The real-world problems of providing affordable medical care for seniors and the non-elderly have intensified and, yet, the range of what policy makers and reform advocates see as responsible or even conceivable remedies is narrower in the 2004 presidential campaign than what it was during Bill Clinton's campaign in 1992. This article explains this paradox by studying what is on the minds of voters and how the candidates are responding. It suggests that the political response to comparable real-world conditions in health care have been diminished by the new found attention to national security, changing public perceptions toward health care, and the political calculations of politicians as they react to well-organized interest groups and the demands of new national and international issues.
In the fall of 2001, the need for a vigorous and effective public health system became more apparent than it had been for many decades. With the advent of the first widescale bioterrorist attack on the United States, the government's obligation to respond and take steps to protect the public health became self-evident.
Also obvious was the need for of an effective partnership between federal, state, and local officials. Local officials are almost always on the front lines of the struggle against bioterrorism. They are the first to recognize a suspicious case and to provide testing and treatment for the affected population. At the same time, state officials are needed to support and coordinate local efforts, providing an expertise that may be lacking in many communities, especially smaller ones.
But few would doubt that the federal government has a key role to play. The Centers for Disease Control and Prevention (CDC) is expected to lead the epidemiological investigation and provide expertise on how to cope with diseases that remain unfamiliar to most physicians.
The BiDil affair brought once again to the fore questions of race and medicine. As discussed in other essays in this collection, the emergence of BiDil as the first medication approved and marketed for treating specific racial groups raises important questions for medicine and society: How are race and ethnicity framing our understanding of health and illness? Should treatment decisions be based on the race and ethnicity of patients? Should we encourage the development of race-specific medical treatments in order to reduce health disparities? Or is this approach dangerous, and can it lead to unwanted consequences including racial stigmatization? These questions are not new, and since the introduction of race as a scientific construct in the late-19th century, race has played an important part in the history of medicine, most notoriously during World War II and the Holocaust. Yet the identification of race medicine with Nazi science tends to obscure the vast use of race as a medical construct by a wide range of medical scientists and practitioners across the political spectrum. In many instances, racial minorities were preoccupied with race medicine in order to promote the health of their own communities. One such group was that of Jewish physicians.
Author discusses the role of the Australian Institute of Criminology in monitoring deaths in people in custody in Australian prisons on a national basis. She provides an overview of deaths in prison custody between 1980 and 1998, noting a shift in the cause of death of Indigenous prisoners from natural causes to self-infliction.
Antibiotic use triggers evolutionary and ecological responses from bacteria, leading to antibiotic resistance and harmful patient outcomes. Two complementary strategies support long-term antibiotic effectiveness: conservation of existing therapies and production of novel antibiotics. Conservation encompasses infection control, antibiotic stewardship, and other public health interventions to prevent infection, which reduce antibiotic demand. Production of new antibiotics allows physicians to replace existing drugs rendered less effective by resistance.
In recent years, physicians and policymakers have raised concerns about the pipeline for new antibiotics, pointing to a decline in the number of antibiotics approved since the 1980s. This trend has been attributed to high research and development costs, low reimbursement for antibiotics, and regulatory standards for review and approval. Professional societies and researchers around the world have called for renewed emphasis on antimicrobial stewardship, while also supporting antibiotic research and development through grants, changes to intellectual property laws to extend market exclusivity periods, and modification of premarket testing regulations to reduce antibiotic development time and expenses.
American health policy today faces dual problems of too little coverage at too high a cost. The mix of private and public financing leaves about one seventh of the population without any insurance coverage. At the same time, the coverage Americans do have costs an ever-larger share of our country’s productive capacity. The U.S. pays well above what other countries pay and what many people, health plans, businesses, and governments want to pay. This “paradox of excess and deprivation” results from the incremental approach the U.S. has taken to promoting incompatible policy goals of increasing health insurance coverage and medical quality while trying to control costs, without squarely confronting tradeoffs. This essay examines the record of incremental developments and draws lessons for current efforts at reform.
... This article will analyze legal developments relating to abortion that have taken place in 1991-1992 in six countries of western and eastern Europe: Poland, Hungary, Albania, Germany, Ireland, and Belgium.
The first meeting of the Global Forum for Bioethics in Research was initiated by the Fogarty International Centre of the National Institutes of Health (NIH) and sponsored by the World Health Organisation (WHO), the Pan American Health Organisation (PAHO) and the NIH. Held in Bethesda on November 7-10,1999, the intent was to bring together individuals involved in medical research in low- and middle-income nations to share views with each other and with organisations that support clinical research. Approximately 120 persons from 34 countries participated, including individuals from developing countries, pharmaceutical organisations, and communities where medical research is under way.
