LabWatch

Biodefense, Biolabs & Bugs: Council Takes Important First Step

2010-06-30T11:09:00.000-07:00

Seattle, WA – 06/04/10 - With a growing number of high-containment biolabs operating in Seattle neighborhoods, Labwatch.org commends the Seattle City Council for its unanimous support of a resolution urging the State of Washington to set standards for biosafety laboratories.

“Seattle is quietly becoming a hotbed of the U.S. Biodefense program with work on dangerous pathogens taking place right under our noses.” said Mike McCormick of Labwatch.org.

In 2005 the University of Washington abandoned plans to build a new Regional Biocontainment Laboratory to house its current biodefense program. Individual citizens, businesses and neighborhood organizations opposed siting a complex that worked on dangerous infectious diseases in a densely populated neighborhood. During public hearings UW representatives stated there were over 30 similar labs at the UW and “five or six scattered thoughout the Seattle area, many in South Lake Union”. Since that time, more labs have been built in SLU.

Contrary to lab proponents, accidents and safety failures at labs are not unusual. Numerous investigations (including at UW) find an ever-increasing incidence of serious problems as the number of biolabs and personnel exponentially increase. A 2009 GAO report titled “High-Containment Laboratories: National Strategy for Oversight is Needed” states “even laboratories within sophisticated biological research programs—including those most extensively regulated—have had and will continue to have safety failures.”

Last year the University of Washington helped create a second Regional Center for Biodefense & Emerging Infectious Diseases in the Pacific NW, making this area the only region in the country with two biodefense programs.

“At the same time that the UW is decommissioning half it’s high-containment biolabs due to deficiencies, it’s expanding its biodefense program. We need a vigorous citizen debate before the University of Washington goes any farther on its work with ebola, avian influenza and the recreated 1918 influenza.” says McCormick.

US military flu virus collection parallels WHO virus system

2008-11-27T11:37:00.000-08:00

Bogota, 26 Nov (Edward Hammond*) -- A large and rapidly growing global US military virus collection system parallels the World Health Organization's Global Influenza Surveillance Network (WHO GISN) but does not entirely share its public health purposes.

The US military system is a source of viruses for the WHO GISN; but it does not give most of its virus collections to WHO. It does keep all the lab specimens and viruses it collects for its own use.

Wider knowledge of the extent of the US military virus collection system and its ambiguous relationship to the WHO GISN system will raise important questions for the WHO Pandemic Influenza Preparedness Inter-Governmental Meeting (PIP IGM), which will convene in Geneva the second week of December.

The extent of the Pentagon's quiet but large virus collecting and its relationships with the WHO GISN will surprise many. For example, the Pentagon claims credit for having collected several important influenza viruses that were subsequently selected by WHO for use in seasonal and H5N1 pre-pandemic vaccines from 2000 through the present, including viruses from Panama, Peru, Nepal, Malaysia, and Indonesia.

Some developed countries, including the United States, have insisted that developing countries only share influenza viruses with the WHO GISN and not bilaterally with others. Yet, contradictorily, the United States has a massive military influenza virus collection program, but only provides a very small percentage of the materials that it collects to the WHO.

It is unclear if and how viruses collected by the US military in other countries would be covered by a WHO GISN material transfer agreement because they are obtained and transferred outside what is now- understood to be the WHO system.

If one WHO Member State unilaterally amasses influenza viruses without full participation in the WHO access and benefit sharing system there is strong potential for the WHO system to be undermined.

Also undefined is the legal status of a virus received by the WHO system; but not from an approved lab of its country of origin - a situation that now frequently occurs due to the activities of the US military virus collection system.

The US military system is active globally, including at least 56 countries where it is collecting influenza viruses (as of 2007). The system pulls in clinical specimens and locally isolated viruses that are shipped to the United States. It provides some of these viruses to the WHO GISN network, mainly through the US Centres for Disease Control (CDC), a WHO Collaborating Centre in Atlanta, Georgia (and part of the US health ministry), but keeps all specimens and viruses for its own purposes.

The size and capacity of the US military program is dramatically expanding and has more than doubled in recent years. In 2005, it was active in 30 countries and included three BSL-3 labs and a total sample processing capacity of 9,000 specimens per year. By 2007, the network was active in 65 countries and included eight BSL-3 labs and the capacity to process 18,000 samples annually.

The network is named the US Department of Defense Global Emerging Infections Surveillance & Response System ("DoD-GEIS"). A DoD-GEIS program called the US Department of Defense Worldwide Influenza Surveillance Program focuses specifically on flu viruses.

The military network has "sentinel" sites around the globe, reported by US military sources to include 128 or more locations. These are installations where US military personnel are based, as well as collaborating non-military sites that collect samples from US personnel and local civilian populations.

In 2006-2007, the system collected influenza viruses from developing countries including:

-- Americas: Belize, Guatemala, Honduras, El Salvador, Nicaragua, Venezuela, Colombia, Ecuador, Peru, Bolivia, Paraguay, and Argentina.
-- Africa: Morocco, Libya, Egypt, Eritrea, Djibouti, Sudan, Uganda, Kenya, Burundi, Gambia, Ghana, Nigeria, and Cameroon.
-- Middle East: Turkey, Jordan, Iraq, and Oman.
-- Central/South Asia: Azerbaijan, Kazakhstan, Uzbekistan, Mongolia, Afghanistan, Pakistan, India, Nepal, and Bangladesh.
-- Southeast Asia/Oceania: Myanmar, Thailand, Vietnam, Laos, Cambodia, Philippines, Indonesia, Papua New Guinea, and Solomon Islands.

A US Air Force lab at Brooks City Base in San Antonio, Texas coordinates the system. In 2006 and 2007, its systemwide budget was over $40 million per year. In the 2006-2007 flu year, the Texas lab alone processed 5,810 specimens from persons across the globe suspected to have respiratory infections. Of these, 2,444 tested positive for a respiratory virus, including 1121 positive for influenza virus. According to the US Department of Defense (DOD), "All original specimens are archived and kept for requests from [Department of Defense] partners or the CDC."

Another lab at a US Navy facility in San Diego, California processes an unknown number of additional samples. Of note, the Navy lab systematically isolates flu viruses from military personnel who become infected during port visits. Using this unusual collection method, in 2007, it isolated seasonal influenza viruses from countries including Indonesia, Papua New Guinea, and the Solomon Islands after US Navy ships docked there and US sailors became infected while ashore.

Including the Navy lab and other facilities (see below), the military system handled an overall total of approximately 8,000 influenza and other viral cultures in 2007. Of these, only a small percentage are given to CDC. In 2006, this number was 120 viral isolates (about 1.5%), meaning that over 98% of the viruses collected by the US military program do not enter the WHO system.

In addition to the CDC, collected viruses (especially H5N1 viruses) are provided to US Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick in Frederick, Maryland. USAMRIID is the historical home of the US offensive biological weapons program (terminated in 1969), and is presently the headquarters of the US military's biological defense effort. Drawing on viruses collected by the US military and WHO sources, as of 2007, USAMRIID maintained a collection of thirty different H5N1 strains plus many other flu types that it uses in research and provides to other US military labs.

According to the program, the primary purpose of the virus collection system is to ensure US military readiness: "The principal objective is to enable the rapid discovery of novel strain mutations that could trigger a pandemic and to monitor these strains for their ability to transmit and to causedisease... the priority of the DoD is to maintain readiness and protect the health of service-members and beneficiaries, the contributions from the [San Antonio-based] surveillance program also benefit the greater global health community."

Five overseas laboratories operated by the US Department of Defense act as regional coordination centres for the collection effort. The five labs are:

-- Naval Medical Research Unit No. 2 (NAMRU-2) in Jakarta, Indonesia.
-- Naval Medical Research Unit No. 3 (NAMRU-3) in Cairo, Egypt.
-- Naval Medical Research Centre Detachment (NMRCD) in Lima, Peru.
-- Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok,Thailand.
-- United States Army Medical Research Unit-Kenya (USAMRU-K) in Nairobi, Kenya.

With the exception of NAMRU-2, which was recently closed by the Indonesian government, each of the above labs works not only in the country in which it is located; but also in nearby countries, where laboratory and personnel detachments are sometimes placed.

NMRCD operates a high containment (BSL-3) lab in Peru, and coordinates virus collections in several South and Central American countries and, for example, has staff in Guatemala. In 2007, it reported that it is seeking to expand virus surveillance efforts in Ecuador, Bolivia, Paraguay, and Uruguay.

AFRIMS in Bangkok operates a BSL-3 lab and, in addition to work in Thailand, maintains a facility in Nepal and collects samples from other countries in the region. In total in 2007, AFRIMS collected over 1,000 respiratory samples from seven countries in Southeast and South Asia.

NAMRU-3 in Cairo has at least BSL-3 capability and collects human and animal influenza viruses. It is a WHO GISN H5 reference lab, submitting viruses both to other US government labs as well as WHO labs. NAMRU-3 maintains activities in many African, Middle Eastern, and Asian countries, from Ghana eastward all the way to Pakistan.

It states that in 2007, "From Egypt, 141 human specimens were received for influenza A/H5N1 reference testing, and 26 specimens tested positive for H5N1. H5 reference testing was performed on 459 animal specimens, with 92 positive for H5N1 from Afghanistan, Egypt, and Ghana." From these H5N1 isolates, MANRU-3 deposited HA gene sequence information for 74 strains in GenBank.

USAMRU-K in Nairobi collects virus samples from hospitals and Kenyan military facilities and says that it is developing collection capabilities through universities in Uganda and Cameroon and the Nigerian defense ministry. Flu viruses it collects are provided to the CDC and the US military.

Until the Indonesian government closed it, NAMRU-2 in Jakarta played a similar role, including coordinating US laboratory detachments in Indonesia, Cambodia and Laos. In 2007, it says that it collected and tested more than 4,500 respiratory samples in Indonesia alone. It is unclear what will happen to NAMRU-2's activities outside of Indonesia now that the Jakarta laboratory has been closed.

Other US military BSL-3 labs in the network are located in Germany and South Korea. The DoD-GEIS network also collaborates with the US Defense Threat Reduction Agency (DTRA), although the exact nature of the collaboration has not been publicly described.

Despite the Pentagon's claims that it has frequently contributed to WHO vaccine strain selections, none of the negotiating texts or background documents made available by WHO in the course of the Pandemic Influenza Preparedness Inter-Governmental Meeting have discussed the large US viruscollection system that parallels the GISN, much less explained the relationships between the two.

Nevertheless, the purpose of the US military system does not wholly coincide with WHO's public health ends, and its activities at times do not appear to be compatible with most proposals for a revised WHO GISN virus and benefit sharing system.

The massive US military virus collection system, which parallels the WHO system yet does not currently operate under the same rules, creates an additional complication for diplomats seeking an agreement on virus and benefit sharing. Its extent and different purposes than the WHO system may also be of concern to some countries, particularly because WHO system virus sharing is for public health and not military purposes.

Efforts should be made to ensure that all virus collection and transfers take place within the WHO system, using a WHO material transfer agreement, and that virus collections for purposes other than public health not be permitted.

(* Edward Hammond is an independent researcher and an expert on patents and biological resources. He contributed this article to SUNS.)

Statement on the U.S. Biodefense Program from Communities Living in its Shadow

2008-09-21T09:09:00.000-07:00

We, the undersigned, face the reality or prospect of federally-funded high containment “biodefense” labs being built and operated in our communities. We all have specific, local health, safety and environmental concerns about these labs existing in our midst. We represent citizen groups from around the U.S., united in our belief that the massive proliferation of “biodefense” laboratories creates a significant threat not just to our communities, but also to our nation, and to our world. We join Biological Weapons Convention non-proliferation experts in concluding that we risk creating a biowarfare arms race with those who do not trust and cannot verify our intentions. The proliferation of these labs makes us all less safe.

Since the August 2008 revelations about the 2001 anthrax letters originating from within the premier U.S. “biodefense” lab, it has become tragically clear that Congress must move quickly to investigate the nation’s “biodefense” programs.

We have many concerns about the proliferation of bio-safety level 3 and 4 laboratories in federal complexes, and in the hundreds of poorly regulated academic and private sector laboratories around the country.

 In each of our communities, we have found that environmental impacts and hazards associated with these labs have not been analyzed with thoroughness, clarity and scientific rigor. It is not possible to mitigate unacknowledged risks.

 Our experience is that State and local governments have not been well integrated into lab planning and operations.

 We are concerned about the threats associated with genetically modified pathogens and dual-use research.

 We are most concerned about supposedly “low-probability” but “high-consequence” accidents that could result in a public health disaster.

 Now we also know that the possibility of internal sabotage is quite real. We have been told officially that both the “weaponized” anthrax and the perpetrator of the only bio-terror attack in our history came from within the U.S. “biodefense” program.

 We are sobered by the fact that since the anthrax letter attacks, the number of workers in these labs has grown from a small number to over 16,000; laboratory space has grown tenfold.

 Numerous laboratory accidents have been reported. It is plain that many others go unreported, as demonstrated by the unreported accidents discovered by non-governmental watchdog groups.

 It has become clear that laboratory regulation and oversight are poor.

 Transparency has been lacking.

 The GAO and others, such as the Sunshine Project, report that safety programs and protocols are inadequate and have not been followed with consistency and rigor.

Since 2001, “biodefense” funding has provided a $57 billion economic boon, much of it for the private sector. “Biodefense” programs are spread among many federal departments, but are frequently duplicative and poorly coordinated. We have seen no evidence of an integrated federal policy, still less one openly debated by Congress.

Congress must investigate current research and development priorities, funding levels and research requirements in relation to verifiable threats to human and livestock health. Our country needs a fact-based assessment of biological threats, both natural and man-made.

In 2005, more than 750 scientists, including Nobel Prize-winners, decried the diversion of funds to “biodefense” programs away from vital and pressing human health research of broad applicability.

We are aware that intense debate is taking place within the scientific community about whether or not much of the new “biodefense” research is relevant to or would be effective in protecting the population against a biological attack. At the same time, funding has been cut for local preparedness against potential natural or lab-generated outbreaks. These issues are equally present in the debates taking place about the enormous high-containment agricultural research laboratory complexes proposed for some of our communities.

The size and research agenda of the U.S. “biodefense” program has become out of control in the wake of the 2001 anthrax letters. Who decided it was an acceptable risk to genetically re-create and work with the formerly extinct 1918 flu virus, no matter how interesting that research may be? There are far too many comparable examples.

We need a national moratorium on “biodefense” research and, simultaneously, a serious and transparent reevaluation of the big picture. We need a great many more answers before our government pours yet more money into these programs and creates new public health risks and international strain.

Consistent with standard procedures for other federal science programs that pose potential threats to health and safety, we call upon our elected representatives to:

 Conduct a thorough independent investigation of the executive policies that have driven the unprecedented expansion of “biodefense” research and development since 2001; and

 Call an immediate halt to development of new “biodefense” facilities and an operational stand-down of existing programs until the many serious questions have been resolved, including those related to:

- public safety,
- biosafety and biosurety compliance,
- laboratory regulation,
- research focus,
- select agent use and control,
- dual-use research,
- a right-sized program and
- appropriate locations for high containment laboratories.

Signed September 17, 2008:

Organization Contact LAB

Boston Coalition to Stop the BioTerror Lab
Klare Allen, Lead Organizer
Safety Net, Roxbury MA
safetynetrox@yahoo.com

Dr. Vicky Steinitz, Co-coordinator of the Greater Boston Committee of the
Coalition to Stop the BioTerror Lab,
www.Stopthebiolab.org

Angela Kelly
Massachusetts Peace Action, Cambridge, MA
members@masspeaceaction.org
www.masspeaceaction.org

Claire Gosselin, Co-Chair, Women’s International League for Peace & Freedom, Greater Boston Branch
http://boston.wilpf.org

Mike Prokosch
Dorchester People for Peace

Tony Palomba, President
Ernesta Kraczkiewicz, Planning Committee Member
Watertown Citizens for Environmental Safety
Watertown, Massachusetts
wces@rcn.com
http://www.watertowncitizens.org

Duncan McFarland
United for Justice with Peace
UJPCoalition@gmail.com/ www.justicewithpeace.org
Boston University, NEIDL; BSL-4 and BSL-3 Labs (NIH)
Boston, MA

Ellen Browne
Grafton, MA Cummings School of Veterinary Medicine,
Tufts University, Grafton, MA
BSL-3 labs, BSL-4 ready (NIH)

Frederick Citizens for Bio-lab Safety
Beth Willis
National Interagency Biodefense Campus, Fort Detrick;
BSL-4 and BSL-3 labs (USAMRIID, DHS, NIH) Frederick, MD

Granville Non-Violent Action Team (GNAT)
Kathryn Spann
admin@nobio.org
www.nobio.org
NBAF, proposed site at Butner, North Carolina; BSL-4 and BSL-3 labs (DHS)

No NBAF in Kansas
Dr. Thomas R. Manney, Chair of No NBAF, and Professor Emeritus, Department of Physics and Division of Biology, Kansas State University
www.nonbaf.wordpress.com
NBAF, proposed site at Manhattan, Kansas, at Kansas State University; BSL-4 and BSL-3 labs (DHS)

Mid-Missouri Branch of WILPF, (No NABAF in Columbia, MO)
Therese Folsom
Columbia, MO 65203
University of MO, BSL-3 lab; and formerly proposed site for NBAF, Columbia, MO (NIH)

Tri-Valley Cares
Marylia Kelley, Executive Director
Robert Schwartz, Staff Attorney
marylia@earthlink.net
www.trivalleycares.org
BSL-3 facility at Lawrence Livermore National Laboratory, Livermore, CA (DHS)

Labwatch - Seattle, WA
Mike McCormick
nobioterrorlab@yahoo.com - www.labwatch.org
WWAMI Regional Center of Excellence for Biodefense and Emerging Infectious Disease, Seattle, Washington, BSL-3 labs (NIH)

Labwatch 2007 Year-end Wrap-up

2008-01-01T09:54:00.000-08:00

Time for a wrap-up of the past years biolab related news. Below are the
major themes that emerged this year with related article links.

U.W. on probation
In February in anticipation of documents being released to the public,
the University of Washington leaked to the press that their animal
research programs had been put on probation during November of
the previous year. The nine page report listed numerous violations,
many stemming from the UW’s lack of maintenance dating back more
than 20 years. Additionally the report identified a lack of internal
oversight of the UW's Institutional Animal Care and Use Committee
(IACUC).

UW on probation for animal lab violations - Seattle PI 02/13/07
"Serious deficiencies" in UW's animal care - Seattle Times 02/13/07
Animal Testing: Increase oversight - Seattle PI 02/15/07

Labs being built in SLU at record pace
While local papers discuss businesses like Amazon moving to South Lake
Union, they choose to downplay that more high-containment biolabs are
being built next door to the neighborhoods condos and grocery stores.

Biotech projects spring to life - Puget Sound Business Journal 01/19/07
Betting on biotech adding more room - Seattle Times 04/24/07
Water gushes in South Lake Union area after road crew breaks main -
Seattle Times 04/25/07
Developer buys Cascade block for $22 million - Seattle-PI 05/10/07
Children's Hospital eyes South Lake Union site for $40M - Seattle
Business Journal 05/11/07
Growth spurt for Children's - Seattle Times 05/18/07
Children's Hospital acquires Denny Triangle tower - Seattle Times
12/27/07

Citizen opposition to biolabs spreading across U.S.
Across the U.S. citizen groups are forming in opposition to existing and
proposed biolabs. From Boston to Berkeley and Seattle to Durham,
citizens are organizing vocal opposition to building dangerous labs in
their communities.

City Objects to BU Biolab Building Harvard Crimson 01/10/07
Biolab security issues gain attention at coffee - Tonganoxie Mirror
02/21/07
Dunn says ‘No’ to facility - The Badger Herald 04/25/07
In-Depth: Not in Dunn’s backyard - Badger Herald 05/03/07
Biotech protest draws modest turnout - Boston Globe 05/07/07
Boston Residents Face to Face with Bio-War - Inter Press Service
05/15/07
UW, town in tiff over lab turf - Milwaukee Journal Sentinel 05/21/07
Cattlemen end support for biolab - The Missourian 07/03/07
Detrick opponents call for end to growth - Frederick News Post 08/26/07
Judge's remarks irk BU biolab opponents - Boston Globe 09/06/07
Some sure, some not, of lab's safety - Athens Banner-Herald 09/15/07
Residents Voice Concerns Over Bio-Defense Lab - WRAL Raleigh 09/18/07
Hundreds turn out for BioLab hearing - South End News Boston 09/20/07
The battle against the bio-lab - Independent Weekly 10/10/07
Biolab faces new scrutiny from state - Boston Globe 10/14/07
Facing down 'big dogs' on NBAF site - Athens Banner-Herald 10/14/07
Scientists spar at BioLab hearing - South End News Boston 10/25/07
Group Demands Full Report on Impact of Livermore Lab Bioterrorism
Research Facility - The Daily Californian 11/01/07
Biolab protest creates horrific scene - The Daily Free Press Boston 11/08/07
Biodefense lab causing qualms - Baltimore Sun 11/19/07
Public discusses Fort Detrick lab expansion - Frederick News Post 11/20/07
Commissioners split on Detrick review - Frederick News Post 11/28/07
Experts 'Fail' Risk Analysis for Boston Bioterror Lab - Washington Post 11/29/07
US review of BU biolab inadequate, panel finds - Boston Globe 11/30/07
Menino says biolab ’will go forward’ - Boston Globe 12/12/07
SJC upholds biolab ruling requiring further environmental review -
Boston Globe 12/13/07
Ruling may stall opening of biolab - Boston Globe 12/14/07
Not sound, not credible - Frederick News Post 12/17/07
Butner lab foes step up efforts - The News & Observer 12/18/07
Biolab protesters appeal to Durham - The Durham News 12/22/07
Doctors Take Different Stances on Biodefense Lab in Butner -
WRAL Raleigh, NC 12/25/07

Texas A&M Biodefense program shut down (for now)
In July Texas A&M had their biodefense program shut down by the CDC
for a long list of previously unreported violations. Documents dug up by
The Sunshine Project (www.sunshine-project.org) and released to the
public revealed multiple exposures to lab personnel over a period of
four years. This marks the first time that a federally funded biodefense
program has been shut down by CDC.

A&M faces inquiry over brucella infection - The Eagle 04/18/07
A&M under investigation after disease transmission - The Batt 04/24/07
CDC probes A&M bioweapons infections - Dallas Morning News 06/27/07
CDC investigates A&M - The Battalion 06/28/07
CDC suspends A&M research on infectious diseases -
Dallas Morning News 07/01/07
A&M admits errors in bioagent case - Dallas Morning News 07/03/07
A&M lab employee lacked clearance in bioagent case -
Dallas Morning News 07/28/07
Texas A&M admits violating rule - Bryan-College Station Eagle 07/28/07
A&M research chief steps down amid bioagent lab furor -
Dallas Morning News 08/01/07
CDC reprimands Texas A&M over lab safety - Dallas Morning News 09/04/07
CDC finds breaches at A&M disease lab - Houston Chronicle 09/05/07
A&M biosafety director resigns in wake of CDC report -
Dallas Morning News 09/05/07
Second Texas A&M research official resigns amid biosafety report -
Dallas Morning News 09/06/07
A&M chief vows to fix lab troubles - Houston Chronicle 09/07/07
Until this year, CDC missed worst of A&M lab problems -
Dallas Morning News 09/25/07
Ex-Texas A&M head of biodefense research, Richard Ewing, dead at 61
- Dallas Morning News 12/06/07
A&M unsure when federal ban on its biodefense research will be lifted -
Dallas Morning News 12/27/07
A&M biodefense work still banned - Houston Chronicle 12/28/07

Accidents much worse than previously reported
An investigation by the Associated Press revealed in October that U.S.
biolabs had more than 100 accidents and missing shipments since 2003,
and that numbers were increasing steadily as more labs began biodefense
work.

U.S. labs mishandling deadly germs - Associated Press 10/02/07
Mishandled Germs - Associated Press 10/02/07

Congress holds hearing on biolab proliferation
In response to the U.S. biolab building boom combined with the unreported
lab accidents and mishaps, Congress held hearings in November.

House panel asked to look at biowar labs - UPI 07/31/07
Biosafety lapses prompt govt. review - The Scientist 09/25/07
No snap inspections at high-level germ labs - Associated Press 10/04/07
U.S. Called Lax at Policing Labs Handling Biohazards - New York Times 10/05/07

Proposed regulations for Seattle biolabs
In 2005 the Northeast District Council recommended that the City of
Seattle establish citizen oversight of existing labs. In response we now
have a proposed set of regulations for biolabs, based on those successfully
adopted in Boston.

http://labwatch.org/docs/seattlebioregs.pdf

What can you do?
Your individual support can be the difference between a city filled
with unregulated high-containment biolabs versus a city where citizens
make the decisions that affect their health and safety. Though regulations
are not the end-all solution to neighborhoods dealing with potentially
hazardous facilities, we believe it’s an important first step in bringing back
citizen oversight and control to our community. Please ask groups you
belong to (especially neighborhood councils) to endorse our proposed
regulations.

University of Washington on Probation

2007-02-25T21:48:00.000-08:00

Earlier this month the UW made the news when they were put on
probation by AAALAC (Association for Assessment and Accreditation
of Laboratory Animal Care) for not maintaining their animal research
facilities and not exercising proper oversight over animal research
experiments. Though extensive review of UW documents is ongoing,
here are some highlights from the nine page report that was released
to select local media in mid February 2007.

The report focused on the IACUC (Institutional Animal Care and Use
Committee), the oversight group for animal research at the University
of Washington. Basically they are the “police” for animal research.
Their two primary tasks are to review protocols (research
experiments) and to inspect animal research facilities at the UW. As
such, items in the report focused on UW facilities and areas where
the IACUC failed to do its job.

Under the category of facilities and what should have been identified
during regular IACUC inspections, the report states;

“Serious deficiencies that had the potential to negatively impact the
health, well-being, and safety of animals and humans were not being
identified during the facility evaluations.” (p. 2)

“Deficiencies that were identified were not classified as significant or
minor, and no time frame for corrections were detailed.” (p. 2)

“none of the laboratories where animals were housed had emergency
power or environmental alarms.” (p. 3)

“The primate center had no mechanism in place for alerting key staff
members and eliciting a response if there was an HVAC failure.” (p. 7)

“There was no after hours mechanism for monitoring heating,
ventilation, and air conditioning system performance in Guthrie,
Hitchcock, Kincaid, Fish Teaching Research Facilities (as well as
the campus based WaNPRC mentioned above) and alerting
personnel to malfunctions.” (p. 7)

Questionable procedures within the labs were also cited;

“In a number of laboratories, personnel areas (e.g., refrigerator for
food, employee workstations) were immediately adjacent to and/or
intermingled with animal housing and procedural areas and personal
vehicles were used to transport mice.” (p. 5)

“At the Western Primate Facility, one hallway located outside of Room
124 (office), 125 (break room), and 115 (dirty cage wash) was divided
by a taped line. One side of the line was considered a Biosafety Level
(BSL) 2 nonhuman primate area requiring full personal protective
equipment (PPE). The other side of the taped line was used by
personnel to enter offices and a shared break room. No PPE was
required on this side of the taped line. Personnel that were passing
through the hallway to the break room without the benefit of PPE
were exposed to SHIV-infected nonhuman primates and dirty
nonhuman primate cages that were transported in the same hallway.
Other than a taped line on the floor demarking entrance to a BSL-2
area, there was no physical separation between SHIV-infected
monkeys and personnel carrying their lunches to the break area.”
(p. 4)
(Authors note - This is the same facility that was going to be
upgraded for work on the 1918 influenza virus (currently being
worked on at other facilities). Due to numerous problems Western
has yet to begin work on the upgrade that began in 2003).

“At the time of the site visit, there was no pre-employment medical
evaluation, or ongoing evaluations, for those employees who were
subject to substantial risk in the animal care and use program, such
as employees of the Department of Comparative Medicine who would
be routinely exposed to allergens in ergonomic inquiries.”(p. 5)

Finally, the UW IACUC itself was cited for numerous problems with it’s
lack of process, objectivity and transparency;

“Out of approximately 250 new/renewed protocols submitted each
year, approximately 1 - 3% of the protocols were brought up for full
Committee review.” (p. 8)

“The vast majority of protocols were reviewed by four permanent
designated reviewers. Of these individuals, 3.5 were funded through
the Office of Animal Welfare with three of those members having
performance evaluations made by the Director of the University’s
Office of Animal Welfare. Given their salary source, these reviewers
could be perceived as having a conflict of interest impeding their
ability to perform unbiased protocol reviews.” (p. 8)

“The participation of the nonaffiliated member of the IACUC in protocol
or programmatic review process was not readily apparent and/or
adequately recorded for many of the protocols or semiannual facility
reviews evaluated by the site team. Chronic nonattendance by IACUC
members, especially those explicitly required by Public Health Service
(PHS) Policy or U.S. Department of Agriculture Animal Welfare
Regulations (AWRs), implies a lack of participation in the oversight
responsibilities of the IACUC.” (p. 4)

“Minutes of the IACUC meetings did not reflect actual content of
discussions regarding full Committee reviews of protocols or
programmatic deficiencies.” (p. 8)

At this point in time, the UW has until May 1, 2007 to demonstrate to
AAALAC how it proposes to fix the problems cited in the report. It
should be noted that the UW received the report on November 1, 2006
and only choose to release the information to the public in February
2007 in anticipation of FOIA document releases to PETA and Labwatch.
Had citizen organizations not made those requests, it is reasonable to
assume the University of Washington would never had informed the
public.

Labwatch End of Year Update

2007-01-08T16:49:00.000-08:00

As 2006 comes to a close and we begin 2007, it appears that Seattle
will never have to worry about a shortage of BSL-3 labs in our
neighborhoods.

As of this writing and yet to be added to the labwatch.org map are
a total of six more labs. Three are already existing labs, two that are
under construction and one additional already existing lab that needs
to be confirmed. The three already existing labs are Zymogenetics in
SLU, the Western Fisheries Research Center at Magnuson Park, and
the Roosevelt Commons on the 4300 block of Roosevelt Ave. In
addition, there are two being built in SLU, one at 815 Mercer by Paul
Allen for the UW and another being built on Mercer by a private
corporation. The final holdout is the newly acquired Childrens
facility at 1900 9^th Ave.

Back in May we reported that a BSL-3 lab at UW had been shut
down due to faulty air circulation and that early estimates were
$1 million in repairs before it would be back up and running.
Current estimates are over $1.8 M with no report yet on when
the lab will be functional again.

Also in May we reported that more than half-a-dozen UW
scientists working at a new lab on Mercer had "initiated their
studies without getting final approval and without having the
appropriate biosafety cabinets, the appropriate rooms, the
appropriate education, the appropriate paperwork on file and
without the appropriate waste stream". What we didn’t know
then but have since found out is that the UW never reported
these violations to any State or Federal authorities even
though the chair of their Biosafety Committee was calling for
just that. So much for institutional oversight.

