As biodefense research booms, reward is weighed against risk
http://www.star-telegram.com/state_news/story/211098.html
As biodefense research booms, reward is weighed against risk
By PETE ALFANO, Star-Telegram Staff Writer
Ellen Vitetta is a chairwoman at the Cancer Immunobiology Center at UT Southwestern Medical Center in Dallas. Her research centers on ricin, a potentially lethal toxin that paradoxically may have benefits as a vaccine to fight cancer.
But her work interested the federal government for different reasons.
In the aftermath of the anthrax attacks in October 2001, bioterrorism was seen as more than just an idle threat.
The drumbeat for more biodefense spending as part of the war on terror resulted in passage of Project BioShield in 2004, which appropriated $6 billion for research over 10 years.
"If I had put in for a federal grant for ricin vaccine pre-9-11, it would have come back in a garbage pail," Vitetta said.
But because ricin is a potential biological weapon, UT Southwestern received a federal grant to continue its research -- with a dual purpose.
While she is somewhat dismayed that her work has been co-opted in the name of national security, Vitetta is hopeful that in the long run a ricin vaccine will help win the war on cancer as well as the war on terror.
"We'll use the money to learn as much as we can," she said, "and be poised to use vaccines [in a way] that are more useful to the American public."
Biological and chemical warfare may be as old as conflict itself, but before anthrax-laced letters infected 22 people, resulting in five deaths, research in the U.S. had been almost exclusively the domain of the military.
Now, some estimate that more than 400 university laboratories alone are involved in biodefense research, up from a handful just a decade ago.
Many research labs work with infectious agents such as Ebola, anthrax, West Nile virus, Q fever, tularemia and avian flu, as well as emerging drug-resistant forms of tuberculosis. Others work with more garden-variety organisms.
"Everyone and their cousins are trying to get into it because it's where the money is and it's necessary," said Ronald Blanck, former president of the University of North Texas Health Science Center, who previously served as the U.S. Army surgeon general and commander of the Army's medical branch during a 32-year military career.
He says that even though the focus is on biodefense, the expanded research will eventually benefit public health.
"The work being done is beginning to leverage against threats from naturally occurring diseases like avian flu," he says. "A lot of the infrastructure for biological-weapons research is also preparing us to deal with things like a flu epidemic."
But there is grumbling in the scientific community among researchers who feel that they have been "drafted" into working on national defense.
And watchdog organizations say that the facilities conducting research have proliferated to extremes, increasing the risk of accidents or security breaches and making oversight more difficult for federal agencies.
Edward Hammond, director of the Sunshine Project in Austin, says that government oversight is not stringent enough, that laboratory security is suspect and that accidents sometimes go unreported, or worse, are covered up.
"Ultimately we don't need 400 institutions across the U.S. working on biological-weapons agents," Hammond said. "We've gone way overboard. I request records from universities, and there are wildly divergent interpretations of what constitutes security.
"They're all doing it by the seat of their pants."
Ronald Kendall, director of the Institute of Environmental and Human Health at Texas Tech University, defends the escalation in biodefense spending, saying, "When we [Tech] got into it in 1998, there was a national consortium of just four universities. It might be debated whether we are overreacting ... but the consensus of 16 intelligence agencies is that there is a high level of threat from an attack.
"If we don't prepare ourselves, the consequences could be devastating."
But Hammond -- who does not argue with the need for biodefense research, only the scope of it -- says the popular notion that an international terrorist will smuggle biological weapons into the U.S. is not nearly as likely as an accident or a nefarious act by a rogue scientist, which may have occurred in the 2001 anthrax attacks. The crimes have not been solved.
"The greatest threat is not going to be a guy in a turban but in our own biochemical labs," Hammond said.
Incidents at Texas A&M
Are Hammond's allegations the rhetoric of an overzealous, self-appointed public whistle-blower? Or does he have a valid case?
In July, the Centers for Disease Control and Prevention temporarily suspended work at Texas A&M's Level 3 biosafety lab for failing to report two separate incidents in which workers became ill working with infectious agents. Probing by the Sunshine Project brought the violations to light.
Three lab workers were infected with Q fever and one other with the agent Brucella. None of the cases was fatal, and none of those infected spread the diseases.
The CDC investigation has since found other violations of federal regulations at the College Station lab, and, early this month, the vice president who oversees biodefense research at A&M stepped down. The university chancellor has repudiated the lab's actions.
The revelations created a public relations nightmare for biodefense advocates.
