FDA Panel Rejects Proscar and Avodart for Prostate Cancer

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Regular Member

Date Joined Mar 2010
Total Posts : 134
   Posted 12/2/2010 9:44 AM (GMT -6)   
Saw this article today.

FDA Panel Rejects Two Drugs For Prostate Cancer Prevention.

The AP (12/2) reports, "A panel of federal health experts unanimously rejected the use of Merck's Proscar to prevent prostate cancer, saying the drug could actually raise the risk of the most serious types of tumors." The panel also decided against recommending that the label of GSK's Avodart (dutasteride) "be changed to say that they can reduce a man's risk of getting prostate cancer," the New York Times (12/2, A21, Kolata) reports. "Both are already on the market to shrink the prostate, alleviating a harmless but uncomfortable condition that results in frequent urination in older men."

        As for cancer prevention, Richard Pazdur, director of FDA's office of oncology drugs products, pointed out that the agency must "have a very high level of certainty" regarding study results because the drug, if approved, would be prescribed to relatively healthy men, the Wall Street Journal (12/2, Dooren) reported. He added, "We are talking about a population of people -- not patients -- men who don't have disease so your level of certainty...has to be heightened."

        And, the "panel agreed that a reduction in the less-risky tumors -- which may never even turn into serious cancers -- is not a big enough benefit if the drugs may actually lead to life-threatening cancers," MedPage Today (12/1, Walker) reported. But the drugmakers "argued at the meeting that their trials didn't show the drugs lead to serious prostate cancers and offered other explanations for the higher number of high-grade cancers in the treatment arms." In fact, "Merck isn't seeking an expanded indication, but the company would like the label of finasteride to detail positive results of the Prostate Cancer Prevention Trial (PCPT), which demonstrated the drug's chemopreventive potential."

        Nevertheless, "FDA regulators already had several concerns about using the medications for the prevention of prostate cancer," HealthDay (12/2) reported. "For one thing, black men, who are at high risk for the disease, were underrepresented in the clinical trials." Bloomberg News (12/2, Larkin) and Dow Jones Newswire (12/1) also covered the story.

52 at Dx (3/12/10), father died of PCa
PSA: 10/16/09 - 2.8; 1/11/10 - 3.8
RALP 5/19/10, Dr. Lee, U. Penn Presby
Gleason 6, gland involvement < 2%; tumor in peripheral zone both sides; no capsular, extracapsular extension, lymph node, or seminal vesical involvement; no positive margins
Incontinence: no pads except specific exercises
ED: pump. Levitra 10mg every other night. Still no-go.

Veteran Member

Date Joined Nov 2009
Total Posts : 1100
   Posted 12/2/2010 11:06 AM (GMT -6)   
Thanks for posting this! I have sought expert advice on whether to take dutasteride or finasteride for prevention purposes, since I am at high risk. Suffice it to say that very well-regarded prostate cancer experts have given me opposing views, ranging from "you are nuts if you take this" to "you are nuts if you do not take this." (though they did not use those precise words). Tough call...
Age 46.  Father died of p ca. 
My psa starting age 40: 1.4, 1.3, 1.43, 1.74, 1.7, 1.5, 1.5

Regular Member

Date Joined Nov 2009
Total Posts : 486
   Posted 12/2/2010 11:18 AM (GMT -6)   
Medved, I used Proscar to treat BPH for many years.  The first reports about the risks of agressive PCa came out about the time of my original Dx.  I have often wondered if there was any link and if so, just what the mechanism is that creates the aggressive tumors.

Diagnosed 2/2008 at age 71, PSA 9.1, G8 (5+3), stage T1c.
Robotic surgery 5/2008, LFPF at 6 wks.,nerves spared, stg. pT2c, N0, MX, R0, G8 (5+3)
PSA .12 at 2.5 years, rechk 2 wks later 0.2. All prior tests <0.1.

Veteran Member

Date Joined Apr 2009
Total Posts : 990
   Posted 12/2/2010 11:21 AM (GMT -6)   
One should remember that the FDA sets much stricter approval standards on drugs for prevention of a disease. This ruling reflects that caution.

Veteran Member

Date Joined Jul 2010
Total Posts : 3895
   Posted 12/2/2010 12:26 PM (GMT -6)   
The fact remains...There seems to be a lot of Gleason 8,9.10 guys (including myself) that had been treated with these drugs...

Merck and Glaxo are trying to turn a $Billion$ dollar drug into a $Trillion$dollar drug(s)...It just goes to show you how, backstage, these "studies" can be manipulated to produce the desired results...
Age 68.
PSA at age 55: 3.5, DRE normal. Advice, "Keep an eye on it".
age 58: 4.5
" 61: 5.2
" 64: 7.5, DRE "Abnormal"
" 65: 8.5, " normal", biopsy, 12 core, negative...
" 66 9.0 "normal", 2ed biopsy, negative, BPH, Proscar
" 67 4.5 DRE "normal"
" 68 7.0 third biopsy positive, 4 out of 12, G-6,7, 9
RRP Sept 3 2010, pos margin, one pos vesicle nodes neg. Post Op PSA 0.9 SRT, HT, Dec
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