"Action Required on Influenza Research"

by John Steinbruner

The Hill's Congress Blog dated April 2012

In the sobering annals of disaster prevention, genetic manipulation of the H5N1 influenza virus is looming as a seminal case. As has been widely reported, laboratory experiments have rendered the highly virulent avian strain transmissible among ferrets, strongly suggesting that it would be transmissible among humans as well. The potential is seriously alarming. The 1918 H1N1 strain is believed to have killed some 20 to 100 million people worldwide with a case fatality rate of 2- 20 percent, disproportionately young adults. The naturally occurring H5N1 virus has so far infected only about 600 people but half of them have died. If the virus could achieve efficient transmissibility while retaining anything like its current case fatality rate, it could inflict global disaster of unprecedented proportions.

The principal U.S. government entity seized with the matter – the U.S. National Security Advisory Board for Biosecurity (NSABB) – initially attempted to remove details from published reports of the experiments that they imagined would prevent replication. They then abandoned that effort and have now indicated they will initiate a process to draft global guidelines for conducting and disseminating research on dangerous pathogens. That step, which they had previously resisted, implicitly concedes that the U.S. alone cannot exercise comprehensive jurisdiction.

At the moment some prudential oversight of highly consequential biological research is being practiced in some countries, but prevailing procedures are largely voluntary in character, are not consistently applied and do not have global scope. A more effective arrangement would have to be mandatory and would have to be based on the principle of independent oversight applied to other matters of great consequence. Those who handle large sums of money are subjected to audit. No single individual is ever allowed exclusive control of a nuclear weapon.

The basic features of an appropriate oversight arrangement are evident. Established procedures for peer review of scientific merit would be extended to questions of social consequence and made mandatory. A record of judgment would be recorded in each instance. For lines of research of moderate concern a process would be created for comparing judgments across local and national jurisdiction in order to encourage harmonization. For lines of research of extraordinary danger, such as the H5N1 experiments, the review process would be globally representative and access to the results would be restricted to globally vetted public health professionals whose use of the results would be globally monitored. That degree of enforced transparency would require legislative action and appropriate regulatory specification to assure compliance and prevent misuse, but less than 1 percent of current biomedical research efforts would be affected.

The impediments to such an arrangement are largely matters of attitude, but they are formidable indeed. A few of the leading research scientists see the situation and understand the implications, but most are categorically opposed to any mandatory intrusion into basic research. Their resistance is reinforced by broadly pervasive anti-regulation ideology.

Presumptions of antagonistic interest make any international coordination difficult to accomplish and pose a danger of competitive national biological weapons development programs, so far largely unrealized but not reliably prevented.

Nonetheless it is prudent to assume that protective regulation will ultimately have to be imposed. Whether comprehension evolves naturally or is forced by disaster, mandatory oversight will eventually be indispensable. The sooner and the more gracefully that is realized the better off we all will be.