Health Law and Policy Commons^™

Ulysses And The Fate Of Frozen Embryos - Reproduction, Research, Or Destruction?, George J. Annas

Faculty Scholarship

On his 10-year voyage back to Ithaca from the Trojan War, Ulysses was warned by Circe to take precautions if he wanted to hear the Sirens' transfixing song, or there would be “no sailing home for him, no wife rising to meet him, /no happy children beaming up at their father's face.” Ulysses accordingly ordered his men to stop their ears with beeswax and bind him firmly to the mast and instructed them that if he gestured to be set free, they should stick to the original agreement and bind him tighter still. Making an agreement that has as a …

Tobacco, The Food And Drug Administration, And Congress, Leonard H. Glantz, George J. Annas

Faculty Scholarship

Smoking has been the number-one target of public health professionals in the United States for more than a decade because it is the leading cause of premature death. Nonetheless, no unified public health strategy has been developed. In 1995, with the strong endorsement of President Bill Clinton and Vice President Al Gore, the commissioner of the Food and Drug Administration (FDA), Dr. David Kessler, announced that the agency had jurisdiction over tobacco and would regulate cigarettes as “drug-delivery devices. The tobacco companies objected and sued the FDA, arguing that Congress had not given the FDA jurisdiction over their product. The …

Rules For Research On Human Genetic Variation: Lessons From Iceland, George J. Annas

Faculty Scholarship

Research on genetic variation aims to understand how genes function and requires the comparison of DNA samples from groups of individuals to identify variations that might have importance for health or disease. This work is easier if the samples are linked to accurate medical records and genealogic information. Iceland has medical records for all its citizens going back to World War I and detailed genealogic information going back even further. Because Iceland's small population (270,000) has long been isolated and homogeneous, it is thought by many to be an ideal place to search for disease-related genes. Journalists have cavalierly labeled …

Introduction: Fifteenth Anniversary Of The Edward V. Sparer Public Interest Law Fellowship Program, Elizabeth M. Schneider

Faculty Scholarship

No abstract provided.

Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah

Faculty Scholarship

Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA's spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of postapproval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization …

Are Ethics Committee Members Competent To Consult?, Diane E. Hoffmann, Anita J. Tarzian, J. Anne O'Neil

Faculty Scholarship

No abstract provided.

Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel

Faculty Scholarship

Despite the continuing "war on drugs," the last decade has witnessed the creation and nationwide spread of a remarkable set of institutions, drug treatment courts. In drug treatment court, a criminal defendant pleads guilty or otherwise accepts responsibility for a charged offense and accepts placement in a court-mandated program of drug treatment. The judge and court personnel closely monitor the defendant's performance in the program and the program's capacity to serve the mandated client. The federal government and national associations in turn monitor the local drug treatment courts and disseminate successful practices. The ensemble of institutions, monitoring, and pooling exemplifies …

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 …

Regulating Through Information: Disclosure Laws And American Health Care, William M. Sage

Faculty Scholarship

Efforts to reform the American health care system through direct government action have failed repeatedly. Nonetheless, an alternative strategy has emerged from these experiences: requiring insurance organizations and health care providers to disclose information to the public. In this Article, Professor Sage assesses the justifications for this type of regulation and its prospects. In particular, he identifies and analyzes four distinct rationales for disclosure. He finds that the most commonly articulated goal of mandatory disclosure laws-improving the efficiency of private purchasing decisions by giving purchasers complete information about price and quality- is the most complicated operationally. The other justifications-which he …

The Second Revolution In Informed Consent: Comparing Physicians To Each Other, Neil B. Cohen, Aaron D. Twerski

Faculty Scholarship

No abstract provided.

Standards Of Care And Standard Form Contracts: Distinguishing Patient Rights And Consumer Rights In Managed Care, Wendy K. Mariner

Faculty Scholarship

There is hardly a legislature in the country that is not currently debating the issue of patient rights in managed care. Not surprisingly, legislators, as well as reporters covering the debate, have called upon George J. Annas, Edward R. Utley Professor of Health Law and Chair of the Health Law Department at Boston University, for information and advice. Professor Annas has earned the title of "father of patient rights" for his decades of research, writing, and advocacy on behalf of individuals who need health care and deserve justice.

