NIH Struggling To Regulate Employees' Outside Income

Despite their efforts to curb conflicts of interest, officials lament that some abuses will persist among scientists who consult WASHINGTON--Stung by recent episodes of improper behavior by some of its own researchers, the National Institutes of Health has begun to keep a closer eye on those employees who consult for industry. But even clearly blatant violations of the rules on reporting and limiting how much scientists earn for outside work activities are nearly impossible to detect, say NIH officials, if these employees choose to ignore existing agency policies. "You can't catch people with the system we have in place. But that's not the point," says Philip Chen, NIH associate director for intramural affairs. "If someone wants to lie, cheat, and steal, the chances are we're not going to find out about it unless someone tells us." Professional courtesy may be a major obstacle to tracking down and punishing National Institutes of Health scientists who violate its policy regulating outside work activities. That's the message Rep. John Dingell (D-Mich.), chairman of the oversight and investigations subcommittee of the House Committee on Energy and Commerce, received from NIH officials during a March hearing on a case involving one intramural researcher. The committee was investigating Prem Sarin, the former deputy chief of the tumor cell biology lab at the National Cancer Institute. Sarin was suspended from the agency last winter for alleged improprieties and violations of NIH rules on outside work activities. It took congressional probing and prodding for NIH to delve deeply into Sarin's case. "While we don't want to distrust everyone," then-acting NIH director William Raub told Dingell, "we need to develop the investigative capability to reach beyond the obvious. . . . We do know how to do it [conduct a full and complete investigation], but we didn't do it here." Another obstacle may be the feeling, reportedly common among NIH scientists, that their job is to do science, not to make sure that their colleagues are following the rules. That feeling surfaced in Dingell's questioning of NCI's Robert Gallo, who was Sarin's boss. "If you and NIH know about it [Sarin's alleged activities], I don't understand why I am being asked to investigate him, too," Gallo snapped at Dingell. "I'm a scientist, not a policeman, and I don't know why I would need to be involved." At the same time, however, Gallo stated that he discourages outside consulting because he doesn't think it looks right to see NIH scientists with their hands out. "I've said it many times," Gallo told the subcommittee. "I don't like consulting because of the appearance of conflict of interest, because our lab is already under a microscope, and because it's not a good idea." --J.M. The NIH rules are meant to safeguard the reputation of the federal government's premier biomedical research institutes in the face of lucrative opportunities for some of its scientists to cash in on their expertise. Laid down in 1985 and revised three years later, the rules regulate activities that include consulting with industry or providing expert witness testimony in court. NIH officials say they aren't interested in creating an intrusive auditing system that would involve companies as well as individual scientists, nor do they think that such a system is needed. "Whatever we do," says Stephen Benowitz, director of the Division of Personnel Management at NIH, "the responsibility still lies with the employee as part of the agreement that permits him to consult." Under provisions adopted in September 1988, no scientist can earn more than $12,500 annually from any one company, nor a total of more than $25,000 over any 12-month period, for consulting work. Scientists must also seek permission to accept consulting work from the agency on a case-by-case basis. The existing regulations impose even greater restrictions on any such activities by extramural scientists, those program managers who handle applications for funds from the scientific community. They are prohibited from having any type of financial ties with a company, university, or institution that could receive a grant or contract from the institute for which they work, a definition that in effect precludes their serving as a consultant. The rules are more lenient for intramural scientists, those who work in on-campus labs at NIH. For those situations without a conflict of interest, the rules are intended to limit the extent of such interactions with industry. Intramural scientists are also permitted to maintain a medical practice, so long as they do not work more than 400 hours a year. There is no ceiling on these clinical earnings, although such work is usually limited to those specialties--such as emergency room care or psychiatry--in which physicians can work predetermined and set hours. NIH has found it difficult, with the procedures it has in place, to police the conduct of employees who step outside those limits. That was brought out during testimony before a congressional subcommittee investigating the outside work activities of Prem Sarin, the former deputy chief of the tumor cell biology lab headed by pioneer AIDS researcher Robert Gallo (see accompanying story). Sarin, who was suspended last winter after having worked at the National Cancer Institute (NCI) for nearly 20 years, has been found by congressional investigators and NIH officials to have collected money from drug companies that was intended for a scholarship fund, as well as failing to declare, and exceeding the limits on, various consulting agreements with industry. He is currently under investigation by the inspector general's office of the Department of Health and Human Services, NIH's parent agency. Sarin had been investigated by NIH in 1987, for testifying before the Food and Drug Administration on behalf of a drug company, and received a mild reprimand. But it took a year-long probe by the oversight subcommittee of the House Energy and Commerce Committee, which culminated in a hearing last March, to convince NIH officials to investigate the matter further. But Sarin's is not the only case in which NIH was forced by outsiders to look harder at the conduct of its own employees. A second instance involves four NCI scientists who testified in 1988 on behalf of the electric utility industry in a case that raised the issue of the potential