Issue Date: February 14, 2011
Details about a plan to create a bold new drug discovery center at the National Institutes of Health emerged from the agency last month, sparking an uproar in the biomedical community. Of concern to many scientists is the proposal to dissolve NIH’s National Center for Research Resources (NCRR) to make way for the new center. Many people say that the process has been rushed, and some are questioning whether taxpayer dollars should be used to fund drug R&D in the first place.
The proposed reorganization was prompted by a recommendation from a key NIH advisory committee, the Scientific Management Review Board (SMRB). In December, the committee voted 12-1 to create a center focused on accelerating the pace of drug development. NIH Director Francis S. Collins took the committee’s recommendation and ran with it.
“Scientific advances, many supported by NIH, are providing new and very exciting insights into the molecular causes of disease at a dizzying rate,” Collins said during a briefing with stakeholders just days after the committee’s decision. “It is our view that we’ve arrived at a point where this circumstance requires an entirely new look at organization and not just an incremental tweak.”
During the past two months, Collins has forged ahead at lightning speed to create the new center, now called the National Center for Advancing Translational Sciences (NCATS). But under the NIH Reform Act of 2006, Congress capped the number of NIH institutes and centers at 27, which is the current number. In order to create the new center, NIH has to eliminate one. The agency believes that NCRR should be the one to go, and it is currently working to reassign affected programs to NCATS and other institutes and centers.
If all goes as planned, NCATS will be up and running by the beginning of fiscal 2012, which starts in October. Part of the reason NIH has been moving so quickly is to ensure that the new center is included in the President’s 2012 budget request, which is due out this week.
Collins believes it is essential to create NCATS this year to accelerate the translational work ongoing at NIH. His plan is to consolidate, under one roof, about $1.1 billion of existing NIH programs—including one from NCRR—focused on drug development and clinical research.
NIH’s Molecular Libraries & Imaging Program, which is currently supported by the NIH Common Fund and offers research opportunities in high-throughput screening and medicinal chemistry of small molecules, is one of these programs. The National Human Genome Research Institute’s Therapeutics for Rare & Neglected Diseases program (C&EN, May 25, 2009, page 25), and the Rapid Access to Interventional Development program, which is currently supported by the NIH 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.
The question now is what to do with the remaining 60% of NCRR. To better assess the situation, Collins asked NIH Principal Deputy Director Lawrence A. Tabak and Alan E. Guttmacher, director of the National Institute of Child Health & Human Development, to lead an effort to evaluate NCRR’s programs.
“It is highly unlikely that you would keep the remaining programs together,” Tabak told stakeholders in December. “Frankly, if you looked at what remains, it really does represent a bit of a patchwork quilt,” he said.
Many researchers are upset because they say they weren’t brought into the discussion to dissolve NCRR early on. But NIH officials have repeatedly said that they are still in the planning process and nothing has been finalized.
“This is not an effort to dismantle programs,” Collins reassured grantees and other stakeholders in December. “It’s rather to identify new opportunities for scientific adjacencies that will make the whole even more than the sum of the parts,” he stressed.
Lawmakers were informed about the reorganization in a Jan. 14 letter from Health & Human Services (HHS) Secretary Kathleen Sebelius. Congress 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 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 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.
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 tech-transfer 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-by-project 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 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.
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.”
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