I N T E R V I E W :
P O S T E & G O L D S M I T H
W E B E X C L U S I V E
5 June 2002
Facing
Reality In Preparing For Biological Warfare:
A Conversation With George Poste
A
longtime bioterrorism adviser warns against complacency on the part
of the
American people and their government.
by
Jeff Goldsmith
Learning From Anthrax
Jeff Goldsmith: What did we learn from the anthrax episode about
our degree of readiness to deal with a biological terror threat?
George Poste: There are multiple lessons. The first, in concert
with the events that preceded it on September 11, is that we can no
longer assume invulnerability to serious terrorist incidents on American
soil. We are fortunate that the number of people affected in the anthrax
incident was less than one day's carnage on America's roads. Nonetheless,
the relentless media coverage brought home to the American public
just how devastating a bioattack could be if conducted on a much larger
scale. In addition, the economic dislocations accompanying the anthrax
episode were substantial.
Biological terror is just one element in a complex, and rapidly changing,
equation of new national security threats. We have entered an era
of catastrophic terrorism in which our greatest vulnerability will
be created by our own technological sophisticationthe phenomenon
of blowbackin which the technology and infrastructure that contribute
to our economic comfort and social welfare can be exploited by terrorists
determined to damage us, erode people's confidence in government,
and provoke legislative actions that erode our civil liberties. So
whether it be a liquefied natural gas container ship being exploded
in the ports of Boston, New Orleans, or Houston, or contamination
of the interstate highway system with radioactivity in a tunnel, or
the grotesqueness of the kind that we witnessed in the Twin Towers
attack, every element of contemporary society is vulnerable.
Biological terror today probably ranks lower on the threat spectrum
than many other kinds of catastrophic terrorism. The real challenge
is what the "bio" threat will become over the next two decades
as a consequence of the dizzying pace of progress in genetics and
other areas of research in biology and medicine.
The twentieth century was dominated by weapon systems that evolved
from advances in physics, engineering, computing, and mathematics,
colloquially known as "big bang, big metal." This produced
weapons with ever greater explosive charges delivered with ever greater
precision from ever greater distances, whether it be from land, air,
sea, or space.
But we are now entering an era in which biothreats will be far more
than bugs. It will not just be the threat from microorganisms that
may have been engineered for greater nastiness but also new ways of
crippling major body functions to produce injury or death. As molecular
biology elucidates every key regulatory circuit for key body functions,
this information can also be used malevolently. Just take brain function,
for example: One could trigger depression, lethargy, amnesia, violence,
hallucinations, or convulsions at will. As knowledge of the biological
basis for normal human functioning increases, any function of the
body can become susceptible to bioattacks.
Decline Of The Public Health Infrastructure
Goldsmith: Is the real vulnerability here a threat to our lives
or a threat to our economy?
Poste: It's a threat to our health, economy, and way of life.
Also, in our anthropocentric arrogance, we always think about people
as the targets. Agriculture is equally at risk from biological agents
that target animals and plants. As President Bush stated, the first
war of the twenty-first century is about basic ideology. It's a conflict
that involves the need to protect the post-Enlightenment view of the
world based upon open democracy, technological and economic progress,
and the quest to reduce human suffering and offer the greatest freedoms
for fulfillment of individual aspirations. Our opponents, now revealed,
want to impose a crushing, theocratic, anti-intellectual worldview
that thrusts us back into a barbarous dark age. Our enemies resent
us, our accomplishments, and our freedoms in a way that the average
American cannot understand.
The anthrax episode served to highlight what many prescient commentators
have been saying for a long time: that America and the Western democracies
are ill prepared to deal with bioassaults as a result of the appalling
neglect of public health infrastructure over the past three decades.
Public health capabilities have suffered from the widespread, delusional
belief held by political leaders that the battle against infectious
disease had been won.
Similarly, in the populist quest for ever cheaper health care, we
have eliminated most of the reserve capacity in the hospital system.
There is no "surge capacity" in the hospital system to deal
with any bioincident that caused extensive casualties. The carnage
of September 11 in New York City was so absolute, in that so many
people died. The New York hospital system would have been utterly
overwhelmed if it had to accommodate thousands of critically injured
people. It doesn't matter whether it's a biological attack or a 747
crashing into an urban areawe have excised urban hospital systems'
capacity to deal with a massive disaster, irrespective of its origin.
The American public is completely unaware of this stark deficit. Patronized
by cheap political sloganism from legislators eager to duck the real
causes of health care inflation, they want more health care at ever
cheaper cost. The reality is that there is a cost attached to this
desire; one cost has been the erosion of reserve capacity.
Emergency Preparedness: The Front Line
Goldsmith: A lot of the institutions that you've talked about
in New York, for months prior to 9/11, were diverting ambulances because
they couldn't staff their emergency rooms or operating suites. So
it's actually a little worse than you've suggested. Doesn't this situation
get dramatically worse in a bioterrorist incident, in that workers
would not come to work if they felt they were going to be exposed
to infectious agents? Simultaneously, you would have people surging
into these institutions to be diagnosed or treated. What do we do
about that?
Poste: We have very limited proactive planning across the health
system for disaster management, whether it be an airliner that crashes
spontaneously or is crashed deliberately by terrorists. Preparedness
to cope with bioterrorism and other lurking evils requires pro-active
planning. Health care professionals are not exempt from fear. If there
is a significant bioattack, we will undoubtedly see defection of health
care personnel.
Another problem is the legal impediments to moving physicians and
other health professionals between states in an emergency. We already
have acute shortages in nursing staff all across the nation, as well
as pharmacists and other critical health personnel.
Seventy percent of health care workersand I'm not just talking
about professionalsare women, and many of them are single parents.
They have a fully appropriate concern about their children at home.
Yet hospitalsindeed, disaster planning in generalhave
given scant concern to the emotional welfare of their front-line workers.
If we actually had in place plans whereby people understood that their
children were protected and that front-line personnel and their families
had priority access to treatment or protective vaccines, they would
be far more likely to stay on the front line. Health care professionals
are a remarkable group of people with enormous dedication. They don't
want to abandon their roles, but when their families are at risk,
they will understandably feel ill at ease.
Another formidable problem in a bioattack will be posed by the worried
wellnamely, individuals who believe that they have been infected
and who will swamp already overloaded health facilities. This problem
will also be fueled by the media. In all contemporary events, the
media must be indicted for superficial sensationalism in all aspects
of its coverage. If CNN had presented viewers with a risk scale as
to what the carnage in the nation was from road accidents, handguns,
and domestic violence on any given day versus the toll from anthrax,
people would quickly have put the anthrax incident in perspective.
If they had this information, every time someone got a sore throat,
fever, or stiff neck, they wouldn't run to the emergency room. Media
irresponsibility, compounded by appalling communication skills on
the part of several government officials in the early stages of the
anthrax incident, served to fuel public concern. Training to deal
with the media must be a prerequisite for all public spokespersons.
Communication: Key To Assurance
Goldsmith: What do you do to assure people of a rational, substantive
response to the actual threat?
Poste: Recognizing that public concern is both inevitable and
legitimate, it is crucial to have a proactive communication plan that
conveys authoritativeness and realism without provoking panic. Those
in charge at all levels should each be able to communicate in clear
terms the status and implications of an incident. Preparedness and
planning should define in advance who is responsible for working with
the media. In any incident, the media will try to get someone to make
an off-the-record comment or they will invade an emergency room to
ask someone inappropriate questions and then broadcast inept or inaccurate
commentaries proffered by people who may have no substantive knowledge
of the true situation.
Proactive preparedness planning is everything: planning about resources;
planning about the location, scope, and staffing of a command center;
planning to establish specific operating procedures and clear delineation
of roles and responsibilities, including the talks to the media. Specific
plans need to exist at the local, regional, and national levels.
Goldsmith: Well, certainly the anthrax episode wasn't a case
study of how to do that right. How much learning has taken place from
the difficulty in responding authoritatively to anthrax, and what
happens next time, based on that learning?
Poste: I think that the lessons learned are consistent with
what I just said about planning. We need to get our act together.
Don't make statements about issues or risks that you don't understand,
whether it be premature declarations about the amount of antibiotic
available for the entire country, or debate with frightened postal
workers exposed to contaminated mail, as if you were addressing the
American Society of Epidemiology on the nuances of statistical risk.
In a crisis, people want to trust those in authority, but such trust
will evaporate quickly if the spokesperson is ill informed or arrogantly
dismissive of public fears.
The ultimate pragmatic test in medical ethics is whether you would
have a specific procedure done to yourself or your family. In the
context of advising postal workers about the pros and cons of the
postexposure anthrax vaccination, you don't have to portray the issue
in terms understood only by professionals. You're dealing with scared
people; in the anthrax episode it was postal workers who could have
been exposed to a lethal infection. Individuals worried that they
could be going home to their families not knowing whether they were
carrying spores on their clothes. The veneer of advanced academic
debate has no place in this setting. Focus on the key question: "Doc,
should I take the vaccine or not?" It's a simple matter of advising
yes or no.
At the final level, informed consent, by definition, is individual
choice. My answerif I were asked whether I would have taken
the anthrax vaccineis yes. As the recent Institute of Medicine
study reported, there is no evidence of an unusual level of significant
adverse events associated with this vaccine.
Goldsmith: Isn't fear the real weapon?
Poste: Absolutely. Remember the dictum of the famous military
strategist, Sun Tzu: "Kill one, terrorize a million."
Linking Jurisdictions
Goldsmith: Our health system is the size of the country you
were born in, Great Britain, in economic terms. Who speaks for it?
It is a vast enterprise with a lot of conflicting opinions and conflicting
beliefs, as well as a jurisdictional morass. How do you produce authoritative
pronouncements from that about what individual citizens ought to do?
Poste: You can't, without reforming the organizational framework
for disaster management and public health competencies. It was designed
to respond to hurricanes, earthquakes, industrial disasters, and so
forth. Above all, we currently face chaos in consequence management
because of serious organizational deficits at the national level.
Everyone is in charge, so no one is in charge. More than forty federal
agencies claim primacy in responsibility for different aspects of
a bio-incident. Then you impose on this the equally Byzantine turf
battles about organizational responsibilities at the state and local
levels. So what does Tom Ridge really have responsibility for in homeland
defense? Ridge has only one stated responsibility: to "coordinate,
coordinate, coordinate." Irrespective of this commitment to meet
this goal, without control of the resources needed to build a robust
homeland defense, the Office of Homeland Security will be subject
to constant challenges by those who don't want to surrender their
current resources and power.
The reality, tragically, is that the shock to the system post-September
11 has still not been enough to force enough people to stop their
territorial turf wars, abandon their rice-bowl mentalities, and face
the ugly fact that the nation does not yet have a cogent, overarching
strategic plan for bioterrorism. In the absence of such a plan, there
are no declared priorities for biodefense or enunciation of defensible
technical rationales for what it is choosing to fund. Third, there
are no metrics to measure performance to know whether we are making
progress and getting value for the vast sums being invested.
The president and Congress, with good intentions, have added $37 billion
for counter-terrorism initiatives, of which bioterrorism is a part.
But these monies have been allocated in a rather knee-jerk fashion
without careful assessment. It's throwing money against a problem
without any attempt to set up a realistic set of priorities as to
what is doable within one year, three years, five years, or what will
require ten years. The current approach may make the legislators feel
good and allow the American people to feel that all is well, but the
risk is that five years from now the defense of this great republic
will be no better served than it is today, thanks to the lack of stringent
assessment of what is needed, how it will be achieved, and who will
be held accountable for progress.
