WASHINGTON, July 1 (UPI) -- An administration program to build a nationwide system of biodefense laboratories is geographically haphazard and duplicative, according to critics, created by disparate government agencies with differing missions and too much money.
The $10.6 billion biodefense program is administered by a dizzying array of agencies: the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, the Department of Defense, the Department of Energy, the Environmental Protection Agency, the Department of Agriculture, the Department of Homeland Security, the Food and Drug Administration and the Centers for Disease Control and Prevention.
Some $2.5 billion or more of this massive budget is earmarked for building or upgrading high-security biodefense research labs sponsored by different agencies. Yet there is no organization coordinating the buildup, nor has there ever been a public hearing examining all the different laboratory construction and security plans and whether they complement or duplicate one another.
"We are in need of an overarching look at what labs are needed and where," said Marylea Kelley, executive director of the Tri-Valley CAREs, a watchdog group in Northern California that opposes the development of an Energy Department biodefense lab at Lawrence Livermore National Laboratory in Livermore, Calif. "This is being played out in community after community across the nation."
"There is no coordinating council as such; maybe there will need to be at some point," John R. La Montagne, NIAID deputy director told United Press International, "At the moment it's done through informal processes between the agencies."
Making clear he was speaking only of NIAID's plans, La Montagne said in a later interview there was such an acute shortage of laboratories he did not believe there was going to be duplication. He explained when NIAID contracts for labs are let later this year, their locations would be selected for scientific merit and to get a geographic distribution of facilities.
"I think one has to wait until this whole (contracting) process is through but I think we are very committed (to minimizing) any duplication," said La Montagne. While admitting he was not familiar with some of the other organizations' plans, he said "In the real world of scientific research... or any kind of human endeavor, there is invariably going to be some level at which one could argue that this person is doing something similar to another person. In science we generally think about that as a positive because it gives an independent confirmation of a laboratory investigation."
Kelley told UPI it was unclear why a Biosafety Level 3 lab -- a facility with the second highest level of germ containment -- was needed at Livermore. "Nobody in this community really knows what the proposal is, what the ramifications are. It's just sort of happened really fast and under the radar."
"There needs to be a thorough analysis and there need to be public hearings," Kelley said.
The lab proposed for Livermore would study defenses against biological terrorist weapons. This lab would be less than 75 miles from where the University of California at Davis wants to build a Biosafety Level 4 lab to study bioterror defenses. The BSL 4 lab would have a higher safety level than Livermore's and presumably could accomplish everything that could be done at the Livermore facility. In fact, the university says in its proposal documents it is planning to conduct experiments for Livermore at the lab. To finance the facility, UC Davis is trying to obtain $200 million in federal money from the National Institutes of Health.
At the Edgewood Arsenal/Aberdeen Proving Ground in Maryland -- a chemical and biological warfare base for the Army since 1917 -- the Edgewood Chemical Biological Center, the Army's principle research center, is planning to upgrade a BSL 3 lab. Meanwhile, on the Aberdeen portion of the same base, the Battelle Memorial Institute, a government contractor, has used its own funds to build a new BSL 3 laboratory to do work for the Army.
The University of Maryland, representing a group of private institutions, is seeking a $200 million NIH grant to build a BSL 4 laboratory, the highest safety level -- also to be located at Aberdeen.
But only some 85 miles west of Aberdeen, at Fort Detrick in Frederick, Md., the Army and NIH both already operate separate BSL 4 laboratories and the NIH is planning to construct a second BSL 4 laboratory facility. The Southern Research Institute, a private research group that does work for the Army, also has a BSL 3 laboratory in Frederick.
Some 60 miles south of Frederick at a campus of George Mason University in Manassas, Va., Ken Alibek, a famous Russian biological weapons expert who came to the United States a decade ago, operates yet another BSL 3 laboratory doing defense work.
Prior to the 2001 terrorist attacks, the CDC was the primary civilian agency to identify dangerous pathogens and alert public health facilities nationwide while the Department of Defense operated the main laboratories searching for vaccines and antidotes against such weapons. The Department of Energy was given a role in this defense work in the late 1990s.
After anthrax-laden letters killed five people in the fall of 2001, the pressure to take action against the bioterror threat became intense. Richard Ebright, a prominent microbiologist at the Waksman Institute at Rutgers University in Piscataway, N.J., said Washington reacted as it would to a traditional war -- voting money for scientific research as though they were buying tanks for the Army. Congress allocated billions of dollars for bioterrorism defense, virtually overwhelming a public health industry that historically has been starved for dollars.
The NIH's National Institute of Allergy and Infectious Diseases, the core agency in the civilian portion of the effort, received $1.2 billion for biodefense research in 2003.
"This will be the largest single increase of any discipline, in any institute, for any reason for any disease in the history of NIH, including escalation of HIV resources and the war on cancer," NIAID director Anthony Fauci told a December 2002 conference on federal bioterrorism research. The Bush administration is requesting an increase of 17 percent in NIAID's total budget for 2004.
Chief among NIAID's new programs is the planned expansion of biodefense research labs across the country. These costly and highly complex laboratories are not testing facilities to identify a suspicious substance from samples -- there is a different federal program to upgrade those private and public testing labs. Instead the NIAID researchers will search for cures and vaccines to protect people against bioweapon-borne diseases, creating small amounts of the deadly substances to study as they go.
There are, however, already defense and energy labs working in these areas and by all accounts they will continue operating. They will also make improvements to their lab structure.
There is no central authority making sure the plans of all the various government agencies are coordinated so no unnecessary labs are built, officials confirmed. Despite the expense, tens to hundreds of millions of dollars for a new lab, each of the different departments, they said, will decide what labs it needs and build accordingly.
Officials from both NIAID and the Department of Homeland Security told UPI that there was coordination being done through the National Science and Technology Council, which is run by the White House Office of Science and Technology Policy. NSTC, however, is not addressing lab construction issues UPI discovered. It is working instead on setting broad priorities for the different agencies.
"(NSTC) is where we draw in the relevant agencies to have discussions about basically vaccines, diagnostics, any research and development gaps, animal pathogens -- a whole range of issues," said an administration official who asked not to be named. "This is just talking about the research and development side of it. In terms of construction, NIH is responsible for whatever grants they are sending out. Individual agencies are responsible for any construction."
Contracts for several NIAID labs are set to be released at the end of this year. Other projects, including the DHS plans for Fort Detrick, are already underway or under consideration across the country.
Many of the different projects are shrouded in secrecy and several experts like Ebright, who has studied the Bush proposals, believe that the U.S. government has never published a comprehensive list of what BSL 3 and BSL 4 labs exist or a study of how many more are needed. Nor is there a comprehensive government list of how many BSL 3s or BSL 4s are being planned.
UPI has identified roughly 20 operating or nearly completed labs in the United States of which six are operating BSL 4 laboratories. Five are at the CDC in Atlanta, Fort Detrick in Maryland, the National Cancer Institute in Bethesda, Md., the Southwest Institute for Biomedical Research in San Antonio and the University of Texas at Galveston. The University of Georgia in Athens also has a small facility.
In a report entitled "America's Biodefense Spending Spree," the Sunshine Project, a private study group in Austin, Texas, estimated there are plans for some 14 BSL 4 labs and some 16 BSL 3s. Not all of these plans are new construction, some labs are being upgraded to BSL 4s, and not all may be aimed at anti-terror research. UPI has identified seven proposed BSL 3 labs specifically for bioterror research and a dozen proposals and plans for BSL 4 labs.
While many BSL 4 labs are being proposed, only a small portion of the work requires a BSL 4 facility.
Ebright told UPI the NIH's guidelines specify using BSL 4 "containment only for four sets of biological agents: hemorrhagic fever viruses, Hendra viruses, hantaviruses, and cercopithecine herpesvirus."
"Furthermore, for three of these four sets of biological agents, the NIH guidelines specify BSL 4 containment only for a subset of activities, typically involving production quantities," he said. "Very little research falls within these categories." He found the proposals for building a large number of BSL 4 laboratories "unlikely, in the extreme, to have significant positive impact on ... U.S. biodefense preparedness."
"BSL 3 laboratories have different capabilities. Not all work can go on in all laboratories," said Maureen McCarthy, acting director for DHS's Office of Research and Development for the Science and Technology Directorate. "So even if something has been described as a BSL 3, it doesn't necessarily mean that the research that can go on there -- (that both the critical) capability and the capacity exist (there)."
"It is far more expensive (to build BSL 4s) but it adds a level of safety and security," added Ron Atlas, president of the American Society for Microbiology. Atlas admitted most of the diseases involved could be studied at a BSL 3 lab but argued it is better to use a higher security lab for research because it was safer.
Atlas added that the labs were spread around the nation to tap into academic and private sector researchers.
"Through the biodefense program, we expect to call upon the academic community, to lean on their expertise to a much greater extent." There is a side value, Atlas said, in that the labs would help scientists deal with emerging diseases.
Ebright believes the expansive lab program was driven less by research needs than by the limitations of NIH's contracting program, its inexperience in funding major construction projects and the political desires of Congress.
"There are two parts to that," Ebright said. "The most important one is the structural constraints at NIH. There was a six-and-a-half-fold increase in appropriations in the biodefense area. It represents an increase that was absolutely too large to be absorbed by the normal granting and contracting mechanisms that NIH operates under."
According to Ebright, NIH traditionally disperses most of its money in what it calls an extramural grants program. "So people on the outside of NIH government, universities and industry write grant applications and proposals and these are reviewed by peers. The most meritorious are awarded funds. The funding is multi-year funding, typically for four years or five years. If an institute like this gets enormous bowls of additional support in one year, the $1.3 billion increase, they need to spend this."
He said research grants are usually issued over a five-year period because it takes that long to complete many projects. If NIAID used the $1.3 billion in the first year, they would begin a raft of research projects they could not complete.
"That was unacceptable so the alternative was to find some way during the first year of the program of spending most of the money on something else. Obviously the best thing to do here is to give it back to Congress, but of course no agency will do that. This was the problem: How does one shovel out the money during the first year? The solution of 'how' was to go for BSL 4 facilities," he said.
"If there was $1.3 billion suddenly to spend, and there was perhaps ($300 million) of that that could be spent in the extramural program, that leaves about a billion to spend on BSL 3 and BSL 4 (labs)," he said.
Ebright and others argued that NIH could not cluster many facilities in one geographic area because a broader distribution was part of the programmatic and political justification for the number of bioterror labs it was asking for. "They needed them all over the place to spend the money and, of course, it also distributes it over congressional districts."
(UPI photos WAX2003063001, WAX2003063002, WAX2003063003 and WAX2003063004 are available)