The following is a policy paper I wrote for class.  There is this prevailing thought among certain friends and acquaintances that what I study is irrelevant.  I assure you it isn't.  It's timely, relevant, and bioterrorism it a growing threat.  Although I've made claims that I believe terrorists will choose easier and less expensive means to attack America in the near future, which I still hold to, biotechnology is making it easier to build viruses from "scratch" and bioterrorism wrought by terrorists with basic knowledge of microbiology will become a bigger threat in the future.  It is also an international concern: The Cold War ended but what we've learned since is that nations see nonproliferation agreements as welcome opportunities to gain the upper hand by establishing secret biowarfare programs. 

EXECUTIVE SUMMARY

The convicted one waits patiently under heavy lock and key. Incarcerated since 1976, this killer has continued to receive a stay of execution since its death sentence was advocated. Set to die in 1996, this killer remains alive today. After 15 years of debate, international authorities cannot come to consensus on whether this horrible monster should be left to live or should be executed, once and for all.

The convicted is the virus that causes smallpox. Eradicated from nature in the 1970s by a world-wide campaign to cause its extinction, remaining smallpox stocks at two World Health Organization (WHO) repositories are the cause of heated international debate. Is there viable reason to continue to shelter the live virus so that scientists can continue research and development goals or should it be destroyed and finally labeled “extinct”?

     The variola virus that causes smallpox has killed more than 500 million humans in the 20th century alone (Weinstein, 2011). An ancient disease, smallpox causes 30% of its victims to succumb to death and those that live bear the permanent scars and disfigurement smallpox leaves behind. A vaccine made from another genetically similar virus, vaccinia, has made it possible to eradicate the disease and was declared so by the WHO in 1980. The World Health Assembly requested that any remaining stocks of smallpox be destroyed or be sent to one of two repositories, either the Center for Disease Control and Prevention (CDC) in the United States or to a laboratory in Russia, where it was later moved to a repository called Vector. The WHO maintained little oversight during this period. Destruction or transfer of smallpox strains to one of the repositories was based on the “honor system”. In 1975 a WHO survey indicated that of all biomedical labs existing 74 held stocks of the smallpox virus (Tucker, 2011). This, too, was taken at the word of the countries holding the virus. However, since its eradication from nature smallpox outbreaks have not been unheard of. Laboratory accidents have been reported. An outbreak that occurred in Aralsk, Kazakhstan, in 1971 proved that the Soviet Union had an extensive biological warfare program that included the development of smallpox, including the more deadly strains of “flat type” and “hemorrhagic” smallpox. The “flat type” smallpox, where lesions run together, has a nearly 100% fatality rate and hemorrhagic smallpox has a 100% fatality rate. (Center for Nonproliferation Studies, 2002). This indicates that even while countries such as the Soviet Union were in the forefront of the eradication program, behind the scenes they continued to develop smallpox as a biological weapon. Because of this, there is no certainty that all smallpox stocks are contained within the two repositories the WHO endorses. There remains a possibility that stocks are hidden elsewhere and perhaps developed by rogue nations as weapons or sold on the black market to terrorist groups. Careful consideration must be given to the risks of smallpox being used as a bioweapon in the future before the two known smallpox stocks are destroyed.

Current policy that addresses the problem:    

      Current policy is at an international stalemate. The United States and several of its allies favor continuing research on smallpox. Many bioweapons and bioterrorism experts are in favor of retaining smallpox for defensive reasons. Those who wish to see smallpox spared from destruction are called “retentionists”. On the other hand, there are those experts who favor the destruction of smallpox stocks because there will always be a risk of an outbreak from a laboratory setting as long as smallpox is used for research, and most believe that the threat of a bioterrorism or bioweapons attack using smallpox has been grossly exaggerated. Those who favor destruction are, appropriately, called “destructionists” (Tucker, 2011). Many developing countries favor destruction. The ravages of smallpox still fresh in their memory, they suffered the longest because of the disease and lack the financial and public health resources to fight smallpox should it make a comeback. During the World Health Assembly in May of 2011, smallpox was once again given a stay of execution. The debate will continue to rage on.

Potential alternatives in addressing the problem:

     There appear to be only two viable alternatives as to what to do with smallpox. Destroy existing stocks at the two repositories, or keep them under lock and key, continuing to use them for research purposes. Either alternative is a gamble. There appears to be no promise of compromise. With only two repositories, each in a country unlikely to voluntarily destroy their stocks when the other refuses to, the only viable option is an international consensus on the fate of smallpox and international oversight if destruction is finally decided upon.

Arguments for and against each alternative:   

    Fenner believes the greatest danger of a smallpox outbreak comes from the laboratory stocks of the variola virus (Fenner, Henderson, Arita, Jezek, & Ladnyi, 1988). Due to the conditions in which the stocks are heavily sealed, locked and guarded, combined with the extensive procedures qualifying scientists work with the virus, there seems little danger that an outbreak should come from either repository due to a mishap (Henderson, 2011). Scientists working with the virus would quickly recognize a mistake and take precautions to contain the disease before it could infect the public. It is the virus stocks that are not known to exist, if they do at all, that pose the biggest threat should they be mishandled or sold on the black market.

