Risky topic. researchers Ilaria Capua Italy, Joseph Sriyal Malik Hong Kong Periris, and Adel Mahmoud of the United States ( rl ) discuss the risks and benefits of research involving the H5N1 virus AI to me
D. Malakoff / Science
BETHESDA, Maryland- The end of one, 13 months long historical global debate on the safety and wisdom of H5N1 bird flu research may finally be in sight.
After a 2-day meeting here, the US government officials said today they are moving quickly to adopt a new policy for reviewing some studies on H5N1 in order to identify high-risk research before it begins. The scientists said the move long discussed will allow them to quickly lift a historic moratorium on certain types of H5N1 research they have voluntarily imposed in January. The controversy was sparked by two studies that showed how to make the virus transmissible in mammals, which could spark a deadly human pandemic. Some researchers flu working outside of the United States said they may even declare the moratorium dead before the US National Institutes of Health (NIH) adopts its new policy review, scheduled no earlier than the month next.
"I think we'll see a lifting of the moratorium on the part of people who are not funded by the NIH," Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) said today at the end of a special meeting to discuss, fine tune, and test drives of the proposed policy H5N1. Many of the 39 flu researchers who organized the moratorium, he said, were "waiting patiently for this particular event ... I would not be surprised if they [now say] :. 'OK, we've heard all this." ... Some will move forward with their experiences if their country and donor permit. "
" We will discuss lifting the moratorium soon. ... I'm sure I'll be seeing a lot of emails about it tomorrow morning, "said virologist Ron Fouchier of Erasmus MC in Rotterdam, the Netherlands, who led one of the teams research that helped create controversy and also helped organize the moratorium. "it would be nice if all 39 of us agree to lift, or at least 37 or 38. But I think that some researchers outside the US will decide to resume "their studies in break even without unanimity, he said.
the last debate was held in front of some 0 people, including many top researchers H5N1 the world who gathered in an auditorium on the NIH campus to discuss the draft guidelines for consideration. the rules are supposed to help NIH reviewers decide what types of research H5N1 agency should, and should not, funds . participants also implemented the project, which the US Department of Health and Human Services (HHS) published on 27 November, four hypothetical studies.
The moratorium and the new rules apply only to a small range of experiences, called the studies "gain of function" in which researchers use genetic engineering or other techniques to naturally more deadly H5N1 virus or able to jump to new hosts, such as mammals. many researchers say that such studies are essential to understanding how the virus could mutate into a form that is capable of triggering a deadly human pandemic but others argue that the risks of this type of research outweigh its benefits. the issue came into focus hard at the end of 2011, when two research teams created the H5N1 virus capable of infecting ferrets . This work has aroused worldwide controversy as to whether the results should be published and whether funding agencies should do more to identify issues before they start school.
The review framework is designed to do. It sets out seven criteria that a study had to meet to be eligible for NIH funding. A researcher should show a gain of function experiment "great importance to public health," for example, and that there was "no possible alternative methods" to do. Scientists should also provide "evidence" that the H5N1 virus, they want to create "could be produced by a natural process of evolution in the foreseeable future." A study that fails to meet one of the criteria would get further review by HHS and other agencies and possibly a recommendation that he be transferred to a body that classified research, such as security services defense or homeland if their authors thought the results would be too dangerous to share.
The plan has drawn mixed reviews scientific, with critics saying that some of the criteria, especially one that requires researchers to show that their designed virus could appear one day in nature are formulated too vaguely and set too high a bar for funding. Others fear that politics could undermine international collaboration, particularly if other countries do not follow the example of the United States.
Participants here had many suggestions to avoid such problems. A major recommendation seems to be gaining traction is to limit additional notice HHS level for a subset of studies that propose to create particularly dangerous H5N1 specifically, viruses that may infect mammals and spread through the air, eg by saliva droplets. A "growing chorus" of researchers seems to approve the idea, according to Amy Patterson of the NIH, which helps write the new policy. These limits, supporters argue, could allow reviewers to sift less risky experiences that are easier to hold and more difficult to exploit for evil purposes. Researchers could, for example, propose experiments aimed at making a more infectious or deadly virus among birds, but not the air in mammals, regardless roadblocks. And the narrower scope would reduce the number of proposals that could be lost in the bureaucracy, they say.
"As written, many of H5N1 studies that are not intended to come to the examination will be considered," said Nancy Cox, a virologist at the Centers for Disease Control and Prevention in Atlanta. "If you read this conservatively [HHS is] will have to review 75% of H5N1 in the NIH studies portfolio," said Richard Webby, a researcher H5N1 at St. Jude Children's Hospital. Bureaucratic delays, he said, could lead researchers to leave the field or discourage students to work on the virus.
Patterson and other officials of the NIH could not promise they would do this and other proposed changes; the meeting was to gather information and not make decisions, they said. And the government plans to release a second version of rules based on public comments received to January 10. But Fauci was clear that he wants to move quickly. "I am sensitive to the fact that it can be drawn over a long period," he said. "We want to accelerate it."
should notThe new policy will affect many studies. H5N1 gain of function studies represent less than 10 million or $ less than 1% -of overall influenza research spending NIAID, Fauci said, and less than 10% of the subsidies it gives to research on H5N1 (there many other flu viruses).
It is unclear whether other countries will follow the example of the United States. At the meeting, researchers from Indonesia, Malaysia and other countries where the H5N1 virus is a simmering problem generally expressed support for studies and concerns about policies that might hinder the function of gain field. But many said they are more interested in making studies characterizing the natural virus found in their country, or to help more directly with drug and vaccine development. Europe's researchers noted that some of their nations develop their own systems for the examination of potentially risky research. Many researchers of influenza, however, say that the requirements of safety and laboratory safety in many countries are already strong enough to allow the gain of function studies of H5N1 proceed.
The voluntary moratorium on these studies, Fouchier said, "has now achieved its goal." He gave governments, scientists and the public time to discuss and implement new policies and ensure that the H5N1 researchers do their work safely. It is time, he says, "to get back to work."
Not everyone at the meeting agreed. "I think we should continue the moratorium," said Thomas Inglesby, head of the Center for Biosecurity at the University of Pittsburgh Medical Center. Scientists have not yet demonstrated that the benefits of gain of function studies outweigh the risks, he said. And "if we decide to proceed, all should recognize the extraordinary risk."
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