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.
Plans to fight changes
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.
But a detailed NIH review of the 100 or so scientists identified by the congressional inquiry has found that "more than half," and perhaps up to 80 percent, were mistakenly implicated, said Suzanne Servis, director of the NIH Office of Management Assessment, who has been overseeing the internal review.
In some cases, discrepancies arose because NIH provided data on collaborations only through Dec. 31, 2003, while the drug companies included the names of people going into 2004 who, it turned out, had gained NIH permission.
In other cases, people whom the drug companies named as having collaborations with them had the same names as scientists at NIH but were not NIH employees.
Mistakenly implicated
In other cases, scientists did not appear on the NIH list because the agency had coded those scientists' activities as something other than consultancies -- the only category requested by Congress.
Neal Young, chief of hematology at the National Heart, Lung and Blood Institute, was one of those mistakenly implicated. It started with a surprise announcement last summer that he was under investigation, Young said. Over a period of weeks, he was asked to turn over more and more records, and only recently, after eight months of questions, did he receive a draft notification that he had been cleared.
At issue was a talk he gave at a company, which had been approved and properly reported in 2004.
The investigation, he said, was a "very intrusive, time-consuming and anxiety-provoking experience." And although he has come through relatively unharmed, he is concerned about the cumulative effect of such errors on the agency's image.
"This is really a wonderful place and one of the best deals the American public has ever gotten, and I hate to see it portrayed as badly as it's been portrayed, and I'd hate to see it destroyed."
A number of NIH employees are gearing up for a fight. Some have been consulting with the American Civil Liberties Union, which is considering the argument that the broad restrictions infringe on employees' rights to privacy and free speech.
Another group on the Bethesda campus, known as the Assembly of Scientists, is pursuing other legal strategies to keep the rules from affecting the vast majority of employees who have no power over NIH purse strings. Some noted that the rules affect not only well-paid scientists and administrators but also low-level secretaries and clerks who could stand to lose significant sums if forced to divest stock holdings.
Already, the new rules have begun to discourage medical residents and fellows who are being recruited to the agency's newly expanded clinical center -- the nation's largest medical research hospital, which taxpayers just financed to the tune of $1 billion and which opened in October.
Hundreds of the nation's foremost physician-researchers rotate through the center for two- or three-year stints to run studies and care for patients undergoing experimental therapies. But with the new rules insisting that even these temporary employees and their family members must sell their biomedical stock portfolios and forgo various professional privileges, some top candidates are now reconsidering options at other institutions where such restrictions do not apply, according to administrators tracking the recruitment process.
"There are a lot of things that can be done at NIH that can't be done anywhere else in the field of clinical research, but you can't run the clinical programs without the interns," said Elaine Jaffe, chief of hematopathology at the National Cancer Institute, who knows of at least two top candidates having second thoughts. "Having just spent a lot of money on a new hospital, I'd hardly think you'd want to shut it down."
Scientists with long histories at NIH are as frustrated as incoming interns. One scientist who, under the new rules, was informed he could not accept an unpaid adjunct professorship at Johns Hopkins University was told he might be unduly influenced in favor of the university because the appointment came with free campus parking -- even though the scientist, who has no say over grant decisions, said he was happy to refuse the parking pass.
"I think this is the end of the [on-campus] research program if people are not allowed to do these professional activities, which are all unreimbursed," said Alan Neil Schechter, chief of molecular biology and genetics at the National Institute of Diabetes and Digestive and Kidney Diseases.
Kington said he is aware that the rules could hurt recruiting and is hopeful that the agency could make exceptions for temporary or short-term employees.