A government task force is recommending that men should stop receiving a routine blood test to check for prostate cancer because the test does more harm than good. At best, the prostate specific antigen (PSA) blood test will save one life out of 1,000 men tested, but another man will develop a dangerous blood clot, two will have heart attacks, and 40 will become incontinent or impotent because of unnecessary treatment.

The U.S. Preventive Services Task Force made this proposal to drop routine screenings last fall, and it’s sticking by the final guideline despite outrage from the medical community.

Not every form of prostate cancer needs to be treated because most of the cancers found through the PSA blood test are slow-growing and unlikely to cause harm, so a member of the task force said better ways to detect prostate cancer will help:

The controversy will end only with development of better tests — to finally tell which men’s tumors really will threaten their lives, and who will die with prostate cancer rather than from it, said Dr. Virginia Moyer of the Baylor College of Medicine, who heads the task force.

“We have been told for decades to be terrified of cancer and that the only hope is early detection and treatment,” she said. The reality: “You don’t need to detect all cancers.”

“We don’t want this to be the answer,” Moyer added. “We want to screen for the ones that are going to be aggressive, manage those early — and leave everyone else alone.”

Even with the new guidelines, it is unclear how many men will skip testing. The task force already recommends that men over 75 skip the blood test, but research shows that about half still have it. And for those who test positive and learn they have have prostate cancer, low-risk patients often choose aggressive treatments with few benefits, according to a 2010 study.

Overall, unnecessary health costs add $158 billion to the nation’s health care tab each year, and the Affordable Care Act invests in comparative effectiveness research to help determine the most cost-effective course of treatment to cut down on those unnecessary health costs. And to cut down on overtreatment, the task force’s guidelines to cut out PSA blood tests that do more harm than good — and lead to sometimes unnecessary treatment — are a good place to start.

Our guest blogger is Emily Oshima, a research associate/policy analyst with the Health Policy team at American Progress.

Earlier this week, CAP Senior Fellow and oncologist Zeke Emanuel co-authored an editorial that questions the increasing use of proton beam therapy to treat cancer patients, given the clear lack of clinical evidence on its efficacy and substantially higher costs.

In theory, proton beam therapy can zap cancerous tissue with much greater precision than conventional photon radiation treatment, minimizing damage to healthy tissue surrounding a malignancy and reducing side effects. Although proton beam therapy has been in use since the 1950s, randomized clinical trials for the treatment of prostate cancer -– which proton therapy is frequently used to treat — are completely lacking. Existing studies are smaller, single institution, and short-term, and are unable to evaluate long-term outcomes, including onset of delayed side-effects. Additionally, although proton beam therapy has been shown to effectively treat certain rare childhood cancers — mainly brain and spinal cord tumors — the treatment’s precision may actually miss potentially treatable disease that could be addressed through less-precise x-rays.

As major medical centers — including the University of Pennsylvania, M.D. Anderson, and the Mayo Clinic, among others –- invest hundreds of millions of dollars in building the football-field-size buildings needed to house the proton accelerators and in light of rapidly rising health care expenditures, we’re forced to ask, “It Costs More, but Is It Worth More?”

It seems that Mayo Clinic President and C.E.O. John Noseworthy might have an answer in several years, after spending more than $360 million building two new Mayo proton beam facilities, inevitably passing at least some of these costs on to cancer patients. Noseworthy states that Mayo, along with other proton centers in the U.S., will enroll patients in clinical trials once their proton facilities are up and running. But even if the results of the planned phase III clinical trials show that the protons are no more effective than photons, Mayo and others would still continue to use the machines, given their substantial up-front investment in the technology.

In his editorial, Noseworthy also claims that “hundreds of manuscripts” were reviewed over a six-year period to research the effectiveness of the treatment. Yet, he does not cite a single study, and doesn’t refute the lack of randomized clinical trials, the gold standard of clinical effectiveness assessments. If proton beam therapy does, in fact, produce more effective treatment outcomes, improve quality of life for cancer patients through reduced side effects and minimal damage to surrounding tissue, it may be a worthy investment for a wider population of cancer patients. But until then — show us the data!

Newt Gingrich reignited the “death panels” meme during Tuesday night’s GOP presidential debate in New Hampshire, arguing that the U.S. Preventive Services Task Force’s draft recommendation that men shouldn’t be routinely tested for prostate cancer was “going to kill people.” The panel found that the test does more harm than good, noting that “The common perception that early detection prolongs lives is not supported by the scientific evidence.” Gingrich disagreed:

GINGRICH: I am really glad you asked that, because I was just swapping e-mails today with Andy von Eschenbach, who was the head of the National Cancer Institute, the head of the Food & Drug Administration. But before that, he was the provost M.D. Anderson, the largest cancer treatment center in the world.

And he wrote me to point out that the most recent U.S. government intervention on whether or not to have prostate testing is basically going to kill people. So, if you ask me, do I want some Washington bureaucrat to create a class action decision which affects every American’s last two years of life, not ever.

