Dr. Ian Lipkin Addresses Concerns About H5N1 Research

Director of the Center for Infection & Immunity at the Mailman School of Public Health, W. Ian Lipkin, MD, lends his expertise on biosafety in laboratory research in a special issue of the American Society of Microbiology’s journal mBio.

Last year, two independent research groups bred new strains of H5N1 influenza with enhanced transmissibility in mammals. In nature, the global lethality of H5N1—kills nearly 60% of cases—is curbed only by its inability to easily spread from person-to-person.

With biosafety concerns raised over the possible release of these H5N1 strains, via accident or bioterrorism, the scientific community agreed on a 6-month moratorium on gain-of-function H5N1 research—classified as “dual-use research of concern” or “DURC”. To advance the discussion, Dr. Lipkin and other global experts in virology and public health published a collection of their views on the pros and cons of DURC in this issue of mBio.

In the article, Professor Lipkin discusses the global standards of biocontainment at advanced research laboratories and gives recommendations for who should conduct DURC. He advocates that the global scientific community should consult and agree on DURC regulations before further research is performed.

Recommendations:

• A key component of risk is the level of containment employed. Work is more expensive and less efficient when pursued at biosafety level 4 (BSL-4) than at BSL-3 or at BSL-3 as modified for work with agricultural pathogens (BSL-3-Ag).
• However, there is a risk-to-benefit ratio analysis. BSL-4 procedures mandate daily inspection of facilities and equipment, monitoring of personnel for signs and symptoms of disease, and logs of dates and times that personnel, equipment, supplies, and samples enter and exit containment. These measures are not required at BSL-3 or BSL-3-Ag.
• Given the implications of high-threat pathogens with pandemic potential, it is critical that the World Health Organization establish strict criteria for biocontainment that can be applied in the developing world, as well as in more economically developed countries.  

Other commentators include the original authors and proponents of the controversial research (Ron Fouchier, Yoshihiro Kawaoka, Adolfo García-Sastre), the Director of the National Institute of Allergy and Infectious Diseases (Anthony Fauci), public health professors from Harvard (Marc Lipsitch and Barry R. Bloom) and Stanford (Stanley Falkow), and officials from the American Society of Microbiology (Arturo Casadevall and Thomas Shenk).