Public Policy and the Health of the Public

June E. Osborn, M. D.

The Simon Lecture — Brown University

January 29, 2001
Introductory Remarks

I am honored to have been invited to give this year’s Simon Lecture —
especially so in light of the distinguished speakers in whose footsteps I
follow. In conversation with Dr. Epstein I ascertained that an important
theme underlying the lecture series is that of activism. That word has many
meanings, but to me it connotes involvement — a way of taking one’s
knowledge and expertise and putting them to best use in a community
context; and so I chose as a title for this talk: “Public Policy and the Health
of the Public.”

I was a bit abashed at the “hype” advertising my lecture; but at least it
makes the point that I have had a varied — indeed, one might say, a
checkered — career. Over the years, particularly as I became noticeably |
involved in public policy matters, students have occasionally asked me
“How do I get to do what you do?” During this talk I will give you a partial
response to that question — at least I will tell you a bit about how I got to do
it. But a short answer is: you must work to become as good as you can be,
aiming your best talents at things you consider important and interesting;
and then you must “look up from the detail” at least long enough to find
ways to make your trained self useful to the world.

My career meanderings were governed by that principle, along with
two others that served as useful guides, both for me and later for my
children. First, don’t burn any bridges until you are sure you are done using
them; and second, try to make yourself as uniquely useful as possible. With
those precepts in mind, I went from med student to pediatric resident to
virology/infectious disease post-doc to medical school faculty member — and
that finally is where I began to recognize the importance of the “unique”
part; for by being dually trained in both clinical and basic sciences I began to
play a bridging role across the fault line between science and health care that |

 
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_ was just opening then but which has become a gaping chasm in present
times. I'll pick up on the further evolution of my career in a few moments,

but I wanted to be sure to make those points before getting distracted with
~ anecdotes and stories. .

Let me return to my title just briefly. You may notice that I didn’t use
the term “public health.” Public health as an organized field of academic
and professional endeavor is related in important ways to the health of the
public, but the terms are not congruent in their meaning — a fact that is
sometimes lost in policy discussion. There is a regrettable tendency to mix
and match indiscriminately between “medicine” and “health care,” between
biotechnologic advance and “major public health benefit.” And there is a
pervasive assumption, at least on the part of the medical profession, that the
entire domain of health —- public and otherwise -- and all related good works
flow from a medical education — or at least would, if physicians just had
enough time....And therein lies the seed of a serious problem, for in point of
fact, there are several health professions for a reason, and in addition there
are many other fields of expert endeavor that impinge directly on the health
of the public. To the extent that we are currently in difficulty concerning the
nation’s health status, not to mention the cost, access to and utilization of
care, a very real and affordable part of the solution lies in re-thinking and

optimizing medicine’s role as part of a teamwork approach in the overall
system.

At present, however, the profession of medicine is in the throes of a
severe and apparently progressive case of hubris — one that seriously
threatens our ability to take advantage of what we know just as the blossoms
of one hundred years of intellectual endeavor are coming to fruition. In my
view we need to back off, to recognize the complexities inherent in our
medical efforts in the interest of the health of the public, and to learn to work
in teamwork with the other profoundly important components that together
constitute the context for optimal human health and well-being.

So teamwork and humility are major themes for this homily — but
along the way I will try to give you an idea of how I came to feel so strongly
about such things and, in particular, how I ended up from time to time in the
public policy arena.
Background stories

Let me tell you some of my own story. First, it must be said that from
earliest days I was an inveterate reader. Even as a little kid I can remember
the pleasure of squirreling away with a good book in an alcove — sometimes
successfully hiding from my mother for hours at a time while she sought me
out to do chores. [I grew to suspect that she knew quite well where I was
_ but had just gone along with the ruse, since she was pleased with the

_Yationale.] Anyway, voracious reading has played a huge role in my life,
and I am often grateful that I was born before the distractions of television
threatened to obscure for me the mesmerizing, transforming effect of a really
good book! :

I also was of a practical bent, and without realizing exactly what I was
doing, I held a series of jobs as a college student that put my wide-ranging
curiosity to the test. I worked in sequential summers as a psychiatric aide in ©
a state mental hospital; then as an assistant to the nursing staff in a state
institution for the retarded; and next as a medical secretary for the chairman
of an academic ob-gyn department. Later on I realized that my early work
experience in what one might call “subordinate” roles in the health care
system had a lasting effect on my attitudes to the need for teamwork and the
efforts of those around me. [In case it sounds like I was all-work-and-no-

_ play, I should tell you that I spent the final summer before medical school
occupying — if not always playing -- last chair of the second violin section in
a Gilbert and Sullivan troupe on Cape Cod]. |

When I entered medical school in 1957 it was still that era when it
was generally assumed that women (or at least normal women) had no place
in medicine. Since I had been blessed with an easy capacity to learn,
memorize, etc., I wasn’t worried about academic success per se. Moreover I
discovered quickly that my gender could be turned to distinct advantage, in
that I stood out, the faculty learned my name instantly, and thus they became
more approachable and potentially useful as mentors.

