More on the M&M Study

By Scott Burris

Stephanie Morain and Michelle Mello’s recent paper in the March issue of Health Affairs is an extremely important contribution. It reports on a survey of American adults investigating their support for a range of current health interventions, and finds – contrary to the myth being propagated in politics and the media – that people strongly support the public health mission and the interventions that accomplish it. There is no better way to celebrate the end of Public Health Week than by sending a pdf to every one you know.

Having praised the piece, though, I want now to disagree with one part of the authors’ analysis. The table below shows the support for a fruit basket of public health interventions.

From this, M&M conclude “that the greater the restraint a legal intervention imposes on individual liberty, the greater public opposition to the intervention is likely to be. There was much support among our respondents for strategies that enable people to exercise healthful choicesfor example, menu labeling and improving access to nicotine patchesbut little support for more coercive measures, such as insurance premium surcharges.”

I don’t see that in the data.

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Of Evergreening and Efficacy

By Ryan Abbott

An important case was decided yesterday that may have a significant impact on access to medicines for patients in developing countries. India’s high court rejected an appeal by the pharmaceutical company Novartis to grant a patent for its cancer drug Glivec.

The case involved a challenge to Section 3(d) of the Indian Patents Act which was designed to prevent patent holders from extending the duration of their patents by making minor changes to existing formulations—a practice referred to as “evergreening.” Section 3(d) stipulates that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not eligible for patent protection.

The drug Glivec was initially invented and patented as a compound in its free base form. Novartis subsequently obtained a patent in the U.S. and Europe on a beta crystal version of the compound, which was found to possess 30% greater bioavailability. In yesterday’s case, one of the central questions before the court was whether the “new” drug form qualified for a new patent under Section 3(d). The court ruled that it did not.

To arrive at this conclusion, one of the more interesting issues the court had to resolve was how to define efficacy. It elected to define efficacy as therapeutic efficacy, but even within that definition the court was presented with multiple visions.

On the one hand, efficacy could be thought of as the capacity of a drug to produce an effect. That is, the property of a drug that causes a stimulus at a receptor site, as distinct from characteristics such as affinity, potency, and bioavailability. A broader conception of efficacy would include considerations such as improved safety or reduced toxicity.

Theoretically, I suspect a more holistic approach is justified.

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The Iraq War and Health Worker Brain Drain

I am writing my student fellowship paper under the broad topic of health worker “brain drain,” so I have been keeping an eye out for related news stories.  Two stories that caught my eye in the past few weeks were about the health worker migration from civil war torn Syria and economic-crisis ridden Sudan.   In Syria for example, half the doctors in Homs and all of the country’s nine psychiatrists have recently migrated.   In Sudan, 1620 doctors left the country last year compared to 338 in 2008.  In countries like these, especially Syria where medical personnel have been targets of violence, solutions to stem the migration or replenish the ranks seem particularly futile.  Additionally, these countries’ self-inflicted wounds, including civil wars and poor administration, complicate matters.  Not only do these internal struggles diminish the probable efficacy of potential solutions to the brain drain, but they also negate the perceived responsibility of the countries receiving these migrants, diminishing their will to help counteract the deleterious effects of the brain drain.

Civil war stricken countries like Syria present especially difficult cases for developed nation responsibility and intervention.  But these news stories led me to think about brain drain and responsibility that results from war, specifically wars waged by developed nations in developing ones.  A prime example is the recent war in Iraq.  The Brookings Institute estimates that 20,000 of the 34,000 Iraqi doctors in the country in 2003 have migrated, and only 1525 had returned as of 2009.  They also cite that 2000 Iraqi physicians have been murdered and 250 have been kidnapped over the same period.  50% of surveyed Iraqi doctors living both in Iraq and abroad said they had been threatened.[1]  A recent article in Lancet describes that before 2003 the major problems facing the Iraqi healthcare system stemmed from drug shortages and poverty.  These problems have been superseded by violence and failing infrastructure in the intervening years.  The brain drain has likely been exacerbated by these new threats.

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Reminder, Upcoming Conference on Universal Health Coverage in Low-Income Countries

A reminder that the Harvard University Program in Ethics and Health annual conference, Universal Health Coverage in Low-Income Countries: Ethical Issues, will be held in Boston on April 18-19, 2013.

AGENDA

http://peh.harvard.edu/events/2013/universal_coverage/agenda.html

REGISTRATION

No fee. Space limited. Registration required. Please register on our registration website.

Contrasting Views: Recent Publications on Access to Medicines

by Adriana Benedict

Last week, the World Health Organization (WHO), World Intellectual Property Organization (WIPO) and World Trade Organization (WTO) released a trilateral study on Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade.  According to the official summary of the book, the publication is aimed at policy makers and is divided into four parts:

I. Fundamentals: the background of health policy and medical technology, the work of the three organizations, the burden of disease that challenges health policy, and the factors shaping that policy.  Much attention has been paid to diseases such as HIV/AIDS, malaria and tuberculosis, but noncommunicable diseases such as cancer, diabetes and heart diseases are a rising challenge.
II. The Policy Context: the international framework, linking health policy, intellectual property and trade, the contributions of economic analysis, and the use of traditional medical knowledge in research.
III. Innovation in Greater Detail: the evolution of research and development, alternative ways of promoting innovation for neglected diseases, the role of intellectual property rights, with examples.
IV. Access: how to ensure pharmaceuticals and other medical technology reach the people who need them: pricing policies, taxes and import duties, procurement, regulation, technology transfer, local production, patents, compulsory and voluntary licences, trade agreements, and competition policies, etc.

