04/13/2012 05:36 EDT | Updated 06/13/2012 05:12 EDT

Expert slams process for releasing bird flu studies; 'kicked can down the road'

A member of the U.S. biosecurity panel that recently lifted its objections to the publication of two controversial bird flu studies has slammed the way the decision was reached, saying the meeting held to reconsider the issue was "one-sided" and designed to produce the eventual outcome.

Michael Osterholm, a flu expert and a member of the National Science Advisory Board for Biosecurity, warned that the decision to recommend the two studies could be published in full merely "kicked the can down the road" towards what may be another standoff with one of the scientists involved in this affair.

Osterholm revealed that Ron Fouchier, the Dutch virologist who led one of the studies, told the NSABB at a closed-door meeting in late March that he had discovered another mutation that makes it easier still to engineer H5N1 flu viruses that transmit from mammal to mammal.

"This work ... surely must be considered as a candidate for the next manuscript to be before the NSABB for review," said Osterholm, whose term on the board is coming to an end.

His letter was obtained by the news department of the journal Science. They published it on their website, ScienceInsider.

The letter was addressed to Dr. Amy Patterson, associate director for science policy at the National Institutes of Health, and the official to whom the NSABB reports. It was copied to members of the 21-person board and to NSABB staff.

Osterholm wouldn't comment on the sharply worded seven-page letter, which read like a minority report. (The NSABB's full report has not yet been made public.)

"I have no comment beyond: the letter speaks for itself," Osterholm told The Canadian Press.

In the letter, Osterholm, who is the director of the Center for Infectious Diseases Research and Policy at the University of Minnesota, suggested experts who made presentations to the board about various aspects of the issue had an interest in the outcome of the meeting.

"I believe there was a bias toward finding a solution that was a lot less about a robust science- and policy-based risk-benefit analysis and more about how to get us out of this difficult situation," he wrote.

The controversy has dragged on since last fall, enmeshing influenza researchers, two prominent scientific journals, the U.S. government and even the World Health Organization in a messy fight where it seemed capitulation, not compromise, was the inevitable outcome.

The controversy started when research teams led by Fouchier at Erasmus Medical Centre in Rotterdam and Yoshihiro Kawaoka of the University of Wisconsin-Madison tried to publish scientific papers revealing they had managed to mutate H5N1 viruses to the point where they could transmit easily among ferrets.

Ferrets are used a stand-in for people in this type of work because they are considered the best animal model for predicting how flu viruses will act in humans.

Currently H5N1 viruses in the wild decimate poultry flocks, but do not readily infect mammals. Occasional human cases occur, but spread from person to person is believed to be rare and transmission quickly peters out.

Fouchier and Kawaoka have been working — with funding from the U.S. National Institutes of Health — to try to see what it might take to make the virus transmissible among mammals. Their proof that H5N1 can make these changes means the virus must be considered a pandemic threat.

The journals Science and Nature have accepted the studies for publication. But the papers were referred to the NSABB because of fears the information in them qualified as so-called "dual use research of concern" — legitimate science that could be used for dangerous purposes.

Fouchier would not comment on Osterholm's letter, which said the Dutch scientist had discovered a mutation that makes H5N1 viruses transmit by aerosol without requiring the virus to be passaged. Passaging is the scientific process of serially infecting animals in an attempt to force mutations, a labour-intensive and time-consuming step.

In an email, Fouchier noted Dutch export control law currently bars him from publishing or talking publicly about his H5N1 transmission work.

Late last fall the NSABB recommended that the Fouchier and Kawaoka papers be published in abbreviated or redacted form only. Acting on that advice, the U.S. government asked the journals to publish without the details of how the work was done.

But a meeting organized by the World Health Organization in February concluded that publishing redacted versions of the papers was unworkable.

When material is withheld for security reasons, export control laws in the United States and the Netherlands come into play. Those laws could conceivably prevent Fouchier from sending his study to his U.S.-based publisher, Science, or Kawaoka from sending his to U.K.-based Nature.

And those laws would prevent the information in the studies from being shared across borders with public health authorities or influenza scientists with a legitimate need to see the complete material.

At a second meeting held March 29 and 30, the NSABB changed its position, voting unanimously that Kawaoka's paper should be published in full. In a 12-to-6 vote, it also agreed that Fouchier's paper should be published.

Osterholm was one of the six who objected to full publication of Fouchier's paper.



Osterholm's letter can be found on the ScienceInsider website at: