Battle over biodefense
As the U.S. pumps billions into research on
everything from anthrax and plague to military biohazard
suits, what's the effect on our science—and our
security?
Like a proud father who puts his first-born on display
for family and friends, Alan Cross shows off his new
infectious- diseases laboratory with flourish. The 7,000-square-foot
lab is equipped with highly sensitive alarm systems,
special ventilation hoods, decontamination showers,
a hacker-proof computer system, and a variety of other
trappings that give rich meaning to the phrase “state
of the art.”
The $2 million facility at the University of Maryland
School of Medicine in Baltimore soon will be home to
researchers studying anthrax, tularemia, and other potential
bioterrorist pathogens. So, it follows that the lab
would be equipped with a little more than run-of-the-mill
safety systems.
“The biosafety efforts are extraordinary,”
says Cross, an affable, engaging researcher who enjoys
discussing his work. A professor of medicine affiliated
with the school’s Center for Vaccine Development,
Cross was an infectious-diseases scientist for many
years with the United States Army before going into
academic research.
The design and equipment for the Maryland lab must
be approved by federal authorities—a safety precaution
that was put into place following the 2001 anthrax attacks,
which left five people dead, sent another 17 to the
hospital, and forced some 30,000 to take prophylactic
antibiotics. The government also mandates strict screening
and registration procedures for all personnel with access
to dangerous biological agents.
This scrutiny has led to the advanced safety systems
that outfit Cross’s new lab: an independent ventilation
system in each of the seven workrooms to prevent leakage
of airborne microbes; electronic locking systems on
every freezer housing test specimens; and monitoring
systems that track the number of times that specimens
are removed from the freezer—and who removed them.
The health sciences building that houses the laboratory
was opened in May 2003, but Cross and his colleagues
still are awaiting the official go-ahead from the Centers
for Disease Control and Prevention to begin working
in the facility. “And after they review all the
safety features of the facility, and also check the
qualifications of each of the investigators—taking
months and months and months—then the next level
is the FBI,” Cross says. “The FBI investigates
every single person who is on that application.”
Built with a construction grant from the National Institute
of Allergy and Infectious Diseases (NIAID for short),
the Baltimore lab represents a relatively modest component
of an ambitious, heavily funded federal effort intended
to build up countermeasures against bioterrorism and
biological warfare agents, as well as naturally occurring
pathogens.
Despite vocal criticism from some quarters of the scientific
community and organized opposition by citizen activist
groups, the government is moving ahead with plans to
construct at least 11 new high-security infectious-disease
laboratory buildings at universities across the country,
and to pump out funds for biodefense research involving
eight consortia of universities and other institutions.
NIAID’s spending on biodefense now exceeds the
support it provides for HIV/AIDS research, which previously
was the biggest item in the institute’s budget.
(NIAID makes up about half of total National Institutes
of Health spending on the disease.)
Government officials and other proponents of the new
labs say they are badly needed to deal with incidents
such as the anthrax letter episodes. Supporters also
argue that the biodefense effort serves to guard against
the specter of large-scale bioterrorist or state-sponsored
biological warfare attacks against the United States.
Critics, however, contend that the civilian biodefense
program—involving NIAID and the CDC, along with
the Department of Homeland Security and other federal
agencies—amounts to a politically motivated overreaction
to a relatively limited threat. In addition, they charge,
the rapidly ramped-up biodefense effort is putting significant
pressure on federal funding for other areas of biomedical
research.
Their complaints aren’t falling on deaf ears.
Strong local opposition factored into NIAID’s
decision last year not to build an infectious-diseases
lab complex at the University of California, Davis.
Vocal criticism from community groups and scientists
may succeed in delaying, scaling back, or possibly stopping
construction of a similar facility planned for Boston
University.
Only a major policy change will alter the government’s
plans for a significant expansion in the nation’s
biodefense research infrastructure. Still, the battle
over biodefense is far from over.
Building up, and up
President Bush has singled out bioterrorism as a “real
threat” on more than one occasion. “Armed
with a single vial of a biological agent … small
groups of fanatics, or failing states, could gain the
power to threaten great nations, threaten the world
peace,” Bush told senior military officials at
the National Defense University in Washington, D.C.,
earlier this year. “We must confront the danger
with open eyes and unbending purpose.”
This “unbending purpose” will not be cheap.
