HEALTH -- October 17, 2011 at 2:00 PM ET
PSA Testing Controversy Reignites 'Over-Screening' Debate
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Denham Kelsey seems like a healthy man -- a chronic dog-walker, professional pilot, and occasional scuba diver. The 54-year-old from Tucson recently hauled several tons of supplies to the top of his house and replaced the roof himself.
But the appearance of good health is also why Denham Kelsey would be living with undiagnosed prostate cancer if not for a routine screening test last fall. It simply never would have occurred to him to be checked for it.
"I was just the regular guy who did just about everything you wanted to do. The last thing I thought they'd say is that I have prostate cancer," said Kelsey, who is currently in treatment at MD Anderson Cancer Center in Houston and expects to be cancer-free soon. "If not for that test, this probably would have spread outside my prostate within a few years."
Kelsey received the prostate-specific antigen (PSA) test -- a screening widely conducted for men over 40 and one that measures a protein in the blood that often spikes when prostate cancer is present. And like most American men with any knowledge of the simple blood screening, his opinion on whether it saves lives runs deep.
A week after the U.S. Preventive Services Task Force released a draft of its decision to no longer recommend routine PSA screening for seemingly healthy men -- largely because it's not entirely clear whether the test leads to life-saving treatment -- a heated battle over the issue continues to rage within the health care world. And given that the independent panel commissioned by the U.S. government holds such sway over policy, insurance decisions, and the practices of everyday Americans, it's unlikely to let up any time soon.
The Testing Conundrum
On one side of the fight are men like Kelsey and a fleet of doctors who have embraced the test as a "best practice" for decades. They're noting -- loudly -- that prostate cancer remains the second-leading cause of cancer deaths in American men, but that fatalities have dropped by up to 40 percent since the PSA screenings came on the scene nearly two decades ago. And they vow to tell everyone they know to ignore the recommendation of the task force.
Then there are those who say that the recommendation discouraging the tests is long overdue -- that the routine screenings too often deliver flawed results and have contributed to an epidemic of anxiety, unnecessary surgery and overtreatment in the United States. For the most part, they applaud the task force decision to discourage the PSA screenings on the grounds that "there is moderate or high certainty that the service has no net benefit." Or even worse: "that the harms outweigh the benefits."
"On the surface, it sounds like a simple blood test that could save your life. But men need to understand what the potential benefits and the downsides before making the decision with their doctor about whether this is right for them," said Dr. Michael J. Barry, president of the Boston-based Foundation for Informed Medical Decision Making.
Barry worries "that we've oversold screening," he said. The popular belief that it's better to catch cancer -- any cancer -- early and treat it until it's gone might just be plain wrong, he said.
For one thing, few would argue the test is perfect. While high PSA numbers can throw up a red flag about truly dangerous cancer, they can also indicate a number of other, far more common things - a vigorous bike ride, an infection or recent sexual activity. The only way to determine whether it's cancer is an uncomfortable biopsy through the rectum, a procedure that results in fever, infection, bleeding or temporary urinary difficulty in 68 of every 10,000 cases, according to the task force.
To many men, any amount of discomfort or risk would be worth it if it meant they're less likely to die of cancer. But it's not entirely clear that's the case. Many prostate cancers are slow-growing and would never cause serious harm during a man's natural lifetime. It's hard, Barry said, to look at prostate cancer and determine whether it's deadly. "So they're all treated," he said. And those treatments can cause some substantial side effects -- impotence, incontinence, even death.
"Many people assume that if we screen for prostate cancer, that it will give them a lower chance of getting the disease and dying of it. And the outcomes of screening -- when they're really studied -- tend to be relatively modest," he said. "But they come with a whole lot of terrible side effects."
Clinically Testing the Test
While the American Cancer Society hasn't officially taken sides in the debate, Dr. Leonard Lichtenfeld, the organization's deputy chief medical officer, regrets that he once fell into the routine screening camp. As a primary care physician 20 years ago, Lichtenfeld's mantra was to find cancer early and treat it, he said.
