Human Error and Biosafety Laboratories
(Carelessness, Poor Training, and Poor Judgment)
Testimony of: Lynn C. Klotz, PhD
Scientists Working Group on Chemical and Biological Weapons Center for Arms Control and Non Proliferation
Today, I wish to address public-health risk from human error in Biosafety-level 3 and 4 laboratories. These errors include accidents from carelessness or inadequate training, or poor judgment. Intensive public-health, scientific and political oversight of biosafety laboratories can reduce this risk.
I will illustrate human error with a few of many recent, real examples.
Documentation is provided in Attachment II.
Accidents involving dangerous pathogens
Here are two examples from a number of recent accidents involving work with dangerous pathogens.
The first example:
Southern Research Institute accidentally shipped the deadly Ames strain of anthrax from Frederick Maryland to a Research Institute associated with a Children’s Hospital in Oakland California. The anthrax was live. It was supposed to have been killed before shipping. After experimental mice died when injected with the anthrax, five vaccine researchers at the Oakland facility were placed on antibiotics. Fortunately, the anthrax was in liquid form, not the potentially very deadly powder.
This accident appears to be the result of either carelessness or inadequate training of Southern Research Institute employees.
The recent accident at Boston University where students were infected with tularemia is strikingly similar to the Oakland anthrax story. The BU researchers thought they were working with non infectious tularemia shipped to them from a Nebraska laboratory.
The second example:
Less than two months ago, a Cincinnati company, Meridian Bioscience, shipped a very deadly influenza virus to 5,000 diagnostic laboratories in 18 countries. This particular virus killed between 1 million and 4 million people around the world in the year 1957. The virus was to be used as a quality control sample. A non-deadly virus would have served just as well for quality control.
While the Centers for Disease Control downplayed the incident,
“The risk is low and we've taken appropriate action.” Others, such as the World Health Organization were not so reassuring, “If someone does get infected, the risk of severe illness is high, and this virus has shown to be fully transmissible.” That is, a deadly epidemic could ensue.
This accident is likely a case of very poor judgment.
These are only two of many recent accidents over the last four years
involving deadly pathogens such as biological weapons agents.
Poor judgment
Here is another kind of poor judgment involving the conduct of dangerous experiments without adequate discussion and oversight.
At least three university laboratories are conducting experiments on
the recently resurrected 1918 pandemic flu virus. The goal is to
understand why it was so deadly.
This flu virus killed 40 million people worldwide in 1918 to 1919.
The virus has not been in contact with the world’s population
since then—until now.
What seems incredible to me is that much of the present research on the resurrected 1918 flu virus is being carried out in BSL3 laboratories, not the highest level of biocontainment. My grave concern is better conveyed by someone recognized as a world-class expert on deadly pathogens. I quote, “The potential implications of an infected lab worker – and spread beyond the lab – are terrifying…” This quote is from D. A. Henderson, formerly chairman of the U.S. Council on Public Health Preparedness and the key scientist in eliminating smallpox from the world.
Conclusions
If biosafety labs and money for research are available, scientists will dream up experiments to get funded to do deadly pathogen research. For most academic research, “free and independent pursuit” of knowledge is a good thing. But for research that involves deadly pathogens, “free and independent pursuit” is not a good thing. University biosafety laboratories will be inhabited, by and large, by young scientists. Fort Detrick, by comparison, is populated by older scientists, well trained in the ways of working safely with dangerous pathogens. And even at Fort Detrick there have been a number of accidents. I judge the risk of accidents
to be much greater in university biosafety laboratories.
While many scientists abhor oversight and will argue strongly against it, the people of Massachusetts should not be persuaded by their arguments. Intensive local-community regulation and oversight of biosafety labs is necessary to reduce the risk of devastating disease from poor judgment caused by scientific curiosity. Misadventure motivated by ego, arrogance, or greed is also not out of the question.
Of course, we cannot eliminate all risk from these labs. And we must
be prepared to tolerate some risk to help prevent natural epidemics
and to protect ourselves against biological weapons. But it behooves
us to be very cautious, so the dangers from our own research
activities do not exceed the risk of natural epidemics and attacks
with biological weapons.
Regulation and intensive oversight of biosafety laboratories is necessary to reduce the risk of devastating disease caused by human error in a laboratory. Another risk-reducing action that the State of Massachusetts must take is to insist on locating Biosafety level 3 and 4 laboratories as far outside population centers as is practical.
Attachment I. Brief Biography
Lynn Klotz, PhD, is expert in many areas of biological-weapons control. He was formerly with the Scientists Working Group on Biological Weapons Control at the Federation of American Scientists and is presently with the Center for Arms Control andNon Proliferation. He has published several papers on biological- and chemical-weaponsissues relating to biotechnology, industry, and the now-abandoned BWC Protocol.
In addition to his arms control activities, Dr. Klotz has worked as
a consultant in technical and business strategy for more than a
dozen biotechnology companies and universities. He participated in
the founding of five biotechnology companies: BioTechnica
International, BioTechnica Diagnostics, BioTal, Oncor
Pharmaceuticals (renamed Codon), and Precision Genetics.
Dr. Klotz was Associate Professor Biochemistry and Molecular Biology at Harvard University. He served as Vice President and was a Board Member of BioTechnica International. He also was Professor and Course Director, at the Harvard University Summer Executive Program, for the course "Biotechnology and Modern Drug Discovery and Development."
