February 27, 2012 - IMM@BUCT

NEWS OF THE WEEK
UNCERTAIN PATH
FOR H5N1 RESEARCH
POLICY: A closed-door meeting and a
vague statement from an international
panel muddy the road ahead
HOW TO MOVE forward with controversial research
on the H5N1 avian flu virus, including
publication of two papers reporting on recent
experimental work, has grown murkier in the wake of a
Feb. 17 statement from the World Health Organization .
According to WHO, an expert panel it convened
“reached consensus on two urgent issues related to
the newly created H5N1 influenza viruses: extending
the temporary moratorium on research with new
laboratory-modified H5N1 viruses and recognizing that
research on naturally occurring H5N1 influenza virus
must continue in order to protect public health.” The
statement also says that the panel supports full publication
of two research papers on the work, accepted
by Nature and Science , “however, there are significant
public health concerns surrounding this research that
should first be addressed.”
“I am not sure exactly what the decision means
because it’s qualified,” said Bruce M. Alberts, editorin-chief
of Science , at a hastily assembled news briefing
in Vancouver, British Columbia, on the same day WHO
released the statement. Alberts agreed to talk to the
press at the American Association for the Advancement
of Science annual meeting, in part to squelch rumors
concerning the paper Science controls. The journal is
published by AAAS.
The WHO panel of experts met behind closed doors
at WHO headquarters in Geneva on Feb. 16–17. WHO
required each expert, including the primary authors of
the Science and Nature papers, to sign a confidentiality
agreement barring them from open discussion of the
deliberations. Public fear about avian flu along with the
panel’s detailed review of the unpublished experimental
work—deemed “dual use” and thus dangerous—
dictated the secrecy, WHO says.
At the AAAS press briefing, Alberts revealed that
Science and Nature had been planning to publish in
mid-March redacted versions of the two papers that
describe experiments to artificially mutate the H5N1
virus, making it more contagious
and virulent. Under
this plan, the journals would
have been following the recommendations
of the U.S.
National Science Advisory
Board for Biosecurity ( C&EN,
Feb. 6, page 6 ). NSABB Acting
Chair Paul Keim of Northern
Arizona University was a
member of the WHO panel.
“Certainly now that’s not
going to happen,” said Alberts,
referring to the March
publication plan.
In a statement, Nature Editor-in-Chief
Philip Campbell, who was a member of the
WHO panel, said: “Discussions at the WHO meeting
made it clear how ineffective redaction and restricted
distribution would be for the Nature paper. It also underlined
how beneficial publication of the full paper
could be. So that is how we intend to proceed.”
Alberts was less definitive: “My reading is that both
Nature and Science are to wait until we get some further
information from WHO and other authorities about
when, in fact, we are to publish the full manuscripts.”
But WHO is not dictating decisions for Science ,
Alberts insisted. Instead, “we’re allowing them to say,
‘Delay publication until issues are resolved.’ ” It is
reasonable, Alberts said, that public fears about the research
be addressed first. — WILLIAM SCHULZ
AAAS
Alberts
PHARMACEUTICALS Food & Drug Administration acts to ease cancer drug shortages
FDA has taken steps to boost the supply
of two critical cancer drugs—Doxil and
methotrexate—both of which have been
facing nationwide shortages.
FDA will temporarily allow importation
of the unapproved drug Lipo-Dox, from
India-based Sun Pharma, as a replacement
for Doxil, FDA Commissioner Margaret
A. Hamburg announced on Feb. 21.
FDA has also fast-tracked the approval of
preservative-free methotrexate from APP
Pharmaceuticals, and the agency is working
with other companies to ramp up production
of methotrexate, Hamburg said.
FDA’s latest actions add to a growing
list of measures the agency has taken
since President Barack Obama signed an
executive order last October to alleviate
the growing problem of drug shortages in
the U.S. Those measures include developing
a database to track drug shortages,
sharing information with the Justice Department
to address stockpiling of drugs
and exorbitant pricing, and collaborating
with industry and other stakeholders.
There has been a sixfold increase in
the number of firms voluntarily notifying
FDA of potential drug shortages since the
executive order. Despite the increase, FDA
fully supports legislation, H.R. 2245 and
S. 296, that would require manufacturers
to report all drug shortages to the agency
and would give it enforcement authority.
“We know that advanced notification
works. But to truly be most effective,
Congress must grant FDA the authority
it needs to require notification for all
lifesaving drugs,” Rep. Diana L. DeGette
(D-Colo.), sponsor of H.R. 2245, said in a
statement. “And manufacturers that do
not comply should be penalized for putting
patients at risk.” — BRITT ERICKSON
WWW.CEN-ONLINE.ORG 9 FEBRUARY 27, 2012