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.

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.

In 1989 the Oregon Legislature voted not to wait any longer for national leaders to serve up a solution to the problem of the millions of Americans (450,000 in Oregon) who are uninsured for health care. Under the leadership of Senator John Kitzhaber, President of the Oregon Senate, the lawmakers put together a package of bills designed to bring every Oregonian the security of third party financing for needed health care. The Oregon Plan's key innovation is the idea that, from a societal perspective, some health services can be declared more important than others. From that central idea came the thought that the whole range of health services could be arrayed to reflect social priorities relevant to Medicaid budgeting and the design of new health insurance programs for “the uninsured.”

“Acceptability research” is a term first coined to describe inquiries into individuals’ responses to family planning and contraceptive technology. As defined by WHO, “acceptability” is a “quality which makes an object, person, event, or idea attractive, satisfactory, pleasing or welcome.” In fact, the word “acceptable” in English is distinct from other issues that are also encompassed within “acceptability research.” “Acceptable,” to many, connotes faint praise. It may mean that something is tolerable only to the point of not being protested. On the other hand, the attributes “desirable” and “preferable” are more positive. In fact, all of these qualities are examined within the meaning of “acceptability research” as currently used by the Population Council.

Acceptability of a product or a medical procedure is most commonly studied in terms of patients or clients. Do those who will undergo the procedure or be the subjects of the technology find its use acceptable? But, in fact, acceptability can also be tested in relation to the providers of the technologies (i.e., the medical professionals), to the program managers or to policymakers.

Joseph Finelli, after a heart transplant, is being artificially maintained by medications and a gastrostomy tube (G-tube). He is not brain dead nor in a persistent vegetative state. In my role as court-appointed Guardian ad Litem (GAL-court investigator), it appears to me that Mr. Finelli is being treated against his stated goals and values. After applying the substituted judgment factors, I recommend the withdrawal of the medication which sustains his life. His family adamantly opposes my position.

Joseph Finelli is a 57-year-old Italian-American Catholic husband and father of four adults. Mr. Finelli was an “extremely active” man. He enjoyed training dogs, hunting, running, and was an “avid” biker. Debilitating congestive heart failure eventually confined his activities to walking ten steps at a time. Surrendering his active life produced pronounced depression.

Approximately 35 million Americans have no health insurance coverage. They receive no health insurance where they work, nor do they qualify for Medicare, Medicaid, or any other program of health insurance. Eighty-five percent of these Americans live in households headed by someone working full time. One third of the 35 million uninsured are children.

Several reasonable inferences can be drawn from these statistics. First, the problem of the uninsured is a serious one in the United States. Thirty-five million Americans represent approximately 15 percent of the population. Second, the fact that the vast majority of the uninsured are in households headed by a working American shows that this problem is systemic. It is not simply a matter of unemployment, nor is it linked significantly to laziness or refusal to work. Finally, the fact that over 10 million uninsured Americans are children shows that many of the uninsured have this status beyond any intelligible notion of personal responsibility.

In countries where abortion is performed safely in medical settings, the vast majority of up to several generations of women have come to identify early abortion as a surgical experience—whether on an inpatient or outpatient basis, whether with local or general anesthetic or whether in a freestanding clinic or a hospital.

In this context, the introduction of RU 486 with prostaglandin (RU 486/PG) as an alternative method of early abortion will once more alter women's experience of abortion.

The first part of this paper explores the similarities and differences between an abortion with RU 486/PG and vacuum aspiration from a women-centered perspective. This comparison is limited by the fact that only women in France have so far had access to both methods, along with those who have participated in clinical trials, and that very few in-depth women's experiences and reactions to this method have been published.

Two of the patient's rights in a Uniform Act for the Terminally Ill should he a) the right to be treated if there is reasonable doubt of the patient's wishes until it becomes clear that the treatment is not beneficial and that the patient is indeed terminally ill, and b) the right not to he subjected to treatment with no medical benefit. A physician with appropriate supporting independent opinions would he the logical individual to whom the responsibility of protecting those rights should be given. This is particularly true when the patient is incapable of his or her own medical decisions and has left no instructions regarding his or her personal goals in medical care in the event of severe illness. Two cases and an analysis of power in medical decision-making illustrate these points.

