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UNIVERSITY OF CALIFORNIA, LOS ANGELES

 

 

BERKELEY * DAVIS * HIVINE * LOS ANGELES * RIVERSIDE *« SAN DIEGO * SAN FRANCISCO SANTA BARBARA ° SANTA CRUZ

 

 

OFFICE OF THE DEAN SCHOOL OF PUBLIC HEALTH

THE CENTER FOR HEALTH SCIENCES
28 July 1976 . LOS ANGELES, CALIFORNIA 90024

Senator Edward M. Kennedy,
Chairman,

U.S. Senate Subcommittee on Health
U.S. Senate

Washington, D.C.

. Dear: Senator Kennedy:

' Since my testimony 17 June 1976 before the Subcommittee on Health
concerning the Report of the President's Biomedical Research Panel and
_ your questioning, as well as that of Senators Eagleton and Beall, I have
been giving further thought to the matter.. A recent letter from Senator
Cranston, a member of the Subcommittee on Health, has likewise stimulated
me to make additional comment on two issues”*raised by the Report.

One issue is the differentiation of biomedical research from the -
development cf applications of new kncewlcdge in health care.

The second issue is the form and place of responsibility in the
Federal government for development of applications of new.knowledge in
health care. oo os

f°

Ne

. This differentiation is important because, as the Congress. recognizes,
we need to take advantage of what.is found thrcugh biomedical .research
by developing it for use in health care. That development for use does
not take place automatically... It does not result from simply publishing
research findings. It does not flow from the present. activities:of NIH.

. That agency, influenced by its research constituency and now buttressed
by the Report of the President's Biomedical Research Panel, regards
"explor(ing) applications of new knowledge that are. effective in health
care (as something) in addition to its basic mission." The quoted words
cone from the Report of the Panel; the underlining is mine. NIH has
looked upon exploring applications in health care as a distraction from
its primary mission, to be undertaken only enough to meet vigorous
complaints and demands of Congress.

There is a difference between biomedical rescarch and exploring its
applications in health care. ‘That difference should be clearly understood _
by all parties concerned as one basis for accomplishing the intent of
Senator Edward M. Kennedy
2% July 1976 - \
Page Two

Congress that research findings be used to improve health care. One way
to understand the difference is to examine carefully what is described
-in the words of the Panel:

"The continuum from the development of new knowledge to
the application of such knowledge in health care includes a
number of steps:

_1. discovery, through research, of new knowledge and
the relating of new knowledge to the existing base;

_-2. translation of new knowledge, through applied research,
into new technology and strategy for movement of
discovery into health care;

. 3. . validation of new technology through clinical trials;

-.4. determination of the safety and efficacy of new
. .technology for widespread dissemination through
demonstration projects;

5. _ education of the professional community in proper
use of the new technology and of the lay community
on the nature of these developments; and
.6. skillful and balanced application of the new developments
- . to the population."

Step 1 is clearly in the realm of biomedical research. Steps 4, 5
- and 6 are clearly beyond the realm of biomedical research. Steps 2 and
. 3 comprise the area of present ambiguity and uncertainty. The problem
in that part of the "continuum" encompassed in Steps 2 and 3 is:

to" identity in the findings of research (from Step 1) the

" Potential or improving health care;

of pe and a strategy for spplying it in health care;
- and .

to Validate that technology through clinical trials with a
view to proceeding on to Steps, 4, 5 and 6.

It is in the above-underlined activities that American health
policy. has been weak. That weakness has been delaying disease control
and giving rise to concern in the general public and in Congress that as
a nation we are not doing all we can and should to advance health through
prompt application of what we know in health care. Some progress, of

course, is being made, for example, in the increasing use of clinical
trials.
Senator Edward M. Kennedy
28° July 1976 | : \
Page Three

What is needed now is explicit recognition of the underlined activities
in health policy; vigorous leadership and adequate funding of them; and
‘decision as to whether they can be entrusted to the biomedical research
community with its present orientation, or whether they should be combined
with the activities encompassed in Steps 4, 5 and 6 and made part of a
‘new thrust in disease control for the country.

Some examples from experience with disease control in recent decades
may be helpful. In the testimony on 17 June 1976, reference was made to
the Papanicolaou smear. Briefly, the chronology of that technic has been:

_ 1928. First reference in the U.S. to possibility of
using the technic against cervix cancer.

°4943. . Definitive work published, establishing the
technic as useful in detecting cervix cancer.

_ 1960. Less than one-half the women in the U.S. had
received the smear even once.

