Showing papers in "American Journal of Law & Medicine in 2002"

Protecting the endangered human: toward an international treaty prohibiting cloning and inheritable alterations.

Abstract: I. INTRODUCTION 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 the wealthy few. Reversing the worldwide trends toward market-based atomization and increasing indifference to the suffering of others will require a human rights focus, forged by the development of what Vaclav Havel has termed a "species consciousness."1 In this Article we discuss human cloning and inheritable genetic alterations from the human species perspective, and suggest language for a proposed international "Convention of the Preservation of the Human Species" that would outlaw all efforts to initiate a pregnancy by using either intentionally modified genetic material or human replication cloning, such as through somatic cell nuclear transfer. We summarize international legal action in these areas over the past five years, relate these actions to arguments for and against a treaty and conclude with an action plan. B. HUMAN RIGHTS AND THE HUMAN SPECIES The development of the atomic bomb not only presented to the world for the first time the prospect of total annihilation, but also, paradoxically, led to a renewed emphasis on the "nuclear family," complete with its personal bomb shelter. The conclusion of World War II (with the dropping of the only two atomic bombs ever used in war) led to the recognition that world wars were now suicidal to the entire species and to the formation of the United Nations with the primary goal of preventing such wars.2 Prevention, of course, must be based on the recognition that all humans are fundamentally the same, rather than on an emphasis on our differences. In the aftermath of the Cuban missile crisis, the closest the world has ever come to nuclear war, President John F. Kennedy, in an address to the former Soviet Union, underscored the necessity for recognizing similarities for our survival: [L]et us not be blind to our differences, but let us also direct attention to our common interests and the means by which those differences can be resolved .... For, in the final analysis, our most basic common link is that we all inhabit this small planet. We all breathe the same air. We all cherish our children's future. And we are all mortal.3 That we are all fundamentally the same, all human, all with the same dignity and rights, is at the core of the most important document to come out of World War II, the Universal Declaration of Human Rights, and the two treaties that followed it (together known as the "International Bill of Rights").4 The recognition of universal human rights, based on human dignity and equality as well as the principle of nondiscrimination, is fundamental to the development of a species consciousness. As Daniel Lev of Human Rights Watch/Asia said in 1993, shortly before the Vienna Human Rights Conference: Whatever else may separate them, human beings belong to a single biological species, the simplest and most fundamental commonality before which the significance of human differences quickly fades .... We are all capable, in exactly the same ways, of feeling pain, hunger, and a hundred kinds of deprivation. Consequently, people nowhere routinely concede that those with enough power to do so ought to be able to kill, torture, imprison, and generally abuse others .... The idea of universal human rights shares the recognition of one common humanity. and provides a minimum solution to deal with its miseries.5 Membership in the human species is central to the meaning and enforcement of human rights, and respect for basic human rights is essential for the survival of the human species. …

The routinization of prenatal testing.

Abstract: The technology was available, so why not use it? - Words of an expectant father By now everyone is familiar with the recent accomplishments of the Human Genome Project. Accomplished in ten, rather than the initially expected fifteen, years, the human genome has been fully sequenced. Genetics is in its golden age. A product of the technology era, genetics has, in a short time, offered vast amounts of information. This increased knowledge promises potential benefits for our understanding of the disease process and, ultimately, treatment and prevention. The rapid flow of information, however, presents complications and challenges. It can complicate the decision making process for those involved in genetic testing, not only because our knowledge of genetics is more complex, but because there is so much more potential information to obtain. The sheer quantity of information for both researcher, clinician and especially patient, can be overwhelming. In addition, our ability to glean predictive or susceptibility information has vastly exceeded our ability to develop cures for diseases; patients can increasingly identify risks for conditions that they can do little to avoid. The expansion of genetic information has created a new class of genetics patients: the adult at risk for late-onset conditions. Once a field devoted primarily to expectant or future parents, genetic counseling increasingly includes adult genetics. With this growing area have come concerns about the costs of getting genetic information. A woman might learn that she has the BRCA1 gene, but data are still uncertain about precisely what this means in terms of her risk of breast or ovarian cancer and what she can do to reduce her risk. People with a family history of Huntington Disease (HD) may choose to find out whether they have the gene that virtually guarantees they will develop the disease, if they live long enough. But it is currently impossible to predict the age of onset and no cure or prevention is available. As a result, anxiety and distress can be associated with finding out one does or does not have a late-onset gene.1 Geneticists and ethicists have therefore urged caution and care in the decision making process. More importantly, many have suggested that knowledge may not always benefit everyone. For some, it can be "toxic." The circumspection regarding knowledge and genetic testing in the context of adult genetics applies equally well in the reproductive context. Yet, the same level of restraint and caution does not exist. Instead, prenatal genetic testing and screening has become de rigeur; nearly as commonplace and widely accepted as some of the more routine aspects of prenatal care. The routinization of prenatal testing2 has impoverished the informed consent process in many ways; little emphasis is placed on the many emotional and psychological ramifications of undergoing such testing, leaving patients unprepared for certain choices and emotional reactions. This Article argues that the same concerns about informed decision making with respect to genetic testing for late-onset conditions apply to prenatal testing. Part I outlines the history and evolution of genetic testing. It explores some of the issues that arise with genetic testing for late-onset conditions (late-onset testing) and reviews recommendations that have been made to address these concerns. Part II describes the routinization of prenatal testing and screening and the role that healthcare professionals, patients, society and the legal profession have played in this process. Part III then describes the implications of this routinization and the ways in which it has impoverished the informed consent process. While caution has been exercised to address the psychosocial risks associated with late-onset testing, the field of reproductive genetics today increasingly minimizes the psychosocial risks of prenatal testing. Therefore, patients are often uninformed about the implications of undergoing such testing, which can result in anxiety or decisions inconsistent with their values or preferences. …

Neither Moore nor the market: alternative models for compensating contributors of human tissue.

