SMRB and Thee

Last 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 from NIAAA and NIDA into a new IC focused on addiction research. Pretty powerful stuff from the new kid on the block.

The SMRB was authorized by the Great Zerhouni-era NIH Reform Act of 2006 (signed into law in January 2007), was chartered in Aug 2007, had its membership announced in 2008, and met for the first time in April 2009. According to its charter:

The purpose of the SMRB is to advise the NIH Director and other appropriate agency officials, through reports to the NIH Director, on the use of these organizational authorities and identify the reasons underlying the recommendations.

… Not less than once each 7 years, … the Board will (1) determine whether and to what extent the organizational authorities should be used; and (2) issue a report providing the recommendations of the Board regarding the use of the authorities and the reasons underlying the recommendations.

So the SMRB issues reports. How are they told to discharge this duty, at least with regard to recommended organizational changes?

… the Board will (a) analyze the budgetary and operational consequences of the proposed change(s); (b) take into account historical funding and support for research activities at national research institutes and centers that have been established recently relative to national research institutes and centers that have been in existence for more than two decades; (c) estimate the level of resources needed to implement the proposed changes; (d) assume the proposed changes will be made and make a recommendation for the allocation of the resources of NIH among the national research institutes and national centers; and (e) analyze the consequences for the progress of research in the areas affected by the proposed changes.

In issuing a report on one or more specific contemplated organizational issues, the Board will consult with (1) the heads of national research institutes and national centers whose directors are not members of the Board; (2) other scientific leaders who are officers or employees of NIH and are not members of the Board; (3) advisory councils of the national institutes and national centers; (4) organizations representing the scientific community; and (5) organizations representing patients.

The SMRB has even issued a report on its report-generating process, which itself notes the importance of conducting risk-benefit analyses and examining the broader impacts (not in the NSF sense) of each option for change. So, of course this is how they approached the ginormous responsibility of proposing an entirely new Center.

Or not.

At the Dec 7 meeting, Collins explained that the TMAT working group was charged to assess only the potential value of a new IC focused on translational medicine – not the potential consequences of creating this new entity. He and Arthur Rubenstein emphasized the need for further deliberation of the potential consequences should a new IC be proposed. Indeed, during the public comment period and in its submitted letter, FASEB urged that the potential consequences be examined before any recommendation be made to establish a new IC (the bureaucratic process of which could in fact delay progress on translational research).

Then what to make of the next agenda item, presciently titled, “The NIH Clinical Center and the Proposed New Center: Opportunities for Partnership” by Director John Gallin. Opportunities for partnership with a Center that had not yet been formally proposed?

Well, not to worry. Just prior to Gallin’s presentation, a motion was introduced that:

  1. A new translational medicine and therapeutics center be created as recommended in the TMAT Working Group Report;
  2. The Board endorse and support the NIH’s commitment to undertake a more extensive and detailed analysis through a transparent process to evaluate the impact of the new Center on other relevant extant programs at NIH, including NCRR; and
  3. The NIH report their findings to the SMRB at its next meeting in approximately 3 months.

With this motion on the table and the clear intention to rapidly approve it, Jeremy Berg quickly asked the obvious question: did the TMAT Working Group consider simply restructuring NCRR to accomplish the desired scientific goals?

Rubenstein indicated that “I think almost by default we did that” and suggested the group quickly came to consensus that a new organization was needed to overcome pharmaceutical company problems and Congressional interest in the CAN. Stephen Katz confirmed the group held no in-depth discussion of such an option. How reassuring.

End of discussion. No one else on the SMRB had any questions or concerns. The motion was brought up for a vote … only Jeremy Berg’s hand went up as opposed (and I got the impression that Augustine almost forgot to ask if there were any “nays”).

In a conference call less than 48 h later, CTSA PI James Heubi (U Cinn) found it “unfortunate” that he, as an NCRR Advisory Council Member, had not been part of the TMAT Working Group discussions. Considering again their charter and operating guidelines, one wonders with which stakeholders the SMRB consulted, if not the likes of NCRR Advisory Council members, particularly one who is also a CTSA PI.

Nonetheless, in his interview with Nature, Collins reports that:

The SMRB took a comprehensive look at the situation and concluded that the scientific opportunities are here now.

A comprehensive look? Based on some global concepts presented in September (where the focus was on the NIAAA-NIDA merger) plus one working group PowerPoint presentation by Rubenstein in late November? How many of you out there were consulted for stakeholder input on such a major (and abrupt) change at the NIH?

(With only 3 months allocated to study potential impacts, you should not delay in registering any comments you have on the new center and/or the fate of NCRR.)

And how much deliberation on the potential consequences can realistically be expected if NCATS is already a ~$650M line item in the FY12 budget?

