Phil - I do not have answers to your specific questions.  However, I have
had a good deal of experience with the interpretation NIH applies to
Congressional "direction," which I would guess is a level or two higher
than "urging" and a quantum leap from "request."

In any event, I am (I hope) including a copy of a letter I wrote to Zach
Halll regarding an August, 95 report by NIH in response to the "direction"
of the Senate Labor and Health and Human Ressources subcommittee in July,
94.  Well, not exactly "in response to" - but you'll see what I mean.

Kind of scary is the fact that NIH essentially disregarded the 1994
"Committee directs" language.  If NIH can disregard DIRECTION, what will
its response be to mere "urging" and "requesting?"

                                Bob Dolezal

                                ***********


June 11, 1996

Zach W. Hall, PhD.
Director, NINDS
Bldg. 31, 31 Center Drive  MSC2540
Bethesda, MD  20892

Dear Dr. Hall:

As promised in my letter of May 11, I am responding to the Parkinson's
disease workshop report you gave me at our May 8 meeting.

There are two sets of comments.  The first set responds to the instructions
to prepare the report given the National Institutes of Health by the Senate
Labor and Health and Human Services appropriations subcommittee in July,
1994.  The second deals with  the direction the report points for future
Parkinson's research.

If this is not the report "directed" by the committee, parts of this letter
have no relevance.  But since I asked you that question in my earlier
letter, and have not heard to the contrary, I assume it does represent the
defintive NIH response to the committee.

The Committee's Instructions

It is important to understand just what  the committee directed the NIH to
do, so I quote directly from the legislation.  The specific events or
products requested by the  committee are underlined for emphasis:

While there is compelling evidence to suggest that recent scientific
breakthroughs may open new avenues to understanding and treating
Parkinson's, the Committee is troubled that the disproportionately low
level of resources devoted to research in this field as well as the absence
of a coordinated research program will stymie efforts to capitalize on
those breakthroughs.  The Committee, therefore, directs that the National
Institutes of Health convene a consensus conference as soon as possible,
but not later than next year's hearings to develop a comprehensive plan for
a coordinated research agenda among the National Institute for Neurological
Disorders and Stroke, the National Institute of Aging, the National
Institute of Environmental Health Sciences, and others as appropriate. In
the interim, the Committee directs the NIH to reassess and increase its
commitment of resources to research on Parkinson's disease."

Hard as I look, I find no response to any of the committee's "directions"
in this report.

For starters, the report says merely that "Congress encouraged a research
planning workshop,"  somehow linking it to1995 being the midpoint of the
"Decade of the Brain."  No mention is made of it being a "consensus
conference" as directed by the Congress.

Nor is there any mention of the "comprehensive plan for a coordinated
research agenda," which was the single mission of the "consensus
conference."

Perhaps most troubling, rather than focussing on research to "capitalize on
recent scientific breakthroughs," as the committee directed, the report
says "workshop planners asked participants to suggest fundamentally new
ideas rather than strategies for achieving incremental advances."  That
suggests, instead of doing what the committee directed the NIH to do, that
workshop planners, I assume from the NIH, actually asked participants to do
the opposite of what the committee had directed.

The final direction from the committee was for the NIH "to reassess and
increase its commitment of resources to research on Parkinson's disease."
That hasn't  happened, either.  Data  from the NIH shows a lower estimate
for direct expenditures in FY96 than the actual direct expenses in FY95.

Direction of the Report

Even more unsettling is the apparent rush by the NIH to an unspecified
agenda of "basic research."   By asking for "new ideas rather than
strategies for achieving incremental advances" the NIH  relegates to the
back burner advancement in discrete therapies that may promise millions of
Parkinsonians a better life.

Indeed, the final two sentences of the document summarize a pessimistic
outlook on therapies and point to a future of "basic science" research:
"...Parkinson's is a complex disease and there is no definitive cure on the
immediate horizon.  Improved understanding of the underlying biology of the
disease will lead to better ways of relieving the symptoms of Parkinson's
patients and ultimately halting the underlying degeneration of brain
cells."

Taking your admonition at face value, that there is "no definitive cure on
the immediate Defining it is a continuous process, based on knowledge
obtained from all types of research.

Science may need to re-develop a definition of Parkinson's disease, and
obtain an "improved understanding of the underlying biology of the
disease," and "a basic understanding of pathogenesis ... to identify
practical biomarkers."   But Dr. Hall, if no definitive cure is on the
immediate horizon, isn't the allocation of already inadequte funds to a
"study the brain" strategy an abandonment of those currently suffering with
the disease, and millions more not yet diagnosed?

Why not intensify efforts into therapies which give promise of both
immediate relief and improved understanding of the total disease?   For
example,  the report has some negative conclusions concerning  "electrical
brain stimulation," which many view as a promising therapy, but offers no
indication that further research to develop improvements will be funded
through the NIH.

Can't much be learned from research in discrete areas such as electrical
brain stimulation, knowledge that will also spin off benefits in the
broader areas?

If this report is not the product of the consensus of the participants,
isn't a "plan for a coordinated research agenda" still needed?  Why not
reconvene - if live bodies are impractical, then by phone, FAX and e-mail -
the same group, with the  present report as a jumping off point.  A
consensus of experts in Parkinson's disease could actually result in a
coordinated, prioritized, comprehensive, goal-oriented research agenda,
responding to the Senate subcommittee's mandate.

Clearly, the above comments are mine alone, and not intended as a technical
scientific critique.  That must come from others, with vastly greater
knowledge than mine, and I fully expect that it will.  I trust, however,
that in the meantime you will respond to the issues I have raised.

                                                Sincerely,





cc      Sen. John McCain
        Sen. Jon Kyl
        Sen. James Exon
        Sen. Mark Hatfield
        Sen. Arlen Specter
        Rep. Ed Pastor
        Rep. Jim Kolbe
        Dr. Ole Isacson
        Dr. Erwin Montgomery





At 5:32 AM 7/28/98, Phil Tompkins wrote:
>Not all the links to the report from H.R.4274 within
>http://thomas.loc.gov appear to be active at this time.  If you
>start at http://thomas.loc.gov, then click on
>
>House and Senate: Floor Activities
>
>H. R. 4274
>
>Text of Legislation
>
>Link to House Committee Report 635
>
>you will find the report.
>
>I do not understand some of the passages or phrases in the report.
>
>> The Committee is encouraged by the initiation of a
>> core center program and urges NINDS to expand the program.
>
>What is the core center program?
>
>> In addition, the Institute is urged to utilize all other available
>> mechanisms, as appropriate, including requests for applications,
>> program announcements, and extended funding of selected
>> investigators now working in the field, to further implement the
>> 1997 Morris K. Udall Parkinson's Research Act.
>
>What is meant by "further"?  What has been implemented thus far?
>
>> The Committee requests NINDS to report on its progress in
>> implementing the Act at its fiscal year 2000 appropriations
>> hearing.
>
>Does the report have the same force of law as H.R.4274 will when it
>is enacted?
>
>Phil Tompkins