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When the Udall authorization Bill became an amendment to the Labor,
Health and Human Services General Appropriations Bill for fiscal
1998, a related amendment was inserted.  The latter was a request,
originated by Senators Bill Frist and Dan Coats, that the Institute
of Medicine (IOM) review how research priorities are set and research
funds allocated in the NIH and report back to Congress with
recommendations for improvement.  Senator Frist, an M.D., is
Chairman of the Senate Subcommittee on Public Health and Safety and
had been working on an NIH reauthorization bill.

The IOM reported its findings and recommendations in July of this
year in a document "Scientific Opportunities and Public Needs:
Improving Priority Setting and Public Input at NIH".  The report is
full of issues which I think deserve to be addressed by people who
are seriously concerned with PD funding.  The report may be purchased
from the National Academy of Science Press (1-800-624-6242), and it
can also be viewed and/or downloaded without charge via the National
Academy of Science web site www.nap.edu/readingroom.

In the hope of stimulating some interest in and responses to the
report, I will summarize and comment on a few of the points it
raises.  I hope I will be forgiven if at this point I oversimplify
anything.

The report describes the NIH funding context in which the Udall Bill
effort took place, with specific references to the bill itself.  It
also recommends avoiding disease-specific funding legislation and
proposes other mechanisms than Congressional disease-specific bills
through which disease-specific funding requests may be channeled in
the future.

The report refers to the NIH booklet "Setting Research Priorities"
(www.nih.gov/news/ResPriority/priority.htm) used by NIH in its
funding decisions. I found an excellent summary in Dr. Varmus'
statement before the Subcommittee on Public Health and Safety of May
1, 1997 (www.nci.gov/legis/varmus2.html).

One of a number of criteria is "public health needs," as indicated
for a disease by the number of people who have it, the number of
people who die from it, the degree of disability it causes, the
degree to which it shortens a normal, productive life, the economic
and social costs, and the degree to which it may spread.  A major
point in the report is that the NIH does not make adequate use of
disease burden data in setting priorities.

The IOM accepts all the criteria put forth by the NIH, but notes
that, especially in regard to meeting public health needs, the NIH
has no systematic method of applying the criteria.  Data on the above
named public health indicators is not gathered or analyzed
sufficiently, nor is there any written justification of funding level
in terms of these indicators using the data that does exist.  It is
not apparent just how the NIH uses its own criteria.  IOM recommends
a greater effort in gathering and using disease burden data.

Another point made in the report is the need for a mechanism to
receive input from the public into the priority setting process and
to resopnd to public concerns.  To achieve this the IOM recommends
creating a Public Liaison Office and a council of public
representatives, and creating public memberships in the existing NIH
advisory groups.  These channels of communication are proposed as a
preferable altenative to appeals to Congress, which should be made
only as a last resort.

After reading the report I have the following questions:

*  Will the IOM recommendations be taken seriously by Congress?

*  If so, is there a chance that the IOM recommendations will cause
Congress to not make appropriations for the Udall Bill?

*  In the light of this plus the unpopularity in Congressional
leadership circles of disease-specific legislation, does a stronger
case need to be made that addressing PD funding in the Udall bill is
justified as a last-resort measure due to a history of NIH not
providing sufficient funds?

*  Senator Frist is working on a NIH reauthorization bill.  Can we
expect to see many of the IOM recommendations incorporated into this?

*  What should the criteria for priorities be?

*  How would the recommended communication channels work in practice?

Phil Tompkins
Hoboken NJ
60/9