The PSA debacle

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©

Related articles

Drastic treatment of early prostate cancer

Just say no to the PSA test

Overtreatment of early prostate cancer

Why have a PSA test?

A new review of all clinical trials involving the treatment of early-stage prostate cancer with radiation therapy was published online first by Annals of Internal Medicine and funded primarily by the Agency for Healthcare Research and Quality. It is yet-another example of the inadequacy of the current state of medical knowledge about how to treat early prostate cancer. The trials in this review compared different forms of radiation therapy and/or different doses of radiation. But the review authors bemoaned the lack of trials comparing radiation therapies with watchful waiting—that is, no treatment until symptoms develop.

Two earlier clinical trials (one conducted in Sweden and the other in the U.S.) compared watchful waiting (WW) with radical prostatectomy and came up with mixed results click here. The possibility that WW is better than any treatment has lingered ever since and remains a valid choice for men with early prostate cancer. Don’t take my word for it, see what heads the list of options at the National Cancer Institute website click here. Uncertainty will continue because no head-to-head comparison study has compared all treatment options with WW.

An obvious question comes to mind about the widespread use of the PSA (prostate-specific antigen) screening blood test: Why search for early prostate cancer in symptom-free men when leaving it untreated is reasonable? It is well documented in autopsy studies of older men who died of other causes that most prostate cancers remain dormant. It is also well established that all prostate cancer treatments hold the possibility of severe complications like incontinence, sexual dysfunction, and bowel injury, just to name a few. Prostate cancer kills about 32,000 American men yearly, but the PSA can’t accurately determine whether an early prostate cancer will remain dormant or become life-threatening.

Two trials sought the definitive answer to the question of whether regular PSA screening saves lives; both were published in the same 2009 issue of the New England Journal of Medicine and the results were contradictory. One (U.S. trial) found no lifesaving benefit but lots of harm. And the other (European) found a modest reduction in prostate cancer mortality which came at the great cost of overtreatment: Out of every 1,400 men given PSA screening tests regularly for ten years, one man avoided death from prostate cancer and 48 healthy men were treated unnecessarily for a form of prostate cancer that would never have become symptomatic or life-threatening.

PSA Screening: A brief history
As recently as 1990, there wasn’t much research devoted to the treatment of prostate cancer. It was (and still is) an elderly man’s disease; and “who cares” was the general attitude about a disease that was typically diagnosed at age 75. Surgery was the usual way it was treated … but only after symptoms appeared. Then, in the late 1980s, the PSA (prostate-specific antigen) blood test was introduced as a screening test to find the disease “early” in symptom-less men. Till then, the PSA test was administered only to detect recurrences in men already treated for prostate cancer. And who was behind the expanded use of the PSA? The companies that make the ultrasound machines and biopsy “guns” to diagnose prostate cancer and the drugs that might prevent prostate cancer recurrence (I read this in the N.Y. Times in 1993).

In time, research would show that the PSA isn’t accurate when used as a screening test. But an industry had already begun to build around this usage. Hospitals, for example, offer free PSA screening, seemingly as a good will gesture to the community but also a great way to drum up future customers. The list of treatment options expanded to include different forms of radiation therapy, cryotherapy, and androgen-deprivation therapy. Watchful waiting might be offered, but it did not catch on. Studies showed that most men, even when fully informed of the lack of evidence for the superiority of treatment, opted to be treated because they just couldn’t live with the knowledge of having an untreated cancer.

Some doctors were initially skeptical about PSA screening, but most eventually seemed to fall in line. Malpractice concerns, no doubt. And if any man had doubts about PSA as a lifesaver, they were alleviated by celebrity survivors like General Norman Schwarzkopf and Mayor Rudolph Giuliani who think their lives were saved by the PSA and had multiple opportunities to publicly attest to the wisdom of their respective treatment choices.

If a great many lives were saved as a result of all this early-detection activity, we should know it by now. But in fact there is not only a small decrease in the U.S. prostate cancer death rate but also a large increase in the number of men diagnosed with the disease. And just to make things more complicated, an equivalent drop in prostate cancer mortality has also been shown in countries that do not offer PSA screening tests. click here

What to do
Think twice about having a screening PSA. Consider all options prior to accepting the test. And make sure your doctor doesn’t include it in the routine blood test without your knowledge. At best (the European trial), the chance of being treated unnecessarily as a result of PSA screening is 48 times higher than the chance of avoiding death from prostate cancer. At worst (the U.S. trial), men are treated unnecessarily and no prostate cancer deaths are avoided.

Maryann Napoli, Center for Medical Consumers©