A US government-sponsored panel of independent experts that reviews evidence and develops recommendations for preventive clinical services says the harms of PSA-based testing for prostate cancer outweigh the benefits. The recommendation has provoked a strong and angry response from many patient and medical groups.
In a report published early online before print in the 21 May of Annals of Internal Medicine, the US Preventive Services Task Force (USPSTF) writes of PSA-based screening for prostate cancer: “[it] may benefit a small number of men but will result in harm to many others”.
The USPSTF is a group of primary care physicians and epidemiologists that is appointed and funded by the US Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ). Its recommendations are important because they influence how health policy is shaped and what insurers do. For instance, it is empowered by the Affordable Care Act to decide which screenings Americans receive.
This recommendation is the task force’s “final word” on PSA-based testing. It follows a period of public comment after its last published recommendation in 2008, when at the time it concluded there was no evidence to support PSA testing for men over 75.
The task force says it has since then reviewed the evidence published since 2008 and concluded that the harms of PSA-based testing outweigh the benefits, regardless of age. The task force does not take costs into account when developing recommendations: it just weighs health benefits against harms.
The task force posted a draft of this final recommendation for public comment in October 2011. At the time it gave PSA-based screening a “D” grade, which means doctors should not offer the test to their patients because there are more harms than benefits.
Many who commented at the time suggested the “D” be changed to a “C” which says doctors could offer the test to patients who ask for it. But the panel has not changed its draft recommendation, and has stuck to the “D” grade.
According to its Annals of Internal Medicine report, the task force considered two major trials that assessed the life-saving benefits of PSA-based testing in asymptomatic men.
The first trial took place in the US. It did not show that PSA-screening reduce deaths to prostate cancer. The second trial took place in seven European countries and found PSA screening reduced deaths by one death per 1,000 men screened in a subgroup aged 5 to 69 years, mostly in two countries. The other five countries did not find a statistically significant reduction deaths.
The task force reports there is strong evidence that PSA-based screening can be harmful.
Just under 90% of men whose prostate cancer is detected via PSA undergo early treatment, either with surgery, radiation, or androgen deprivation therapy, they write. They say the evidence shows up to 5 out of every 1,000 men die within 1 month of surgery, and between 10 and 70 that survive have to live the rest of their lives with urinary incontinence, erectile and bowel dysfunction.
The reaction against the recommendation has been fierce.
The American Urological Association (AUA) says it is “outraged” at the task force’s final word on PSA testing.
“It is inappropriate and irresponsible to issue a blanket statement against PSA testing, particularly for at-risk populations, such as African American men. Men who are in good health and have more than a 10-15 year life expectancy should have the choice to be tested and not discouraged from doing so,” they told the press on Monday.
The AUA says that disparaging the PSA test when newer tests and diagnostics are not yet widely available does a great disservice to American men.
The Association says there is “strong evidence that PSA testing saves lives”, and draws attention to evidence within the trials the task force examined.
“Rather than instruct primary care physicians to discourage men from having a PSA test, the Task Force should instead focus on how best to educate primary care physicians regarding targeted screening and how to counsel patients about their prostate cancer risk,” says the AUA.
A statement from the Men’s Health Network (MHN) and the Veteran’s Health Council also voices strong opposition to the task force decision, describing it as a “deeply flawed process” that has led to “a dangerous and life-threatening recommendation”.
MHN VP Scott Williams, told the press that “this recommendation essentially eliminates access for patients and their healthcare providers to the only test available for early detection of prostate cancer.”
The Veterans Health Council expresses concern that the panel did not consider a study that found Vietnam veterans exposed to Agent Orange were more than twice as likely to develop prostate cancer and that when diagnosed the cancer was more aggressive.
“If allowed to stand, USPSTF clearly abrogates its responsibility for the health and well-being of America’s Vietnam veterans,” said their Executive Director, Thomas Berger.
In an editorial accompanying the task force’s report, William J. Catalona, Medical Director of the Urological Research, and colleagues, express concern that the new recommendations will take Americans back to an era when prostate cancer was often discovered at advanced, incurable stages.
They write that the task force underestimates the benefits and overestimates the harms of prostate cancer screening, and largely bases its recommendation on flawed studies with inadequate follow-ups.
They also point out that the task force panel does not include urologists or cancer specialists, and focused too much on mortality without taking sufficient account of how sick people living with advanced cancer can get.
One of Catalona’s co-authors, Henry Lynch, Director of the Hereditary Cancer Center at Creighton University, told the press:
“The recommendations of the USPSTF carry considerable weight with Medicare and other third-party insurers. My colleagues and I strongly believe that the Task Force recommendations should not be used as justification by insurers, including Medicare, to deny diagnosis of prostate cancer to the male population at risk.”
Yet, in another editorial accompanying the task force report, Otis W. Brawley, Chief Medical Officer of the American Cancer Society, says overdiagnosis makes screening seem to save lives when it truly does not. He points out that many men diagnosed with prostate cancer may never experience disease progression in their lifetime. But because they were screened and treated, they assume screening saved their lives.
“Many people have a blind faith in early detection of cancer and subsequent aggressive medical intervention whenever cancer is found,” writes Brawley, adding:
“There is little appreciation of the harms that screening and medical interventions can cause.”
In its report, the task force panel sas that while the “D” recommendation clearly states that physicians should not offer PSA screening, it leaves the ultimate power in the hands of the health care providers.
Task force chair Virginia A. Moyer, of Baylor College of Medicine in Houston, Texas, said:
“The USPSTF recognizes that clinical, policy, and coverage decisions involve more considerations than evidence alone. Clinicians and health care providers should understand the evidence but individualize decision-making to the specific patient or situation.”
Written by Catharine Paddock PhD