-Caveat Lector-
Begin forwarded message:
From: [EMAIL PROTECTED]
Date: September 19, 2007 9:00:22 AM PDT
To: [EMAIL PROTECTED]
Cc: [EMAIL PROTECTED], [EMAIL PROTECTED], [EMAIL PROTECTED]
Subject: Don't Drop the Genetically Altered Ebola Virus-- Oops!
"Cleanup in Aisle 2 ..."
The Sunshine Project
News Release
19 September 2007
http://www.sunshine-project.org/publications/pr/pr190907.html
Ebola Error in Wisconsin Shows Lax Federal Biodefense Oversight
Similar Violations May be Undetected Elsewhere
In 2005 and into the summer of 2006, researchers at the University
of Wisconsin at Madison (UW) made and manipulated copies of the
entire Ebola virus genome without proper safety precautions.
Although federal safety rules required a maximum protection
Biosafety Level Four (BSL-4) lab for the research, UW allowed it to
proceed at the much less safe and secure BSL-3 level. The rules
that UW broke are intended to ensure that agents that are easily
transmissible and usually incurable don't escape maximum
containment. They prohibit working at BSL-3 with Ebola (and
similarly dangerous) virus material that has not been rendered
irreversibly incapable of reproducing. UW does not have a BSL-4 lab
suitable for handling Ebola virus, which is one of the most
dangerous pathogens in the world.
Despite the contrary provisions of the NIH Guidelines for Research
Involving Recombinant DNA Molecules, permission for UW scientist
Yoshihiro Kawaoka to perform the Ebola genome work at BSL-3 was
granted by the University of Wisconsin Institutional Biosafety
Committee (IBC). This significant violation of NIH Guidelines was
not detected in a timely manner by the National Institutes of
Health (NIH) or, apparently, by the CDC Select Agent Program staff
that inspect the Kawaoka lab.
Ebola virus was first recognized in 1976 in Africa. It is one of
the more dangerous pathogens on earth. It is transmitted from
person to person and causes a deadly hemorrhagic fever. Most people
who contract Ebola quickly die from the disease. Its gruesome
progression has provided horrific grist for innumerable popular
books and movies, such as "The Hot Zone". An Ebola outbreak
currently underway in the Democratic Republic of Congo has claimed
an estimated 170 lives.
(A sources section a the bottom of this news release provides links
to more information.)
KEEPING EBOLA IN THE BSL-4: The degree of danger posed by the work
at UW, which involved manipulation of full-length Ebola cDNAs (see
"The Science" below) is scientifically debatable. Some might argue
the work was not terribly unsafe, because the Ebola constructs were
not used together with two critical proteins whose presence would
trigger growth of virulent virus. Others would argue that it was
irresponsible to handle complete DNA copies of a virus as deadly as
Ebola at less than BSL-4 when the copies were capable of producing
virulent virus. From a security standpoint, it may also be argued
that it is inadvisable to facilitate access to the Ebola virus by
distributing the means to produce it (i.e. the cDNAs) to facilities
other than BSL-4 labs, which are fewer and have the strongest
security measures in place.
OVERSIGHT FAILURE: The research was not halted until Kawaoka
remarkably repeatedly pushed for permission to lower it to
biosafety level two (BSL-2), which is used for diseases that are
comparatively mild and easy to treat. Kawaoka's persistence in
requesting the even lower BSL-2 standard prompted a UW official to
consult with the National Institutes of Health, whereupon it was
determined that UW did not have appropriate facilities and should
never have approved the studies at all.
But the organization that was funding the research, which
explicitly included precisely the activity that violated NIH rules,
was none other than NIH itself. "NIH disapproved its own project,"
says Sunshine Project Director Edward Hammond, "but it wasn't
stopped because NIH's left hand knew what the right was doing, it
was essentially by chance and long after the project started." Says
Hammond, "After of years of studying NIH's toothless enforcement of
its own Guidelines, it is dismaying but not surprising that NIH's
biodefense program was funding work that violates NIH's safety
rules. The Guidelines have been an unenforced afterthought for years."
There are several troubling questions that remain:
1) Why did the Madison IBC approve the project in the first place?
2) Why doesn't the National Institutes of Health Office of
Biotechnology Activities, which is supposed to oversee this work,
have a system in place that detects such violations, especially
when NIH is funding the work?
3) Why did the Centers for Disease Control apparently fail to
identify the problem? The Kawaoka lab handles select agents and is
thus subject to registry and inspection by CDC. Is not an
inadequate lab experimenting with the complete means to produce
Ebola something that CDC's Select Agent Program should identify and
act upon?
Says Hammond, "NIH's Office of Biotechnology Activities has no idea
what's going on in the labs it allegedly oversees. It is well-
established that there is practically zero oversight NIH under the
NIH Guidelines and common knowledge that there is never any penalty
for disobeying them."
CELEBRITY STANDARDS? The Kawaoka Lab is known for work on the
bleeding edge of virology. It is a world of dangerous experiments
with dangerous diseases, such as infecting monkeys with deadly
agents. Daring lab workers frequently deal with diseases like 1918
influenza and - by protocol - preemptively pop Tamiflu like it was
breath mint. Engineering controls clearly don't seem to themselves
inspire complete confidence. It is doubtful that many other
virologists would gain institutional approval for some of the lab's
practices or, for that matter, would be willing to routinely
subject themselves to some of the lab's risks.