The Immediate Future
Goldsmith: The idea of staging it is a good way of approaching
this. What needs to be done right now, in the next year to eighteen
months?
Poste: What you have to do is to shape a tractable, pragmatic
agenda for biodefense, with transparent rationales and definitions
of time frames in which specific objectives could be fulfilled. I
would love to have ways of identifying the illicit production of bioweapons
by terrorists, to be able to excise them before an attack occurs.
The reality is that this isn't going to happen for years, because
we don't have the requisite intelligence-gathering capabilities. Detection
of "bio" agents in production is far more difficult than
finding illicit activities directed to the construction of nuclear
weapons. Vast amounts of money have been invested in environmental
sensors to detect biothreats, but with minimal success. Yet you still
have people who, in my opinion, dishonor science by claiming that
their sensors can do what they can't. We're not going to have environmental
sensors that offer comprehensive detect-to-warn capabilities that
can be deployed in key facilities, offices, or sports stadiums in
the foreseeable future. Such sensors may eventually be developed,
but the practical reality for the coming five years, and probably
longer, is that the first time that we will know that a bioincident
has happened is when ill people start appearing in health care system,
just as the anthrax episode illustrated.
Based on this reality, the biggest single point of leverage we have
available to us today in improving our biodefense capabilities is
to improve the speed with which we can detect infected individuals
and to accurately identify the infectious agent involved. Faster diagnosis
will save lives, particularly in a major epidemic, since it will drive
decisions about treatment and consequence management. Because we won't
have drugs and vaccines against many of the agents that could be used
against us for at least five to ten years, or possibly longer, new
diagnostic tools will enable appropriate containment actions to at
least be implemented to curtail expansion of the incident.
Over the next twelve months we need to completely rebuild the vital
first line of public health defense and consequence management preparedness.
We've started to do that. More money for the CDC (Centers for Disease
Control and Prevention) and for state and local public health departments
will help to accomplish this. Most don't have even diagnostic testing
capabilities to detect a bioincident.
Goldsmith: They don't have the microbiology?
Poste: Not at most state and local levels. Or if they do, misdiagnosis
is still a real risk. These are symptoms of how much we've allowed
our public health system to deteriorate.
A second urgent objective is to ensure that every major health care
network in the United States be required, let us say
byit's probably too late nowby December 2002, but no later
than June 2003, to have in place a disaster management plan for handling
a mass casualty disaster, including significant casualties caused
by bioterrorism. They should be required to also have in place compliance
programs for training and simulation exercises. But who will audit
competencies in meeting these taxing requirements? We don't currently
have audit capabilities on the scale needed.
How will we ensure that sufficient reserve capacity is available across
hospitals to deal with different types of bioterrorist assaults? We
have no inventory of what reserve capacity even exists. The current
system has been squeezed dry. In formulating disaster plans, you will
need to address which patients already in the hospital are movable,
and where you are going to put them. Is a plan in place to requisition
local hotels or to offer and monitor provision of home care?
When the worried well start to flood in, is there a plan established
not just for the hospitals, but for the emergency preparedness system
at large, so that the worried well don't all come to the hospital
but are directed instead to alternative triage sites set up in advance?
Are plans in place to ensure that they travel to these centers by
prescribed routes within the city? This is to assure that they're
not contaminating neighborhoods in the event they are infected. Bioattack
simulation exercises such as TOPOFF and Dark Winter revealed that
ill-defined legal authority to act to control infectious disease at
the national, state, or local level can quickly compromise mounting
effective epidemic control actions. What are the powers of the governor,
the state attorney general, or the mayor? Who sets priorities for
access to, and distribution of, the national pharmaceutical stockpile
in the event of conflicting demands from multiple locations?
Detecting The Nature Of The Problem
Goldsmith: Unless the terrorists tell us, how do we actually
know there's a problem? Isn't it true that seven of the eight principal
vectors that you worry about present themselves like the flu? How
do we know it isn't the flu?
