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NIH To Hold Hearing on Infectious Disease Lab Facing Opposition from BU Neighborhood

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Opponents of a National Emerging Infectious Diseases Laboratory being constructed by Boston University will present publicly this week their criticisms of a recent National Institutes of Health report that concluded the facility poses no threat to the safety of nearby residents or their neighborhood.
 
NIH on Sept. 20 will hold a hearing at Boston’s Faneuil Hall at 7 p.m. to solicit public comment on its Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University. The report, available here, concluded NEIDL poses no increased risk of transmitting ebola, monkeypox, Sabia virus, or Rift Valley Fever in the South End site where it is being built, compared with two alternative locations where BU operates programs, Tyngsborough, Mass., and Peterborough, NH.
 
NIH also rejected another argument of NEIDL opponents — that the project would undermine “environmental justice” because if an infectious agent were released from the lab, the health risk would fall disproportionately on residents of the nearby black neighborhoods of Roxbury and Dorchester.
 
“It is clear that the identified Environmental Justice populations surrounding the Boston-BUMC Albany Street site would not be subjected to disproportionate adverse health effects should Ebola virus, Sabia virus, monkeypox virus, or RVF virus be introduced into the general population through an infected worker, infected pet, transportation accident or other mishap,” NIH concluded in the environmental report. In fact, NIH claimed, the nature of the communities surrounding Boston-BUMC (e.g., urban environment, lack of animal carriers of the virus, etc.) places citizens of these communities at “much less risk” of acquiring a RVF infection than persons living in Tyngsborough or Peterborough.
 
Boston University has trumpeted the study’s conclusion favoring its preferred location for NEIDL, an Albany Street site within BU’s BioSquare research park. The university has cited NIH’s finding, included in the environmental report, that: “To date, there has not been a laboratory-acquired infection in the United States resulting from work in a BSL-4 laboratory.”
 
“The research in these laboratories can be done safely, for the workers and for the community. High-containment laboratories are needed to do this research, which holds the promise of finding ways to prevent and treat the many emerging infectious diseases that are serious public health problems,” said NEIDL director Mark Klempner in an Aug. 24 report of the NIH findings published on the university’s official news website BUNews. Klempner is also a professor at BU’s School of Medicine and associate provost for research at BU’s medical campus.
 
BU’s $178 million, 192,000-square-foot NEIDL is intended to perform basic and clinical research into infectious diseases, which in recent years have included West Nile virus, Ebola, avian flu, and HIV.
 
Since it first proposed NEIDL in 2003, BU has encountered a torrent of criticism by a coalition of neighbors, community activists, and researchers. They have long contended the facility would be unprepared to combat an accidental release of toxins outside its lab, and would minimize its risk to the community by operating in a less-densely populated neighborhood.
 
The Conservation Law Foundation and 10 residents living near the lab site filed a series of lawsuits in federal and state courts to overturn city, state, and federal approvals. The plaintiffs prevailed in July 2006 when Suffolk Superior Court Judge Ralph ordered a new environmental review with more information on the merits of a less-populated site for the lab as well as how well it could respond if a toxin escaped from the lab.
 
Following that decision, NIH and BU agreed to conduct the draft supplemental study, even while appealing the superior court ruling. On Sept. 5, BU and the NIH joined opponents in presenting arguments before the Supreme Judicial Court. The state’s highest court has not announced a date or timetable for its decision.
 
Study Design at Issue
 
Two critics of NEIDL insisted NIH’s report offered insufficient data to conclude the biosafety lab project could operate safely in an urban area, citing what they termed serious flaws in the NIH report.
 
Lynn Klotz, a senior science fellow with the Center for Arms Control and Nonproliferation in Gloucester, Mass., told BioRegion News NIH underplayed the potential safety hazard posed by NEIDL through the design of its study.
 
The study discussed the effects of four ailments on hypothetical sufferers:
  • A 37-year-old male NEIDL researcher coming into contact with Ebola virus.
  • A 46-year-old man contracting Sabia virus that infects his family’s pet hamster, which in turn infects his wife and daughter and 25 of the daughter’s first grade classmates.
  • A virologist contracting monkeypox through exposure to the biosafety level 2 arenavirus, Tacaribe, after it spills onto a lab floor during centrifugation, due to a crack in the seal of a centrifugal bottle containing the virus while stored in a lab freezer. The virologist notifies two co-workers, who help him clean up the spill. Seven days later the virologist starts feeling ill; he is hospitalized and begins ribivirin antiviral therapy 13 days after exposure. The two co-workers report symptoms 14 days after exposure.
  • An over-pressurized package of Rift Valley Fever virus explodes in a van driven by a lab chief after it hits a pothole while traveling down a street. The driver panics, and crashes the van into a utility pole, releasing RVF virus into the van’s interior. The driver is shaken up and has a mild concussion, but within a week he begins running a fever and stays home from work. While in his backyard, he develops a mosquito bite on his neck.
“The risk assessment scenarios described in this section have been designed to cause infection in the index patient 100 percent of the time. This is a gross overstatement of the risk,” NIH declared in its study. “In reality transmission rates of diseases are rarely, if ever, 100 percent in a given population due to modifiers of susceptibility that differ among individuals and populations (e.g., health, nutritional, and immune status; genetic susceptibility; pregnancy; drugs such as chemotherapeutic agents or steroids) and exposure cannot be directly equated to disease development 100 percent of the time.”
 
BU echoed NIH, countering in the August statement that locating NEIDL in Boston’s South End “would neither elevate nor create a public health risk in the community.”
 
Klotz contended NIH should have instead studied more contagious diseases such as avian flu and SARS rather than ebola, sabia, monkeypox, and Rift Valley fever.
 
“These are all ‘exotic’ viruses, to use the NIH terminology, and represent no present or likely future public health threat to the United States. While death from some of these viruses is horrific, outbreaks cause deaths in the tens to hundreds, not millions. Thus, they are not major public health threats even in the countries where they are endemic, such as Africa,” Klotz said.
 
Klotz said the NIH analysis should have addressed factors where population density would add to risk. One such example would have been the aerosol release of avian flu and SARS within a densely populated community. In such communities, infected employees of NEIDL are more likely to transmit disease to strangers simply by traveling to and from work via mass transit, raising the potential numbers of deaths and injuries, Klotz said.
 
“NIH’s analysis was not responsive to the court’s instructions, which were to conduct a better analysis of risk to the population-dense community where the lab is located, and an alternative site analysis,” Klotz concluded. “A responsive analysis would also compare Boston, Tyngsborough, and Peterborough for both aerosol releases of agents from the lab and highly contagious agents.”
 
BU defended the NIH study last week, with university spokeswoman Ellen Berlin telling BioRegion News that the agency incorporated input from local residents into its study design: “NIH asked the community what to study, so those are interesting criticisms.”
 

“NIH’s analysis was not responsive to the court’s instructions, which were to conduct a better analysis of risk to the population-dense community where the lab is located, and an alternative site analysis.”

Klotz noted the NIH study marked the second effort to assess potential health risks from NEIDL. In the first effort, BU assessed the effects of a release of anthrax spores into the surrounding community. A consultant to BU concluded there was zero risk of infection, reasoning spores would disperse into the air.
 
But Jeanne Guillemin, a senior fellow at the Massachusetts Institute of Technology Security Studies Program, said the consultant, RWDI, initially miscounted the number of spores in a gram of anthrax (a trillion, not the billion cited by the consultant before it corrected itself) and used a model for dispersal based on a wind tunnel, not an urban atmosphere. She has also faulted the first study for making no mention of the potential for long-term environmental contamination from such a release.
 
Guillermin has faulted BU for downplaying potential risks from the biosafety lab even before the NIH study.
 
“Everyone’s worst nightmare is that the new laboratories will be the source of an outbreak that would panic city residents and perhaps spread beyond Boston —and for which medical interventions might be unavailable. Instead of discussing those fears or possible medical responses with community representatives, BUMC officials promoted economic incentives such as construction jobs and scholarships for technical training, transitory benefits for a few that cannot outweigh the threat of lethal epidemics over a projected 20 years of high-risk agent research,” Guillermin wrote last year in a response to a final environmental impact statement submitted by BU.
 
“The unfounded assertion of ‘zero risk’ precludes consideration of necessary public health resources and education to minimize danger. This complex problem has to be addressed no matter where a BSL-4 site is located, but by denying it will ever happen BUMC avoids considering its responsibilities in choosing a densely-populated area for its NEIDL,” Guillermin added. “If risks of a dangerous outbreak are not confronted and addressed in advance, the NIH could be facing the infectious disease equivalent of a Hurricane Katrina.”
 
BU Projects $2.9B in Activity
 
According to BU, benefits from the project include more than 1,300 construction jobs and an anticipated 660 permanent jobs. The university will pay the city of Boston $1.9 million in job training and housing linkage payments, and BU and the medical center have promised to maintain previously agreed payments to the city — a combined $3.2 million in annual in-lieu-of tax payments and a combined $3 million in taxes.
 
Over the next 20 years, BU has projected the lab would generate $2.9 billion in economic activity in Boston.
 
The NEIDL is one of two National Biocontainment Laboratories planned by the NIH to battle emerging infectious diseases in the years since the Sept. 11, 2001, terrorist attacks and a subsequent wave of anthrax attacks. The other biocontainment lab is at the University of Texas Medical Branch in Galveston, Texas.
 
The NIH also designated 13 regional biocontainment laboratories, all of them Biosafety Level 3. The nearest level 3 lab to the BU facility is one planned for Tufts University in Grafton, Mass.
 
BU has received $128 million from the NIH toward the biosafety lab; the university and its medical center will raise the remaining $50 million.

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