Research into potent bioagents increases the risk
The researcher at Texas A&M; University had never been trained to handle Brucella, a bacterium included on the government’s select list of potential bioweapon microbes.
Her work was in a different type of bacteria, but when asked to help clean a chamber that had been used to create an aerosol version of Brucella, she leaned inside and wiped it down.
The bacteria entered her body through her eyes, investigators later surmised. She was infected for more than a month before doctors diagnosed her with brucellosis and put her on a regimen of strong antibiotics.
The incident last year was part of a small but unsettling number of laboratory accidents that has followed a boom in research funding after the Sept. 11, 2001, terrorist attacks and the still-unsolved anthrax mailings that came a week later.
The burst of money has spread biodefense work to hundreds of university and research laboratories. In some cases, the labs have been ill-prepared to work on the exotic microbes.
“Universities aren’t set up to handle these programs,” said Edward Hammond, U.S. director of the Sunshine Project, a nonprofit group in Austin, Texas, that tracks information on biological weapons research. “I think we made a serious mistake putting 400 labs, thousands of people in the U.S., in the driver’s seat behind biological weapons.”
All told, there have been 111 cases involving potential loss of bioagents or human exposure reported since 2003 to the national Centers for Disease Control and Prevention or the U.S. Department of Agriculture.
The incidents include the potential exposure of 12 laboratory workers to live anthrax bacteria after an incorrect sample was sent to Children’s Hospital Oakland Research Institute in 2004, the infection of three researchers at Boston University in 2004 after they mistakenly handled a sample of live tularemia bacteria, and the disappearance of a mouse infected with Q fever at Texas A&M; in 2006.
Federal officials say that the overall number of incidents is small, and they emphasize that no one has died -- and that no one beyond laboratory workers has been infected.
“If you’re looking at the total amount of work in these labs, it strikes me that 100 incidents is very low,” said Dr. Richard E. Besser, director of the CDC’s Coordinating Office for Terrorism Preparedness and Emergency Response. “Full investigations were done, and none of the events were thought to put the public at risk.”
But Richard Ebright, a microbiologist at Rutgers University who has been monitoring biodefense safety issues, said that given the potential danger of the materials, the number of accidents is, in some ways, immaterial.
“Twenty-five incidents per year does not represent a good record,” he said. “It only takes one incident in which a highly transmissible agent is introduced into a human population to produce a catastrophic loss.”
Following the money
Before 2001, experts say much of biodefense research took place in government laboratories, such as the U.S. Army Medical Research Institute of Infectious Diseases at Ft. Detrick in Maryland. There, scientists in full-body suits worked in containment laboratories developing vaccines for some of the world’s most hideous diseases, such as Ebola, Marburg hemorrhagic fever, anthrax, smallpox, tularemia and Lassa fever.
Then, everything changed. A week after the Sept. 11 attacks, letters containing anthrax spores began appearing around the country. Five people died and 17 others were infected.
The incident prompted Congress to dramatically increase biodefense funding. Research money from the National Institute of Allergy and Infectious Diseases, which administers a major portion of biodefense funding, has grown from $187 million in 2002 to $1.6 billion in 2006.
Scientists followed the money. The CDC now counts about 14,000 researchers registered to work with so-called “select agents.”
Biodefense experts were worried from the beginning about the expansion.
Increasing the number of laboratories increased the chances of an accident, experts said. Ebright said that the expansion also raised the problem of spreading the deadly knowledge of bioagents to potential terrorists.
Some of the early fears have not materialized. For example, there have been no confirmed thefts or losses of bioagents.
“We’re in a much better place now than we were four years ago,” the CDC’s Besser said. “Now we have really strong requirements about who is allowed to work with these agents and what kinds of safety and security are in place.”
In 2002, new federal rules required biodefense researchers to register their labs with the CDC or USDA to work with the agents, and pass a Department of Justice background check. They were also required to devise safety plans and report accidents to the government.
Still, concerns linger that the rules are inadequate. Congress has begun investigating the issue, and a hearing in Washington is scheduled for Thursday.
“There are no clear rules about training, ability or the orientation of the lab to handle these matters,” said Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee.
“There are bills for funding and for research, yet nobody knows what regulation there is, how the regulations work and whether they are safe,” he said. “There is a culture of secrecy.”
The results of government inspections have not been encouraging. A 2006 report by the inspector general of the Department of Health and Human Services found 11 out of 15 universities did not fulfill all the federal requirements. Several universities kept sloppy inventory records, and inspectors could not identify who was gaining access to the pathogens, according to the report.
Institutions working on animal and plant pathogens did worse. None of the 10 institutions described in a 2006 report by the USDA inspector general met all standards. Many had not updated their lists of people with access to the pathogens and had failed to fully train their staffs.
Potential for disaster
Many of the accidents have been relatively mundane. Most would be small events if not for the danger of the agents involved.
In May, a researcher at the University of Texas Health Science Center at Houston was working with anthrax in a centrifuge. When the machine began clanking, the researcher opened the cover and saw liquid spilled inside.
She and three others in a nearby room tested negative for anthrax, and no spores were found in the lab, university officials said.
“It was a rookie mistake,” said Robert Emery, assistant vice president for safety, health, environment and risk management at UT Houston. “We exist to teach people to treat and prevent disease. Part of that is a lack of knowledge about technique and learning it.”
Among the most serious incidents were the infections of three researchers at Boston University in 2004. They thought they were working on an inactivated vaccine strain of the bacterium Francisella tularensis, but actually were handling a virulent form that had been mistakenly sent by another laboratory.
The researchers all recovered, but it took months for doctors to diagnose their potentially fatal disease because its symptoms -- coughs, fever, headaches -- are common.
The Brucella case at Texas A&M; turned out to be only the beginning of the university’s troubles. When the CDC began investigating in April -- a year after the incident -- the university disclosed that three lab workers had blood tests in 2006 showing higher-than-normal levels of antibodies for Q fever, a disease caused by the bacterium Coxiella burnetii.
The researchers never showed any symptoms, so the university thought it did not have to report the cases, the university’s interim president Eddie J. Davis told reporters in July.
The CDC found other problems, and on Aug. 31 suspended all work with select agents at the university, the first and only suspension issued by the agency.
Despite the punishment, Hammond, of the Sunshine Project, said the case was another example of how the biodefense program had grown too fast and too large for the government to adequately manage.
The system “is not really working,” he said. “The explosion of biodefense programs is creating dangers.”
Dr. Alan Barbour, a UC Irvine professor who directs a federally funded regional center for biodefense and emerging diseases, said national training standards must be adopted for bioagents.
“I’m a physician, and I’m used to dealing with people in the hospital,” Barbour said. “If you make a mistake, someone could die. I think some people are not used to handling things that way. They’re going to have to learn.”
--
