Who benefits from testing to see if you have prostate cancer?

Being told “You’ve got cancer” can strike fear into a person’s heart. For middle-aged men, prostate cancer is the most common reason to hear this diagnosis.

Here’s how it usually happens. You have a simple blood test and receive a figure for your PSA, the prostate specific antigen. Anything above 4.0 is supposed to be a cause for worry, and possibly more tests. The number gives the PSA blood level in nanograms per millilitre.

I remember having the test done quite some years ago. A nurse rang to give me the results. She said “It’s 4.1”. I thought, this seems a bit high given my lifestyle. Then she said, “Oh, sorry, it’s actually 0.1”. That was okay, then. Little did I know.

An elevated PSA level is considered a cause for worry. The doctor might recommend a biopsy just to be sure, or the patient might want to know. This can lead to trouble. If the biopsy is positive for cancer, what next?

In the US, most urologists recommend removal of the prostate, an operation called a prostatectomy. This is supposed to get rid of the cancer. It sounds straightforward, but the operation is extremely delicate. The prostate straddles the urethra, the channel for urine and semen, and is surrounded by many sensitive nerves.

Sometimes the operation doesn’t get rid of the cancer. And quite often the operation has serious side effects: most men are left impotent and many become incontinent.

Instead of removing the prostate, another option is called “active surveillance” or “watchful waiting”, though it might better be called “worried waiting”. What this means is checking at regular intervals to see whether the PSA score is increasing.

Although most men in their 50s and 60s have cancer in their prostates, relatively few of them die of it. The cancer is usually slow-growing, so slow-growing that something else kills them first. They die with prostate cancer, not from prostate cancer.

Because the advantages of taking a PSA test are so limited, and the possible side-effects of unnecessary treatment are so severe, some researchers and policy-makers have argued that healthy men should not be screened using the test. On the other side are those – including urologists and advocacy groups, among others – who argue that PSA testing saves lives, and accuse the no-screening advocates of playing with men’s lives.

This debate has played out differently in different countries. In Britain, watchful waiting is more common; in the US, testing and aggressive treatment, especially removing the prostate if there is any sign of cancer, is standard.

Into this debate, there’s a new book titled The Great Prostate Hoax. The subtitle indicates the message: How Big Medicine Hijacked the PSA Test and Caused a Public Health Disaster.

The author is Richard J. Ablin, assisted by Ronald Piana. Ablin has credibility in this area: he discovered PSA in 1970. And he is appalled at the widespread use of the PSA test in the US. He says that as the discoverer of PSA,

I have been linked to the 30 million American men … who undergo routine PSA screening for prostate cancer. The result: a million needle biopsies per year, leading to more than 100,000 radical prostatectomies, most of which are unnecessary. (p. 4, emphasis in the original)

Richard J. Ablin

Ablin provides one key point that undermines the argument for testing: the PSA test is not a test for prostate cancer. It is only a test for the prostate specific antigen, in extremely tiny amounts in the blood. This is not the same as a prostate-cancer specific antigen. Ablin says that using the PSA test is roughly as accurate as flipping a coin. Furthermore, the level of 4.0 as a warning of whether there might be cancer is arbitrary: it was more or less picked out of the air.

Researchers have been searching for a prostate-cancer indicator, but haven’t found one yet. The next question is how the PSA test ever became accepted, given its dubious diagnostic value.

This is where “big medicine” comes in. The PSA test does have some value. For men being treated for prostate cancer, the PSA level is an indicator of whether the cancer has returned, and therefore of how effective treatment is.

For a company selling a PSA test, there’s not much money to be made in testing men being treated for prostate cancer. But there are big bucks in screening. In the US, this means tens of millions of men per year.

Ablin tells the story of how the US Food and Drug Administration (FDA), which licenses medical tests, was swayed by emotion over rationality in approving a PSA test. For example, one of the test’s advocates, Jim Wise, used this approach:

Queried on the suffering of countless numbers of men harmed by PSA false positives, Wise circled the wagons around his insular community – men who claim they were saved by PSA screening – in essence, seemingly implying that their lives outweigh the harms to other men produced by false-positive PSA results. This is the common emotion-based type of exchange used by advocates to promote PSA screening. It’s a kind of flag-waving patriotism that people are loath to challenge; we’ve seen the results of that sheeplike mentality. (pp. 66-67)

But there is more to the FDA story than emotional pleas. Corporate interests played a role. Some FDA advisory committee members tried to expose the scientific shortcomings of the PSA test, but corporate connections prevailed. Ablin describes the FDA advisory committee meeting in considerable detail, down to individual exchanges, revealing a system that is corrupt at several levels.

