Call for applications: Brocher Summer Academy 2014: Ethical Choices for DALYs and the Measurement of the Global Burden of Disease

Confirmed speakers: Christopher Murray (IHME)—Keynote, Matt Adler (Duke), Greg Bognar (La Trobe U), John Broome (Oxford), Dan Brock (Harvard), Richard Cookson (York U), Owen Cotton-Barratt (Oxford), David Evans (WHO), Marc Fleurbaey (Princeton U), Ned Hall (Harvard), Dan Hausman (U of Wisconsin, Madison), Elselijn Kingma (U of Eindhoven), Jeremy Lauer (WHO), Colin Mathers (WHO), Erik Nord (Norwegian Institute of Public Health, Oslo), Ole Norheim (U of Bergen), Andreas Reis (WHO), Joshua Salomon (Harvard and IHME), Abha Saxena (WHO), Erik Schokkaert (KU Leuven), Drew Schroeder (Claremont McKenna), Alex Voorhoeve (LSE), James Woodward (U of Pittsburgh).

Organizers: Daniel Wikler (Harvard), Nir Eyal (Harvard), Samia Hurst (U of Geneva)

The biennial Summer Academy in the Ethics of Global Population Health is hosted by the Brocher Foundation on the shores of Lake Geneva June 9-13 2014, introducing faculty and advanced graduate students to population‐level bioethics. This fast‐developing academic field addresses ethical questions in population‐ and global health rather than ones in individual patient care.

The Global Burden of Disease (GBD) project is a systematic, scientific effort to quantify the comparative magnitude of health loss due to diseases, injuries, and risk factors. From its inception in the early 1990s, scientists and philosophers recognized that ethical and philosophical questions arise at every turn. For example, it must be decided whether each year in the lifespan is to count alike, and whether future deaths and disabilities should be given the same weight as those in the present. These choices and decisions matter: the share of disease burden due to myocardial infarction could vary as much as 400% depending on what position is adopted on two of the ethical choices described in the GBD 2010 report.  Read More

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

Trials of HIV Treatment-as-Prevention: Ethics and Science. Friday, March 7

High hopes for overcoming the HIV epidemic rest to a large extent on HIV Treatment-as-Prevention (TasP). Large cluster-randomized controlled trials are currently under way to test the effectiveness of different TasP strategies in general populations in sub-Saharan Africa. At the same time, however, international antiretroviral treatment (ART) guidelines have already moved to definitions of ART eligibility including all – in the US guidelines – or nearly all – in the WHO guidelines – HIV-infected people. In this panel, we are bringing together the leaders of three TasP trials in sub-Saharan Africa, bioethicists, and public health researchers to debate the tension between the policy intentions expressed in these guidelines and the historic opportunity to learn whether TasP works or not. Please join us in considering different options to resolving this tension.

  • Till Bärnighausen, Harvard School of Public Health, and Wellcome Trust Africa Centre for Health and Population Science
  • Max Essex, Harvard School of Public Health
  • Deenan Pillay, Wellcome Trust Africa Centre for Health and Population Science, and University College London
  • Velephi Okello, Swaziland National AIDS Programme, Ministry of Health
  • Dan Wikler, Harvard School of Public Health
  • Nir Eyal, Harvard Medical School

 

Moderator: Megan Murray, Harvard School of Public Health and Harvard Medical School

 

Friday, March 7th, 10am-12pm

Kresge G3, Harvard School of Public Health

Global Health Governance: Call for Submissions

Global Health Governance will be publishing a special issue on a proposed Framework Convention on Global Health (FCGH) in December 2014. The proposal for an FCGH would create a new international framework, grounded in the international human right to health, that would support health at the national and global levels.

For this FCGH special issue, Global Health Governance invites submission of theoretical and empirical policy research articles that examine and analyze how the FCGH could improve health through improved governance and realization of the right to health. We have particular interest in articles on: Read More

International Aid, Public Health, and Corruption

My wonderful HLS colleague Matthew Stephenson has just launched the Global Anticorruption Blog (GAB). As it happens, his first two posts may be of interest to BOH readers, especially those  may be of interest to readers interested in international aid for public health projects, of the sort supported by the Gates Foundation.  The first post argues that the extent of corruption in these projects is much larger than the Gates Foundation and others acknowledge.  The second post contends that one reason for lowballing of corruption estimates is political: these projects depend substantially on public funding, and political support for health aid may be undercut by candid assessments of the extent of the corruption and fraud problems. Both the posts and the blog are well worth a read.

Kevin Outterson on the Search for New Antibiotics

Kevin Outterson appeared on NPR’s “Here & Now” to discuss the growing problem of antibiotic resistance and possible ways to incentivize development of new antibiotics. From the interview:

On the misuse of antibiotics

“We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times for people just because they have some sort of a common cold — it’s estimated 18 million prescriptions a year — doesn’t help anyone who has the common cold. It’s a complete waste.”

