Uncertainty at the NCRR

On December 7, 2010, the National Institutes of Health (NIH) Scientific Management Review Board (SMRB) approved a recommendation to create a new center – the National Center for Advancing Translational Science (NCATS) – at the NIH focused on translational medicine and therapeutics. This decision follows the Obama Administration’s growing concern with the slowing rate of new drug production by the pharmaceutical industry. NIH Director Francis Collins believes that consolidating NIH’s translational research programs in the new Center will help attract the pharmaceutical industry’s attention and help drive production of new therapeutics – small molecules, biologics, and devices – for common as well as rare and neglected diseases. Dr. Collins believes that the new Center will approach the drug development pipeline as a scientific problem ripe for experimentation and process engineering in a systematic way.

Although the mission of the proposed NCATS, “to advance the discipline of translational science and catalyze the development of novel diagnostics and therapeutics across a wide range of human diseases and conditions,” is generally supported by the research community, some stakeholders question whether the NIH should get involved in research aimed at attracting the pharmaceutical industry, whether the new Center will be able to actually leverage outcomes of the translational research programs funded by the NIH, and whether this shift of focus toward translational science for creation of therapeutics will negatively affect investigator-initiated basic science research. Dr. Collins has tried to allay those fears by saying that the goals of creating the new Center are to “facilitate – not duplicate – efforts in developing therapeutics, to complement – not compete with – the private sector, and to reinforce – not reduce – NIH’s commitment to basic science research.” ¹

Dr. Collins, as NIH Director, has full authority by law to create this new Center; it does not require new legislation, although the Congress has six months from the introduction of the proposal to intervene if it sees appropriate. However, because the law limits NIH to 27 Institutes and Centers (I/C), the proposal for the creation of NCATS included a recommendation to dissolve the National Center for Research Resources (NCRR). On February 23, 2011, the NIH task force established to study options for this reorganization delivered interim recommendations² to the SMRB regarding transition of NCRR programs to the new NCATS and other I/C. The proposed reassignments include³:

The proposed dissolution of the NCRR has generated significant discussion and controversy among the research community. The major concerns about the transition shared on the NIH feedback blog⁴ are: 1) accelerated timing (NCATS is supposed to be established by October 2011); 2) the lack of transparency of the reasoning behind the transition; 3) the absolute need for NCRR dissolution when the only programs transitioning to NCATS are the CTSAs (about 40% of NCRR budget); and 4) potential harm to the NCRR programs while they are being transitioned to other I/Cs or a yet unnamed “Infrastructure Entity.” Dr. Collins indicated that the main motivation for creation of NCATS is the “deluge” of new discoveries of potential targets and unmet therapeutic needs of rare, neglected, and common diseases. As for the need to dissolve NCRR, Larry Tabak, chair of NCRR task force, said that after deciding to move CTSAs to NCATS, the character and breadth of the remaining programs at NCRR make it difficult to sustain.⁵

Some organizations actively support the transition. For example, patient advocacy organizations such as the Parkinson’s Action Network strongly support the creation of NCATS and the timeliness of the transition. Others are more cautious. The Federation of American Societies for Experimental Biology (FASEB) strongly advised “against creating a new center if that center would disrupt or compete with the existing I/C activities or reduce the funding available to them.” The American Association of Medical Colleges (AAMC) urged the NIH to spend necessary time in determining how to minimize potential disruption to the functionality of important programs being transitioned from NCRR, some of which could potentially be transferred in the middle of the budget cycle and program planning process. In addition, AAMC recommended that the NIH set in place evaluation mechanisms for the early stages of the reorganization to make sure that these programs continue to receive adequate resources and staff support.

All ASH members are encouraged to submit concerns or comments on this issue to ASH Senior Manager for Scientific Affairs Ulyana Desiderio, PhD, at udesiderio@hematology.org. We are especially interested in learning about the impact of this proposal on your program or institution.

1. FasterCures Webinar, March 16, 2011 www.fastercures.org/train/tools/webs.html

2. www.nih.gov/blog/feedback/NCRR_Task_Force_Recs.pdf

3. Adapted from  http://feedback.nih.gov/wp-content/uploads/2011/02/program_placement.jpg

4. http://feedback.nih.gov/index.php/ncats/task-force-recs/

5. http://feedback.nih.gov/index.php/ncats/smrb-hears-from-the-public-about-ncats/