I think it is a disaster. I think, candidly, Governor Palin got attacked unfairly for describing what would, in effect, be death panels.

And what Von Eschenbach will tell you if you call him is, the decision to suggest that we not test men with PSA will mean that a number of people who do not have — who are susceptible to a very rapid prostate cancer will die unnecessarily. And there was not a single urologist, not a single specialist on the board that looked at it. So, I am opposed to class intervention for these things.

Watch it:

Some doctors like Von Eschenbach may disagree with the panel’s recommendations, but the scientific evidence demonstrates that the risk of additional testing and treatments — like biopsy, surgery, and radiation — outweighs the benefits of early detection. Part of the problem, the science concludes, is that the PSA doesn’t actually detect prostate cancer, but rather “reveals how much of the prostate antigen a man has in his blood,” so it triggers additional testing. Nor does it “distinguish between the two types of prostate cancer — the one that will kill you and the one that won’t.” And so the panel concluded that for healthy men who have no other symptoms of prostate cancer, the cancer grows slowly and they end up dying of something else without ever knowing about the disease and avoiding the cascade of treatments and complications that come with diagnosis. For instance, according to the task force, “one million men received surgery, radiation or both as a result of a PSA test from 1986 to 2005,” but about about 0.5 percent of those who received surgery after a PSA test died within 30 days. The treatment also “significantly increased risks for incontinence, impotence and other health problems.”

As Jonathan Cohn observes, ultimately, this is an intensely personal decision. “Do you want to have a test for a cancer that might not be lethal and that might lead you to treatment that could harm or even kill you? Not every patient will answer that question the same way. Not every doctor will either.” This panel or the Affordable Care Act won’t make that decision for you — “nobody is going to stop physicians from giving the test. Nobody is going to stop patients from getting the test. Nobody is going to stop insurers from paying for the test.”

The government will consider the panel’s recommendations when forming the basic benefit packages that insurers will offer beginning in 2014. But its science-based conclusions are just one factor in a complicated process that will certainly take into account the opinions and expertise of doctors like Von Eschenbach and consumer groups that disagree. The Prevention Task Force considered the science and efficacy behind the PSA test, which is a good starting point for making any kind of medical decision.

In case you weren’t convinced that the government is spending millions of dollars on health care that does nothing to improve outcomes, this stat may change your mind: an investigation conducted by iWatch finds that “40 percent of Medicare spending on common preventive screenings [is] regarded as medically unnecessary.” Beneficiaries are receiving these tests “more frequently than medically recommended or at times when they cannot gain any proven medical benefit, extracting an enormous financial toll on the nation’s health care system.” This is because “doctors disregard scientific guidelines out of ignorance, fear of malpractice suits or for financial gain, as patients inundated by medical advertising clamor for extra tests.” The Affordable Care Act tries to tackle this waste by changing the incentives that lead to unnecessary care, funding tort reform demonstration projects, and investing in comparative effectiveness research to weed out ineffective treatments.

Paul Krugman on why Medicare is comparatively more expensive than single-payer health programs in other nations:

What is true is that the U.S. Medicare is expensive compared with, say, Canadian Medicare (yes, that’s what they call their system) or the French health care system (which is complicated, but largely single-payer in its essentials); that’s because Medicare American-style is very open-ended, reluctant to say no to paying for medically dubious procedures, and also fails to make use of its pricing power over drugs and other items.

So Medicare will have to start saying no; it will have to provide incentives to move away from fee for service, and so on and so forth. But such changes would not mean a fundamental change in the way Medicare works.

It’s worth pointing out that the lawmakers who oppose the cost-containment measures Krugman describes are more inclined to fear monger and complain about Medicare’s “unsustainability” and increasing costs. So next time you see Republicans arguing that Medicare is going broke and won’t be there for future generations of Americans, recall that they all voted against, demagogued and proposed amendments to significantly limit the application of comparative effectiveness research in Medicare — so that the program is not paying “for medically dubious procedures” — during the health care reform debate and are now leading the charge to repeal the ACA’s Independent Payment Advisory Board (IPAB).

Via Ezra Klein, Paul Krugman offers this excerpt from Mike Huckabee’s new book lampooning the Recovery Act’s investment in comparative effectiveness research — which compares clinical outcomes of alternative therapies used to manage the same condition:

Huckabee rhetoric is pretty standard Republican fare. Conservatives have long used comparative effectiveness research to further their claim that health care reform would ration treatments based on cost, impose a one-size-fits-all standard for medicine, and keep doctors from prescribing more expensive and effective procedures. But this line of reasoning is well contained to partisan political circles. Health care experts and scientists believe investing in this kind of research will provide doctors with unbiased information about the most effective treatments, help doctors and patients make better informed decisions, and improve the quality of care. Properly conducted, scientists think that CER will actually promote faster adoption of personalized care and provide “more and better information with which to craft a management strategy for each individual patient.”

