Ethical concerns
Bioterrorism
poses real dangers and societies possess a moral obligation to mitigate that
risk. Nevertheless, discussions of biodefense preparedness can lead to political
battles, involve serious questions of research ethics, challenge the
boundaries of professional obligation, and require important value
judgments once ready for implementation. Mistakes in any of these sensitive
areas can jeopardize the integrity of healthcare professionals and public
health officials and their established bond of trust with the public.
Bio
defense vaccine development and implementation
may be one of the remedy to offence the bio weapon application in the war
field. There are several ethical challenges most notably in three areas:
1.
Establishing informed consent during clinical testing,
2.
Defining professional obligations of healthcare workers to participate in
vaccine development research
3.
Fairly allocating vaccines once developed.
Ethical
standards of informed consent require autonomous authorization from
participants with decision-making capacity informed of the risks and benefits
of the research.
There
is panoply of diverse ethical considerations and challenges that must be
discussed or debated that relate to biodefense. In this paper, we review eight
vital ethical issues related to bioterrorism and at the end propose specific
recommendations to be incorporated into policies that relate to bioterrorism.
These eight considerations are:
1.
Allocation of resources and personnel and cost benefit analysis. 2. Triage
assessment. 3. Clinical testing of potential therapies or vaccines in young
children and older adults. 4. Preventing unauthorized individuals from entering
research laboratories. 5. Dual-use: publication of papers containing useful
information that also could be used to create bioweapons. 6. Dual-use:
curtailing the development of harmful technologies while promoting beneficial
applications by scientists of these technologies. 7. Restriction of personal
freedoms. 8. Allocation of educational resources.
In
particular, this principle must extend to all members of society. As one
challenging example, the development of biodefense vaccines could require development
and testing of novel methods of delivery whose risks and benefits are
largely unknown, making informed consent difficult or impossible. There is
considerable uncertainty is adverse events, absent defined or known risks of
exposure. Thus, disclosing the risks and benefits of participation in trials
absent a current and tangible bioterrorism threat may be especially difficult.
Pox
virus can be used as a bioweapon but it is hard to image how, for instance, a
healthcare worker should think about the personal risks and potential benefits
of participating in a trial of a novel smallpox vaccine—the frequency
and severity of a future attack is virtually incalculable, and the marginal
benefits therefore are hard to conceptualize. Thus, often the risks as well as
the benefits of biodefense are and will remain unknown until after their
implementation.
In
such cases, we especially need to acknowledge the limitations of informed
consent and insure that additional ethical safeguards are in place.
The
fledgling attempts to get healthcare workers to accept smallpox vaccination as
part of the 2002–2003 Federal plan to create smallpox response teams
illustrated this struggle. The plan faced stiff opposition from individuals,
institutions, and professional organizations. Even after legislation clarified
liability concerns, health care professionals responded meagerly. A
well-founded case establishing a professional obligation for healthcare workers
to participate in such research based on national security interests has not
yet been developed, given that healthcare workers signed up for patient care,
not national defense.
Unlike
the case of routine seasonal influenza where the risks are clear and
moral obligations of the healthcare provider unambiguous, in the setting of
bioterrorism, collective responsibility to promote public health
preparedness but not necessarily a specific individual obligation. Once
vaccines are developed, tested and are ready for implementation other tough
ethical choices will need to be made. These include deciding who gets priority
in receiving first dosing of vaccines, and what freedoms can be limited for the
sake of the public good. These choices may well raise serious questions
about where our personal and civic obligations lay in the setting of pandemic
or bioterrorism conditions.
Social concerns
Our major defense strategies against
bioweapons have been similar to our major defense strategies against chemical
warfare. Organized nations agreed to conventions such as the Geneva Convention
regarding the prohibition of certain types of weapons including biological and
chemical warfare. The prohibition codified by these conventions was supported
by a shared sense across the international community of their unacceptability
with the understanding that violations of these conventions would be enforced
by some form of recognition and prosecution as war crimes. Indeed, the rise of terrorism
in the 21st century, combined with the actual use of anthrax as a biological
weapon, has created a second social shift in the consideration of vaccines for
biodefense. We now struggle with the conceptualization of a threat or enemy
that is nationless and borderless, an enemy who will not agree to certain
conventions in war and peace, and an enemy who often lacks even a commitment to
self-preservation and survival of its people in pursuit of its ideology.
These
concerns have developed during a time when science and technology have
developed to the point of containing and controlling biological agents effectively
as bioweapons. Simultaneously the ability to travel safely and rapidly
to deploy those bioweapons internationally is easier than ever.
Mass
communication, with rapid and better broadcast than ever, equips terrorists
with the ability to publish their threats and demands, leaving large
populations feeling vulnerable to further attacks. Thus we have witnessed the
emergence of a global need for biodefense against bioterrorism that goes beyond
conventions and treaties and the jurisdiction of war tribunals.
Just as nations before recognized a need to
agree to prohibit the use of bioweapons in times of peace and wars, nations now
might agree for a need to collaborate internationally to develop vaccines
against bioterrorism.
In
preparation for potential bioterrorist use of smallpox in 2003 and 2004, public
health officials gave consideration to a number of strategies including ring
vaccination of those in direct contact with diagnosed smallpox patients in the
event of an attack, preparatory vaccination of first responders, and voluntary
population vaccination. In recent years, the military had to deal with
personnel refusing anthrax vaccinations despite the vaccine’s licensure and
track record of safety. Similarly, following presumed exposures in October 2001,
postal workers and other civilians likewise refused anthrax vaccine when
offered. Furthermore, during the execution of the National Smallpox Vaccination
Program, healthcare workers refused smallpox vaccination. Since some bioweapons
result in contagion, refusal of vaccination affects more than personal risk.
Should
the government depend upon commercial interests to produce sufficient
quantities of safe and effective vaccines? Can we permit private companies to
manufacture and distribute such vaccines freely? What steps should society take
to prevent sales to those who might use the bioweapons and benefit from the
immunity due to the vaccine? What is our basis for restricting their
availability? Such challenges require further debate and rational decision-making.
