Saturday, November 18, 2017

When does it make sense to lower cholesterol with statins?

There has been no shortage of recent guidance on statin use for the primary prevention of cardiovascular disease (CVD). The American College of Cardiology / American Heart Association and the U.S. Preventive Services Task Force (USPSTF) disagree about the appropriate 10-year CVD event risk threshold at which clinicians should recommend statins - 7.5% and 10%, respectively - but both agree that the benefits significantly outweigh the harms. So what should clinicians make of the Medicine By the Numbers in the Nov. 1 issue of American Family Physician, which gave a Red (no benefits) rating to statins in persons at low (less than 20% 10-year) risk of cardiovascular disease?

Dr. John Abramson calculated the numbers needed to treat (NNT) to benefit and harm based on data from the 2012 Cholesterol Treatment Trialists (CTT) meta-analysis and the USPSTF's 2016 systematic review. Excluding patients with existing cardiovascular disease or a greater than 20% 10-year CVD event risk, the results showed no mortality benefit, but 1 in 217 persons avoided a nonfatal myocardial infarction and 1 in 313 avoided a nonfatal stroke. On the harms side of the scale, 1 in 21 persons experienced pain from muscle damage, and 1 in 204 developed diabetes mellitus as a result of taking statins. Dr. Abramson acknowledged that his conclusion of "no benefit" relied on value judgments about the importance of these harms compared with cardiovascular events prevented:

In summary, studies have found no significant overall mortality benefit with statin therapy in low-risk patients, as well as no reduction in the risk of serious illness overall and very small benefits for nonfatal heart attack and stroke. Statins also appear to cause diabetes. Although this is uncommon, diabetes may occur more often than the prevention of a heart attack or stroke in patients taking statins. ... With no mortality benefit, no reduction in serious illness, an approximately 1% chance of avoiding a nonfatal heart attack or stroke, a similar or greater chance of developing diabetes, and a one in 21 chance of muscle damage, it seems wiser to focus on lifestyle changes (such as adopting a Mediterranean diet, exercising, and not smoking) instead of cholesterol drugs in low-risk patients.

These findings are broadly consistent with a 2011 Cochrane for Clinicians that noted that because "most trials included large numbers of persons with known CVD, ... clear evidence of the effectiveness of statins to prevent a first cardiovascular event is lacking." Other Cochrane reviews have found that statins reduce all-cause mortality in patients with non-dialysis chronic kidney disease, but do not prevent dementia or cognitive decline. A previous AFP article summarized considerations for safe use of statins, which should be part of shared decision making discussions with patients when the benefits and harms are so closely balanced.

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This post first appeared on the AFP Community Blog. And yes, I plan to discuss the new ACC/AHA blood pressure guideline in future posts ...

Tuesday, November 14, 2017

We will not be intimidated

Recent weeks have seen a virtual avalanche of allegations of past harassment or inappropriate sexual behavior by (mostly) male politicians, talk-show hosts, and business executives. Since many of these revelations have come out years or decades later, partisans have been quick to suggest that their stories are politically motivated fabrications. If what happened was so despicable or immoral, they ask, why not come forward earlier? Why wait, for example, until the repeat offender is a in a position to be elected to the U.S. Senate? I'll tell you why in one word: intimidation. For the most part, sexual violence isn't driven by an excess of passion; it's driven by an excess of power. Violators count on a combination of embarrassment, guilt, and intimidation to keep their victims from talking, and more often than not, it works.

Intimidation is often used to injure on a societal level, too. As illustrated in the critically acclaimed film The Insider, the tobacco industry was ruthless in attempting to prevent whistleblower Jeffrey Wigand from revealing that its executives intentionally added substances known to be addictive and carcinogenic to cigarettes. More recently, a group that publicly supported a tax on sugary drinks in Colombia was threatened and censored in the weeks leading up to the vote in the legislature. And Dr. Pieter Cohen, a Massachusetts general internist who writes the Updates in Slow Medicine e-newsletter, was hit with a $200 million libel lawsuit by a supplement company after publishing a scientific paper that demonstrated the presence of a designer stimulant in its product. Dr. Cohen (whose lawsuit was eventually dismissed by a jury after a week-long federal trial) and colleagues wrote recently in JAMA Internal Medicine:

When lawsuits target scientists, it does not matter that plaintiffs almost never win. It does not even matter if the case goes to trial. The goal is to intimidate. In the lawsuit over dietary supplements, for example, the head of the company who brought the suit openly admitted that he was “hoping that we were able to silence this guy,” as well as other researchers who might raise questions about the supplement industry. The most frivolous lawsuit can generate substantial legal costs, distract scientists from research, force the indiscriminate disclosure of laboratory notebooks and emails, and create unnecessary stress for colleagues and families.

On August 13, 2013, after reading a blog post where I called his company "unscrupulous" based on its aggressive efforts to sell packages of non-recommended and potentially harmful tests to vulnerable elders at health fairs and churches, the chief medical officer of Life Line Screening mailed me a letter that called my characterization "potentially libelous and actionable" and copied their in-house legal counsel. After a lengthy defense of the technical accuracy of their testing process (which I have never questioned - my problem is that these tests are unnecessary and do not improve patients' health!), he went on to write: "You and I can disagree, but you do not have the right to attack our reputation, our passion for helping people, or the integrity of our team." I subsequently forwarded this letter to my department Chair, who forwarded it to my employer's legal counsel, who concluded that the probability of a libel lawsuit was low, and that of a successful lawsuit virtually nil. Nonetheless, it was enough to scare me into remaining silent for the next 4 years.

Dear Life Line Screening, I am not attacking your company's integrity. I am sure that the vast majority of your employees are passionate about helping people (why else work for a company named "Life Line"?) But the tests you portray to potential customers - like the retired ladies in the next pew at my church who live off fixed incomes - as bargains, however CLIA-certifiably accurate, are ineffective or, like screening for carotid artery stenosis, actually do more harm than good. And I will no longer be intimidated by you or anyone else from saying so.

Tuesday, November 7, 2017

Artificial intelligence will not make family physicians obsolete

Last week, I was speaking on the phone with Dr. Roland Grad, a family physician at McGill University and co-author of the new book "Look It Up! What Patients, Doctors, Nurses, and Pharmacists Need to Know about the Internet and Primary Health Care." We were discussing the (to us, preposterous) notion that there would be no future for primary care physicians because we will all be replaced by cognitive computing / artificial intelligence (AI) systems such as IBM's Watson. Roland told me that whenever someone asks him about this, he points out that Star Trek clearly shows that there will be human doctors well into the 24th century. Even the holographic Doctor on the U.S.S. Voyager is only pressed into service after the entire human medical staff is killed in an accident.

Many of the prospective medical students I interview have asked me about how AI will influence how I practice family medicine in the future. A recent Perspective on machine learning in the New England Journal of Medicine asserted that "the complexity of medicine now exceeds the capacity of the human mind." The authors argued that since doctors can no longer keep all relevant medical knowledge in their heads, and "every patient is now a 'big data' challenge," we will soon need to rely on massive computer-generated algorithms to avoid diagnostic and treatment paralysis.

It's no surprise that neither author of this piece is a family physician. Since I began my residency 16 years ago, and well before that, I knew that no matter how much I learned, it wouldn't be possible to keep everything I needed in my head. I never had to. In medical school I carried around a variety of pocket-sized print references, and in residency and clinical practice I had several generations of Palm Pilots and, eventually, smartphones that allowed me to look up what I didn't know or couldn't recall. The same goes for keeping up with the medical literature. Although I regularly read more journals than the average generalist (nine*), I know that there's no way that I can possibly read, much less critically appraise, every new primary care-relevant study. Drs. David Slawson and Allen Shaughnessy have argued that rather than pursue that hopeless (even for a super-subspecialist) task, clinicians should be taught information management skills, which consist of foraging (selecting tools that filter information for relevance and validity); hunting ("just in time" information tools for use at the point of care), and "combining the best patient-oriented evidence with patient-centered care."

