Thursday, December 1, 2016

The USPSTF weighs in on statins for primary CVD prevention

In other blog posts, I have discussed the 2013 American College of Cardiology/American Heart Association cholesterol treatment guideline, offered additional perspectives on its 7.5% 10-year CVD event risk threshold for starting a statin, and noted that existing cardiovascular risk calculators tend to overestimate risk by significant margins. The ACC/AHA guideline's expansion of the proportion of adults recommended for statin therapy has remained controversial. The American Academy of Family Physicians partially endorsed the guideline with qualifications (disclosure: I am a member of the AAFP Commission that made this recommendation), and a 2014 guideline from the U.S. Departments of Veterans Affairs and Defense recommended higher thresholds for considering (6%) or starting (12%) statins.

Last month, the U.S. Preventive Services Task Force weighed in with a new recommendation statement on the use of statins for primary prevention of cardiovascular events. The recommendations are similar to those from the ACC/AHA; the USPSTF recommends initiating low- to moderate-dose statins in adults aged 40 to 75 years with at least one CVD risk factor (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater ("B" recommendation). They recommend shared decision making and selective statin prescribing for similar adults with a 7.5% to 10% CVD risk ("C" recommendation).

The USPSTF's higher risk thresholds for statin therapy may compensate for uncertainty regarding the accuracy of CVD risk calculators, and the "C" recommendation recognizes that in persons at lower risk, the benefits of statins are less likely to outweigh the harms, which include liver enzyme abnormalities and muscle toxicity and a small increased risk of new-onset type 2 diabetes.

Although a prior USPSTF statement had recommended screening for lipid disorders in adults as early as 20 years of age, a new systematic review found no direct evidence on the benefits and harms of screening for or treatment of dyslipidemia in adults aged 21 to 39 years. So when should family physicians check cholesterol levels in an asymptomatic adult, if statins don't become a treatment option until age 40? This is an area to exercise clinical judgment on an individual basis, keeping in mind that healthy lifestyle counseling is more likely to be beneficial in adults with CVD risk factors than in adults without known risks.

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This post first appeared on the AFP Community Blog.

Thursday, November 24, 2016

Give thanks for small primary care practices

When I was in high school, a national hardware retailer opened a new franchise down the street from the mom-and-pop hardware store that had served my neighborhood for many years. Since the new store had the advantage of larger volumes and lower costs, it seemed to be only a matter of time before it drove its smaller competitor out of business, the way that big bookstore chains and fast-food restaurants had already vanquished theirs.

But a funny thing happened on the way to the inevitable. By the time I left for college, the new hardware store had folded, and the mom-and-pop operation had moved into their former building. How did this small business manage to retain its customers and win new ones without prior loyalties? The answer was quality of service. I remember visiting both stores when a classmate and I were working on a physics project. At the mom-and-pop store, the owner himself happily held forth for several minutes on the advantages and disadvantages of various types of epoxy adhesive. At the national hardware chain, the staff consisted mostly of kids my age who didn't know much more about glue than I did.

Six years ago, an editorial authored by White House officials in the Annals of Internal Medicine blithely predicted that small primary care practices would eventually be absorbed by "vertically integrated organizations" as a result of health reforms. The editorial prompted the American Academy of Family Physicians to send the White House a letter defending the ability of solo and small group practices to provide high-quality primary care. Despite the migration of recent family medicine residency graduates into employed positions, researchers from the Robert Graham Center estimated that up to 45% of active primary care physicians in 2010 practiced at sites with five or fewer physicians.

The limited resources of small practices seem to put them at a disadvantage relative to integrated health systems and Accountable Care Organizations. Small practices have less capital to invest in acquiring and implementing technology such as patient portals, and fewer resources (dollars and personnel) to devote to quality improvement activities, such as reducing preventable hospital admission rates. Nonetheless, like the small hardware store of my youth, some small practices are not only surviving, but thriving in the new health care environment. Dr. Alex Krist and colleagues reported in the Annals of Family Medicine in 2014 that eight small primary care practices in northern Virginia used proactive implementation strategies to achieve patient use rates of an interactive preventive health record similar to those of large integrated systems such as Kaiser Permanente and Group Health Cooperative. An analysis of Medicare data published in Health Affairs found that among primary care practices with 19 or fewer physicians, a smaller practice size was associated with a lower rate of potentially preventable hospital admissions.

In addition to providing superior service, solo physicians or small groups can create their own economies of scale by pooling resources and collaborating with other practices in areas such electronic health record systems and quality improvement. For example, Dr. Jennifer Brull reported how her practice and four others in north-central Kansas succeeded in improving hypertension control rates in an article and video in Family Practice Management.

These examples illustrate that the demise of the small primary care practice has been greatly exaggerated. Whether small practices can continue to flourish in the era of health care consolidation and questionable quality metrics remains an open question, but I do know this: the small hardware store in my home town is still thriving, a quarter century later.

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This post first appeared on Common Sense Family Doctor on September 22, 2014. Happy Thanksgiving, everyone!

Friday, November 11, 2016

Repeal Obamacare; sustain the Affordable Care Act

On the Election Day that made Donald Trump the next President of the United States, I traveled to Lancaster, Pennsylvania to give a lecture. Long a conservative political stronghold, Lancaster County was dotted with "Make America Great Again" campaign signs, forecasting Trump's comfortable 47,000 vote margin there, which ended up being more than two-thirds of his 68,000 victory margin in Pennsylvania, one of the states that effectively decided the election. Ironically, Lancaster is where I trained to become a family physician from 2001 through 2004, and it is the place where I first recognized that the health care system our country had then was not up to the task of caring for all the people. Lancaster, which started me on my path toward advocating for reforms that ended up in the Affordable Care Act, voted overwhelmingly for a candidate who has promised to repeal it.

Let me admit that I've never had particularly warm feelings toward President Obama. I think his foreign policy has been a mess. The trillions of dollars in debt that the U.S. has run up over his term will hurt my generation and future generations, and if Republicans should be faulted for their fantasy that the federal budget can be balanced exclusively through spending cuts, Obama has sustained the Democratic fairy tale that raising taxes on "millionaires and billionaires" is all that is necessary to pay the skyrocketing bills. On multiple occasions during my time in government, the President had no qualms about squashing science and scientists for political convenience. And for all of his rhetorical gifts when preaching to the choir, he's been one of the least effective persuaders-in-chief to have held the office.

And so, naturally, I oppose Obamacare. I oppose a government takeover of health care that included morally repugnant death panels staffed by faceless bureaucrats who decide whose grandparents live or die and make it impossible for clinicians to provide compassionate end-of-life care. I oppose the provision in Obamacare that said that in order for some of the 50 million uninsured Americans to obtain health insurance, an equal or greater number must forfeit their existing plans or be laid off from their jobs. I oppose the discarding of personal responsibility for one's health in Obamacare. I oppose Obamacare's expansion of the nanny-state that regulates the most private aspects of people's lives.

It's a good thing that Obamacare, constructed on a foundation of health reform scare stories, doesn't exist and never will.

Instead, the Affordable Care Act (which I support) is based on a similar politically conservative law in Massachusetts that was signed by a Republican governor and openly supported by the administration of George W. Bush. It achieved the bulk of health insurance expansion by leveling the playing field for self-employed persons and employees of small businesses who, until now, didn't have a fraction of the premium negotiating power of large corporations that pool risk and provide benefits regardless of health status. The ACA discouraged irresponsible health care "free riders" and provided support for people of modest means to purchase private health insurance in regulated open marketplaces. It told insurers that in exchange for millions of new customers, they could no longer discriminate against the old and sick. Finally, the ACA rewarded physicians and hospitals for care quality and good outcomes, rather than paying for pricey tests and procedures that may not improve health.

The ACA has flaws. It didn't narrow the income disparity between different types of physicians or encourage more medical students to choose careers in primary care. It didn't prevent pharmaceutical companies from arbitrarily jacking up prices on old but essential drugs. Its provisions to discourage overuse of unnecessary medical services were limited and inadequate to the scope of the problem. But it's worth noting that all of these problems all predated the law. We don't have enough family physicians and other primary care clinicians, drugs in the U.S. cost more than anywhere else in the world, and overdiagnosis and overtreatment have been rampant for years. That the ACA took on these issues at all was a small victory.

It's interesting to consider the counterfactual exercise of what might have happened if Mitt Romney had captured the 2008 Republican Presidential nomination and then narrowly defeated Hillary Clinton, the odds-on favorite for the Democratic nomination in that year. No doubt affordable health care would have been an important focus of that hypothetical contest, with Romney successfully linking Clinton to her husband's failed 1994 reform plan that makes right-wing objections to the ACA look insignificant by comparison. Once elected, a President Romney would have felt compelled to advance national health reform, and would have naturally modeled his proposals on his Massachusetts plan. We might have ended up with a conservative law that looked much like the Affordable Care Act, only this time criticized by the left for being too administratively complex and not generous enough in providing coverage for all.

A farfetched scenario, you say? Perhaps. But it underlines the need for thoughtful Republicans to look past their leaders' overheated rhetoric about repealing Obamacare and focus on strengthening and sustaining the ACA, starting now.

