Building Artificial Viruses

In the past five years, new technology has made it easier to genetically modify microbes and even create new ones from scratch. Some worry that the developments could lead to novel and more dangerous kinds of bioterror threats.

In his small lab, Eckard Wimmer recently examined a tray that held a newly created virus growing in a cellular broth. (By Joby Warrick -- The Washington Post)

In the United States, the federal "Select Agent" rule restricts access to a few types of deadly bacteria, viruses and toxins. But, under the CDC's interpretation of the rule, there are few such controls on transfers of synthetic genes that can be turned into killers. Changes are being contemplated, but for now the gap is one example of technology's rapid advance leaving law and policy behind.

"It would be possible -- fully legal -- for a person to produce full-length 1918 influenza virus or Ebola virus genomes, along with kits containing detailed procedures and all other materials for reconstitution," said Richard H. Ebright, a biochemist and professor at Rutgers University. "It is also possible to advertise and to sell the product, in the United States or overseas."

While scientists tend to be deeply skeptical of government intrusion into their laboratories, many favor closer scrutiny over which kinds of genetic coding are being sold and to whom. Even DNA companies themselves are lobbying for better oversight.

Blue Heron Biotechnology, a major U.S. gene-synthesis company based in suburban Seattle, formally petitioned the federal government three years ago to expand the Select Agent rule to require companies to screen DNA purchases. The company began voluntarily screening after receiving suspicious requests from overseas, including one from a Saudi customer asking for genes belonging to a virus that causes a disease akin to smallpox.

"The request turned out to be legitimate, from a real scientist, but it made us ask ourselves: How can we make sure that some crazy person doesn't order something from us?" said John Mulligan, Blue Heron's founder and chief executive. "I used to think that such a thing was improbable, but then September 11 happened."

Some scientists also favor greater scrutiny -- or at least peer review -- of research that could lead to the accidental or deliberate release of genetically modified organisms.

In theory, such oversight is provided by volunteer boards known as institutional biosafety committees. Guidelines set by the National Institutes of Health call on federally funded schools and private labs to each appoint such a board. A 2004 National Academy of Sciences report recommended that the committees take on a larger role in policing research that could lead to more powerful biological weapons.

In reality, many of these boards appear to exist only on paper. In 2004, the nonprofit Sunshine Project surveyed 390 such committees, asking for copies of minutes or notes from any meetings convened to evaluate research projects. Only 15 institutions earned high marks for showing full compliance with NIH guidelines, said Edward Hammond, who directed the survey. Nearly 200 others who responded had poor or missing records or none at all, he said. Some committees had never met.

Stockpiles Aren't Enough

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New techniques that unlock the secrets of microbial life may someday lead to the defeat of bioterrorism threats and cures for natural diseases, too. But today, the search for new drugs of all kinds remains agonizingly slow.

Five years after the Sept. 11 attacks, the federal government budgets nearly $8 billion annually -- an 18-fold increase since 2001 -- for the defense of civilians against biological attack. Billions have been spent to develop and stockpile new drugs, most of them each tied to a single, well-known bioterrorism threat, such as anthrax.

Despite efforts to streamline the system, developing one new drug could still take up to a decade and cost hundreds of millions of dollars. If successful, the drug is a solution for just one disease threat out of a list that is rapidly expanding to include man-made varieties.

In a biological attack, waiting even a few weeks for new drugs may be disastrous, said Tara O'Toole, a physician and director of the Center for Biosecurity at the University of Pittsburgh Medical Center.

"We haven't yet absorbed the magnitude of this threat to national security," said O'Toole, who worries that the national commitment to biodefense is waning over time and the rise of natural threats such as pandemic flu. "It is true that pandemic flu is important, and we're not doing nearly enough, but I don't think pandemic flu could take down the United States of America. A campaign of moderate biological attacks could."