The intentional use of BW by state and nonstate actors has spurred
discussions on a number of controversial topics that affect many people in
society. Many of these dilemmas have been discussed at length in the past
(40).
However, in the light of a BW threat they are being discussed from a different
perspective. Dilemmas abound in a world threatened by those that would
intentionally use BW in any number of ways to cause fear-inducing outbreaks and
widespread catastrophes. Should individual rights be forfeited because of
national security concerns? Should the details of research funded by governmental funds and
found to be useful for producing a BW be published in a public forum? How should a physician decide who to rescue and who to let die during a
massive causality situation? These
dilemmas and more will be discussed briefly. There is no desire here reveal the
“right” conclusion but rather to cause each reader some time to discuss,
debate, reflect and determine what course of action might be taken.
How should scientific knowledge concerning BW be disseminated?
When does a defensive BW program become an offensive program?
Is the private health care “system” prepared to meet the needs of the public during a catastrophe?
How does a physician decide whom to save during a catastrophe?
Does biodefense-spending cause other important areas of endeavor to suffer?
How should scientific knowledge concerning BW be disseminated? Data
obtained from scientific studies can be used in different ways. Most in the
scientific community have chosen to use data to benefit mankind. In the 1970’s
scientists determined that certain protocols should be enforced in laboratories
that use recombinant DNA techniques to avoid accidental release of a “superbug”(40). Recombinant DNA technology has resulted in safer vaccines and has helped
scientists better understand how certain organisms cause disease.
Data used to benefit others can also be used to harm. Data is neutral and is
simply the representations of a particular series of experiments. The DNA
sequence of the lethal toxin from the anthrax bacterium could be used to develop
a treatment to prevent death following infection. Mutations in the same gene
might be identified that could destroy the toxin’s lethal effects but at the
same time maintain the ability of the immune system to develop neutralizing
antibodies to protect people from dying from anthrax. The vast majority of
scientists upon getting this data would want to know if there is any unique
aspect of this sequence that they could use to inhibit this toxin’s lethal
effects. However, the DNA sequence of the lethal toxin might also provide the
means by which a person could synthesize the lethal toxin gene and produce a
recombinant plasmid that could express lethal toxin in a nonpathogenic
bacterium. This new BW might then escape detection and may even be genetically
manipulated to be even more deadly. Should the details of this data be published
in a journal anyone can subscribe to?
The human genome project has given scientists vast amounts of knowledge. Some
are conducting research that will change a person’s genome to eliminate
certain genetic mutations or defects. Viruses that do not cause disease are used to place new genetic material in these patients to correct their
genetic mutations. Could this same knowledge and the techniques associated with
it be used to make people more susceptible to a previously nonpathogenic
microorganism in a BW? Or could people be genetically changed so that a
particular trigger in the environment could induce their own immune system to
hurt them?
A scientist’s ability to maintain their job depends on publication.
Publication of their findings helps them secure funding to discover still more
about the world. If the data can’t be published it could have a drastic effect
on the faculty member’s ability to remain employed. Besides that many
laboratories are funded with public funds and many feel that the public has the
right to see what is being discovered with their money.
What should be done? Some say that in the interests of national security the
government should make it illegal to publish these findings or to at least
restrict enough details in the publication to prevent replication of the
experiments. The scientific community has had a long-standing opposition to the
restriction of the flow of knowledge. If the details of the studies are not
included how can others repeat the experiments to confirm the author’s results
and conclusions?
Others have argued that editors of scientific journals and peer-reviewers,
not laws, should restrict the publication of articles that could be a threat to
national security. Meanwhile, others ask how good are scientists at regulating
themselves? After all didn’t scientists develop all the WMD? If the data is
well documented some editors might publish the findings in spite of the public
interest. There are many different scientific journals and if a researcher
looked long enough they might be able to find an editor that would publish their findings. Science is a
human endeavor so politics has some influence on publishing decisions. World
famous scientists have the potential to be more successful in convincing an
editor to publish their findings.
Even if the scientist is not well known and can’t get their study published
by conventional means the Internet allows anyone to publish articles that can be
viewed all over the world. Only a few dollars a month to purchase time on a
webserver, an easy to use webpage editor and the time to list their pages on
various search engines and directories could give a scientist potential access
to others. Many may question the validity of such a study but there maybe some
who would have enough of the skills and equipment needed to repeat the Internet
study and to use the data for production of a new BW.
What is the government’s role in regulating the flow of scientific
information? Can and does the scientific community regulate itself in the
interest of national security? Will scientists from other countries abide by
laws if they are established for information flow in the U.S.? Would
establishing laws to regulate information flow infringe on the civil rights of
the scientist and of those that are paying for them to do the research? Will
scientists/journal editors regulate themselves and not publish parts of their
studies that could jeopardize national security?
Back to top
Should the smallpox virus be kept or destroyed? Unlike other BW, the
smallpox virus is no longer a cause of human disease on this planet. It only
infects humans so it will not infect humans from a previously unknown
environmental or animal source. The last case of naturally occurring smallpox
was reported in Somalia in 1977. The last case of lab-acquired smallpox occurred
in 1978. The current vaccine used to protect people against smallpox is not the
smallpox virus but rather the Vaccinia virus. There is no need to keep smallpox
strains to make the current vaccine. Other poxviruses like the monkeypox virus
have 95% DNA homology with the smallpox virus and some say it could be used to
learn more about smallpox pathogenesis (62).
However, virulent smallpox strains as of this writing are still kept alive in
two repositories: Centers for Disease Control in Atlanta, Georgia, U.S. and the
State Research Center of Virology and Biotechnology in Novosibirsk, Russia. The
WHO resolved in April of 2000 that the smallpox repositories should be destroyed
no later than 2002 (WHA52.10; http://www.who.int/gb/ebwha/pdf_files/EB106/ee3.pdf).
Others feel that destroying the repositories will end the continuing need to
find out how this virus causes disease and would spell an end to finding new
treatments for those infected with the virus. Others indicate that the viruses
like monkeypox are not exactly like smallpox and might result in inaccurate
conclusions concerning smallpox pathogenesis. A recent study at the CDC was able
to find several new antiviral drugs effective in stopping smallpox replication in
vitro (66).
However, some believe that by allowing the repositories to exist invites the
possibility that state/nonstate actors could take smallpox samples from the
repository by force or by some covert means. They could then use the smallpox
samples to construct a BW. Keeping these smallpox strains alive causes everyone
to ask questions. How secure are these laboratories? Why are these repositories
maintained? If they are going to be maintained then why doesn’t the government
increase funding to complete the needed experiments so that the repositories can
be destroyed? Since there is no evidence that BW grade smallpox has ever been
released why should we keep these repositories? Does keeping repositories of
smallpox for study also increase the risk of development of a super-smallpox
strain? Is the risk of keeping smallpox alive worth the benefit of potentially
finding out more about the virus and how to detect and treat smallpox
infections?
Should researchers obtain informed consent from humans in clinical trials
to determine safety and efficacy of countermeasures to BW (individual rights
verses the public interest)? Human studies are essential for testing the
safety and efficacy of drugs that will be used to treat human disease. Although
animals are in many ways very similar to humans they are not humans. Many
treatments that work fine in animal models have been unsuccessful or toxic when
used in humans. As a result humans at some time must be involved in studies to
test new treatments. To involve humans in such studies requires “Informed
Consent”. The person in the study must be told exactly what they are
volunteering for and what the possible negative and positive outcomes may be.
They must be able to understand the instructions and be willing to participate
in the study. They must also be allowed to withdraw from the study at anytime
and they must in writing acknowledge they have been informed of the conditions
of the study. If a person cannot comprehend the information they may only
participate if a legal guardian is willing to sign for them. The legal guardian
also can choose to withdraw the person they are responsible for at anytime.
This has not always been the case in the U.S. informed consent was not placed
into law until the 1974 National Research Act. This act established the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research. The commission met from 1974 to 1978 and established basic ethical
principles that would guide human research studies. There were several studies
that when revealed to the public outraged people and finally lead to this act. A
few examples include the Willowbrook study that infected mentally handicapped
children with hepatitis (1963-1969), the U.S. radiation experiments involved
over 400 experiments in which people were exposed to radiation (early 1940’s
to early 1970’s; 67), the 1963 study
in which chronically ill and debilitated non-cancer patients at the Jewish
Chronic Disease Hospital in New York were injected with live human cancer cells
and the Central Intelligence Agency’s lysergic acid (LSD) study (1960’s) that tested the effects of
LSD on subjects without their knowledge (68).
One especially notorious study was titled, “The Tuskegee Syphilis
Experiment”. This study was funded by the Public Health Service and was
conducted from 1932 to 1972. It looked at the effects of not treating
late stage syphilis in 399 black men from Macon County, Alabama. When the study
began there was no treatment for syphilis and it was designed to follow these
men with syphilis to see how the disease progressed. However, even when
penicillin, known to be effective in treating some of the effects of late-stage
syphilis, was available (late 1940’s) the investigators still did not treat
the patients. The subjects did not know
that they were part of a research study designed to understand the natural
progression of the disease. Many thought they were receiving beneficial medical
care. At least 28 subjects had died by 1969 of direct complications due to
syphilis. The public was not informed of this until Jean Heller of the
Associated Press wrote a news story about the Tuskegee study in 1972 (69).