Abstract: I. INTRODUCTION Parts and products of the human body are increasingly important to biomedical research. Tumors removed in surgery help researchers map the molecular progression of cancer. Blood samples matched to clinical profiles suggest the role of genes and other factors in disease. Both hospital patients and visitors to the World Wide Web1 may be approached to provide tissues for study. Sometimes this research results in commercial developments that produce substantial financial rewards for researchers, biotechnology companies and pharmaceutical or medical device makers.2 Frequently, the use of human tissue is crucial to the scientific discoveries on which those products rely.3 Yet, the individual sources of tissue seldom share in the ensuing profits. The acceptability of this arrangement, often criticized as a double standard, has been scrutinized thoughtfully and vigorously in the literature of law and ethics for more than a decade. Debate was stimulated by a controversial 1990 decision in Moore v. Regents of the University of California.4 In that case, a divided California Supreme Court rejected a patient's claim that his property rights had been violated when his doctor and others made highly profitable use of the patient's surgically excised spleen cells without obtaining his permission or sharing the commercial proceeds.5 Since the Moore decision, commentators and the medical community IMAGE FORMULA5 have wrestled with the appropriate treatment of human tissue sources, whose contributions still tend to be handled as gifts. In twelve years of controversy, no professional consensus or concerted public policy response has emerged. A central reason for the continuing policy impasse appears to lie in the difficulties associated with the only legal model seriously contemplated as an alternative to the status quo: the treatment of human biological materials as the salable private property of the persons from whom they are taken.6 The creation of a market in human tissue, which appears to follow inevitably from a private property model, would entail its own formidable ethical and practical problems. Neither the Moore-based donation paradigm nor the market-based alternative is sufficiently satisfactory to quiet professional and social concerns. Today, as will be detailed below, there are increasing domestic and international pressures to reconsider compensation for those who contribute human tissue for research. The situation demands a systematic response that comports with public values. Recently, in its report on research uses of human biological materials, the National Bioethics Advisory Commission (NBAC) deferred consideration of such a response, citing the need for fuller review of "conflicting religious and philosophical traditions" with respect to the treatment of the body as property.7 It is important that further consideration of the issue take into account a broader range of possible approaches than the two extreme alternatives that have dominated the debate to date. In particular, it is time to consider alternatives that represent a middle course between regimes of donation and private property. One such alternative would take a hybrid approach: maintain a general rule of donation for research tissue at the time it is acquired and provide an objective, non-market mechanism for compensation after research use for unusual cases in which samples prove to have significant commercial utility. This hybrid approach would draw from models of publicly mediated compensation in other areas of the law. Its implementation could be designed to take advantage of existing structures in the patent and drug approval processes. To suggest such an intermediate course is not to presume that it, or any other compromise, can satisfy all of the objections raised to date with respect to both the donation paradigm and the market alternative. …

Informed consent and the elusive dichotomy between standard and experimental therapy.

Abstract: A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context. Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

How research will adapt to HIPAA: a view from within the healthcare delivery system.

Abstract: How Research Will Adapt to HIPAA: A View from Within the Healthcare Delivery System^ ^ A version of these remarks was given as the Fourth Annual Justice Louis Brandeis Lecture, delivered at the 24th Annual Meeting of the Massachusetts Health Data Consortium, Boston, Mass., April 12, 2002; sponsored by Nutter, McClennen & Fish, LLP. I. INTRODUCTION While the new Health Insurance Privacy and Accountability Act (HIPAA)1 research rules governing privacy, confidentiality and personal health information will challenge the research and medical communities, history teaches us that the difficulty of this challenge pales in comparison to the potential harms that such regulations are designed to avoid. Although revised following broad commentary from researchers and healthcare providers around the country, the HIPAA privacy requirements will dramatically change the way healthcare researchers do their jobs in the United States.2 Given our reluctance to change, we risk overlooking potentially valid reasons why access to personal health information is restricted and regulated. In an environment of electronic information, public concern, genetic information and decline of public trust, regulations are ever-changing. Six categories of HIPAA requirements stand out as transformative: disclosure accounting/tracking, business associations, institutional review board (IRB) changes, minimum necessary requirements, data de-identification, and criminal and civil penalties. However, the silver lining is that these requirements will push research organizations to improve data policies, processes and technology, and these improvements may lead to enhanced trust on the part of the American public. It is time to find constructive ways to implement HIPAA-ways that will accommodate the interests of science while protecting the privacy of medical records. II. HIPAA PRIVACY STANDARDS "[It is] the most dangerous attack on academic freedom in this land in modern times."3 Discussions around the academic water cooler would certainly lead one to believe this quote came from a modern scientist's discussion of HIPAA. It might refer to HIPAA's privacy standards, as today's researchers are wary and indignant about its limitations: much research will have to be "delayed or perhaps forgone";4 the rule "[burdens] biomedical and behavioral research with onerous procedural requirements, ambiguous regulatory standards, and extensive new liability concerns";5 "access to medical information may become more burdensome and costly, and some [medical research] may not happen."6 In a letter to the Secretary of Health and Human Services, the Association of American Medical Colleges (AAMC) complained that "[these] limits . . . will seriously impair our ability to conduct clinical trials, clinico-pathological studies of the natural history and therapeutic responsiveness to disease, epidemiological and health outcome studies, and genetic research."7 The above quotation,8 however, is not a comment on the HIPAA privacy standards. Instead, it was the reaction of a political scientist testifying before Congress in the late 1970s as he described the institutional review of ethics in scientific research. This reaction represents a valuable historical lesson that, although our society's attitude toward scientific research and the resulting limitations placed on research are ever-changing, this does not precipitate a dramatic end to research. Indeed, this is not the first time we have changed research as we know it. It is also not the first time that researchers have bewailed such regulations. In 1978, a document known as the Belmont Report declared that certain ethical principles and guidelines should be used to resolve the problems that "underlie the conduct of research involving human subjects."9 This report culminated years of intense and often caustic debate-a debate that began in earnest with the opening of the Nuremberg Trial in 1946-about "the medical ethics applicable to experimentation on human beings. …

Genetics and privacy.

