Caring for the underserved: the National Health Service Corps

Forty years ago, Eric Redman's classic book The Dance of Legislation provided a compelling "insider's account" of how the U.S. Senate worked by following the winding path of Public Law 91-623 (The Emergency Health Personnel Act of 1970), which created the National Health Service Corps (NHSC). Envisioned by Seattle pediatrician Abraham Bergman, MD as a way to recruit idealistic young physicians to "doctor deficient" communities throughout the U.S., the NHSC and its authorizing legislation successfully navigated a perilous policymaking process, an unsupportive Administration, and the threat of a pocket veto to become law in the final days of the 91st Congress. Later legislation added scholarship and loan repayment programs to the NHSC, and recent funding increases provided by the American Recovery and Reinvestment Act and the Affordable Care Act have tripled the size of the corps from 3600 to nearly 10,000.

In this month's Georgetown University Health Policy Seminar, we critically evaluated the accomplishments and limitations of the NHSC in improving access to care for the medically underserved. A literature review by Dr. Robert Politzer and colleagues in 2000 found mixed results: although the NHSC relieved health professional shortages in many communities over the years, physicians often did not stay in these communities beyond their 2-year service commitments, and the neediest areas were actually less likely to be successful in recruiting clinicians. The absence of a service analogous to the National Resident Matching Program meant that the NHSC placement process favored well-organized communities with more resources, rather than matching greater numbers of clinicians to areas with greater needs. At around the same time, a commentary by Dr. Fitzhugh Mullan advocated for a more expansive role for the NHSC in the 21st century, including options to practice community-oriented primary care, in urban hospitals, in public health, and in prison and international health settings.

Currently, the collective impacts of the individual and employer mandates and guaranteed insurance issue provisions of the Affordable Care Act on underserved communities remain uncertain. Will the implementation of the ACA make the NHSC less necessary, or will projected gaps in coverage among immigrants and Medicaid-ineligible adults continue to leave many areas with health professional shortages? Physicians of all ethnic and cultural backgrounds tend to migrate to affluent areas, and retirements of small-town family doctors may end up relegating some communities to welcoming a new crop of primary care clinicians every few years. Are there alternative health policies that could attract primary care and subspecialist physicians to areas where they are most needed?

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The above post first appeared on The Health Policy Exchange.

$10 billion per year to train the wrong physicians

Earlier this year, the physicians at my academic family medicine practice met with two senior officials from our parent health care organization to be oriented to its new initiatives and projects. Their presentation documented the organization's ongoing investments of many millions of dollars into renovating subspecialty care suites and purchasing new radiology equipment that was likely to be highly profitable, but provide dubious benefits to patients. Two of my colleagues asked why, given the expected influx of millions of newly insured patients into primary care starting in 2014, and an estimated shortfall of more than 50,000 primary care physicians by 2025, the organization had not identified expansion of primary care training as a financial priority. Where exactly did they expect to find family physicians to staff all of the new community offices they planned to open? An awkward silence ensued, followed by some polite hemming and hawing about how this was a complicated issue, and that supporting generalist training would likely require additional funding that was perhaps beyond the organization's limited resources.

Additional funding required? How about $9.5 billion? That's the approximate amount that that Medicare spends each year, with no strings attached, to subsidize the cost of training physicians in U.S. residency programs. Noting that the federal government doles out these dollars without requiring any particular outcomes from the institutions that benefit from them, some have called for Medicare to hold institutions more accountable for meeting America's physician workforce needs. If we have a surplus of radiologists and a shortage of general surgeons, why not tie funding to training more of the latter and fewer of the former? Given the decentralized nature of the U.S. health system, though, that has been easier said than done. In particular, it is challenging to follow the money trail and determine which institutions end up producing which types of doctors.

A new study in Academic Medicine by health services researchers at The George Washington University and the Robert Graham Center fills this information gap. Painstakingly assembling and cross-checking data from several sources on actively practicing physicians who completed their residency training from 2006 to 2008, they were able to identify residency-sponsoring institutions that were top producers of primary care physicians, that produced lower proportions relative to all physicians, and that produced none at all. Notably, they conclusively disproved "The Dean's Lie" that counts all internal medicine residents as going into primary care (when only 1 in 5 actually plan to do so), demonstrating that at some institutions fewer than 1 in 10 internists become primary care physicians. They also identified a large funding discrepancy between the top and bottom primary care producers.