"We're not at all pleased to learn that this happened," said Stanley Lemon, principal investigator for the University of Texas Medical Branch in Galveston, which has a BSL-4 lab, dealing with the highest-risk agents such as Ebola, for which there are no treatments or preventives.
"We try to be as faithful as possible to the laws. It is complicated because different agencies are involved, but I'm very comfortable with the level of security here."
Kendall of Texas Tech, which has a BSL-3 lab, called the incident "unfortunate," adding, "It's a barometer of society that when an organization or university makes a mistake, we're all lumped together."
Ironically, if ramping up fear among Americans about the threat of biological warfare was intended, in part, to drum up public support for biodefense spending -- as some conspiracy buffs theorize -- then the downside is that accidents may result in an overreaction by the public and in the media.
Gigi Kwik Gronvall, a senior associate at the Center for Biosecurity at University of Pittsburgh Medical Center, knows firsthand how public opinion can scuttle a growth industry. Her father worked at a nuclear power plant.
The nuclear-power industry suffered a catastrophic blow in the U.S. after an accident at Three Mile Island in Pennsylvania in 1979 produced a partial meltdown.
Although the danger of an explosion was remote, and inspections at the time and in the months afterward did not turn up abnormal radiation in the atmosphere, public confidence in nuclear energy waned.
Biodefense research may not be strictly analogous, but some of the same apprehensions are in play.
Proponents say the research being done in containment labs is not a significant risk to the public.
"Research labs work with relatively small amounts of agents, which are not weaponized, and only certain people have access to them," said Rona Hirschberg, a microbiologist and senior program officer for the National Institute of Allergy and Infectious Diseases. "I can't say there is no risk to the public at large, but the real danger in a lab is to the people who work there."
The Texas Tech institute, which does some work with ricin and screens for West Nile virus, has strict safeguards in place, said Steve Presley, a research coordinator involved with the program.
"We have three layers of secure access to the labs," he said, "and any agent or toxin at high risk is under locked access."
At UT Southwestern, Vitetta said there are significant amounts of ricin in the BSL-3 lab.
Security was one of the issues on the agenda a year ago when Gronvall of the University of Pittsburgh led a meeting of biodefense experts from around the country.
One recommendation from that meeting was to always keep the community informed and reassured.
The UT Medical Branch and the Texas Tech institute have advisory boards composed of people in the community, part of the effort to be more accountable to the public.
UTMB even lists accidents in its containment labs on its Web site.
BSL labs were not always so forthcoming. Credit for this type of disclosure has been given to the Sunshine Project, which uses open records requests to scrutinize laboratory practices and put pressure on the labs to be more forthcoming.
"It's about the right to know," Hammond said.
A strict system
Vitetta acquiesced to stepped-up security measures and the intrusion into her personal life imposed by the federal government when the emphasis of her ricin research shifted to biodefense.
Key codes and passwords are required to gain access to the lab and the bioagents.
Personnel are subject to background checks, and the FBI fingerprints them. There are site checks by the CDC.
"But there are no secret handshakes," she said.
"The system, though, is only as good as the people who work in the labs. We spend a lot of time with how things can be circumvented or sabotaged," Vitetta said. "My life is consumed with compliance."
At Texas Tech, the doors to the institute lock automatically at 5 p.m., said Kendall, the director. "We have a very sophisticated system. It's expensive, and it would take a pretty intense effort to get in.
"We know we can't afford to make mistakes relevant to exposure" even though the amounts of the materials involved are often small, Kendall said. "The stakes are high, and we have enormous public support."
This is not a Hollywood disaster movie in the making, the researchers say. Even if a terrorist were to gain access to a laboratory, finding an infectious agent would be difficult.
"There is no vial in a refrigerator labeled 'avian flu,'" said Lemon of UTMB.
Labs typically use only small quantities, and a great deal of scientific expertise would be needed to weaponize the bioagents.
Nonetheless, the recent events at Texas A&M will keep the biodefense industry under a microscope, and there is no way of knowing the ramifications as the CDC continues its investigation.
Will pop-quiz-type inspections increase? Will congressional subcommittees with oversight of biodefense issues begin asking pointed questions?
Will support erode for new BSL-4 labs, such as the one that San Antonio is vying for now?
"A lot of universities are trying really hard," Kendall said. "Mistakes don't help us."
