Bioethics has no theory of process. We have labored to develop a widely shared set of substantive values, but have been slow to spell out exactly what processes our values command. Nor have we examined process itself, to gauge the impact of different procedures and debate what we should value in process itself.

The little work that has been done on process focuses almost exclusively on what action should be taken in one-to-one encounters. Thus, much has been said on the obligation of the physician to speak with the patient, share information, and seek consent. Indeed, it would have been difficult to advocate respect for patient autonomy at all, without at least requiring this minimal and individualistic sort of procedure. But the requirement of certain behaviors in individual encounters has not been set in any broader vision of institutional process.

RU 486 is a synthetic drug with antisteroid hormone properties, synthesized by the Roussel-Uclaf Company, Paris, France, which owns a world-wide patent for all uses.

I have summarized the story of RU 486's discovery, testing and use in the Journal of the American Medical Association, in Science? and in a book entitled The Abortion Pill, also published in French as Génération Pilule.

Based on antiprogesterone action, RU 486 was first approved in France for voluntary pregnancy interruption (VIP), within the framework of the abortion law, as a medical method to replace the instrumental technique in use when the law was passed in 1975. Registration of RU 486 was obtained in September 1988.

Progesterone is essential both for ovulation and for the formation of the secretory endometrium which is required for nidation: it plays a central role in the establishment and maintenance of pregnancy. Given the multifaceted role of progesterone in the reproductive process, an anti-progestational compound such as RU 486 (Mifepristone, Roussel-Uclaf, Paris, France) could be expected to have a number of potential clinical applications in human fertility regulation including termination of pregnancy, induction of missed menses, postcoital contraception and inhibition of ovulation and implantation.

Our research and clinical evaluation have mainly been directed to termination of pregnancy and to inhibition of implantation. The aim of this presentation is to summarize briefly our experience with the use of RU 486 in these areas.

Major segments of the news media, as well as many scientific journals, have produced innumerable articles and stories that polarize issues about proper protections for animals involved in research. The prevailing exposition of the issues is the following: On the one hand, animal lovers make emotional appeals to the public's attachment to animals and use clever tactics to increase the vulnerability of universities and institutions of research. On the other hand, arrogant scientists refuse to respond to public controversy, have an inherent conflict of interest in reviewing research involving animals, and are out to advance their careers and interests, callously using animals as means to that end. As a result, journalists warn NIH officials that they “can expect continuing criticism from two disparate and opposing groups—animal welfare activists, who consider NIH the fox guarding the chickens … and scientists and administrators from the research community, who regard tighter restrictions as unnecessarily burdensome.”

Susan Wolf, in an important article on hospital or institutional ethics committees (IECs) and due process, writes:

There are few data upon which to draw to disagree with Wolf's first claim about a due process “wasteland.” I suspect that it is mostly true, although one can observe, as I do, that Susan Wolf has omitted a great deal of evolution concerning ethics consultation in her article.

Violations of the ethical canons of research have been reported with increasing frequency in recent years. Nowhere have the reported incidents been so numerous or so troubling or attracted so much Congressional attention as in biomedical research. Research ethics, once “something everyone agrees about,” has become the subject of disagreement now that issues of culpability and enforcement are demanding attention. How to distinguish mistakes from fraud has stopped being theoretically obvious and has become a practical problem.

Defining culpable research misconduct has proved to be controversial. Good definitions are a prerequisite for intelligent discourse and sensible regulations. Regulations based on unclear or misdirected definitions stimulate resistance, hostility and evasiveness. The case in point is the definition of what it is that a research institution must investigate and report to the appropriate federal funding agency if allegations of misconduct are received.

Two Athenians set out to found a city free from the sophistry, power struggles, and litigiousness of Athens in Aristophanes’ play, The Birds. Their creation is to stand as a shining example of a virtuous demos in which reasoned discourse will give birth to goals beneficial to the individual and the community. The city that emerges, “Cloudcuckooland,” turns out to be a replica of Athens, driven by a morality of self-interest and the lust for world conquest. Its founders’ dream fades in a maze of doubtful arguments, crippling red tape, and insatiable litigiousness. Even so, Aristophanes hints, the dream survives, for no Athenian can escape from the restless hubris that leads to daring creation.

Special committees have been created in recent years to address difficult ethical issues in clinical care free from the bureaucratic amorality, professional friction, and litigiousness that can characterize problem-solving within health care institutions.

The development of antiprogestins and their use for early legally induced abortion have caused considerable heated debate concerning the appropriateness of this new technology for introduction into health care settings around the world. This debate is obviously complicated by broader issues such as abortion itself, women's rights and reproductive freedom, hormone-related medications, and other controversies. While these issues cannot be completely separated, this paper focuses on the management challenges that surround the introduction of new reproductive health technologies. This problem is central to the availability, accessibility, and applicability of new abortion technologies such as the RU 486/Prostaglandin combination.

Introduction of new contraceptive and abortion technologies has yielded important lessons that can guide decision-making regarding RU 486/Prostaglandin. Specifically, these experiences have highlighted the need to concentrate on quality of care concerns in introducing technologies, to ensure new services’ acceptability and, thereby, their effectiveness.

Ethical debate on human germ-line gene therapy is in a new stage. After an era when only individual convictions could be examined, technology is on a threshold of real possibilities. Germ-line gene therapy can conceivably be carried out in either of two practical ways: 1) insertion of a gene into a pre-embryo, which is the subject of this paper, or 2) insertion of a gene into the germ cells of an individual.

