Security Fears At Anthrax Labs
New Risks Seen In Huge Growth Of Pathogen Research

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Security Fears At Anthrax Labs

New Risks Seen In Huge Growth Of Pathogen Research

By DAVE ALTIMARI
Courant Staff Writer

October 8 2006

After the anthrax letter attacks of 2001, federal officials poured billions of dollars into increasing the nation's biodefense system with a goal of developing vaccines for deadly biological agents.

While experts say the results have been mixed at best, some worry that an unintended side effect has increased the threat to national safety: The number of laboratories actively working with dangerous substances has skyrocketed and there are questions about the security at many of those facilities.

That revelation comes just weeks after the FBI publicly acknowledged for the first time that the person who sent anthrax spores through the mail - killing a Connecticut woman and four others - needed no sophisticated equipment or intimate knowledge to produce the strain.

Anthrax experts and many media reports had long theorized that the killer would have needed to mix the deadly substance with an additive to aerosolize it - a feat most likely accomplished by a limited number of people with access to high-level labs such as those operated by the U.S. military.

There are currently 335 laboratories - from private companies to hospitals to colleges - registered with the U.S. Centers for Disease Control and Prevention to handle deadly biological agents such as anthrax, Ebola and smallpox, according to CDC records. Of those labs, 245 are registered to work with live anthrax. Many began their work after receiving federal funds.

CDC officials said there are now more than 100 university laboratories using live anthrax. Before the anthrax attacks, experts say, the total number of U.S. labs performing significant research with live anthrax was only a dozen or so.

Records also show that there are now more than 7,200 scientists or lab workers cleared to work with live anthrax, including the so-called Ames strain used in the October 2001 attacks. It is unclear how many lab workers were involved with live anthrax before the attacks, because they were not required to register with the CDC.

The CDC produced the data in response to questions by The Courant about the increased number of labs working with deadly biological agents since the anthrax attacks.

Laboratories that must register with the CDC include universities or colleges, private research companies such as the Battelle Memorial Institute in Columbus, Ohio, and government labs such as the U.S. Army Medical Research Institute of Infectious Diseases in Frederick, Md.

Laboratories under control of the U.S. Department of Agriculture, which include Plum Island in Long Island Sound, must report to a separate entity, the Animal and Plant Health Inspection Service. There are at least 75 laboratories registered with that agency, records show.

Lori Bane of the CDC's Select Agent Division disputes the notion that there has been a large increase in labs with access to anthrax and other potentially dangerous biological agents.

Bane said there probably were many labs or hospitals that stored agents such as anthrax but weren't actively using them in research. Since the law was enacted, those labs must now register with the CDC.

But microbiologists and other specialists say the large increase in government grants has led to more labs working with live pathogens, particularly anthrax.

"The huge U.S. investment in biodefense research - including dozens of new high-security labs and thousands of additional researchers - has actually made the biosecurity problem worse," said Jonathan Tucker, a senior fellow at the Monterey Institute Center for Nonproliferation Studies.

All scientists and lab workers who work in a registered laboratory must undergo a security risk assessment conducted by the Department of Justice. But Tucker said the process is a "superficial vetting" that is far from foolproof.

"It is likely that the newly expanded pool of biodefense researchers with access to dangerous pathogens includes a few sociopaths or people with extreme political views who might be motivated to divert pathogens or toxins for criminal or terrorist purposes," Tucker said.

Recent government investigative reports, which examined a small pool of university labs, raised additional questions about whether there is an adequate system in place to prevent deadly pathogens from falling into the wrong hands.

In 2004, investigators from the U.S. Department of Health and Human Services' inspector general office visited 15 university laboratories and discovered that 11 did not comply with federal regulations in at least one of five categories: record-keeping, lab access, training, security and emergency response planning.

The report does not name the universities because of national security concerns. Among the findings:

Eight universities had problems with record-keeping. In some cases records did not identify who had even entered areas where dangerous substances were being used.

Six universities had problems with limiting lab access. At one school anyone could have gained access to the computer system used to generate electronic key passes to high-security labs.

Four universities had not completed full security plans and had not detected weaknesses such as unlocked laboratory doors when researchers weren't present or fire alarms that unlocked laboratory doors when pulled.

One university admitted it had not taken an inventory of its "select biological agents" in more than eight years.

A January audit by the U.S. Department of Agriculture's inspector general produced similar findings. All 15 laboratories visited had violations ranging from shoddy record-keeping to potentially unrestricted access to labs.

