At 5:28 PM 3/28/97, Camilla Flintermann wrote:
>Our Rep. John Boehner opposed "earmarking" of funds for SPECIFIC diseases
>last year--he didn't thing Congress "should tell the NIH what to work on "
>(!!!) He also argued that the FDA needed to be reformed so drug companies can
>get new drugs approved (and make money) sooner, than we'd get all the new
>meds we need, and not need money --eg=Udall.  We're trying to get an appt.
>with him now, but I'm not too hopeful of outcome.
>
>Camilla Flintermann, CG for Peter, 78/7, Oxford,Ohio
>[log in to unmask]
>*   *   *   *   *   *   *   *   *   *   *   *   *   *
>"Ask me about the CARE list for PD caregivers!"
>*   *   *   *   *   *   *   *   *    *   *   *   *

To Camilla, and to all:

This is a response to the "earmarking" issue.

What follows is an examination of the NIH review process for PD funding.

It begins with a letter to Sen. Kyl, arguing, among other points, the issue
of "earmarking."  It includes as well our subsequent letter to Dr. Hall
questioning the NINDS review process, and a short excerpt from his
response.

The letter to Dr. Zach Hall, attempts to demonstrate why "earmarking" is
needed for PD research.  Our data, and Dr. Hall's reply, points to a type
of discrimination - benign, perhaps, but terribly deleterious
discrimination nonethless - which faces PD researchers in the viciously
competitive world of medical research funding competition.




                        May 17, 1996

Senator Jon Kyl
702 Senate Hart Office Building
Washington, D.C.  20510

Attention:  Tom  Alexander, Legislative Aide

Dear Tom:

It was good meeting with you last week to seek Senator Kyl's support for
the Morris K. Udall Parkinson's Research and Education Act.  Your questions
were pertinent, and your request for additional cost savings data to
present to the senator was reasonable and valid.

I believe my responses are reasonable and valid as well.  I hope you share
that belief when you have finished reading them.

Population

We don't know the Parkinson's population in America.  No one has taken a census.

Nonetheless, for a number of years NIH consistently estimated the
Parkinsonian population of this country at 500,000.  Recently it has cited
"up to 1.5 million" as a  possibility.  Other analysis indicates even this
number may be below the true total.

Whatever the current number, as the "Baby Boomers" grow older the
Parkinsonian population will skyrocket.  Here is the Census Bureau's
numbers, with emphasis on the 55 and older population:

                                Pop.  55Yrs.      % of the Pop.         %of
Pop.55
Year    U.S. Pop.(mil.)         &Older(mil.)     Increase55&Up       &Older

1995            263.4                   54.9                    -
20.84%
2000            276.2                   59.0                  38.3%
21.36
2005            288.3                   65.9                  57.0
22.86
2010            300.4                   74.6                  71.9
24.83
2025            338.3                    102.6               73.9
30.33

Notice the increasing rate of growth projected in the "55 and older"
population.  Four years from now almost one-half of our population growth
will be "55&Older."   By 2010 almost three-quarters will be in that
category.

What is significant about age 55?  Fifty-seven is the average age of
diagnosis for Parkinson's.  As the growth of population in this age group
accelerates, the incidence of Parkinson's disease in America will also
accelerate.

A recent study in the New England Journal of Medicine presented pertinent
data on a sample of  East Boston residents over 65.  Applying data from
that study to the American population, an estimated 2.2 million Americans
over 65 have PD.  Also, the incidence of "Parkinsonism" would double every
ten years in that same age group.


Separately, Dr. Erwin Montgomery, a reknowned University of Arizona
neurologist specializing in PD, estimates some 2 million plus Americans
currently have PD.  By 2025, he projects a Parkinson's population at 3.7
million.

For this analysis, let's assume that some 3% of Americans over 55 are
victims of PD, recognizing that while this number may be somewhat high it
serves to compensate for the estimated 40% of PD patients who are under 60.

Costs


Total annual cost of the disease is said by NIH to be about $6 billion.  At
500,000 Parkinsonians, that's only $12,000 per patient, and at 1.5 million,
$4,000.  Either cost is fiction.

Dr. Ole Isacson, a noted neuroregeneration researcher at Harvard, estimates
that PD costs the nation between $31 billion and $56 billion annually.   On
a micro scale, in the early stages of a study designed and undertaken byThe
Parkinson's Action Network  to identify specific disease-related costs, the
average for fifty-two Parkinsonians  approximates $46,400 per person (see
the enclosed "Cost of Parkinson's' Summary").  For the sake of simplicity
and to be conservative, let's call it $40,000.

