Count Your Calories, Says the FDA

By Nicholas J. Diamond

Fast Food emblems set on chalkboard. Hand drawn doodle style. Image via Thinkstock.

On May 7, a provision of the Affordable Care Act (ACA) relating to nutrition-labeling requirements finally went into effect, following three extensions to its compliance date by the U.S. Food and Drug Administration (FDA). In brief, under the requirements, most chain restaurants must now display calorie counts per serving on their menus. You may have already noticed that some of your favorite establishments have been ahead of the curve for awhile.

As I outline below, I broadly agree with the direction of the nutrition-labeling requirements, but highlight weaknesses and offer a way forward.

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Why Are So Many American Women Dying in Childbirth?

By Clíodhna Ní Chéileachair

In November Serena Williams, indisputably one of the greatest – if not the greatest – tennis player in history gave birth to her daughter by emergency Caesarean section. After the surgery, Williams reported to an attending nurse that she was experiencing shortness of breath and immediately assumed she was experiencing pulmonary embolism. The star athlete has a history of blood clots and had discontinued blood thinners before the surgical delivery. Contrary to William’s requests for a CT scan and blood thinners, medical staff assumed that pain medication had made her confused. A later CT scan confirmed Williams’ self-diagnosis. Stripping out the fact of Williams’ identity turns this near-miss into a terrifyingly common story in US maternal care, albeit one with a happier ending than many. The global trend in maternal death rates – the rate of women dying in childbirth and post-childbirth – has rapidly decreased over the past 15 years. At the same time, the US, despite recording one of the highest per capita income levels in the world, has one of the highest maternal mortality rates in the developed world.

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George Annas on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with George J. Annas, Chairman of the Bioethics & Human Rights Department, and William Fairfield Warren Distinguished Professor, at Boston University. George’s work is legendary among health policy experts; a 1998 tribute from Jay Katz gives some sense of its breadth and depth. Having reviewed numerous works, Katz states:”I have barely conveyed the richness of George Annas’ observations on the ambiguities in motivations and actions that persist in current research practices. The many recommendations he makes, should be of valuable assistance to those interested in reforming current rules governing research on humans. Plagued by Dreams…reveal[s] another facet of George Annas’ personality: His commitment to public advocacy. He values scholarship but he also wants it to have an impact on shaping institutions and health care policies…In the many settings in which I have encountered George Annas over the years, I have admired his boldness, intellect, compassion and moral vigor.” Our conversation had the theme  “paternalism & its critics,” based on articles George had recently authored (or co-authored with last week’s guest, Wendy Mariner) on informed consent, genomics, and sugary drinks.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Who needs to be involved in creating community health?

A slew of organizations, including most notably the Robert Wood Johnson Foundation, are talking about creating a “culture of health” as a new way forward in US health policy. The underlying thinking assumes that legislative fixes, including the Affordable Care Act, will continue to be vehemently fought if attitudes towards health do not in some ways fundamentally change. Inherent in the idea of building a culture is incorporating unconventional actors and voices into discussions about how to improve outcomes at a local level. This has led public health strategists to ask new questions about who to involve in community health building efforts with an eye towards employers, small businesses, social service organizations and community institutions.

With this in mind, I recently spoke with Peter Doliber, Executive Director of the Alliance of Massachusetts YMCA about how he sees the Ys fitting into a plan to create health. His background is in public health and hospital administration, having worked in a range of communities to develop programs that increase access to health care, improve health outcomes and create a return on investment. Here’s an abbreviated version of our conversation.

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The Ethics of Punking the Diet-Research Media Complex (and Millions of Readers)

Scale

By Michelle Meyer

A remarkable new “sting” of the “diet research-media complex” was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.

Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn’t have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.

But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being. Read More

Bioethicist Art Caplan: Deep-Fat Fryers in Schools is Business, Not Freedom

A new piece by contributor Art Caplan on NBC News:

How bad is the obesity epidemic among kids in America?

Bad enough that 69 percent of young adults in Minnesota cannot serve in the military due to obesity-related health problems, according to a recent report “Too Fat, Frail and Out-of-Breath to Fight,” from a group of retired generals.

And how is one public official responding to the child obesity crisis? With a call for more fried foods in school. The Texas Agriculture Commissioner, Sid Miller, says he wants to restore deep-fat fryers in Texas school cafeterias. In his mind, this “isn’t about french fries, it’s about freedom.”

The freedom to develop cardiovascular disease?

School cafeterias are the front line on the battleground for childhood obesity prevention. They serve as test kitchens for interventions designed to increase the consumption of fruits and vegetables and decrease the intake of processed and fried foods. In 2012 the USDA and First Lady Michelle Obama announced standards for more nutritious school food. As part of the rules, schools are expected to serve fruits, vegetables and whole grains daily, and limit calories in servings. […]

Read the full article here.

The Beginning of the Broccoli Mandate?

By Deborah Cho

In National Federation of Independent Businesses v. Sebelius, 132 S. Ct. 2566  (2012), the Court famously struck down the “individual mandate” of the ACA under the Commerce Clause.  The Chief Justice noted that the Government’s argument for regulation under the Commerce Clause — that individuals were participating in interstate commerce by not purchasing health insurance and were thereby subject to regulation — “would justify a mandatory purchase to solve almost any problem.”  He continued, “To consider a different example in the health care market, many Americans do not eat a balanced diet.  [The] failure of that group to have a healthy diet increases health care costs, to a greater extent than the failure of the uninsured to purchase insurance . . . Under the Government’s theory, Congress could address the diet problem by ordering everyone to buy vegetables.”

