Volume 2, March 2002
www.psljournal.com/archives/newsedit/bioethics_bioterrorism.cfm
Bioethics
and Bioterrorism*
Brent Garland,
M.S., J.D.**
* Based on “Bioethics
and Bioterrorism,” a conference held at the National Press Club in Washington,
D.C., and jointly sponsored by the Center for Bioethics at the University of
Pennsylvania and the Center for Biomedical Ethics at the University of
Virginia, February 28, 2002.
** Senior Program
Associate, Program on Scientific Freedom, Responsibility, and Law, Directorate
of Science and Policy Programs, American Association for the Advancement of
Science.
A
day-long conference was convened to discuss bioethical concerns arising in the
wake of September 11th and the subsequent anthrax mailing
incidents. As Jonathan Moreno, Director
of the Center for Biomedical Ethics at the University of Virginia, observed in
his opening remarks, while substantial funds have been earmarked for combating
bioterrorism, none of those funds have been set aside for studying the ethical,
social and legal implications of the research and practices to be
developed. It was, Moreno remarked, the
stated purpose of the conference to “begin the public dialogue.”
The opening remarks of Arthur Caplan, Director for the
Center for Bioethics at the University of Pennsylvania, echoed Moreno’s concern
that this developing area of bioethics not be overlooked. Caplan identified a number of what he
described as “systematic and thematic issues” posed by the recent acts of
bioterrorism and by U.S. efforts to combat bioterrorist threats. It was around these themes that the five
panels of the conference were organized: “Biological Weapons: Threat and
Response”; “Vaccination Policy and Prevention”; “Patents, Profits and Public
Health”; “The Duty to Face Danger”; and “Science in the Interest of National
Security.”
Among
the panels, some further themes emerged: a blurred line between treatment and
research in emergency response care; the need for diverse public involvement in
ethics dialogue; and the risk that ethics will be compromised in times of
war. The following report covers the
conference speakers in order of presentation.
Biological
Weapons: Threat and Response
The New Jersey Anthrax Crisis
The
first speaker, Dr. Eddy Bresnitz, is a State Epidemiologist for the state of
New Jersey, and was integrally involved with the state’s response to the
anthrax contamination incidents.
Bresnitz made the point that New Jersey, as well as the nation as a
whole, had been preparing for bioterrorism, albeit with minimal resources. The thinking on bioterrorism, he said, was
shaped by the preparations for a pandemic influenza outbreak, which some
thought would be more likely to occur than a bioterrorism incident. Further, it shares some of the same public
health concerns as bioterrorism responses.
Among the common issues, Bresnitz named allocation of treatment, supplies
and vaccines; coordination of response; and surveillance of outbreaks.
While
prior thought had been given to public health and medical responses, Bresnitz believed
that decision-makers primarily acted without any deliberate ethical analyses to
guide them. The ethos, Bresnitz
suggested, was one of “do the right thing.” The difficulty, he contended, was
that the “right thing” changes based on the information available at the time,
resulting in a “moving target.”
Bresnitz
then explored anecdotally the substantial ethical questions that arose in New
Jersey regarding post-exposure prophylaxis policy.[1] Bresnitz attempted, in his anecdotal
overview, to give the participants a “taste of what happened in New Jersey.”
The three main issues Bresnitz discussed were: treatment allocation; acting in
the face of medical uncertainty; and coercion in treatment.
In
terms of treatment allocation, a question arose relating to who should receive
prophylactic medication. The guiding
ethos, according to Bresnitz, became one of risk analysis—those at the most
risk should receive the medication. A
fairly straightforward approach, as long as resources aren’t scarce.
Additionally,
questions need to be answered concerning appropriate and effective
treatment. As there were no developed
civilian treatment protocols, there was uncertainty about appropriate
prophylaxis, duration of medication, and best first-line medication in the
event of exposure. A related issue was
that the vaccine, which had previously only been available to the military, had
yet to be approved by the FDA for general use.
Ultimately, acting on preliminary data, New Jersey extended the period
of prophylactic antibiotics to 100 days.
The vaccine and antibiotic combination treatment was brought in and
administered by the CDC, which gave rise to Bresnitz’s third concern: coercion.
According
to Bresnitz, the CDC provided the drug as part of an “investigational new drug
trial,” requiring all participants to sign informed consent releases. Bresnitz suggested that the forms sought to
limit the government’s liability, and had a statement to the effect of
‘refusing the treatment may result in [the patient’s] death’. The situation is inherently coercive, and
therefore ethically problematic in Bresnitz’s view.
