Access to Drinking-Water as a Fundamental Human Right

by Martín Hevia

Access to drinking-water is obviously necessary to lead a healthy life. However, in Latin America, many lack access to this vital resource.

Very recently, in December 2, the Argentine Supreme Court discussed the legal status of access to drinking-water in the Argentine legal system (the case is “Kersich, Juan Gabriel y otros c/Aguas Bonaerenses y otros s/amparo”). The Argentine Constitution does not explicitly recognize a right to have access to drinking-water. The Court discussed the claim of citizens of 9 de Julio against “Aguas Argentinas,” which was allegedly providing water with levels of arsenic higher than those allowed by Argentine law. In deciding the case, with the vote of 4 of the 5 Supreme Court judges, the Court reached two important conclusions.

First, invoking General Comment 15 on the right to water of the UN Committee on Economic, Social, and Cultural Rights, the Court concluded that Access to drinking water is a fundamental human right: it is necessary to lead a life with dignity, as well as necessary to fulfill other human rights, mainly, the right to health. The Court also invoked human rights treaties incorporated to the Argentine Constitution such as the Convention on the Rights of the Child - its Article 24.2.c mandates providing clean drinking water to combat disease.

Second, the Court held that the provision of drinking-water is a community interest. Thus, the right to access to drinking water is a “collective right” (the Spanish term is “derecho de incidencia colectiva”): drinking water is one of the elements of the environment, which is collective good under Section 41 of the Argentine National Constitution.

Although the Court discussed the particular claim of the inhabitants of 9 de Julio, and it ordered lower courts to analyze again the case on the basis of the aforementioned two conclusions, it is worth asking about the legal implications of this decision for the Argentine legal system. The decision of the Court expressly recognizes access to drinking water a collective constitutional right. This means that, from now on, inhabitants of Argentina will be able to file collective claims to demand both the Federal and the Provintial States that they make access to drinking-water a priority. Not doing so will entail not taking the Constitution seriously.

Worth Reading This Week

By Nicolas Terry

The Constitutionality of Damage Caps in Pennsylvania

By Alex Stein

In its recent decision, Zauflik v. Pennsbury School Dist., — A.3d —- (Pa. 2014), the Supreme Court of Pennsylvania upheld the constitutionality of the statutory $500,000 cap on tort compensation payable by the local government. This decision was delivered in a case involving a student who lost her leg in an accident in which a school bus accelerated out of control onto a sidewalk and struck her (along with other nineteen students). The jury awarded the student $14,036,263.39 ($338,580 for past medical expenses, $2,597,682 for future medical expenses, and $11.1 million for past and future pain and suffering), but the court reduced the award to $500,000.

In affirming that ruling, the Pennsylvania Supreme Court rejected a number of constitutional challenges against the statutory cap. Continue reading

Art Caplan: Support Nurse Who Resisted Force-Feeding at Guantanamo

Art Caplan has a new piece supporting the nurse who resisted force-feeding at Guantanamo, on NBC News:

Lost in all the talk about the CIA’s history of brutal interrogation tactics after Sept. 11 is this: A real live case involving a U.S. Navy nurse on trial for what he did not do at the notorious Guantanamo prison.

The nurse, in his 18th year in the Navy, volunteered to serve at Guantanamo, where some of those being held prisoner went on hunger strikes. They were following a long tradition going back to the H-Block Irish hunger strikers in Britain who found no other way to protest their internment and prison conditions but to refuse food.

The Navy brass at Gitmo decided that these prisoners were going to eat. They dragged them out of their cells, put them in full body restraints, shoved a tube through their nose and down into their stomachs and force-fed them with artificial food.

Read the full article here.

How Should the FDA Regulate Fecal Transplantation Safely and Effectively?

Last week’s issue of the New Yorker featured a terrific article about fecal microbiota transplantation, or FMT.  Much of the article focused on OpenBiome, a nonprofit stool bank spun off from MIT that screens donors, processes samples, and ships them to hospitals around the country.  For those who are unfamiliar with FMT, it is a startlingly effective treatment for recurrent C. difficile infection.  C. diff infections have become among the most common hospital-acquired infections in the United States, causing more than 300,000 hospitalizations and 14,000 deaths annually.  And unfortunately, many of these infections are resistant to antibiotics, with resistance rates rising rapidly.  But FMT may provide a way forward: a recent randomized trial (antibiotics versus antibiotics plus FMT) was stopped early, when 94% of patients in the FMT group were cured, as compared to roughly 30% of those in the antibiotics groups.