Poste: Right now, we don't. As I emphasized earlier, we don't
have the medical diagnostic infrastructure in place. So, for example,
when the emergency rooms across America were filling up in February
2000 with what we assumed was influenza, we didn't know for sure that
it wasn't anthrax, plague, or tularemia. Until we have in place comprehensive,
rapid, robust, point-of-care diagnostic capabilities, we will be vulnerable,
and the attacker will have the advantage gained by the delay before
it is recognized that a bioassault has actually occurred. That's why
within a three-year time frame we must have in place an aggressive
program to widely deploy diagnostic capabilities for those biological
agents for which diagnostic tests can be developed.
Every physician is taught that the most common diseases occur most
commonly; if you hear hoofbeats, it's more likely to be a horse than
a zebra. How do you detect zebras (the rare biological incident) among
the vast herd of horses (routine infections)? It's not enough just
to have the diagnostic tests. You also need real-time information
linkages to ensure that if you detect a zebra in Washington, D.C.,
for example, you can quickly assess whether zebras are being found
at other locations in DC and also disseminate alerts to other cities,
in the United States and abroad, to be monitoring for zebras in their
midst.
Goldsmith: What are the economics of a comprehensive zebra
detection system, George? I mean, how much is it going to cost to
deploy it, and who's going to pay for it?
Poste: This applies to much more than diagnostics. Your question
goes to the heart of the challenge: Who pays for preparedness at large?
It's the most important overarching question. So even with the congressional
largess of allocating $37 billion to counterterrorism and homeland
defense, the amount of money that's dedicated to health care systems
is small relative to what is needed to build and deploy the full spectrum
of new diagnostic capabilities and other critical medical services.
Building the diagnostic tests themselves is relatively straightforward.
It's the question of their deployment and routine adoption. Primary
health care practice must now accommodate a seven-to-fifteen-minute
consultation per patient. When someone comes in with nonspecific symptoms
such as headache, stiff neck, and flu- and cold-like symptoms, a physician
or his practice nurse are not going to disrupt their already pressured
schedule to undertake a test that is either too complicated or too
time-consuming. Similarly, hospital or clinic administrators are not
going to allow the required high throughput of patients to be disrupted
by conducting zebra tests unless they are low cost, are rapid, and
do not interfere with conventional medical practice. The diagnostic
test instruments must also have an automated readout to report the
result not just to the requisitioning physician; if a zebra is identified,
it activates an automatic electronic alert to communicate the incident
to the relevant public health counterterrorism authorities. You can't
expect busy physicians to report individual patient information; they
may not see it for hours because they get distracted by something
else. This means that the diagnostic instruments that read out the
tests have got to link to an automated biological incident warning
communication system.
The technological challenge posed by the need for new diagnostic tests
is how to rapidly find any infectious agent, whether it be a horse
or a zebra, in a clinical specimen, and do it much faster than we
can do it now. It's a matter of taking a sophisticated molecular diagnostic
test, which may cost tens if not hundreds of dollars today, and reducing
the cost to a few dollars per unit test, with the results being available
in less than an hour.
Goldsmith: Is the instrumentation in physicians' offices and
emergency rooms now, or is it going to have to be put in there somehow?
Poste: It would have to be deployed to all relevant points
of care, from primary care to hospital ERs. The type of instrumentation
needed doesn't yet exist, but this does not present formidable technical
barriers based on current technologies.
Technological Challenges
Goldsmith: Are those current "industrial" providers
of microbiology testing being networked together electronically? Don't
we already have a sampling mechanism now in their microbiology volume?
Poste: Tragically not, and that, of course, is even when we're
dealing with the detection of conventional medically important pathogens.
It's very difficult to get an accurate, real-time national picture
of infectious disease. The GAO report on infectious disease reporting
systems from local and state public health authorities revealed that
not only is there significant underreporting of infections, but a
high proportion of the data is still submitted on paper rather than
electronically, leading to inevitable time lags.
