The Political Economy of Medicaid Expansion

By Christopher Robertson

Many health law profs have wondered about how state officials can turn down bucketloads of federal money, without suffering the ire of their local constituents.  In states like Arizona, that frustration was spoken most vocally by the local healthcare industry and their employees, who have the most to gain from the expansion of coverage, even if the Medicaid beneficiaries are unlikely to themselves have political clout.

Well, over at the New Yorker, Sam Wang has now compiled the polling data for the gubernatorial races to ask whether “In Swing States, Is Obamacare an Asset?”  This graphic tells the whole story, focusing on states where Republican incumbents who made Medicaid-expansion decisions are now up for re-election:

Chart09-09-updated[1]

Although voters respond to a mix of positions and personalities, and these are only nine states, it is striking that the governors who declined federal money to cover their most vulnerable are also the most vulnerable at the polls.

Ethics of experimental Ebola interventions

By Annette Rid

In “Ethical considerations of experimental interventions in the Ebola outbreak“, published yesterday by The Lancet, Zeke Emanuel and I discuss what we take to be the key ethical questions about the use of Zmapp and other investigational agents in the current Ebola epidemic. In essence, we argue that the national and international response to the epidemic should focus on containment and strengthening health systems, rather than experimental treatments and vaccines; that experimental interventions, if they are used, should be distributed fairly and only in the context of clinical trials; and that advance planning is needed for research in future Ebola and other epidemics, as well as for making any proven interventions against Ebola accessible in affected regions.

The full article is available open access. Be sure to check out the Lancet’s new Ebola Resource Centre as well, which includes many other interesting pieces and a podcast (access here podcast) covering—among other things—our paper.

Is it ethical to hire sherpas when climbing Mount Everest?

By Emily Largent

In “Is it ethical to hire sherpas when climbing Mount Everest?,” a short piece out today in the British Medical Journal, I suggest that the question of whether it is ethical to pay sherpas to assume risks for the benefit of relatively affluent Western climbers is a variant of cases–common in medical ethics–where compensation and assumption of risk coincide.  Consider offers of payment to research subjects, organ sales, and paid surrogacy.  As a result, medical ethics can offer helpful frameworks for evaluating the acceptability of payment and, perhaps, suggest protections for sherpas as we look forward to the next climbing season on Everest.

I owe particular thanks to Nir Eyal, Harvard Medical School Center for Bioethics and Harvard School of Public Health Department of Global Health and Population; Richard Salisbury, University of Michigan (retired); and Paul Firth, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital.

Take a look and let me know what you think.

The Regulation of Dietary Supplements

By Joanna K. Sax
[Ed. Note: Cross-posted on HealthLawProfBlog.]

How have the massive amounts of dietary supplements on the market evaded significant regulatory oversight for so long? Dietary supplements are regulated as food, which means that for practical purposes the FDA only has the ability to pull them off the shelves upon a showing that they are harmful.

Many consumers use dietary supplements for the same purposes that someone may use a non-prescription drug. Some consumers actually feel safer using a dietary supplement because it is labeled as “natural,” rather than using an FDA approved over-the-counter drug. This doesn’t and shouldn’t make sense. Many natural things are harmful – would you eat any wild mushroom? Tobacco in in cigarettes is natural. Just because something is natural doesn’t mean that it is safe. Conversely, just because something isn’t “natural” in a drug doesn’t mean it is unsafe.

One of the main problems with regulating dietary supplements is that they are not all the same. We probably don’t need heavy regulation for Vitamin C, except maybe in formulation/content. We know, for example, that it is water soluble, so it is hard to take too much. So, maybe Vitamin C doesn’t pose the same safety concerns as other supplements. However, a recent article in Nature, vol. 510, pages 462-4, described different scientific viewpoints about the efficacy of vitamin supplements in healthy populations. So, unless you have a Vitamin C deficiency, then there is probably little reason to take it.