Coincidentally, I’ve been working with OpenBiome over the past few months on an interesting question that the New Yorker article touched on only briefly: how should the FDA regulate FMT to best ensure its safety and efficacy?  At present, the FDA is proposing to regulate FMT as a biologic drug.  However, many (including OpenBiome’s co-founder, Mark Smith) have argued that it ought to be regulated like human tissue, which from a scientific standpoint it resembles more closely than it does a small molecule drug, given the challenge of characterizing stool’s active ingredients and providing consistency across batches.  OpenBiome’s Policy Director, Carolyn Edelstein, and I are currently working on a paper examining the pluses and minuses of the FDA’s current approach.  I want to briefly summarize a few key points of our paper here, but essentially we argue that classifying FMT as a drug is simultaneously underregulatory and overregulatory.  Our primary goal is to ensure that patients have access to safe, effective treatments – and that means the FDA should be more involved in regulating some aspects of FMT, and less involved in others.

Continue reading

Worth Reading This Week

By Nicolas Terry

The Right to Try Meets the Reality of Drug Approval

By Joan H. Krause

[Cross-posted at HealthLawProf Blog]

Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial issue. Two recent articles, published on the same day, illustrate the difficulty of trying to balance desperate patients’ willingness to try unproven therapies with the very real concerns faced by manufacturers undergoing the drug approval process. The first was a Kaiser Health News article describing the passage of “Right to Try” laws in five states. The second was a brief note in the Los Angeles Business Journal that shares of CytRx Corporation, a biopharmaceutical R&D company, had fallen 9% after the company announced that the FDA had placed a partial clinical hold on its clinical trials after a patient’s death.

Right to Try laws are designed to give patients who have exhausted all other treatment options the right to access investigational medications, devices, and biological products that have met Phase I safety milestones. Right to Try legislation has been enacted in Colorado, Louisiana, Michigan and Missouri, and voters recently approved it by initiative in Arizona. The laws are based on model legislation drafted by the Goldwater Institute, which issued a detailed report on the issue in February 2014. While prohibiting states from blocking patient access to such medications, however, the model legislation does not require manufacturers to provide the products, nor does it require insurance companies to cover the costs. Continue reading

Arthur Caplan on Hyperbaric Oxygen Therapy

Art Caplan has a new piece on hyperbaric oxygen therapy over at NBC News:

Hyperbaric oxygen therapy. Have you ever heard of it? The Internet sure has.

Centers and clinics tout the benefits of sitting in a tank breathing 100 percent oxygen at higher than atmospheric pressure for treating autism, infant brain trauma, multiple sclerosis, chronic fatigue, cerebral palsy and many other conditions.

There’s just one problem: There is no solid evidence that hyperbaric oxygen therapy does anything for any of these disorders.

Read the full article here.

Introducing Joan H. Krause

We are pleased to introduce our newest contributor, Joan H. Krause, to Bill of Health.

Joan Krause PhotoProfessor Joan H. Krause is Associate Dean for Faculty Development and Dan K. Moore Distinguished Professor of Law at the University of North Carolina School of Law; professor (secondary appointment) in the Department of Social Medicine, UNC School of Medicine; and adjunct professor of health policy and management in the UNC School of Public Health. She previously served as George Butler Research Professor of Law and Co-Director of the Health Law & Policy Institute at the University of Houston Law Center, where she joined the faculty in 2001. From 1997-2001, Professor Krause was a member of the health law faculty at Loyola University Chicago School of Law. Before attending law school, Professor Krause worked as a medical writer/editor in the pharmaceutical industry. After law school, she served as a law clerk for the Honorable Dorothy W. Nelson of the United States Court of Appeals for the 9th Circuit. Following her clerkship, Professor Krause was an associate in the Health Practice Group of Hogan & Hartson in Washington, D.C., where her work focused on regulatory and administrative health care matters with an emphasis on health care fraud and abuse. She teaches a variety of health law courses, as well as Criminal Law for first-year students. Her research interests include Health Law, Criminal Law, and Women and the Law. Her co-authored book, HEALTH LAW AND BIOETHICS: CASES IN CONTEXT, was published in 2009.

Professor Krause received her B.A. with Honors in Political Science from Yale University, where she graduated summa cum laude. She received her J.D. with distinction from Stanford Law School, where she was elected to the Order of the Coif and served as Senior Articles Editor of the Stanford Law and Policy Review, as well as a Writer and Copy Editor for the Stanford Law Journal.

Representative Publications:  Continue reading

FDA Updates System for Explaining Risks of Meds in Pregnancy

By Emily Largent

On Wednesday, the FDA published the “Pregnancy and Lactation Labeling Rule” (PLLR), which “requires changes to the content and format for information presented in prescription drug labeling . . . to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children.”  The FDA also issued draft guidance for industry to assist drug manufacturers in complying with the new labeling and format requirements.