Goldsmith: Isn't a very large fraction of our local public
health infrastructure not even Internet enabled, so it's basically
telephone and fax connected? Is that going to change?
Poste: I hope it will, but at the present time your characterization
is correct. Once again, these deficits are but elements of the more
serious problem caused by budgetary cutbacks in the course of myopic
political actions that have reduced vital public health capabilities.
Goldsmith: Let's move out beyond a couple years and look at
the five-to-ten-year outlook. You were pessimistic about the cycle
time in developing vaccines and therapeutic responses to new biological
agents. Is that a fixable regulatory problem, or a problem with inadequate
science? What can be done with our existing scientific apparatus to
respond more aggressively to a novel threat?
Poste: I don't think I was being pessimistic. I was simply
being realistic. For the most part, it is not a regulatory problem,
but rather it reflects the complex nature of the scientific problem.
Too many in politics, the media, and society at large succumb to H.L.
Mencken's dictum: "Yes, of course complex problems have simple
solutions; and they are always wrong." We have spent tens of
billions looking for the cure for cancer and billions looking for
an AIDS vaccine. The bioterrorism challenge is no different. The state
of science has never been more sophisticated than it is today, but
we do not know how to create anti-viral drugs that are active against
categories of viruses other than herpes viruses and the retroviruses
and agents with some efficacy against myxo- and paramyxoviruses.
Forget bioterrorism for a moment. We are as vulnerable to new viruses
that could emerge in analogous fashion to AIDS or unique agents such
as prions [as in the human form of mad cow disease] as we are to assault
by deliberate infection. If we suddenly had a new lethal virus of
natural origin emerge in our midst, it would still take us, in all
likelihood, many years to come up with new drugs and vaccines. And
while there are many on the Hill who actually believe that just throwing
money at this will yield an instant solution, they're wrong. I wish
it were otherwise, but it isn't.
The Swine Flu Lesson
Goldsmith: We do have a recent contemporary example of an abortive
response to a public health threat in the 1976 swine flu fiasco. Did
we learn anything from that about how to use existing technologies
and craft a more effective public health response?
Poste: I don't characterize the swine flu episode as a fiasco.
It was motivated by genuine belief that we might have the 1918 pandemic
flu strain coming back, which killed fifty million people worldwide.
What was done in preparing vaccine stocks in a remarkably short time
was actually very impressive. Massive amounts of vaccine were generated
quickly against a perceived threat. But don't forget, that was because
we know how to produce a flu vaccine. Where we got it wrong was accurate
prediction of the precise flu strain that was coming. If the 1918
Spanish flu, or a near relative, had arrived, the vaccine would have
saved the lives of millions of Americans.
I've spoken repeatedly about the decay of our domestic public health
infrastructure. Sadly, the international public health infrastructure
is in even worse shape. We don't have robust data to allow us to understand
what infectious agents are doing and how they could assault us, not
through deliberate release but just via natural mechanisms of epidemic
or epizootic spread. If we had something of comparable virulence to
the 1918 influenza pandemic revisit us now, we would be very little
better off than we were eight decades ago unless we had enough advance
warning to mobilize the vaccine manufacturers. Antibiotics would undoubtedly
save more people from bacterial complications. But a high fraction
of the people who died in 1918-19 weren't just the very young or the
very old, or those with cardiac or lung problems; it was people in
that age range of twenty-five to forty-five, who are normally the
most resistant.
Goldsmith: But when you examine the swine flu episode, there
were multiple months of delay in that responsefrom the political
debate over liability and from the reluctance or unwillingness of
drug companies to assume it. Then, when Congress resolved the question
of making the federal government liable, there was an entirely predictable
flood of liability actions. Have we learned anything from that? Is
the liability problem, which is far worse now, going to delay the
political and scientific response to a legitimate new threat?
Poste: Absolutely. Welcome to the perversity of tort activity
and U.S. society's abandonment of any pretense of understanding risk
and benefit. Modern society wants it all. It wants technology to solve
all of its problems and at the same time to have zero risk. But people
believe it because politicians and the media have told them they can
have zero risk, and if there is a problem there must be some conspiracy
by greedy multinational companies. There's no such thing as zero risk.
