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Vol. LXII, No. 14
July 9, 2010
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100th Session
ACD Meeting Covers Gamut from Restructuring to Conflict, Oil Spill Response

On the front page...

The agenda of the 100th meeting of the advisory committee to the NIH director covered a range of topics that could not have been imagined by the first, 50th or probably even 95th edition of the meeting, touching as it did on subjects as various as internal reorganization, potential extramural use of the Clinical Center, proposed new regulations governing grantee conflict of interest, increasing the number of stem cell lines eligible for federal study and NIH’s response to the massive oil spill in the Gulf of Mexico.

Continued...


  NIH director Dr. Francis Collins  
  NIH director Dr. Francis Collins  

At the 5/6ths pole of his first year on the job, NIH director Dr. Francis Collins gave evidence of the breadth of the modern NIH directorship during a half-hour presentation that touched on such additional topics as personnel comings (including four new ACD members, and incoming NCI director Dr. Harold Varmus, who used to chair these sessions during his 6 years as NIH director) and goings (most notably, NIH principal deputy director Dr. Raynard Kington, who leaves this month to become president of Iowa’s Grinnell College), an enhanced relationship with the Food and Drug Administration, a new Genetic Testing Registry to be situated in the National Center for Biotechnology Information, a sobering FY 2011 budget prospect and Big Thoughts on how to maximize the effectiveness of the Common Fund.

NINDS director Dr. Story Landis reports on stem cell policy at the recent ACD meeting. ACD member Dr. Maria Freire (r), president of the Albert and Mary Lasker Foundation and an NIH alumnus, said that “finding a way to finance the Clinical Center is absolutely essential.” Looking on is Dr. Keith Yamamoto, executive vice dean at the University of California, San Francisco, School of Medicine.

Above, l: NINDS director Dr. Story Landis reports on stem cell policy at the recent ACD meeting.

Above, r: ACD member Dr. Maria Freire (r), president of the Albert and Mary Lasker Foundation and an NIH alumnus, said that “finding a way to finance the Clinical Center is absolutely essential.” Looking on is Dr. Keith Yamamoto, executive vice dean at the University of California, San Francisco, School of Medicine.

The challenge of internal restructuring (chiefly, a potential merger between NIDA and NIAAA—see sidebar) and CC utilization and budgeting falls to a separate body advising the NIH director, the Scientific Management Review Board (SMRB), which was created by the NIH Reform Act of 2006. ACD member Dr. Thomas J. Kelly, director of the Sloan-Kettering Institute in New York, summarized SMRB working group findings so far: the merger group is split, with five members in favor of “functional merger” (something akin to the Neuroscience Blueprint, a cooperative undertaking among 12 institutes that would leave the two institutes largely intact) and three touting outright structural merger into a single entity.

“There is quite broad agreement that the status quo is not optimum,” Kelly reported.

Merger Prospect Yields Debate, Pro and Con


lem, whether you are talking about alcohol or drugs.

“Yes, I am impatient,” she told the SMRB, which has considered the possibility of merger since its creation by the NIH Reform Act of 2006. “Why put roadblocks in the way of treatment and prevention?” she said, noting that a merged institute would offer more resources than separate entities. Volkow said NIDA is constrained by limited resources and that separation is resulting in missed opportunities.

Acting NIAAA director Dr. Kenneth Warren said the merger debate has been “seemingly interminable” and that his institute, now celebrating its 40th year, is at the forefront of research on alcoholism. He said NIAAA has “a strong his-

tory of collaboration with other institutes,” including addiction studies with NIDA, studies of mental health co-morbidities with NIMH, and work with NICHD and NIDDK.

“The best way forward is a structure that increases collaboration all across NIH,” he said. “What strikes me most…is that nothing is gained by structural merger. Enhanced institutionalized cooperation is preferable.”

Warren warned that “much could be lost by structural merger,” including the multiplicity of viewpoints that add value to research on alcoholism and drug addiction. He favors functional merger and “a separate, but equal” NIDA and NIAAA. “Alcoholism is a much broader issue than simply addiction,” he said.

At the most recent meeting of the Scientific Management Review Board on May 18, the directors of the two institutes being considered for merger offered defenses of their points of view. Both made reference to the amount of time spent on deliberations.

Dr. Nora Volkow, director of the National Institute on Drug Abuse, admitted upfront, “I am biased in favor of structural [as opposed to functional] merger.” Having headed NIDA for the past 7 years, she argued that “all psychiatric disorders have similar roots involving combinations of genes and environment…it is a serious problem, a devastating prob-

The working group focusing on intramural NIH, including the CC, is considering five options. “The immediate problem,” Kelly explained, “is that NIH has this fantastic new facility that is currently underutilized as a resource and has high fixed costs that are growing more rapidly than the total NIH budget.”

