Get out the Cigars … it’s a Center

As noted yesterday, the SMRB met to consider whether to create a new IC to “establish new and innovative approaches to conducting research to advance the science of process engineering of the therapeutics development pipeline, in the context of strengthening and streamlining the process itself … and … to promote quick-win, fast-fail paradigms and further develop the pre-competitive space.”

Damn, I cannot wait to work on applications for research that fulfill these priorities … time to kick my creative writing skills up a notch.

This recap from Science reflects concerns raised about the concept and the rapid time frame involved, which does not permit stakeholders to think things through well:

Debate over the proposal flared at an NIH advisory board meeting this morning. Nearly 20 groups and investigators supported by the National Center for Research Resources, which would be partly absorbed by the new center, sent letters or gave testimony expressing concern that existing NCRR programs might be lost. “It’s a very large organization being done on a very fast time scale, and the community that will be affected needs more time to provide input,” said biochemist Mark Lively of Wake Forest University School of Medicine in Winston-Salem, North Carolina, a member of NCRR’s advisory council, before the meeting. NCRR Director Barbara Alving urged the board instead to expand NCRR into the new translational center.

My thoughts exactly, Dr. Alving. Let’s just rename/rebrand/expand a perfectly functional NCRR … a well-functioning NCRR – I’ve always liked my dealings with NCRR and want to see them do well (big shout out of support for yinz from BICO) – but no:

Despite such concerns, the board voted 12-1 to create the new center. Only Jeremy Berg, director of the National Institute of General Medical Sciences, voted no; he is “concerned that the implications for the rest of NIH hadn’t been adequately discussed,” he said afterward.

So, even with all the promised deliberations and assessments, does Collins just go ahead and combine NIAAA and NIDA (at the same speed with which this Center was created), since he cannot increase the total number of ICs, or will NCRR be cut into programmatic pieces to be dispersed (or discarded) like the victim of some hostile takeover? What I really, really don’t understand is Collins’ crowing comment:

Collins called the decision to go ahead “a momentous occasion” because the center is being created “on the basis of scientific arguments” and not politics, which has “rarely” happened at NIH.

Let’s see … the Center was created in no small part to house the Cures Acceleration Network, which was spontaneously generated by that outstanding scientist, Arlen Specter (who is now standing out of the Senate and unable to garner any support for this Center or the rest of the NIH). CAN as a vote-buying line item in health care reform. Nah, of course there were no politics involved here.

What happens next?

This week, Collins expects to send his recommendation for the new translational center to Health and Human Services Secretary Kathleen Sebelius, who will forward it to legislators. Congress will have 180 days to object; otherwise, the new institute will move forward.

Poof – just like that. If only cures were so easy.

Update: FASEB has included this nice recap of what happens next in their latest update:

Immediately following the SMRB decision to recommend a reorganization (reprogramming), NIH likely notified Congress, starting the clock for the 15 day period before the Director can publically accept the SMRB recommendations. It also started the 180 day period that Congress has to object to the recommendation. Concurrently, NIH has begun to develop a more detailed draft implementation plan in consultation with NCRR Staff, NCRR grantees, and CTSA institutions. After the 15 day period, the NIH Director may issue a statement of acceptance of the recommendations. Assuming acceptance of the recommendations and the development of the more detailed draft plan, broader public input would then be sought. A “final” plan would be presented at the next SMRB meeting and submitted to the Secretary of the Department of Health and Human Services. The Secretary would then have 30 days to accept or reject the final plan. FASEB will continue to monitor this issue closely.

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19 Comments »

  1. curie said

    I don’t understand the purpose of the new institute. The motivation is good, but the implementation is flawed. This single institute is expected to cover all translational aspects of science in medicine. This ignores the fact that applications in all areas will be competing against each other, ignoring the fact that the quality of the application need to be judged individually based on the state of the literature in each field. Some application/translational areas are so behind, for e.g., if you compare cardiovascular vs. gastrointestinal work.

    Instead, every existing institute should have been made to share a portion of applications in the translational area related to the topic of the institute. Some how, NIGMS has been largely ignored in this debate which handles lots of translational application / general medicine.

    May be people want to tell themselves they are doing great by creating new programs because that is more exciting and without any baggage to carry in comparison to improving existing programs. It is like “the simplest solution to spousal fights is diverse and a new marriage”.

    My 2 cents.

    • whimple said

      Instead, every existing institute should have been made to share a portion of applications in the translational area related to the topic of the institute.

      This doesn’t work, has been known to not work for some time now, and is probably motivating the creation of the new center. Regardless of what the Institutes say they want, study sections give translational work poor priority scores(1) so the work tends not to get done. It is important in these difficult days for discretionary spending programs like the NIH that the direct benefit to the taxpayer is emphasized. Creation of the new Institute may help generate some excitement in Congress for NIH funding generally.

