Responses to NIH-Specific Recommendations (Extracted from: America Living with AIDS)

#4 The National Institutes of Health should develop a formal
mechanism for disseminating state-of-the-art treatment
information in an expeditious and far-reaching manner.
The NIH agrees that rapid dissemination of results of
clinical trials and state-of-the-art treatment information
is critical to the clinical management of HIV-infected
individuals. The report notes the programs and recent
efforts of the NIH to facilitate and accelerate the
dissemination of information, including the January 1991
workshop to develop guidelines. The NIAID is currently
developing internal policy for the dissemination of
information resulting from NIAID-sponsored clinical trials.
The development and dissemination of "standard of care"
guidelines would involve the efforts of several PHS agencies
and private organizations. In line with discussion and
recommendations of the NIH AIDS Program Advisory Committee
and the NIAID AIDS Research Advisory Committee, the
Director, NIH has requested the leadership of the National
AIDS Program Office in coordinating this activity, and we
understand that the issue is to be discussed at November
meetings of the PHS Executive Task Force and HIV Leadership.
#5 The Department of Health and Human Services should conduct a
study to determine the policies of third-party payers
regarding the payments of certain health service costs that
are provided as part of an individual's participation in
clinical trials conducted in the development of HIV-related
drugs.
This issue has been of interest to the NIH since June of
1989 when it was first discussed at a meeting of the NIH
AIDS Program Advisory Committee (APAC). It was subsequently
raised at two additional meetings, most recently in April
1991. In addition, it has been raised during Congressional
hearings by Mr. Weiss in August 1991 and again in March
1991. As a result of these discussions, the NIH has in turn
raised the subject for discussion at meetings of the PHS
Executive Task Force and HIV Leadership, and has recently
proposed a small working group of NIH and HCFA staff to
discuss this issue as it relates to NIH-sponsored clinical
trials and HCFA programs and to identify problems and gaps.
The NIH is in the process of convening a meeting to be held
during this calendar year and to include appropriate
Congressional staff in addition to DHHS staff.