And although Watson and its AI predecessors have made short work of the previously invincible Ken Jennings on Jeopardy! and vanquished world chess champions with ease, it is having a much harder time cracking medicine. Although IBM started selling Watson for Oncology as a "revolution in cancer care" to hospital systems worldwide in 2014 and has spent millions of dollars lobbying Congress to exempt its software from FDA regulation, a STAT investigation found that the system has fallen far short of its hype:

At its heart, Watson for Oncology uses the cloud-based supercomputer to digest massive amounts of data - from doctor's notes to medical studies to clinical guidelines. But its treatment recommendations are not based on its own insights from these data. Instead, they are based exclusively on training by human overseers, who laboriously feed Watson information about how patients with specific characteristics should be treated.

AI will no doubt play a supporting role in the future of health care, alongside smartphone physicals and precision medicine and many other promising innovations borrowed from other industries. But based on past experience, I'm not convinced that any of these innovations will be as revolutionary as advertised. In my own career, doctors have gone from using paper charts that were time-consuming to maintain and couldn't communicate with each other to electronic health records that are even more time-consuming to maintain and still can't communicate with each other. You get my point. Even if IBM or some other tech company eventually harnesses AI to improve primary care practice, here's what Roland and his colleagues have to say in Look It Up!:

Some might wonder whether this new automated world of information will create a medical world that is dominated by artificial intelligence, where doctors - if we even need them anymore - will just repeat what the machines say. On the contrary, as more information becomes readily available, doctors, nurses, pharmacists, and allied health professionals will become more important as the interpreters of that information in accordance with the specific clinical and social history, values, and preferences of the patient and her or his family. 

Right. I couldn't have said it better myself.


* - American Family Physician, Annals of Family Medicine, Annals of Internal Medicine, Health Affairs, JAMA, JAMA Internal Medicine, Journal of the American Board of Family Medicine, Journal of Family Practice, New England Journal of Medicine

Thursday, November 2, 2017

Can social media misuse be a downer?

Social media use provides several professional benefits for family physicians and other health care professionals: it can promote one's practice and engage patients, increase the dissemination of insightful or practice changing conference findings, and amplify the voice of our specialty to advocate on public health concerns. Similarly, patients can also benefit from social media's networking and community-enhancing functions. However, social media's potential downsides include cyberbullying, which targets persons of all ages but may be particularly damaging to children, and problematic internet use / Internet gaming disorder. The American Academy of Pediatrics issued a policy statement last year on office counseling for families and children five to 18 years of age on media use.

Curbside Consultation in the October 15 issue of American Family Physician explored the relationship between social media and mood disorders. For some persons, particularly in the millenial age group, social media misuse can cause or contribute to the anxiety-related condition "fear of missing out" (FOMO), wrote Drs. Kaitlyn Watson and David Slawson:

Viewing social media intensifies feelings of irritability, anxiety, and inadequacy. Additionally, the drive to stay in the loop can contribute to a cycle of unhealthy social media use. The more time individuals spend on social media, the more likely they are to feel that they are missing out on something, which many will then try to alleviate through more social media activity. Higher FOMO scores, as measured by a validated 10-question scale, are significantly associated with lower feelings of competence, autonomy, and connectedness with others compared with persons who do not worry about being left out.

For patients whose social media misuse is causing adverse emotional or physical symptoms, clinicians can recommend any of several free or low-cost apps that help users "unplug" by limiting total social media time per day or restricting use of certain sites (e.g., Facebook, Snapchat) to specific time windows. Other suggested interventions include "changing notification settings to daily or weekly instead of instantly, developing offline relationships, committing to daily personal improvement practices (e.g., yoga, meditation, exercise), and cutting back on the number of social media formats on which the same person is followed." Finally, cognitive behavioral therapy and mindfulness exercises may also be helpful.

What has been your experience with symptoms of depression or anxiety linked to social media use?

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This post first appeared on the AFP Community Blog.

Thursday, October 26, 2017

Once a Cesarean ... now, a vaginal delivery

A 2015 essay in the "Narrative Matters" section of Health Affairs by physician and health policy researcher Carla Keirns highlighted the challenges that even a highly educated, well-informed patient faces in achieving the desired outcome of a vaginal childbirth, especially if her pregnancy is classified as high risk. Dr. Keirns, whose pregnancy was complicated by "advanced maternal age" (there's that term again) and gestational diabetes, narrowly avoided a Cesarean delivery by obstetricians who often seemed to be "watching the clock" more than assessing her individual circumstances. She observed how the "Cesarean culture" of medical practice overshadows the ideal of shared decision-making about delivery preference:

I was naked and uncomfortable, had invasive lines in place, and hadn’t slept or eaten in three days. If a doctor I trusted, instead of one I didn’t know, had suggested a cesarean forty-eight hours into my labor induction, I might have agreed. If they had told me that my baby’s life or health was in jeopardy, I would have consented to anything. The vision of the empowered consumer, or even the autonomous patient, is laughable under these circumstances.

Once a woman has had one Cesarean delivery, she faces considerable pressure from the medical system to choose repeat Cesarean deliveries in subsequent pregnancies. A 2014 article in The Atlantic explained why the dictum "once a Cesarean, always a Cesarean" increasingly holds true despite good evidence that planned VBAC is safe for, and desired by, most women. After the American College of Obsetricians and Gynecologists (ACOG) published guidelines in 1996 (later challenged by the AAFP) recommending that in-house surgical teams be "immediately available" during planned VBAC, many hospitals stopped allowing women to attempt labor after a Cesarean. Even though ACOG now acknowledges that there is no evidence that hospitals with fewer resources have worse maternal or neonatal outcomes from planned VBAC, these restrictive institutional policies have remained in place.

After our first child was born by Cesarean section, my wife, who is also a family physician, proceeded to have three consecutive uncomplicated vaginal deliveries after the age of 35. To change the culture of medicine to support this kind of outcome, and to reduce the overall frequency of Cesarean deliveries, patients, physicians, and hospitals must advocate for aligning medical protocols with the best evidence and putting mothers and babies back at the center of care.

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A slightly different version of this post appeared in Common Sense Family Doctor on February 5, 2015.

Wednesday, October 18, 2017

Three reasons for optimism in health policy

For clinicians like me who worry about how health policy changes may harm our patients, there have been plenty of reasons for pessimism this fall. Congressional re-authorization of the highly effective, popular, bipartisan Children's Health Insurance Program (CHIP), whose funding expired on September 30, was derailed by yet another "repeal Obamacare" attempt that failed to muster 50 of 52 Republican votes (or any Democratic votes) in the Senate. Dr. Tom Price, the now-former Secretary of Health and Human Services, was dismissed after billing taxpayers nearly $1 million for travel on private and military jets between obscure destinations with few commercial options such as ... Washington, DC to Philadelphia. (I was happy to see him go.) And building on his Administration's record of partisan actions on science policy, President Trump has confused just about everybody on whether he will ultimately support a bipartisan agreement to pass legislation stabilizing the Affordable Care Act's health insurance marketplaces in exchange for making it easier for states to obtain waivers to develop their own programs.

So why am I feeling optimistic, instead? Two weeks ago, I attended the 25th anniversary celebration of the Alliance for Health Policy, "a nonpartisan forum for learning and dialogue among policymakers and other leaders working to address the country’s most pressing health and health care issues." (Thanks to my friends at Health Is Primary for the invite.) This is one of the few health-related groups in Washington that could bestow honors on prominent conservative (Gail Wilensky) and liberal (Uwe Reinhardt) health care economists, as well as longtime Republican and Democratic congressional staffers, on the same night. And it was reassuring to see that family medicine had not one but many seats at the table, with the American Academy of Family Physicians' CEO, immediate past President, President, and President-Elect all in attendance.