Abstract: I. INTRODUCTION The science of genetics holds great promise. Ideally, the more scientists learn about the human genome and the functions of specific genes, the better they will understand what causes disease, what can prevent disease and what can cure it.1 But the hoped for advances in medicine that genetics may bring about will never happen if people are afraid to provide their DNA and work with scientists and doctors on the necessary research. From a privacy perspective, two things are clear: 1) people are afraid of genetic testing and 2) genetic information has been used to hurt people, rather than to help them. Unfortunately, Americans cannot be assured that their DNA will not be taken or used against their will or without their knowledge. The United States has no coherent policy for whether, when or how genetic testing should be encouraged, facilitated, discouraged or prohibited. Instead, we have policies and practices that impact some people, in some places, under some circumstances. This kind of weak patchwork leaves gaping holes. Why are the concerns about inappropriate uses and disclosures of genetic information so intense? Genetic information, which is a subset of medical information, is particularly sensitive because it reveals unique and immutable attributes. Those attributes are not just personal, but shared by family members as well. This information has the potential to give us, and others, a frightening, or reassuring, glimpse into the future. Part II of this Article argues that the concept of genetic "privacy" encompasses genetic "nondiscrimination" and that public policies designed to protect against genetic discrimination should be thought of as part of the larger effort to protect the IMAGE FORMULA142 privacy of genetic information. Part III of this Article discusses how major federal laws protect the privacy of genetic information. This section focuses on the new medical privacy regulation issued by the U.S. Department of Health and Human Services (DHHS) in December 2000(2) and other aspects of the Health Insurance Portability and Accountability Act (HIPAA).3 It also includes a discussion of private employer access to genetic information. Part IV addresses bills pending in Congress that build on existing federal protections and add significant privacy protections for genetic information. Part V looks at the largely unregulated new frontier of the Internet to which millions of Americans are turning for health care information and services. II. WHAT DOES IT MEAN TO PROTECT THE PRIVACY OF GENETIC INFORMATION? Protecting the privacy of medical information, including genetic information, is a multifaceted endeavor with at least four interrelated components: * Access: Who should have access to a person's genetic information, under what circumstances and for what purposes? * Use: How should those who obtain a person's genetic information be allowed to use it? * Disclosure: To whom should those who obtain/create/receive genetic information be allowed to disclose it, and for what purposes? * Storage/security: What safeguards and safety precautions should be in place to make sure that genetic information is not obtained, used or disclosed inappropriately? Looking at each of these components and how they interact is a bit like peeling an onion. One finds layer upon layer of complexity. At its core, the access component includes whether and when one person or entity can request or require that an individual divulge genetic information or undergo genetic testing. Society may very well conclude that the divulging of genetic information in some circumstances is appropriate (e.g., voluntary treatment-related disclosures) yet totally inappropriate in others. Similarly, the use component encompasses how health care providers, health insurers, researchers, pharmaceutical companies and employers, to name a few, should be allowed to use a person's genetic information. …

DNA-based identity testing and the future of the family: a research agenda.

Abstract: I. INTRODUCTION Many of the societal challenges associated with the genetic revolution rest on predictions about the effects of the future development and diffusion of technologies for manipulating the human genome. Identity testing is different. Relatively sophisticated techniques for identity testing using DNA currently exist, and these techniques are already creating conflicts and challenges for families and policymakers. More precisely, scientific advances and social trends are raising difficult questions about the source and nature of parental obligation, the steps required to protect the privacy of individuals when suspicion begins to corrode family relationships and the role of attorneys and other professionals in these volatile situations. The Article discusses the social context for the expansion of identity testing in Part II. Part III addresses the prevalence of misattributed paternity. Part IV explores historical and philosophical perspectives on parentage determination. Part V discusses the relationship between the new wave of identity testing and the law. This Article concludes in Part VI by setting out a research agenda for assessing and addressing the ethical, legal and policy implications of DNA-based identity testing for the family. By "identity testing," we mean the use of technology to establish or rule out a relationship of genetic relatedness between at least two biological samples. The term would include testing to determine the degree of genetic relatedness between two or more persons (e.g., paternity testing) and testing to determine the identity of a person or the remains of a person. Over the next year, we will be working with Thomas H. Murray and Gregory Kaebnick of the Hastings Center, and a group of expert consultants in law, philosophy, the social sciences and social services to advance our understanding of and contribute to a coherent policy response to a range of problems triggered by genetic testing to determine identity. II. THE SOCIAL CONTEXT FOR THE EXPANSION OF IDENTITY TESTING In the last several decades, a number of social developments or trends have combined to expand the use of DNA-based identity testing and intensify conflict around applications of this technology within families and, more broadly, intimate relationships. Here we highlight four of these developments: the Human Genome Project (HGP), federal welfare policy, the fathers' rights movement and media interest in domestic drama. A. THE HUMAN GENOME PROJECT The HGP has shaped the social impact of testing in at least three ways. First, the HGP has accelerated the development of techniques for cheap, efficient analysis of regions of DNA and comparison of the resulting genetic profiles. Emerging technologies, such as microarrays, are likely to lower cost, speed the process and increase accuracy.1 Even with existing technologies, analysis can be performed on DNA extracted from almost any biological material, with important implications for privacy. While testing at one time involved a blood draw, many laboratories that offer testing by mail now use cheek swabs. The testing of hair and other materials easily collected without the knowledge or cooperation of the subject is also becoming more common. Second, the HGP has led to heightened concern about genetic identity as a factor in healthcare. If individuals lack accurate information concerning their ancestry, they may believe they are at a genetically increased risk for an inherited disorder when their risk is in fact no greater than the population-wide risk. On the other hand, other individuals may fail to take appropriate preventive measures because no presumptive parent has or is at risk for an inherited disorder. Diagnostic testing for many conditions produces ambiguous results, and testing of genetic relatives may provide information that is essential for good clinical decision making.2 Third, the emphasis on genetic identity and ancestry in the clinical setting has had consequences beyond the clinic. …

The genetic revolution at work: legislative efforts to protect employees.

