Sunday, April 15, 2012

Osterholm's Letter to the National Institute of Health

From the previous post (link to this letter is included in the post):

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's Letter [bolding and editing are mine]
Excerpt
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.
-snip-
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
for the information in one of the manuscripts to be immediately and directly enabling. He stated;
“I am an influenza virologist myself, and we routinely create viral mutants in my
lab using reverse genetics, so I have a good sense of the technical issues involved.
As such, I can recognize that some outspoken researchers in our field have been
under-representing the increased risk that would be entailed by full publication of
the specific mutations versus the current situation where only the general outline
of the ferret-passage scheme is known. A ferret-passage experiment is expensive
and technically demanding, and could only be done by a handful of labs in the
world. Once the mutations are public, individuals in my lab (or many other labs)
could generate the mutants in a few weeks given several thousand dollars for gene
synthesis.
I remain agnostic about what is the best policy going forward. I recognize that
there also important potential benefits from this research, and think that research
along these lines does have valid scientific and public-health justifications. But
these benefits need to be carefully weighed against the real risks, and I am
definitely concerned that there has been a rush to judgment for full publication
within our own research community.”
I have talked with many similarly minded influenza researchers from around the world who
agree with the above statement. Yet these voices were notably absent in the NSABB
deliberations.

The data may benefit public health and surveillance efforts.
The Board received no formal or informal presentation from those on the front lines of H5N1
animal surveillance and control. Specifically, no one with H5N1 virus surveillance and control
expertise from either the Food and Agriculture Organization (FAO) or the World Organization
for Animal Health (OIE) were invited to participate. I have discussed with officials from both
organizations the implications of sharing the mutation data; the general response indicated that
such information without major new resources and government commitment to active animal
surveillance and control would not fundamentally change current surveillance and control
practices in most of the endemic H5N1 countries. Yet, there was a series of very general and
unsubstantiated statements made by others invited to the meeting who are not involved in the
day-to-day animal surveillance activities in the H5N1 endemic countries (including the authors)
as to the benefits of making the mutational data available for this purpose.

No comments: