Ten years ago, Jesse Gelsinger died while participating in a human genetherapy trial at the University of Pennsylvania (“Penn”). His death came to signify the corrosive influence of financial interests in human subjects research. After Jesse's death, the media reported that one researcher, Dr. James Wilson, held shares in a biotech company, Genovo, which stood to gain from the research's outcome—shares that The Wall Street Journal later valued at $13.5 million, although Wilson maintains he did not make nearly this much. At the time Penn authorized Wilson's deal, internal Penn documents implicitly valued Wilson's stake in Genovo at approximately $28.5 to $33 million.

Jesse's death sparked two separate lawsuits: one by the family, who sued in tort, and one by the federal government, which framed alleged errors in the research trial as a civil False Claims Act violation.

Tort “crises” and serious interest among policy-makers in tort reform are inter-related, cyclical phenomena in the United States. In the mid-1970s, and again in the mid-1980s, medical malpractice markets across the country experienced rapid increases in the frequency of claims, rising premiums, and in some places, shrinking options for professional indemnity coverage. A wave of tort reform measures followed, the majority of which were designed to chill the interest of plaintiffs' attorneys in bringing suit.

There is a long history of attacks on scientists. During the Inquisition, the Roman Catholic Church charged Galileo with heresy and, after imprisonment and threats of torture, forced him to renounce his theory that the sun, not the earth, was the center of the universe. In the 1950s, politicians sought to silence scientists that allegedly held political views sympathetic to Communists.

In recent years, research results, rather than the scientist's religion or politics, have motivated attacks on scientists. As environmental issues grow in economic significance and as science takes on increasing importance in influencing public opinion and resolving environmental policy debates, suppression of environmental science has become increasingly common. As one author observed, the power of science to legitimate environmental positions by claiming exclusive truth makes ownership of science one of the most contested issues in modern environmentalism.

Telemedicine became a significant part of the health care equation long before we realized what it was or how important it will be in the future. Telephone discussions and consultations between health care providers have been a part of medical practice since Alexander Graham Bell gifted society with telephones. Furthermore, who among us has not been transfixed watching and learning about open heart surgery on cable television? Propelled by the information superhighway and the breadth of emerging computer and communication technologies, telemedicine will change the face of medicine and methods of interaction between providers and patients. Access, quality and cost of health care may all improve, but not without the sacrifice of some time-honored norms in medical practice.

Very large biomedical research databases, containing electronic health records (EHR) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is “big data” necessarily better data?

This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons for approaching such research with care and being cautious in relying on its outcomes for purposes of public policy or litigation. First, the data contained in biomedical databases is surprisingly likely to be incorrect or incomplete. Second, systematic biases, arising from both the nature of the data and the preconceptions of investigators, are serious threats to the validity of research results, especially in answering causal questions. Third, data mining of biomedical databases makes it easier for individuals with political, social, or economic agendas to generate ostensibly scientific but misleading research findings for the purpose of manipulating public opinion and swaying policymakers.

In short, this paper sheds much-needed light on the problems of credulous and uninformed acceptance of research results derived from biomedical databases. An understanding of the pitfalls of big data analysis is of critical importance to anyone who will rely on or dispute its outcomes, including lawyers, policymakers, and the public at large. The Article also recommends technical, methodological, and educational interventions to combat the dangers of database errors and abuses.

On December 6, 2005, shortly before the World Trade Organization (“WTO”) Ministerial Conference in Hong Kong, WTO member states agreed to accept a protocol of amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPs Agreement”). This amendment sought to provide a permanent solution to implement paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (“Doha Declaration”). If ratified, the new article 31bis of the TRIPs Agreement will allow countries with insufficient or no manufacturing capacity to import generic versions of on-patent pharmaceuticals.

To facilitate the supply of essential medicines to countries with insufficient or no manufacturing capacity, article 31bis(3) creates a special arrangement not only for the affected countries, but also for those belonging to a regional trade agreement. Such an arrangement allows less developed countries to aggregate their markets to generate the purchasing power needed to make the development of an indigenous pharmaceutical industry attractive.

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. People can be maintained on life-support even after permanently losing the ability to breathe spontaneously and remaining unconscious and unable to interact meaningfully with others. In part because this group of people could help fulfill the growing need for organ donation, there has been a great deal of pressure on the way we determine death. The determination of death has been modified from the old way of understanding death as occurring when a person stops breathing, her heart stops beating, and she is cold to the touch. Today, physicians determine death by relying on a diagnosis of total brain failure or by waiting a short while after circulation stops. Evidence has emerged that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from our biological and common-sense understandings of death.

We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. However, the considerable debate over the determination of death in the medical and scientific literature has not informed the public of the fact that our current determinations of death do not adequately establish that a person has died. It seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution of acknowledging the legal fictions involved in determining death. This move in the direction of greater transparency may someday result in allowing us to face squarely these issues and effect the legal changes necessary to permit ethically appropriate vital organ transplantation. Finally, this paper also provides the beginnings of a taxonomy of legal fictions, concluding that a more systematic theoretical treatment of legal fictions is warranted to understand their advantages and disadvantages across a variety of legal domains.

The barriers to women's participation as subjects in biomedical research are currently being challenged as a matter of legislative policy, medicine, and law. This Article catalogs the ways in which women have been disadvantaged by their exclusion and recent developments to redress them, and goes on to dissect the underlying rationales for excluding women from clincial trials. The author reveals the ‘fundamental misconception’ behind exclusionary rationales, and argues that research sponsors in fact have more to fear in the way of potential liability from the exclusion of women, even pregnant women and women of child-bearing capacity, than from their inclusion. Finally, the Article suggests strategies for achieving reform of these exclusionary practices.

In the United States we have very mixed feelings about research with human subjects. The Nuremberg Code (the Code), which provides a foundation for the protection of human subjects, was written by American judges in the context of trying Nazi doctors who committed atrocious acts of human experimentation on concentration camp inmates. The Code provides ten common-sense guidelines controlling research. For example, a researcher may not conduct research on human subjects without that subject's informed consent, or if there is an a priori reason to believe that the research will cause death or disabling injury to the subject. What is remarkable about the creation of the Code is that it was thought to be necessary to document and impose the most fundamental moral principles on researchers. The Code demonstrates a remarkable suspicion of research with human subjects and those who perform such research.

There is perhaps no greater tragedy in a parent's life than learning that one's child is terminally ill. Today, more than at any time in the past, when conventional treatment fails, dying children are given access to experimental treatment. To a surprising extent, society takes for granted the participation of dying children in medical experiments. In part, this is because we have come to view participation in clinical trials as a potential benefit. This view contrasts sharply with the dominant perception of the mid to late 20th century, which viewed medical research as a potential threat to vulnerable populations. Upon closer scrutiny, both of these perspectives carry with them some important truths. This Article seeks to build upon those truths by undertaking a critical analysis of contemporary ethical and legal policies governing the inclusion of terminally ill children in clinical research.

Improving global health conditions has been one of the most important and difficult challenges for the world community. Despite concerted efforts by international organizations, like the World Health Organization, great disparities in health conditions remain between developed and developing countries, as well as within those countries. The World Health Organization has achieved some successes through its Health for All strategy; however, it can and should encourage member nations to enact national and international laws to protect and promote the health status of their populations. A comparison to the lawmaking efforts in other areas by international organizations indicates that WHO may have the authority and the means to institutionalize efforts to improve global health conditions.

Financial conflict of interest has become one of the most contentious issues in medicine today. Several decades ago studies disclosed that physicians who had investments in medical facilities were referring patients for more tests and procedures than physicians who had no such investments. More recently, physicians who forego expensive tests and treatments for patients have been accused of skimping on care for personal financial gain. Physicians who emphatically tout certain treatments have been criticized for possessing hidden financial ties to the manufacturer of the products. Some physicians engaged in clinical trials have been suspected of enrolling patients who do not strictly conform to the research protocols so that they can collect fees from contract research organizations. And in the aftermath of deaths and complications in gene therapy experiments, some scientists and their institutions have been criticized for possessing a financial stake in companies that are involved in the studies.

Dramatic scientific breakthroughs in medical technology have revolutionized the physician’s diagnostic prowess in the art of obstetrics. Scientific procedures now reveal previously undetectable secrets about the womb’s tiny inhabitants. In the last few years, perinatologists have not only demonstrated the ability to discern fetal abnormalities of an extraordinary variety, but also have become increasingly successful in correcting many of these defects in utero. This article identifies the potential medicolegal conflicts that may arise as fetal surgery becomes an accepted medical practice. It begins by surveying the legal rights of unborn persons with a particular emphasis on the role of viability in determining those rights. The article will then examine the concept of viability as developed by the Supreme Court in Roe v. Wade and later abortion decisions and concludes that the current judicial deference to the medical community in determining viability is adequate for balancing rights in the abortion context. However, conflicts among physicians and between the mother and her unborn child that may arise in the fetal surgery context suggest that viability may be an inadequate benchmark for resolving such conflicts. The article concludes with a recommendation to reform the current method of resolving the critical question of when a fetus becomes viable.

The Food and Drug Administration (FDA) regulates the promotion of pharmaceutical products. The FDA's regulations issued under the Food, Drug and Cosmetic Act (FDCA) require that prescription drug broadcast advertisements include the following: (1) a major statement of the product's risks in at least the audio part of the advertisement; and (2) that an adequate provision for the dissemination of the approved package labeling be made “in connection with the broadcast presentation,” if the brief summary is not also part of the advertisement. Under the FDCA, the brief summary provides information concerning the major risks of the drug.

Patent rules matter to the structure and evolution of pharmaceutical markets. If they did not, pharmaceutical multinationals would not spend resources on their globalization and content. The role of pharmaceutical multinationals in shaping the patent provisions of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been well documented. The contributions of developing country coalitions and nongovernmental organizations (NGOs) in the World Trade Organization (WTO) on TRIPS and access to medicines have also been studied.

One actor, the patent office, has largely escaped detailed scrutiny in the literature that has grown around intellectual property law and access to medicines. There is an obvious explanation. Patent offices are administrative bodies. They administer patent standards that are decided and defined by others – the courts, legislatures or the executive acting in the context of treaty negotiation. For those interested in the structural reform of pharmaceutical markets, reforming patent office administration has not been a high priority.

For the past two decades, the medical profession and society have debated the definition of death. Some reasonable consensus has been reached on this issue, in theory and in practice. In the last few years, however, a far more important debate has been evolving — the definition of human personhood. Human personhood has been discussed extensively in the past with respect to the abortion question and other issues concerning the beginning of life. More recently, however, the definition of personhood has been raised with respect to termination of treatment decisions at the end of life and, in particular, on the appropriate care of patients in a persistent vegetative state.

Our major premise is that consciousness is the most critical moral, legal, and constitutional standard, not for human life itself, but for human personhood. There is nothing highly original in our approach to this particular issue; others have advanced similar arguments in recent years.

The body of the nineteenth century philosopher Jeremy Bentham is on display in a glass cage at University College, London. Bentham applied his utilitarian perspectives to the body by suggesting that corpses, including his own, would be of greater use to society stuffed and displayed as an “auto-icon” rather than simply buried away. Preserved, exhibited and studied, the corpse, he said, could serve “moral, political, honorific, dehonorific, money-saving, money getting, commemorative, genealogical, architectural, theatrical, and phrenological” ends.

Twentieth century biology began with the rediscovery of Gregor Mendel's work on peas and ended with the sequencing of the human genome. In between came Thomas Morgan's studies of fruit flies, the grand synthesis between genetics and evolutionary biology in the 1930s, and Watson and Crick's publication in 1953 of the double helix structure of deoxyribose nucleic acid (“DNA”), the substance in the nucleus of cells, which carries the genetic code of all eukaryotic life.

The genetics of the second half of the century focused on learning how DNA coded for proteins, how to splice, clone, and recombine pieces of DNA, and how genetic mutations caused disease. In the late 1980s, a project to identify the actual sequence of all 3.2 billion base pairs of the human genome began. In June 1999, President Clinton and Prime Minister Blair announced that a working draft of the human genome was complete, with the final completed draft to 99.9% accuracy expected in May 2003, fifty years after the publication of Watson and Crick's landmark paper.

This could be the world's largest friendly fire incident.

In his classic treatise On War, Karl von Clausewitz emphasizes that courage is the “first quality of a warrior.” He defines two types of courage: “courage in the presence of danger to the person; next, moral courage, or courage in the presence of responsibility, whether before the judgment seat of an external authority or before that of the internal authority of conscience.“ Both were involved in the U.S. military's decision to seek a waiver of informed consent requirements for the use of investigational drugs and vaccines on U.S. troops in the Persian Gulf War. The danger of chemical and biological attack was seen as demanding this waiver; while the Nuremberg Code, medical ethics, and respect for the human rights and dignity of American soldiers cautioned against it. The legal maneuvering to revise consent regulations for wartime conditions provides a case study illustrating how the boundary line between therapy and experimentation can become hopelessly blurred, the differences between law and ethics, and the ethical obligations of military physicians.