Applying the 3% incidence rate and a constant $40,000 cost per capita to
the growing American population over 55 through the year 2025, and the
numbers validate Dr. Isacson's estimates:

                Pop.   in   Millions            Cost in
Year            Over 55 w/PD            $Billions
1995            54.9            1.65            $65.9
2000            59.0            1.77                      70.8
2005            65.9            1.98              79.2
2010            74.6            2.24              89.5
2025              102.6         4.10                164.0

Whether these costs are met privately or through the government is only a
matter of bookeeping - they are ultimately borne by all of us.

Savings through Therapies

Delaying the severe symptoms of the disease through improved therapies will
save society considerable money.  Within one year of diagnosis the typical
PD patient loses his job.  And, odds soon double that he will fall, causing
increased disability, even his eventual death.

As the illness progresses, in spite of treatments currently available, he
loses more and more of the human capacities we typically take for granted.
When all therapies fail, he may go on, in a vegetative state, for many
years, imposing pain for family and friends and a financial burden on
society.  In the latter stages of the disease, if he can think, he can't
communicate those thoughts.  In fact, he can't do a thing for himself, not
a thing.  He is a prisoner encapsulated in a totally useless body and, most
cruelly, with a mind that may still work.

If Dr. Isacson and other specialists are correct, and new and improved
therapies are developed that alleviate symptoms or delay the disease,
immense savings will be achieved.

To illustrate, assume that, under Udall funding, savings would not begin to
accrue until the third year, and then would be rather modest booth in the
number of patients and per patient cost savings.  Even with this guarded
optimism, the outlook for a significant and early "return on investment"
from Udall funding is terrific.

If during the third year - because promising therapies now being developed
could be accelerated with additional funds - a mere one hundred thousand
people could stay on the job one additional year (average $18,200 each),
keep assisted living or a nursing home out of their lives for one year
(average $8,800), and not require any "'Dis/SSI/SS" (average $11,200) for a
year, savings of $1.82 billion, $.88 billion, and $1.12 billion,
respectively, would accrue to the national economy.

The projected $70.8 billion cost to the nation in the year 2000 would be
reduced by almost $4 billion in the third year of Udall funding.  That's a
return of $4 billion on $300 million - 13,333% - over three years.

Unrealistic?  Not at all!  The experimental drug I am taking has delayed my
departure for places unproductive for at least a few years.  It is clear
that, if the research dollars proposed under Udall are authorized,
appropriated and invested wisely, even an annual return of 13,333% may be
conservative!

Earmarking

Your explanation that the senator is not fond of "earmarking," and has
voted against measures on that principle, got my attention.

The Udall bill may be "earmarking,"  but if it is I'd like to point out
that it is so only because research in PD has been, and is to this minute,
so terribly underfunded.

As evidence, please look at the three enclosed graphs.  Graph 1 shows the
amount of NIH direct research funding in FY91, by disease, for six selected
diseases.  Graph 2 shows the incremental dollar increase in direct funding
in the FY95 budget over that in the FY91 budget.   Graph 3 shows the
percentage increase for direct research funds between those years, by
disease.

Parkinson's, with the tiniest base to start with, continued to see the gap
widen.  PD funding had the lowest  percentage increase among the six
diseases.  Last in FY91, a more distant last four years later!

And the per patient numbers are just as pitiful:  $26 for Parkinson's,
$1,069 for AIDS, $295 for cancer - but, I left that data with you.

If this doesn't show that we've been underfunded, too much and too long,
please tell me how to prove it.

Perhaps this condition is partially our fault - the Parkinson's community
has not done the effective job of lobbying, both in the Congress and with
the American people, that  needs to be done.

 Maybe it is because "people don't die from Parkinson's,"  a common
allegation even in medical circles, but seldom believed among friends and
family of a late Parkinsonian.

Or, maybe it is because Parkinson's has been indelibly ingrained in many
minds as a disease of stumbling old people whose time has come to fall by
the wayside.

I don't know.  But I do know that this sixty year old is not prepared to
cash in his chips.  Nor are the many superior people I met while in
Washington, most younger than I, who are courageously fighting this
insidious disease.  They, and I, have faith in the research  people who say
- not for self-aggrandizement but because they truly believe it - that  a
relatively insignificant infusion of funds would result in absolutely
monumental results, even a cure.

"Earmarking" may be the technical term that applies to the process, but
wouldn't "catching-up," or "equalizing,"  be a more accurate description of
the result?


(NOTE:  Since this letter was written to Senator Kyl, we sent the letter
found at the end of this letter to Dr. Zach Hall, NINDS director,
concerning the preponderance of PhDs in the NINDS review process for
Parkinson's funding, as well as the  lack of published documents on the
subject of Parkinson's disease by the committee members.  The jist of our
argument to Dr. Hall is "If the reviewers are not up to date in their
familiarity with the disease (and they are not, according to our research),
and don't understand the disease, how can they  appreciate the potential
the many PD applications may hold?

Dr. Hall did not refute, or even seriously respond to, any of the data we
submitted.  If I had a scanner I'd include his entire response, but it was
a "puff ball," wordy and non-responsive, technical, obtuse and conclusive
without furnishing data to support his conclusiveness.  A couple quotes
deserve mention, however:

1)   "I do not agree that Parkinson's disease is underfunded relative to
other diseases.  The NINDS has a rich and varied program in Parkinson's
research, one which we are very proud of."

2)  "Finally,  I am very pleased to inform you that NINDS funding for
Parkinson's disease research increased significantly in Fiscal Year 1996.
The total for the past year is $54,283,000.  This represents an increase of
approximately 10 percent from the 1995 level of $45,396,000.   Most of the
increase is in the "direct" category."

Are  you surprised?  Do  you think a senator's aide, or a congressman's
aide, can argue with this type of presentation?  Question is, can we?)

Other Data

Other pertinent information concerning the disease was left with you.  But
if there is anything lacking, anything at all that will help convince
Senator Kyl of the fiscal and human validity of our cause, we will do all
in our power to provide it.

I appreciate your time,Tom, and the genuine interest you have shown in our
request.  For the tens of thousands of Arizonans with the disease, and
their many caregivers and friends, I ask that Senator Kyl join Senator
McCain, and Representatives Kolbe and Pastor, to honor the man and his
legacy, and become a co-sponsor of the Morris K. Udall  Parkinson's
Research and Education Act.

                                                Sincerely,



The letter to Dr. Hall:
__________________________________________________________________

                        ARIZONA PARKINSON'S ADVOCATES
      A COMMITTEE OF THE AMERICAN PARKINSON'S DISEASE ASSOCIATION
                    5319 E CALLE BOSQUE, TUCSON  AZ  85718
          TEL. 520-299-1030    FAX  520-299-8795   E-MAIL [log in to unmask]
_________________________________________________________________

                                December 18, 1996

Dr. Zach Hall, PhD
Director, NINDS
Bldg 31, 31 Center Drive MSC2540
Bethesda, MD  20892-2540

Dear Dr. Hall:

        Thank you for speaking to us at AGENDA 97.   We are honored to be
the first local Parkinson's group to hear from you.

        Our only regret was that your visit with us passed too quickly.
With more time I am sure we would have covered many issues, particularly
related to Parkinson's research funding, that now  perplex us.

        As you already knew, and heard again, many in the Parkinson's
community believe research of the disease is terribly underfunded within
the NIH/NINDS structure.  Hence the push for the Udall bill.   Increasingly
they are also concluding that what funding is available is being directed
more toward "basic science," which offers little promise for those with the
disease,  rather than "clinical" research which could result in more
immediate improved treatments.

        Some attribute this conflict to the composition of the committees
within NINDS that  pass on the merits of  funding proposals.  They contend
that the committees are far less interested in clinical research, often
favored by investigators who are also "hands on" medical doctors and have a
greater involvement with Parkinson's patients,  and  more interested in a
search for "the underlying biology of the disease," more frequently
identified with PhDs.

        And, recently some have even questioned whether those reviewing
applications and determining the allocation of funds to Parkinson's
research are sufficiently aware of recent developments in the field to
assess  their merit vis a vis applications in areas with which they are
more familiar.

        The issue, then, is the validity of these beliefs.  From
information provided by your office concerning the Neurological Sciences
Program Project Review Committees, NSPA and NSPB, as well as from
"Medline," we have found that

        1)  there is  compelling evidence that PhDs vastly outnumber
medical doctors on these committees, resulting in a "basic science"
philosophy, and

        2)   remarkably few  members of the committees have written
remarkably little for publication on Parkinson's issues, reflecting a lack
of involvement in current Parkinson's research.