On the rise of antibiotic-resistant bacteria

“It’s frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said on top of that, there’s another 14,000 dying from a horrible disease, intestinal disease, called Clostridium difficile [C-diff] in the United States. Together, that’s larger than the number of people who die in this country each year from AIDS. And we’re not — as bad as things are now, the more troubling aspects, or what might happen in five or 10 years if some sort of a pathogen was resistant to everything we had got out to the population. It sounds like a Hollywood movie.”

You can listen to the full interview here.

New paper on “Standardization, IPRs and Open Innovation in Synthetic Biology”

By Timo Minssen

I am pleased to announce that we have today published the following paper:

Minssen, Timo and Wested, Jakob Blak, Standardization, IPRs and Open Innovation in Synthetic Biology (February 14, 2014). Available at SSRN.

This brief book contribution stems from a presentation given at the 2013 conference “Innovation, Competition, Collaboration” at Bucerius Law School, Hamburg, Germany. It is currently under review by Edward Elgar.  A longer journal-version will follow.

Abstract: 

An effective and just sharing of resources for innovation needs a supportive infrastructure. One such infrastructure of both historic and contemporary significance is the development of standards. Considering recent developments within the software and ICT industries, it seems fair to assume that the process of standardization may also have significant impact on the development and adoption of Synthetic Biology (SB). Within SB different standardization efforts have been made, but few have assumed dominance or authority. Standardization efforts within SB may differ within various technical areas, and also the basic processes of standard creation can be divided into various categories. The different technical areas and processes for standardization differ in their speed, handling of interests and ability to dodge possible IPR concerns.

Out of this notion arises i.a. the following questions: How comparable is engineering in SB to more traditional fields of engineering?; What type of standards have emerged and what bearing have IPRs on these?; and, How applicable are the approaches adopted by the standards-setting organizations in the information and communication technology (ICT) to biological standards? These and further legal issues related to IP, regulation, standardization, competition law & open innovation require a careful consideration of new user-generated models and solutions.

Before this background, our paper seeks to describe IP and standardization aspects of SB in order to discuss them in the context of the “open innovation” discourse. We concentrate on describing the technology and identifying areas of particular relevance. Ultimately we also sketch out open questions and potential solutions requiring further research. However, due to the limitation of this paper we do not aim to create elaborated theories or to propose solutions in more detail. Rather this paper, which will be complemented by more extensive follow-up studies, provides a first overview on the complex questions that we are currently dealing with.

To achieve this modest goal, section 1 commences with a brief introduction to the fascinating science of SB and a description of recent technological advances and applications. This will lead us to section 2, in which we will address standard setting efforts in SB, as well as the relevance and governance of various IPRs for specific SB standards. This provides the basis for section 3, in which we debate problematic issues and summarize our conclusions.

The bright side of antibiotic resistance

My parent’s generation grew up in fear of a nuclear apocalypse: the cold war was raging, team USA and team USSR were competing in a frightening arms race, and people were building bomb shelters in preparation for a nuclear end to the world. That’s like so 1950’s though; what’s hot now is the environmental apocalypse. We all know about rising water levels, and some doomsayers are even warning that enough methane is about to be released from the icecaps to cause the greatest mass extinction since the dinosaurs.

Me? I’m not too concerned about either of these scenarios, but it’s not because I’m much of an optimist. It’s because I’m convinced that bugs will kill most of us before we kill ourselves.

In 1928, Alexander Fleming discovered penicillin, and it was being mass produced by World War II. This means it has effectively been around for at least 70 years, and it still works against a broad range of bacteria. Superb; 70 years is a hefty amount of time–enough for billions of doses to have been administered–and we’re still going strong.

But bacteria don’t care. They’re (still) here, they’re (always) evolving, get used to it.

Read More

2/3 Petrie-Flom Health Law Workshop: Paper Now Available

Kevin Outterson will join us on Monday, February 3, for the first spring meeting of the Petrie-Flom Center’s Health Law Policy Workshop. He is a Professor of Law and Professor of Health Law, Bioethics, and Human Rights at Boston University. Professor Outterson teaches health law and corporate law, and his interests include global pharmaceutical markets, finance and organization of health care systems, antimicrobial resistance, poverty tourism, and health disparities. He serves as the editor-in-chief of the Journal of Law, Medicine & Ethics, the faculty co-advisor to the American Journal of Law & Medicine, the immediate past chair of the Section on Law, Medicine & Health Care of the AALS, and a member of the Board of the American Society of Law, Medicine & Ethics. Before teaching, Professor Outterson was a partner at two major U.S. law firms.

His research work focuses on the organization and finance of the health sector. Areas of specialization include global pharmaceutical markets, particularly antibiotics and other antimicrobials that can degrade in usefulness over time through resistance.

On Monday, Professor Outterson will discuss his paper “New Business Models for Sustainable Antiobiotics.” For more information on the Health Law Workshop, including meeting time and location, and to download the paper, please visit our website.