Everyone admits to having the same initial sides. Yet somehow, in only 2% they remain persistent. Alternatively, maybe the other supposed 98% become used to the new normal. Like when unemployment hits record highs, you and your friends forget what it feels like to have jobs.
The old medical shell game is to turn these studies upside down and dazzle them with the benefits, the rest leave to fineprint. Soon not having a job seems like the best possible option.
I was shocked at discovering by comparison the amount of erectile dysfunction I experienced after discontinuing finasteride. Also surprising the amount of members here who self-medicate and use Hairlosstalk to reinforce their decisions.
This forum is a Roman Colosseum where gladiators go to be jeered and die. Yet another story about finasteride and dutasteride to keep away from the regulars.
FDA Panel Rejects Prostate Drugs for CA Prevention
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: December 01, 2010
SILVER SPRING, Md. -- An FDA advisory panel has voted overwhelmingly that GlaxoSmithKline's dutasteride (Avodart) and Merck's finasteride (Proscar) should not be used to prevent prostate cancer because the drugs are linked to a higher incidence of high-grade tumors.
Although the 5-alpha reductase inhibitors were shown to prevent low-risk cancers better than placebo, clinical trials painted a disturbing link between both drugs and an increased incidence of higher-risk prostate cancers.
The FDA's Oncologic Drugs Advisory Committee voted 17-0, with one member abstaining, that the risks outweigh the benefits of finasteride; and 14-2, with two members abstaining, that the risks of dutasteride outweigh the benefits.
The FDA is not required to follow the advice of its advisory committees, but it often does.
If approved to prevent cancer, the drugs could potentially be given to hundreds of thousands of otherwise healthy men with elevated PSAs who are concerned about dying from prostate cancer.
That means "we [would] use this to treat men -- not patients -- men who don't have a disease," said Richard Padzur, MD, director of oncology drugs at the FDA.
Dutasteride and finasteride are currently approved to treat benign prostatic hypertrophy, or an enlarged prostate. GlaxoSmithKline is seeking to expand dutasteride's indication to include reducing the risk of prostate cancer in men who have had a prior negative biopsy, and who have an elevated PSA.
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.
How to handle low-grade prostate cancer is controversial in the urology community, in part because it is unknown if the low-grade tumors would ever develop into high-grade tumors, and also because the method used to originally detect prostate cancer -- the PSA test -- is inexact.
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. In addition, the standards need to be much higher for a chemopreventive agent.
Both GlaxoSmithKline and Merck 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.
If the drugs were intended to treat terminal cancer patients, some risks might be tolerated, said Patrick Walsh, MD, a urologist who has studied 5-alpha reductase inhibitors for 40 years.
"If you're going to give normally healthy people a drug, there need to be no side effects," said Walsh, who was brought in by the FDA as a guest speaker.
The panel spent much of Wednesday discussing the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, which randomized 8,200 high-risk men ages 50 to 75 from 250 sites in 42 countries to receive either dutasteride or placebo.
The men took dutasteride daily for four years and had prostate biopsies at two years and at the end of the study. REDUCE found that men assigned to dutasteride had a 23% lower risk of being diagnosed with biopsy-detectable prostate cancer when compared with men on placebo (P<0.0001).
The panel agreed with an earlier FDA assessment that the reduction in cancer risk was driven by a reduction in low-risk cancers.
"This study met an un-need," said panelist Patrick Loehrer, MD, an oncologist who is the director of the Melvin and Bren Simon Cancer Center at Indiana University. "It decreased the risk of low-grade cancers."
The panel also examined data from Merck's Prostate Cancer Prevention Trial (PCPT) which randomized nearly 19,000 healthy men over 55 to receive finasteride or placebo.
At the end of the PCPT, 9,060 men had prostate needle biopsy data available for analysis, and prostate cancer was detected in 803 (18.4%) men receiving finasteride and 1,147 (24.4%) men receiving placebo.
Taken together, data from both trials showed the 5 alpha-reductase inhibitors both provided a statistically significant reduction in the cumulative incidence of prostate cancer after four years (REDUCE) and seven years (PCPT) of treatment with dutasteride and finasteride, respectively.
Both trials also found an unexpected increase in the incidence of high-risk prostate cancers among men receiving the 5-alpha reductase inhibitors.
In the REDUCE trial, 29 high-grade tumors were found among patients being treated with dutasteride compared with 19 in the placebo group. In the PCPT, there was a 26% decrease in all prostate cancers but an absolute increase of 1.3% in the incidence of high-grade tumors.
According to an FDA statistician, if 200 men are treated with the drugs, it is expected that there will be one additional tumor with a Gleason score of eight to 10.
And the benefit didn't appear great when boiled down to a statistical snippet: 60 men would need to be treated with one of the 5 alpha-reductase inhibitors in order for one man to avoid developing a clinically relevant prostate cancer, the statistician said.
In a prepared statement, GlaxoSmithKline expressed disappointment with the panel's decision on dutasteride and said it would work with the FDA to answer any questions as the FDA completes its review of the drug.
Meanwhile, a new study published in Journal of the American Medical Association yesterday supports the school of thought in the urology community that active surveillance -- not treatment -- leads to a better quality of life in men with low-risk prostate cancer.
