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
"I'm very optimistic that our approach is going to lead to a much more fair and balanced set
of rules," he said.
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
"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."
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.
|Zerhouni expresses confidence that the CoI
issue will be resolved to employees’ satisfaction.
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
"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."
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
"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."