The top 20 primary care producing sites graduated 1,658 primary care graduates out of a total of 4,044 graduates (41.0%) and received $292.1 million in total Medicare GME payments. The bottom 20 graduated 684 primary care graduates out of a total of 10,937 graduates (6.3%) and received $842.4 million.

In short, where physician production is concerned, you get what you pay for. In this case, Medicare pays a disproportionate amount of its nearly $10 billion per year in subsidies to institutions that produce mostly subspecialists, even in specialties where supplies are plentiful, at the expense of training sorely needed family physicians and other generalists whose presence has been shown time and again to deliver better health outcomes.

That's the big picture. Since all politics is local, policymakers who want to know what types of physicians their teaching hospital or health system is training can use the Graham Center's free GME Outcomes Mapper tool to find out. And if enough of them do so, maybe we can all have a serious national conversation about moving beyond guaranteed health insurance coverage to ensuring that the care (and the workforce) that coverage is paying for will actually help us to live longer or better.

Rosiglitazone for diabetes: helpful, harmful, or neither?

Recently, an advisory panel convened by the U.S. Food and Drug Administration (FDA) voted to relax safety restrictions on the diabetes drug rosiglitazone (Avandia) that were put in place in response to previous evidence that rosiglitazone may increase the risk of heart attacks and cardiovascular deaths. American Family Physician first highlighted these safety concerns in its March 15, 2008 Tips From Other Journals, which Dr. Kenneth Moon concluded:

There is substantial circumstantial evidence that rosiglitazone is associated with higher risks of heart failure and myocardial infarction. Despite the awkwardness of persuading a patient to use a drug that may provide similar benefits but pose greater risks than other proven agents, the legitimate concerns raised by these studies make this a serious issue. Until there is conclusive evidence about the safety of rosiglitazone, many physicians and their patients may be more comfortable using alternative treatments.

Subsequent AFP articles on management of blood glucose in type 2 diabetes and rosiglitazone vs. pioglitazone reinforced cautionary messages about rosiglitazone. However, the results of a large randomized trial published in 2009 found similar risks for cardiovascular hospitalizations and death in patients using rosiglitazone compared to patients taking other oral diabetes drugs. This trial, which was sponsored by rosiglitazone's manufacturer GlaxoSmithKline, was criticized for methodological problems, but an independent re-analysis of the trial's data persuaded the FDA advisory panel that the drug's safety risks had been exaggerated in previous studies.

If the FDA acts on the advisory panel's recommendations and makes rosiglitazone more widely available, should family physicians prescribe it? It is worth noting that the panel considered only the drug's safety, not its effectiveness. A previous AFP Journal Club reminded readers that the disease-oriented outcome of improved glycemic control does not necessarily lead to patients living longer or better. Rosiglitazone causes more weight gain and congestive heart failure than metformin, and is more expensive than metformin and sulfonylureas. For those reasons, it should be a second- or third-line drug choice for patients with type 2 diabetes.

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This post was first published on the AFP Community Blog.

Guest Post: The myth of unrestricted pharmaceutical grants

A free clinical monograph from the American Academy of Family Physicians on "Diagnosis and Management of Obesity," sponsored by an educational grant from VIVUS, Inc. (manufacturer of the prescription weight-loss drug Qsymia) has stirred controversy about the financial relationships of the AAFP (which, full disclosure, pays me to provide independent editorial and consulting services for their journals American Family Physician and Family Practice Management). I received a copy of the obesity monograph and patient education materials in my clinical office but have been unable to find it online. Although this is hardly the first time that the AAFP has sought questionable commercial sponsorship for educational material (see my previous blog post about its agreement with Coca-Cola), the timing of this monograph's publication and a renewed sales push for the thus-far-disappointing diet drug is unlikely to be coincidental.

