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05 Dec 2002

Source: Baltimore Sun, February 19, 2002.

Biodefense funding creates quandary

Increase designed to fight terror also raises risk of attack

By Scott Shane, Sun Staff

Even as the FBI investigates a possible link between U.S. biodefense programs and last fall's anthrax attacks, a flood of new funding for bioterrorism research promises to increase rapidly the number of labs and people with access to such lethal pathogens.

Some scientists say that without new limits and tougher regulations, the law of unintended consequences could come into play. The biodefense research boom could lead to diversions of organisms or expertise for new terrorist attacks, making Americans less safe rather than safer.

"Each one of these labs in essence becomes a full-service shopping center for someone who wants to get hold of a lethal agent for nefarious purposes," says Richard H. Ebright, a Rutgers University chemist who helped spark a debate among scientists with a letter he co-wrote last month to the journal Nature calling for new restrictions. He says the number of laboratories approved to work with potential bioterrorist pathogens should be "fewer than five nationally," a drastic decrease from the scores of labs doing such work.

He acknowledges that, with the federal government budgeting $2.4 billion in new money for bioterrorism preparedness, scientists aren't rallying to support him.

"No one wants to say anything that is likely to decrease funding," he says. "This money is going to attract applications from institutions that have no experience with these pathogens and no previous interest in them."

"It's a sticky problem," says Michael Mair, a molecular biologist at the Johns Hopkins Center for Civilian Biodefense Strategies. "The question is how to provide for security while not putting shackles on scientists. Science works best when there's a free flow of ideas."

The problem is illustrated by the situation of Ebright's co-author on the letter to Nature. Nancy D. Connell, director of the Center for Biodefense at the University of Medicine and Dentistry of New Jersey, is calling for tighter regulations even as she prepares her lab in Newark to handle dangerous organisms in bioterrorism research. The first supplies of such microbes, including the Bacillus anthracis bacteria that cause anthrax, are expected to arrive next month, she says.

In preparing her lab for the new work, Connell has voluntarily contacted local law enforcement agencies and imposed strict security rules. A "buddy system" will ensure that no scientist is left alone with the dangerous agents, and advance approval will be required for night and weekend work, she says.

But most of those precautions are not required by law. They should be, Connell says.

Connell, an associate professor of microbiology and molecular genetics, says she believes research on bioterrorism agents is important. She knows some colleagues may see her as trying to slam the door to bioterrorism research just after her lab has gotten approval from the Centers for Disease Control and Prevention in Atlanta to ship and receive dangerous pathogens.

But unless rules are tightened, "we're concerned that the increased research could actually decrease security," she says.

As a possible model, scientists point to the far stricter regulation of radioactive materials by the Nuclear Regulatory Commission and state agencies. NRC inspectors, for example, conduct surprise inspections of university laboratories, showing up unannounced to check inventories and record-keeping.

"Universities know exactly how much they have of every radioisotope and where it is," Ebright says. That's not the case with biological agents. After the anthrax attacks, some universities discovered poorly secured anthrax samples with few records of where they had come from or how they had been used.

That's because handling of deadly biological pathogens was not regulated until 1997, when an anti-terrorism act required labs that wished to ship or receive certain "select agents" to go through a demanding registration process with the CDC. The select agents are a nightmarish arsenal including 13 viruses, 12 toxins, seven kinds of bacteria and four other organisms.

There are a little more than 250 labs nationally that are registered to receive the select agents, and the number is growing at about one lab a week, says Jonathan V. Richmond, director of the CDC's office of health and safety. Since 1997, more than 1,500 shipments of such organisms have been reported to the CDC, he said.

But the regulation has many holes, scientists say. Labs that were using select agents in research before 1997 do not have to register, and the CDC can't keep up with the required lab inspections, they say. Bills pending in Congress would close some of the loopholes and tighten oversight.

Richmond says the CDC may not be the right agency to police the burgeoning bioterror field. "CDC's whole mission in life is to be part of the scientific effort, to be collegial with the people we work with," he says. "If CDC pushes the regulatory side too hard, that collegial element could dry up."

He suggests that the Food and Drug Administration, the Office of Homeland Security and the Department of Justice might be better suited to regulate labs.

Some scientists are skeptical about the need for more regulation. Steven M. Block, a biophysicist at Stanford University, notes that many of the lethal agents can be obtained from natural sources -- notably Bacillus anthracis, which infects cattle and other animals in dozens of countries.

"Anyone bent on obtaining anthrax doesn't have to raid Fort Detrick or a university lab," Block says. A natural source for the anthrax used in last fall's attacks can't be ruled out, though the FBI appears to be aggressively pursuing a possible connection to Army labs at Fort Detrick in Frederick or Dugway Proving Ground in Utah.

Block says he is worried about the possibility of attacks -- but that's why he wants to see more work on drugs, vaccines and defenses against genetically altered organisms. "I think we should encourage research on these pathogens, not discourage it," he says.

Mair, at the Hopkins Center for Civilian Biodefense Strategies, says regulation of radioactive materials may not offer a precise model for bioagents.

For one thing, a radioactive isotope is always decaying -- left alone, it becomes less of a problem over time. But biological agents can grow. A gram of Bacillus anthracis recorded in January may be a kilogram by March.

Inspections, too, are far harder. Radiation experts can use a Geiger counter to check a lab, determining instantly where radioactive substances are stored. But biological agents, stored in test tubes inside freezers, usually don't have a distinctive appearance. "If a vial is intentionally mislabeled, there's no way to know what it is without actually culturing it," Mair says.

Elisa D. Harris, a bioweapons expert at the University of Maryland and former National Security Council official, is helping lead a project at the university's Center for International and Security Studies to design an oversight system for bioagents.

"I'm afraid of an enormous increase in classified research in U.S. government and even university labs," she said. "That would stimulate concerns in other countries about whether we're really doing the work for defensive purposes."