Last month, a fifty-eight-year old man developed bleeding into his cheek and oozing from sites where previously he had had blood samples drawn. This bleeding was caused by disseminated intravascular coagulation, a complication of colon cancer that had spread to his liver and lungs. This complication occurred even though he was on chemotherapy for the cancer. In the hospital, he received transfusions and was administered medicine to stop the bleeding. However, his condition did not improve. He developed more bruises. When he tried to go to the bathroom without assistance, he fell, struck his head, requiring stitches, and developed a black, swollen eye. The patient, a successful businessman, had already overcome another type of cancer—lymphoma—through chemotherapy, twenty-five years ago. In a few days, this dynamic individual who expected to start experimental chemotherapy now saw his quality of life deteriorate steadily.

We talked about more chemotherapy, about hospice, and about withholding attempts at resuscitation if his heart should stop.

Physicians have long aided their patients in dying in an effort to ease human suffering. It is only in the nineteenth and twentieth centuries that the prolongation of life has taken on new meaning due to the powers now available to physicians, through new drugs and high technology interventions. Whereas earlier physicians and patients could readily acknowledge that nothing further could be done, today that judgment is problematic.

Most often, aiding the dying took the form of not doing anything further to prolong life. Morally, this act of restraint was not difficult, because few options could have been considered. However, some physicians, rarely, would help patients die either by hastening death directly or by increasing pain control with the risk of hastening death, the so-called double effect. When directly hastening death, physicians either directly caused the death of the patient through euthansia, or supplied the means to the patient to bring about death with or without encouragement to use these means. The latter is physician-assisted suicide (PAS).

The legal treatment of physician-assisted suicide (PAS) is in flux. Reform has been impelled by several forces, including the recent success of novel constitutional arguments in the Ninth and Second Circuit Courts of Appeals. I will review and discuss Compassion in Dying v. State of Washington and Quill v. Vacco, addressing the constitutional arguments, and then briefly considering the attractions and difficulties of these new constitutional theories.

Before 1990, state criminal laws dealing with assisted suicide had reached a remarkably stable consensus: suicide was not illegal, but assisting suicide was a criminal action with no distinction typically made between physicians and others who assisted. The details of the relevant criminal law varied from state to state. Some states had criminal statutes specifically addressing assisted suicide, while others treated the practice under more general homicide statutes. But in no state was it clearly legal for a physician to prescribe a lethal medication at the request of a dying patient. While remarkable legal developments took place during the 1970s and 1980s regarding other aspects of the rights of dying patients (including the right to refuse resuscitation and other life-sustaining treatments and the right to withdraw from life-sustaining treatment including nutrition and hydration), there was relative quiescence regarding the law of PAS.

If the Supreme Court affirms either Compassion in Dying v. State of Washington or Quill v. Vacco, state legislatures will be presented with a new and unwelcome task: regulating physician-assisted suicide (PAS). This article focuses on the states task of specific policy making in light of the due process reasoning in Compassion in Dying and the equal protection reasoning in Quill. Policy makers must try to predict whether a particular regulation would in practice achieve its intended objective. They must also try to predict whether the regulation would survive constitutional review if challenged. Finally, they must consider the extent to which they could, or should, maintain two different regulatory regimes: a more permissive one for decisions to forgo life-sustaining medical treatments, and a more restrictive one for decisions to obtain a prescription for a lethal dose of medication. This last issue will be especially challenging if the equal protection analysis in Quill prevails.

The question of legalizing physician-assisted suicide (PAS) has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.

As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted.

With breathtalung speed, traditional criminal prohibitions against assisted suicide have been declared unconstitutional in twelve states, including California and New York. This poses great promise and great peril. The promise is that competent terminally ill patients, as a compassionate measure of last resort, will have the option of putting an end to their suffering by physician-assisted suicide (PAS). More sigmficant, legally permitting this controversial option may be a catalyst for doctors, health care institutions, and society to improve the care of the dying. PAS should be limited only to those relatively few competent patients who continue to suffer intolerably despite unrestrained efforts to palliate and who face a continued existence that they regard as worse than death. When dying patients know they will not be abandoned to miserable and pointless suffering if palliative care fails, they will be fortified to cope better with the process of dying.

The immediate peril is that PAS will become a quick fix, available on demand to any patient diagnosed as terminally ill, thus bypassing palliative care and producing premature deaths.

As I write, I hear that Dr. Jack Kevorluan has delivered another victim to the emergency room of his local Michigan hospital. Why do physicians and terminally ill patients feel we need to change the law with respect to assisted suicide when a rogue pathologist, who has been stripped of his medical license, is allowed to pursue his appetite for providing his clients with inhalation treatments of carbon monoxide gas? If no court will convict this outlaw, what makes the physicians and patients who brought Compassion in Dying v. State of Washington and Quill v. Vacco fear that any court would ever convict a licensed physician of assisting in a suicide when he/she writes one of her established patients a prescription for a short-acting barbiturate? Moreover, it is not even clear that laws against assisted suicide in most jurisdictions were ever intended to apply to the actions of licensed physicians. Nonetheless, the plaintiffs in the Second and Ninth Circuit Courts of Appeals were clearly seeking some kind of redress, some kind of protection from potential legal claims they feared might be made against them.

Nursing prides itself on a commitment to caring for patients and their families. Daily, nurses support patients and their families as they face life-threatening disease and injury and help them through the painful decisions to initiate or remove ventilators, artificial nutrition and hydration, and other life-sustaining technology.

The opinions of the Second and Ninth Circuit Courts of Appeals, in Compassion in Dying v. State of Washington and Quill v. Vauo, strike at the heart of the nursing value system. If the United States Supreme Court upholds either opinion, physicians will be legally allowed to help patients die, and nurses will be called on to assist with this process, just as nurses have assisted with electroconvulsive treatment, abortion, and other controversial procedures. Advanced practice nurses (APNs), who are licensed to prescribe drugs, may also be allowed by law to assist patients to end their own lives.

The use of statistics in medical research has been compared to a religion: it has its high priests (statisticians), supplicants (journal editors and researchers), and orthodoxy (for example, p <.05 is significant). Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical and scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues.

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration (FDA), to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.

In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration.

The debate about the definition of scientific miscon duct is being revisited by the scientific community in response to the Commission on Research Integrity's (CRI) recommendation for a new definition. Scientists and lawyers are debating whether scientific misconduct should include acts that are not unique to the scientific community and do not affect the research. Falsification of credentials is one form of such misconduct.

The Office of Research Integrity (ORI) and the National Science Foundation (NSF), the two federal agencies primarily responsible for developing policies on scientific misconduct, have struggled to define scientific rnisconduct and to decide which forms of professional misconduct do and do not fall within the definition. Although falsification of credentials is not unique to the scientific community, OR1 and NSF have determined that when researchers lie about their credentials, such conduct may constitute scientific misconduct. The question is why this form of professional misconduct has been labeled scientific misconduct when it occurs in a research setting, and whether any distinction exists between this white coat crime and white collar crime.

The United States District Court of Kansas, in Gudenkauf v. Stauffer, Znc.(922 F. Supp. 465 (D. Kan. 1996), granted the defendants motion for summary judgment for the plaintiff's claims of pregnancy-related discrimination under the Americans with Disabilities Act (ADA) and the Family and Medical Leave Act of 1993 (FMLA), but the court denied a similar motion for the plaintiff's claim under the Pregnancy Discrimination Act (PDA). The court found summary judgment to be appropriate for the ADA claim based on its finding that the plaintiff's pregnancy did not constitute an impairment as required by the statute; as for the FMLA claim, it determined that the defendants failure to grant the plaintiff's leave request did not violate the statute. However, the court determined that summary judgment was inappropriate for the PDA claim because of material questions of fact about whether the defendant had acted with discriminatory intent.

In considering the motions for summary judgment, the court accepted the following facts as incontrovertible. Plaintiff Michaela Gudenkauf worked for the defendant Stauffer, Inc.

The United Court of Appeals for the Eleventh Circuit, in Amstrong v. Flow ersffospital, Lnc. (33 F.3d 1308 (11th Cir. 1994)), held that a hospital's termination of a pregnant employee for refusal to treat an HIV-positive patient did not violate the Pregnancy Discrimination Act (PDA), based on either the disparate treatment or the disparate impact theory. As an employer, a hospital is not required to make policies specifically addressing the needs of pregnant employees and is not to be held liable for discrimination absent a showing of differential treatment based on the facial intent of employer policies or on actual impact through policy application. Hence, although women cannot be forced to decide between employment and pregnancy, they will not be afforded special treatment based on their pregnancy.

Pamela Armstrong worked for Southeast Alabama Medical Center (SAMC). After one year, Armstrong took a position with the Home Care Services (HCS) division of Flowers Hospital.

On July 3, 1996, in Jones v. United States(No. 93-20137, 1996 U.S. Dist. WL 382937 (N.D. Cal. July 3,1996)), the United States District Court for the Northern District of California held that plaintiffs in a wrongful birth action cannot recover costs or damages associated with the birth and upbringing of their daughter absent evidence of causation and proof to satisfy liability requirements. Plaintiffs scientific evidence regarding the alleged interaction between antibiotics and oral contraceptives did not satisfy the Daubertstandard (Daubert v. Merrell Dow Pharmaceuticals, Inc.,509 US. 579, 597 (1993) (remanded, Daubert v. Merrell Dow Pharmaceuticals, lnc.,43 F.3d 1311, 1315 (9th Cir.), cert. denied,116 S. Ct. 189 (1995))) for admissibility developed by the Supreme Court. In addition, the plaintiffs failed to meet their burden of persuasion on duty of care and causation.

On January 16, 1992, Karyn Jones went to a U.S. Army gynecologist, Dr. James Murphy, to obtain a prescription for birth control pills.

In the summer of 1979, a group of experts on law, medicine, and ethics assembled in Siracusa, Sicily, under the auspices of the International Commission of Jurists and the International Institute of Higher Studies in Criminal Science, to draft guidelines on the rights of persons with mental illness. Sitting across the table from me was a quiet, proud man of distinctive intelligence, William J. Curran, Frances Glessner Lee Professor of Legal Medicine at Harvard University. Professor Curran was one of the principal drafters of those guidelines. Many years later in 1991, after several subsequent re-drafts by United Nations (U.N.) Rapporteur Erica-Irene Daes, the text was adopted by the U.N. General Assembly as the Principles for the Protection of Persons with Mental Illness and for the Improvement of Mental Health Care. This was the kind of remarkable achievement in the field of law and medicine that Professor Curran repeated throughout his distinguished career.