PROCEEDINGS
OF THE 30TH BETHESDA CONFERENCE. THE FUTURE OF ACADEMIC
CARDIOLOGY. BETHESDA, MARYLAND, OCTOBER 26-27, 1998.
JACC Vol. 33, No. 5, April 1999:1091-1135
30th
Bethesda Conference:
The Future of Academic Cardiology*
Task
Force 2: Research
Jeffrey
S. Borer, MD, FACC, Co-Chair, Robert A. Vogel,
MD, FACC, Co-Chair
EFFECT
OF CURRENT NATIONAL MEDICAL PRIORITIES AND REIMBURSEMENT
STRATEGIES ON CARDIOVASCULAR RESEARCH ACTIVITIES IN
ACADEMIC MEDICAL CENTERS
Scope
of the Problem (continued)
Current
research funding for academic cardiology and its limitations.
The future of cardiovascular medicine depends on the
creation of new knowledge resulting from high quality
clinical research and clinically relevant basic research.
These efforts require well trained and experienced investigators,
a collegial atmosphere, protected time, highest quality
facilities and financial support. By their organization
and tradition, academic cardiovascular centers are best
positioned to produce new knowledge from cardiovascular
research. Unfortunately, the productivity of clinically
trained cardiovascular researchers is being eroded by
increasing pressure to enhance diminishing clinical
revenues, loss of time due to increasing requirement
for redundant documentation and other administrative
burdens and the performance of nonreimbursed activities,
including teaching. Today, clinical reimbursements no
longer are sufficient to subsidize otherwise unfunded
research efforts; sources of funding specifically earmarked
for research also are in jeopardy. Although research
funding has increased during the past decade, research
costs have increased even more rapidly, in part due
to the complexity of modern research and its associated
facility and specialized labor requirements. The public
demand for research products also appears to have increased,
fueled by the successes of the recent past. This factor,
as well as the increased emphasis on research as a measure
of excellence of academic centers, has led to a marked
increase in the number of investigators, especially
in basic science disciplines, resulting in heightened
competition for research support. Consequently, a progressively
increasing proportion of investigator time must be devoted
to obtaining research support (5).
As
this overview suggests, during the past three decades,
financial support of U.S. medical schools has changed
dramatically (Table 1)
(5). Total support from
all sources has increased. However, as a proportion
of total funding, support from the federal government
has decreased and has been replaced by reliance on revenues
generated within academic institutions. Such self-support,
which includes revenues from practice plans, hospitals
and clinics, as well as from tuition, fees and allocations
from the parent university, increased from 17% to 57%,
whereas support from the federal government decreased
from 54% to 21%. However, self-support is precisely
the component most adversely affected by recent health
care reforms.
Though
total funding for medical schools has increased since
1965, the proportion allocated to research has decreased.
Overall research expenditures have decreased more than
25% as a proportion of total health care expenditures.
Thus, from 1970 to 1994, the gross domestic product
increased from $1,036 billion to $6,931 billion, a near
sevenfold increase; during this same period, national
health care expenditures increased from 3.8% to 14.7%
of the gross domestic product (more than a 25-fold increase
in total expenditures) and reached $1,021 billion in
1995. However, since 1965, the proportion of health
care expenditure allocated to research has fallen from
4.8% to the current level of approximately 3.5%, where
it has remained since 1989 (5).
As
allocation of health care funds has changed, so too
have the sources of research financing (5).
The dramatic rise in total health care expenditures
since 1970 has been accompanied by a slower growth in
National Institutes of Health funding, which has risen
15-fold during this period (actual dollars). Moreover,
though apparently substantial in absolute dollars, this
increase in National Institutes of Health funding must
be viewed in the context of the explosion of complex
technology and associated costs that has occurred during
this period. Research funding requirements have been
made up in part by industry; industrial contributions
to academic research have jumped 41-fold during the
same period. However, industrial research generally
is directly tied to product development and is less
likely to be investigator-originated than National Institutes
of Health funding.
