Prostate test cost-benefit clash gets to heart of health care debate

By Diane Carman

Peering into the controversy over routine use of the blood test to screen for the prostate-specific antigen is like falling down, down, down into the dark and bewildering rabbit hole that is the health care system in the United States. In many ways the debate over the PSA test illustrates why the system is so confounding, expensive, unmanageable and resistant to change.

As men, their providers and policy experts wrestle with the PSA conundrum, recent battles over mammography and hormone replacement therapy illustrate key lessons. When women learned that there was potential harm from annual breast screening and hormone therapy, far fewer demanded mammograms and hormone sales tanked. Evidence shows informed consumers could actually save millions of dollars by realizing that when it comes to health care, less often may be more.

Last month, the U.S. Preventative Services Task Force recommendedagainst the routine use of the PSA test, citing data from clinical trials in Europe and the U.S. saying that statistically the risks outweigh the benefits.

One man in 1,000 at most avoids death from prostate cancer because of screening, the task force report said. Meanwhile, for every 1,000 men screened, 30 to 40 will develop erectile dysfunction or urinary incontinence; two will experience a serious cardiovascular event, such as a heart attack; and one will develop a serious blood clot in his leg or lungs due to treatment. For every 3,000 men screened, one will die of complications from surgery.

On the other side of the debate were doctors who treat prostate cancer, prostate cancer survivors, patients and the patients nervous wives or partners who feared that leaving any cancer untreated was simply too risky.

Few on either side mentioned the economic considerations, but practitioners who diagnose and treat prostate cancer, hospitals that compete for patients, and pharmaceutical companies that produce drug therapies for prostate cancer and side-effects resulting from its treatment have a vested interest in maintaining the status quo. The annual cost for PSA screening alone is estimated at $3 billion. Just how much that vested interest influences medical protocols is a question few dare even ask.

Dr. Allan S. Brett and Richard J. Ablin raised the issue in a commentary in the New England Journal of Medicine last November. They said that when it comes to responsible stewardship of health care resources policymakers cannot ignore economic aspects of screening.

They cited an estimate that at a minimum, $5.2 million is spent on screening and prostate cancer intervention for every life saved. We believe that the current PSA-based screening paradigm does not compare favorably with competing health care priorities.

Unless its your prostate.

Despite the fact that health care spending in the U.S. in 2010 reached $2.6 trillion, nearly 18 percent of the GDP, when it comes to their own health care, the public clamors for more.

We do not have a system that tries to buy value right now, Atherly said.

Benefits of test unclear

Never mind issues relating to cost, from a purely personal standpoint accepting the task force recommendation to forgo PSA screening is tough for most men to wrap their heads around.

Dr. Tim Byers

The idea that detecting cancer earlier is better than detecting it later is indelibly etched into our consciousness because that seems to hold true for pretty much all cancers, said Dr. Tim Byers, an epidemiologist and professor at the Colorado School of Public Health. Generally, the earlier the diagnosis, the better the outcome.

The trouble with the PSA test and most of the other diagnostic tests that are used to screen for prostate cancer is that they dont accurately determine how dangerous the specific cancer is.

We really need to educate our patients more about how common prostate cancer is and that there are benign or fairly inconsequential types of cancer, said Byers.

For men over 85, an estimated 75 percent have prostate cancer that poses little or no risk to their health

People think all screening is good, said Dr. Ned Calonge, president and CEO of The Colorado Trust and a member of the U.S. Preventative Services Task Force that produced the PSA test recommendation.

The champion all-time winner of cancer screens is the Pap test, which reduces the risk of dying of cervical cancer by as close to 100 percent as we can ever get, Calonge said. Mammography, by comparison, reduces the risk of death from breast cancer by 25 percent and the PSA test at best is one in a thousand.

Its not a good test, he said. Weve oversold the public on it.

Richard Ablin, the inventor of the PSA test, has called it a hugely expensive public health disaster.

Still, the American Cancer Society estimates that 28,170 men will die of the more aggressive forms of prostate cancer this year.

And yet, the potential side-effects of prostate cancer treatment, including incontinence, impotence or both, are serious considerations for most men as well.

Its a hard thing to make a recommendation on, said Byers. I know men who have had screening complications and Ive had friends who have died from the disease.

Calonge has no hesitation about recommending against the test.

I think prevention needs a higher bar of evidence, he said. Remember, you are an otherwise well and asymptomatic person and now Im going to reach out and do something to you. I need absolutely the best evidence that it will be helpful.

For those who are diagnosed with prostate cancer, treatments range from surgery or radiation to active surveillance, an increasingly common recommendation that involves monitoring the cancer over months or years instead of treatment.

Not all patients can handle the less invasive option though.

Some patients get anxious, Byers said. You feel like youre sitting on a time bomb or else your wife does.

Calonge counseled patience.

Its important to recognize that the fusion of information takes time.

Screening, treatment a booming industry

Since the test was approved by the U.S. Food and Drug Administration in 1986, the PSA blood screen has been used on millions of men, many of whom were uninformed about it when they submitted to the test. Doctors simply checked off PSA on the lab form for blood analysis along with cholesterol screens and other routine tests. Then, if the PSA numbers were high, the doctor broke the news to the patient and outlined his options.

The American Cancer Society estimatesthat 242,000 new cases will be diagnosed in 2012 and most will result in some form of costly treatment.

Atherly explained that under Medicare and most private insurance plans, the financial incentive is always to do more for patients. And cancer survivors become walking, talking advertisements for aggressive intervention.

