Digital Commons Network^™

Designing Global Climate Regulation, Jonathan B. Wiener

Faculty Scholarship

No abstract provided.

Youngstown: Pages From The Book Of Disquietude, Philip Chase Bobbitt

Faculty Scholarship

The Youngstown holding is widely admired. One reads with pride those passages in which the Supreme Court denies to a president with whom they are in considerable political sympathy the power to enlarge executive authority by militarizing the homeland. And yet one wonders, as we confront in the 21st century a lethal foreign enemy who has demonstrated the ability to infiltrate and assault the domestic environment, precisely what restraints ought to govern a presidential response to that enemy.

Protecting The Endangered Human: Toward An International Treaty Prohibiting Cloning And Inheritable Alterations, George J. Annas, Lori B. Andrews, Rosario M. Isasi

Faculty Scholarship

We humans tend to worry first about our own happiness, then about our families, then about our communities. In times of great stress, such as war or natural disaster, we may focus temporarily on our country but we rarely think about Earth as a whole or the human species as a whole. This narrow perspective, perhaps best exemplified by the American consumer, has led to the environmental degradation of our planet, a grossly widening gap in living standards between rich and poor people and nations and a scientific research agenda that focuses almost exclusively on the needs and desires of …

Bioterrorism, Public Health, And Civil Liberties, George J. Annas

Faculty Scholarship

The prospect of having to deal with a bioterrorist attack, especially one involving smallpox, has local, state, and federal officials rightly concerned. Before September 11, most procedures for dealing with a bioterrorist attack against the United States were based on fiction. Former President Bill Clinton became engaged in the bioterrorism issue in 1997, after reading Richard Preston's novel The Cobra Event. In Tom Clancy's 1996 Executive Orders, the United States is attacked by terrorists using a strain of Ebola virus that is transmissible through the air. To contain the epidemic, the President declares a state of emergency, orders that …

Legal Issues In Hiv/Aids Prevention And Treatment In The Russian Federation – Summary And Conclusions Of The Boston University Hiv/Aids Project, Wendy K. Mariner

Faculty Scholarship

The Russia Federation faces an urgent need to control the spread of HIV. Although infection has been concentrated primarily among high risk groups so far, the risk that it will spread rapidly throughout the general population is growing daily. Controlling the HIV epidemic requires leadership and strategies that are somewhat different from traditional infectious disease control models because there is no vaccine yet available to prevent disease and people spread infection by engaging in activities that are hidden from public view and not susceptible to simple prohibitions.

Boston University conducted several studies as part of USAID’s HIV/AIDS Strategy to assist …

The Role Of Law In Russian Health Reform: Report To The United States Agency For International Development, Wendy K. Mariner, Frank G. Feeley

Faculty Scholarship

True reform necessarily entails new law. In the newly independent Russian Federation, law has played a formative role in efforts to reform the health care system. Both historically and structurally, the health care system in Russia is more dependent on legal authorization than that in most Western industrialized countries. Reforms that providers might institute independently elsewhere are not likely to happen in Russia without specific laws authorizing them. Policy makers often formulate the substance of policy in the context of developing legislation, instead of drafting legislation to codify settled policy decisions. Thus, identifying and developing suitable laws has become an …

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

Health Care, Technology And Federalism, Kevin Outterson

Faculty Scholarship

The regulation of health care has traditionally been the province of the states, most often grounded in the police power. In Colonial times, this division of responsibility was a rational response to the technological level of the eighteenth century, although even in the youth of the Republic some health and safety regulation required national and international action. With the growth of distancecompression technology, the increase in mobility of goods and services, and a significant federal financial role in health care, the grip of the police power on the regulation of health care has been weakened. Discussion of the police power …

The Merger Between Public Health And Health Law – The Us Situation, Wendy K. Mariner

Faculty Scholarship

Law is an essential tool for protecting the public’s health. It is often the law that turns public health science into public health action. Sanitation, clean air and water, universal vaccination, injury prevention, tobacco control, drug policy, and a vast array of other interventions are achieved through a complex web of local, provincial and national statutes, regulations and judicial cases. The Institute of Medicine in the United States defines public health as “what we, as a society, do collectively to ensure the conditions in which people can be healthy.” And society acts collectively most often through law.

Thus, the merging …

Regulating Research With Decisionally Impaired Individuals: Are We Making Progress?, Diane E. Hoffmann, Jack Schwartz, Evan G. Derenzo

Faculty Scholarship

No abstract provided.

Balancing Public Health Against Individual Liberty: The Ethics Of Smoking Regulations, Thaddeus Mason Pope

Faculty Scholarship

Ten years ago, philosopher Robert E. Goodin published "No Smoking: The Ethical Issues." Goodin argued that the liberty of smokers can be justifiably limited for two reasons: to prevent harm to third persons and to prevent harm to smokers themselves under circumstances which make their decision to smoke substantially non-autonomous. In this article Thaddeus Pope reexamines the harm principle and the soft paternalism principle in light of more recent legal developments, gives them additional content, and carefully demarcates the justificatory scope of each. Pope also defines and defends a third liberty-limiting principle, hard paternalism, arguing that the liberty of smokers …

Social Risk And The Transformation Of Public Health Law: Lessons From The Plague Years, Elizabeth B. Cooper

Faculty Scholarship

Acquired Immune Deficiency Syndrome (AIDS) was the wake-up call that disturbed America from its mid-twentieth century slumber concerning the dangers of communicable diseases. Until AIDS was identified in 1981, most Americans felt largely impervious to health threats posed by viruses or bacteria. Polio, smallpox, and tuberculosis had been brought under control by the "magic bullets" of antibiotics and vaccines." We felt more susceptible to the ravages of cancer or the debilitation of heart disease. But, over the last twenty years, the (re)emergence of serious or life-threatening microbial- based conditions such as Ebola, hantavirus, Lyme disease, West Nile virus, and even …

Symposium: Advances In Biomaterials And Devices, And Their Financing, Ronald A. Cass, Michael S. Baram, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King

Faculty Scholarship

My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.

Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …

Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant

Faculty Scholarship

You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …

Whatever Happened To Anti-Semitism? How Social Science Theories Identify Discrimination And Promote Coalitions Between "Different" Minorities, Clark Freshman

Faculty Scholarship

No abstract provided.

Bioactivity Of Marine Organisms: Relationships With Taxonomy, Geography And Depth., John K. Reed, Susan H. Sennett, Peter J. Mccarthy, Tara P. Pitts, Amy E. Wright, Shirley A. Pomponi

Faculty Scholarship

Harbor Branch Oceanographic Institution (HBOI) has a worldwide collection of over 25,000 marine macro-invertebrates and algae representing diverse geographical, latitudinal, and depth (0-3000 ft) ranges. Samples are tested for biological activity in a panel of whole cell and enzyme/receptor assays, including antibacterial, antifungal, cytotoxicity, antitumor, and immunomodulatory assays. Of the taxa sampled, Porifera have the greatest incidence of activity within these screens and especially within the antimicrobial assays. Cnidaria, Chordata (Ascidiacea), Phaeophyta, and Chlorophyta also show strong antimicrobial activity. A comparison of bioactivity and depth of collection indicates that benthic organisms are active throughout the depth range of this study. …

Protecting Patients From Discrimination: The Americans With Disabilities Act And Hiv Infection, George J. Annas

Faculty Scholarship

The Americans with Disabilities Act (ADA) was passed in 1990 to expand the reach of the Rehabilitation Act of 1973 and make discrimination on the basis of disability unlawful. The wheelchair symbol has become a universal sign of disability, but there are, of course, many types of disability that have been the basis of discrimination over the years, including blindness, deafness, epilepsy, cancer, heart disease, and mental retardation. AIDS is a disability under the ADA, and most commentators have assumed that infection with the human immunodeficiency virus (HIV) also qualifies as a disability under this act. It was not, however, …

Human Rights And Maternal-Fetal Hiv Transmission Prevention Trials In Africa, George J. Annas, Michael A. Grodin

Faculty Scholarship

The human rights issues raised by the conduct of maternal-fetal human immunodeficiency virus transmission trials in Africa are not unique to either acquired immunodeficiency syndrome or Africa, but public discussion of these trials presents an opportunity for the United States and other wealthy nations to take the rights and welfare of impoverished populations seriously. The central issue at stake when developed countries perform research on subjects in developing countries is exploitation. The only way to prevent exploitation of a research population is to insist not only that informed consent be obtained but also that, should an intervention be proven beneficial, …

Bioethics Policy: Looking Beyond The Power Of Sovereign Governments (Foreword), Robert L. Schwartz

Faculty Scholarship

Lawyers are trained to think in terms of power exercised by a sovereign-an institution authorized to enforce a procedurally appropriate decision with coercive force.' Generally, lawyers have a broad notion of what constitutes a sovereign. In the United States, for example, this notion includes the federal government, state governments, most tribal units, traditional territorial governments and their agencies-e.g., school boards, local public park districts, water run-off management districts, and flea abatement boards-and a host of other institutions. As a result, it is difficult for lawyers to recognize that policy also may emanate from other institutions that possess only persuasive authority, …

Gender Differences In Biological And Sociological Predictors Of Crime, Deborah W. Denno

Faculty Scholarship

One of the many goals of the Biosocial Study that I directed was determining whether there were gender differences among the numerous possible correlates of crime that the study examined. The purpose of my presentation today is to describe the Biological Study and its results, particularly as they relate to gender differences in crime. Another aim is to respond briefly to some of the potential political reactions to the study, despite its results. I will begin with a quick account of historical attitudes toward gender differences in crime. I will then discuss the Biosocial Study and its major findings relevant …

