Rebecca Dresser

THE UBIQUITY AND UTILITY OF THE THERAPEUTIC MISCONCEPTION

The term “therapeutic misconception” was coined in 1982 by Paul Appelbaum, Loren Roth, and Charles Lidz. Appelbaum and his colleagues interviewed participants in several psychiatric studies, including a drug trial with a placebo control arm. Appelbaums group found that many people were unaware of the differences between participating in a study and receiving treatment in the clinical setting. Rather than understanding these differences, study participants tended to believe that therapy and research were governed by the same primary goal: to advance the individual patients best interests. Appelbaums group labeled this mistaken belief the therapeutic misconception.

First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless

The 21st-century translational science campaign could lead to an increase in first-in-human (FIH) trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: (1) the requirement for adequate preclinical research; (2) study design safeguards; and (3) choice of subject population. I also examine specific ethical considerations relevant to the three subject populations (healthy volunteers, seriously ill patients lacking standard treatment options, and stable patients) involved in FIH research. I recommend a variety of actions that could increase subject protection and the value of the information generated in FIH trials.

Quality of life and non-treatment decisions for incompetent patients: a critique of the orthodox approach.

Since the Quinlan’ decision in 1976, courts and legislatures have made substantial progress in defining rules to govern nontreatment of dying and debilitated patients. For example, the right of the competent patient to refuse necessary care is now widely established, and the legality of withdrawing respirators and even nutrition and hydration from permanently unconscious patients is increasingly recognized. More difficult questions arise, however, when the patient is neither competent nor permanently unconscious, but instead is in a conscious, severely demented and debilitated state, with experiences that appear quite limited. Thousands of patients in this condition are cared for in private homes, hospitals, and nursing homes, the victims of stroke, senility, Alzheimer’s disease, and other illnesses. Even though they usually require only low-tech, minimally supportive care, such patients can impose great stress on their families and high financial costs on the health care system. As the population of frail elderly and demented patients grows, determining the limits of family and societal obligations to sustain them has become a major ethical, legal, and policy issue. Its resolution requires balancing the importance of life in such compromised conditions against the social and familial burdens that prolonging such lives entails. A conflict between a patient-centered and other-directed approach inevitably arises, testing the scope of society’s respect for vulnerable and debilitated persons.* Unfortunately, the orthodox judicial approach to non-treatment decisions is not an adequate guide to resolution of these issues. Judicial analysis is too focused on the model of a competent person refusing treatment, even when the case involves a person who is incompetent and unable to choose. Although many of the decided cases have produced defensible results, the courts’ efforts to fit incompetent patients to the model of a competent decision-maker are seriously flawed and ultimately threaten harm to many incompetent patients. Courts, legislators, and physicians would do better to focus directly on the interests of the incompetent patient before them. Competing interests, such as family distress and financial costs, may then be directly evaluated and their role in such decisions properly assigned. Such an approach has the best chance of respecting incompetent persons, while giving due regard to the interests of families and society.

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

The Incompetent Patient on the Slippery Slope

Most patients suffering from progressive dementia have thoughts, emotions, perspectives, and perceptions of a world of experience. Decisions about life-sustaining treatment should incorporate a principled approach to evaluating what life is like for these patients.

Informed consent in emergency care: Illusion and reform

Many patients seeking care in the modern emergency center are capable of participating in treatment decision making. In the traditional emergency center consent process, the patient or a surrogate is asked to sign a general consent form purporting to authorize any treatment the emergency physician deems necessary. We discuss the ethical and legal inadequacy of this procedure. In addition, we present the results of a questionnaire assessing the comprehension of emergency center patients who participated in the general consent process. We found that few patients understood the purpose of the consent form and that patients in general had little understanding of their decision making authority. In light of our analysis and findings, we offer suggestions for improving the emergency center consent process.

Public advocacy and allocation of federal funds for biomedical research.

Members of Congress and officials of the National Institutes of Health face heightened pressure from public advocacy groups seeking more funding for research on specific health conditions. In response, Congress and the Institute of Medicine have urged the NIH to create more opportunities for the public to participate in decision making on allocation of biomedical research resources. The ethical and policy implications of including advocates in the deliberations are explored, leading to the conclusion that public participation could contribute to more defensible decisions under three conditions: public participants are fairly selected and meaningful opinions are solicited; public participants look beyond their narrow constituencies to consider the health needs of the broader public; and NIH officials develop materials to assist participants with their deliberations.

Stem Cell Research as Innovation: Expanding the Ethical and Policy Conversation

Research using human embryonic stem cells raises an array of complex ethical issues, including, but by no means limited to, the moral status of developing human life. Unfortunately much of the public discussion fails to take into account this complexity. Advocacy for liberal and conservative positions on human embryonic stem cell research can be simplistic and misleading. Ethical concepts such as truth-telling, scientific integrity, and social justice should be part of the debate over federal support for human embryonic stem cell research. Moreover, the debate should be conducted in accord with principles of deliberative democracy, including respect for people holding competing views.

When patients resist feeding. Medical, ethical, and legal considerations.

In the recent past, public and professional attention has focused on the question of whether and when it is appropriate to discontinue nutritional support from patients unable or unwilling to ingest food orally. This article addresses the special problems raised by patients who resist medical feeding. It discusses the following issues relevant to this patient group: competency to make treatment choices, decision making on behalf of incompetent patients, the competent patients right of self-determination, and procedures for reviewing treatment decisions. Legal decisions bearing on the nourishment question are analyzed as well. Although the author concludes that cessation of nourishment is morally and legally permissible in a few cases, she also cautions that the option should be carefully and narrowly applied.In the recent past, public and professional attention has focused on the question of whether and when it is appropriate to discontinue nutritional support from patients unable or unwilling to ingest food orally. This article addresses the special problems raised by patients who resist medical feeding. It discusses the following issues relevant to this patient group: competency to make treatment choices, decision making on behalf of incompetent patients, the competent patients right of self‐determination, and procedures for reviewing treatment decisions. Legal decisions bearing on the nourishment question are analyzed as well. Although the author concludes that cessation of nourishment is morally and legally permissible in a few cases, she also cautions that the option should be carefully and narrowly applied.

Subversive Subjects: Rule-Breaking and Deception in Clinical Trials

Research subjects do not always conform to research requirements. When their personal interests conflict with the demands of participation, some subjects surreptitiously break the rules. These subjects are subversive--they undermine the research endeavor. In rejecting the restrictions research imposes, subversive subjects diminish the value of research results. From one vantage point, subversive subjects engage in unethical behavior. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At the same time, subversive subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for subject subversion. Intensified policing and guidance are two common strategies for reducing subject subversion, but collaborative reforms are more consistent with the partnership model of clinical research.