And finally it appears that the most dangerous aspects of the
1918 influenza experiments the UW planned for the Western
Ave. Primate Center have for the time being been moved to a
community less demanding of citizen oversight. Several
internal emails indicate Michael Katze was unhappy with the
slow progress of the upgrade at the Western Ave. facility
and has found a new home for that work at the Battelle labs
in Ohio. It should be noted that earlier this week the Dept.
of Homeland Security announced that Battelle will be
running the new Biodefense Analysis Center at Fort Detrick.
Score another one for the military contractors.

And on that happy note, looking forward to a more
democratic and active year in 2007!

Why Worry About Bird Flu When We Are Bringing The 1918 Influenza To Town?

2006-09-29T18:04:00.000-07:00

Seattle reached another milestone this week. From the Seattle-PI to
the BBC, corporate media reported that the UW has been working
with tissues from mice infected with the 1918 influenza virus and
versions of the influenza virus specially engineered to include
segments from the 1918 strain. It appears that some of the
experiments in question took place in South Lake Union.

Though working with the entire 1918 influenza virus should require
a BSL-4 lab (that work being done at the CDC), working with infected
tissues and the man-made strain appears to only require BSL-3
facilities and the UW has at least two such labs now in South Lake
Union. Since the research grant on 1918 influenza was awarded to
Michael Katze and since the Katze labs are located at the Rosen
Building (a designated BSL-3 facility) it’s safe to say that the
experiments reported this week took place at that facility.

Though this particular phase of research is not nearly as dangerous
future phases that involve aerosolizing the virus on live monkeys
(slated to happen at the Primate Center in Belltown), it is none-the-less
dangerous to those working at Rosen and therefore merits community
concern.

Just another indicator that Seattle needs citizen oversight and lab
regulation.

Labwatch.org Update 07/24/06

2006-07-24T16:59:00.000-07:00

Last week Tufts University was fined by OSHA for an accident
involving botulinum toxin that had occurred on April 5, 2006.
The accident involved a cracked test tube in a centrifuge (a
fairly common accident in labs). Though five lab workers tested
negative for the toxin, investigators found that Tufts had
violated the experiments protocols, improper use of protective
equipment, lack of personnel training regarding lab equipment,
safety, and emergency response procedures. It should be noted
that Tufts is attempting to build a new BSL-3 laboratory in the
nearby community of Grafton, a project opposed by Grafton
residents.

In related press release today, the DHHS Office of Inspector
General has issued a report "Summary Report on Universities'
Compliance With Select Agent Regulations" that looked at 15
universities working with bioweapons agents. The report found
that 11 of 15 universities were not in compliance with bioweapons
agents security regulations in at least one of five areas, five were
not in compliance in at least three of five areas, and one was not
in compliance in five of five areas. "Due to the sensitivity of the
issues" the names of the universities will not be released to the
public.

Labwatch.org Update 07/14/06

2006-07-14T18:47:00.000-07:00

It’s been a while since I’ve sent an update so I thought I’d better send
something so you don’t think I was run over by a car (as my Mom likes
to say).

First off, no headway in reversing the decision to ban recording of IBC
meetings. Counsel for the UW reviewed the authorization and function
of the UW Institutional Biosafety Committee (IBC). UW's counsel
concluded that, in counsel's opinion, the IBC is not subject to the Open
Public Meetings Act. With respect to recording the proceedings of
public meetings of the IBC, it has decided that when the public is
allowed to attend, then audio taping will not be allowed. Apparently,
some of the volunteer IBC members felt that they would feel inhibited
in discussing certain issues if the meetings were tape recorded.

Meanwhile BSL-3 expansion continues in South Lake Union with the
UW breaking ground on a new lab at 815 Mercer in June of this year.
The building’s 100,000 sq. ft. of lab space will be slightly less than
double the size of the proposed Regional Biocontainment Laboratory
that citizens had successfully opposed on the UW campus in 2005.

In other news, it appears that a local biotech industry front group
is leading the charge in opposing citizen efforts of lab oversight.
In documents recently received from the UW through an FOIA
request, Susan Adler, Executive Director of the Northwest
Association for Biomedical Research sent out an email to her
industry listserv titled "Blurring of Lines Among Activist Groups"
that included "Last week, a new website came into our radar -
www.labwatch.org. Click on it and you will see pictures and
maps of Biosafety Level 3 Labs that the webmaster believes
are operating in the Puget Sound. We have learned that
Mike McCormack, who created this site, is a Seattle based
community activist who has repeatedly inundated UW with
Freedom of Information Act request about its BSL-3 Labs.
These communications are disturbing because they point to
a new blending of people who are now connecting
misinformation about select agents along with animal rights
and ego ideologues." (If you’d like to see a complete copy of
the email, drop me a line).

Beyond wondering what an "ego ideologue" must be (we are
pretty sure she must have meant "eco ideologue") it’s nice to
note that when it comes to university research, industry front
groups, and the biotech corporations they serve, there definitely
is no blurring of lines (they are all on the same side).

Lastly it was reported yesterday that a baboon had escaped and
was eventually recaptured from the Southwest Foundation for
Biomedical Research (not to be confused with NWABR mentioned
above). SFBR is a large private biodefense facility in San Antonio
with a BSL-4 lab and a questionable history when it comes to
dangerous pathogens. This incident again highlights the fact that
research monkeys regularly escape from research facilities (see
the Sunshine Projects Biosafety Bites #14 June 6, 2006 at
www.sunshine-project.org).

All for now.

Mike McCormick

www.labwatch.org

UW Losing Accountability

2006-05-20T18:01:00.000-07:00

I was saddened to discover this week that I'd completely missed this
months UW Institutional Biosafety Committee (IBC) meeting. I say
this months but since the meetings really only happen a few times
per year, if you miss one you find yourself waiting a long time until
the next one (the next scheduled meeting is in September). I thought
I'd find consolation in the fact that I could obtain an audio copy of
the meeting but discovered that as of the May meeting, the UW
will no longer make audio recordings.

That's bad news for a lot of reasons, not the least of which is public
oversight. The UW IBC meetings have been recorded for years,
"something they were doing when I took over" according to
Susan Alexander of EH&S. EH&S had them recorded so they
could later use the audio to make more accurate meeting minutes.
So why the change? Susan says it was because the AG
(Attorney General) found out they'd been recording the meetings
and said they had to stop because the UW didn't have permission
from the individuals involved.

Really? So what's the big deal with asking permission of the
participants? It's not like one doesn't know (as in a phone
conversation) if one is being recorded since there are four large
microphones sitting on the table when one arrives at the meeting.
How hard would it be to verbally ask participants at the beginning
of the meeting when, say, they are being asked "did everyone
receive a copy of the last meeting minutes?" or "is there is anything
anyone would like to add to the agenda" to ask "is there is anyone
who objects to audio recording the meeting"?

And since when are meetings that are held at public institutions,
attended by public employees, doing the publics business (and
in this case overseeing public safety) off limits to electronic
recordings? I understand the concept of if there are portions of
meetings where for reasons of security or proprietary information
that the public be excluded but that's not the case here.

And it's not just that the UW isn't going to record the meetings,
the public won't be allowed to record them either. That's important
to note. I'd gotten permission to videotape the January IBC meeting
and was prepared to do so but didn't exercise my right when I saw
that a sufficient audio recording was being made of that meeting.
I later obtained a copy through the UWs Office of Open Records
and Public Meetings and it is this act that I believe began the ball
rolling towards where we are now. I did the crazy thing of taking a
recording of an open meeting and putting both the audio and a
transcript of the same up on the internet for the public to access.
It's something I think all public institutions should do automatically
(without being asked) but very few do. From that transcript I later
sent out a press release pointing out some disturbing incidents that
had been brought up at the January IBC meeting. As a concerned
citizen I felt it was important to report to the public what the UW
was doing (since clearly no one else was) with regard to biosafety
issues and their potential impacts on public health and our economy.

To that end, I hope that people will support keeping the UW IBC
meetings open to all and allowing both EH&S and the public to
record them.

Thanks,

Mike McCormick
Labwatch.org

Interview about UW Violations with Test Animals

2006-05-13T16:20:00.000-07:00

Click on photo to watch interview

Interview with Dr. Debra Durham, Primatologist with PETA
Given Friday April 28, 2006 at a protest at the WaNPRC,
UW Western Avenue Primate Facility in Belltown

Mike McCormick: Tell me your name and what brings you out here today?

Debra Durham: My name is Dr. Debra Durham and I’m a Primatologist
with PETA and I’m here to let people know about the abuse of animals
at the University of Washington.

MM: And why have you singled out this particular facility?

DD: We’ve singled out this facility here on Western Avenue because it’s
a facility that tests very dangerous pathogens in monkeys and the abuses
here are particularly egregious. One of the most disturbing incidents we
learned of at this facility involved exsanguination practices that were
completely unauthorized. They were a violation of guidelines established
by the Office of Laboratory Animal Welfare and in these procedures
multiple monkeys were subjected to them. They were essentially blood
letted until they were on the verge of death. The animals were gasping for
air, in cardiac distress and going into shock. And the researchers would
simply take as much blood as they could before the animal died. They
would keep them alive and do it again the next week. And these were
entirely unauthorized procedures. And we’re horrified that the University
of Washington would let activities like this go unpunished. The individual
who was actually in charge of these experiments is a member of the
University's Institutional Animal Care and Use Committee, the committee
that’s supposed to have oversight of animal experiments at the University
of Washington. And we’re horrified that a man would do this is given
authority and oversight over animal activities.

MM: Now did you find that this was an anomaly or is this the norm for
this facility and/or the University itself?

DD: Unauthorized procedures are amazingly frequent at the University
of Washington. We have dozens of instances that involve unauthorized
surgeries, use of unauthorized drugs, use of unauthorized studies and it’s
actually shocking how frequent this is. And these violations range from
using animals without permission to killing them without permission.
And sometimes they can’t even get that right. There were several
instances where animals were supposedly euthanized and put in a
dead animal freezer and people later found them to be alive. And
this is really, really appalling.

MM: And how does the University and this facility compare to other
universities and facilities?

DD: I find the violations here at the University of Washington particularly
egregious. There are facilities that have more USDA violations than the
University of Washington but those aren’t facilities with as much money
as the UW. The UW receives the second most money in public health
service funds of any U.S. institution, second only to Harvard. So to have
these violations at an institution that receives so much government support
I think makes it especially troubling.

MM: So what, based on your knowledge, what would have been the
proper response to, for instance, the experiment you first talked about,
where they bloodlet the animals to such a degree?

DD: Well clearly that individual should not have permission to work with
animals. They were given permission to take 10 ml per kilogram of weight
each week and that’s an extraordinary amount of blood. So for example,
a person can donate a pint of blood every two months and if a person was
put on this regimen they would have six liters of blood taken out in that
same period. It would prove very, very lethal for people to be involved
in this procedure. And to think that someone could violate even that level
and then continue to have permission to use animals and actually have
authority to give other people permission to use animals is shocking. I
think the individuals involved should have been suspended and have their
authority to use animals permanently revoked because they are killing
animals. {editors note - the violation was for the bloodletting, not the
killing}.They represent an extreme threat to their very lives. At the very
least they should have disclosed the fact that these violations are taking
place and the University definitely doesn’t. All of these things happen
under wraps and they’re just hoping people don’t notice and that they
continue to do more and more deadly experiments here in our backyard.

MM: What oversight mechanisms are currently in place and what oversight
mechanisms would you like to see in place?

DD: The current oversight mechanism is the Institutional Animal Care and
Use Committee, which is a committee that’s mandated by the Animal
Welfare Act, which is enforced by the United States Department of
Agriculture, in terms of giving permission for animal experiments at the
University of Washington. This committee obviously doesn’t do much
given the dozens of violations that take place at the UW, and their very
severe nature. I honestly don’t think there’s any oversight that could be
good enough to manage animal experiments because I don’t believe
animals are ours to exploit in experimentation. But while that is legal and
while we continue to work to change that, the minimum protections should
involve oversight by groups that include animal protectionists. People like
me, people from organizations like PETA and NARN for example here
locally, who would actually be advocates for the animals and have authority
to say no, this experiment is too painful, no this experiment is useless, no
this experiment is duplicating prior work, because right now the AWA
does not have authority to do that. They do not deny permission to do
any experiment no matter how painful, no matter how deadly it might be
and that’s something that has to change.

MM: So when a particular scientist is found to have, you know,
committed a violation, does that then go on a record, their record
of some sort?

DD: Violations are almost always responded to with what’s called
a letter-of-counsel, which is simply a letter from the IACUC to the
investigator that describes the offense and tells them not to do it again.
And that letter does become part of their University of Washington
record, in terms of their permissions to do animal experiments. So
once someone has committed a violation, the next time they ask for
permission to do experiments, the Committee could see the fact that
they had a violation before, however this is not part of their personnel
record, and there’s no federal database such that as if someone commits
a violation here at the University of Washington and leaves and goes to
join the faculty at Harvard, their history of animal abuse and violations
does not follow them. And they can continue to commit abuse at other
institutions. And that’s sometimes the case that a problem employee will
go from place to place until they’re sort of shot out by disciplinary action.
And it just sort of creates a perpetual problem in terms of animal abuse.
And this is with investigators, with veterinary staff and with technician
level staff that are used in animal care operations.

MM: So it sounds like we really need a national database to keep track
of all this?

DD: A registry of offenses by individual investigators and by institution
so that its easy to find out when violations have taken place and activist
groups don’t have to spend months making Freedom of Information Act
requests to find out what kind of abuses are taking place. University
should be forthright about what’s happening and forthright the disciplinary
actions that are taken.

MM: How can people find out more about these issues?

DD: People can find out more about these issues by visiting Stop Animal
Tests Dot Com. And there’s lots of information about the abuse of animals
in laboratories and alternative methods that do not involve animals. So
there are scientists that are using progressive methods that are non animal
based.

MM: All right, thank you.

DD: Thank you.

UW Plagued by Biosafety Problems

2006-05-02T15:05:00.000-07:00

UW Plagued by Biosafety Problems

Seattle, WA 05/02/06 - Less than a year after the University
of Washington withdrew a request for federal funding for a
high security biodefense lab, recently released transcripts reveal
systemic safety problems at several UW biosafety labs.

At the January 2006 meeting of the UW Institutional Biosafety
Committee, members discussed multiple safety lapses that
included both procedural and equipment failures.

At least six and possibly more than a dozen scientists ("PIs" or
"Principal Investigators") working at a biosafety lab in South Lake
Union disregarded SOPs (standard operating procedures) on
assigned work with biohazardous agents.

The PIs "initiated their studies without getting final approval and
without having the appropriate biosafety cabinets, the appropriate
rooms, the appropriate education, the appropriate paperwork on
file and without the appropriate waste stream," according to David
Emery, Chair of the UW IBC (Institutional Biosafety Committee).
"For the life of me, I can’t figure out exactly what happened here".
(From a transcript of the January 13, 2006 meeting of the UW IBC).
It appears neither of the two oversight groups, Environmental Health
& Safety (EH&S), nor the IBC, upon discovering the violations,
sought to halt the biohazardous work.

In addition, IBC meeting transcripts indicate that a backup air
handling system--a primary laboratory safety component--failed
during a 2005 test at one of the BSL-3 labs located in the UW’s
Health Sciences Building. The incident triggered an immediate
shutdown of the affected labs, and all associated researchers
received medical surveillance. Due to the failure, the UW plans
to begin regularly testing its 30 other BSL-3 labs located
on-campus, in the U-District and in South Lake Union.

Biosafety laboratory concerns are nothing new to Seattle.

