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Published Date: 2012-01-22 07:41:06
Subject: PRO/AH/EDR> Avian influenza, human (10): research moratorium
Archive Number: 20120122.1017851

AVIAN INFLUENZA, HUMAN (10): RESEARCH MORATORIUM
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[1]
Date: Fri 20 Jan 2012
Source: CIDRAP News [edited]
http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/news/jan2012pause.html

Researchers announce pause in controversial H5N1 studies
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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 The letter was signed by 39 researchers, including the authors of two as-yet-unpublished studies that involved the generation of mutant H5N1 viruses that spread readily in ferrets.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 [reproduced below as part (2)].

In late December [2011] 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. 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 [haemagglutinin] 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 that 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.

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. "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."

(byline: Robert Roos)

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[2]
Date: Fri 20 Jan 2012
Source: Nature (2012) doi:10.1038/481443a, published online [edited]
http://www.nature.com/nature/journal/vaop/ncurrent/full/481443a.html

Pause on avian flu transmission studies
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(formal statement by: Ron A M Fouchier, Adolfo García-Sastre, Yoshihiro Kawaoka, and 36 co-authors)

The continuous threat of an influenza pandemic represents one of the biggest challenges in public health. Influenza pandemics are known to be caused by viruses that evolve from animal reservoirs, such as birds and pigs, and can acquire genetic changes that increase their ability to transmit in humans. Pandemic preparedness plans have been implemented worldwide to mitigate the impact of influenza pandemics. 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.

Recent research breakthroughs identified specific determinants of transmission of H5N1 influenza viruses in ferrets. Responsible research on influenza virus transmission using different animal models is conducted by multiple laboratories in the world using the highest international standards of biosafety and biosecurity practices that effectively prevent the release of transmissible viruses from the laboratory. These standards are regulated and monitored closely by the relevant authorities. This statement is being made by the principal investigators of these laboratories.

In two independent studies conducted in two leading influenza laboratories at the University of Wisconsin–Madison and Erasmus MC in Rotterdam, the Netherlands, investigators have proved that viruses possessing a haemagglutinin (HA) protein from highly pathogenic avian H5N1 influenza viruses can become transmissible in ferrets. This is critical information that advances our understanding of influenza transmission. However, more research is needed to determine how influenza viruses in nature become human pandemic threats, so that they can be contained before they acquire the ability to transmit from human to human, or so that appropriate countermeasures can be deployed if adaptation to humans occurs.

Despite the positive public-health benefits these studies sought to provide, 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.

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. 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 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.

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