Red Tape and DNA

The fight to establish guidelines for recombinant DNA research has raised hackles in every quarter--in Washington over a series of legislative and administrative maneuvering, in Cambridge over the way universities conduct their DNA research, and in the academic community over charges of conflict of interest and exploitation of DNA research.

The furor over recombinant DNA research stems from two considerations--its possible adverse impact on the environment and on health conditions, and its potential lucrativeness. Recombinant DNA experiments involve creating new combinations of genetic material by injecting a piece of DNA into bacteria, possibly giving them new characteristics. Environmentalist critics of recombiant DNA experiments fear inadvertent development of harmful bacteria strains that could not be controlled.

Other critics in the academic community and elsewhere fear exploitation of recombinant DNA research for profit. George S. Wald, Higgins Professor of Biology Emeritus, mentioned a recent court ruling allowing researchers--whether affiliated with academic institutions or industry--to patent any new micro-organisms they develop. The pharmaceutical industry in particular is conducting intensive research, and would stand to gain from any products it develops as a basis for new antibiotics. Proponents of legislation to regulate recombinant DNA cite this possibility of industry profiteering as a rationale for nationwide legislation.

Wald and Jonathan King, assistant professor of biology at the Massachusetts Institute of Technology, also fear academic exploitation of DNA research. Wald says that some "pioneers" of recombinant DNA research are also on the boards of corporations that wish to use the fruits of such research to develop new products, and which fund scientists' experiments. By accepting private, rather than government, funding, researchers do not have to abide by NIH guidelines.

These arguments have persuaded many people that national legislation is needed to prevent exploitation of recombinant DNA research and to lessen the possibility of damage. The existing NIH guidelines apply only to researchers who use government grants to fund their experiments. Private industry can conduct recombinant' DNA experiments with no imposed restrictions or safeguards.

The legislation now before both the House and Senate would extend the NIH guidelines to all recombinant DNA research. The bills have a rocky legislative history. Most of the controversy surrounding the bill revolves around how the federal guidelines would affect the status of state and local governments' restrictions on DNA research. The House bill contains a clause providing for uniform national standards for regulation that would override any local regulation. If a local government wished to apply a stricter standard than the federal guidelines, it would have to apply to the Secretary of Health, Education and Welfare (HEW), who would administrate the guidelines. Critics of this clause protest it would not give local governments enough leeway to regulate DNA research in their own communities.

Harvard firmly believes the federal government, not the local governments, should control standards, and has lobbied intensively to ensure that the House and Senate bills contain this clause. The current House bill is a compromise between congressmen's diverging views on this clause and Harvard's determination to see federal control of DNA regulatory standards. Much of Harvard's determination stems from friction with Cambridge over recombinant DNA experimentation. City Councilor and then-Mayor Alfred E. Vellucci spearheaded a drive to ban all recombinant DNA research here. After a series of public meetings, the Cambridge City Council imposed in the summer of 1976 a three-month moratorium on all recombinant DNA research, later extended for four more months. The city council also set up a citizens' board to review and evaluate recombinant DNA research, which recommended permitting research following the NIH guidelines. During a stormy session in February 1977, the council approved the recommendation, ending the moratorium.

Many Harvard professors bitterly resented the moratorium, which they felt slowed the progress of their research while scientists from other universities made significant discoveries. An example occurred in the spring of 1977, when researchers at the University of California made a discovery that workers in a Harvard DNA lab said they could have pursued if they had not been banned by the regulations.

Wald says the moratorium was "unprecedented," but unlike many of his colleagues, he believes it accomplished a useful purpose in bringing the issue of recombinant DNA to the public's attention. This is as unusual as it is important, "because everything possible is done to make them think the issue is beyond their comprehension," Wald says, adding that many professors did not support his position. "People in the Biology and Biochemistry department were exceedingly eager--passionately anxious, in fact--to get on with their research," he says.

But he adds there exists a group of professors who supported the public's right to check the research who nonetheless remained silent in the face of University administrators' lobbying for the federal override clause.