The participants addressed the partnerships required between research sponsors and investigators involved in clinical trials in developing countries and the long-term needs for international multicentred training programs.
On January 25, 2013, the Federal Register published the Department of Health and Human Services (HHS) omnibus amendments to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act (HITECH Act) and the Genetic Information Nondiscrimination Act (GINA). Although the amended rules were effective on March 26, 2013, covered entities and their business associates (which now have direct liability for violations of the regulations) have a compliance date of September 23, 2013.
It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule. Despite HHS’ clarification of some issues by posting answers to frequently asked questions (FAQs), there have been no significant amendments to the Privacy Rule since 2003.
Web 2.0 innovations may enhance informed patient decision-making, but also raise ethical concerns about inaccurate or misleading information, damage to the doctor-patient relationship, privacy and confidentiality, and health disparities. To increase the benefits and decrease the risks of these innovations, we recommend steps to help patients assess the quality of health information on the Internet; promote constructive doctor-patient communication about new information technologies; and set standards for privacy and data security in patient-controlled health records and for point-of-service advertising.
In China, there have been numerous reports that doctors or other health care workers have been attacked by patients or members of patient's families. Those acts of violence have been attributed, in part, to the inadequacy of the legal system for handling medical disputes that was in effect prior to 2002. On February 20, 2002, the State Council of the People's Republic of China adopted the Regulation on the Handling of Medical Accidents. The new 2002 regulation increases the adequacy and fairness of compensation, makes some improvements in the procedure for resolving medical disputes, and has the potential to reduce medical errors and improve quality of care. Therefore, the 2002 regulation was an important step in the right direction, but some problems remain to be solved in the continuing process of reform.
The Ethics and Regulation of Research with Human Subjects , edited by Professors Carl Coleman of Seton Hall, Jerry Menikoff of the University of Kansas, Jesse Goldner of Saint Louis University, and Nancy Dubler of the Albert Einstein College of Medicine, is an up-to-date and authoritative collection of readings on ethical, legal, and policy issues in research with human subjects. The authors have modeled their text on the casebook style commonly used in law schools. At 746 pages, plus front matter and an appendix, this book contains just about everything one needs to know for a thorough grasp on human subjects research, including federal and state regulations governing this research, interpretive guidance from federal agencies, international guidelines and codes, court decisions, historical documents and case studies, and selected readings from scholarly articles and books. The book includes written comments and questions to help students understand and interpret the readings.
In 2004, the journal Health Matrix published a very interesting symposium volume titled “The Field of Health Law: Its Past and Future. As the title implies, the various commentators took both a retrospective and a prospective look at past trends and future prospects in health law. Some, including Clark Havighurst, Skip Rosoff and Walter Wadlington, wrote thoughtful essays on the development of health law over time and the implications of those trends. Others, including Rob Schwartz, Jim Blumstein, Rand Rosenblatt, and Mark Hall and Carl Schneider, wrote equally thoughtful essays that reflected on the past but focused more on future directions and prospects. And one, Kep Wing, wrote a semi-dyspeptic essay debunking the entire field of health law.
Taken together, these essays present a comprehensive view of how health law has developed so far and where its future might lie. Four themes emerge from the collected writings. First, there is considerable agreement on how and why health law has developed, but little agreement on where it is headed.
The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Its most recent 2008 version declares unprecedented universal primacy over all existing national or international ethical, legal, or regulatory requirements. This self-proclaimed status as a set of minimal ethical standards raises important questions about the Declaration's appropriate normative status. The present paper argues that the new claim of ethical primacy is problematic and makes the Declaration unnecessarily vulnerable to criticism. Future revisions of the Declaration should therefore remove this claim and strengthen the document, first, by clarifying its normative status as a set of strong default recommendations, to be followed unless there is compelling ethical reason to do otherwise; and second, by improving the substance of the Declaration through further precision, specification, and argument.
The detection and spread of pandemic 2009 H1N1 influenza in the United States led to a complex and multi-faceted response by the public health system that lasted more than a year. When the first domestic case of the virus was detected in California on April 15, 2009, and a second, unrelated case was identified more than 130 miles away in the same state on April 17, 2009, the unique combination of influenza virus genes in addition to its emergence and rapid spread at the end of the typical Northern Hemisphere influenza season suggested the potential for a high morbidity, high mortality event. In response, federal, state, and local public health officials conducted epidemiologic investigations with federal and state laboratory support to help to determine the scope of the H1N1 pandemic. On April 26, the Secretary of the U.S. Department of Health and Human Services (HHS) declared a public health emergency that was renewed through June 23, 2010. The pandemic that ensued tested virtually every aspect of U.S. public health preparedness and response systems, from laboratory capabilities and capacities to social distancing plans.
This article examines the history of assigning a banned status to medical marijuana; describes the politics of medical marijuana research; provides evidence of the scientifically demonstrated efficacy and safety of Cannabis for certain pathologic conditions; analyzes several vaguely worded state statutes governing the recommendation, distribution, and use of "medical marijuana" that render its use open to abuse; and recommends the development and enforcement of statutory and regulatory reforms that would bring state oversight of this drug into agreement with stringent federal regulation of other controlled substances with proven medical utility.
Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty - that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted "in the public square."
Law is indispensable to the public's health. The twentieth century proved this true as law contributed to each of the century's ten great public health achievements: vaccination, healthier mothers and babies, family planning, safer and healthier foods, fluoridation of drinking water, the control of infectious diseases, the decline in death from heart disease and stroke, recognition of tobacco use as a health hazard, motor vehicle safety, and safer workplaces.
The readers of this journal can give examples of the relevant types of laws with ease: Jacobson v. Massachusetts , the 1905 U.S. Supreme Court case that upheld the constitutionality of compulsory vaccination; mandatory immunization for school admission; authorization of state prenatal care programs; mandatory fortification of foods; Title X of the Public Health Service Act; the Pure Food and Drugs Act of 1906; the Safe Drinking Water Act of 1974, and hundreds of state and local enactments regulating food; fluoridation ordinanceswater, and sanitation; the Surgeon General's warning notices on cigarette packs and restrictions on marketing tobacco; seat belt laws and mandated vehicle and highway design features; and laws like the federal Occupational Safety and Health Act of 1970 that regulate working conditions.
Professor Gostin is a leading authority on health law, whose writing and teaching are among the most authoritative in the United States, as exemplified by his recent work, Public Health Law: Power, Duty, Restraint. Gostin's article in this issue of the Journal of Law, Medicine & Ethics pays homage to Jonathan Mann (1947-1998) by expressing the debt he feels toward this extraordinary doctor and public health official with whom he had collaborated on several projects.
As many will remember, Mann held high-level positions at the Centers for Disease Control and worked on AIDS research in Central Africa before setting up the World Health Organization's Global Programme on AIDS, which he ran from 1986 to 1990. Thanks to his profound commitment and consummate communication skills, he achieved the unprecedented feat of raising the budget within two years to almost $100 million from the initial set-up of “himself, a secretary, and one typewriter,” as described by Daniel Tarantola.
Institutional review boards (IRBs) and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.
Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal.
The concept of brain death was recently described as being “at once well settled and persistently unresolved.” Every day, in the United States and around the world, physicians diagnose patients as brain dead, and then proceed to transplant organs from these patients into others in need. Yet as well settled as this practice has become, brain death continues to be the focus of controversy, with two journals in bioethics dedicating major sections to the topic within the last two years.
By way of background, the Uniform Determination of Death Act states that “[a]n individual who has sustained either: (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards.” In other words, death can be defined by either cardiorespiratory or neurological criteria, with “brain death” representing the loss of all brain function. This standard, or closely related variants, has become the accepted approach throughout the United States and in many parts of the world.
In 1848 Dorothea Dix, the famous 19th century advocate for the indigent mentally ill, appealed to the United States Congress to support the setaside of a very large tract of land that was to be used for the “Relief and Support of the Indigent Curable and Incurable Insane.” She stated:
It will be said by a few, perhaps that each State should establish and sustain its own institutions; that it is not obligatory upon the general government to legislate for maintenance of State charities…. But may it not be demonstrated as the soundest policy of the federal government to assist in the accomplishment of great moral obligations, by diminishing and arresting wide-spread miseries which mar the face of society; and weaken the strength of communities?
In August 2001, the Maryland Court of Appeals harshly criticized the Kennedy Krieger Institute of Johns Hopkins University for knowingly exposing poor children to lead-based paint. The court’s decision made national news, and is worth examining because it raises several very important issues for research ethics.
The research conducted by the Institute was an attempt to understand how successful different lead abatement programs were in reducing continued lead exposure to children. Previously, Julian Chisolm and Mark Farfel, of John Hopkins University, had disclosed the dangers of traditional dust-generating deleading practices. In the current study, Dr. Farfel and colleagues sought to document the longevity of various lead-based paint abatement strategies.