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A slightly different version of this post first appeared on Common Sense Family Doctor on September 30, 2013.

Thursday, November 3, 2016

When treating addiction, the words we use matter

In a JAMA editorial last month, Director of National Drug Control Policy Michael Botticelli and former DHHS Assistant Secretary for Health Howard Koh wrote that it was time to change the language health professionals and researchers use to refer to patients who suffer from addictions. This isn't simply an exercise in political correctness. Stigmatizing terms that "describe [patients] solely through the lens of their addiction or their implied personal failings" have been shown to negatively influence mental health clinicians' attitudes: someone described as a "substance abuser" was considered less treatable and more likely to be blamed for his or her condition than a "person with a substance use disorder." Similarly, they recommended describing someone with a history of having abused substances as "in recovery" rather than "clean." Botticelli knows his subject perhaps better than any previous U.S. "drug czar" (another term he prefers to not use), being in recovery himself from alcoholism.

I've written before about the failure of our criminal approach to drug misuse and the problems that misuse of legal pain medications have created for patients who suffer from chronic pain. Abetted by pharmaceutical companies whose sales representatives convinced many doctors that opioids were safe and non-addictive, the medical profession handed out powerful drugs like OxyContin as freely as Halloween candy, with devastating consequences.

Those consequences were more devastating in some communities than others. For almost every imaginable medical condition, members of racial and ethnic minorities receive less care and have poorer health outcomes, and addiction is not an exception. An article titled "Deconstructing Addiction" in NYU Physician began by describing two men in their 20s who sought treatment for heroin addictions and severe mood swings. One was diagnosed with bipolar disorder and prescribed antipsychotic medications and supervised methadone treatment. The other received an antidepressant and buprenorphine. Why were their medical plans so different? The first man was "a Latino living in a poor section of Brooklyn," while the second was a "middle-class white man from suburban Queens." Helena Hansen, an NYU psychiatrist and medical anthropologist, has worked to unravel the complex web of social and political forces that created these care disparities:

Methadone, she learned, was initially presented to the public as a tool for lowering crime in black and Latino communities. Accordingly, methadone clinics were mostly located in those areas. ... By the start of the new millenium, media reports warned of an epidemic of OxyContin addiction sweeping suburban and rural America. Buprenorphine maintenance, Dr. Hansen found, was aimed expressly at this new, overwhelmingly white cohort of substance abusers. ... When buprenorphine came on the market, ads portrayed the typical user as a white, middle-class dad who'd become addicted to painkillers after a back injury and wanted to return to coaching the son's baseball team. Even now, many buprenorphine providers accept only private insurance or out-of-pocket payments - unlike methadone clinics, which rely mostly on Medicaid reimbursements.

Although this two-tiered approach to treatment was not intended to create inequality, Hansen emphasized, it rapidly became incorporated into the structure of medicine and perpetuated stereotypes about white versus nonwhite patients with substance use disorders:

For addicted people in private care, most of whom are white, therapy is designed to minimize stigma and get the patient back to work or college; buprenorphine is used as a means toward these ends. Addicted people in public care - which covers most poor and nonwhite patients - are administered methadone under stringent supervision, steered into perceiving themselves as permanently disabled, and prescribed psychotropic medications that may further compromise their health.

On a related note, I've given some serious thought recently to going through the certification process to prescribe buprenorphine. Few family physicians currently possess a Drug Abuse Treatment Act (DATA) waiver to do so, not because the process is particularly onerous (eight hours of mandated education, half live and half online), but because most feel poorly trained and equipped to manage the psychosocial needs of these patients. I can't get a psychiatrist to see my few patients with mental illness that I consider beyond my capabilities unless they can pay cash; my heart sinks when I ponder how to arrange necessary care and social services for patients with substance use disorders. Working for a health system connected to a tertiary medical center, living in a city where the doctor to population ratio is one of the highest in the country, I rarely view myself as the health care option of last resort for anyone. But the need for accessible addiction treatment is great, and it isn't being met.

Wednesday, October 26, 2016

Underperforming big ideas in diabetes and breast cancer

Management of type 2 diabetes and screening for breast cancer make up a large portion of most family physicians' practices, including my own. Care and prevention for these patients is based on straightforward underlying theories of disease causation and behavior. Patients with type 2 diabetes have high blood glucose levels; treatment involves normalizing blood glucose through lifestyle modification and medication. Small, nonpalpable breast cancers eventually become large, symptomatic tumors. Smaller tumors are more likely to be curable, so undergoing regular screening mammography is preferable to not doing so.

But what if these underlying theories are wrong?

In a recent editorial in JAMA, Drs. Michael Joyner, Nigel Paneth, and John Ioannidis explored how the "big idea" or narrative that investments in genetics and information technology will lead to a revolution in health care has captured a large share of biomedical research funding and journal publications. They then illustrated how this big idea has "underperformed," as central assumptions of precision/personalized medicine have not been borne out in studies and tens of billions of dollars invested into electronic health records since 2009 have not made patient care measurably better or patient data more accessible to researchers.

Is tight glycemic control for patients with type 2 diabetes mellitus an underperforming clinical big idea? In an analysis in Circulation: Cardiovascular Quality and Outcomes, Drs. Rene Rodriguez-Gutierrez and Victor Montori compared clinical policy statements and practice guidelines for patients with type 2 diabetes between 2006 and 2015 with evidence from randomized controlled trials. Despite little or no evidence that tight glycemic control (hemoglobin A1c less than 6.5 or 7.0%) improves microvascular or macrovascular outcomes compared to less strict hemoglobin A1c goals, the majority of guidelines continued to endorse tight control for one or both of those outcomes. (In contrast, American Family Physician editorials and articles have asserted that "Physicians should not let well-intentioned but misguided concern for glucose levels distract them from attending to other interventions that more profoundly affect mortality [in patients with type 2 diabetes]: smoking cessation, blood pressure control, metformin therapy, and lipid reduction.")

And do small breast tumors detected by mammograms become large, lethal ones? Sometimes, but not as often as most patients and physicians think, according to an observational study in the New England Journal of Medicine that concluded: "Women [with tumors detected on mammography] were more likely to have breast cancer that was overdiagnosed than to have earlier detection of a tumor that was destined to become large." This study also concluded that most of the reduction in breast cancer mortality over the past 40 years could be attributed to improved systemic therapy rather than earlier tumor detection. In an editorial on counseling women about breast cancer screening, Dr. Mark Ebell and I discussed the benefits and harms of mammography in younger women and noted that for every additional breast cancer death prevented by starting at age 40, two women will be overdiagnosed with (and overtreated for) breast tumors that never would have become clinically apparent.

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This post first appeared on the AFP Community Blog.

Thursday, October 20, 2016

The missing piece in diabetes prevention

Some of my posts, like this one on problems with proliferating systematic reviews, have very brief gestational periods. I read something that stirs my thinking on a topic, I am inspired, and I write about it in one sitting. Others can take longer, such as this post about direct primary care entering the mainstream of medicine, which came together after a few months of reading and speaking with others about the topic. And sometimes I have a topic in mind to write on but just can't decide where it fits best: this blog, the AFP Community Blog, my Medscape commentary series, or a "professional" publication such as a medical journal.

What I had in mind was a sequel of sorts to last summer's post about the folly of screening for prediabetes, which I believed was more likely to cause harm by labeling more people as being diseased than it was to motivate them to take action to prevent diabetes. As the American Medical Association and the Centers for Disease Control and Prevention stepped up their efforts to identify people "at risk" for prediabetes (and an analysis published in JAMA Internal Medicine calculated that 60% of U.S. adults under age 60, and 80% of adults age 60 or older, would fall into this category), I wanted to say more about this over-medicalized approach to diabetes prevention and what a better alternative could look like. Several times I started writing, but couldn't quite decide where the post was leading.

My thoughts finally gelled in a Medscape commentary published earlier this week, where I pointed out three problems with preventing diabetes by screening for prediabetes:

1) The evidence suggests that this approach doesn't help people live longer (mortality) or better (quality of life).

2) Screening (especially with the CDC's tool) will lead to lots of overdiagnosis.

3) By ignoring social determinants of health, such as poverty and inequality, that resist lifestyle changes, this strategy may worsen health disparities.

Here is what I concluded:

Changing unhealthy environments can be a far more effective and long-lasting intervention than one-on-one clinical counseling. In the late 1990s, the US Department of Housing and Urban Development randomly assigned 4500 women with children in high-poverty urban areas to no housing vouchers, unrestricted traditional vouchers, or vouchers that could only be redeemed for housing in low-poverty areas. Ten to 15 years later, the group receiving traditional vouchers was no healthier than the control group, but the group receiving low-poverty vouchers had significantly lower body mass index and glycated hemoglobin levels.


Although the Medicare DPP as proposed should improve the health of many of our patients, in order to prevent diabetes without worsening health disparities, family physicians also require resources to address social determinants of health. To this end, the American Academy of Family Physicians recently published a position paper describing strategies for collaborating effectively with public health partners to lead the prevention of chronic diseases in our communities.