Smallpox virus retention controversy

The smallpox virus retention controversy is a debate that has been ongoing among international scientists and other officials since smallpox was declared eradicated by the World Health Organization (WHO) in 1980. It centers on whether to finally and irreversibly destroy the two last remnants of the virus that causes smallpox, which reside in government laboratories in the United States and Russia . Advocates of final destruction maintain that there is no longer any valid rationale for retaining the samples, which represent a hazard, while opponents of it maintain that the samples are needed for further research as smallpox virus may still exist in the world outside of the two labs, and thus may re-emerge, particularly as a bio-weapon.

## Contents

* 1 Background
* 2 Ad Hoc Committee on Orthopox Infections
* 3 U.S. pro-retention argument (2011)
* 4 Post-1984 instances of smallpox virus discovery
* 5 WHO 2018 position
* 6 References
* 7 External links

## Background

The last cases of smallpox occurred in an outbreak of two cases, one of which was fatal, in Birmingham, UK, in 1978. A medical photographer, Janet Parker, contracted the disease at the University of Birmingham Medical School and died on September 11, 1978.[1] In light of this incident, all known stocks of smallpox were destroyed or transferred to one of two WHO reference laboratories which had BSL-4 facilities—the Centers for Disease Control and Prevention (CDC) in the United States and the State Research Center of Virology and Biotechnology VECTOR in Koltsovo, Russia.[2] Since 1984, these two labs have been the only ones authorized by the WHO to hold stocks of live smallpox virus.

In 1986, the WHO first recommended destruction of all virus, and later set the date of destruction to be 30 December 1993. This was postponed to 30 June 1999,[3] then again to 30 June 2002. Due to resistance from the U.S. and Russia, in 2002 the World Health Assembly agreed to permit the temporary retention of the virus stocks for specific research purposes.[4] Destroying existing stocks would reduce the risk involved with ongoing smallpox research; the stocks are not needed to respond to a smallpox outbreak.[5] Some scientists have argued that the stocks may be useful in developing new vaccines, antiviral drugs, and diagnostic tests;[6] A 2010 review by a team of public health experts appointed by the WHO, however, concluded that no essential public health purpose is served by the U.S. and Russia continuing to retain virus stocks.[7] The latter view is frequently supported in the scientific community, particularly among veterans of the WHO Smallpox Eradication Program (1958–79).[8]

## Ad Hoc Committee on Orthopox Infections

An Ad Hoc Committee on Orthopox Infections, advising the WHO, has debated the fate of the remaining samples of smallpox in the remaining two official repositories since 1980. Smallpox expert D. A. Henderson has been foremost in favor of destruction, while U.S. Army scientist Peter Jahrling has been against it on the basis that further research is needed since he believes that smallpox almost certainly exists outside of the repositories.[9] Other scientists have expressed similar opinions.[10]

## U.S. pro-retention argument (2011)

In 2011, Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services, laid out the rationale of the Obama Administration in a New York Times op-ed piece. She said, in part:

> [In 1980], the WHO called on all nations to destroy their collections of smallpox virus or transfer them to the WHO-sanctioned collections at one of two labs in Russia or the United States. The global public health community assumes that all nations acted in good faith; however, no one has ever attempted to verify or validate compliance with the WHO request…. Although keeping the samples may carry a minuscule risk, both the United States and Russia believe the dangers of destroying them now are far greater…. It is quite possible that undisclosed or forgotten stocks exist. Also, 30 years after the disease was eradicated, the virus’ genomic information is available online and the technology now exists for someone with the right tools and the wrong intentions to create a new smallpox virus in a laboratory…. Destroying the virus now is merely a symbolic act that would slow our progress and could even stop it completely, leaving the world vulnerable…. Destruction of the last securely stored viruses is an irrevocable action that should occur only when the global community has eliminated the threat of smallpox once and for all. To do any less keeps future generations at risk from the re-emergence of one of the deadliest diseases humanity has ever known. Until this research is complete, we cannot afford to take that risk.[11]

## Post-1984 instances of smallpox virus discovery

* In 2013, cloned variola major DNA fragments were found to be in a South African laboratory. The WHO arranged to oversee their destruction, which took place in January 2014.[12][13]
* On July 1, 2014, the U.S. National Institutes of Health (NIH) notified the regulatory agency, the Division of Select Agents and Toxins (DSAT) of the U.S. Centers for Disease Control and Prevention (CDC), that employees had discovered vials labelled "variola" (smallpox) in an unused portion of a storage room in a U.S. Food and Drug Administration (FDA) laboratory located on the NIH Bethesda campus. An investigation is ongoing.[14] A media statement was released by the CDC regarding the Bethesda variola major (smallpox virus) situation seven days after the discovery. It confirmed that variola major had been found and it had been transferred to a BSL-4 laboratory at the CDC in Atlanta. Overnight PCR testing had shown the vials did contain variola major. The vials were believed to have been from the 1950s. Further testing to find out if the virus was viable was in progress.[14] Further testing showed that the vials which dated from the 1950s contained viable (live) variola major virus. As of the end of 2014 the vials were placed in a secure freezer to await destruction. The protocol for destruction of variola major virus involves a member of the WHO being present at the destruction. Usually the observer watches via close circuit television outside the room where the variola virus will be autoclaved to destroy it. As a result of the Ebola outbreak in parts of Africa at the time, the WHO were overstretched and stated they had no one locally with sufficient security clearance to enter a BSL-4 laboratory. Due to this the WHO were planning to fly an official into Atlanta to oversee the destruction at a future date.[13] The vials were finally destroyed on February 24, 2015, under the supervision of WHO officials.[15]

