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TWN Info Service on Health Issues (Jul14/03)
25 July 2014
Third World Network

Dear friends and colleagues,

Time for International Oversight of Research with Lab-Created Potentially Pandemic Influenza?

Naturally emerging pandemic influenza strains have always been the focus of public health and research, but disturbing new possibilities for a man-made pandemic are increasing. At their own initiative and with little supervision, a few labs are now undertaking highly controversial research to deliberately create novel potentially pandemic influenza strains that would put the entire world at risk if were they to escape.

While US and Dutch researchers are currently at the forefront of the risky experiments, others are following, and dozens of labs spread across the world have facilities and specialists capable of conducting such risky research. This deepens international public health concerns because within a few years, dozens more labs in various locations could be conducting such experiments. With each additional lab that creates and handles novel influenza viruses with pandemic potential, however, the possibility of an accident leading to a pandemic increases.

Initial efforts at oversight have been inadequate, with limited applicability and a reliance on non-binding mechanisms. Recent lab incidents in the US involving influenza, smallpox and anthrax have underscored the lack of oversight and flaws in the system, adding urgency to the situation.

We are pleased to share the TWN note below, which calls for international oversight of research with lab-created potentially pandemic influenza virus strains. It suggests that the WHO, as the global body overseeing public health, is best placed to put rules in place to govern such research.


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Third World Network
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Time for International Oversight of Research with Lab-Created Potentially Pandemic Influenza?

Third World Network, July 2014

Influenza has no respect for borders. A pandemic strain can spread faster than the best healthcare efforts can keep up, and no matter where it first appears, it is likely to quickly circle the globe. Within two years of appearance, a new pandemic strain of influenza will typically have infected 25% of the global population – about 1.75 billion people.

Naturally emerging pandemic strains have always been the focus of public health and research, but disturbing new possibilities for a man-made pandemic are increasing. At their own initiative and with little supervision, a few labs are now undertaking highly controversial research to deliberately create novel potentially pandemic influenza strains that would put the entire world at risk if were they to escape. 

With the intrinsically global implications of every influenza pandemic, is it time for international oversight, through the World Health Organization (WHO), of these particularly dangerous research projects? Should they be conducted at all?  Are there any benefits that merit the extreme risks? Should all countries, whose citizens and health care systems would be endangered by a laboratory escape, have a say?

In a small number of labs, most visibly in the United States and The Netherlands, strains of influenza such as H5N1 or H7N9 have been altered to, for example, evade human immune reaction and transmit more easily between people. The proponents of such projects claim that they are simulating what might happen in nature. By imagining and then creating especially dangerous strains, they claim to be aiding response to a possible natural pandemic. 

A large number of critics, including senior scientists, say that the benefits are overstated, that the risks outweigh knowledge gained, and that many – maybe all – of the questions that these US and Dutch researchers seek to answer can be probed using less dangerous experimental techniques.

Enhancing surveillance of naturally emerging strains, a task that is prioritized under the WHO Pandemic Influenza Preparedness Framework, also mitigates the alleged need to create these strains in the lab.

Scientific opponents of the research, who include researchers at top institutions, have recently taken to the media, writing editorials and in articles in the New York Times, Financial Times, Science, Nature, and other publications - calling for the research to be halted. (Links to a selection of such articles are provided at the end of this note.)

While US and Dutch researchers are currently at the forefront of the risky experiments, others are following, and dozens of labs spread across the world have facilities and specialists capable of conducting the research. This deepens international public health concerns because within a few years it could be not only the existing handful of labs conducting these experiments, but dozens more labs in various locations.

In a perverse scientific incentive, the risks of these studies garner wide attention and the results have been prominently published, making them seem an attractive choice for virologists seeking a public profile.

With each additional lab that creates and handles novel influenza viruses with pandemic potential, however, the possibility of an accident leading to a pandemic increases.

Indeed, some argue that hubris – rather than public health need – is misguiding influenza labs into unprecedentedly dangerous territory.

Timeline of Influenza Research with a Potential Pandemic Result

October 2005
US researchers reveal that after collecting sequences from the bodies of victims and stored medical samples, they have recreated the “Spanish Flu”, which caused the great pandemic of 1918-19. This is the first known case of deliberate creation of a pandemic strain.

September 2011
Lab-made pandemic strain experiments in the Netherlands first revealed in an oral presentation at a scientific conference. After news reports, public concern mounts.

January 2012
A voluntary moratorium on the studies is announced by a group of influenza scientists.

May 2012 
2011 experiments by researchers at the University of Wisconsin (US) adding H1N1 sequences to H5N1 influenza and thereby making the engineered flu transmissible by air are published in Nature. More studies by the Wisconsin group later follow.

