T H E   N I H   C A T A L Y S T     M A R C H  –   A P R I L   2006




This is the first in what will be a continuing AOS column in The NIH Catalyst to address issues of concern to NIH scientists. The views expressed are those of the signer. Individuals who wish to write a column should contact a member of the ViewPoint editorial board (Abner Notkins, chair; Harvey Alter; Edward Korn; Alan Schechter; Joshua Zimmerberg). More information about the AOS can be found at its website.

It was a dark and stormy fall night, and I was sitting in an airport lounge at Dulles—frustrated. Frustrated at the hours-long rain delay of my flight, but more frustrated at what was happening all around me at NIH. So I plugged in the computer and tried to put words to feelings that I was pretty sure were shared by others.

What emerged was a draft letter, whose intended recipient was NIH Director Elias Zerhouni, that focused on the severe restrictions on the ability of NIH scientists to speak and interact with the extramural community that were instituted in the wake of the Congressional hearings about NIH scientists who had financial interests with drug companies. I circulated the letter to a haphazardly selected group of NIH scientists. Thankfully, they substantially edited it before it was circulated more widely around NIH. It collected nearly 200 signatures in just a few days. 

Reacting to this letter, Dr. Zerhouni scheduled a meeting at the end of November 2004 at which NCI's Lee Helman presented the scientists' view, a position echoed spontaneously by many others in attendance.

The AOS Gets Going

And the rest, as they say, is history. In February 2005, the NIH Assembly of Scientists was reconstituted, and elections were held for an Executive Committee.  (A complete history of the AOS will appear soon in a subsequent column.) Simultaneously, DHHS issued the "interim final" conflict-of-interest rules. Meeting virtually every week from February to July, the AOS Executive Committee—composed of scientists who understand NIH's culture by dint of many years and decades of service—began an intense effort to educate the public, professional societies, the media, and others about the serious adverse consequences of these new regulations and to devise alternative rules.  It also drafted new bylaws and planned the elections of the "real" Assembly of Scientists' Council.

What has been accomplished? The first and most important accomplishment was changing the atmosphere around the conflict-of-interest issue. When the rules were initially issued, few inside or outside the NIH read and analyzed them to understand how unjustifiable they were. To oppose them seemed to some to be equivalent to opposing ethics, motherhood, and apple pie. Fortunately, the AOS executive committee was able to craft a message that made it clear that we found it reprehensible that some NIH scientists had conflicts of interest and that we endorsed absolute prohibitions on such—but also that we opposed unjustified restrictions that undermined the NIH's ability to recruit and retain scientists. Changing the atmosphere was an absolutely essential prerequisite to changing the rules.

The second accomplishment was that the Executive Committee proactively devised and proposed a reasonable conflict-of-interest policy as a substitute for the Draconian "interim final" regulations. This alternative aimed to prohibit conflicts of interest without over-reaching. The preamble to the final rules issued in August by DHHS makes clear that the AOS' recommended policy informed the revision. Obviously, the rule changes were not accomplished by AOS alone but required substantial efforts by the NIH administration to craft the reasonable changes.

The third accomplishment was structural: reconstituting the AOS, drafting new bylaws, holding an election in October 2005 for the new AOS Council, and, most recently, electing an Executive Committee.  Nearly 700 NIH scientists voted, giving NIH intramural scientists a legitimate collective voice that had been lacking.

Finally, one of the most important accomplishments was more procedural. Much of what has been accomplished was the result of the collective wisdom of the original 17 members of the AOS Executive Committee. Discussions usually encompassed a wide variety of views and were, on occasion, even heated. No person was right on all the issues, and all of us learned from the perspectives of people we disagreed with. We were repeatedly able to generate a consensus around what we considered to be the wisest and most prudent decisions, avoiding what could have been disastrous missteps. This was a triumph of open and deliberate governance in which the group proved consistently wiser than any single person.

What Lies Ahead

Frequently, after the change in the conflict-of-interest regulations, reporters would ask whether with this "victory"  the AOS could declare "mission accomplished"  and go home. This reflects a serious misunderstanding. The conflict-of-interest regulations were only the nidus that crystallized the frustrations of NIH scientists. There are many serious issues that still need addressing. Regarding the conflict-of-interest issue:

There is implementation. Scientists have been promised less paperwork and an electronic system for submitting activities. What we have experienced is the opposite, symbolized by the 716 form. Furthermore, the implementation committee—which was established to help implement the new conflict rules and has two members that serve on the AOS Council—does not appear to have real authority to address the problems and thus far has made little progress.

There is the matter of consulting. For the last 16 months, there has been a moratorium on consulting to permit a systematic review of its merits and risks. The AOS believes this review is critical and should proceed as rapidly as possible.

There is the conflict-of-interest impact assessment. Through a survey of NIH scientists and a systematic assessment of departures and challenges to recruiting, the NIH is to assess the impact of these regulations. The AOS thinks that once the survey is completed, it is important for NIH scientists to participate in the assessment of the data and the development of solutions to the problems.

Importantly, there are many other issues beyond conflict of interest that are sapping morale and the ability to attract and keep first-rate scientists. Travel policies, the continued employment at NIH of scientists and nurses retiring from the PHS, the ever-growing nettlesome bureaucracy, and the lack of decision-making transparency are all of great concern to the AOS.

It is our hope that the AOS—which lies outside the formal NIH chain of command and can work with the deputy director for intramural research, the scientific directors, and outside professional organizations—will provide a clear voice to help reduce the bureaucratic frustrations of working at NIH and to ensure that top-quality science continues to be done on campus in a collegial and collaborative atmosphere that ensures scientific and personal integrity without restricting scientific and personal freedom.

Ezekiel Emanuel, Director

Department of Clinical Bioethics, CC


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