Furthermore — and much to the point — my professors were, in general,
very grateful to find out that I had a sense of humor. Political correctness
had not yet begun to permeate academia (to put it mildly), and so a sense of
humor came in very handy on occasion. I could regale you with
superficially sexist anecdotes; but in truth I can only remember two or three

 
men who seemed to be genuinely and unfairly sexist — the rest just didn’t
quite know what to make of the likes of me but were sufficiently flexible to
find out and to give me the benefit of the doubt (which is, after all, the most
anyone can ask for). :

Luck was with me, too, in my choice of medical school. I had been
accepted at Harvard, where they were eager to attract and admit women,
having started to do so only eight years earlier. Instead, however, I enrolled
as a member of the fifth class in what was then Western Reserve University
Medical School’s “New Curriculum,” an audacious educational experiment
that had just broken the lock-step of twentieth-century medical education
irretrievably.

_ The changes were so drastic that the term “new curriculum” survives
to this day; but most people use it rather narrowly to connote the conversion
of standard curricular material into an integrated, multi-disciplinary format.
However, there was much more to the “new curriculum”’ than that; for the
goal of the ambitious cadre of faculty revolutionaries who launched the new
program had been to acquaint medical students with all facets of medicine as
a profession, from which we could then select a specific career path while at ~
least being aware of the myriad alternatives that coexisted.

Thus, over and above the startling innovations of an integrated
curriculum with a pass/fail grading system, we were required to do research
one day a week, to continue it in the summers if possible, and then to submit
a thesis as a graduation requirement. We were also required to have a family
under our care for whom we were shepherded into the role of primary care
physician over the course of our four years. And we were strongly
encouraged to do something outside of our strictly medical-school endeavors
in order to “stay human.” For that purpose there was allocated another day a
week of “free time,” and I interpreted that as an invitation to study art
history (which was an hiatus in my liberal arts education), and to do
volunteer work sweeping the floors of the Cleveland offices of the American
Civil Liberties Union on Saturdays.

Now, experiments like the new curriculum tend to lead to a
“Hawthorne effect” — the very fact that an optimistic experiment is in
progress leads to an enhanced result. We certainly experienced that; as the
fifth class to enter the experimental program, most of the fine-tuning was
done and yet ennui had not yet set in. We were excited! I joined (and later
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led) something called the Student Educational Policy Committee [think of it
— we're talking mid-fifties here! I have often taken pains to point out that
being “radical” in the 1950s was easy: one only had to entertain non-
traditional thoughts to qualify].

And I, and a like-minded group of activist classmates, banded together
to invite a series of speakers who were well outside of mainstream medicine.
One time we asked Walter Reuther to come talk to us about health care and
the UAW. On another occasion we invited the head of Kaiser-Permanente
to tell us about the earliest incarnation of “managed care,” which was very
avant garde at the time. Proponents of family planning told of their efforts —
keep in mind that this was not only before Roe v. Wade but pre-pill! And
Dr. Tom Dooley told us about the rigors of saving lives in Laos [which so
inspired me that it nearly aborted my future plans as I gave serious thought
to climbing on a plane and going to southeast Asia for a prolonged
“elective.” That was one of several times when my enthusiasm threatened to
get ahead of my ability to be helpful — so it was good that I calmed down in
due course. |

On what might be termed the “home front” we had prime seats from
which to experience, at a safe distance, a blast of racism so torrid that it was
within just a short while of burning down whole chunks of Cleveland (and
lots of other parts of the world besides). As students we lived in apartments
in the Hough area of Cleveland that-were being unabashedly converted from
decent to indecent housing. Between our first and second year we were told
to move out because both the rents and the occupancies were about to be
doubled. The landlords didn’t want majority witness to the outrage, and the
city fathers winked.

But we hung in there: we joined community groups, and in a city of
posh suburbs with names like Cleveland Heights and Shaker Heights, we
had stationery printed up with “Hough Heights” as our generic address.
[That the times had not yet changed as radically as they soon would was ~
evidenced by the fact that, when I climbed on the bus to go make house calls
on “my family” in the Hough Area, I wore my short white coat and carried a
black bag as protection! Drugs were still a few years away].

~ So medical school was full of facts and rigorous discipline; but also of
broad awakening to the health care issues accumulating and to the racial and

 
economic fault lines that were about to open wide. But rather than
hunkering down, we engaged! In fact, we interpreted our entry into the
world of medicine as a pass — an invitation — to involve ourselves with the
‘world at large. I am rather sure I didn’t think of John Donne then, but
hundreds of times later in my medical career his words echoed forward

_ across centuries of pain and progress: “No man is an island. Each is a part
of the continent, a piece of the main. Any man’s death diminishes me, for I
am part of mankind.”

Before I go further with the narrative, let me divert briefly to one
particularly important course I took in my last year at Oberlin. I saw pre-
medicine as something of a non-major. As a liberal arts student I was
supposedly becoming broadly educated; but I had learned the word
“dilettante” along the way and was worried. I toyed with the idea of doing a
double major, but instead I decided to take advanced courses to follow up on
“101” in each of as many fields as I could, working on the assumption that if
a little knowledge was a dangerous thing, a little more would at least serve a
cautionary purpose.

