The Doctor Who Invented PSA Test Calls It “A Profit-Driven Public Health Disaster” . . . Why This Is Good News

Times are changing. Americans are beginning to acknowledge that “early detection” is not the absolute answer to cancer. And many are  recognizing that what seems a simple diagnostic test can carry more risks than benefits.

Tuesday, the New York Times ran an Op-ed by Richard J. Ablin,  the man who invented the prostate-specific-antigen (PSA) test which is widely used to detect signs of  early-stage prostate cancer.  Ablin, who is  now a research professor of immunobiology and pathology at the University of Arizona College of Medicine and the president of the Robert Benjamin Ablin Foundation for Cancer Research,  reveals that “in approving the procedure, the Food and Drug Administration relied heavily on a study that showed testing could detect 3.8 percent of prostate cancers, which was a better rate than the standard method, a digital rectal exam.

 “Still, 3.8 percent is a small number,” he observes. “Nevertheless, especially in the early days of screening, men with a reading over four nanograms per milliliter were sent for painful prostate biopsies. If the biopsy showed any signs of cancer, the patient was almost always pushed into surgery, intensive radiation or other damaging treatments.”

Prostate cancer is a tricky disease because the cancer grows so slowly. A great many men who are diagnosed with prostate cancer will die of something else—long before the symptoms of the cancer catch up with them. As Ablin points out , because PSA testing is pervasive, “American men have a 16 percent lifetime chance of receiving a diagnosis of prostate cancer, but only a 3 percent chance of dying from it.”

This is why, in many cases, doctors recommend “watchful waiting.”  Keep an eye on the cancer, but don’t treat it unless there is evidence that it is growing.

30 Million Men, $30 Billion Dollars –Little or No Reduction in Mortalities?

Ablin has been frustrated by the widespread use of the test. Each year, he notes, some 30 million men undergo PSA testing, at a cost of $30 Billion.  Yet “the test is hardly more effective than a coin toss. As I’ve been trying to make clear for many years now, P.S.A. testing can’t detect prostate cancer and, more important, it can’t distinguish between the two types of prostate cancer — the one that will kill you and the one that won’t.

Moreover, the benefits of treatment are uncertain.  Last year, The New England Journal of Medicine published results from the two largest studies of the screening procedure, one in Europe and one in the United States.  The results from the American study that over a period of 7 to 10 years, screening did not reduce the death rate in men 55 and over. The European study showed a small decline in death rates, but also found that 48 men would need to be treated to save one life. “That’s 47 men who, in all likelihood, can no longer function sexually or stay out of the bathroom for long,” Albin adds, referring to the fact that treatments can lead to long-term incontinence and/or impotence.

He acknowledges that “Prostate-specific antigen testing does have a place. After treatment for prostate cancer, for instance, a rapidly rising score indicates a return of the disease. And men with a family history of prostate cancer should probably get tested regularly. If their score starts skyrocketing, it could mean cancer. But these uses are limited. Testing should absolutely not be deployed to screen the entire population of men over the age of 50, the outcome pushed by those who stand to profit.”

Indeed, “drug companies continue peddling the tests and advocacy groups push ‘prostate cancer awarenes’” by encouraging men to get screened. Shamefully, the American Urological Association still recommends screening.  But slowly others in the medical community are responding to the research. The American Cancer Society now urges more caution in using the test and the American College of Preventive Medicine has concluded that there was insufficient evidence to recommend routine screening.

Many Reluctant to Hear the News

I’ve been writing about PSA testing and prostate cancer since I began this blog in August of 2007:  “Screening for Prostate Cancer: Before Medicare Pays, Patients Need to Know more About Risks”  ;  “What Rudy—And Most Americans Don’t Understand About Prostate Cancer”  ;  “How the Mainstream Media Hypes HealthCare”. In each case, I  was trying to warn  that patients who are tested and treated may suffer life-changing side effects that outweigh the uncertain benefits of early detection.

