Biotech Mailag:

What a difference a day makes for some people. Today we elect a new president. Presumably Barak Obama will be elected. Yet, only yesterday, Madelyn Dunham, Obama's maternal grandmother, died from cancer. What would she have done to see just one more day Critics of Provenge who contend the survival benefits of Provenge aren't robust enough to warrant [Food and Drug Administration] marketing approval demean the human reality.
We all know that patients who received Provenge had longer median survival (4.5 months) than that reported for the placebo arm. That is nearly twice as effective as Taxotere's 2.3-month survival benefit. Yet, that was enough to garner FDA marketing approval for Taxotere. Even more impressive, patients who received Provenge followed by Taxotere were shown to increase their median survival to 35 months.
Without question, there is a large unmet medical need. Each year approximately 50,000 men die from prostate cancer. Yet, the only FDA-approved treatment for end-stage prostate cancer in 45 years has been Taxotere. These barriers to reason must not stand. We must bring truth and reason to power in the public arena. I pray for change at the highest levels of the FDA.
I'm sure there are others like Madelyn Dunham who would like to see one more day. I've commented more than enough on, so I don't feel the need to repeat myself. Paul clearly speaks for a large group of retail investors and prostate cancer advocates who believe the FDA was wrong to delay approval of Provenge in 2007.
I will join Paul in hoping for a change at the top of the FDA. The agency is in turmoil. Morale is low, resources are scarce and too many drug approvals have been delayed at best, or worst, have become politicized. Paul will disagree with me on this, I assume, but I don't think Provenge fits that latter category. I think we need a grown up in the job of FDA commissioner. Someone who is not interested in grabbing headlines, but a competent and intelligent leader who can make a strong case to Congress that the FDA needs more attention and funding.
The next FDA commissioner has to forget about politics and focus 100% of his (or her) energies on two things: 1) Review more new drugs in a timely manner and make sure those decisions are based on science, nothing else; and 2) Make sure that countries like China aren't putting poisonous crap into our food and drugs. A strong and sustained recovery for biotech stocks depends on this happening.