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Senior U.S. Lawmaker Leaps Into H5N1 Flu Controversy

Representative Jim Sensenbrenner (R-WI)

U.S. House of Representatives

It was only a matter of time, it appears. After months of silence from members of Congress, a senior member of the U.S. House of Representatives has publicly inserted himself into the debate over two controversial studies that showed how to make the H5N1 avian influenza virus transmissible between mammals.

Representative Jim Sensenbrenner (R-WI), a former head of the House committees on science and the judiciary, and currently vice chair of the House Committee on Science, Space, and Technology, last week sent a "fact-finding letter" to White House science adviser John Holdren, asking pointed questions about how the U.S. government has handled the controversy—and questioning whether it should have funded the two flu studies.

"The [Obama] Administration's response has appeared ad hoc, delayed, and inadequate," says the letter, which was first reported by Chemical & Engineering News. And a recent request that a government advisory board conduct a second review of the two studies "only adds to the confusion," wrote Sensenbrenner. "An ad hoc approach is inadequate to balance the priorities of public health and the free flow of academic ideas."

Washington insiders have been somewhat surprised by the lack of a public congressional reaction to the H5N1 controversy. Similar past controversies—such as a 2005 debate over the publication by Science of a paper detailing the reconstruction of the flu virus that caused the 1918 pandemic—sparked criticism from some members of Congress, and even an effort, ultimately unsuccessful, to pass a resolution opposing publication of that paper. This time, however, key lawmakers and their staff members had appeared content to receive private briefings on the issue from senior staff at the National Institutes of Health (NIH) and its parent agency, the Department of Health and Human Services (HHS).

Observers of the flu debate have also noted that Holdren has not played a prominent role in public discussion of the issue; his predecessor under President George W. Bush, the late John Marburger, had taken a much more public role in explaining and debating government biosecurity policies. This time, however, other officials—Anthony Fauci, head of NIH's National Institute of Allergy and Infectious Diseases, and HHS official Amy Patterson—have been the public face for the Obama Administration. By addressing his letter to Holdren, however, Sensenbrenner may put the spotlight on the president's science adviser.

The full text of Sensenbrenner's letter follows:

March 1, 2012

The Honorable John P. Holdren
Office of Science and Technology Policy
Executive Office of the President
725 17th Street, Room 5228
Washington, DC 20502

Dear Dr. Holdren:

Last summer, two research teams funded by the National Institutes of Health (NIH) genetically modified the H5N1 avian influenza virus making it capable of respiratory transmission between ferrets, and presumably, between humans as well. The National Science Advisory Board for Biosecurity (NSABB) recommended that journals refrain from publishing the details of the research because it believed that the benefits were outweighed by the risk that terrorist groups could use it as a recipe to create a biological weapon. Yesterday, NIH announced that it will ask the NSABB to reconvene to reexamine new versions of the two studies.

The specter of a deadly flu pandemic is truly frightening. While explaining its recommendation, the NSABB asked, "Could this knowledge, in the hands of malevolent individuals, organizations or governments, allow construction of a genetically altered influenza virus capable of causing a pandemic with mortality exceeding that of the 'Spanish flu' epidemic of 1918?"

The risk of biological attack is great enough that Secretary of State Hillary Clinton took the unusual step of travelling to Geneva to address the United Nations Biological Weapons Convention Review on December 7, 2011. Clinton warned that the threat of biological weapons could no longer be ignored and that "there are warning signs," including "evidence in Afghanistan that . . . al-Qaida in the Arabian Peninsula made a call to arms for-and I quote-'brothers with degrees in microbiology or chemistry to develop a weapon of mass destruction.'"

The outstanding question is less about why the NSABB is recommending against publication than it is about why this research was performed at all. I place great value on open scientific research and the free flow of ideas-these principles are truly the foundation for innovation and scientific advancement-but in the present case, researchers have created an organism that, if released, could kill millions of people worldwide. At a time when malevolent actors are actively seeking biological weapons of mass destruction, scientists have succeeded in creating an organism that we have all prayed nature would not.

The Administration's response has appeared ad hoc, delayed, and inadequate. The NSABB's recommendation against publication came only after the research was finished and submitted for publication. According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the health and security risks of the H5N1 research "didn't hit the radar screen" either in the home research institutions or during the NIH's multilayered review system.

Highlighting the danger, Dr. William Schaffner, professor and chair of the Department of Preventive Medicine at Vanderbilt University School of Medicine, argued that it may already be too late to control the research. Dr. Schaffner said, "We already have a growing pyramid of people who know all these data, and that pyramid will continue to grow over time."

The NIH's recent request that the NSABB reconsider its recommendation only adds to the confusion. An ad hoc approach is inadequate to balance the priorities of public health and the free flow of academic ideas. Further, if circumstances pose a legitimate threat to global health, the government needs a review system that is capable of identifying and preventing the spread of dangerous research, ideally before the research is conducted. Broad oversight is needed at both national and worldwide levels by objective scientists with knowledge in the relevant fields.

Please respond to the following questions by March 31, 2012:

1. How does the NSABB weigh the potential risks and benefits of dual use research? When does it advocate against publication?

2. What systems exist to identify and, if necessary, control early stage dual use research?

3. Science editor Bruce Alberts said that he takes the NSABB recommendations seriously and was willing to withhold some information, but only if the government creates a system to provide the missing information to legitimate scientists who need it. What is the government's current system for disseminating legitimate dual use research worldwide? How is that system being implemented with respect to the articles in question?

4. Is the NIH's review system adequate to identify potentially dangerous dual use research? Why did it fail to identify the avian flu research until it was completed and submitted for publication?

I appreciate your attention to this matter and look forward to your response.


Vice Chairman, House Committee on Science, Space, and Technology