Dr. Klotz has published over 40 research papers and review articles in leading scientific journals, and numerous articles on biotechnology business articles and on biological weapons arms control. He was recipient of a Camille and Henry Dreyfus Foundation, Teacher-Scholar Grant. He coauthored with Edward Sylvester "The Gene Age: Genetic Engineering and the Next Industrial Revolution," which was nominated for Pulitzer Prize by the publisher, Charles Scribner's Sons.
Attachment II. Newspaper Articles Relevant to the Testimony
Accidents involving dangerous pathogens
Live anthrax accidentally shipped from Frederick to California lab
Exposed workers undergo treatment; CDC opens investigation of slipup
By Scott Shane
Sun Staff
The federal Centers for Disease Control and Prevention are
investigating how a Frederick research institute mistakenly
shipped live anthrax bacteria to a California lab where
at least five people were exposed to the potentially
deadly germs.
The five vaccine researchers at Children’s Hospital Oakland Research
Institute were placed on antibiotics and none has shown symptoms
of infection, said Bev Mikalonis, a hospital spokeswoman.
Scientists at Southern Research Institute in Frederick intended to
send dead anthrax bacteria to their collaborators in Oakland, said
Thomas G. Voss, vice president of homeland security and emerging
infectious diseases at the institute.
The killed germs were to be injected into mice to produce antibodies
against the disease, one step toward developing an improved vaccine.
But when the mice were inoculated over the past two weeks, nearly
all died, prompting the researchers to perform tests to determine
the cause of death.
When the tests confirmed that the mice had died of anthrax, state and
federal health officials were notified and researchers who had contact
with the anthrax samples or the mice were placed on the antibiotic
Cipro as a precaution, Mikalonis said.
FBI agents from a bioterrorism unit in San Francisco removed the
bacteria from the Oakland facility Wednesday.
Bill Carter, a spokesman at FBI headquarters in Washington, said bureau personnel were called in only because of their equipment and expertise. No wrongdoing is suspected and no criminal investigation is planned, he said.
CDC experts are investigating the incident in order to determine why the bacteria were not “inactivated” by the standard procedure of immersion in a hot-water bath, Voss said. CDC officials could not be reached for comment.
Voss said that before the anthrax was shipped, the sample was tested for the presence of live bacteria, but none was detected.
”We’re trying to go through the lab notebooks and make sure we know
(Carelessness, Poor Training, and Poor Judgment)
Testimony of: Lynn C. Klotz, PhD
Scientists Working Group on Chemical and Biological Weapons Center for Arms Control and Non Proliferation
Today, I wish to address public-health risk from human error in Biosafety-level 3 and 4 laboratories. These errors include accidents from carelessness or inadequate training, or poor judgment. Intensive public-health, scientific and political oversight of biosafety laboratories can reduce this risk.
I will illustrate human error with a few of many recent, real examples.
Documentation is provided in Attachment II.
Accidents involving dangerous pathogens
Here are two examples from a number of recent accidents involving work with dangerous pathogens.
The first example:
Southern Research Institute accidentally shipped the deadly Ames strain of anthrax from Frederick Maryland to a Research Institute associated with a Children’s Hospital in Oakland California. The anthrax was live. It was supposed to have been killed before shipping. After experimental mice died when injected with the anthrax, five vaccine researchers at the Oakland facility were placed on antibiotics. Fortunately, the anthrax was in liquid form, not the potentially very deadly powder.
This accident appears to be the result of either carelessness or inadequate training of Southern Research Institute employees.
The recent accident at Boston University where students were infected with tularemia is strikingly similar to the Oakland anthrax story. The BU researchers thought they were working with non infectious tularemia shipped to them from a Nebraska laboratory.
The second example:
Less than two months ago, a Cincinnati company, Meridian Bioscience, shipped a very deadly influenza virus to 5,000 diagnostic laboratories in 18 countries. This particular virus killed between 1 million and 4 million people around the world in the year 1957. The virus was to be used as a quality control sample. A non-deadly virus would have served just as well for quality control.
While the Centers for Disease Control downplayed the incident,
“The risk is low and we've taken appropriate action.” Others, such as the World Health Organization were not so reassuring, “If someone does get infected, the risk of severe illness is high, and this virus has shown to be fully transmissible.” That is, a deadly epidemic could ensue.
This accident is likely a case of very poor judgment.
These are only two of many recent accidents over the last four years
involving deadly pathogens such as biological weapons agents.
Poor judgment
Here is another kind of poor judgment involving the conduct of dangerous experiments without adequate discussion and oversight.
At least three university laboratories are conducting experiments on
the recently resurrected 1918 pandemic flu virus. The goal is to
understand why it was so deadly.
This flu virus killed 40 million people worldwide in 1918 to 1919.
The virus has not been in contact with the world’s population
since then—until now.
What seems incredible to me is that much of the present research on the resurrected 1918 flu virus is being carried out in BSL3 laboratories, not the highest level of biocontainment. My grave concern is better conveyed by someone recognized as a world-class expert on deadly pathogens. I quote, “The potential implications of an infected lab worker – and spread beyond the lab – are terrifying…” This quote is from D. A. Henderson, formerly chairman of the U.S. Council on Public Health Preparedness and the key scientist in eliminating smallpox from the world.
Conclusions
If biosafety labs and money for research are available, scientists will dream up experiments to get funded to do deadly pathogen research. For most academic research, “free and independent pursuit” of knowledge is a good thing. But for research that involves deadly pathogens, “free and independent pursuit” is not a good thing. University biosafety laboratories will be inhabited, by and large, by young scientists. Fort Detrick, by comparison, is populated by older scientists, well trained in the ways of working safely with dangerous pathogens. And even at Fort Detrick there have been a number of accidents. I judge the risk of accidents
to be much greater in university biosafety laboratories.