Abstract: I. INTRODUCTION In justifying the cost of the Human Genome Project, supporters predicted fantastic benefits would result from decoding the human genome: cures for fatal diseases, effective treatments for common illnesses burdening individuals and society and a greater understanding of ourselves as human beings. Fear that genetic information will be misused to harm individuals, however, casts a shadow over this glowing portrait of the future of genomic medicine. Over the last decade, these concerns have led approximately twenty-six states to enact genetic nondiscrimination laws.1 Although no similar law has been passed by Congress, many, including Francis Collins, Director of the National Center for Human Genome Research, have repeatedly endorsed proposed federal legislation aimed at prohibiting health insurers and employers from using predictive genetic information.2 The result has been growing bipartisan support for The Genetic Nondiscrimination in Health Insurance and Employment Act introduced in February of 2001 by Representative Louise Slaughter in the House and by Senators Kennedy and Daschle in the Senate.3 Despite concerns over genetic discrimination in employment, some members of Congress hesitate to place additional regulations on employers and have questioned whether existing federal law, particularly the Americans with Disabilities Act (ADA), already provides sufficient legal remedies for workers who may be treated differently on the basis of their genetic makeup. Hearings convened by Senate and House committees have focused on this issue4 and may lead committee members to conclude that genetic discrimination in employment, although not explicitly mentioned in the statute, is nevertheless already prohibited by the ADA. That would not, however, preclude committee members from concluding that the ADA does not go far enough in protecting American workers. That being the case, Congress could decide to strengthen the rights of workers in one of several ways: by amending the ADA, by enacting a separate law addressing genetic discrimination or by enacting a comprehensive law that protects genetic privacy as well as prohibiting genetic discrimination. In the meantime, employees seeking relief from genetic discrimination in the workplace can argue to the Equal Employment Opportunity Commission (EEOC), the agency authorized to enforce the ADA, or to a court, that they are protected by the ADA, or they can look to their own state laws for alternative protections. Although no court has had the opportunity to rule on the applicability of the ADA to a genetic discrimination claim, the EEOC has taken the position that the ADA does encompass such claims. This view was initially articulated by the EEOC in an enforcement guidance on the definition of disability in the statute,5 reiterated in a subsequent guidance on disability related inquiries and medical examinations under the ADA,6 and relied upon in its recent action against Burlington North Santa Fe Railway.7 In the Burlington case, the agency had received complaints from Railway employees that the company had been secretly testing their DNA. Acting on the assumption that unauthorized testing and use of genetic test results violated provisions of the ADA, the EEOC immediately sought an injunction against any further genetic testing by the company. However, the Railway Company agreed to cease its genetic testing program before it became necessary for the court to rule on the applicability of the ADA to the circumstances surrounding the Railway workers complaints.8 Presumably, this was a satisfactory outcome for the employees involved. Nevertheless, it leaves those of us curious as to how the court would have dealt with the agency's interpretation of the ADA dissatisfied, because we can only speculate as to what the court's reasoning would have been and who might have ultimately prevailed. Oddly enough, had the Burlington Railway employees' complaints been brought under a state genetic nondiscrimination law, they would not necessarily have been on stronger legal ground. …

Coding for change: the power of the human genome to transform the American Health Insurance System.

Abstract: I. INTRODUCTION Truthfully, we are fearfully and wonderfully made. - Samuel J. Holmes While science does advance steadily over time, occasionally a scientific breakthrough occurs that does not merely augment current scientific explanations and understandings, but instead radically redirects the focus of the scientific inquiry, fundamentally reconfigures our conception of our world and community, and threatens our existing social and moral conventions. We are currently experiencing such a scientific revolution, precipitated by advances in decoding our genetic makeup.1 While the revolution began at least by 1952 with the discovery by James Watson and Francis Crick of the structure of the DNA molecule2- the molecule that contains our genetic information-the pace of the revolution has accelerated most rapidly in the last ten years. The engine for this change is the Human Genome Project. The Human Genome Project (HGP)3 is an international effort to decipher the contents of the human genome by sequencing all of the base pairs. Once these base pairs are sequenced, scientists can quicken the rate at which they can identify what genes code for which functions, when genetic variation results in the expression of a genetic disorder, and ultimately how to use this information not just to diagnose, but to prevent and cure genetic abnormalities.4 The information unleashed by the HGP is changing the direction and focus of medical research, it is supporting and IMAGE FORMULA6 undermining long standing scientific assumptions and it is systematically deconstructing and reconstructing our social identities, our social priorities and our moral vision.5 With every new genetic breakthrough comes great apprehension that the information contained in the human genome and deciphered by the HGP will be used for ill.6 The anticipated problems are legion and include the fear of genetic discrimination. While the phrase "genetic discrimination" has become ubiquitous in both popular and academic presses, the exact definition of the term, and the nature of the anticipated problem, remain unclear. Speaking generally, fears about genetic discrimination with respect to insurance seem to stem from concerns over an insurance company's consideration of a potential enrollee's genetic information in making coverage and premium setting decisions.7 There is a consensus within the public and among health professionals that health insurers should not be able to use genetic information in making coverage determinations.8 While health insurers have long relied upon family and applicant medical histories as well as demographic and health habit information in making coverage decisions, the use of genetic information seems to strike a different discordant chord with the public, and there are significant demands for new and different rules for genetic information. The policy preference for different rules for genetics than for other types of health information is coined "genetic exceptionalism."9 Treating genetic information differently, however, is the wrong decision. As IMAGE FORMULA8 this article suggests, the entry of the genome into the public stream of information should not give rise to genetic exceptionalism rules. Rather, it should be an occasion for the wholesale revision of the rules we already have. People fear-and abhor-- insurance companies using genetic information in risk determinations because it offends their sense of fairness. While "discriminate" is defined as "to discern" or to "to distinguish by discerning or exposing differences" and even "to use good judgment," the definition that probably best reflects the way we typically use the term is "to make a difference in treatment or favor on a basis other than individual merit."10 In the strictest sense, we all discriminate when we size up two different things and make a choice between them. …

Adoption medicine and the internationally adopted child.