In
closing, Bresnitz observed that these issues were a fertile area for policy and
ethics debate, and that while he had posed many questions, he offered few
answers. In many ways, however,
Bresnitz’s speech was a microcosm of the core issue that would be discussed
throughout the day: bioterrorism presents
problems for which we don’t yet have systems of response.
For
example, Bresnitz pondered at one point, what if the disease had not been
anthrax, but highly contagious smallpox? Would we be obligated to treat those
exposed, potentially against their will, as a matter of public health? Would we
forcibly quarantine, through use of police powers, those refusing medicines? We
do have public health systems for dealing with communicable disease, but rarely
do we press citizens to use experimental medications, even for the common good.
A
number of audience members pointed out that there were analogous systems which addressed
some of the issues presented. One
example cited was emergency medicine where a treatment protocol may be used
which has not been proven when the emergent condition fails to respond, or has
no known treatment. Emergent conditions
can also be inherently coercive, as the patient’s life is often at risk. The point several audience members made, and
which was echoed by speakers throughout the day, is that while we may be facing
new problems, medicine, public health, and bioethics have an existing platform
of relevant work on which to build.
“Psychological Responses to Bioterrorism: It’s About Time”
The
second speaker, Dr. Greg Saathoff, serves as the Executive Director of the
Critical Incident Analysis Group at the University of Virginia. Saathoff sought to distinguish the critical
difference between bioterrorism and other forms of terrorist attacks using more
conventional “NICE weapons” (Nuclear, Incendiary, Chemical, and
Explosive). Unlike NICE weapons, which
are self-limiting in impact by the nature of the weapons materials themselves,
bioterrorism weapons can be deployed without victims knowing they are under
attack. Further, some of these weapons
have the capacity to reproduce.
Bioterror weapons, therefore, are not limited (or fixed) in time. Bioterror carries on, and can advance
substantially before we are even aware of a problem.
Saathoff
echoed the concerns of Bresnitz, stating that we do not yet have an
establishment for dealing with bioterroristic infectious disease. Not only do we lack models and studies, but
we already know we have “limited surge capabilities,” generally defined as the
ability to provide emergency care for situations resulting in mass injuries or
mass casualties. Further, vaccine
availability and response protocols may be insufficient.
The
psychological response to such insidious attacks, and to the fear created by
them, depends on a number of factors articulated by Saathoff: leadership
response; medical resources; media; law enforcement; communications; individual
responses; community responses; and governmental emergency responses.
Saathoff
indicated that there are seven elements to the leader’s response that would
help determine the psychological response of the public. First, the leader must have clear and
effective communication skills. Second,
the existing level of trust in the leader at the time of the response is
vitally important. (Similarly, Saathoff
stated that the leader’s charisma was critical, which he defined as the
leader’s ability to be trusted and be followed.) Third, the leader’s relationship
with, and understanding of, the media is important. The leader must understand that the media’s critical role is not
adversarial, but one which more rapidly fosters solutions. The fourth element is the leader’s previous
training and experience dealing with bioterrorism. Fifth, the leader must have a thorough understanding of the
interaction and availability of local, state and federal response systems. Sixth, the leader must be able to transcend
partisanship and lead the entire group or entire society. And finally, the leader must be able to
express what Saathoff calls “vigilant hope,” an ability to deal with the
uncertainty presented by the situation and move forward.
Some
of the other factors Saathoff mentioned rather briefly. The “medical resources” factor, he said,
will turn on the following: experience of clinicians, especially in managing
disasters and working with incomplete information; relationship of medical
institutions with the government, the media and public alliances; having and
using a communication network to disseminate information about the bioterrorism
event; and adequate mental health resources, not just for victims, but also
care providers. For the “media” factor,
the critical elements are: their own leadership; the level to which the
community trusts them; their bioterrorism knowledge and training; their prior
experience with disasters; their relationship with medical service providers;
their local and national perspective, and ability to see the relationship
between the two arenas; and their ability to recognize their role as one which
fills an important information void for the public. For “law enforcement”, the key elements are: prior experience
with disasters; bioterrorism training; relationship with the media; and sensitivity
to their own medical and other needs.
For “communications,” Saathoff identified the critical elements as: the
level of overlap or redundancies; prior disaster experience; and surge
capability.
In
closing, Saathoff remarked that although predicting the psychological response
of the public to bioterrorism attacks should be sought after, the ability to do
so will depend largely on the aforementioned factors.
A Brief Response
Colonel
Dr. Art Anderson, Chief of Clinical Pathology at the U.S. Army Medical Research
Institute of Infectious Diseases, addressed some of issues raised by Bresnitz
and Saathoff. Col. Anderson suggested
that his comments represented his own views, and not those of the Department of
Defense or USAMRIID.
Anderson
pointed out that the military makes top-down, scenario-driven response plans,
so that when catastrophic events occur, be they bioterrorism or battle, there
is an institutional protocol in place to handle the response. He added that a mechanism is needed for
promoting and disseminating the military response protocols for bioterrorism
incidents for the benefit of the public, something which was not done well with
the anthrax exposures. One problem,
Anderson noted, was that there is a stigma attached to military research
because its dissemination and discussion among scientists and physicians might
be restricted.
Conference Discussion and Questions
Following
the presenters' speeches, much of the discussion focused on how consent forms could
be developed for an investigational trial performed in response to a terrorist
incident. The general consensus among
audience members and speakers was that state and local communities must be
involved in all levels of planning the network of response, including such
items as consent forms. Several
audience members, as well as Col. Anderson, urged an open, inclusive process
similar to the one currently used by local Institutional Research Boards, a
process which Anderson said needed to avoid becoming “politicized.”
Additionally,
many were concerned by the nature of the CDC prophylaxis response to the
anthrax incidents by making medication and vaccination available as an
“investigational new drug trial.” As Bresnitz observed, many individuals in New
Jersey felt they were being experimented upon, rather than prophylactically
treated. Bresnitz asserted that it might
be problematic ethically, because you are acting with intent to benefit, but
portraying the treatment as research, because the treatment is not yet proven
or licensed. Anderson suggested that
perhaps a contingency licensing scheme be developed for use in the event of
emergencies.
Vaccination
Policy and Prevention
“Approaching Vaccines for Agents of Bioterrorism”
The
second panel started with the comments of Dr. David Weiner, a molecular immunologist
and professor in the Department of Pathology at the University of Pennsylvania,
who touched briefly on the types of bioterrorist threats we might face in the
future and how we might develop appropriate vaccines to reduce our risk.
Weiner
noted that there were numerous agents[2]
which could be used in a bioterrorism attack, but that recent attention had
been focused on “chimeric viruses” as a possible new threat. A chimeric virus is typically created out of
two or more separate viruses, for example, a combination of smallpox and the
Ebola/Marburg virus. The terrorist goal
could be to create a virus which would spread rapidly and that would be highly
lethal.
Weiner
expressed the opinion that the threat posed by chimeric viruses might not be as
grave as many seemed to think. First,
he pointed out that, paradoxically, chimeras may be less lethal than their
counterparts are separately (or perhaps only as lethal). What makes smallpox so lethal, for example,
is its lengthy incubation period (leaving hosts infectious, but not yet
symptomatic), which is eliminated by a cross with fast-acting Ebola. Thus, if hosts die quickly, then the
chimeric disease may not spread as well as the original smallpox. In addition, Weiner said that it was not
clear that there would be a need for new vaccines, as the current multi-strain
vaccines may be more effective than many assumed initially.
What
is clearly needed is a vaccine strategy for containment, Weiner claims. He added that prophylaxis is typically given
to confirmed cases, caregivers, hospital staff, mortuary staff, and others who
have had contact with infected persons.
Those at risk from vaccination itself include persons with suppressed
immune systems (organ transplant recipients, cancer patients, etc.), people
with autoimmune disorders, the elderly, and infants. Weiner pointed out that many of these risk groups were larger
than when we last battled smallpox in the 1960’s, so that the exact impact of a
current vaccination campaign is harder to predict.
Weiner
concluded by setting out some possible future directions. First, he mentioned the possibility of
future gene-based vaccines as possibly both safer than current live vaccines,
and with a stronger response than current non-live vaccines. In addition, gene-based vaccines could be
very complex, so it would be difficult for bioterrorists to “engineer around”
the vaccine.
Bioterrorism and Public Health
Dr.
Phillip Nieberg, Associate Director for Public Health in the Global AIDS
Program at the Centers for Disease Control, followed Dr. Weiner with a
macro-scale perspective of issues that might arise in respond to a bioterrorist
attack. It was noted that Dr. Nieberg’s
remarks are his own views, and do not reflect the opinions of his employer.
Nieberg
framed the issues presented by bioterrorism as public health issues, and
applied a different set of ethical standards than many bioethicists, who have
tended to treat bioterrorism as more of a medical issue. The ethics of public health and the ethics
of biomedicine can vary, with biomedicine typically acting to protect the
interests of the individual and public health acting on behalf of the state to
protect the health and well-being of citizens generally. The “public” in “public health,” Nieberg
asserted, refers to the public decision-making process, not the intended target
of the policies.
As
an illustrative example, Nieberg pointed to the public health laws that mandate
vaccinations for school children. From
a public health view, the citizens are somewhat inconvenienced, but the health
of the community is improved—even for those students who are exempted for
religious reasons.[3] It is, he said, a classic case of the
tension between a public interest and an individual one.
Nieberg
gave three examples where public health concerns would likely arise, and where
public health ethics might be most appropriate: rationing of medical resources;
mobility restrictions; and dealing with human remains. With rationing of resources like vaccines,
there are many possible metrics that could be used, he said. Some common ones are “first come, first
served,” “ability to pay,” or a lottery.
When you take into account public health concerns, other metrics may
come into play, based on societal or role values: “first responders,” “medical
care providers,” “those at highest risk,” or exposed familial caregivers. A situation may arise where the government
may have to take “control of health care supplies” to ensure a uniform
society-wide policy, Nieberg proposed.
The implied question, it seems, is when should we, as a society, have a
discussion about that possibility.
The
next example was that of the state using its police powers to restrict mobility
to prevent or reduce exposure. The
modern analogues for bioterror attack response may well be the systems for
infectious disease control already in place, or those used in the
not-too-distant past: isolation/quarantine; voluntary curfew; prohibition of
mass gatherings; and compulsory treatment or vaccines. Again, a sharp example of balancing
individual freedom with community protection—a classic public health concern.
The
final example, which Nieberg briefly touched on, was that of safe disposal of
human remains. Previous epidemics lead
to requirements for rapid burial or embalming, even though often risk was
actually fairly low. Public health here
seeks to balance religious, cultural and personal beliefs with protection of
the larger community.
In
conclusion, Nieberg stated that all the concerns he raised require public
discussion, with a transparent process for decision making and policy
setting. Good communication with the
public, as well as refined risk assessments when information is unavailable,
will facilitate the process.
“Of
Utmost National Urgency: Lynchburg Colony Hepatitis Study, 1942”
Dr.
Paul Lombardo, director of the Law and Medicine Program at the Center for
Biomedical Ethics at the University of Virginia, asked the question “do ethical
touchstones change (or go out the window) during war?” An attorney and historian,
Lombardo used the 1942 Lynchburg Colony Hepatitis Study as an example and
cautionary note in exploring his question.
Lombardo
presented the following case: in the early 1940’s, the Yellow Fever Vaccine had
been given to US soldiers, which resulted in an outbreak of jaundice, with one
death for every 461 cases. In 1942, a
study began at the Lynchburg Training School and Hospital in Lynchburg,
Virginia to examine the link between the vaccine and jaundice. Researchers at the Training School injected
approximately 190 children with a host of potential pathogens, including the
vaccine and infected blood from jaundice patients. The research was conducted upon the institutionalized children
without informed consent, and the goal was to observe the children to see if
they became ill. While some of the
children had permanent liver damage, none died. Ultimately, the researchers concluded, correctly, that the serum
being used to produce the vaccine was contaminated with hepatitis and causing
jaundice. The serum was modified, the
study was published, and there was no public outcry over the treatment of these
children as unwilling experimental subjects.
As
Lombardo pointed out, such work was considered ethical at the time, some even
invoking language to describe the children as “draftees in the war against
disease.” Certainly, Lombardo said, there are uncomfortable parallels to the
Nazi practices roundly and rightly condemned by the world, but the Lynchburg
experiment was not as malignant in its intent and purpose as the acts of the
Nazis. It does, however, help to
illustrate the question Lombardo asked the audience to consider: do ethical
rules change to accommodate the exigencies of war?
It
seems, Lombardo concluded, that we always answer the question in retrospect,
rather than by proactive discussion.
Public health and war are a volatile mix, he said, adding that
“combining official secrecy and the fear of disease can yield ethically
problematic situations.”
Patents,
Profits and Public Health
Lessons from the Cipro Case
Arti
Rai, a professor of law at the University of Pennsylvania Law School, sought to
raise some “provocative points” about the potential effects of “breaking”
pharmaceutical patents under the “Takings Clause” of the U.S. Constitution.[4] Under certain circumstances, the Takings
Clause allows the federal government to take the property of persons (including
corporations, who are an “artificial person” in the eyes of the law) by
utilizing their power of eminent domain.
The government is required to pay some amount of “just compensation,” an
amount often determined by litigation.
During
the initial anthrax incidents, the Department of Health and Human Services
suggested that the government might use eminent domain and the Takings Clause
to “break” the patent on Cipro, a broad-spectrum antibiotic produced by the
Bayer pharmaceutical company. Breaking
the patent, according to Rai, would allow the government to arrange to have the
drug manufactured without compensating Bayer beyond the amount determined as
“just compensation.” With this threat in the background, the government then
negotiated a lower-than-market price for the purpose of creating a Cipro
stockpile.
