EDITORIAL

Steering
clear of the
federal
bureaucracy

IRVINE H. PAGE, MD
Editor

 

Donald Fredrickson,
current head of the
National Institutes

of Health, is a

man of strong
convictions who aims
to save his ship from
bureaucratic piracy

 

 

 

 

@ Most piacuitioners are unaware
of the physical and intellectual
magnitude of the National Insti-
tutes of Health (NIH) and of its
importance to them. It is the
taxpayer's major contribution to
furthering better medical practice.
Its Bethesda campus gives work-
ing room to a vast array of basic
scientists, among them such stel-
lar Nobel winners as Julius Axel-
rod, Christian Anfinsen, and
Marshal Nierenberg, and a huge
clinical center where costly but
worthy human studies are con-
ducted.

It is fair to say that in the early
1940s, when the NIH was getting
into full swing, conservative sci-
entists and physicians thought it
would become a wasteland.
But—due in no small measure to
the persuasiveness of Mary
Lasker, Lister Hill, and John
Fogarty—the NIH took off. Its
guiding genius was James Shan-
non, the articulate, highly intelli-
gent, courageous director from
1955 to 1968.

Once it became evident that a
genuinely first-rate organization
had been created, the problem (as
with most large organizations,
especially those coming under the
bureaucratic domination of
Washington politics) was how to
mold its future to ensure that so
costly a project would make medi-
cal practice progressively better.
The two immediate successors to
Shannon's 13-year reign faced the
determined fire of those who
wanted political control.

But in the current NIH director,
as in HEW’s assistant secretary
for health, Theodore Cooper, the
power seekers have met their
match. Donald Fredrickson is a
person of suave charm and vision
who is schooled in the hard
disciplines of science and dialec-
tics. He has long participated in
the Washington scene as well as
being an NIH scientist. He is
unlikely to find many surprises.
His greatest danger is that he will
conceal his true character behind

a diplomatic shield, which might
prevent his leadership from being
fully exerted. Sometimes it seems
that he knows too many of the
“right people” on both sides of the
street and will never be able to
please the advocates and the crit-
ics of medical science equally.

FREDRICKSON HAS strong feelings
about three major policy areas. He
is devoted to the vigorous pursuit
of basic science under the grant
system, with peer review. Like
most of us, he believes peer review
has been a major contribution to
science policy and should never
be scrapped. The millions of
hours devoted to evaluation of
research grants by members of the
nonfederal science community
have been an unsung major con-
tribution to good science and
sound economics. Appointment to
study sections has been kept free
of political control.

As much cannot be said for
membership in NIH councils, al-
though, on balance, they too have
performed well. The fact that the
directorship of the NIH has been
made a presidential appointment
shows the ever-present danger of
encroachment by politics.

AN EXAMPLE CLOSE to everyone's
heart has been the cancer crusade.
Launched at a time when knowl-
edge of neoplasia was inadequate
for a great leap forward, it was
overorganized in a plan that, had
it been carried out rigidly, might
have spelled disaster. I received
my lumps at the time for saying so
CMM, July 26, 1971, p 73), but I can
report that management of the
National Cancer Institute (NCI)
has been better than we had any
right to expect. Still, the project
came under severe criticism after
scientists finally, and reluctantly,
realized what had happened right
under their noses and often with
their blessing. It speaks poorly for
their prescience.

Fredrickson was one who saw
the potential danger. If the very

Reprinted from MODERN MEDICINE, Vol. 44, No.15, pp. 6-12, September 1, 1976
Copyright 1976 by The New York Times Media Company, Inc.
capable Dr Frank J. Rauscher,
NCI’s current head, leaves be-
cause of inadequate salary, Fred-
rickson faces another major
problem. It is ironic that the
government can spend $700 mil-
lion, or 32% of the NIH budget, for
cancer research and deny a raise
in salary from some $37,800 to
perhaps $45,000 to a first-rate
director of the cancer institute.

A SECOND MAJOR policy on which
Fredrickson stands firm is the
separation of funding for research
and education. Support of science
should not finance education. He
believes that research and scien-
tific education are indissoluble,
but the costs of research may not
be inflated to support clinical
training or much of the doctor's
basic education. The days when
NIH would underwrite more than
research have gone. Fredrickson
wants schools to get scholarships,
capitation, Medicare, and Medic-
aid. This may well force them into
the practice of medicine not only
for teaching material but also for
financial support.

A THIRD MAJOR policy area is edu-
cation in preventive medicine for
both patient and doctor. Fredrick-
son looks upon such an endeavor
as being extremely difficult but
one that in the long run will pay off
handsomely. If physicians will
take the matter more seriously, he
believes, their effectiveness will
be greatly enhanced.
Fredrickson talks about the
“interface” between science and
the public, because the public
must believe in science. Like
everyone else, he is stymied as to
how this is to come about. The
press should be the most impor-
tant medium, but it fails because
of its penchant for the flamboyant
and bizarre. A newspaper will give
two columns to some exotic non-
sense but little or nothing to a
major discovery. The Institute of
Medicine was founded to act as an
ecumenical meeting ground for

government, the public, medicine,
and science. So far it has not filled
the need as hoped. Using his own
advisory committee as a starter,
Fredrickson believes he can create
a better forum for airing tough
issues in public view.

I ASKED HIM whether he believed
that the antiscience movement
was threatening. He replied, “Yes,
there is—and probably always
has been—an antiscience move-
ment in the world. It has been
augmented recently by some
economists and health care
analysts who argue that research
adds to health care costs more
than it improves health. Some of
the antiscience movement is a
deflection to science and other
elite institutions of general dis-
affection with the American polit-
ical and economic systems. Issues
such as environmental protection
and civil liberties essentially are
not the substance of science.”

New technologies are con-
stantly being added at consider-
able cost. “Don’t learn anything
more because it will cost too
much!” Perhaps technologic
assessment to determine the cost
and effect of scientific advance
should precede widespread use of
any innovation. If only one person
can be saved—for example, the
one youngster living for four years
in an enormously expensive,
germ-free room at NIH’s clinical
center—is society willing to pay?
Is this what the public wants?
Who knows? Politicians find this
just as tough to decide as do
physicians.

THE NEW DIRECTOR of NIH is of the
opinion that discussion of ethics
has helped, not hindered, medical
research. He thinks it has im-
proved the setting of proper limits
to clinical investigation. The
Quinlan case is not really a medi-
cal research issue. Respirators
and cardiac pacemakers have an
essential, positive role in medical
care, and limiting their use is an

issue for all of society, not science
alone, to decide.

The only casualty of the debate
on fetal research was the use of
federal funds for research on
methods of abortion. This means
that research on new methodol-
ogy, such as use of prostaglandin
derivatives, has become a
monopoly of Scandinavia and
western Europe. We will have to
accept their technologies, when
they arrive, without our own re-
search base for evaluation.

WHAT ABOUT the ethics and utility
of large clinical trials, such as
those for heart disease and
cancer? Fredrickson is all for
them and has committed a sub-
stantial part (10%) of the total
NIH budget to them. The really big
ones are the kinds of experiments
only government can do. NIH now
has more than 30 projects in
progress that involve more than
1,000 subjects each.

For those who have a “pet”
disease, Fredrickson prays that
Congress will not be persuaded to
mandate yet another institute for
its study. Every new institute
starts small but soon catches fire
and proliferates epicenters, core
programs, and bureaucrats. With
financial support dwindling, such
added programs could spell dis-
aster. The NIH must be trusted to
set priorities according to its
skills and resources.

FREDRICKSON HAS this to say about
his views: “The relationship be-
tween biomedical science and the
practice of medicine is an extraor-
dinarily close and interdependent
one. Nearly all of the additions to
the doctor's bag—the new tests in
the clinical laboratories and the
steadily increasing capabilities
for treatment and prevention of
disease—come from science. At
the same time, this new knowl-
edge and technology has little
power over illness until it is
skillfully used by physicians or
other health practitioners and
their patients. The full loop must
be closed if discovery is to benefit
the human condition. Physicians
and scientists share the admira-
tion of the public when they are
successful. They also share the
criticism when costs of their inno-
vations seem to exceed benefits,
when access to them is uneven, or
when they create ethical dilem-
mas that He beyond the capa-
bilities of science or medicine to
resolve.

“NIH is the custodian of the
largest share of the nation’s re-
sources dedicated to biomedical
science. NIH has no regulatory

activities, in the sense of those
carried out by FDA or certain other
federal agencies, except the steps
it requires to assure that the
research supported by us is pro-
tective both of the subjects in-
volved and of the environment that
all of us share. The agency is fully
responsible to the public demand
for transduction of knowledge to
the power to heal. The medical
profession is the principal trans-
lator of this power. The measure of
our combined contributions to
mankind lies in the diligence,
wisdom, and accountability with
which we continue the enterprise

that inseparably links medicine
and science.”

The shakedown cruise for a
reconditioned ship with a new
captain has begun. The waters are
already rough and will get
rougher. What Fredrickson and
his advisers do in the next decade
will profoundly affect the practice
of medicine. We have a good man
and true. He needs our support
and our criticism as well, the
support to stand for what he
believes and the criticism to keep
the ultimately fatal Washington
syndrome at bay. m