Abstract: Throughout its history, this nation has opened its doors to people who, for more reasons than anyone can count, have needed new homes. It has taken us in, given us new lives. Adopted us.1 I. INTRODUCTION A. DATE, SUSAN AND LILIANA2 Dave and Susan brought five-year-old Liliana home from Romania in January. The couple was ecstatic about their new beautiful blonde-haired daughter. They had waited months for Liliana after beginning the international adoption process with a reputable agency based in the United States. Many aspects of the process-carrying large amounts of cash to Romania, bribing officials to release their new daughter from the orphanage and the total lack of information about Liliana's health or background-had disturbed them.3 Dave and Susan were relieved when Liliana received a visa to travel to the United States because they thought that the physical examination for her visa had revealed nothing of import.4 Their concerns disappeared when they boarded the plane to head home to the United States. Liliana seemed healthy and happy, and she would adjust in no time. IMAGE FORMULA142 In February, Susan and Dave knew that something was wrong.5 Liliana was hoarding food6 and she was emotionally detached from Susan.7 She was also disturbingly affectionate with Dave.8 Additionally, Liliana's blonde hair had darkened significantly and her fair skin was taking on an olive tone.9 Alarmed, Dave and Susan took Liliana to a physician they found on the Internet. As a specialist in Adoption Medicine, the physician exclusively treated foreign-born adopted children like Liliana. The physician diagnosed Liliana with Reaction Attachment Disorder,10 severe malnutrition and intestinal parasites. Unexpectedly, Liliana needed significant medical treatment and, potentially, years of emotional therapy. Dave and Susan were outraged that the agency, the orphanage and the Immigration and Naturalization Service (INS) physicians all missed or did not disclose Liliana's medical conditions. They were grateful to have access to an Adoption Medicine specialist rather than a general practitioner unfamiliar with the medical realities of a post-institutionalized Romanian child. B. INTERNATIONAL ADOPTION As more American couples face the challenges of infertility or choose to add another child to their household, adoption is becoming a solution that many investigate.11 Although domestic adoption is an option for some couples, it can be an expensive, time-consuming and heart-breaking experience.12 As birth rates decline and more unwed mothers choose to raise their children, fewer American infants are available for domestic adoption.13 This, along with the fact that IMAGE FORMULA146 international adoption can be both quicker and cheaper than domestic adoption,14 has lead to an annual increase in international adoption.15 Recognizing this annual growth, the federal government has recently passed legislation addressing the needs of internationally adopted children, their adoptive parents and the public as a whole.16 By making international adoption easier and safer, however, more foreign-born children will enter the United States with incomplete or nonexistent medical histories after receiving only cursory medical examinations.17 Some adoptees have physical, emotional or mental challenges that are undetectable to adoptive parents, screening physicians and other U.S. physicians who are simply unfamiliar with common foreign diseases.18 The rise of international adoption and the complexity of the medical issues have led to the creation of a new medical specialty, Adoption Medicine. The few Adoption Medicine specialists in the United States are experienced in recognizing and treating the medical needs of internationally adopted children.19 This Note addresses issues related to international adoption and the expanding specialty of Adoption Medicine. …

Informed consent in the military: fighting a losing battle against the anthrax vaccine.

Abstract: In civilian life, an individual has the right to refuse medical treatment in almost any circumstance. While a patient who refuses treatment may face adverse consequences such as prolonged illness, our society recognizes the importance of individual choice in health matters. Members of the military, however, enjoy no such right. Service members are required to submit to certain medical treatments as a part of their employment contract. Refusing such treatments is disobeying an order, and the service member then faces the prospect of a dishonorable or "other than honorable" discharge, and even imprisonment.1 Disobeying an order to receive treatment can thus result in the equivalent of a felony conviction on the individual's employment history forever.2 The lack of a right to refuse treatment in the military has become public in recent years because of the anthrax vaccine controversy. In 1998, well before the recent civilian cases of anthrax, the Department of Defense (DOD or Pentagon) ordered that all 2.4 million active duty and reserve service members be vaccinated against anthrax.3 While the vaccine was approved by the National Institutes of Health (NIH) for general use in 1970,(4) concerns over potential side effects, primarily sterility, arose among the soldiers, and significant numbers of them began refusing the vaccine.5 Some soldiers recently may have eased their stance on the vaccine because of the new reality of the anthrax threat. However, the question of whether a member of the armed forces can decide which drugs and biological agents enter his body has not lost its significance. Service members argue that the right and the duty to refuse the vaccine arises IMAGE FORMULA79 from the armed forces' policy that service members must disobey "illegal or immoral orders."6 Air Force reservist Thomas Rempfer claims that "professional standards justify disobedience" when an order is "militarily absurd," and that the vaccine is such an order.7 Therefore, Rempfer asserts that punishment of such disobedience through courts-martial is inappropriate.8 To support this argument, members of the military claim that the vaccine is in fact an investigational drug.9 Even the military must obtain informed consent from research subjects. Therefore, if the vaccine is actually experimental, the DOD is violating not just its own regulations, but also international principles of human dignity.10 Several issues thus arise from the anthrax vaccine order.11 First, can the military require its forces to give up their right to refuse treatment? Is this a valid employment contract? The answer to both of these questions is most assuredly yes. Those joining the military voluntarily give up many of their freedoms and rights for the good of the country. Second, can members of the military succeed with the argument that the order to receive the anthrax vaccine is immoral or illegal because of the possible health risks, and thus that they have the right, and even the duty, to refuse the order? Because the reasons behind such refusal are based on personal fears and not on larger moral issues or goals, and because a reasonable person in the situation would not view this order as illegal, service members are unlikely to succeed with this argument. Finally, should the anthrax vaccine be considered experimental for the purpose of protecting combatants against germ warfare? If so, soldiers could refuse the vaccine as a violation of national and international law. While the vaccine is not approved for this very narrow purpose, a broad interpretation of its labeling will allow the vaccine to be legally used to protect susceptible populations from airborne anthrax. Thus, the military has the right to require that its service members receive the anthrax vaccine, and resignation from the service is the only recourse for a soldier who does not wish to take it. Part I of this Note will discuss the history of the anthrax vaccine and the concerns of the soldiers, which are based in rumors of side effects as well as distrust of the Pentagon's health-related decisions. …

Use and disclosure of health information in genetic research: weighing the impact of the new federal medical privacy rule.