Though
research funding has lagged, public expectations for
medical progress have increased, fueled by the successes
of the 1970s and 1980s. Simultaneously, in response
to a "doctor shortage" predicted in the 1950s
and 1960s, the number of medical school graduates and
PhD scientists has grown markedly. Cardiovascular specialists
also have increased, though it may be argued that their
number has not increased in proportion to the growth
of new knowledge which they are specifically trained
to apply. In recent years, the increase in researchers
has exceeded the increase in research funds, leading
to heightened competition for research support and a
growing disenchantment with research as a realistic
career option. The recent dramatic reductions in clinical
fee structures have compounded the problem. Thus, with
diminishing federal support, academic medical institutions
have depended increasingly on clinical remuneration
for survival, and reductions in fees have led to extraordinary
pressure on clinically trained academic faculty to devote
increasing time to clinical activities to maintain total
remuneration. In earlier times, clinical income, as
well as more readily available training grants, commonly
were employed to support the initial research efforts
of trainees and junior faculty, as well as new lines
of investigation by established researchers. This "seed
funding" enabled the generation of data to support
subsequent applications for peer-reviewed extramural
funding. These opportunities are progressively diminishing,
with a concomitant fall in the proportion of junior
faculty members who are successful in establishing a
career of clinical research or clinically relevant basic
science research.
Increasing
research costs and increasing competition for available
research dollars (as evidenced by the current, historically
low 16% rate of funding National Institutes of Health
RO1 grant applications) both have contributed to a reduction
in the frequency with which MDs now enter cardiovascular
research. These issues are compounded by dramatic alterations
in the requirements of modern clinical practice of cardiovascular
medicine which have led to increased clinical subspecialization
in both invasive (e.g., interventional cardiology, electrophysiology)
and noninvasive (e.g., echocardiography, transplantation
medicine) areas. Such subspecialization now requires
intensive and lengthy training and prolonged experience
for acceptable competence, minimizing time available
for research by many cardiovascular physicians, except
as the research may relate to evaluating new equipment,
drugs and techniques. In 1995, 19,152 physicians in
the U.S. were classified as cardiovascular physicians
(6). Of these, only
775, or 4%, identified themselves as devoted primarily
to research.
Because
of the increased competition for research funds, successful
research proposals must be of higher quality and supported
by greater quantities of "preliminary" data
than in earlier decades. Three products of this apparently
salutary trend require comment. First, the need to justify
the goals of new proposals with preliminary data, in
the context of increasingly limited funding to support
acquisition of these data, minimizes the opportunity
for new researchers to obtain peer-reviewed funds. Second,
the requirement for preliminary data, most readily available
from previously funded investigators, tends to diminish
funding for exploration of new ideas not generally accepted
by the research establishment. Third, with limited "seed"
funds for research by clinical trainees, the growing
requirement for "preliminary" data minimizes
the opportunity for clinicians to compete effectively
for peer-reviewed research dollars, foreclosing future
research options (7).
The net effect of these trends is diminution of clinician
involvement in research.
Attempts
by academic centers to minimize negative financial trends
by capturing more clinical health care dollars have
been thwarted, in part, by the inherent disadvantages
of academic centers in competing for clinical market
shares against nonacademic providers. As noted above,
funding for medical research and education are becoming
increasingly limited. However, it remains an inalienable
responsibility of academic centers to teach new physicians
and to create new knowledge through research. Therefore,
available resources must be deployed to effect these
responsibilities as well as to support clinical service.
Traditionally, departments of medicine have subsidized
relatively less profitable divisions from clinical cardiology
revenues. Though reimbursements have diminished, the
tradition of taxation has not, further handicapping
academic divisions of cardiology in their capacity to
undertake research.
As
noted previously, the loss of sources of research support
has resulted in ever greater dependence on industry.
Even in this area, in which academic medical centers
have exercised a virtual monopoly, new competition has
developed (8). Clinical
research organizations now frequently employ nonacademic
physicians to perform clinical research and centralized
industrial data managers to document and analyze data.
The outsourcing of pharmaceutical research is due to
both nonfinancial and financial factors. The primary
problem for the academic center is its inefficiency
in recruiting patients and delivering the research product
required by industry. This problem is attributable,
in part, to the increasing capacity for outpatient management
of patients even with relatively severe disease. The
result is that the academic center tends to attract
the sickest and most complex patients, who may not meet
the rigorous inclusion and exclusion criteria for modern
drug trials. This factor is compounded by the relatively
high indirect costs in academic medical centers, needed
to support other institutional priorities, and by the
administrative complexities and delays involved in developing
contractual relations between industry and academic
centers. The result is that clinical research organizations
and pharmaceutical manufacturers seek alternative sites
for applied clinical research.
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