Biosecurity experts laud withholding of data on new toxin

The omission of key genetic data from a recently published report of a newly discovered botulinum toxin has drawn a strong round of applause from a group of six biosecurity experts who were deeply involved in the controversy last year over publication of details on lab-modified H5N1 viruses.

In an editorial in mBio, the experts write that the action of the Journal of Infectious Diseases (JID) in publishing the redacted report on the new Clostridium botulinum toxin was an example of "responsible scientific journalism" and reflected "prudence and responsibility."

But the experts, four of whom serve as mBio editors, also said the publication of the redacted version left several questions unanswered regarding the handling of future reports on "dual use research of concern" (DURC), meaning scientific findings that can be used for good or evil.

The JID report, published in October, described the discovery of a hitherto unknown botulinum toxin, called botulinum neurotoxin type H. The authors and journal decided to withhold the toxin's genetic sequence data until an antitoxin can be developed, out of concern that someone could use the data to create the toxin in a lab and wield it as a weapon for which there is no good countermeasure.

The authors of the mBio editorial are Arturo Casadevall, MD, PhD, founding editor-in-chief of the journal; Lynn Enquist, PhD, former editor-in-chief of the Journal of Virology; Michael J. Imperiale, PhD, of the University of Michigan Medical School; Paul Keim, PhD, of Northern Arizona University; Michael T. Osterholm, PhD, MPH, of the University of Minnesota; and David A. Relman, MD, of Stanford University.

Imperiale, Keim, and Relman work with Casadevall as editors of mBio. Osterholm directs the University of Minnesota's Center for Infectious Disease Research and Policy, publisher of CIDRAP News.

Authors serve on biosecurity advisory group

All six are current or former members of the National Science Advisory Board for Biosecurity (NSABB), which initially recommended against publication of full details of lab manipulations that produced H5N1 viruses that showed airborne transmissibility in ferrets. (Such experiments are known as "gain of function" research.)

They write, however, that their views in the editorial do not represent the official policy of the NSABB, which advises the US government on biosecurity issues.

In the H5N1 case, the NSABB wanted crucial details of the research omitted from the published reports but shared with responsible scientists who have a need to know. But eventually the board endorsed publication of the full manuscripts, after the authors briefed the panel and made some clarifications in the papers.

The board voted unanimously in favor of full publication of one of the reports, but it split 12-6 on the other one. The papers were published in May and June of 2012.

In the editorial, the experts write that the NSABB's change of stance came after it was told that "redaction was not feasible because a number of factors, including export control requirements, required that all or none of the research methods and results be published."

Referring to JID's redaction of the botulinum toxin report, the group writes, "We consider this action to be an example of responsible scientific journalism and commend JID and the authors for exercising prudence and responsibility."

"JID has shown that it is willing to follow through with the mechanism that the NSABB originally recommended in regard to the H5N1 gain-of-function work," they add. "This redaction provides an example of responsible authors and editors working together to diminish the negative externalities associated with DURC."

The editorial notes that the standard arguments against omission of key data from published reports include that it precludes reproduction of the study, that the full data are essential for supporting the conclusions of the study, and that principle and tradition require full disclosure.

Still another concern, the piece says, is that export-control rules and "International Traffic in Arms Regulations" (ITAR) constitute a barrier to redaction of scientific papers. The JID action may establish an important precedent if it complies with such regulations or if it inspires changes in them, the experts believe.

Unanswered questions

At the same time, the JID action "leaves many unanswered questions and opens new conundrums," they add. For example:

  • How will the data omitted from JID be shared with responsible scientists so they can confirm the work and develop antidotes?
  • Which scientists will have access to the data?
  • Are there sunset provisions on the withholding of data?

To address these and related questions, the authors call for a discussion by all stakeholders in scientific information, including the media and the public. The aim should be to build a consensus on how the results of future studies involving DURC should be handled.

The experts conclude that the action by JID and the authors of the redacted report "suggests that redaction is a feasible option for some in the world of scientific publishing who are willing to take the lead in pushing forward important issues for discussion."

The editorial comes on the heels of a letter in which 56 scientists from around the world called on the European Commission to hold a briefing on gain-of-function research and formally assess its risks and benefits. The letter, dated Dec 18, was spearheaded by the Foundation for Vaccine Research, based in Washington, DC.

The letter took issue with claims that gain-of-function research can help predict viral evolution, lead to better vaccines, and help evaluate candidate drugs.

Casadevall A, Enquist L, Imperiale MJ, et al. Redaction of sensitive data in the publication of dual use research of concern. mBio 2014;5(1) (Early online publication Dec 31, 2013) [Full text]

See also:

Oct 10 CIDRAP News story on new botulinum toxin

Dec 20 CIDRAP News item on letter from Foundation for Vaccine Research

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