Propecia, the FDA, and High Grade Prostate Cancer

Dear Dr. Rassman:

I am a bit concerned about continuing with Propecia in light of the recent finding on the risk of high grade prostate cancer. At the FDA hearing in June of last year, the FDA statistician estimated that the risk of getting high grade prostate cancer using 5mg of Finasteride over a 7 year period was 1 in 200. I realize that Propecia is one fifth that, but even a 1 in 1,000 risk when it comes to an aggressive cancer seems, well, risky. If you told me that there was a 1 in 200 or 1 in 1,000 chance the plane I was about to board would crash, I would not board. So, my question is this: is there anything in the study you see that makes you think it’s safe to keep going with this drug?

I believe you are reading things out of context. The FDA site states:

“The labels of all 5-alpha reductase inhibitors (5-ARIs) are being revised based on FDA’s review of two large studies examining whether these drug products (Proscar, Avodart) reduce the risk of prostate cancer. The studies did find an overall reduction in the risk of lower-grade forms of prostate cancer, but both studies also showed an increased risk of high-grade prostate cancer.

As a result of these two studies, the labels of all FDA-approved 5-ARIs will be revised to include new information that these drug products may increase the risk of high-grade prostate cancer. The product labeling will also state that 5-ARIs are not approved for the prevention of prostate cancer.” [Source]

I did a quick Google search and found prostate cancer statistics, unrelated to finasteride use. “Based on rates from 2006-2008, 16.48% of men born today will be diagnosed with cancer of the prostate at some time during their lifetime.” That is about 16 in a 100 or 1 in 6 men.

My point is: Propecia does not cause cancer. The studies that the FDA quotes and the media has latched on to point to how those men who ended up with prostate cancer while on finasteride had a higher grade prostate cancer than men who did not take finasteride… but the controversy of why this is, was not clear from the studies.

A final point is that if you are concerned about the medication, you do not have to take it. It is an option I give to all my patients. This is one of the many reasons why a doctor should prescribe you the medication, because each and every patient is different and the prescribing doctor should be there to address all of these issues one on one with the patient.