A study by University of Pittsburgh biosecurity analyst
Ari Schuler, published this summer in the journal Biosecurity
and Bioterrorism, offered a detailed look at federal
biodefense spending. The United States has spent about
$14.5 billion on the overall civilian biodefense effort
from 2001 to 2004, according to Schuler’s study.
The president’s budget request for 2005 is $7.6
billion, 18 times higher than the amount budgeted just
four years ago. About $1.7 billion of this is earmarked
for biodefense research.
NIAID biodefense research spending jumped from only
$53 million in 2001 to an estimated $1.4 billion in
2004, and is budgeted to reach nearly $1.5 billion in
2005. For other civilian agencies, the administration’s
budgeted biodefense outlays for 2005 include: Department
of Homeland Security, $2.9 billion; CDC, $1.1 billion;
Health Resources and Services Administration (particularly
hospital preparedness and infrastructure), $504 million;
Depart-ment of Agriculture, $381 million; Food and Drug
Administration, $246 million; Environmental Protection
Agency, $92 million; and National Science Foundation,
$32 million. (For a comparison of NIH spending on biodefense
research compared to selected other major NIH programs,
see this chart.)
NIAID is funding two large National Biocontainment
Laboratories at the Boston University Medical Center
and the University of Texas Medical Branch in Galveston,
with construction grants of about $120 million apiece.
Annual operating costs for each of these facilities
are expected to be about $70 million.
They’ll each include BL-4 labs with the highest
biosafety rating assigned by the Centers for Disease
Control and Prevention.
BL-1 labs, such as those used by high school biology
students and college undergraduates, are for work with
microbes not known to cause disease in healthy adult
humans. BL-2 applies to work performed with biological
agents of moderate potential hazard, such as measles
virus and salmonella. BL-3 labs, such as the new facility
at the University of Maryland, include those with such
pathogens as anthrax, tularemia, and tuberculosis.
BL-4 laboratories, such as those planned for the Boston
and Galveston labs, have been described as “submarines
inside a bank vault.” Heat, pressure, chemical,
and incineration systems housed in the vault area process
all liquid and solid wastes completely to render them
sterile or safe. High-efficiency filtration removes
any airborne material. Researchers wear positive-pressure
suits connected to independent air sources through breathing
tubes. To prevent possible exposure through punctures
to the suits, glass and most sharp objects are not permitted.
Researchers exiting the workspace must go through a
multi-stage shower, including a chemical disinfectant
cycle, to wipe out any infectious agents.
Along with the two large National Biocontainment Laboratories,
nine smaller Regional Biocontainment Laboratories with
BL-2 and BL-3 labs are planned at universities around
the country, with federal construction grants of between
$7 million and $21 million each. In addition, NIAID
is supporting the establishment of eight Regional Centers
of Excellence for Biodefense and Emerging Infectious
Diseases Research, involving consortia of universities
and other institutions. The University of Maryland School
of Medicine, home to Cross’s lab, is lead institution
for one of these centers. Federal grants for these centers
total about $350 million over five years.
Aside from such biodefense research initiatives, the
Bush administration’s “Project BioShield”
involves large-scale government outlays to procure and
stockpile vaccines and drugs to cope with anthrax, smallpox
and other pathogens, and to set up a national network
of sensors for potential bioterror agents.
Bigger programs, bigger risks?
Officials emphasize that all these initiatives are
strictly defensive measures. The United States renounced
biological weapons during the Nixon administration.
But some critics of the biodefense program contend that
it might lay the groundwork for reconstituting a bioweapons
capability. This is partly because research at the infectious-disease
labs could be turned to developing more virulent, genetically
engineering, drug- and vaccine-resistant strains of
pathogens.
“The intent, or at least the expressed intent,
of the U.S. bioweapons agent program is defensive,”
says Richard Ebright, a professor of chemistry and chemical
biology at Rutgers University in Piscataway, New Jersey.
“However, in practice, this is a de facto offensive
bioweapons agent program. It has all the characteristics,
all the properties. The scale is larger, in terms of
dollar volume and also in terms of research personnel,
than the Soviet offensive bioweapons program.”
"In part, the current response is one that
is dictated by political reasons rather than scientific
reasons."
Stanley Falkow |
Ebright, a laboratory director at the university’s
Waksman Institute of Microbiology, is one of the most
outspoken critics of the biodefense program. He worries
that the biodefense effort will lead to an unnecessary
excess of infectious-disease lab space and increase
the risk of an intentional or accidental release of
a deadly pathogen.
