Paul A. Lombardo

Infected Physicians and Invasive Procedures: Safe Practice Management

There is currently no public policy that provides guidance concerning whether and when physicians infected with hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV) can safely perform invasive procedures. A committee of experts in the fields of medicine, law, and biomedical ethics and 1 community member, aided by an advisory board, was established to produce recommendations for policy reform. An extensive literature review was conducted for these 3 infectious diseases, medicine, surgery, epidemiology, law, and bioethics to gather all relevant data. Special recommendations are made regarding the management of physicians who are infected with HIV, HBV, and/or HCV. This policy proposal includes a list of exposure-prone procedures and a decision chart that indicates under what conditions infected physicians can practice beyond the need for disclosure of their serological status.

Eugenics, medical education, and the Public Health Service: Another perspective on the Tuskegee syphilis experiment.

The Public Health Service (PHS) Study of Untreated Syphilis in the Male Negro (1932–72) is the most infamous American example of medical research abuse. Commentary on the study has often focused on the reasons for its initiation and for its long duration. Racism, bureaucratic inertia, and the personal motivations of study personnel have been suggested as possible explanations. We develop another explanation by examining the educational and professional linkages shared by three key physicians who launched and directed the study. PHS surgeon general Hugh Cumming initiated Tuskegee, and assistant surgeons general Taliaferro Clark and Raymond A. Vonderlehr presided over the study during its first decade. All three had graduated from the medical school at the University of Virginia, a center of eugenics teaching, where students were trained to think about race as a key factor in both the etiology and the natural history of syphilis. Along with other senior officers in the PHS, they were publicly aligned with the eugenics movement. Tuskegee provided a vehicle for testing a eugenic hypothesis: that racial groups were differentially susceptible to infectious diseases.

Recent Developments in Health Care Law: Culture and Controversy

This article reviews recent developments in health care law, focusing on controversy at the intersection of health care law and culture. The article addresses: emerging issues in federal regulatory oversight of the rapidly developing market in direct-to-consumer genetic testing, including questions about the role of government oversight and professional mediation of consumer choice; continuing controversies surrounding stem cell research and therapies and the implications of these controversies for healthcare institutions; a controversy in India arising at the intersection of abortion law and the rights of the disabled but implicating a broader set of cross-cultural issues; and the education of U.S. health care providers and lawyers in the theory and practice of cultural competency.

Swimming Upstream: Regulating Genetically Modified Salmon

Humans have been manipulating their food supply for thousands of years, often by consciously breeding both plants and animals for traits that made foodstuffs more plentiful, more convenient to use, and even more nutritious. Most of us have eaten items as common as hybrid corn, steaks from beef cattle bred for lower fat content, or tomatoes specifically bred for tougher skins and more efficient transport. But with the advent of genetic engineering in the last 30 years, it has become possible to create completely novel organisms, whose characteristics have been fixed altered at the molecular level by the introduction of new combinations of genes. This prospect is troubling to some, who see intrusion into plant and animal genomes as somehow less “natural” than the more traditional methods of horticulture or animal husbandry. Fears also arise at the practical level, when novel varieties of food products—plant or animal—appear to pose a threat to the environment, or alternatively, to people who have survived on the cultivation of established plants or the nurture or capture of existing varieties of animals. The emergence of these newly designed sources of food has generated a call for additional legal regulation of food production, or at least of some the biotechnologies, such as recombinant DNA technology, used to produce genetically modified organisms. Unlike most of the world, the United States has been slow to adopt such a regulatory scheme. By focusing on the example of genetically modified salmon, this paper explores why that reluctance persists, and how model regulations already in place internationally might be employed in the U.S.

From in vivo to in vitro: How the Guatemala STD Experiments Transformed Bodies Into Biospecimens: From in vivo to in vitro

Policy Points: While most scholarship regarding the US Public Health Services STD experiments in Guatemala during the 1940s has focused on the intentional exposure experiments, secondary research was also conducted on biospecimens collected from these subjects. These biospecimen experiments continued after the Guatemala grant ended, and the specimens were used in conjunction with those from the Tuskegee syphilis experiments for ongoing research. We argue there should be a public accounting of whether there are still biospecimens from the Guatemala and Tuskegee experiments held in US government biorepositories today. If such specimens exist, they should be retired from US government research archives because they were collected unethically as understood at the time. CONTEXT The US Public Health Services Guatemala STD experiments (1946-1948) included intentional exposure to pathogens and testing of postexposure prophylaxis methods for syphilis, gonorrhea, and chancroid in over 1,300 soldiers, commercial sex workers, prison inmates, and psychiatric patients. Though the experiments had officially ended, the biospecimens collected from these subjects continued to be used for research at least into the 1950s. METHODS We analyzed historical documents-including clinical and laboratory records, correspondence, final reports, and medical records-for information relevant to these biospecimen experiments from the US National Archives. In addition, we researched material from past governmental investigations into the Guatemala STD experiments, including those of the US Presidential Commission for the Study of Bioethical Issues and the Guatemalan Comisión Presidencial para el Esclarecimiento de los Experimentos Practicados con Humanos en Guatemala. FINDINGS Identified spinal fluid, blood specimens, and tissue collected during the Guatemala diagnostic methodology and intentional exposure experiments were subsequently distributed to laboratories throughout the United States for use in ongoing research until at least 1957. Five psychiatric patient subjects involved in these biospecimen experiments died soon after experimental exposure to STDs. The same US government researchers working with the Guatemala biospecimens after the exposure experiments ended were also working with specimens taken from the Tuskegee syphilis study. CONCLUSIONS There should be a complete public accounting of whether biospecimens from the Guatemala and Tuskegee experiments are held in US government biorepositories today. If they still exist, these specimens should be retired from such biorepositories and their future disposition determined by stakeholders, including representatives from the communities from which they were derived.

