Prostate-cancer screening doesn’t save enough lives to justify exposing men to risks of death, incontinence and impotence, a U.S. panel will say today in a report that sparked immediate criticism from patient advocates.
The draft recommendations from the Health and Human Services Department’s Preventive Services Task Force may prompt insurers to stop paying for tests measuring PSA, a protein associated with prostate cancer at high levels. The panel will give the public four weeks to comment.
The task force’s findings also refocus attention on comparative effectiveness research, work that assesses the benefits of various medical treatments. The research drew criticism during debate over the U.S. health-care law when the same panel in 2009 recommended women should start regular breast cancer screening at age 50, not 40.
The PSA test “doesn’t distinguish cancer that will never make a difference in a man’s lifetime from cancers that will make a difference,” prompting many men to undergo aggressive treatments they don’t need, Virginia Moyer, the panel’s chairwoman, said yesterday in an interview.
“So you go from being a guy who feels fine and who potentially is one of the majority who never would have known they had this disease, to being a guy who wears adult diapers,” said Moyer, a professor of pediatrics at Baylor College of Medicine in Houston. “This is not insignificant.”
Downgraded Recommendation
The panel of scientists voted in March to change its current inconclusive assessment of PSA screening to a recommendation that the tests provide no benefit or can do more harm than good.
“We’ve been working on finalizing the wording of the document” for today’s report, Moyer said. The task force’s recommendations were previously reported by the New York Times.
The panel’s findings are based on “out-of-date evidence” and may condemn “thousands of men to die this year,” Skip Lockwood, chief executive officer of ZERO-the Project to End Prostate Cancer, said yesterday in a statement.
Screening for prostate cancer has been the subject of controversy for years as the disease is slow growing in most men. In 2009, a European study of 182,000 men found that 48 men were diagnosed and treated for each prostate cancer death prevented. Prostate cancer treatment can cause impotence, incontinence and other side effects.
An estimated 217,730 new cases of prostate cancer were diagnosed in the U.S. in 2010 and the disease will kill about 32,000 patients, according to the National Cancer Institute.
New Threat
Studies emerging during the past two years have uncovered that a small, yet growing percentage of those undergoing routine needle biopsy tests are becoming critically ill and dying from bacterial infections.
Infectious complications including sepsis from prostate biopsies have more than doubled in less than a decade, studies from three countries show. Nine out of 10,000 men whose tests were negative died within a month, researchers in Toronto reported in the Journal of Urology in March last year.
“Not only is PSA screening over-diagnosing and over- treating, it’s now causing these increased infections,” Richard J. Ablin, the scientist who discovered PSA in 1970, said in an interview in May. “The whole basis of the test is flawed because there is no level of PSA that is diagnostic of prostate cancer because it’s not specific for prostate cancer.”
Expensive Disaster
“The test’s popularity has led to a hugely expensive public health disaster,” Ablin, a research professor of pathology at the University of Arizona College of Medicine in Tucson, wrote in a March 2010 opinion piece in the New York Times.
Research on PSA tests indicates there is “minimal benefit in terms of decreasing cancer death, there’s no benefit in terms of decreasing overall death, and there are very significant harms,” Baylor College’s Moyer said.
About 300 of every 1,000 men treated for the disease will suffer urinary incontinence, impotence, or both, and some experience bowel complications, she said.
About one in 200 men who get a prostate biopsy because of their PSA score will develop a serious infection or have trouble urinating, researchers said in a draft scientific review that prompted the task force’s recommendations. The draft document was posted yesterday online by the Cancer Letter, a health newsletter.
‘False-Positive’
One in eight men will have a “false-positive,” in which the results suggest a tumor that isn’t there, the researchers said. Other men will be diagnosed and treated for low-risk cancers that wouldn’t have impaired their health or shortened their lives even without treatment or detection.
Among those who get treatment, one in three who undergo surgery and one in seven who get radiation will develop erectile dysfunction, according to the draft review.
The panel’s recommendations may dissuade patients from consulting with doctors to decide whether they would benefit from PSA tests, said Dan Zenka, a spokesman for the Prostate Cancer Foundation in Santa Monica, California. Zenka said he was diagnosed with prostate cancer last year, at age 51, after having annual PSA screenings since age 40.
“I can’t imagine, had I not had that PSA reading, where I’d be today,” he said. “From my perspective, PSA saved my life and it will continue to save my life as we measure my response to treatment and look for recurrence.”
The panel’s recommendation shows doctors need a way to match the test with patients who may benefit most from screening, said Christopher Logothetis, chairman of genitourinary medical oncology at the University of Texas M.D. Anderson Cancer Center.
“The question is, have we moved from one extreme -- screening everyone with PSA even into advanced ages -- to not measuring PSA in anybody because we are using the information incorrectly,” Logothetis said yesterday in an interview. “We’re trying to thread this needle with incomplete information on how to use this test and use it wisely.”
To contact the reporters on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net; Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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