*Lab safety was the primary concern raised at public hearings
when the UW proposed building a high-security biodefense
BSL-3 complex on-campus last year. Since then, the Northeast
District Council (NEDC), an organization representing 20
neighborhoods has proposed public oversight of biosafety labs
in Seattle.

*In 2004 three researchers at the IDRI/Corixa BSL-3 labs on
First Hill in Seattle were exposed to TB from a faulty animal
aerosol chamber.

*The UW plans to aerosolize the recreated 1918 influenza virus
on monkeys at BSL-3 labs located in the densely populated
neighborhood of Belltown next year. The 1918 influenza strain
killed an estimated 40 to 100 million people. It currently has no
known cure.

For more info: Mike McCormick 206-525-9998
Labwatch Seattle www.labwatch.org

Why the BU Lab is Not Important or Needed in Boston

2006-04-02T13:29:00.000-07:00

Why the BU Lab is Not Important or Needed in Boston

By: Lynn C. Klotz, PhD, Senior Science Fellow,
Center for Arms Control and non Proliferation

The author, a former biotechnology executive,
currently consults on biotechnology and
pharmaceutical strategy to many kinds of business
clients.

Boston University's proposed laboratory complex
is to house a "Biosafety Level" BSL4 laboratory,
the numeral "4" designating the highest level of
biohazard security. (Other levels are BSL3s,
which study pathogens like anthrax for which
there are treatments, and BSL2s, which house
less-threatening infectious disease agents.)
BSL4s experiment only on the most dangerous
disease agents usually not endemic to the US like
the hemorrhagic fever viruses, Ebola and Marburg.
At present, only a very few highly exotic
pathogens qualify for BSL4.

One of Boston University's main arguments for the
BSL4 is that it is vital to Boston's economy and
bioscience communities - these composed of major
pharmaceutical companies, biotechnology
companies, and academic and other non commercial
labs. I don't believe BU's claim. Of the ten or
so major pharmaceutical company facilities, the
more than 200 biotechnology companies, and
hundreds of infectious- disease non-commercial
research labs in Massachusetts, perhaps only a
handful will ever use the BSL4 lab at Boston
University. Indeed, failure to build the BSL4
will cause at most a hiccup in the area’s
bioscience industry.

To understand why this is so, consider the major
international disease threats that won't be
studied at the BSL4: malaria, HIV/AIDS, and
tuberculosis. All three require only BSL2 level
containment since they are already present in the
population and there’s no need to protect the
public from exposure to them from escape from the
laboratory. The same is true for the vast
majority of infectious disease agents endemic to
the U.S. The deadly 1957 and 1968 influenza
strains require only BSL3 containment, even
though they are not currently present in the
population. The recently resurrected pandemic 
1918 strain requires containment between BSL3 and 
BSL4 (though it should require BSL4 containment.)

A closer look at the different parts of the
Massachusetts bioscience community reveals why
the Boston University BSL4 would be - at very
best - redundant, as there are already four BSL4s
elsewhere in the country.

Major pharmacetical companies

The modern pharmaceutical industry, composed of
the 40-odd companies comprising the member list
of the Pharmaceutical Research and Manufacturers
Association, cut its teeth on antibiotic
development in the 1950s and 1960s. They had
considerable expertise in developing
"countermeasures" - biodefense language for
antibiotics, antivirals, vaccines and other such
agents - against natural disease. But lately it
has been far more profitable for companies to
drift away from antibiotic development, focusing
instead on drugs for chronic conditions like high
cholesterol and depression. Sold over and over
again to patients, these drugs have sales of well
over an annual $1 billion. By contrast,
biodefense "countermeasure" sales will usually be
one-time sales to the Strategic National
Stockpile only representing a few hundred million
dollars at most.

There are other reasons why the companies are
unlikely to make use of the BU facility for
biodefense research:

Liability: Concerns over law suits from possible
use of non FDA approved drugs during emergencies.

Damage to their reputations: Concerns over
sickness or death from use of drugs, FDA-approved
or not, in false-alarm emergencies. The industry
likely would not want to see untested drugs used
at all.

Bad publicity: Working with biological weapons
agents, for whatever reason, makes for bad
publicity. The US public and our enemies, often
suspicious of the industry’s motives, could
mistake defensive research for offensive
bioweapons development. The industry stresses
that “Disease is our enemy. Working to save lives
is our job.”

Increased inspections and oversight: The industry
already feels over-inspected by the government.
Possession and work with biological weapons
agents will require considerable paper work,
security clearances, and oversight by the
government. In any mishap, an FBI investigation
could result – for a company, to be avoided at
all costs.

Confidentiality: Pharmaceutical companies are
secretive; they dislike any disclosure they deem
inappropriate or premature. So a company is
unlikely to be attracted by a facility located in
a context with a large population of students
with no financial stake in their company. The
inability to guarantee confidentiality will be a
disincentive to a company.

Here are some additional observations. The
BioShield 2004 legislation provides for the use
of non-FDA- approved countermeasures in an
emergency -- countermeasures that may never have
been tested in humans. The pharmaceutical
industry won’t support any BioShield legislation
when they’re not protected from liability for
harm caused by haphazard use of their drugs. And
while Senator Bill Frist has attached an immunity
clause to a large biodefense bill soon to pass,
it’s unlikely that the immunity provision will
survive very long. Many Congress members have
been putting up stiff resistance to letting major
corporations off the hook by granting them
immunity from lawsuits.

Ebola and the like have no natural incidence in
the US. For a market large enough to catch a
major pharmaceutical company’s interest, a
disease must be prevalent in the population or
highly expensive to maintain patients, diseases
studied in BSL2s not BSL4s. There are plenty of
BSL2s: most laboratories doing infectious disease
research have them. Moreover, for reasons of
confidentiality, major pharmaceutical companies
can easily afford and are likelier to prefer
having their own BSL2 labs.

Biotechnology companies

Biotechnology companies are different from the
forty- odd major pharmaceutical companies: they
have no products on the market and they are
struggling financially. For them, a one-time sale
worth several million dollars to the so-called
Strategic National Stockpile could be attractive.
Some biotechnology companies, drawn to antibiotic
markets, are applying their novel research skills
to infectious disease.

There are about 275 Massachusetts biotech
companies profiled by the Massachusetts
Biotechnology Council [MBC.] Seventeen of these
say they are engaging in research and development
of infectious disease therapies. Only one company
describes itself as conducting defense research
-- developing rapid means of identifying
pathogens. Only three companies identify
themselves as vaccine companies. Of these, only
one, Acambis, is actually developing a
bio-defense vaccine, which is for smallpox. Thus,
from their MBC descriptions, none of the
seventeen companies appears to need a BSL4
facility.

If the Boston University BSL4 laboratory were not
built, perhaps none, but at most only a few of
the 275 Massachusetts biotechnology companies
would be affected. Those few would have to go
elsewhere to do final experiments. Moreover, the
biotechnology industry took root around
universities in Boston and San Francisco, not
around the extant BSL4 facilities in Maryland and
Atlanta. Cambridge has no BSL4 laboratory, and a
law prohibiting rDNA research in BSL4
laboratories, yet that city has a significant
biotechnology company presence.

Academic and other non-commercial labs

There may well be over a hundred academic
laboratories carrying out infectious disease
research in the Boston area. A few quick PubMed
searches using key words such as “filovirus,”
“Ebola,” “Marburg,” “biodefense,” “bioter ror,”
“smallpox,” and the like, yield between 3 and 30
hits for each key word in the Boston-area. A
brief examination of titles and abstracts of the
Pub Med hits reveals that only a few are actual
research papers. Most are commentaries on general
areas like history, policy, and epidemiology.

So there seems to be little academic research
activity in the Boston area that would require a
BSL4 laboratory. Of course, some scientists at BU
and other surrounding universities plan research
in the BSL-4 laboratory. The BU-NIH grant
application to build the facility includes 43
resumes. Some of these came from administrators.
Some were from scientists who could "benefit"
from the lab, others were unclear about how they
would use the lab

A final comment: outbreaks of the filoviruses
which are prominent in the handful of exotic
diseases to be studied in BSL4s, have been
localized on their continent of origin, Africa.
Ebola and Marburg, two of the dreaded hemorrhagic
fever viruses, are among the filoviruses. But
while death from them is horrific, outbreaks
cause deaths in the tens to hundreds, not
millions. Thus they have not represented
international public health threats. Apparently,
they do not pose biological weapon threats to the
US, either. Government biodefense researchers at
USAMRIID have stated that most evidence suggests
they aren’t very stable by aerosol dissemination,
the only mechanism that would make them a
bioweapons threat. Since there are so few of
these agents and existing BSL4 labs are working
on them, a Boston- area laboratory would be
redundant, hardly the necessity its proponents
claim. There is no reason that work on these
agents cannot be carried out in the four existing
BSL4 facilities.

Credits: Thanks to Prof. Daniel Goodenough, Prof.
Patrica Hynes, Dr. Marc Pelletier for important
contributions. Special thanks to Ellen Cantarow
for many rounds of editing.

EPA Seeks Portable Anthrax Aerosolizer

2006-03-31T09:43:00.000-08:00

A--Development of System for Dry Inoculation of Building
Material Coupons

* Synopsis - Posted on Mar 16, 2006

General Information

Document Type:  Sources Sought Notice
Solicitation Number: PR-CI-06-10372
Posted Date:  Mar 01, 2006
Original Response Date: Mar 10, 2006
Current Response Date: Mar 10, 2006
Original Archive Date: Apr 09, 2006
Current Archive Date: Apr 09, 2006
Classification Code: A -- Research & Development
Set Aside:  N/A

Contracting Office Address
Cincinnati Procurement Operations Division 26 W. Martin Luther
King Drive Cincinnati, OH 45268

Description
The U.S. EPA hereby issues this Sources Sought synopsis in
search of any vendor capable to complete a project entitled
?Development of a system for dry inoculation of building
material coupons. THIS IS NOT A REQUEST FOR QUOTATIONS. This
request for information does not commit the Government to pay
any cost incurred in preparation of any submission to this
Sources Sought Notice or to a contract for services. This is
a market survey for written information only, to ascertain
whether the services contemplated for this procurement can
be set aside for small business concerns. The North American
Industry Classification System Code (NAICS) is 541710, the
size standard of which is 500 employees.

The U.S. EPA?s National Homeland Security Research Center
(NHSRC) is currently investigating various decontamination
technologies for high value building materials contaminated
with Bacillus anthracis.  Current on-going studies inoculate
building material coupons using a syringe (liquid droplets).
However, the likely dissemination method for B. anthracis is
aerosol dispersion, thus building materials will be
contaminated by dry deposition. Liquid inoculation may yield
non-comparable decontamination efficacy results to actual
event decontamination efforts for porous materials such as
cinder block and wood.  A system for the dry inoculation of
building material coupons is needed to ensure comparable
efficacy results during decontamination efforts. In response
to the need for reproducibly dosing building material
coupons with dry B. anthracis, the U.S. EPA/NHSRC's
Decontamination and Consequence Management Division (DCMD)
is seeking to develop an aerosol deposition system for use
in the systematic decontamination studies.  The system shall
be able to reproducibly (within 20%) dose coupons with user
defined spore loadings in the range of 102 - 108 spores per
coupon (7 cm2).  The terminal velocities of these spores
shall mimic those expected in an anthrax release.  The
system shall be applicable to all building materials of
interest, specifically: painted and unpainted cinder block,
stainless steel ductwork, industrial carpet, decorative
laminate, ceiling tile, painted wallboard, and glass.  The
system shall be able to dose at least twenty-five 20 mm x
35 mm coupons during a single deposition and the coupons
shall be easy to remove, ensuring minimal disruption of
the deposited particulate matter.  As the B. anthracis
innoculant is limited in availability, the deposition
process must be efficient so as to conserve inocculant.
The deposition system shall be entirely contained to
prevent environmental interference and contamination.
The system shall be both portable and autoclavable.
The performance of the aerosol deposition system shall
be evaluated with a suitable surrogate for B. anthracis
that is 1-3 ?m in diameter.  Uniformity of the aerosol
deposition and reproducibility of coupon dosing shall be
determined using Scanning Electron Microscopy or another
comparable technology.  The ability for the system to
deliver the needed concentrations of the spores to the
building material coupons will be accessed here at the
EPA and if the aerosol delivery system is unable to meet
the specifications listed in the statement of work then
the system shall be modified until it fulfills these
requirements.  Interested parties shall submit capability
statements that demonstrate their experience in this field.
Capability statements shall not exceed 3 pages and standard
company brochures will not be reviewed. Reference
PR-CI-06-10372. Again, this statement is for information
purposes only.  Interested parties shall submit their
capability statement to the Contracting Officer via email
at bowers.joshua@epa.gov no later than 5:00 PM Eastern
Time, Friday, March 10, 2006.
Point of Contact
JOSHUA M. BOWERS, Placement Contracting Officer,
Phone: 513-487-2104, E-Mail: bowers.joshua@epa.gov
Email your questions to JOSHUA M. BOWERS at
bowers.joshua@epa.gov
Additional Information
U.S. Environmental Protection Agency

Sunshine Project 2006 IBC Survey

2006-03-29T11:24:00.000-08:00

The Sunshine Project
Information Pointer - 20 March 2006
http://www.sunshine-project.org

The Sunshine Project has begun a major study of US Institutional
Biosafety Committees (IBCs). The survey focuses on how IBCs are
adapting to new roles brought about by the dramatic expansion of
research on biological weapons agents in the United States. A
webpage for the survey has been established where updates will
be posted as it progresses.

The initial survey group consists of 444 IBCs registered with the
National Institutes of Health Office of Biotechnology Activities,
including committees at corporations, institutes, universities,
and government labs.

As of 20 March 2006, 436 IBCs have received the survey letter.
A reply to the survey is required by the NIH Guidelines on
Research Involving Recombinant DNA Molecules at Section
IV-B-2-a(7), which stipulates that IBC minutes shall be made
available to the public upon request.

The survey seeks to assess compliance with the NIH Guidelines
and how IBCs are going about addressing issues raised by the
dramatic expansion of biodefense research, particularly studies
involving biological weapons agents (select agents).

Replies are requested by 28 April 2006, giving institutions
approximately six weeks to pull together a response.  While the
Sunshine Project hopes to avoid doing so, it will lodge a formal
complaint with the US National Institutes of Health against any
IBC that fails to reply to the survey.

In 2004, the Sunshine Project conducted its first survey of
Instituional Biosafety Committees. The report of that survey can
be downloaded at the Sunshine Project website. Although the 2006
survey will reprise some features of the first, the current survey
will has a significantly different focus and rely on additional
sources.

A list of the institutions that have been surveyed can be found
at the link below. As the survey progresses, updates will be
posted there:

http://www.sunshine-project.org/ibc

Surveyed institutions with questions about the survey should
visit the URL above for more information and contact details.

NEDC Wants Citizen Oversight of Labs

2006-02-12T15:25:00.000-08:00

The following is text from the latest letter from the NEDC (Northeast District Council) which represents 20
neighborhoods in Seattle. The NEDC continues to lead the way in attempting to bring some democratic control
to the booming biolab situation in Seattle. You can get copies of all three letters off the nobioterrorlab.com website.

February 6, 2006

Seattle City Councilmembers
600 Fourth Avenue, Floor 2
P.O. Box 34025
Seattle, Washington 98124-4025

RE: Community oversight of biosafety labs in Seattle and King County

Dear Seattle City Councilmembers: President Nick Licata, Peter Steinbrueck, Jan Drago, Richard Conlin,
David Della, Jean Godden, Tom Rasmussen, Richard McIver, and Sally Clark,

The Northeast District Council, a group that represents over 20 Seattle neighborhood groups, recommends independent regulation of Seattle biosafety laboratories. Such independent oversight of biohazardous research is critical to our public health system.

