Researchers announce pause in controversial H5N1 studies

Jan 20, 2012 (CIDRAP News) – Leading influenza researchers from around the world, faced with a relentless controversy over experiments dealing with potentially dangerous H5N1 viruses, today announced a 60-day pause in such research to allow time to discuss its risks, benefits, and oversight.

The letter was signed by 39 researchers, including the authors of two as-yet-unpublished studies that involved the generation of mutant H5N1 viruses that spread readily in ferrets. The statement was published simultaneously today in Science and Nature, the journals to which those studies were submitted.

In late December the US government, following a recommendation from the National Science Advisory Board for Biosecurity (NSABB), recommended that the two journals delete key details from those reports before publishing, out of concern that the findings could be misused. The journals indicated consent, provided a way could be devised to share the details with responsible scientists who need them. Neither study has been published yet.

Today's statement from the researchers says nothing about postponing publication of the studies, referring only to a break in research activities.

"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," the letter says. "We propose to do so in an international forum in which the scientific community comes together to discuss and debate these issues.

"We realize that organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work. 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.

"In addition, no experiments with live H5N1 or H5 HA [hemagglutinin] reassortant viruses already shown to be transmissible in ferrets will be conducted during this time."

No plans for an international conference on the issues raised by the two H5N1 studies have yet been announced. But the US National Institutes of Health (NIH) said in a statement today that the World Health Organization (WHO) is working to organize a forum in the coming weeks. Also, a news story published today by ScienceInsider, citing unnamed sources, said the WHO is planning the meeting for late February in Geneva.

The researchers' letter seemed designed in part to allay fears about the risk of an accidental release of highly transmissible H5N1 virus. Noting that a "perceived fear" of such an accident has generated "intense public debate," the scientists say, "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 risks of accidental release."

Previous reports have noted that the two studies were conducted in labs rated at biosecurity level (BSL) 3+, a notch below BSL-4, the highest rating.

The lead signer of the letter is Ron A. M. Fouchier of Erasmus Medical Centre in the Netherlands, lead author of the H5N1 study that was submitted to Science and the one that has been discussed in greatest detail. The third signer of the letter is Yoshihiro Kawaoka of the University of Wisconsin and the University of Tokyo, lead author of the study submitted to Nature.

The idea of a research pause was promoted by NSABB Chair Dr. Paul Keim of Northern Arizona University in Flagstaff along with Fouchier and Kawaoka, according to the ScienceInsider report. The story said it is modeled in part on a moratorium that recombinant DNA researchers agreed to in 1975, when the public was worried about the safety of their research.

In a ScienceInsider interview published this afternoon, Fouchier said that Dr. Adolfo Garcia-Sastre of Mt. Sinai Medical Center in New York City was involved with Kawaoka and Fouchier himself in initiating the letter. He acknowledged they were concerned about the possibility of a government move to stop the kind of research reported in the two papers.

"It's a pity that it has come to this," Fouchier said, referring to the moratorium.

In today's NIH statement, the research pause was praised by NIH Director Francis S. Collins, MD, PhD, and Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, which sponsored both of the H5N1 studies in question.

"We applause the decision by these scientists, who have demonstrated great responsibility and flexibility in pausing their work to allow for a full dialogue about the risks and benefits of this research," Collins and Fauci said. "NIH, the Centers for Disease Control and Prevention and other US government agencies that conduct or fund such research will also abide by this moratorium."

The two officials also commented, "Understanding how influenza viruses become human pandemic threats is vitally important to global health preparedness."

According to a news story published today in Nature, Fauci acknowledged that the announced pause is not long but said researchers were concerned about having an open-ended moratorium. "Sixty days as a start I think is reasonable, and after 60 days we will re-evaluate it," he told the journal.

Dr. Michael T. Osterholm, an NSABB member, praised the moratorium but voiced concern that it will be too short. He is director of the University of Minnesota's Center for Infectious Disease Research and Policy, publisher of CIDRAP News.

"This is a very positive step forward, and will be helpful in bringing an opportunity for a very thoughtful and far-reaching discussion about next steps," he said. "But I think it's overambitious to think we can come up with an international plan and implementation strategy in 60 days. We know it needs to be done as quickly as possible, but at the same time it's got to be done right."

In the ScienceInsider interview, Fouchier said he expects it will be late February before the US government unveils a mechanism for sharing the details of his study with scientists.

See also:

Jan 20 statement by flu researchers in Science

Same statement in Nature

Jan 20 ScienceInsider story on the statement

Jan 20 Nature news story

Jan 20 statement from Collins and Fauci

Jan 20 ScienceInsider interview with Fouchier

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