This hypothetical was raised as an example of a potential absurd result of accepting the Government’s line of reasoning in this case.  It was provided as an extreme outcome to catch the reader’s attention.  Justice Ginsburg even responded to this “broccoli horrible” hypothetical by stating that the Court would have to accept a lengthy chain of inferences, something that the Court has refused to do in the past, to find that a vegetable-purchase mandate would affect health-care costs.  Some of those inferences included accepting that individuals would eat the vegetables rather than throw them away once purchased, that they would cut back on other unhealthy foods, and that the healthy diet would not be offset by an individual’s lack of exercise.  In addition to this piling of inferences, Justice Ginsburg noted that the democratic process would serve as a “formidable check” to prevent a situation such as the broccoli horrible.   Discussions about this broccoli mandate outside the courtroom were framed similarly.  One article from 2012 stated that Congress would need to be “crazy” to pass such legislation and that “absurd bills like a broccoli mandate are likely to fail other constitutional tests.”

Yet, here we are, just a couple years later, and it seems that some of the weakest and most vulnerable in our population have indeed found themselves in the midst of the broccoli horrible.  Read More

Designing policy interventions in the context of obesity—what we can learn from the effects of cigarette taxes on children’s health

By Diana Winters (@diana3000)
[Cross-posted at HealthLawProf Blog.]

An important new study shows that a child will most likely be healthier throughout her childhood if a tax on cigarettes is in place when her mother is pregnant. Economist David Simon (who, full disclosure, is my cousin) at the University of Connecticut has extended the findings that the health of infants can be improved by a policy intervention that improves the in-utero environment, and has provided strong evidence that cigarette taxes can improve the health of children into their teen years.

It is well established that smoking during pregnancy can harm a developing fetus. In his paper, Simon cites studies that demonstrate the negative effects of taxes on cigarette smoking, and in a second paper, he collects and reviews the literature that shows that pregnant women are responsive to cigarette taxes. Simon uses a restricted-use version of the National Health Interview Survey, which the Centers for Disease Control and Prevention has used since 1957 to collect data on the health of the U.S. population, to examine medium-term childhood health outcomes for individuals exposed to a cigarette tax in-utero.  Read More

Weight Status: When Ignorance May Not Be Bliss

By Deborah Cho

A recent data brief summarizing a national survey spanning from 2005-2012 on the perception of weight status in U.S. children and adolescents highlights one major finding — many children and adolescents who are overweight or obese don’t know it.  Key findings were that about 81% of overweight (defined as having age- and sex-specific BMI greater than or equal to the 85th and less than the 95th percentile of the 2000 CDC growth chart) boys and 71% of overweight girls believe they are about the right weight.  Additionally, nearly 48% of obese (defined as having age- and sex-specific BMI greater than or equal to the 95th percentile of the 2000 CDC growth chart) boys and 36% of obese girls consider themselves to be about the right weight.  

As an article on the NPR blog noted, “Kids can be cruel, especially about weight. So you might think overweight or obese children know all too well that they’re heavy.”  But it seems that this is not the case, at least according to the survey.  Furthermore, not only do overweight or obese children generally seem to be unaware of their weight status, but the misperception rate appears to be higher in those children and adolescents whose families have a lower income-to-poverty ratio.  Non-Hispanic black and Mexican American children and adolescents were also found to have higher rates of misperception than Non-Hispanic white children and adolescents.

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McCullen and New York Statewide Coalition: The Erosion of Public Health as a Legal Norm

By Wendy Parmet

At first glance, last Thursday’s decisions by the Supreme Court in McCullen v. Coakley and the New York Court of Appeals in New York Statewide Coalition of Hispanic Chambers of Commerce v. New York City Department of Health and Mental Hygiene, have little in common. McCullen, which struck down a Massachusetts law establishing a 35 foot buffer zone around reproductive health clinics, was a First Amendment case that dealt with the always contentious issue of abortion. In contrast, N.Y. Statewide Coalition, which upheld a lower court decision striking down a regulation of the New York City Board of Health barring the sale of large portions of sugary soda, was decided on state administrative law grounds, with the court finding that the Board exceeded its authority.

On closer inspection, however, the two cases share several features in addition to their date of decision. One is the failure to give substantial weight to the state’s interest in protection health. In his opinion for the Court in McCullen, Chief Justice Roberts accepted that the buffer zone law was content neutral and therefore not subject to strict scrutiny. Nevertheless, a unanimous Court held that the Massachusetts law was not narrowly tailored to serve the government interests of protecting public safety and access to health care. In reaching this decision, the Court focused on the “toll” that the buffer zone placed on the abortion opponents who tried to dissuade woman from having abortion, rather than the impact of the lack of such a zone on woman seeking reproductive health care. Equally important, the Court showed no willingness to defer to the state’s contentions that alternative regulatory approaches had proved unsatisfactory. Rather the Court insisted that given “the vital First Amendment interests at stake, it is not enough for Massachusetts simply to say that other approaches have not worked.”

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