Today, however, one might ask whether patient rights are compatible with managed …

Genetic Privacy: There Ought To Be A Law, George J. Annas

Faculty Scholarship

If you don't believe in privacy, you probably don't believe in genetic privacy. I believe in privacy, including the constitutional right of privacy. But my interest is not to persuade you to believe in privacy, but rather to expose the major issues involved in genetic privacy. What makes genetic information different from other sensitive medical information? Are we getting carried away? Are we just treating DNA-based information differently because it is new?

Privacy In Genetics Research, Barbara Fuller, Mary Jo Ellis Kahn, P. A. Barr, L. Biesecker, E. Crowley, J. Garber, M. K. Mansoura, Patricia Murphy, J. Murray, J. Phillips, Karen H. Rothenberg, Mark Rothstein, J. Stopfer, Gary Swergold, B. Weber, Francis Collins, Kathy Hudson

Faculty Scholarship

No abstract provided.

Competing On Quality Of Care: The Need To Develop A Competition Policy For Health Care Markets, William M. Sage, Peter J. Hammer

Faculty Scholarship

As American health care moves from a professionally dominated to a marketdominated model, concerns have been voiced that competition, once unleashed, will focus on price to the detriment of quality. Although quality has been extensively analyzed in health services research, the role of quality in competition policy has not been elucidated. While economists may theorize about non-price competition, courts in antitrust cases often follow simpler models of competition based on price and output, either ignoring quality as a competitive dimension or assuming that it will occur in tandem with price competition. This unsystematic approach is inadequate for the formulation of …

"Being Human": Cloning And The Challenges For Public Policy, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Physicians As Advocates, William M. Sage

Faculty Scholarship

The principal theme of this Article is that many dimensions of physicians' advocacy in managed care remain to be established, and those dimensions may turn out to be inconsistent with one another or with normative goals for the health care system. Specifically, attempting to map physician behavior onto an advocacy template created for lawyers raises three difficult questions. First, given the undisputed importance of clinical expertise to an efficient health care system, should physicians' primary role be to advocate for causes or to direct the provision of care? Second, would the medical professions' reputation for independent competence withstand the adversarial …

Social, Legal, And Ethical Issues, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Burden Of Proof: Judging Science And Protecting Public Health In (And Out Of) The Courtroom, George J. Annas

Faculty Scholarship

The breast implant cases alleging systemic disease would in all likelihood have been lost had recipients been properly warned of potential dangers by the manufacturer or their surgeons.

Municipal Home Rule In New York: Tobacco Control At The Local Level,, Laura Hermer

Faculty Scholarship

This paper will examine the nature and scope of the ability of both municipalities and local public health departments to govern the local sale, use, availability and advertising of tobacco products in the context of New York state law and the recent Multistate Settlement Agreement.

Part I will begin with a description of municipalities in New York and a summary of the provisions of article 9 of the New York Constitution and section 10 of the state Municipal Home Rule Law, which delimit spheres in which municipalities may act without state interference and others in which the state may act …

Preface: Electronic Medical Information: Privacy, Liability And Quality Issues, Frances H. Miller

Faculty Scholarship

This symposium issue explores the timely topic of health care information and information technology, and their impact on health care delivery. The potential for mischief in this area has been the subject of many a dire prediction, but documented instances of negligence or abuse are thus far relatively rare. As information technology becomes more and more sophisticated and pervasive, however, legal problems are increasingly possible-if not probable-and these articles examine a wide range of issues related to the phenomenon.

