Race,Money and Medicines

Roberts D. E. , “Legal Constraints on the Use of Race in Biomedical Research: Toward a Social Justice Framework,” Journal of Law, Medicine & Ethics 34, no. 3 (2006): 526–534.

Cohn J. N. , “The Use of Race and Ethnicity in Medicine: Lessons from the African-American Heart Failure Trial,” Journal of Law, Medicine & Ethics 34, no. 3 (2006): 552–554.

Bhopal R. , “Race and Ethnicity, “Responsible Use from Epidemiological and Public Health Perspectives,” Journal of Law, Medicine & Ethics 34, no. 3 (2006): 500–507.

This, of course, isn't necessarily true in a quantitative sense: what has happened is not an indicator of the probability of the thing happening again, absent a sufficient number of similar past scenarios to make prior occurance statistically meaningful.

Kahn J. , “How a Drug Becomes ‘Ethnic’: Law, Commerce, and the Production of Racial Categories in Medicine,” Yale Journal of Health Policy, Law & Ethics 4 (2004): 1–46.

Indeed, it once was, with disappointing results, achieved years before the current, state-of-the-art drug treatment for heart failure (an angiotensin converting enzyme (ACE) inhibitor) became standard. BiDil in conjunction with an ACE inhibitor has never been studied in a multi-ethnic population.

From a patent law perspective, BiDil's developers could have chosen a racial or ethnic group other than African-Americans. In this issue, the BiDil patent holder, Jay Cohn (who licensed his intellectual property rights to NitroMed, the drug combination's developer), summarizes the BiDil investigators' scientific rationale for selecting African-Americans. Cohn , supra note 2.

Bloche M. G. , “Race-Based Therapeutics,” New England Journal of Medicine 351 (2004): 2035–2037.

See generally, Avorn J. , Powerful Medicines: The Benefits, Risks, & Costs of Prescription Drugs (New York, N.Y.: Knopf, 2004) (reviewing the pharmaceutical industry's responses to market and regulatory incentives).

Reichman J. , unpublished manuscript on file with author.

Conflicts-of-interest arising from relationships with pharmaceutical and biotechnology companies have become a matter of controversy for NIH-employed scientists as well as for researchers who receive regular funding from NIH's extramural grant programs. See Kassirer J. , On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health (New York, N.Y.: Oxford University Press, 2004). These conflicts present serious problems, but the problems would be even greater absent a large, dependable flow of funding allocated in non-commercial fashion by NIH's peer review system.

This approach would fit well with more robust FDA efforts to induce drug makers to track prescription-related adverse events after the agency approves new medicines.