Abstract: I. INTRODUCTION Perceived threats to medical privacy arouse intense emotion, even among those who might otherwise approach complex health policy issues with academic dispassion. The author of an August 2001 editorial in the New England Journal of Medicine describes medical records as "sacred secrets," and decries the use of medical information for purposes unrelated to patient care as "an abridgement of individual rights" and "an unfolding American tragedy."1 A like-minded commentator in the Journal of the American Medical Association strikes a more apocalyptic note, warning that with respect to medical privacy, "[t]here is, increasingly, no place to hide."2 Not surprisingly, privacy advocates also depict a full-blown crisis in medical privacy, one that Janlori Goldman of the Georgetown Health Privacy Project asserts has led consumers "to withdraw from full participation in their own healthcare" for fear of "discrimination, loss of benefits, stigma and unwanted exposure."3 The distraught tenor of such rhetoric only amplifies consumer fears about the potential misuse of personal health information and has engendered strong support for increased government oversight of medical privacy. Potential threats to the privacy of genetic test results have been a particular source of public anxiety. Public IMAGE FORMULA95 reaction has stimulated legislative initiatives at both the state and federal levels targeted toward the amorphous category of "genetic information."4 It is inarguable that basic safeguards for the privacy and confidentiality of genetic information and, for that matter, all other types of medical information are essential. Consumers perceive themselves to be at significant risk when third parties such as employers or commercial entities enjoy unfettered access to medical records and other confidential health data. The anticipated risks may be psychological, including annoyance at becoming the target of an intrusive marketing scheme for a medical product and embarrassment if a stigmatizing condition is revealed, or they may extend to the loss of health insurance or employment upon disclosure of a genetic predisposition to serious diseases.5 Whatever the actual magnitude of these privacy risks,6 a thoughtful, measured response on the part of policymakers is necessary and appropriate. Yet, problems arise when the response overreaches, attempting a utopian ideal of medical privacy that may ultimately do more harm than good. This is especially so when new limits on the use or disclosure of health information are adopted in haste (or fear). Such measures may prove costly and difficult to implement and threaten to constrict the flow of essential health data to researchers who develop insights into the determinants of health and disease, as well as new medical products, therapies and disease prevention strategies. Amidst the strident demands of privacy advocates for near absolute individual control over medical information, the challenge for policymakers has been to keep the broader, more "communitarian" goals in sight-namely, the advancement of medical knowledge and improvement of public health through research that cannot be accomplished without ready, albeit controlled, access to medical information.7 Across the nation, the stored clinical records and archived tissues of generations of patients-a veritable library of human encounters with illness and responses to therapies-has proved over decades to be a unique, irreplaceable source of new knowledge about diseases and their treatment. Researchers recount this new IMAGE FORMULA97 knowledge in medical literature; healthcare providers turn to the literature to inform decisions about diagnosis and treatment. Consequently, every patient has a direct and personal stake in preserving researchers' ready access to medical information accumulated in archived clinical records and tissue samples. …

Any DNA to declare? Regulating offshore access to genetic enhancement.

Abstract: I. INTRODUCTION Imagine a world in which parents can genetically enhance their child's height so that he becomes a professional basketball player. Or imagine a law school student preparing for the bar who takes out an extra loan to genetically enhance his intelligence. What if going to your physician for a routine physical included the option of genetically enhancing any trait you desired? And what if such a practice was expensive and, therefore, only available to the privileged members of society? Is this desirable or should the U.S. government ban genetic enhancement? What if the government bans it and citizens travel abroad to receive genetic enhancement treatments? Can the U.S. government do anything to prevent access to illegal genetic enhancement abroad? Genetic technologies such as cloning, gene therapy and genetic enhancement (GE)1 raise a host of social concerns that might prompt the U.S. government to restrict either research in these areas or patient access to the available technologies.2 In fact, the government has already attempted to regulate biotechnology in a number of ways. Under the Fertility Clinic Success Rate and Certification Act of 1992, the Centers for Disease Control and Prevention developed a model program for the certification of embryo laboratories.3 In response to a concern about human embryo research, likely stemming from pro-life protests, President Clinton banned the use of federal funds for any experiment creating human embryos solely for research purposes.4 Three years later in 1997, the President also banned the use of federal funds for any research in furtherance of human cloning.5 More recently, President Bush banned the creation of new stem cells for research.6 In addition to federal statutes and mandates restricting "distasteful" biotechnological experiments, there have also been attempts by states to prohibit a wide range of biotechnologies such as pre-implantation genetic screening, embryo cryopreservation and donation, human embryo research, cell line development and cloning.7 Federal and state regulations often follow either scientific breakthroughs or news of an adverse outcome in a scientific study involving biotechnology. For example, since the 1999 death of Jesse Gellsinger, an eighteen-year-old gene therapy patient, notices in the Federal Register have announced plans to regulate human gene therapy.8 Recently, scientists at Advanced Cell Technology announced that they had scientifically engineered the world's first cloned human embryo from differentiated adult cells.9 While the House of Representatives passed a bill in August 2001 banning the creation of cloned human embryos, the Senate has yet to pass a cloning bill. 10 The scientific community is already reacting to the government's prohibitions on biotechnology and restrictions on funding. Some researchers have obtained private funding to avoid governmental control and others have left the United States to pursue their research in foreign countries. In January 2001, Panayiotis Zavos, an American infertility specialist and his Italian partner, Severino Antinori-famous for helping a sixty-two-year-old woman give birth via in vitro fertilization (IVF)announced that they were forming a consortium to produce the first human clone.11 Three months later the pair announced that they would begin their human cloning operation in an undisclosed Mediterranean country in October 2001.12 This announcement brings to the forefront an issue that has been looming over government leaders whenever they restrict biotechnologies such as cloning. Can the United States prevent human cloning, GE or other biotechnological procedures that are performed or sought by its citizens abroad? Specifically, can the United States restrict genetic enhancement abroad? This Article begins by briefly addressing in Part II why GE should receive special consideration from a theoretical perspective in light of the many other biotechnologies that have raised concern. …

The EPICC quest for prescription contraceptive insurance coverage.