Many BW are lethal and it is difficult to obtain volunteers for a study that could potentially end their life. Could thoughts of national security override individual rights and in spite of the law studies begin without subject consent? To get approval for a study involving humans requires a local Institutional Review Board (IRB) look over the study proposal before it can begin. Could a local IRB fearful of news stories of heartless groups interested in destroying their society decide the safety of the country is more important than the safety of the human subjects in a BW countermeasures study? Could a world famous scientist intimidate a local IRB to such an extent that the IRB would approve a highly dangerous human study? Scientists, in the past, have felt justified in giving people certain diseases without asking permission. Are they any different now?
Should victims of a catastrophe be examined by several research studies to
help us better understand the aftermath of such an event? Local IRB’s only
approve research studies in their area. In a large city with several places that
conduct human research there may be many different IRB’s. These IRB’s do not
know what other IRB’s are doing. All the IRB’s answer to the federal
government and upon request need to produce all IRB proposals they have
received. Unfortunately, none of the IRB’s are required to communicate with
each other.
Following the Twin Towers 9/11 event many survivors were asked to give informed consent to be subjects in their studies. Unfortunately, the victims in many cases were overwhelmed by requests from lots of different researchers from all over the country. Previous work has demonstrated that when a victim relives a traumatic event they again feel enormous amounts of anguish. This reliving the event over and over again some believe could cause significant psychological damage to an already highly traumatized person. A person in anguish can also be more easily influenced to take part in studies making the potential for injury more likely.
Following the Oklahoma City bombing of the Federal Building the
city required that all researchers go through one IRB in Oklahoma City before
approaching victims. Some say this might be a better approach. However, there is
no legal requirement to force researchers to go through one IRB in these
situations (40). Should easily influenced subjects and traumatized victims be
subjected to many different researchers wanting data for their studies? Should
another mechanism for getting approval for human studies be developed? What, if
anything, should the government do to protect traumatized victims of
catastrophes?
When does a defensive BW program become an offensive program? After
the U.S. signed the BTWC it agreed to declare any offensive BW program.
Defensive BW programs did not have to be declared. Defensive weapons programs
include studies to determine the efficacy and safety of vaccines, therapeutics,
and equipment used to protect and decontaminate people during a BW release.
However, to test these products the researcher may need to also produce some of
the BW. For instance, the Department of Defense (DOD) disclosed in 2002 to the
Washington Post that its personnel, “may use live biological agents in a
number of research settings: for vaccines and treatment; protective clothing and
containment; alarms and detection; and decontamination.” They also stated that
the DOD “…does not set quantitative thresholds for the agents or toxins in
its possession,” but that “…these quantities are generally small”(23).
What does generally small mean? If no limit is set on the quantities of BW used
for these experiments what limits them from becoming an offensive BW research
project?
In 2002 the FBI also disclosed that it was going to produce dry powder anthrax of the quality that had been obtained/produced by the perpetrator of the anthrax containing letters in 2001. They claimed that this was necessary to complete a forensic investigation (23). Knowledge obtained for defense can also be used for offensive purposes. Others have done research placing smallpox genes in vaccinia in hopes of producing a better vaccine. The same techniques used to make a better vaccine could also be used to make a better BW. How does a society set limits on these sorts of research projects? Should the government limit these sorts of projects even if the research is being conducted with private funds? Should the details of these studies be released to the public? How will the details of these studies be limited and to what extent should they be limited? Should we even be doing defensive BW research if it means an offensive program could begin again? Does the benefit outweigh the cost in light of the rare number of actual BW releases that have occurred in the last 50 years?
Is the private health care “system” prepared to meet the needs of the
public during a catastrophe? “When the American public thinks of the
medical system in the United States they think of high quality medical care
provided on demand. The problem with the “medical system” is that it is not
a system at all; rather, it is a collection of independent business entities
that deliver health care for a fee.” (30) There has also been very little
funding to support communications between the governmental public health system
and the “medical system”. Communication between local health care providers
in the "medical system" and public health officials is essential
during an catastrophe. Local health care providers
primary mission is to provide medical care for their patients. They are not
usually concerned about the general welfare of the population at large. Public
health officials are concerned about the general welfare of the population at
large. Once mobilized
public health officials determine the source of the BW release, identify
victim’s contacts, identify and get in touch with and advise those that leave
the area and are possibly infected, advise on means of protecting those that are
not ill, coordinate the efforts to keep ill and contagious patients isolated and
keep the public informed. Both entities are essential for keeping the public
safe and avoiding panic.
During the anthrax letter events it was discovered that local physicians
became key decision makers on many public health issues. Local public health
officials had a difficult time maintaining a continuous situational awareness.
They had little idea of what was going on. This was because there is a complex
report that physicians must use to communicate with public health officials.
Before the public health officials can be notified of an event the disease must
have laboratory confirmation, which can take several days to complete.
Therefore, public health officials will not know what is going on until several
days into any unusual event.
The Rajneeshees placed Salmonella in restaurant salad bars on
September 12-15, 1984 however; public health officials were not alerted to the
epidemic until September 17th by a concerned citizen who had been
ill following a visit to one of the contaminated restaurant salad bars (5).
Unusual patient symptoms’ reporting is time-consuming and laborious and the
public health response is usually of no help to a physician. This also leaves
public health officials in the dark. Many times when a physician sees an unusual
disease they will not report it.
Past catastrophes have revealed that most victims will go to a hospital emergency room if they are able. If large numbers of causalities arrived at a hospital in the U.S. they would be quickly overwhelmed. The competition among hospitals has caused them to cut excess patient capacity, utilize minimal staffing, and to support just-in-time medical care. They do not have stockpiles of medical supplies and medicines. They only have on hand what they will normally need. In 2000 there were 5,810 hospitals registered with the American Hospital Association in the U.S. In 2004 there were 5,764 registered hospitals. There is no room in hospital budgets to handle a catastrophe. There are no hospitals in the U.S. that could even handle 100 casualties resulting in intensive care treatment let alone several thousand (40). Will funds be available to help the 5,764 hospitals in the U.S. develop appropriate capabilities to respond to a disaster? Can better communications be developed to speed public health official’s response time? Since hospitals are so close to shutting their doors in normal times what will keep a hospital going if caring for patients following a BW is not reimbursed? Who pays the hospital and physicians for working during a catastrophe that could last for weeks to months? What if the hospital refuses to allow any more admissions due to overcrowding? What if all the hospitals in the area are near capacity during a catastrophe? Where will the victims go?
How does a physician decide whom to save during a catastrophe? Triage
is a French word that means sorting, picking, grading or selecting according to
quality. It is one way of rationing health care when caregivers are unable to
meet everyone’s needs at the same time. Triage in the emergency room (ER)
attempts to do the greatest good for the greatest number of people. ERs triage
patients when they enter the facility. They will treat those in danger of
rapidly losing their life immediately. Those with less pressing needs will wait.
Many ER waiting rooms are filled with people that complain they have waited
hours to see a doctor. That is because those with severe life-threatening
injuries and illnesses move ahead of the line before those with minor maladies.
It is also due to the fact that by law (Emergency Medical Treatment and Active
Labor Act of 1986 or EMTALA) ERs must treat everyone, even those without medical
insurance that arrive in their facility. In this case there are usually plenty
of medical supplies to meet the demand. However, if too many patients arrive at
the ER they are usually diverted to a different hospital ER for care. If the
person does not have medical insurance diverting them to other ERs requires
under EMTALA regulations a considerable amount of time-consuming paperwork (40).
When a catastrophe occurs all the ER’s in an area will quickly reach
capacity. Supplies that would normally last several days are now likely to be
gone in a few hours. With limited resources a different sort of triage must
occur. In this case the caregivers must decide ahead of time that they cannot
treat everyone. In normal situations large amounts of resources could be used to
save one person. During a catastrophe there may be some severely injured
patients that would require nearly all the ER’s resources to save. At the same
time the ER will see many more patients that would require fewer resources but
would die if not treated. There will also be those that will not die even if
care is delayed for days. What does a physician do?