Inevitably, the posts drew some irate responses from readers who were sure that they, their husband, or their uncle’s life had been saved by PSA testing.  The truth is that once a patient is treated for early-stage prostate cancer there is usually no way of knowing whether he would have been one of the very few who might have died of the disease if he had not been treated– or one of the many who would have died of something else, long before the diseases caused problems. If they hadn’t been tested, those men would never have known that they had prostate cancer.  But once treated, few want to admit that the treatment might have been unnecessary, particularly if they wind up coping with life-changing side-effects. Human beings will do anything to avoid regret.

At this point, I believe the answer is to make sure that patients are s given full information about the risks and benefits of PSA testing and treatments for early-stage prostate cancer before making a decision as to whether they want  the test. I have written about “shared decision-making” programs that help men decide whether they to go ahead with the test —and whether they want treatment if they are diagnosed here.

Shared decision-making also can protect a doctor against the possibility of a lawsuit  a  patient who decides against the test later develops prostate cancer. In the state of Washington, a relatively new law makes it extremely difficult for a patient to sue for malpractice if he has gone through the “shared decision- making” protocol before deciding on elective surgery for a variety of conditions.. Other states are considering passing similar laws.

The Media Begins to Help Educate: More Care Is Not Always Better  

Ablin has been trying to get the word out for some time. Yet it is only now that the New York Times ran his very candid Op-ed. I doubt that the Times would have accepted it two years ago.
But now the health care reform movement has opened up the  discussion of over-treatment and over-testing.  The mainstream media is beginning to explain that diagnostic testing can be a double-edged sword.  (See Naomi’s HealthBeat post on mammograms here). At best, very good tests will detect a disease that can be cured. At worst, an epidemic of testing leads to diagnosis of diseases that never would have hurt the patient.  Too often, diagnosis of a “pseudo-disease” leads to unnecessary surgeries and radiation.

Patients are hurt—needlessly. And health care dollars are squandered. As a HealthBeat reader reminded me in an e-mail today: “The growth of PSA use led to the explosion in radical prostatectomies which is the procedure which made the business case for robotic surgery , and is now the underlying reason that two incredibly expensive proton beam accelerators are in planning or being built in the Chicago area.  A tangled web and one reason our healthcare costs are what they are and still growing.”

26 thoughts on “The Doctor Who Invented PSA Test Calls It “A Profit-Driven Public Health Disaster” . . . Why This Is Good News

  1. Would it be picky to point out that the AUA hasn’t recommended universal screening in years? The recommendation is to OFFER testing. It may seem semantic but I grew up in an age where precision in the use of words mattered much more then today. The AUA has done a marvelous job protecting the interests of their constituency and yet communicate the correct degree of uncertainty. You should actually read each of their guidelines for the last 20 years with particular attention to these kind of subtleties as they change in each revision. It is sad that things seem to come down to semantics, but such is the world and such is the AUA’s primary responsability.

  2. The word may be starting to get through about over treatment and over testing. Look at this AP link:
    I think the most effective approach would be not to just suggest that over testing and over treatment may be unnecessary, but to point out proof of how both may be dangerous from a mortality-morbidity point of view. That should have more impact than just saying it may be unnecessary!

  3. Memorial Sloan Kettering in NYC runs what it calls an active surveillance program for early stage prostate cancer patients. The program has now been in place for 10 years and has about 500 participants. Of those, 75% have not yet progressed to treatment. The initial protocol calls for an annual biopsy and a semi-annual PSA test. If there are several consecutive clean biopsies, the frequency of testing can be stretched out.
    Separately, there is an interesting group of letters to the editor in today’s NYT in response to its recent article on PSA testing. Each individual needs to make up his own mind on this. Nationally, however, there should be an absolute safe harbor against lawsuits by patients who decline the PSA test after receiving the appropriate information both pro and con and later develop prostate cancer. The PSA test itself is comparatively cheap and painless so it’s not surprising that many doctors prefer to just order it in light of the perceived litigation environment in much of the U.S.