        >  Education and experience of the members

        As illustrated in the tables immediately below, a substantial
majority of the members of the NSPA and NSPB have not been medical doctors
experienced in dealing with hands-on problems of Parkinson's disease.
Non-medical doctors predominate the membership on the review committees.

        Based on education and experience alone - and no judgment is  made
questioning their ability or intentions -  the majority of the members are
simply underequipped to understand  the significant therapeutic benefits a
Parkinson's research proposal may hold for the ultimate consumer, the PD
patient.

        Here is the representation by degree status - MD, PhD, both, and
other - in the "A" and "B" Committees (lists from NINDS) over the last five
years:

                                "A" Committee (person years)
                        PhDs.           MDs             Both
Other (M.S.P.H.)

1995-96         9               5               1               1
1994-95         8               4               2               1
1993-94         9               5               1               1
1992-93         7               5               3               -
1991-92         8               5               3               -
Totals                  41              24
10              3

                                "B" Committee (person years)
                        PhDs            MDs             Both            Other

1996-97         10              5               1               -
1995-96         10              5               1               -
1994-95         10              4               2               -
1993-94         10              4               2               -
1992-93         11              5               -               -
Totals                  51              23              6               -

Combined Totals 92              47              16              3

Nearly twice the number of committee members were PhDs as compared with
MDs.   Even if we assume that all of those with "Both" degrees were more
inclined  toward a "hands on" approach, and added them to the MD total,
PhDs would still constitute the vast majority of proposal reviewers.



       >  Who  has written about Parkinson's?

        Very few.

        Using information supplied by your office, and from "Medline," we
identified  publications containing one or more of four terms -
Parkinson's disease, dopamine, basal ganglia, and motor control - any one
of which would trigger an examination of the abstract  to determine the
publication's relationship, if any, with the disease.

        The following table presents the numbers of publications published
by current members and past members (term expired during the period) of
both committees from 1992.  The first number is the total of all
publications written by committee members.  The second is the number
apparently related to Parkinson's  disease.  The percentage that PD
articles comprise of the total published is in parentheses.

                        "A"               "B"             Total
Current                 371 - 1         348 - 8         719 - 9
  Members               (.27%)          (2.3%)          (1.25%)

Past                    407 - 2         327 - 4         734 - 6
  Members               (.49%)          (1.22%)         (.82%)
                        _____            ______          ______
Totals                  778 - 3         675            1,453 - 15

                        (.39%)          (1.77%)         (1.03%)

Aside from Dr. Caroline Tanner's eight publication contribution on the
"Current B" committee, Parkinson's clearly is not a priority among the
sixty-two men and women who played such a critical role in distributing
scarce research dollars.

        Caveat , conclusions and request

        While it was undertaken with all due diligence, we do not claim
this analysis is without inadvertant error.  Also, we were unable to obtain
from your office the names of the "ad hoc" committee members, some of whom
may have provided some technical assistance in reviewing PD proposals.

        But it is difficult to conceive of any error or errors, or any "ad
hoc" committee representation, which could alter the obvious conclusion
that Parkinson's research specialists are underrepresented in this review
process.  Further, it strains credibility to believe that research
scientists who are predominantly not medical doctors, and who  specialize
overwhelmingly in areas other than Parkinson's research, could be capable
of reviewing funding proposals for Parkinson's with the same understanding,
appreciation and empathy with which they review applications in their own
areas of specialization.

        In light of the above, we would  appreciate responses to the following:

        1)  Would you please send us the complete description of the review
process(es)  for any research proposal from the moment it is received at
the NIH.

        2)  If not contained in the description, how are reviewers named?

        3)  If not contained in the description, what are the criteria used
to determine a proposal's "scientific excellence?"

        4) How are the relative continuing costs of diseases - health
costs, lost productivity, long-term care costs, etc. -  factored into the
review process?

        5)  Finally,  for the most recent  five year period, a list of the
members of any other committees that review and determine the fate of
Parkinson's funding proposals.

        Your review of and response to this data - and we sincerely
appreciate your offer to do so - will help the Parkinson's community
understand how the funding process works, and provide some insight into how
to better design our appeal  for additional funds for Parkinson's research.


        Again, thank you for taking the time and making the effort to be
here for  AGENDA 97.  We are confident that  the goal of our symposium -
"Researchers and advocates carry the torch" - will  be well-served by the
thoughts and suggestions you articulated during your brief stay.

                                                Sincerely,



                                                Robert L. Dolezal
                                                Chairman, Arizona
Parkinson's Advocates


cc      Morton Kondracke
        Joan Samuelson
        Paul Smedberg