Most of the 100 or so National Institutes of Health researchers who the agency has said are under investigation for allegedly engaging in secret deals with pharmaceutical and biotechnology companies have been cleared by NIH investigators, according to agency officials.
The unexpected finding that as much as 80 percent of the seeming improprieties were actually the result of errors by government investigators has undermined the rationale behind NIH Director Elias A. Zerhouni's recent decision to impose severe restrictions on the personal activities and finances of all of the agency's more than 5,000 employees, said scientists and NIH officials upset about the new rules.
Scientists said the finding is fueling an already simmering backlash among them and others on the Bethesda campus who feel that the new restrictions will seriously damage the crown jewel of the nation's biomedical research enterprise.
Zerhouni has repeatedly said that a congressional committee's discovery several months ago that about 100 NIH scientists had failed to notify the agency about their outside deals, as required, compelled him to impose the new limits. The rules, which took effect Feb. 3, are forcing thousands of employees and their family members to sell stock holdings. They also ban scientists from accepting even uncompensated professorships and board positions with professional societies on their own time.
The finding that most of the allegations are false has many scientists complaining that Zerhouni did not get a better measure of the problem before succumbing to pressure from Congress and the government ethics office to prohibit virtually every kind of outside collaboration and to demand across-the-board divestitures.
Some are organizing to fight the changes through internal lobbying and legal challenges.
"All of us are in favor of strong regulations to avoid conflicts of interest," said Abner L. Notkins, chief of experimental medicine at the National Institute of Dental and Craniofacial Research. But the new rules, he said, "go to an extreme. We're hearing from a number of people that they want to leave. And a number of people who were about to start here have said they are now thinking they will not come."
NIH Deputy Director Raynard S. Kington, who serves as chief ethics officer for the $28 billion agency, defended the decision to institute major restrictions despite the fact that as few as 20 scientists out of the agency's thousands of employees may have violated approval and disclosure rules.
"The number is just one dimension of this problem," he said. "There is also the severity of the problems."
One scientist allegedly collected hundreds of thousands of dollars in fees and travel reimbursements over five years as a result of largely undisclosed activities.
Kington would not say how many scientists have been found to have violated disclosure rules, but he noted that the new rules were the result of multiple reviews.
"We came to the conclusion the system was not at a point where we could carefully monitor and manage the types of conflict we can identify," Kington said. He added that the agency is considering creating some exceptions to the new rules.
The confusion over the alleged failure to report consulting arrangements dates back to last year, when congressional investigators asked 20 pharmaceutical and biotechnology companies for the names of all NIH scientists with whom they had consulting arrangements. When Congress compared those lists to a similar list provided by NIH officials, about 130 arrangements on the company lists involving about 100 scientists did not appear on the NIH list, suggesting that those scientists had not reported the arrangements to their NIH superiors as required.
Zerhouni, who until then had been a staunch defender of such collaborations as an important means of speeding the translation of research into marketable treatments, recently said he felt "shot in the back" when he learned that so many scientists were ignoring the rules. Convinced that "the system was broken," he and Kington instituted the Feb. 3 restrictions.