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Vol. LXIII, No. 1
January 7, 2011
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ACD Hears of Historic Structural Changes Proposed for NIH

On the front page...

NIH’s science structure is likely to change as NIH director Dr. Francis Collins announced major proposals to add and subtract institutes/centers on Dec. 8 at the 101st meeting of the advisory committee to the director. NIH is considering creation of a National Center for Advancing Translational Sciences (NCATS, potentially), he said, and an institute studying substance use, abuse and addiction.

NCATS would essentially replace the National Center for Research Resources, as was discussed Dec. 7 by the Scientific Management Review Board. Plans are to establish the new center by Oct. 1, 2011, as part of the 2012 fiscal year budget.

The board also endorsed a new funding structure for the Clinical Center and agreed that the hospital’s state-of-the-science resources should be open for extramural researchers to use.

Continued...

  NIH director Dr. Francis Collins and NIH deputy director for science, outreach and policy Dr. Kathy Hudson at the December ACD meeting  
  NIH director Dr. Francis Collins and NIH deputy director for science, outreach and policy Dr. Kathy Hudson at the December ACD meeting  

“The time is right for us to take bold action to try to transform our nation’s translational research enterprise,” said Collins. “We will continue of course to invest the majority of our resources in basic science—that is what NIH is all about. That is the foundation for all possible future translational effort, but we are faced now with unprecedented scientific opportunities. NIH has an opportunity now to move forward in a more integrated way to develop new tools and fresh approaches for turning these discoveries into health.”

Collins explained that a SMRB working group determined such opportunities “require an entirely new view and not an incremental tweaking.”

The new institute on substance use would combine significant portions of research portfolios from both the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse (and probably draw science programs from other ICs as well). At a Sept. 15 meeting, SMRB proposed that NIAAA and NIDA be dissolved to form the new entity.

Consultation with HHS Secretary Kathleen Sebelius and Congress are required for all of these reorganizations. To gather input from as many other stakeholders as possible, NIH launched a new web site, http://feedback.nih.gov/, where the public can weigh in on these and other important proposals.

Continuing Resolutions Continue

Since Oct. 1, the beginning of FY 2011, NIH—like the rest of the federal government—has been operating under a series of continuing resolutions. Those CRs keep the agency funded at the 2010 budget level. President Obama had proposed about a $1 billion increase in that amount for 2011.

Just before Thanksgiving, congressional negotiations ended on an omnibus bill that would include a 2011 appropriation for NIH. Collins said NIH has not been told exactly what’s in the omnibus bill for the agency, but that the $1 billion proposed uptick might be trimmed.

“It’s clear from our perspective that it’s going to be a difficult budgetary circumstance for the next few years,” Collins said. “It is time for NIH to be able to consider the reality of flat budgets at best.”

‘This Is the Moment’

Addressing the ACD meeting, NIH principal deputy director Dr. Lawrence Tabak and NIH acting associate director for science policy Dr. Amy Patterson discuss ways the SMRB recommendations might be implemented. ACD member Dr. Reed Tuckson stresses the importance of telling the NIH story in Congress.

Above, l:
Addressing the ACD meeting, NIH principal deputy director Dr. Lawrence Tabak and NIH acting associate director for science policy Dr. Amy Patterson discuss ways the SMRB recommendations might be implemented.

Above, r:
ACD member Dr. Reed Tuckson stresses the importance of telling the NIH story in Congress.

Discussing NIH implications following the 2010 election, Collins noted that incoming Speaker of the House of Representatives John Boehner (R-OH) has proposed cutting NIH 2011 funding back to 2008 levels. Soon-to-be House majority leader Eric Cantor (R-VA) announced his agreement and further proposed holding a major congressional oversight hearing each week.

“These are all going to be major changes in terms of the way NIH is connected to the Congress,” Collins said, announcing new chairs of congressional committees. “I think we now have an opportunity, with all of these new members and senators, to tell the NIH story. Many of the incoming members have no real track record on research and health issues. I think we have a responsibility to make sure that the message of NIH’s role in alleviating suffering and ensuring competitiveness in the global economy and contributions we make, comes across.

“At every opportunity,” he continued, “we will be emphasizing in Congress that if government doesn’t support basic research, it doesn’t happen...that we are in fact the source of stimulus for the economy with creation of highly skilled and well-paid jobs, and that biomedical research has always been bipartisan.”

ACD member Dr. Reed Tuckson of United Health Group strongly endorsed Collins’s determination and suggested adding to the NIH message.

“If ever there was a time that we needed more knowledge that helps us to use these expensive resources in cost-effective ways, to save dollars for the American people while we also improve health status, this is the moment,” Tuckson stressed. “NIH’s value to the nation is extraordinary.”

Work Groups Report

The committee also heard updates from several of its work groups. ACD member and former NIH’er Dr. Maria Freire, president of the Lasker Foundation, discussed the latest findings on the Therapeutics for Rare and Neglected Diseases (TRND) program.

Because the potential market is relatively small for therapies to treat rare and neglected diseases, most traditional pharmaceutical companies are reluctant to spend the resources—time, money, science staff—to study such drugs. Congress instructed NIH to form TRND in fiscal year 2009 to jumpstart projects in this area. TRND’s main goal is to speed new drugs through development.

Freire showed TRND’s fast-tracked timeline that includes full operation by FY12. Already more than 60 projects have been submitted to TRND for review and possible funding in its first cycle.

ACD member Dr. Shirley Tilghman, president of Princeton University, agreed to chair a new work group to examine biomedical workforce issues including supply, demand and diversity of investigators in the next decade.

Comings & Goings

“ACD member Dr. David DeMets of the University of Wisconsin hears of major restructuring in the wind for NIH.

ACD member Dr. David DeMets of the University of Wisconsin hears of major restructuring in the wind for NIH.

In his director’s report, Collins noted several senior staff changes at NIH since the June 2010 ACD meeting.

Among new additions to the Office of the Director, he acknowledged NIH deputy director for extramural research Dr. Sally Rockey, who assumed her title officially on Aug. 15; principal deputy director Dr. Lawrence Tabak, former director of NIDCR who was named to the #2 NIH leadership post that next week; and new deputy director for program coordination, planning and strategic initiatives Dr. James Anderson, who began at NIH in late September.

NIH deputy director for science, outreach and policy Dr. Kathy Hudson rose to a newly created post Oct. 24 from her position as Collins’s chief of staff.

New directors of budget (Neil Shapiro) and behavioral and social sciences research (Dr. Robert Kaplan, who’ll start his job Feb. 1) also join OD’s senior staff. In November, Collins added a senior advisor on translational research, Dr. Rajesh Ranganathan, formerly of Novartis.

On the IC leadership front, Collins announced that negotiations are under way in the search for an NHLBI director and that a search has been started for NIDCR director.

Already in place since July are former NIH director Dr. Harold Varmus, who returned to lead NCI, and Dr. Alan Guttmacher, sworn in as NICHD director.

Finally, Collins lamented that NIGMS director Dr. Jeremy Berg had, just a few days before the ACD meeting, announced his intention to leave NIH for the University of Pittsburgh in June 2011.

“Jeremy’s leadership will be profoundly missed,” said Collins. “He is a most able leader of that institute and has volunteered his time repeatedly and extensively to many other trans-NIH efforts, including his much-needed contributions to peer review, to our efforts to try to improve the diversity of our workforce and especially more innovative awards types like the Pioneer Awards. We are truly sorry to hear of his decision.”

A search to replace Berg will be undertaken shortly.

Over the course of the meeting, the group also heard reports on feedback about major changes to conflict-of-interest policies for grantees, as well as updates on pending lawsuits by the ACLU against patents on such DNA products as the BRCA genes and the still-unsettled status of NIH funding for human embryonic stem cell research.

Pilot changes to streamline NIH peer review and announcement of a new intramural- extramural collaboration, the Lasker Clinical Research Scholars Program, were up for discussion as well.

The all-day public portion of the ACD meeting ended in late afternoon. “This is about a three-day meeting packed into one day,” quipped Collins. NIHRecord Icon


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