Keeping biological research safe

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Among the most important tasks for the closing months of the Obama Administration is to set a policy governing risky biological experiments that create highly contagious and deadly new germs.

In 2011, scientists reported experiments that made lethal strains of bird flu transmissible between ferrets (lab-animal proxies for human transmission). This news raised concerns that such novel viruses could be deliberately misused, or their accidental release could lead to an accidental pandemic of a virulent new pathogen. Reports of misplaced smallpox vials at the National Institutes of Health, potential anthrax exposures at the Centers for Disease Control, and other incidents at federal labs highlighted safety lapses in even the country’s top facilities.  In October 2014, the White House halted federal funding for a handful of the riskiest experiments while advisory groups deliberated on recommendations for a long-term policy.

The deliberative process is now complete, and the White House is expected to announce a long-term policy before January. The National Science Advisory Board on Biosecurity, charged to lead the deliberation, concluded that certain experiments – those with a high likelihood of producing novel, contagious and highly virulent infectious agents – are particularly worrisome and deserve special vetting for scientific necessity and safety before they are undertaken. The question is who should scrutinize them, and how.

There are precedents for vetting high-risk research. Global agreements restrict experiments involving smallpox virus to only two labs in the world, only if they involve small amounts of virus under tight security. Even then, each experiment requires approval by an international committee. Smallpox was once among the most horrific of human diseases but has been eradicated globally thanks to extraordinary public health efforts. Now, the human population lacks immunity and would be at high risk if accidental or malicious release led to renewed transmission. This is just the scenario that is feared in the event of an accident with a novel, contagious, virulent virus like an enhanced bird flu strain.

The US tightly restricts dangerous experiments with germs and toxins that might be tempting weapons for bioterrorists, called Select Agents. One part of the Select Agent Rule prohibits making any of these microbes resistant to drugs in a way that would threaten our ability to treat or control them. Another prohibits genetic manipulation to alter a microbe to produce a Select Agent toxin. Each of these restrictions can be waived in a particular case if a government panel is persuaded that the value of the experiment is so great as to justify the risks.

The Select Agent Rule provides a natural framework to regulate experiments that create new deadly, transmissible viruses. The Rule should be amended to prohibit the riskiest research that might produce highly virulent, contagious new strains of a pathogen, while permitting exceptions if an interagency expert panel judges the risk is warranted. Microbiologist and biosafety expert Richard Ebright of Rutgers University notes that this would expand a successful approach to cover a new category of exceptionally risky experiment, regardless of its funding source. Novel provisions should provide narrow and precise criteria to restrict experiments that could create novel, virulent and contagious pathogens. This would ensure that the vast majority of research on dangerous microbes — which is important for public health and does not create new threats — would continue unhindered. The scope should be reviewed periodically to keep pace with new threats and with innovations in biosafety.

We must modernize our approach to biosafety to keep pace with modern biology: in an era when we can readily change the properties of organisms, curbs on dangerous experiments must consider what might come out of the experiments, not only what the researcher started with. It is urgent to establish a policy to regulate the small but uniquely hazardous category of experiments where an accident could pose risks well beyond the lab. It is also time to heed the repeated calls from Congressional committees, journalists and many scientists for transparent reporting of biosafety lapses when they occur. Reporters spend years waiting for government agencies in charge of biosafety to fulfill requests for information on accidental exposures to dangerous pathogens, often finding that when the data are released they are so heavily redacted as to be unintelligibleEven Congressional committees get incomplete information from the agencies they oversee. White House action on this front so far has been ineffectual. The best way to prevent future laboratory accidents — and to make sound judgments about the levels of risk involved is to know when and how these accidents happen.

Marc Lipsitch is Professor of Epidemiology and Director, Center for Communicable Disease Dynamics, Harvard TH Chan School of Public Health, Boston.

The views expressed by authors are their own and not the views of The Hill.


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