In Dramatic Move, Flu Researchers Announce Moratorium on Some H5N1 Flu Research, Call for Global Summit

Stung by a growing global controversy over the potential dangers of experiments involving the H5N1 avian flu virus—and worried about heavy-handed government regulation—the world's leading H5N1 researchers have agreed to a 60-day moratorium on a controversial category of studies "to allow time for international discussion."

"We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks," a group of 39 researchers write in a statement published today by Science and Nature. "To provide time for these discussions, we have agreed on a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals."

"It's a pity that it has to come to this," says Ron Fouchier, of Erasmus Medical Center in Rotterdam, the Netherlands, one of the scientists who took the initiative for the announcement. (Fouchier's H5N1 paper, under review by Science, was one of two that triggered the international debate.) "I would have preferred if this hadn't caused so much controversy, but it has happened and we can't change that. So I think it's the right step to make."

The group calls for "an international forum in which the scientific community comes together to discuss and debate these issues. We realize organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work." That meeting will be hosted by the World Health Organization (WHO) in Geneva in late February, sources tell ScienceInsider.

Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, which funded the studies, strongly supports the moratorium and discussed it at length with Fouchier. "I thought it would be a good idea for the investigators themselves to call for a time-out rather than seeming like we're rushed," says Fauci. "He said if I'm going to do it, let me take the pulse of the others in the field. I really admire that and the fact that he agreed to do it. I felt strongly this was the way to go."

Fauci says he hopes the moratorium will lead to "a more transparent and intelligent discussion" by regulators, scientists, and the public about the issues raised by these experiments. "I have concerns that people understandably concerned about security may put restrictions on important research that might go a little bit too far," he says. "We have to be extremely sensitive to safety and security, and everyone is in agreement on that, but what I would not want to see is an overreaction."

One vocal critic of the flu studies, however, is not impressed, calling the moratorium "pure PR." The letter "includes flatly false statements" about the safety of influenza research labs, Richard Ebright, a biologist at Rutgers University in Piscataway, New Jersey, and the Howard Hughes Medical Institute, wrote in an e-mail. And "the letter rejects, out of hand, the need for enhanced biosafety, biosecurity, and dual-use oversight, and, instead, maintains that all that is needed is an opportunity for researchers 'to assure the public' and 'to clearly explain the benefits of this important research and the measures taken to minimize its possible risk.'" The letter is "strictly symbolic," he writes. "An empty gesture."

"I welcome this development," wrote another critic, John Steinbruner of the University of Maryland, College Park. "But I question the capacity of 'governments' to do anything meaningful within the 60 day period of the announced moratorium. What happens if they do not?" And Steinbruner says he would feel more reassured about the safety of H5N1 research if it took place in more secure laboratories.

The call for the moratorium and summit follows months of rising tension over two studies that describe how researchers made the deadly H5N1 avian influenza more transmissible between mammals—possibly providing a blueprint on how to set off a flu pandemic. In late December 2011, the U.S. National Science Advisory Board for Biosecurity (NSABB) asked flu researchers to strike key details from the papers, which are in press at Science and Nature. The researchers and the journals agreed, provided that the U.S. government comes up with a mechanism to share those details with bona fide researchers and public health experts. But the deal has sparked extensive criticism—with some scientists saying the redactions went too far, and others arguing the research should not have been conducted in the first place.

Meanwhile, the episode prompted the U.S. government to rapidly restart a long, moribund process aimed at tightening oversight of so-called "dual use" research—and WHO to complain that the deal could imperil a carefully negotiated global agreement to share flu viruses and research results. Earlier this month, a New York Times editorial, headlined, "An Engineered Doomsday," even called for the scientists to destroy the H5N1 variants they had created in the name of safety. In Washington, science policy experts warned that, unless the scientific community could reassure the public and lawmakers that it could adequately regulate itself, the controversy could result in onerous new regulations. "The debate is so controversial that we can't rule that out," Fouchier says. "We'd rather have everybody take a breather to reflect carefully on how to handle this."

Against that backdrop, leading scientists—including NSABB Chair Paul Keim, a microbiologist at Northern Arizona University, Flagstaff—began promoting the idea of a moratorium. It is modeled in part after a landmark moratorium agreed to by recombinant DNA researchers in 1975, who were also facing public doubts about the safety of their new field of research and potential government regulation. That moratorium led to a meeting in Asilomar, California, at which scientists drew up safety guidelines for genetic engineering.

Signers of today's moratorium agreement include the leaders of virtually every major lab in the world conducting H5N1 research.

"The continuous threat of an influenza pandemic represents one of the biggest challenges in public health," the statement begins. "A major obstacle in preventing influenza pandemics is that little is known regarding what makes an influenza virus transmissible in humans. As a consequence, the potential pandemic risk associated with the many different influenza viruses of animals cannot be assessed with any certainty."

In addition to halting H5N1 transmissibility research, "no experiments with live H5N1 or H5 HA reassortant viruses already shown to be transmissible in ferrets will be conducted during this time. We will continue to assess the transmissibility of H5N1 influenza viruses that emerge in nature and pose a continuing threat to human health."

The statement also seeks to reassure the public about safety. Labs currently conducting H5N1 research use "the highest international standards of biosafety and biosecurity practices that effectively prevent the release of transmissible viruses from the laboratory," the authors note. Still, "a perceived fear that the ferret-transmissible H5 HA viruses may escape from the laboratories has generated intense public debate in the media on the benefits and potential harm of this type of research. We would like to assure the public that these experiments have been conducted with appropriate regulatory oversight in secure containment facilities by highly trained and responsible personnel to minimize any risk of accidental release. Whether the ferret-adapted influenza viruses have the ability to transmit from human to human cannot be tested."

According to several sources, WHO is planning a meeting in late February to discuss the issues raised by the research. One of the organization's main worries is that limiting access to the research results and the virus would flout the new pandemic influenza preparedness (PIP) framework, agreed to earlier this year after 4 years of often-acrimonious debate. That agreement stipulates that countries that provide virus samples should also receive the benefits of research with the virus. The main benefit of the research, says WHO in a statement sent to ScienceInsider, is the knowledge that the virus is potentially capable of spreading between mammals and therefore "must continue to be regarded as a high priority risk for pandemic flu. "Beyond that, however, knowing which mutations make transmission possible will be an important tool for global surveillance efforts, it says. Limiting access to that data could hamper global efforts to contain potential pandemic strains.

WHO isn't the only organization that will be hosting discussions of the issue. The American Society for Microbiology is hosting a discussion of the NSABB controversy at a major biodefense meeting in Washington, D.C., on 29 February.

This article was updated at 2:15 p.m. on 20 January. It was corrected on 2 February; AAAS has not added panels on the flu controversy to its annual meetings. ScienceInsider regrets the error.