Faculty Bibliography

Fertility preservation is a newly developed branch of reproductive medicine aimed at preserving the potential for genetic parenthood in adults of reproductive age or children, who are at risk of sterility before undergoing anticancer treatments. Except for embryo and semen freezing, all the available options to preserve fertility are considered experimental and thus, they raise ethical issues. In this study, we reviewed the informed consent and the risk-benefit analysis of offering experimental procedures for both adults and children when they are in vulnerable situations. In particular, children represent a special category of patients and their assent to treatment to be sought at anytime should be possible. Overall, there should be no ethical objections to offer these services as they are offered with the scope of preserving future fertility.

Clinical research has been expanding into poor nations in recent years. In doing research in such settings, the response to challenges arising due to the vulnerability and resultant potential exploitation of very poor subject populations is heightened awareness of the need for adequate local oversight and regulation. More regulation, however, often is difficult to implement and may not be practical. The provision of benefit at the conclusion of clinical trials in poor nations or for poor people is a better response to the moral challenge of exploitation.

In the wealthy nations of the world, access to implantable cardiac rhythm management devices is widespread. In many underserved low- and middle-income countries (LMIC), where cardiovascular disease is fast becoming a major public health problem, access is often limited. Reuse of pulse generators was practiced regularly in some European nations in the 1990s with good results. It is performed in LMIC, although the rates of device reuse are unknown. The available literature suggests there is no increased risk of morbidity or mortality with the reuse of devices. Donations of pacemaker and defibrillator pulse generators from developed nations constitute an important source of devices for the poor in LMIC. There are opportunities to increase this supply, but logistical barriers and legal and ethical concerns must be addressed. With proper sterilization, meticulous chains of custody, and advance directives for device handling (pacemaker/defibrillator living wills), patients in LMIC who would otherwise lack access to these devices could benefit from their reuse.

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated.

Caplan talks about the need for reexamination of a regulatory system that is not keeping its people safe. Hardly a month goes by without a medication or medical device being identified as having dangerous side-effects, the Food and Drug Administration (FDA) holding hearings, lawyers taking out ads looking for victims, class-action suits getting filed, or patients being left to talk with their equally confused doctors about whether they should stop treatment given the newly identified deaths, risks, recalls, or warnings. These things happened because the regulatory system is too skewed toward looking at the earliest stages of research

Competing visions for health reform in the United States and renewed interest in health technology assessment (HTA) have led to fierce national debates about the appropriateness of rationing. Because of a limited supply of organs, kidney transplantation has always required rationing and overt discussion of the ethics that guide it, but the field of transplantation has also contended recently with internal calls for a new rationing system. The aim of the Life Years from Transplantation (LYFT) proposal is to allocate kidneys to patients who obtain the greatest survival benefit from transplantation, which would lengthen the lives of kidney transplant recipients but restrict the ability of older Americans to obtain a transplant. The debate around the LYFT proposal reveals the ethical and policy challenges of identifying which patients should receive a treatment based on the results of cost-effectiveness and other HTA studies. This article argues that attempts to use HTA for healthcare rationing are likely to disadvantage older patients. Guiding principles to help ensure that resources such as kidneys are justly allocated across the life span are proposed.

J. Craig Venter announced in May that he and his colleagues had made a new living bacterium from a genome they decoded, artificially rebuilt and then stuck into the cored-out remains of the bacterium Mycoplasma. When the hybrid bug began to reproduce, it became the first artificial organism, putting to rest the ancient and tenacious conceit that only a deity or some special power can create the spark of life. It was the most dramatic demonstration yet of the power of synthetic biology, a nascent field that promises to solve many of the most pressing problems. Here, Caplan discusses the probable effects of biotechnology