We appreciate Karen Van Dusen's response on behalf of the University of Washington to our previous letter
seeking independent citizen oversight of biosafety labs. We believe that the UW is a good yardstick that one can use to measure safety at other local similar facilities. Although the UW makes a good reference point, we don’t believe the UW is doing all it can do to protect the public from future incidents or accidents.

What the community is looking for in an independent biosafety oversight committee is a group that is financially independent of those being overseen and which (by definition) represents the community, in order to foster public trust, accountability and best practice.

NIH Guidelines, which govern the operation of biosafety labs across the country, are not regulations but are as close to regulatory standards as exist for governing operation of biosafety labs. The Guidelines require Institutional Biosafety Committees [IBCs], which provide a level of transparency, of public process, and of community involvement in oversight of biosafety labs.

In particular, the Guidelines specify there be at least two community representatives on each IBC. They further specify what "community representative" means: namely, "not affiliated with the institution...and who represent the interest of the surrounding community with respect to health and protection of the environment". The Guidelines provide examples: such representatives could be "officials of state or local public health or environmental protection agencies, or persons active in medical, occupational health, or environmental concerns in the community".

One of the roles for a municipal-level oversight committee such as we are proposing would be to confirm and authenticate the representativeness of those members. In Cambridge MA, the Cambridge Biosafety Committee, one of our models for an independent oversight committee, requires that community reps have neither financial ties to the bio-tech sector nor work in an academic department which is directly associated with the biotech sector.

The UW IBC, however, lists as one "public member" an employee of Zymogenetics, who would not pass the
Cambridge conflict of interest test. Another is a former employee of the UW Environmental Health and Safety Dept., who would also flunk that test. The UW IBC includes a member of the county board of health,
who clearly does meet the standard.

When the UW RBL proposal became public a year ago, the greater Seattle community discovered that not only
were there 30 UW biosafety level 3 labs [BSL-3s] in the vicinity, but there were at least a half-dozen private such labs. A local public interest group has recently compiled a map of the known such labs, a copy of which is attached. While the UW BSL-3s are governed by the UW IBC, the others are not. Some have IBCs, some apparently do not. In any case, the NIH Guidelines only apply to labs funded by public dollars. BSLs which are privately funded apparently have no governmental oversight and are not necessarily even identified to local authorities.

Part of the point is that there is no central registry; there is no comprehensive oversight of such facilities. It is a public health issue, and our request is that an independent oversight committee, modeled upon the CBC, be set up under the auspices of the Seattle-King County Public Health Department.

Thank you for considering our request to improve our public health system.

Sincerely,

Matthew Fox, Co-Chair Jim O’Halloran, Co-Chair

Boston Proposes Lab Regulations

2005-11-16T19:46:00.000-08:00

Boston is taking the lead nationwide by proposing local oversight and regulation of labs in that city. Seattle could learn a lot from Boston. Check out the proposed regulations at the Boston Public Health Commission site http://www.bphc.org/board/regs_main.asp or in the docs section of the http://www.nobioterrorlab.com site.

NEDC Recommends Independent Oversight of Labs

2005-11-15T18:40:00.000-08:00

October 17, 2005

Dorothy Teeter, Interim Director for Public Health
Members, King County Board of Health
999 3rd Avenue, Suite 1200
Seattle, Washington 98104

Mayor Greg Nickels
City of Seattle
600 4th Avenue, Floor 7
P.O. Box 94769
Seattle, Washington 98124-4749
Seattle City Councilmembers
600 Fourth Avenue, Floor 2
P.O. Box 34025
Seattle, Washington 98124-4025

Mark A. Emmert, President
University of Washington
301 Gerberding Hall
Box 351230
Seattle, Washington 98195-1230

RE: Independent Oversight of Seattle Biosafety Laboratories

Dear Elected and Appointed Leaders,

We are writing on behalf of the Northeast District Council, a group that represents over 20 Seattle neighborhood groups, recommending independent regulation of Seattle biosafety laboratories. We made this recommendation to UW President Emmert in a letter in April. Clearly recent events indicate such independent oversight of biohazardous research is critical to our public health system.

The 1918 influenza virus, dead for over eighty-five years, was recently recreated in U.S. laboratories. Nationally and internationally scientists have criticized both lab procedures as well as the overall lab safety level used for this work. Similar questions have been raised here in Seattle where the next stage of work on the 1918 influenza virus is scheduled to take place.

However, local work on the 1918 virus is not the only problem. As recent newspaper articles have indicated, hazardous biological work is occurring in numerous labs across Seattle. Just last year there was an accident that infected three researchers with Tularemia at the IDRI/Corixa facility on First Hill in Seattle. During that same period two similar incidents happened in Boston infecting several researchers there. In both cases, lack of meaningful oversight led to the incidents only coming to light through the investigative work of diligent reporters. The public was the last to know.

We believe that there should be independent oversight by representatives of the public who are unconnected to biohazardous research and who have no financial or other self-interest in the conduct of such research. As we wrote in April (see attached/enclosed) we are concerned when the researchers themselves are the arbiters of what is safe enough. Self-regulation is inadequate for the protection of the public or for the development and preservation of public trust in our local biotechnology industry. We recommend that an independent biosafety oversight committee be located within the King County public health department.

Cambridge, Massachusetts has set a valuable model. The Cambridge Biosafety Committee has operated there for three decades as part of the public health system. The Committee is charged with reviewing research proposals and developing oversight procedures consistent with federal standards. Its director is Sam Lipson, whose contact information is below. We believe this model would also work well for Seattle and King County.

Thank you for considering our request to improve our public health system.

Sincerely,

Matthew Fox, Co-Chair
1407 1/2 NE 56th
Seattle, WA 98105
206-527-0648
mattfoxseattle@hotmail.com

Jim O'Halloran, Co-Chair
6219 Brooklyn Avenue NE
Seattle, WA 98115
206-523-1770
jim@ohalloran.cc

ENC: Letter of April 8, 2005 from NEDC to UW President Emmert
cc: Sam Lipson, Director of Environmental Health, Cambridge Public Health Department, 119 Windsor Street, Cambridge, MA 02139 (617) 665-3838, slipson@challiance.org

One Step Closer to Disaster

2005-10-05T20:06:00.000-07:00

Today we are one step closer to a total disaster that doesn’t have to happen. The corporate media reported on Wednesday that U.S. scientists have completed the reconstruction of the deadly 1918 influenza virus (up to now they had only completed several segments). That’d be the one they are going to be spraying on monkeys in downtown Seattle in a facility that is in the process of being upgraded to the minimum standards necessary so they can proceed with this disaster.

You probably also saw the news where the Bush Admin is talking publicly about using the military for quarantine operations in case of a major outbreak. What’s interesting isn’t that they’d use the military (that’s already SOP for such incidents) but that they are publicly setting citizen expectations that such an incident is likely. Yes avian influenza is on an upsurge in Asia with reports just last week of a possible human-to-human transmission (since that time shown NOT to have occurred) but experts continue to indicate the most likely origin in the short term will be from the numerous labs working on "biodefense" (bioweapons) work.

Welcome to ground zero.

<>
Mike McCormick
http://www.nobioterrorlab.com

Researchers Reconstruct 1918 Flu Viru s

Bush Weighs Strategies to Counter Possible Outbreak of Bird Flu

Visting Red Crescent official says biological weapons programmes pose biggest threat

No One is Hunting 3 Missing Lab Mice

More Labs in Seattle - Where's the Oversight?

2005-09-15T16:49:00.000-07:00

One of the big reasons UW ran into trouble with it’s grant application for a large biodefense lab on campus was oversight. In this case citizen oversight. If not for the citizen representatives on CUCAC (City/University Community Advisory Committee) asking tough questions of the UW we’d be reading articles in this weeks papers about how grant monies had been approved for the 60,000 sq. ft. facility. That’s the good news.

The bad news is that the UW and private companies are building labs off campus where there are no CUCAC’s to protect us. As UW Dean Paul Ramsey stated in this mornings PI "we are building across the city" and he’s right. The UW has at least one functional BSL-3 lab in South Lake Union (SLU) and has earmarked $170 million more for a major lab on Mercer St. (bringing a potentially whole new meaning to "the Mercer Mess"). This would be in addition to two other private BSL-3 facilities in the SLU neighborhood. With the recent reports of flooding/breaching of labs in the New Orleans area (BSL-3 & BSL-4) and now reports of missing plague mice in New Jersey it again begs the question of where is the oversight for labs in Seattle?

(Please note included articles below)

Mike McCormick
www.nobioterrorlab.com

Lab loses track of three mice that had plague
As FBI probes Newark mystery, officials say risk to public safety is small
Thursday, September 15, 2005
BY JOSH MARGOLIN AND TED SHERMANStar-Ledger Staff

Three lab mice carrying deadly strains of plague have turned up missing from separate cages at a bioterror research facility in Newark, sparking a hushed, intensive investigation by federal and state authorities.
Officials said the animals could have been stolen from the center or simply misplaced in a colossal accounting error at one of the top-level bio-containment labs in the state.

The incident occurred more than two weeks ago and was confirmed only yesterday after questions were raised by The Star-Ledger.

The research lab is located on the campus of the University of Medicine and Dentistry of New Jersey. It is run by the Public Health Research Institute, a leading center for research on infectious diseases, now participating in a six-year federal bio-defense project to find new vaccinations for the plague -- which federal officials fear could be used as a biological weapon.

UMDNJ has responsibility for the security of the building.

At least two dozen employees and researchers at the lab have been interrogated and, in some cases, subjected to lie detector tests. However, the disease-carrying lab mice may never be accounted for, federal officials said. The Centers for Disease Control and Prevention is also investigating.

"The FBI has expended substantial resources and put many agents into this investigation to satisfy -- among other things -- the most compelling question of whether public safety is at risk," said Special Agent Steve Siegel, a bureau spokesman.

He said the investigation was continuing. The agents on the case are members of the Joint Terrorism Task Force and experts in biological agents that can be turned into weapons of mass destruction.

Although the FBI typically refuses to comment on open investigations, Siegel said the bureau took the unusual step of issuing a statement because of the "compelling public safety issue here" in the case.
"Right now, we are as satisfied as we can be that there is no public safety risk," Siegel stated.

State Health Commissioner Fred Jacobs said mice infected with plague die "very fast," so "the risk to the public ... is probably slim to none. We didn't think -- nor did the CDC think -- there was any public health threat."

Jacobs did acknowledge that the incident seemed to be the result of "internal sloppiness in the management of that lab."

Infectious-disease experts agreed that if the mice did escape the confines of the lab, the public health risk was likely minimal. However, they called the episode at UMDNJ's International Center for Public Health at University Heights Science Park very troubling -- raising serious issues of security and control at the lab.
The lab is a facility of the Public Health Research Institute, a separate entity that leases space from UMDNJ but is in discussions to become an operating division of the university.

In a statement released late yesterday, UMDNJ said: "The FBI has coordinated the investigation of the PHRI incident and UMDNJ has fully cooperated with their investigation."

While UMDNJ did not operate the lab, the investigation was more unwelcome news for a university that has had its reputation tattered in recent months by the disclosure of millions of dollars in financial abuses and no-bid contracts to politically connected firms.

Its administrative offices were also recently hit with a series of unsolved break-ins -- apparently tied to documents subpoenaed by federal investigators.

The lab where the mice disappeared is known as a Biosafety Level 3 containment lab, which works with diseases that are lethal or can cause serious health problems, including bubonic plague, pneumonic plague, West Nile virus and typhoid fever. The number of research labs has been expanding in response to the Bush administration's funding for bio-defense research.

Investigators said the lab mice were injected as part of an inoculation and vaccination experiment with the bacterium Yersinia pestis. The bacterium causes bubonic and other forms of plague -- an infectious disease which has claimed more than 30 million lives through history and even today sparks fear and panic around the world at the very mention of its name.

"It's a bad disease," noted John G. Bartlett, chief of the division of infectious diseases at the Johns Hopkins University School of Medicine.

With modern antibiotics, plague can be treated if quickly diagnosed and is not the scourge that wiped out a third of Europe during the years of the Black Death in the 14th century, but it remains a deadly killer.

"Once it starts, it's awful," said Bartlett, recalling a case of bubonic plague three years ago in New York City involving a tourist from New Mexico. Thought to have been infected by fleas while hiking near Santa Fe, where plague is still not uncommon, the 53-year-old man began hemorrhaging and suffered an infection that shut down his kidneys and lungs. Doctors were forced to amputate his legs.

Bartlett said if the mice escaped, they probably were dead by now and should not be the cause of great concern. "What people should worry about is that plague is an agent of bio-terrorism," he suggested.
According to David Perlin, the scientific director of the Public Health Research Institute, the mice were part of a group of 24 animals injected with the plague bacterium Aug. 18. The brownish-gray mice, about the size of mice one might find in houses or buildings, were specially bred to be lab animals -- meaning they have almost identical genetic makeups so results can be compared from mouse to mouse.

The trials involved eight mice in each of three cages. One group was given a known and effective vaccine against the plague. A second was given a test vaccine. The third received no vaccine.

Three days later, the mice in two of the cages were all dead. The carcasses were bagged and frozen without being counted. Their cages were sterilized and the bedding and other materials inside were incinerated, according to Perlin.

In the third cage, the eight mice that had received the proven vaccine were still alive and accounted for on Aug. 25.

But four days later, on Aug. 29, just seven were found in the cage, and researchers went back to the frozen carcasses, only to find just seven in each set. They immediately called the CDC. Then the FBI was called.
Perlin placed the blame for the incident on an animal care handler.

'It was sort of basic animal care; Animal Care 101. The person didn't follow the basic standard protocol," Perlin remarked. "The individual is not working in the facility right now."

Perlin said investigators and scientists believe the missing mice had been eaten by the others in the cages, but that no one will ever know because the handler sterilized the cages and incinerated the contents before probing through all the bedding and waste in the cage to determine that there were no mouse remains.
Richard H. Ebright, a Rutgers University microbiologist and a critic of the government's rapid expansion of bio-terrorism labs, said whatever the ultimate disposition of the animals, the incident raises red flags.
"There is a modest public health risk if they escaped, but the more important issue is that of control and security of the facility," he said.

He noted there has been a series of serious incidents across the country involving accidental human infections at several of the labs working with agents like anthrax and plague. At the same time, he said, federal guidelines call for only minimal security -- a lock on the lab door and a lock on the sample container and cage.
"You have more security at a McDonald's than at some of these facilities," Ebright said.

Josh Margolin may be reached at jmargolin@starledger.com or (609) 989-0267. Ted Sherman may be reached at tsherman@starledger.com or (973) 392-4278

http://www.sfgate.com/cgi-bin/article.cgi?file=/n/a/2005/09/13/state/n152751D34.DTL&type=printable

Years of research swept away by Katrina's rising waters
By PAUL ELIAS and ALICIA CHANG, Associated Press Writers
Wednesday, September 14, 2005

As rising floodwaters swamped New Orleans, Louisiana's chief epidemiologist enlisted state police on a mission to break into a high-security government lab and destroy any dangerous germs before they could escape or fall into the wrong hands.

Armed with bolt cutters and bleach, Dr. Raoult Ratard's team entered the state's so-called "hot lab," and killed all the living samples.

"This is what had to be done," said Ratard, who matter-of-factly put a sudden end to his lab's work on dangerous germs, which he wouldn't name. At least Ratard's team was able to retrieve laptop computers containing vital scientific data. Many other scientists in the region weren't so fortunate, losing years of research, either through storm damage or voluntary destruction.