Another nonpartisan health policy group that I've been following for the past few years is the Milbank Memorial Fund, which focuses on developing evidence to support state-level population health strategies, including but not limited to insurance reforms. In three recent reports, the Fund examined how some states achieved "significant, sustained improvements ... in one or more key population health outcome measures" and what lessons could be generalized from those experiences. For example, Georgia and Florida both made significant strides in reducing infant mortality relative to the rest of the nation between 2004 and 2014. In Georgia, a campaign led by then-public health commissioner Dr. Brenda Fitzgerald (now director of the Centers for Disease Control and Prevention), the Fund concluded that stakeholder engagement, champions, strategic use of data, and partnerships focused on postnatal care were crucial elements.

My third reason for optimism is my students. It strikes me as ironic that the medical school course that I co-direct at Georgetown was not even part of the curriculum of my own alma mater (NYU) or any other school of medicine in the 1990s. This year, for the first time, the course is concentrated into two intensive one-week blocks - one last week on Health Disparities and Health Equity, and another next spring on Health Policy and Advocacy - rather than being parceled out through five months of the academic year in direct competition with basic science courses. The result has been the most engaged, enthusiastic group of first-year medical students whom I've had the pleasure to teach. These students not only understand social determinants of health, they are ready to take action to address the root causes of health disparities where people live, work and play. They are prepared to advocate for patients in their neighborhoods and communities, far outside the walls of the hospital and clinic. They are motivated to change the culture of medical education to provide more than lip service to the social mission of caring for historically disadvantaged populations. They are part of the future of medicine and population health in this country, and they give me reason to believe that the future is bright.

Thursday, October 5, 2017

What we choose to name a disease matters

A couple of years ago around this time, I was dealing with a series of minor health problems. I developed a sinus infection that took several weeks to resolve. I twisted one of my knees ice skating, and for a while I feared that I had torn a meniscus. Occasionally after eating a heavy meal, I had the sensation that food was getting stuck on the way to my stomach - so along with an x-ray and MRI for my knee, my doctor also sent me for an upper GI series. Finally, my blood tests for a new life insurance policy came back with a slightly high hemoglobin A1c level. The A1c test was once used only to monitor glucose control in patients with established diabetes, but in 2010 the American Diabetes Association changed their diagnostic criteria to classify an A1c level of 6.5% or greater as consistent with diabetes, 5.7% to 6.4% as prediabetes, and 5.6% or lower as normal. So on top of knee tendinitis and gastroesophageal reflux disease (GERD), I also found out that I had prediabetes.

Intellectually, I knew that there was no evidence that screening for prediabetes is beneficial (the life insurance company, not my doctor, had ordered the test), and that a screen-and-treat approach to diabetes prevention leads to lots of overdiagnosis. Emotionally, it was a different story. I had recently turned 40 and was feeling old. It had been years since I had gotten the recommended amount of physical activity for adults, and now I was doing even less because my knee hurt. It didn't help that the afternoon I found out about my A1c level, my wife called and asked me to pick up some Burger King sandwiches and fries to bring home for dinner. Not exactly what a pre-diabetic adult with GERD should be eating.

Would I have felt less sick if I had instead been told that I had "slightly high blood sugar"? In recent years, oncologists have recommended re-naming slow-growing lesions that we currently call cancer, such as "ductal carcinoma in situ" of the breast, indolent lesions of epithelial origin (IDLE), hoping that a less scary term will discourage patients from pursuing unnecessarily aggressive (and potentially harmful) treatment. Similarly, some doctors believe that telling patients that they have a "chest cold" rather than "acute bronchitis" will make them less likely to ask for antibiotics.

systematic review published this year in BMJ Open supported the notion that what clinicians choose to name a disease influences patients' management preferences. Some study examples: women who were told they had "polycystic ovary syndrome" were more likely to want a pelvic ultrasound than those who were told they had a "hormone imbalance." Women were more likely to want surgery if they had "pre-invasive breast cancer cells" versus "abnormal cells" or a "breast lesion." Patients were more likely to expect surgery or casting of a "broken bone" or "greenstick fracture" than a "hairline fracture" or "crack in the bone." In each of these cases, the use of a more medicalized or precise term led patients to prefer invasive management options that were no better than more conservative choices.

How will I apply this knowledge to my daily practice? Although I already use the term "prediabetes" sparingly (preferring "increased risk for diabetes"), I'm going to start telling more patients with A1c levels similar to mine that they have high blood sugar instead. That they have heartburn rather than GERD. That they have overuse knee strains instead of tendinitis. And certain medical terms, such as "advanced maternal age" (i.e., pregnancy after the age of 35, or my wife's age when she gave birth to 3 of our 4 children), I will strive to eliminate from my vocabulary entirely.

Tuesday, October 3, 2017

Medication-assisted treatment for opioid addiction: the family physician's role

Millions of Americans suffer from a potentially fatal disease that has become so common over the past decade that it has lowered the average life expectancy and has particularly devastated vulnerable populations, such as adults with mental health disorders. Although effective medications exist to treat this national health emergency, only a small fraction of family physicians can prescribe them, and even certified physicians face numerous obstacles to providing treatment where their services were most needed. Instead, efforts have focused on disseminating guidelines to prevent this condition, mostly by reducing known risk factors. Unfortunately, most of what we know about prevention is only supported by low-quality evidence on patient outcomes.

I am writing, of course, about the epidemic of opioid use disorder and overdoses. In an editorial in the Sept. 15 issue of American Family Physician, my fellow editor Dr. Jennifer Middleton argued that while reducing the risk of addiction through the selective and responsible prescribing of opioid medications for pain is important, it is not sufficient to turn the tide. Observing that there is a critical shortage of substance abuse subspecialists, she encouraged family physicians to obtain a Drug Abuse Treatment Act of 2000 (DATA 2000) waiver to prescribe buprenorphine:

Family physicians ... are already adept at combining behavioral interventions with medication management for chronic diseases such as diabetes, cardiovascular disease, and chronic obstructive pulmonary disease; addiction treatment requires a similar combination of lifestyle coaching and prescription oversight. ... 


Buprenorphine is no more complex or difficult to manage than many other treatments routinely used in primary care. Additionally, our specialty has historically embraced the needs of populations labeled as difficult or challenging, such as homeless persons, refugees, and those with developmental disabilities or mental illness. Patients who are struggling with addiction are no less deserving of our attention.

Whether or not medication-assisted treatment (MAT) for opioid use disorder should become part of every family physician's scope of practice is a subject of intense debate, most recently in a pair of Point/Counterpoint editorials in the Annals of Family Medicine. Echoing Dr. Middleton, Dr. David Loxtercamp wrote about his "conversion experience" - the 19 year-old patient with whom he realized that he needed to be able to prescribe MAT to provide adequate care to her and so many others like her. "I am still involved [in MAT]," he wrote, "because I am a doctor and this is the epidemic of our time, a social tsunami that can be traced to my prescription - and yours. ... Addiction is a chronic disease that is decimating our communities. We need no other reason to embrace its treatment within every primary care practice."

Taking the opposite view that not every family physician can "be at the front lines" of the fight against the opioid epidemic, Dr. Richard Hill outlined several other factors that weigh against most family physicians prescribing MAT: specialized treatment required, comorbid psychiatric illness, methods shortcomings of emerging models of care, and the risk that taking on this additional responsibility would create more job dissatisfaction and burnout. "Even if further research establishes an 'optimal' model of care for use in primary care," he asserted, "the nature of the disease [opioid use disorder] itself will place undue clinical burden on an already overextended clinical workforce. Perhaps future efforts and funding should be directed toward the development of readily accessible referral networks of mental health/addiction centers, both public and private."

Both sides of the debate make compelling points. Personally, I am torn. What do you think the family physician's role should be in prescribing MAT for opioid addiction?

