BSL-4 Lab Worker - Photo Credit –USAMRIID
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Most readers will recall that, beginning in the fall of 2011 and extending well into the summer of 2012, the global scientific community was roiled by controversy over the wisdom of conducting – and publishing – Gain of Function (GOF) research on the avian H5N1 virus.
Objections were raised initially after the 2011 ESWI Influenza Conference in Malta, where Dutch researcher Ron Fouchier revealed that he’d created a more `transmissible’ form of the H5N1 virus (see Debra MacKenzie’s New Scientist: Five Easy Mutations).
That discovery, along with similar news coming from Yoshihiro Kawaoka, a highly respected virologist at the University of Wisconsin-Madison School of Veterinary Medicine, set alarm bells ringing in the biosecurity community.
By December of 2011 The Biosecurity Debate On H5N1 Research reached fevered pitch, which led to a group of internationally renowned Scientists to Announce a 60 Day Moratorium On Some H5N1 Research in January, 2012. That moratorium was subsequently extended until January of 2013 (see NIH Statement On Lifting Of The H5N1 Research Moratorium).
In the meantime, after much heated debate, last summer Science Published The Fouchier Ferret Study and Nature Published The Kawaoka H5N1 Study.
In March of 2012 the NIH - which funds many of these research projects - promulgated new DURC Oversight Rules (Dual Use Research of Concern), which also includes some types of GOF research.
For those unfamiliar with the lexicon of biomedical research, DURC in this new policy is defined as:
. . . life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment,
Since then the debate has continued, mostly in academia, over what restrictions (if any) should be placed on potentially dangerous gain of function research.
A couple of recent examples include:
Nature: H5N1 viral-engineering dangers will not go away
Morens & Taubenberger - Influenza Viruses: Breaking All the Rules
Today, in a bid to head off the kind of controversy they encountered with the surprise announcement of H5N1 GOF studies in 2011, 22 respected international scientists have published a pre-emptive letter (in the Journal Science and the Journal Nature) calling for gain of function research using the H7N9 virus.
In this letter they outline the benefits they believe such studies will provide along with the biosecurity measures they will work under.
Many of the signatories to this letter are well known to the readers of this blog.
RON A. M. FOUCHIER, YOSHIHIRO KAWAOKA, CAROL CARDONA, RICHARD W. COMPANS, ADOLFO GARCÍA-SASTRE, ELENA A. GOVORKOVA, YI GUAN, SANDER HERFST, WALTER A. ORENSTEIN, J. S. MALIK PEIRIS, DANIEL R. PEREZ, JUERGEN A. RICHT, CHARLES RUSSELL, STACEY L. SCHULTZ-CHERRY, DEREK J. SMITH, JOHN STEEL, S. MARK TOMPKINS, DAVID J. TOPHAM, JOHN J. TREANOR, RALPH A. TRIPP, RICHARD J. WEBBY, ROBERT G. WEBSTER
You can read the full letter here or at the following link:
Published Online August 7 2013
Science DOI: 10.1126/science.1243325
Letters
Gain-of-Function Experiments on H7N9
*Corresponding author. E-mail: r.fouchier@erasmusmc.nl (R.A.M.F.); kawaokay@svm.vetmed.wisc.edu (Y.K.)
- Abstract
Since the end of March 2013, avian a influenza viruses of the H7N9 subtype have caused more than 130 human cases of infection in China, many of which were severe, resulting in 43 fatalities. Although this A(H7N9) virus outbreak is now under control, the virus (or one with similar properties) could reemerge as winter approaches. To better assess the pandemic threat posed by A(H7N9) viruses, NIAID/NIH Centers of Excellence in Influenza Research and Surveillance (CEIRS) investigators and other expert laboratories in China and elsewhere have characterized the wild-type avian A(H7N9) viruses in terms of host range, virulence, and transmission, and are evaluating the effectiveness of antiviral drugs and vaccine candidates. However, to fully assess the potential risk associated with these novel viruses, there is a need for additional research including experiments that may be classified as “gain-of-function” (GOF). Here, we outline the aspects of the current situation that most urgently require additional research, our proposed studies, and risk-mitigation strategies.
But as you might expect, not everyone is in agreement on the value, or the safety, of doing these studies. In an accompanying news and analysis article in Science Magazine, David Malakoff writes:
Avian Influenza
Critics Skeptical as Flu Scientists Argue for Controversial H7N9 Studies
<EXCERPT>
The openness offensive isn't quieting critics. “The scientific justification presented for doing this work is very flimsy, to put it mildly, and the claims that it will lead to anything useful are lightweight,” says Adel A. F. Mahmoud, an infectious disease specialist at Princeton University and the former president of Merck Vaccines. And the security precautions are “insufficient and amazingly lame,” says molecular biologist Richard Ebright of Rutgers University in Piscataway, New Jersey.
The NIH, responding to today’s letter, has published their position regarding additional oversight they will require for H7N9 influenza virus gain-of-function research.
Extra Oversight for H7N9 Experiments
Harold Jaffe, Amy P. Patterson, Nicole Lurie
The U.S. Department of Health and Human Services (HHS) announces a new review process for certain gain-of-function (GOF) experiments with the avian influenza A (H7N9) virus, some of which are proposed this week by influenza scientists (1). Specifically, before being undertaken using funds from the HHS, proposed studies that are reasonably anticipated to generate H7N9 viruses with increased transmissibility between mammals by respiratory droplets will undergo an additional level of review by the HHS.
Ed Yong – writing for The Scientist – has penned an excellent overview of this controversy, including extended remarks from a number of experts, including CIDRAP director Michael Osterholm.
Bird Flu Experiments Proposed
In a bid to avoid the controversy that dogged H5N1 research last year, flu researchers have published a letter proposing how to approach potentially dangerous research on H7N9.
By Ed Yong | August 7, 2013
And for a last stop, we have the always reliable Helen Branswell, who writes:
Flu researchers propose controversial 'gain-of-function' studies for H7N9 virus
By Helen Branswell, The Canadian Press August 7, 2013 10:30 AM
Whether this controversy will reach the contentious levels we saw last year with H5N1 research is difficult to predict, but there are strong feelings on both sides of this issue.
Stay tuned.
