function (the affected cell in CGD) failed to show any improvement. In contrast, a recent large clinical trial (Cardiac Arrhythmia Suppression Trial) looking at prevention of sudden death due to cardiac arrhythmias after myocardial infarction (heart attack) was stopped when two agents (ecainide and flecanide) were found to suppress cardiac arrhythmias, but paradoxically, to lead to sudden death (Ruskin, 1989).

In addition to emphasizing the need to include in trials people whose clinical status is representative of all those with the disease, AIDS trials have also raised the issue of access to trials for groups that historically have been excluded (passively or actively) from participation, such as intravenous drug users, minorities, and women of childbearing age. Initially, AIDS trials almost exclusively enrolled white, middle-class gay men. These participants were, in general, better educated than average, usually well informed about treatment options, and able to enter and remain in trials. As AIDS increased among intravenous drug users and their sexual partners, advocacy groups began to argue not only for increased enrollment of these groups in trials, but also for the provision of social support services to enable participation, such as translators, transportation vouchers, and child care services. Advocates have argued that inclusion of a demographically representative group of patients is warranted not only for reasons of fairness (recognizing that for a disease with few options for licensed drug treatment, experimental trials are themselves rare), but also because drugs may have different efficacy or toxicity on demographically different patient groups.

Thus, arguments of justice and science have been put forth to support increased access. Trial sponsors and community leaders now publicly support this approach, but there is as yet little indication that groups other than gay men are entering trials in appreciable numbers. Indeed, the pragmatic obstacles to such participation are considerable. In a recent report, the National Commission on AIDS (1991:104) noted:

the difficulties in deciding who pays for health care associated with research vividly reveals the discontinuity in federal health programs. NIH-based researchers claim no jurisdiction over health care provision, and the federal agencies responsible for the reimbursement and delivery of health care, HCFA and HRSA, are not designing program strategies that would take these research-related issues in account.

NIH, charged with conducting drug trials, has no mandate or funding support to provide health care services.

There has been little research to explore the desire or capabilities of underrepresented groups to participate in trials. Some have argued that at least among African Americans, distrust of the medical system is so high and the collective memory of clinical trial abuses (as in the Tuskegee syphilis study) so strong that many people are actively opposed to participation



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