Urologists respond to the FDA's ruling on dutasteride and finasteride.
Murali Ankem, MD, in New Brunswick, NJ, says the positive results from the studies weren't enough to justify approval of the drugs for the cancer-related indication. (Both drugs remain approved for the treatment of BPH.)
"To achieve a 20% to 25% prevention of prostate cancer, you have to treat hundreds of patients," Dr. Ankem said. "So in practice, you can make a case to tell the patient, 'Listen, you have a one in six chance of developing prostate cancer. Whether you have urinary symptoms or not, I want you to start seriously considering one of these two drugs to prevent prostate cancer.' But that's a hard sell.
"I wasn't surprised the FDA said there wasn't enough clinical evidence. A community urologist or university urologist will not have enough patients to recommend this with confidence. So, no, I wasn't surprised at all."