These questions are important not only for this situation but also for the future operation of the NIH. If such major changes can be implemented so quickly with such little input beyond “working” group members, what else might the SMRB do on behalf of NIH Directors seeking to push through special initiatives?

Of course, if NIDA and NIAAA are merged and NCRR is mothballed (its programs scattered among other ICs), Collins will have an extra slot to fill. Nominations for the next IC anyone?

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22 Comments »

  1. curie said

    But why the rush in creating the new institute, other than “the time is right”? I’m not saying its not a good idea, but wish they do it right considering all repercussions.

  2. Vicky said

    Not only disappointing but frightening that advisory boards, or rather some members, without touching base with the involved communities have such a powerful influence in directing and accommodating research and health needs in this country. …..going backwards..?

  3. Alfred Hudson said

    Wondering if there are “few heads” thinking of a Plan for a Transformative NIH more attuned to recent waves on US Health Care and better New but Old Deals.

  4. James Hudleyson said

    In spite of claiming: “The Board endorse and support the NIH’s commitment to undertake a more extensive and detailed analysis through a TRANSPARENT PROCESS TO EVALUATE THE IMPACT of the new Center on other relevant extant programs at NIH, including NCRR..”, the whole thing looks much less than transparent.

    The rush is overwhelmingly obvious and Arthur Rubenstein‘s soft, ambiguously crafted responses in the face of apparent already made decisions are indicative of a “leadership” style. Unfortunately, most Board members including the Chair did not appear to feel at liberty to question the whole strategy much harder. It is now in the hands of all the stakeholders involved to reverse an obscure-like procedural strategy. NIH should be about participation in solidifying achievements and creating new opportunities for the national enterprise.

    Collins will have no problem in filling the slot for the new IC. A Rubenstein jokingly mentioned at the last SRMB meeting that he told his colleagues at Penn “he was attending so many meetings at the NIH because he had been fired”. Maybe he is looking for a job.

  5. SG said

    There are thoughts/rumors that the reason NIH is moving so fast on this is to grab a big chunk of new HHS Research Money ($500,000,000-$2,000,000,000) for Prevention Research that is in the New Health Care Law. (http://en.wikisource.org/wiki/Patient_Protection_and_Affordable_Care_Act/Title_IV) Whether the money would go to the Translational Research Institute or to a brand new 27th Institute is not clear to me. Or maybe some other money buried in the law.

    • writedit said

      Create a whole new Center as a strategic opportunity for a one-time money grab (well, potentially through 2014)? And essentially a grab for funds that have been authorized but not appropriated (or using “any funds in the Treasury not otherwise appropriated” …)? I only see the NIH mentioned in conjunction with the pain research bit. Most of the authorized items look like earmarks for the CDC and HRSA with some AHRQ gimmes …

      • SG said

        To paraphrase The Shadow…Who knows what greed lurks in the hearts of NIH bureaucrats…..

        More money is the only reason I can think for things moving along so fast.

  6. Michael said

    That the “momentous occasion” and “scientific basis” for an organizational change at NIH (moathbolling NCRR and create a new center) is based on the possibility of getting a big chunck of money is UNBELIEVABLE. This is not only rumors but reality. I attended the NCI Town Hall Meeting and Varmus spoke enthusiastically about this new Center and the great repercussions for cancer researchers…. Would the repercussions for NCI be different if the new opportunities for translational science were part of NCRR?. What are Collins and Varmus thinking ?. How could they possibly let slip the explanations given by the TMAT Working Group Chair without asking further?. Establishing collaborations with the outside world is great but let be in guard !. Just go and read the latest posts on Health Care Renewal. They are very revealing.

  7. Padrino said

    There’s more. The TMAT working group reported to SMRB on December 7 (unintentional irony??). Collins forwarded the recommendation to HHS Secretary Sibelius and Congress within 48 hours. By the first week of January, plans were essentially complete (but still closely held) to redistribute the NCRR portfolio. Was the intention to get the whole dismantling of NCRR accomplished over the holidays, when academic researchers (the most threatened stakeholders) were away or out of action?

    There has been not a trace of genuine dialogue or consultation in this whole thing.

    (Hint: Look at the TMAT working group report, and see the list of people they brought in to talk to them during their consideration of NCATS. Look at the affiliations. This smells like a backdoor deal with Big Pharma. Second hint: Look up Billy Tauzin’s role prior to the healthcare legislation.)

    • Padrino said

      When you’re wrong, you’re wrong, and may as well fess up. The post above was dead wrong. The leadership of the NCRR Task Force (esp. Tabak) has been holding semi-public conferences and aiming for maximum transparency. I apologize for suspecting sinister intentions.

