BSL-4 Lab Worker - Photo Credit –USAMRIID
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`Gain of Function’ research (aka GOF) seeks to enhance the virulence, transmissibility, or host range of potentially deadly microorganisms. Proponents believe this could give us an early warning system for the next pandemic, and could aid in the timely creation of a vaccine.
Opponents say those benefits are likely overstated, and there is a small - but genuine - risk that one of these `engineered’ pathogens could escape the lab, and actually cause the pandemic it was supposed to mitigate.
While GOF research isn’t new, the bioengineering tools we have today make possible tasks that would have been considered literally impossible a couple of decades ago.
All of this really came to a head about three years ago, when Dutch Virologist and flu researcher Dr. Ron Fouchier announced, at the 2011 ESWI Influenza Conference in Malta, that he’d created a `more transmissible’ form of the H5N1 virus (see Debra MacKenzie’s New Scientist: Five Easy Mutations).
At roughly the same time we saw a similar announcement from Yoshihiro Kawaoka, a highly respected virologist at the University of Wisconsin-Madison School of Veterinary Medicine, that together set alarm bells ringing in the world of biosecurity.
The early reaction outside of academia was fairly negative, with scathing editorials like An Engineered Doomsday appearing in the New York Times. There was a year-long self imposed moratorium by a group of major researchers, to allow time for `public discussion and scientific debate’ of the issue, but in the end, very little of that actually took place.
Instead, the moratorium was quietly lifted in early 2013, and research resumed, often in Biosafety level 3+ (Ag) facilities – not – as some have recommended, restricted to the highest containment Biosafety level 4 facilities.
The revelation two weeks ago of a major breach in biosafety at a CDC lab in Atlanta (see CDC Statement On Possible Lab Exposure To Anthrax), along with the announcement earlier this month that Dr. Kawaoka had recreated viruses similar to the 1918 pandemic strain in his lab (see Cell Host & Microbe: 1918-like Avian Viruses Circulating In Birds Have Pandemic Potential) has helped to reignite the debate.
Today the Wisconsin State Journal carries a long article on concerns raised by University of Wisconsin biosafety expert.
UW-Madison flu studies raise risk more than prevent it, biosafety panelist says
By David Wahlberg | Wisconsin State Journal
UW-Madison scientist Yoshihiro Kawaoka says he’s creating potentially deadly flu viruses to help prevent a pandemic, but a campus biosafety panel member says the research could cause more harm than good because the viruses could escape from the lab.
“You’re increasing the probability of having a pandemic rather than decreasing the probability,” said Tom Jeffries, a member of the university’s Institutional Biosafety Committee, which reviews sensitive research.
Jeffries said the flu viruses Kawaoka creates in his lab at University Research Park on Madison’s West Side should be genetically modified to minimize the risk to humans. Kawaoka said doing that would undermine his studies, aimed at identifying troublesome flu viruses that could arise in nature.
Late last week, the Journal Nature – which published Dr. Kawaoka’s H5N1 study in 2012 – published a cautionary opinion piece on the risks of doing this type of research. Follow the link to read it in its entirety.
Nature | Editorial
An accident with anthrax demonstrates that pathogen research always carries a risk of release — and highlights the need for rigorous scrutiny of gain-of-function flu studies.
25 June 2014
The news last week of an accident involving live anthrax bacteria at the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, is troubling. Some 84 workers were potentially exposed to the deadly Ames strain at three CDC labs. But the incident will cause much wider ripples: it highlights the risks of the current proliferation of biocontainment labs and work on dangerous pathogens. If an accident can happen at the CDC, then it can happen anywhere.
As you might imagine, speaking out against this sort of research isn’t exactly popular in academia, as these research projects can bring in large government grants, along with substantial publicity and prestige to Universities.
Suggestions that this sort of research be confined to biosafety level 4 facilities are often met with stiff resistance, since that would exclude most of the University based labs in this country.
Last November, in BMC Medicine: Containing Laboratory Escape Of Pandemic Viruses, we looked at a report that found the risks of seeing an accidental release from one of these labs is far from zero.
They calculated a .3% chance of release from any given lab each year, which works out to be roughly one every 100 years of lab operation. With hundreds of of BSL-3 and BSL-4 labs around the world, the odds of seeing an accident in any given year somewhere in the world go up substantially.
While one can certainly argue with the methodologies used to come up with estimates for future events, we do know that between 2003 and 2009, US government laboratories had 395 incidents that involved the potential release of select agents (see CIDRAP News report Report: 395 mishaps at US labs risked releasing select agents).
While only 7 related infections were reported, this does add weight to the concerns being expressed by GOF research critics. As does the most recent breach at the CDC lab in Atlanta.
For more background on all of this, you may wish to revisit a presentation by Dr. Marc Lipsitch on the the risks of these types of experiments from last September, while last December (see The Call For Urgent Talks On `GOF’ Research Projects), we saw a letter – signed by 56 scientists – and published both in SciAm and the journal Nature - calling for `urgent talks’ over the future course of GOF research on influenza viruses, and other pathogens.
And more recently, we’ve seen the debate renewed, first in the pages of PLoS Medicine last month:
The debate then moved to CIDRAP News, where Kawaoka & Fouchier responded to this paper:
Experts call for alternatives to 'gain-of-function' flu studies
And most recently, a response back by Lipsitch & Galvani, again at CIDRAP.
COMMENTARY: The case against 'gain-of-function' experiments: A reply to Fouchier & Kawaoka
Unfortunately, despite the ongoing debate, this issue doesn’t seem to be any closer to resolution than it was two and half years ago when the fate of the Fouchier & Kawaoka H5N1 papers was still in doubt.