So I took courses in international economics, in abnormal psychology,
in modern European history, in biochemistry and — notably for these |
purposes — I took advanced readings courses in the philosophy of education
and of science. In the latter pursuit two life-long insights took form. First,
that the basic strategy of science is reductionism; and second, that the basic
methodology of science, when done right, is to attempt to disprove testable
hypotheses. Those two features of the scientific method twist and turn _
around the pillars of biomedical progress that now seem so solid. But I think
they are poorly appreciated, and failure to recognize their importance and
impact can lead to serious distortions.

I'll get back to reductionism later. But the disproof of hypotheses
deserves a moment of attention, for — while I didn’t see it then — it is the
most difficult aspect of the scientific endeavor, precisely because it runs so
counter to human nature. One observes, one reduces and isolates variables,
one sets up possible explanations .... and then designs and conducts
experiments that, ideally, are constructed to shoot down one’s very own best
ideas! How can one help but be invested in those ideas? Yet how can one
do the experiments dispassionately if one is embracing a central dogma?
That is the rationale for double-blind controls, of course, for indeed, without
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blinding it is rare to watch someone remain entirely uncommitted to a given
experimental outcome, much less to stick to his guns in the face of flak.

Later, during my faculty career, I had the privilege of watching at
close range as my wonderful colleague, Dr. Howard Temin, stayed
tenaciously with his experimental data over many years before the world
(and then the Nobel committee) would accept the notion that he (and,
subsequently, David Baltimore) had upended the central tenet of molecular
biology with the demonstration of reverse transcription. But don’t
underestimate the flak! It is now legendary, but no less true, that people
would walk out of sessions in which Howard was presenting papers with
experimental data suggesting ever more strongly that DNA could be copied
from RNA; but he slogged on.

Let me return to my main theme, however, for I promised to focus on
how I ended up in the public policy arena. Unquestionably my credentials
as a so-called “hard scientist” brought me credibility at critical junctures.
I’m not going to say much about my several-years career as a laboratory or
_ “basic” scientist (except to tell you that I was a modestly successful one,
publishing and not perishing, getting grants and serving on NIH’s
Experimental Virology Study Section).

But I must admit that I was very susceptible to the distorting effect of
that paradox in scientific method, whereby one needs to conjure up one’s
best ideas but then to attempt to disprove them. I am, by nature, an
 -enthusiast and I tended to love my ideas. When I was just getting started in
his laboratory, I was distressed when Dr. John Enders cautioned me that
“ideas are cheap” — for coming up with new ways of explaining biological
phenomena didn’t seem all that easy or cheap to me. A colleague who was a
much better scientist than I was summarized my problem well when he
commented, during those years, that I was forever having “ideas that
deserved to be right.” My tendency to iconoclasm was a potent generator of
such schemes and theories; but in general, they weren’t right. Nevertheless | .
always went after them with enthusiasm and often had to be “shot down” by
tougher-minded colleagues.

Early on, my post-doctoral professor, Dr. Donald Medearis, had
spotted that potentially fatal flaw of enthusiasm in my scientific armor.
There was a time when I had bounced into his office with a rather flimsy
research finding that seemed to lend marginal support to my idea of the day;

 
and he was clearly worried about my capacity for self-criticism. He said, in
anxious annoyance: “By all that’s holy, June, know ye that ye may be
wrong!’ Actually he didn’t just say it — he shouted it! Believe me, that
captured my attention. And while, when we later became close friends, he
learned that my tendency to enthusiasm wasn’t quite as distorting as he
feared, it happens to this day when I find myself climbing on another
bandwagon about something, that I mutter to myself “... Know ye that ye
may be wrong!” |

So the scientific method per se interested me. Dispassion, and a
willingness to be wrong, were added to my arsenal, although they needed
much attention and care in order to flourish. And I kept on reading with zeal
although somewhat furtively. There was a time in my residency at
Massachusetts General Hospital when, sitting with the same group of junior
and senior staff at lunch every day, I let it slip three times in one week that I
had recently read one or another non-medical book. On the third such
occasion, one of the faculty at the table turned to me and said, with ill-
concealed disapproval: “My, you read a lot, don’t you!” From that point on
I was much more careful about letting people know of my bibliophilia.

I said-I’d get back to reductionism, for that is the other concept that
grew in importance for me over the years. I am working my way towards a
discussion of hubris, as I said earlier, and much of the source of that hubris
resides in a forgetfulness about the intellectual reductionist tricks we play in
order to achieve step-by-step progress toward new biomedical insights. I am
not enough of a science historian to know if reductionism originated with
bacteriology, but certainly the microbiologists of one hundred years ago
exemplified the approach. From a sea of bacteria they would fish one single
bacterial cell and give it a clear pond of its own on an agar plate or in a test
tube. That allowed them to ignore the gaudy, confusing variety of its
surroundings, and instead let it do its own pure biochemical and
physiological thing in splendid isolation.

Reducing the complexity of life thus permitted study of phenomena
that were unique to that bacterium — but it also sometimes misled the
researchers, for the answers they derived in pristine surroundings had to hold
up in an intricately complex world of limited nutrients and competing
organisms, susceptible hosts and hostile environs. Pure reductionist science
is almost the exact opposite of the chaos of “real life.”
In the same way, clinical researchers in more recent years have been
trained, appropriately, to isolate one set of questions — does a small dose of
daily aspirin influence the risk of heart disease? Does a serum lead
concentration above a certain level hurt a child’s neurologic status and
potential?...and so forth. In a well-designed experiment, new levels of
understanding emerge about that variable, while all else is held constant.
But in the real world, “all else” almost never holds constant — so that the
daily dose of aspirin will rarely be the only change in heart-disease risk
factors, and an environment containing lead is likely to contain other toxic
elements that threaten a child’s developmental potential as well.

- The reductionist approach to human health and disease, backed up by
increasingly sophisticated biostatistical and epidemiological sciences, has
proved to be a mighty scalpel — dissecting out risk factors and mechanisms —
of disease and yielding insights that have liberated us from many fears,
while identifying specific threats that can be dealt with. It is good, and
useful...but it is subject to the same interpretive hazards that pertain to
laboratory-based reductionism: individual idiosyncrasy, familial malfunction
and potent societal poisons are very active factors in the final therapeutic or
preventive equilibrium and it is dangerously misleading to forget them or |
pretend they are not there. |

The great physicist Leo Szilard took up biology in the years after his
recantation of work on atomic weaponry. Throughout his career he was a
brilliant, iconoclastic thinker who tried to see science clearly and in human
context. As the shadow of nuclear war began to glower in the late 1930s, he
wrote his own set of Ten Commandments, the very first of which opened
with an admonition to recognize and remember the connectedness of
things. (Another, which grows increasingly relevant as interventionist
medicine gathers steam, was “Do not destroy what you cannot create.”]

My awareness of the pitfalls of reductionism as they pertained to
clinical medicine allowed me, increasingly, to recognize that one must
commit to putting pieces back together after having taken them apart for
purposes of diagnosis — to seeing the whole picture in the context of patients
and their complicated lives. It is superficially attractive to think of disease
as the enemy; but one needs to be aware that such a mind-set could lead to a
sense of failure or rejection if a patient’s problem proved chronic or

 
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intractable. Reductionist biomedical science allowed some things to be
cured — a wonderful fact that was almost never true one hundred years ago.

_ But in the glow of that success, physicians began to resist involvement
- with chronic or multifactorial disease, and to resent or even to blame

patients for what was called “non-compliance.” [In fact, one could actually
argue that so-called “failures of compliance” are at least equally the fault of
the putative care-giver, if indeed the proposed interventions are truly in the
best interest of the patient].. And of course in the real world, cures are
uncommon and never guaranteed to last forever — but illnesses and lives tend
to go on, and so does the need for care and compassion. One must, indeed,
yield up the superwoman cloak from time to time to keep in mind the
connectedness of things.

A Fast-Forward to My Faculty Career

J have paused over those special aspects of scientific method and of
reductionism because they grew in importance to my thinking as I |
progressed in my career in medicine. As a medical student, the excitement
implicit in their marvelous power was exemplified by the creation of polio
vaccines and the addition of new antibiotics to the short list that was
available when I started. And technology brought further wonders: I vividly
remember the film of the first cardiac catheterization which was shown to us
in class (since it was done in Cleveland, or so I was given to understand at
the time — and one needed to maintain a positive view of being in
Cleveland). We had to accept with faith the assertion that the snaky, jerky
whitish shadow was indeed a tube that had been threaded through someone’s
blood vessels; and that the intermittent plumes of white cloud that the tube

emitted were radio-opaque materials lighting up the inner workings of the
human heart. What a leap of faith! But the leap was extended well beyond
those shadows, for the implication was left that abolition of human heart
disease was just a few steps further down the technological road.

Indeed, there did follow a veritable cornucopia of biomedical
advances, wondrous and seemingly all-powerful. But the advances were, in
fact, only incremental — leading mostly to what Lewis Thomas referred to as
half-way technologies; and the sad fact was that all that extraordinary
progress was occurring against a background of racism, classism and social
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~ turmoil that would soon explode with enough fury to slash, scar and then
reconfigure our world. | |

I am glad to remember that I was at least somewhat aware of that
discordancy — but ashamed to realize how little it seemed one could do. I
guess that is where, over the years, I changed most profoundly — for over the
years I have found that it is a truly remarkable fringe benefit of being a well-
trained professional and maintaining one’s awareness of the needs of one’s
community to find out just how much one can do. My beloved friend
Jonathan Mann, who died at age 51 in the Swissair crash in 1998, had
managed to change the world in stunning ways before his tragic and
untimely death. He was the quintessential activist, and he chose the hardest
path possible, working within the stiff and bureaucratic constraints of the
international health community. And concerning activism, he said: “Some
people say that you can’t change the world. But if we don’t try, will it

change?”

| Again, I must get back to business. I finished medical school, did
pediatric training in Boston, virology and infectious disease training at Johns
Hopkins and at Pittsburgh, and then began my faculty career. Again, luck
and fate took a curious guise — nepotism laws were still in sway at the
University of Wisconsin where my about-to-be-husband was being sought
by the Department of Pediatrics. The rule was that spouses could not have
dominant appointments in the same department. I was co-equally trained as

_ a pediatrician and as a virologist at that point. Furthermore, they already had

a pediatric infectious disease person. And so I became, officially, a medical

- microbiologist and took over the teaching of infectious diseases in the
preclinical curriculum for the medical school. That suited me well, since I
happily had a son and then twin daughters fifteen months later, and I felt that
when I needed to cut corners in the interest of my kids, my career (rather
than someone else’s children) was what would be at stake. In fact I later
ended up doing plenty of pediatric infectious disease, since the Department
of Pediatrics suddenly lost the faculty member who had been playing that —
role; but by that time I had control of the situation and was able to call my
shots. |

And as a virologist, I had fallen into a veritable bed of clover — for I
had colleagues like Duard Walker and Howard Temin, Roland Rueckert and
Bob Hanson, who were preeminent leaders in the newly emerging field of
virology. We team-taught graduate courses together, ran joint seminars,

 
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served on doctoral students’ committees, and kept each other current and on
our toes. When Howard won the Nobel Prize in 1975 it was a particular —
thrill since he was as modest, analytical and thoughtful as anyone I had ever
known; and when his critiques of my science seemed particularly cutting and
I complained, he would say “You’d rather hear it here at home, wouldn’t |
you?” :

Howard’s rigor had a profound effect.on me in many ways, but one is
worth noting in view of what happened next. In 1975 a new virology study
section was created at NIH, since the original one (on which Howard was
serving) was being flooded with applications. I was asked to be on the new
one and said to Howard, when my first stack of 135 applications arrived: “I
understand what to do with the fifteen for which I am primary or secondary
reviewer...but what do I do with the rest?” His reply was: “That’s
everybody’s own decision. As for me, I read them.”

So I did too, and thus ended up inadvertently well prepared for what
was looming in our future. Over my years on study section (1975-1980) we
reviewed dozens — in fact hundreds — of research proposals having to do
with retrovirus infections. I used to complain about that, muttering sourly
that I thought it was outrageous to give them so much time and attention
when there wasn’t a single known retrovirus infection of humans! I was, of
_ course, about to be VERY wrong — for HIV was spreading silently and
relentlessly in human populations around the globe even as I complained!

And then came a final factor that impelled my entry into matters of
public policy: in 1972 Eliot Richardson, then-Secretary of Health, Education
and Welfare, declared that HEW advisory committees should include
women in their representation. [’ll never know how he came up with 42% as
the appropriate fraction, but he did — which meant that nearly 600 positions
_ should be filled by women at a time when there were only 300 tenured
women faculty in all the nation’s medical schools. My colleague Duard
Walker spotted the announcement of Richardson’s fiat in Science and put it
on my desk with a note attached that read like a Chinese fortune cookie,
saying “You will get many offers; hold out for what you want.” And boy,
was he right!

 

The first several requests were highly inappropriate to my expertise,
and I was in full turn-down mode when I got a call one day from Saul
Krugman asking me to serve on an FDA panel whose charge was to review
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all existing licensed viral and rickettsial vaccines — both the generic licenses
and the specific products on the market — for safety, efficacy and appropriate
labeling. Efficacy had only just been added to that list of FDA mandates and
a number of the vaccines for such diseases as yellow fever and smallpox pre-
dated the criteria that had later become available to judge them. I was torn;
there was no question that I was appropriately trained for that task, but it
sounded so dull....never have I been more wrong! Over the years from 1973
to 1979 our panel (composed in equal numbers of members over 60 and
under 40, in order to achieve a balance, I suppose) not only reviewed those
licenses, but we got caught in a maelstrom of dissident complaint and legal
protest that threatened to depose the very capable leadership of the Bureau
of Biologics at the FDA. |

There are some talents you don’t know you have until they are called
for. In my case it turned out that, under those kinds of circumstances, I was
able to remain cool and analytical in the face of ferocious attack and,
furthermore, that I could communicate clearly and in plain language with the
press. As time went on it became customary for the “feds” to cast me in lead
roles, and when in 1977 Russian flu followed quickly in the wake of “swine
flu,” I was pressed into service to chair and/or summarize meetings at the
level of the Secretary of HEW, who by then was Joseph A. Califano, Jr. [To
this day Joe has remained both a public policy mentor and a wonderfully
supportive personal friend. ]

Finally came AIDS. People have asked how I happened to be
involved in it so quickly, for by January of 1984 I was made chairwoman of
the NIH’s advisory group on AIDS and the nation’s blood supply, a role I
held until 1989 when I was elected chair of the National Commission on
AIDS. But there wasn’t much mystery about why they turned to me: it was
as if I had been in training for the epidemic, with both virology and clinical
infectious disease in my background, and plenty of time logged as both a
federal advisor and as a communicator to the press. And all of that was
needed, as you know, for the complexity of the AIDS epidemic begged
every question I had ever pondered and added vastly more to the long list of
unknowns with which we were grappling. All of my awareness of
complexity, of the social context within which dreadful epidemic things
were happening, and of the need to bring both expertise and compassion to ©
the approach to matters of public health were put to the test. And all the
eclectic reading I had been doing suddenly took on the value of my most

 
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cherished resource. Even so, as I look back I am humbled to realize how
little I knew then, and what a steep learning curve I had yet to mount.