Not since the torrential floods from Tropical Storm Allison, which badly damaged the Texas Medical Center in 2001, has scientific research been disrupted on such a large scale. Doctors and researchers in the Crescent City became exiles overnight, indefinitely locked out of their labs and unable to see patients.

Thousands of laboratory animals - many genetically engineered with human diseases like cancer and painstakingly bred and cared for - perished along with vital tissue samples thawed in abandoned labs.
Important work on heart disease, cancer, AIDS and a host of other ailments may be lost forever to scientists at Tulane and Louisiana State universities' medical schools in New Orleans.

LSU lost all of its 8,000 lab animals, including mice, rats, dogs and monkeys. Many drowned. Others died without food and water and the rest were euthanized, said Dr. Larry Hollier, dean of the LSU Health Sciences Center School of Medicine.

About 300 federally funded projects at New Orleans colleges and universities worth more than $150 million - including 153 projects at Tulane - were affected in some way, according to an initial survey by the National Institutes of Health.

One of the biggest blows is the likely destruction of frozen urine and blood samples from thousands of patients enrolled in the Bogalusa Heart Study, the world's longest-running racial study of risk factors for heart disease.
Samples collected and frozen since 1973 thawed out when the hurricane knocked out electricity and backup generators failed at a Tulane lab in New Orleans.

"It's irreplaceable. That's decades of research," aid Dr. Paul Whelton, senior vice president for health sciences at Tulane. "It makes you want to cry."

If the blood and urine samples are damaged or contaminated, future tests can't be done using them. However, Bogalusa's chief researcher, Tulane cardiologist Dr. Gerald Berenson said he had analyzed much of the data already collected and saved it on his computer, which was not damaged.

"The Bogalusa Heart Study will go on," said Berenson who visited New Orleans, but not his lab, on Tuesday. "We'll just have to pick up the pieces from what we have."

Tulane cancer specialist Dr. Tyler Curiel was one of the few researchers who decided to ride out the hurricane in New Orleans in an effort to salvage decades worth of research.

After the storm passed, Curiel spent the first few days transferring vials from broken freezers to liquid nitrogen tanks with the help of a flashlight.

He later fled to his in-laws' house in Denver and then returned to his lab for a day, grabbing whatever he could in an effort to save blood and tissue samples from an ongoing ovarian cancer project.

But he had to leave most of his experiments behind.

"This is a dramatic blow to our research," said Curiel, who plans to temporarily relocate his lab to the University of Alabama in Birmingham. "My researchers are scattered across the country and our facilities are still contaminated."

One thin silver lining to all the lab damage: It appears that no deadly diseases were released from the area's "hot labs," where researchers routinely handle and store some of the world's most dangerous germs.
In Covington, just north of New Orleans, Tulane's high-security National Primate Research Center reported only minor damage and said none of its 5,000 research animals escaped.

Ratard, the state epidemiologist, said the lab he returned to appeared undamaged and untouched by looters. He wouldn't disclose what germs the laboratory was working on when Katrina struck.

All the labs in Katrina's path that handle bioweapons defense research involving pathogens such as anthrax reported to the Centers for Disease Control and Prevention that their security wasn't compromised, according to CDC spokesman Von Roebuck. "A few reported minor damage, but there was no issue of escape."

A message from the President

2005-07-21T19:45:00.000-07:00

A message from the President:

To President's Cabinet and Board of Deans

In recent weeks, there have been several iterations between the National Institute of Allergy and Infectious Diseases (NIAID) regarding the University's application for funding to build a Regional Biocontainment Laboratory. NIAID has asked a number of questions about the grant proposal and sought some additional information. Among the questions was whether the University has identified sources for the additional funding--approximately $35 million--required to match the proposed $25 million grant. NAIAD has asked for our response by July 23.

As many of you know, the University applied for this grant because of our remarkable strengths in infectious disease research. Last year, we were awarded a $50 million grant by NAIAD to establish a Regional Center of Excellence in infectious disease research. Our faculty are among the best in the nation in this field, and building a facility to house this, and possibly additional research, would clearly enhance our capabilities in this area. A number of important issues were raised over the safety, security and location of such a facility, and as you also know, we set about to address these issues and assure ourselves that if the project did move forward, we would be able to build a safe and secure facility in an appropriate location.

While these matters have occupied our attention, Paul Ramsey and David Thorud have also been trying to identify potential sources for the additional $35 million required to build the facility. Our efforts to identify such funding ultimately have proved fruitless, and we will be informing the NAIAD and the Board of Regents this week that we do not have the necessary funds to proceed with the project. In all likelihood, this will ensure that the grant will not be awarded.

A great deal of excellent work by many people at the Univerity has gone into this project, and we are grateful to them for their effort. Regardless of any eventual siting decision that might have emerged, this experience points up the critical need for high quality research space at the University and the paucity of resources available to meet the needs. We will no doubt encounter other such challenges in the future. We need to find ways to meet these funding challenges if we are to maintain our position as one of the nation's leading research universities.

Sincerely yours,

Mark Emmert

Faulty Aerosol Chamber Infects Three

2005-04-18T21:17:00.000-07:00

The Sunshine Project
New Release - 18 April 2005
http://www.sunshine-project.org

Faulty Aerosol Chamber Infects Three
NIAID Encourages Use of Leaky Device in BiodefenseChambers are Located in Nine US States, India, New Zealand, and Northern Ireland

(Austin, 18 April 2005) - A leaky aerosol chamber manufactured by the University of Wisconsin at Madison was responsible for three laboratory-acquired tuberculosis infections in a Seattle BSL-3 lab last year. The infections have not been made public until now. Nearly twenty Madison chambers exist across the US and in India, New Zealand, and Northern Ireland. While tuberculosis is not a biological weapons agent, the accident underscores the inherent dangers when working with dangerous disease agents, and the grave safety risks of the US biodefense program, which is encouraging more scientists to deliberately aerosolize bioweapons agents in Madison chambers and similar equipment.

The Madison chamber incident is the latest to be reported in a series of US lab accidents, including infections and/or mishandling of anthrax, tularemia, and pandemic influenza. At the encouragement of the National Institutes of Health (NIH), Madison chambers have been purchased for use in Massachusetts, Connecticut, New York, North Carolina, Georgia, Texas, Colorado, Wisconsin, and California, as well as India, Northern Ireland, and New Zealand. More of the suspect chambers may be in use; but the legal counsel of the University of Wisconsin at Madison has refused to answer questions and has been reluctant to promptly answer requests filed under Wisconsin open records law.

The Chamber: The Madison aerosol chamber is a specialized type of lab equipment. The chamber is used to infect animals with disease through their lungs. Cultures of organisms causing tuberculosis or the bioweapons agents anthrax, Q fever, or brucella and others are placed in a part of the device called a nebulizer, which mixes the agents with air. The resulting aerosol is directed into a metal chamber in which animals have been placed on racks. The animals then breathe in the agent. The integrity of the complicated device's "O rings", seals, and other fittings is critical to preventing the aerosols from escaping the chamber and causing accidental infections. But the Madison chamber in Seattle, Washington leaks badly, and in 2004 it caused three laboratory-acquired tuberculosis infections at a BSL-3 lab shared by Corixa Corporation and the Infectious Disease Research Institute (IRDI).

"Foolproof": In late 2003, the Seattle lab began using a Madison aerosol chamber to infect guinea pigs with tuberculosis. Several batches were exposed over a period of months. By March 2004, a serious problem was detected when three employees, who previously tested negative for tuberculosis, came back with positive tests, or "conversions", indicating that they had been exposed to the agent.

The State of Washington opened an investigation. The State's report was obtained by the Sunshine Project and is available at our website. According to the report, in 2003 the IDRI team was trained to use the chamber by its inventor, a professor at Texas A&M University. IDRI was also trained by representatives of the University of Wisconsin at Madison. According to the State of Washington's investigation, Dr. David McMurray, the inventor and a tuberculosis researcher, made audacious safety claims about the chamber. The report says that McMurray claimed that "the chamber was so safe that there was no need to even locate it in a BSL-3 environment", that it was "foolproof", and that "respirator use was not necessary".

The Leaks: Interviews with IDRI staff by state investigators revealed that a leaky airflow meter was probably responsible for the infections. The investigation also revealed that IDRI staff had repeatedly encountered other dangerous problems. The chamber operator told state investigators "the Chamber seals deteriorate quickly, crack and last about a month" and in June 2004, well after the first problems were thought to be fixed, "another big leak was recently found." Another researcher said "several seals of the Chamber were found to be cracked". IDRI does not conduct biodefense research.

Leak Replicated, No Apparent Safety Advisory: The airflow meter also leaked in tests of a Madison chamber located in Fort Collins, Colorado. Although the University of Wisconsin at Madison was contacted by the State of Washington in the course of the investigation, two Madison aerosol chamber customers contacted by the Sunshine Project say that they have not received any safety advisories. Nor has the chamber's manual been changed in response to the State's findings. The current manual, obtained by the Sunshine Project under Wisconsin open records law, is dated 22 April 2002.

Biodefense Use: Many Madison chambers are used for tuberculosis studies; but others are used for biodefense. In December 2003, the Madison chamber was presented at a National Institute of Allergy and Infectious Disease (NIAID) biodefense workshop. Biodefense use includes: At Texas A&M University, scientists are using it to aerosolize brucella and Q fever. At the University of Texas Medical Branch at Galveston, it is used by an anthrax researcher funded by the Department of Defense and NIAID. With NIAID encouragement, other biodefense projects using the Madison chamber are likely planned or even underway.

Known Madison Aerosol Chambers and Locations*
---------------------------------------------
University of California San Francisco, CA
Corixa / Colorado State Univ. Fort Collins, CO
Yale University New Haven, CT
University of North Carolina Chapel Hill, NC
University of Georgia Athens, GA
Harvard University Cambridge, MA (possibly 2 chambers)
Corixa / IDRI Seattle, WA
HHMI / Albert Einstein Univ. Bronx, NY
Rockefeller University New York, NY
University of Texas HSC San Antonio, TX
Univ. of Texas Medical Branch Galveston, TX
University of Texas HSC Tyler, TX
Texas A&M University College Station, TX (possibly 2 chambers)
University of Wisconsin Madison, WI (presumed)
Queens University Belfast, N. Ireland
Astra Zeneca Bangalore, India
AgResearch Wallaceville Upper Hutt, New Zealand
*Some chambers may not yet be delivered. Source: Open Records requests to the University of Wisconsin at Madison, and "Pulmonary Delivery of Mycobacteria and Other Respiratory Pathogens to Small Animals in a Specially-Designed Aerosol Chamber", presentation to the NIAID Workshop "Aerosol Challenge Technology and Applications in Biodefense", Bethesda, 3 December 2003, URL: http://www2.niaid.nih.gov/Biodefense/Research/AEROSOL/davemcmurray.htm

Conclusions: The Sunshine Project has been calling attention to the safety and security dangers of the US biodefense program since 2000. This case underscores how the 'precise, clean and neat' public image of BSL-3 and BSL-4 facilities that is promoted by NIAID and labs is frequently at odds with messy and risky realities.

According to the Sunshine Project's Edward Hammond, "It should not fall to a small non-profit to reveal incidents such as this one. In this case, the institutions involved apparently didn't even inform their peers about the problems. Public safety and an informed debate about the biodefense program require the government to mandate public disclosure of all significant lab accidents. This may be more cold water on overheated biodefense safety claims; but we frankly wonder how many more serious problems have been kept out of the public eye."

The United States does not have comprehensive laboratory safety law. The Madison chamber failure and consequent lab-acquired infections are yet more evidence of the urgent need for binding laboratory biosafety law, backed by enforceable international standards.
-END-
--
"Dr. Spencer Wells, a population geneticist at the [National Geographic] society who is leading the program, said he hoped to head off charges of exploitation by offering money to the tribes for education and cultural preservation." - New York Times on HGDP: Reloaded, 13 April 2005
_______________________________________________
Distributed via the Sunshine
Project Announcements List
(See: http://www.sunshine-project.org)

How Many BL-3's Have Ye?

2005-04-11T22:51:00.000-07:00

In newspaper articles and public forums UW representatives have stated that the UW has approximately 30 BSL-3 labs on campus. At the February 23rd public forum John Coulter clarified that it had 29 operational and one being renovated.

On 01/24/05 I'd requested via the UW Office of Open Records "documents that identify the number and owning/controlling department of BSL-3 labs"

UW Environmental Health and Safety sent this:

Why the discrepency? How many BSL-3's do you have UW?

Northeast District Council Letter to UW President Mark Emmert

2005-04-10T14:17:00.000-07:00

Northeast District Council
4534 University Way NE
Seattle, WA 98105
(206) 233-3732

Members

Belvedere Terrace Community Council
Greater University Chamber of Commerce
Hawthorne Hills Community Council
Inverness Community Club
Inverness Park Homeowners Association
Laurelhurst Community Club
Montlake Community Club
Portage Bay/Roanoke Park Community Council
Ravenna Bryant Community Association
Ravenna Springs Community Group
Roosevelt Chamber of Commerce
Roosevelt Neighborhood Association
Roosevelt Neighbors’ Alliance
University District Community Council
University Park Community Club
View Ridge Community Council
Wedgwood Community Council
Windermere Corporation
Windermere North Community Association

April 8, 2005

Mark A. Emmert
President, Office of the President
301 Gerberding Hall
Box 351230
University of Washington
Seattle, Washington 98195-1230

RE: Proposal for BioLab on UW Campus

Dear President Emmert,

We are writing on behalf of the Northeast District Council, a group that represents over 20 Seattle neighborhood groups, to offer our comments on the proposed Regional Biocontainment Laboratory now under consideration.

While we strongly support much of the vital research that goes on at the University of Washington, the proposed RBL raises too many concerns for us to support siting this facility on the UW Campus.

Security and Safety. The security of such a facility raises concerns. The proposed location is adjacent to three public streets and is readily accessible to the public. The UW has already experienced eco-terrorist attacks, and this facility would present both a high profile and a high-risk target. In addition, there have been a number of accidents at other laboratories nationwide that highlight the very real risks of human error, most notably the tularemia release at a Boston University lab, the incidence of anthrax samples found outside of a Fort Detrick lab and the cross-country shipment and exposure to live anthrax in Oakland last year. It also bears mentioning that the anthrax used in the 2001 terrorist attacks almost certainly came from a U.S. facility.

Location. In addition, the proposed site is located in a shoreline management zone, within 200 feet of Portage Bay, which raises concerns about the potential effect on local waters and questions about the appropriateness of the facility given land use and design considerations.

Transparency and Public Disclosure. The fact that this facility is part of a national biodefense program that focuses on "select agents" that can be used in a possible bioterror attack creates another set of concerns. The first is the question of transparency – particularly since research on select agents is sometimes classified or proprietary. There will likely be little or no public notification in the event of thefts or accidents. The lack of transparency and the disregard for established procedures in the initial site selection process have been noted elsewhere. Note that over 70 pages of the UW’s application to the NIH were redacted for security reasons, an unusual procedure for an academic institution.

Biodefense research encompasses far more than simply generating vaccines for infectious disease. Select agent research requires the presence of pathogens that are likely to be used in bioterrorism attacks, and research on vaccines for "defense" does in fact have offensive potential. As David Ozonoff, Professor of Environmental Health at Boston University stated in testimony re the proposed NBL at BU, "In other words, no terrorist can use agents that have yet to be created, but the very act of protecting ourselves from these non-existent organisms will likely bring them into existence. That is when the danger moves from theoretical to real."