You're also right in stating that the delay was compounded by failure
to provide indemnification to vaccine producer companies. On the other
hand, if companies had gone ahead and produced the vaccine, who would
have been the first to launch lawsuits if there was a problem? Either
their shareholders for fiduciary irresponsibility if share price collapsed,
or lawyers representing vaccine recipients.
The problem lies not in pharmaceutical science. Rather, it reflects
the urgent need for tort reform in the United States and a more sophisticated
debate about risk and benefit. The Vaccine Injury Compensation Bill
went some way toward addressing this problem. If a vaccine carries
a small, but nonetheless real, risk of injury, the bill established
a superfund-type mechanism in which a small surcharge was applied
to every vaccine to create a compensation fund for the people who
were unfortunately affected by the real, but unavoidable, very low
incidence of adverse reactions. When my child or your child is affected,
statistics don't mean much. You just want revenge, and the courts
have provided the mechanism. In the case of injury produced by drugs
or vaccines against bioterrorist weapons, most will not have been
tested in human beings. It is impossible to test them for efficacy
and safety in clinical trials since the organisms in question do not
occur naturally or are too dangerous to infect volunteers. This raises
a plethora of indemnification issues. Even if you solve the indemnification
issue, the government has also got to reform its purchasing practices
if manufacturers are to have sufficient economic incentives to produce
these products. If a pharmaceutical company is to commit three to
four hundred million dollars of capital investment, with a construction
lead time of four to five years, to build a manufacturing facility
for just for a single vaccine, it needs guarantees to ensure that
the government won't bail out after one year, leaving them holding
the debt baby.
Liability Laws And Regulatory Plans
Goldsmith: Let's leave aside the capital investment for a minute.
Isn't there a fairly compelling argument for suspending the traditional
liability laws in dealing with a biothreat?
Poste: At one level, yes. But it shouldn't create a vehicle
that predisposes pharmaceutical and biotechnology firms to adopt shoddy
practices. A more important requirement is that the FDA (Food and
Drug Administration), and equivalent regulatory agencies overseas,
must have in place well-defined plans for approving drugs and vaccines
on the basis of the so-called animal efficacy standard (that is, without
human protection efficacy trials). The FDA has been tardy in producing
standardized guidelines for the evaluation of drugs and vaccines against
biological agents. We're told that these will soon be forthcoming.
The pharmaceutical industry (and its stockholders) cannot be expected
to spend vast amounts on R&D for no commercial return. Each constituency
in the debate has a legitimate excuse for its inertia. What we must
now shape is a new national agenda to address these complex technical,
regulatory, legal, and commercial issues. What has happened in Washington
since September 11 isn't the way to deal with it. As stated earlier,
there is no overarching plan for national biodefense. We lack clear
priorities, and there is little to no assessment of the technical
feasibility of the large number of questionable and overhyped proposals
now being offered by academia, government laboratories, and industry
as they seek to tap the new funding bonanza. For those scientific
tasks that may well require more than five to ten years to complete,
you may wish to be more prudent in what you disclose to our potential
enemies, because it identifies our Achilles' heel. On the other hand,
we also need policymakers to understand that biodefense is not simply
a one-time problem that is solved by throwing billions of dollars
around without a plan.
Who Pays The Bill For Preparedness?
Goldsmith: Less than 10 percent of US hospitals even have an
electronic medical record, so 90 percent of the hospitals, including
the public ones, are still dealing with paper records, with no potential
for interoperability for moving the information quickly or connecting
to a national surveillance system.
Poste: Exactly.
Goldsmith: That's certainly not going to be resolved in a few
months.
Poste: And certainly not with the amount of money that's been
allocated to it in recent counterterrorism funding initiatives.
