PSA redux: The USPSTF finally recommends NOT getting it!

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The US Preventive Services Task Force (USPSTF), the independent group of physicians and scientists who make recommendations to the government, medical community, and American people on the value of screening tests, recently came out with a new recommendation on the use of laboratory tests for Prostate Specific Antigen (PSA) in screening for prostate cancer.  It recommended AGAINST it --in their terms, a “D” recommendation. Previously, USPSTF had recommended against PSA screening for men over the age of 75, but had not taken a position for or against screening in younger men (an “I” recommendation, insufficient evidence to recommend for or against screening).

My belief is that this is a good, appropriate, and very overdue recommendation which will come as no surprise to those who have read this blog for some time. I, and guest authors, have addressed this issue several times (PSA Screening: What is the value?, Mar 21, 2009; PSA Screening: “One of Medicine's Great Success Stories"?, Oct 27, 2009 (by Robert Ferrer);, Men’s Health? Women’s Health? Valid screening opportunities or “Hallmark Holidays”?, Mar 15, 2011). In addition I have often linked to and cited the work of Kenny Lin, MD, who writes the Common Sense Family Doctor blog, and resigned from the Agency for Healthcare Quality and Research (AHRQ) as a member of the USPSTF support team in November, 2010, over his perception that these recommendations were being delayed by political considerations. Dr. Lin has also written about PSA testing often  (including  "It is time to stop this [PSA] June 21, 2011, PSA testing: will science finally trump politics? Feb 28, 2011) and has recently addressed the new recommendations on Oct 7, 2011, Shannon Brownlee on the pros and cons of early cancer screening.

Of course, a lot of people do not think that this recommendation is a good thing. Two large groups, in particular, oppose the new recommendations: urologists and others who earn their livings treating prostate cancer and “advocacy” groups, supported by many high-profile (as well as just regular folks) men who have survived prostate cancer. Many of these men are quoted in Gardner Harris’ NY Times article “US panel says no to prostate screening for healthy men”, October 7, 2011. One of those who is quoted (actually not in the published NY Times piece, but in another version of Harris’ article published in the Seattle Times, is my colleague Brantley Thrasher, MD, Chair of the Department of Urology at the University of Kansas Medical Center, who said, "It appears to me that screening is accomplishing just what we would like to see: diagnose and treat the disease while it is still confined to the prostate and, as such, still curable."

I like Brant Thrasher, I think he is a good and knowledgeable doctor and great surgeon, but I strongly disagree with him on this one.  As much as we would like, and believe me as a family doctor I would like, and Kenny Lin would like, a test that could find disease early while it was still curable and make a difference in people’s live, PSA is not that test and, at this point prostate cancer is not that disease. These are two separate issues, so let’s take them separately.

PSA is not a good test. Yes, it is often, maybe usually, elevated in men with prostate cancer. Of course, in some men with prostate cancer it is not above the “normal” cutoff. This has led some advocates of PSA screening to suggest use of “PSA velocity”: check it yearly and watch the rate of rise rather than the absolute value. But the bigger problem for PSA as a screening test is that it is often elevated in men who do not have prostate cancer but just have a big prostate (“hypertrophy”, almost universal in men above a certain age), or even DO have cancer, but the very-slow-growing-that-is-not-going-to-kill-you-before-you-die-of-something-else kind, which is by far the most common variety. These men are subjected to ultrasounds, biopsies, and treatments that cause significant morbidity (impotence, incontinence of urine, and “radiation proctitis” of the rectum and anus, developing congestive heart failure from hormone treatment, to name a few) with no benefit.  Baylor physician and panel chair Virginia Moyer notes in the Times article that “This test cannot tell the difference between cancers that will and will not affect a man during his natural lifetime. We need to find one that does.” In 2010, Richard Ablin, PhD, who discovered the a prostate specific antigen (but not the PSA test) in 1970, called use of the test “a public health disaster” and “not much better than a coin toss.” (“The Great Prostate Mistake”, NY Times, March 9, 2010.

