The business of prostate cancer: putting profit before patients

There’s a simple blood test done routinely to screen men for a condition that is rarely serious.  But if your screening test happens to be positive, the resulting treatment and side effects are likely to be devastating to your day to day quality of life, and may include stress incontinence, overflow incontinence, urge incontinence, or continuous incontinence. And impotence, temporary or permanent.

Should you get this blood test done?

That’s the controversial question behind two large, randomized clinical trials this past year studying the relationship between PSA-based screening and prostate cancer mortality: The European Randomized Study of Screening for Prostate Cancer and the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial in the U.S.  According to the European study, which involved over 162,000 men between the ages of 50 and 74 in seven countries, PSA-based screening reduced the already low rate of death from prostate cancer by 20%, but was also associated with a high risk of overdiagnosis and overtreatment.

The American PLCO trial found the rate of death from prostate cancer was very low for both the 38,343 men in the group that received annual PSA-based screening and the 38,350 men in the control group who received “usual care.” The conclusion:

“Screening was associated with no reduction in prostate cancer mortality.”

‘Non-intervention’ is what urologist Dr. Anthony Horan says he was taught when he attended medical school and also during his urology residency at the Columbia Presbyterian Hospital in New York in the mid-1970s. Explains the author of The Big Scare:  The Business of Prostate Cancer:

“We didn’t go looking for the incidental cancers that were of no clinical significance.  And if we found them, we did nothing about them.” 

Dr. Horan says that this non-treatment approach came originally from a Mayo Clinic study that showed most men diagnosed with prostate cancer had a survival curve identical to the general population of men.

“That was the conventional wisdom of the 1960s, and it is still true today. During my 30+ years as a board-certified urologist, I’ve seen quite a bit of suffering, much of it needless, in my opinion. 

“In my work both in private practice and with the Veterans Administration in California, I’ve encountered many men who’ve received treatment for prostate cancer that greatly diminished their quality of life and produced horrible side effects, but did absolutely nothing to prolong their lives.”

The American Cancer Society, the Canadian Task Force on Preventative Health, the National Cancer Institute, the US Preventative Services Task Force and the American Medical Association recommend against screening for the early detection of prostate cancer in healthy men without symptoms because of the lack of evidence at this time.

PSA, or prostate-specific antigen, is a protein produced by the prostate gland, blood levels of which generally rise when a prostate tumour is present. PSA blood tests can catch the cancer in its early stages, but can also produce false-positive results that result in devastating and unnecessary overtreatment.

prostate cancer cells

Normally, as men age, the walnut-sized prostate gland increases in size. If it grows large enough, it may press on the urethra, the tube that carries urine from the bladder. This may make the urine flow weaker or slower or make men have to urinate more often, especially at night. In the large majority of cases, an increase in the size of the prostate and a change in urine flow do not mean you have cancer – these are just a normal part of aging. Nonetheless, healthy men who experience symptoms should consult a physician.

In March 2009, an editorial about the two large clinical trials in the New England Journal of Medicine by Dr. Michael Barry appeared to confirm Dr. Horan’s longtime belief in ‘non-intervention’.

“Serial PSA screening has at best a modest effect on prostate cancer mortality during the first decade of follow-up. This benefit comes at the cost of substantial overdiagnosis and overtreatment.

“It is important to remember that the key question is not whether PSA screening is effective, but whether it does more good than harm. For this reason, comparisons of the effectiveness of PSA screening with,for example, the similarly modest effectiveness of breast cancer screening cannot be made without simultaneously appreciating the much higher risks of overdiagnosis and overtreatment associated with PSA screening.”

Prostate cancer is a relatively common disease, with about 260,000 men over the age of 50 diagnosed each year in North America.  But as daunting as that number may sound, Dr. Horan reminds us that prostate cancer is a very slow-moving disease.

“Estimates show that 94% of the cancers detected with the routine PSA blood test would not cause death before the age of 85.  More men die in car accidents than of prostate cancer each year.

“The PSA is a test I have major qualms about and objections to. The PSA test has triggered an enormous number of expensive and unnecessary prostate biopsies, which have led to treatments, a rash of radiation and radical surgery injuries, and even death.  After undergoing radiation, over 45% of men experience severe problems such as erectile dysfunction and incontinence.  So this is an issue that not only impacts the lives of many men, but the lives of their significant others as well.”