The Power of Heredity and the Relevance of Eugenic History

INTRODUCTION This journal is celebrating its 20th anniversary, and those who have subscribed since the beginning may remember reading its first issue. Perhaps they also remember the day, only a few weeks later, when the cover of Time magazine displayed a double helix entwined around a caduceus, as the gateway image to a special theme issue on the future of medicine. The subhead announced the focus of the articles inside: “How genetic engineering will change us in the next century.” There were articles about the race to map the human genome, using DNA to solve crimes, genetic privacy, gene therapy, cloning, and more. But compared with the excitement and hope conveyed by most of the futuristic reportage, one piece stood out as dark and foreboding. It was titled “Cursed by Eugenics,” and it was introduced by a dramatic assertion: “A belief that human intelligence could guide evolution led the world to concentration camps.” What need was there, some readers may have asked, to dampen the excitement that swirled around all things genetic by invoking memories of Dachau and Auschwitz and the dreaded word eugenics? Surely those long vanquished images of evil were irrelevant to the medical wonders genetic research was delivering, and could only delay the conquest of disease by genetic medicine. A reader in this journal’s anniversary year might ask the same questions. This article is an attempt to give some reasoned answers. It is worth reviewing what this journal had to say about eugenics two decades ago. Had a skeptical reader of Time consulted the first issue of this journal she might have left with suggestions of how hard it is to disentangle the field of genetics from the troubling history of eugenics. Leaders in medical genetics demonstrated that difficulty in their own words. In his 1998 presidential address to the American College of Medical Genetics (ACMG), Reed Pyeritz directed his listeners’ attention to the “intellectual forefathers” of his field, including Francis Galton, who coined the term eugenics, and is the acknowledged godfather of what was known as the “science of good birth.” Pyeritz listed threats to the profession of medical genetics including “genetic determinism,” and warned that “we can never overlook the fear that the concepts of genetic manipulation... and eugenics can engender.” He also understood that the historical face of eugenics was often masked by financial concerns, and cautioned that “economic issues will potentially drive application of genetic information and technologies.” A later president of the ACMG, speaking in a similar vein, said: “The worst accusation that can be leveled against modern human genetics and medical genetics is that they are eugenic.” But by then, the call for attention to eugenic history had already been raised by others in the field of medical genetics. The details of that history were widely available both to scholars and the public by 1998, and emphasis by genetic counselors on nondirective counseling had occurred, to some extent, in reaction to it. Historians like Mark Haller and Kenneth Ludmerer wrote important monographs on the topic in the 1960s and 1970s. As early discussions to analyze the entire human genome took place, Daniel Kevles’ In the Name of Eugenics appeared in serial form in the New Yorker, and was published as a single volume soon thereafter. By the time the human genome had been sequenced in 2001, several dozen books had been published about eugenics, detailing its pervasiveness in the United States and its worldwide impact. And the budget for the Human Genome Project itself had provided funding for ethical, legal, and social implications (ELSI) research, which supported a significant body of scholarship on eugenics. Twenty years later, what has the medical genetics community learned about eugenics?

How to Escape the Doctor's Dilemma? De-Medicalize Reproductive Technologies.

Kara Swanson details the professional evolution of Alan Guttmacher, and the quandary he faced when the law interfered with prerogatives he wished to exercise in his practice of reproductive medicine. This response focuses on how decoupling reproductive technologies from a regime requiring medical licensure could lead to more complete reproductive autonomy for women.

When Harvard Said No to Eugenics the J. Ewing Mears Bequest, 1927

James Ewing Mears (1838–1919) was a founding member of the Philadelphia Academy of Surgery. His 1910 book, The Problem of Race Betterment, laid the groundwork for later authors to explore the uses of surgical sterilization as a eugenic measure. Mears left

Bioethics on the Subcontinent: The Sindh Institute in Karachi

60,000 in his will to Harvard University to support the teaching of eugenics. Although numerous eugenic activists were on the Harvard faculty, and two of its Presidents were also associated with the eugenics movement, Harvard refused the Mears gift. The bequest was eventually awarded to Jefferson Medical College in Philadelphia. This article explains why Harvard turned its back on a donation that would have supported instruction in a popular subject. Harvard’s decision illustrates the range of opinion that existed on the efficacy of eugenic sterilization at the time. The Mears case also highlights a powerful irony: the same week Harvard turned down the Mears legacy, the U.S. Supreme Court endorsed eugenic sterilization in the landmark case of Buck v. Bell. Justice Oliver Wendell Holmes, Jr., graduate of Harvard and former member of its law faculty wrote the opinion in that case, including the famous conclusion: “Three generations of imbeciles are enough.”

Recent Developments in Health Care Law: Partners in Innovation

In this personal narrative the author recounts his experiences teaching bioethics in Pakistan. He notes the different moral, cultural and legal environments of Pakistan as compared to the United States, and in particular, the ways in which subtle interpretations of Sharia law shape bioethical reflections as well as the biomedical legal environment. As he argues, any attempt to export models of bioethics from one country to another with no attention to social and cultural differences is a recipe for failure. To presume that all ethical considerations are universal is to devalue moral traditions that differ from our own, and dismiss cultural values of other societies.