2007 National Causus

The overall purpose of the Caucus is to provide our participants information on the
status of major issues relating to teaching and research in all basic science
disciplines of academic medical centers. These issue include contemplated changes
in the National Board examination procedures, adjustments in the operation of grant
application reviews by study sections, and discussion of plans in the enhanced
allocation of NIH funds for interdisciplinary and multi-institutional activities. An
important and major Caucus activity involves discussing with our political
representatives in the Senate and House of Representatives the shrinking NIH
budget which prevents taking full advantage of medical science break-throughs
which could improve the health of our nation.

We were briefed by colleagues from FASEB ( Dr. Howard Garrison) and the Coalition
for the Life Sciences (Lynn Marquis), Research!America (The Hon. John Porter and
Mary Woolley) and the AAMC (Elisa Siegel) in order to present a united front, with
non-conflicting requests, when we visit with members of Congress. Major points of
advice:

To let our representatives in Congress understand that, in spite of the tight
Federal budget, the NIH needs to sustain the momentum of new discoveries in
health research. This requires increases in the appropriation for the NIH, to
overcome the declining purchasing power over the past few years because of
inflation, which has negated previous generous increases for the NIH.
To demonstrate to our young people that there is a national commitment to
improve health through research, and to encourage the best and brightest to
enter careers in fighting and preventing disease.
To inform our political leaders about significant recent scientific
accomplishments in the fight against disease, many of which resulted from the
recent doubling of the NIH budget.
To stress the dependence on innovation in science and technology in the
future of the country’s economy and prosperity, including benefits in their own
local districts, and to explain that the cost of health research is amply repaid by
improved health.
To encourage scientists to continue communications with their political
leaders, but especially to make them aware of accomplishments in their own
districts, leading to local economic benefits.
and last but certainly not least, to thank our political leaders for their previous
NIH support.

We discussed these goals with the staffs of members of the House and Senate
including many of their leaders from both political parties, including some members
on NIH appropriations committees and others with special interest in the NIH. We
reiterated the need for the Congress to provide adequate budget increases for the
NIH, in spite of present federal financial pressures, and thereby maintain our
momentum of scientific discovery.

Our invited guests included presentations from Dr. Peter Scoles, of the National
Board of Medical Examiners, who discussed the contemplated modernization and
improvement of the Board examinations. He indicated that proposed modifications
would not be adopted imminently but would take several years, and would not curtail
basic science testing. Dr. Bruce Alberts, former President of the National Academy of
Sciences and now Editor of Science, provided his views on the necessary cross-
fertilization of ideas from different laboratories, encouraging the role of innovations
from individuals rather than mega-scientific groups, and the need for focusing on
doing research rather than writing (and rewriting) grant applications. Dr. Lawrence
Tabak reviewed the various modifications proposed to improve the functions of
study sections laboring under the insufficient NIH budget allocations. Suggestions
include promoting applications from new (i.e., previously unfunded) scientists,
rewarding outstanding senior reviewers for their intense efforts, shortening the size
of applications, reducing the requirement for amended reapplications, and
encouraging the submission of applications for truly transformative research. Dr. Al
Teich (AAAS) explained the federal research budget process and the relatively
limited funding available for discretionary federal expenditures which limits NIH
funding. Nevertheless, the U.S. supports health research more generously than
most other countries. He also emphasized the need to permit more generous
allocations for non-biomedical basic sciences which are required for biomedical
progress. Peter Farnham, ASBMB, presented data on the shrinking role of truly
unsolicited NIH R01 proposals in contrast to NIH-solicited projects . Dr. Alan
Krensky, the Director of OPASI, described efforts to broaden the NIH portfolio by
including special innovative grants, pioneer awards for transforming new research
ideas, multi-institutional CTSA awards and other Road-map approaches. There was
concern that with the constraints in the NIH budget a redistribution of dollars has
deemphasized more traditional research investigator- initiated programs. David
Moore (AAMC) mentioned that for FY2008 there may be a small additional allocation
for the NIH, but there was also a chance that a Continuing Resolution would delay any
consideration of budgets for the immediate future. For FY2009, once our political
direction has been clarified, annual 6.5% increases in the NIH allocation would help
restore the NIH purchasing power. Dr. Robin Robinson, Director of the newly formed
BARDA designed to anticipate public health catastrophes, is organizing for U.S.
preparedness by optimizing the availability of vaccines, drugs, diagnostics and
special equipment to minimize emergency problems. We also had the pleasure of
hearing Dr. Dora Hughes, of the Obama campaign, describe the Senator’s strong
interest in and understanding of health research which we thought was most
impressive. Senator McCain did not provide a spokesperson although requested to
do so.

The National Caucus of Basic Biomedical Science Chairs, comprised of presidents and other
officers of associations of chairs of the basic science departments of U.S. Medical Schools,
now completing its 17th year, held its annual meeting in the Department of Pharmacology &
Physiology, The George Washington University School of Medicine and Health Sciences,
Washington, D.C. Nineteen representatives attended, and there were three invited
participants.. Dr. Anne Hirshfield, Associate Vice President for Health Affairs, GWU SMHS
welcomed our guests on behalf of our Medical Center, and explained her pleasure that
leadership in efforts supporting biomedical research could be provided by our Medical
Center.

Before meeting with our political leaders, the Caucus was briefed by experts on the political
process regarding health research issues, the present status of funding for the NIH, and the
apparently dim prospects for significant increases in funding even this late for FY2008.There
is still great uncertainty about the political future in this election year, but it was proposed that
for FY2009 a 6.5% increase in the NIH budget be requested. This briefing was especially
important because a third of our members at this meeting were new to the Caucus, due to
annual turnovers of constituent association officers. We were fortunate that five of the 8
constituent associations were represented by their presidents. The Caucus efforts were
coordinated with those of other Washington experts speaking up for the scientific community,
to consider our major aims, and to maximize our effectiveness. Briefing us were Dr. Howard
Garrison Director of Public Affairs, Federation of American Societies for Experimental
Biology (FASEB),; Lynn Marquis; Director, Coalition for the Life Sciences; and Elisa
Siegel, Chief Communications Officer of the Association of American Medical Colleges
(AAMC). We should aim for funding for all biomedical sciences, rather than focusing on
specific diseases. Excellent advice was offered on successful approaches to staff members,
many of whom are young, not familiar with how the NIH spends its funds but enthusiastic
about curtailing disease and reduce suffering. Contacts with our political leadership are very
important, and should be followed by local appointments in the district of each political leader.
They should be invited to our medical schools to see the scientific advances provided by their
constituents, as well as the increased economic benefits (jobs) being provided by the NIH
programs. Again, it was stressed to thank them for their past interest and support of
biomedical science

Mary Woolley, President and CEO of Research!America, described survey data on the
strong desire of our citizens for increases in health research, associated with a willingness to
pay for such efforts. Economic growth depends on interactions of all disciplines of science
and technology, an investment we need to make and sustain, since it represents creation of
new jobs, and actually leads to cost savings when considering the huge expenditures caused
by disease. Science can actually solve problems otherwise impossible to understand.
Because the country is largely unaware of where scientific research is conducted, and who is
doing it, scientists should speak up in their home districts on the contributions provided by
their own local institutions, should challenge candidates running for political office on their
stand on biomedical research, and should offer editorials to local newspapers to explain the
need for furthering health research. Research!America has initiated a project, to identify
positions of their political representatives regarding health research. All citizens, including
research scientists, are encouraged to question their political leaders, including Presidential
candidates, (www.yourcongressyourhealth.org) on their beliefs about the country’s policy to
improve health and fight disease. This is especially pertinent because this is an election year.

The Honorable John Porter, Chair of Research!America, who previously had chaired the
House Subcommittee on Labor, Health and Human Services and Education, (responsible for
formulating the NIH budget), was one of the major instigators of the doubling of the NIH
budget. He was extremely supportive of our efforts on the Hill, and proposed that scientists
become more active in contacting their representatives for supporting scientific research. He
expressed concern that the U.S. was losing its international scientific leadership because of
lack of adequate financial support for the NIH. He provided 5 principles to consider for our
visits:

Congressional staff is just as important as the Congressional Member, since it is rare
to see the latter;
Thank the staff and their political Member for their efforts on behalf of their efforts for
the NIH
Be brief, but speak with passion about your personal feelings about the role of
research and the need for appropriate funding
Make sure they know exactly what you are requesting from the Member
Volunteer to become a scientific adviser for the political leader.

The visit with Congress. Because this is an election year, and a new President will be
inaugurated in January of 2009, together with elections of all seats in the House of
Representatives and a third of the Senate, there presently is great political uncertainty.
Nevertheless, we should not hesitate to express realistic recommendations. We should
encourage enhanced funding for the NIH in FY2008, which is almost over. A sizeable
increase in funding would encourage a presidential veto which probably cannot be over-
ridden by the Legislators. Actually, during the afternoon we spent on the Hill, the House
added $ 150 million to the NIH appropriation (undoubtedly because of our excellent
presentation), and at the time of this writing the proposal is still being developed. It is also
quite likely that there will be a “Continuing Resolution” maintaining previous level of funding
until spring of 2009. Regardless, we should now prepare our requests for FY 2009, (which
starts October 1, 2008), and should document our requests based on previous scientific
accomplishments promoting better health..

