Navigation Links
FDA Panel Votes Against Drugs Said to Prevent Prostate Cancer
Date:12/1/2010

WEDNESDAY, Dec. 1 (HealthDay News) -- A U.S. Food and Drug Administration advisory committee on Wednesday voted against approving two drugs for the prevention of prostate cancer, the third-highest cancer killer of men.

The panel voted 17-0, with one abstention, that the risks of Merck's Proscar outweighed its benefits, according to the Associated Press. And in a similar vote, the panel voted 14-2, with two abstentions, against GlaxoSmithKline's Avodart. Both drugs are already approved to treat enlarged prostates.

"In a setting like this, the onus is on the drug to be completely safe, and to show benefit, and I don't think it reached that level," said panel Chairman Dr. Wyndham Wilson, of the National Cancer Institute.

The FDA does not have to heed the advice of its advisory panels, but it typically does.

Research presented to the panel by Merck and GlaxoSmithKline showed a 25 percent decrease in the incidence of low-grade prostate tumors among users of the drugs.

But concern that a small number of men taking the drugs actually developed more aggressive tumors led the panelists to find that the risk of aggressive tumors outweighed the benefit of reducing tumors that are seldom fatal, the wire service reported.

FDA regulators already had several concerns about using the medications for the prevention of prostate cancer, the AP reported. For one thing, black men, who are at high risk for the disease, were underrepresented in the clinical trials. "The applicability to African-American men is not known due to marked under-representation," the FDA's online review stated.

Blacks made up just 4 percent of Merck's patients and only 2 percent of Glaxo's patients, according to the AP.

The panel of outside experts assembled by the FDA is also likely to discuss the overall value of preventing low-grade tumors. According to the FDA, more than three-quarters of the tumors the drugs prevent are slow-growing, meaning they are non-aggressive and probably not life-threatening for anyone with a life expectancy of less than 20 years.

But even if the tumors aren't aggressive, Glaxo has said they often involve unnecessary treatment and biopsies, or surgical procedures, to diagnose cancer, that pose risks of their own.

Also, slightly more aggressive tumors were seen in men taking Avodart and Proscar, compared with those taking placebo pills, according to the FDA. But the pharamaceutical companies say the drugs simply make those tumors easier to detect because they shrink the prostate.

The U.S. National Cancer Institute estimates that 217,730 men will be diagnosed with prostate cancer this year and 32,050 men will die of it.

More information

For more on prostate cancer, visit the U.S. National Library of Medicine.

-- Margaret Steele

SOURCES: U.S. Food and Drug Administration; Associated Press


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA Panel to Vote on Drugs Said to Prevent Prostate Cancer
2. FDA Panel to Vote on Drugs to Prevent Prostate Cancer
3. Medicare Panel Endorses Vaccine for Prostate Cancer Patients
4. Teens Should Get Meningitis Booster Shot: CDC Panel
5. Expert Panel Links Popular Bone Drugs to Rare Fracture
6. FDA Panel to Mull Ban on Diet Drug Meridia
7. Experts Support FDA Panels Backing of New Blood Thinner
8. Avandia Raises Heart Risk But Should Stay on Market, FDA Panel Finds
9. FDA Panel Seems Skeptical Over Key Avandia Data
10. FDA Panel Appears Skeptical Over Key Avandia Data
11. NJIT professor heads panel studying sudden car acceleration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... To deal with these feelings, many turn to unhealthy avenues, such as drug or ... Center of Marne, Michigan, has released tools for healthy coping following a traumatic event. ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing skills ... patients and their families pay tribute to a genetic counselor by nominating him or ... Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome magazine ...
(Date:6/24/2016)... Frederick, Maryland (PRWEB) , ... June 24, 2016 ... ... Mid-Atlantic Angels is actively feeding the Frederick area economy by obtaining investment capital ... support over the past 2½ years that have already resulted in more than ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... , June 23, 2016 ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, ... Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast to ... The global pharmaceutical excipients market ... at a CAGR of 6.1% in the forecast period ...
Breaking Medicine Technology: