BETHESDA, Md., Aug. 26-In its final stance on financial conflicts of interest among NIH staffers, the agency dropped some of the restrictions proposed in an interim rule last February.
In particular, NIH relaxed some proposed prohibition on staffers owning stock in drug, device or biotech firms. The final regulations were announced here yesterday.
Senior staffers and their spouses and dependent children will not be allowed to hold drug, medical device, or biotech company stocks worth more than $15,000 per company. But other NIH staffers will be asked to divest only "if, after review, a potential conflict resulting from their holdings or those of their spouses and minor children would impede their ability to do their government job," according to an NIH press statement.
NIH will continue to bar staffers at all levels -- from workers in the trenches on up to senior management -- from doing outside consulting work with what the agency calls "substantially affected organizations," meaning companies whose bottom lines may be affected by research findings, publications, speeches or other activities by NIH employees.
That means no moonlighting by NIH staffers for drug or biotech companies, medical device makers, health insurers, or research institutions that receive NIH grants.
"We have a balanced set of conflict-of-interest rules that protect the integrity of NIH and its ability to provide the American public with an unbiased and trusted source of scientific and health information, while preserving our ability to recruit and retain world class scientists and staff," said NIH director Elias A. Zerhouni, M.D.
When more restrictive changes in ethics rules were proposed by the NIH last February, many researchers balked, pointing out that they could hamper NIH's mission by making research posts less attractive to leading investigators.
While an NIH title may have a certain cachet, that prestige is not accompanied by the salaries that top-notch researchers could command in private industry or heavily endowed universities, critics of the interim ethics rules said.
Under the proposed rules, about 6,000 scientists and senior staffers would have had to rid themselves of all equity holdings where they might have had a financial conflict of interest. Another 12,000 or so employees would have been prevented from holding more than $15,000 worth of stocks in the substantially affected companies.
In its statement, NIH said that the three guiding principles of the ethics rules are:
"1. The public must be assured that research decisions made at NIH are based on scientific evidence and not by inappropriate influences.
"2. Senior management and people who play an important role in research decisions must meet a higher standard of disclosure and divestiture than people who are not decision-makers.
"3. To advance the science and stay on the cutting edge of research, NIH employees must be allowed interaction with professional associations, participation in public health activities, and genuine teaching opportunities."
Jerome P. Kassirer, M.D., a professor of medicine at Tufts and former editor-in-chief of the New England Journal of Medicine, is an outspoken critic of the corrosive effects of pharmaceutical industry influence on medical ethics, but he said in an interview that some provisions of the rules as originally proposed were too restrictive.
For example, the rules as originally written would have barred all NIH employees from "compensated or uncompensated employment, including consulting and advisory or other board service, and compensated teaching, speaking, writing, or editing for…hospitals, clinics, health maintenance organizations, or other health care providers," as well as "health, science, or health research-related trade organizations, professional associations, or consumer or advocacy groups."
In other words, Dr. Kassirer said in an interview, the rules would have prohibited NIH employees at any level from participating in academic activities such as grand rounds or lectures, and in that regard the easing of the rules is welcome.
Dr. Kassirer also said that while he supports restrictions on financial holdings and the review process for lower-level employees, he doubts whether the oversight function will be sufficient to prevent conflicts of interest in the future.
"The problem is that creates a lot of work for a conflict-of-interest committee to examine all the details, and if they do that, well that may be okay, but it's not clear that they'll be able to manage it all," he said.
Other features of the new regulations include making receipt of monetary awards from outside sources contingent on prior approval, required disclosure of interests in affected companies, and permission with prior approval "to engage in compensated academic outside activities such as teaching courses at universities, writing general textbooks, performing scientific journal reviews or editing, and providing general lectures to physicians and scientists as part of a continuing professional education program."