Dr. Horan recalls that, starting in 1986, just after the PSA test was introduced, many physicians other than urologists started buying testing machines in order to do the tests in their offices. Following this, diagnoses of prostate cancer and its treatment rate started to soar.  The biopsy rate quintupled and the number of men labeled prostate cancer victims doubled between 1989 and 1992.

“Despite this, statistics prove that no more cancers have been discovered since the introduction of the routine PSA test than would have been found in a random series of men the same age whose PSA is unknown.  

“You can tell your doctor that you don’t want the PSA test.  That’s your right.  The only men who should be having the test are those at high risk or who’ve already been biopsied and diagnosed with prostate cancer.”

According to Canadian health policy analyst Alan Cassels at the University of Victoria, a recent American study, which monitored a group of men aged 55 and older over 10 years, found that there were no additional lives saved by carrying out PSA screening. Meanwhile, a European study showed that to save one life, 1,410 men would need to be screened and 48 men would need to be treated. The question remains: how many unintended problems were produced in the other 1,409 men who were screened – 47 of whom were also treated?

The fact of the matter is that most men over 60 have prostate cancer, according to a decision guide published by the U.S. Center for Disease Control.

Though this might seem like an alarming statistic, says Cassels, many cancers are so slow growing they would never spread and kill. Most men who live long enough will die with prostate cancer, but not because of having it. He warns, however, that if you’ve gone through the PSA mill, and cancer has been detected in your prostate, it can then be difficult to say: let’s wait and see what happens.

New York Times reporter Dana Jennings has been writing about his own experience with Stage 3 prostate cancer since 2008. He wrote:

“The cancer itself never did any damage. It was the treatments that razed me — the surgery, radiation and hormones producing a catalog of miseries that included impotence, incontinence and hot flashes.”

He recommended the book called Invasion of the Prostate Snatchers  co-written by cancer patient Ralph H. Blum and oncologist Dr. Mark Scholz. The authors say nearly all prostate cancers are overtreated. Most men, they persuasively argue, would be better served having their cancer managed as a chronic condition.

Why? As Dana Jennings explained:

“Because most prostate cancers are lackadaisical — the fourth-class mail of their kind. These two authors say ‘active surveillance’ is an effective initial treatment for most men.

“They add that only about 1 in 7 men with newly diagnosed prostate cancer are at risk for a serious form of the disease.”

Dr. Scholz writes that out of 50,000 radical prostatectomies performed every year in the United States alone, more than 40,000 are unnecessary.

“In other words, the vast majority of men with prostate cancer would have lived just as long without any operation at all. Most did not need to have their sexuality cut out.”

Yet radical prostatectomy is still the treatment recommended most often, even though a study in The New England Journal of Medicine suggested that such surgery extended the lives of just one patient in 48.

And even as Dana Jennings acknowledged that he does seem to be the one in 48 men whose cancer actually needed to be treated, he explained:

“For patients, their rational thinking has been short-circuited by the word cancer. Scared, frantic and vulnerable – relying on a doctor’s insight –  they are ripe to being sold on surgery as their best option. Just get it out.

“In my experience, doctors play down punishing side effects like incontinence, impotence and shrinking of the penis. Those are just words when you hear them, but beyond language when you go through them.”

Despite growing evidence that PSA screening should not be routinely done, this road will not be an easy one for either patients or their doctors.  As one physician commented in a prostate cancer online support community:

“Many PSA tests are administered as yet another manifestation of defensive medicine. I think a physician could be successfully sued for failure to offer this test to men in a given age/risk group based on some previous guidelines. “

And make no mistake: regular PSA testing is a money-maker for many physicians.

As Health News Review’s Gary Schwitzer explained, men are wooed with rewards like Buffalo Sabres NHL hockey tickets or Buffalo Bills football tickets if they show proof that they have talked to their doctor about prostate cancer. And now, says Gary, some Georgia radiotherapy centers and the Morehouse School of Medicine are among those promoting the “Georgia Prostate Cancer Coalition” and luring men in for PSA blood tests by offering them Atlanta Hawks basketball tickets to men who “pledge” to go in for prostate screening.

“They also promote this misleading statistic: ‘One in six men will be diagnosed with prostate cancer in their lifetime.’ No explanation is given of what lifetime risk means. And no explanation is given of how many of these ‘cancers’ are indolent and would never have harmed a man.”