In her remarks at the launch of the publication, WHO Director-General Dr. Margaret Chan emphasized the importance of the public interest not only in public health, but also intellectual property and trade policy.  Importantly, Dr. Chan noted that it “is worth considering” an extension of the TRIPS Agreement (WTO Agreement on Trade-Related Aspects of Intellectual Property) transition deadline (currently set to July 1, 2013) for least-developed countries (LDCs) to implement the agreement’s provisions.

In stark contrast, last week the Journal of Economic Perspectives released an empirical study by two Federal Reserve economists calling for the abolition of the patent system. Read More

India Releases New Rules on Clinical Trial Injury

Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.”  You’ve really got to read the whole thing, but some of the provisions are pretty remarkable:

  • “In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.”  Note that this doesn’t say anything about the injury being study-related.
  • If an injury is related, then the subject is also entitled to financial compensation above any medical expenses.
  • If the subject dies as a result of clinical trial participation, his or her “nominees” would be entitled to financial compensation.
  • Injury or death will be considered related to trial participation in a variety of usual circumstances, including adverse effects of the investigational product and protocol violation or negligence.  But here’s the kicker: injury or death will be deemed trial-related, and therefore eligible for care/compensation, if it results from “failure of investigational product to provide intended therapeutic effect” or “use of placebo in a placebo-controlled trial”.  Read that again – if an investigational product doesn’t work, the sponsor will be liable for free medical care and further financial compensation.
Like all of the presidential bioethics commissions and many others that have considered this issue, I’m all for the adoption of reasonable and appropriate compensation systems to make subjects whole in the event of study-related injury.  And I think US policy is woefully inadequate on this score.  But the pendulum can also swing too far in the other direction.  Will sponsors take their trials elsewhere or will research in India still be worth it?
[H/T to Rebecca Li for the head’s up re: publication of the new rules.]

No Access to Medicines without Access to Research

by Adriana Benedict

In December, I wrote a blog post noting that access to biomedical research is critical not only for informed patient care, but also for the sustainable development of pharmaceutical R&D responsive to local needs, especially in developing countries.  In recent years, open access issues have taken on an increasingly important role in global health discussions.  In 2009, the Institute for Information Law and Policy, the Justice Action Center and Health Information for All 2015 made the case for a rights-based approach to the issue in a report called Access to Health Information under International Human Rights Law.  In 2011, a medical student in the Right to Research Coalition explained 6 Reasons Open Access Matters to the Medical Community.  And the 2012 WHO CEWG Report recommending a binding treaty on Research and Development to Meet the Needs of Developing Countries includes as one of its proposals “open approaches to research and development and innovation which include precompetitive research and development platforms, open source and open access schemes.”

In response to the increasing demand for open access to biomedical research, PLOS Medicine partnered with WHO to issue a call for papers “intended to culminate in an open-access collection of original research and commentary articles to coincide with the launch … [of] World Health Report 2012: No Health without Research.”  However, the 2012 World Health Report was unexpectedly called off to be replaced by a 2013 report on “contributions to research to universal health coverage,” a far less politically polarizing topic.  In its editorial response to the cancellation of the 2012 Report, PLOS Medicine noted that “The reasons for these delays and for the changes in scope of WHO’s flagship publication, are unclear,” not in the least because “Previous World Health Reports … have represented bold political statements.”

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Conference Announcement: Governance of Tobacco in the 21st Century

Governance of Tobacco in the 21st Century:
Strengthening National and International Policy for Global Health and Development

February 26-27, 2013
Harvard University, Cambridge, MA, USA

Keynote Speakers:
Dr. Nkosazana Dlamini-Zuma
Chairperson, African Union Commission
Dr. Margaret Chan
Director-General, World Health Organization

How do international laws and institutions regarding tobacco, trade, investment, agriculture and economic development intersect? What are the implications for global tobacco control efforts? How should public health concerns be taken into account in international economic policymaking? What is the proper balance between a government’s obligations to protect the health of its citizens and other international agreements to which it has subscribed? What are the broader implications for global governance and for global health?

This conference will bring together representatives from governments, intergovernmental organizations, civil society, business, and academia to explore these questions with the objective of:

  • Enhancing knowledge, information-sharing, network-building and learning across countries, contexts and policymaking arenas
  • Identifying strategies to strengthen the governance of tobacco at national and international levels;
  • Fostering greater policy coherence among actors working in health, trade and investment to ensure the protection of global health

The conference is being hosted by the Harvard School of Public Health’s Center for Global Tobacco Control and the Harvard Global Health Institute’s Forum on Global Governance for Health, with advice and support from the World Health Organization’s Tobacco-Free Initiative.

Additional support is provided by: American Legacy Foundation; American Cancer Society; the International Development Research Centre Canada; Campaign for Tobacco-free Kids; Harvard Law School; Framework Convention Alliance; O’Neill Institute for National and Global Health Law, Georgetown University; Institute for Global Tobacco Control, Johns Hopkins University; International Tobacco Control Policy Evaluation Project, University of Waterloo, Canada; Southeast Asia Tobacco Control Alliance (SEATCA).

Additional information is available here.  Registration is required.