Trust and ethics in health care
Jennifer Miller contends that underprivileged people are targeted for unsafe studies . . .
by Jennifer E. Miller and Marie Catherine-Letendre
Gaps in trust and ethics continue to challenge the bio-pharmaceutical industry, providing fodder for the media and provoking chagrin from consumers — including concerns about the quality and accessibility of medicine, essential life-saving therapies and human research subject protections.
Curiously, despite the number of publicized breaches of trust and ethics, we’re in an age that demands excellence in health care ethics in developed countries. We’re also concerned that the poor in developing countries aren’t used solely as means to an end. Yet the practicality of articulating, ensuring, monitoring and evaluating excellence in ethical standards remains both a challenge and an opportunity.
A surmountable challenge in crafting biomedical ethical standards includes marrying ethical theory with real life practice. Ethics scandals by U.S.-based clinical researchers in the mid-20th century have been particularly well documented, including cases like the Tuskegee, Guatemala syphilis and Willowbrook studies. These studies have been criticized for their unethical treatment of traditionally vulnerable populations.
During this era, it wasn’t uncommon for established experts to conduct their federally funded studies with disadvantaged people. For example, Dr. W. Paul Havens Jr., a WHO viral disease expert and pioneering hepatitis research scientist, furthered his studies by exposing patients in mental institutions to hepatitis. Similarly, the man who invented the polio vaccine, Dr. Jonas Salk, conducted his flu vaccine clinical trials on Michigan state insane asylum patients in 1942.
Unethical research practices have not necessarily been ameliorated over the past two decades. In the mid-1990s, Johns Hopkins Medical School’s Kennedy Krieger Institute recruited 108 poor black families to live in lead-painted houses in East Baltimore to study pediatric retardation resulting from lead paint ingestion.
Some researchers claimed the study was justified because it provided the benefit of otherwise unaffordable housing to the research subjects. Many of these families subsequently reported that they were deliberately recruited into a study with inadequately disclosed foreseeable harms. At least one family’s children suffered learning disabilities and cognitive impairments.
While in Thailand last month, a doctor from a public clinic shrugged when I asked about the use of placebos. He said that on one hand his patients have little access to cancer drugs without enrolling in a drug trial, and on the other hand only half of the participants he enrolls will receive care in a placebo-controlled trial. Compounding the situation, paternalism in many countries can be common, prompting patients to defer to doctors without reading consent forms.
New and emerging ethical issues still challenge the industry. A 2007 Harris poll found that only 11% of the U.S. population believes pharmaceutical companies are “generally honest and trustworthy,” ranking barely above tobacco and oil companies. In the area of research, some 50% of white and 73% of minority respondents reported that it’s “very likely” or “somewhat likely” that they might be used as guinea pigs without their consent. Moreover, the industry’s role is often not well understood: Surveys suggest that about 70% of Americans “believe that drug companies are too concerned with profits and not concerned enough about helping people.”
To address these and other emerging ethics and trust challenges, I founded Bioethics International (BEI) in 2005 — and its initiative, the BEI World Council for Ethical Standards (WCES). This council comprises key stakeholders in health care, including doctors, academics, ethicists, patient advocates, senior company executives and former regulators. WCES is committed to the delivery of ethically responsible and trustworthy decision making and innovation in biomedicine.
WCES has been working to map a comprehensive set of ethical standards and assessment methods for ethical biomedicine. The work is now poised to invite large and small bio-pharmaceutical companies to enlist in a pilot program that combines ethical principles and theory with the corporate day-to-day practice of implementing policy, complying with regulations and laws, and respecting industry codes of ethics. The process also aims at a comprehensive understanding of how to pursue excellence in ethics in the biotechnology and pharmaceutical industries — as well as to identify strengths and opportunities for improvement.
This initiative is both timely and representative of the cultural changes in the health care sector. A culture of trustworthy innovation mirrors the words of Aristotle that “we are what we repeatedly do. Excellence, then, is not an act but a habit.” BEI’s initiative is committed to providing a practical tool to attain excellence because in matters of health and life, just enough isn’t good enough.
Jennifer E. Miller is the founder and executive director of Bioethics International. She co-wrote this article with Marie Catherine-Letendre, Religious Studies Department Chair at Marymount International School.