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Vol. LVII, No. 11
June 3, 2005
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'Just Keep True North'
Zerhouni Predicts Balanced End To Conflict of Interest Issue

On the front page...

The conflict of interest (CoI) issue that has so absorbed NIH since a series of news articles brought concerns to light in late 2003 will subside, predicted NIH director Dr. Elias Zerhouni. The agency will emerge balanced, trustworthy and as deeply involved in the vitality of science as ever, he said in an interview May 12.

"I'm very optimistic that our approach is going to lead to a much more fair and balanced set of rules," he said.

Continued...

On Feb. 1, the director announced an "interim final HHS supplemental ethics rule" that immediately drew fire from employees on grounds that it was too strict, too intrusive on personal financial decisions, too broadly applied and detrimental to recruitment and retention of top scientists. But what employees didn't appreciate at the time, according to Zerhouni, was that the rule was both open to comment and dissent, and temporary; it posited a 1-year moratorium on some previously permissible outside activities, a year during which NIH could collect evidence about its ethics program.

 
  NIH director Dr. Elias Zerhouni

Zerhouni received more than 1,100 opinions from NIH staff who emailed him personally, and more than 1,000 people sent messages to HHS during the public comment period. "I want to thank everybody who's been responsive and forthright in sending me both angry letters as well as informative letters," he said. HHS stated in the introduction to the interim rules that it would revisit them based on comments and feedback.

"We've had a good response from many of the employees," Zerhouni added. "The most helpful comments have been the ones that were very specific — people who came to me with emails saying, 'Here is my specific situation and look what it would do to me.' This process, as painful as it is, is going to protect the agency and we're going to put it behind us."

He admitted that the Feb. 1 announcement was poorly received. "Clearly the impact of the interim proposal that was advanced by HHS and the Office of Government Ethics has had quite a detrimental effect on morale. That's the one thing that just was not intended at all," he said. In the intervening months, he has met with hundreds of employees and is fully acquainted with — and sympathetic to — many of their concerns. But he is unyielding when it comes to NIH's need to provide unimpeachable scientific authority. "We are absolutely not going to compromise on real ethical problems," he said. "The old rules were just not designed to be protective of the agency's interest...There is nothing that is more important to NIH than to maintain the integrity of its advice and public trust."

Zerhouni expressed surprise that many people "interpreted [the HHS interim rule] as being NIH rules. They don't know that, by statute, ethics rules are not under the control of the agency that is subject to the ethics rules." The virtue of the interim rule (upon which NIH insisted), he says, is that it permits "fine-tuning," and that it gives NIH time to collect data on the effectiveness of its ethics program.

"This is an interactive process," he emphasized. "You look at a variety of different proposals from across government — no one has the final answer. You weigh the evidence as you proceed.

"We're making great progress now," he declared. "I've been meeting with OGE, HHS and other components of the government, and I'm very optimistic that our approach is going to lead to a much more fair and balanced rule."

 
Zerhouni expresses confidence that the CoI issue will be resolved to employees’ satisfaction.  
The two concerns that most riled NIH'ers — that employees with no chance of conflict faced mandatory stock divestiture, and that outside activities as innocent as choir membership seemed to require official permission — will likely not survive the review process unchanged, Zerhouni noted.

What most gratifies him is that, out of the hashing process, a streamlined, quick, uniform and comprehendible set of ethics guidelines will emerge, replacing the scattershot approach that results when all 27 institutes and centers at NIH have their own ethics offices with unique interpretations of what the rules really mean.

To Zerhouni, the 1-year moratorium gives NIH a chance to develop a fully transparent, sensible ethics program. "It's very important to solidify the office...and create a good administrative service center. We have committed to having a very strong administrative service that will be responsive and quick."

He wants to institute a "much more centralized ethics management system" where "all operate under the same rules and methods for applying them.

"We are going to come out of this much stronger," Zerhouni said. "The agency will stand for the right things and our rules will not impose an incredible burden on our employees — I don't want that."

