USPSTF “forced” to release PSA recommendations earlier than expected


The U.S. Preventive Services Task Force (USPSTF) — after previously stating that it would be releasing its new recommendations about PSA testing for risk of prostate cancer on Tuesday next week — has been pressured (by a variety of organizations, and by the media) to release its draft recommendation today.

The full text of the recommendation is available if you click here. Comments on this draft recommendation statement may be submitted to the USPSTF beginning on Tuesday, October 11, 2011. Click here to submit your comments, starting on Tuesday.

The basic recommendation now being proposed by the USPSTF is as follows:

The U.S. Preventive Services Task Force (USPSTF) recommends against prostate-specific antigen (PSA)-based screening for prostate cancer. This is a grade D recommendation.

This recommendation applies to men in the U.S. population that do not have symptoms that are highly suspicious for prostate cancer, regardless of age, race, or family history. The Task Force did not evaluate the use of the PSA test as part of a diagnostic strategy in men with symptoms that are highly suspicious for prostate cancer. This recommendation also does not consider the use of the PSA test for surveillance after diagnosis and/or treatment of prostate cancer.

The “New” Prostate Cancer InfoLink has never been an advocate for the annual mass screening of all men for prostate cancer with the PSA test. And we have never been shy about stating that fact. However, the right of individual patients — and most particularly the right of individual patients who are at increased risk for clinically significant prostate cancer — to seek and obtain the best possible guidance from their physicians for their personal risk regarding prostate cancer and how they may wish to manage that risk is a very different issue.

The PSA test is far from being a “perfect” test for assessment of risk for prostate cancer, but at this time it is perhaps the only test that allows us to assess initial, possible risk for prostate cancer in anything approaching a coherent manner.

A key question that needs to be addressed in assessing the USPSTF’s new draft recommendation is therefore what they mean by “screening” in the above statement.

Does “screening” include the value of obtaining a baseline PSA level in one’s early 40s? Does “screening” mean “annual population-based screening of all men over X years of age”? If it does, we might actually agree with this. On the other hand, it is clear that there are men at high risk for prostate cancer because of genetics, family history, and ethnicity who most certainly need to be able to understand and monitor that risk. There is no other good test available for these men to assess their risk at this time. It is not right to suggest that these men should defer all testing (if they are otherwise “healthy”) until they have urologic symptoms that are highly likely to be associated with disease that is not organ-confined and therefore is potentially incurable at the time of diagnosis.

The current, draft recommendation is symptomatic of a major rift within the medical community about the value of PSA testing. The USPSTF’s recommendation is just as extreme — at one end — as the current guidance from the American Urological Association, which recommends a baseline PSA test for all men in their 40s, annual PSA testing of all males over the age of 50, and annual testing of all men at known risk for prostate cacner staring at a younger age.

The “New” Prostate Cancer InfoLink does not expect the current, draft USPSTF recommendation to survive in its present form. However, we also believe that it is high time some common sense was applied to assessment of the value of PSA testing — based on individualized patient need and risk. The longer we go on dealing with PSA testing as if it were a “black” or “white” issue, the longer we shall fail to find a sensible resolution to this problem. There are very definitely shades of gray involved.

14 Responses

  1. The following items provide additional information that may be either of interest or relevant to the above commentary:

    — “Recommendation against routine PSA screening for in the US” is an article just published on the Medscape Oncology web site.

    — “Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force” is an article by Chou et al. just published in the Annals of Internal Medicine.

  2. I agree that more common sense needs to be applied ~ but by whom? The doctors that test? The patients? The doctors diagnosing the disease do need to do a better job of weighing treatment versus monitoring. And the patients need to know that knee jerk reaction can be devastating. But men will die from this action from the USPSTF. Their message is blaming the PSA test and that it’s the enemy. I read an article today on CNN quoting an advisor to the USPSTF that stated that politics was indeed interfering with the task force from doing it’s duty. That was in reference to the USPSTF recommendation to stop screening for breast cancer in women under the age of 40, and then it’s immediate reversal of that decision. I agree that men, and doctors, need better education about screening and treating prostate cancer. I would rather hear the task force talking about this than simply blaming the screening process for treatment side effects.