Cases in Point: Public Policy and AIDS

Obviously there is a long story there that won’t be told today; but I
started this talk by saying that, to do what I did, one needed to be deeply
trained and then look for ways in which that competence could help. At the
outset of the AIDS epidemic we had to deal with raw fear, and later (and
still) with the public’s insistence on what I call “their perceived right to be
fearful.”? But with time, reductionism served; HIV was identified and
vaccines suddenly loomed as the putative way out of a worldwide mess.
Firm data had shown that the routes of transmission of HIV were few, were
avoidable, and that prevention worked when those concepts were
implemented with conviction.

Yet the world in general was in the habit of associating viruses with
vaccines and invoking the word “vaccine” almost worshipfully as the
ultimate solution to nearly anything. I found that attitude particularly
unsettling, since I had just spent years fending off dissidents and nay-sayers
who declaimed about the imputed evils of demonstrably wonderful vaccines
for relatively straightforward diseases. The idea that a vaccine against HIV
would somehow be a “magic bullet” to ease the world’s fears (and thus erase
its need to rethink sexual and drug-using mores) was astonishing to me.

That reliance on a vaccine approach was problematic was all the more
clear to me, given that HIV was one virus that actually could be avoided,
and my years of viral vaccine review told me that there was no vaccine as
~ good as that. The very best vaccines we had — against measles or yellow
fever, for instance — were live and attenuated, and they imitated natural
protective immunity; but while they were good they were only 98%
effective, not 100%, and then only against sporadic epidemic pressure. HIV
was a sexually transmitted agent that was difficult if not impossible to
attenuate, for which there was no known protective immunity to be imitated,
and that was rapidly becoming endemic, as well as presenting a steady threat
throughout a sexually-active lifetime. |

- Altogether, then, I found it very worrisome that the public viewed a
_ vaccine approach as the ultimate solution to the AIDS pandemic, and indeed
15

in 1991 I gave a talk entitled “What would we do with a good AIDS vaccine
if we had one?” The “we” I was talking about in that case was Americans —
for there never was any question that a vaccine would be crucial to parts of
the world where double-digit seroprevalence was already a fact of life. But
in the U. S. it was not then (and, I might add, is not now) clear to me what
we would do with an HIV vaccine that wouldn’t displace, and do less well
than, other prevention efforts.

Needless to say I was not always very popular with the leadership of
NIH when I said such things. [In fact, there was one amusing episode in
which I was being interviewed about some facet of AIDS vaccines on Good
Morning America in New York, and Tony Fauci, Director of the National
Institute on Infectious Diseases, was being interviewed from a studio in
Washington. Unbeknownst to Tony, he was visible on our screen in the
New York studio even when he wasn’t talking, and when I went into my
prevention-not-just-vaccine routine, he all but crossed his eyes and mouthed
“There she goes again!”] To be fair to Tony, we were and have remained
good friends over the years, and in fact he is one of my strongest supporters
in trying to keep behavioral prevention on the table when so-called “hard
science” threatens to displace it entirely.

Anyway, I persevered -- which I suppose is the other quality I should
mention about being a public policy person. If your data are appropriate and
pertinent, then being scowled at or shouted down becomes irrelevant, and it
doesn’t make much sense to take it personally. Indeed, one of my favorite
anecdotes about that appeared just as my involvement in policy matters was
starting. I had begun to enjoy reading the comments of an analyst named
Daniel Greenberg, who wrote about health and public policyina
Washington biweekly publication. One day he had a column entitled: “On
the importance of stamina in the political process.” In it he told a story
about the grand opening of Lincoln Center in the early 1960s, for which
event Victor Borge had been asked to perform and to comment in his usual
fashion. |

On the appropriate evening Borge played the piano while expressing,
from the stage, his admiration for all the lavish and plush accoutrements —
the carpets, the tapestries, the chandeliers and so forth. He then proposed to
go into the audience to solicit their reactions. He got to the edge of the stage
holding his microphone, but then its cord stopped him; assuming that it was
snarled, he turned to untangle it, but it turned out that that was all the cord

 
16

there was. So he turned to the audience, sighed loudly into the microphone,
and said “Ah, and to think that for $1.29 more they could have gone all the
way!” [I can’t tell you how many times I have whispered to myself in public
policy discussions: “Only $1.29 more.”]

