GOVERNMENT & POLICY
RESHUFFLING NIH Plan to create DRUG DEVELOPMENT CENTER spurs fierce debate BRITT E. ERICKSON, C&EN WASHINGTON
Common Fund and provides resources such as animal toxicology, would also move into NCATS. In addition, a joint initiative between NIH and the Food & Drug Administration on regulatory science (C&EN, March 1, 2010, page 12), and a program called the Cures Acceleration Network (CAN), which was authorized by the health care reform bill but has yet to receive any funding, would join the new center. CAN currently resides in the Office of the Director of NIH. The final proposed piece of NCATS is the Clinical & Translational Science Awards currently administered by NCRR. The program, which at $458 million makes up about 40% of NCRR’s budget, provides opportunities for various clinical activities, training, and community outreach efforts.
DETAILS ABOUT a plan to create a bold NCATS and other institutes and centers. new drug discovery center at the National If all goes as planned, NCATS will be up Institutes of Health emerged from the and running by the beginning of fiscal 2012, agency last month, sparking an uproar in which starts in October. Part of the reason the biomedical community. Of concern to NIH has been moving so quickly is to enmany scientists is the proposal to dissolve sure that the new center is included in the NIH’s National Center for Research RePresident’s 2012 budget request, which is sources (NCRR) to make way for the new due out this week. center. Many people say that the process Collins believes it is essential to create has been rushed, and some are questioning NCATS this year to accelerate the translawhether taxpayer dollars should be used to tional work ongoing at NIH. His plan is to fund drug R&D in the first place. consolidate, under one roof, about $1.1 bilThe proposed reorganization was lion of existing NIH programs—including THE QUESTION NOW is what to do with prompted by a recommendation from a one from NCRR—focused on drug develthe remaining 60% of NCRR. To better key NIH advisory committee, the Scientific opment and clinical research. assess the situation, Collins asked NIH Management Review Board (SMRB). In DeNIH’s Molecular Libraries & Imaging Principal Deputy Director Lawrence A. cember, the committee voted 12-1 to create Program, which is currently supported Tabak and Alan E. Guttmacher, director of a center focused on accelerating the pace of by the NIH Common Fund and offers rethe National Institute of Child Health & drug development. NIH Director Francis S. search opportunities in high-throughput Human Development, to lead an effort to Collins took the committee’s recommenscreening and medicinal chemistry of evaluate NCRR’s programs. dation and ran with it. small molecules, is one of these programs. “It is highly unlikely that you would keep “Scientific advances, many supported The National Human Genome Research the remaining programs together,” Tabak by NIH, are providing new and very excitInstitute’s Therapeutics for Rare & Netold stakeholders in December. “Frankly, if ing insights into the molecular causes of glected Diseases program (C&EN, May you looked at what remains, it really does disease at a dizzying rate,” Collins said dur25, 2009, page 25), and the Rapid Access represent a bit of a patchwork quilt,” he ing a briefing with stakeholders just days to Interventional Development program, said. after the committee’s decision. “It is our which is currently supported by the NIH Many researchers are upset because view that we’ve arrived at they say they weren’t a point where this circumbrought into the discusSTART-UP Proposed makeup of NIH’s new drug discovery center stance requires an entirely sion to dissolve NCRR new look at organization early on. But NIH officials and not just an incremenhave repeatedly said that Clinical & Translational Science Awards tal tweak.” they are still in the plan$458 million During the past two ning process and nothing months, Collins has forged has been finalized. ahead at lightning speed to “This is not an effort Cures Acceleration NIH-FDA Regulatory create the new center, now to dismantle programs,” Networka Science Initiative Up to $500 million $3 million called the National Center Collins reassured grantfor Advancing Translaees and other stakeholdNCATS $1.1 billion tional Sciences (NCATS). ers in December. “It’s But under the NIH Reform rather to identify new opRapid Access to Molecular Libraries & Act of 2006, Congress portunities for scientific Interventional Imaging Program capped the number of NIH adjacencies that will make Development $107 million $8 million institutes and centers at the whole even more than 27, which is the current the sum of the parts,” he number. In order to create stressed. Therapeutics for Rare & Neglected Diseases the new center, NIH has to Lawmakers were in$24 million eliminate one. The agency formed about the reorgabelieves that NCRR should nization in a Jan. 14 letter NOTE: Dollar amounts reflect fiscal 2010 appropriations. a Authorized, but not yet funded. be the one to go, and it is from Health & Human NCATS = National Center for Advancing Translational Sciences. currently working to reasServices (HHS) Secretary SOURCE: Department of Health & Human Services sign affected programs to Kathleen Sebelius. ConWWW.CEN-ONLINE.ORG
25
FEBRUARY 14, 2011
GOVERNMENT & POLICY
gress had 180 days after it received that letter to object to NIH’s proposal, and no reorganization could occur during that time. Although it is unclear whether Congress will try to stop the process, some lawmakers are already asking questions. On Jan. 19, John Bartrum, a staffer on the House Appropriations Committee, sent an e-mail to HHS and NIH officials asking for details about the new center, how much it will cost, and how NIH decided to eliminate NCRR. Hearings on the topic are likely, particularly when budget discussions get under way. Meanwhile, within days of notifying Congress of its plan, NIH released a draft model, showing where it believes the remaining NCRR programs should go. The purpose of the model is to spur discussion, Tabak said during a meeting of the advisory council for NCRR on Jan. 25. Considering
the more than 1,300 comments NIH has received on its online feedback site, the model will likely change, he noted. In the proposed model, some NCRR programs would be transferred to the National Institute of General Medical Sciences (NIGMS), which is a major supporter of chemical research within NIH. Those programs include nonprimate model organisms, biotechnology resource (P41) grants for beamline and mass spectrometry, and P41 grants for high-end and shared instrumentation. P41 grants for imaging, however, are proposed to move to the National Institute Collins
of Biomedical Imaging & Bioengineering, and all other P41 grants will be placed in an interim unit under NIH’s Office of the Director. Most other NCRR programs, including the national primate centers and chimpanzee projects, the Institutional Development Awards for promoting geographic distribution of NIH funds, the Science Education Partnership Awards, and extramural construction, will also be put under that interim unit. At the Jan. 25 council meeting, NCRR Director Barbara M. Alving expressed her concerns about the way the reorganization process has been handled so far. She warned that it will have a lasting impact on how NIH does business and questioned the push to create the new center by Oct. 1. She also emphasized that the disintegration of NCRR was done without public input, except for a few phone N IH
“It is our view that we’ve arrived at a point where this circumstance requires an entirely new look at organization.”
computational toxicology Thematic Collection: Computational Toxicology Thematic Collections are Editor-selected collections of previously published research on topics of current scientific interest. These collections highlight just a portion of the high quality content published by the journal. View all Chemical Research in Toxicology Thematic Collections at pubs.acs.org/crt
WWW.CEN-ONLINE.ORG
26
FEBRUARY 14, 2011
calls, and it was not voted on by SMRB. Other officials at NIH are also concerned about the process. NIGMS Director Jeremy M. Berg, the lone SMRB member who voted against the new center in December, discussed some of the potential negative impacts of the reorganization at an NIGMS advisory council meeting on Jan. 28. At that meeting, council members agreed to write a letter to HHS and NIH officials, highlighting management problems associated with incorporating NCRR programs into NIGMS. For stakeholders, the biggest problem with the proposed reorganization is the speed at which it is moving. “The scientific community has not had the time or the information to assess” the proposals properly, William T. Talman, president of the Federation of American Societies for Experimental Biology, warned the SMRB committee in December. Although the federation supports NIH’s efforts to accelerate the development of therapeutics, the group questions whether the creation of NCATS is the best way to meet that goal. “Translational research, by its very nature, must draw upon the investment in basic research made by the various institutes and centers,” Talman said. “The creation of a new entity could delay translation by creating a new bureaucratic structure that is cut off from the research base,” he stressed.
the chance to boost public-private collaborations in drug discovery. “Bold and ambitious proposals, such as Collins’, will be key to how we collectively progress in discovering novel compounds for addressing patients’ unmet medical needs,” says David E. Wheadon, senior vice president of the Pharmaceutical Research & Manufacturers of America, an industry group.
OTHER PEOPLE are worried that NIH will
be using taxpayer dollars to discover promising new drug leads, only to give them away to industry to profit from them. But Collins sees opportunities for NIH to gain from such collaborations. “There are some very interesting techtransfer issues here that relate to intellectual property and royalty arrangements, which we think will be fascinating to pursue and actually could be quite productive in terms of resulting in a win-win for NIH, for the company, and another more important win for the public,” Collins said during a stakeholder briefing. “But much of that will need to be dealt with in a project-byproject way.” Collins emphasized that the new center is not intended to compete with pharmaceutical and biotech companies. “The goal here is to identify projects which might otherwise lie dormant for lack of economic incentive or scientific certainty,” he said. The pharmaceutical industry, which spent about $65 billion in 2009 to discover and develop new drugs, welcomes WWW.CEN-ONLINE.ORG
27
FEBRUARY 14, 2011
The odds of success in drug discovery are incredibly steep—“just one approved medicine, on average, for every 10,000 promising molecules initially studied,” Wheadon notes. “We’re encouraged by Collins’ goal of taking a sharper focus on early-stage research in the hope of improving the ultimate success rates in drug development.” ■