The usual defense of such medical-industry relationships goes as follows: the drug manufacturer provided an "unrestricted" educational grant and had no influence over the content, other than that it had to be about a certain topic (in this case, management of obesity). So why not accept this funding with no strings attached to produce unbiased clinical content for one's member physicians? In fact, why shouldn't a medical specialty society such as the AAFP seek funding from multiple competing drug companies to reduce the chance that its educational offerings will be biased one way or another? Dr. Jerome Hoffman strongly disagrees in his guest post below.

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It is possible that when Ford Motor Company puts out a brochure comparing mid-sized SUVs that it contains some "educational material," but this is hardly guaranteed! Same for this; it's possible they include some other stuff that is factual, in order to dress up the advertisement -- but neither is this guaranteed ... nor even relevant. Or if Ford paid Car and Driver to publish an "educational review" of auto companies, would you say, "Let's read it to see if it's fair before we presume to imagine it might be biased"? Of course if Ford assured us the funding was "an unrestricted grant," and the paid authors assured us they had no conflicts of interest -- well, OK, then I take it all back.

What if a law firm gave an unrestricted grant to a judge, to write an educational review of the firm's pending case before him? No worries, especially if the judge denies any conflicts.

I say that all those unrestricted grants corporations give to politicians (who certainly never fail to put the public interest first) don't ever buy influence, but merely "access."  When Enron gives millions to candidates on all sides, they're giving away their money merely as a generous public service ... just as the scientific monographs that they sponsor -- all written by non-conflicted authors (or ghostwriters) -- are simply attempts to educate us. Heaven forbid we prejudge them.

Excuse me, but Pharma doesn't throw away its money. There is no such thing as an unrestricted grant; if it didn't buy value in return, why would they pay for it? And if the author didn't write something they like to read, do you think he'd ever get another unrestricted grant?

Finally, I don't believe it's actually about favoring one company over another; it's about favoring them all. They may compete over certain individual drugs, but they all thrive when "Key Opinion Leaders" (and our "independent" societies, and journals, and universities) help doctors, and the public, buy into the myth about wonder drugs (for sexual performance, for weight loss, etc.) ... at a cost of many many billions to all of us. That's why their extremely active lobbying trade group (PhRMA) represents all of them together.

Walking the walk: Day #5

This may be a startling admission to some of you, but the last time I did any sort of regular physical exercise was nearly 15 years ago, during my first two years of medical school. Back then, to relieve stress brought on by anatomy, pathology, and life in general, I would jog up First Avenue in Manhattan from my dormitory on 30th Street into the tony neighborhoods of the Upper East Side, then reverse course around 82nd Street and retrace my route home. During my third and fourth years of medical school; family medicine residency and fellowship; clinical, government, and academic careers; and a recently completed Master of Public Health degree, my running for fitness became increasingly sporadic, then ceased entirely.

Until now.

I can't pinpoint exactly what inspired me to start exercising regularly again after so long. Certainly, I'm not a spring chicken anymore, and there are limits to relying on my abundant genetic fortune (both of my paternal grandparents are going strong well into their 90s) to prevent future health problems. Maybe it's because half of my Facebook friends are doing 10Ks, or at least it seems that way. Maybe because my sister-in-law and her husband, both several years older, just completed Ironman triathlons. Maybe I'm tired of counseling patients my age or younger to make time for exercise when I'm not walking the walk myself. (And since it's day #5 after more than 5000 days of physical inactivity, I am mostly walking, though my goal is to slowly but surely get myself back into running shape.)

The fastest I've ever been was at age 14, when I clocked personal records for the mile (5:25) and 3 miles (18:39). I don't expect to approach these again. But this time I'm not aiming for fast - I'm aiming for slow and steady and keeping it up for years and years. I won't turn this blog into a runner's diary, but I thought I'd give you a heads up about what I'm doing amid my posts on clinical and policy issues and broadsides against too much medicine.

Low-value care for acute chest pain in the ED

Last week, the family medicine residency inpatient service that I supervise admitted several patients from the emergency department with acute chest pain that had resolved. Most of them had no history of cardiovascular disease, but were deemed to have enough risk factors to undergo pre-discharge cardiac stress testing after they had "ruled out" for acute coronary syndrome with normal cardiac enzymes. Rationales for the American Heart Association's recommendation for routine stress testing in patients with resolved chest pain include reducing malpractice liability, improving cardiac risk stratification, and initiating appropriate interventions earlier in high-risk patients. Although this practice is widely accepted, there is no evidence that it improves patient-oriented outcomes compared to outpatient management, and some researchers have argued that randomized trials are needed to prove that the benefits actually exceed the harms.

