Roughly two-thirds of all men on Medicare are screened for prostate cancer. Most feel they have no choice. After all, this year more than 27,000 American men are likely to die of the disease. When men are asked about their fear of cancer, a survey from the Harvard Risk Management Foundation reveals that prostate ranks at the top of the list. Colon cancer, which kills roughly as many men in the U.S. each year, ranks number seven. There is something about prostate cancer that pushes buttons. No wonder so many men sign up for the “PSA” test which measures levels of prostate-specific antigen in the blood.
But the truth is that current research offers no proof that widespread screening and early diagnosis saves lives. What we do know is that patients who are tested and treated may suffer life-changing side effects that outweigh the uncertain benefits of early detection.
In June the National Cancer Institute made its position clear: “Screening tests are able to detect prostate cancer at an early stage, but it is not clear whether this earlier detection and consequent earlier treatment leads to any change in the natural history and outcome of the disease.” The U.S. Preventive Services Task Force agrees.
On the other side of the controversy, the American Urological Association, and the American Cancer Society recommend annual PSA testing beginning at age 50 for healthy men who expect to live another ten years.
Still, available evidence calls this advice into question this advice. Skeptics point out that if early detection and treatment saved lives, one would expect that the mortality rate (or deaths per 100,000 in the population) would have plummeted in the twenty years since the PSA test was developed. But the number of men who die of prostate cancer has fallen by a modest amount. Moreover, researchers are not certain that PSA testing has caused the slide in mortalities. Multiple factors could be involved. We need controlled, randomized clinical trials, they say, before we can measure the benefits of testing. But because prostate cancer usually progress very slowly, a trial must follow patients for many years. (In 1993, the National Cancer Institute began a 23-year trial it projects will end in 2016.)
In the meantime, Dr, Tomasz Beer, director of prostate cancer research at the Oregon Health & Science University Cancer, worries that early detection is leading to unnecessary surgery and radiation treatments– and the unnecessary side effects that can follow from those treatments, in particular, impotence and incontinence.
Experts like Beer point out that most men who are diagnosed with early-stage prostate cancer don’t need to be treated because it is such a slow-growing disease. Thanks to widespread screening, 20 out of 100 American men will be told that they have prostate cancer at some point in their lives, but only three will die of it. The other 17 will die of something else, in most cases long before they experience symptoms of the cancer.
Unfortunately, doctors cannot tell, with certainty, which cancers will prove fatal. This is why some recommend aggressive treatments like radiation or surgery. Beer disagrees. “Many men would live just as long—and be happier—if they never found out they had prostate cancer” Beer told Bloomberg Markets magazine last year. “Too many men are risking impotence and incontinence to treat tumors that may never kill them.”
Men do have another option. Instead of electing to have surgery or radiation treatment, those who are diagnosed with early-stage prostate cancer can pursue a more conservative strategy called “watchful waiting.” Patients come in for regular PSA tests so that their doctors can monitor whether their PSA levels are rising. The patient will be treated only if there is evidence that the cancer is progressing.
Yet many patients feel compelled to pursue more aggressive treatment. This may be in part because men are so very afraid of prostate cancer; for many, the idea of watching and waiting is just too stressful. Dr. H. Gilbert Welch, who has spent a decade studying screening at Dartmouth Medical School, also suggests that our for-profit health care industry encourages testing: “More diagnoses mean more money for drug manufacturers, hospitals, physicians and disease advocacy groups,” he explains. “Researchers, and even the disease-based organization of the National Institutes of Health, secure their stature (and financing) by promoting the detection of ‘their’ disease.” And once the patient is diagnosed, fear of malpractice suits may help drive overtreatment.
As Gilbert puts it, an “epidemic of diagnosis” of cancers that usually prove harmless may be leading to “an epidemic of [often harmful] treatments.” If you are interested a fuller discussion of the odds of suffering severe side effects as a result of radiation therapy or surgery –versus the chances of dying while “watching” and “waiting”—I’ve written in more detail about this issue on tpmcafe: “What They Don’t Tell You When They Screen You for Prostate Cancer”
Here, I’d like to pursue a larger policy question: as noted, two-thirds of men on Medicare currently are going for PSA tests. Given the uncertainty about benefits—and what we know about risks—should Medicare be paying for screening and treatment of asymptomatic men? At the very least, shouldn’t Medicare insist that men be fully informed about the pros and cons of screening before they line up for the test?
It would seem to make more sense to save Medicare dollars for treatments that we know are effective: long-term home care of patients who need only custodial care, for example, or regular eye check-ups (neither of which are now covered). Moreover, we need to keep in mind that Medicare’s resources are finite. Unless we begin to cut wasteful spending, in eleven short years Medicare’s trust fund will no longer be able to cover all of Medicare’s expenses—a problem I have written about on the heatlhcareblog
In the meantime, if all Medicare beneficiaries were screened for prostate cancer annually, researchers estimate that the costs for testing and treatment could easily exceed $20 billion in five to seven years.
Nevertheless, it’s unlikely that Medicare will stop picking up the tab for PSA testing –at least not until the results come in from NCI’s long-term randomized clinical trial, and they’re not due until 2016.