Reductionism and AIDS Vaccines: Some Further Comments

So to diligent training applied in an appropriate context and in
‘teamwork with others who bring different backgrounds to the table, I add
stamina as a necessary ingredient if one wants to change the world. That
sounds like a rather trivial comment, unless you realize that many
professionals try to substitute authority for stamina. Once having
declaimed, they feel good about having done so; and if their authoritative
assertions are not quickly and fully embraced, they stalk off, congratulating
themselves that they have done their best. That isn’t their best! It is in the
“heavy lifting” between having expertise and making it useful that the public
policy issues are at their most tendentious and important, and it is there, too,
that the awareness of reality constraints and of the intermeshing roles of
multiple kinds of expertise become crucial. .

And that brings me back once more to the topic of AIDS vaccines, for
as you know there is now a much-increased and broadened set of efforts

being devoted to their development as the global disaster of HIV/AIDS
continues to unfold. |

My role with the National Commission on AIDS ended in the fall of
1993, but I was pressed into service in a few contexts thereafter. One of the
most interesting was a fascinating series of discussions — co-sponsored by
the AIDS Action Council and by NIH over an 18-month period to ascertain
what social and cultural impediments there might be to the large-scale
(Phase III) testing of an AIDS vaccine should one become available. The
idea was to anticipate and grapple with as many problems as possible so that
time wouldn’t be lost later; and the group was the most heterogeneous
collection of bright, earnest, dedicated individuals you could imagine — in
fact, the heterogeneity went well beyond what I could have imagined. I
think it is enough to say, for purposes of this discussion, that I was one of
very few so-called health “credentialed” participants in the group, and the
temptation to pull rank was dangerously attractive. :
But the deeper into our charge we dove, the more challenging it
became, for, as the group “gelled” and began to trust one another, whole
worlds of fear and anxiety surfaced. We were shown a videotape of African
American men and women berating a peer because he had participated in a
phase I trial of a candidate HIV vaccine — they were implying that he had
been “duped,” and he looked miserably embarrassed, as one does when
castigated for naivete. We heard anecdotal accounts of the bad things that
had happened to people who had lined up for such trials out of altruism:

_ even though by definition they had to be “low risk” in order to participate in
the Phase I trials, suddenly they faced the threat of spousal mistrust or even
(in one case) divorce. Problems with the military or with travel were
documented for it was, and still is, illegal for someone who is HIV-positive
to enter the United States. And we learned to know of all sorts of other
uncertainties about their fates that arose from the fact that they might
become seropositive in the context of vaccine trials.

~~ Equally worrying, on the other hand, we heard detailed accounts of
people who completely ignored the careful, cautious disclaimers from
investigators in such trials that they might be given placebo. The concept of
placebo is difficult for most people in the health care setting, and
enthusiastic trial participants would state with great confidence that they
were quite sure they were “getting the vaccine” and that it would protect |
them because “that nice doctor wouldn’t do anything to hurt me.” And,
throughout, we heard that the world considered behavioral interventions too
difficult, although it was acknowledged that they had worked and could
continue to work when applied with diligence and conviction.

- Finally, to do any Phase III trial that could yield meaningful evidence
of protection from vaccine, one needed populations with 1-2% annual
seroincidence of HIV infection. It was uniformly assumed that no trials
would be ethical if the highest level of valid behavioral interventions were
not offered to everyone throughout, but it was problematic as to how that
could be done in settings where untreated substance abuse, homelessness
and lack of access to health information and care provided the very backdrop
against which such trials (in the U.S.) were even statistically feasible, given
seroincidence data. Oh dear! A genuine Catch-22! The magic glow
emanating from that word “vaccine” certainly began to fade during those
_ discussions. :

 
18

That was in the mid-1990s. With the energy and resources now being
devoted to AIDS vaccine efforts, things have moved along. The very
strategies have shifted as recognition has come that cytotoxic T lymphocytic
responses, rather than antibody responses, are more likely to correlate with
protection; and at last people are trying to develop vaccines with HIV-1
subtypes appropriate to the populations that need protection. But the
disconnect between high science and earthy reality remains, as I was
reminded the other day.

I was skimming through Science magazine, when, in the
correspondence section, I noticed a thoughtful letter about use of a DNA
vaccine against simian immunodeficiency virus in rhesus monkeys. The
vaccine itself was only marginally protective, but it seemed, when |

‘augmented, to have been greatly enhanced in its capacity to prevent clinical
AIDS. The augmentation effort was targeted at eliciting CTLs and other
TH1 responses, using a purified fusion protein (representing IL-2 and the Fc
portion of IgG). That augmentation had a very impressive effect, raising the
‘DNA vaccine from marginally to distinctly protective in rhesus monkeys
when they were subsequently challenged with virulent virus. So far so good.

