Is it low T? Maybe not, but pharma advertising pays off

Men's health can be a minefield, and I recently learned that applies to more than screening for prostate cancer.

A few weeks ago, I taped a Medscape commentary about the recent results of the Testosterone Trials, the largest and most rigorous randomized trials to evaluate the effects of testosterone supplements for the pharmaceutical industry-invented condition known as "low T" in older men. I was careful to distinguish low T from hypogonadism, a disease that is also characterized by low testosterone levels but stems from causes other than aging. I began by noting that President Donald Trump had his testosterone level measured last year for no apparent reason, and after analyzing the trial results, I concluded:

Although the Testosterone Trials did not completely rule out benefits of screening for or treating low T, in my view these findings should discourage family physicians from intervening in the vast majority of older men. Most men with low T have no symptoms that will respond to supplements, and for those who do, there are safer and more effective drugs for erectile dysfunction, low bone density, and depression. ... I believe that the story of testosterone supplementation in older men may end up being similar to that of estrogen supplements in postmenopausal women: lots of early hype, but ultimately limited benefits and significant potential harms.

Most of my Medscape pieces receive between 20 to 30 comments; the most I had ever received prior to this was 67 for my analysis of the CDC's opioid prescribing guidelines. I was surprised by the fast and (mostly) furious responses that came in, eventually well over 100. Several suggested that I was "cherry picking" or taking a selective approach to the evidence, even though I placed the new trials in the context of a recent, meticulous systematic review of previous RCTs. A medical student (!) and an endocrinologist questioned my breadth of clinical experience. One physician (not knowing my age) opined that I was obviously too young to have any sympathy for men suffering from the indignities of older age. Another physician (not knowing my testosterone level, which has never been measured) accused me of having a "normal testosterone bias" against low T sufferers. A registered nurse felt that I was motivated by an anti-Trump bias - which I freely admit, but I was not making fun of the President, whose testosterone level was normal. Finally, many disagreed with my contention that testosterone supplements are currently overprescribed, in large part due to aggressive direct-to-consumer (DTC) advertising.

It was a fair point of disagreement. Although testosterone prescribing has skyrocketed (to the tune of $4 billion per year) since televised DTC advertising for prescription medications became legal in 1997, that is an association, not necessarily cause-and-effect, and implies nothing about the appropriateness of such prescribing.

Just in time, a March 21 study in JAMA provided stronger evidence to support my assumptions. Dr. J. Bradley Layton and colleagues linked Nielsen ratings for television programs during which DTC ads for "low T awareness" and specific supplements appeared to a population-level database of testosterone testing and prescriptions from 2009-2013. They found that "each exposure to a testosterone advertisement was associated with monthly relative increases in rates of new testosterone testing of 0.6%, new initiation of 0.7%, and initiation without a recent baseline test of 0.8%." In other words, not only did testosterone-related DTC advertising pay off in thousands of new prescriptions, but many of them occurred without prior testing, despite the Endocrine Society's Choosing Wisely recommendation against doing so.

Does family medicine training lead to high-value care?

The American Academy of Family Physicians this month celebrated the results of the 2017 Match, which saw a record 3,237 medical students and graduates fill first-year positions in family medicine residency programs. Although there is ample evidence that providing primary care improves population health, it is less clear how residency training specialty or location influences future health care quality and spending.

As Dr. Jennifer Middleton and I mentioned in prior posts, the AAFP was an early adopter of the American Board of Internal Medicine Foundation's Choosing Wisely campaign against questionable or unnecessary medical interventions, but so far, studies have shown limited effects of the campaign in primary care. Since an estimated 30 percent of health care spending is wasted on unnecessary services, and a recent case study in JAMA suggested that "excessive resource utilization" may be considered an adverse event, it is worth studying if residency training spending patterns persist in clinical practice.