In addition to the new BL-4 facilities at the new National
Biocontainment Laboratories in Boston and Galveston,
Ebright notes that construction on other high-risk labs
is planned in Hamilton, Montana, at the NIAID Rocky
Mountain Laboratory; in Fort Detrick, Maryland, with
new labs there for the Defense Department, NIAID, and
the Department of Homeland Security; and also in Atlanta,
Georgia, for the CDC.
According to Ebright, this new BL-4 space will amount
to between 200,000 and 300,000 square feet—10
to 15 times more than the amount of similar lab space
being operated in 2001.
These concerns are heightened by the number of research
personnel now approved for work with anthrax, plague,
and other “select agents.” The CDC has inspected
and fully certified 235 facilities and given provisional
approval to 82 more, a spokesperson says. An official
at the FBI’s Criminal Justice Information Services
Division says the bureau has processed about 12,000
aplications to work with such agents.
Research on potentially dangerous organisms “isn’t
just going on unfettered and unmonitored,” emphasizes
Gerald Fink, Whitehead Founding Member and chair of
the National Academies Committee on Research Standards
and Practices to Prevent the Destructive Application
of Biotechnology. “The government is setting up
a system to review it. Of course, the devil is in the
details.”
As Fink’s committee advised last year, the government
is establishing a National Science Advisory Board for
Biosecurity. Managed by NIH, the new board is described
as a critical component of a set of federal initiatives
to promote biosecurity. It will provide security guidance
and leadership about dual-use bioresearch (studies with
legitimate scientific purpose that may be misused to
pose a biological threat).
Draining the funding pool?
Ebright and other opponents of the biodefense effort
say that it will end up siphoning away federal support
for basic scientific studies in other biomedical areas
that affect the health of tens of millions of people.
“There’s a tremendous waste of funding,”
declares Ebright.
Since 2001, Ebright says, biodefense has seen the largest
targeted increase in any research area at an NIH institute
in the history of NIH—higher growth than the buildups
for the War on Cancer and for HIV/AIDS. “No agency
at NIH can absorb a targeted increase of that magnitude
without effectively eliminating peer review,”
he maintains.
Other scientists, such as world-renowned microbiologist
Stanley Falkow at Stanford University, also worry that
this strategy could cut funding for other disease studies.
“It’s going to be done at the expense of
some organisms that are causing serious health problems
in the United States but are not getting the same emphasis,
like drug-resistant staphylococci, pneumococci, and
the like,” says Falkow. “There’s a
need to be vigilant about biodefense, without any question,”
he adds. “On the other hand, I think, in part,
the current response is one that is dictated by political
reasons rather than scientific reasons.”
“I don’t think anybody would argue that
biodefense isn’t important, and certainly we learned
that with the anthrax thing and 9/11. But we still have
1,500 people or thereabouts a day dying from cancer,”
says Wendy Selig, vice president for legislative affairs
at the American Cancer Society. “Pressure on the
budget, forcing these arbitrary ceilings on spending,
is causing very difficult choices.”
One potential indicator of this stress: Following a
five-year period in which funding for the National Cancer
Institute jumped by 81 percent, the institute received
only a 3.9 percent increase in 2004.
Doing double duty
NIAID chief Anthony Fauci, a key architect of the current
biodefense effort, flatly denies that politics are driving
research or that the program has reduced allocations
for other areas of biomedical research. “It is
brand new money,” he insists. “It wasn’t
money that was moved around from one research direction
to another.”Fauci also emphasizes that the research
being supported is dual-purpose.
“Because of the threat of bioterror on this nation,
we need to be prepared from the standpoint of understanding
the microbes that could be used and developing countermeasures,
which is probably the most important component of the
research,” he says. But he maintains that programs
to study naturally occurring infectious diseases also
will play a significant role.
“In fact, a naturally evolving catastrophic epidemic
is incredibly more likely than a deliberately released
one,” Fauci says. “The intellectual capital,
the resources, the amount of effort you put into understanding
the natural evolution of microbes is absolutely complementary
to work that’s done on trying to develop countermeasures
for deliberately released microbes,” he emphasizes.
Infectious-disease specialist Cross agrees, saying
that the biodefense program is spinning off some very
good basic science, pointing to advances such as sequencing
the whole genome of the anthrax bacillus. “We
have a whole new database to work with,” he says.
“We have a whole new concept of how toxins work.”
Additionally, the University of Maryland researcher
says he isn’t particularly concerned about the
possibility of draining down money for other fields
of research. “Obviously, there is a limited pot,”
he acknowledges. “Some choices will have to be
made.”
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