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This post first appeared on the AFP Community Blog.

Thursday, September 21, 2017

Blood pressure goals in patients with kidney disease: how low should we go?

In 2013, the Eighth Joint National Committee (JNC 8) recommended that adults with hypertension and chronic kidney disease (CKD) be treated to a blood pressure (BP) goal of lower than 140/90, after finding no evidence that treating to lower BP goals showed the progression of CKD. At the same time, the American College of Physicians published a guideline on screening, monitoring, and treatment of Stage 1 to 3 CKD that suggested pharmacologic therapy with an ACE inhibitor or angiotensin II receptor blocker, but noted "no difference in end-stage renal disease or mortality between strict blood pressure control (128 to 133/75 to 81 mm Hg) and standard control (134 to 141/81 to 87 mm Hg)."

Less than two years later, however, findings from the Systolic Blood Pressure Intervention Trial (SPRINT) suggested that some older adults at high risk of heart disease and stroke, including those with CKD, may experience additional benefits if treated to a systolic BP goal of 120. After reviewing SPRINT and other recent studies, the American Academy of Family Physicians and the American College of Physicians decided in a new guideline for adults aged 60 years or older to stick with a systolic BP goal of 140 for adults at high cardiovascular risk.

Two systematic reviews and meta-analyses published recently in JAMA Internal Medicine ensure that debate about BP goals for adults with CKD will continue. The first study, by Dr. Wan-Chuan Tsai and colleagues, identified 9 randomized trials (n=8127) that compared intensive BP control (less than 130/80 mm Hg) with standard BP control (less than 140/90 mm Hg) in nondiabetic patients with chronic kidney disease. They found no significant differences between the groups in annual rate of change in glomerular filtration rate (GFR), doubling of serum creatinine level, a composite renal outcome, or all-cause mortality over a median follow-up of 3.3 years.

The second study, by Dr. Rakesh Malhotra and colleagues, reviewed data from 18 randomized trials that included 15,924 participants with CKD to determine if more intensive (mean systolic BP 132 mm Hg) compared with less intensive (mean systolic BP 140 mm Hg) control reduced mortality risk in persons with CKD stages 3 to 5. The authors found that more intensive BP control was associated with a statistically significant 14% lower relative risk of all-cause mortality.

An accompanying editorial by Dr. Csaba Kovesdy did a good job of putting these findings into perspective. Dr. Kovesdy pointed out that the benefits of a systolic BP goal of 120 for persons with CKD remain uncertain, and that the meta-analysis could have low external validity because trials had much lower death rates than those in observational cohorts of adults with CKD. Finally, he observed that any incremental mortality benefit from intensive BP control is small in comparison to that already achieved by standard BP control:

We must remember that the highest risks of hypertension occur in those with extremely elevated BP levels, and the benefits accrued with treating systolic BP to levels below about 140 mm Hg are much smaller. ... More intensive vs less intensive BP lowering resulted in a [number needed to treat] to prevent 1 death of 167 based on the absolute risk reduction estimated in the meta-analysis by Malhotra et al and an NNT to prevent 1 composite renal failure event of 250 based on the results of another meta-analysis. These diminishing absolute benefits have to be weighed against the increased likelihood of adverse effects and the higher costs associated with more intensive BP lowering.

Bottom line: if family physicians choose to devote more resources to patients with CKD or other cardiovascular risk factors who might benefit from lower-than-usual BP goals, they should not lose focus on improving care for the 46% of U.S. adults with hypertension whose BP numbers are not adequately controlled by any standard.

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This post first appeared on the AFP Community Blog.

Monday, September 18, 2017

Ambition, rejection and leadership

Most readers are aware that it was my work as a medical officer in the U.S. Preventive Services Task Force program at the Agency for Healthcare Research and Quality that catapulted me from a little-known junior faculty member to a recognized authority on preventive medicine and guidelines. What you probably didn't know is that AHRQ turned me down the first time I applied for the job, fresh out of my medical editing fellowship at Georgetown. In retrospect, they absolutely made the right decision. Not only was the physician they selected considerably more qualified, she is still working there, while I left four years after being hired (2006-2010). But that initial rejection, painful as it was, put me in excellent position to seize the next opportunity to join the program one year later.

I've been reflecting on this and other early-career disappointments to put my more recent leadership setbacks into perspective. Even though I won't take the helm at American Family Physician (the medical journal with the third highest print circulation in the world, behind the New England Journal of Medicine and JAMA), I will continue to contribute behind the scenes and support the new Editor in a variety of ways. And although I won't have the opportunity to Chair the AAFP's Commission on the Health of the Public and Science (and my 4-year term as a member ends in December), I will continue to work on evidence-based clinical practice guidelines and other projects in family medicine, such as this position paper on incarceration and health and last week's presentation at FMX on the challenges of providing preventive services to adolescents and young adults. Finally, I remain a go-to source for reporters looking for a skeptical perspective on overused screening tests, especially the prostate-specific antigen test; I was recently quoted in the New York Times and STAT about a modeling study that in my estimation didn't live up to the hype surrounding its conclusion that PSA screening "saves lives."

In short, I'm down but certainly not out. Although I have again fallen slightly short of my high ambitions, I will find other avenues to demonstrate leadership in medical publishing, evidence-based medicine, and population health. At least one silver lining is that I should have more time to devote to blogging about subjects that need the context that a Common Sense Family Doctor can bring.

Monday, September 11, 2017

Too much medicine disrupts end-of-life care

During one of the plenary sessions at the Lown Institute's Road to Right Care conference in 2015, a speaker recounted how overdiagnosis and overtreatment ruined her father's last year of life. Diagnosed with symptomatic multi-vessel coronary artery disease but otherwise in good health and independent at age 85, her father underwent successful coronary artery bypass surgery. His postoperative course was happily uneventful, except for a single stool sample that was positive for blood.

Why her father's stool was tested at all was unclear, since his blood counts were normal during his hospitalization. But his heart surgeon nonetheless strongly recommended that he see a gastroenterologist and undergo a colonoscopy. She tried to dissuade her father from doing this, since at his age even an advanced colorectal cancer would be unlikely to progress enough to cause symptoms before he died a natural death, most likely of heart disease. But her father was accustomed to following doctors' orders, so he dutifully underwent the colonoscopy, which showed a single precancerous lesion.

That should have been the end of the story, but since the gastroenterologist was unable to completely remove the lesion, he recommended consulting a surgeon to operate and take out the entire affected section of large intestine. Her father was barely four weeks out from heart surgery, and she again advised him to disregard this spectacularly ill-advised plan. But he wanted to get everything taken care of, to get this all behind him, so he consented to going under the knife again. This time, the postoperative course did not go well. He developed profuse and unremitting diarrhea, most likely from an antibiotic given prior to the surgery. His doctor pronounced the surgery a success - the cancer was cut out, after all - and expressed little interest in dealing with diarrhea. Her father was then transferred to a nursing home, where his diarrhea continued to resist all treatment, and where he died, miserable beyond all imagining, 6 months later.

Lown Institute senior vice president Shannon Brownlee told another sad end-of-life story about her own father in the Washington Monthly. The article's subtitle said it all: "How Medicare and other federal subsidies rope the elderly into painful, futile, and costly end-of-life care." Despite her father's expressed wish to never go to "the big hospital in Portland" again, he not only ended up there anyway, but underwent a totally unnecessary nuclear stress test and was hooked up to intravenous nutrition before his hospitalist could be persuaded to call in the palliative care team. Brownlee minced no words in describing the deficiences of what passes for end-of-life care in America:

When a frail, elderly person gets sick, takes a fall, or has trouble breathing, it’s as if they have stepped onto a slippery chute leading straight into the hospital, no matter how fervently they and their families might wish to avoid invasive treatment as they age and approach death. That’s because hospital services are what our medical industrial complex has been built to offer, and delivering invasive end-of-life care is the job for which we have trained our doctors and nurses. ... What we don’t do is train clinicians to talk to patients, and what we don’t have is the community-based infrastructure for delivering “high touch” care to people where they live.


