BSL-4 Lab Worker - Photo Credit –USAMRIID
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In September it will have been three years since 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.
While the media furor (see New York Times An Engineered Doomsday) has since quieted, the debate over the wisdom and safety of conducting certain types of Gain of Function (GOF) experiments – designed to enhance the transmissibility, virulence, or host range of potentially deadly microorganisms - has not gone away.
I’ve covered both sides of this debate previously, in:
Laurie Garrett On Biosecurity Reforms
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
Last September we looked at a presentation by Dr. Marc Lipsitch on the the risks of these types of experiments, while last December (see The Call For Urgent Talks On `GOF’ Research Projects), we saw a 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.
Yesterday Dr. Lipsitch - Professor of Epidemiology and Director of the Center for Communicable Disease Dynamics at the Harvard School of Public Health – along with Yale's Alison Galvani, published an opinion piece in PLoS Medicine on the risks involved in experimenting on potential pandemic pathogens (PPPs).
Ethical Alternatives to Experiments with Novel Potential Pandemic Pathogens
Marc Lipsitch mail, Alison P. Galvani
Published: May 20, 2014 DOI: 10.1371/journal.pmed.1001646
Summary Points
- “Gain of function” experiments involving the creation and manipulation of novel potential pandemic pathogens (PPPs) deserve ethical scrutiny regarding the acceptability of the risks of accidental or deliberate release and global spread.
- The Nuremberg Code, a seminal statement of clinical research ethics, mandates that experiments that pose a risk to human life should be undertaken only if they provide humanitarian benefits that sufficiently offset the risks and if these benefits are unachievable by safer means.
- A novel PPP research program of moderate size would pose substantial risks to human life, even optimistically assuming a low probability that a pandemic would ensue from a laboratory accident.
- Alternative approaches would not only be safer but would also be more effective at improving surveillance and vaccine design, the two purported benefits of gain-of-function experiments to create novel, mammalian-transmissible influenza strains.
- A rigorous, quantitative, impartial risk–benefit assessment should precede further novel PPP experimentation. In the case of influenza, we anticipate that such a risk assessment will show that the risks are unjustifiable. Given the risk of a global pandemic posed by such experiments, this risk assessment should be part of a broader international discussion involving multiple stakeholders and not dominated by those with an interest in performing or funding such research.
Although you’ll want to read the whole article, the Harvard School of Public Health has published a press release with a summation of their findings. A few excerpts follow:
Experiments using virulent avian flu strains pose risk of accidental release
Boston, MA — Experiments creating dangerous flu strains that are transmissible between mammals pose too great a risk to human life from potential release, according to an editorial by researchers from Harvard School of Public Health (HSPH) and Yale School of Public Health. The researchers are calling for greater scrutiny of experiments that make virulent influenza strains transmissible, and for future studies on flu transmission to use safer and more effective alternative approaches.
<SNIP>
The authors call for the U.S. government and other funders to conduct a comprehensive risk-benefit analysis before backing further PPP studies. They estimate that if 10 high-containment laboratories in the United States were running such experiments for a decade, there would be a nearly 20% risk of at least one laboratory-acquired flu infection with the potential to spread. In countries operating under less-stringent conditions than the United States, the risk is much greater.
If a PPP were released, it could lead to widespread human-to-human transmission of a highly virulent virus. It is believed that the H1N1 flu strain that caused a pandemic in 1977 and continued to circulate for 20 years was accidently released from a lab in Russia or China.
While accidents in well regulated Bio-level 4 labs are rare, they are not unheard of. And many researchers doing GOF studies only have access to Bio-level 3 or 3+ labs, where safety standards are not as rigorous. 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.
Between 2003 and 2009, US government laboratories had 395 incidents that involved the potential release of select agents, according to this report from CIDRAP NEWS. While only 7 related infections were reported, this does add weight to the concerns being expressed by GOF research critics.
While there is often a tendency of the public (and the press) to overreact to new fields of scientific research – imagining the worst possible outcome – over the past three years we’ve seen a growing number of sober, rational, and highly skilled scientists who see a genuine and unacceptable risk in certain types of GOF research, and are concerned enough to take an unpopular position in academia.
Something that ought to give us serious pause, regardless of how we might feel about the benefits that this type of research might someday yield.
