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Under the Microscope

Under the Microscope
October 4, 2007

When the House of Representatives Energy and Commerce Subcommittee on Oversight and Investigations takes up the issue of "The Silent Proliferation of Bio-Laboratories in the United States" at a hearing this morning, it will take testimony from researchers, and public safety and health experts grouped into three panels.

A fourth panel consists of only one person: Eddie J. Davis, interim president of Texas A&M University.

That Davis is the only speaker going it alone is indicative, perhaps, of the interest in and importance of his testimony addressing a much-criticized episode in early 2006 in which the university failed to report to the federal government incidents of human exposure to dangerous biological agents.

Amid the backlash that ensued, the Centers for Disease Control and Prevention this summer suspended research on select agents and toxins at Texas A&M until new safeguards are in place.

Reverberations from the Texas A&M case are still being felt both within higher education and beyond. And, as recent comments from Congressional leaders illustrate, there's a growing concern that not enough is known about what happens within labs like these that contain some of the world's most potent pathogens.

“It appears that there has been a surge in construction of biosafety labs over the past several years which have been financed, at least in part, with federal funds,” Rep. John D. Dingell (D-Mich.), chairman of the Energy and Commerce Committee, said in a statement. “Yet, little information is available about the number of labs being operated in the U.S. and whether they are safely run. While the research conducted at these labs is certainly valuable, we must make sure that it does not pose a risk to the public health.”

Federal regulations require that labs handling so-called "select agents" report all incidents of exposure or confirmed illness to the CDC. At the request of the House committee, the agency has released information on more than 100 incidents that resulted in possible injury over the past four years. The U.S. Government Accountability Office, Congress's research arm, is set to release a report that shows the rapid growth of biolabs and lays out the danger of lax oversight.

"No single federal agency ... has the mission to track the overall number of these labs in the United States," The Associated Press quotes the report as saying. "Consequently, no agency is responsible for determining the risks associated with the proliferation of these labs."

Rep. Ed Whitfield (R-Ky.), the House subcommittee's senior Republican, agreed, telling the AP that "currently, there is a hodgepodge system of federal oversight regulating the ... laboratories responsible for researching the deadliest germs and diseases."

Top CDC officials are expected to introduce during the hearing the idea of forming an independent group charged with reviewing the current system for overseeing the labs, according to Von Roebuck, an agency spokesman. That panel would look at the Select Agent Plan that regulates the use and transfer of dangerous agents, and could recommend ways of promoting better lab safety practice and timely incident reporting. (More on the oversight issue shortly.)

Since the 2001 terrorist attacks, there has been heightened interest in medical research on biological agents. Buoyed by mega-grants from the National Institutes of Health to build biodefense research labs, researchers are vying to host the next big center.

"Universities are the only place where you have the scientists who really are not only engaged in the current practice but who have a knowledge base to look at the fundamental mechanisms," said Ara Tahmassian, associate vice president for research compliance at Boston University and Boston Medical Center, which are preparing to open a Level IV lab, which requires the highest-level security, in 2008.

Much of the action is taking place at major research universities -- and it is there where the scrutiny has increased in the wake of Texas A&M.

Edward Hammond, head of the Sunshine Project, a watchdog group that investigates potentially dangerous research, said he's confident that far more accidents have happened in biodefense and other high-containment labs in recent years than the public knows about. (His group regularly publishes Freedom of Information Act request responses from institutions.)

“How many more Texas A&M’s are there out there? I don’t know, but I’m sure there are many," he said. “My instinct is to say, gosh, I can’t imagine how many others are as spectacular as this case, but I don’t underestimate how willing universities are to cover up.”

Many point to the Texas A&M case as an example of what happens when lab procedures aren't followed and the accident reporting system breaks down. An aerosol chamber accident in February 2006 caused a researcher working in a lab involved in biodefense research to be infected with the bioweapons agent brucella. It has since been revealed that the employee lacked a permit to be handling the dangerous agent. The university also failed to report that three other researchers had tests showing elevated levels of Q fever antibodies.

The exposures weren't revealed until the Sunshine Project investigation spurred news media coverage. Texas A&M officials have since apologized for not reporting the incidents until a year after they occurred, and two top officials involved in research have resigned.

Davis, the Texas A&M president, was unavailable for comment. Mike McKinney, chancellor of the university, told the Dallas Morning News: "Folks here, they're saying, 'Nobody died.' That's not the point. That doesn't make it OK to make a mistake. Yes, we messed up, but we didn't mess up on purpose. There's that saying, never assume a conspiracy if it could just be incompetence."

Reporting violations aren't confined to College Station. The University of Texas at Austin has admitted failing to report 10 of 13 laboratory accidents over the past seven years that called for federal notification. Among the most recent lab mishaps, the University of Wisconsin at Madison allowed a researcher to study material that can be used to create the Ebola virus in a lab that did not meet federal requirements.

Hammond said federal agencies need to devise a centralized and "more effective" way of ensuring that labs report to them after accidents occur. The current atmosphere doesn't encourage reporting, he said.

"Now, if you ask for accident data, some places say it doesn't exist," he said. "But if you think about it, how can it be that you have a major research university and not have a single piece of paper about an accident or a near-miss?"

Added Ronald Atlas, past president of the American Society for Microbiology and co-director of the Center for Health Hazards Preparedness at the University of Louisville: "Clearly the number of incidents is higher than one would like to see, and that does call for re-examination of biosafety practices and pulling together people in academia, government and experts in biosafety to ask what can be done to better protect the researchers."

Atlas said that labs always need to act in the best interest of public safety -- and that sometimes means reporting incidents in ways that won't fuel mass anxiety. He supports the idea of pushing labs to first report to local or state public health authorities, who can determine the safety risks and contact federal agencies when appropriate.

"It's often a case of balancing privacy vs. [media] exposure," Atlas said. "That's not to say labs shouldn't be truthful, and researchers are welcome to share the details of their work. But the question becomes what purpose is served by putting these accidents in headlines if there's no public risk of injury."

Tony DeCrappeo, president of the Council on Governmental Relations, a Washington-based group that helps universities navigate federal rules on research, said another concern is the privacy of information. Location and specifics about material aren't details that lab directors want to be made public in some cases.

But Hammond favors transparency in almost all cases. “If you choose to do this kind of research, be prepared to explain yourself. I don’t think a lot of institutions quite understand that."

Tahmassian, the Boston University vice president, has done plenty of explaining in recent years to citizen groups and politicians who don't like the idea of a lab that deals with emerging infectious diseases located in the South End, a low-income Boston neighborhood. (The NIH has determined that the lab poses no health risks for the neighbors.)

Some fear a repeat of a 2004 lab accident at the university that involved researchers becoming ill after being exposed to a lethal bacterium. In part as a response to that incident, Boston's Public Health Commission began requiring earlier this year that Biosafety Level III and IV labs register with the commission. Boston University must also get approval of the agents it wishes to research by a panel that includes university scientists and community members.

Tahmassian, who favors accident reporting starting at the local level, said he understands the increasing attention paid to biolabs.

“Even if you are a scientist and you look at some of these [agents], you should be concerned with the possibility of exposure," he said. "It's critical we maintain as clean and safe an operating environment as we can. Anytime we break that trust, we’re damaging the environment."

 

 

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