The Last Resort: The Use Of Physical Restraints In Medical Emergencies, George J. Annas

Faculty Scholarship

Public awareness of the use of restraints in medicine has been greatly heightened by a five-part investigative series on physical restraints in psychiatric hospitals by the Hartford Courant and reaction to it by Connecticut's U.S. senators, Joseph Lieberman and Christopher Dodd. In October 1998 the Courant 's 50-state survey identified 142 patients who had died while in restraints or seclusion in the past decade, and the total number is probably much higher. The newspaper advocated the need for national standards for the use of restraints, impartial oversight, and accountability “for behavior that is cruel and even criminal.” The use of …

Waste And Longing: The Legal Status Of Placental Blood Banking, George J. Annas

Faculty Scholarship

Waste is not always what it seems. In his Cold War novel Underworld, for example, Don DeLillo explores the multifaceted qualities of waste. “Waste,” he notes, “is the secret history, the underhistory, the way archaeologists dig out the history of early cultures, every sort of bone and broken tool, literally from under the ground.”1 And waste can also be transformed into money:

They are trading garbage in the commodity pits in Chicago. They are making synthetic feces in Dallas. You can sell your testicles to a firm in Russia that will give you four thousand dollars and then remove …

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Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas

Faculty Scholarship

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the …

Stem Cell Politics, Ethics And Medical Progress, George J. Annas, Arthur Caplan, Sherman Elias

Faculty Scholarship

Controversy over how to fund and regulate stem cell research continues in the US and is unlikely to be resolved anytime soon. The National Institutes of Health (NIH) has announced that it is prepared to fund stem cell research under yet-to-be-specified guidelines. The National Bioethics Advisory Commission (NBAC) issued a report on stem cells in mid-September, recommending that Congress change the law to permit the derivation and use of stem cells from embryos no longer needed for reproduction purposes that are stored at in vitro fertilization (IVF) clinics. The NBAC also recommended that the Department of Health and Human Services …

The Social Implications Of The Use Of Stored Tissue Samples: Context, Control, And Community, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Social Implications Of Genetic Testing, Karen H. Rothenberg

Faculty Scholarship

This paper examines the social implications of predictive genetic testing and its impact on the insurance industry. Although the Human Genome Project has the potential to improve the health of our nation, it also may serve as a means of highlighting genetic differences among individuals and ethnic groups. Thus, if we are to reach the full promise of the Project, society must address the public's fears of genetic discrimination in insurance and employment context. Following an analysis of state and federal legislation on genetic privacy and discrimination, the paper concludes with a challenge to the insurance industry to work with …

Reviving The Public/Private Distinction In Feminist Theorizing Symposium On Unfinished Feminist Business, Tracy E. Higgins

Faculty Scholarship

The public/private distinction has been a target of thoroughgoing feminist critique for quite some time now. Indeed, attacking the public/private line has been one of the primary concerns (if not the primary concern) of feminist legal theorizing for over two decades. If Carole Pateman is correct, one would think that this particular problem might be assigned to the category of "finished business" by this time. In this Essay, I do argue that the critique is, in certain ways, finished business in that it is no longer particularly useful in its most common forms. More importantly, however, I suggest several ways …

Testing For Genetic Traits: The Need For A New Legal Doctrine Of Informed Consent , Elizabeth B. Cooper

Faculty Scholarship

Innovative medical technology has made it possible to test whether you are at increased risk for certain types of cancer. The mere processing of a vial of blood can reveal whether you have a genetic predisposition to develop breast, ovarian, or prostate cancer, or other life-threatening conditions. The Human Genome Project, an international endeavor seeking to map our genetic structures, has facilitated this increasing ability to test for genetic flaws. It is expected that as the human genetic map is filled in, and as flaws in our fundamental building blocks are identified, there will be a concomitant drive to test …

Medical Ethics And Human Rights: Legacies Of Nuremberg, George J. Annas, Michael A. Grodin

Faculty Scholarship

Many of our most important human rights documents are the product of the world's horror during the carnage of World War II. The broadest and most powerful declaration of human rights, the Universal Declaration of Human Rights, was adopted by the membership of the new United Nations in 1948. But there are also much more specific statements of the world's aspirations for all of its inhabitants. August 1997 marked the 50th anniversary of the conclusion of the trial of Nazi physicians at Nuremberg, a trial which has been variously designated as the "Doctors' Trial" and the "Medical Case."² In …

Pain Management And Palliative Care In The Era Of Managed Care: Issues For Health Insurers, Diane E. Hoffmann

Faculty Scholarship

No abstract provided.