FDA officials tried to cover themselves by issuing warnings about inappropriate use of the test, but their inaction sent a different message. The FDA did nothing about massive off-label promotion of the PSA test.

Advocacy groups were part of the promotion of PSA screening; many of them are sponsored by the companies. Before long, PSA screening became the basis for a massive commercial enterprise. Screening is only the beginning. False positives keep the money rolling in. Men are told their PSA might indicate prostate cancer and should have a biopsy. Then, quite commonly, cancer is detected in the prostate, and prostatectomy is recommended.

An experienced surgeon can usually do a good job, but many men opt for a much more expensive method using a robot. The surgeon is still involved, but using a complicated piece of equipment. Robotic prostatectomies have become the primary method used in the US, even though there is little evidence they are any more successful than conventional surgeries.

If radiation is the preferred option, the latest generation of high-tech treatment is proton-beam therapy, in centres costing over $100 million to construct. Without sufficient patients, these centres would go bankrupt.

Then there are the side effects of treatment, though they might be better described as the main effects: impotence and incontinence. Ablin offers some moving stories from men whose lives have been seriously damaged by prostate removal. Some of them feel their manhood has been lost.

and so does a prostatectomy

Because of impotence and incontinence, there’s an additional market in medical fixes, for example penile implants and bulbourethral sling surgery. Ablin quotes experts saying that half of urology practices in the US would go out of business if not for the steady stream of patients whose problems begin with PSA testing.

From Ablin’s perspective, PSA testing is a gravy train for urologists and for drug and medical device manufacturers, with a seemingly inexhaustible stream of men entering the shadow of a prostate cancer diagnosis. Ablin calls PSA testing a hoax because there is no good evidence that it reduces the death rate and there is ample evidence that it causes a huge amount of suffering.

The Great Prostate Hoax is powerful testimony to the dangers of a profit-driven health system. It can be added to the growing body of writing about corruption in corporate healthcare, something that causes far more suffering and death than most of the hazards that exercise the public mind.

The book does have some limitations. It deals almost exclusively with the situation in the US, giving little attention to practices and debates in other countries. The US situation is important, to be sure, but insight into ways to control the PSA-testing juggernaut could be obtained by an examination of what is happening in countries where different attitudes and policies prevail. (For an Australian critical commentary on PSA testing, see Let Sleeping Dogs Lie?)

Another context for the book is screening for other conditions. A decade ago, H. Gilbert Welch wrote Should I Be Tested for Cancer? Maybe Not and Here’s Why, providing close scrutiny of the hazards of screening people with no symptoms. More recently, he and two colleagues extended their critique of screening to a wide variety of conditions, in a 2011 book titled Overdiagnosed: Making People Sick in the Pursuit of Health.

The implication of Ablin’s book is that any man without symptoms should be reluctant to enter the screening roller coaster. But is there anything else worth doing? Ablin doesn’t mention non-standard treatments of prostate cancer, for example hyperthermia, available in Germany. Nor does he mention the possibility of nutritional prevention. There is a considerable body of information about the possible benefits of selenium, zinc, fish oil, natural vitamin E and saw palmetto, as well as more general benefits from a diet with cruciferous vegetables. Hyperthermia and nutritional prevention are controversial, to be sure, but their hazards are far lower than conventional treatment.

For men concerned about their personal risks from prostate cancer, it is worth considering a range of information, about prevention, screening and treatment methods. In this, The Great Prostate Hoax is essential reading, especially to appreciate the intersection between science and politics. Ablin deserves the last word.

Medical industry profiteers have squandered trillions of health care dollars since the PSA test was first brought to the market. Given the utter failure of PSA screening, scientifically and clinically, why are we continuing to drain our health care system by repeating something we already know does not work. The late Albert Einstein defined insanity as doing the same thing over and over again and expecting different results. Repeating the same mistakes borne at the beginning of the PSA saga borders on criminal insanity. (p. 228, emphasis in the original)

Brian Martin
bmartin@uow.edu.au