The Georgia website says:

“It is recommended that men with a family history of prostate cancer and African-American men be tested annually beginning by age 40 years old. All other men should begin testing by age 50.”

But Gary asks:

“It is ‘recommended’ by whom? Not by the American Cancer Society. Not by the U.S. Preventive Services Task Force.”

See also:

NEWS UPDATES:

October 28, 2014: Task Force Recommends PSA Test Should be Abandoned

The Canadian Task Force on Preventive Health Care reviewed the latest evidence and international best practice to weigh the benefits and harms of PSA screening with or without digital rectal exams.

Available evidence does not conclusively show that PSA screening will reduce prostate cancer mortality, but it clearly shows an elevated risk of harm. The task force recommends that the PSA test should not be used to screen for prostate cancer,” Dr. Neil Bell, chair of the prostate cancer guideline working group member, and his team concluded.

The guideline is aimed at physicians and other health-care professionals and policymakers. It updates the task force’s recommendation from 1994 on screening with the PSA test.

The new recommendations include:

  • For men under age 55 and over age 70, the task force recommends not using the PSA test to screen for prostate cancer. This strong recommendation is based on the lack of clear evidence that screening with the PSA test reduces mortality and on the evidence of increased risk of harm.
  • For men aged 55–69 years, the task force also recommends not screening, although it recognizes that some men may place high value on the small potential reduction in the risk of death and suggests that physicians should discuss the benefits and harms with these patients.
  • These recommendations apply to men considered high risk — black men and those with a family history of prostate cancer — because the evidence does not indicate that the benefits and harms of screening are different for this group.

Canadian Task Force on Preventive Health Care, October 2014.

September 23, 2011 Prostate Biopsy Increases Risk of Hospitalization

Men who underwent prostate biopsy were more than twice as likely to be hospitalized within 30 days compared with men who did not undergo the procedure, according to a study of over 17,000 men over a 17-year period published in the Journal of Urology. Both infectious and non-infectious complication rates were increased significantly. Hospitalization for biopsy-related infection increased the mortality odds 12-fold, as compared with men who did not have prostate biopsies.   Loeb S, et al “Complications after prostate biopsy: Data from SEER-Medicare” Journal of Urology 2011; DOI: 10.1016/2011.06.057

January 7, 2012 – No Mortality Benefits Seen From PSA Screening

Prostate cancer screening with prostate-specific antigen (PSA) afforded no obvious prostate cancer mortality benefit during 13 years of follow-up in a large randomized trial reported in  the Journal of the National Cancer Institute. In fact, screened patients had a slightly higher prostate cancer mortality: 3.7 per 10,000 person-years, versus 3.4 for unscreened men.Study  authors suggest that PSA screening is appropriate only for a small subset of men: young, with no comorbidities, generally very healthy, and with the longest life expectancy overall, or who have an above-average risk of prostate cancer, such as African Americans and men with a strong family history of the disease.  Andriole GL, et al “Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian cancer screening trial: Mortality results after 13 years of follow-up” J Natl Cancer Inst. 2012; 104: 125-132.

9 thoughts on “The business of prostate cancer: putting profit before patients

  1. I absolutely agree with the Doctor who wrote this book, but my suspicion is that if a man hears the C-word, he is unlikely to tolerate cancer of any kind, no matter how benign, to go untreated inside his body.

    • Luiz, I’m betting you have never been diagnosed with cancer yourself. Let’s see how willing to do nothing you’d be if you were one day diagnosed or if you had symptoms consistent with prostate cancer. My guess is that both you and the guy who wrote this book would be demanding both the test and then immediate treatment.

      • “PSA-based screening reduced the already low rate of death from prostate cancer by 20%, but was also associated with a high risk of overdiagnosis and overtreatment.”

        That makes it sound like these researchers are saying a 20% reduction in death rate is not considered significant!? Anti-screening advocates like this author have a long way to go to win the PR war waging over the benefits of early detection – much like the breast cancer awareness movement that urges the equally controversial screening mammograms.

  2. Oh, yeah, it’s a business alright. And what a business! A license to print money for many doctors. I’ve read this book and I encourage everyone to read this – especially men who have bought into the growing demand for routine PSA testing (a movement largely funded by industry and for-profit medicine).