The original bill, sponsored by Rep. Paul D. Rogers (D-Fla.), contained strong language on federal standards, but when an amendment softened the bill's language, Harvard withdrew its support. Rep. Harley O. Staggers (D-W. Va.), chairman of the House Interstate and Foreign Commerce Committee's subcommittee on Health and Environment, asked a Harvard lobbyist to draw up a new bill. Staffers associated with drafting the DNA legislation said the Harvard bill contained errors in procedural language, and said Rogers developed an alternative bill. Rogers persuaded Staggers to accept this bill, which restored the strong federal override clause. The bill has now passed out of committee and should be considered by the full House shortly.

The history of the Senate bill is equally convoluted. Unlike the House version, the bill does not contain a provision for strong federal override. Sen. Edward M. Kennedy '54 (D_Mass.), the bill's sponsor, is a strong supporter of local governments' right to enforce guidelines more stringent than the federal ones. Kennedy's strong stand against total federal control of standards may be one reason for the legislative confusion presently surrounding the bill. Knowledgeable aides say many influential senators do not support Kennedy's position and that the bill will probably not pass the Senate without some form of the federal override clause. Aides' predictions vary, but rumor on Capitol Hill has it that Kennedy is growing less and less enthusiastic about the bill, and may withdraw it altogether.

Kennedy and Sen Adlai Stevenson III '52 (D-Ill.) have already explored an alternative to legislation. They sent a letter in late May to Joseph A. Califano Jr., secretary of HEW, asking him to consider the possibility of using section 361 of the Health and Public Safety Act, which would enable him to impose the NIH guidelines on all DNA research without special legislation.

HEW has already taken a position against such a proposal. In a letter sent to Kennedy a few weeks ago, signed by Hale Champion, Harvard's former financial vice president and now undersecretary for HEW, he expressed his support for new legislation, and explained that department lawyers had advised that the secretary might exceed his authority if he invoked section 361. However, a source involved in monitoring DNA legislation, who asked to remain unidentified, says there are indications that Califano may reconsider the policy, especially if legislation is tied up indefinitely in Congress, a situation Kennedy's inaction on the bill may precipitate.

There were other pressures to ensure that some kind of bill passes, including White House and university lobbying. Joseph Oneck '62, associate director of domestic policy staff, said last week the administration's original bill contained no federal override clause. Now, he says, the administration may settle for a moderate federal override clause that would allow local government more say. "We take a pro-environmental stance," Oneck explained. "Cambridge seems to have worked out a liveable compromise, and we'd hate to override the work of the community," he added.

Burke Simmerman, a staffer on Stagger's committee, said last week he believes a combination of administrative and House pressure will force Kennedy to take action on the Senate bill. The House will act on the bill soon, he said, and if the bill passes, some action will have to follow on the Senate side.

Harvard would also probably prefer some type of legislation rather than enactment of Section 361. But the University has shown it will not accept legislation without strong federal override provisions. Michael F. Brewer, director of the government section of the Office of Government and Community Affairs, explained Harvard believes uniform national standards are necessary to protect researchers from excessive red tape caused by overlapping state and federal regulations. Such regulations would allow them to conduct research in any university they want, so they would not have to choose their university based on local regulations. Brewer also said the overlapping enforcement of federal and state guidelines creates bureaucratic chaos, and wastes valuable energies.

Because of these views, Harvard has engaged in intensive lobbying focusing on the House side, where Harvard and two other universities formed a loosely organized group known as "Friends of DNA," which produces a monthly newsletter to keep approximately 75 universities on the mailing list informed of the progress of DNA legislation. The Friends of DNA also hired Nan Nixon to represent the group to legislators. Nixon later registered as an official lobbyist. Staffers described Harvard lobbying as arrogant and aggressive, but Harvard administrators said they believed their lobbying was not extraordinarily aggressive.

Harvard has maintained a much lower profile on the Senate side, although Steven Merill, a staffer on the Senate Science and Technology subcommittee, said last week the lobbying "may be out of the ordinary for a university--especially a particular university." But generally, because of the murkiness of the legislative situation in the Senate, Harvard has not expressed a very firm position on the Senate bill.

