Can Science Survive Research by Quota?

Article excerpt

IN THE REALM of public health, it is one thing for Congress to target diseases for special study--breast cancer and AIDS are two examples. It is quite another for politicians to dictate how scientists must do their work. Nonetheless, that is the unprecedented thrust of the "Clinical Research Equity for Women and Minorities" provision, enacted in 1993 by Pres. Clinton and implemented in June, 1994.

Under the bill, Public Law 103-43, Section 492B, the National Institutes of Health (NIH) was mandated to develop guidelines ensuring the involvement of women and minorities in clinical research to compensate for years of their actual and perceived under-representation. This is a seemingly laudable goal, but the guidelines, entitled "Inclusion of Women and Minorities as Subjects in Clinical Research," hardly guarantee an equitable distribution of medical breakthroughs. If anything, the inclusion policy--which is steered by a political, rather than a medical, agenda--likely will result in fewer breakthroughs.

Three years ago, the Congressional Women's Caucus tried its hand at "research methodology," the academic discipline concerned with systematic evaluation of experimental therapies. Undeterred by its collective lack of formal credentials, the Caucus entered this arena-properly reserved for professional researchers and statisticians--and called for the specific inclusion of minorities and their subpopulations in NIH-funded clinical research to determine "whether variables [treatments] being studied . . . affect . . . minority groups differently than other [read: white male] subjects."

This sounds innocent enough, but it's not. Wholesale inclusion of minority groups--defined as black, Hispanic, Asian/Pacific Islander, and American Indian/Alaskan Native--makes little sense unless reason exists to expect that different groups will respond differently to particular treatments. For instance, a researcher would need to hypothesize that aspirin would be more or less effective in attenuating neurological complications of stroke in blacks than in, say, Asians.

It should be noted that the guidelines do acknowledge exceptions to the inclusion rule, as when a particular disease under study clearly is limited to a specific minority. A good example of this is sickle cell anemia, which only affects blacks. However, relatively few conditions confine themselves so neatly to a single group. Consequently, most investigators likely will be compelled to search far and wide for minority research subjects even in places like New Hampshire, locales with a relatively homogeneous demography.

That aggressive recruitment efforts cost time and money is irrelevant, according to the law, which reads: "the costs of such inclusion in the trial is not a permissible consideration" for exclusion. Simply sprinkling a few minority participants into the subject pool won't help either because the detection of group-based differences in treatment response requires threshold numbers of subjects be entered into each group. If there are not enough subjects per group, statistical results will be invalid and conclusions about treatment effect impossible to draw.

Furthermore, by the time a diligent researcher has ensured that adequate numbers of minorities participate, including the required members of subpopulations--among them, Cuban, Puerto Rican and Mexican Hispanics, African and Caribbean blacks, Chinese, Korean, Indian, Samoan, Vietnamese, Japanese Asians, American Indian ("please specify tribe"), and Alaska Eskimo and Aleutian Natives--the size and subsequent price tag of his or her grant proposal study will skyrocket.

When the inclusion policy was considered by Congress in 1992, Bush Administration officials denounced diversity-driven research. NIH director Bernadine Healy warned lawmakers that the new research requirement would have "grave implications" affecting "the design of all clinical studies despite the fact that no important differences across racial/ethnic groups are expected for most clinical questions. …