Bane said the universities have addressed their deficiencies. She said CDC officials weren't surprised by the report because their own inspections had turned up similar problems.

Bane didn't deny that labs have safety or security concerns. She likened it to a restaurant that may pass an inspection one day but have numerous violations on another visit.

"When our inspectors go out and find things, we try to work with the laboratories to fix the problems. But if they are severe enough we can take away their registration or not give them one," Bane said.

Bane said CDC officials, out of safety or security concerns, have rejected some laboratories' attempts to register with the agency. Any lab that wants to register to use a biological agent must undergo an inspection by CDC inspectors first.

All labs must renew their registrations every three years.

The Center for Biosecurity at the University of Pittsburgh Medical Center has been studying high-containment laboratories across the country and recently met with representatives of the CDC and several labs to discuss its findings.

Senior Associate Gigi Kwik Gronvall said the biggest problem may be finding properly trained people to work in labs that are now conducting research on vaccines, but added that scientists at universities can provide vital research in an increasingly changing field.

"Where are they going to get the right level of training to work at these labs?" Gronvall said. "I wonder what will happen the first time that somebody kills themselves or someone else because of a mistake made in a laboratory."

Laws regulating laboratories were passed in June 2002 to, among other things, keep track of the transfer of pathogens between institutions. Federal officials have acknowledged that, before 2002, there was no tracking of which laboratories were working with dangerous materials such as anthrax or who had access to them.

Scientists told of shipping each other live anthrax in the mail or packing it up and bringing it with them to a conference.

FBI agents investigating the anthrax attacks said it was difficult to trace stocks of the Ames strain because it was so easily traded among scientists, with little or no record-keeping.

From 2003 to 2005, the CDC recorded more than 1,300 transfers of biological agents, records show. Anthrax accounted for about 400 of those transfers. The CDC would not release specific information on which labs transferred the pathogens.

In 2004, President Bush announced a major increase in bioterrorism funding. Project BioShield authorized spending $5.6 billion over 10 years to encourage the development of antidotes and vaccines to treat and protect against potential biological agents or nuclear attack.

The biggest contract, $878 million, was given to VaxGen, a small biotech company outside San Francisco, to develop and produce 75 million doses of a new anthrax vaccine. The product was supposed to be delivered this year, but it now has been postponed until at least 2008.

Most of the anthrax research being done in laboratories throughout the country now is being funded by grants from either the National Institutes of Health or the National Institute of Allergy and Infectious Diseases.

"I think it's fair to say that the jury is still out as to what you are getting for your money," Gronvall said.

But Gronvall said it is too early to label BioShield or the other research a failure, because it takes years to develop a vaccine and get it approved for use in humans. VaxGen has had success with its preliminary vaccine testing.

"It takes a long time to go from characterizing a problem and then figuring out a way to combat it," Gronvall said. "You can't find solutions unless you actually do the research. Why wouldn't you want the brains at universities involved in that process?"

The jump in bioterrorism funding and the increase in universities and private companies interested in working with biological agents may have been exactly what the anthrax mailer was after.

FBI officials have said the anthrax might have been mailed by one or more U.S. scientists who had access to the Ames strain and wanted to throw a scare into the country and force authorities to make bioterrorism a top priority.

What the sender didn't count on, authorities have surmised, is that the anthrax would leak through the envelopes, killing five people, sickening 23 more and paralyzing the nation's postal system.

FBI officials have said the so-called Amerithrax investigation remains a high priority, and they cite the thousands of subpoenas that have been issued and the hundreds of scientists who have been interviewed as proof of how far-reaching the investigation has been.

While they haven't acknowledged the case has stalled, retiring FBI agent Brad Garrett may have given the best indications of what the bureau is up against in an interview on National Public Radio last month. Garrett was considered one of the bureau's top agents and was part of the Amerithrax investigation.

"This is a unique case and very difficult to investigate because one of the things as to why people get caught is replication of behavior. Now we did have two sets of mailings, but after that we had no one who mailed anthrax through the mail," Garrett told NPR. "So now you are left with, `Can you track the origin of the anthrax?' and that's not easy to do."



A discussion of this story with Courant Staff Writer Dave Altimari is scheduled to be shown on New England Cable News each hour Monday between 9 a.m. and noon.



Contact Dave Altimari at daltimari@courant.com.