I've written before about my belief that the future of medicine is low-tech and high-touch, and I agree with Brownlee that changing Medicare regulations that value ineffective "technology-rich, hospital-centric" interventions rather than house calls and social services to help elderly persons age in place are a necessary first step in fixing the way we provide care near the end of life. It's equally critical that we change the mindsets of physicians who see their roles as sustaining life at all costs ("doing everything," in classic medical parlance) even when they are only prolonging death. Hospitalist Aaron Stupple made a highly sensible proposal in an editorial in BMJ: pair advanced cardiovascular life support (ACLS) training with communication training about palliative care:

Coupling ACLS with communication training has several advantages. Firstly, it legitimizes the skill set as an important and valid component of today’s medical practice. ... Secondly, affixing communication training to mandatory ACLS training binds this material to an established curriculum with a good track record of reliability and measurability. ... Thirdly, all clinical disciplines receive ACLS training, so it could be used to teach a common message and an essential skill set.

Alas, Dr. Stupple's proposal makes so much sense that I fear it may be ignored. How long have we been trying to change the health care system to protect older patients from harmful interventions near the end of life? I remember reading the late surgeon Sherwin Nuland's How We Die in college and being shocked that most of us will die in hospitals, receiving "heroic" interventions that we don't want and won't do us a bit of good anyway. That was more than twenty years ago, and very little has changed. Let's spread the word about the Right Care Movement and dedicate ourselves to making sure I won't be able to write that again twenty years from now.

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This post first appeared on Common Sense Family Doctor on April 2, 2015.

Monday, September 4, 2017

Taking stock of a new guideline for high blood pressure in children

Last month, the American Academy of Pediatrics (AAP) published a new practice guideline on screening, evaluation and management of high blood pressure in children and adolescents, updating a 2004 guideline from the National Heart, Lung, and Blood Institute. The new guideline includes 30 evidence-informed "key action statements" and 27 other recommendations based on consensus opinion. The AAP recommends that blood pressure be measured annually in every child starting at 3 years of age, and at every health care encounter in children with obesity, renal disease, diabetes, aortic arch obstruction or coarctation, or who are taking medications known to increase blood pressure. Notably, the guideline's blood pressure tables lower previous thresholds for abnormal blood pressure in children by several mmHg because they are based on normal weight children only.

The American Academy of Family Physicians (AAFP) currently supports the U.S. Preventive Services Task Force's (USPSTF) 2013 statement that "current evidence is insufficient to assess the balance of benefits and harms of screening for primary hypertension in asymptomatic children and adolescents to prevent subsequent cardiovascular disease in childhood or adulthood." According to the USPSTF, the accuracy and reliability of blood pressure screening protocols in children has not been well studied; a sizable percentage of persons with high blood pressure in childhood will have normal blood pressure as adults; and there is inadequate evidence that lifestyle modification or pharmacotherapy results in sustained blood pressure decreases in children or prevents cardiovascular events. Also, abnormal blood pressure thresholds in the AAP guideline are based on a normal population distribution (with 3 different readings greater than the 95th percentile defined as hypertensive) rather than on patient-oriented evidence of improved outcomes, as in the JNC-8 guidelines for hypertension management in adults.

How can family physicians know if a new guideline is trustworthy and applicable to their patients? In a 2009 article, Dr. David Slawson and I proposed several attributes of good practice guidelines:
  • Comprehensive, systematic evidence search with end date noted
  • Evidence linked directly to recommendations via strength of recommendation grading system
  • Recommendations based on patient-oriented rather than disease-oriented outcomes
  • Transparent guideline development process
  • Potential conflicts of interest identified and addressed
  • Prospectively validated (i.e., guideline use has been shown to improve patient-oriented outcomes)
  • Recommendations offer flexibility in various clinical situations
Subsequently, the Institute of Medicine (IOM; now the National Academy of Medicine) published a report, "Clinical Practice Guidelines We Can Trust," that recommended many similar criteria. The IOM report informed the American Academy of Family Physicians' current processes for developing and endorsing clinical practice guidelines from other organizations. The AAP guideline will undergo a structured quality assessment by AAFP staff and members of the Commission on the Health of the Public and Science (including me), who will recommend to the Board of Directors if the guideline should be fully endorsed, receive an Affirmation of Value, or not endorsed. So stay tuned for more analysis of this guideline in the coming months.

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This post first appeared on the AFP Community Blog.

Monday, August 28, 2017

In health care and disasters, details make all the difference

In October 2012, when I heard that Superstorm Sandy was projected to make landfall somewhere in the vicinity of DC and Maryland, I prepared for the worst. I stocked up on non-perishable goods and evacuated to higher ground. (The rest of my family was already coincidentally out of town and harm's way.) I put fresh batteries into two flashlights and installed a flashlight app on my smartphone for good measure. Although I didn't give it much thought at the time, I assumed that hospitals in Sandy's path were taking similar precautions - stocking medical supplies, testing backup generators and so forth. So when a power failure at NYU Langone Medical Center (one of the teaching hospitals for NYU School of Medicine, where I received my medical degree) forced an evacuation of the entire hospital, with heart-stopping scenes of neonatal ICU nurses cradling respirator-dependent newborns down several flights of stairs to safety, I couldn't understand what had happened. How had they not been better prepared? Had NYU administrators been the equivalent of residents of low-lying coastal areas who ignored repeated warnings and defied evacuation orders?

As it turned out, NYU did a lot of things right before the storm. According to an article in ProPublica, after the scare of last year's Hurricane Irene, the hospital moved its emergency generators from street level to the rooftop and thoroughly waterproofed the generators' fuel pumps. Unfortunately, they neglected to relocate or protect the electricity distribution circuits, which remained in the basement and were quickly disabled by the flooding. As in many areas of health care, doing everything "almost right" wasn't good enough.

All people are fallible, and health professionals no less so than others. But medicine is usually less forgiving of simple mistakes. A technically perfect surgery is a disaster because it was performed on the wrong body part. A patient develops a life-threatening infection because a doctor forgot to wash his hands. A child dies three days after being discharged from an emergency room because his parents were not notified of critical lab values that came back hours after they left.

People are fallible, but health systems need not be. Despite the staggering complexity involved in flying passenger jets and constructing skyscrapers, commercial airline accidents are rare and building collapses even rarer. Atul Gawande argued in The Checklist Manifesto that checklists are the best way to make sure that small but critical details of health care are addressed systematically, so that every member of a care team feels empowered to preempt potential disasters. I believe that checklists and decision support tools are applicable not only to surgery or intensive care settings, but to primary care as well.

Fortunately, the emergency evacuation of NYU Langone Medical Center went off smoothly. But today, as the news of Hurricane Harvey's devastating impact on Houston's hospitals and nursing homes is just coming into focus, I hope that the good outcome of NYU's near-miss did not make any hospital or public health system complacent about addressing the little details and vulnerabilities that can make all the difference.

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An earlier version of this post was publised on Common Sense Family Doctor on December 4, 2012.

Monday, August 21, 2017

Procedures and prevention: the challenges of Choosing Wisely

A 55 year-old woman with chronic low back pain and symptomatic knee osteoarthritis asks her family physician's opinion about lumbar fusion surgery and some arthritis walking shoes she saw advertised on television. She is prescribed long-acting oxycodone and physical therapy for back pain, and her orthopedist recently began a series of hyaluronic acid injections for her knees. She is up-to-date on cervical and breast cancer screening, but also desires screening for ovarian cancer.

