A brave new beef: The US Food and Drug Administration's review of the safety of cloned animal products.

To meet its public mandate, the US Food and Drug Administration (FDA) collected studies on the potential health hazards of eating or drinking cloned food products. Based on an earlier National Academy of Sciences study that, on closer analysis, was not nearly as sanguine, the FDA's report found no evidence of a health risk from the public's ingestion of cloned food products. This article analyzes the risks the FDA considered, and concludes that there is a disconnect between the risks the FDA assessed in these studies and the risks that might arise from cloned food products. The FDA should consider instituting effective tracking mechanisms and other diagnostics that would permit scientists and the public to answer the question of health risks posed by cloned food products.

Cognitive enhancements in human beings.

In the area of genometry-the nascent field of science and technology that proposes to apply enhanced understanding of the human genetic code to reshaping our individual and collective destinies-research and development directed toward improving the function of the human brain has not advanced at the same rate as studies focused on physical enhancement. This article describes developments in the area of cognitive enhancement, including the rise in nonmedical uses of prescription drugs. As those without medical ailments continue to take prescription drugs for their cognitive-enhancing side effects, social policy questions about the fairness of such actions will arise. This article also examines the regulation of cognitive enhancers, both by US law and the rules of international competition.

Physical enhancement of human performance: is law keeping pace with science?

In the area of genometry-the nascent field of science and technology that proposes to apply enhanced understanding of the human genetic code to reshaping our individual and collective destinies-no topic has generated more interest among the general public, as well as in the athletic community, than the potential for physical enhancement of the human body and its performance. Genometric experiments have produced physically enhanced mice, and the production of similarly enhanced humans may not be far off. Although it is not the objective of most genometric research, the day will come when gene-based "treatments" will enable individuals to build muscle or increase endurance faster than is possible through conventional methods. This article describes developments in the area of physical enhancement that may find application in the "gene doping" of athletes. For example, human performance-related genes may be delivered to athletes using tools developed for research in gene therapy; the protein products of these genes may be administered in recombinant form; and recently discovered small-molecule activators of the major genetic regulatory pathways of physical prowess may be taken orally, providing "exercise in a pill". This article also describes US and international attempts to regulate and punish the use of prohibited techniques for performance enhancement among athletes. As science advances, defining and detecting "gene doping" becomes increasingly complex. Thus, the study of physical enhancement provides an ideal starting point for the interdisciplinary Redefined Destinies Colloquium's examination of the intersection between law and science.

Compelled organ donation.

Along with ethical considerations, compelling an individual to donate organs, tissues, or bodily fluids brings several legal doctrines into conflict. The privacy of one's body is generally considered sacrosanct by American courts, which have upheld a competent adult's right to refuse medical procedures, even in cases when they are necessary to save the life of another. Although medical and legal communities stress "respect for the individual" as being paramount under American jurisprudential principles, the doctrine of "substituted judgment" permits a court to act (for example, by consenting to organ donation) on behalf of an incompetent individual or child. Parents also have the right to cause a child to "donate" an organ, and although a means exists by which the child can refuse, this may not be realistically feasible for young children. The revised Uniform Anatomical Gift Act of 2006, while clarifying issues of who may make organ donation decisions, does not resolve all the practical issues of compelled organ donation for minors.

Reshaped destinies: confronting our human future the need for and promise of an interdisciplinary colloquium.

The genomic revolution is bringing with it simultaneous needs for both scientists and nonscientists to understand and assess, in an unvarnished and nonjudgmental way, the implications of genometry. This is the field of science and technology that is taking the genetic code and what we have learned from its secrets, and reshaping our individual and collective human destinies. Together with the editor-in-chief of Gender Medicine, the authors propose an interdisciplinary group-populated by those in science, law, ethics, social policy, and the interested public-to observe, understand, and disseminate information about what is occurring in the fields of biology and chemistry that is the driving force of the genomic revolution. This article discusses the background to the Redefined Destinies Colloquium (RDC) and summarizes 4 of the topics the RDC is studying.

The weaker sex: is being male a legally cognizable defect, impairment, or disability?

Compared with women, men die from cancer and coronary artery disease in disproportionately higher numbers and are more susceptible to a host of emotional and developmental disorders. The authors of this article consider what scientific proof or evidence would be required to legally recognize "being male" as a disability, based on the overwhelming number of physical deficiencies to which males are genetically predisposed. The article summarizes major scientific findings on male health problems and explores various laws and policies that might be implicated by treatment of males as a special category recognized by the law. How the law creates categories of individuals and the reasons why these categories are created for legal classification are reviewed. In addition, the potential for a "maleness" defense in the context of criminal law and procedure is assessed. Lastly, the authors examine the policy implications of treating men as a disabled class, and consider how judges, juries, and legislators would view a scientifically based approach to the creation of a class. Given the many false starts in the past, in which the law had embraced what later was shown to be bad science, substantial historical baggage will have to be overcome to convince judges, juries, and legislators that science has now got it in the sense of having established a valid, causal, genetic or biological determinant for behavior. The consideration of a "male deficiency" theory under the law would have to rely on a more inclusive view of legal "disability" and a willingness to allow technologic advances in genetics to inform our understanding of criminal behavior.

Physician-assisted suicide and euthanasia: disproportionate prevalence of women among Kevorkian's patients.

End-of-life decisions are among the most difficult to make or study. When we examined these decisions made under the auspices and protection of stringent state laws, we found no gender bias among patients who chose to end their lives in the face of documented debilitating and terminal diseases. However, in the case of euthanasia as practiced by Jack Kevorkian, we found significant statistical bias against women. Moreover, other data have questioned whether all of Kevorkian's patients did, in fact, have debilitating and terminal illnesses. In this article, we explore why a gender disparity exists in end-of-life decision making. We conclude that if physician-assisted suicide and euthanasia are to be integrated into any end-of-life medical care policy, stringent legal and medical safeguards will be required. Institution of these safeguards should prevent selection bias in a vulnerable population hastening death for reasons other than medically justifiable conditions or issues of individual autonomy, and should ensure that end-of-life decisions are truly reflective of competent personal choice, free from economic considerations or societal pressure.

Embryonic stem cells in science and medicine, part II: law, ethics, and the continuing need for dialogue.

Just as our first article, "Embryonic Stem Cells in Science and Medicine: An Invitation for Dialogue," in the December 2007 issue of Gender Medicine went to press, two groups of researchers had just announced that adult human somatic cells had been reprogrammed to behave like pluripotent stem cells, and that the reprogrammed cells were able to differentiate into cell types of the 3 germ layers in vitro and in a mouse model. A third group has since done so. Because the reprogrammed cells were not embryonic in origin, the announcements were heralded as "stunning" and "leaps forward," because, it was argued, the ability to generate stem cells, without destroying embryos in the process, would avoid the difficult ethical questions raised by human embryonic stem (hES) cell research. This article addresses the most recent announcements and briefly retraces the relevant history so that we may consider whether the moral, ethical, and social issues do in fact disappear as a result of these new advancements. We conclude that, despite the hoopla, little has changed. If indeed there were ethical issues surrounding hES cell research, they remain-and remain as urgent to address and resolve as they had been previously. Lastly, we argue that the medical and scientific communities continue to do themselves a disservice by failing to create a cohesive governing body to address and make concrete recommendations concerning the moral, ethical, and related social issues affecting their communities.

Impact of the US Patent System on the promise of personalized medicine.

The biotechnology revolution promises unfathomable future scientific discovery. One of the potential benefits is the accelerated introduction of new diagnostics and treatments to the general public. The right medication for the right patient is the goal of personalized medicine, which directly benefits from many of biotechnology's biggest and most recent advances. The US patent system rewards innovation in medicine and other arts and sciences by granting innovators, for a period of time, the right to exclude others from using what was invented. One of the purposes of the patent system is to trade that right to exclude, and in its stead obtain the patent holder's obligation to fully and publicly disclose the essence of the innovations so that they can be improved, thus advancing the common welfare. A tension exists between personalized medicine's need for access to and use of scientific advances and the patent system's reward of exclusive use or nonuse to innovators. This tension may result in fewer diagnostic and therapeutic tools brought to the market and generally adopted. The risk seems particularly acute with respect to the diagnostic and therapeutic tools arising from genetic testing that hold specific value for a subset of the population. The judicial system has introduced ethical exceptions that overcome a patent holder's right to exclude; these judicial overrides relate to the provision of certain types of medical procedures and the development of certain types of new drugs, and not, apparently, to the use of diagnostic and therapeutic tools essential to the success of personalized medicine. A serious question exists as to whether legislative action is necessary to increase public access to genetic testing.

Male versus female genital alteration: differences in legal, medical, and socioethical responses.

The different legal, social, and medical approaches to ritually based male and female genital circumcision in the United States are highlighted in this article. The religious and historical origins of these practices are briefly examined, as well as the effect of changing policy statements by American medical associations on the number of circumcisions performed. Currently, no state or federal laws single out male circumcision for regulation. The tolerant attitudes toward male circumcision in law, medicine, and societal opinion stand in striking contrast to the attitudes of those disciplines toward even the least invasive form of female genital alteration. US law tacitly condones male circumcision by providing exemptions that are not available for other medical procedures, while criminalizing any similar or even less extensive procedure on females. The increase in immigration, over the past few decades, of people from countries in which female genital alteration is a cultural tradition has brought the issue to the United States. The medical profession's changing approach over time toward male circumcision is primarily responsible for such different legal and societal reactions toward female genital alteration.