Another way to obtain the information necessary for racial and ethnic groups to benefit from pharmacogenomic testing would be government grants or programs that directly study racial and ethnic associations with drug responsiveness. If government may mandate inclusion of women and minorities in clinical research to ensure that their health care needs are met, then it may also fund research into the drug response profiles of African Americans or how they respond to particular drugs.
Congress took that approach in the 1993 NIH Reauthorization Act when it also created an Office of Women's Health and an Office of Minority Health Care. The Women's Health Initiative and Office of Women's Health resulted from a recognition that different factors may affect the health of women and men, that women have been excluded from much past clinical research, and that if their health needs are to be met, special attention to research on women is needed, for example, of the effects of estrogen replacement therapy on osteoporosis. This program does not constitute impermissible gender discrimination because men are not being denied research into diseases that they uniquely have, for example, prostate cancer. The purpose is to meet the health needs of a large group of the population that would otherwise go unmet.
Similarly, the Office of Minority Health Care should also be within the power of government. Past disparities in research and clinical funding have contributed to the great differentials that now exist between the health and health care received by whites and minorities. An Office of Minority Health Care attempts to address those problems, to serve the health needs of a major group of the populace that otherwise might go unserved. Neither creating such an office nor funding African American-only studies denigrates or hurts African Americans or denies anything to whites. The amount of money the Office of Minority Health Care has received is quite small, in fact, smaller than that received by the Office of Women's Health Care. Without such an office or research grants that focus on racial differences in disease or drug responsiveness, the health care needs of minorities may not be adequately served. The use of race as a surrogate for the unique health care needs of large numbers of the population thus serves the goal of equality in meeting the health needs of the population, which could not be met as effectively by other means. Given wide legislative discretion in spending for the general welfare, focusing some funding and research on the special needs of minorities should be constitutionally acceptable.
If so, it would also be acceptable to give a grant for study of a drug that is expected to work in a particular racial or ethnic group only. As noted above, African Americans with heart disease respond less well than whites to beta-blockers and ACE inhibitors, the main agents now used for heart conditions. An earlier clinical trial of Bidil, a drug that combines two ACE inhibitors with a nitrous oxide source, showed little beneficial effect on mortality for patients generally, including whites, but a subset of patients, all African American, seemed to have been helped. On the basis of this information, the FDA has agreed to a 2-year trial that will test Bidil and other drugs on 600 African American patients at 100 sites (Science Editors, 2001).
Such race-based research should be constitutionally acceptable. The situation is a variation on the issues underlying mandatory inclusion of women and minorities in clinical research. The government would be funding a study that only African Americans could enter, so a racial classification is involved. In this case whites are excluded because there is evidence that the drug will not work for them but may for African Americans. Because most studies for heart disease have included white patients, indeed, have disproportionately benefited them in the past, whites are not being disadvantaged by this instance of government funding of a study that focuses exclusively on a drug that might work in African American heart patients. Without the study, many African Americans may be left with few effective treatments for heart disease, when most whites can be treated with beta-blockers and ACE inhibitors. Nor are whites denied research funding, for there has been ample study of therapies that benefit whites disproportionately, if not exclusively.
Whether there will be sufficient funding for such studies depends on the NIH's and the public's commitment to improving the health care of minority populations, for example, its willingness to ask for and get budgetary support, and then awarding grants to researchers studying these questions. After a long disregard of the health needs of African Americans, there is now a willingness to fund more race-related research. With the large budget increases given to the NIH in recent years and the past neglect of minority health, even larger increases for minority health care should be acceptable. With wide discretion to spend resources to improve the general welfare, Congress and federal agencies may use race and ethnicity in research and treatment funding decisions when medical evidence shows that racial and ethnic differences affect health care.
E. FUND RESEARCH INTO DISEASES THAT
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