## WHO 2018 position

As of May 2018, based on the latest (19th) meeting of the WHO Advisory Committee on Variola Virus Research (1–2 November 2017), the question remained as to whether the use of live variola virus for their further development was "essential for public health".[16]

## References

1. ↑ Pennington H. (2003). "Smallpox and bioterrorism". Bull. World Health Organ. 81 (10): 762–7. doi:10.1590/S0042-96862003001000014. PMID 14758439. PMC 2572332. http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862003001000014&lng=en&nrm=iso&tlng=en.
2. ↑ Connor, Steve (2002-01-03). "How terrorism prevented smallpox being wiped off the face of the planet for ever". London: The Independent. https://www.independent.co.uk/news/science/how-terrorism-prevented-smallpox-being-wiped-off-the-face-of-the-planet-for-ever-672121.html. Retrieved 2008-10-03.
3. ↑ Altman, Lawrence (1996-01-25). "Final Stock of the Smallpox Virus Now Nearer to Extinction in Labs". The New York Times. https://query.nytimes.com/gst/fullpage.html?res=9800EED61639F936A15752C0A960958260&sec=&spon=&pagewanted=print. Retrieved 2007-11-23.
4. ↑ MacKenzie, Debora (2002-01-26). "Stay of execution". New Scientist. https://www.newscientist.com/article/mg17323271.300-stay-of-execution.html. Retrieved 2007-11-23.
5. ↑ Hammond, Edward (2007). "Should the US and Russia destroy their stocks of smallpox virus?". BMJ 334 (7597): 774. doi:10.1136/bmj.39155.695255.94. PMID 17431261. PMC 1851992. http://www.bmj.com/cgi/content/full/334/7597/774.
6. ↑ Agwunobi, John O. (2007). "Should the US and Russia destroy their stocks of smallpox virus?". BMJ 334 (7597): 775. doi:10.1136/bmj.39156.490799.BE. PMID 17431262. PMC 1851995. http://www.bmj.com/cgi/content/full/334/7597/775.
7. ↑ Comments on the Scientific Review of Variola Virus Research, 1999‐2010. Advisory Group of Independent Experts to review the smallpox research program (AGIES) WHO document WHO/HSE/GAR/BDP/2010.4
8. ↑ Lane, J.Michael; Poland, Gregory A. (2011). "Why not destroy the remaining smallpox virus stocks?". Vaccine 29 (16): 2823–2824. doi:10.1016/j.vaccine.2011.02.081. PMID 21376120.
9. ↑ Preston, Richard (2002), The Demon in the Freezer.
10. ↑ Damon, Inger k; Damaso, Clarissa R; McFadden, Grant (May 1, 2014). "Are we there yet? The smallpox research agenda using variola virus". PLOS Pathogens 10 (5): e1004108. doi:10.1371/journal.ppat.1004108. PMID 24789223.
11. ↑ Sebelius, Kathleen, (2011), “Why We Still need Smallpox”, The New York Times (25 April 2011).
12. ↑ "Smallpox eradication: destruction of variola virus stocks Report by the Secretariat". World Health Organisation EXECUTIVE BOARD EB134/34 134th session. 20 December 2013. http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_34-en.pdf.
13. ↑ 13.0 13.1 Reardon, Sara (2014-10-30). "'Forgotten' NIH smallpox virus languishes on death row". Nature 514 (7524): 544. doi:10.1038/514544a. PMID 25355337. Bibcode: 2014Natur.514..544R. http://www.nature.com/news/forgotten-nih-smallpox-virus-languishes-on-death-row-1.16235.
14. ↑ 14.0 14.1 Centers for Disease Control and Prevention “CDC Media Statement on Newly Discovered Smallpox Specimens” (July 8, 2014).
15. ↑ "FDA Review of the 2014 Discovery of Vials Labeled "Variola" and Other Vials Discovered in an FDA-Occupied Building on the NIH Campus". Director of Laboratory Science and Safety, FDA. 13 December 2016. https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM532877.pdf.
16. ↑ "WHO Advisory Committee on Variola Virus Research Report of the Nineteenth Meeting". World Health Organization. May 2018. http://www.who.int/csr/resources/publications/smallpox/variola-research-november-2017/en/. Retrieved May 31, 2018.

## External links

* Errol Morris New York Times video op-ed (2016)

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