  3. Tony:

    By everyone. We need to stop thinking in black and white terms. It has long been clear that testing needs to be considered to the greatest degree possible in the context of risk, and there are now ways to categorize men by risk — especially if men were to have a baseline PSA test taken sometime between the ages of 35 and 40.

  4. Mike,

    I am trying to understand your position and can’t parse it.

    On hand you state: “The “New” Prostate Cancer InfoLink has never been an advocate for the annual mass screening of all men for prostate cancer with the PSA test.” On the other hand you go on saying: “Does “screening” include the value of obtaining a baseline PSA level in one’s early 40s? Does “screening” mean “annual population-based screening of all men over X years of age”? If it does, we might actually agree with this.”

  5. Hi Sitemaster,

    I find it fascinating that you deplore the AUA’s categoric recommendation to have baselilne PSA testing at age 40, and then you stipulate (in response to Tony) that “there are now ways to categorize men by risk — especially if men were to have a baseline PSA test taken sometime between the ages of 35 to 40.”

    In my view one persuasive argument in favor of routine PSA testing at the young age of 40 (as advocated by the AUA) is precisely that by and large prostate cancer is asymptomatic, but routine testing has revealed cases of asymptomatic ADVANCED prostate cancer at that age. If 40-year-old men were not routinely given PSA screening, hundreds if not thousands would go to their graves early without the possibility of medical intervention. Would you or members of the task force want that on your conscience?

    Besides I believe all this talk about PSA screening being the enemy is a red herring. The real enemy is the passivity of the US government in raising sufficient funds to determine which localized prostate cancer case is likely to become aggressive sooner rather than later. If that could be determined with even 80% reliability, I imagine more docs would concur with watchful waiting (aka active surveillance).

    Another more critical issue is that the federal government continues to withhold vital funds needed for research to prevent or erradicate prostate cancer. We know that millions more are allocated for breast cancer prevention or erradication,even though a solution is tragically not yet in sight.

    Finally a question: Didn’t Pres. Obama indicate 2 years ago when the same task force drew the same conclusion that this would not affect Medicare coverage for men who elect to be screened?

  6. Reuven:

    If — by “screening” — the USPSTF does, in fact, mean “the annual, mass, population-based PSA testing of all men over X years of age,” then The “New” Prostate Cancer InfoLink would agree with the USPSTF that this is not, in fact, an appropriate application of the PSA test. As we have said many times before, there are now sufficient data to suggest that large numbers of man with a baseline PSA value of 0.7 at about 40 years of age is at real risk for clinically significant disease, and therefore may well need regular testing (perhaps every 2 or 3 years) to monitor the stability of his PSA levels and his risk for clinically significant disease.

    Of course, the USPSTF does not mean “the annual, mass, population-based PSA testing of all men over X years of age.” The USPSTF is run by epidemiologists who don’t actually see patients and therefore have little ability to appreciate the clinical nuances of clinical risk assessment. They seriously believe that PSA testing has had nothing to do with the decline in prostate cancer deaths over the past 20 years. They happen to be misguided … but that is, in all seriousness, what they believe.

  7. Dear Rabbi Ed:

    I am more than willing to let anyone who wants to have a baseline PSA test get one at 40 or thereabouts. It offers them guidance as to their risk. What I reject is the idea that everyone “should” get one. That is a matter of personal choice. For those of us who are and always have been at minimal risk for prostate cancer, that choice might well be that we aren’t interested. What gets lost sight of over and over again in this discussion is that as individuals we should all be entitled to make those personal choices. For every man who gets a diagnosis of prostate cancer in his lifetime (including all the ones with a diagnosis of what is actually indolent disease) there are five of us who do not. My conscience is completely clear on that matter (by comparison with some of the items mentioned below).

    This is not about “the Government.” The Government has, as yet, made no decisions whatsoever. A group of “experts” (on epidemiology) has made a (misguided) recommendation. The Secretary of the Department of Health and Human Services is just as likely to reject that recommendation as she did the one about mammography. A significant group of congressmen and women is already “up in arms” about this. And as you point out, President Obama has continuously stated that the recommendations of this particular group of experts would not influence access to either mammography or PSA testing. (Of course he is a politician, so he could change his mind at the drop of a hat, but I don’t think he will.)

    As you may have noticed. The Government cannot afford to fund everything we would like them to. Would I like all the money in the world to be available to answer questions related to prostate cancer? Sure I would … right after malnutrition, starvation, malaria, and a whole bunch of other diseases that kill people who currently never get a chance to make it to even 10 years of age. The “real enemy” in my view is the passivity of men themselves, who ignore 95% of their health issues until it is too late. How much of all the prostate cancer research money that is raised each year is actually raised by individual men? Not much, that’s for sure. Men are always so quick to “blame” anyone except themselves. You want a cure for prostate cancer? We need about another $500 million a year. Let’s raise that with the Michael Milkens and Lance Armstrongs of the world. That is not the job of Government when they already can’t even fix the jobs crisis. It’s ours.

  8. As a continuing prostate cancer patient since 1992, after a PSA test determined I had an abnormal PSA level that led to a DRE and subsequent biopsy that determined the presence of prostate cancer, I am too well aware of the completely idiotic stance being put forth by this United States Preventive Services Task Force (USPSTF), of individual who arguably have sufficient knowledge regarding prostate cancer to have their conclusions accepted and who obviously have yet to experience prostate cancer (read on for the specialties of these supposed experts on prostate cancer). I expect, or at least hope, that our several prostate cancer support organizations will rise up and challenge the conclusion of this group as the women did when a similar recommendation was made regarding breast cancer. I would be much more acceptable to conclusions determined by a mixed group of medical oncologists, urologists, radiation oncologists, and pathologists with direct prostate cancer experience than the background of the physicians on this USPSTF panel. However, the reality is that this “expert” panel consists of the following specialties, completely unrelated to understanding prostate cancer: pediatrics, family medicine, geriatrics, palliative care, epideminology, public health, obstetrics, gynecology, maternal/fetal medicine, and — get this – preventive care!

    To come out and state that prostate cancer screening should no longer be provided because it has served no useful purpose is ridiculous. In my currently 19 years of dealing with my prostate cancer, I have read the comments of many thousands of men whose cancer was discovered as the result of a PSA test either separately or in company with a digital rectal exam (DRE). There are likely a million or more of us still alive because this test was made available to us either through our reading of it, of other men telling us about it, a physician recommending it based on urinary issues being experienced, or from “free prostate cancer screening” that had been offered (and still is being offered in many locations in the U.S. and elsewhere and should continue to be offered) in many communities. This is how I found out I had prostate cancer.

    Until science and the medical community come up with a form of testing as inexpensive and as reasonably helpful as the PSA test in at least bringing attention to an abnormal PSA level, there is no logical reason to absolutely do away with even the suggestion of being tested. There wouldn’t be any “over-treating” if physicians who perform biopsies were targeted by health authorities to not encourage immediate treatment if biopsy results indicated the patient’s diagnostics did not warrant immediate intervention. Rather, in the presence of low evidence, low-grade prostate cancer, active surveillance (AS) should be explained to patients, whereby patients are encouraged to continue or begin a healthy lifestyle, be tested for other important health levels to determine biological end-points that may require improving, participate in reasonable exercises, and continue close monitoring between physician and patient to only consider treatment when diagnostics indicate the cancer is becoming more developed and aggressive.

  9. Unlike the Sitemaster, the USPSTF has completely discounted the interests and perhaps lives of men who are likely to have more advanced disease; they number approximately 15% or so of men diagnosed annually.