The current system, which was developed in the 1970s, uses letters of the alphabet–A, B, C, D, and X–to denote risk, with X being the most dangerous.  The PLLR removes pregnancy letter categories from all prescription drug and biological product labeling.  The new system breaks the risk into three categories: Pregnancy, Lactation, and Females and Males of Reproductive Potential.  Companies will be required to provide a summary of risks, a discussion of the data supporting that summary, and relevant information to help clinicians make prescribing decisions.  The changes go into effect on June 30, 2015.  Labeling for over-the-counter medications will not change.

The PLLR should help many women, as there are more than 6 million pregnancies in the U.S. each year.  Research suggests that over 90% of women use at least one medicine during pregnancy, and about 70% use at least one prescription medicine.  I think the PLLR is a wonderful step to enhance patient education and decision-making.  It will not, however, address our limited current knowledge of the safety of medication use during pregnancy.  About 98% of medicines approved for use in the United States between 2000 and 2010 had limited data to assess the risk for birth defects, for example.  More research is urgently needed, and it’s unfortunate that the rule stops short of requiring companies to conduct studies if none exist.

Dec 8-10: Seminar Series on Social Medicine in South Africa

By Kelsey Berry

The Harvard School of Public Health Department of Global Health and Population (GHP) is hosting what promises to be a fascinating 2-seminar series on Monday Dec 8 and Wednesday Dec 10 entitled: “A Practice of Social Medicine: South Africa and Beyond.” This event should be of interest to those thinking about models for Universal Health Coverage, community-based approaches to health, history and sociology of medicine and health care delivery, and population-level ethics.

The series will feature Professor Shula Marks, Emeritus Professor, University of London, and Fellow of the British Academy.

A word from the organizers: For just over a decade in the mid-twentieth century, perhaps somewhat surprisingly, South Africa was widely acknowledged as being in the forefront of progressive thought in health care delivery, its distinctive social conditions and developed medical practice making possible an experiment in social medicine with far-reaching implications.  These two lectures trace the story to its South African roots in the 1930s and 1940s, its propagation via the subsequent diaspora of progressive physicians, and its links to kindred developments throughout the world.  Its vision of a community-based, equitable, effective, inclusive, low cost approach to health emphasizing prevention and education may offer a distinctive model for Universal Health Coverage.

*The first lecture South Africa’s Experiment in Social Medicine, 1940-1960: A Model to the World? will be held on Monday December 8th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208.

*The second lecture Social Medicine in South Africa, 1960s to the Present will be held on Wednesday December 10th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208

For non-Harvard affiliated attendants, please email mclark@hsph.harvard.edu to arrange for access to the buildings in advance.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital/Harvard Medical School reviews the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from November. The selections feature topics ranging from the use of e-prescribing defaults to promote physician prescribing of generic drugs, to the characteristics of post-approval studies of medical devices ordered by the FDA, to a comparison of existing and emerging accelerated access pathways in the United States, European Union, Canada, and Singapore. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Alpern JD, Stauffer WM, Kesselheim AS. High-cost generic drugs–implications for patients and policymakers. N Engl J Med. 2014 Nov 13;371(20):1859-62.
  2. Baird LG, Banken R, Eichler HG, Kristensen FB, Lee DK, Lim JC, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G. Accelerated access to innovative medicines for patients in need. Clin Pharmacol Ther. 2014 Nov;96(5):559-71.
  3. Becker JE, Ross JS. Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications. Ann Intern Med. 2014 Nov 18;161(10):760.
  4. Gagne JJ, Thompson L, O’Keefe K, Kesselheim AS. Innovative research methods for studying treatments for rare diseases: methodological review. BMJ. 2014 Nov 24;349:g6802.
  5. Lexchin J. Postmarket safety warnings for drugs approved in Canada under the Notice ofCompliance with conditions policy. Br J Clin Pharmacol. 2014 Nov 12. [Epub ahead of print]
  6. Manz C, Ross JS, Grande D. Marketing to physicians in a digital world. N Engl J Med. 2014 Nov 13;371(20):1857-9.
  7. Patel MS, Day S, Small DS, Howell JT 3rd, Lautenbach GL, Nierman EH, Volpp KG. Using Default Options Within the Electronic Health Record to Increase the Prescribing of Generic-Equivalent Medications: A Quasi-experimental Study. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S44-52.
  8. Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF. Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval: FDA-Mandated Postapproval Studies. JAMA Intern Med. 2014 Nov 1;174(11):1773-9.
  9. Vermeer NS, Spierings I, Mantel-Teeuwisse AK, Straus SM, Giezen TJ, Leufkens HG, Egberts TC, De Bruin ML. Traceability of biologicals: present challenges in pharmacovigilance. Expert Opin Drug Saf. 2014 Nov 5:1-10. [Epub ahead of print]
  10. Woloshin S, Schwartz LM, Frankel B, Faerber A. US Food and Drug Administration and design of drug approval studies. JAMA. 2014 Nov 26;312(20):2163-5.

