It seems as if FDA has decided that it wants some people to be able to choose for themselves. Avandia will be made available to more patients than the currently severely restricted group.

I feel obliged to post this because it seems to be a step in the right direction, however limited and however late. I rail against the FDA so much that I risk losing my objectivity (some might argue that I have already), so I think noting this is important.

But my excitement only extends so far. Partly my reservation is due to this:

Even if the restrictions are eased, sales of the drug are not likely to be revived. Glaxo lost the right to sell the drug exclusively in 2011, when Avandia’s patent expired. Although the drug company Teva has approval to sell a generic version, it has not placed one on the market, probably because of the restrictions and the tiny pool of patients.

When you create a harsh environment for selling drugs, then you don’t get drugs. There has to be some incentive for the producers to produce; and if the producers don’t produce, then the consumers suffer. (Yes, Say’s Law is the correct way to think about supply and demand.)

My other reservation – nay, frustration – is because of this:

The meeting, which stretched over two days, was not without its moments of levity. Michael Proschan, a statistician at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, drew rare laughs when he suggested that one reason not to do a new trial was to avoid having to sit around the same table in another four years to talk about Avandia.

Apparently Michael Proschan doesn’t know anybody who has died because of lack of access to a drug. Indeed, probably most of us don’t; those who die because of drugs that were never created or never approved are the silent ones and we will never know how large their numbers are.

And, incidentally, this story is remarkably similar to the back and forth that takes place in Evolve with respect to life saving cancer drugs.

-JD Cross

 

Advertisements