In a research paper in the Annals of Family Medicine, Dr. Robert L. Phillips, Jr. and colleagues at the American Board of Family Medicine and the Robert Graham Center analyzed spending patterns of a nationally representative sample of 3,075 family physicians and general internists who graduated from residency between 1992 and 2010 and who cared for a total of more than 500,000 Medicare patients. The physicians' residency program locations were matched with Hospital Service Areas (HSAs) and categorized by spending per patient into low-, average-, and high-cost groups. The researchers found that the "imprint" of residency training spending patterns persisted regardless of where physicians ended up providing primary care:

Physicians trained in high-cost HSAs spent significantly more per patient than those trained in low-cost HSAs, no matter what the spending category of the practice HSA. Averaged across all practice HSAs, this difference was $1,644. ... This relationship held true for family physicians and general internists in our multivariable analysis; general internists, however, made up two-thirds of sample physicians trained in high-cost HSAs, and family physicians made up two-thirds of those trained in low-cost HSAs. [Residency] graduates were significantly more likely to be low-cost physicians if their sponsoring institution produced fewer total physicians, more rural physicians, or more primary care physicians.

The researchers found no relationship between spending patterns and diabetes quality measures, suggesting that lower spending did not lead to worse health outcomes. And it is important to note that family physicians who trained in high-cost HSAs were as likely to be big health care spenders as general internists from high-cost programs; in other words, there did not appear to be anything inherent in family medicine training that caused graduates to spend less. However, more general internists provided costlier care by virtue of having trained in high-cost areas - most likely, those with tertiary academic medical centers. I agree with Dr. Phillips and colleagues' conclusion that their study "supports efforts to test interventions in residency training that may bend imprinting toward teaching and modeling behaviors that improve value in health care." One intervention has borne fruit for the past 8 years in a row: attracting more medical students to the specialty of family medicine.

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This post originally appeared on the AFP Community Blog.

#No2AHCA and positive trends in prostate cancer screening

Without a doubt, today's biggest health policy story is the anticipated House of Representatives' vote on the American Health Care Act, the first step toward fulfilling President Trump's campaign promise to "repeal and replace" the Affordable Care Act. I outlined my position on the AHCA in detail in my latest Medscape commentary; for those of you who are not health professionals, suffice to say that I don't think it will do anything to improve the lives of patients, caregivers, or primary care physicians. Even the AHCA's strongest selling point - billions of dollars saved for the federal government over the Congressional Budget Office's 10-year time horizon - is achieved by shrinking premium tax credits relative to costs to make insurance policies unaffordable for more people (meaning that they will not be able to actually use the tax credits) and forcing states to carry more of the financial burden of Medicaid or (more likely) drop people from their programs. The result is that the AHCA, if passed, could actually result in one million fewer people having health insurance than if the ACA was simply repealed.

The bottom line is that the AHCA doesn't reduce the cost of health care; it just shifts more of those costs on to the backs of people who are least able to afford them.

If we want to actually reduce costs, we can start by not providing health care services that are unnecessary, ineffective, or potentially harmful, which is the premise of the Choosing Wisely campaign, the Right Care Alliance, and the Too Much Medicine initiative. There is some good news on this front: a research letter published this week in the Annals of Internal Medicine reported that among men aged 40 to 64 years who received health insurance from Aetna between 2009 and 2015, substantially fewer are receiving PSA screening, prostate biopsies, and prostate cancer treatments. This finding suggests that U.S. physicians are screening more selectively, raising the threshold for biopsy, and for men with a prostate cancer diagnosis, choosing watchful waiting or active surveillance more often than aggressive therapy with its associated side effects. Thank you, U.S. Preventive Services Task Force.

In my practice, after I counsel older men about projected benefits and harms of PSA screening, some will still choose to have the test, but more will decline. Many men in the latter group ask me if there are any better tests in development, and my answer is yes, but they aren't yet ready for routine use. HemeOnc Today recently invited me to respond the question: "Is genetic testing sophisticated enough to make PSA screening viable for mainstream use?" Below is an excerpt from my "No" response:

The search is on to identify more specific biomarkers that can either replace PSA as a screening test, or augment PSA by predicting which men with elevated levels are at the greatest risk for harboring clinically important — and potentially curable — cancers. However, utilizing genetic tests for this purpose outside of clinical trials is premature. The only genetic test for prostate cancer approved by the FDA is the PCA3 urine assay. In 2014, the Evaluation of Genomic Applications in Practice and Prevention Working Group concluded that PCA3 has insufficient supporting evidence to inform decisions to conduct initial or repeat biopsies for prostate cancer in at-risk men. ...

A 2016 systematic review commissioned by Agency for Healthcare Research and Quality found insufficient evidence to assess analytic validity of 18 commercially — or close to — available multigene panels for prostate cancer risk assessment, evidence of modest clinical validity beyond patient age and family history, and no studies of clinical utility (eg, effects on process of care, health outcomes, harms and economic outcomes).

It is understandable that physicians and patients who are concerned about prostate cancer are impatient for new tests that promise to maximize the benefits and minimize the harms of PSA testing. But we should have learned our lesson from the PSA experience. Now is not the time to perform more uncontrolled experiments on older men by incorporating unproven genetic tests into clinical practice.

Is screening African American men for prostate cancer warranted?

Regular readers of my blog know that I believe that the harms of prostate-specific antigen (PSA) screening for prostate cancer outweigh the benefits, if benefits exist at all. That isn't to say that I will not order the test in a man who understands the risks and expresses a clear preference to be screened. In a recent editorial in American Family Physician, I explained my approach to counseling patients about potential screening harms:

Many older men, especially those who have received PSA tests in the past, may be surprised to learn that screening is no longer routine. Primary care physicians should anticipate this possibility and be prepared to explain that more is now known about the outcomes of testing. Phrases that may be helpful to communicate changes in our understanding of the evidence include “the PSA test is now optional,” “this test has limitations and may not be for everyone,” and “there are some important downsides to being tested.” These strategies, combined with decision aids, should help our patients make informed choices that are consistent with their personal preferences on PSA screening.

One question that arises frequently at the hospital and clinic where I precept family medicine residents is: what about African-American men? Should we advise that they be screened because they have a higher prostate cancer incidence and mortality than other racial or ethnic groups? This question came up during the development of the U.S. Preventive Services Task Force's 2008 recommendations, which included this statement:

Older men, African-American men, and men with a family history of prostate cancer are at increased risk for diagnosis of and death from prostate cancer. Unfortunately, the previously described gaps in the evidence regarding potential benefits of screening also apply to these men.

The publication of the U.S. and European randomized trials of PSA-based screening, which ultimately caused the USPSTF to change its "I" (insufficient evidence) statement to a "D" (recommend against) in 2012, unfortunately did not do much to clarify benefits and harms of screening in men of African descent, who comprised only 4% of participants in the U.S. trial and an unknown (but probably low) percentage of those in the European trial. And even the subsequent negative findings of the Prostate Cancer Intervention Versus Observation Trial (PIVOT), whose participants were more than 30% African-American, didn't discourage authors in academic journals and prominent medical blogs from arguing that Black men need separate prostate cancer screening guidelines.

What troubles me about this position is that race is as much a social construct as it is a biological one. Much of the disparity in prostate-cancer mortality between African-American and Caucasians can be explained by lower access to and quality of care, rather than a genetic predisposition for more aggressive and/or lethal cancers. In contrast to national data, studies of equal-access healthcare systems in the U.S. such as the Veterans Health Administration and the Department of Defense found no differences in prostate cancer mortality between Black and White men.