  4. Lack of Urgency, Not PSA, is the Problem
    I remain grateful to Dr. Ablin for his PSA discovery. I recently learned my PSA nearly doubled within a year’s time. With no indication of other prostate problems, my next step is a needle biopsy. Yes, I feel stress. But I can’t imagine how I would feel if I were to learn a year from now that I had an aggressive variety of prostate cancer that metastasized without early detection.
    In my work, I have met countless survivors and other men who are fighting advanced metastatic disease. Others, as young as 40, have lost their battles because their cancer wasn’t diagnosed earlier. If my biopsy is clear, I will continue to be screened.
    27,000+ U.S. continue to die from this disease every year. Rather than a wholesale damnation of the PSA test, what’s needed now is accelerated government and private investment in finding a better, cancer-specific diagnostic so we can over-treat less and cure those patients who need it most.
    Dan Zenka
    Vice President
    Prostate Cancer Foundation

  5. What pure garbage above about over use of PSA tests. My PSA test saved my life and there is no doubt. I’m 54, and went from a 1 to 4.6. After anti-bio’s to rule out prostatitus, next PSa was 5.6. Biopsy showed aggressive form, gleason 8. Had we relied upon a digital exam, at that point it would have been too late to catch it before it had spread. My cancer was completely contained and I’m cured. FYI, the 30 billion dollars is an incredible exageration. It does not cost $1000 for a psa test.

  6. Dan, Barry, Dino, NG
    Dan –The problem is that We Don’t Have a Cure For Prostate Cancer.
    As the inventor of the PSA tests points out, at the very best, one study suggests that if you screen 1410 men and find 48 additional cases of prostate cancer, those 48 men would need to be treated to prevent just one death from prostate cancer. (And the other 47 risk winding up incontinent and impotent.)
    When very young men develop prostate cancer, it often kills them– in young men, it tends to be a type of cancer that moves quickly and we don’t know how to stop it.
    The other big study shows No Reduction in Mortality if you use PSA tests and then treat prostate cancer.
    Almost all of the men who have been treated and have survived would have survived even if not tested or treated– the cancer moves slowly.
    Those who were treated and died would have died whether or not we found the cancer early.
    I would note that your Foundation was founded by Mike Milken after he had prostate cancer. Milken is neither a scientist nor an M.D. He is a former Wall Street white collar criminal with a huge desire to rehabilitate his reputation. And compared to the inventor of the PSA test, he understands little about prostate cancer, though Milken knows much about hype & fund-raising.
    (Milken also served as Ken Lay’s mentor.)
    The CEO of the Prostate Cancer Foundation makes over $450,000 a year. And after looking at how the Foundation uses the money it raises, the “Charity Navigator” gives it one star out of four for efficiency.
    By contrast, the Michael J. Fox Foundation for Parkinson’s Research gets 4 stars.
    The PSA test is not “cheap and painless.”
    It leads to many diagnosis (often false) which create great psychological pain for the men who are told that they have prostate cancer. They are put in a very stressful situation: should they be treated? Chances are the cancer will never progress to create symtoms? But what if it does? Many man can’t live with the anxiety, so go on to treatment which too often leaves them both incontinent and impotent.
    Many who find themselves incontinent and/or impotent at age 50 are devastated, especially when they realize that odds are they never needed the treatment. (Though many never admit this to themselves and few doctors will tell them.)
    Those who do admit that chances are they didn’t need the treatment says that they wish they had never had the test.
    I know urologists who say that they would never undergo the PSA test themselves for just that reason–it puts you on a “slippery slope” of very stressful decision-making, with no real clue as to what you should od.
    The test itself may be inexpensive, but it leads to very, very expensive and unnecessary treatments.
    Here’s what the WSJ said about PSA testing and treatment in a recent
    article: “At least 50% of men diagnosed with prostate cancer in the U.S. have a low-grade form of the disease that experts say doesn’t need immediate treatment and may never [need treatment]. But less than 10% opt to put treatment off and just monitor their cancer. That’s in part because it can be psychologically difficult to live with untreated cancer, and in part because the medical system is geared toward active treatment.”
    I really think that asymptomatic low-risk men who decide to have a PSA tests and are told that they have early-stage prostate cancer that doen’t need immediate treatment (and may never need treatment) should be told that if they want to treat it, they will have to pay a large share of the cost (on a sliding scale, based on income—ranging from 90% of the cost to 0 if they just don’t have the money.)
    I agree that doctors should be protected from litigation in this case. As far as I know there has been only one successful lawsuit in a case where the doctor laid out risks and benefits, and patient later developed cancer. The case is considered an outlier. (The judge was opposed to evidence-based medicine and so advised the jury to find against he medical school that trained the doctor in evidence-based medicine.)
    I understand the importance of words. I’m a writer and taught English lit for many years.
    The AUA’s 2009 guideline says that doctors “should offer PSA testing to men over 40 who want it and can be expected to live 10 years.”
    You’re right, it doesn’t say doctors should force
    men to have PSA tests.
    And it even talks about risks.
    But it talks about a “20% reduction of mortalities”– a very misleading use of statistics. (See above on how many men have to be tested and treated to save one life.) Most men won’t understand what the 20% means–it sounds like a big number.
    By contrast the Nat’l Preventive Services Task Force” advises doctors not to test men over 75, and says that “there is no conclusion that screening of men under 75” lengthens lives.
    The TAsk Force also warns of a 75% false-positive rate with PSA testing.. (75 percent of the time, the PSA tests diagnosis cancer when the patient doesn’t have cancer. This creates great anxiety and leads to a painful and unnecessary biopsy.)
    NG– For some reason, the link to the AP story didn’t work, but I’m glad to hear that they are getting the story out there.
    I’ve noticed that AP often does a better job than some others in the mainstream media of getting the facts right without slanting the story. Perhaps editors do less re-writing of the facts that reporters find.