"But the truth is we didn't start using this test because we had clinical trials that showed it worked -- we started using it because it was around and we were told it saves lives," he said. "There's nothing to indicate that was true. Looking back, I'm forced to realize that perhaps some men were benefited and some were not. And for a physician, that's a difficult thing to accept."
The U.S. Preventive Services Task Force made its recommendation after studying five of the most widely respected clinical trials conducted since the advent of the PSA test. The two biggest offer a mixed portrait of whether it actually works.
The first, based in the United States, showed that the survival rate for average-risk, asymptomatic men was negligible after PSA testing. But around half of the participants who were supposed to be in the control group were screened for prostate cancer anyway, possibly muddying the results.
A second, longer trial in Europe, demonstrated a 20 percent drop in the relative risk of prostate cancer-specific deaths. But that trial wasn't without its flaws either. When a Swedish center with abnormally good outcomes was excluded, the positive results vanished and the PSA tests seemed to have little impact.
Collectively, the trials led the task force to conclude that the best evidence available indicates PSA screenings are a wash and therefore aren't worth the risks or worry. Advocates of PSA testing say that both of the biggest tests were too flawed to be the basis for sweeping recommendations that could impact policy.
So what is an already confused public supposed to do with all the conflicting information? Lichtenfeld predicts that in the short term, most men will probably do little to change their behavior. Doctors and patients who have made up their mind about the procedure are unlikely to waver an inch from their treatment plans, he said.
"Changing a practice takes time. There's an old saying that it takes 17 years for medicine to change with a new idea," Lichtenfeld said. "But I do think that the discussions between doctors and patients will tilt toward a more balanced one as opposed to everyone automatically assuming this is a great test everyone should have every year."
Medically Sound or Paternalistic?
Dr. Raoul Concepcion, president of the Large Urology Group Practice Association, agrees that the best approach is for a man to talk about the risks and benefits of testing with their doctor. But like most urologists, he not only firmly believes that the tests save lives, he also says that outcry over the recommendation from politicians, celebrities and the general public proves that many everyday Americans believe that, too.
Even if doctors and patients ignore the task force recommendation, insurance companies often turn to the panel for guidance on which preventive services they should cover. In this particular case, most insurers have stated they will continue paying for the PSA tests, but Concepcion worries that the influential position could lead to an eventual reversal of that decision -- especially in an era of cost-cutting.
"If the test is not being covered by insurance, many men would choose not to have it done even though they feel strongly they need it -- simply because they can't afford to pay the expense out-of-pocket," he said. "And if that happens, it throws us immediately back to the 1980s. We have wiped out 20 years in the diagnosis and advancement in prostate cancer."
In Houston, Dr. Andrew Lee, an associate professor of radiation oncology at MD Anderson Cancer Center, said that the PSA tests could probably be scaled back a bit from the overwhelming number administered today. But he also sees the task force decision to shield patients from worry by denying them potentially critical information is a more dangerous notion than anything else.
"It's a very paternalistic attitude that may have been ok in the era they were trained. But in the era I was trained, the role of the physician should be to provide the patient with enough information so that they can make a medically informed decision," he said. "Not to deny the patient information because it might scare them."
Underlying the debate are loud echoes of another controversy that exploded two years ago after the U.S. Preventive Services Task Force announced it would no longer recommend routine mammograms for women under 50.
Just as in the current debate, many patients and health care providers decided to tune out the recommendation and go about their normal screening routines. Even Health & Human Services Secretary Kathleen Sebelius noted publicly that "there are many groups who have disagreed with this information," and that mammograms would still be covered by health plans backed by the federal government. This summer, the breast cancer screenings were also included in a list of preventive services that health insurance companies will be required to provide to all women free-of-charge under the new health reform law.
It's unclear whether those opposed to the U.S. Preventive Services Task Force recommendation will carry such clout this time around. The 30-day public comment period won't close until Nov. 8, leaving plenty of time for both sides to pressure the group to change its mind -- or not -- in the name of improving the health of American men.