Plagues, Products, and Politics: Emergent Public Health Hazards and National Policymaking

111 Pages·1994·6.518 MB·English

by  Christopher H. Foreman

Plagues,
Products,
anPd olitics
Plagues,
Products,
Politics
and
EmerPguebnHltei acHl atzha rds
anNda tiPoonlailc ymaking
ChriphsetHro.F oremJarn.,
The Brookings Institution
WASHINGTOND,. C.
(B
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Foreword
The American public fears for its health in many ways. Chronic threats
such as cancer and heart disease are a familiar worry. Another concern,
however, is the infectious disease or dangerous product that victimizes
quickly and perhaps in ways unfamiliar to the general public. Although
science, sanitation, and regulation have triumphed over diseases such
as polio and smallpox and ended the most egregious horrors of product
adulteration, new or suddenly prominent dangers, whether natural
(AIDS, Lyme disease) or artificial (hazardous medical devices), still
pose significant policy challenges.
In this volume Christopher H. Foreman, Jr., a senior fellow in the
Brookings Governmental Studies program, offers a wide-ranging dis­
cussion of emergent public health hazards. Despite public expectation
that the federal government will handle health and safety problems
swiftly and effectively, he argues, the appropriate agencies remain
largely hostage to technical uncertainties and external political forces
that are often hard to overcome. Although critics often point their finger
at an agency's upper echelons, Foreman shows how policy tends to be
shaped more often by technical and political constraints than by the
quality or commitment of agency leadership. Foreman advocates
improved national and global surveillance as an essential and politically
feasible weapon against emergent public health hazards.
The author wishes to thank several persons who read all or part of
the manuscript. They include Christopher J. Basso, Stephen Klaidman,
Thomas E. Mann, Gilbert S. Omenn, Paul J. Quirk, Bert A. Rockman,
Harvey M. Sapolsky, R. Kent Weaver, Joseph White, and James Q.
Wilson. He also appreciates the helpful discussions with Mark C. Rom,
formerly at the General Accounting Office. Daniel A. Hofherr, Lawrence
F. Jindra, Paul Joyce, Jonathan Kay, Mark Lotwis, and Ilyse Veron
offered research assistance at various stages of this project.
vii
viii Foreword
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LockwaonoCddyn thTiear arseslisis ntth peerd e paorfta htmeia onnu ­
Contents
script.
Thvei eewxsp rehsesraeersd eo ltehloyos fte h aeu tahnosdrh ould
nobtea scrtiotb hpeeed r swohnosas ses isitasac nkcneo wlaebdogveed
ort toh ter usotfefeioscro,e t rhsset,rma efmfb oetfrh sBe r ookIinnsgtsi ­
tution.
BRUCE K. MACLAURY
VisiVbilcet ims
President 1. 1
July 1994 A LitaonfPy r obl/e 5m s
Washington, D.C. EmergPeunbtlH ieca lHtahz a/r d7s
TheS pecPiraolb loefAm I D/S 1 1
Institutions
2.
14
PoliAccyt /o r1s4
PolicMya nda/t 2e3s
Conclu/s 2i7o n
3.D etection
RecognainzdRi enpgo r/t 2i9n g
Mobil/i z4i1n g
SourocfeC so ntro/v 4e7r sy
Conclu/s 5i5o n
4.I nterventions 58
FedeCraapla caintEdym ergPeunbtlH ieca lth
Haza/r d6s0
Conclu/s 7i5o n
5.E ducation
AID/S 77
ReyeS'ysn dr/o 8m1e
ToxSihco Scykn dr/o 8m5e
Conclu/s 8i7o n
ix
x Contents
6.R egulation
One
Product Withdrawals / 90
Product Approvals / 100 VisiVbilcet ims
Process Regulation / 105
Conclusion / 112
7. Research 115
Funding/ 116
Research and Its Management/ 123
Conclusion/ 136
T HISB OOK is about unpleasant surprises. It examines the
8. Prospects American national government's capacity to respond to a
diverse but distinctive category of public health problem: the suddenly
Limits of Anticipation / 140
prominent, and often newly recognized, imminent hazard that may
Prospects for Resilience / 143
spread unless contained. The threats discussed include communicable
diseases such as acquired immunodeficiency syndrome (AIDS), Lyme
Notes 155
disease, Legionnaires' disease, and drug-resistant tuberculosis (TB) as
well as product-related dangers such as injurious vaccines, silicone
Index 201
breast implants, and cyanide-laced Tylenol. These problems share traits
that make prompt and effective action desirable but differ dramatically
in their susceptibility to intervention.' Because such hazards can cause
serious harm to identifiable individuals and could victimize more
widely unless something is done, aggressive federal involvement usu­
ally is expected.
What can the national government realistically deliver? Govern­
ment's responsibility is to investigate the scope, severity, and cause of
victimization. If the problem is a product, regulators might want to
withdraw it or limit its availability. Government may also facilitate the
search for, or distribution of, ameliorative technologies and preventive
information. The environment in which government must do all these
things imposes many constraints. The most basic and crucial one is the
state of relevant technical knowledge and how easy it is to acquire. But
institutional and political factors also hinder effectiveness. Bureaucrats,
politicians, and organized interests may disagree among themselves.
Federal officials may also be unable to influence adequately state-level
and local dynamics, and public health is predominantly a state and
local function. An independent media may be an engine of excessive
fear or an invaluable tool for public education and awareness. Agencies
1
2 Plagues, Products, and Politics Visible Victims 3
at all levels may have to reallocate resources or reorganize to handle Having told the public for years that AIDS was such a threat that
a new problem. The way society at-large regards hazard victims, and it demanded changes in fundamental human behavior, many
whether those victims are vocal or silent, is also significant. [researchers and public health officials] wonder whether ii is now
The dangers discussed here confront federal policymakers with at too late to tum around and tell the world that AIDS poses no special
least five broad and overlapping tasks: outbreak discovery; field investi­ risk in the health care setting or from immigrants. And if AIDS really
gation; field intervention (including education for professionals and does become like just any other disease, how will it be possible to
the public); the regulation of products and processes; and biomedical maintain its privileged political status as the medical condition on
research. This book examines the blend of technical, institutional, and which more is spent per capita than any other in U.S. history?'
political challenges inherent in these tasks. Each produces different
constraints from every other (even for the same hazard), and success The second tension is the extent to which decisionmaking by scien­
is often limited, underappreciated, or difficult to evaluate. tific or technical experts can and should be insulated from politics.3
politics
Two overlapping tensions afflict policymaking for emergent public The word carries at least two connotations. One is anchored in
health hazards. The first is the challenge of striking a workable and self-interest. Individuals and institutions try to maximize credit, avoid
justifiable balance between urgency and restraint. The practical diffi­ blame, conserve power, and protect their interests.4 For scientists and
culty of striking such a balance in public health is formidable and in officials alike, political often implies "undesirably nonscientific." More
some respects resembles the formulation of national defense policy. broadly, the term describes the struggle to govern-the process by
When confronted by a resourceful and unpredictable military foe, the which agendas emerge, coalitions form or expire, and fundamental
nation might have to be rallied quickly in support of tangible counter­ public values (accountability, fairness, responsiveness, and efficiency)
measures while remaining sensitive to limited knowledge, shifting cir­ claim attention.5
cumstances, and the possibility that some types of response might Every aspect of the way society handles hazards to human health
either make war more likely or strengthen the enemy's hand should is inherently political in both senses. Once victimization by disease has
war break out. On the one hand, a state of continued alert may be hard occurred, the problem must be both recognized and believed worth
to sustain and may prove costly, in ways both tangible and intangible, reacting to. Enlarging the share of staff time, research funds, or regula­
if substantial resources are committed but no major threat emerges. tory enforcement committed to a problem requires that its priority be
No one wants a disruptive panic. On the other hand, tardy response raised where it counts-in the relevant government agencies and, in
is also intolerable. Failure to anticipate or to respond quickly to a some cases, among elected officials and the general public. And the
significant threat invites blame. Neither public health officials nor mili­ resulting agendas and policies are never fixed but are instead continu­
tary commanders want to have to explain to administrative superiors, ally open lo challenge and renegotiation. After more than a decade
politicians, or inquiring reporters why caution prevailed when vigorous and many tens of thousands of deaths in the United States alone, the
action was clearly called for. priority given to the AIDS epidemic is still contested. Some activists
The AIDS epidemic has become the most complex balancing act remain convinced that the government is not doing enough, despite
between urgency and restraint in public health. Health authorities and the thorough institutionalization of the clisease as a top priority among
AIDS activists tell the American people to view AIDS as a grave and public health agencies and the evolution of a virtual "AIDS establish­
immediate threat, but not to succumb to panic or encroach on the rights ment."6 Meanwhile, some critics argue that the epidemic has been
of infected persons. Efforts to straddle the divide between urgency oversold, clisplacing attention and draming resources that could be
and restraint risk confusing the public, however. As one perceptive better deployed elsewhere.' Other ailments such as Lyme disease and
journalist observed in mid-1991: chronic fatigue syndrome engage smaller and less aggressive constitu-
Plagues, Products, and Politics
4 Visible Victims 5
encies and are less visible to politicians, but they are political in the A Litany of Problems
same sense.