Another twist in the effort to regulate DNA research is the recent proposal to make the NIH guidelines more lenient, lowering the containment restrictions on certain viruses used in the research and giving the local biohazards committees more leeway. While the proposals cannot be approved for at least a few months, sources involved in monitoring DNA legislation say the director of NIH has already given tacit consent to the proposal.

Many critics of the proposals, such as Pamela Lippe, legislative assistant for the environmentalist lobby, Friends of the Earth, say the NIH move is purely political, an attempt to soften the standards before any legislation goes into effect. Dr. Bernard Talbot, a spokesman for NIH, denies this charge, saysing the proposals originated a year ago, before the present legislation was drafted.

King is openly skeptical about NIH's motives. He says the director of NIH said in a guidelines meeting he wanted to get the revisions approved before the legislation went into effect. Many observers also question the data upon which the recent proposals are based. NIH cites a lessening of scientists' fears about the danger of recombinant DNA research; many scientists have testified at public hearings they believe they initially exaggerated the potential danger of recombinant DNA research. However, other scientists, including King, maintain that NIH is "weakening the guidelines without any scientific criteria whatsoever." He noted that the NIH data base has no risk assessment program to determine exactly how dangerous such experiments may be.

"There is constant pressure to push for the lowest common denominator--there's only one way these restrictions are going, and that's down," King said. He added the NIH is not accountable to the public, but is an autonomous institution with responsibility for guiding and funding research.

Another controversial NIH proposal is the issue of greater autonomy for local biohazards committees. NIH's new proposals would allow these groups to grant preliminary approval for research, allowing the researcher to begin his experiments, with a review by NIH to follow. Talbot said this provision would eliminate bureaucratic red tape and frustrating delays for scientists. Matthew S. Meselson, Cabot Professor of the Natural Sciences, supported Talbot's contentions earlier this spring when he testified against a state bill that would have imposed more restrictions on research.

Macy D. Koehler, the biohazards safety officer for the University, says the proposed change is welcome. The old system "is a phenomenal waste of time and paper," she added. Some critics, however, believe this provision might entrust too much power to local committees, whose objectivity they question. Zimmerman noted that the local committees, which are vulnerable to pressure from local universities and scientists, approve at least 60 per cent of the projects they review. Dr. Daphne Kmely, an officer at NIH, said stopping research that is already underway is difficult, if not impossible.

Harvard DNA researchers are subject to both the University's own biohazards committees and the Cambridge Biohazards Committee. Harvard has three such committees, two at the Med School and one at the Faculty of Arts and Sciences. The Faculty biohazards committee is comprised of one undergraduate, one graduate student, a postdoctoral fellow, a lab employee, a faculty scientist, and a community member, with Koehler as an ex-officio member. With this varied membership, Koehler says, the committee can be objective in its evaluations and enforcement of NIH regulations. However, skeptics could point to the case last year of Dr. Charles A. Thomas, then a Harvard researcher, who was accused of conducting experiments above the containment level of his lab. The alleged violation was not reported until a local citizen complained to NIH. Harvard subsequently filed a report.

Reports issued by the Med School and NIH released earlier this spring state Thomas essentially followed the NIH guidelines although he did not have NIH approval for the experiments. Thomas is now on leave in California.

The Cambridge Biohazards Committee acts as a further check to possible abuses of recombinant DNA experimentation. The Commission of Public Health, the City Manager, and the City Council must approve the group's decisions, in an attempt to neutralize universities' pressures on the review board, Dr. Donald Cressler, the committee chairman, says.

The melange of institutions regulating recombinant DNA research and the chaotic legislative attempts to oversee such experimentation vastly complicates the efforts to standardize regulations. The success or failure of devising a satisfactory regulatory process is still an open question. Less uncertain is Harvard's future role. As a sponsor of much of the important recombinant DNA research conducted in the country, Harvard has a huge stake in this issue. The University will clearly continue to use its considerable lobbying clout to shape the outcome.