Adverse Reactions To Hiv Vaccines Medical Ethical And Legal Issues

AIDS researchers are investigating new vaccines that would prevent infection with HIV and reduce the spread of AIDS. Some have argued that product liability concerns have discouraged investment in HIV vaccine research and development. The purpose of this OTA background paper is to describe the current state of development of HIV vaccines, and to discuss what is known about adverse reactions that may occur. The background paper provides an overview of ethical issues that arise in the conduct of HIV vaccine trials. The report also discusses alternatives to the current product liability system to encourage the development of HIV vaccines and to fairly compensate those who are harmed as a result of adverse reactions to the vaccine. This background paper was prepared in response to a request from the Subcommittee on Health of the House Ways and Means Committee. It is eleventh in OTA's series of studies on HIV-related issues.

AIDS researchers are investigating new vaccines that would prevent infection with HIV and reduce the spread of AIDS. Some have argued that product liability concerns have discouraged investment in HIV vaccine research and development. The purpose of this OTA background paper is to describe the current state of development of HIV vaccines, and to discuss what is known about adverse reactions that may occur. The background paper provides an overview of ethical issues that arise in the conduct of HIV vaccine trials. The report also discusses alternatives to the current product liability system to encourage the development of HIV vaccines and to fairly compensate those who are harmed as a result of adverse reactions to the vaccine. This background paper was prepared in response to a request from the Subcommittee on Health of the House Ways and Means Committee. It is eleventh in OTA's series of studies on HIV-related issues.

The motivation and inspiration for this book come directly from expe- ences with clients during the years that I practiced HIV-related law at the Legal Aid Society of San Diego, Inc. The issues discussed in this work reflect issues that arose on a recurring basis with clients participating in HIV research studies, with investigators calling for guidance on the legal implications of particular aspects of their proposed studies, and with research institutions and health care facilities struggling to make sense of legal maneuvers aimed at obtaining the records of their HIV-infected patients. It is impossible to thank each of these persons individually for their provocative questions and their insights. The discussion of ethical and legal issues relating to the design of clinical trials reflects questions raised during discussions with Donald J. Slymen, Ph.D. Don was one of the first researchers, in my realm of experience, to pay close attention to ethical concerns, and I am greatly appreciative of his contribution to both my professional growth and the development of various scenarios discussed in this text. The portions of this text dealing with confidentiality are the result of many hours of thoughtful discussion and analysis with Penn Lerblance, J.D., now deceased and still missed. Penn and I often participated together as presenters of in-service training programs for health prof- sionals. Penn addressed discrimination, and I focused on confidentiality.

New and improved therapies to treat and protect against drug dependence and abuse are urgently needed. In the United States alone about 50 million people regularly smoke tobacco and another 5 million are addicted to other drugs. In a given year, millions of these individuals attemptâ€"with or without medical assistanceâ€"to quit using drugs, though relapse remains the norm. Furthermore, each year several million teenagers start smoking and nearly as many take illicit drugs for the first time. Research is advancing on promising new means of treating drug addiction using immunotherapies and sustained-release (depot) medications. The aim of this research is to develop medications that can block or significantly attenuate the psychoactive effects of such drugs as cocaine, nicotine, heroin, phencyclidine, and methamphetamine for weeks or months at a time. This represents a fundamentally new therapeutic approach that shows promise for treating drug addiction problems that were difficult to treat in the past. Despite their potential benefits, however, several characteristics of these new methods pose distinct behavioral, ethical, legal, and social challenges that require careful scrutiny. Such issues can be considered unique aspects of safety and efficacy that are fundamentally related to the distinct nature and properties of these new types of medications.

An estimated forty million people carry the human immunodeficiency virus (HIV), and five million more become newly infected annually. In recent years, many HIV-infected patients in wealthy nations have enjoyed significantly longer, good-quality lives as a result of antiretroviral therapy (ART). However, most infected individuals live in the poorest regions of the world, where ART is virtually nonexistent. The consequent death toll in these regionsâ€"especially sub-Saharan Africaâ€"is begetting economic and social collapse. To inform the multiple efforts underway to deploy antiretroviral drugs in resource-poor settings, the Institute of Medicine committee was asked to conduct an independent review and assessment of rapid scale-up ART programs. It was also asked to identify the components of effective implementation programs. At the heart of the committee's report lie five imperatives: Immediately introduce and scale up ART programs in resource-poor settings. Devise strategies to ensure high levels of patient adherence to complicated treatment regimens. Rapidly address human-resource shortages to avoid the failure of program implementation. Continuously monitor and evaluate the programs to form the most effective guidelines and treatment regimens for each population. Prepare to sustain ART for decades.