The next patient is her husband, a 60 year-old man with stable coronary artery disease. He was recently hospitalized for an episode of chest pain, and although tests did not show a myocardial infarction, a cardiac catheterization found an 80% stenosis in the left anterior descending artery. He already takes a baby aspirin daily, but his cardiologist has advised adding clopidogrel and having a coronary stent placed. Last year, he quit smoking after going through a pack of cigarettes a day for 40 years, and he is interested in screening for lung cancer. Also, since his brother was diagnosed with colorectal cancer at age 50, he has undergone screening colonoscopies at ages 40, 45, 50, and 55. These have all been normal, and he wonders if it is necessary for him to continue having them every 5 years.

Although both of these patients are fictitious, they represent common clinical scenarios in family medicine that contain enormous potential for overdiagnosis and overtreatment. In the August 15 issue of American Family Physician, Drs. Roland Grad and Mark Ebell presented this year's edition of the "Top POEMs Consistent with the Principles of the Choosing Wisely Campaign," which included the following suggested clinical actions:
As with last year's Top POEMs list, questioning unnecessary procedures or non-beneficial treatments is an effective way to protect patients from harm. But it's important to take a critical approach to preventive care as well to avoid overscreening. For example, as Dr. Jennifer Middleton noted in a previous blog post, one high-profile screening test for ovarian cancer still has big gaps in the evidence regarding its effect on mortality. Drs. Grad and Ebell advised not screening for ovarian cancer and carefully weighing the risks and benefits of lung and colorectal cancer screening:
It is challenging, and sometimes uncomfortable, to question long-accepted practices that feel like "old friends," AFP assistant medical editor Allen Shaughnessy wrote in a 2016 editorial. He suggested that clinicians keep in mind that the purpose of these evidence-based recommendations, and all of those from the Choosing Wisely campaign, is to improve care and reduce harm:

Every aspect of patient care—every word we say, every test or exam we perform, every treatment or procedure we employ—carries with it the possibility of harm as well as the opportunity for benefit. Although eliminating overuse is often perceived as a way of cutting medical costs, it is really about decreasing wasteful, unnecessary testing and treatment that offer only the potential of harm without the corresponding possibility of benefit. Sometimes, we need to leave our old friends behind.

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This post first appeared on the AFP Community Blog.

Wednesday, August 16, 2017

How about ranking how well hospitals serve their communities?

I'm sure that many fabulously talented, skillful, compassionate physicians work at the Cleveland Clinic. If I lived in Cleveland or a nearby town and suffered from a rare or life-threatening disease, I would strongly consider going to the Clinic for specialty care. Maybe I would even work there. But ranking the Cleveland Clinic the #2 hospital in America, as U.S. News and World Report did last week, is outrageous. (Full disclosure: I once blogged for U.S. News.)

My use of the term "outrageous" has little to do with deficiencies in U.S. News's ranking methodology, whose past versions have been criticized for relying more on subjective reputation rather than objective data on safety and quality, and having no correlation with other ratings such as those on Medicare.gov's Hospital Compare website. As Elisabeth Rosenthal has previously reported, hospital rankings are mostly about hype, and it's questionable how much impact they really have on patient choices when every academic or community hospital can probably find at least one high-ranked specialty or service line to brag about.

No, I think this top-notch ranking is outrageous because it only accounts for the patient care that the hospital and its affiliated practices provide, rather than including the health status of the surrounding community - which is awful. Although the Clinic may provide excellent care to patients who walk or are wheeled through its doors, Dan Diamond's recent article in Politico sharply contrasted the overflowing wealth of the medical institution with the barren, crumbling neighborhoods that surround it:

Yes, the hospital is the pride of Cleveland, and its leaders readily tout reports that the Clinic delivers billions of dollars in value to the state. ... But it’s also a tax-exempt organization that, like many hospitals, fought to preserve its not-for-profit status in the years leading up to the Affordable Care Act. As a result, it doesn’t have to pay tens of millions of dollars in taxes, but it is supposed to fulfill a loosely defined commitment to reinvest in its community. That community is poor, unhealthy and — in the words of one national neighborhood-ranking website — “barely livable.”

Hospitals and health systems can't be expected to shoulder the entire burden of improving a community's economic prospects, and many hospitals were originally located in poor neighborhoods because that's where more sick people live. But according to Diamond, its financial figures indicate that the Cleveland Clinic hasn't been doing nearly enough for the community to offset the tax benefits it receives:

[The Clinic's] hospital system cleared $514 million in profit last year and $2.7 billion the past four years, when accounting for investments and other sources of revenue. And since the ACA coverage expansion took full effect, the Clinic’s been able to spend a lot less to cover uninsured patients; its annual charity care costs fell by $106 million from 2013 to 2015. But its annual community benefit spending only went up $41 million across the same two-year period, raising a $65 million question: Did the Clinic just pocket the difference in savings?

“I think we have more than fulfilled our duties,” [Clinic CEO Toby] Cosgrove said in response, pointing to the system’s total community benefit spending, which was $693 million in 2015. The majority of that spending, however, wasn’t free care or direct investments in community health; about $500 million, or more than 70 percent, represented either Medicaid underpayments — the gap between the Clinic’s official rate, which is usually higher than the rate insurers pay, and what Medicaid pays — or Clinic staffers’ own medical education.


It's not that the Cleveland Clinic is blind to the health crisis occurring outside of its doors. Like all nonprofit hospitals, it is required to perform a community health needs assessment (CHNA) every three years. The 189-page document it issued in 2016 provides a dismal accounting of all of the ways in which its local neighborhoods have worse indicators of health than other counties in Ohio and the vast majority of the nation. When Diamond suggested that the Clinic consider increasing its investments in population health, "where fixing community problems like lead exposure and food deserts are viewed as equally important as treating heart attacks," CEO Cosgrove sounded doubtful about what his hospital could or should do about these problems:

"That’s a good direction to go," he allowed. “But how much can we do in population health? We don’t get paid for this, we’re not trained to do this, and people are increasingly looking to us to deal with these sorts of situations,” Cosgrove added. “I say that society as a whole has to look at these circumstances and they can’t depend on just us.”

Judging from readers' comments posted at the end of the article, Cosgrove is far from alone in thinking that it isn't the place of medical institutions to solve the problems of distressed neighborhoods. Physicians and health executives have long believed that the responsibility of medicine is solely to provide health care, not social services or economic benefits outside of employment. But it's 2017, not 1967. As Susan Heavey reported for the Association of Health Care Journalists, in many parts of the U.S. health professionals have successfully partnered with advocates, local officials, and housing developers to "reinvent neighborhoods with [an] eye on health." If the leaders of the Cleveland Clinic wanted a road map for how to help rebuild the surrounding community, they could review one of 10 recent case studies posted by the Build Healthy Places Network, an organization whose mission "is to catalyze and support collaboration across the health and community development sectors, together working to improve low-income communities and the lives of people living in them."

On a national level, rather than allowing CHNAs to gather dust on a shelf (or the online equivalent), health policymakers could use them to allocate public funding for graduate medical education where it is needed most, rather than where it is currently going. As Dr. Melanie Raffoul, one of my past Policy Fellows, wrote recently in an analysis of Texas CHNAs and regional health partnership plans in the Journal of the American Board of Family Medicine:

Many [CHNAs] mentioned problems such as “low literacy,” “food deserts,” or “high levels of teen pregnancy.” Many of these concerns cannot be meaningfully addressed by hospitals, but they can be tackled through increased access to primary care and mental health services, and residency training sites are one way to provide this to the community. This should increase institutions' thinking about their role in larger community strategies to tackle community issues that affect health. Workforce gaps similarly need to be seen in this context—a community resource meant to resolve community needs. ... Community assessments could help refocus the use of publicly funded physician training as part of a broader hospital-community partnership for resolving health needs.

