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The Man-made H5N1 Controversy Heats Up: What Next? (Part Five)

Posted on by Laurie Garrett

What should be done about the deadly man-made H5N1 flu strain made in the laboratory of Dutch scientist Ron Fouchier? And generally, what measures are appropriate to limit dangers from experiments that either make bird flu more virulent or increase its potential to spread from person-to-person? On February 16-17 the World Health Organization convened 21 scientists (mostly flu experts) and one ethicist to decide the fate of the H5N1 experiments, including whether further research should be allowed, and should the papers be published.

Yes, the group decided, on all counts: More research, publish the details in full, and let the deadly manmade H5N1 remain locked in university labs in Rotterdam and Madison, Wisconsin. But there was a big caveat: All work and publication will be on indefinite hiatus while efforts are made to “educate the public” in order to “lower anxieties” about bioterrorism, biosecurity, and general global safety. Scientists seem to be saying, “We know what is right, and safe. But we need to calm the public down and convince everybody to trust us.”

This is the fifth of a daily series of blog postings over the next week that will dwell on issues surrounding the H5N1 controversy.

Today we address: The Danger of Excluding the Public From the Debate

One of the most common myths now circulating is that the controversies surrounding the 1975 dawn of genetic engineering were amicably settled that year by scientists at a retreat in Asilomar, California. Many biologists have called for “an Asilomar moment,” to settle the H5N1 disputes in similar fashion. The romantic vision of Asilomar imagines that in 1975 biologists took care of the entire debate among themselves, created a set of self-imposed rules, and then merrily proceeded to conduct their research without further controversy.

I was in the middle of the genetic engineering debate, as a grad student doing such experiments at Berkeley and as a cub reporter for Pacifica and NPR. It was not a time of harmonious resolution. It was a time of tremendous strife, largely because the public, and its political and religious leaders, felt that science was foisting both a new problem and its solution upon the rest of the world. Scientists that were at Asilomar had their debate, then went home, perhaps grumbling about some details but generally content. It was months, in many cases years, before the public generally learned what science had decided, and anger was felt.

There were municipal bans on genetic engineering in key centers of research, such as Berkeley, Seattle, Portland, San Francisco and Cambridge. The prime outcome of the Asilomar process was creation of theRecombinant DNA Advisory Committee (RAC), which reviewed and approved genetic engineering experimental applications. Throughout the 1970s, RAC meetings were foci of protests, demonstrations, and outcry. Anybody that served on the RAC during that period would find the current romantic descriptions of the Asilomar outcomes sharply in contrast with historic reality. Every minute of RAC proceedings was dogged by Jeremy Rifkin, a man Time magazine dubbed “The Most Hated Man in Science.” Rifkin’s 1977 book, Who Should Play God? was the activist framework for opposition to genetic engineering research.

Eventually the RAC developed routines, guidelines, and smooth operation, but these came after prolonged public argument.

Scientists in the 1970s were often befuddled and frustrated by the public outcry, insisting that completely unrelated fears and issues were mixed into the fight. And they were. From the left came attacks on alleged corporate uses of recombinant DNA technology for profiteering purposes. From the right arose allegations that science was defying religion. Citizens complained that Frankenstein creations would escape laboratories, bringing harm to their children. Animal rights activists charged that genetic engineers were going to create freakish creatures. And the common theme underlying all was public suspicion that scientists were up to something, and could not be trusted.

Science and policymakers would do well to correctly recall the post-Asilomar days, and consider with due respect how decisions made today regarding “super flu” may trigger anger from unexpected quarters. The current Republican primary Presidential elections inside the U.S. have already featured such allegations as HPV vaccination causes mental retardation, evolution is a false theory of life, and climate change is entirely unrelated to fossil fuel burning. The H5N1 debate has not yet reached the presidential electioneering level, but should it do so, a well-fastened seat belt will be essential for everybody on the ride.

The Catholic Church was particularly upset about genetic engineering in the 1970s, and continues to dispute the right of scientists to alter God’s plans by manipulating life forms. The Church weighed in on basic recombinant DNA work in the 1970s, the stem cell controversies of the 1990s, sequencing of the human genome, and is beginning to be heard on synthetic biology. Other Christian faiths have taken issue with manipulation of God’s blueprint. Theologians have described Christian resistance to genetic manipulation as fundamental to basicspiritual beliefs. For example, Lutheran Ted Peters says that DNA, itself, is sacred under the tenets of many Christian systems. In some nuanced Christian views it is appropriate for biologists to create life forms and manipulate DNA, but only if the motivation is for the good of mankind.

Of course “motivation for good” is an awfully subjective concept. Some Islamic leaders argue that what seems “good” today, such as enhancing human intelligence or eliminating a brain disorder, might lead to fundamental alterations of human beings – and that would clearly defy the principles of the Qur’an. During the Middle Ages when European theology constrained science, mathematics and astronomy flourished in the Islamic world. Some contemporary leaders argue that the Qur’an offers a unique perspective of the relationship between Man and Nature, defining the limits on humanity’s right to control natural order.

H5N1 is now in circulation in India, Nepal, and Bangladesh – all countries with millions of followers of Hinduism. The Hindu faith, as diverse as it is, has key gurus that argue alteration of life can only be executed through reading and closely following the sacred Hindu texts. Within India, every aspect of biosecurity comes up against three issues: Hindu/Islamic domestic tensions and varying ethical world views; national aspirations to both grow GDP and become a scientific superpower; and relations/paranoia about Pakistan both in terms of direct Delhi-to-Islamabad tensions and as a possible host for al-Qaeda, Indian insurgents, and Taliban forces.