ABOUT THE LABS
Research in bioterror and biomedicine is conducted in hundreds of laboratories at U.S. universities and centers. The biosafety research labs are classified by the type of organisms used and the risk posed to personnel. The Centers for Disease Control and Prevention stipulates standards for each level of laboratory and the degree of protection required for personnel, the environment and the community. Rona Hirschberg, a microbiologist and senior program officer for the National Institute of Allergy and Infectious Diseases, describes each level:
BSL-4
Work is with the most dangerous organisms and viruses as well as with some related viruses for which there are no effective vaccines or treatments. There is considerable risk to people working in these laboratories if they don't follow precautions. The staff must have training in handling extremely hazardous infectious agents and must understand the primary and secondary containment functions of standard and special practices, containment equipment, and laboratory design. Access is limited and controlled by the laboratory supervisor.
Types of agents: Ebola, plague, drug-resistant tuberculosis, hemorrhagic fevers, smallpox (only in CDC lab in Atlanta).
Texas sites: University of Texas Medical Branch, Galveston; Southwest Foundation for Biomedical Research, San Antonio
BSL-3
Work with dangerous organisms, particularly those transmitted through the air. In some cases, there are vaccines or effective treatments available. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents and must be supervised by scientists competent in handling infectious agents and associated procedures.
Types of agents: Anthrax, West Nile virus, Q fever, tularemia, avian flu.
Texas sites: University of Texas, Austin; Texas A&M; UT Southwestern, Dallas; UT Health Science Center, Houston; Texas Tech University
BSL-2
Work involves agents that cause human disease but pose only a minor risk and are not transmitted through the air. Access to the lab is restricted when work is being conducted; all procedures in which infectious aerosols or splashes may be created are conducted in designated physical containment equipment.
Type of agents: Staph, strep, salmonella, garden-variety influenza.
Texas sites: University and medical labs
BSL-1
Basically teaching labs found on most university campuses, and organisms do not cause human disease. Work involves well-characterized agents not known to consistently cause disease in healthy adult humans and presents minimal potential hazard to laboratory personnel and the environment. Special containment equipment or facility design is not required but may be used as determined by appropriate risk assessment. Basic precautions are still followed.
Type of agents: Soil bacteria and bacteria commonly found in food such as dairy products.
Texas sites: University and medical labs
Sources: Centers for Disease Control and Prevention, www.cdc.gov; National Institute of Allergy and Infectious Diseases, www3.niaid.nih.gov; Sunshine Project
Pete Alfano, 817-390-7985
palfano@star-telegram.com
As biodefense research booms, reward is weighed against risk
By PETE ALFANO, Star-Telegram Staff Writer
Ellen Vitetta is a chairwoman at the Cancer Immunobiology Center at UT Southwestern Medical Center in Dallas. Her research centers on ricin, a potentially lethal toxin that paradoxically may have benefits as a vaccine to fight cancer.
But her work interested the federal government for different reasons.
In the aftermath of the anthrax attacks in October 2001, bioterrorism was seen as more than just an idle threat.
The drumbeat for more biodefense spending as part of the war on terror resulted in passage of Project BioShield in 2004, which appropriated $6 billion for research over 10 years.
"If I had put in for a federal grant for ricin vaccine pre-9-11, it would have come back in a garbage pail," Vitetta said.
But because ricin is a potential biological weapon, UT Southwestern received a federal grant to continue its research -- with a dual purpose.
While she is somewhat dismayed that her work has been co-opted in the name of national security, Vitetta is hopeful that in the long run a ricin vaccine will help win the war on cancer as well as the war on terror.
"We'll use the money to learn as much as we can," she said, "and be poised to use vaccines [in a way] that are more useful to the American public."
Biological and chemical warfare may be as old as conflict itself, but before anthrax-laced letters infected 22 people, resulting in five deaths, research in the U.S. had been almost exclusively the domain of the military.
Now, some estimate that more than 400 university laboratories alone are involved in biodefense research, up from a handful just a decade ago.
Many research labs work with infectious agents such as Ebola, anthrax, West Nile virus, Q fever, tularemia and avian flu, as well as emerging drug-resistant forms of tuberculosis. Others work with more garden-variety organisms.
"Everyone and their cousins are trying to get into it because it's where the money is and it's necessary," said Ronald Blanck, former president of the University of North Texas Health Science Center, who previously served as the U.S. Army surgeon general and commander of the Army's medical branch during a 32-year military career.
He says that even though the focus is on biodefense, the expanded research will eventually benefit public health.
"The work being done is beginning to leverage against threats from naturally occurring diseases like avian flu," he says. "A lot of the infrastructure for biological-weapons research is also preparing us to deal with things like a flu epidemic."
