Wendy K. Mariner

Business vs. Medical Ethics: Conflicting Standards for Managed Care

he increased competition for a share of the market of insured patients, which arose in the wake of T failed comprehensive health care reform, has provoked questions about what, if any, standards will govern new “competitive” health care organizations.’ Managed care arrangements, which typically shift to providers and patients some or all of the financial risk for patient Carey2 are of special concern because they can create incentives to withhold beneficial care from patient^.^ Of course, fee-forservice (FFS) medical practice creates incentives to provide unnecessary services, and managed care can avoid that type of harm.4 Still, as Edmund Pellegrino has noted, “managed care, by its nature, places the good of the patient into conflict with ... (1) the good of all the other patients served by the plan; (2) the good of the plan and the organization, themselves ...; and (3) the self-interest of the phy~ician.”~ These potential conflicts have sparked a small flurry of articles and conferences that examine the “ethlcs” of managed care.6 Participants in this discussion recognize the benefits of managed care, including its focus on disease prevention and health promotion (long overdue in American medical practice), its coordination of services based on the totality of a patient’s health needs (rather than on isolated responses to specific symptoms), and its ability to hold down premiums. Yet financial incentives to limit services may undermine managed care’s ability to achieve such benefits. Carolyn Clancy and Howard Brody distinguish good managed care organizations (MCOs), which they call “Jekyll care,” from “bad” organizations or “Hyde care.’” In their view, Jekyll organizations typically are well-established, nonprofit health maintenance organizations (HMOs), like Group Health Cooperative of Puget Sound and Kaiser-Per-

Risky Business: Setting Public Health Policy for HIV-Infected Health Care Professionals

An analysis of the restrictive proposals provoked by the case of Kimberly Bergalis and four other patients apparently infected with HIV during the course of dental treatment reveals that they resulted from an inability to evaluate appropriately the infinitesimal risk of HIV transmission from practitioner to patient. The proposals also resulted from an effort to create risk prevention policy without appreciating the distinction between regulating things or procedures, which have no human rights, and regulating people, who have rights that should not be infringed without serious justification. This analysis demonstrates that the proposed restrictive policies are not justified because they do nothing to prevent the spread of HIV, and they cause unnecessary and substantial harm to health care practitioners.

Rationing health care and the need for credible scarcity: why Americans can't say no.

With adequate cost containment unlikely in the foreseeable future, health care use will have to be curtailed, ideally with open and explicit criteria for equitably allocating resources or rationing. Yet, consensus on any such criteria appears remote because Americans cannot say no to health care. Americans may refuse to accept rationing for two reasons. The absence of any global limitation on health care resources may encourage patients to believe that health care resources are not scarce and do not need to be rationed. A belief in vitalism--that everyone is morally entitled to unlimited longevity and good health--may discourage setting limits on ones own care. Together, these characteristics may foster the belief that denials of health care services, especially by health insurers, are arbitrary or unfair refusals to pay for existing resources and not a necessary method of rationing scarce resources. If this hypothesis is true, Americans are unlikely to achieve consensus on any equitable allocation of health care unless they face an actual shortage (credible scarcity) of health care resources that makes it necessary to ration care.

Decision Making in the Care of Terminally III Incompetent Persons: Concerns about the Role of the Courts

There appears to be a growing trend among caretakers for patients who are terminally ill and incompetent to seek judicial authorization of decisions concerning such patients’ care and treatment, especially when such decisions may shorten or prolong a patient’s life. Ironically, this trend is occurring at the same time that physicians, nurses, clergy and others decry judicial involvement in the decisionmaking process. There have been several major court decisions concerning the rights of incompetent patients and procedures for making treatment decisions on their behalves and countless obscure decisions that remain unpublicized in the records of court clerks. One would think that, in the seven years that have passed since the Supreme Court of New Jersey issued its opinion in the case of Karen Ann Quinlan, society might have reached some consensus about how to make decisions concerning the treatment of terminally ill incompetent patients. Yet the controversy over who should make decicions rages on, with the greatest furor provoked by the issue of whether the courts should play any role and if so, what their role should be. Professor Charles Baron has argued persuasively that ideal of the judicial adversary proceeding is the only procedure that can protect an incompetent person from euthanasia by assuring a “detached but passionate investigation and decision” (Baron 1978, 1979, 1981). Dr. Arnold Relman has disagreed strongly with what he termed the “judicialization” of such decisions, claiming that treatment decisions properly belong to the physician or health care team, perhaps in consultation with the patient’s family (Relman, 1978a, 1978b). Yet few authors have advocated vesting the courts with exclusive authority for treatment decisions (Brant, 1981; Kindregan, 1977). When a patient is critically or terminally ill and the “treatment”-maintenance on a respirator, chemotherapy, or the insertion of a nasogastric tube-will merely prolong the inevitable process of dying, the decision is fraught with intense moral and psychological tension. We seem to feel uneasy with allowing such personal decisions to be made in the glare of courtroom publicity.