But the bigger issue is that there is no good evidence that treatment of any kind – surgical, radiation, hormonal – makes any difference in the outcome of prostate cancer. Surgeons like Brant Thrasher think it does, and he may be some day proven correct , at least in some circumstances, currently there is much more evidence supporting that it doesn’t than that it does. If you have the common, less-aggressive kind of prostate cancer, you won’t die from it, with or without treatment. If you have the rarer, highly-aggressive kind, you will probably die from it, with or without treatment.  The Times article notes that  “…advocates for those with prostate cancer promised to fight the recommendation. Baseball’s Joe Torre, the financier Michael Milken and Rudolph W. Giuliani, the former New York City mayor, are among tens of thousands of men who believe a P.S.A. test saved their lives.” They may believe it, but they are probably (I obviously don’t have access to their medical records) wrong. The test diagnosed prostate cancer, they were treated for prostate cancer, and they are alive. QED. But it’s false logic, an association that doesn’t demonstrate cause. If they are alive now, they would be alive (at least as far as the prostate cancer is concerned) without the treatment. And they wouldn’t have those “little” problems like incontinence and impotence that seem like a small price to pay for not dying of cancer, but are a big price if the treatment didn’t make any difference. The famous folks who have died of prostate cancer, like Frank Zappa, died despite treatment.

The Times quotes Thomas Kirk, of Us TOO, the nation’s largest advocacy group for prostate cancer survivors, saying “The bottom line is that this is the best test we have, and the answer can’t be, ‘Don’t get tested.’” He’s wrong. That is the answer. We not only need a test that can distinguish the “bad” kind of prostate cancer that will kill you from the kind that probably won’t, we need treatments that evidence shows makes a difference in survival and quality of life if you do have the bad kind. In the meantime, getting tested is likely to create more harm than benefit.

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Direct-to-Consumer Advertising and the Role of Advocacy Organizations: Two Threats to Evidence Based Testing

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Two recent “Commentaries” in the same issue of JAMA address different challenges to the implementation of evidence-based practice guidelines. One, “Direct-to-consumer cardiac screening and suspect risk evaluation” by Lovett and Liang[1] addresses the challenges posed by the potential for profit that occurs when companies market screening tests direct to the consumer (DTC) that may not be indicated, may not be indicated for the people who it is marketing to, or may even be harmful to the recipients of such screening. This harm can, of course be physical, as in untoward events, or in risks inherent in the further procedures for those who “screen positive” but turn out to have been “false positives”. The harm is also financial, for there is a cost to doing these tests – to the individual (sometimes) or to their insurer; in the latter case, whether that insurance is public (e.g., Medicare, Medicaid) or private, the cost is to all of us. And, of course, that cost is the reason for such marketing, as it is what translates into profit for the company selling the test.

In the case of cardiac screening, Lovett and Liang, using the recommendations of the US Preventive Services Task Force (USPSTF), the American Heart Association/American College of Cardiology Foundation (ACCF/AHA), describe heavily-marketed tests that can cause more harm than benefit to the many people who are not in the narrowly-targeted group for whom the tests are indicated; other tests which have valid indications although, again, in the appropriate populations; and finally tests for which there is little or no evidence. The marketing of these tests can incur anxiety or fear in people who have no reason to be worried about these conditions and may occur outside the physician-patient relationship, thereby not allowing people to get the physician’s analysis of the results even when the test is indicated, and cost a great deal of money. This is particularly true when a possibly-positive test needs to be followed up with a number of other tests to rule it out, this time covered by insurance. They make several suggestions for how DTC companies should be regulated. They conclude that, “DTC cardiac testing may pose more harm than benefit to many consumers. Oversight efforts are needed to protect the public from inappropriate testing and to ensure that the health care dollar is spent on care promoting health in an evidence-based fashion.” I would say that is a mild suggestion!

