Category: Global Health

Measles Can Kill, And It’s Spreading. Sue Parents Who Didn’t Vaccinate? Absolutely.

The Petrie-Flom Center Staff Leave a comment

A new piece in Forbes on suing parents who don’t vaccinate, by Dan Diamond:

I heard it over dinner at a friend’s house. I talked about it on a call with a scientist. I discussed it while waiting for public health officials to issue an update on the measles outbreak.

The same murmured question, the same growing fear.

What happens if a child dies because some parents decided not to vaccinate their own kid?

What happens if it’s my child?

Thankfully, it’s still a hypothetical. But there’s reason to worry: More than 100 people in six states are now sick with the measles, in an outbreak that can be traced directly back to Disneyland. Dozens of newborns have been put into isolation.

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Tomorrow: 3rd Annual Health Law Year in P/Review

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P-Review_2015_poster_with_borderJanuary 30, 2015 7:45 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during 2014 and what to watch out for in 2015. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

The full agenda with speakers is available on our website.

Attendance is free and open to the public, but space is limited and registration is required. Please register here. Contact petrie-flom@law.harvard.edu with questions.

Global Health Impact and Access to Essential Medicines

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By Nicole Hassoun, The Global Health Impact Project

Ebola is ravaging parts of Africa, yet it is not the worst health problem facing people in the region. Millions more are infected with and die every year from diseases like malaria, TB, and HIV/AIDS because they cannot access the essential medicines they need. To change this, we need to understand where we are succeeding in combating these diseases, and where we need to focus our efforts. Until now, this information has been sorely lacking.

Fortunately, the beta for a new Global Health Impact index has just launched that can help us address the access to medicines problem (check out: global-health-impact.org). Using the index, you can see the impact of the drugs for HIV, malaria, and TB in each country in the world. You can also get a sense for the overall impact we are having on the different diseases in the model. Finally, one can see drugs’ impacts by originator company. Read More

Pregnancy in the Ebola Epidemic – An update

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By Kelsey Berry

A few weeks ago, I posted on this blog a discussion of an ethical dilemma in the treatment of Ebola-infected pregnant women in West Africa. I wanted to follow-up with two brief updates concerning Ebola and pregnancy in West Africa.

First, Medecins Sans Frontieres has opened the first care center specializing in treatment for Ebola-infected pregnant women in Sierra Leone. The care center will have 80 beds once it is fully operational and at present has one patient under care. In my last post I called for greater investigation into the reasons underlying higher mortality rates among Ebola-infected pregnant women, claiming that the causes of disparate outcomes in various population groups may be important to determine the justifiability of outcome-driven resource allocation. The new care center is ideally positioned to investigate and perhaps parse out biological, practice based, and institutional factors contributing to the disparity. There are some remaining questions — for instance, will capacity be reserved solely for pregnant women or other infected individuals seeking care? Further, we have already seen that MSF is investing resources in caring for a population for whom survival rates are nearly zero in the current Ebola epidemic; will continued commitment to treating this population depend upon observed changes in survival rates or other outcomes; or will the mere provision of care continue to justify the center if outcomes don’t improve measurably? This is a development I will continue to follow.

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Access to Drinking-Water as a Fundamental Human Right

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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.

Clinical Trials Regulation in India

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An op-ed from our friends Mark Barnes and Barbara Bierer at Harvard’s Multi-Regional Clinical Trials Center on recent legal changes to India’s clinical trial requirements, arguing that using the clinical trial context to promote a social or political policy agenda in India may sacrifice scientific integrity in the service of social justice.  A quick snippet:

The overbreadth of these requirements, and how poorly tailored they are to achieve the specific goal of protecting clinical trial participants from risks directly caused by trials themselves, leaves one wondering whether the regulatory authorities fully comprehend the clinical trial process and the nuances of complex medical and biological processes. One further wonders whether what animates these measures may be less a concern for specific justice in individual cases than the goal of righting social wrongs and achieving social justice, unrelated to but prompted by clinical trial experiences. Achieving social justice and a more just allocation of social resources may be completely laudable – even desirable – as social or political policy, but unconsciously using the clinical trial context to promote this agenda threatens to corrupt science and to undermine health, with results that may create more social distress than social justice.

Read the full piece here.

And more commentary from MRCT on this issue:

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

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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.

The Ethics of Using Placebo Controls in Ebola Clinical Trials

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[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.]

By Carl H. Coleman

With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments.  Earlier this month, US government officials announced plans to launch a study of multiple Ebola interventions at the NIH Clinical Center, Emory University, and the University of Nebraska.  Shortly thereafter, the international relief organization Médecins sans Frontières (MSF) announced that it would soon begin testing of three experimental interventions at its treatment centers in West Africa, in collaboration with a coalition of European partners and the World Health Organization.

