1 post tagged “in which i rant”

Well, I guess the FDA advisory panel does.  Well, not exactly.  They just don’t dislike it enough to pull it off the market.

Avandia

In a remarkable 22-1 decision, the advisory panel voted to allow Avandia (the multi-billion dollar drug from Glaxo for Type-II diabetes).  I find this remarkable because I wasn’t sure the Agency had the cajones to stem a rapidly swelling tide against the drug. 

Much hay was made in May when a NEJM article described a meta-analysis of thousands of patients and found an increase in myocardial ischemia (a loss of bloodflow usually caused by a blockage) which can offer be a pre-cursor to a heart-attack. 

A meta-analysis is performed by combining results from several studies to form a database with a large number of patients.   And that's the problem -- because the combined trials were all run differently, its really hard to extract statistically meaningful data – and so such analyses are used to guide specifically designed clinical trials that WILL yield statistically significant data – if there’s anything to find.

And here’s the kicker – Glaxo’s been DOING THAT TRIAL.  They know they need this answer.  The damn thing is Avandia has always had a “heart disease” issue, and is contra-indicated in people likely to have congestive heart failure. They think their compound is safe (enough) and that the trial will show it.  But suddenly, there were ascending cries to remove the compound from the marketplace right now.

And I’m glad it wasn’t.  The FDA can not let media feeding frenzies dictate the nation’s health policy. 

That said – if I was diagnosed as a Type II diabetic, would I want to take Avandia?  No.  Not because of the heart risk (if its there), but because Avandia is hell on your liver, causes edema AND there are new medicines that take advantage of a different mechanism that has a good chance of being way better than Avandia.  I would choose to take Amylin’s Byetta or Merck’s Januvia.

But that’s just me – if you’ve got questions, go talk to your doctor – better yet get your PCP to recommend an endocrinologist and get the real deal from someone that knows.

(end of rant -- back to travel and music and books and movies...)