    Thanks for helping to spread the word – it’s an uphill battle.

  3. This is an outstanding book, yet I fear its very thesis will frighten off men and their doctors. There is a very powerful lobbying faction out there snowballing out of control in an effort to raise awareness of this diagnosis and then the “need” for treatment. Thanks for helping to share the experts’ opinions of the other side of this issue.

  4. I was diagnosed 7 years ago with a Gleason 9 (4 plus 5), which to date has not been treated at all. I’ve done the prerequisite scans, MRSI’s, Color Dopplers, PSA’s etc,,,,but no further biopsies(believe they can be very harmful to my health,,,,sepsis and all. And to date I am doing very well, but PSA is a bit high and of some concern.

    Some 2 years ago I purchase my first copy of The Big Scare by Dr. Horan; subsequently purchased many more that I present to members of our local support groups. This book gave me confidence of my strategy to basically ignore this disease, first because I had long believed that treatment was of zero or almost zero value, and 2nd that even without treatment my chance of surviving this disease long enough to expire from some other disorder was close to 80 plus percent and I would rather enjoy an excellent QOL for my remaining years and not to be incontinent and impotent; additionally not wish to die from some treatment related morbidity such as surgery related or hormone related complication.

    Now I find that the book The Big Scare is no longer available except at extremely high used pricing and too that the Kindle version (was available for a short time as such) was unavailable.

    Did Dr. Horan step on a few too many toes, was he bought off or just what? Any ideas from anyone as to why this very important book is gone? The facts and statistics were outstanding in presenting information that was not available in any other book that I have read… and I’ve read them all, ranging from Dr. Sturm’s to Scholz’s, to Scardino and Walsh.

    I’ve called Dr. Horan. He was extremely polite but non-responsive as to my query as to if there would be a re-print of the book.

    Another point of interest was that most all books had numerous reviews on Amazon, but this book in 2 years only engendered 3 reviews. What is this all about?

    Any comments or information would be welcome.

    • Hello Rozier – very odd. I found a number of used books available for sale online (Amazon, Abe Books) but the prices are crazy ($80-120 – for a used book!) Why don’t you consider submitting your own customer review on Amazon?

      I hope Dr. Horan does consider releasing another edition.
      Stay healthy!
      regards,
      C.

  5. The PSA is a simple and thoroughly benign screening test, and I see nothing positive in this growing chorus to stop collecting useful information. In the event of an elevated PSA, we do need calm, rational discussion of likely benefit vs. damage from treatment or none, and fear drives many people to over treat, to their own detriment.

    We need to weigh the benefit/damage of every screening and treatment, and, while we also need discussion about fear-driven treatment applied to breast lumps (and more), routine mammography screening is different from PSA tests. Mammograms are not benign: they subject healthy women to repeated radiation, and initial ambiguous results mean yet more radiation.

    About medical statistics: they are crude tools for individual decisions and provide only odds. Each person has or does not have a condition, and in either case it is 100%. After many misdiagnoses, at the age of 21 I was diagnosed with an aggressive cancer so rare that I think I was the 35th case worldwide; troops of researchers visited my bedside daily, and the 70th case was diagnosed over 30 years later. So obviously, “But that would be very rare” sounds different to me. Radiation treatment most likely caused my brain tumor, recently removed, but, having lived longer after cancer than before, I consider those years a good trade.

    With my radiation history, I only let my dentist xray my mouth every 5 years, would gladly put mammograms on the same schedule. But that is based on an assessment of my own risks and benefits, not on a policy driven by insurance company profit, as many of these recommendations seem to be. Doctors need to spend more time with patients, to get information and to build understanding and trust, but a spate of recent policy articles head in the opposite direction.

    While there are many problems in how we use information, the PSA test itself is benign and useful.

    • Thanks for your perspective, Kathleen. But the PSA test is not considered “benign and useful” just because no radiation is involved in the test. In fact, more and more science-based evidence shows that, as the European studies mentioned above showed, the PSA test was clearly linked with “a high risk of overdiagnosis and over-treatment” and thus associated with needless suffering based on that screening. As for radiation-induced cancers, there has long been a recognized link between one and the other, often decades down the road, but as you wisely say – it’s a trade-off.
      regards,
      C.

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