The acquired immunodeficiency syndrome (AIDS) has raised perplexing ethical and public policy dilemmas. Early in the epidemic, closing of bathhouses, testing blood donors for human immunodeficiency virus (HIV) infection, and notifying seropositive blood donors evoked passionate controversies. Current dilemmas include testing and using promising new treatments, notifying partners of seropositive persons, and, most recently, restricting the clinical activities of seropositive health,care workers who perform invasive procedures.

These dilemmas about HIV infection involve scientific judgments, cultural norms, and social values. In the HIV epidemic, public rhetoric and political pressure have been prominent. On the one hand, some persons have launched moralistic crusades against homosexuals and injection drug users. For these persons, AIDS symbolizes the breakdown of traditional family values and the social order. On the other hand, some advocates for persons with HIV infection have used confrontational tactics such as sit-ins and disruptive demonstrations.

Is it futile to sustain biologic life when the patient will permanently require intensive medical care? Dr. Koch and Dr. Miles agree that such treatment would be futile; however, their concept of futility rests on no explicit standards and reflects no communal judgment. The authors view the lack of widely accepted medical standards as an impediment to answering this question definitively. Dr. Koch laments that patients and their families have seized too much power and have begun deciding that mere biologic life is worth sustaining. And Dr. Miles sees benefit to perceiving a decision not to sustain such life as “primarily biomedical” and “realistic.”

Here is where we disagree with these authors. We do not see the problem as a lack of standards that are medical. The question of prolonging a patient's life when the patient has no likelihood of regaining consciousness confronts moral, political, and economic issues.

Is it futile to sustain biologic life when the patient will permanently require intensive medical care? Dr. Koch and Dr. Miles agree that such treatment would be futile; however, their concept of futility rests on no explicit standards and reflects no communal judgment. The authors view the lack of widely accepted medical standards as an impediment to answering this question definitively. Dr. Koch laments that patients and their families have seized too much power and have begun deciding that mere biologic life is worth sustaining. And Dr. Miles sees benefit to perceiving a decision not to sustain such life as “primarily biomedical” and “realistic.”

Here is where we disagree with these authors. We do not see the problem as a lack of standards that are medical. The question of prolonging a patient's life when the patient has no likelihood of regaining consciousness confronts moral, political, and economic issues.

There is little experience with, and virtually no documentation of, adolescents’ use of RU 486 as a means of terminating pregnancy. While this void is understandable presently, it must be filled in order to determine how best to apply this new medical method to a special population—teenagers. It is imperative to know how adolescents might react differently from older women physiologically and psychologically, how they would accept this method of abortion and how health service providers should respond to their special needs. Counseling, for example, is particularly important for adolescent use of any family planning or abortion service.

Although it is not possible to review directly adolescent experience with RU 486, it is instructive to examine related attitudinal and behavioral patterns to assess the potential for adolescent use of a medical method of abortion. Documented experience with contraception and surgical abortion underscores the major challenges—present and new—for adoption of a new approach.

There is little experience with, and virtually no documentation of, adolescents’ use of RU 486 as a means of terminating pregnancy. While this void is understandable presently, it must be filled in order to determine how best to apply this new medical method to a special population—teenagers. It is imperative to know how adolescents might react differently from older women physiologically and psychologically, how they would accept this method of abortion and how health service providers should respond to their special needs. Counseling, for example, is particularly important for adolescent use of any family planning or abortion service.

Although it is not possible to review directly adolescent experience with RU 486, it is instructive to examine related attitudinal and behavioral patterns to assess the potential for adolescent use of a medical method of abortion. Documented experience with contraception and surgical abortion underscores the major challenges—present and new—for adoption of a new approach.

Does the prospect of introducing RU 486 into the United States pose any unique ethical issues? Or are the ethical questions raised by antiprogestins similar to those that arise when any new medical technology comes along? The short answer is that the ethical issues are not new or different, but the politics of abortion can seduce us into thinking that antiprogestins bear ethical hazards of a novel sort.

One transcending ethical question stands before us: Would it be the right thing to do to introduce RU 486 into the United States today? The deceptive simplicity of that question requires further analysis.