Abstract: I INTRODUCTION A BACKGROUND On the October 18, 2001 episode of The Late, Late Show with Craig Kilborn, the show's host announced that a woman in Georgia had sued her employer, WalMart, for not covering her contraceptives under its health insurance plan1 He then cracked, "Hey, isn't working at WalMart all the birth control you need?"2 Kilborn's crude joke met with howls of laughter from the audience, but it likely struck a raw nerve with the millions of American women who do not have access to health insurance plans that cover birth control, and the many men and women who are battling to ensure that all women ultimately obtain such coverage3 WalMart is one of hundreds of employers in the United States that do not cover any of the five most common forms of birth control4 that were created exclusively for women5 In fact, half of the large health insurance plans in America do not cover any form of contraception6 Some of these plans do, however, cover Viagra, a drug used to treat male impotence7 Insurance coverage of Viagra for men by plans that do not cover contraceptives for women has provoked a great deal of controversy,8 with some critics claiming that it constitutes sex discrimination9 Many of these plans also cover birth control and birth-related procedures that are far more costly than the coverage of contraceptives For instance, eighty-six percent of health plans cover tubal ligation, nearly 100 percent cover maternity care and two-thirds cover certain abortion services10 Only fifteen percent cover all five of the most common forms of birth control11 As a result, women pay what many call a gender tax,12 which results in women paying sixty-eight percent more out-of-pocket for prescription drugs than men 13 Recognizing the need for broadened access to contraceptives, state legislatures and federal courts have made some progress in mandating coverage of the FDA-- approved forms of birth control Twenty states have enacted legislation that compels insurance plans that cover prescription drugs to cover prescription contraceptives 14 Further, the Equal Employment Opportunity Commission (EEOC) has ruled that employers that exclude contraceptive coverage from health insurance plans covering other preventative medicine or services engage in sex discrimination in violation of Title VII of the Civil Rights Act of 1964 15 In spite of these efforts, many women do not yet benefit from insurance coverage for their contraceptives The women who either have to pay for contraceptives out-of-pocket or go without include those who live in the thirty states without equity in contraceptive coverage laws 16 Also included are the women whose employers have fewer than fifteen employees, 17 and those whose employers have self-funded insurance plans since the Employee Retirement Income Security Act of 1974 18 (ERISA) preempts state laws that relate to employee benefit plans19 The Equity in Prescription Insurance and Contraceptive Coverage Act (EPICC), as proposed in the US Congress,20 seeks to broaden access to birth control The law would mandate that all plans that offer coverage of prescription drugs also cover all FDA-approved forms of birth control21 This Note will explain why broad-based, federal legislation mandating contraceptive coverage is crucial, and make recommendations for the improvement of EPICC Part I will examine current legislative, judicial and administrative efforts aimed at increasing access to insurance coverage of contraceptives It will also demonstrate that in spite of these efforts, many women still go without insurance coverage for this staple of female health Part II will analyze EPICC, as well as conscience clauses Conscience clauses allow religious institutions fundamentally opposed to contraception to opt out of compliance with contraceptive coverage mandates Although conscience clauses appear in the vast majority of state statutes, a conscience clause is conspicuously missing from EPICC, and this may impede its passage …

Foreword: phase II of the genetics revolution: sophisticated issues for home and abroad.

Abstract: The distinguished health law and policy scholars we invite to contribute to the American Journal of Law & Medicine's annual symposium issue are given carte blanche to write about any aspect of the designated topic that appeals to them. The authors in this year's genetics symposium, The Genetic Revolution: Conflicts, Challenges and Conundra, are already well known for their work in the field-in fact three of them have just co-authored the only casebook specifically dedicated to the law, policy and ethics of genetics-and we deliberately asked them for relatively short pieces on the theory that taken together their articles would build a unique conceptual whole. We are always intrigued with what our experts choose to write about in these annual symposia, and this year is no exception. Our eminent authors have produced an array of articles on Phase II of the Genetics Revolution that take on a wide spectrum of sophisticated legal questions, from the specifically global to the explicitly individual. In looking back to the Symposium issue that AJLM produced ten years ago, The Human Genome Initiative and the Impact on Genetic Testing and Screening Technologies,2 many of the same issues in genetics are still relevant, but they have taken some interesting twists and turns in the interim. In 1991, the debate on prenatal testing focused on why social norms encourage pregnant women to weed out fetuses with apparent disabilities, suggesting that prenatal testing reflects intolerance in our society.3 Now that prospective parents are expected to get prenatal testing, practically as a matter of course, we are wondering whether testing is really healthy for all concerned.4 Discourse on genetic testing in the workplace has advanced from advocating regulation that would limit genetic testing and disclosure? to encouraging genetic testing, but forbidding discrimination.6 Genetic discrimination in the workplace concerned those who wrote in 1991 as well,7 but today we can better recommend policy by evaluating the adequacy of recently-passed legislation to protect against genetic discrimination.8 While the bioethical issues that were discussed in the 1991 symposium still surface, improvements in available scientific data enable us to address social, ethical and legal implications at a more sophisticated level. Several law journals followed in the footsteps of our 1991 symposium to focus on genetics-related themes. Some have done symposia on broad subjects related to genetics and the law,9 while others have covered more targeted fields such as genetic privacy and family disclosure,10 the implications of identifying the breast cancer gene,ll maintaining autonomy with the advancements in genetics,12 legal disputes over body tissue,13 international implications on genetic researchl4 and racial issues associated with genetic testing.15 In this current symposium, we hope to broaden the available literature on genetics and the law, and further the dialogue surrounding previously raised issues. The thought-provoking articles in this issue of AJLM demonstrate that for all its medical promise, the science of genetics is a double-edged sword. On the one hand, genetics offers unprecedented insight into the mechanisms of diseasel6 and has stimulated a plethora of new theories about ways to outsmart disease processes.17 On the other hand, it brings with it disturbing potential for detrimentally altering the character of social and employment relationships, and for distorting our deeplyingrained notions of what it means to be human.18 Our first two articles assess global rather than more narrowly conceived perspectives relating to human cloning and genetic enhancement. The next three pieces focus more closely on the impact of genetic advance on family relationships, reproductive decision making and the security of employment. Finally, the last two articles in the symposium contribute a detailed analysis-from differing perspectives-of privacy concerns related to genetic information. …

ERISA: Supreme Court Holds ERISA Does Not Preempe Illinois Independent Review Law-Rush Prudential HMO, Inc. V. Moran

