WASHINGTON—In a document that is being roundly condemned by science administrators, lobbyists, and other observers, the National Institutes of Health has proposed vol- untary guidelines on financial conflicts of interest by university researchers.
The criticism from experts in the field is expected to sharpen the explosive debate on how to preserve the integrity of federally funded research while at the same time translating that research into products that are designed to improve public health.
The guidelines appear in the September 15 issue of the NIH Guide for Grants and Contracts (vol 18, no. 32). They apply to any research funded by NIH or the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). Under the proposal, universities and other recipients of federal funds are advised to draw up policies to monitor potential conflicts of interest by faculty and other employees that could distort the conduct or results of such research.
The key element is a confidential disclosure by scientists to their institution “of all financial interest and outside professional activities including the financial interests of their spouses, dependent children, and other dependents.”
The proposal seems to target investigators who are carrying out clinical trials. In the case of NIH-funded research, these involve the testing of experimental drugs on many patients at several sites around the country, often for several years. Specifically, NIH proposes a ban on “personal equity holdings or options in any company that would be affected by the outcome of the research, or that produces a product or equipment being evaluated in the research project.” It allows for a waiver if the institution decides that “such holdings are so insignificant that they do not have the potential to influence research results or the direction of the research.” And it also bans honoraria, fees, or a management position with that company unless the university decides that “their acceptance does not jeopardize the recipient’s objectivity.”
The criticism of the guidelines, which draw on comments offered by the public during a two-day NIH workshop in June, reflects a range of views on the topic. Some observers say that the guidelines don’t go far enough, and that waivers and the promise of confidentiality will allow institutions to hide improper relationships between faculty and private companies. Others say that the guidelines are intrusive and would be costly and burdensome for unversities to enforce. They see the guidelines as an overreaction to congressional concern about the issue, and as a threat to the research enterprise. Still others say the guidelines are premature, and that scientists must first agree on what constitutes conflict of interest before the federal government tries to prohibit it.
“I find [the guidelines] terribly unfortunate,” says David Korn, vice president and dean of Stanford University’s medical school and president of the National Cancer Institute’s advisory board. “They’re like a vacuum cleaner going over a rug—they will pick up everything, without discriminating the important from the trivial. They recommend disclosure to an extent that is unnecessary, and they represent a terrible invasion of privacy.”
The head of a small nonprofit organization that has fought against the burgeoning academic alliance with the corporate world finds the guidelines equally flawed, but for a very different reason. “Universities haven’t shown any willingness to monitor what their most profitable researchers do,” says Leonard Minsky of the National Coalition for Universities in the Public Interest. “If those researchers with business ties decide to cut corners or present their results in a way that is more positive than the data warrant, to increase its commercial value, then universities are likely to ignore such behavior. We’d like NIH to declare that the university community can’t be trusted, and that they are going to look closely at everything.”
The biomedical lobbyist for the Association of American Universities, which represents the country’s leading research universities, thinks NIH has gone off entirely in the wrong direction. ‘They need to work on a very different sort of document,” says Carol Scheman, “starting with the goal of funding productive and important research .and then figuring out how to reach that goal in light of concerns about conflict of interest. What they need is a system of triage, to sort out acceptable from unacceptable conflicts. In the meantime, the mechanism that they have proposed is ludicrous. It’ll never work; they’ve asked for way too much information.”
Many observers see the guidelines as a response to a series of hearings in the past year by Rep. Ted Weiss (D-N.Y), chairman of the human resources subcommittee of the House Government Operations Committee. “If Weiss hadn’t held his hearings,” says Jerry Roschwalb of the National Association of State Universities and Land Grant Colleges, “we wouldn’t be holding this piece of paper in our hands.”
But while Roschwalb praises NIH for reoognizing the political nature of the issue, others criticize it for acting precipitously. “I think that they overreacted,” says attorney Robert Charrow, who served as deputy general counsel in the Department of Health and Human Services during the Reagan administration. “There’s no evidence that the guidelines are necessary, and I don’t think that the Weiss hearings reflect the true interests of Congress.”
Although the NIH proposal is being presented as voluntary guidelines, there is a widespread assumption that it will wind up as a manda- tory regulation, which Weiss prefers. “I think they have to be more than guidelines. They should be regulations,” he says. “They need to spell Out very clearly the responsibilities of researchers, regardless of whether they are monitored by NIH or the institutions where they work.”
But Charrow and others think that regulations would be a serious mistake. He draws a distinction between this issue and the related question of scientific misconduct. That issue spurred a celebrated investigation by Rep. John Dingell (D-Mich.) into a 1986 Cell paper coauthored by Massachusetts Institute of Technology biologist David Baltimore and led to formal regulations, which go into effect next month, for universities to follow in investigating allegations of misconduct.
“With misconduct there clearly was a problem, and action was required,” says Charrow. “But that’s not the case here. Before you invoke government action, you should ask the question, ‘Do we really have a problem here?’”
Some say that the real intent of the guidelines is to address the appearance of conflict, rather than any actual skewing of the research process by commercial interests. “There’s a fear out there ‘that researchers are getting too deeply involved in the profit side of research and that it could taint the results,”' says Robert Roberts, a political scientist at James Madison University who served on an Institute of Medicine panel that examined how to bring the fruits of biomedical research to the marketplace. “Even the appearance of impropriety is enough tQ threaten the credibility of research, and jeopardize public support for it.”
But Korn says that the government has encouraged researchers to forge ties with industry, and that it shouldn’t be surprised if the result is a mingling of academic and commercial interests. “The messages out of Washington are terribly conflicted,” says Korn. “We’re supposed to be working with industry. But the guidelines fail to distinguish between my holding 10 shares of stock in a billion-dollar company and someone who has been given a major equity position in a startup company.
Other scientists go further in asserting the innocent nature of most commercial relationships.. “I serve on a number of advisory boards for startup biotech companies,” says Alan Sartorelli, a Yale professor of pharmacology and the director of an NIH-supported Comprehensive Cancer Center at the university. “It’s exciting work, and there’s no doubt that these companies attract scientists by offering them large consulting fees or a share of the company. But it doesn’t have to be a problem. When colleagues ask me for advice, I tell them, ‘Make sure you don’t do research for that company.’ But to prohibit a scientist from serving on their board would be wrong, and it would cripple progress in the field.”
Despite all the criticism, NIH is given credit for putting something Out on the table for discussion. The proposal asks the community for comments, by December 15, on whether the guidelines address the important issues and how they would affect extramural research. And NIH officials say they plan to listen closely to the response.
“We want to make sure that conflicts are eliminated, but we don’t want to impose any unnecessary restrictions on the conduct of research,” says Janet Newburgh, head of NIH’s institutional liaison office that is charged with promoting responsible conduct among the research community. “Now that we have proposed a guideline, our preference is not to move to a rule. But that will depend on how Congress reacts, and what the community thinks is appropriate.”