A recent study published in JAMA Internal Medicine adds fuel to this debate by presenting prospectively collected outcomes of adult patients evaluated in the emergency department chest pain unit of Mount Sinai Medical Center from 2004 to 2010. A total of 4181 patients underwent stress testing (512 with exercise ECG tests and the rest with nuclear perfusion imaging), and 470 tests suggested potential myocardial ischemia. 123 patients underwent cardiac catheterizations; 60 of these patients were found to have normal coronary arteries. Of the 63 patients whose catheterizations showed obstructive coronary artery disease, only 28 had lesions that warranted stenting or coronary artery bypass grafting according to expert consensus guidelines.

There are at least two ways to view this study's results. A positive interpretation is that cardiac stress testing led to in the presumptive diagnosis of coronary artery disease in more than 10 percent of patients, who could then have received medical interventions shown to improve outcomes. On the other hand, the high false positive rates on coronary angiography suggest that up to half of these diagnoses were incorrect (and, consequently, that more than 150 patients would have received therapy inappropriately). Nearly 90 percent of patients were exposed to significant radiation doses through nuclear imaging, but less than 1 percent had coronary artery lesions that warranted revascularization. So are the benefits of routine pre-discharge stress testing in patients with resolved chest pain worth the harms? If not, is reducing medical liability risk enough reason to continue a low-value practice?

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The above post was first published on the AFP Community Blog.

Biased research, aggressive sales, harmful drugs

Approval from the U.S. Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. Unfortunately, recent case studies have illustrated that FDA approval does not necessarily provide assurances of effectiveness and safety. In last month's Georgetown University Health Policy seminar, we discussed two examples, anemia drugs and the diabetes drug rosiglitazone (Avandia), which were prominently featured in recent articles by Peter Whoriskey in The Washington Post.

Image courtesy of scienceblogs.com

The original impetus for the development of the anemia drugs Epogen, Procrit, and Aranesp, which mimic the  actions of the hormone erythropoietin, was to spare dialysis patients with severe anemia the inconvenience and risks associated with periodic blood transfusions. However, noted Whoriskey, pharmaceutical companies moved aggressively to market these drugs to a far larger patient population who were much less likely to benefit from them:

The trouble would arise as the drugmakers won FDA approval for vastly expanded uses, pushing it in larger doses, for milder anemia and for patients with a wider array of illnesses. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. The size of average doses would more than triple. And over the next five years, the FDA would approve it to treat anemia in patients with cancer and AIDS, as well as those getting hip and knee surgery.

Doctors were motivated to give more doses of these drugs due to generous financial incentives (estimated at between $100,000 and $300,000 annually for a typical oncologist) and the seductive thinking that if some drug was good, more was better. Even the publication of a 1998 study in the New England Journal of Medicine showing no survival advantage to boosting hematocrit levels to normal ranges in cardiac patients did little to discourage overprescribing. Not until 14 years later did an independent researcher obtain access to the complete study report from the FDA and conclude that the NEJM authors had used statistical slight-of-hand to obscure an increased risk of heart attacks and death in the normal-hematocrit group. In the meantime, lobbyists working for the drug manufacturers successfully blocked efforts by Medicare administrators to stop paying for the higher (harmful) doses.

Similarly, the evidence that rosiglitazone (Avandia) increased the risk of heart attacks was slow to come to light, due in part to the drugmaker's research emphasis on the surrogate outcome of glycemic control. Although a 2007 meta-analysis first sounded the alarm about rosiglitazone's cardiovascular risks, the manufacturer successfully stalled regulatory action in the U.S. for three more years, during which thousands of new patients were prescribed the drug.

Could the FDA and other U.S. government agencies do more to protect patients from the effects of biased research and aggressive sales tactics for newly marketed drugs? What concrete steps could health policymakers take to encourage research to identify unexpected harms earlier in the drug approval process?

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The above post first appeared on The Health Policy Exchange.