Though essential, the political process tends to be messy and unpre­ At the beginning of the 1980s a general impression existed that the
dictable. The behavior of journalists, organized interests, and politicians battle against infectious diseases had been largely won in the industrial­
may have both positive and negative effects. Their attention may gener­ ized Western nations. The result was a complacency later widely recog­
8
ate additional resources, heightened accountability, and necessary pub­ nized as misguided. With smallpox officially proclaimed eradicated,
lic awareness. But a perception of crisis or insufficient response might and many other communicable scourges largely tamed by the combined
assaults of science and sanitation, an era of chronic and degenerative
also spawn destructive political meddling, stressful (and perhaps
9
unnecessary) change in established agency routines or priorities, and ailments seemed to have dawned. A much-noted irony is that the most
undue public alarm. Controversy is hard to anticipate or control once feared and publicized health threat of the 1980s would tum out to be
unleashed. Organized interests will push for either a more aggressive an infectious disease: AIDS triggered by the spread of the human
immunodeficiency virus (HIV),10 Since the early 1970s numerous other
response or a more restrained one, independently of (and perhaps in
public health threats posing serious and quickly manifested harm
opposition to) the desires of government officials.
achieved sudden, and usually brief, prominence:
Professed dissatisfaction among even successful policy advocates is
-In 1976 Americans were told by the federal government that a
not surprising and must be interpreted with caution. Advocates suc­
particularly virulent strain of influenza, the so-called swine flu, might
ceed, in part, by asserting that their efforts have borne insufficient fruit.
soon appear, perhaps lo cause a degree of flu-associated illness and
Such claims, a routine part of the political process, keep followers
death not seen since the infamous 1918-19 pandemic that killed more
and allies mobilized, the press attentive, and target institutions on the
than half a million persons in the United States alone.11
defensive. Advocates are cross-pressured to appear both reasonable
-In the summer of 1976 a previously unknown ailment struck 182
and tough, with the relative emphasis depending on the circumstances.
persons attending the Pennsylvania state convention of the American
Moreover, only something close to a genuine state of war (not the
Legion. Of these, 29 would die." Ever since, Legionnaires' disease has
occasional bursts of attention to ongoing problems such as poverty,
been part of the lexicon of public health, and outbreaks recur."
cancer, or illegal drugs that sponsors hyperbolically trumpet as war)
-In late 1976 the swine flu vaccine program was abruptly halted
elicits from the nation the kind of coordinated and committed emer­ when officials discovered an association between the vaccine and a rare
gency response that would satisfy advocates.
ascending paralysis called Guillain-Barre syndrome (GBS). Although
Public policies generally should be effective and balanced, maximiz­
swine influenza did not sweep the United States, 532 vaccinees would
ing positive impact while minimizing damaging diversions and various 14
contract GBS, leading to 32 deaths.
kinds of overkill. Health hazards are no exception. The central theme
-In the early 1980s American women learned that tampons used
of this volume is that government's ability to achieve ideal public policy to absorb menstrual flow could also produce a serious and potentially
hinges mostly on characteristics and uncertainties inherent in specific deadly condition called toxic shock syndrome (TSS). Although an aver­
hazards, and on conflicts uncontrollably provoked by them, far more age of 420 cases of TSS per year was reported to the Centers for Disease
than on the strategies and leadership of federal agencies. This book Control (CDC) during the period 1983-88, the actual number of cases
does not posit, let alone specify, a precise path to the perfect balancing was doubtless much higher.1 5
of the tensions it demonstrates. But a review of past problems can be -In the early 1970s an intrauterine contraceptive device used by
useful for coping with future ones despite the unpredictability of haz­ more than 2 million American women, the Dalkon Shield, caused pain­
ards yet to come. History can be instructive and, among other things, ful infections and irrevocable injuries, including infertility, triggering
16
teaches its students to be wary of refighting the same wars. litigation that would stretch throughout the 198os.
