Dr. Maha Hussain, an oncologist who was one of 4 out of 17 members of the FDA Advisory Committee to vote against accepting against the company’s claim to efficacy for Provenge (Sipuleucel-T) prostate cancer vaccine, is calling for an expanded access program to empower patients who want and need it to receive the drug while an ongoing 500 man clinical trial of Provenge is completed.

In her oral comments to the Advisory Committeee on March 29 Dr. Hussain said:

There is another, to me, concerning observation and that is none of the disease-related manifestation was impacted. So as a clinician it’s hard to conceive if the disease is progressing at the same rate, what else is keeping people alive. And that really is very concerning. In most of the prostate cancer trials, and I cannot think of any solid tumor, understanding it’s not vaccines, but chemotherapy or other biologics that we talk about, generally the disease manifestation and disease-related, I guess, manifestation of disease go together with the survival. So when you see a survival advantage you see a time-to-progression advantage, you see a pain response benefit, you see all of that. And that was true in the Taxotere trials, at least if we talk about prostate cancer. That has not occurred here and that to me says something. It’s maybe the vaccine didn’t really work and maybe that’s why there was no – anything picked up in terms of immune stimulation and everything that we’re talking about. Maybe something else was the reason why these patients lived longer.

Dr. Hussain said she would no problem if Provenge were made available now to all the men who need it while Dendreon completes the 500 man trial already underway. She said:

the reason we do clinical trials and we use statistics it is because we want to put a standard for care that is – that if it’s my father, I am happy with him doing that. I don’t want something that two people look at and say, well, really oh yes, absolutely this works, or it really doesn’t work. And in this case I think that a combination of two trials that went to different ends, a very limited observation on 80 patients, I feel very uncomfortable recommending it to the patients out there. There is an ongoing definitive trial which I have asked about three times how far is that trial, so how many patients have been accrued of the 500? Four hundred? Okay. So 400 of 500 have been accrued which means within 100 patients we would have those results in the next two to three years reported. If you couple that with a potentially open or expanded access program, which is not an impossible thing. And an expanded access program, I don’t know if – I’m sure you’re all familiar with it, but other companies when there is a promising drug, and you could always make it available within certain guidelines to the patients while you’re waiting for your definitive trial. So I don’t see that rushing to say this is great now is of utmost urgency because certainly the company could choose to have open access programs.

The full printed record of the FDA Advisory Committee meeting March 29, 2007 is online in pdf at the FDA. Dr. Hussain practices in Michigan.