The very obvious question when it comes to CER isn’t “who will get rationed.” It’s: if the government doesn’t base its coverage decisions on science or comparing the effectiveness of one drug or treatment against another, then what metric does Huckabee propose? Absent a credible source of sound scientific information, Medicare and Medicaid are wasting taxpayer dollars on treatments that don’t work or paying for medicines that achieve the same result as a cheaper alternative. Consequently, health care costs are increasing and 45 million Americans are uninsured. But Huckabee, Klein notes, supports this kind of “dumb rationing” rather than the “smart rationing” that is grounded in eliminating ineffective treatments through scientific research.

The Affordable Care Act invests in research to compare the effectiveness of different treatments, but it doesn’t allow Medicare to use that research to make coverage or reimbursement decisions. Currently, the program uses a “reasonable and necessary” standard when evaluating a new drug or procedure and sets a “payment level with the primary goal of reimbursing hospitals or providers for their cost plus some profit margin.” The manufacturer is not required to prove that the service in question is equally or more effective than other available options and so the government ends up spending billions of dollars a year on ineffective or overpriced treatments.

In this latest issue of Health Affairs, Steven Pearson and Peter Bach have a plan to change all that. “We believe that the time is ripe for Medicare to use comparative effectiveness research to reach a new paradigm of paying equally for services that provide equivalent results,” they write. “To accomplish this goal, the program’s coverage and reimbursement processes would need to be linked from the outset, when the evidence for or against a service’s comparative clinical effectiveness would be weighed.” Medicare would pair its traditional “reasonable and necessary” standard with an assessment of the treatment’s comparative effectiveness. Pearson and Bach propose classifying treatments into three separate categories:

1) Superior comparative clinical effectiveness: if the service is more effective or has fewer side effects, or both than the most relevant clinical standard.

2) Evidence of comparable comparative clinical effectiveness: the service’s clinical effectiveness was comparable to its most relevant alternative. Such a service would be assigned a payment level equal to that of the alternative.

3) Insufficient evidence to determine comparative clinical effectiveness: insufficient evidence for whether the new service is comparable, superior, or inferior to relevant alternatives. The program would set payments according to the current cost-plus reimbursement formula for a period of three years. At the end of this period, Medicare would decide whether additional evidence was now available to determine if the service were superior, comparable, or inferior to alternatives.

The authors use the example of intensity-modulated radiation therapy, a treatment first introduced into practice in the early 2000s, which uses “computers to create three-dimensional pictures in order to target the highest possible dose of radiation to cancerous tumors while sparing normal tissue.” Clinicians felt that intensity-modulated radiation therapy was an advance to the traditional three-dimensional therapy, but “there had been neither randomized trials nor contemporaneous cohort studies comparing the effectiveness and toxicities of intensity-modulated radiation therapy to traditional three-dimensional therapy”:

Under the existing reimbursement system: The reimbursement rate is set in recognition of the increased cost of the necessary equipment and the complexity of its treatment planning process. A single course of treatment was set at approximately $42,000. For three-dimensional therapy providers received only $10,000. “This discrepancy led providers around the country to buy intensity-modulated radiation therapy machines and to abandon conventional three-dimensional therapy.” Medicare costs increased an estimated $1.5 billion per year to for prostate cancer alone.

Reimbursement Using Proposed Framework: Medicare’s decision to cover the treatment would have been accompanied by a determination that there was insufficient evidence with which to judge the comparative clinical effectiveness of the newer treatment against the standard three-dimensional therapy. Thus, the new treatment would have been slated to receive the higher—$42,000 per course—reimbursement for only three years.

Over that period, “if the evidence had shown that the new treatment had lower risks of side effects than the old one, then reimbursement for the new service would have remained higher.” If not, “Medicare would have reduced its reimbursement for the new therapy to equal that paid for the traditional treatment.” “Intensity-modulated radiation therapy would still have been available to patients, but incentives for developing less expensive versions of the treatment would have been strong. And Medicare would not have been trapped into years of significantly higher payments for a new technology that might not improve patients’ outcomes more than the older treatment.”

This is filled with all kinds of complications and will be subject to intense resistance from PHRMA and devise manufacturers who’ll argue that the approach stifles innovation and keeps needed treatments out of reach. Politicians will interpret this as an effort to ration care and many others will have trouble reconciling this payment system with the unfortunate conventional wisdom that any medical advance as an improvement over existing treatment. As Pearson and Bach explain, we’ll have to make some trade-offs, but that’s something worth considering. “When there is insufficient evidence to assess comparative effectiveness, it is possible that further evidence would show that a new service was inferior to existing options, at least for some types of patients. Limiting the rapid dissemination of such a service is likely to be in the best interest of most patients. Therefore, it is neither unethical nor without precedent for Medicare to institute a coverage and reimbursement strategy that may limit access to some new services.”