Clinical trials as treatment option: Bioethics and health care disparities in substance dependency

• Published in: Social science & medicine (1982) Vol. 69; no. 12; pp. 1784 - 1790
• Main Authors: Timmermans, Stefan, McKay, Tara
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.12.2009; Elsevier; Pergamon Press Inc
• Series: Social Science & Medicine
• Subjects: Addiction; Bioethical Issues; Bioethics; Biological and medical sciences; Clinical trials; Clinical Trials, Phase III as Topic - ethics; Conflict of Interest; Drug abuse; Drugs; Ethics; Health care; Health Services Accessibility - ethics; Healthcare Disparities; Human subjects; Humans; Interviews as Topic; Medical research; Medical sciences; Medications; Methamphetamine; Miscellaneous; Pharmaceutical industry; Primary care; Public health. Hygiene; Public health. Hygiene-occupational medicine; Randomized Controlled Trials as Topic - ethics; Research Design; Research Ethics; Research Subjects - psychology; Researcher-Subject Relations; Social research; Substance Abuse; Substance dependency; Substance-Related Disorders - therapy; Teaching. Deontology. Ethics. Legislation; U.S.A; United States; United States of America; USA; USA Clinical trials Pharmaceutical industry Human subjects Research ethics Substance dependency Bioethics; United States; North America; America; United States > US; Human subjects; USA; Substance dependency; Clinical trials; Bioethics; Research ethics; Pharmaceutical industry; Human; Social Inequality; Care; Ethics; Treatment; Scientific research; Dependence; Clinical trial; Social medicine; Public health
• ISSN: 0277-9536; 1873-5347; 1873-5347
• DOI: 10.1016/j.socscimed.2009.09.019

Bioethicists have warned against the dangers of mixing research with treatment. They are concerned that research priorities may take precedence over individual patient needs and that research subjects tend to misunderstand the purpose of research or overestimate the direct medical benefits of participating in studies. Yet, other work has questioned whether clinical research can always be separated from therapeutic benefit for participants. Using in-depth interviews with participants in two phase III randomized U.S. clinical trials for methamphetamine dependency, we examine the treatment options available to participants, their experiences with participating in the trials, and potential problems of trial participation. We find that while participants have experience with four alternative treatment modalities – quitting alone, support groups, in-patient treatment facilities, and consulting primary care physicians – the randomized clinical trials compare favorably to alternatives because they provide access to evidence-based behavioral treatments, specialized medical professionals, non-judgmental staff, and the possibility of receiving an experimental drug. We conclude that while randomized clinical trials are imperfect substitutes for clinical care, they constitute a fragile and sporadic therapeutic niche in a country with fundamental problems in access to health care, a mixed punitive-therapeutic drug addiction policy, and a profit-driven pharmaceutical development and approval process.