There is no animal reservoir that carries the variola virus, so reintroduction from nature is highly unlikely. Suggestions that interred corpses of smallpox victims and the ability of a smallpox scab to still be infectious, after smallpox has been eradicated for so long, has been debunked (Fenner, Henderson, Arita, Jezek, & Ladnyi, 1988).

     Retentionists believe ongoing research is needed on the live variola virus. Vaccine and drug development, they believe, is necessary while the virus is still available to study. A third generation vaccine and antiviral agents are at the center of the argument. Since smallpox was eradicated new diseases and length of life expectancy has added to the number of immune-deficient individuals in the population. These individuals, along with those who have atopic dermatitis are at risk when receiving the smallpox vaccine, and retentionists claim that a vaccine which is safe for these individuals must be developed. Added to that, most of the world’s population is either unvaccinated or, if vaccinated during the eradication program, immunity is no longer viable. Studies have shown that few countries have smallpox vaccine stocks (Henderson, 2011).

     Retentionists also argue that with scientific capabilities being developed, re-creating a smallpox virus is possible, either from a monkey pox or even from scratch. There is also a possibility that a closely related pox virus in nature would morph into a virulent strain that can once again plague mankind (Weinstein, 2011).

     Biotechnology is increasing exponentially, making the creation of viruses from scratch a reality. In 2002 scientists reassembled the entire polio virus using genomic sequencing. It took 2 years to recreate polio’s 7,500 DNA base pairs. In 2003 it took scientists a mere 2 weeks to recreate a bacteriophage containing only 5,300 base pairs. By 2006 the Epstein-Barr virus, which sports 170,000 base pairs in its DNA, was recreated. Smallpox, by comparison, has 180,000 base pairs. Researchers have already assembled a bacterial genome containing 583,000 base pairs. Baker believes it is only a matter of time before smallpox is recreated by a group with nefarious intentions (Baker, 2010). Retaining the original virus could make sense if bioscience brings smallpox back and into the wrong hands.

     There are logistical and financial problems associated with keeping stocks of smallpox vaccine. Henderson quotes a cost of $1.25 billion to have enough vaccine in storage to vaccinate 50 million individuals. Added to that is the exorbitant cost of research and development, a very contentious issue considering the current economy. Advocates for a third generation nonreplicating vaccine (one that is safe for those with immune deficiencies or dermal problems), which would require 2 doses to be effective, are suggesting a cost of $8 billion for 350 million doses (Henderson, 2011). This does not solve the issue of underdeveloped and developing countries who do not have the resources to acquire and stockpile the vaccine. Retentionists must remember that this is a global issue.

      Destructionists may argue that a smallpox outbreak will be quickly recognized and contained. Awareness of bioterrorism issues has been highlighted since the 2001 Anthrax attacks. Preparedness is indeed a current concern and it is unlikely that a smallpox outbreak would demand mass vaccination (Henderson, 2011). The need for development of antiviral medications, based upon research with the smallpox virus, is also considered by Henderson to be a moot argument. Because there are no animal models to test the drugs on, it cannot be certain that antiviral drugs developed from the smallpox stocks would be effective and testing on humans brings ethical considerations to the debate.

Final Recommendations:

      In the remaining time smallpox has left before destruction, research goals should be met if possible. Stockpiles of existing vaccine should be maintained. Since the development of genomic sequencing, it is becoming more likely that smallpox can be made “from scratch” and that warrants keeping the National Strategic Stockpiles up-to-date with viable vaccines. Scientists should work on making the manufacturing of vaccines an easier and timelier process. If smallpox is used as a bioweapon by a state entity, it is likely to be discovered quickly and contained by good public health practices. This, however, may not be true for developing countries. An international agreement must be made to ensure that any smallpox outbreak is considered a global concern and nations with smallpox vaccine are obligated to help struggling nations. As biotechnology increases the need for retaining smallpox stocks should become irrelevant. Therefore, it is financially prudent to look to other sources for vaccine and antiviral development, and to spend needed federal dollars on preparedness and response initiatives than on continued research. Execution should proceed at the next proposed date.

WORKS CITED:

Baker, S. (2010). Skating on Stilts: Why We Aren't Stopping Tomorrow's Terrorism. Stanford, California,USA: Hoover Institution Press.

Center for Nonproliferation Studies. (2002, June). The 1971 Smallpox Epidemic in Aralsk, Kazakhstan and the Soviet Biological Weapons Program. (J. Tucker, & Z. R.A., Eds.) Retrieved October 7, 2011, from Center for Nonproliferation Studies: http://cns.miis.edu/opapers/op/op9/pdf

Fenner, F., Henderson, D., Arita, I., Jezek, Z., & Ladnyi, I. (1988). Smallpox and its Eradication. Retrieved October 5, 2011, from World Health Organization: http://whqlibdoc.who.int/smallpox/9241561106.pdf

Henderson, D. (2011). Smallpox Virus Destruction and the Implications of a New Vaccine. Biosecurity and Bioterrorism , 9 (2), 163-168.

Tucker, J. (2011). Breaking the Deadlock Over Destruction of the Smallpox Virus Stocks. Biosecurity and Bioterrorism , 9 (1), 55-67.

Weinstein, R. (2011). Should Remaining Stockpiles of Smallpox Virus (Variola) Be Destroyed? Emerging and Infectious Diseases , 17 (4), 681-683.