_ 1974, Only about three-fourths of the women in the U.S.-
had received the smear even once, and the most
neglected were those who had the most cervix
. cancer. From 1950 to 1975 over a quarter-
million American women died (unnecessarily)
from cervix cancer. .

At present considerable attention is being given to mammography
(X-ray examination of the breast) as a means of combatting breast cancer.

“Briefly the chronology has been: ~
. 1930. First reference in the U.S. to possibility of
< using mammography against breast cancer.
_ 1960. Definitive work published, establishing the

technic as useful in detecting breast cancer.

* 1964. First (and still the only) significant clinical
trial launched.

"1973. Nation-wide demonstration project undertaken.
1976. Confusion as to whether the demonstration project
adequately took into account the findings of
the clinical trial with respect to age of women
when benefit occurs, and the hazard of radiation.
With respect to anti-hypertensive drugs, the chronology briefly is:
1950. Anti-hypertensive drugs available.

1964. Clinical trial of anti-hypertensive drugs for
hypertension launched.
senator Edward M. Kennedy
28 July 1976
Page Four

1967, 1970. Above study reported to show effectiveness.

_ 1974, Surveys indicate that 36 percent of males with
hypertension did not even know that they had
the condition; of all those with the condition
(previously known and not known) only 22 per-
cent of black males and 28 percent of white
wales were under adequate control.

In the case of measles:

- 1960. Measles vaccine first developed and used in
number of small trials in children.

' 1963. Measles vaccine licensed and placed on market.

se 4970, 47 percent of U.S. children 1-13 years of age an

still unprotected.

. 1975. "Continuing outbreaks of measles occur; for
. -€xample, several hundred cases in San Francisco,
more than in the preceding seven years.

Dozens of additional examples could be cited from the experience of recent |
_ years, using only situations now recognized. How many are unrecognized?

‘.The conclusion is clear. There has been a failure in American health policy
to recognize that: ~~ Te "

a
QQ) Biomedical research alone is not sufficient to assure reasonably
prompt application of findings. to health care. .

(2) Explicit attention is needed to the steps involved in moving from
research findings to incorporation into health care, namely:

(a) Identification of the potential
(b) Systematic exploration of the potential.

(c) Validation through clinical trials; then demonstration
projects; professional and public education; and
skillful, balanced general application of new develop-
ments--for maximum benefit to the American people from

' their support of biomedical research. _

The Panel did not make clear in its report this serious weakness nor propose
effective means of dealing with it. :
Senator Edward M. Kennedy . .
28 July 1976
Page Five

Form and Place of Responsiblity in the Federal Government ‘for Development —
‘o£ Applications of New Knowledge in Health Care.

 

One important reason for inadequate attention to the development of
applications of new knowledge in health care has been the failure to
define the mission clearly and to place responsibility for it in the Federal
_ govermment.

Since establishing in 1937 the National Cancer Institute, the

_first of the National Institutes of Health, and down. to the present, Congress
has nudged NIH toward "control" activities, i.e., developing the application
of research findings to disease control. Suiccess has been hardly outstanding.
For example, the National Cancer Act of 1971 established a program whose

_ goal was "To develop, through research and development efforts, the means to
. ‘Significantly reduce the morbidity and mortality from cancer.'' But whereas
the National Cancer Institute called a series of conferences of national
leaders in the biomedical research community as early as 1970 (before.

_ the Act was passed) to.consider.its implementation with respect to

research, it was not until 1973 that the NCI called such a conference on

- and otherwise began seriously to approach the development of cancer

From time to time during the past quarter-century, the Public
Health Service and, more recently, the Department of Health, Education,
and Welfare established units for cancer control, heart disease control,
. Chronic disease control, tuberculosis control, communicable disease
control, regional medical program for heart disease, cancer and stroke,
etc., outside the National Institutes of Health. None of these, however,
ever developed a solid base of support in and outside of Congress even
remotely comparable to NIH. Many explanations may be advanced, but the
fact remains.

Apart from efforts to establish organized disease control activities
in NIH and in the several programs referred to outside NIH but in Washington,
it should also be noted that places outside Washington have been designated

for the purpose of organizing disease control activities. Notable among
these are the Center for Disease Control (C.D.C.), formerly the Communicable
Disease Center, in.Atlanta; and the National Institute for Occupational
Safety and Health (NIOSH), in Cincinnati.

Somehow neither NIH nor PHS nor HEW has mounted the kind of sustained
effort to develop the application of research findings to health care
that would reasonably promptly take advantage of what the nation has
developed in biomedical research. _ .

