End-stage heart disease, high-risk research, and competence to consent: the case of the AbioCor artificial heart.

Some commentators believe that persons facing imminent death are incapable of making autonomous, informed decisions about whether to enter high-risk, end-of-life research trials. Using the AbioCor artificial heart trial as an example, this essay argues to the contrary. Although some people are incapacitated, many are capable of making such decisions. To forbid dying people to make a decision about whether to enter a clinical trial may insult deeply held personal values at a time when honoring those values may be most important. Moreover, to deny dying persons entry into high-risk clinical trials leaves ethically worse alternatives: using healthier people, requiring surrogates to decide even when the patient is competent, or simply forgoing all research featuring high-risk, potentially life-saving interventions. Once we agree that it is at least sometimes acceptable to permit dying persons to choose high-risk research, a number of practical safeguards can be implemented to ameliorate the challenges that can hinder decision making in this difficult area.

Consumer-defined health plans: emerging challenges from tort and contract.

The emergence of Consumer-Defined Health Plans with large deductibles means that many people will be financially responsible for all or most of their healthcare during any given year. This increasing exposure to costs will bring important changes in the physician-patient relationship, as patients seek more information about the care their physicians propose. Litigation can be anticipated in two areas. First, in tort law, informed consent claims may allege that providers failed to disclose the likely costs and medical importance of their care. Second, in contract law, patients may challenge the reasonableness of the prices they are charged. This Article explores potential causes of action in both areas. Ultimately, increasing transparency of pricing may lend greater rationality not only to pricing structures but also, it is to be hoped, to healthcare itself, as cost-worthiness of care assumes higher priority in medical decisionmaking.

Surgically implanted devices: ethical challenges in a very different kind of research.

Research on surgically implanted devices not only can raise issues familiar from drug studies, but also can raise special challenges. This article suggests some ways in which device trials can raise distinctive ethical issues. The AbioCor artificial heart trial is used as an example. Although this particular trial should not be deemed typical of surgically implanted device studies, it can highlight some particularly significant methodologic and ethical features.

Clinical trials litigation: practical realities as seen from the trenches.

Litigation involving human clinical research trials has escalated rapidly in the past few years. Whereas these suits raise many important theoretical questions, they also have important practical and human dimensions of which many people are unlikely to be aware until, by some unfortunate turn, they must live the reality. From the vantage of a fairly close view on one recent lawsuit, this article offers some ground-level observations and reflections that, it is hoped, may be of use to people in clinical research who might one day find themselves in a similar position.

Professionalism and clinical autonomy in the practice of medicine.

Professionalism in medicine requires a reasonable measure of freedom for physicians to determine patients needs based on their own judgment. However, because virtually every medical decision is also a spending decision, third-party payers concerned about rising health care costs have introduced cost-containment tactics that significantly limit physicians accustomed autonomy. In response, groups of physicians have filed class-action lawsuits against managed care plans, alleging causes of action such as fraud, breach of contract, extortion, and violations of federal RICO (Racketeer-Influenced and Corrupt Organizations) law. Such litigation may have merits, but it also faces significant obstacles, in part because the contracts involved may not actually have promised the broad measure of clinical autonomy that the physicians allege was promised, then denied. As physicians seek to restore and retain their professional autonomy, it will be important for them to be increasingly proactive in structuring or modifying the contracts under whose terms they practice as some physicians have successfully done.

The impossibility and necessity of quality of life research.

There are probably a number of reasons why the medical community pays surprisingly little systematic attention to quality of life, either in research or in clinical care. Possibly our society's fascination with high technology and the rescue of endangered lives has encouraged the medical profession to focus on acute care, where their interventions can bring dramatic results. And perhaps because such high-tech acute care requires great knowledge and skill, medical educators have not devoted as much time to educating students and residents about the more mundane matters of medicine. Another reason, on which I will focus here, is the fact that scientific research into quality of life is particularly difficult, methodologically. It does not lend itself easily to the crisp, clean answers for which we strive in basic science. It is "soft," inexact, not "hard." In this article I hope to explain why such research is indeed fraught with hazard. The scientists are attempting a task that is, in a profound philosophical sense, impossible. They have no direct access to the data they most need, and every method of validating their results is fundamentally flawed. Nevertheless, I will also suggest how we can fruitfully undertake such research and, equally important, why we must.