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“Gluten-Free” Labeling – Feeding a Fad

By Emily Largent

As of August 5, 2014, all foods labeled “gluten-free” must meet the requirements of the gluten-free labeling final rule.  The rule implements a portion of the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, which directed the Secretary of Health and Human Services to issue a regulation to define the term “gluten-free.”  The U.S. Food and Drug Administration (FDA) set a gluten limit of less than 20 parts per million for foods that carry the “gluten-free” label, which is the lowest level that can be reliably detected using scientifically validated analytical methods.

According to the FDA, the “final rule provides a uniform standard definition to help consumers with celiac disease manage a gluten-free diet.” Celiac disease is an immune reaction to eating gluten–a protein occurring in wheat, rye, and barley–that causes damage to the lining of the small intestine. This damage limits patients’ ability to absorb nutrients and can lead to a host of serious health problems. While there’s no cure for celiac disease, following a strict gluten-free diet can alleviate its symptoms. The new labeling requirements will surely give patients with celiac disease a powerful tool for managing their health, and has been lauded by patient advocacy organizations such as the American Celiac Disease Alliance.

Yet, folks with celiac disease won’t be the only ones keeping an eye on the new labels. While only three million Americans have celiac disease, avoiding gluten has become a food fad. Eleven-percent of households report that they buy gluten-free products, and almost a third of Americans report that they are trying to avoid gluten. Food producers feeding the growing appetite for gluten-free have put the gluten-free label on foods that never included gluten, like vegetables and yogurt. As a result, U.S. sales of foods labeled gluten-free (which may or may not have had gluten to begin with) have doubled to $23 billion in the past year from $11.5 billion four years ago.

Unfortunately, current research doesn’t support the numerous health claims that have been made about gluten-free diets. Moreover, buying gluten-free isn’t necessarily a healthier option—many gluten-free foods contain fewer vitamins, less fiber, and more sugar.  It will be interesting to watch what happens to the sale of “gluten-free” foods as the gluten-free labeling final rule takes effect.

DARPA Announces Disease Forecasting Prize

By Rachel Sachs

On Friday, the Defense Advanced Research Projects Agency (DARPA) announced a challenge to the public: provide the most accurate forecast of the spread of chikungunya virus in each of the countries in the Pan American Health Organization, win $150,000. Innovation prizes like DARPA’s are increasing in popularity, with public and private entities alike issuing challenges across a variety of subjects and methodologies. DARPA isn’t the first to announce a disease forecasting prize, either – the Centers for Disease Control (CDC) recently awarded a prize for predicting the timing and intensity of last winter’s flu season. But the choices both to focus on chikungunya and to do so using a prize fund are interesting ones that deserve further discussion.

Chikungunya is a viral disease spread by infected mosquitoes, much like the better-known malaria and dengue fever. Its symptoms often resemble those of dengue, whose other common name – breakbone fever – is telling. Chikungunya is rarely fatal, but it is often temporarily disabling, until the disease has run its course. And unfortunately, also like dengue, there is no specific treatment for chikungunya, although recent Phase I trials of a candidate vaccine appear to have been successful. But perhaps most importantly for DARPA’s purposes, chikungunya is also experiencing a resurgence in the Americas, including in the United States.

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AHLA Health Law Curriculum Manual

By Kevin Outterson

The American Health Lawyers Association is the nation’s largest group of practicing health law attorneys, with awesome CLE programs.

For the past couple years, a group at AHLA has been evaluating how health law is taught at law schools, with a view to prepare students for the practice of health law. AHLA surveyed many health law practice group chairs and other leaders. With that data, a large group of AHLA members and some full time professors evaluated health law curricula nationwide. A guidance document is now out (html or pdf):

We found some significant gaps, however, between what law schools offer and what the profession hopes to see in new health lawyers. Members of the American Health Lawyers Association (AHLA) want to see more substantive classes in fraud & abuse, business, tax, life sciences, and health care reimbursement. Desired skills include working in teams, processing practical transactional skills, and effectively analyzing client-focused problems.

Two take-away slides from the AHLA survey of health law practice leaders and hiring partners:

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