health effects of electromagnetic fields (EMFs). It was a letter from an outside researcher, who held opposing views on EMFs, that prompted NIH to examine the conduct of the four. In the fall of 1989 NIH concluded that the scientists had violated rules relating to income limits and seeking permission for such consulting, but it took no disciplinary action against the them. Some 700 to 800 scientists, almost all of them intramural researchers, are currently engaged in outside work activities, according to Benowitz. Some have ties to more than one company or organization, he notes. The most common activities, according to Chen, are lecturing and consulting. A 1988 NIH study of consulting fees found that half of the recipients of such fees worked at the National Cancer Institute. While NCI is, by a small margin, the single largest institute at NIH, its employees are 10 times more likely to be engaged in consulting than those at the National Heart, Lung and Blood Institute, the next largest institute. Moreover, more than half of those scientists earning the highest fees from consulting worked at NCI. In testimony before Congress, then acting NIH director William Raub said that one of the biggest flaws in the current system is the fact that NIH relies entirely on information provided by its own scientists. "We don't engage outside companies [for whom the scientists consult] in this matter," Raub said. "But we are considering involving them in such a way that we are sure they know what the rules are." NIH officials emphasize that Raub was not speaking about any type of reporting system that would require companies to detail money paid to NIH scientists. Such a system would far exceed NIH's resources, they say, and would also be inconsistent with how NIH sees its role in monitoring outside work activity. "We want some assurance that they [companies] are not violating the limits on payments," says John Mahoney, NIH's associate director for administration. "But we don't want it to be burdensome." Mahoney says it's possible that companies may be asked to certify that they are aware of the NIH rules governing potential conflicts of interest, and also that their relationship with a particular scientist does not violate those rules. In the meantime, NIH has begun to collect follow-up information from scientists who have received permission to consult with industry. The researchers are being told to report which activities they actually went ahead with and what they were paid. The data, says Chen, will be used as part of an ongoing review of the NIH salary structure to determine the real incomes of NIH scientists in comparison with their counterparts in the private sector. Chen says he has "a gut feeling" that most NIH scientists earn much less than they have declared on their requests. "Sometimes people don't do what they asked permission for," says Chen. "They figure they'd better be safe, so they request it, but then something comes up and they don't go ahead with it." If that's the case, he says, "we may use that information as an argument in favor of the need to modify the salary structure to become more competitive with the outside world." On the other hand, he says, "if we find out that they are earning a lot, we might decide that it would be better to find some other way for them to be compensated." Stuart Aaronson, chief of NCI's laboratory of cellular and molecular biology, is an intramural scientist who at one point, fit that description. In 1988 alone, he earned $51,800 from Crowell & Moring, a Washington, D.C.-based law firm representing the electric utility industry in a case involving the potential health effects of electromagnetic fields from power transmission lines. Two of Aaronson's NCI colleagues at the time, Lucius Sinks and Margaret Tucker, received $29,500 and $12,480, respectively, from the law firm that year for similar consulting, which included expert testimony, in the same case. An investigation by NIH's Division of Management Survey and Review found that Aaronson "clearly exceeded the approved fee" in his consulting for Crowell and Moring. The internal NIH memo, the contents of which were first reported by Microwave News, a New York newsletter, also noted that Sinks "did not request approval to work for the company in 1987," when he earned $10,500, and that he "received $40,000 in [overall] fees even though he received approval to earn $4,000." Tucker was found to have received payment for activities carried out before the period for which she had received permission. The case also illustrates how individual institutes are free to limit their scientists' outside activities. Elliott Stonehill, NCI's chief ethics officer, says that his institute has moved electromagnetic field radiation onto a list of "taboo" subjects and would deny any request from intramural scientists to testify on the subject. The change, he says, came about as a result of a shift in the science. "Mistakes happen," says Stone-hill about the approvals given Aaronson, Sinks, and Tucker to testify. "At the time, we thought we knew what the scientific evidence said about the issue. But it later became clear that we didn't know the answers. In short, we don't know what an expert should know about this topic, and that means it's not a proper area for a scientist from the NIH to address in court." Stonehill says that any request from NCI scientists to consult in an area relating to environmental pollutants and toxicity would be "scrutinized carefully." The final decision would rely heavily on the views of in-house experts about the state of scientific knowledge in any particular field, he says. There's no question, say NIH officials, that what Chen calls "heightened public concern" about ethical issues has led NIH to take a more vigorous approach to monitoring an employee's outside work activities. Still, they say, a tougher, more intrusive system is not the solution. "In science, we depend on the idea that our neighbor is honest," Stonehill says. "That's the underlying principle when you read a paper or hear someone describe his work. Without that, we can't function as scientists. "And it's that fact, not whether we have the power to find out how much somebody really earned last year, that will determine whether we can have an effective system of regulating outside work."

NIH Struggling To Regulate Employees' Outside Income

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