Terminal illness and access to Phase 1 experimental agents, surgeries and devices: reviewing the ethical arguments.

BACKGROUND: The advent of AIDS brought about a group of patients unwilling to accept crucial aspects of the methodological standards for clinical research investigating Phase 1 drugs, surgeries or devices. Their arguments against placebo controls in trials, which depended--at the time--on the terminal status of patient volunteers led to a renewed discussion of the ethics of denying patients with catastrophic illnesses access to last-chance experimental drugs, surgeries or devices. SOURCES OF DATA: Existing ethics and health policy literature on the topic of access to experimental drugs. AREAS OF AGREEMENT: The positions of those arguing for or against free access to experimental drugs for terminally ill patients are irreconcilable. AREAS OF CONTROVERSY: At stake are questions about the kinds of personal sacrifices society can reasonably expect patients in clinical trials to make to ensure statistically predictive results. These would benefit by necessity a much larger number of current and future patients--the conflict is about individual versus public interests. It is also about the question of whether or not the state can legitimately prevent patients with terminal illnesses from unfettered access to experimental drugs, surgeries or devices in order to motivate them to participate in clinical trials. We review the ethical arguments for and against the provision of access to Phase 1 agents for terminally ill patients. GROWING POINTS: Finding a compromise between providing free or no access to Phase 1 drugs for terminally ill patients. AREAS TIMELY FOR DEVELOPING RESEARCH: We ought to investigate means to increase access to experimental drugs for terminally ill patients without sacrificing necessary clinical trials' sounds scientific methods.