Finasteride, FDA, and Prostate Cancer Prevention

One of my favorite BaldingBlog contributors (who shall remain nameless) sent in some great insights about FDA advisory committees. We’ve previously posted his thoughts on the LaserComb, clinical trials, and FDA trials. This post will be used in the future as a point of reference:

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Dr Rassman,
Given the many questions related to consideration of FDA expansion of the finasteride label for prevention of prostate cancer, your readers may wish to access the data themselves and better understand the process (which becomes more transparent and less “conspiratorial”).

 
The recent finasteride and dutasteride opinions noted in the Dec 3 Balding Blog posting are not from the FDA, but are from an independent group termed the Oncologic Drugs Advisory Committee. The committee is composed of 18 voting members (and several non-voting members) – mainly oncologists, with some statisticians, epidemiologists, and a patient representative, the former mainly from academic institutions.

The FDA eventually considers the committees opinion in approval or withdrawal of drugs (or “expansion” of a drug label for a new indication). The FDA usually follows the recommendations of advisory committees, as the committees’ recommendations are presumably “data-driven” and the FDA typically comes to similar conclusions. However, as in the case of many decisions that are split or where significant differences in interpretation of risk-benefit exist, the FDA has occasionally approved or rejected a drug against the recommendation of an advisory panel. Examples of split Advisory decisions (where a majority vote did occur) are the opinions this year related to several weight loss drugs.

The Oncologic Drugs Advisory Committee voted 17-0 against expanding the label for finasteride to include prevention of prostate cancer. A unanimous vote by FDA Advisory Committees is rare. I have no special knowledge of the meeting. This decision was based in part on data from the 19,000 patient Prostate Cancer Prevention Trial and the belief that the data did not support the risk benefit profile (i.e. possibility of increased aggressiveness of tumor did not outweigh reduced risk of low-grade tumors). As with all such committee meetings, which are open to the public (including listening via live webcasts), the transcript will be published and available within a few weeks at the FDA’s web site.

However, interested readers can go to the FDA web site now and access the Briefing Document and presentations given to Committee members from the drug company seeking approval. This information is public and typically posted several days before the meeting. The meeting was held on Dec 1, but the date of posting was Nov 26 (see under Oncologic Drugs Advisory Committee). The info can be found at the following links [note – all are PDF files]:

1. Draft Agenda for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
2. Briefing Information for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
3. Draft Questions for the November 30, 2010 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
4. Merck Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
5. FDA Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
6. GlaxoSmithKline Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
7. Draft Questions for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
8. Draft Meeting Roster for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
9. Webcast Information for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee