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The PSA debacle

Posted by medconsumers on October 16, 2011

So now it’s official.  The PSA screening test leads to a cascade of more tests and drastic treatments that cause serious harm AND saves no lives.  But there were plenty of warning signs 20 years ago, when the PSA test began to be aggressively promoted to men and their physicians. The demand for PSA screening was created by the companies that make the test, the equipment to diagnose prostate cancer, and the drugs to treat it. These companies also fueled consumer advocacy—but only the groups of cancer survivors who encouraged other men to undergo PSA testing. Now a panel of independent experts has announced its recommendation against PSA screening for healthy men at any age. In the meantime, a multibillion-dollar industry has grown up around PSA screening that’s not likely to disappear any time soon.

I became interested in the selling of prostate cancer screening somewhere around 1989, when prostate cancer went from obscurity to a widely feared disease.  It didn’t generate much interest because the average age at diagnosis was 75.  Autopsy studies of men who died of causes unrelated to cancer had already shown that the incidence of prostate cancer increases with age, 30% of men in their forties have prostate cancer, and by the time they reach their eighties, 70% have it.  Yet only 3% died of prostate cancer. The deaths were due to an aggressive form of prostate cancer, but it was not clear whether whether early detection and prompt treatment would make a difference. To this day, no test can accurately distinguish the aggressive form of prostate cancer from the type that’s slow-growing and not life-threatening.

What set prostate cancer apart from other cancers was the uncertainty about whether no treatment was superior to the drastic treatments like radical prostatectomy.  All this could be found in the 1989 version of cancer information from the database of the U.S. National Cancer Institute.  Of course, the NCI never put it that way.  Instead, “watchful waiting” (aka no treatment) was listed along with treatment options.  Severe treatment complications like impotence and incontinence were mentioned in the doctors’ version of this database, but not in the patients’ version. (Today, this database can be accessed directly at http://www.cancer.gov)

Screening creates customers, but first the public must be made to fear the disease and believe it can be treated successfully if found early. (Note how often your local hospital offers free cancer screenings.) Next, there must be easy access to the screening test. There was a time—around 1990—-when Merck thought its new drug Proscar had the potential for prostate cancer prevention. (It didn’t.) What was memorable about Merck’s early “prostate awareness” ads was the fact that some were aimed at women. They had a “get your man to the doctor” theme with no mention of Proscar, making them appear like public service announcements. Just one of many ways that set the path to a PSA.

By 1993 Gina Kolata would report in The New York Times that an astounding 92% of all American men had had a PSA screening test.  How did this test with no data to show it improves outcomes and a high rate of false alarms become so widely and quickly accepted by physicians and patients, she asked rhetorically.  Answer:  The demand had been created by the drug and device companies who sponsored the annual “Prostate Awareness Week”. (For the women’s version of this story read, “The Marketing of Osteoporosis”.)

In time, the PSA test would be included in the routine blood test with the result that men could now be given the test without their knowledge. Studies would show that most of the men who chose “watchful waiting” after a prostate cancer diagnosis could not live with the idea that they were living with an untreated cancer. The majority would go on to be treated.

In 2009 the results of two large clinical trials were published in the same issue of the New England Journal of Medicine.  Both compared men randomly assigned to receive either regular PSA screening test s or no screening. The results were devastating in terms of exposing  the high incidence of severe complications suffered by the men treated for prostate cancer as a result of PSA testing.  Only one study found screening reduced the rate of prostate cancer deaths, and it was minimal. The bad news about the PSA received plenty of media attention complete with quotes from urologists challenging the findings. click here

These two trials form the basis of the “new” recommendation against PSA screening by a 16-member panel of independent experts, sponsored by the U.S. Preventive Services Task Force.  This recommendation was actually decided back in 2009 after an in-depth review of all PSA-related studies, but not made public—that is, until October 7.  The New York Times (Sunday) magazine was about to print a hard-hitting article about PSA screening that would reveal that the task force recommendation had been withheld for nearly two years. Worse, the delay was due to fears that this unpopular conclusion would jeopardize the task force’s funding.

The predictable backlash came immediately—from doctor groups, especially the urologists, patient groups whose members believe their lives were saved by the PSA, and politicians against healthcare reform quick to charge “rationing”. In 2009, this charge was leveled at another task force that raised questions about the value of starting screening mammograms at age 40.

PSA screening has been called “the largest iatrogenic public health disaster of our time”.  It’s not over until men make it clear to their doctors that they do not want this test and make sure that it is not included in a routine blood test.

Maryann Napoli, Center for Medical Consumers©

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