Lots of folks have been making noise about drug prices, but not offering much in the way of fixes. Too much lobbying money to be lost, I expect. The Pharma Pholks justify the sky-high prices of new-ish drugs on the fact that 90% (or so; depends on whose numbers one looks at) of compounds fail to be approved. Of those, more than a few end up not making much.
Today brings an archetype of the problem. Xenoport, a small drug company, just announced the results of a Phase II trial for its psoriasis drug. (For those not following clinical trials: three phases, I being basically safety, II being a few cherry picked patients, III being large sample with a control (often placebo, but sometimes an existing therapy) to gather sufficient data to ask FDA for OK.) The main reason so many drugs don't get approved, or used if approved, is they simply aren't better (efficacy and/or side effects).
The pharma gadfly, Adam Feuerstein has a piece on the trial, and here's the punchline:
The side effects of XP23829, however, raised some alarm bells, notably diarrhea rates ranging from 22% to 40% at the highest, most effective dose. Other GI side effects noted in the study were nausea, abdominal pain and vomiting. Fifteen percent of psoriasis patients treated with the highest dose of XP23829 discontinued the study compared to 2% for placebo patients.
Xenoport, in its press release, said it would proceed to Phase III trials. Now you know where the money goes: pissed down a rat hole. And the CxO folks pull down six and seven figure compensation each and every year. Xenoport is down 28 percent, and change, today. Will that dissuade the Suits from spending the money? Not hardly.
XenoPort, however, said it expected to start late-stage trials next year and that it would explore partnerships to speed up the development of the oral drug globally.
There oughta be a law.