The most remarkable thing about the U.S. Supreme Court's 1998 decision in Bragdon v. Abbott was that it was necessary at all. Seventeen years into the epidemic of the acquired immunodeficiency syndrome (AIDS), the Supreme Court, by a mere 5-4 majority, finally affirmed what most public health officials, health providers, and lawyers working with people with human immunodeficiency virus (HIV) believed all along: that individuals with HIV infection are entitled to the protections of antidiscrimination law, and that health care providers must respond to a patient's infection based on reason and science, not fear and prejudice. For individuals with HIV, and for those with other disabilities, the Court's ruling was a critical victory. But the very fact that the issues had to be decided by the Supreme Court and that only five justices joined the majority, shows the fragility of legal rights pertaining to HIV as well as the wide gulf between the perspectives of public health and those of public law.
Emergency physicians commonly evaluate those with chronic pain and substance abuse disorders; they are more common among emergency department patients that in the general population. Concern regarding coexisting substance use disorders among patients with pain influences treatment; however, the relationship between these two conditions is often murky and limited research is available to guide clinical decision making. At both individual and population levels, a balanced perspective in approaching this difficult issue will best serve patients.
The author details the conflicts of interest facing individual investigators and research institutions and describes the current mechanisms, primarily focused at the relationship between the investigator and the research institution, to regulate these conflicts. The author finds these mechanisms insufficient and believes that the best approach is not to regulate conflicts, but to abolish them. The author acknowledges, however, that there is a lack of political will in an abolitionist approach. He proposes, therefore, institutional review board oversight at the level of the relationship between researcher and individual subjects as the next best solution.
Researchers are increasingly interested in creating chimeras by transplanting human embryonic stem cells (hESCs) into animals early in development. One concern is that such research could confer upon an animal the moral status of a normal human adult but then impermissibly fail to accord it the protections it merits in virtue of its enhanced moral status. Understanding the public policy implications of this ethical conclusion, though, is complicated by the fact that claims about moral status cannot play an unfettered role in public policy. Arguments like those employed in the abortion debate for the conclusion that abortion should be legally permissible even if abortion is not morally permissible also support, to a more limited degree, a liberal policy on hESC research involving the creation of chimeras.
The World Conference on Human Rights (the Vienna Conference) that was held in Vienna in 1993, marked an important beginning in the recognition of reproductive and sexual rights as human rights. Among other goals, the Vienna Conference sought to end gender discrimination in all its manifestations; gender-based violence, sexual harassment, and sexual exploitation. However, the turning point for the development of reproductive and sexual rights was the consensus that emanated from the International Conference on Population and Development held in Cairo in 1994 (the Cairo Conference), and the Fourth World Conference on Women in held in Beijing 1995 (the Beijing Conference) as evidenced by the programs for action that were adopted.
The Cairo Conference defined reproductive health as “a state of complete physical, mental and social well-being and not merely the absence of infirmity, in all matters relating to the reproductive system and to its functions and processes.”
On January 18, 2006, the United States Supreme Court unanimously held that the constitutional challenge to New Hampshire's Parental Notification Prior to Abortion Act would be remanded to the United States Court of Appeals for the First Circuit, to determine whether the Court of Appeals could, consistent with New Hampshire's legislative intent, formulate a narrower remedy than a permanent injunction against enforcement of the parental notification law in its entirety.
In 2003, New Hampshire enacted the Parental Notification Prior to Abortion Act (“The Act”). The Act specifies, in pertinent part, that “No abortion shall be performed upon an unemancipated minor or upon a female for whom a guardian or conservator has been appointed… until at least 48 hours after written notice of the pending abortion has been delivered....” The Act allows for three exceptions where a physician may perform an abortion on a minor child without parental or guardian notification.
In order to explore ways of dealing with this phenomenon of illegal abortions and restrictive abortion laws in Latin America, several special sessions were held at last summer's international conference in Toronto, sponsored by the American Society of Law, Medicine & Ethics. The sessions brought together lawyers, health professionals, and reproductive rights advocates from a number of Latin American countries; their counterparts in the developed world; and representatives of non-governmental agencies concerned with this issue, including Catholics for a Free Choice. The goal of the sessions was to share information on the status of abortion in various countries and to try to devise strategies to make abortion law reform more palatable to Latin American governments and public opinion. One major component of the sessions was a series of papers prepared by some of the Latin American representatives describing and analyzing the situations in their countries. The papers illustrate some of the issues facing women in this part of the world.
The doctrine that it is wrong to end the existence of something because it is a human life (unless special circumstances obtain) I call “the standard view.” I argue that attempts by proponents of abortion choice to avoid the implications of the standard view by suggesting that we don't know when life begins or by suggesting that fetuses are only potential lives fail. Nevertheless, opponents of abortion choice should not base their arguments on the standard view, for the standard view is false. I propose a substitute for the standard view that avoids the difficulties with it, that explains why most people believe that the standard view is true and that also underwrites opposition to abortion choice.
