Journal Nature wants FDA to Fess Up About Provenge

I'm glad the prestigious journal Nature is taking up the Provenge cause and asking the FDA for some answers. We have conflicts of interest, leaked letters and all sorts of dirty dealing from the FDA over this and everyone is keeping their mouth shut. This is what Nature says:

Efficacy is key here because in both Dendreon trials presented to FDA,
Provenge failed to meet its primary endpoints. In certain respects, Dendreon
shot itself in the foot by setting an over-optimistic efficacy
expectation/hazard ratio for the trial of 0.585, which no conventional drug or
chemotherapeutic has ever achieved in a comparable setting of late-stage
disease. At the same time, however, Provenge did extend median overall survival
by 4.5 months, and after 3 years, 34% of the men who received the therapy were
still alive, compared with only 11% who received a placebo.

I still don't understand how the FDA can stand in the way of a drug that keeps people alive for an extra 4.5 months and doesn't kill 300 patients a year like the current late stage therapy (Taxotere) does. The drug might even give the patient an extra 23% chance of living as much as 3 years longer. This is terminal prostate cancer we are talking about. I'd take a 23% chance of living 3 years longer any day if I only had a few months to live (and the only other therapy may strait up kill me).

This is one of the few areas where I actually like having a Democratic Congress in charge. You can bet that they want to score points against the FDA just to "get Bush." The next step is for House Energy & Commerce Committee Chairman John Dingell (D-MI) to put this topic on the Committee Agenda for 2008.

Dendreon Supporters take out Washington Post Ad

Now this is an interesting development from the Dendreon support camp.

Usually activist shareholders target an actual company for change to
enhance share prices, but a group of shareholders, patients, advocates, and
activists have a made an unusual move. In Sunday's Washington Post, this
group took out an advertisement calling for citizens to contact their
Congressional representatives to urge the FDA to reverse their delay of
Provenge.

This drug is a big deal for these people because Provenge is one of the few drugs that will combat late stage Prostate Cancer. It is a drug that could potentially keep a guy alive for another few months so people are going to be passionate about it.

A few months doesn't seem like much to some people but it is enough to gather your family members together for a nice sendoff. And to these people the FDA is standing in the way waiting by waiting 2 or 3 years for more data. I think I'll e-mail my Congressman like the ad says to do.