Wednesday, April 22, 2009

Biolab Questions Meet Clarity of Gray Areas

Two City Councilors trying to clarify the possible hazards on the frontiers of research at Boston University’s Level 4 Biocontainment Laboratory in the South End found themselves last Wednesday turning headlights on a fog.

The line of questioning at a hearing by the Council Committee on Health and Environment, almost entirely from Councilor Chuck Turner, was mainly to find out whether some research requiring extra precautions might even be ruled out by the city’s regulations.

The Boston Public Health Commission (BPHC) restricts research involving recombinant DNA (rDNA), defined as DNA molecules constructed outside of a living organism or synthetic molecules joined with natural molecules. The city prohibits research with rDNA in Level 4, which is the setting with the highest risk and security precautions.

The head of the laboratory, Dr. Mark Klempner, had reportedly said he expected it would include research on vaccines produced with rDNA— “chimeric viruses.” And the city regulations incorporate guidelines from the National Institutes of Health (NIH) which do include standards for work with rDNA in a Level 4 setting.

Located on the Boston University Medical School Campus, the lab is already built, but its environmental safety review by the NIH is expected to continue for at least another year.

The Director of the Bureau of Community Initiatives at the BPHC, Roger Swartz, acknowledged the rDNA ban, but said he could only address issues “in terms of applications submitted” for specific research proposals. The BPHC would decide whether to approve a proposal after receiving a recommendation from an advisory committee. Swartz told councilors the question of rDNA would “be discussed in its entirety” once the committee comes together.

“We have had a number of discussions with experts,” said Swartz, “and it’s clear to us that there are some areas of, some gray areas. And we want to make sure that from the start, as we address rDNA and Level 4, that we have the scientific experts that will be providing guidance and recommendations to the executive director (of the BPHC). So, at this point, I would say we’re not prepared to address specific proposed or hypothetical research. We’re not there in the process.”

In his testimony to the councilors, Klempner denied the lab would engage in development of biological weapons.

“Let me state clearly and unequivocally,” said Klempner, “that all the research and every one of our researchers in the NEIDL (National Emerging Infectious Diseases Laboratories) will completely abide by the BPHC regulation, which bans recombinant DNA research in Biosafety Level 4.”

After Klempner was asked about a statement he reportedly made last year indicating that some research at the lab under its associate director, Dr. Thomas W. Geisbert, would include rDNA, he gave neither confirmation nor denial.

“I want to reiterate again to you,” said Klempner, “that we are absolutely committed to transparency and we are in every case going to submit every proposed research proposal to the regulatory bodies that we need to respond to in order to be able to have approvals to do the research in the laboratory. I certainly have made statements about work that we hope to conduct in the laboratory, and we will continue to do that. We are continuing to recruit new scientists to do research, but that is different than making statements about the regulator.”

As Klempner reminded councilors, the decisions about which research would be allowed would be up to the BPHC. In other words, the lab was the regulated and the city was the regulator.

For one opponent of the lab at the hearing, the distinction between the two wasn’t clear enough. The legal counsel for the Roxbury-based non-profit Alternatives for Community and Environment, Eugene Benson, said one reason for this was that the president and CEO of Boston Medical Center, the main affiliate of Boston University Medical School, was the vice chair of the BPHC’s Board of Health. And he noted that a BPHC official who would be part of the committee reviewing proposals for research had previously recommended designation of the Biolab for Boston by the NI H.

“What you have is, in two ways, you have an impossible situation here,” Benson argued, “where the Boston Public Health Commission has refused to actually articulate what are very, very bright lines in their regulations. And then you have this back-and-forth between people who work for the Boston Public Health Commission and Boston University. So you’re setting up a dynamic where the dynamic is going to be to approve proposals that clearly violate the regulation. That is really no way to operate a regulatory agency. And, while it wasn’t my intention to make this recommendation, but I think the only recommendation that I can make coming out of this is that you need to prohibit all BSL-4 regulation in the City of Boston because what this tells you is that you are trying to do your oversight role but it can’t be done, considering the interaction between BU, the Boston Public Health Commission, and their failure to adequately and completely respond to Councilor Turner.”

Another lab opponent, a professor of Cell Biology at Harvard Medical School, Daniel Goodenough, went a step further. Though he acknowledged that rDNA was “a fundamental tool” for research, he said using it in work that required a Level 4 setting was “too dangerous.” He argued that it was difficult to oversee research that, once it gets under way, could take new directions, involving new personnel over time.

“All of these regulations, as we all know, just get harder and harder to maintain,” said Goodenough. “More and more people are coming and the turnover rate is huge—in academic that’s the name of the game, it’s up or out: you either succeed and you go somewhere else, or you fail and you leave. So there’s very high turnover, huge, huge amounts of training issues here, and I don’t think that the Boston Public Health Commission can possibly assess that. And it’s my belief that this regulation (banning rDNA research) was put in place initially with the understanding that we can’t regulate this—it’s too hard. And the only solution is to say, ‘No, we just don’t have any of this going on in a BSL-4 facility.’”

In one of his few comments on testimony at the hearing, the chair of the Committee on Health and Environment, Councilor John Connolly, described the remarks by Swartz as “very comprehensive, as far as covering the major points.”

Turner insisted there should be more definite information, and more transparency, about what would happen at the lab should it be approved for operation. He said it was “disheartening” that the BPHC was “unwilling to help the public understand the confusion that is here.”

“I think that really just puts wood on the fire,” he added, “that just makes people more distrustful of what’s going on.”