White House suspends enhanced pathogen research

Past research made the H5N1 virus transmissible in ferrets.

Past research has made the H5N1 virus transmissible in ferrets.{credit}Sara Reardon{/credit}

As the US public frets about the recent transmission of Ebola to two Texas health-care workers, the US government has turned an eye on dangerous viruses that could become much more widespread if they were to escape from the lab. On 17 October, the White House Office of Science and Technology Policy (OSTP) announced a mandatory moratorium on research aimed at making pathogens more deadly, known as gain-of-function research.

Under the moratorium, government agencies will not fund research that attempts to make natural pathogens more transmissible through the air or more deadly in the body. Researchers who have already been funded to do such projects are asked to voluntarily pause work while two non-regulatory bodies, the National Science Advisory Board for Biosecurity (NSABB) and the National Research Council, assess its risks. The ban specifically mentions research that would enhance influenza, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Other types of research on naturally occurring strains of these viruses would still be funded.

This is the second time that gain-of-function research has been suspended. In 2012, 39 scientists working on influenza agreed to a voluntary moratorium after the publication of two papers demonstrating that an enhanced H5N1 influenza virus could be transmitted between mammals through respiratory droplets. The publications drew a storm of controversy centred around the danger that they might give terrorists the ability to create highly effective bioweapons, or that the viruses might accidentally escape the lab. Research resumed after regulatory agencies and entities such as the World Health Organization laid out guidelines for ensuring the safety and security of flu research.

The OSTP’s moratorium, by contrast, is mandatory and affects a much broader array of viruses. “I think it’s really excellent news,” says Marc Lipsitch of Harvard University in Cambridge, Massachusetts, who has long called for more oversight of risky research. “I think it’s common sense to deliberate before you act.”

Virologist Yoshihiro Kawaoka of the University of Wisconsin–Madison, who conducted one of the controversial H5N1 gain-of-function studies in an effort to determine how the flu virus could evolve to become more transmissible in mammals, says that he plans to “comply with the government’s directives” on those experiments that are considered to be gain-of-function under OSTP’s order. “I hope that the issues can be discussed openly and constructively so that important research will not be delayed indefinitely,” he says.

The NSABB, which has not met since 2012, was called back into action in July, apparently in response to a set of lab accidents at the US Centers for Disease Control and Prevention in which lab workers were exposed to anthrax and inadvertently shipped H5N1 virus without proper safety precautions. The NSABB will spend most of its next meeting on 22 October discussing gain-of-function research, and the National Research Council plans to hold a workshop on a date that has not yet been set. Lipsitch, who will speak at the NSABB meeting, says that he plans to advocate for the use of an objective risk-assessment tool to weigh the potential benefits of each research project against the probability of a lab accident and the pathogen’s contagiousness, and to consider whether the knowledge gained by studying a risky pathogen could be gained in a safer way.

Correction: This post has been changed to specify that Yoshihiro Kawaoka’s 2012 gain-of-function research increased the transmissibility of H5N1.

New guidelines announced for risky research

Twists and turns: researchers use ferrets to assess the transmissibility of H5N1 in mammals.{credit}Credit: Tambako the Jaguar via Flickr{/credit}

US government officials have passed two more checkpoints on the long, winding road towards a policy for dealing with risky research. That journey was forced into overdrive at the end of 2011, when a government body recommended against publishing two studies showing how a deadly form of avian influenza H5N1 could be made to pass between mammals.

Today, the US National Institutes of Health (NIH) announced a final framework for vetting specific types of experiments before funding them. The US Office of Science and Technology Policy (OSTP) also published a long-awaited draft policy for how scientists and institutions should monitor and report on a wide range of research that malevolent forces could manipulate to do harm. This type of research, called dual-use research of concern (DURC), is fundable if the potential benefits are deemed significant and the risks deemed manageable. Continue reading

Flu researchers bristle under federal policy

Adolfo Garcia-Sastre

It has been four months since the US government issued a hastily released policy for monitoring what is called dual-use research of concern (DURC), research that could pose significant risks to the public if misapplied. At a meeting in New York on Monday, representatives of leading institutions that perform such research discussed their experiences fitting the new policy into their current procedures for managing research projects. Some were frustrated at the lack of definition in the policy and some expressed concern about what would be contained in an expansion of the policy that is soon to be released for public comment.

“We are trying to comply with as rational an approach as possible,” said Adolfo Garcia-Sastre, who runs one of the Centers of Excellence for Influenza Research and Surveillance (CEIRS) at Mount Sinai School of Medicine in New York, which hosted the meeting for other CEIRS researchers.

On 29 March, as US government advisers were considering as whether or not to publish two controversial papers describing a lab-created, mammalian-transmissible avian H5N1 strains of influenza, the government released a new DURC policy. It required federally funded institutions to take stock of any projects engaging in such research and develop plans for mitigating potential consequences.  The policy was meant to shore up what some saw as a hole in the government’s approach to DURC, and government advisers said its existence was integral in persuading them to ultimately recommend publication of the two papers.

The researchers on the panel Monday morning included Yoshihiro Kawaoka of the University of Wisconsin–Madison and Ron Fouchier of Erasmus Medical Center in Rotterdam, the Netherlands, who finally published papers in May and June. Kawaoka described an approach to assessing the safety and appropriateness of laboratory protocols that is relatively unchanged since the adoption of the policy, except, he says, for the fact that it is put more specifically into the context of DURC. It means specific research protocols are assessed against a list of seven experimental approaches that should raise eyebrows.

Fouchier, with more than a bit of exasperation in his voice, described procedures for biosafety and security reviews that he says his group and institution have been in compliance with for years owing to existing laws. He urged fellow flu researchers to push back against what he feared would be further bureaucratic measures to come. Particularly worrying, he said, was that regulators are now taking issue with experiments — like the ones described in his recent paper — that result in a gain of function to existing pathogens. Fouchier said that these studies have to be done to fully understand how influenza works.

Continue reading

Congressman criticizes US handling of H5N1 papers

Congressman Jim Sensenbrenner of Wisconsin{credit}https://sensenbrenner.house.gov/{/credit}

An influential member of the US Congress remains dissatisfied with the government’s handling of two research papers on mutant forms of avian influenza, and is threatening legislation to control the controversial research.

Jim Sensenbrenner (Republican, Wisconsin) today said that the lack of a cohesive policy for handling risky research funded by the National Institutes of Health (NIH) and other federal agencies could necessitate new laws, a situation that researchers have been trying to avoid. “I prefer not to pursue legislation on this issue, with the hopes the scientific community can create its own approach. But failing a consequential … policy, Congressional action could be required,” Sensenbrenner told Nature in a statement.

The second of the controversial papers showing that H5N1, or ‘bird flu’, can spread through the air between mammals was published last week, providing some closure to the months-long debate about the work and whether its publication would result in the proliferation of dangerous viruses and increased risk of an accidental or intentional release. Sensenbrenner says not enough work has been done to ensure that such controversies don’t arise again.

On 21 June, NIH director Francis Collins responded to some pointed questions issued by Sensenbrenner’s office after a 29–30 March meeting when the National Science Advisory Board for Biosecurity (NSABB) reversed its initial opposition to the publication of the papers, in light of some manuscript revisions and the addition of data. Sensenbrenner, who is the vice-chairman of the Congressional committee on science and technology and sits on a subcommittee on terrorism and homeland security, had requested details on the provenance of a new government policy on reporting and overseeing ‘dual-use research of concern’ (DURC), research that could conceivably be put to nefarious ends.

Continue reading

Video: Debating H5N1 and dual-use research

On 2 February, scientists and public health officials squared off in a panel discussion at the New York Academy of Sciences. Debate raged around the fate of two papers that describe a mutant strain of the avian influenza virus H5N1. The virus is capable of mammal-to-mammal transmission, which has raised concern that it might be transferable to humans. Several panelists sat down with Nature News to discuss their positions.

See also our web special on the H5N1 controversy.

*Update 08/02/12: New York Academy of Sciences has posted full video of the 2 hour debate.