I welcome the long-overdue recognition of medical futility represented by the contributions of Koch, et al., Miles, and Dew, although I would be more comfortable with using the more global (and optimistic) term of “beneficence.” However labeled, the notion that medical treatment decisions are primarily that—medical decisions—is a far more appropriate starting point in both law and ethics than the customary departure point of patient autonomy. This is particularly true in cases in which the patient is not competent, and prior expressions of intent are remote, vague, or otherwise unreliable. Despite such flaws, prior statements have been invested with a talismanic quality, permitting avoidance of the genuine moral issues of duty and benefit that are presented by every severely ill and incompetent patient.

The rise of patient autonomy may actually have had less to do with genuine concern for the liberty of the patient than with the moral vacuum created by an excessively pluralistic view of medical ethics. Courts in particular have fallen out of the habit of a priori moral reasoning, replacing this discipline with balancing tests of asserred personal and governmental power.

The patient in a persistent vegetative state (hereafter, the PVS patient) has played a central role in recent American bioethical discussions and in recent litigation involving bioethical issues. From Quinlan’ to Cruzan and Wanglie, some of the most important cases involving ethical issues at the end of life have involved PVS patients. Major American medical groups such as the AMA and the American Academy of Neurology have adopted important policy statements on the care of such patients, statements that have been followed by at least one European group.

I have always found this activity a bit of a mystery. There is, after all, a relatively clear consensus about decision-making at the end of life, a consensus embodied in such documents as a report from the President's Commission and a report from the Hastings Center.

The subject of physician efforts to limit care by unilaterally withholding particular therapies, even if the patient, or the family of an incompetent patient, wishes continued care, plays an increasingly prominent role in discussions of clinical medical ethics. Some providers have described a professional duty to define the futility of care, and to act on the determination of futility even in the face of the patient’s, or a surrogate’s, resistance. This aggressive stance has gained intellectual momentum and may be percolating down into clinical practice.

Given the history of the medical profession's diffident attitude toward patients’ rights and its reliance on well-meaning paternalism, the notion that doctors should determine futility and limit access to specific interventions must be carefully scrutinized. Indeed, the emergence of two other themes in health policy and ethics, in particular the living will/power of attorney initiative on the one hand and the open discussion of rationing care in Oregon on the other, tends to undermine the key rationales for physician control over futile care.

Some pharmacists who believe that abortion is immoral are troubled by the thought that they might be required to fill prescriptions for abortifacient drugs like mifepristone. Do pharmacists have the right to refuse to fill such prescriptions?

Questions about the rights of professionals have both moral and legal dimensions. I will assume—although this assumption is by no means axiomatic or uncontested—that the rights and responsibilities of persons in general and professionals in particular ought to be grounded in morality and not the law. For example, a person who breaks the speed limit to bring a critically ill friend to a hospital's emergency room violates the law, but may be morally justified in doing so. There is no legal duty to rescue a person in danger, but many moral communities hold that our moral duty of beneficence requires us to prevent harm to others, at least if in so doing we are not placing ourselves and others at great risk of harm.

In March, 1989, 12 physicians published an article on the provision of care to hopelessly ill patients. Unfortunately, many of the substantive points in that article received insufficient attention from readers because the authors call for appropriate, continually adjusted care for terminally ill patients was overshadowed by a portion of the document in which ten of the authors agreed that “it is not immoral for a physician to assist in the rational suicide of a terminally ill person.”

In June, 1970, Jack Kevorkian, a retired pathologist in Michigan, gained international media attention by enabling Janet Adkins, a woman in the early stage of Alzheimer's disease, to terminate her life with the help of his “suicide machine.” The features of the case were so unusual that physicians, ethicists, and attorneys in health law who were interviewed by journalists were unanimous in judging this particular act of physician-assisted suicide deplorable.

One key legal question on everyone's mind is whether RU 486 can meet the standards for Food and Drug Administration (FDA) approval for a drug indicated for abortion. It would seem that it can. Under the Food, Drug, and Cosmetic Act, a sponsor must show that a drug is safe and effective for its intended use. Efficacy must be demonstrated by substantial evidence, which means evidence consisting of adequate and well-controlled investigations, including clinical investigations by experts qualified by scientific training and experience to evaluate the effectiveness of the drug. If on the basis of the clinical trials it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed in the labeling, and if the drug is safe, the FDA will approve it.