The current shortage of US physicians willing to perform induced abortions has created a conflict between women's legal right to access to pregnancy termination and physicians' right to refuse participation in a procedure they regard as morally objectionable. According to a 1993 survey, 84% of US counties (housing 30% of women of reproductive age) had no abortion provider. This situation has been exacerbated by a trend to isolate abortion from other medical procedures; in 1992, only 12% of residency programs in obstetrics and gynecology routinely offered training on first-trimester abortion. Also contributing to physician reluctance to become abortion providers have been the violence, death threats, property damage, and harassment of abortion seekers perpetrated by anti-abortion groups. To ameliorate the abortion access crisis, without intruding on the religious convictions of individual physicians, there must be greater collaboration between professional and community groups. Local community officials and pro-choice supporters are urged to use their influence to protect abortion providers from harassment. Professional organizations should provide both symbolic and practical support, e.g. increased status and remuneration, to physicians who commit to the hardship of abortion provision. Older physicians, most aware of the threat to women's health posed by any erosion of abortion rights, should educate their younger colleagues about the importance of safe abortion. Finally, training on abortion techniques should be integrated into the medical school curriculum and rotations should be established at local abortion clinics.
On April 13, 2010, Nebraska enacted a new state ban on abortion in the Pain-Capable Unborn Child Protection Act that ha caught the attention of many on both sides of the abortion debate, and has inspired other states to attempt similar measures. The statute requires the referring or abortion-providing physician to make a “determination of the probable postfertilization age of the unborn child” (defined as, “the age of the unborn child as calculated from the fertilization of the human ovum”) and makes it illegal to induce or attempt to perform or induce an abortion upon a woman when the “probable postfertilization age” of the fetus is “twenty or more weeks” unless the doctor determines in “reasonable medical judgment (1) she has a condition which so complicates her medical condition as to necessitate the abortion of her pregnancy to avert her death or to avert serious risk of substantial and irreversible physical impairment of a major bodily function or (2) it is necessary to preserve the life of an unborn child.”
Even Americans who have only a vague knowledge of health policy know that the U.S. is different. We do not have “socialized medicine,” like our European or Canadian neighbors. We believe that health care is not rationed here, and that, unlike citizens of other nations, we do not have to wait in long queues when we need medical care. We believe that U.S. health care is the best in the world.
At the same time, the U.S. spends more on health care - both per capita and as percentage of gross domestic product (GDP) - than other nations do. One in six non-elderly Americans has no health insurance, and voluminous studies show that lack of health insurance has a dramatic effect on both access to care and on health status. Furthermore, on many of the most important indicators of population health, such as infant mortality and life expectancy, the U.S. scores worse than do other nations.
The main value of carrier detection in the general population is to determine reproductive risks. In this manuscript I examine the practice of providing carrier screening programs in the school setting. While the data show that high school screening programs can achieve high uptake, I argue that this may reflect a lack of full understanding about risks, benefits, and alternatives, and the right not to know. It may also reflect the inherent coercion in group testing, particularly for adolescents who are prone to peer pressure. The problem of carrier screening in the schools is compounded when the condition has a predilection for certain groups based on race, ethnicity or religion. I examine programs around the world that seek to test high school students for Tay Sachs and Cystic Fibrosis carrier status. I argue that carrier programs should be designed so as to minimize stigma and to allow individuals to refuse. The mandatory school environment cannot achieve this. Rather, I conclude that screening programs should be designed to attract young adults and not adolescents to participate in a more voluntary venue.
In Patel v. Midland Memorial Hospital & Medical Center, the U.S. Court of Appeals for the Fifth Circuit held that the defendant hospital did not violate the plaintiff's due process rights by suspending his clinical privileges without a pre-suspension hearing, where there were reasonable grounds for assuming that patient safety was at risk. Dr. P.V. Patel, a board-certified cardiologist, brought an action against Midland Memorial Hospital and several of its doctors, alleging that the suspension of his clinical privileges violated his right to a pre-suspension hearing; was the result of racial discrimination; and resulted in anticompetitive behavior in violation of antitrust laws. The U.S. District Court for the Western District of Texas granted Midland's motion for summary judgment. The parties filed cross appeals, Dr. Patel on the ground that there were genuine issues of fact for all of his claims, and Midland on the ground that, with the exception of the civil rights claim, it was immune from all of Dr. Patel's claims under the Health Care Quality Improvement Act of 1986 (HCQIA).