 

The letter writers, from South Africa, applauded the study and .
commented on the therapeutic effect noted with interleukin-2 treatment in
people living with AIDS. From their vantagepoint, however, those findings
raised the potentially complicating problem of a high prevalence of parasitic
infestation in sub-Saharan Africa — especially helminthic infections which
have been shown to impair pathways leading to IL-2 (and related) responses.
Their query was: should not treatment or prevention of helminthiasis be
considered as a necessary prelude to HIV vaccine trials, since otherwise one
might be misled and fail to demonstrate potential efficacy in helminth-
infested trial participants. ©

I thought that was a terrific question and an unusually fine example of
keeping in mind Leo Szilard’s connectedness of things. But the response
quite took my breath away; for in answering the letter the American
investigators who had authored the initial paper, while paying lip service to
the importance of the issues raised concerning HIV vaccine trials in Africa,
suggested (and I quote): “...a possible solution to this problem might be to
co-administer cytokines such as IL-2 or IL-12 with candidate HIV vaccines
to drive the vaccine-elicited Thl immune response, perhaps by using a
protocol similar to the one we reported in our research article.”
Ta-dah! Their solution to a worldwide pandemic that, in the area in
question, threatens to decimate young adult populations, was not a
suggestion to attack helminths but rather a proposal to escalate the
technology and cost of vaccine with fusion protein or interleukin-2
augmentation, thus rendering it essentially meaningless to the region, even if
it proved to be protective! Wow! That is a fine example of what I have
been referring to when I speak of hubris — the “piling on” of one technologic
intervention on top of another at the expense of common sense and “low-__.
tech” prevention. |

And it doesn’t just occur in the AIDS arena. That written exchange in
Science put me in mind of a talk I heard at a meeting at the Howard Hughes
Medical Institute about a year ago in which a molecular genomics enthusiast
declaimed brilliantly on progress in the human genome project, noting that
soon we would be the proud possessors of data that defined (by his estimate)
80,000 genes and their products. His happy conclusion was that that would
give us 80,000 new targets for pharmaceuticals! The idea that anything else
might be needed to deploy that information in the interest of the health of
the public seemed not to have occurred to him.

Such truncated thinking can be found in other aspects of health care.
In a 1996 meeting that was called by the Kaiser Family Foundation to try to
- bring together the entirely separate worlds of managed care and of
HIV/AIDS care. As the topic of homelessness came up, I was somewhat
startled to hear the managed care types say that they had to draw the line
short of providing social services. During the AIDS Commission years I had
come away with a very strong conviction that housing was the single most
important, fundamental determinant of health status for a person living with
AIDS, and so the categorical drawing of a line in that part of the sand
astonished me. Before I could figure out what to say, however, a colleague
beat me to it, commenting dryly that “...so far as I’m concerned, ‘managed
care for the homeless’ is an oxymoron!” Yes!

I could go on like this at even greater length, but time is flying, and I
suspect that by now you can tell where I am coming from. I hope no one
thinks I am decrying the wonderful biomedical progress that has been made
over the course of recent decades. It is crucial, and momentum must be
maintained. But it is not available to all — the old, ugly backdrop of

 
20

‘community and social ills that complicate its usage has not gone away.
Systematic health care is not available to millions of our fellow citizens, and
health care of any kind whatsoever is not available to great numbers of
denizens of the global village.

And then there are whole areas of health and of medical care in which
we are not even using common sense. Substance abuse, for instance. It has
been declared a national problem so severe that we have been conducting a
“war on drugs” for decades — but mostly at the borders, rhetoric to the
contrary notwithstanding. Actually the war has been on drug users, with no
accommodation made for the prisoners of that war; in fact our chief
therapeutic weapon to date has been incarceration.

Now things may be changing, with many thanks to the extraordinary
efforts of your colleague David Lewis, whose inspiration it was to call
together a group called Physician Leadership on National Drug Policy. That
- group epitomizes almost perfectly what I have been trying to get at
throughout this talk, for it enjoys voluntary contributions of the genuine
expertise of countless professionals involved in trying to bring substance
abuse treatment to the fore; but it is led by physicians not in that field who
collectively have extensive public policy experience. We are thus able to
convey the simple, clear message that substance abuse and addiction are
illnesses, that they are treatable in the same way as are other chronic
diseases, and that the cost-effectiveness of that approach puts our
incarceration mode to shame. And my earlier experience has been strongly
affirmed: the very fact that dedicated professionals are willing to make the
effort to grapple with complex problems has captured the attention of policy
makers and moved us distinctly closer to revising policy. In fact, the
response from involved parties in other professions — the judiciary and law
enforcement officials, for instance -- has been genuine delight that “doctors
are at last willing to get involved.”

Let me conclude with a few remarks aimed at those of you who are
still early in your careers and to whom it sounds unreal at present to think
about doing anything beyond what is required of you. I want to point out
that the key role you can play is never obvious in advance, and that the
secret lies in your willingness to maintain an awareness of the world around
you. In the AIDS epidemic, the critical players were experts in their fields
(whether epidemiologists or oncologists or other health care professionals),
21

but they knew enough about the world around them to recognize an urgent
and unprecedented need. Some re-directed their careers entirely. Others,
like me, kept close track so that expertise could be brought to bear quickly
when called for. And you — who are currently-immersed in demanding
courses of training — can keep yourselves prepared to do likewise. The
needs for activism will change and evolve, but they will never go away!

- And J assure you that, if you decide to be an active participant, your lives
will be greatly enhanced! |

‘Thank you.