The preferred option, he reported, would fund the CC out of a line item in the OD budget, rather than via the current “school tax” on IC intramural budgets. This option provides more stable funding and “may facilitate the use of the CC by the extramural community,” said Kelly. It would also bolster NIH’s focus on clinical research, he added.

Collins opened his state-of-the-NIH remarks by welcoming new ACD members and lamenting the imminent departure of Kington. “Raynard has had a tremendous career at NIH,” he said. “He took on a huge number of complex issues during his time here, including how to spend wisely the $10 billion in ARRA money that NIH received. I have depended on Raynard for all kinds of advice on all kinds of topics…I can’t tell you how many potholes he has kept me from stepping into.” Expressing deep gratitude, Collins led the meeting in an ovation for Kington, concluding, “We wish you all the best.”

New ACD member Dr. Clyde W. Yancy (c), president of the American Heart Association, makes a point at the June 3 meeting.
New ACD member Dr. Clyde W. Yancy (c), president of the American Heart Association, makes a point at the June 3 meeting.

Collins said that “NIH is engaged in significant ways in trying to assist” in the Gulf oil spill. “We are currently collecting information from all the ICs. NIEHS has been very much engaged since the beginning. The institute has trained 22,000 cleanup workers in the last few weeks,” he said. Trainees complete a 4-hour course in safety and health awareness.

He said NIH has received cofunding with the National Science Foundation to study ecological impacts of the spill and is “also fleshing out studies of exposure effects.” Also under study are the potential toxicities of dispersants used at the spill site, which will utilize high-throughput chemical screening at NIH’s Twinbrook outpost.

“We are certainly doing what we can in what is obviously a very troubling circumstance,” Collins said.

Allowing that partnership between NIH scientists and outside entities “is probably more essential now than ever,” Collins warned that “at the same time, the NIH research enterprise must be free of any taint of suspicion and must maintain the public trust.”

He described NIH’s proposed new conflict of interest guidelines—the first in 15 years—governing grants to extramural institutions and dwelled specifically on the case of a researcher who was able to avoid sanction by moving to a new institution, a loophole Collins hopes may now close as the proposed guidelines receive public comment.

“We can do nothing less than the maximum in assuring public trust,” he said.

Turning to the budget, Collins said that FY 2011 “will be known as the ‘Year After ARRA.’” While lauding the President’s proposed budget of $32 billion for NIH, Collins said “it’s going to be very stressful going from $36 billion (NIH’s ARRA-enhanced FY ’10 budget) to $32 billion. Turning that cliff into a slope will be a challenge.”

The Office of Management and Budget has asked all agencies to prepare for a possible 5 percent budget reduction in FY ’12, Collins reported. NIH’s best case for avoiding cuts “is based on our science and the promise of improving human health…NIH science is quite breathtaking in its sweep and accelerating pace,” he argued. “We are not just cranking along.”

Collins said the Common Fund—amounting to slightly more than half a billion dollars, most of which is already committed until FY 2012—was recently the subject of a “Big Think” meeting at which the IC directors, assisted by 54 outside “thought leaders,” spent a day brainstorming about best uses for the money. Several fields, including metabolomics (especially in cancer), single-cell measurement technology and the need for more mouse models of disease, seem ripe for funding, Collins said. He met again July 8 with IC directors to revisit Big Think topics.

Turning finally to personnel issues, Collins said he was greatly pleased with the President’s intent to name Varmus as NCI director. “This is an enormous recruitment for NIH and an enormous moment of personal pleasure for me,” he said.

Collins said searches are either under way or nearing completion for directors of the Office of Behavioral and Social Sciences Research, the Division of Program Coordination, Planning, and Strategic Initiatives, NICHD, NHLBI, the Office of Extramural Research and the Office of Budget. Two new searches just began—for the director of the Office of Science Policy and for NIH’s principal deputy director. “We are looking for extensive NIH experience,” said Collins of the latter post.

On the stem cell front, the ACD working group for human embryonic stem cell (hESC) review presented its findings for 53 lines from four institutions. The group, supported by unanimous consent of the full ACD, recommended to Collins approval of submissions from three of the four institutions, covering a total of 8 lines; a submission from Chicago’s Reproductive Genetics Institute, covering 47 cell lines, was turned down.

NINDS director Dr. Story Landis, who chairs NIH’s stem cell task force, said 67 hESC lines have been approved since last July; 108 lines are currently under review and 234 more are in the pipeline. NIHRecord Icon

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