The evidence has long been shaky on the benefits of the PSA screening test for prostate cancer, so it should have been little surprise when the U.S. Preventive Services Task Force, a group of primary care doctors that advises the Department of Health and Human Services, downgraded its rating of the test from I (for insufficient evidence) to D (evidence that there is no benefit) for men without symptoms of disease.
The experts had done a comprehensive review of the evidence, including a new, big study, and concluded it was not worthwhile to use the blood test for regular screening of most men over 40.
Nonetheless, there was still an outcry. The controversy about such scientific analysis shows just how hard it will be to nudge our medical system in the direction of evidence-based practice.
ZERO, a prostate cancer patient group committed to improving early detection of the disease, immediately released a statement expressing its outrage on the panel’s scientific judgment. “Today's decision of no confidence on the PSA test by the U.S. government condemns tens of thousands of men to die this year and every year going forward,” Skip Lockwood, the group’s CEO, said in a statement.
Urologists, the specialists who most frequently treat the disease, also weighed in, saying that the guidelines would discourage men in high-risk groups from getting needed tests.
The panel, whose findings are advisory, examined several large, long-term studies that compared men with no symproms who got the screening test with men who were not regularly screened. What they found was that the screened men did not live longer, but they were still diagnosed and treated for prostate cancer at much higher rates.
“The common perception that PSA-based early detection of prostate cancer prolongs lives is not supported by the scientific evidence,” the report said. Because prostate cancer treatment carries high risks of impotence and urinary incontinence, among other complications, the panel determined that more men were being hurt than helped by the test.
The task force did not consider cost in its evaluation, but the widespread screening, diagnosis, and treatment of prostate cancer is hugely expensive to the medical system. According to the American Cancer Society, about 240,000 men are diagnosed with the disease every year and 34,000 die of it. About 90 percent of men who are diagnosed are treated with radiation, surgery, or drugs. But the task force’s evidence review found that there was no evidence that PSA screening saved lives overall.
The PSA test looks for a prostate specific antigen, a compound made only by prostate cells. The more active the prostate -- such as when it's growing or inflamed -- the more PSA it makes. So a rise in PSA could indicate either cancer or a natural enlargement of the prostate gland that occurs in many men with age.
What the research has found is that prostate cancer is so slow-growing in most men that men who are not tested for the chemical often die with prostate cancer, but not from it. There is still no good test that distinguishes between the slow growing tumors and those likely to spread and cause disease.
Still, many urologists believe that discouraging PSA testing will cause needless deaths and sickness for many men.
“Before we had PSA testing, we used to have clinics filled with people who were alive, who died of a heart attack or a stroke, but had terrible quality of life because they had diffuse prostate cancer,” said Dr. Thomas Jarrett, a professor and Chairman of Urology at George Washington University Hospital in Washington, D.C. Jarrett was diagnosed and treated for prostate cancer at 46, after beginning annual screening at 40.
Jarrett had a family history of the disease, and he, along with the American Urological Society, expressed particular concern that African-American men and men whose family members had been diagnosed still need to be tested. The task force’s report said those groups have been studied in smaller numbers than the general population, but there is no evidence, so far, that such men benefit from testing.
Current recommendations about when and how often men should be screened vary. The American Cancer Society suggests men at normal risk should discuss the benefits and risks of testing beginning at age 50, and men in risk groups should begin talking to their doctors at 45. The American College of Physicians and the American College of Preventive Medicine suggest discussions between men and their doctors starting at 50. The American Urological Society suggests a baseline screening test at 40, annual screening in all men beginning at 50, and annual screening after 40 for men in known risk groups.
A pillar of last year’s health care reform law was the notion that providing better medical care that is proven to work will improve the country’s health and cost the medical system less money. It’s a principle that was echoed in an anticipated Institute of Medicine report, also released Friday, that gave Health and Human Services Department regulators advice about how to decide what benefits should be considered “essential” and required of all insurance products offered on public exchanges in 2014.
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That report homed in on two main themes: make the coverage affordable enough that people can buy it, and cover medical interventions that are “evidence-based.” Those guidelines sound like common sense, but crafting medical practice around what’s evidence-based, especially with emotionally charged diseases like cancer, can be difficult.
When the task force downgraded its rating of mammograms two years ago, saying women between 40 and 50 need not get the test every year, controversy abounded, resulting in legislation guaranteeing that all new health insurance plans offer annual mammograms to women in the affected age group. (Low income women without insurance already had access to free screenings subsidized by the federal government.) Congress has already passed a law guaranteeing that Medicare pay for annual PSA tests for all men. That’s despite a longstanding recommendation that the test has no value for men over 75.
The mammogram recommendation was released in the midst of the debate about the larger health care reform law, and critics of the law seized upon the new guideline as an example of how government regulation of health care could lead to the denial of lifesaving interventions. That analysis misunderstood the nature of the recommendation—that it was advisory, that it recommended leaving choices with women and their doctors, and that, as with prostate cancer, the task force found that the evidence of harms from screening outweighed any improved rates of survival.
But that firestorm apparently chastened the task force. According to the New York Times, the group had been ready to release the prostate cancer guideline shortly after the mammography one, but had held back twice out of fear of a backlash. A physician on the support staff of the panel, Kenneth Lin, resigned from the task force in protest after the second such delay, in 2010. “Politics trumped science,” he wrote in a blog post explaining the decision.
It will take time to see what the fallout is from the PSA guideline change. Though men with prostate cancer have recently begun organizing into groups like ZERO to raise money for research and encourage early detection, prostate cancer still lacks the grassroots organization of breast cancer advocates, who were able to protest the mammography decision so loudly.
The message on the PSA test is also more clearly negative. While the task force found that the risks of mammography outweighed the benefits, it still acknowledged a small survival improvement in screened women under 50—and it has been long established that older women do survive longer if they get mammograms.
But it is highly unlikely that any insurance company will stop paying for the test any time soon, whether insurance regulators require it or not. Responsibility for change, and any cost savings that result, will come from patients and doctors who decide to forgo testing.