Perhaps the reponsibility for this situation comes back to Congress.
The latter body has defined policy and provided..funds for. biomedical...
research on the one hand, and for health care (Medi-Care, Medicaid and
apparently soon some form of National Health Insurance) on the other.
_ , Senator Edward M. Kennedy
* - 28 July 1976
Page Six

But Congress has yet to define policy, establish responsiblity and

provide funds for the critical link between the two. However generously
our nation supports biomedical research and health care as separate
entities, the failure to provide a bridge between them will mean continuing
“loss on both sides. We fail to benefit from research findings and we
pay for out-moded and wasteful health care.

In my testimony 17 June 1976, I outlined several aspects of this
‘problem as follows: « .

“1, Clear definition of the mission, especially differentiation

fron biomedical research as it has developed in this country;
and emphasis on epidemiological studies and controlled field
trials, © - : co He

2. Establishment of a coherent staff and leadership dedicated to
the mission, not bits and pieces scattered through NIH and
- other: agencies of: the Federal government. _- ps

3. Sufficient budget, including present allocations scattered
_.,,through NIH and elsewhere in the Federal health agencies. __

‘4, Development of a substantial partnership with those outside
the Federal government, especially in state and local govern- —
ment, voluntary health agencies and many elements of the
health professions.

“5. Careful oversight by the Congress."

Some elaboration of these points may be useful.

The mission to be undertaken is to systematically (a) identify the
potential for improving health in the findings of biomedical research;

(b) explore the potential through technological development and strategic
-planning; (c) conduct clinical and field trials (demonstrations) of the
‘technology; (d) educate the health professions and the general public
"concerning health care technology, its uses and limitations; and (e)

promote a skillful and balanced application of new developments to
‘benefit the population. . oo

This mission should be differentiated fron that of biomedical
‘research, which is to discover new knowledge that may add to the potential
for improving health. The mission should also be differentiated from
that of health care, which is to deliver services that will improve

_.,,,health to the entire population, Obviously there will be overlap and. ....g6ec

ee hho. ok.
“ty Be

' interdigitation. Failure to recognize explicitly and provide for the
critical mission that lies between biomédical research and health care,

:.- however, continues. to. bea fundamental.weakness of U.S. national -health: 0 were Soe.

policy.
. Senator Edward M. Kennedy \
28 July 1976
Page Seven

To accomplish this mission will require establishment of a coherent
staff and leadership dedicated to it. Presently, to the extent that
this mission is undertaken, responsibility for it is scattered throughout
(a) NIH; (b) specific disease control programs fitfully started and
stopped by Congress and HEW, most recently in the Health Resources
Administration (HRA); and (c) various other units of the Federal health
. establishment such as C.D.C. and NIOSH. It certainly appears that not
‘much of this mission will be accomplished as long as Congress and HEW do
not charge some unit of HEW with responsibility for it and commit sufficient
funds to carry it out. Whether that unit should be NIH, C.D.C., HRA or
- some other should be determined by Congress after careful consideration
of where the mission fits best on the basis of history, current constituency,
‘present responsibilities and likely future development of each unit--
with or without this mission. Making the best determination will require
extensive and meticulous analysis.

Designating responsibility for the mission will be effective largely

_...to the extent that it is clearly. defined and sufficient resources appropriated.

‘to carry it out. Even a casual search will disclose hundreds of millions
of dollars already appropriated more or less for this purpose but so
diffused throughout the Federal health establishment that a critical

‘ “.mass’of talent, organization’ and resources does’ not exist in one place. “"~

.. The mission will require hundreds of millions of dollars, not the billions
now committed to biomedical research nor the tens of billions now committed _
- to health care, but still essential to realizing the benefit from those
larger present committments. ,

In this mission the Federal government cannot function effectively
alone. Many other elements of our nation are already striving, some of
‘them desperately and looking for Federal leadership, to develop the
application of biomedical research findings in health care. Important
‘among these elements are state and local governmental agencies, voluntary
health agencies committed to control of specific diseases, and several
groups of health professionals. A partnership should be established,
‘with the Federal government taking the lead and providing some coherence
‘and guidance.

Finally, of course, the Congress cannot deal with this matter "once and
for all."" Continuing oversight will be required.

I hope that these comments will be helpful in your consideration of
this important topic.

‘Sincerely yours,

Lester: Breslow, M.D.,°M,P.H.
Dean , ,

LB/P36

cc: Senator Alan Cranston