  7. My understanding is that the aggressiveness of prostate cancer is determined by the Gleason score. According to a friend who is in Sloan Kettering’s active surveillance program, a Gleason score or 5 or less is considered low grade and doesn’t need to be treated. A score of 6 is on the borderline while 7-10 is more serious. I don’t know where the American Urological Association is on this but they should be able to evolve a consensus if they haven’t already. The pernicious part of prostate cancer, as well as numerous others, is that by the time symptoms appear, it’s often too late to treat it successfully. It’s a conundrum. I’ve been getting a PSA annually for years as part of my corporate physical and I probably couldn’t decline it if I wanted to because it’s done, along with many other tests that my employer’s protocol calls for.
    It would be interesting to learn how treatment outcomes vary depending on the initial Gleason score when the cancer is first discovered – 7-10 in one group vs. 2-6 in the other and what percentage of those with scores below 7 opted for treatment or were pushed into it by their doctors.

  8. Barry–
    As I explained in the post, there is no clear evidence that any treatment works.
    Of the two large studies, the U.S. study shows No reduction in mortalities, while the other study shows that if you screen 1400 men, and find 48 additional cases of prostate cancer, those 48 men would have to be treated to save one life.
    And that means that a fair number of the other 47 would be left impotent or incontinent.
    Many men aren’t willing to be treated because they don’t like those odds.
    Of course many men are treated for prostate cancer, survive, and assume that the treatment “saved” them.
    But medical evidence suggests that they would have survived anyway because prostate cancer moves so slowly that many men die with it, but not of it (never experiencing symptoms).
    Meanwhile, other men are treated and die anyway– the cancer catches up them them, even if it was detected early.
    Bottom line: if you’re diagnosted with early stage prostate cancer probably “watchful waiting” just keeping an eye on it is the wisest thing to do, but many men find this psychologically difficult. They feel like a sword is hanging over their head.
    What is important to understand is that we don’t have a “cure” for prostate cancer, even if detected early.
    So all of this screening seems pointless.
    Except in cases where the cancer is growing and spreading– then you can keep track of how fast it is moving, and if it’s growing, try a treatment–since there is nothing else to do.
    But again, the most hopeful evidence shows only that if 1400 men are screened and 48 treated, just one will be saved–while the other 47 are exposed to the risks of treatment.
    Finally, I’m afraid that your corporate physical (like most physicals for men who are not experiencing symptoms) is a waste of health care dollars. Medical research shows that unless a person comes to a phsyical with a new symptom, there’s little value to all of the tests.
    And corporate physicals, in particular are expensive. I’m afriad we all pay for them in the form of higher premiums.

