For Science, Red Tape Follows Greenbacks

It’s a warm October evening in Washington, D.C., and some of the nation’s top biological researchers mingle in the ballroom of the Omni Shoreham Hotel over drinks and a dinner buffet.

Eyes fall to the identification badges hanging from their necks as they circle the hall, stopping to peruse poster-board displays and talk in small circles.

They’ve come together from the labs of academia, industry, and government for “Biosecurity 2003,” a three-day conference that Harvard has sponsored as concern for the nation’s safety mounts in the wake of Sept. 11.

For a dinner party, the scene is a strange one. Representatives from biological supply companies hawk arcane apparati—airborne pathogen detectors, emergency treatment kits—from booths along the periphery of the room. Conversation topics range from the banal to the bioanthropological.

George S. Panton Jr. has traveled to Washington from Florida in order to spend a couple of hours in this milieu. As founder and president of Extreme Response, a small company that manufactures biologically resistant aquatic rescue equipment, he is trying to claim the niche market that many of the evening’s guests represent.

He wiggles something that resembles a surfboard at the passing scientists. It’s slick and neon green. Panton’s tie is neon yellow.

“The MAXx is not just another plastic backboard,” he tells anyone who will listen, chanting the slogan printed on the display behind him. He designed the floating stretcher himself, he explains, to be entirely resistant to pathogens in the case of a biological cataclysm.

For the time being, Panton is pitching to a broad consumer base. He gestures proudly toward a photograph of the MAXx sporting military camouflage.

Three years ago, Panton’s esoteric product might have met with a tepid reception at best. He would have had little reason to take the long trip for two hours in the company of professors and government officials. Three years ago, in fact, many of the people standing elbow-to-elbow at the buffet—representing three very different spheres of biological research—might not have found themselves in the same room.

The sudden importance of this peculiar device reflects an abrupt change in scientific priorities in the post-Sept. 11 world. Biological researchers in academia, industry, and government have an incentive to work together now more than ever.

This priority change originated in Washington but has had effects nationwide. At Harvard, the bottom line hasn’t been floatable backboards, but millions of dollars worth of research support.

But while the new funds are a boon to research at the world’s wealthiest university, new opportunities have proved a double-edged sword.

With new resources have come new regulations designed to keep technology from falling into the wrong hands—regulations that limit the subjects and personnel research enterprises can include.

Researchers from certain countries are effectively barred from work with “select” substances, results publishable before Sept. 11 can no longer find a place in many of the nation’s top scientific journals, and research previously considered open may now be shrouded in secrecy.

For a research community used to what has essentialy been a laissez-faire system of self-regulation, the new oversight is inherently unsettling. Many however, see in its excess something even more harmful: an attack on the value of openness intrinsic to scientific work and the intellectual culture that sustains it.

Dean of the School of Public Health (SPH) Barry R. Bloom has been among the most outspoken of this latter camp, arguing that effective protection from bioterrorism can only originate from open communication among scientists.

“The greatest threat is putting restrictions on knowledge that you need for security,” he says. “Fundamentally, censorship of science is the antithesis of its objective.”

It is into this setting that University leadership has been thrown, as Harvard has been faced with an array of often unprecedented questions, forcing administrators to determine exactly where the boundaries of openness and academic freedom lie.

Their new challenge is to find a way to use innovation to protect the nation without sabotaging the values of science itself.

A CHANGED TERRAIN

The Sept. 11 terrorist attacks and the series of anthrax attacks that followed reorganized governmental priorities.

The zeitgeist shifted toward national defense, and a mandate from Washington apportioned a large slice of the national budget toward protecting the country from terrorism—a new type of national threat.

In pursuing projects geared toward this end, the government turned largely to institutions working at the vanguard of research, and in a large way to universities like Harvard.

In January of last year, Bush unveiled Project BioShield, a $6 billion budgetary allotment to fund research on biological defense.

The program has helped to bring about a burst of new opportunities for Harvard and its peers.

At the beginning of this academic year Harvard Medical School received $45 million from the National Institutes of Health (NIH) to build a new biodefense research center. The facility will initially house nine research projects working to develop vaccines and treatments for anthrax, SARS, botulism, West Nile virus, and other of the world’s most dangerous pathogens.

