Global Health and Human Rights Imperative

Open any magazine, click on a television news channel, or surf the net and you are likely to find global health highlighted as one of the foremost challenges of new millennium. First, this article will consider the meaning and measures of global health and detail the path to improved health and development prescribed by the United Nations Millennium Development Goals. Second, it will trace the development of international human rights law as it relates to health. Third, it demonstrate how human rights and health, long traversing parallel routes, are in fact converging in the 21st Century quest for global health–a quest that is simultaneously being driven by evolving international rights and norms related to trade, labor, the environment and human security. The article will conclude that global health and human rights are products of new international norms of governance borne of our interdependence and ongoing multilateral collaboration

Balancing the Barriers: Exploiting and Creating Incentives to Promote Development of New Tuberculosis Treatments

This Article considers the many barriers that health-care providers and public health authorities face in stemming the modem TB epidemic. Part II reviews historical public health measures, their results, and their adaptability to resurgent and MDR-TB. Part III considers the fundamental barriers to a successful global effort using these public health strategies, concluding that these barriers are insurmountable given the current arsenal of anti-tuberculosis therapies. Part IV examines the reasons why research and development of new anti-tuberculosis drugs and vaccines have stagnated over the last quarter century. Finally, part V explores incentives that might revive research and development of such therapies and thus tip the scales toward control of this dangerous new white plague

Balancing the Barriers: Exploiting and Creating Incentives to Promote Development of New Tuberculosis Treatments

This Article considers the many barriers that health-care providers and public health authorities face in stemming the modem TB epidemic. Part II reviews historical public health measures, their results, and their adaptability to resurgent and MDR-TB. Part III considers the fundamental barriers to a successful global effort using these public health strategies, concluding that these barriers are insurmountable given the current arsenal of anti-tuberculosis therapies. Part IV examines the reasons why research and development of new anti-tuberculosis drugs and vaccines have stagnated over the last quarter century. Finally, part V explores incentives that might revive research and development of such therapies and thus tip the scales toward control of this dangerous new white plague

Telemedicine and Integrated Health Care Delivery: Compounding Malpractice Liability

This Article considers how theories of medical negligence might be applied in the context of telemedicine and integrated delivery health plans. Part Two summarizes the history of telemedicine, its increasing breadth of application and opportunity and promise for the future. Part Three reviews traditional negligence principles and precedents and demonstrates how they might be applied when a telemedicine interaction results in negligence and harm to the patient. Part Four discusses evolving theories of shared liability applicable to health plans and managed care entities. Finally, Part Five demonstrates how shared liability theories will be applied to situations involving telemedicine technologies

Financing Clinical Research and Experimental Therapies: Payment Due, But from Whom?

This article will explore the realm of clinical research and the question of who should finance such research. The first part will define the various types and levels of clinical research in terms of the regulatory controls and oversight applied to such research. Then the article will summarize how the costs of clinical research and experimental therapies have been covered in the past. Finally, the article will evaluate the risks and benefits derived by the various stakeholders and propose a financing rationale for therapies that places the burden of cost squarely on the stakeholders most likely to benefit

Curing Conflicts of Interest in Clinical Research: Impossible Dreams and Harsh Realities

This article will explore conflicts of interest in the context of clinical research, focusing on the incentives and practices that foster such conflicts. Part I will briefly define and categorize the revenue streams at play in clinical research—both contemporaneous with the clinical trial, and the downstream, long-term gains available to the researcher and research university. Part II will discuss how these entangled revenue streams result in financial and non-financial conflicts of interest that affect the nature and balance of the research enterprise and potentially endanger patients and human subjects. Part III will summarize current conflicts of interest regulations and policies, including methods for addressing and preventing conflicts of interest. Finally, Part IV will suggest some reforms to the current conflict of interest management strategies, with the concession that, absent a major culture shift in research institutions and existing law, conflicts of interest will continue to undermine confidence in the integrity of the research enterprise

\u3ci\u3eVolk v. DeMeerleer\u3c/i\u3e Study

The University of Washington School of Law Center for Law, Science and Global Health was asked to “convene a study on the Washington State Supreme Court decision Volk v. DeMeerleer, 386 P.3d 254 (Wash. 2016).” The Volk case elaborated on the duty of mental health providers to protect foreseeable victims of a dangerous patient. The goal of the study was to evaluate whether or not this case “substantially changed the law [in Washington] on the duty of care owed to third parties by mental health providers and whether it has had an impact on access to mental health services in the state.” See Appendix A, Volk Appropriation, §(25)(a). This portion of our report details the results of the nationwide comprehensive survey of law and how Washington’s current law compares to other jurisdictions. The legislative appropriation for a comprehensive review of “duty to warn” and “duty to protect” law required three major subsets of legal research. First, it required an in-depth 50- state survey of legislative and case law related to the duty to warn and duty to protect. In the interest of being complete, we also included the District of Columbia. See Appendix A, Volk Appropriation, §(25(a)(i). Second, it included a detailed historical review and analysis of “duty to protect” lawsuits brought in Washington against outpatient mental health care providers since the decision in Petersen v. State, 671 P.2d 230 (Wash. 1983), the preeminent case in Washington prior to Volk. See Appendix A, Volk Appropriation, §(25(a)(iii). Finally, it included an analysis of how the Volk decision changed the law in Washington and how “Washington state’s law compares to other states.” See Appendix A, Volk Appropriation, §(25(a)(i). NOTE: All cases and statutes referred to in this text are available in the Appendix I, the complete summary of the fifty states and District of Columbia, and in the Supplementary Materials (each state’s statute and cases) available on the submitted USB drives or archived with the House Judiciary Committee. Note: Commissioned by the Washington State Legislature, House Judiciary Committee, Dec. 1, 2017. Patricia C. Kuszler and Terry J. Price, faculty supervisors. Research team: Tanya E. Karwaki, Jaclyn Greenberg, Annemarie Weiss, Gavin Keene.https://digitalcommons.law.uw.edu/clsgh/1000/thumbnail.jp

Biotechnology Entrepreneurship and Ethics: Principles, Paradigms, and Products

Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug or technology, ethical questions arise with respect to protecting human subjects and society from danger and exploitation by researchers. As development gives way to marketing and dissemination of a new product, government regulators are pressed to get drugs and biologics through the regulatory pipeline into the market faster, walking an ethical tightrope between speed and safety. As new biotechnology products enter the market place, doctors and patients traverse yet another tightrope, that between unknown risk and the promise of benefit. And finally, patent protection is increasingly viewed as a unethical culprit in keeping prices high and depriving the global poor from lifesaving drugs and biologics. Bioethics has, to date, been largely a creation of Western research and medicine. As such it is wholly inadequate to respond to the cascade of ethical issues that flow from a vibrant biotechnology industry. And if biotechnology is in its infancy, as most believe, it is crucial that scientists, entrepreneurs and governments engage in dialogue about the ethical and societal questions raised on the road of scientific progress. Note: Posted with the permission of the World Association for Medical Law and the journal, Medicine and Law

A Question of Duty: Common Law Legal Issues Resulting from Physician Response to Unsolicited Patient Email Inquiries

Reviewer: Terry, Nicolas