As the Ebola outbreak rages in West Africa, a seven-story laboratory designed to study that virus and others like it stands mostly empty in Boston’s South End.
But researchers at Boston University, which built the high-security lab with $200 million in federal money, expect a decade of frustration to end soon, perhaps within a year.
BU’s plans have survived 11 years of risk assessments, public hearings, and lawsuits from critics who question the laboratory’s safety and value. Now, a review by the Boston Public Health Commission and an inspection by the US Centers for Disease Control and Prevention are the final hurdles before scientists can hunt for treatments and vaccines against the world’s deadliest pathogens.
“There are superb scientists anxious to get on with their work,” said Jean L. Patterson, a scientist at the Texas Biomedical Research Institute in San Antonio, who used to work at Harvard and has been following the BU struggle from afar. “This has been their life’s dream to work on these pathogens.”
The biolab nears approval, however, just as controversy about this type of facility — known as a Biosafety Level 4 laboratory — heats up in the United States and around the world.
Embarrassing mishaps at US government laboratories have prompted calls to suspend Level 4 work and close some of the labs. And scientists argue about the wisdom of research that involves making microbes more dangerous, research that some fear might take place in Boston (although BU says it has no plans to do so).
The recent laboratory safety breaches have intensified the concerns of some neighbors and scientists who have long opposed BU’s National Emerging Infectious Diseases Laboratories, built six years ago and today about 25 percent occupied, with researchers working on less dangerous pathogens in Biosafety Level 2 labs. Utilities and security at the seven-story building cost $700,000 a month, most of it to support the empty Level 4 lab.
Research in a Level 4 lab is cumbersome and exceedingly expensive, said biolab opponent Lynn C. Klotz in an interview in August. Klotz, a Gloucester resident, is senior science fellow at the Washington, D.C.-based Center for Arms Control and Non-Proliferation. He noted that there are already 10 Level 4 labs around the country.
“This lab is not needed and there are many, many other things they could be studying,” including more common diseases such as drug-resistant tuberculosis and AIDS, he said.
Research on deadly organisms for which there are no vaccines or treatments, including Ebola, can take place only in a Level 4 laboratory, which must meet federal standards. BU won a competitive federal grant to build its biolab in 2003, part of the Bush administration’s response to biowarfare fears in the wake of the anthrax mailings that followed the Sept. 11, 2001, attacks.
Over the years, the university has obtained more than 50 permits or approvals from federal, state, and city agencies for the lab, prevailed in two lawsuits that sought to block the facility, and in May persuaded the Boston City Council to reject a proposed ordinance banning Level 4 labs.
Opponents had pinned their hopes on Mayor Martin J. Walsh, who as a candidate last year proclaimed his opposition to the biolab. But he has made no move to prevent its opening, saying only that he supports “furthering Boston’s position as a leader in the life sciences while ensuring the safety and security of our residents.”
A risk assessment by the environmental consulting firm Tetra Tech, whose conclusions were backed by two independent panels of specialists, examined more than 300 possible ways something could go wrong at the BU biolab. It found that the risk of infections to the public is “extremely low or beyond reasonably foreseeable.”
But recent news about the mishandling of dangerous pathogens at the CDC, the very agency that will inspect the biolab, pointed to the potential for flaws in even the toughest security protocols.
“The thing is, you can’t prepare for human error,” said Klare Allen, a Roxbury activist who was the lead plaintiff in the unsuccessful federal lawsuit against the lab. And if a microbe escapes, she and other opponents say, low-income residents of the South End and nearby Roxbury will suffer the most.
At the CDC earlier this year, a low-risk strain of influenza was inadvertently contaminated with highly dangerous bird flu and sent to another laboratory without proper transfer procedures. Then in June, 80 people were exposed to deadly anthrax after samples wrongly thought to be harmless were delivered in plastic bags.
Neither incident resulted in illnesses, but both involved a failure to follow protocols.
Ronald B. Corley, the BU lab’s director, said his team studied the causes of the CDC errors and concluded that BU has checks and balances to prevent such incidents. “The likelihood of that happening here is next to zero,” Corley said.
John R. Murphy, who put aside retirement plans to serve as the lab’s interim director, called the breaches of protocol at CDC “unconscionable,” but emphasized: “As bad as that was, there was not a single person that got sick.
“Does the public really want,” Murphy said, “to close down facilities that could develop or help develop a therapeutic agent against a disease as terrible as Ebola?”
Lab opponent Marc Pelletier, who described himself as a biotechnology professional who has worked in drug development, said that many other laboratories are developing Ebola treatments and vaccines that work in nonhuman primates.
Patterson, whose San Antonio lab has developed potential Ebola vaccines, said there is still ample work to be done on Ebola, as evidenced by the surprises in the West African epidemic.
“If we had another one [Biosafety Level 4 lab], would we be addressing the Ebola outbreak in a better way?” she asked.
Klotz and Pelletier raised concerns the laboratory might someday conduct research manipulating the genes of pathogens to make them more dangerous, such as the recent case when two laboratories altered a deadly bird flu to make it more easily transmissible. The purpose is to better understand how these pathogens might evolve in nature and work on measures to contain them.
Scientists are sharply divided on whether such work is worth the risk that the genetically engineered virus could escape. In July, hundreds of them formed the Cambridge Working Group to argue against such research. Soon after, hundreds of others scientists who believe such work is essential formed Scientists for Science.
Will BU engage in such research? “We do not plan on making pathogens more dangerous,” Corley said. “I cannot go on record that we will never do work that is similar, but our goal is never to make a pathogen more virulent or more dangerous.”
Each project the lab wants to undertake must first win approval, in a public review process, from BU’s Institutional Biosafety Committee and the Boston Public Health Commission, which gets advice from an 18-member committee composed primarily of scientists knowledgeable about biosafety.
But first, the health commission has to decide whether to allow the lab to open. It has held eight meetings on the issue and expects to make a decision this fall.
If the biolab wins approval, Ebola and its cousin, Marburg, will be the first microbes studied. A BU microbiologist, Elke Mühlberger, plans to examine how Ebola undermines the immune system when it first invades cells.
The BU biolab would be the 11th Level 4 lab in the country, but only the second at a university academic medical center. The academic setting, Corley said, brings together people from diverse fields, potentially sending research in surprising and fruitful directions.
A new human pathogen arises every 18 months, and no one knows “what nature is going to throw at us” in the coming years, Corley said. “Two or three years from now, there will be pathogens that you or I have never heard of that we’ll be studying.”