While
the recent WTO Agreement on Trade Related Aspects of Intellectual Property
(TRIPS) may preclude such takings, the federal government can and has taken
patents previously, said Rai.
Typically, she added, the “just compensation” was about ten percent of
the monopoly sales price.
Rai
is concerned that the threat of breaking a patent with the Takings Clause may
have a chilling effect on pharmaceutical research and development. One alternative that has been proposed is
the “voluntary buy-out,” whereby the government buys the right to manufacture
the drug from the patent holder. The
obvious concern is that there will be extortive pricing in the case of an
emergency or disaster situation, like a bioterrorist attack.
Rai
proposed a model where public funds are used for research and development, much
like the government currently does with National Defense. This model seems to make particular sense in
light of bioterrorism concerns, as bioterrorism touches on issues of defense
and public health, Rai added.
This
model, Rai suggests, would stimulate research on vaccines and antibiotics,
which are not often big moneymakers for pharmaceutical companies. It would be important, she added, to
evaluate closely which cases would get public funding, so as not to waste
research funds.
Scarce Resources, Triage and Bioterrorism
Dr.
James Childress, Professor of Religious Studies and Faculty Member of the
Center for Biomedical Ethics at the University of Virginia, raised the question
of what to do in situations of scarce medical resources, and proposed that we
consider a triage[5] model in
advance. Childress referred directly to
an article by Pesik, et al.[6]
as a starting point for considering a triage model, though he made some general
comments as well.
Generally, Childress said, triage models are expressly
utilitarian, and thus come under attack by biomedical ethicists that tend to
support more individualistic and egalitarian viewpoints. Yet, Childress argued, we do have a prima facie duty to maximize good within
the constraints of our ethical principles.
He would put forth, then, a triage model for doing so.
Childress pointed out that a frequent metric for
determining who receives treatment first is those who can satisfy medical
utility concerns. Obviously excluded,
he continued, are constructs and categories such as ethnicity, age, gender,
disabilities, antisocial behaviors, and socioeconomic status. Coupled with these distinctions are factors
such as the likelihood of responding to treatment, especially to minimal
treatment, if medical resources are limited.
Such a model can be constructed, Childress argues, in an ethical
framework, but it must be acceptable and justifiable to the public. We must have a collective consensus, he
argued, on how to treat and how to react to bioterrorism.
Childress argued that the dialogue on triage response systems must
begin, and it must consider the following issues in addition to those mentioned
above: justice; public cooperation, even in face of increasing illness;
possibility of a weighted lottery favoring those with essential medical and
social functions; and what we do when infected victims become transmission
vectors, or unwitting “secondary agents of terror.”
Pharmaceutical Companies and Pricing
Dr.
Patricia Danzon, an economist and professor at the Wharton School of Business,
made some brief comments on issues regarding pharmaceutical companies, drug
pricing, and patents. Economists, she
said, use the criterion of “economic efficiency“ to evaluate policy. Economists will favor the policy that
delivers the greatest value from limited resources from the perspective of both
current and future users.
Danzon
argued that the pharmaceutical industry is unique, as pharmaceutical companies
must spend a substantially higher amount of earnings on research and
development than any other industry. In
addition, the pharmaceutical companies have a high cost to market, many
research failures, a lengthy approval process for products, and like other
companies, responsibilities to shareholders for return on investment. Patents, she argued, protect the
pharmaceutical companies' investments, and should only be broken in rare
circumstances.
One
such circumstance, Danzon suggested, would be where there is a production
restraint preventing access to a medication, rather than a price
restraint. Her particular concern for a
chilling effect is in the development end.
Who, she asked, would risk money developing a vaccine, if the patent
might get broken? Who should take the risk? While Danzon had no suggested
model, she clearly felt that patent breaking was too heavy-handed a tactic, and
that other solutions should be considered.
Research and Health System Efforts
Dr.
William Haseltine, CEO of Human Genome Sciences, was brief but posed several
questions to consider. First, he
observed that the US is attempting to deal with bioterrorism threats by
increasing funding to the National Institutes of Health (NIH). This, he said, means that we have turned the
health system to war efforts. We should
ask, Haseltine asserted, “Is this good for us?” This is a dialogue we need to
have, even if we have it post facto, Haseltine argued.
He
encouraged people to think through the issues involved, and not to act without
careful consideration. As examples of
the kinds of issues to consider, Haseltine posed the following questions:
-
Should we use this effort to reinvigorate our research programs in defense?
-
Should we use this effort to reinvigorate our research programs in public
health?
-
Should there be vaccine research for anti-biowarfare?
-
What will be the reactions of universities? How will their policies affect this
research?
