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.