengthened in light of what her office's analysis of the available research. Quoted directly in the Times, she is also going to appear before the Senate committee today.

Obviously this stuff has accountability issues written all over it, and I would be more gleeful if it wasn't for the fact that I was into my second month of Avandia on May 21 when the story first broke....

My attempt to live with Type 2 started a decade ago when I was first diagnosed, and like the millions of others who have the same "late onset" version I have been through a variety of regimens to control this malady. I was doing pretty well in terms of controlling the symptoms until a few months ago when I began to feel that things were not quite right (as documented in some of my earlier "personal" posts). Finally I asked my GP, and he set me up with an endocrinologist who, in February, started to get me back on track.

First thing she suggested was a switch in medication -- initially to Glocuphage (metformin), a medication I recall having taken years ago which (I was soon reminded) did not quite agree with my digestive system. Another switch followed -- to Avandia as it turns out, although at the time she thought it probably won't do the trick given my indications of problems. But given the next possible option -- Byetta, which would have to be injected twice a day -- she thought we would see how this worked.

Monitoring my blood sugar carefully, I noticed that the numbers with Avandia were actually up about fifty notches initially, although things started to settle down over a couple of weeks time. Still, she thought the Byetta was definitely now the best option -- so we set an appointment for May 22 when she would brief me on how to take this new medication.

Thus, while others were dialing in to their doctors to get off Avandia after the May 21 news reports hit, I was already set to do so the next day for entirely unrelated reasons. I began the Byetta regimen on May 23 (which relates to another story about weight loss that I will post at some point) and moved to the sidelines as observer of the tribulations surrounding Avandia.

But while my personal connection with the Avandia episode is over, my scholarly interest is deepened by recnet events. What a great case study for insights into our complex system of accountability -- formal and informal, official and unofficial, scientific and political. Great stuff, and a further confirmation that accountability is not merely something we aspire to in governance, but is actually a fundamental (and I would argue, defining) characteristic of modern governance in all its forms (i.e., public, private, social, etc).

So while personally I am relieved to be off Avandia, professionally I am thrilled that its widespread use is stirring such consternation. Mixed emotions, indeed!

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