6 Plagues, Products, and Politics Visible Victims 7
-In the 1980s Reye's syndrome (RS), a rare and sometimes fatal -In 1991-92 a long-simmering dispute over the potential risks asso­
condition striking children after they took aspirin for flu or chicken pox, ciated with silicone breast implants made headlines. As many as one
captured headlines across the country. The number of cases reported to million to two million American women had implants, which were
the CDC reached a high of 555 in 1980, declining to a mere 20 by 1988 employed both for cosmetic breast enlargement and for postsurgical
because adults had learned to avoid giving aspirin to ill children. reconstruction. Some recipients, plagued by pain, scarring, hardened
As with TSS, the peak figure for reported cases understated the true tissue, silicone leakage, and other problems, deemed the product a
incidence of RS." curse. But to others implants were a psychological boost.24
-In 1979 two soy-based infant formulas, inadvertently rendered -ln late 1991 the press reported on new drug-resistant strains of
chloride-deficient, were found to cause serious metabolic disturbances, tuberculosis associated with thirteen deaths in the New York prison
prompting a recall, a wave of publicity, and a congressional investiga­ system.25 By the following May, the federal government had announced
tion resulting in new protective legislation. In 1982 a batch of vitamin­ a plan to combat the spread of drug-resistant TB. Officials declared
deficient formula triggered another public scandal.18 that TB was "out of control in the United States."26
-In the autumn of 1982, the nation was stunned by reports that -In January- February 1993 news came that hamburgers consumed
at certain fast-food outlets in Washington state had been contaminated
capsules of Tylenol, a popular pain-reliever, had been emptied, refilled
Escherichia coli (E.coli
with a particular serotype of 0157'H7), a bacterium
with cyanide, and placed back on a store shelf in the Chicago area.
that thrives in the intestines of healthy cattle. The nearly five hundred
Seven persons died as a result. In February 1986 a woman in Yonkers,
New York, died when she, too, took cyanide masquerading as Tylenol, reported cases of bloody diarrhea and hemolytic uremic syndrome in
causing another wave of media attention and public concern. 19 Washington were part of an eventual four-state outbreak of an illness
first identified in 1982.27
-In 1984 an intravenous form of vitamin E known as E-Ferol, mar­
-May 1993 brought reports of a frightening new illness in the south­
keted without Food and Drug Administration (FDA) approval, was
western United States, characterized by "abrupt onset of fever, myal­
implicated in thirty-eight infant deaths, prompting a congressional
investigation.20 gias, headache, and cough, followed by the rapid development of
respiratory failure."28 By June 21, eighteen persons had died from what
-In 1988 the United States reported some five thousand cases of
would be formally labeled hantavirus pulmonary syndrome (HPS),
Lyme disease, an ailment first recognized in the mid-197os and associ­
acquired from rodent droppings.29
ated with headache, fever, arthritic symptoms-it was originally
dubbed Lyme arthritis-and neurological abnormalities.21
-In late 1989 public health authorities reported that an over-the­ Emergent Public Health Hazards
counter diet supplement, L-tryptophan, was associated with a rare
Despite their many differences, these episodes share certain general
blood disorder called eosinophilia-myalgia syndrome. L-tryptophan
characteristics that make them a distinctive challenge to policymakers,
was recalled, but not before thousands had been poisoned and twenty­ emergent public
especially at the federal level. Each is an example of an
seven were killed by what turned out to be a contaminant.22 health hazard,
which is an infectious disease or product-associated dan­
-Beginning in the early 1980s large numbers of persons, young ger with three general attributes: First, such a hazard victimizes rela­
Caucasian women in particular, began to seek treatment for what public tively soon after exposure. Second, the potential exists for the hazard
health authorities would ultimately label chronic fatigue syndrome to spread, by one means or another, to many more victims far beyond
(CFS). An ailment whose onset is often marked by flu-like symptoms, the points of origin or discovery (unlike a plane crash or bridge col­
CFS tends to strike "suddenly and is relentless or relapsing, causing lapse). Third, the hazard embodies a large measure of novelty, which
tiredness or easy fatigability in someone who has no apparent reason facilitates uncertainty and even panic. The hazard that is new or newly
for feeling this way."23 recognized or suddenly ascendant as a matter of public anxiety is a
8 Plagues, Products, and Politics Visible Victims 9
30
special challenge. In the more persistent and better-publicized epi­ eat, Alar was withdrawn from the market. The scare yielded a major
35
sodes, a nationwide apprehension prevails. Tangible victimization is epidemic of fear but no identifiable victims of Alar.
