Exploiting a Research Underclass in Phase 1 Clinical Trials

Authors

Carl Elliott, University of Minnesota - Twin CitiesFollow
Roberto Abadie, University of Nebraska LincolnFollow

Date of this Version

5-29-2008

Citation

The New England Journal of Medicine 358:22 (May 29, 2008), pp 2316-2317

Comments

Copyright © 2008 Massachusetts Medical Society

Abstract

In November 1996, the Wall Street Journal reported that Eli Lilly was paying homeless alcoholics from a local shelter to participate in safety testing of new drugs at its trial site in Indianapolis.1 “These individuals want to help society,” asserted Lilly’s director of clinical pharmacology. The subjects, however, said they took part for easy money and free room and board. Although Lilly reportedly offered the lowest per diem in the business, it managed to attract poor subjects from all over the country.1 The medical director of the local Homeless Initiative Program said Lilly had created a “shadow economy” of paid human subjects. Today, the Lilly episode seems like an early warning about an emerging set of ethical problems. Over the past decade, clinical trials have moved from universities to private testing sites, the pressure to recruit subjects quickly has intensified, and ethical oversight has been outsourced to for-profit institutional review boards (IRBs). Payment to subjects has escalated, creating “shadow economies” in cities throughout North America and elsewhere. In 2005, Bloomberg Markets reported that SFBC International, a contract research organization, was paying immigrants to participate in drug trials under ethically questionable conditions in a dilapidated Miami motel. A few months later, nine apparently previously healthy subjects at an SFBC subsidiary in Montreal contracted latent tuberculosis during a trial of an immunosuppressant. In 2006, six healthy subjects required intensive care in a phase 1 trial of a monoclonal antibody at a London facility run by the contract research organization Parexel. For all the ethical debate over these cases, however, few commentators have addressed the most troubling question: Is it ethically problematic to pay poor people to test the safety of new drugs?