Alarmed over the creation of mutant strains of the H5N1 avian influenza virus, scientists have called for a 60-day voluntary halt to research in a statement jointly published on Friday in Nature (481, 443; 2012) and Science journals.
The United States government has sought both journals to publish only the main conclusions of two flu studies, but not to reveal details “that could enable replication of the experiments by those who would seek to do harm” and the journals and the authors have agreed to it, on the condition that a mechanism is established to disseminate the information to legitimate flu researchers on a need-to-know basis.
The US government, the World Health Organization (WHO) and other bodies are trying to put together this mechanism, along with a framework for international oversight of such research. The sscientists say that the pause is intended to allow time for discussion. “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,” they write.
The scientists have also sought an international forum be created to debate the risks and benefits of the research. “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,” they said.
“Scientists need to have their voices heard in this debate,” says Yoshihiro Kawaoka of the University of Wisconsin-Madison, lead investigator on the paper submitted to Nature and a signatory of today’s statement. “We hope that by having a calm and reasoned discussion of the facts, scientists and biosecurity experts can reach a better understanding and find ways to enable the research to go forward while minimizing risks.“
Fears of Bio-terrorism:
While bioterrorism is just one potential risk of such research, more worrying fat is that if a mutant virus were to accidentally escape from the lab, it could cause a H5N1 pandemic. The authors of the statement say that they hope to “assure” the public that the viruses are in safe hands in secure containment facilities. Such research is currently classed as requiring biosafety level 3 (BSL-3) enhanced containment facilities, but many scientists argue that it should be done only in BSL-4 labs, which have the highest biosafety rating.
“I am very much in favour of having a pause,” says Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases (NIAID). He concedes that the length of the pause is not long, but that researchers were concerned about having an open-ended moratorium. “60 days as a start I think is reasonable, and after 60 days we will re-evaluate it,” he says.
“The pause is welcome in the sense that hopefully it will relieve some of the immediate urgency in terms of trying to chart a course forward,” agrees Michael Osterholm, who heads the University of Minnesota’s Center for Infectious Disease Research and Policy in Minneapolis, and is a member of the NSABB.
However, he says the duration of the pause is too short. “The 60 days will likely not be adequate in terms of getting a truly workable international policy and applying that. I just don’t think that’s realistic,” he says. Moreover, the statement makes no mention of any voluntary moratorium on the publication of such work. The NSABB is currently considering recommending one, but given the scale of the controversy over the papers and the moves to establish a data-sharing mechanism, a de facto moratorium may already exist.
The controversy is splitting the scientific and wider community into two camps: those who think that the research should never have been done, and those who feel that it is crucial. What’s needed now is to find some middle ground, says Osterholm, for example by assessing what public-health benefits the research realistically offers in the near- and long-term. That should guide decisions as to the levels of acceptable risk, he says, so that the research can proceed “safely, and in a way that does not put the world at potential risk”.
The 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. Though, 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,” said scientists.
The 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,” the scientists added.