Transgenic animal research and pre-implantation embryo diagnosis have implications for human embryonic germ-line experiments to correct single gene disorders. When would such experiments be feasible and ethically acceptable? If further animal research supports it, we argue for a moral obligation to learn if human germ-line experiments are feasible and safe to attempt. The obligation is grounded in several social-ethical principles that lead society and researchers to set gods for studies that promisc to relieve and to prevent human suffering and premature death. These principles also shape the practices and restrictions of biomedical research.

It has recently been observed that in the United States hospital ethics committees have passed through their infancy and that, even though they may not yet have come of age, they have entered their adolescence. Accordingly, they must increasingly expect to be held to account for their conduct, and be prepared for others to anticipate not only that they can be self-reliant but that their communities may rely on them to undertake several functions of public significance. The claim that they have grown beyond their infancy remains contentious in the U.S., and is unlikely to be made of Canadian hospitals ethics committees with the same confidence. It is not too early, however, to anticipate a time when Canadian committees too may be considered capable of performing acts that are of considerable public importance, particularly concerning hospital policies on organ transplantation.

Antiprogestins represent a new class of promising drugs in fertility regulation, especially in early termination of pregnancy. RU 486 (mifepristone), manufactured by Roussel-Uclaf and marketed under the international trade name Mifegyne, is an antiprogestin tablet that is used sequentially with a prostaglandin for non-surgical termination of pregnancy. It has been chosen as a pregnancy termination method by over 100,000 women in France since its regulatory approval there in 1988. In addition, RU 486/prostaglandin was approved in July 1991 for use in the United Kingdom and an application for approval is being considered in Sweden. In Western Europe, it seems, RU 486/prostaglandin is increasingly accepted by medical experts, regulatory officials and women as an alternative to vacuum aspiration or dilation and curettage (D&C) for early pregnancy termination.

As the use of RU 486/prostaglandin becomes more established, health practitioners and women's health advocates are beginning to consider the feasibility of using this method for pregnancy termination in low-resource settings.

In the “olden days,” only a few years ago, physicians were free to order virtually any service they believed their patients needed, confident that virtually everything would be paid for. Reimbursernent was retrospective, fee-for-service and generous, essentially a cost-plus system in which insurers only rarely challenged medical decisions. That system is now gone. Uncontrolled escalations in the cost of health care have prompted those who pay its costs—primarily governments, businesses, and insurers—to initiate a broad array of cost controls in hopes of at least restraining the rise of their expenditures, even if not actually reducing them. Among the most prominent cost-containment mechanisms is utilization review (UR).

Insurers have always engaged in retrospective review, denying payment for services that are not medically necessary, or not covered by the patient's policy, or not documented in the patient's records. Recently, however, payers have added prospective review, in which physician and patient must secure advance payer approval for certain interventions if they wish to ensure reimbursement.

Although RU 486 has been the subject of extensive research and media coverage, in the United States the actual clinical use of the drug remains largely a theoretical possibility. California is the site of the only American clinical research on the use of RU 486 for termination of early pregnancy, and the California state legislature has adopted a strongly-worded resolution in favor of the testing and use of RU 486 in the state. However, the degree of physician awareness, the nature of physician opinion and the potential use patterns of this drug remain speculative.

To gain a better picture of what the physicians most likely to utilize RU 486 think about the drug, licensed California obstetricians and gynecologists were surveyed regarding their opinions about RU 486. The physicians were queried about their general awareness of the history of RU 486, their level of confidence in the existing data regarding the drug and their possible plans to administer the drug clinically if it were to become available.

In the landmark case of Crzan v. Director, Missouri Department of Health; the United States Supreme Court went out of its way to emphasize that the state was paying for Nancy Cruzan's care. The court refused to allow removal of the artificial nutrition and hydration that was maintaining Nancy Cruzan in a persistent vegetative state (PVS). What if, instead of the state's paying for the care, the parents had to “spend down” in order to be eligible for Medicaid? Could the state opt for life and require the family to pay for the care? If not, do constitutional rights depend on who can or will pay the cost of care?

Now turn the facts of Cruzan around and assume that the parents want to keep the child alive. Could the parents force the state to bear the cost of keeping a PVS patient alive indefinitely? If not, why should the state, but not the parents, have a constitutional right to preserve life? Do constitutional rights boil down to dollars?

The escalating cost of health care has forced people to confront the possibility of rationing—forgoing beneficial care for patients so that the resources might be used either for other current or prospective patients or for entirely different things in life than health care. Rationing of some sort makes eminent sense, not just economically; only those who are fanatics about health and medicine would urge that everything possible be spent on health care for even the slightest marginal benefit. Yet actual rationing of health care is usually thought to exact high, or at least disturbing, ethical costs.

I will examine four of these costs here: (1) the sacrifice of physician loyalty to patients, (2) the substitution of misleading and discriminatory numerical measurements of medicine's human benefit for more sensitive qualitative judgments, (3) the unfair bite that rationing is likely to take first out of poor people's care before it affects wealthier patients, and (4) the general Substitution of public, group standards about life and health for the values and decisions of individuals.

Traditionally, fertility regulating methods were devised and offered in accord with the convenience of service providers and/or with their perceptions of the convenience of the population served. Generally, the focus was on a method's safety, efficacy, and affordability. It was not until a June 1972 planning meeting of the World Health Organization Human Reproduction Unit that the concept of acceptability was adopted as an additional criterion. The purpose was “to modify technology and programs to fit people, rather than modifying people to fit technology and programs.” A WHO Task Force on the Acceptability of Fertility Regulating Methods was established in January 1973 within what has now become the WHO Special Programme of Research, Development, and Research Training in Human Reproduction. Research conducted in the subsequent 17 years has had a profound effect on the field.

It is the purpose of this article to review the current status of early pregnancy interruption with mifepristone (RU 486) combined with a prostaglandin analogue from the standpoint of its acceptability to women.