While many scientists abhor oversight and will argue strongly against it, the people of Massachusetts should not be persuaded by their arguments. Intensive local-community regulation and oversight of biosafety labs is necessary to reduce the risk of devastating disease from poor judgment caused by scientific curiosity. Misadventure motivated by ego, arrogance, or greed is also not out of the question.
Of course, we cannot eliminate all risk from these labs. And we must
be prepared to tolerate some risk to help prevent natural epidemics
and to protect ourselves against biological weapons. But it behooves
us to be very cautious, so the dangers from our own research
activities do not exceed the risk of natural epidemics and attacks
with biological weapons.
Regulation and intensive oversight of biosafety laboratories is necessary to reduce the risk of devastating disease caused by human error in a laboratory. Another risk-reducing action that the State of Massachusetts must take is to insist on locating Biosafety level 3 and 4 laboratories as far outside population centers as is practical.
Attachment I. Brief Biography
Lynn Klotz, PhD, is expert in many areas of biological-weapons control. He was formerly with the Scientists Working Group on Biological Weapons Control at the Federation of American Scientists and is presently with the Center for Arms Control andNon Proliferation. He has published several papers on biological- and chemical-weaponsissues relating to biotechnology, industry, and the now-abandoned BWC Protocol.
In addition to his arms control activities, Dr. Klotz has worked as
a consultant in technical and business strategy for more than a
dozen biotechnology companies and universities. He participated in
the founding of five biotechnology companies: BioTechnica
International, BioTechnica Diagnostics, BioTal, Oncor
Pharmaceuticals (renamed Codon), and Precision Genetics.
Dr. Klotz was Associate Professor Biochemistry and Molecular Biology at Harvard University. He served as Vice President and was a Board Member of BioTechnica International. He also was Professor and Course Director, at the Harvard University Summer Executive Program, for the course "Biotechnology and Modern Drug Discovery and Development."
Dr. Klotz has published over 40 research papers and review articles in leading scientific journals, and numerous articles on biotechnology business articles and on biological weapons arms control. He was recipient of a Camille and Henry Dreyfus Foundation, Teacher-Scholar Grant. He coauthored with Edward Sylvester "The Gene Age: Genetic Engineering and the Next Industrial Revolution," which was nominated for Pulitzer Prize by the publisher, Charles Scribner's Sons.
Attachment II. Newspaper Articles Relevant to the Testimony
Accidents involving dangerous pathogens
Live anthrax accidentally shipped from Frederick to California lab
Exposed workers undergo treatment; CDC opens investigation of slipup
By Scott Shane
Sun Staff
The federal Centers for Disease Control and Prevention are
investigating how a Frederick research institute mistakenly
shipped live anthrax bacteria to a California lab where
at least five people were exposed to the potentially
deadly germs.
The five vaccine researchers at Children’s Hospital Oakland Research
Institute were placed on antibiotics and none has shown symptoms
of infection, said Bev Mikalonis, a hospital spokeswoman.
Scientists at Southern Research Institute in Frederick intended to
send dead anthrax bacteria to their collaborators in Oakland, said
Thomas G. Voss, vice president of homeland security and emerging
infectious diseases at the institute.
The killed germs were to be injected into mice to produce antibodies
against the disease, one step toward developing an improved vaccine.
But when the mice were inoculated over the past two weeks, nearly
all died, prompting the researchers to perform tests to determine
the cause of death.
When the tests confirmed that the mice had died of anthrax, state and
federal health officials were notified and researchers who had contact
with the anthrax samples or the mice were placed on the antibiotic
Cipro as a precaution, Mikalonis said.
FBI agents from a bioterrorism unit in San Francisco removed the
bacteria from the Oakland facility Wednesday.
Bill Carter, a spokesman at FBI headquarters in Washington, said bureau personnel were called in only because of their equipment and expertise. No wrongdoing is suspected and no criminal investigation is planned, he said.
CDC experts are investigating the incident in order to determine why the bacteria were not “inactivated” by the standard procedure of immersion in a hot-water bath, Voss said. CDC officials could not be reached for comment.
Voss said that before the anthrax was shipped, the sample was tested for the presence of live bacteria, but none was detected.
”We’re trying to go through the lab notebooks and make sure we know
what was done and how it was done,” Voss said. “We may need to
increase the sensitivity level on our testing.”
Voss said there was no danger to Southern Research personnel
Voss said there was no danger to Southern Research personnel
because they always use protective equipment in handling anthrax
and are vaccinated against the disease.
The anthrax was shipped in March from Frederick to Oakland, where
The anthrax was shipped in March from Frederick to Oakland, where
it was stored in test tubes. Voss said even killed bacteria are
transported in plastic tubes enclosed in a sealed container inside
a secure shipping box.
On May 28, it was injected into 10 mice, all of which were found dead May 31. A second group of 40 mice were inoculated June 4, and all but one were found dead Monday, Mikalonis said.
Only then did the scientist in charge of the project learn that the mice had died and begin an inquiry, she said.
Southern Research Institute, founded in 1942 and based in
On May 28, it was injected into 10 mice, all of which were found dead May 31. A second group of 40 mice were inoculated June 4, and all but one were found dead Monday, Mikalonis said.
Only then did the scientist in charge of the project learn that the mice had died and begin an inquiry, she said.
Southern Research Institute, founded in 1942 and based in
Birmingham, Ala., is a not-for- profit organization that
conducts research under contracts with the government
and private companies.
Its infectious disease branch in Frederick employs 70 people, including 20 who work on biodefense and emerging diseases, Voss said. The Frederick lab is rated at Biosafety Level 3, the second- highest level of security, Voss said.
That is sufficient to work with anthrax, which the lab has used for research on vaccines, antibiotics and germ detection methods since 2001, he said.
******************************
Scientists Scramble to Destroy Flu Strain
By EMMA ROSS and MARILYNN MARCHIONE
AP Medical Writers
Scientists around the world were scrambling to prevent the possibility of a pandemic after a nearly 50-year-old killer influenza virus was sent to thousands of labs, a decision that one researcher described as ``unwise.''
Nearly 5,000 labs in 18 countries, mostly in the United States, were urged by the World Health Organization to destroy samples of the dangerous virus because of the slight risk it could trigger a global outbreak. The labs received the virus from a U.S. company that supplies kits used for quality control tests.
``The risk is low and we've taken appropriate action,'' said Dr.
Nancy Cox, chief of the influenza branch at the Centers for Disease Control and Prevention in Atlanta. Her counterpart at WHO, Klaus Stohr, agreed but
said, ``If someone does get infected, the risk of severe illness is high,
and this virus has shown to be fully transmissible.''
The germ, the 1957 H2N2 ``Asian flu'' strain, killed between
Its infectious disease branch in Frederick employs 70 people, including 20 who work on biodefense and emerging diseases, Voss said. The Frederick lab is rated at Biosafety Level 3, the second- highest level of security, Voss said.
That is sufficient to work with anthrax, which the lab has used for research on vaccines, antibiotics and germ detection methods since 2001, he said.
******************************
Scientists Scramble to Destroy Flu Strain
By EMMA ROSS and MARILYNN MARCHIONE
AP Medical Writers
Scientists around the world were scrambling to prevent the possibility of a pandemic after a nearly 50-year-old killer influenza virus was sent to thousands of labs, a decision that one researcher described as ``unwise.''
Nearly 5,000 labs in 18 countries, mostly in the United States, were urged by the World Health Organization to destroy samples of the dangerous virus because of the slight risk it could trigger a global outbreak. The labs received the virus from a U.S. company that supplies kits used for quality control tests.
``The risk is low and we've taken appropriate action,'' said Dr.
Nancy Cox, chief of the influenza branch at the Centers for Disease Control and Prevention in Atlanta. Her counterpart at WHO, Klaus Stohr, agreed but
said, ``If someone does get infected, the risk of severe illness is high,
and this virus has shown to be fully transmissible.''
The germ, the 1957 H2N2 ``Asian flu'' strain, killed between
1 million and 4 million people. It has not been included in flu
vaccines since 1968, and anyone born after that date has
little or no immunity to it.
The WHO said Tuesday that there have been no reports of infections
in laboratory workers associated with the distribution of the samples
and that ``the risk for the general population is also considered low.''
Still, the decision to send out the strain was described by Stohr as
'`unwise'' and ``unfortunate.''
The CDC learned Friday that test kits prepared by Meridian Bioscience Inc. of Cincinnati contained the virus. The company makes kits for at least four groups that help labs do proficiency testing, which involves identifying viruses to check a lab's quality controls or to acquire certification.
The largest of those groups, the College of American Pathologists,
The WHO said Tuesday that there have been no reports of infections
in laboratory workers associated with the distribution of the samples
and that ``the risk for the general population is also considered low.''
Still, the decision to send out the strain was described by Stohr as
'`unwise'' and ``unfortunate.''
The CDC learned Friday that test kits prepared by Meridian Bioscience Inc. of Cincinnati contained the virus. The company makes kits for at least four groups that help labs do proficiency testing, which involves identifying viruses to check a lab's quality controls or to acquire certification.
The largest of those groups, the College of American Pathologists,
said it had sent 3,747 kits to various labs starting last year
and ending in February.
Dr. Jared Schwartz, an official with the pathology college, said Meridian was told to pick an influenza sample and chose from its stockpile the deadly 1957 strain, which it had received from a ``germ library'' in 2000.
Other test kit providers also used the strain. Schwartz identified them as Medical Lab Evaluators, the American Association of Bioanalysts and the American Association of Family Practitioners.
Officials at Meridian could not immediately be reached for comment
late Tuesday after business hours.
Most of the labs that received the test kits were in the United States, Stohr said. Fourteen were in Canada and 61 samples went to labs in 16 countries in Europe, Asia, the Middle East and South America, according to the WHO.
Some of the labs outside the United States have already incinerated
their samples, he said, and WHO hoped the rest of the vials would
be destroyed by Friday. The health agency would not name the
other countries whose labs received the samples.
The kits contain blind samples that labs must correctly identify to pass the test. The influenza virus included in the kits typically is one that is currently circulating or has recently circulated.
A Canadian laboratory detected the 1957 pandemic strain on March
26 in a sample that was later traced to a test kit.
The WHO notified health authorities in countries that received the kits and recommended that all samples be destroyed. The College of American Pathologists asked labs to incinerate the samples immediately and confirm their actions in writing.
The virus' presence in thousands of labs focused fresh attention on the safe handling of deadly germs - an issue that led to toughened U.S. rules after anthrax was sent in the mail in 2001, killing five Americans.
Cox said officials strongly doubt someone deliberately planted the dangerous germ. ``It wouldn't be a smart way to start a pandemic to send it to laboratories because we have people well trained in biocontainment,'' she said.
But Stohr said the test kits are not the only supplies of the 1957 pandemic strain sitting in laboratories around the world. ``The world really has to think what routine labs should be doing with these samples they have kept in the back of their fridges,'' he said.
