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AIDS patients' access to experimental drugs poses a serious medical and ethical dilemma, physicians and policy analysts said last night at a Kennedy School of Government forum.
Most experts agreed that medical responses to the epidemic have been handicapped by the conflicting needs to distribute drugs quickly and to maintain safety standards.
But one panelist, Martin Delaney, the head of an AIDS information program called Project Inform, said the government should allow AIDS patients to determine for themselves what risks they are willing to accept when they take unapproved medications.
"Let us decide what risks to take," Delaney said, adding, "we should move the fulcrum to acceptance of risk on the patient's part."
But Ellen Cooper, a Federal Drug Administration (FDA) official, said that while "no one argues against the principle of individual autonomy," her organization must consider certain ethical and scientific realities before it can make experimental drugs widely available.
Cooper said that when the FDA reviews applications by drug companies to test and develop new drugs, the government organization tolerates more risk with AIDS drugs than for other newly-developed medications.
Panelists also were divided as to whether grass roots programs or large-scale government efforts are more helpful to AIDS research.
Delaney said community-based research programs have some advantages over official government-funded research, explaining that "the groups are unencumbered by the endless nitpicking and rivalry between researchers."
But Jerome Groopman, a doctor at New EnglandDeaconess Hospital, said he questions the methodsused by community groups. He said that communitygroups, unlike government agencies, may not takeinto consideration the necessary legal, scientificand ethical ramifications of their research.
The fourth speaker, Daniel Hoth, and AIDSspecialist from the National Institute of Allergyand Infectious Diseases, found a middle ground,saying that while community groups have had somesuccess, he feared their experiments may not havebeen properly controlled and conducted.
The four-person panel, entitled "AIDS DrugTrials: Racing Against Time," was the second in aseries of monthly discussions sponsored by theHarvard AIDS Institute. About 150 people attendedthe presentation, which was moderated by Dr.Deborah Prothrow-Stith, the former Massachusettscommissioner of public health
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