      (1) Am J Med. 2008 Jul;121(7):637-41. “Why are peer review outcomes less favorable for clinical science than for basic science grant applications?” Martin MR, Lindquist T, Kotchen TA.

    • curie said

      Whimple: You are pin pointing the root cause of why this new institute is going to be created; which is, translational applications get poorly scored because they are considered alongside basic research applications.

      Now, that being the main problem, why can’t we just fix that? For e.g., by creating a new track or the special z-series study sections in every institute which will only accept and review translational applications. It can be done within the existing framework of the institutes and CSR.

      And by reviewing translational application in each area within the respective institute, the institute could be sure it is recruiting experts in their respective fields to review. As I said before, if under the new institute, a study section may have to review applications in cardiovascular vs. gasterointerology; in which case, the study section will have members with a very wide expertize; for e.g., a biomechanics experts in cardiovascular area may say the proposed biomechanics translation application in gasterointerology is so far behind in technology without a knowledge of the gasterointerology research. This is a danger in pooling all translational applications under a single institute. That is even a worse bias than the bias you are talking about because of the differences in the state of “translational” literature in each field. I wish Berg or someone else speaks up to first understand and document what is going on right now before jumping into the new institute.

      Any other reason why you would still think a separate institute is needed?

  2. writedit said

    Thanks for posting the link, curie … I am most puzzled by FitzGerald’s comments:

    “This can offer the beginning of a brand that can lure the best and the brightest into training. Because the absence of those people has come at an immense price,” he says.

    Um, what has UPenn been doing with the KL2 and TL2 components of their CTSA funding?

  3. BB said

    I’m with whimple on this. Translational loses out to the next best thing or gene or whathaveyou.
    Translational is sometime boring (kinetics, tox, that stuff). But it has to be done before moving to Phase I trials.

  4. drugmonkey said

    wait. I thought we were reducing the number of ICs on the books.

  5. writedit said

    In an interview with Nature, Collins gives a less than reassuring response to the question, How should basic researchers regard the centre?:

    I think some basic scientists will be quite excited about the opportunity to be more connected with the clinical benefits of their own discoveries. Not that that’s at all necessary or required, or that basic scientists who don’t feel that inclination should be considered somehow unmotivated. Science for science’s sake is also a wonderful way to learn about life. But I do think there is more here that is positive than is negative for a basic scientist, if people will step back from their anxieties about budgetary considerations. That being said, we should all be anxious about the overall budget right now with the expectation that dollars for biomedical research are going to be very hard to come by in the next year or two. But that can’t be a reason to stop promoting innovation.

  6. whimple said

    The creation of the center is a response to basic scientists not properly delivering value to the American taxpayer. Basic scientists should regard the center as motivation to actually make a useful contribution for a change. :)

  7. writedit said

    Update: FASEB has included this nice recap of what happens next in their latest update:

    Immediately following the SMRB decision to recommend a reorganization (reprogramming), NIH likely notified Congress, starting the clock for the 15 day period before the Director can publically accept the SMRB recommendations. It also started the 180 day period that Congress has to object to the recommendation. Concurrently, NIH has begun to develop a more detailed draft implementation plan in consultation with NCRR Staff, NCRR grantees, and CTSA institutions. After the 15 day period, the NIH Director may issue a statement of acceptance of the recommendations. Assuming acceptance of the recommendations and the development of the more detailed draft plan, broader public input would then be sought. A “final” plan would be presented at the next SMRB meeting and submitted to the Secretary of the Department of Health and Human Services. The Secretary would then have 30 days to accept or reject the final plan. FASEB will continue to monitor this issue closely.

  8. writedit said

    In his commentary in Forbes, Learning From Experience: Let NIH Be NIH, Dr. Henry Miller notes that he does not want the NIH to “become something akin to a combination venture capital fund and drug company.”

    • Luna Halloween said

      Thanks for the link writedit.

  9. writedit said

    More from Francis Collins on the gospel of drug discovery in Nature Reviews Drug Discovery.

  10. writedit said

    More on the new Center from Nature Medicine.

  11. [...] month, the Scientific Management Review Board (SMRB) recommended the creation of a new National Center for the Advancement of Translational Sciences (NCATS). They have also recommended merging programs [...]

  12. writedit said

    Hmmm. I guess these new drug discovery academic-industry partnerships being launched by Pfizer and GSK don’t count with the TMAT Working Group …

  13. [...] approval for NCATS might not be as easy as Collins had thought … certainly not as easy as fluffing it past the SMRB last December: The question remains, however, as to whether NCATS is the right approach to solving this issue. [...]

  14. [...] center with such urgency and immediacy. First, the current directors were caught off guard by the December SMRB meeting at which NCATS was abruptly approved (though no word at that time regarding NCRR’s fate). In [...]

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