The ethics of innovation for Alzheimer's disease: the risk of overstating evidence for metabolic enhancement protocols.

Medical practice is ideally based on robust, relevant research. However, the lack of disease-modifying treatments for Alzheimer's disease has motivated "innovative practice" to improve patients' well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients (clinical ethics); second, about the way in which data from new non-validated practice are communicated via the scientific and lay press (scientific communication ethics); and third, about the prospect of making new non-validated interventions widely available before more definitive testing (public health ethics). We argue that the authors of metabolic enhancement protocols for Alzheimer's disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer's disease.

How Can Law Support Development of Genomics and Precision Medicine to Advance Health Equity and Reduce Disparities?

There is growing recognition that the genomic and precision medicine revolution in health care can deepen health disparities. This has produced urgent calls to prioritize inclusion of historically underrepresented populations in research and to make genomic databases more inclusive. Answering the call to address health care disparities in the delivery of genomic and precision medicine requires a consideration of important, yet understudied, legal issues that have blocked progress. This article introduces a special issue of Ethnicity & Disease which contains a series of articles that grew out of a public conference to investigate these legal issues and propose solutions. This 2018 conference at Meharry Medical College was part of an NIH-funded project on "LawSeqSM" to evaluate and improve the law of genomics in order to support appropriate integration of genomics into clinical care. This conference was composed of presentations and interactive sessions designed to specify the top legal barriers to health equity in precision medicine and stimulate potential solutions. This article synthesizes the results of those discussions. Multiple legal barriers limit broad inclusion in genomic research and the development of precision medicine to advance health equity. Problems include inadequate privacy and anti-discrimination protections for research participants, lack of health coverage and funding for follow-up care, failure to use law to ensure access to genomic medicine, and practices by research sponsors that tolerate and entrench disparities. Analysis of the legal barriers to health equity in precision medicine is essential for progress. Progressive use of law is vital to avoid worsening of health care disparities.

Report of the Northern California Conference for Guidelines on Aid-in-Dying: definitions, differences, convergences, conclusions.

In September 1996, the Stanford University Center for Biomedical Ethics convened a conference entitled "Comprehensive Care of the Terminally Ill: The Northern California Consensus Development Conference for Guidelines on Aid-in-Dying." The regionally based, multidisciplinary conference gathered people from a variety of disciplines and diverse perspectives on physician aid-in-dying. This report documents important points of convergence, disagreement, and uncertainty that emerged from the conference and provides commentary on crucial issues: the definition of terminal illness, ensuring adequate palliative care, psychiatric challenges, coping with family pressures, the doctor-patient relationship, the managed care context, the role of ethics committees, and institutional challenges. Should physician aid-in-dying become a legal practice in California, the report will provide guidance to health care organizations, health professionals, and public policy officials engaged in local or state guideline or policy development.