Tuesday, March 15, 2011

Men’s Health? Women’s Health? Valid screening opportunities or “Hallmark Holidays”?

This blog has previously discussed the use of PSA as a screening tool for prostate cancer (March 21, 2009: PSA Screening: What is the value?, and a guest column by Robert Ferrer, MD MPH in October 27, 2009: PSA Screening: “One of Medicine's Great Success Stories"? ), and indicated that it was not only a poor test, but a dangerous one, leading to unnecessary biopsies, diagnosis of disease that was unlikely to progress and treatment that would probably not change the outcome but would almost certainly lead to significant morbidity.

A new study by Vickers, et al., published in the Journal of the National Cancer Institute (An Empirical Evaluation of Guidelines on Prostate-specific Antigen Velocity in Prostate Cancer Detection, JNCI, doi: 10.1093/jnci/djr028, first published online: February 24, 2011), shows that the use of “PSA velocity” as a screening test for prostate cancer, is flawed and not a valid indicator. PSA velocity refers to the rate of change (presumably, increase) in the level of prostate-specific antigen (PSA) over time; the theory, which this study demonstrates to be invalid, is that the faster the rate of rise (velocity), the more likely someone is to not only have prostate cancer, but to have aggressive cancer needing intervention. In fact, the study shows that “Biopsying men with high PSA velocity but no other indication would lead to a large number of additional biopsies, with close to one in seven men being biopsied….We found no evidence to support the recommendation that men with high PSA velocity should be biopsied in the absence of other indications; this measure should not be included in practice guidelines.” And so another effort to find a way to use PSA to diagnose prostate cancer, like “highly sensitive PSA” before it, bites the dust.

Unfortunately, the issue of PSA screening will probably not die out, despite this study and the recent change in the recommendation of the US Preventive Services Task Force (USPSTF), downgrading PSA testing from an “I” recommendation (evidence is insufficient to recommend for or against testing), to a “D” – not recommended. The political pressure from physicians, hospitals, and others who are at best “true believers” (they know that eventually their faith will be proven correct) to, at worst, motivated by the fear of losing a major source of income, will continue. Indeed, the “PSA velocity” was never even seen as a way of confirming the veracity of a high single PSA value (which, for the true believers, was sufficient) but a way to identify men who had a normal PSA – but maybe slowly rising from one normal value to another – as a market who could be treated.

The USPSTF recommendation was in fact ready several months before it was released, as discussed by Kenny Lin, MD, on February 28, 2011 his blog Common Sense Family Doctor, PSA testing: will science finally trump politics?. Dr. Lin was, at the time, the staff member at the Agency for Health Research and Quality (AHRQ) that put together the evidence review upon which USPSTF based its recommendation, and then quit over political interference from the White House: “The USPSTF scheduled its "re-vote" on prostate cancer screening for its November 2010 meeting. As reported in the Wall Street Journal and on this blog, the Task Force was forced to cancel that meeting due to the unfortunate "scheduling conflict" with the critical midterm Congressional elections.” (Editorial note: postponing the recommendation didn’t help the President’s party in those elections!)

The attraction of PSA screening and prostate cancer goes beyond that single disease; it is the cornerstone of the ostensible discipline of “Men’s Health”. This is a conceit developed by astute marketers to compete, or more correctly, profit from the cachet associated with, the long-established “Women’s Health”. After all, if Women’s Health is a good and established (and profitable) area, why should men – and particularly, those who want to make money caring for men – be left out? Women’s Health (capitalized) has its own specialty, obstetrics and gynecology, but, because this is essentially a surgical discipline, has brought in also providers in family medicine, internal medicine and some of its subspecialties (especially endocrinology, because of the issue of bone loss and osteoporosis), nurse practitioners, and others. There are Women’s Health clinics, journals, and meetings all over the place; surely Men’s Health should be just as important?

The centerpiece from which Women’s Health derived is the classic “Well-Woman Exam”, an annual ritual for most adult women, so deeply enshrined in both the national culture and insurance reimbursement system that it is no danger of being overturned by a USPSTF recommendation, or probably anything else. The essential characteristic of the Well-Woman exam is the provision of preventive services because the woman is, well, Well. This is a critical concept – once someone has symptoms that are addressed by any examination (more history questions, physical exam, laboratory, imaging) or treatment, this is no longer “Well-woman”; these are problems, conceived of, addressed, and even billed separately. “Well-woman” means that the women has no symptoms and involves only screening. This screening has long been centered around the Pap smear for cervical cancer, and the internal examination (medical: bimanual = using two hands) that is so associated with the Pap that popular usage considers them together. In addition, breast health is addressed through some combination of provider exam of the breasts, teaching of self-breast exam, and referral for mammography. All of these have been re-evaluated by evidence-based studies and recommendations have changed, often for fewer tests.

Breast cancer screening has been a subject of intense controversy, with USPSTF recommending that not all women over 40 receive mammography screening, reversing a position that they took 8 years earlier, and which even at that time was not based on evidence (see October 30, 2010: Breast cancer screening: conflicting evidence? what are the important questions for health?). The political response from the “breast cancer” community – and it was a political and emotional, not evidence-based scientific response, was huge, and was likely a major reason for the White House pressure on USPSTF to not release its PSA recommendation. In addition, teaching self-breast exam was no longer recommended (this is not to argue against doing self breast exam, a major way women find lumps, but rather to acknowledge the evidence that routinely teaching it does not add benefit). Pap smears themselves, the single best cancer screening tests among a group that are mostly less effective than we would hope, are no longer recommended in women under 21 by the American College of Obstetricians and Gynecologists (ACOG), and do not need to be done annually if they have been normal. Bimanual exams never had any evidence to support their routine use in asymptomatic women, because they cannot screen for any disease. Osteoporosis treatment with bisphosphonate drugs can sometimes lead to serious fractures; recommendations are now to treat only frank osteoporosis, not the less severe osteopenia, and then only for a limited time. Even calcium supplementation has been found to have risks (August 2, 2010, Calcium, Heart Attack and Osteoporosis).

Does this mean that there is no valid place for Women’s Health as a concept or even a discipline? Not necessarily. Women do have risks for conditions that are different from those of men, including for a number of things that men are deeply involved in – contraception (not a risk if there are not men involved), sexual abuse, domestic violence. Asking about these issues is critical, with counseling about them necessary, even if this is not what “Well-Woman” exams usually pay for. And, to the extent that it increases the likelihood that these issues are addressed, Men’s Health may have a place. But in general, the examples above indicate the slippery slope of creating such a field, because there is a need to justify its existence. This means finding tests that can be done, expanding the use of these tests beyond those in whom they were originally found to be useful, and even implementing treatment for which there is no evidence, and which are often found to create net harm.

Prevention is a good thing, but if a test or intervention has not been shown to actually prevent something, doing it is useless and costly at best, and maybe dangerous at worst. Women and men should get the screening tests that are indicated, but not those that aren’t. These include Pap smears and mammography (in the appropriate women), colon cancer screening, blood pressure screening and treatment, counseling about tobacco and alcohol, contraception and investigation of risks of violence and abuse. There are others, particularly in certain sub-populations. But we need to be cautious about the creation of new disciplines and the motivation for their creation – is it increasing health or increasing revenue? Providers, doctors and hospitals, like to do things that make money and promote the fact that they do them; cancer prevention and care is particularly emphasized (January 16, 2010: Cancer Care and Hospital Advertising).

We have “Hallmark holidays” (and as a resident of Kansas City, home of Hallmark, I have to be cautious here), like Mother’s Day and Father’s Day, created and promoted to sell things, that have become very beloved by a large number of people. We don’t need “Hallmark medical care”, designed by marketers to fill a niche as an opportunity to make profit.

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