-
Should graduate students be working on biowarfare issues?
Although
Haseltine did not offer solutions to these questions, he suggested that the
governmental responses to these issues were overly complex and viewed
governmental complexity as a barrier to solutions.
The
Duty to Face Danger
An
introduction given by Dr. Ann Hamric, professor of Nursing and Faculty Member
of the Center for Biomedical Ethics at the University of Virginia, preceded the
full presentations by the panel members.
Hamric noted that the panel chose to focus on the duties of doctors and
nurses, rather than all possible responders, and to conceive of the “duty to
face danger” as a continuum construct.
HIV as a Model for Epidemic Coping
Dr.
Leslie Blackhall, Director of Research at the Center for Biomedical Ethics at
the University of Virginia, argued that the medical community’s response to HIV
disease might offer a good model for coping with epidemic illnesses, such as
those which might result from a bioterrorism incident. Early reaction from medical personnel,
Blackhall said, was typically overreaction: fear of contagion, reluctance to
provide care, extreme precautions to avoid contact, and other unnecessary
behaviors. Blackhall argued that the
risk of contagion and the reasonable desire to avoid contagion are not uncommon
aspects of the medical profession.
There were predictions that the medical system would never be able to
respond to HIV-positive patients, she said.
Yet, the medical system held and began to treat HIV patients
appropriately.
What
led to the medical system’s success in responding, Blackhall argued, was not
volunteerism by physicians and medical professionals who felt it was their duty
to provide care. The actions of selfless
volunteers were only a part of the solution, she claimed. Blackhall identified four factors integral
to the medical system finally responding in an appropriate fashion. These factors are: 1) the illness was seen
as a crisis by affected communities, who organized and mobilized resources to
cope, including demanding care; 2) involved institutions, including medical
schools and professional organizations, created disincentives for those who
refused to provide treatment; 3) incentives became available for those who did
provide treatment, including funding for research and palliative treatment; and
finally, 4) early predictions about high levels of contagion were groundless.[7]
From
the HIV experience, Blackhall concluded that in order to provide adequate care,
there must be: volunteer care providers, responding to a call to duty;
disincentive and incentive systems, with the support of the medical
establishment; an effort to reasonably protect health care providers; and a
perception of opportunity for those who provide care, be it prestige, wealth,
or some other reward.
Reconsidering the Common Law Rule of “No Duty”
Dr.
Eric Feldman, professor of law at University of Pennsylvania School of Law,
argued that bioterrorism concerns might lead us to reconsider the Common Law
rule regarding the duty to help.
According to Common Law, there is no duty to render aid or assistance to
a person in need, even if one could do so with no risk to oneself.[8]
Feldman
argued that there are a number of mechanisms that could be used to encourage
health care providers to face danger by reframing the duty to care, both
legally and ethically. For example,
Feldman pointed out that health providers could be required to provide care in
the event of an emergency through licensure requirements. In addition, while individual doctors don’t
have a duty to provide care, hospitals and other institutions sometimes do,
particularly for emergent situations.
Feldman says the current legal regime, including the requirements of the
Americans with Disabilities Act, seek to protect doctors, while still
encouraging them to act. The system
provides “weak incentives to be a hero,” he says.
So
far, only the Model State Emergency Health Powers Act (MSEHPA) had
systematically addressed the duty to care issue.[9] While the MSEHPA is not law, it does serve
to offer guidance to state legislators, and may influence the types of laws and
schemes enacted. MSEHPA would allow
states to require health care providers to provide care in the event of
emergencies, Feldman noted. The duty
does vary by risk, he continued, since no one would want a scheme which would
overburden health care providers.
In
closing, Feldman offered five reasons why the current situation offers an
opportunity to reconsider the Common Law rule.
First, it is the right political climate, in light of the development of
the Model Act, as well as the recent bioterrorist concerns. Second, if provision of care is only linked
to bioterrorism incidents, you could end up with people who put themselves in
the zone of risk to get access to other needed care. Third, reliance on the ethos of “volunteerism” will be
insufficient to provide adequate care.
Fourth, the hierarchy of medicine means that doctors can refuse to
treat, but medical aides and nursing staff cannot, without the risk of being
fired. This hierarchy results in the
least empowered providers being required to face dangers that others do not
have to face. And finally, the duty
should be imposed to reflect the societal status and professionalism of health
care providers. Feldman added that even
though we would require the duty, health care providers should be given credit
for acting well in the face of danger.
The Ethical Duty to Face Danger
Dr.
Hamric presented the view that facing danger was ethically obligatory for the
health care professional. This
obligation, she argued, is rooted in the professional roles of physicians and
nurses and in the prominent status accorded these professions. In addition, this obligation stems from the
responsibility of having increased skills and knowledge to help others, which
intertwines with the duty of beneficence.
In
nursing, Hamric noted, there is a strong presumption of a duty to treat, and of
an altruistic duty to provide care.
This presumption (really, a set of presumptions) is part of the culture
of nursing, and those who refuse are informally sanctioned within the community
of nurses.
Additionally,
Hamric said, the presumption is reflected in both the 2001 American Nursing
Association Code of Ethics and in the 1994 American Nursing Association Risk
versus Responsibility Statement. Both
documents encourage nurses to provide care in the face of danger, though they
recognize that nurses also must be concerned with their own safety, Hamric
noted. One of the difficulties nurses
will face in evaluating appropriate levels of risk to self, Hamric concluded,
is that bioterrorism may present situations where the risk is not known.
Medicine and Limits
Dr.
Walt Davis, the Director of Education for the Center for Biomedical Ethics at
the University of Virginia, examined the “duty to face danger” as it applies to
doctors. He noted that the earliest
American Medical Association (AMA) codes of ethics referred to a doctor’s
“responsibility to provide treatment”, but that this language was dropped from
the code in the 1950s.
Following
the events of September 11th, the AMA’s Council on
Ethical and Judicial Affairs issued a “Declaration of Responsibility”
addressing the responsibility of doctors to respond to bioterrorism.[10] The Declaration uses an aspirational, not
mandatory, form of a voluntary pledge.
The Declaration used language which implies a strong duty, such as
“bound,” “fulfilled this obligation,” and to “(a) pply our knowledge and skills when needed, though doing so may put us at
risk.”
“Risk,”
Davis noted, is undefined. It seems
clear, he added, that the “duty to face danger” is context dependent, and
balances the risk of harm to the provider and the potential benefits to the
patient. To adequately render service
and “face danger”, there is an expectation on the part of health care providers
that they will have adequate information, a coherent plan, protective
mechanisms in place, and that the obligations of others (such as government agencies
and officials) will be met, Davis said.
Davis concluded by echoing the remarks of Dr. Hamric, saying that the
difficulty we currently face is that we are in a time of unprecedented
uncertainty regarding possible threats and harms.
Conference Discussion and Questions
In
discussion with conference participants, there were two primary issues of
concern. A number of participants were
concerned about laws or regulations “forcing” health care providers to provide
care. Most participants framed the issue
as one of “who wants to be treated by someone who doesn’t want to treat them,
and what kind of care can you expect?”
The
other main issue related to which health care providers can refuse to provide
care and which cannot, and what the ethical implications of that difference
might be for providers, a point raised by Dr. Feldman in his talk. For example, where a doctor might be free to
refuse care, a physician’s aide or orderly might not, particularly where instructed
to provide said care by a doctor or nurse.
The doctor might refuse without the risk of losing her job, but the
situation may differ for an orderly. In
addition, Dr. Hamric made the point that the doctor usually is in a position to
dictate the conditions under which the care will be provided, whereas the nurse
or orderly is not typically in that position.
Many participants asserted that this differential authority in
decision-making must be addressed for a fair and ethical response system to be
developed.
Science
in the Interest of National Security
“Ethics of Enrolling Vulnerable Subjects into Research”
Dr.
Jason Karlawish put forth what many might cast as a contrarian viewpoint
regarding research with vulnerable subjects.
Karlawish, a Professor of Medicine in the Division of Geriatrics at the
University of Pennsylvania, made a case for including physically frail and
cognitively impaired subjects in research designed to protect us (and them)
from bioterrorist incidents.
Karlawish
argued that it is time for researchers to recognize that while some people are
more vulnerable than others, scientists can do a vulnerable population a grave
disservice by developing medicines and treatment protocols whose efficacy in
treating vulnerable patients is not known.
By utilizing only the healthiest subjects, no information is gathered
regarding the efficacy of the experimental protocol on less healthy people.
Using
a hypothetical example of a frail, cognitively impaired 75 year old woman,
Karlawish asked, “Will the fruits of bioterror research be available to her?” Karlawish
argued that researchers typically put the vulnerable last in line for
experimental trials, but that they should be moved more towards the front.
In
identifying some barriers to vulnerable people’s opportunity to participate in
research, Karlawish pointed out the following: the institutions which care for
vulnerable persons are usually have a preponderance of low-paid staff, and are
frequently understaffed besides; health issues in the frail, elderly, and other
wise vulnerable person introduces experimental confounds and increases the risk
to the subject; and issues of cognitive impairment obviously complicate the
issue of consent (or proxy consent for which there is little to no
guidance). In addition, Karlawish said,
we must be able to ensure access to the “fruits of research” and find a way to
monitor the trial efficacy and safety for the vulnerable population.