One week later, the University garnered another $15 million to support a Center of Excellence in Complex Biomedical Systems research at the Bauer Center for Genomics Research.

And in January, SPH received a $20.5 million biodefense grant—the largest in its history—for a study of immune response to pathogens. The study’s results, when ready, will suggest how the human immune system can best be fortified against biological agents, many of which could be used for bioterrorism.

According to Senior Director of Federal and State Relations Kevin Casey, there’s been a significant rise in funding in the wake of Sept. 11.

In the year before the terrorist attacks, Harvard received $348 million of federal funding. Last year, by contrast, research projects at the University brought in a total of $412 million. Casey points out however, that other factors, such as a planned increase in the grant budget of the NIH, likely helped drive these gains.

Harvard is also reaping the benefits of increased funding through partnership with other local institutions. Over the course of the past two years, federal funds have spawned a wave of growth throughout greater Boston.

Last fall, funding cleared for the first and only top-security biological laboratory in New England—bringing the vanguard of biological research to Boston with it.

The so-called BioSecurity Level 4 lab (BSL-4) is the crown jewel of biological research facilities, comprised of an array of sealed chambers and locked freezers intended less to keep intruders out than to keep test subjects in.

The new facility will be used as a refining ground for previous research, providing a secure environment in which researchers can test their research on whole pathogens.

When the South End facility, technically under the auspices of Boston University, opens in 2006, it will enable scientists from several local institutions—including Harvard—to carry out research on everything from AIDS vaccines to the Plague.

THE FLIP SIDE OF FUNDING

Not everyone is convinced, though, that the wave of new funding is bringing the benefits it promises.

Kendall Hoyt, a fellow in the International Security Program at the Kennedy School of Government, has been tracking the effects of increased funding for science since Sept. 11.

She says her research indicates that the new rivers of federal money flowing into higher education may actually be working to sink the national-security boat—in part because the NIH, through which most funds are funneled, lacks a system for ensuring that projects are relevant, unique, and ultimately worthwhile.

Mismanagement of projects has already led to a huge waste of resources made worse by flawed threat assessment, she says.

But she cites another danger that has aroused controversy at Harvard and its peers.

More work on biological pathogens means more potentially subversive knowledge about them, Hoyt says.

“As you expand these programs, you’re training more and more people to deal with these pathogens,” she says. Some could eventually use the findings for harm rather than help.

This possibility is the government’s worst fear—and one that has motivated a series of new restrictions on scientific research since Sept. 11.

NEW OBSTACLES

The wave of anthrax strikes that followed Sept. 11 brought concerns about biological terrorism to the fore, and the government responded by attempting to seal off the information channels through which biological information could be turned against the nation.

In the wake of the attacks, biological science has accumulated more red tape than it has faced since the Cold War.

Some new restrictions affect who can conduct research. Others limit the dissemination of research findings themselves. And President Bush has authorized federal officials to craft these regulations based on what many feel is a vague new research category and a blank check for further restriction.

Many of the restrictions are based on a current list of almost 80 biological pathogens called “select agents.” Before Sept. 11, this list was about 10 times smaller.

At present, SPH is the only school at Harvard to perform research involving select agents—and even then, according to Bloom, very sparingly. Most research, he explains, is undertaken only on pathogens’ components, rather than the substances in their dangerous forms.

“There’s an enormous amount of science that does not involve the actual substance, whole in a freezer in the lab,” he says.

Section 817 of the USA PATRIOT Act, the broad-ranging anti-terrorist legislation passed in October of 2001, bars “restricted persons”—researchers who either have criminal backgrounds or who come from countries that the U.S. has identified as state sponsors of terrorism—from any access to select agents.

And many potential researchers from foreign countries have trouble even making it into the U.S. to start with.

The Technology Alert List, which predated Sept. 11 but was expanded in its wake, is a compilation of fields that the government fears could be applied toward subversive activity. Flagged pursuits range from biological research to landscape architecture, but Washington addresses them uniformly.

If a foreign researcher’s interests match those on the list, his or her visa is subject to extra scrutiny—a process that accounts for considerable backlog and, in some cases, prevents scientists from meeting their research objectives in the U.S.

Meanwhile, legislation following the terrorist attacks changed research standards themselves.

An executive order on homeland security that President Bush issued in 2002 authorized government officials to bar “certain international students” from education and training in “sensitive areas.”

It’s unclear what “sensitive” research—a formal Cold-War category just short of classified that was abandoned in the 1960s—means today.

National Security Advisor Condoleezza Rice says the “sensitive” category has not been formally revived.

According to Casey, though, those on the ground aren’t convinced.

Meanwhile, other pressures have begun to inhibit the dissemination of information itself.

In response to urging from U.S Attorney General John Ashcroft, thirty-two of the nation’s leading scientific journals—the primary forum for the exchange of vanguard research—announced last year their intention to self-censor, pledging to nix publications that could lead to a terrorist attack.

In addition to these broad directives and prohibitions, restrictions can rear their head on the more localized level, in the form of conditions placed on an individual federal grant.

Harvard automatically rejects contracts that place any conditions on researchers’ freedom to use their findings—such as their ability to publish results.

Last year, MIT refused a $400,000 grant from the National Security Agency because it would have required disclosure of information about international researchers contributing to an unclassified study.

CONCERNS AND OPPOSITION

A cadre of researchers at Harvard and its peers says the new regulations create a culture clash, closing science’s vital channels of openness in both directions: talented researchers are no longer able to contribute, and important information can no longer be shared for further progress.

A conference last year at the Kennedy School of Government’s John F. Kennedy Jr. Forum brought many of these concerns to the public eye. There, Bloom, the SPH dean, joined MIT President Charles M. Vest and Former Secretary of the Air Force Sheila Widnall to argue that opportunities for the free exchange of knowledge must remain available, even in the wake of Sept. 11.

“I believe that restriction is rarely advisable, and certainly rarely feasible, in this environment,” Vest said. “Restrictions on our teaching and where our students come from are unlikely to counter [national security] concerns.”

Bloom alleged that the set of post-Sept. 11 restrictions undermines the basic pedagogical goals of a research university.

“It’s creating ignorance among the greatest universities and the brightest students,” he said.

At Harvard, restrictions on who can work with select agents mean that SPH scientists from a few blackballed nations, mainly Middle-Eastern countries, aren’t able to pursue work with the most dangerous biological pathogens.

According to Bloom, the restrictions haven’t sunk any projects so far, but the University isn’t yet out of the woods. The rigorous background scrutinies now required by the government could dissuade some scientists from taking on major projects, he explains.

Casey has been trying to make sure that background checks take place as expediently as possible, so that prospective researchers aren’t prevented from meeting academic deadlines.

In the realm of publication restrictions, Casey is working with peer universities to document and devise a unified strategy against conditional contracts.

According to critics like Bloom, both restrictive contracts and self-censorship could have devastating effects on the exchange of information, ultimately paralyzing, rather than protecting, the biological advances that might be used to protect the country.

The sort of material that ordinarily appears in peer journals, he says, is so specific and esoteric that a terrorist would have difficulty in appropriating it in any case.

The ambiguous reinvocation of a “sensitive” research category has drawn particular ire from scientists.

Vest, who last spring organized a special conference at MIT after his panel discussion at the Forum, said he thought an undefined “sensitive” category could lead to a “slippery slope” in restriction.

“Whenever possible, we should draw distinct boundaries,” he said. “Basic research should be open, and [applied] research should be either classified or unclassified.”

Bloom takes issue with the implications of the presidential directive more broadly.

“It’s creating ignorance among the greatest universities and the brightest students,” he said of efforts to red-flag international students and keep them from research opportunities. “We have to create a culture of science where no one wants to misuse it.”

But a year later, he says the path toward achieving this culture is still undefined.

DIALOGUE WITH WASHINGTON

In the months since Sept. 11, mounting concerns about the new regulations have initiated a dialogue between academia and government.

Governmental leaders say they now recognize the difficulty in tracing a path between the imperatives of national security and the academy’s cherished openness.

“We don’t know what to do,” says Elizabeth George, portfolio manager for BioDefense technologies in the U.S. Department of Homeland Security (DHS), which culls available research resources in the interest of national security. She says the DHS has asked leaders in academia to help arrive at a better balance between national security and academic openness, but without a definite outcome. “We’ve reached out to the experts and the jury is still out.”

John H. Marburger III, who heads the White House’s Office of Science and Technology, has been at the center of these efforts.