In the meantime many doctors and patients believe that screening saves lives—even if they don’t have proof. Politically, it’s probably impossible for Medicare to pull back now.
But the story of how PSA testing can lead to unnecessary and hazardous treatments does serve as a warning: Once Medicare agrees to cover something, it becomes part of “standard medical practice”—even if we don’t know whether or not it works. In the past, Medicare has refrained from talking about “cost-effectiveness.” In fact Medicare doesn’t even demand hard evidence of effectiveness. If the FDA approves a treatment, Medicare usually rubber stamps it. And to win FDA approval,drug-makers and device-makers only need to test their products against placebos—proving simply that the new product is better than nothing. They don’t have to show that it is better than existing, usually less expensive drugs and devices already on the market.
There are signs, however, this will have to change. In its June report, The Medicare Advisory Payment Commission (MedPac), the independent commission that advises Congress on Medicare spending, addressed the issue of comparing the effectiveness of various treatment, noting that:
“Researchers have suggested several ways for CMS to use comparative-effectiveness information in the payment process including:
• Creating a tiered payment structure that pays
providers more for services that show more value to
• Creating a tiered cost-sharing structure that costs
patients less for services that show more value to the
• Using the cost-effectiveness ratio to inform the
• Not paying the additional cost of a more expensive
service if evidence shows that it is clinically
comparable to its alternatives; and
• Requiring manufacturers to enter into a risk-sharing agreement, which links actual beneficiary outcomes to the payment of a service based on its comparative effectiveness.
Manufacturers might rebate the Medicare program for services that do not meet expectations for their effectiveness (Chernew et al. 2007,MedPac 2006).
In future weeks, I plan to write more about Medicare reform—and how setting up panels of physicians to take a closer look at the risks and benefits of treatments that Medicare pays for could pave the way for national health care reform.
For now, let me just suggest that one of the best ways to cut back on ineffective and sometimes hazardous over-treatment is to involve patients in the decision-making process. Here, Dartmouth Hitchcok Medical Center’s program for “Shared Decision-Making” might serve as a model. The Center’s program is designed to give patients the most up-to-date information about the pros and cons of many elective treatments, and to make sure patients realize that when it comes to elective surgery as well many tests, they have a choice.
In the case to Prostate Cancer, Dartmouth offers patients decision-making aids in the form of videos and booklets. The first set, “Is a PSA Test Right for You” is designed for men age 50 and older who are not experiencing symptoms of prostate cancer, and who are trying to decide whether they should have a PSA test performed as part of their routine medical care.
The second set of videos and booklets is designed for patients who have been tested and diagnosed to help them decide which treatment is best for them: “Treatment Choices For Prostate Cancer.”
The booklets outline the risks and potential benefits of PSA screening and early treatment, and underline the controversy: some physicians believe PSA testing saves lives; others point out that there is little or no hard evidence that early diagnosis reduces mortalities. Yet if the test turns out positive, a patient faces having to make a decision about treatments that can lead to incontinence and impotence.
They also explain that because the cancer does not usually appear until after age 50, and because early-stage prostate cancer usually moves so slowly, odds are high that a patient will die of something long before he is bothered by the cancer.
Thus, a patient needs to make a choice based on his own values and temperament. Is he willing to try watchful waiting and risk that the cancer will progress quickly? (PSA tests do not always catch it.) Of would he rather risk the side-effects of treatments that he may not need—and that may not help him even if the cancer does progress? This is a tough decision particularly for African-American men and younger men who face a greater risk that the cancer will prove fatal.
The videos help patients identify their own priorities by featuring patients who explain why they did or didn’t chose screening and treatment. In the video titled “Is A PSA Test Right for You,” Dr. David Ransohoff, a gastroenterologist and professor of medicine at UNC Chapel Hill spells out why he has decided to skip PSA testing altogether : “If the result is negative, everyone is happy. But if it’s positive, you have to face a much more complicated series of decisions.” Do I opt for surgery? Wait and See? Maybe I should try radiation, but what if it doesn’t get all of the cancer? “You’re going to feel compelled to consider treatment,” says Ransohoff. “My own decision is that this is a slippery slope I don’t want to get on.” In the second video, a patient who was screened and diagnosed explains that he chose surgery because he “just wanted to get it over with”—and he is glad that he did.
Typically Dartmouth-Hitchcock’s patients take the booklets and videos home and discuss them with their families. Then they meet with their doctors. Patients are not expected to make their decisions alone: videos and booklets only complement the dialogue between patient and doctor. Typically, the physician asks questions to make sure that patients understand what they stand to gain or lose if they pick a particular option and helps the patients sort out his own hopes and fears.
Last week, presidential candidate Senator Hillary Clinton praised Dartmouth’s shared decision-making” program as a model that deserves federal funding so that it can be tried by health care providers around the nation. No doubt other presidential candidates will address the idea as they lay out plans for health care reform.
Like Medicare reform, shared decision-making is something I plan to discuss , in more detail, in the future. In the meantime, I would be interested in hearing from any patients or physicians who have been involved in shared decision-making at Dartmouth.