******************************
Faulty Aerosol Chamber Infects Three
The Sunshine Project
News Release
18 April 2005
NIAID Encourages Use of Leaky Device in Biodefense
Chambers 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….
******************************
Lab tightens policy after lax anthrax spore study
By DUNCAN MANSFIELD
Associated Press
KNOXVILLE — Dead anthrax spores used in research were not hazardous but still should have been handled more carefully by the Oak Ridge National Laboratory, according to federal investigators.
''While not a safety hazard, dead anthrax spores can cause false-positive results in biological detectors,'' the Department of Energy's inspector general said in a report released yesterday.
At a time when terrorists are searching for weapons of mass destruction, and live anthrax spores could be such a weapon, ''a false positive result could cause public panic and unnecessary deployment of emergency response resources,'' the report said.
The probe focused on an unnamed ''guest researcher,'' a former lab employee, who used a specific laboratory and its equipment in the Oak Ridge complex ''without authorization to conduct research on the anthrax spores'' in 2003.
The investigators said the slack manner in which the lab kept track of 20 vials of dead anthrax spores — routinely leaving them out on a lab countertop after normal working hours and failing to advise senior lab officials of the researcher's project — violated the lab's own security protocols.
In response, DOE-Oak Ridge Manager Gerald Boyd said lab contractors, the University of Tennessee and Battelle Memorial Institute would work to ''strengthen the program ... to assure that only authorized researchers are conducting work.''
''We followed our approved security procedures in handling this material,'' insisted Jeff Smith, the lab's deputy director of operations.
''We did authorize the work. However, some of the work was conducted in a laboratory not specifically designated for that work.''
An anonymous complaint to the inspector general suggested that still ''created a safety concern because the guest researcher used the same equipment as other laboratory workers'' who didn't know about it, the report said.
During the course of its investigation, the inspector general identified 55 other researchers who failed to file appropriate documentation to support the work on their specific projects. The lab promised to improve the system and its inventory controls of biological materials.
© Copyright 2005 The Tennessean
******************************
Dangerous experiments
10:33 21 October 04
Exclusive from New Scientist Print Edition.
The 1918 flu virus spread across the world in three months and killed at least 40 million people. If it escaped from a lab today, the death toll could be far higher. “The potential implications of an infected lab worker – and spread beyond the lab – are terrifying,” says D. A. Henderson of the University of Pittsburgh, a leading biosecurity expert.
Yet despite the danger, researchers in the US are working with reconstructed versions of the virus at less than the maximum level of containment. Many other experts are worried about the risks. “All the virologists I have spoken to have concerns,” says Ingegerd Kallings of the Swedish Institute for Infectious Disease Control in Stockholm, who helped set laboratory safety standards for the World Health Organization. Work on the 1918 flu virus is not the only worry. Some experiments with bird flu have also been criticised as dangerous (New Scientist print edition, 28 February 2004). Kallings and others are calling for international discussions to resolve the issues related to such work. “It is time for influenza scientists to find a consensus on containment,” she says. John MacKenzie of the University of Queensland in Australia, who investigated how the SARS virus escaped from high-level containment labs in east Asia on three occasions after lab workers became infected, agrees. “A meeting would be beneficial.”
Gene sequencing
The researchers working on the 1918 virus say their work is vital to
understand what changes make flu viruses dangerous. So far five of
the 1918 flu virus’s eight genes have been sequenced, using
fragments retrieved from victims of the pandemic. Several teams have
added one or more of these genes to modern flu viruses, or plan to –
in effect partially recreating the long-vanished pandemic virus.
The latest work was done by Yoshihiro Kawaoka at the University of
Wisconsin at Madison. His team showed that adding the 1918 gene
for the surface protein haemagglutinin to modern viruses made
them far deadlier to mice. The researchers also found that people
born after 1918 have little or no immunity.
The team started the work at the highest level of containment, BSL-4,
at Canada’s National Microbiology Laboratory in Winnipeg. Then they
decided the viruses were safe enough to handle at the next level
down, and did the rest of the work across the border in a BSL-3Ag lab
in Madison. The main difference between BSL-4 and BSL-3Ag is that
precautions to ensure staff do not get infected are less stringent:
while BSL-4 involves wearing fully enclosed body suits, those working
at BSL-3Ag labs typically have half-suits.
Kawaoka told New Scientist that the decision to move down to BSL-3Ag was taken only after experiments at BSL-4 showed that giving mice the antiviral drug oseltamivir (Tamiflu) in advance prevented them getting sick. This means, he says, that if all lab workers take oseltamivir “they cannot become infected”.
Contradictory results
Yet this assumes that the mouse results apply to humans. And the findings have not been published. In similar experiments, Terrence Tumpey’s team at the US Department of Agriculture’s poultry research lab in Athens, Georgia, got quite different results: they found that mice given oseltamivir still got sick and 1 in 10 died. It is not clear why Kawaoka’s mice fared better.
What is more, all the safety precautions are aimed at preventing escape, not dealing with it should it occur. If any of Kawaoka’s lab workers are exposed to the virus despite all the precautions, and become infected despite taking oseltamivir, the consequences could be disastrous.
“I experienced disbelief…regarding the decision to relocate the reconstructed 1918 influenza strain from a BSL-4 facility to a BSL-3 facility, based on its susceptibility to antiviral medication,” Ronald Voorhees, chief medical officer at the New Mexico Department of Health, wrote on ProMED-mail, an infectious diseases mailing list. Yet Kawaoka’s decision does comply with the US National Institutes of Health guidelines for BSL-3 agents: those causing “serious or lethal human disease for which preventive or therapeutic interventions may be [its italics] available”. In fact, he is considered unusually cautious. “Kawaoka should be applauded for using BSL-4 at all,” says Richard Webby, a flu researcher at St Jude’s Children’s Hospital in Memphis, Tennessee.