But there is grumbling in the scientific community among researchers who feel that they have been "drafted" into working on national defense.
And watchdog organizations say that the facilities conducting research have proliferated to extremes, increasing the risk of accidents or security breaches and making oversight more difficult for federal agencies.
Edward Hammond, director of the Sunshine Project in Austin, says that government oversight is not stringent enough, that laboratory security is suspect and that accidents sometimes go unreported, or worse, are covered up.
"Ultimately we don't need 400 institutions across the U.S. working on biological-weapons agents," Hammond said. "We've gone way overboard. I request records from universities, and there are wildly divergent interpretations of what constitutes security.
"They're all doing it by the seat of their pants."
Ronald Kendall, director of the Institute of Environmental and Human Health at Texas Tech University, defends the escalation in biodefense spending, saying, "When we [Tech] got into it in 1998, there was a national consortium of just four universities. It might be debated whether we are overreacting ... but the consensus of 16 intelligence agencies is that there is a high level of threat from an attack.
"If we don't prepare ourselves, the consequences could be devastating."
But Hammond -- who does not argue with the need for biodefense research, only the scope of it -- says the popular notion that an international terrorist will smuggle biological weapons into the U.S. is not nearly as likely as an accident or a nefarious act by a rogue scientist, which may have occurred in the 2001 anthrax attacks. The crimes have not been solved.
"The greatest threat is not going to be a guy in a turban but in our own biochemical labs," Hammond said.
Incidents at Texas A&M
Are Hammond's allegations the rhetoric of an overzealous, self-appointed public whistle-blower? Or does he have a valid case?
In July, the Centers for Disease Control and Prevention temporarily suspended work at Texas A&M's Level 3 biosafety lab for failing to report two separate incidents in which workers became ill working with infectious agents. Probing by the Sunshine Project brought the violations to light.
Three lab workers were infected with Q fever and one other with the agent Brucella. None of the cases was fatal, and none of those infected spread the diseases.
The CDC investigation has since found other violations of federal regulations at the College Station lab, and, early this month, the vice president who oversees biodefense research at A&M stepped down. The university chancellor has repudiated the lab's actions.
The revelations created a public relations nightmare for biodefense advocates.
"We're not at all pleased to learn that this happened," said Stanley Lemon, principal investigator for the University of Texas Medical Branch in Galveston, which has a BSL-4 lab, dealing with the highest-risk agents such as Ebola, for which there are no treatments or preventives.
"We try to be as faithful as possible to the laws. It is complicated because different agencies are involved, but I'm very comfortable with the level of security here."
Kendall of Texas Tech, which has a BSL-3 lab, called the incident "unfortunate," adding, "It's a barometer of society that when an organization or university makes a mistake, we're all lumped together."
Ironically, if ramping up fear among Americans about the threat of biological warfare was intended, in part, to drum up public support for biodefense spending -- as some conspiracy buffs theorize -- then the downside is that accidents may result in an overreaction by the public and in the media.
Gigi Kwik Gronvall, a senior associate at the Center for Biosecurity at University of Pittsburgh Medical Center, knows firsthand how public opinion can scuttle a growth industry. Her father worked at a nuclear power plant.
The nuclear-power industry suffered a catastrophic blow in the U.S. after an accident at Three Mile Island in Pennsylvania in 1979 produced a partial meltdown.
Although the danger of an explosion was remote, and inspections at the time and in the months afterward did not turn up abnormal radiation in the atmosphere, public confidence in nuclear energy waned.
Biodefense research may not be strictly analogous, but some of the same apprehensions are in play.
Proponents say the research being done in containment labs is not a significant risk to the public.
"Research labs work with relatively small amounts of agents, which are not weaponized, and only certain people have access to them," said Rona Hirschberg, a microbiologist and senior program officer for the National Institute of Allergy and Infectious Diseases. "I can't say there is no risk to the public at large, but the real danger in a lab is to the people who work there."
The Texas Tech institute, which does some work with ricin and screens for West Nile virus, has strict safeguards in place, said Steve Presley, a research coordinator involved with the program.
"We have three layers of secure access to the labs," he said, "and any agent or toxin at high risk is under locked access."
At UT Southwestern, Vitetta said there are significant amounts of ricin in the BSL-3 lab.
Security was one of the issues on the agenda a year ago when Gronvall of the University of Pittsburgh led a meeting of biodefense experts from around the country.
One recommendation from that meeting was to always keep the community informed and reassured.
The UT Medical Branch and the Texas Tech institute have advisory boards composed of people in the community, part of the effort to be more accountable to the public.
UTMB even lists accidents in its containment labs on its Web site.
BSL labs were not always so forthcoming. Credit for this type of disclosure has been given to the Sunshine Project, which uses open records requests to scrutinize laboratory practices and put pressure on the labs to be more forthcoming.
"It's about the right to know," Hammond said.
A strict system
Vitetta acquiesced to stepped-up security measures and the intrusion into her personal life imposed by the federal government when the emphasis of her ricin research shifted to biodefense.
Key codes and passwords are required to gain access to the lab and the bioagents.
Personnel are subject to background checks, and the FBI fingerprints them. There are site checks by the CDC.
"But there are no secret handshakes," she said.
"The system, though, is only as good as the people who work in the labs. We spend a lot of time with how things can be circumvented or sabotaged," Vitetta said. "My life is consumed with compliance."
At Texas Tech, the doors to the institute lock automatically at 5 p.m., said Kendall, the director. "We have a very sophisticated system. It's expensive, and it would take a pretty intense effort to get in.
"We know we can't afford to make mistakes relevant to exposure" even though the amounts of the materials involved are often small, Kendall said. "The stakes are high, and we have enormous public support."
This is not a Hollywood disaster movie in the making, the researchers say. Even if a terrorist were to gain access to a laboratory, finding an infectious agent would be difficult.
"There is no vial in a refrigerator labeled 'avian flu,'" said Lemon of UTMB.
Labs typically use only small quantities, and a great deal of scientific expertise would be needed to weaponize the bioagents.
Nonetheless, the recent events at Texas A&M will keep the biodefense industry under a microscope, and there is no way of knowing the ramifications as the CDC continues its investigation.
Will pop-quiz-type inspections increase? Will congressional subcommittees with oversight of biodefense issues begin asking pointed questions?
Will support erode for new BSL-4 labs, such as the one that San Antonio is vying for now?
"A lot of universities are trying really hard," Kendall said. "Mistakes don't help us."
ABOUT THE LABS
Research in bioterror and biomedicine is conducted in hundreds of laboratories at U.S. universities and centers. The biosafety research labs are classified by the type of organisms used and the risk posed to personnel. The Centers for Disease Control and Prevention stipulates standards for each level of laboratory and the degree of protection required for personnel, the environment and the community. Rona Hirschberg, a microbiologist and senior program officer for the National Institute of Allergy and Infectious Diseases, describes each level:
BSL-4
Work is with the most dangerous organisms and viruses as well as with some related viruses for which there are no effective vaccines or treatments. There is considerable risk to people working in these laboratories if they don't follow precautions. The staff must have training in handling extremely hazardous infectious agents and must understand the primary and secondary containment functions of standard and special practices, containment equipment, and laboratory design. Access is limited and controlled by the laboratory supervisor.
Types of agents: Ebola, plague, drug-resistant tuberculosis, hemorrhagic fevers, smallpox (only in CDC lab in Atlanta).
Texas sites: University of Texas Medical Branch, Galveston; Southwest Foundation for Biomedical Research, San Antonio
BSL-3
Work with dangerous organisms, particularly those transmitted through the air. In some cases, there are vaccines or effective treatments available. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents and must be supervised by scientists competent in handling infectious agents and associated procedures.
Types of agents: Anthrax, West Nile virus, Q fever, tularemia, avian flu.
Texas sites: University of Texas, Austin; Texas A&M; UT Southwestern, Dallas; UT Health Science Center, Houston; Texas Tech University
BSL-2
Work involves agents that cause human disease but pose only a minor risk and are not transmitted through the air. Access to the lab is restricted when work is being conducted; all procedures in which infectious aerosols or splashes may be created are conducted in designated physical containment equipment.
Type of agents: Staph, strep, salmonella, garden-variety influenza.
Texas sites: University and medical labs
BSL-1
Basically teaching labs found on most university campuses, and organisms do not cause human disease. Work involves well-characterized agents not known to consistently cause disease in healthy adult humans and presents minimal potential hazard to laboratory personnel and the environment. Special containment equipment or facility design is not required but may be used as determined by appropriate risk assessment. Basic precautions are still followed.
Type of agents: Soil bacteria and bacteria commonly found in food such as dairy products.
Texas sites: University and medical labs
Sources: Centers for Disease Control and Prevention, www.cdc.gov; National Institute of Allergy and Infectious Diseases, www3.niaid.nih.gov; Sunshine Project
Pete Alfano, 817-390-7985
palfano@star-telegram.com