    This year that number may represent some 36,000 men who are at significant risk of dying from prostate cancer; of course this does not include men who currently go undiagnosed until they are symptomatic. Perhaps early baseline screening can identify and follow this subset with more aggressive disease.

    Most of us on this site acknowledge that the PSA test is a poor diagnostic tool, and progressively more so as we now know there are more than 25 genetic variations of our disease. We should also acknowledge that the PSA test is about information, not treatment. The risks stated by the USPSTF arise from ensuing decisions taken by patients in consort with their doctors. We need better education as well as better tests — not no tests.

    By following the task force’s recommendations, we can safely say the mortality rate will rise, although the number of new cases will likely fall; furthermore most of those who will suffer are men with the more aggressive gene(s) that are expressed in locally advanced and advanced prostate cancer.

    The current recommendations are criminal and will result in a death sentence for many men with the aggressive form of our disease.

  10. My 2 cents as someone who was asymptomatic is that it should be upgraded to a level C category. I personally feel that it should be done starting at age 50 for all men and followed up every 5 years minimum.

  11. Who are the “doctors” on this task force? Where do they work? Who are they paid by? Are they out in the community actually treating and interacting with the concerns and issues of patients and their loved ones or are they “statisticians and epidemiologists living in an ‘ivory tower’ dealing with cost-benefit ratio issues?”

    Hint: The doctors on this panel, Otis Brawley, the doctors in the white jackets in front of the White House supporting national healthcare are all one and the same, and different than the doctors actually practicing medicine. Who do you believe?

    I ain’t saying nothing. … I’m just saying.

    JM

  12. Dr. McHugh,

    Your insinuation of politics and wrong-doing are wholly unfounded.

    This link provides a description of criteria for membership and a description of the process for appointment and service on this task force. Based on the length appointment, the largest percent of current members were appointed during previous administrations.

    I don’t know the background of all members, but I do know that the current vice-chair’s practice is a long 9-iron from my office. He is a highly-regarded local practitioner and educator of future healthcare providers at our state’s flagship public (R-1) university and medical school. He also contributes a great deal to our community as a volunteer in issues related directly and indirectly to public health.

    The point of this task force is to inform primary care providers of recommendations based on vetted findings of the existing research; thus, most of its membership is comprised of the various specialties that do that work.

    I find having an informed medical and research opinion from those not directly profiting from the current standard practices for the treatment of prostate cancer to be not only helpful, but necessary in order to separate real outcomes and risks from perceived outcomes and risks by both patients and physicians with “skin in the game.”

    The role of an informed, independent opinion in helping patients make medical decisions is commonplace (and, I would argue, invaluable), not suspicious.

    Not everyone who disagrees with you is conspiring against you, or conspiring at all. You may disagree with the recommendations, but to use innuendo to cast aspersion on the motivations of the task force members is not just specious, but unprofessional, unhelpful, and quite frankly, unkind.

  13. Interesting that a task force making recommendations on prostate cancer does not include one urologist, the doctors that specialize in the disease.

    I suspect that much of the task force’s decision was based upon the PLCO trial. I encourage everyone to read the full study. I would love to see the raw data, but it appears from the paper published in the NEJM that the cause of death analysis is weak as much of it was obtained from death reports. Most men dying from prostate cancer are on androgen ablation which we now know increases the risk of cardiac events. How many prostate cancer deaths were attributed to heart attack? Many others dying with bone metastases are in hospice on large doses of narcotics. How many many of these were reported as death from pneumonia?

    Buy stock in Abbot. Sad to say, but Lupron sales will go up.

  14. Dear Dr. Mike:

    I am sorry to say that I cannot agree with you less. The PLCO trial was poorly designed and poorly executed for all sorts of reasons. As a consequence it did not demonstrate a cause-specific or an overall survival benefit. There may be dozens of reasons why, but post hoc speculation will not change the trial result.

    In addition, if you have read the paper by Chou et al. that reviewed all the available data, you will be able to see that the PLCO trial was only one of a number of studies on which the panel based their recommendation.

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