Ectromelia/IL-4 - repeat

Extracted statements

Rule-extracted, not adjudicated. The grade says what may be done with each one; read the document above before relying on any of them.

In context

A single line often inverts meaning once you see what it answers, so neighbouring messages are always shown.

1. 2002-07-16 16:14 Carole Heilman
   Tony: Mark Buller has been working on repeating the Australian experiment that demonstrated that insertion of the IL4 gene in ectromelia resulted in a more virulent form. I wanted to update you with respect to these results. * He has successfully repeated these studies ¢ Prior vaccination with an ectromelia vaccine, however, protected the mice equally well from this new virulent virus when compared to WT ectromelia.. * However, prior vaccination with the related orthopox virus, vaccinia, protected only against ectromelia challenge and NOT against the ectromelia-IL4 construct. * The mechanism of the break-through immunity associated with the IL-4 insert is being further evaluated but appears to be mediated through the IL4 receptor, as Balb-C-IL-4 knockout mice appear to be protected under the heterologous challenge scenario Carole UNIVERSITY OF MINNESOTA Twin Cities Campus Driven to DiscoverTM Center for Infectious Disease Research & Policy Academic Health Center School of Public Health Mayo Memorial Building 420 Delaware Street S.E. MMC 263, Room C315 Minneapolis, MN 55455 Office: 612-626-6770 Fax: 612-626-6783 www.cidrap.umn.edu April 12, 2012 Amy P. Patterson, M.D. Associate Director for Science Policy National Institutes of Health Office of Science Policy, OD, NIH Building 1, Room 103 9000 Rockville Pike Bethesda, MD 20892 Dear Amy, We all realize that the National Science Advisory Board for Biosecurity (NSABB) is currently in "uncharted scientific and public policy waters" with the request by the United States Government (USG) to review and make recommendations regarding publication of manuscripts from Dr. Ron Fouchier and colleagues and Dr. Yoshihiro Kawaoka and colleagues reporting their respective research methods and results related to the transmissibility of H5N1 in mammals. As a member of the NSABB, I appreciate the extensive efforts by the Board over the past six months to provide this comprehensive review and to make recommendations based on the previous extensive work of the Board to define dual-use research of concern (DURC.) It has been a gratifying professional and personal experience for me to work with such a dedicated group of scientific and policy leaders with a common purpose of both enabling the ongoing critical life science research that provides answers to some our most challenging health and environmental issues and at the same time protecting the world from potential catastrophic outcomes resulting from similar research. It has been two weeks since the NSABB meeting of March 29-30 where the Board was requested by the USG to reconsider our previous decision recommending the redaction of both the above referenced manuscripts before publication. During this time I have given considerable thought to the way the meeting was conducted and the subsequent decision by the NSABB to change its recommendation to full publication of both manuscripts without redaction. While we all realize any effort by the NSABB members and staff to arrive at a "Solomon-like" decision regarding the dissemination of the methods and results included in these manuscripts will be questioned by those who do not agree with the outcome, there is also a critical consideration for establishing precedence for how the NSABB will move forward with similar complex issues in the future. It is for this reason I share this letter with the NSABB members and the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) staff that support the Board's work. The views in this letter are mine and mine alone; I have not communicated with members of the NSABB or staff since the meeting. I write this letter in the spirit of moving forward and with an understanding of how the recent events related to the H5N1 influenza manuscript review informs us on why the USG-NSABB process for evaluating DURC issues must fundamentally change to both protect life science research and the risk to the public of such research. For the record, I voted at the meeting to approve the full publication of the Kawaoka manuscript and the continued requirement of redaction of the Fouchier manuscript. First, I believe that the agenda and speakers for the March 29 and 30th NSABB meeting as determined by the OBA staff and other USG officials was designed to produce the outcome that occurred. It represented a very "one sided" picture of the risk-benefit of the dissemination of the information in these manuscripts. The agenda was not designed to promote a balanced reconsideration of the manuscripts. While I don't suggest that there was a sinister motive by the USG with regard to either the agenda or invited speakers, 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. I also believe that this same approach in the future will mean all of us, including life science researchers, journal editors and government policy makers, will just continue to "kick the can down the road" without coming to grips with the very difficult task of managing DURC and the dissemination of potentially harmful information to those who might intentionally or unintentionally use that information in a way that risks public safety. Merely providing a "minority report" in the final findings and recommendations of the meeting does nothing to address the fundamental issues of how the risk and benefits were determined, described, and considered at the meeting. For example we heard from Dr. Fouchier that he has already identified an additional mutation (not included in his current manuscript) that results in ferret-to-ferret transmission (mammalian transmission) without the need for repeated passage of the virus in ferrets. This work, which may have been supported by NIH funds, surely must be considered as a candidate for the next manuscript to be before the NSABB for review. What scientific and policy issues will differ with this "incrementally changed manuscript" compared with the issues we just considered? If such work represents only incremental changes in results from previously approved work, will the Board ever find a bright line for redacting publication and all the issues that go with that decision? For you to better understand my concerns, I will detail specific examples of how I believe the agenda and selected speakers resulted in the one-sided risk-benefit analysis that I described above. I will use in part the general considerations and conclusions in the April 11th draft NSABB findings and recommendations document as the framework for these points. The data in the newly revised manuscripts are immediately and directly enabling. There was no objective review provided by a disinterested subject matter expert that addressed the current state of the art regarding the proliferation and use of reverse genetics technology that can incorporate the methods and results presented in the current manuscripts to allow those who would not have the ready expertise or resources to more easily repeat these experiments. The implications of doing such work, even by well-meaning scientists who do not have adequate biosafety measures in place, should have been reviewed. The subject matter experts that addressed this issue at the meeting have a real conflict of interest in that their laboratories are involved in this same type of work and the results of our deliberations directly affect them, too. The same can be said about the attendees and outcome of the February World Health Organization consultation. In short, it was the "involved influenza research community" telling us what they should and shouldn't be allowed to do based on their interested perspective. Such a perspective is very important and should be included in this discussion, but it shouldn't be the only voice. As director of one of the five NIH-supported centers of excellence in influenza research and surveillance, I can speak with firsthand knowledge and experience that the voice of an important group of senior influenza researchers not doing similar mutation/transmission work was not heard regarding this issue. I personally tried to have their voices represented at the meeting. They were not invited. One of them wrote me a very clear and compelling comment on the potential

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