Dilemmas Associated with the Potential BW Threat.


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. 

  1. How should scientific knowledge concerning BW be disseminated?

  2. Should the smallpox virus be kept or destroyed?

  3. Should researchers obtain informed consent from humans in clinical trials to determine safety and efficacy of countermeasures to BW?

  4. Should victims of a catastrophe be examined by several research studies to help us better understand the aftermath of such an event?

  5. When does a defensive BW program become an offensive program?

  6. Is the private health care “system” prepared to meet the needs of the public during a catastrophe?

  7. How does a physician decide whom to save during a catastrophe?

  8. Who is a first-responder’s neighbor?

  9. Do public health officials have the right to confiscate property and force people into quarantines and to receive vaccines?

  10. 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; 

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?   

Back to top

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?

Back to top

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?   

Back to top

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?

Back to top

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?

Back to top

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?   

Back to top

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?   

Back to top

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?   

Back to top

Does biodefense-spending cause other important areas of endeavor to suffer? Resources are limited in terms of the amount of tax dollars the federal government has to spend. Billions of dollars are being spent in the U.S. (2004 around $11.9 billion; 39) on biodefense. Several new initiatives have been started by the National Institutes of Health to do more research on BW. This “new” money is being used to fund research proposals and build new laboratories (BSL-3 and BSL-4) to work with these very lethal pathogens. However, at the same time every year in the U.S. 30,000 people die following influenza infections, 5,000 people die of food-borne infections, between 44,000 and 98,000 people die due to medical errors. Worldwide 2-3 million people die of either tuberculosis or malaria each year (8, 20, 23). Some feel that attention is being diverted to rare BW events (6 deaths due to BW releases by nonstate actors in last 50 years) when thousands of people die of infectious diseases every year in the U.S. and around the world. Rather than spending all this money on biodefense some indicate the money would be better spent helping alleviate the injustices and poverty that some feel cause nonstate actors to threaten the U.S. How much money should be spent on biodefense? Could it be better spent in other ways? Are more urgent day-to-day actual threats to human health (heart disease, cancer, tuberculosis, malaria, influenza, pneumonia, AIDS) being under funded to support potential threats?

Back to top


© 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.: