October 7, 2011

More Controversy about PSA Screening for Prostate Cancer

The Wall Street Journal (and others) report that the U.S. Preventive Services Task Force will recommend against screening for prostate cancer using the PSA blood test having apparently concluded that more harm than benefit results from testing.

This recommendation will certainly be controversial.  This is the same panel that recently recommended that women not do breast self examination and that screening mammography not be offered to women between ages 40 and 50.  Those recommendations have not been widely adopted.


Here are a few of the articles discussing this change:



Panel Faults Widely Used Prostate-Cancer Test
By JENNIFER CORBETT DOOREN And THOMAS M. BURTON
Published: October 7, 2011 - Wall Street Journal online


A key federal advisory panel is poised to recommend that healthy men shouldn't be screened with a widely used blood test for prostate cancer, indicating that the test offers more harm than benefit.

The U.S. Preventive Services Task Force will recommend a "D" rating for prostate specific antigen, or PSA, testing, said a person familiar with the draft document. A "D" rating means "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," according to the group's website. It also is a recommendation to "discourage use" of test or treatment.

The task force is set to make its proposal Tuesday, and then allow for a four-week comment period before issuing a final recommendation.

The task force is an influential group whose recommendations can influence coverage decisions by the federal Medicare program and other insurers.

The scientific findings behind the recommendation are scheduled to be published Monday by the Annals of Internal Medicine. A copy of the paper was obtained by the newsletter Cancer Letter, which posted the paper on its website Thursday night.

The paper concluded that after about 10 years, PSA screening "results in small or no reduction" in death from prostate cancer but is "associated with harms," including biopsies, other tests and treatments, "some of which may be unnecessary."

Virginia A. Moyer, who chairs the task force,declined to comment on what the updated advisory would be. She noted that the current guidance is that the evidence is insufficient to recommend for or against screening in men younger than 75. That recommendation was last updated in August 2008. "New evidence has become available, and we had to reconsider our statement," Dr. Moyer said.

The new report is the latest in a long-running controversy over the value of PSA screening. Advocates say the test, when given regularly to men age 50 and over, facilitates the discovery of the cancer at an early stage, improving the chances of successful treatment. Critics say the test has a significant rate of false positives—apparent detection of cancer that isn't confirmed with further tests—or that it identifies so-called indolent tumors that are ultimately of little health consequence. This leads to unnecessary biopsies and cancer treatments.

Because such interventions can lead to infections, impotence and incontinence, critics say the risks of testing often outweigh the benefit.



U.S. Panel Says No to Prostate Screening for Healthy Men
By GARDINER HARRIS
Published: October 6, 2011 - New York Times online

Healthy men should no longer receive a P.S.A. blood test to screen for prostate cancer because the test does not save lives over all and often leads to more tests and treatments that needlessly cause pain, impotence and incontinence in many, a key government health panel has decided.

The draft recommendation, by the United States Preventive Services Task Force and due for official release next week, is based on the results of five well-controlled clinical trials and could substantially change the care given to men 50 and older. There are 44 million such men in the United States, and 33 million of them have already had a P.S.A. test — sometimes without their knowledge — during routine physicals.

The task force’s recommendations are followed by most medical groups. Two years ago the task force recommended that women in their 40s should no longer get routine mammograms, setting off a firestorm of controversy. The recommendation to avoid the P.S.A. test is even more forceful and applies to healthy men of all ages.

“Unfortunately, the evidence now shows that this test does not save men’s lives,” said Dr. Virginia Moyer, a professor of pediatrics at Baylor College of Medicine and chairwoman of the task force. “This test cannot tell the difference between cancers that will and will not affect a man during his natural lifetime. We need to find one that does.”

But advocates for those with prostate cancer promised to fight the recommendation. Baseball’s Joe Torre, the financier Michael Milken and Rudolph W. Giuliani, the former New York City mayor, are among tens of thousands of men who believe a P.S.A. test saved their lives.

The task force can also expect resistance from some drug makers and doctors. Treating men with high P.S.A. levels has become a lucrative business. Some in Congress have criticized previous decisions by the task force as akin to rationing, although the task force does not consider cost in its recommendations.

“We’re disappointed,” said Thomas Kirk, of Us TOO, the nation’s largest advocacy group for prostate cancer survivors. “The bottom line is that this is the best test we have, and the answer can’t be, ‘Don’t get tested.’ ”

But that is exactly what the task force is recommending. There is no evidence that a digital rectal exam or ultrasound are effective, either. “There are no reliable signs or symptoms of prostate cancer,” said Dr. Timothy J. Wilt, a member of the task force and a professor of medicine at the University of Minnesota. Frequency and urgency of urinating are poor indicators of disease, since the cause is often benign.

The P.S.A. test, routinely given to men 50 and older, measures a protein — prostate-specific antigen — that is released by prostate cells, and there is little doubt that it helps identify the presence of cancerous cells in the prostate. But a vast majority of men with such cells never suffer ill effects because their cancer is usually slow-growing. Even for men who do have fast-growing cancer, the P.S.A. test may not save them since there is no proven benefit to earlier treatment of such invasive disease.

As the P.S.A. test has grown in popularity, the devastating consequences of the biopsies and treatments that often flow from the test have become increasingly apparent. From 1986 through 2005, one million men received surgery, radiation therapy or both who would not have been treated without a P.S.A. test, according to the task force. Among them, at least 5,000 died soon after surgery and 10,000 to 70,000 suffered serious complications. Half had persistent blood in their semen, and 200,000 to 300,000 suffered impotence, incontinence or both. As a result of these complications, the man who developed the test, Dr. Richard J. Ablin, has called its widespread use a “public health disaster.”

One in six men in the United States will eventually be found to have prostate cancer, making it the second most common form of cancer in men after skin cancer. An estimated 32,050 men died of prostate cancer last year and 217,730 men received the diagnosis. The disease is rare before age 50, and most deaths occur after age 75.

Not knowing what is going on with one’s prostate may be the best course, since few men live happily with the knowledge that one of their organs is cancerous. Autopsy studies show that a third of men ages 40 to 60 have prostate cancer, a share that grows to three-fourths after age 85.

P.S.A. testing is most common in men over 70, and it is in that group that it is the most dangerous since such men usually have cancerous prostate cells but benefit the least from surgery and radiation. Some doctors treat patients who have high P.S.A. levels with drugs that block male hormones, although there is no convincing evidence that these drugs are helpful in localized prostate cancer and they often result in impotence, breast enlargement and hot flashes.

Of the trials conducted to assess the value of P.S.A. testing, the two largest were conducted in Europe and the United States. Both “demonstrate that if any benefit does exist, it is very small after 10 years,” according to the task force’s draft recommendation statement.

The European trial had 182,000 men from seven countries who either got P.S.A. testing or did not. When measured across all of the men in the study, P.S.A. testing did not cut death rates in nine years of follow-up. But in men ages 55 to 69, there was a very slight improvement in mortality. The American trial, with 76,693 men, found that P.S.A. testing did not cut death rates after 10 years.

Dr. Eric Klein of the Cleveland Clinic, an expert in prostate cancer, said he disagreed with the task force’s recommendations. Citing the European trial, he said “I think there’s a substantial amount of evidence from randomized clinical trials that show that among younger men, under 65, screening saves lives.”

The task force’s recommendations apply only to healthy men without symptoms. The group did not consider whether the test is appropriate in men who already have suspicious symptoms or those who have already been treated for the disease. The recommendations will be open to public comment next week before they are finalized.

Recommendations of the task force often determine whether federal health programs like Medicare and private health plans envisioned under the health reform law pay fully for a test. But legislation already requires Medicare to pay for P.S.A. testing no matter what the task force recommends.

Still, the recommendations will most likely be greeted with trepidation by the Obama administration, which has faced charges from Republicans that it supports rationing of health care services, which have been politically effective, regardless of the facts.

After the task force’s recommendation against routine mammograms for women under 50, Health and Human Services Secretary Kathleen Sibelius announced that the government would continue to pay for the test for women in their 40s. On Thursday, the administration announced with great fanfare that as a result of the health reform law, more people with Medicare were getting free preventive services like mammograms.

Dr. Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence in Britain, said he was given a P.S.A. test several years ago without his knowledge. He then had a biopsy, which turned out to be negative. But if cancer had been detected, he would have faced an awful choice, he said: “Would I want to have it removed, or would I have gone for watchful waiting with all the anxieties of that?” He said he no longer gets the test.

But Dan Zenka, a spokesman for the Prostate Cancer Foundation, said a high P.S.A. test result eventually led him to have his prostate removed, a procedure that led to the discovery that cancer had spread to his lymph nodes. His organization supports widespread P.S.A. testing. “I can tell you it saved my life,” he said. 


Answering Questions About the P.S.A. Test
By TARA PARKER-POPE
Published: October 6, 2011 - New York Times online


News that an influential panel of experts is advising healthy men not to be screened for prostate cancer with a widely used test is certain to cause confusion and anxiety among men and their doctors, and reignites a debate about the benefits and risks of screening tests.

The recommendations, to be officially announced on Tuesday by the United States Preventive Services Task Force, affect more than 44 million men age 50 and older who typically are candidates for a simple blood screen call the prostate-specific antigen (P.S.A.) test.

The panel, which already recommends against P.S.A. screening for men age 75 and older, will cite recent research suggesting that the testing does not save lives but does lead to unnecessary treatments that can cause impotence, incontinence and a number of other complications.

Here are some answers to common questions about P.S.A. testing and what the task force recommendations mean for men.

Will the new recommendations prevent me from getting a P.S.A. test if I want one?

No. Whether to be screened for prostate cancer is still a decision that each man must make for himself with the advice of a doctor he trusts. But now that the independent panel has taken a stand, many doctors who were ambivalent or opposed to P.S.A. testing may be more willing to express their own doubts about the test and to advise patients against it.

What if I have a family history of prostate cancer or worrisome symptoms? Should I still be checked for cancer?

The panel’s advice is based on studies of healthy men. Men who have symptoms related to prostate health should always be seen by a doctor; the task force did not address whether P.S.A. testing is appropriate for them. And men with a strong family history of prostate cancer may have more to gain from screening than men at low risk, so they also should discuss the issue with their physician.

In addition, a man who already has prostate cancer that has been diagnosed or treated is likely to continue to undergo P.S.A. testing, which can help doctors determine whether cancer has returned or is spreading.

What do other groups say about P.S.A. testing?

Most major medical groups have not taken a stand against routine P.S.A. screening and say it is a decision a man should discuss with his doctor. The American Cancer Society suggests that the conversation start at age 50 for most men, earlier for African-Americans and men with a strong family history of prostate cancer.

The American Urological Association recommends that P.S.A. screening be offered to men 40 or older. Most organizations discourage prostate cancer screening for men with less than 10 years life expectancy.

Why not get screened? Isn’t it always better to find cancer early?

The argument against P.S.A. testing is that prostate cancer is typically so slow growing that most men would be just fine if they never knew it was there. But once cancer is detected, it is psychologically difficult for a man to do nothing.

As a result, tens of thousands of men each year are left impotent and incontinent as a result of aggressive treatment for a cancer that would never have caused them harm. But it is impossible to tell which men have comparatively benign cancer and which men have aggressive cancer. As a result, many doctors believe the overall benefits of screening outweigh the negatives.

How much weight do the task force recommendations carry?

The task force is an independent panel of experts in prevention and primary care appointed by the federal Department of Health and Human Services. While the group only makes recommendations, a change by the task force often prompts other organizations to review their guidelines and can influence how insurance companies reimburse for certain services.

But the influence of the panel is often determined by how controversial its recommendations are. Two years ago, for instance, the task force concluded that healthy women under age 50 should no longer get annual mammograms. That recommendation was met with strong resistance by many cancer organizations, women and their doctors, many of whom continue to ignore it.

And even though the panel has already recommended that men over age 75 not undergo P.S.A. testing, many men and their doctors continue the practice. Earlier this year, the Journal of Clinical Oncology reported that men ages 80 to 85 are being screened as often as those 30 years younger. The task force’s advice is not necessarily the final word.