Exposing monkeys
Dr. Jared Schwartz, an official with the pathology college, said Meridian was told to pick an influenza sample and chose from its stockpile the deadly 1957 strain, which it had received from a ``germ library'' in 2000.
Other test kit providers also used the strain. Schwartz identified them as Medical Lab Evaluators, the American Association of Bioanalysts and the American Association of Family Practitioners.
Officials at Meridian could not immediately be reached for comment
late Tuesday after business hours.
Most of the labs that received the test kits were in the United States, Stohr said. Fourteen were in Canada and 61 samples went to labs in 16 countries in Europe, Asia, the Middle East and South America, according to the WHO.
Some of the labs outside the United States have already incinerated
their samples, he said, and WHO hoped the rest of the vials would
be destroyed by Friday. The health agency would not name the
other countries whose labs received the samples.
The kits contain blind samples that labs must correctly identify to pass the test. The influenza virus included in the kits typically is one that is currently circulating or has recently circulated.
A Canadian laboratory detected the 1957 pandemic strain on March
26 in a sample that was later traced to a test kit.
The WHO notified health authorities in countries that received the kits and recommended that all samples be destroyed. The College of American Pathologists asked labs to incinerate the samples immediately and confirm their actions in writing.
The virus' presence in thousands of labs focused fresh attention on the safe handling of deadly germs - an issue that led to toughened U.S. rules after anthrax was sent in the mail in 2001, killing five Americans.
Cox said officials strongly doubt someone deliberately planted the dangerous germ. ``It wouldn't be a smart way to start a pandemic to send it to laboratories because we have people well trained in biocontainment,'' she said.
But Stohr said the test kits are not the only supplies of the 1957 pandemic strain sitting in laboratories around the world. ``The world really has to think what routine labs should be doing with these samples they have kept in the back of their fridges,'' he said.
******************************
Faulty Aerosol Chamber Infects Three
The Sunshine Project
News Release
18 April 2005
NIAID Encourages Use of Leaky Device in Biodefense
Chambers 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….
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Lab tightens policy after lax anthrax spore study
By DUNCAN MANSFIELD
Associated Press
KNOXVILLE — Dead anthrax spores used in research were not hazardous but still should have been handled more carefully by the Oak Ridge National Laboratory, according to federal investigators.
''While not a safety hazard, dead anthrax spores can cause false-positive results in biological detectors,'' the Department of Energy's inspector general said in a report released yesterday.
At a time when terrorists are searching for weapons of mass destruction, and live anthrax spores could be such a weapon, ''a false positive result could cause public panic and unnecessary deployment of emergency response resources,'' the report said.
The probe focused on an unnamed ''guest researcher,'' a former lab employee, who used a specific laboratory and its equipment in the Oak Ridge complex ''without authorization to conduct research on the anthrax spores'' in 2003.
The investigators said the slack manner in which the lab kept track of 20 vials of dead anthrax spores — routinely leaving them out on a lab countertop after normal working hours and failing to advise senior lab officials of the researcher's project — violated the lab's own security protocols.
In response, DOE-Oak Ridge Manager Gerald Boyd said lab contractors, the University of Tennessee and Battelle Memorial Institute would work to ''strengthen the program ... to assure that only authorized researchers are conducting work.''
''We followed our approved security procedures in handling this material,'' insisted Jeff Smith, the lab's deputy director of operations.
''We did authorize the work. However, some of the work was conducted in a laboratory not specifically designated for that work.''
An anonymous complaint to the inspector general suggested that still ''created a safety concern because the guest researcher used the same equipment as other laboratory workers'' who didn't know about it, the report said.
During the course of its investigation, the inspector general identified 55 other researchers who failed to file appropriate documentation to support the work on their specific projects. The lab promised to improve the system and its inventory controls of biological materials.
© Copyright 2005 The Tennessean
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Dangerous experiments
10:33 21 October 04
Exclusive from New Scientist Print Edition.
The 1918 flu virus spread across the world in three months and killed at least 40 million people. If it escaped from a lab today, the death toll could be far higher. “The potential implications of an infected lab worker – and spread beyond the lab – are terrifying,” says D. A. Henderson of the University of Pittsburgh, a leading biosecurity expert.
Yet despite the danger, researchers in the US are working with reconstructed versions of the virus at less than the maximum level of containment. Many other experts are worried about the risks. “All the virologists I have spoken to have concerns,” says Ingegerd Kallings of the Swedish Institute for Infectious Disease Control in Stockholm, who helped set laboratory safety standards for the World Health Organization. Work on the 1918 flu virus is not the only worry. Some experiments with bird flu have also been criticised as dangerous (New Scientist print edition, 28 February 2004). Kallings and others are calling for international discussions to resolve the issues related to such work. “It is time for influenza scientists to find a consensus on containment,” she says. John MacKenzie of the University of Queensland in Australia, who investigated how the SARS virus escaped from high-level containment labs in east Asia on three occasions after lab workers became infected, agrees. “A meeting would be beneficial.”
Gene sequencing
The researchers working on the 1918 virus say their work is vital to
understand what changes make flu viruses dangerous. So far five of
the 1918 flu virus’s eight genes have been sequenced, using
fragments retrieved from victims of the pandemic. Several teams have
added one or more of these genes to modern flu viruses, or plan to –
in effect partially recreating the long-vanished pandemic virus.