There are literally millions of men who are prostate cancer survivors who have become strong advocates for screening, Byers said. For those who have undergone treatment for early-stage prostate cancer, the belief that it saved their lives is nearly unshakable.

Recommendations can affect profits

If the recommendations of the U.S. Preventative Services Task Force were rigorously followed, the economic impact to health care providers and drug companies would be serious.

When the task force called for less routine mammography screening among women in 2009, providers began to see a drop in the numbers of women seeking the tests. A survey conducted by the Avon Foundation found that within three months of the task force announcement, 24 percent of providers surveyed reported a decrease in the number of women requesting mammography.

The response to findings released in 2002 by the Womens Health Initiativethat challenged the safety of routine use of hormone replacement therapy for post-menopausal women offers another a case in point.

In 2001, before the release of the Womens Health Initiative findings, 61 million prescriptions were written for the two most popular forms of hormone replacement therapy, Wyeths Prempro and Premarin. An estimated 6 million women took the drugs. The two pharmaceutical compounds produced $2 billion in sales for Wyeth that year.

When the Womens Health Initiative findings were announced, the companys stock fell by 24 percent.

By 2004, the number of prescriptions for Prempro and Premarin dropped to 21 million.

(Last month, the U.S. Preventative Services Task Force issued a recommendationadvising against routine use of hormone replacement therapy for women over 50. It said, as it did with PSA screenings, that the risks outweigh the benefits. The task force cited findings of increased incidence of dementia, stroke and other serious conditions among women using hormone replacement therapy.)

Calonge said during his tenure from 2004 to 2011 as a member and a chair of the task force, cost was never a factor considered in determining recommendations.

It did come up, he said. The members held entire meetings on whether to include economic considerations in their recommendations. Repeatedly, members voted that down.

Other task force recommendations, such as those calling for screening and intervention for treatment of obesity, were destined to cost the health care system, proving that the task force wasnt just out to save the health care system money.

We separated our recommendations from the issue of cost, Calonge said. They were based entirely on science.

Managing costs a minefield

While health care providers have much to lose by changing treatment protocols, it would seem that the national economy would benefit by any such changes that might lower health care costs. But few policymakers have the temerity to broach the subject of cost control in health care out of fear of being accused of rationing care or advocating for death panels.

Politicians nearly always rail about the runaway costs of Medicare, Medicaid and health care in general as they campaign across the country, but with the exception of cutting reimbursement rates to providers, they seldom propose concrete policies for reducing health care costs.

I understand the political volatility, said former Gov. Richard Lamm, co-director of the Institute for Public Policy Studies at the University of Denver and the author of The Brave New World of Healthcare. But so much of public policy is driven by cost-benefit analysis, why does health care have no limits?

Taxpayers pay for more than 50 percent of health care in the U.S., he said, which means that a system without serious cost-containment measures is a fiscal black hole.

Theres definitely a belief that we over-treat in this country, said Athlerly, who pointed to studies showing high numbers of diagnostic scans and images ordered by doctors in the U.S. compared to those in other countries.

Yet, evaluating medical protocols to identify unnecessary treatments is almost unthinkable.

The Affordable Care Act includes language ruling out that sort of cost analysis, Atherly said, and when it comes to the American public, there is little support for cost controls in health care.

I see a million avenues for controlling costs, Atherly said. Tell me what system you want, and Ill tell you how to control costs. There is no problem getting health care costs under control.

The trouble is we as a society havent been willing to allow anyone to control costs, he said. There are plenty of tools available. Its purely a matter of the public not being willing to have that happen right now.

Good medicine is the bottom line

The PSA test recommendation flare-up reveals medicine as science, art and industry.

The data from the clinical trials are persuasive: the screening finds lots of men with prostate cancer but cannot yet identify which cases are harmless and which are deadly. The pathology of cancer cells is one of the critical frontiers in science, but the answers remain elusive. As a result, many men are treated unnecessarily and many will suffer lifelong consequences.

Both here and in Europe, were seeing the same kinds of complications or side-effects, Byers said. A not insignificant proportion of men treated for prostate cancer are ending up with complications of one kind or another affecting urinary or sexual functions and problems with their rectum related to surgery or radiation.

Counseling men to help them make good decisions about whether to undergo PSA screenings or prostate cancer treatment is not easy. Its an art. Not all doctors have the time or the ability to do it well, and not all patients are willing to accept any level of risk when it comes to cancer.

At the same time, across most of the U.S. health care system, the financial incentives argue for more not less testing and treatment. The only patients inclined to consider costs first in deciding whether to undergo a PSA test are the uninsured.

Still, Byers said, if the angle is that economic self-interest can outweigh objective evidence, even though I think thats true, its probably an oversimplification.

In the case of the PSA test, he said the goal really is good medicine.

Atherly agreed.

I dont think the PSA discussion is at all about economics, said Atherly. The task force is essentially saying that the clinical benefit doesnt justify the clinical risks. There are no dollar signs attached to it.

Calonge is adamant that the task force recommendation on the PSA test is a powerful reflection of the science and the data and nothing else.

Doing something that doesnt work and that overall is harmful just to do something is a bad strategy for prevention, he said.

The debate over PSA tests wont be the last to put established cancer screening and treatment practices under the risk/benefit/cost microscope.

As clinical trials continue, Byers said researchers have begun to wonder, How good is the evidence that finding and treating small cancers really does save lives?

Until scientists crack cancers genetic code and find the way to identify which cancers kill and which ones are harmless, the question will remain.