In this context, the USPSTF recently published a thoughtful methods paper explaining their approach to developing recommendations for diverse populations. The research plan for their updated systematic review on prostate cancer screening included explicit questions about whether the effectiveness or harms of PSA-based screening or treatment approaches varied by subpopulations, including race. Such data may or may not be sufficient to permit the Task Force to assign a separate recommendation letter grade to screening in African-American men this time around (I suspect it will not), but it will hopefully result in more helpful guidance for primary care clinicians.

Here is what I currently tell African-American men over 50 who are considering the PSA test: "In general, this test is more likely to harm than to help. Your personal risk of having prostate cancer is higher than other men, which may make it more likely that you benefit from testing, but also increases the potential harms. So while the general statistics on PSA screening might not apply to you specifically, the decision to be screened still comes down to your personal preference."

Prioritizing effective clinical preventive services: an update

In a widely cited 2003 study, Dr. Kimberly Yarnall and colleagues estimated that in order for a family physician to provide all U.S. Preventive Services Task Force-recommended services to a patient panel of 2500 with an age and sex distribution similar to that of the U.S. population, he or she would need to spend 7.4 hours per working day, leaving little time to address acute or chronic medical problems. Although the subsequent rise of the patient-centered medical home model has allowed physicians to share this work load with other primary care team members, it remains difficult to meet all preventive care needs. In 2006, the National Commission on Prevention Priorities (NCPP) ranked 25 preventive health services recommended by the USPSTF and the Advisory Commission on Immunization Practices (ACIP) based on clinically preventable burden (health impact) and cost-effectiveness. The three services that received the highest score were aspirin use to prevent cardiovascular disease (CVD), the childhood immunization series, and tobacco use screening and brief interventions in adults.

In the January/February Annals of Family Medicine, the NCPP published an updated ranking of effective clinical preventive services, using similar methods as in their 2006 study. The childhood immunization series and adult tobacco use screening and counseling remained the most highly prioritized services, joined by counseling to prevent initiation of tobacco use in children and adolescents, first recommended by the USPSTF in 2013. Although low-dose aspirin for primary prevention remained important, the more targeted 2016 USPSTF recommendation to discuss use with high-risk adults lowered the estimated population health impact of this service. In a recent editorial in American Family Physician, former USPSTF member Douglas Owens explained the rationale for focusing on persons 50 to 59 years of age with a 10% or greater 10-year CVD risk:

The decision to initiate aspirin should be based on a discussion of potential benefits and harms. ... Persons who value avoiding long-term medication use may benefit less from taking aspirin. Cardiovascular risk is also important: the higher a person's risk of CVD, the more potential benefit aspirin provides. The most favorable balance of benefits and harms occurs in persons who are at substantially elevated CVD risk but are not predisposed to bleeding complications. Finally, although older age increases the risk of cardiovascular events, it also increases the risk of bleeding complications.

Dr. Jennifer Middleton discussed the nuances of this recommendation statement, including aspirin's benefits for reducing colorectal cancer risk, in a previous post on the AFP Community Blog.

Finally, clinicians and patients should be aware that the Affordable Care Act (ACA) mandated that in addition to the USPSTF and ACIP, preventive services recommended by the Bright Futures guidelines and the Women's Preventive Services Initiative be fully covered by private insurance plans without cost-sharing. The methods of these groups differ significantly, and unlike the NCPP, none of them review cost-effectiveness. Although political uncertainty surrounding possible repeal of the ACA makes it unlikely that this process will change in the near future, a 2016 editorial in JAMA Internal Medicine proposed improving the consistency of the groups' evidence review methodologies and forming a separate advisory committee "to integrate economic considerations into the final selection of free preventive services." Or, perhaps the NCPP itself could take on that role?

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This post first appeared on the AFP Community Blog. Be sure to also check out the Feb. 15 AFP Podcast, which includes "The Prevention Priorities Game" (starting at 16:10).