June 2012
Science publishes 2011 experiments by Erasmus University in the Netherlands to introduce mutations in H5N1 and enable its airborne spread. More studies follow from Erasmus authors.

December 2012
The US National Institutes of Health (NIH) holds a public consultation on the research. No members of the public attend. At the meeting, an Erasmus University scientist says that he may ignore any NIH-promulgated restrictions on research, despite NIH being one of the Dutch institute's funders.

January 2013
Influenza labs rescind their voluntary moratorium announced a year earlier.

February 2013
NIH re-opens funding channels that permit proposals for laboratory creation of potentially pandemic influenza strains.

March 2013 
NIH publishes a "framework" for review of proposed research, but the framework is not rooted in legally-binding obligations and does not apply to research funded by others.

July 2013
Chinese scientists in Harbin publish experiments on enhancing transmission of H7N9.

October 2013
University of Maryland (US) researchers publish studies on genetic re-assortment of H9N1 to increase transmissibility in mammals. More studies follow.

July 2014
News reports state that Wisconsin researchers have genetically engineered H1N1 to evade the human immune system.

July 2014
The US Centers for Disease Control (CDC) halt shipments from and close high containment labs at its WHO Collaborating Center for Influenza after it accidentally sent samples of a virulent H5N1 strain to a collaborating lab. When notified of the problem, the WHO Collaborating Center lab failed to inform CDC's leadership of the incident until a separate accident investigation uncovered it.

Flawed Initial Effort at Oversight

After US-funded experiments at the University of Wisconsin and Erasmus University in the Netherlands came to public light in late 2011, the US National Institutes of Health (NIH) responded to concerns by developing an oversight framework, which was published in early 2013. This framework only applies to certain influenza types and relies on non-binding mechanisms to decide upon funding and oversee the research, using loose safety criteria mainly implemented through discussions between funding agencies and labs, and local oversight provided by unregulated institutional biosafety committees. 

While the NIH and some influenza researchers were satisfied with the framework, others weren't.  Following the recent publication of more risky studies, some appearing even more dangerous than the first studies that were revealed, and a recent spate of high profile laboratory accidents in the US, discord in the scientific community is growing.

A number of mainly American biologists and epidemiologists, including several Nobel laureates, have taken the unusual step of publicly criticizing the US NIH (a primary research funder), and calling for such risky research involving potential pandemic influenza strains to be “curtailed” until the risks and benefits can be properly assessed.  Referencing the 1975 Asilomar Conference on Recombinant DNA, the Working Group proposed an urgent meeting be convened to recommend new rules.

Lab Accidents Underscore Risks

A trio of disturbing incidents in the US that started to unfold in June has increased the sense of urgency to develop stricter oversight.

In early July, the US Centers for Disease Control revealed that its influenza laboratory, a WHO Collaborating Center in the Global Influenza Surveillance and Response System (GISRS), contaminated a sample of low pathogenicity H9N2 influenza with a dangerous strain of H5N1 capable of infecting people and causing severe agricultural losses. The contaminated sample was sent to a collaborating lab - labeled as a low pathogenicity strain. By good fortune, the receiving lab handled the sample under higher than necessary containment and detected the contamination when experimental animals (chickens) exposed to it repeatedly died.

More recently, CDC officials have said that they may never be able to pinpoint how and why the contamination event occurred.

Adding to concern, is that upon being notified of the problem, CDC scientists at the WHO Collaborating Centre failed to properly report the incident, leading to delays in investigation, and leaving CDC's leadership unaware. The lab, which among other things prepares and distributes seed stock for GISRS-recommended influenza vaccines, has since been prohibited from sending out biological samples pending review and overhaul of safety procedures.

Critics observed that if the CDC lab, which is central to the GISRS system and is a global distributor of vaccine seed strain and samples of pathogenic viruses used in research, was capable of such mistakes, that the university and other labs deliberately creating novel pandemic strains could commit similar errors with disastrous results.

Almost simultaneously, US officials announced that decades old vials containing freeze dried smallpox had been discovered in a cold room on the US National Institutes of Health campus in Maryland.  The vials were shipped to CDC in Atlanta, Georgia, where some proved to contain viable smallpox virus.  By World Health Assembly (WHA) resolution, the vials should have been destroyed or shipped to the WHO-authorized laboratory at CDC decades ago yet, inexplicably; they remained in storage in Maryland.