Triage during a catastrophe is much different. Not everyone can be treated. To save the most people with the fewest resources would require the physician to only treat those with less severe life-threatening injuries and illnesses. They would have to let the severely injured resource intensive patients die and tell those with non-life threatening injuries to seek care elsewhere. This is extremely difficult for physicians who all their lives have been told to save everyone they can no matter what the cost. Physicians in normal situations want to save everyone no matter what it takes. Most physicians and healthcare workers chose the professions they did because they wanted to help others. People in the U.S. also expect this of their caregivers. How does a person that normally tries to rescue everyone now decide that some will have to die and others will have to be turned away without any treatment? Are physicians informed of the differences between normal ER and catastrophe triage? Who is responsible to teach them these differences? What are the legal ramifications for healthcare workers that are forced to triage patients in a catastrophe that results in people not receiving care and dying? Will EMTALA regulations force physicians in a catastrophe to still treat all those without medical insurance even if their maladies are not due to the catastrophe? Has the government made provisions to protect healthcare personnel caught between helping the most people they can and saving a few people? If so what are the provisions healthcare workers must work under during and after a catastrophe?
During a catastrophe caregivers will also be injured and infected. Should
these people even though their maladies are not life threatening be treated with
precious medical supplies so that they can help in the effort to treat more
patients?
Who is a first-responder’s neighbor? During a catastrophe many
people willingly risk life and limb to save those in need of help. Some
first-responders will travel to other places and other countries to help. During
a widespread BW catastrophe first-responders will be more likely to come in
contact with the BW. They will also be concerned about their family and close
friends. Most peoples’ first response is to help their family but first
responders, if on duty during a time of catastrophe, may not be able to go home.
Should they be allowed to help their own family while many others are not
getting the care they need?
First responders from other places and countries may use a different set of
criteria for saving people. In some cases they could make situations worse
rather than better. For instance in some societies helping injured males might
be of first priority. Females might be rescued only when all the males are
helped. How does a local and state government inform these first-responders of
the specific criteria they use in a catastrophe? Is it appropriate to turn away
first-responders that come to an area but may cause more problems than
solutions? With the large amount of confusion and disarray that occurs following
a catastrophe how does a local or state government monitor who is helping their
people? Should they monitor who is helping?
Do public health officials have the right to confiscate property and force
people into quarantines and to receive vaccines? During any epidemic the
common practice of public health officials has been to limit who is going out of
and into the area of the epidemic. They also in the case of a contagious disease
will quarantine the ill as well as those that have had contact with an ill
person. In most cases people will voluntarily do whatever the public health
official requests they do so that others will not be infected. However, what
happens when a person does not want to cooperate? Should those that are
potentially infected be allowed to go free thereby putting others at risk? How
does a society balance the needs of public health officials with the rights and
dignity of individuals?
One proposal called the Model State Emergency Health Powers Act (6) is a
suggested act that states could use to modernize their public health laws. In
the U.S. public health law is governed by the states. Each state has its own set
of public health laws. Many of these laws are out of date. Following 9/11 and in
light of the antiquated public health laws in many states the CDC asked public
health law scholars at the Center for Law and the Public’s Health at
Georgetown and Johns Hopkins Universities to develop MSEHPA. It was to be a
model that states could follow as they updated their public health laws. The
model act would empower the governor for a limited amount of time (up to 30
days) to declare a state of emergency. During that state of emergency the
governor can empower public health officials to limit travel to and from an area
of disaster, take over private property (hospitals, hotels, homes) for
quarantines, enlist caregivers, require vaccination and/or treatment of people
in the area, quarantine contacts of ill patients, and charge uncooperative
caregivers and persons in contact with ill patients with misdemeanors. The
governor is limited to some extent by the state legislature and due process is
afforded those in quarantine however, does the needs of the public trump the
rights of individuals in a catastrophe?
Several groups and individuals felt the first edition of the MSEHPA released
October 30, 2001 gave too much power to the governor and public health
officials. Due to their objections it was revised (December 31, 2001). Many feel
that the revision still infringes too much on individual human rights.
Thirty-three states [AL, AZ, CT, DE, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MN,
MO, MT, NV, NH, NM, NC, OK, OR, PA, RI, SC, SD, TN, UT, VT, VA, WI, and WY] and
Washington D.C. have passed bills or resolutions that include provisions from or
closely related to MSEHPA.
If confiscation of property results in damage or permanent loss of the
property should the property owner be paid for their losses? Who should pay
them? Should those caregivers fearful of being infected by the BW be forced to
treat highly infectious people? Should people afraid of being quarantined with
people they think might give them an illness submit to public health officials?
If a child is exposed to an infected person should they be taken away from their
parents to be quarantined with strangers? Should the safety of the public trump
individual rights in such times?
© 2005 Neal Chamberlain. All rights reserved.
Site Last Revised 5/6/05
Neal Chamberlain, PhD. A. T. Still University of Health Sciences/Kirksville
College of Osteopathic Medicine.
Site maintained by: Neal R. Chamberlain PhD.: nchamberlain@atsu.edu