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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China Issues 2014-2020 Development Blueprint on Food and Nutrition

By Ching-Fu Lin

China’s highest executive organ, the State Council, put out the Food and Nutrition Development Outline 2014-2020 (the Outline) in February of 2014.  The Outline was jointly drafted by China’s Ministry of Agriculture (MOA) and National Health and Family Planning Commission.  The Ministry of Finance, Ministry of Education, Ministry of Commerce, Ministry of Science and Technology, and National Development and Reform Commission also participated in its development.  Based on a review of China’s growth and problems in food and nutrition, the Outline sets a seven-year plan that highlights basic policy objectives.  The areas of focus are food supply systems, nutrition intake and balance (especially amongst population sub-groups), regulatory and surveillance mechanisms, industry development, research, and education.

The Outline lays out its “guiding strategy” that the government should regard the effective supply of food, balanced nutritional profile, and production-consumption coordination as its chief missions.  To execute these missions, the government identifies certain key products (quality agricultural products, convenient processed foods, and dairy and soy foods), key areas (poor, rural, and newly urbanized areas), and key population groups (the pregnant women and nursing mothers, infants and children, and the elderly) as starting points to promote better food and nutrition development patterns.  Such points are further elaborated in the document.  The guiding strategy ultimately aims to improve public health and a well-off society.

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Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Read More

How Coke might help cure obesity

Coca-Cola has an interesting symbolic presence the world of public health.

Its delivery system is the envy of vaccine programs: the committed global health workers who’ve trekked for days through harsh and inhospitable lands to reach even the most distant communities are likely to find a refreshing, cold Coke already waiting for them at the village store.

For those who focus on non-communicable chronic diseases (NCD), (regular) Coke is the scourge that is providing the extra calories that fuels the obesity epidemic. Many experts believe that eliminating the calories contained in a single, 16oz serving of regular Coke from daily diet would be more than enough to revert the trend towards rising obesity and return average weight in the population back to where it was 30 years ago. 

But the symbolic presence of Coca-Cola in US culture and politics is perhaps even more interesting, and the resulting dynamics could have some unexpected consequences in terms of population health.

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TOMORROW: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More

1/31: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More