Art Caplan on Companies Paying for Egg Freezing

Over at Medscape, Art Caplan has a new video critiquing some companies’ new policies to pay for women to freeze their eggs:

Facebook and Apple recently announced a new perk for female workers. They will pay to freeze their eggs, a benefit that has sparked an appropriate ethical controversy.

There is no doubt that some women at these companies will think it is a great benefit, and they are glad to have it. But I am afraid that things aren’t so simple.

Part of the reason that those companies offer egg freezing is that they don’t want women distracted from their careers by having children. One way to manage both career and motherhood is to freeze your eggs. But freezing eggs is not simple, nor is the choice to do so…

Watch the full video here.

Do hospitals have a role in population health?

Population health advocates have identified health care providers, and hospitals in particular, as key allies in the effort to create better health and longer lives for Americans nationwide. Despite a growing interest in “community-based’ models of care, hospitals remain the most visible component of the US health care system. What’s more, hospitals are where the money, not to mention many of leading brains and cultural authority, reside. Of the 17.4% of GDP that the United States invests in health care, roughly 30% goes to hospitals – more than any other spending category. Hence why people interested in population health wish to have hospitals on board as they aim to address the always-challenging social, behavior and environmental determinants of health.

But the question remains open: do hospitals really have a role in the pursuit of population health?  Continue reading

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.  Continue reading

First Circuit Upholds ACA’s Medicaid Maintenance-of-Effort Provision Against Constitutional Challenge

By Rachel Sachs

Last week, the First Circuit Court of Appeals upheld the ACA’s maintenance-of-effort provision against a constitutional challenge brought by the Maine Department of Health and Human Services. The court’s opinion has received relatively little media attention, but it should be of interest to all in the health policy space. Its post-NFIB v. Sebelius Spending Clause analysis will be relevant to scholars who are interested in King v. Burwell, challenging the grant of subsidies on health insurance exchanges run by the federal government. Its procedural posture will fascinate those who are interested in plural executive systems. And its fulsome discussion of the Medicaid program and its history will be of broader interest to health policy scholars.

States participating in Medicaid must agree to cover certain groups of people up to certain income thresholds, but states may choose to expand these groups in various ways. Relevant to this case, most states have increased the income thresholds for covering children or pregnant women through the SCHIP program (sometimes quite substantially), and some have extended SCHIP to include low-income 19- and 20-year-olds. Maine had done both, providing coverage to 19- and 20-year-olds since 1991. The ACA subsequently included a maintenance-of-effort provision (42 U.S.C. § 1396a(gg)), requiring states participating in Medicaid to maintain their eligibility standards through 2019. As such, in 2012 HHS denied Maine’s request to stop providing coverage to 19- and 20-year-olds.

Maine’s Department of Health and Human Services sought review in federal court. Maine’s executive branch was not united in this choice: the Attorney General declined to represent the state and even intervened on the side of HHS Secretary Burwell. This mirrors a phenomenon that was often observed in the context of the Medicaid expansion, in which several states whose Attorneys General joined the legal fight against the expansion in NFIB subsequently expanded anyway, as that separate power was exercised by Governors and legislatures.  Continue reading

College Athletic Trainers Report Being Bullied

By Christine Baugh

A recent study indicates that college athletic trainers feel bullied on the job. The study, published in the Journal of Athletic Training, surveyed 723 collegiate athletic trainers, and found that approximately 15% of them felt that they were the victim of workplace harassment and about 20% had witnessed an instance of workplace bullying. Although there were no differences found in who was bullied, the bullies were identified as predominantly male and were most often coaches. A related examination of the perceptions of bullying in this environment, consisting of semi-structured qualitative interviews with select collegiate athletic trainers, identified structural factors associated with increased bullying and suggested workplace training as a potential solution.

The findings of these studies are in line with previous work describing the college sports medicine working environment as fraught with conflicts of interest (discussed in a previous blog post: here). However, the prevalence of bullying found in this study is actually lower than found in other studies examining bullying in other medical workplaces. That said, NCAA guidance suggests that medical professionals, including athletic trainers, should be given “unchallengeable authority” with regards to medical decision-making in the college sports medicine setting. Bullying in the college sports medicine setting occurred more frequently, according to the recent studies, when there was administrative indifference that allowed individuals who “lack respect for the athletic training professional” to act on his feelings.

Given the primary role of the athletic trainers as healthcare providers in the college sports medicine setting, it is possible that the hostility experienced in the workplace ultimately affects collegiate athlete health outcomes. Future research examining the interaction between athletic trainer workplace experience and athlete health outcomes is needed, as are interventions to ensure that athletic trainers are allowed to provide healthcare to collegiate athletes without external impediment.