Forum: H5N1 research tussle shows need for clear policies

Feb 15, 2012 (CIDRAP News) – The acute need for clearer policies concerning the handling of potentially risky life-sciences research was the main theme that came across today in a Harvard forum on the controversy over studies on H5N1 avian influenza viruses with increased transmissibility.

"This is an area that is really ripe for policy definition," said Jean Guillemin, PhD, senior advisor in the MIT Security Studies Program and author of the book American Anthrax, one of four experts who participated in the hour-long discussion, which was presented by the Harvard School of Public Health.

Others on the panel spoke of the need for policy discussions at the international level. The first such discussion will begin tomorrow, when the World Health Organization (WHO) convenes a group of experts in Geneva to talk about issues raised by the two H5N1 studies.

The two studies involved the generation of an H5N1 virus and an H5N1-H1N1 reassortant that spread among ferrets by the airborne route. In December the National Science Advisory Board for Biosecurity (NSABB), which advises the Department of Health and Human Services (HHS), recommended that the details be deleted from the two reports before they are published. HHS agreed and passed the recommendation to Science and Nature, the journals considering publishing them.

The two journals have said they will go along with the recommendation if a way can be found to provide the details of the reports to scientists with a legitimate need for them. But since the NSABB recommendation was unveiled, scientists, biosecurity experts, and public health officials have vigorously debated the issue in the media and in journal commentaries.

Today's forum, which was streamed over the Web, was shorter and less heated than a discussion presented on Feb 2 by the New York Academy of Sciences. In that session, experts supporting and opposing the NSABB recommendation argued about the threat represented by the mutant viruses, the potential public health benefits of the research, and related issues.

Biodefense vs public health
The general shape of H5N1 research controversy was sketched by panelist Marc Lipsitch, PhD, professor of epidemiology at the Harvard School of Public Health and director of the Center for Communicable Disease Dynamics. He was followed by Barry R. Bloom, DSc, PhD, former dean of the school and a professor in its Department of Immunology and Infectious Diseases, who outlined the major arguments and counterarguments in the debate.

The central questions, Bloom said, come down to two: "What do we publish, what do we make available? And how do we work with recombinant viruses?"

Guillemin said the controversy has exposed the divide between the biodefense and public health worlds. By way of background, she noted that the spate of biodefense funding unleashed by the terrorist attacks of 2001 focused initially on class A bioterror pathogens, including anthrax, plague, and smallpox.

But over the years the emphasis shifted to global emerging diseases (such as H5N1), a category that now claims about 60% of the money, while about 28% goes to the bioterrorism area. The SARS (severe acute respiratory syndrome) epidemic of 2003 did much to shift the emphasis away from bioterrorism, she said.

"Uniting the bioterrorism threat with the infectious disease threat meant the merger of two very different camps," Guillemin said. "The biodefense mentality is very allied to a military mentality of getting ahead of the enemy. You try to figure out what the pathogens are going to do and get ahead of them."

In defense research, secrecy is one of the things scientists routinely accept in return for their funding, she went on. In contrast, she said, "From the public health point of view, the idea is that the protection of the public is an absolute priority, and secrecy is the last thing you want.

"You can look at all sorts of outbreaks . . . where secrecy was a factor in the playing out of an epidemic, and people died. That's a very strong public health position. There is kind of a conflict of cultures."

This conflict points up the need for clear policies on the conduct and dissemination of potentially dangerous research, she added.

The other panelist was David R. Franz, DVM, PhD, an NSABB member and former commander of the US Army Medical Research Institute of Infectious Diseases. He expressed concern about the ability to mount an adequate public health response if a highly transmissible H5N1 virus got loose.

The powerful tools now available to life-sciences researchers have been used for good and will continue to be used for good, he said, "But we can't ignore the possibility that they'll be used for harm."

"This particular virus is special," he said, referring to the mutant viruses generated in the two studies. "This is one that has really made us stand up and take notice."

Lab safety worries
"We may not be able to mount an appropriate and adequate public health response for something like this . . . if it were lethal and transmissible," Franz added. "I'm not sure we could get medical countermeasures to the right places and in the right quantities. On this one I'm more concerned about [lab] safety than about security. I think there'll be more scientists working in legitimate labs on bugs like this than bioterrorists working in caves."

Lipsitch said the H5N1 studies are valuable because they remind the world that the H5N1 pandemic threat is real in the face of growing complacency. At the same time, he seconded Franz's concern about the risk of lab accidents that could release the mutant viruses. He noted that the two H5N1 studies were done in biosafety level 3 (BSL-3) labs, a notch below the top biosecurity level.

"I feel strongly that this [research] should be done under very high containment," he said. "On balance I'd favor redacting the details [of the studies], but I don't feel as strongly about that as about the containment issue. This should not be in hundreds of labs around the world."

Bloom dissented on the need to use BSL-4 restrictions for this type of research: "I disagree with Marc on working in extreme containment. Working in a space suit and rubber gloves seems like a way to predispose to accidents and spills. Containment is in your fingers and concentration and in the training you have."

Skepticism on bioterrorism
The panelists voiced some skepticism about the risk of bioterrorist exploitation of the H5N1 studies. Guillemin said such an eventuality would be "amazing," commenting, "the one case we had, if the FBI is right, came from an insider at a military lab."

Panel moderator Sharon Begley, senior US health and science correspondent for Reuters, noted that one of the H5N1 viruses was generated by passing it 10 times through ferrets. She asked if someone with a B.S. degree and access to mail-order could do that.

Lipsitch replied that both experiments involved a combination of genetic engineering and passaging in ferrets. To suggest that terrorists in caves are the main concern is a little misleading, he said, adding, "There are countries that have aspirations to cause destruction in other countries, and they have a certain amount of technical sophistication."

Bloom said his view is that "transparency and openness is the best constraint for people intending to do harm." He added, "The general public of all countries should know what we're up to and know that there are people concerned about their safety."

Bloom and Franz both called for global discussions to develop policies on dual-use research.

"I hope the WHO meeting will lead to clear guidance," said Franz. "But more important, I hope that in future they might bring together the other 190 states of the world that have a vote and are involved, so that we might think about this as a truly global problem."

Guillemin called for the United States to take the lead: "I think the US leads the way in defining norms and policies that influence the rest of the world, and I think it would be wonderful if we could hold a kind of Asilomar conference . . . to talk about how the money should be spent." She referred to a conference in 1975 at which scientists developed guidelines for research involving recombinant DNA.

See also:

Harvard School of Public Health forum page

Feb 15 CP story on the WHO meeting

Feb 3 CIDRAP News story "Live debate airs major divisions in H5N1 research battle"

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