As predicted in an earlier blog post, a major area of contention in these trials involves the ethical acceptability of using placebo controls.  Plans for the US study are to give some participants the experimental drugs and others placebos, with everyone receiving the best supportive care available, such as fluid replacement and medications to fight off other infections.  In the MSF trials, by contrast, none of the participants will be given placebos; instead, everyone will receive one of three different experimental interventions.

From a methodological perspective, it is easy to see why the designers of the US study have chosen to use placebos.  Placebo-controlled trials are widely considered the “gold standard” of clinical research.  Using placebos makes it possible to identify the extent to which observed outcomes in participants are the result of the experimental intervention, as opposed to factors such as access to better health care facilities, receipt of supportive care, or psychological expectations (the so-called “placebo effect”).  Read More

Is Pregnancy a “Disability” in the Ebola Epidemic?

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By Kelsey Berry

Much of the recent Ebola coverage has brought to the forefront principles of disaster triage and served as a reminder of the inescapability of rationing health care resources. A piece in The New Yorker recently highlighted the plight of pregnant women and their apparent exclusion from standard Ebola wards in Sierra Leone. Professor and Ethicist Nir Eyal at Harvard Medical School was quoted discussing the role of disaster triage guidelines in allocating resources for Ebola in the case of pregnant women.

Pregnant women have long been identified as more vulnerable to viral infections than other healthy adults, due perhaps to immune system changes occurring naturally during pregnancy. This may have accounted for the increased mortality rate among pregnant women during the 2009 H1N1 influenza pandemic in the US (17% in pregnant women vs. 0.02% in the general population), and it may impact Ebola survival rates as well. A smaller 1995 Ebola outbreak in Kikwit, Zaire had a case fatality rate among pregnant women of 93%, and anecdotal accounts from the current epidemic in Sierra Leone state a 100% case fatality rate. Recent figures from West Africa put the case fatality rate in the general population at 70%. These statistics, among other concerns for resource utilization, lead to an ethical dilemma: whether and how to allocate scarce resources to pregnant women in the present ebola epidemic in West Africa.

If the mortality rates from Kikwit are accurate, Dr. Eyal notes that it means that, “what’s needed to justify giving regular priority to a pregnant woman is a willingness to allow six other people to perish to save her.” But, he notes, the permissibility of excluding pregnant women is sensitive to these rates; if they are wrong, than so too may be triaging pregnant women last.  Read More

Will the Real Evidence-Based Ebola Policy Please Stand Up? Seven Takeaways From Maine DHHS v. Hickox

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By Michelle Meyer

Ebola pic

The case I mentioned in my last post, Maine Department of Health and Human Services v. Kaci Hickox is no more. Hickox and public health officials agreed to stipulate to a final court order imposing on Hickox the terms that the court had imposed on her in an earlier, temporary order. Until Nov. 10, when the 21-day incubation period for Ebola ends, Hickox will submit to “direct active monitoring” and coordinate her travel with Maine public health authorities to ensure that such monitoring occurs uninterrupted. She has since said that she will not venture into town or other public places, although she is free to do so.

In a new post at The Faculty Lounge,* I offer a detailed account of the case, which suggests the following lessons:

  1. As Hickox herself described it, the result of her case is a “compromise,” reflecting neither what Hickox nor what Maine initially wanted.
  2. That compromise was achieved by the parties availing themselves of the legal process, not through Hickox’s civil disobedience.
  3. The compromise is not easily described, as it has been, as a victory of science-based federal policy over fear-based state demagoguery. By the time the parties got to court, and perhaps even before then, what Maine requested was consistent with U.S. CDC Guidance, albeit a strict application of it. What Hickox had initially offered to do, by contrast, fell below even the most relaxed application of those guidelines, although by the time the parties reached court, she had agreed to comply with that minimum.
  4. The compromise applies only to Hickox, and was based on a stipulation by the parties to agree to the terms that the court had temporarily imposed after reviewing a limited evidentiary record. Additional evidence and legal arguments that the state might have raised in the now-cancelled two-day hearing could have resulted in a different outcome.
  5. A substantially different outcome, however, would have been unlikely under Maine’s public health statute. Indeed, it is not clear that Maine’s public health statute allows public health authorities to compel asymptomatic people at-risk of developing Ebola to do anything, including complying with minimum CDC recommendations.
  6. “Quarantine” is a charged, but ambiguous, term. It allows us to talk past one another, to shorthand and needlessly politicize a much-needed debate about appropriate policy, and to miss the fact that the CDC Guidance in some cases recommends what could be fairly described as a “quarantine” for people like Hickox and requires it for asymptomatic people with stronger exposure to Ebola (but who are still probably less likely to get sick than not).
  7. It’s not clear who has bragging rights to Ebola policy “grounded in science,” or what that policy looks like.

* The piece is quite long, and I cannot bear the fight with the WordPress formatting demons that it would require to cross-post it here.