The latest work was done by Yoshihiro Kawaoka at the University of
Wisconsin at Madison. His team showed that adding the 1918 gene
for the surface protein haemagglutinin to modern viruses made
them far deadlier to mice. The researchers also found that people
born after 1918 have little or no immunity.
The team started the work at the highest level of containment, BSL-4,
at Canada’s National Microbiology Laboratory in Winnipeg. Then they
decided the viruses were safe enough to handle at the next level
down, and did the rest of the work across the border in a BSL-3Ag lab
in Madison. The main difference between BSL-4 and BSL-3Ag is that
precautions to ensure staff do not get infected are less stringent:
while BSL-4 involves wearing fully enclosed body suits, those working
at BSL-3Ag labs typically have half-suits.
Kawaoka told New Scientist that the decision to move down to BSL-3Ag was taken only after experiments at BSL-4 showed that giving mice the antiviral drug oseltamivir (Tamiflu) in advance prevented them getting sick. This means, he says, that if all lab workers take oseltamivir “they cannot become infected”.
Contradictory results
Yet this assumes that the mouse results apply to humans. And the findings have not been published. In similar experiments, Terrence Tumpey’s team at the US Department of Agriculture’s poultry research lab in Athens, Georgia, got quite different results: they found that mice given oseltamivir still got sick and 1 in 10 died. It is not clear why Kawaoka’s mice fared better.
What is more, all the safety precautions are aimed at preventing escape, not dealing with it should it occur. If any of Kawaoka’s lab workers are exposed to the virus despite all the precautions, and become infected despite taking oseltamivir, the consequences could be disastrous.
“I experienced disbelief…regarding the decision to relocate the reconstructed 1918 influenza strain from a BSL-4 facility to a BSL-3 facility, based on its susceptibility to antiviral medication,” Ronald Voorhees, chief medical officer at the New Mexico Department of Health, wrote on ProMED-mail, an infectious diseases mailing list. Yet Kawaoka’s decision does comply with the US National Institutes of Health guidelines for BSL-3 agents: those causing “serious or lethal human disease for which preventive or therapeutic interventions may be [its italics] available”. In fact, he is considered unusually cautious. “Kawaoka should be applauded for using BSL-4 at all,” says Richard Webby, a flu researcher at St Jude’s Children’s Hospital in Memphis, Tennessee.
Exposing monkeys
By contrast, the team in Georgia, the first to experiment with genetically engineered 1918 viruses, did all its work at BSL-3Ag. Meanwhile, Michael Katze at the University of Washington at Seattle is planning to expose monkeys to aerosols of 1918-type viruses at BSL-3, a step down from BSL-3Ag. The recent SARS escapes were from BSL-3 labs. “We would have to do any such work at BSL-4,” says John Wood of the UK’s National Institute for Biological Standards and Control. In the US, the differing standards applied by different groups are due to the fact that experiments on engineered viruses such as the 1918 flu are approved on a case-by-case basis by Institutional Biosafety Committees (IBCs), composed of local scientists and officials. Critics say these are free to interpret the official guidelines in a way that suits them.
“There is no effective national system to ensure consistency,
responsibility and good judgement in such research,” says
Edward Hammond of the Sunshine Project, a biosecurity
pressure group in Austin, Texas. In a review of IBCs
published this month, he found that many would not provide
minutes of recent meetings as required by law.
He says the IBC that approved the planned 1918 flu study at the
University of Washington considered only one scenario that
could result in workers being exposed to airborne virus – the
dropping of samples. Its solution: lab workers “will be trained
to stop breathing”.
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http://www.newscientist.com/news/news.jsp?id=ns99994713
Superflu is being brewed in the lab
After the worldwide alarm triggered by 2003's SARS outbreak, it might seem reckless to set about creating a potentially far more devastating virus in the lab. But that is what is being attempted by some researchers, who argue that the dangers of doing nothing are even greater.
We already know that the H5N1 bird flu virus ravaging poultry farms in Asia can be lethal on the rare occasions when it infects people. Now a team is tinkering with its genes to see if it can turn into a strain capable of spreading from human to human. If they manage this, they will have created a virus that could kill tens of millions if it got out of the lab.
Many researchers say experiments like this are needed to answer crucial questions. Why can a few animal flu viruses infect humans? What makes the viruses deadly? And what changes, if any, would enable them to spread from person to person and cause pandemics that might prove far worse than that of 1918? Once we know this, they argue, we will be better prepared for whatever nature throws at us.
Others disagree. It is not clear how much we can learn from such work, they argue. And they point out that it is already possible to create a vaccine by other means. The work is simply too dangerous, they say.
"I'm getting bombarded from both sides," says Ronald Atlas, head of the Center for
Deterrence of Biowarfare and Bioterrorism at the University of Louisville in Kentucky. "Some say that this sort of research is dangerous because of the risk of the virus escaping or being using in bioterrorism, and others that it's good science."
Rodents and monkeys
Some researchers refuse to discuss their plans. But Jacqueline Katz at the US Centers for Disease Control (CDC) in Atlanta, Georgia, told New Scientist her team is already tweaking the genes of the H5N1 bird flu virus that killed several people in Hong Kong in 1997, and those of the human flu virus H3N2.
She is testing the ability of the new viruses to spread by air and cause disease in ferrets, whose susceptibility to flu appears to be remarkably similar to ours.
Albert Osterhaus of Erasmus University in Rotterdam in the Netherlands plans to test altered viruses on rodents and macaque monkeys. Other groups are also considering similar experiments, he says.
