Tuesday, October 09, 2012

mBio: Should The H5N1 Research Moratorium End?



BSL-4 Lab Worker - Photo Credit –USAMRIID  



# 6618


Ten months ago, during the prolonged debate over the publication of a pair of controversial research papers (see The Furor Over H5N1 Research Continues), a group of the world’s leading researchers announced a 60 day moratorium on specific types of bird flu research (see Scientists Announce 60 Day Moratorium On Some H5N1 Research).


While the research papers by Fouchier and Kawaoka on the genetic changes needed to provide H5N1 with enhanced transmissibility have now been published, the self-imposed moratorium remains in place.


Scientists, biosecurity experts, and policy makers continue to struggle with how to proceed with H5N1 research that potentially falls under the category of DURCDual Use Research of Concern.


For those unfamiliar with the lexicon of biomedical research, DURC 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, materiel, or national security.


Last March the Office of Science Policy at the NIH released a 4 page set of guidelines for DURC projects, and ordered a review of all current life sciences projects (U.S. Issues New DURC Oversight Rules).


Later today the journal mBio will publish a series of opinion pieces regarding H5N1 research by some of the most influential researchers in influenza virology and biosecurity.

We’ve got a preview from a press release, which ought to whet or appetites until the new issue goes live later today (LINK).    Some excerpts follow:


American Society for Microbiology

Research on enhanced transmissibility in H5N1 influenza: Should the moratorium end?

How can scientists safely conduct avian flu research if the results could potentially threaten, as well as save, millions of lives? In a series of commentaries appearing on Tuesday, October 9 in mBio®, the online open-access journal of the American Society for Microbiology, prominent microbiologists and physicians argue the cases both for and against lifting a voluntary moratorium on experiments to enhance the ability of the H5N1 virus to move from mammal to mammal, so-called "gain-of-function" research, and discuss the level of biosecurity that would be appropriate for moving that research forward.




Enhancing and analyzing the transmissibility of the H5N1 virus could, on the one hand, provide insights that could help prevent or treat a future outbreak of H5N1 , or, on the other hand, it may provide a roadmap for a "bad actor" to deliberately bring about an influenza pandemic or lead to an inadvertent release of a virus with enhanced transmissibility.

Authors of the commentaries are prominent scientists, including:

  • Ron Fouchier of Erasmus MC Rotterdam in The Netherlands, Adolfo García-Sastre of the Mount Sinai School of Medicine, and Yoshihiro Kawaoka of the University of Wisconsin-Madison, lead authors of the two papers that began the controversy, argue that in the eight months since the moratorium was agreed upon, the international research community has had sufficient time to review biosafety and biosecurity measures and that H5N1 transmission studies ought to proceed.
  • Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases contributes his voice as a representative of an organization that is a key funder of influenza research. Although Fauci acknowledges that the benefits of gain-of-function research outweigh the risks, he argues that scientists have yet to fully meet their responsibility for engaging the public in weighing these matters and making the case for proceeding. He outlines how the U.S. government plans to augment policy guidelines related to "dual use research of concern" like the experiments on enhanced influenza transmission.
  • Marc Lipsitch and Barry R. Bloom of the Harvard School of Public Health explain why they view H5N1 with enhanced transmissibility as a "potential pandemic pathogen," representing an even greater threat to global health than Ebola and other biosafety level 4 (BSL-4) pathogens. They argue that research on enhanced H5N1 and other potential pandemic pathogens requires a new, more stringent set of guidelines for safety, thorough public discussion of the risks and benefits involved, and global guidelines for laboratory procedures, among other measures to minimize the risk of laboratory-released infections or epidemics.
  • Ian Lipkin of Columbia University argues that once research on enhanced strains of H5N1 continues it may be advisable to conduct the work only in BSL-3 Ag laboratories that meet additional, enhanced guidelines for handling agents with pandemic potential. Lipkin proposes that any course should be charted in consultation with and oversight from the global scientific and regulatory community.
  • Stanley Falkow of Stanford University provides perspective on the H5N1 research moratorium based on his own experiences with a similar situation in the 1970s, when research in recombinant DNA techniques was halted while a committee of scientists and non-scientists could establish a set of guidelines for conducting the work safely. Falkow argues that research on H5N1 viruses with enhanced transmissibility should move forward once scientists work with the public to establish standardized guidelines using common sense and scientific creativity.

(Continue . . . )


While the papers of Fouchier and Kawaoka sparked this vigorous (and at times heated) debate over the risks of creating a better bird flu virus, many of the same issues apply to other areas of biological research.


Among them:

  • How are we to handle this brave new world of life sciences, where new viruses and other life forms can be created in the laboratory?
  • Who is to decide on what is appropriate, or safe research?
  • Who decides what should be published, and who should have access to redacted information?
  • What laboratory protocols and protections are necessary for working the the H5N1 virus, and other virulent pathogens?


We are entering a new era of scientific discovery, one where great things are possible. But those advances will be for naught if the public loses faith in the science, or the scientists.


You can create a genetically modified dengue-resistant mosquito, but if the public fears it more than the disease, all you have is an expensive laboratory curiosity.


And a universal flu vaccine – one that could forever stave off the global threat of influenza pandemics -only works if it is accepted by the vast majority of the public as being safe, effective, and necessary.


As I wrote in Science At The Crossroads, the public’s faith in science and technology is teetering. 


According to a UK poll (Public Attitudes To Science, May 2011), while the majority of respondents (79%) believe science has, on the whole, made our lives easier . . .  astonishingly, just 54% believe that the benefits of science are greater than any harmful effect.


One only has to look at the deep divisions over climate change, evolution, vaccine safety, nuclear power, and genetically modified food crops to realize just how wide this rift between the public, and scientists, has become.


Which makes getting policy on H5N1 research (and other DURC projects) right, and as safe as possible, absolutely imperative.


Given the public’s sentiment, the burgeoning field of Life Sciences (which includes bio-engineering) can ill afford a misstep if they hope to gain and hold the public’s acceptance.

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