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O’Neill Research Updates

Georgetown Law Journal Special Symposium Article: Meeting Basic Survival Needs of the World's Least Healthy People Toward a Framework Convention on Global Health.

By Lawrence O. Gostin

Dean Gostin's article searches for solutions to the most perplexing problems in global health—problems so important that they affect the fate of millions of people, with economic, political, and security ramifications for the world's population. No State, acting alone, can insulate itself from major health hazards. The determinants of health (e.g., pathogens, air, food, water, even lifestyle choices) do not originate solely within national borders. Health threats inexorably spread to neighboring countries, regions, and even continents. It is for this reason that safeguarding the world's population requires cooperation and global governance. What is truly needed, and what richer countries instinctively (although not always adequately) do for their own citizens, is to meet what this article calls “basic survival needs.”

By focusing on the major determinants of health, the international community could dramatically improve prospects for good health. If meeting basic survival needs can truly make a difference for the world's population, and if this solution is preferable to other paths, then how can international law play a constructive role? This article argues that a system of international governance is necessary to solve the largest global health problems. To succeed, such a system would have to consist of international legal obligations and institutions that are structured in innovative ways that account for the complex global dynamics that underlie the world community's failure to meet so many people's basic survival needs. The article proposes one mechanism that would go a long way toward establishing effective global health governance: a Framework Convention on Global Health.

Available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1014082


Georgetown Law Journal Special Symposium Article: A Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims.

By David Kessler and David Vladick

This article explores the legality and wisdom of the FDA's effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA's justifications for reversing its long-held views to the contrary and explains why the FDA's position cannot be reconciled with its governing statute. The article then examines why the FDA's position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. The article next explains why the agency's view that it is capable of single-handedly regulating the safety of drugs is unrealistic. The agency does not have the resources to perform the Herculean task of monitoring the performance of every drug on the market. Both the Institute of Medicine and the Government Accountability Office have explained the shortcomings in the FDA's recent performance, and they express doubt that the FDA is in capable of facing an increasingly challenging future.

The article then explains how state damages litigation helps uncover and assess risks that are not apparent to the agency during a drug's approval process, and why this “feedback loop” enables the agency to better do its job. FDA approval of drugs is based on clinical trials that involve, at most, a few thousand patients and last a year or so. These trials cannot detect risks that are relatively rare, affect vulnerable sub-populations, or have long latency periods. For this reason, most serious adverse effects do not become evident until a drug is used in larger population groups for periods in excess of one year. Time and again, failure-to-warn litigation has brought to light information that would not otherwise be available to the FDA, to doctors, to other health care providers, and to consumers. And failure-to-warn litigation often has preceded and clearly influenced FDA decisions to modify labeling, and, at times, to withdraw drugs from the market.

Available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1014094


The Difficult Case of Direct-to-Consumer Drug Advertising.
41 Loyola Los Angeles Law Review (forthcoming 2008)

By David Vladick

This article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. The question is whether proposals before Congress to limit or ban DTC advertising would pass constitutional muster. The article canvasses the arguments in some detail and concludes that legislation restricting DTC advertising to enable the FDA to assess the risks of a drug might withstand constitutional attack, but that an all-out ban on DTC advertising would not likely be sustained. The point of this discussion is to illustrate the complexity of commercial speech questions.


Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority.

Testimony of David C. Vladeck, Before the Committee on the Judiciary, United States Senate

Professor Vladeck speaks before Congress on the issue of whether federal regulatory agencies are usurping the authority of Congress and the States by asserting that federal regulatory action preempts state law.


Health Care for All? The New England Journal of Medicine, Sep 20, 2007. Vol. 357, Iss.12; pg. 1173.

By M. Gregg Bloch

This article explores recent trends in health care coverage, namely the trend toward an ethic that calls on Americans to take care of themselves. The author argues that the new compact is likely to start with an enhanced sense of individual obligation - to eat sensibly, exercise regularly, avoid smoking, and perhaps an obligation to buy insurance. Government, in exchange, can offer some protection against the threat of economic and social change that will disrupt people's coverage by destabilizing employment and family relationships.


JAMA Global Tobacco Editorial

By Lawrence O. Gostin

Recent tobacco control regulation in North America and Western Europe has had a salutary effect, even if smoking remains a pressing public health hazard. But in the 21st century, the tobacco industry has quietly moved its locus of activity to lucrative, emerging markets—the vast populations in Africa, Asia, Eastern Europe, and Latin America. The poorest, least educated, and sickest people on earth inhabit these regions. “Big Tobacco's” new marketing strategy will cause untold morbidity for the world's most vulnerable.

However, there are a variety of effective tobacco control policies that nations can and should enact. The World Health Organization's newest treaty, the Framework Convention for Tobacco Control, requires signatory nations to adopt a variety of tobacco control policies to the fullest extent permissible under their constitutions. Effective tobacco control policies include: national tobacco regulatory agencies; comprehensive bans on tobacco advertising, promotion, and sponsorship; health warnings on cigarette packets that cover at least half of the packet, convey the risks, rotate messages, and use images; mandating smoke-free environments; and tax and price policies that make smoking prohibitively expensive. The imperatives of science, ethics, and human rights oblige society to reduce the burden of smoking, particularly among the disadvantaged.


JAMA Pain Editorial

By Lawrence O. Gostin

Medical availability of effective pain medication is being increasingly recognized as a domestic and global health challenge. Important medical advances over the last several decades have significantly improved the technical capacity to control pain and diminish human suffering. Worldwide, millions suffering from chronic, acute and terminal conditions have been able to find relief from excruciating pain through medical intervention. However, improvements in access to and utilization of pain medication have largely centered on the developed world. The tragedy is that for most of the world's population, particularly in developing countries, effective pain control is entirely unavailable.


Addressing the Global Tragedy of Needless Pain: Rethinking the United Nations' Single Convention on Narcotic Drugs

By Allyn L. Taylor

Over the last few years, public and scholarly attention has centered on the important issue of access to medicines, particularly in the context of HIV/AIDS antiretroviral therapy (ARV). Unfortunately, the global attention to ARV therapy has not stimulated broader attention to the universal issue of human pain that plagues millions of persons around the globe with terminal, chronic, and acute conditions. However, there has been little scholarly consideration of the global drug regulatory environment on how international law and international institutions either interfere with or can contribute to national efforts to strengthen pain management. The goals of this article are twofold: (1) to critically analyze the impact of the international drug regulatory regime on medical availability of narcotic drugs and (2) to consider legal and institutional mechanisms that can be employed globally to promote wider accessibility of these critical medicines. This article contends that a more balanced approach to international implementation of the Single Convention on Narcotic Drugs — one that weighs the Convention's dual goals of controlling abuse and ensuring availability — can have an important, albeit limited, influence on States in encouraging medical availability of opioids.