BSL-4 Lab Worker - Photo Credit –USAMRIID
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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 (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 a creshendo, which resulted in 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, often contentiously, over what restrictions (if any) should be placed on potentially dangerous gain of function research. A few recent blogs on those debates include:
H7N9: Reigniting The `Gain Of Function’ Research Debate
Nature: H5N1 viral-engineering dangers will not go away
Morens & Taubenberger - Influenza Viruses: Breaking All the Rules
While we’ve been primarily concerned over GOF (Gain of Function) influenza research, the implications of this revolution in biology go far beyond influenza research. It is now possible for even small laboratories to genetically engineer new (albeit, simple) life forms.
Today, Laurie Garrett - Pulitzer-prize winning journalist (1996 for her series on Ebola) and author of 3 books (including The Coming Plague: Newly Emerging Diseases in a World Out of Balance), and Senior Fellow at the Council on Foreign Relations - has published a Policy Innovation Memorandum on this revolution in the emerging `life sciences’ field, and the biosecurity controls she believes are needed.
Follow the link to read:
Making the New Revolutions in Biology Safe
Author: Laurie Garrett
October 2013Two new revolutions in biology—gain-of-function research and synthetic biology—are forcing policymakers to rethink current national and international surveillance and regulatory systems, and any resolution will require international buy-in since the threat entails all living organisms.
I suspect few would argue against the call to restore disease surveillance and response funding to the CDC and USDA, or the need to `harmonize global laboratory and biosecurity standards’ . A biosecurity Level 3+ lab in India or China really ought to have the same safety standards as one operating in Japan, or Australia, or the United States.
The tougher nut to crack will be developing a suitable `regulatory framework appropriate to the DURC conundrum’ .
While I expect there will be opposition to additional governmental oversight, a failure to come up with clear, concise, and workable rules will (at the very least) leave the scientific community open to continual criticism (like this Editorial in the New York Times called An Engineered Doomsday) every time a new DURC or GOF research project is proposed or published. And in a worse-case scenario, could lead to dangerous a biological release.
Given the stakes, it will be interesting to see how researchers, and regulators, will respond to Ms. Garrett’s proposals.