  9. Please research this. Mr. Albin observed the antigen PSA in 1970 but did not invent the test. The clinicl application came to fruition through a Dr.Chu years later. Albin’s research 40 years ago and his comments today have little relevance to the day in and day out issues that face physicians treating actual patients. The debate however is a relevant one and I am impressed with the comments here. Mr. Albin’s father would have been a patient that would have benefited from PSA and screening. His father represents the tragedy that is the dual nature of prostate cancer. Until we can determine the aggressive type from the benign type a “fit all” commentary about screening is not appropriate. I am working on a rebuttal to the Times in this regard.
    jmchugh md urologist and cancer patient.

  10. john mchugh–
    You’re right, I should have said “discovered” rather than “invented.”
    Here is the “fits nearly everyone truth”–or what what average-risk men need to know about prostate cancer screening and treatment (from a recent med journal article):
    here http://caonline.
    “The best medical evidence that we have suggests that if you screen 1,410 men you will find forty-eight cases of prostate cancer [that wouldn’t have been found if the 1410 men had ‘t been screened) and with treatment, at best, one life will be saved.
    And that’s the most hopeful evidence we have. In other words, the problem is not just that the PSA test isn’t a very good test, the treatments that we have for prostate cancer are not
    very good–and the cancer itself is not that deadly.
    This is what men need to know: The vast majority of men who are diagnosed with early-stage prostate cancer will never experience symptoms and they will die of something else long before the cancer catched up with them.
    Meanwhile, the treatments carry the risk of serious side effects.
    As this jouranl article points out: With screening, “Forty-eight additional men were diagnosed [and with treatment] one life was saved. This means an average man who gets screened is 48 times more likely to be harmed by screening than he is to be saved by screening at 9 years after diagnosis.
    The harms include that he may be diagnosed, undergo needless treatment, and suffer the side effects of prostate cancer treatment, which can include impotence, incontinence, mental anguish, and even death.
    “The real impact and tragedy of prostate cancer screening is the doubling of the lifetime risk of a diagnosis of prostate cancer with little if any decrease in the risk of dying from this disease. In 1985, before PSA screening was available, an American man had an 8.7% lifetime risk of being diagnosed with prostate cancer and a 2.5% lifetime risk of dying from the disease.18 Twenty years later, in 2005, an American man had a 17% lifetime risk of being diagnosed with prostate cancer and a 3% risk of dying from prostate cancer.”
    In other words, despite all of the screening, the risk of dying from prostate cancer has gone up slightly. (We don’t know why).
    If screening and treatment were effective, one would expect that the risk of dying of prostate cancer would have gone down.

  11. PSA is Prostate Specific Antigen, a protein discovered in 1986, and a marker for prostate cancer and inflammation. PSA screening for prostate cancer is, in fact, a 20 year failed medical experiment which provides little or no benefit in saving lives.
    The large US study, the PLCO, showed no mortality benefit from PSA screening. The Europeans, on the other hand, did much better. Their ERSPC study provided a 20% mortality reduction from PSA screening. However, this came at a high cost of significant over-diagnosis. Fifty men were treated for prostate cancer unnecessarily for every life saved. This treatment of surgery, radiation and hormonal castration is associated with erectile dysfunction (ED) and incontinence.
    jeffrey dach md

  12. To PSA or not? That is apparently the question. And those of us who fall into the hands of the incompetant doctor(s)? I saw four doctors in the same surgery from April 2008 to January 2009 before a fifth doctor in the same surgery, prformed a PSA test – too late. The horrendous pain that I had endured through 2008 was advance Prostate cancer entering my spine and lower back. Apparently, there is no cure for ineptitude let alone, Prostae cancer. If I had been screened as a matter of course in April, 2008 I would not be dying now…

  13. I’m not sure why we even use the PSA In the USA any more. I read this really informative book, To Pee Or Not To Pee ( , and I found out that they don’t even use it in the UK and most of Europe abandoned it long ago.

      • Pat Casey–

        They don’t. Mass screening for prostate cancer is not recommended in most EU countries because it leads to over-diagnosis and treatments that do more harm than good. Patients in the U.S. are more likely to ask for pre-screening because they are bombarded with ads from drug companies, hospitals etc. see

        In Europe they do not recommend screening for men who are not showing symptoms of prostate cancer. Such screenings are “fishing expeditions” that discover cancers that would not have progressed 50% of the time, leading to unnecessary treatment. See

        Finally, the UK does not have a prostate cancer screening program–here they explain why.