The issue raised by the other article is probably more insidious;  because it lacks the obvious profit motive present in DTC marketing, we may be less wary.  In “Health advocacy organizations and evidence based medicine”[2], Sheila Rothman examines the tendency for groups that are created around a single disease (e.g., breast cancer, epilepsy, autism, etc.) to push for screening tests, diagnostic tests, and treatments for “their” disease whether or not there is evidence to support their use. In response to an Institute of Medicine (IOM) survey that sought to identify what tests and treatments should be included in a basic benefits package, “They contended that EBM [evidence-based medicine] should serve merely as an aid in medical decision making, not as the basis for it. Outcome data, they insist, should not limit patient choice or restrict available services.” This is truly remarkable. These groups are basically saying “our disease is so important we should screen everyone, everyone who screens positive should have diagnostic tests, and everyone who has it should be able to get any treatment that they want, even if there is weak or no evidence for its efficacy. And, of course, someone else should pay for it.” This would probably be unreasonable if there was only one such disease, but there are hundreds and each is the “most important” for its advocacy organization. The reason that this is more insidious is that these groups are not seeking to make a profit on these tests and treatments (usually); they are (usually) functioning as advocates for people who are truly suffering.

However, the fact that people are truly suffering does not mean that society should screen large numbers of low-risk people for all of these conditions. There are, of course, some things that we should and do screen everyone for. We screen all newborns for a set on genetic or congenital conditions for which identification makes all the difference. Two good examples are congenital hypothyroidism (in which the newborn thyroid doesn’t function) and phenylketonuria (in which the newborn lacks the enzyme to break down a certain protein). Undetected (and thus untreated) these lead to serious disease, mental retardation and death. Detected, and easily treated (by thyroid hormone replacement and avoidance of phenylalanine-containing foods, respectively) the child can lead a normal life. But every condition with an advocacy organization is not one of these, nor are the screening, diagnostic tests, and treatments so straightforward.

Sometimes, these advocacy groups may indeed have a financial interest in a test or treatment, but even when they do not, they may push for policies that allow physicians to prescribe expensive brand-name drugs even when generic drugs have not been tried. Or to demand the availability of expensive but unproven treatments: “’Autism Speaks’ criticized insurance companies that refused to pay $300 000 for 4 years of applied behavior analysis therapy for toddlers, despite a lack of evidence of effectiveness.” That is a lot of money even if we know a treatment is effective, but it is an awful lot when we do not. The issue is that this organization is focused only on people with “its” disease, and has no concern for what the money could otherwise be used for to treat other people with proven therapies. Maybe this is their role, but there is no reason that the rest of society must buy into this logic.

Cancer, of course, has the strongest set of advocacy organizations, and breast cancer is far and away the leader. I wrote about the issue of advocacy versus evidence regarding the most recent USPSTF recommendations for screening in Breast Cancer Screening and Evidence-based Medicine, November 25, 2009. More recently I looked at these issues, including both breast and prostate cancer screening, in Men’s Health? Women’s Health? Valid screening opportunities or “Hallmark Holidays”?, March 15, 2011. In this context, the Food and Drug Administration recently approved several new drugs for metastatic prostate cancer. The cost can be over $90,000 for each treatment cycle and might exceed $500,000. In the June 28, 2011 NY Times article, “New prostate cancer drugs extend lives but raise costs”, Andrew Pollack notes that Medicare is going to look into whether to pay for these drugs, but that “…some patient advocates and politicians portrayed the review as a step toward rationing.” Excuse me? Don’t we already have rationing based on whether or not one has money or insurance? I recently addressed this in my recent post The real face of lack of access to health care, June 19, 2011. It is not ok for “patient advocates” to advocate for some people to get any kind of treatment paid for by someone else (e.g., Medicare) when everyone who has that medical need is not able to get care. And since there will be more things to spend money on than there is money, there needs to be a more rational system than “Me first!” This system is the use of evidence-based guidelines.

Rothman concludes her commentary:

“However valuable independent advocacy organizations are for a democratic society and however important their services provided to targeted populations, their advocacy positions and the related underlying assumptions must be scrutinized with the same diligence as those of other stakeholders. There should be no automatic assumption that all health advocacy organizations deserve special standing or represent the common good.” 

And for good reason, because they probably do not.

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[1] Lovett KM, Liang BA, “Direct-to-consumer cardiac screening and suspect risk evaluation “,JAMA  2011Jun23/29;305(24):2567-8.

[2] Rothman SM, “Health advocacy organizations and evidence based medicine”, JAMA  2011Jun23/29;305(24):2569-10.