Control. In addition, the U of W, in the Cooperative Agreement Terms and Conditions of Award specified by the RFA, would effectively cede ultimate control over use of the RBL facility to the National Institutes of Health under the Regional Centers of Excellence biodefense program. The language specifically states that "Awardees agree to participate in projects identified by the NIAID Biodefense Network that include common research interests and address a specific biodefense problem or threat" and "The NIAID Biodefense Network will provide overall scientific coordination of the RBL Program." Even worse, the UW would cede this control over what occurs in the RBL facility for a period of 20 years under the agreement.

Although this is to be an RBL [BSL-3] rather than an NBL [BSL-4] facility, there remain unaddressed concerns that the level of containment required for a given pathogen can be redefined. This has already occurred in the UW project to study the 1918 influenza virus, when the level of containment required was reduced by the UW Institutional Biosafety Committee (IBC) to BSL-3 from the more stringent original standard of BSL-3ag. Which leads to a further concern.

Oversight. There is a potential conflict of interest between the roles researchers have in overseeing their own activities. The analogy is a fox guarding the henhouse, and we would like to propose an alternative to the current practice wherein the UW IBC, made up predominantly of researchers, provides sole local biosafety oversight. UC-Davis announced plans in 2003 to form a community liaison committee, modeled after an independent review committee in Winnipeg, whether or not it proceeded with its NBL proposal. An alternative is the successful model of the Cambridge Biosafety Committee, which oversees biosafety work at Harvard, MIT and private laboratories as part of the Cambridge public health system and has done so for the past three decades.

The existence of thirty BSL-3 labs on campus now and six more at other nearby Seattle institutions came as news to the community. We note that contrary to the impression given initially, the proposed facility is not expected by the Med School to result in the closure of any BSL-2 or BSL-3 labs at UW.

Resources. The general question of the use of federal resources for the biodefense program has been raised at the national level recently. More than 750 scientists, including 17 from the UW, sent a letter in March to the director of NIH stating, "The diversion of research funds from projects of high public-health importance to projects of high biodefense but low public-health importance represents a misdirection of NIH priorities and a crisis for NIH-supported microbiological research."

This particular proposal also impacts local resources. To be eligible for the $25 million federal grant, the UW has already committed $8.3 million in university matching funds, and is seeking an additional $32 million to meet the grant requirements. Allocation of these funds competes with other state and University needs.

In summary, we oppose the siting of this facility on the UW Campus. We urge you to consider the communities surrounding the University of Washington as you make your decision whether and how to proceed. We hope you will decide not to pursue the current proposal to locate an RBL on the campus.

Sincerely,

Matthew Fox, Co-Chair
1407 1/2 NE 56th
Seattle, WA 98105
206-527-0648
mailto:mfoxmail@aol.com

Lynn Ferguson, Co-Chair
6422 NE 60th Street
Seattle, WA 98115
206-523-0391
lynnferguson@standfordalumni.org

cc: UW Board of Regents, Center for Scientific Review, National Institutes of Health; John Bogdan, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases; Mayor Greg Nickels, Seattle City Council, Senator Patty Murray, Senator Maria Cantwell, Governor Christine Gregoire

International Campaign to Stop Smallpox Genetic Engineering

2005-04-08T10:59:00.000-07:00

Press Release
The Sunshine Project
Third World Network
http://smallpoxbiosafety.org

This text is also available in:
Chinese: http://smallpoxbiosafety.org/who/prchinese.html
French: http://smallpoxbiosafety.org/who/prfrench.html
German: http://smallpoxbiosafety.org/who/prgerman.html
Italian: http://smallpoxbiosafety.org/who/pritalian.html
Spanish: http://smallpoxbiosafety.org/who/prspanish.html

International Campaign to Stop Smallpox Genetic Engineering Announced

Non-Governmental Organizations Urge the World Health Organization to Put Smallpox in the History Books Instead of the Genetic Engineering Lab

(4 April 2005) - An international alliance of non-governmental organizations has launched a campaign to urge the World Health Organization to reject a proposal that would permit the genetic engineering of smallpox and to instead ensure that all remaining stocks of the virus are destroyed within two years. Debate on the proposal will take place at the World Health Assembly (WHA), which meets in Geneva, Switzerland beginning on May 16th.

The NGOs, led by Third World Network and The Sunshine Project, have opened a website, www.smallpoxbiosafety.org, where organizations and individuals can send letters to the WHO Director General. The website provides links to health ministries, so that people can also contact their government's representatives to the WHA. The website is available in Chinese, English, French, German, Italian, and Spanish.

The proposal to genetically engineer smallpox, which would also permit smallpox genes to be inserted into related poxviruses and the unlimited distribution of small segments of smallpox DNA, poses a large number of public health, biosafety, and biological weapons risks. It was prompted by the United States, and has been recommended to the WHA through an imbalanced advisory committee. A Briefing Paper (The Genetic Engineering of Smallpox: WHO's Retreat from the Eradication of Smallpox Virus and Why it Should be Stopped) at the website explains the political process that led to the proposal, the risks, and why it should be rejected. An edited excerpt from the paper that provides more background is appended to this news release.

Between now and the May opening of the WHA, the NGOs will be seeking to mobilize a wide variety of non-governmental organization and citizens. They will contact all member governments of WHO and urge them to reject the committee's recommendations and to instead:

* Prohibit the genetic engineering of smallpox, the insertion of smallpox genes in other poxviruses, and any further distribution of smallpox genetic material for non-diagnostic purposes;

* Set a firm and irrevocable date, within two years, for the destruction of all remaining stocks of smallpox virus (including viral chimeras, or hybrids with other poxviruses);

* In the interim before destruction, ensure that the WHO Advisory Committee on Variola Virus Research and its advisors are regionally balanced and that the Committee and its subsidiary groups conduct their oversight activities in a fully transparent and accountable manner.

Interested organizations and people are urged to visit www.smallpoxbiosafety.org to learn more about this issue and to send a letter to the WHO Director General.

Contacts:

The Sunshine Project
Austin, Texas US
Tel: +1 512 494 0545
GMT -6
E-mail: tsp@sunshine-project.org

Third World Network
Kuala Lumpur, Malaysia
Tel: + 603-2300 2585
GMT +7
E-mail: twnkl@po.jaring.my

----------

Background

The World Health Organization (WHO) is justly proud of the global effort that brought about the eradication of smallpox in 1977; but the truth of the matter is that the job was never finished. The United States and Russia still retain stocks of the smallpox virus (Variola major), an easily transmitted disease and ancient scourge of humanity that is a potent biological weapons agent. Smallpox kills one quarter or more of the people it infects and leaves many that do not die disfigured and blind.

In 1999, the remaining stocks of smallpox virus were slated for imminent destruction. But Russia and the US balked at the World Health Assembly (WHA) resolution calling upon them to destroy the virus. Instead, the US has accelerated smallpox research. Now, it wants open the Pandora's Box of genetically-engineered smallpox. A plan to genetically engineer the virus could be approved by the World Health Assembly in May 2005. The plan also includes the expression of smallpox genes in related poxviruses, and unlimited distribution of segments of smallpox DNA. If implemented, this plan would pose serious biosafety risks and open the road to an artificial reconstruction of the virus for biowarfare purposes.

Fewer and fewer people, and their leaders, have personal memories of the horror of smallpox, or even the scars left by vaccination, which had ended in most countries by the late 1970s. As if the world is condemned to repeat history through forgetfulness, WHO has now lost the political will that it once had to finish the job of smallpox eradication. Much of the blame can be laid at the feet of WHO's decision to leave oversight of smallpox research in the hands of an unbalanced and highly politicized "technical" advisory committee that is dominated by a small number of countries and scientists with a personal interest in pursuing smallpox research. It was US pressure that rammed the proposal for genetically-engineered smallpox through that committee, and now the World Health Assembly is in an inglorious position of being on the verge of endorsing what may prove to be the undoing of one its own greatest achievements.

Civil society and like-minded governments must urgently come together to turn the tide. The creation of genetically-engineered smallpox and hybrids of smallpox and other viruses (called chimera) pose serious public health, biosafety, and biological weapons dangers to the entire world. With increased smallpox experimentation, the world stands closer to the accident or deliberate act that would cause a release of the virus.

Because many poxviruses are closely-related to each other and, in their natural state frequently not entirely species-specific, the insertion of smallpox genes in related viruses has the potential to create dangerous new human (and animal) pathogens. Through genetic engineering or targeted mutations, labs that receive pieces of the smallpox genome may develop the ability to create smallpox or a novel virus with its characteristics without ever receiving an actual sample of Variola major. Moreover, laboratory safety practices and technology cannot erase human error and equipment failures that lead to accidents, as evidenced by a recent string of lab-acquired infections and environmental releases of SARS, Ebola, tularemia, and other dangerous diseases. In fact, the last reported human cases of smallpox were laboratory-acquired (see page 3 of the Briefing Paper - The Genetic Engineering of Smallpox: WHO's Retreat from the Eradication of Smallpox Virus and Why it Should be Stopped).

Contained to only two labs in Russia and the US, smallpox has a unique multilateral research oversight structure that has no parallel with any other disease. Because of the unique situation of smallpox research, if WHO approves these experiments it will not only increase the threat posed by smallpox itself. WHO will also broadcast the signal that it is internationally acceptable to have genetic engineering of other germs, including experiments in which new and more dangerous forms may result - or even be intended.
If endorsed by the WHA, the intergovernmental encouragement of the creation of designer disease will come at a particularly dangerous time. Globally, the number of high containment facilities handling dangerous disease agents is expanding and the hazardous applications of biotechnology increasing. This is reflected in a growing number of lab accidents in a variety of countries in recent years involving highly pathogenic agents in high containment facilities. Particularly in the US, the scope and quantity of research on biological weapons agents is growing, and now exceeds the cost of the effort that created the atomic bomb (the Manhattan Project), adjusted for inflation.

Individuals and civil society organizations should take action and voice their opposition to WHO and their national public health authorities, urging them to reject the recommendations of the committee and to instead ensure prompt destruction of all remaining virus stocks. This briefing provides a political overview of smallpox eradication, the WHO processes that led to the present state of affairs, and related issues of biosafety and prohibitions on biological weapons.

_______________________________________________
Distributed via the Sunshine Project Announcements List
(See: http://www.sunshine-project.org)

The Pathology of Government-Funded Research

2005-04-05T22:07:00.000-07:00

This article was sent to me today and well worth a read. Mike

The Pathology of Government-Funded Research
U.W.'s Biocontainment Lab: Coming to a Neighborhood Near You!

copyleft April 2005by Zbignew Zingh

The University of Washington, whose main campus lies near the heart of Seattle, wants to accept bushels of federal grant money to construct a large Level 3 biocontainment laboratory near the banks of Portage Bay.

Whether intentionally or unintentionally, the U.W. neglected to tell any of the local people what it planned to build in their backyard, nor did the University bother to tell its own faculty senate what it was planning.

A Level 3 biocontainment laboratory is a euphemism for a bio-terrorism R&D center. The facility - to be built adjacent to the University of Washington Medical Center at a cost of $50 million or more would research the development of immunizations and cures for microorganisms that cause the likes of bird flu, anthrax, tularemia, meliodosis and bubonic plague. Of course, there have been no such known local outbreaks in recent memory, but there could be in the future, argues the University. Lethal as these exotic diseases may be, the University has assured everyone that no Level 4 research would be done on campus on still more noxious pathogens like Ebola or Marburg which can have mortality rates as high as 100%... at least not right now, and certainly not that anyone would ever tell you about it if they did do Level 4 bio-terror research on campus.

It is understandable why the University of Washington wants to build a dedicated, state-of-the-art bio-terrorism laboratory. First, thanks to the national government's regressive tax policies and its reallocation of federal money from the public sector to the Perpetual War on Terrorism and the Force-Feeding of American Style Democracy, all states and local governments everywhere have lost the financial subsidies that allowed them to (at best) marginally fund public education. The U.W., like all state education, has been deliberately starved of resources to the point where it wil l take grant money where it can find it. Second, the medical school wants to maintain its âœedgeâ as an eminent research institution, even if that means crawling into bed with proxies for Homeland Security and the military's weapons developers. Third, the University apparently has an incurable institutional penchant for poking itself in the eye by doing incredibly dumb things (such as ruining its athletic programs), also for the sake of prestige, reputation and money.

Once the laboratory cat was out of the bag, the U.W. finally was forced to meet with the public and explain itself. In the two meetings held so far, its explanations have won very few neighbors over to the University's proposal.

The opposition to the U.W.'s bio-terror project falls into three general categories. One category comprises those who believe that we really do need to protect ourselves from terror-mongering Bad People who will try to infect our sons and daughter s with lethal doses of God Knows What. However, this group prefers that the laboratory be constructed somewhere else other than right next door to where so many people live and work. A second group of opponents believes that the construction of a large and consolidated biocontainment lab is inherently unsafe, that it could accidentally discharge toxic microorganisms into an urban petri dish ideally suited for the propagation of deadly epidemics, and that the biocontainment lab would become a magnet for terrorist attack. The third category of laboratory opponents simply oppose it on principle, and because they consider both the University and its federal benefactors to be dishonest and dissembling about their intentions.

The University, for its part, has explained its support for the proposed project. It contends, in sum, that:
1.The threat of bio-terrorism is real and someone needs to research the counter-terrorism measures;
2.The University needs to conduct bleeding edge research in order to retain cutting edge faculty and a cutting edge reputation;
3.The Level 3 biocontainment laboratory will be as safe and secure as modern technology can make it;
4.Neither the military nor the Department of Homeland security will be funding this project; and
5.There are already many bio-terror labs on campus and in the Northwest, so one more will not hurt anything.

None of these arguments advance the University's case.

The Threat of Bio-terrorism. Maybe it is real and maybe it is not. However, the only known uses of biological warfare throughout history have been state-sponsored. Whether it was the catapulting of plague-infested cadavers into medieval cities under siege, or the 18th Century British distribution of small pox infected blankets to the indigenous tribes of North America, or Japanese human experimentation on Chinese POWS during the Second World War, there has always been a âœgovernmentâ behind the use and research of biological weapons. Too often, even in American medicine's checkered past, it was state-sponsored medical research that sacrificed Black Americans to syphilis, tested bacteria aerosols on the citizens of San Francisco and subjected unwitting soldiers and sailors to nuclear radioactivity testing, all in the name of medical research and science.

Moreover, the anthrax attacks of September 11, 2001 â“ ah, yes, those still unsolved and rarely mentioned anthrax attacks - that anthrax was an incredibly sophisticated, highly weaponized âœAmesâ strain of anthrax that most probably was developed in an American Army weapons laboratory. All of which leads one to question who was the terrorist behind the anthrax attacks of 2001 or, at least, to wonder how secure a Level 3 laboratory could be if not even the U.S. Army could keep its toxic little laboratory pets on the leash.

The University Needs to Conduct Bleeding Edge Research. This is a specious argument. There are a lot of medical issues that cry out for urgent scientific study but that do not require the University to sell its soul to Mephistopheles. If the University wants to do cutting edge scie nce for science's sake, then let it research cures for the myriad of congenital, autoimmune and neurological disorders that strike all people everywhere.

Scientists and medical researchers cannot conduct military related work as detachedly as though they are playing with Tinker Toys. The argument that the U.W. needs to conduct leading edge bio-terror research in order to maintain its academic edge is as bankrupt as the argument that it needs to develop thermonuclear weapons in order to attract the best nuclear physicists. Just as all who develop the underlying technology of war bear responsibility with war's perpetrators for the misery they unleash, so, too, must the U.W. accept responsibility for the weaponized technologies that its biocontainment research would inevitably produce.