        Bottom line is that even if a man is at risk for prostate cancer (because several relatives under 60 died of it), doctors
        just “don’t know how to monitor patients” to figure out whether they are developing prostate cancer.

        We need another, much better test.

        The difference between the U.S., EU & UK is that, thanks to constant advertising, Americans have come to believe that they can dodge cancer if they just can’t screened often enough.

        In fact, while a few screening tests are very effective (Pap smears for cervical cancer come to mind) in a great many cases
        “early detection” won’t save you. We want to believe . . . . but it just isn’t true.
        Europeans are more willing to accept that everything can’t be cured, and that we will all die of something sometime.

  14. Dennis Morrod,jeffrey dach, Katie,
    Deinnis Morrod– I am sorry. Yours is a tragic story. But you shoudln’t torture yourself by thinking “if only it had been detected sooner.”
    Prostate cancer that moved that fast is unusually aggressive. And we don’t have any medical evidence that any of our treatments for prostate cancer that is deteced by PSAs save lives.
    When men survive following treatment it is usually because it is a slow-growing cancer. Most men with prostate cancer remain asymptomatic until they die of something else–whether or not they are treated for the cancer.
    In your case it didn’t move slowly. You were horribly unlucky. But, if its any comfort, its far from clear that early detection would have done you any good. (It works for some cancers-cervical cancer for instance–but not others.)
    As jdach notes, the most encouraging research suggests that for every 1 man saved by PSA testing, 50 were treated unnecessaily, and treatment carries heavy risks including incontinence and erectile dysfunction.
    jeffreydach– I agree. So many men have suffered because we have continued this failed experiment for so many years. (I’m thinking if the many men harmed by unncessary treatment.)
    Katie– Yes, I know other countries gave up the PSA long ago. I was an an int’l conference in Berlin a couple of years ago, and doctors from the UK & Sweden were shocked: “YOu still use the PSA?”

  15. On the 2 May, 2010, Dr C. Eden, leading UK Laparoscopic Urologyst wote in a national newspaper: “What I am about to say will be seen as contorversial – but if anything is to change then I must break ranks and admit that thousands of British men are being failed by the medical establishment. Prostate cancer affects 35,000 new sufferers a year and it is a damning indictment of my profession that a third of this number die from the disease annually – about one man every hour. And it is to our shame that many others are consigned to the indignity of living indefinately with horrendous side effects of treatments.” He goes on to say that: “This simply need not be the case. This is wrong.” Dr Christopher Eden:

    • Cancer is not so much a disease, but a business. This Eden fellow in just a salesman scaring people. Healthy living and avoidance of MDs is a tried and true strategy to live healthy and long. Several men I know had their lives ruins by this “roto-rooter” surgery. They had lingering bladder inflections that caused them misery for the rest of their lives. Often biopsies spread cancer, if it is there. There are forbidden cures, so well documented that it is ridiculous. The trance the Medical-Drug Company- establishment has on the public is amazing. Follow the money, look under the covers. Unfortunately, many of these men who worship the purveyors the the prostate butchers have been had. As Mark Twain warned: “It is easier to fool people than to convince them that they have been fooled.” And, if you do not think that science tests can be made bogus, you know nothing about science.

  16. question. What did men do before the PSA test was invented? Well. they did what my father did and enjoyed life. The Veterans Administration had me worried for awhile because they said I had a high PSA and I should have a biopsy. Then I found out that they poke holes in the prostrate and “seed” or spread the cancer. I said, “The heck with it.” I am almost 80, take herbal meds,smile and get on with life. I don’t sit around with my head hanging down and wonder when cancer might take hold. After all, life is “the luck of the draw” Sometimes you win and sometimes you lose. Whenever things got down, my father had the cure. He went fishing. The only reason I check these websites is to gather information to refute the VA doctor,but not to his face. Why argue.My regular MD (HMO) told me, “Don’t do anything, let well enough alone.” I can live with that. Come on,guys,toughen up. Get out there and give it a run for the money. You only go around once.

  17. Pingback: Men’s Health: Inventor of PSA Prostate Test says he is “ashamed” the test has become a “Profit-Driven Public Health Disaster”- The Gaia Health Blog