     In our discussion prior to going to meet our Congressional representatives, it was
emphasized that the concept of incremental % increases is not as meaningful to politicians as
are the actual dollar increases, and these can become relatively large numbers in the Federal
budget. The requested 6.5% increase in NIH funding for FY 2009 represents about $ 2 Billion.
We should focus on the immense importance of basic research in providing translational
achievements in the treatment of disease, which is of great interest for our legislators, since
the H in the NIH represents health. We should encourage our representatives to work with us
to realize those aims. Mentioning rejection of funding for 85% of newly proposed excellent and
peer-reviewed suggestions for innovative research because of insufficient funding is a
powerful argument. Focusing on national competitiveness is also appreciated, and the
increased availability of jobs because of successful research grants in the politician’s own
districts could be a strong incentive for their support of health research. Science should be
viewed as an investment in the nation’s future. It is also extremely important to stress that
decreasing funding for health research, and especially major annual fluctuations in that
support, has detrimental consequences in the recruitment of new scientific recruits. Attracting
excellent young people for careers in scientific discovery is essential since otherwise future
scientific accomplishments will be limited. The Caucus left a brochure in the Congressional
offices during our visit consisting of the attached Summary Statement, together with a listing
of scientific accomplishments prepared by FASEB.

     The Caucus split into small teams to meet with the staffs of many of the leaders of the
Senate and House of Representatives. Included were aids to House Speaker Nancy Pelosi,
Senate Majority Leader Harry Reid, House Minority Leader John Boehner (staff of Senate
Minority Leader Mitch McConnell refused to meet with us); Senators John McCain,
Richard Durbin, Thad Cochran, Arlen Specter, John Cornyn and Jon Kyl. We also
visited with the staff of Congressmen Bart Gordon, Timothy Bishop, Thaddeus McCotter,
Vernon Ehlers, Joe Barton and Congresswoman Betty McCollum.

          We were well received by all of the staff members we had asked to meet. In general
they understood the problem, created largely by the limited amount of discretionary dollars
available for health research. There is enormous turn-over in staff personnel, so that some
aides were more knowledgeable about the NIH funding problem than others, but all agreed to
encourage their chiefs to do their best. Instantaneous success cannot be expected but if we
and other groups don’t continuously raise the issue and explain our concerns there would be
less progress.

      We heard from a series of visitors who had important functions regarding biomedical
research and teaching.. Dr. Peter Scoles, Senior Vice President for Assessment Programs,
National Board of Medical Examiners, discussed the present status of contemplated changes
in the National Board Examination process. Because the present system was established
some 20 years ago, there have been many changes in medical practice, and the Board felt
the examination system needs to be reviewed. There had been a concern expressed that the
Part1 Basic Science examination would be merged with a later clinical examination, but
apparently such a drastic change is no longer being considered. Instead, it is now likely that
additional basic science material will be covered in subsequent examinations. The whole
review process is still in process, and is expected to take 4 or more years before
implementation of any changes. The entire examination process is being evaluated to focus
on testing concepts rather than data. Changes are still being discussed with basic science
and clinical faculty, deans and other educators. A publication as of June 10 can be found at
www.usmle.org/General_Information/review.html.

     Mr. Peter Farnham, Director of Public Affairs, American Society of Biochemistry and
Molecular Biology, presented data accumulated by Dr. Heidi Hamm, current President of
ASBMB, on the decline of investigator-associated research at the NIH. R01 grants did not
participate fully in the NIH doubling, and were reduced from about 80% of research project
grants (RPG’s) between 1996 and 1998, to about 60% in 2007. Within that group, unsolicited
R01’s were reduced from 65% between 1996 to 1998, to 50% in 2007. Further changes
include Program Announcements (P.A.’s), formerly classified as solicited, now are termed
unsolicited investigator initiated RPG’s. P.A.’s and Requests for Applications (RFA’s) until
recently represented about 15% of total RPG’s, now represent 40%. From 2003 to anticipated
2009, during which period there has been a 21% inflationary increase, RPG’s increased 13%
while research center funding rose 20%. These changes represent a diminishing role of
unsolicited investigator-initiated funding.

     Dr. Bruce Alberts, Editor of Science and past President of the National Academy of
Sciences, provided critical thoughts on the current state of science. He expressed concerns
about the difficulties of promoting cross-fertilization of ideas with colleagues, sometimes
hindered by the designs of scientific laboratories where individuals work in “silos”. He was
concerned about the encouragement of large scientific groups which may limit creativity,
rather than effective smaller groups of investigators making brilliant discoveries. An enormous
share of funding now goes to already highly funded large laboratories. Too much time and
effort is expended in designing and perfecting grant applications rather than doing research,
and he discouraged the great emphasis on preliminary results at the expense of developing
truly innovative ideas.