This H5N1 debate moment comes as India is endeavoring to set up its National Biotechnology Regulatory Agency, has just built its first BSL-4 laboratory, and has temporarily tabled a Parliamentary bill on national biosecurity. Given that both naturally arising H5N1 and biosecurity are hot-button issues for the Indian political establishment and farming community, the country’s top officials would like to see the entire debate shifted to the level of the Biological Weapons Convention (BWC). Taking the debate out of the hands of Western scientists, bypassing domestic political controversy, and shifting it all up to high diplomatic level are comfortable steps for India.

India’s primary national security angst boils down to one thing: Pakistan. Islamabad is also now bogged down in biosecurity debate, including how, or if, it will adapt its legal system to meet Biological Weapons Convention requirements. This includes passage of a bill that proved so contentious in the 2011 Parliament that it has beenindefinitely tabled. (Moreover, somebody has mailed anthrax spores to the Prime Minister, and the investigation has opened a Pandora’s Box of jurisdictional and political disputes between government agencies.)

The Biological Weapons Convention negotiations are effectively stagnant. Last year’s meetings displayed little common ground on any of the contentious issues related to putting teeth into its surveillance and verification components. Though consensus documents are released from every BWC gathering, they represent at best incremental changes in the 1975 documents. It is extremely unlikely that this stymied process can – or possibly should – take on the biosecurity H5N1 debate. But there is no clear substitute forum for diplomatic debate on dual use biology.

The danger for science is always the moment when disputes within their disciplines get decided by politicians. Failure to bring political policymakers into the discussion early virtually ensures that miffed politicians will jump on the problem in unsatisfactory ways.

Warning signs already loom in the United States. Because of the H5N1 controversy, two 2011 legislative proposals are gaining momentum in the House, according to the American Association for the Advancement of Science (AAAS). In an alert to Members last week the AAAS warned:

Controversy Over Public Access to Research Continues. As debates continue over public access to research supported by federal funding in the wake of the Research Works Act (H.R. 3699), there is expectation that members of Congress in both chambers will seek to reintroduce The Federal Research Public Access Act (FRPAA). The bill (H.R. 5037), which was introduced in the previous Congress but never passed, would require federal agencies with research budgets over $100 million to issue policies mandating that research articles funded by their grants be made publicly available six months after publication.

H.R.3699, or the Research Works Act is sponsored by Representative Darrell Issa, a powerful member of the Republican Party and Chair of the House Oversight and Government Reform Committee. Issa also serves on the House Intelligence Committee. He introduced the bill to his Oversight Committee in December, where it is now under consideration. The official summary of the bill:

Research Works Act - Prohibits a federal agency from adopting, maintaining, continuing, or otherwise engaging in any policy, program, or other activity that: (1) causes, permits, or authorizes network dissemination of any private-sector research work without the prior consent of the publisher; or (2) requires that any actual or prospective author, or the author's employer, assent to such network dissemination.

    Defines "private-sector research work" as an article intended to be published in a scholarly or scientific publication, or any version of such an article, that is not a work of the U.S. government, describing or interpreting research funded in whole or in part by a federal agency and to which a commercial or nonprofit publisher has made or has entered into an arrangement to make a value-added contribution, including peer review or editing, but does not include progress reports or raw data outputs routinely required to be created for and submitted directly to a funding agency in the course of research.

H.R.5037, or the Federal Research Public Access Act of 2009, is under review in the House Subcommittee on Information Policy, Census, and National Archives. It is sponsored by Representative Michael Doyle, a Democrat from Pittsburgh, Pennsylvania. Doyle is probably best known outside his district for havingcharacterized the Tea Party as terrorists:  "We have negotiated with terrorists. This small group of terrorists have made it impossible to spend any money.” The official summary of the bill:

    Federal Research Public Access Act of 2009 [sic] - Requires each federal agency with extramural research expenditures of over $100 million to develop a specified federal research public access policy that is consistent with and advances the purposes of the agency. Makes each federal research public access policy applicable to: (1) researchers employed by the federal agency whose works remain in the public domain; and (2) researchers funded by the agency. Specifies exclusions. Requires the submission of annual reports by each federal agency on its federal research public access policy.

Final thoughts on the H5N1 Controversy: Several years ago the National Academy of Sciences convened a series of meetings aimed at decided whether there were experiments with such powerful down-sides in the dual use equation that they ought not be done at all. The NAS concluded that there were seven experiments of concern, as summarized by Laura Kahn in the Bulletin of Atomic Scientists. Work should be reconsidered or cautionary if it would:

1.            Demonstrate how to make a vaccine ineffective.

2.            Confer resistance to antibiotics or antiviral agents.

3.            Enhance a pathogen's virulence or make a non-virulent microbe virulent.

4.            Increase transmissibility of a pathogen.

5.            Alter the host range of a pathogen.

6.            Enable a pathogen's ability to evade diagnostic or detection modalities.

7.            Enable the weaponization of a biological agent or toxin.

The manmade H5N1 experiments definitely meet points four and five. 

The argument, overall, is whether the work, in malevolent hands, could lead to points one or seven.

Next Blog: Sobering Moments for Global Health: Kazatchkine Shake-up Spawns Fear

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