He says his interaction with the academic community has ensured that the Bush administration is mindful of tensions and obstacles that governmental oversight might create for research institutions accustomed to being beholden only to their own research concerns.

“This administration is quite serious about preserving openness,” he says.

Still, the government has taken few concrete steps over the course of the past year.

Marburger cites as a major step forward a National Academy of Sciences panel chaired by MIT scientist Gerald Fink that recommended steps to give scientists a greater voice in achieving a post-Sept. 11 balance.

The so-called Fink Report upheld the need for research oversight with an eye to national security. But it proposed establishing a committee of experts to ensure that researchers’ projects are reviewed by peer scientists—rather than lay lawmakers—before being impeded or allowed to progress.

Last month, the government implemented this recommendation by establishing the National Science Advisory Board for Biosecurity, a panel of 25 experts that will provide oversight for institutional projects under governmental aegis.

BACK AT HOME

While scientists were mulling over universities’ concerns in Washington, a committee comprised of some of Harvard’s top scientific administrators plotted the University’s path through the government’s demands back in Cambridge.

Composed of specialists from all of Harvard’s schools pursuing biological research, the Provost’s Committee on Biodefense Research and Regulations stated emphatically that, while new regulations posed a potential threat to the University’s values, the long-term benefits of research made plodding through the regulations worthwhile.

“Federal laws and regulations, aimed at increasing safety and security...are at odds with certain long-standing University values such as openness and the equality of treatment,” the report said.

Still, research covered by the regulations “could contribute significantly to the protection of the public’s health.”

The report, formally presented to Harvard’s Faculty Council in February, suggested that the faculty of each of Harvard’s schools weigh the costs and benefits of participating in research covered by the new regulations. It also refreshed Harvard’s preexisting policy of not accepting grants imposing conditions on research participation.

But the provost’s committee did recommended that graduate students be held off projects that could be subject to last-minute, career-impeding publication restrictions.

Leaders of Harvard’s schools say that little has come of the report’s recommendations so far.

According to Bloom, the committee should have used its pulpit to make a stronger statement against the post-Sept. 11 regulations on biological research.

“I think the report missed an opportunity to emphasize the centrality of access to knowledge within the university,” he says.

Tosteson University Professor S. James Adelstein, who chaired the committee, says he thinks Bloom was expecting too much of the document.

“We’re writing for the provost, we’re not writing for a bully pulpit,” he says. “It’s an understated Harvard document.”

But Bloom suggests that Harvard should have been willing to err on the side of overstatement. He explains he thinks academia in general—as well as Harvard as an institution—has not been vocal enough in its consideration of questions that have risen in the wake of the government’s new demands on research.

“I have heard a fairly deafening silence, at least at my end of the river,” he says. He says he understands that a single institution—even one as influential as Harvard—carries little clout on its own.

“I’m acutely aware of the limitations of one faculty or one institution,” he says. “The PATRIOT Act and the Bioterrorism Act are laws of the United States, and as a dean rather than as an individual, I have to comply with the law,” he says.

Even so, Bloom says the response from the higher-education community as a whole could be stronger. “I would like to see a greater thrust of all the universities to modify the PATRIOT Act.”

According to Bloom, governmental regulations on research are unnecessary because social and professional constraints built into the research process—pieces of what he calls “a social compact for designing knowledge and receiving knowledge”—are already more effective in preventing subversive use of information than any federal oversight could hope to be.

“The public knows what our higher calling and responsibilities are, and it’s the social constraints, to me, that are the most powerful,” he says.

These constraints—and the education that sustains them—are nowhere more powerful than in a thriving research university, he adds.

“Everyone who goes to Harvard and goes into science understands what scientific integrity is about,” he says.

But not everyone thinks the implications of science in a post-Sept. 11 environment are so straightforward.

James T. Kvach, chief scientist in the Defense Intelligence Agency of the Armed Forces Medical Intelligence Center, says that, while the country is unified in its effort to achieve as much security as possible, agreeing upon a standard of success—and a route toward achieving it—has no easy answer.

“It comes down to, as a society, how much risk we’re willing to accept. How much risk am I capable of managing?” he says. “In my mind, what should be made available is as much as possible, [but] I don’t know where that line is.”

—Staff writer Nathan J. Heller can be reached at heller@fas.harvard.edu.