Abstract: ERISA: Supreme Court Holds ERISA Does Not Preempt Illinois Independent Review Law-Rush Prudential HMO, Inc. v. Moran1-The U.S. Supreme Court, in a 5-4 decision, held that the Employee Retirement Income and Security Act (ERISA)2 does not preempt the Illinois Health Maintenance Organization Act (Illinois Act).3 In response to widespread employer mismanagement of employee pension funds, Congress enacted ERISA to create a uniform system of federal law to regulate private sector employee benefits programs, including employment-based health coverage.4 By alleviating the administrative burden of complying with an amalgam of state laws, Congress intended to encourage and enable more employers to provide benefits for their employees and to increase access to these benefits.5 To effectuate these goals of uniform regulation, Congress expressly dictated that ERISA preempts all state laws that relate to ERISA plans.6 ERISA's unbridled preemption raised federalism concerns about the respective roles of the state and federal government. Traditionally, states have regulated insurance; to preserve some role for state authority, ERISA provides a narrow exception to its preemptive power over state laws. Under this "savings clause," state laws that regulate the business of insurance are saved from ERISA preemption even if such state laws relate to ERISA plans. ERISA was enacted in 1974, before the advent of health maintenance organizations (HMOs). As many commentators have noted, the emergence of HMOs as the primary providers of healthcare and health insurance in the U.S. has muddled the question of ERISA preemption. The ERISA preemption quandary results from the fact that many HMOs perform multiple functions, including management and provision of healthcare, and administration of ERISA plans. Moran is the most recent Supreme Court case to address where ERISA regulation ends and state regulation begins under ERISA preemption. Writing for the majority, Justice Souter aptly surmised the general issue that has plagued ERISA jurisprudence, namely the interpretation of the difficult language of ERISA that "seems simultaneously to preempt everything and hardly anything."7 In Moran, the Court addressed another issue stemming from this underlying quandary, which is whether the Illinois Act was a permissible state regulation of insurance or whether the Act was preempted by ERISA. Section 4-10 of the Illinois Act requires HMOs to submit benefit denials to an independent physician reviewer "in the event of a dispute between the primary care physician and the [HMO] regarding the medical necessity of a covered service proposed by a primary care physician."8 Under the Act, an independent physician reviewer must be unaffiliated with the HMO and jointly selected by the HMO and the patient. If the independent reviewer decides that the treatment is medically necessary and is a covered service under the contract, the HMO must provide the covered service. Respondent Debra Moran was a beneficiary of petitioner Rush Prudential's health plan, which was sponsored by her husband's employer. Under its Certificate of Group coverage issued to plan beneficiaries, Rush promised to provide its participants with medically necessary health services. Under Rush's plan, each participant selected a primary care physician from a group of physicians who had a contract with Rush. According to its contract, Rush was obliged to pay for medical services performed by an unaffiliated physician only if the services had been authorized by both the primary care physician and Rush's medical director.9 Moran suffered pain and numbness in her right shoulder. Her primary care physician's attempts to alleviate her discomfort through conservative treatments were unsuccessful. Moran's primary care physician recommended that Rush approve surgery by an unaffiliated specialist who had developed an unconventional treatment for Moran's condition. Despite her physician's recommendations, Rush denied Moran's request for coverage of the surgery because it found that the procedure was not medically necessary. …

Eleanor DeArman Kinney, Protecting American Health Care Consumers (Durham, N.C.: Duke University Press, 2002): 278 pp., ISBN 0-8223-2876-3 (hardback), $42.95.

Abstract: Eleanor DeArman Kinney, Protecting American Health Care Consumers (Durham, N.C.: Duke University Press, 2002): 278 pp., ISBN 0-8223-2876-3 (hardback), $42.95. Eleanor Kinney's book, Protecting American Health Care Consumers, addresses the most pressing issues presented by America's healthcare system. How do we ensure access to health insurance and to healthcare services? How do we protect the quality of healthcare? And, how do we control its cost? Experts in health services research, economics, politics and policy often struggle with these questions. Health law experts, however, can make important contributions to their resolution, and Professor Kinney does so. Professor Kinney approaches these issues from the perspective of a lifetime of work in the field of administrative law. She brings to the topic of protecting the rights of healthcare consumers, therefore, a thorough understanding of the nature and significance of administrative procedure. She also brings an awareness of rulemaking and adjudication; of the range and variety of institutions that can play a role in policy-making and dispute resolution; of the possibilities for consumer involvement in overseeing the delivery and finance of healthcare; and of the importance of procedural and distributional fairness in decisions affecting healthcare. Protecting American Health Care Consumers begins by describing the "patient protection" debate that has occupied Congress and the states for the last five years. Kinney proceeds, however, beyond this debate-which has focused quite narrowly on proposals for protecting consumers from some of the excesses of managed care organizations--to consider more broadly the range of quality, access and cost issues facing American healthcare consumers. Before addressing these issues, Kinney describes the nature of healthcare financing programs in the United States and surveys the areas of law that apply to healthcare delivery and finance. She proceeds to describe the universe of consumer concerns about healthcare and the variety of medical standards and policies that affect healthcare delivery and finance. Kinney then surveys the processes currently used for making policy in healthcare and the procedures available to consumers for raising and resolving consumer issues. In the final two chapters of the book, Kinney moves from description to prescription, laying out principles for policy-making in healthcare and, finally, a vision for the achievement of procedural, and ultimately distributive, justice in healthcare. Perhaps the greatest strength of the book is its broad focus on the wide-ranging problem of adapting healthcare policy-making to respond to the needs of consumers. Thus far, the "patient protection" debate has focused narrowly on procedures for protecting healthcare consumers in the adjudication of particular claims. Kinney acknowledges the importance of these procedures, but further considers how these procedures could be more responsive. For coverage determinations to be fair to consumers, she notes, coverage policies must be fair. In both the public and private sector, coverage (and access and pricing) policy has largely been based on expert opinions and business judgments with little input from consumers. Kinney believes this must change, and she repeatedly returns to the question of how consumers could become involved in these processes. In particular, she focuses on the problem of power imbalance, which often denies consumers a seat at the policy-making table, as well as the need to open decision-making processes in private organizations to consumer participation because private policies often affect public programs. Another strength of Protecting American Health Care Consumers is its taxonomy of disputes and policies. Kinney has a great gift for description and classification, and the tables in Chapters 5 and 6 portray a marvelous typology of consumer concerns and policies governing consumer disputes in healthcare. …