Problems with employer-provided health insurance--the Employee Retirement Income Security Act and health care reform.

Health care reform is in the wind. As the nation prepares for a new presidential term, a more equitable and cost-effective health care system is beginning to sound inevitable.1 But the shape of tha...

Can Congress Make You Buy Broccoli? And Why That's a Hard Question

The continuing uncertainty over the constitutionality of the Affordable Care Act, illustrated by conflicting trial court rulings and scholarly commentaries, raises the question of why this constitutional question is so hard to answer. There are at least four reasons.

Taking informed consent seriously in global HIV vaccine research.

In 1997, the New York Times front page featured a report about women who had participated as subjects in a research study of zidovudine to prevent perinatal HIV transmission in Ivory Coast. Many were confused about research. One woman believed that she received medicine to cure malaria, fever, or AIDS. Another said, “If scientists say that it has to be this way, then I can only agree with them” (1). Did these women understand what the study meant or what they were doing? If not, would they still have agreed to participate if they fully understood the study’s implications? Will they distrust research in the future? We simply do not know, because no valid and reliable method was available to ensure the subjects’ voluntary, informed consent. The process of obtaining human subjects’ consent to participate in research generally is developed on an ad hoc basis for each research study (2). This ultimately haphazard approach to consent is no longer tenable in the face of heightened public awareness—and federal regulatory sanctions—of recent research scandals, both in the United States and abroad (3–6). The good news is that a positive, effective response appears to be within reach. There is a growing body of empirical research on subject comprehension of information about research studies (7–11). The next step, I believe, should be to develop a valid and reliable methodology to ensure the voluntary, informed, and understanding consent of research subjects (I use the terms subjects instead of participants for clarity, to distinguish those who participate as the subject of analysis from those who participate as investigators and analysts, for example). The study by Coletti et al. in this issue (12) represents a new milestone in progress toward this goal. It demonstrates not only that it is possible to implement an informed consent process that most people can understand, but also that informed subjects are not disproportionately scared away from vaccine trials to prevent HIV infection. Most important, it provides the seed for developing a methodology for an effective consent process—as an essential component of well-designed, ethical research. It is time to take that step for all HIV vaccine trials, both here and in the developing world, where phase 3 efficacy trials will be conducted. After years of alternately promising and disappointing results, several vaccine candidates to prevent HIV infection are poised for testing in clinical trials of efficacy (13) (summaries of clinical trials of investigational HIV vaccines can be found at www.clinicaltrials.gov, www.niaid.nih. gov/vrc/clintrials/clin_current htm, and at www.hvtn. org.trials.) This means that formerly hypothetical questions about how to obtain consent to participation in HIV vaccine clinical trials must now be answered—correctly and soon—if we are not to waste the chance to find a safe and effective means of preventing HIV infection.

Why clinical trials of AIDS vaccines are premature.

Considering the current state of scientific knowledge and the fact that no relevant animal model exists for demonstrating a vaccines probable efficacy, the fundamental prerequisites for testing experimental AIDS vaccines in human beings have not been met. The ethical obligations of informed consent, patient confidentiality, and the balancing of risks and benefits are examined in a call for more public debate on the issue before clinical trials are begun.

Limiting “Sugary Drinks” to Reduce Obesity — Who Decides?

A judge has struck down the New York City Board of Health partial ban on selling sugary drinks in containers larger than 16 ounces. Agencies that overstep their bounds invite backlash, the author writes, making meaningful public health regulation impossible.

Slouching Toward Managed Care Liability: Reflections on Doctrinal Boundaries, Paradigm Shifts, and Incremental Reform

The author recommends a test to clarify the classification of managed care liability disputes between tort claims, which should be decided in state court, and contract claims, which are preempted by ERISA. While others have recommended adopting new torts, such as a new fiduciary duty, to hold managed care organizations liable for their own wrongdoing, the author believes that we are likely to slouch toward liability, subjecting an expanding number of managed care functions and decisions to tort law principles, without fundamental change in underlying legal doctrine, and eroding (if not entirely eliminating) ERISAs preemptive effect on state law causes of action. This is because longstanding doctrine is more likely to endure (and evolve) than targeted statutory regimes like ERISA, so that where ERISA preemption is incompatible with fundamental principles of common law, ERISA is the more vulnerable to change.