When Elias Zerhouni, director of the National Institutes of Health (NIH), announced a tightening of conflict-of-interest rules with NIH scientists on 1 February — in effect, significantly expanding the restrictions placed on senior members of NIH last year and extending them to all 5,000-plus NIH scientists — pharmaceutical companies were left quietly puzzled by the move.

Those in industry polled for this story said that the sweeping ban on links between NIH scientists and companies would have no real effect on their businesses, but they were unwilling to speak on the record, citing legal concerns should they stir up the waters, as well as some confusion over the requirements set by the NIH.

The new restrictions prohibit interactions with companies, health-care providers, insurers, trade groups and NIH-supported research institutions. Designated interactions include consulting, participation on scientific and other boards, and compensated teaching, speaking or writing. Such activities must cease within 30 days of the announcement, with some narrow provision for extending the deadline. NIH scientists and their spouses and children must also divest all but nominal stock holdings in health-care affiliated companies, irrespective of whether they have other ties to them.

Despite the fact that affected NIH scientists have little time to act on this interim final rule, some details of implementation remain sketchy. Stock ownership more than US$15,000, for example, is prohibited. But what if a stock shoots up one day, then pulls back? What is the trigger to sell — a one-day closing price?

“We don't know how it's going to shake out,” says a spokesman for the National Academy of Sciences. “Some things are not clear; the NIH has to work through their process.”

How many scientists are affected by the rulings is also not clear. Approximately 600 scientists have been implicated, and around 100 researchers were named by a congressional committee as failing to notify the agency about their outside deals. But a week later, an NIH review found that 50–80% of these scientists might be mistakenly implicated because of confusion over similar names, the time period for which data were collected and differences in data coding.

Also unclear is the amount of money at issue as a result of existing relationships. The NIH has promised to provide some quantitative information, but after the 30-day deadline for implementation the last post on its website is dated 3 February. “The process is ongoing,” explains Don Ralbovsky of the NIH Office of Communications.

Companies are waiting for NIH colleagues to contact them. Wyeth, for example, on seeing the announcement, immediately searched its databases to find out who they were paying, and for what, according to President of Wyeth research, Robert Ruffolo, Jr. But he was not aware of any NIH scientists who had contacted the company.

Ruffolo expects little impact on Wyeth. “The influence NIH has over what we do is so relatively small. I don't know anyone who sees this as an issue that needed to be fixed.”

“What we saw was a very quick, not well-considered, reaction to some political pressure, which should have been resisted,” says Raymond Warrell, Jr., CEO of Genta Inc. and a former long time consultant to industry. A more reasonable approach is to require full disclose, he suggests, along the lines of what the NIH imposed last year on its senior staff. “No one is countenancing a mechanism that does not involve doing that in a public forum, but there's no reason to go beyond that.”

NIH could take a lesson from the way the FDA handled accusations of bias in the approvals of cyclooxygenase 2 (COX2) inhibitors, says Warrell. The FDA called a meeting, including its own whistle-blower, and put it to a vote to see what people thought. The NIH has been reactive, not proactive, during a time that calls for leadership.”