Patients: steer clear of these six orthopedic procedures

After the American Academy of Orthopaedic Surgeons (AAOS) released its Choosing Wisely list, it was criticized for selecting items that are uncommonly used or have little effect on the income of its members. In an editorial in the New England Journal of Medicine, Dr. Nancy Morden and colleagues pointed out that the five services listed by this specialty group were particularly "low impact":

The American Academy of Orthopaedic Surgeons named use of an over-the-counter supplement [glucosamine and chondroitin] as one of the top practices to question. It similarly listed two small durable-medical-equipment items and a rare, minor procedure (needle lavage for osteoarthritis of the knee). Strikingly, no major procedures — the source of orthopedic surgeons' revenue — appear on the list, though documented wide variation in elective knee replacement and arthroscopy among Medicare beneficiaries suggests that some surgeries might have been appropriate for inclusion.

At the Lown Institute's 2015 Road to RightCare Conference, a group of maverick orthopedic surgeons identified five other procedures that, in contrast to the AAOS list, are frequently performed at great expense in the U.S. but provide little or no benefit to patients.

1) Vertebroplasty for spinal compression fractures - in two randomized controlled trials comparing vertebroplasty to a sham procedure, there were no differences in pain or quality of life between the intervention and control groups. Risks of vertebroplasty include causing compression fractures in adjacent vertebrae, dural tears, osteomyelitis, cement migration, and radiculopathies requiring subsequent surgery.

2) Rotator cuff repair for non-traumatic tears in older adults - A randomized trial comparing physical therapy, physical therapy plus acromioplasty, and physical therapy plus acromioplasty and rotator cuff repair found no differences between the control and surgery groups after one year. About 600,000 Americans undergo rotator cuff surgery every year.

3) Clavicle fracture plating in adolescents - In adolescents with clavicle fractures that were displaced and shortened, there were no differences between nonoperative management (a sling for the affected arm) and surgery in appearance, range of motion, or participation in sports activity two years after the injury. However, 1 in 4 adolescents who underwent surgery required re-operation for surgical complications.

4) Anterior cruciate ligament (ACL) reconstruction - In young, active adults with acute ACL tears, a randomized trial comparing early (within 10 weeks of the injury) ACL reconstructive surgery plus physical rehabilitation to rehabilitation plus optional delayed reconstruction up to 2 years after the injury found similar outcomes between the groups. 61 percent of the optional reconstruction group did not require surgery. More than 100,000 ACL reconstructions are performed in the U.S. each year.

5) Partial medial meniscectomy for adults with knee osteoarthritis and no mechanical symptoms - A randomized trial found no benefit of partial meniscectomy compared to sham surgery in adults with degenerative meniscal tears and no osteoarthritis. A systematic review of 7 trials came to the same conclusion. In adults with osteoarthritis, surgery plus physical therapy was not more effective than physical therapy alone. Arthroscopic partial meniscectomy is the most commonly performed orthopedic procedure in the U.S., with 700,000 operations annually.

Finally, a 2015 randomized trial in JAMA suggested that another procedure whose use is increasing worldwide provides no benefits.

6) Surgery for adults with displaced proximal humerus fractures - Patients who underwent fracture fixation or humeral head replacement within 3 weeks of sustaining a displaced fracture of the proximal humerus had no better outcomes than patients assigned to nonoperative management (sling immobilization) after 2 years.

What accounts for the continued popularity of ineffective orthopedic procedures? Excessive magnetic resonance imaging (MRI) plays a role; immediate MRI is rarely indicated for common musculoskeletal conditions, and may often provide deceptive or confusing results, such as identifying meniscal tears that are unlikely to be the cause of patients' chronic knee pain. Some primary care clinicians' lack of comfort with the orthopedic examination may lead to unnecessary referrals. Patients who perceive surgery to be a "quick fix" may not have the patience to stick with physical therapy and rehabilitation. And there is the inescapable reality that, necessary or not, these procedures pay well.

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This post initially appeared on Common Sense Family Doctor on March 20, 2015.