Government Reorganizes to Respond
Gary
Ellis is the Executive Secretary of the National
Science and Technology Council, a Cabinet-level group by which the
President coordinates the diverse parts of the Federal research and development
enterprise as regards science and technology.
It is, Ellis said, a “virtual agency” comprised of the President, Vice
President, Cabinet members, and Agency heads.
Since September 11th, the NSTC has been focusing on the vulnerabilities
“laid bare” by the terrorist attacks.
Ellis
said that Dr. John Marburger III from the Office of Science and Technology
Policy had taken the lead in creating an interagency taskforce designed to
address concerns about terrorism. The
working groups were created focusing on chemical and biological weapon
detection and response, radiological weapon detection and response, protection
of vulnerable systems, and social, educational, and behavioral sciences. In addition, there is a rapid response group
for emergencies.
The
NTSC, Ellis said, has been planning for a systemic approach, and has received a
tremendous amount of advice regarding terrorism, especially from citizens not
working directly for the government.
The Department of Defense, Ellis noted, has formalized the process for
garnering advice, and has received over 1200 responses to a Broad Agency
Announcement soliciting ideas.
The
NTSC’s office role is to form partnership, and is currently focusing on
short-term issues, he said. The fight
against terrorism “needs new tools,” and the NSTC is trying to coordinate that
effort, according to Ellis.
Ethics of Research in Classified Contexts
Dr.
Jonathan Moreno examined the issue of how to ethically conduct human subjects
research in classified contexts for the military. He briefly reviewed some of the previous classified research
where soldiers and citizens were used in experiments, sometimes with the
knowledge and consent of those affected, and sometimes without valid
consent.
One
of the problems, Moreno asserted, is that the Food and Drug Administration is
not set up to handle approving drugs for biowarfare defense. Some options have been explored, including
an informed waiver process, an expedited process for “countering bioterrorism
initiatives,” and a supplementary approval process based on historical
experience, clinical experience, and other available information. No clear system has yet been established,
according to Moreno.
The
return in the U.S. to what Moreno characterized as a “Cold War stance” raises concern that an increase in
classified research is likely to occur.
Two items which Moreno pointed out as particularly important in this
context were: 1) the granting of authority to the Department of Health and
Human Services to classify information as “secret”; and 2) the government’s
failure to put into place human subject research guidelines for classified
research. Moreno pointed out that the
federal Advisory Committee on Human Radiation Experiments, of which he was a
member, had suggested some guidelines for classified research, but none had yet
been adopted. Moreno expressed concern
that failure to develop an ethical framework for bioterror and bioweapon
research would contribute to a “legacy of mistrust” which already overshadows
much of the federal government’s medical experimentation history.
Preparation for Bioexposure Research
For
the final presentation, Dr. Caplan sought to comment and build on much of what
other speakers had said before him at the conference. Caplan, who drew on his experiences with the federal Advisory
Committee on Gulf War Veteran’s Illnesses, stated that the current system is
not set up to undertake bioexposure research and that the system, as it is now,
will not adequately protect subjects.
In
the Gulf War, Caplan noted, studying the soldiers who became ill was difficult
as there was no baseline health data, no rigorous assessment those soldiers who
mustered out, poor or nonexistent records detailing who was exposed to which
agent and in what area of the battlefield, and no sampling or analysis of the
environment in which the soldiers were fighting. These hurdles to good epidemiological analyses and response
planning are substantial. Data must be
gathered to answer these types of questions if we are to be able to respond to
bioexposure attacks, or even to environments made toxic by conventional
attacks, such as the ones on the World Trade Center.
Caplan
argued that we must change the way we view warfare, and we must look at the
battlefield from an epidemiological view.
We must be prepared to learn from disaster, he said, and have a system
in place to consider the effects for five, ten, or twenty years down the
road. Caplan concluded that we cannot
design an experiment that will teach us how to respond to bioterrorism, but we
can prepare to learn as much from natural and man-made disasters as possible,
and to use that experience to prepare for the future.
Commentary
In this author's opinion, what was particularly
informative about this conference is how well it drove home the point that we
are just at the beginning of a dialogue regarding the appropriate societal and
medical response to bioterrorism, and the scope of the discussion to be had.
This conference, and hopefully this report on it, makes clear the current need
to continue the necessary dialogue in earnest.
If this dialogue had been scheduled earlier, the bioethics field might
have been in a better position to advise on secure research methods, attack
response protocols, and other important issues. It is, of course, easier to look back and criticize in
hindsight.