generally restricted, but a secondary "epidemic of fear" is always a The emergent public health hazard is different. It claims authentic
1
possibility and usually far more widespread.3 and visible victims, not invisible or hypothetical ones. The costs of
inaction are thus immediate because further victimization seems immi­
One important reason for the fear triggered by these hazards is that
even a single encounter with a causal agent can inflict serious harm.
nent. Moreover, the costs of taking definitive action usually appear to
A single sex act or exposure lo tainted blood can transmit the HIV that be readily manageable, which is not the case for such hugely expensive
leads to A!DS.32 One tick bite can result in Lyme disease. A single international problems as acid rain, ozone layer depletion, and
vaccination may, if only in extremely rare instances, maim the recipient global warming.
These conditions have al least two important implications for poli­
it is intended to protect. One toxic pill can kill. By engaging in the
wrong behavior even once, a person may become a victim-a fact that cymaking. First, interminable debate over whether a genuine threat
exists is far less likely. Deferral politics, both common and tempting
is often unknown at the outset but that sharply intensifies anxiety once
widely perceived.33 for a wide array of environmental hazards posing largely hypothetical
long-term risks (and potentially astronomical abatement costs), is
Most of the contentious regulatory and health issues that policymak­
largely foreclosed. Second, a special burden resides with government
ers face, and that the public learns to dread, stem from disorders that
officials, who must focus on the new target risk relatively quickly while
are a long time in the making. Neither lung cancer nor emphysema
attending lo competing needs, including forestalling far more serious
develops from smoking a single cigarette; smoking-related ailments do
risks. One of the most vexing challenges confronting policymakers is
not appear within days or weeks of taking up the habit. One trip into
that threats of this sort yield effects that are often both serious and yet
a coal mine does not bring on the dreaded black lung. Workers exposed
comparatively rare, perhaps the most important facet of the urgency
to cotton dust are not thought to face serious risk from one day on the
36
and restraint balancing problem.
job. Long-term or continuing exposure is linked to the perceived harm.
Two well-established insights apply strongly to the circumstance of
Partly because of this, such threats more easily invite prolonged contro­
emergent public health hazards. The first is that newly recognized,
versy about the size and severity of the risks in question-including
rare, unfamiliar, or involuntarily home risks often appear more threat­
claims that they may be minimal or nonexistent. How much is too 37
ening than those that are familiar or taken on willingly. Diseases that
much? How many are too many? Three long-prominent environmental
generate sudden, and perhaps unpredictably recurring, epidemics have
issues (acid rain, ozone layer depletion, and global warming) exemplify
long been viewed differently from those that are endemic. One historian
this characteristic, as does the more recent debate over the potential
of public health remarked that in the early nineteenth century "the
34
risk posed by electromagnetic fields.
dread of yellow fever, plague, and cholera galvanized city authorities
Some discrete threats inspire at least brief bouts of public fear with­ into action," while "more common endemic diseases with less spectacu­
out claiming any identifiable victims. In 1989 an environmental advo­
lar lethal capacities" such as typhus, diphtheria, and tuberculosis "were
cacy group, the Natural Resources Defense Council (NRDC), triggered
met with a stolid indifference born of familiarity and a sense of help­
a national panic over apples. As a result of skillful media management, lessness."38
an NRDC-sponsored report on the cancer risk that pesticides pose to The second insight is that the visibility of victims-and their distribu­
children garnered national attention. The most prominent chemical tion in time, by area, or by various social or demographic categories­
villain was Alar, a substance used to keep apples on trees longer. may be more significant for policymaking than their absolute numbers
Industry revenues plummeted as shoppers and school lunch programs might suggest. ln discussing the rule "Do no direct harm," economist
refused to buy apples. Ultimately, after millions of dollars in industry Charles L. Schultze noted the common tendency to adjust policies that
losses, and despite government assurances that apples were safe to would impose high overt losses on particular firms or groups, even