Aids Phobia, Public Health Warnings, And Lawsuits: Deterring Harm Or Rewarding Ignorance?, Wendy K. Mariner

Faculty Scholarship

Courts in more than a dozen states have decided cases in which a person has claimed money damages for his or her fear of getting acquired immunodeficiency syndrome (AIDS). Although most courts have rejected such claims in the absence of actual exposure to the human immunodeficiency virus (HIV), their reasoning has varied slightly from state to state. This article argues that negligence law should not permit people who are HIV negative to recover damages for an unfounded fear of AIDS. Public health statements intended to educate the public about preventing HIV transmission may have encouraged some fear-of-AIDS lawsuits against health …

Rationing Health Care And The Need For Credible Scarcity: Why American's Can't Say No, Wendy K. Mariner

Faculty Scholarship

With adequate cost containment unlikely in the foreseeable future, health care use will have to be curtailed, ideally with open and explicit criteria for equitably allocating resources or rationing. Yet, consensus on any such criteria appears remote because Americans cannot say no to health care. Americans may refuse to accept rationing for two reasons. The absence of any global limitation on health care resources may encourage patients to believe that health care resources are not scarce and do not need to be rationed. A belief in vitalism--that everyone is morally entitled to unlimited longevity and good health--may discourage setting limits …

Medicine, Death, And The Criminal Law, George J. Annas

Faculty Scholarship

Errors in medicine are common and are at least partly responsible for the deaths of 180,000 patients a year. There is increasing concern about medical errors and the steps that should be taken to prevent them.Until recently, hospitals have addressed errors after the fact, through mortality and morbidity conferences, incident reports, and the like, rather than before the fact, through attention to systems defects and prevention. Likewise, medical-malpractice litigation can be filed only after an injury has occurred. Malpractice litigation is intended to create incentives to improve the quality of medical care by making physicians and hospitals accountable for their …

Something Old, Something New: The Challenge Of Tuberculosis Control In The Age Of Aids, Karen H. Rothenberg, Elizabeth C. Lovoy

Faculty Scholarship

No abstract provided.

The Americans With Disabilities Act And The Reproductive Rights Of Hiv-Infected Women, Taunya L. Banks

Faculty Scholarship

No abstract provided.

Nationalism And Internationalism: The Wilsonian Legacy, Lori Fisler Damrosch

Faculty Scholarship

No twentieth-century leader has had greater influence on the parallel development of both nationalism and internationalism than Woodrow Wilson. Wilson gave expression to the nationalist aspirations of peoples around the world, through is endorsement of the principle of self-determination. He also initiated the first institution that had as its objective the organization of the international community to apply concerted power in support of universal values. My task is to examine one contemporary problem – intervention – in the light of some of the themes implicit in the Wilsonian legacy. Among these themes will be the establishment (and now the invigoration) …

Reproduction And Parenting, Taunya Lovell Banks

Faculty Scholarship

No abstract provided.

Life Style, Health Status, And Distributive Justice, Robert L. Schwartz

Faculty Scholarship

The newest and most original scapegoat upon which we can place the blame for the high cost of health care are those whose life style choices puts their health or lives at risk. Of course, if our health care cost and access problems are a consequence of unhealthy choices made by autonomous individuals, we are relieved of the obligation of figuring out how to reform our health care delivery system. In that case, the solution to our health care problem is obvious - we merely need to impose appropriate penalties on those who make costly, immoral and unhealthy life style …

The Changing Landscape Of Human Experimentation: Nuremberg, Helsinki, And Beyond, George J. Annas

Faculty Scholarship

Since World War II there have been persistent efforts at both the national and international level to develop rules to protect the rights and welfare of subjects of human experimentation.' These efforts have focused primarily on codifying the rights of subjects, and protecting their welfare by prior peer review of research protocols. In recent years research regulations have been under attack by politicians, drug companies, researchers, and advocacy groups. In less than half a century, human experimentation has been transformed from a suspect activity into a presumptively beneficial activity. With this transformation, traditional distinctions between experimentation and therapy, subject and …

Risky Business: Setting Public Health Policy For Hiv-Infected Health Care Professionals, Leonard H. Glantz, Wendy K. Mariner, George J. Annas

Faculty Scholarship

An analysis of the restrictive proposals provoked by the case of Kimberly Bergalis and four other patients apparently infected with HIV during the course of dental treatment reveals that they resulted from an inability to evaluate appropriately the infinitesimal risk of HIV transmission from practitioner to patient. The proposals also resulted from an effort to create risk prevention policy without appreciating the distinction between regulating things or procedures, which have no human rights, and regulating people, who have rights that should not be infringed without serious justification. This analysis demonstrates that the proposed restrictive policies are not justified because they …