Zerhouni acknowledged that all of this has taken its toll on NIH morale. "Especially when it comes on the heels of other things like A-76, and reorganization, and budget issues, and I empathize with that very much. I'm totally in touch with many, many people on the campus who are telling me what they're going through. But I think we'll see it through. I'm confident that this will be worked out shortly, and that we'll get to a better balance on this issue with everybody involved...I have total confidence in the quality of our people here. I am amazed at the resilience of our science administrators and our scientists in the face of great challenges. [CoI] is just one challenge among many."

Zerhouni says NIH'ers need take no action yet on stock holdings and should wait for further direction. But he remains wary of consulting arrangements [with biotechnology and pharmaceutical companies]. "I'm not going to resume or touch any consulting from anybody at NIH until we have a good sense of what's really involved here."

He said the intent "is not to discourage, but to encourage, normal academic pursuits and interactions that are necessary to science" such as the commercialization of inventions... "But I do not believe that all activities are okay as long as they are not overlapping with the official duty. We need to have a better, stronger stance than that...NIH needs to have unimpeachable advice. We need to be the most objective source of advice."

Zerhouni freely concedes that the old ethics system communicated poorly with its clients. His byword for transparent communication is that "those who make the rules need to hear from those to whom the rules apply." He points to two examples of this philosophy in action: When NIH learned from its workforce that parking on campus was becoming intolerable, Zerhouni created an ad hoc parking committee that quickly addressed the problem by adding temporary gravel lots (among other ameliorations). And when security rules in the post-9/11 climate became cumbersome for NIH'ers, he created the CABS — the community advisory board for security.

"You'd be amazed how [these bodies] can improve things" when you give those affected by rules the chance to modify them, he said. The lines of communication between parties "must always be open, frank, honest and adaptive," he added.

Zerhouni could not comment about the progress of individual investigations of those who may have broken the rules, but he did say that "the rule structure that we had...didn't lend itself to good compliance."

What's more important in a crisis is not how you got into it, but how you get out of it...I've been through these sorts of rough times...and if you just keep true north, you'll be fine.

Nevertheless, there is a role for NIH scientists in the larger scientific universe: "There are benefits to consulting," he said. "When it comes to translating discoveries — absolutely! And when it comes to the exchange of ideas, yes, it must be bidirectional. But the involvement in marketing and promotion — this bothered me, especially for government scientists. We have to be above reproach.

"We need to have a clearer view of what's really okay and what's not okay," he concludes. "It's very important to get to a conclusion, and to put this issue behind us. The great majority of our employees are people of great integrity, and really deserving of respect and support.

"What's more important in a crisis is not how you got into it, but how you get out of it," he said. "That's how great institutions determine themselves. You will see that, within a few weeks or months, I think NIH will realize that we've done the right thing, in the right way. Let's resist halftime quarterbacking; the game's not over. Wait for the end of the game," he counseled. "We will end up with a preserved reputation and a good system that will make us proud...Yes, there are difficult moments, but you don't lose sight of what's right.

"I'm totally confident and optimistic about this, despite dire predictions to the contrary," he said. He noted that "Dr. [David] Schwartz [nominee for NIEHS director] is coming, Dr. [James] Battey [NIDCD director, who had planned to leave NIH in the wake of new CoI rules] is not leaving."

Zerhouni pointed toward the several "outstanding directors" he has appointed during this time, observing, "NIH remains very attractive to them. I'm confident that conditions that we offer here are just unparalleled...There is nothing that's as outstanding as the intramural program that we have, in terms of resources, in terms of the ability to focus entirely on your science, the ability to be supported for long periods of time so that you can take real gambles and risks in your research." Zerhouni said it has been most gratifying to him to see "a culture of sharing and collaboration that is growing at NIH...I think we're seeing great maturation of the agency in an era where science is requiring interdisciplinary efforts. I think that bodes well."

He joked that an institute director recently called his tenure as NIH director "a Perfect Storm," because it has coincided with so many upheavals not of his own making. "I'm pleased by the progress of the agency and challenged at the same time by the Perfect Storm," he said calmly. "But I also know that I've been through these sorts of rough times before in my life, and if you just keep true north, you'll be fine. And I think our employees will be too. They're great employees."

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