The Biocontainment Laboratory Will Be Safe. Bio-research laboratories of all levels around the country â“ including Level 4 â“ have suffered security and containment breaches in the past, and they certainly will suffer them in the future. There is no technology that humankind cannot screw up, and there is no computer technology that does not occasionally malfunction due to a software glitch, an electrocuted insect, a hack, or a ten cent piece of hardware failure. Anyone who feels secure in the hands of modern technology obviously has not used a personal computer.

Moreover, as some have already pointed out in public forums, the U.W.'s research at its biocontainment laboratory will be secret. No one will know what they are really up to there and the public will never be told if, accidentally or otherwise, they leak some fast-replicating bio-agent into the neighborhood ecosystem.

Additionally, the University's bio-terror laboratory will first have to create the weaponized pathogens they want to immunize us against, which means, in essence, that the U.W. wil l be developing bio-weapons of extreme potency in order to create the counter-measures to them. The University's researchers will develop their âœtest pathogensâ through genetic engineering of existing bacteria and viruses, which is as smart as creating dozens of fast-breeding microbial Frankensteins in order to test whether they can kill them after all.

Neither the Military Nor Homeland Security Is Funding This Research. This argument is false. All research now serves the interest of the military, directly or indirectly. Except for the rare instances of individual initiative, all big science projects (including everything now associated with NASA) are nurtured by what Dwight Eisenhower accurately described in the 1950s as the military-industrial complex. Science has been in the service of war all the way back to Archimedes. The name of the ostensible funding source for scientific/medical research is irre levant in an age when all government institutions are interlocked and serve the Administration's same Ã¼ber-goal of preemptive military aggression. It is an unfortunate fact that most scientists and engineers graduated by American universities will end up employed either directly or indirectly by the military or its contractors. That is no justification, however, for building one more military related research facility at a publicly owned state university.

Even if the work of the proposed bio-terror research laboratory is purely defensive, then it is as much a military provocation as the development of a national anti-ballistic missile shield. That which would protect Americans alone against a bio-military threat will make other peoples more vulnerable to that same threat from America, wherefore they will work all the harder to overcome our defenses. Thus, the U.W.'s biocontainment laboratory would 'contain' nothing but, ra ther, would increase the very risk it would purportedly protect us from. In short, there is no such thing as a defensive weapons research program, for the strong defense serves the interest of a strong offense.

One More Bio-research Laboratory Won't Matter. There are already many biocontainment research facilities scattered around Seattle. Nevertheless, that does not mean we should have one more. In fact, let us scrutinize each of the existing laboratories as closely as we scrutinize the proposed project, and then let us shut them all down, if that is the reasonable thing to do.

Ultimately, it does not matter whether Seattle's opposition to the U.W.'s biocontainment adventure is based on fear, intellect or real-estate-value nimbyism. All serve the same purpose of trying to stop an ill-conceived and dangerous project in its tracks.

Although the state's senators and business leaders certainly have a lready given their back-door blessing to this endeavor, it is appropriate to let them know that they may pay a social, academic, political and economic price if they try to ram something down the communities' throats that the communities do not want. That price could be paid in the withdrawal of endowment support from the University, in the tarnished PR image caused by civil disobedience when the bulldozers start to break ground, and in the withdrawal of financial and ballot support for certain candidates who run roughshod over local interests. In an age of squeaker elections when even the Governor's election hangs on handfuls of disputed votes, the electorate can parlay that uncertainty into a demand that its wishes be respected.

Back in Washington D.C., the Administration that doles out the political pork must be laughing out loud. Washington State, which did not vote for those who hold power, and specifically Seattle (which politically i nclines more toward Canada than toward Texas), would seem to be the most illogical place to site a bio-terrorism laboratory on this scale. But in the demonic mind of those who know how to pay back political heterodoxy with political terrorism of their own, there is nothing more suitable than that biological warfare research should be conducted right smack in the âœleftyâ city that wants it least.

The next public meeting on the proposed biocontainment laboratory will be held on campus of the University of Washington in Seattle, Room 310 of the HUB, Monday April 11, 2005 from 4:00 â“ 6:00 pm.

A Dangerous Proposition

2005-03-27T14:11:00.000-08:00

(This is an article I just submitted to the current edition of "Eat the State". - MM)

Ever since the anthrax letters shortly after 911 bioterrorism has been a big cash cow in the U.S. This year alone $7.6 billion is budgeted for biodefense programs. When money like that is offered everyone wants a piece--the problem is that this particular funding isn't aimed at things that are significant health threats, and the funds always come with plenty of strings attached.

Take the University of Washington, for example. In December of last year the UW put in for a grant from the NIH for $25 million for a new "Regional Biocontainment Lab." UW reps say that they haven't had funds to build new labs since the '70s and therefore see this as an opportunity to get a brand spanking new, state-of-the-art facility. Ignoring the financial hurdles of where the rest of the $63 million will come from, let alone the operating costs (see: "The Bio-Offense Lab, ETS 01/19/05), this proposal has numerous serious problems that citizens should be very concerned about.

First off, the lab isn't really a "lab" in the sense of a single laboratory, it's a complex of 11 BSL-3 suites/labs with additional supporting labs and aerosolizing facilities (read dual-use). It's kind of like calling a mini-mall a store.

What's a BSL-3 (interchangeable with BL-3)? It's short for Bio Safety Level 3. Labs are rated on a scale of one to four, four being the highest level of containment where the nastiest, most virulent pathogens are handled. BSL-4 labs are where researchers experiment on diseases that have no cure.. BSL-3s are for nasties that have cures or treatments but could be devastating if they escaped from the lab.

So the UW is proposing to put a mini-mall housing a devastating array of death and disease on campus next to several major roadways and waterways in a densely populated neighborhood in the largest city in the state. With me so far? It gets worse.

The lab won't be controlled at the local level. Though the grant only covers 40 percent of the facility's cost, NIAID retains 100 percent control. UW says "we'll be in charge" but supporting documents say exactly the opposite.

According to the NIH Request for Application, the section "Cooperative Agreement Terms and Conditions of Award," item 1. b. states:

b. Awardees agree to participate in projects identified by the NIAID Biodefense Network that include common research interests and address a specific biodefense problem or threat.

and item 3. a.

3. Collaborative responsibilities:

a. The NIAID Biodefense Network will provide overall scientific coordination of the RBL Program

So the Bush Administration will be calling the shots (and let's not forget the biological treaties they've opted out of in the last four years).

Worried yet? Read on.

The three pathogens that are currently listed for study at this RBL are: tularemia, plague, and anthrax. The friendliest of these bugs--tularemia--infected three scientists at Boston University last summer, an incident the University of Boston chose to keep from the public for months, until newspaper reporters discovered the accident. None of these three accounts for more than a couple hundred deaths individually worldwide per year (vs. challenges like HIV, cancer, and malaria that each kill millions per year). Why, when recent reports indicate that the UW is coming up short of funds to continue cancer research, would that institution instead choose to fund and house facilities for pathogens that pose no significant current threat? Could it be tied to a shift in national funding priorities that have increased for these three proposed pathogens by over 1500 percent in the last few years, while HIV funding has been cut by 20 percent and malaria by 40 percent? (It's interesting to note that the three pathogens they'd be working on happen to have been the same that were shipped over to Iraq in the late 80's by the US later to be used as part of the justification for the current U.S. war with that country.)

What about accidents? UW proponents like to say they know of only one accident at a UW facility and know of no accidents where the public was exposed at a BSL-3 lab located at a university (this statement keeps changing slightly at each public forum). Easy to say when there are no national standards for reporting of accidents, thefts, and other incidents. Each state has it's own standards and, although the CDC has a list of 49 notifiable diseases, when it comes to a comprehensive national policy to track incidents, one simply doesn't exist. What does exist, however, are laws stemming from the Bioterrorism Act of 2002 which prohibit public disclosure of theft or loss of bioterrorism agents (also known as "select agents"). So if the UW does discover some of the three pathogens missing, you will never know about it. In addition, when there is an accident, the only people who have to be notified are the City, County, and/or State Secretary of Health, and it's their call what to do from there. Once the UW makes that call they can roll over and go back to sleep.

Safety in terms of an intentional release is also a major concern. As angry citizens have stated during two of the only public hearings so far, the UW recently had one of it's facilities attacked and burnt to the ground by "eco-terrorists". Not a shining example of protecting public property. During these same meetings and in UW documents, proponents have emphasized that the location of the proposed lab complex will be literally across the street from UW Police Headquarters (it's touted as a primary benefit of that location). UW reps state that, unlike Seattle police who have many things to deal with, UW police would give the labs top priority. This begs the question of if the labs are not considered a high profile target of "terrorists" or disgruntled workers (as UW proponents state publicly) then why do these labs require an exclusive police force located literally across the street to protect this facility? If the labs are considered a high profile target, then why locate them in a densely populated sector of the largest city in the state?

These are only a few of the problems with the proposed lab complex at the UW.

Though the grant application states that the UW is required to do extensive outreach, so far the University has been attempting to fly underneath the public radar. It was only due to a member of the UW Senate Faculty speaking out that the proposal became public knowledge at all in January. The University's two public forums received little or no attention. The forums were also heavily controlled by University representatives (people were not allowed to clap, and UW reps had unlimited time to talk, while audience members' time was limited). Luckily, due to mounting public awareness and pressure, the UW has scheduled another public forum on Monday, April 11 from 4 - 6 PM at the HUB (Student Union Building) on the UW campus. This will be an excellent opportunity to be heard both inside at the forum itself as well as outside the HUB on campus grounds. People are encouraged to get there well ahead of the start time to help hand out flyers and participate in the only safe, open air experiment we call "democracy".

More on Biolab Bloopers

2005-03-22T15:26:00.000-08:00

Another excellent source with a listing of known lab accidents over the last decade comes from the Council for Responsible Genetics "Boston University Biodefense" website http://www.gene-watch.org

Check out their page entitled "Mistakes Happen: Accidents and Security Breaches at Biocontainment Laboratories" http://www.gene-watch.org/bubiodefense/pages/accidents.html and the nice pdf file http://www.gene-watch.org/bubiodefense/pages/Accidents1%2027%2005.pdf (a great resource for those public forums).

Accidents, what accidents?

2005-03-21T20:02:00.000-08:00

In light of the UW's constant repetition of the mantra "we know of no public exposures from this type of lab" (with numerous variations based on the given audience they are speaking to) you might find the following of interest. It should be noted that there is no national standard or structure in place for gathering data on lab "accidents". Each state has it's own rules. It certainly makes it easier to honestly say "I know of no accidents" when there nothing there to record them.

From the Feb/March Tri-Valley Cares Newsletter

http://www.trivalleycares.org/newsletters/cwfeb05.asp

Ongoing Saga of Bio-Lab Accidents "That Don't Exist"

by Inga Olson, from February/March 2005 newsletter, Citizen's Watch

Here, in your Citizen's Watch newsletter, we have documented numerous accidents with dangerous biological agents in advanced biosafety labs over the last couple of years. Taken together, these cases show that it is indeed possible for live anthrax and other bioagents to infect workers and escape into the environment.

These incidents highlight problems with implementing biosafety standards, even in high-tech countries and at prestigious U.S. universities. Lab directors who say accidents in high-containment Biosafety Level (BSL) 3 and 4 facilities are virtually unknown, fail to list even publicly-known accidents. Further, they fail to mention that there are no comprehensive, mandatory reporting requirements for lab accidents in high containment facilities. Thus, it is likely that many accidents go unreported.

Here is some of what we do know. A researcher in 2003 at one of the three BSL-3 labs in Singapore contracted SARS while unknowingly working on a cross-contaminated sample. Then, there was another accident at the National Defense University in Taipei --Taiwan's only BSL-4 facility. A medical researcher there contracted SARS in the lab on Dec. 5, 2003, flew to a medical conference in Singapore, returned Dec. 10 and eventually entered a hospital on Dec. 16 where the SARS was diagnosed.

At UC Berkeley, the genetic-modification of tuberculosis accidentally created a novel, virulent form that appears to undermine the body's own immune response. Fortunately, there was no accidental release with this agent. In May 2004, a researcher died at Russia's top bio-lab after contracting the Ebola virus. Another Ebola researcher, this time at the U.S. bio-agent facility at Fort Detrick, MD, stuck herself while working with mice and Ebola. Fortunately, she did not die.

Then, we learned that anthrax leaked at the BSL-3 at Ft. Detrick, MD. Two scientists were placed on ciprofloxacinone for 30 days. Seven linen collectors and one additional worker were also treated with antibiotics. Anthrax was found outside of the containment lab in three different places: the "clean" change room, an office and on the passbox -- an ultraviolet lighted square-area used for "safely" passing potentially contaminated material into and out of the lab suite. More than 200 colonies of Ames strain were found on the passbox. The official report cited a cavalier attitude toward safety among some personnel and multiple, serious safety deficiencies that had been blatantly ignored.

In addition to Ames strain (the strain found in the anthrax-laced letter sent to Senator Tom Daschle in 2001), Vollum 1B anthrax was also leaked at the Ft. Detrick complex. The "B" in the name is from the late Ft. Detrick microbiologist William Boyle, whose blood was used to grow the strain after he died in a 1951 lab accident.

And, what about the supposedly dead anthrax sent via Fed-Ex to the Children's Hospital lab in Oakland in 2004? It turned out to be live Ames strain and seven employees were treated with antibiotics. There is virtually no regulation of inactivated or supposedly "dead" anthrax in this country.

Here's the latest news. In 2004, at the Boston University Medical Center, three BSL-2 lab workers contracted a rare disease called tularemia. Two of the workers were hospitalized. The lab infections were not made public until 2005, after the center won approval to build a new, maximum containment biodefense lab. Now, "New Scientist" is reporting that this is not the first time workers at the Boston lab were accidentally exposed to tularemia. In 2000, a dozen people were exposed to samples from a patient who caught the disease from a wild rabbit and died.

About $14.5 billion has been spent in the U.S. on biodefense since 2001. This rapid expansion in work with dangerous pathogens is neither adequately regulated nor scientifically justified. These advanced biowarfare agent labs are posing a definite risk to the public, and they are siphoning off funds from other, badly-needed medical and public health research and facilities.

We do not want the deaths of workers at Livermore Lab's proposed, new BSL-3, or deaths of their family members or community residents, to be the impetus that finally causes a prudent look at the rash biodefense building boom in America. For this reason, Tri-Valley CAREs, in collaboration with groups across the U.S., has called for a moratorium on building, upgrading and operating new biodefense facilities until a national assessment has been conducted to determine how many, if any, new facilities are actually needed.

We also continue our lawsuit to force Livermore Lab to conduct a thorough and complete Environmental Impact Statement before moving forward with an advanced bio-warfare research lab, which would be the first to be collocated in a Dept. of Energy nuclear weapons facility (see also article on p. 1).

Where's the Outreach?

2005-03-10T15:07:00.000-08:00

One of the things that's supposed to happen prior to federal funding of the UW's proposed "Biocontainment Laboratory" is outreach. So far the UW's outreach presence has been MIA.

It's actually part of the NIH's Request for Application (RFA). Item 8.f. states " Provide a detailed community relations plan outlining initial and ongoing community outreach and involvement related to the intended research activities to be conducted at the RBL. Documentation of community outreach must be provided to the NIAID before award/construction can begin."

To date there's only been a handful of meetings and only two of those were officially stated as "public" meetings. The two public forums were on 2/23 and 3/1. In addition the UW has had lab proponents at two CUCAC monthly meetings, a monthly meeting of the Northeast District Council and a meeting with members of the UW's Student Senate. That's five "public" meetings by my count with two of them including public participation in just over two months. Not exactly an aggressive outreach policy so far.