If such work were to show that H5N1 could cause a human pandemic, everything that is happening in Asia would be even more alarming, Osterhaus argues. If, on the other hand, it failed to transform H5N1 into a highly contagious human virus, we could relax. "It becomes a veterinary health problem, not a public health problem. That would be an enormous relief."
Cell cultures
But Wendy Barclay of the University of Reading in the UK, who "thought long and hard" about trying to create a pandemic flu virus before abandoning the idea, disagrees. "If you get a negative, how can you be sure that you have tested every option?" she says. Health authorities would still have to take the precaution of creating H5N1 vaccines. Barclay concedes, however, that creating a virus that spreads in people might tell us how real the threat is. For instance, do you need one mutation for H5N1 to adapt to humans, or dozens?
Osterhaus is more optimistic. "Within the next decade, the whole thing will be solved," he says. "We will know the rules." In other words, once experts understand what the genetic sequence of any flu virus means, they could predict which animals it can infect, how severe it will be, and how easily it will spread.
Yet any new viruses could only be tested in human cell cultures or in animals, not on
people. None of these methods exactly reflects how flu behaves in humans. This has led some flu experts to argue that attempts to create a pandemic virus should be put on hold until there is agreement on the best way of testing it.
Mix flu genes
And there is an even more fundamental objection to such
experiments: the processes used to create the viruses
may be too artificial. Researchers who want to see if
H5N1 can be pandemic can take two approaches.
One is to tinker with the genome of the bird flu virus to mimic
mutations that might occur naturally. This can be done
precisely using a technique called reverse genetics. The other
approach is to mix bird flu genes with those of human flu
viruses, either using reverse genetics or through random
re-assortment in cells infected with both types.
Although re-assortment sounds more natural, there is a problem. "Re-assortments can be made very easily in the lab using cells or animals," says flu expert Graeme Laver,
formerly at the Australian National University in Canberra. "But one of the big mysteries is that [human] viruses that appear by reassortment are extremely rare in nature. There is something else involved that we don't understand."
Then there is the question of safety. The worst-case scenario is that researchers might end up engineering extremely dangerous viruses that would never have evolved naturally.
Masks or hoods
In 2001, for instance, Australian researchers created a mousepox virus far more virulent than any wild strains. This scenario is unlikely, but not impossible, says virologist Earl Brown of the University of Ottawa, Canada. "You could create something that is right out of whack, but I'd be surprised."
For those reasons, several prominent flu researchers told New
One is to tinker with the genome of the bird flu virus to mimic
mutations that might occur naturally. This can be done
precisely using a technique called reverse genetics. The other
approach is to mix bird flu genes with those of human flu
viruses, either using reverse genetics or through random
re-assortment in cells infected with both types.
Although re-assortment sounds more natural, there is a problem. "Re-assortments can be made very easily in the lab using cells or animals," says flu expert Graeme Laver,
formerly at the Australian National University in Canberra. "But one of the big mysteries is that [human] viruses that appear by reassortment are extremely rare in nature. There is something else involved that we don't understand."
Then there is the question of safety. The worst-case scenario is that researchers might end up engineering extremely dangerous viruses that would never have evolved naturally.
Masks or hoods
In 2001, for instance, Australian researchers created a mousepox virus far more virulent than any wild strains. This scenario is unlikely, but not impossible, says virologist Earl Brown of the University of Ottawa, Canada. "You could create something that is right out of whack, but I'd be surprised."
For those reasons, several prominent flu researchers told New
Scientist that the H5N1 experiments must be done at the
highest level of containment: Biosafety Level 4, or BSL-4.
But the CDC work is being done at BSL-3Ag, an intermediate
level between BSL-3 and BSL-4. Workers wear half-suits
with masks or hoods to prevent infection, for instance,
with masks or hoods to prevent infection, for instance,
rather than full-body suits as in BSL-4.
"US Department of Agriculture guidelines specify that work with highly
pathogenic avian strains be done in BSL-3+ (also known as BSL-3Ag) laboratories," a CDC spokeswomen says.
One of the reasons is that the H5N1 virus is regarded as a non-
contagious, treatable disease in humans. But this is not
necessarily true of all of the genetically engineered strains that
might be created. And drug supplies would quickly run out if
an escaped virus triggered a major epidemic.
New variants
A recent report by the US National Academy of Sciences
recommends a series of checks be put in place to control
such research. It says a panel of leading scientists and
security experts should be set up to regulate it.
"Some public representation is another option," says Atlas, who
helped draw up the report. At the moment, however, such
experiments can be carried out without any special consultation.
Methods like reverse genetics might also be used to create new variants of other diseases.
"You can make some pretty unusual things new viruses that would
never have existed in nature," says Barclay. "It's not just an issue for flu."
Original report posted here.
"US Department of Agriculture guidelines specify that work with highly
pathogenic avian strains be done in BSL-3+ (also known as BSL-3Ag) laboratories," a CDC spokeswomen says.
One of the reasons is that the H5N1 virus is regarded as a non-
contagious, treatable disease in humans. But this is not
necessarily true of all of the genetically engineered strains that
might be created. And drug supplies would quickly run out if
an escaped virus triggered a major epidemic.
New variants
A recent report by the US National Academy of Sciences
recommends a series of checks be put in place to control
such research. It says a panel of leading scientists and
security experts should be set up to regulate it.
"Some public representation is another option," says Atlas, who
helped draw up the report. At the moment, however, such
experiments can be carried out without any special consultation.
Methods like reverse genetics might also be used to create new variants of other diseases.
"You can make some pretty unusual things new viruses that would
never have existed in nature," says Barclay. "It's not just an issue for flu."
Original report posted here.
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