The lab is well funded with biodefense grants and is at once
admired and controversial. In late 2004, UW and the University of
Pittsburgh got into an unseemly bidding war over the scientist,
offering up tens of millions of dollars in salaries, labs, people,
and other public resources in packages more reminiscent of a MTV
pop music star's concert rider than a college professor's salary
contract.
"Pecking order means a lot in biology, in Madison and elsewhere,
and Kawaoka is a big bird," says Hammond. The Sunshine Project
would like to know if celebrity status caused UW to disregard the
NIH Guidelines and lower safety and security standards: "If it had
wanted to, was the IBC even realistically able to veto Kawaoka's
research plans after the University had spent millions to keep him,
blowing cash and political capital all the way to the governor's
office? That these imbalanced situations exist at all is one good
reason to make IBC compliance a matter of law instead of guideline."
SIMILAR RISK ELSEWHERE? In the course of researching this news
release, the Sunshine Project identified a project at Tulane
University in New Orleans, Louisiana that may also be handling
complete cDNAs for BSL-4 agents at lesser safety levels. In the
Tulane case, Ebola is again involved, along with Lassa virus,
another hemorrhagic fever virus with African origins.
Documentation available from Tulane, however, is imprecise. Minutes
from the Tulane IBC state that the Garry Lab will have Lassa and
Ebola cDNAs and that the researcher "could replicate it [the virus]
if he wanted to", suggesting complete cDNAs at another lab with no
BSL-4 containment. In Tulane's case, the US Army is providing the
cDNAs.
The Sunshine Project asked the Tulane researchers and their
supervisors for clarification about the research six times. Tulane
officials refused to respond at all. The Sunshine Project then
asked the NIH Office of Biotechnology Activities about the possibly
noncompliant research. NIH didn't reply to questions either.
THE SCIENCE: Some viruses including Ebola have genetic code that is
composed of RNA, rather than the DNA molecule that is the basis of
heredity in higher organisms. In higher organisms, information from
DNA is translated into RNA that then serves as a "messenger",
directing what other parts of living cells do. RNA viruses lack the
tools to copy themselves independently, and instead reproduce by
hijacking normal DNA-RNA translation processes in cells.
For some RNA viruses, such as influenza, scientists (including the
Kawaoka Lab) have developed so-called "reverse genetics" systems
that take scientific advantage of how RNA viruses multiply. They
have constructed DNA copies of the virus. When the DNA copies
(called cDNAs, or "complimentary DNA") are allowed to reproduce
under appropriate conditions, they will churn out RNA that is
assembled into live virus. The systems allow scientists to "edit"
the RNA virus by tweaking the cDNA that produces it. The effects of
such genetic tweaks are not necessarily predictable, and may change
the virus in ways that make it more or less dangerous. Viruses
produced by reverse genetics may be used for research and vaccine
purposes.
SOURCES:
IBC Minutes of both the University of Wisconsin at Madison and
Tulane University can be downloaded from the Sunshine Project IBC
Minutes archive at:
http://www.sunshine-project.org/ibc/archive.html
E-mail between Bruce Whitney of NIH OBA and Jan Klein of UW
Madison, July and October 2006 (obtained under the Wisconsin Public
Records Law):
http://www.sunshine-project.org/publications/pr/support/UWcDNAs.pdf
Molecular Basis for Ebola Virus Pathogenicity, NIAID grant to UW
Madison's Yoshihiro Kawaoka, #1R01AI055519
Recombinant antigen assays for Lassa and other arenaviru [sic],
NIAID grant to Tulane's Robert Garry, #1UC1AI067188
Summarie accessible here (search on the researcher's last name,
with a relevant keyword, such as "Ebola"):
http://www.sunshine-project.org/crisper/crisper_basic_search.php
"Flight Lessons", an article from the University of Wisconsin
Alumni Magazine concerning UW and Pitt's competition:
http://www.uwalumni.com/home/onwisconsin/archives/winter06/Yoshi.aspx
See what's new at AOL.com and Make AOL Your Homepage.
www.ctrl.org
DECLARATION & DISCLAIMER
==========
CTRL is a discussion & informational exchange list. Proselytizing propagandic
screeds are unwelcomed. Substanceânot soap-boxingâplease! These are
sordid matters and 'conspiracy theory'âwith its many half-truths, mis-
directions and outright fraudsâis used politically by different groups with
major and minor effects spread throughout the spectrum of time and thought.
That being said, CTRLgives no endorsement to the validity of posts, and
always suggests to readers; be wary of what you read. CTRL gives no
credence to Holocaust denial and nazi's need not apply.
Let us please be civil and as always, Caveat Lector.
========================================================================
Archives Available at:
http://www.mail-archive.com/ctrl@listserv.aol.com/
<A HREF="http://www.mail-archive.com/ctrl@listserv.aol.com/";>ctrl</A>
========================================================================
To subscribe to Conspiracy Theory Research List[CTRL] send email:
SUBSCRIBE CTRL [to:] [EMAIL PROTECTED]
To UNsubscribe to Conspiracy Theory Research List[CTRL] send email:
SIGNOFF CTRL [to:] [EMAIL PROTECTED]
Om