In its own right, the smallpox incident raises questions for WHO with regard to its oversight of smallpox stocks. In the context of the controversial influenza research, it signals the serious concern that, over time, tracking and safety measures for lab-created potentially pandemic strains may falter. As a result, a strain created today could be stored and accidentally released, with equal or greater consequences, years from now.

Finally, the CDC revealed that its researchers failed to inactivate (kill) an anthrax sample that was sent to another lab, where it was handled with lower biocontainment procedures, leading to the exposure of over eighty lab workers.  Of special concern in this incident, CDC's failure to effectively inactivate the anthrax was merely the most recent is a series of at least three nearly identical anthrax incidents at CDC and other US labs since 2004.  In fact, CDC's failure to follow its own recommendations for inactivating anthrax, made after past accidents, allowed the 2014 incident to take place. 

Conclusion

The humbling series of lab accidents and strong scientific dissent over projects to deliberately create potentially pandemic flu strains have placed American policy in the spotlight as its health ministry officials make statements to allay public, scientific, and congressional concern. In light of the accidents, particularly the incident at the CDC influenza lab, it is possible that the initial lightweight US framework set up to address risky flu research will be replaced with more rigorous rules. Thus far, however, there has been much discussion but no major concrete commitments.

Meanwhile, there are US discussions on the creation of a new and separate regulatory agency to oversee high containment laboratories, removing powers from the health and agriculture ministries. The US Congress, however, is in a deeply partisan phase and may not be able to vote out a law to create such an agency.

But US moves will not protect the rest of the world from potential consequences of an accident with a novel pandemic strain. If one were to escape a US lab, even if American safety procedures are beefed up, the consequences would immediately become international as the strain spreads. 

In addition, US labs are not the only ones conducting these experiments or capable of doing so.  Assuming that national regulations are developed at all, a country-by-country process to oversee such research would appear to be inappropriate – creating a patchwork of potentially divergent rules to deal with a global problem that requires a consistently very high standard of oversight.

And is it appropriate at all for US, Dutch, or other researchers to impose the risks of their potentially pandemic experiments on other countries?  Everyone would have to deal with the consequences of an accident, but the research labs are not justifying the risk to those imperiled.

Lab experiments to create new potentially pandemic disease strains raise concerns that may necessitate global answers, and as the world's public health agency, the World Health Organization may be the only body positioned to put rules in place.  Precedents for WHO oversight of especially risky research may be found in WHA resolutions on smallpox, since that disease's eradication from nature.

WHO Member States may wish to consider early action on this area of research, beginning at the January 2015 Executive Board meeting, where countries could place the item on the WHA agenda.  Steps may be comprised of:

1. Adoption of a WHA Resolution establishing a moratorium on deliberate creation of novel potentially pandemic influenza strains.

2. The moratorium to remain in effect until an agreed WHO mechanism is established and functioning to review and (dis)approve proposals to conduct such research.

3. The agreed WHO mechanism to be composed of a regionally balanced set of experts, and to operate transparently with full and timely public access to research proposals, evaluations, and decisions.

4. The agreed WHO mechanism to include experts in public health, epidemiology, medicine, microbiology, and outbreak response.

5. The WHA may additionally decide to completely prohibit some classes of experiments whose potential outcomes may include unacceptable public health consequences.

Selected Further Reading

Hale P et al. (2102). The folly of resuming avian flu research (Op-Ed).  Financial Times, 9 August.  URL:  http://www.ft.com/intl/cms/s/e8bbee94-e20d-11e1-b3ff-00144feab49 (paywall).

Sample I (2014). Scientists condemn 'crazy, dangerous' creation of deadly airborne flu virus.  The Guardian, 11 June.  URL: http://www.theguardian.com/science/2014/jun/11/crazy-dangerous-creation-deadly-airborne-flu-virus

Lipsitch M (2014).  Anthrax?  That’s Not the Real Worry (Op-Ed). New York Times, 29 June. URL:  http://www.nytimes.com/2014/06/30/opinion/anthrax-thats-not-the-real-worry.html?

Biosafety in the Balance (Editorial). Nature, 25 June 2014. URL: http://www.nature.com/news/biosafety-in-the-balance-1.15447

Grady, D (2014). Pathogen Mishaps Rise as Regulators Stay Clear. New York Times, 19 July. URL: http://www.nytimes.com/2014/07/20/science/pathogen-mishaps-rise-as-labs-proliferate-with-scant-regulation.html

Steenhuysen, J (2014). U.S. CDC says it 'may never know' how bird flu mishap occurred. Reuters, 21 July 2014.  URL: http://www.reuters.com/article/2014/07/21/us-usa-anthrax-birdflu-cdc-idUSKBN0FQ23N20140721

 


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