     Dr. Lawrence Tabak, Director of the NIDCR and Co-chair of the Peer Review Working
Group on NIH grant reviews, provided an update on the project to enhance NIH peer review.
Dr. Tabak summarized the newly published Implementation Plan, which seeks to improve the
study section experience and ensure that the best reviewers participate. Ideas include more
flexible multi-year reviewer commitments and an expectation of study section service of all
recipients of Merit/Javits/Pioneer awards and heavily funded PIs. One proposal is to allow a
study section to re-calibrate their scores at the end of the meeting to avoid unintended “grade
creep” during the meeting, although a concern was raised because not all members of the
study section may be present at the end. Another proposal would eliminate the current
scoring system and replace it with a 7 scale step system, with subscores provided in each of 5
specific review criteria by the assigned reviewers. Regarding the burden on reviewers and
applicants, a proposal to reduce the number of “science” pages on R01 grants to 12 is being
considered. This should help to focus reviewer discussions on the impact and originality of
proposals, although a concern is whether this would actually increase the number of
applications submitted. Dr. Tabak emphasized that the first rule in implementing any changes
is “do no harm”. A current summary can be found at http://enhancing-peer-review.nih.gov

     Dr. Albert Teich, Director of Science & Policy Programs at AAAS, placed federal funding
of biomedical research into the broader context of all federal science funding. Not
surprisingly, the majority of federal funds (55%) are spent on defense-related research.
What is interesting is that the US spends a much greater proportion of funds on health related
research (25%) than do other major developed nations. The doubling of the NIH budget has
markedly increased the percentage of non-defense funds devoted to health research, and
this has remained relatively stable at about 50% of all non-defense research since 2003. Dr.
Teich attributes this growth to the impact of health research, especially as it relates to new
advances in treatment of diseases, and to successful advocacy by health supporters. Getting
significantly more funds will require substantial growth in available discretionary funds, which
has not happened. Dr. Teich encouraged us to advocate for increased funding for all of the
sciences, since advances in other fields (e.g., imaging, computation) benefit health
research.

     Dr. Alan Krensky, Director of the Office of Portfolio Analysis & Strategic Initiatives at NIH,
discussed some of the newer initiatives at NIH, including the Road Map and Pioneer awards.
The Road Map provides new opportunities for multidisciplinary research, and Dr. Krensky
compared this activity with programs such as the BIO-X program at Stanford, which supports
interactions of bioscientists with researchers in engineering, computer science and physics.
Dr. Krensky pointed out that Congress is focused on disease-related research, and that the
Clinical and Translational Science Awards (CTSA) awards will transform clinical research by
replacing the General Clinical Research Centers (GCRCs). These awards require a
substantial commitment from medical centers, and he indicated that medical centers, in
addition to the NIH, should also be willing to support successful individual scientists. The latter
have been the major contributors of innovative discoveries in the past. He also raised the
issue of whether there should be a minimum effort (25%) on each NIH grant, and emphasized
that when evaluating quality one should look not at total number of awards, but rather funding
per person. With the very tight NIH budgets, there will continue to be “haves” and “have-
nots”.

     We also met with Dr. Robin Robinson, the newly appointed Director of Biomedical
Advance Research Development Authority (BARDOS), whose function is to achieve better
preparedness to combat unanticipated disasters. This includes the capacity for improved
preparation of vaccines, availability of appropriate drugs, protective equipment and
diagnostics, and is located in downtown Washington. It is coordinated with various other
agencies, is under the umbrella of the Department of HHS, but also is coordinated with Dept.
Homeland Security, the Dept. of Defense, and various industrial concerns. Dr. Robinson
encouraged participation of academia, and proposed that scientists should consider offering
their services on a part-time or sabbatical basis.

          Mr. David Moore, Associate Vice President AAMC, discussed the role of the AAMC in
its support of the NIH in its entirety, without pinpointing specific programs. The Ad Hoc Group
for Medical Research Funding has been one of the most effective supporter organizations of
biomedical research, and also has been of immeasurable help in the functioning of the
Caucus. He expressed concern about the increasing division between the ”haves” and “have-
nots” in biomedical organizations, but the role of the Congress is the management of the NIH
and its funding. He noted the well-disciplined Republican congressional team, very concerned
about deficit spending, in contrast to the Democrats who entertain more priorities. He was
optimistic that the next Congress would be more helpful to the NIH.

     Dr. Dora Hughes represented the Obama Campaign for President. The Senator is
extremely interested in science, and wishes to increase, hopefully doubling, funding for all
science. He wishes to bring foreign scientists to the US for training, and supports basic
science and engineering, including climate research. He has formed committees to examine
these areas, is also concerned about improving high school and college teaching in an effort
to increase interest of young people in science. He feels American leadership and continuity
of support for science is essential, while limiting regulatory activities and filling out forms
instead of making discoveries.

     Hopefully, our visits on the Hill and enthusiasm may have had some positive effect on
future funding for biomedical research.