Friday, May 2, 2008

Well, why not?

Since I'm posting, I might as well point toward Derek Lowe's post about the failure of the Singulair/Claritin idea. Too bad for Merck, though one has to wonder how long this drug combination strategy among big pharma is going to play out. After all, wouldn't it be about as cheap to take two pills (since one is over-the-counter) as it would be to ask your insurance to fork it over for a prescription version of a combination? Heck, a lot of people take the combination separately now, anyway.

So at any rate, Derek deduces that the problem lies in efficacy. Is it possible to support a marketing claim that the combination is more than the sum of its parts? Merck apparently thinks so, but the FDA does not. Unless there's an advisory committee meeting on this, or the drug eventually gets approved, or efforts to get results of all clinical trials posted publically succeed, we won't know for sure. But what I do know is that for one of these combinations to gain marketing approval, at the very least there has to be a statistically significant synergistic effect. That means that the treatment effect has to be greater than the sum of the treatment effects of the drugs alone. Studies that demonstrate this effect tend to have a lot of patients, especially if there are multiple dose levels involved. It isn't easy, and I've known more than one combination development program to fizzle out.

Update: but see this serious safety concern for Singulair reported by Pharmalot.