America Living With AIDS

ceived of as having co-morbidities of
bleeding and liver disease are also
often excluded from trials. Such
exclusions should be carefully examined and the judgment of the person's
physician should be respected.
Prisoners' participation in clinical
trials has been hampered by a serious
confusion about the applicability of
federal regulations designed to protect
prisoners from experimentation abuses. Many have assumed that human
subject regulations and prior ethical
analysis all but preclude prisoners'
participation as clinical trial participants; commentators have interpreted
these regulations to preclude only
prisoners' participation on the placebo arm of clinical trials. Practical considerations also pose formidable barriers for prisoners. It is difficult to
ensure voluntariness and informed
consent in the prison setting. Clinical
researchers in academic and community settings may find the regulatory,
ethical, and logistical stumbling blocks
too daunting even to attempt
enrolling prisoners in trials.
Concerns about research in correctional facilities, discussed in the Commission's Fourth Interim Report, warrant close attention because of the
increasing number of people living
with HIV in correctional settings. The
Commission reiterates its recommendation that the Department of Health
and Human Services should issue a
statement clarifying the federal policies on prisoners' access to clinical trials and investigational new drugs. In
addition, FDA, in conjunction with
HRSA and NIH, should initiate an

educational program directed toward
informing inmates and health care
professionals working in correctional
facilities of the availability of investigational new drugs, expanded access
programs, and applicable criteria for
eligibility of prisoners in prophylactic
and therapeutic research protocols.
WHO SHOULD PAY?
The question of who pays or who
should pay for experimental drugs and
treatments is still a topic of considerable debate. Many people with HIV
disease have significant limitations on
their private and public health insurance coverage, if they have insurance
at all. These limitations are typically
more severe in the coverage of experimental drugs. As new proposals to
expand access to experimental drugs
are developed, the debate over who
should pay is sure to continue to force
the government and private sector to
answer this question.
Traditionally, third-party payers
have required evidence of a drug's
safety and efficacy before routinely
providing coverage, often explicitly
denying coverage for experimental
treatments. Such an approach has a
profound impact on people with HIV
disease, for whom experimental treatments are frequently the only
recourse.

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