Goldsmith: Is that a federal responsibility? I mean, billions
of dollars are being spent out of private resources now to computerize
clinical information systems. Is there a national security case for
a federal contribution, and is there going to be enough risk to this
society in having such a large portion of that point-of-care interface
be noncomputerized that it makes sense to invest in it?
Poste: I don't know. The key question is the one I raised earlier:
Who pays for preparedness? It is probably the responsibility of the
federal government, and national governments everywhere, to establish
a basic template of financial resources and performance expectations.
On the other hand, one cannot view this simply as a "let-government-solve-it"
problem. Crucial problems in biodefense preparedness also arise from
the long-standing levels of inefficiency in health care and variations
in clinical practice. These have nothing to do with failing to prepare
for bioterrorism. They reflect the pervasive reluctance of health
care professionals to embrace change, the snail's pace of adoption
of automated clinical systems, and the cultural paranoia of the medical
profession toward anything that challenges its primacy in decision
making even when current performance parameters in such decision making
leave much to be desired. The extravagant variability in clinical
practice between medical centers is unequivocally the responsibility
of the health care system to reform.
These words roll easily off the tongue. Given the economic frailty
of US hospitals and the escalating expense of new technologies and
medicines, both the public and politicians have failed to see that
their strident cries for universal access to care and the constant
slanders against the cost of care are destructive catalysts for triggering
a future health care crisis. Again, this has nothing to do with bioterrorism.
It reflects the problem that no one wants to talk about: how to balance
finite health care resources against infinite demand.
How Ready Are We?
Goldsmith: If you had to assess our degree of readiness to
respond to an organized threat of bioterrorism, where are we now?
Poste: Given that there is no single definition of "bioterrorism,"
the answer depends on what you are encountering. If you have to deal
with twenty-three cases of anthrax, as in the recent incident, then
we're fine. But if you had to deal with a thousand cases of anthrax,
or millions of cases of smallpox, it becomes a very different issue,
with far less sanguine outcomes. In short, it's the magnitude of the
threat relative to response capacity. If we had to treat several hundred
thousand people, not in terms of acute or critical care units, but
just to have them interface with the medical system to receive drugs
and so forth, we would also reveal the cracks in the system. If we
had to rapidly vaccinate more than a couple of million people in a
very short time, even assuming that we had a vaccine available, this
would also likely stress the system beyond its capacity. Just a few
hundred cases, or at most a thousand cases, of a bioattack that required
intensive care of the victims would collapse the current capabilities
of most metropolitan hospitals in the United States and Europe.
The challenge in formulating biodefense postures is that the spectrum
of risk is so broad, ranging from very few casualties to hundreds
of thousands to millions. It saddens me to say this, but the vast
majority of Americans, even though they were shocked by the events
of September 11, are quickly reverting back to worrying more about
whether the inestimable Mr. Combs wishes to call himself Puff Daddy
or P Diddy, and the circuses of Hollywood and professional sports
again provide comfortable diversions. They have lost sight of the
fact that America will almost certainly be bitten again by terrorist
assaults. A comfortable, complacent society that is cocooned from
risk is a great target for our enemies. Too many people in Washington
feel that by dispensing billions in the wake of September's horrors,
they've done their bit and all is now well. They believe this in no
small measure because the people who are the beneficiaries of the
funding have told them that it will indeed be so. Let us hope that
they are right.
George
Poste is chief executive of Health Technology Networks, a consulting
group specializing in the application of genomics technologies and
computing in health care. From 1992 to 1999 he was chief science and
technology officer and president, research and development of SmithKline
Beecham. A board-certified pathologist, he is a member of the Defense
Science Board of the US Department of Defense and in this capacity
chairs the Task Force on Bioterrorism. He is also a member of the
National Academy of Sciences' Working Group on Defense against Bioweapons.
Jeff Goldsmith, a Health Affairs editorial board member, is
a futurist, health technology expert, and consultant in private practice
in Charlottesville, Virginia.
©2002 Project HOPEThe People-to-People Health Foundation,
Inc.