I began by stating that I didn't think that the Cleveland Clinic deserved to be ranked the #2 hospital in the nation, but since U.S. News and World Report already put it on that pedestal, the Clinic should live up to it by not only providing the best health care for their patients, but getting serious about improving the health of their community.

Thursday, August 10, 2017

On liberty and health reform in America

Since 2007, I've participated in more than a dozen American Civil War battlefield tours sponsored by the Smithsonian Associates. Even though a handful of Chinese Americans fought on both sides of the Civil War, none of my ancestors did, and friends and family are often perplexed by my endless fascination with this conflict. In Civil War museums and sites thronged by overwhelmingly white tourists, I'm even more of an oddity than the rare African American. This realization got me wondering why so few African Americans are passionate about the history of the war that freed so many of their ancestors from slavery. To Atlantic columnist and fellow Civil War buff Ta-Nehisi Coates, this antipathy stems from the efforts of white Americans over the past 150 years to write them out of the story:

For my community, the message has long been clear: the Civil War is a story for white people—acted out by white people, on white people’s terms—in which blacks feature strictly as stock characters and props. We are invited to listen, but never to truly join the narrative, for to speak as the slave would, to say that we are as happy for the Civil War as most Americans are for the Revolutionary War, is to rupture the narrative. Having been tendered such a conditional invitation, we have elected—as most sane people would—to decline.

As reflected in the Presidential election of 2016, economic and racial divisions are always resurfacing, with the perennial Republican versus Democratic contest being portrayed in the media as a battle between the "rich" and the "poor," or white citizens versus those of every other color. But these stereotypes ignore the inconvenient facts that plenty of low-income rural whites who bear no racial grudges and a few minority voters in heavily Democratic states and the District of Columbia dependably vote Republican.


In his most recent book, subtitled "Why the Civil War Still Matters," historian James McPherson shed some light on this present-day paradox by explaining that liberty meant two different things to Southern and Northern leaders in 1861. To white Democrats in the pre-Civil War South (slaveholders or not - and the vast majority were not), liberty meant "freedom from" interference by a distant federal government. Historical figures such as Confederate general Robert E. Lee traced their cause back to the Virginian Founding Fathers and slaveholders George Washington and Thomas Jefferson, whose Revolutionary War was fought to break away from a distant British ruler whose arbitrary actions offended colonial sensibilities.

On the other hand, the Republican Party in the North viewed liberty as "freedom to," arguing that it's hard to achieve anything noteworthy when one is penniless, starving, or a slave. Even though the North won the Civil War, achieving full citizenship for African Americans took nearly a century after passage of the the Fifteenth Amendment to the U.S. Constitution. Only after the hard-won passage of the 1965 Voting Rights Act, which prohibited poll taxes and gave the federal government the power to end various discriminatory practices that prevented most Black citizens in Southern states from registering to vote, did African Americans finally gain freedom to participate in the political process.

The more recent history of how and why African Americans turned away from the party of Lincoln to embrace the party of their former oppressors is too long to recount here, but these differing views of personal liberty - "freedom from" versus "freedom to" - go a long way toward explaining the two political parties' diametrically opposed views of the Affordable Care Act. For the most part, Republican governors have resisted health insurance exchanges and rejected Medicaid expansions because they and their constituents have perceived these provisions of the law as encroachments on freedom by the Washington bureaucracy, while Democratic governors have recognized that it's hard to have freedom to achieve personal success if one is too ill, or too worried about the financial implications of unexpected illness or injury, to plan confidently for the future.

Not only can you find the roots of modern medicine in the American Civil War, but the roots of our current national health policy debate, too.

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This post first appeared on Common Sense Family Doctor on October 2, 2015.

Tuesday, August 1, 2017

Pushing back against prescription drug price gouging

Sometimes missed in the headlines about the stratospheric costs of new specialty drugs is the contribution of price hikes for older, established drugs, including generics, to prescription spending increases. In an editorial in the July 1 issue of American Family Physician, Dr. Allen Shaughnessy described several situations that drug manufacturers exploit to raise prices excessively (also known as price gouging):

- Limited to no alternatives
- Older products with few producers
- Same product, different use
- Single producer, no generic available
- Evergreening (minor changes to gain patent exclusivity)
- Pay for delay (paying generics manufacturers not to sell a generic version of an off-patent drug)

In the United States, Dr. Shaughnessy observed, "The biggest driver of the cost hike is, simply put, that pharmaceutical companies can charge whatever they want. Drugs cost what the market will bear. Many medications could be a lot less expensive, but because an insurance company, the government, or a patient is willing to pay the asking price, there is no push to lower the costs."

Price gouging has become such a problem for patients and insurers that the Maryland General Assembly recently passed legislation to discourage price gouging on essential off-patent or generic drugs. As explained by Drs. Jeremy Greene and William Padula in the New England Journal of Medicine:

The law authorizes Maryland’s attorney general to prosecute firms that engage in price increases in noncompetitive off-patent–drug markets that are dramatic enough to “shock the conscience” of any reasonable consumer. ... To establish that a manufacturer or distributor engaged in price gouging, the attorney general will need to show that the price increases are not only unjustified but also legally unconscionable. ... A relationship between buyer and seller is deemed unconscionable if it is based on terms so egregiously unjust and so clearly tilted toward the party with superior bargaining power that no reasonable person would freely agree to them. This standard includes cases in which the seller vastly inflates the price of goods.

The scope of the Maryland law is limited. It restricts action to off-patent drugs that are being produced by three or fewer manufacturers, and requires that manufacturers be given an opportunity to justify a price increase before legal proceedings are initiated. It is too early to know if the law will be effective against price gouging, or if it will be copied by other states that are also struggling to contain prescription drug cost increases in their Medicaid programs.

In the meantime, what can family physicians do to help patients lower their medication costs? In a 2016 editorial on the why and how of high-value prescribing, Dr. Steven Brown recommended five sound strategies: be a healthy skeptic, and be cautious when prescribing new drugs; apply STEPS and know drug prices; use generic medications and compare value; restrict access to pharmaceutical representatives and office samples; and prescribe conservatively.

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This post first appeared on the AFP Community Blog.

Tuesday, July 25, 2017

Community health workers can complement primary care

Several years ago, I attended an academic meeting where the subject of community health workers came up in a discussion. Earlier that year I had read about Vermont's ambitious blueprint for medical homes integrated with community health teams, so I volunteered that we needed fewer specialists and more trained laypersons with ties to their communities to implement prevention strategies. Another physician objected that while community health workers might work well in lower-income countries like India, we didn't need to deploy them in America, where people already know from their doctors that they should eat healthy foods, watch their weight, exercise, and not smoke and don't need others nagging them about it.

But should community health workers be viewed merely as extensions of medical institutions when large proportions of the population will not visit a doctor in a given year? An alternative model, wrote Health Affairs editor Alan Weil,

views CHWs as part of the communities in which they work. The roles of community health workers are defined by the community and CHWs through a process of community engagement. CHWs are valued for their contribution to community health, not for the savings they generate for health plans or providers. CHWs are embedded in the community, not in a clinician’s office or hospital. Advocacy is required to effect a transfer of resources out of clinical care into the community.

On the other hand, a New England Journal of Medicine commentary observed that the absence of connections between community health workers and family physicians can leave them working at cross-purposes:

CHW services are commonly delivered by community-based organizations that are not integrated with the health care system — for example, church-based programs offering blood-pressure screening and education. Without formal linkages to clinical providers, these programs face many of the same limitations — and may produce the same disappointing results — as stand-alone disease-management programs. CHWs cannot work with clinicians to address potential health challenges in real time, and clinicians can't shift nonclinical tasks to more cost-effective CHWs. Indeed, clinicians often don't recognize the value of CHWs because they don't work with them.


How can we bridge this gap? A review in the Annals of Family Medicine provided a list of structure, process, and outcome factors to consider for patient-centered medical homes to partner with peer supporters (a.k.a. community health workers).

For complex patients with multiple health conditions, care coordination is a key role where community health workers could potentially be more successful and cost-effective than expensive projects led by registered nurses or physicians. Reviewing the past decade of Medicare demonstration projects, researchers from the Robert Graham Center drew five lessons for future coordinated care models:

(1) Minimize expenses by sharing resources and avoiding cost ineffective interventions
(2) Concentrate on high utilizers
(3) Foster relationships with both providers and patients
(4) Track patients across the medical neighborhood in real time
(5) Extend rather than duplicate the efforts of primary care practices

Although optimal integration between the roles of community health workers and primary care teams is easier to describe than to achieve, moving both groups toward the common goal of communities of solution will be essential to protecting the health of the whole population.

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This post first appeared on Common Sense Family Doctor on September 11, 2015.

Thursday, July 20, 2017

Unequal treatment: disparities in how physicians are paid

As a family physician and medical school faculty member, I'm naturally a big booster of primary care. America needs more generalist physicians, not fewer, and much of my professional activity involves encouraging medical students to choose family medicine, or, failing that, general pediatrics or general internal medicine. But it's an uphill battle, and I fear that it's one that can't be won without major structural changes in the way that generalist physicians are paid and rewarded for their work.

In a recent Medicine and Society piece in the New England Journal of Medicine, Dr. Louise Aronson (a geriatrician) described visits with two of her doctors, a general internist and an orthopedist. The primary care physician worked in a no-frills clinic, often ran behind schedule, and devoted much of the visit and additional post-visit time to electronic documentation. The orthopedist worked in a newer, nicer office with an army of medical and physician assistants; generally ran on time; and was accompanied by a scribe who had competed most of the computer work by the end of the visit. Although there are undoubtedly a few family doctors with income parity to lower-earning orthopedists, according to Medscape's 2017 Physician Compensation Report, the average orthopedist makes $489,000 per year, while an average general internist or family physician makes around $215,000 per year. Here's what Dr. Aronson had to say about that:

It would be hard, even morally suspect, to argue that the salary disparities among medical specialties in U.S. medicine are the most pressing inequities of our health care system. Yet in many ways, they are representative of the biases underpinning health care’s often inefficient, always expensive, and sometimes nonsensical care — biases that harm patients and undermine medicine’s ability to achieve its primary mission. ...

Those structural inequalities might lead a Martian who landed in the United States today and saw our health care system to conclude that we prefer treatment to prevention, that our bones and skin matter more to us than our children or sanity, that patient benefit is not a prerequisite for approved use of treatments or procedures, that drugs always work better than exercise, that doctors treat computers not people, that death is avoidable with the right care, that hospitals are the best place to be sick, and that we value avoiding wrinkles or warts more than we do hearing, chewing, or walking.


Medical students are highly intelligent, motivated young men and women who have gotten to where they are by making rational decisions. For the past few decades, as the burden of health care documentation has grown heavier and the income gap between primary care physicians and subspecialists has widened, they have been making a rational choice to flee generalist careers in ever-larger numbers.

The cause of these salary disparities - and the reason that more and more primary care physicians are choosing to cast off the health insurance model entirely - is a task-based payment system that inherently values cutting and suturing more than thinking. I receive twice as much money from an insurer when I spend a few minutes to freeze a wart than when I spend half an hour counseling a patient with several chronic medical conditions. That's thanks to the Resource-Based Relative Value Scale, a system mandated by Congress and implemented by Medicare in 1992 in an attempt to slow the growth of spending on physician services. Every conceivable service that a physician can provide is assigned a number of relative value units (RVUs), which directly determines how much Medicare (and indirectly, private insurance companies) will pay for that service.

As new types of services are developed and older ones modified, the RVUs need to be updated periodically. Since the Centers for Medicare and Medicaid Services (CMS) chose not to develop the in-house expertise to do this itself, it farms out the updating task to the Relative Value Scale Update Committee (RUC), a 31-member advisory body convened by the American Medical Association (AMA) and nominated by various medical specialty societies. Here is where the fix is in. Only 5 of the 31 members represent primary care specialties, and over time, that lack of clout has resulted in an undervaluing of Evaluation and Management (E/M) and preventive services (the bulk of services provided by generalist physicians) compared to procedural services. Although an official AMA fact sheet pointed out that some RUC actions have increased payments for primary care, a 2013 Washington Monthly article countered that these small changes did little to alter the "special deal" that specialists receive:

In 2007, the RUC did finally vote to increase the RVUs for office visits, redistributing roughly $4 billion from different procedures to do so. But that was only a modest counter to the broader directionality of the RUC, which spends the vast majority of its time reviewing, updating—and often increasing—the RVUs for specific, technical procedures that make specialists the most money. Because of the direct relationship between what Medicare pays and what private insurers pay, that has the result of driving up health care spending in America—a dynamic that will continue as long as specialists dominate the committee.


We teach our medical students to recognize that inequities in where patients live, work and play are far more powerful in determining health outcomes than the health care we provide. A child living in a middle-class suburb has built-in structural advantages over a child living in a poor urban neighborhood or rural community, due to disparities in economic and social resources. The same goes for how physicians are paid in the U.S. Until the RUC is dramatically reformed or replaced with an impartial panel, the $3 trillion that we spend on health care annually (20 percent of which pays for physician services) will continue to produce shorter lives and poorer health compared to other similarly developed nations.

Monday, July 17, 2017

Self-monitoring doesn't improve control of type 2 diabetes

"Have you been checking your sugars?" I routinely ask this question at office visits involving a patient with type 2 diabetes, whether the patient is recently diagnosed or has been living with the disease for many years. However, the necessity of blood glucose self-monitoring in patients with type 2 diabetes not using insulin has been in doubt for several years.

A 2012 Cochrane for Clinicians published in American Family Physician concluded that "self-monitoring of blood glucose does not improve health-related quality of life, general well-being, or patient satisfaction" (patient-oriented outcomes) and did not even result in lower hemoglobin A1C levels (a disease-oriented outcome) after 12 months. In their article "Top 20 Research Studies of 2012 for Primary Care Physicians," Drs. Mark Ebell and Roland Grad discussed a meta-analysis of individual patient data from 6 randomized trials that found self-monitoring improved A1C levels by a modest 0.25 percentage points after 6 and 12 months of use, with no differences observed in subgroups. Based on these findings, the Society of General Internal Medicine recommended against daily home glucose testing in patients not using insulin as part of the Choosing Wisely campaign.

Still, the relatively small number of participants in trials of glucose self-monitoring, and the persistent belief that it could be useful for some patients (e.g., recent type 2 diabetes diagnosis, medication nonadherence, changes in diet or exercise regimen), meant that many physicians have continued to encourage self-monitoring in clinical practice. In a 2016 consensus statement, the American College of Endocrinology stated that in patients with type 2 diabetes and low risk of hypoglycemia, "initial periodic structured glucose monitoring (e.g., at meals and bedtime) may be useful in helping patients understand effectiveness of medical nutrition therapy / lifestyle therapy."

In a recently published pragmatic trial conducted in 15 primary care practices in North Carolina, Dr. Laura Young and colleagues enrolled 450 patients with type 2 non-insulin-treated diabetes with A1C levels between 6.5% and 9.5% and randomized them to no self-monitoring, once-daily self-monitoring, or once-daily self-monitoring with automated, tailored patient feedback delivered via the glucose meter. Notably, about one-third of participants were using sulfonylureas at baseline. After 12 months, there were no significant differences in A1C levels, health-related quality of life, hypoglycemia frequency, health care utilization, or insulin initiation. This study provided further evidence that although glucose self-monitoring may make intuitive sense, it improves neither disease-oriented nor patient-oriented health outcomes in patients with type 2 diabetes not using insulin. So why are so many clinicians still encouraging patients to do it?

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This post first appeared on the AFP Community Blog.