      • Alfred Hudson said

        You were right before and you are right now: fake transparency, just for the show.

        http://invivoblog.blogspot.com/2010/03/health-care-reform-done-deal-pharma.html

        Saw Scienceinsider reporting on Collins explains “why NCRR must go”.. One of the big reasons, if not the biggest, is that NIH has to have the Drug Dealers and Money Grabbers inside…They have been working on that for some time now. And they got it. What happens to investigators and already existing genuine translational science is a “secondary” issue…..What matters is “the scientific opportunity” in Collins’s words. He has not said a single phrase yet on what that “scientific opportunity will or would consist of….”. For investigators we don’t know yet, for pharma’s dealers like Tauzin, Rubenstein and the like… the opportunities might be huge!.

        Some clues here:

        http://invivoblog.blogspot.com/2010/03/health-care-reform-done-deal-pharma.html

        Some clues might b

  8. Kinskey said

    New Alliances for an old world, fighting desperately in the shadows, whose only search and research is for supremacy to maintain their status quo: big salaries, big pensions, exploitation of young scientists on the promises of a future “if you are with me…” A seductive, dangerous world from which not even Nobel Prizes can escape ?

    We shall overcome, we shall overcome………. and we will.

  9. Larry Tabak has now posted a “straw model” showing a possible scenario for the distribution of NCRR programs to other homes within NIH including NCATS, NIGMS, NIBIB, NIMHD, and an “interim infrastructure unit” in the NIH Office of the Director (http://feedback.nih.gov/index.php/ncats/straw-model/ ). Comments are encouraged.

  10. [...] Guttmacher have posted a grid laying out the proposed re-distribution of NCRR programs (thanks to Jeremy Berg for alerting us to this under the SMRB [...]

  11. Alfred Hudson said

    Does anyone know the rationale used to build the “one possible scenario” and the criteria to select the ICs mentioned, NCATS, NIGMS, NIBIB, NIMH to home NCRR programs? Why those ones and not others ?.

    • In general, the NCRR programs cut across the interests of many institutes and centers so that they align better with cross-cutting rather than categorical institutes and centers. The incorporation of the CTSAs into NCATS was part of the original vision for NCATS. The P41s (Biomedical Technology Resource Centers) include awards focused on synchrotrons and mass spectrometry (that align well with the structural biology and proteomics programs in NIGMS and medical imaging awards that align well with NIBIB. The Shared Instrumentation and High End Instrumentation program align with NIGMS research and technology development programs although these programs are widely used by investigators across NIH. The model organism resources align with NIGMS research programs utilizing a wide range of non-primate model organisms. The RCMI program (Research Centers in Minority Institutions) aligns with NIMHD (the National Institute on Minority Health and Health Disparities).

  12. [...] exceptional service to the extramural community (and for firmly voicing his concerns about recent SMRB and NIH actions on the creation of NCATS and the abolishment of NCRR). His departure from NIGMS will [...]

  13. writedit said

    Interesting comment on SMRB over at the more recent post on communications with Congress about the abolition of NCRR and the creation of NCATS:

    http://writedit.wordpress.com/2011/01/27/sebelius-ncrr-must-go/#comment-10211

  14. the walrus is Paul said

    Apparently Dr. Berg (and his Advisory Council) has even more to say about this….

    ScienceInsider

    Collins’s Plan to Reshuffle NIH Draws More Flak

    by Jeffrey Mervis on 28 January 2011, 5:00 PM

    The revolt is spreading against a plan by U.S. National Institutes of Health (NIH) Director Francis Collins to create a new center on translational medicine by reassigning existing pieces of the $31 billion agency.

    Today, the top advisory body to the National Institute of General Medical Sciences (NIGMS), the component scheduled to inherit many of those pieces, agreed to draft a letter expressing its unhappiness with Collins’s plan, which would bust up the National Center for Research Resources (NCRR) in the course of creating the National Center for Advancing Translational Sciences (NCATS). And NIGMS Director Jeremy Berg, who opposed the new center when an NIH management board recommended it last month, explained in greater detail why he thinks breaking up NCRR is a bad idea.

    “I’ve never understood how dismantling NCRR solves more problems than it creates,” Berg told members of the NIGMS council during its meeting on the Bethesda, Maryland, NIH campus. Berg compared NCRR to a city’s department of public works, calling it an entity familiar with operating large facilities for the common good, and said it helps researchers from all disciplines. Folding its large programs into NIGMS “would be a big management challenge,” added Berg, who is leaving NIGMS in June as the “trailing spouse” as his wife takes up a position at the University of Pittsburgh.

    Collins says that NCATS will help spur the development of drugs and other treatments by industry. But as the NIGMS council discussion made clear, there’s no consensus about where NIH should draw the line between financing basic research to improve understanding of potential targets and helping the private sector push those targets through the drug-development pipeline. “If the reason [to create NCATS] is to derisk opportunities for industry, I think that’s quite bizarre and contrary to the entrepreneurial spirit,” said Yale University chemistry professor Scott Miller. James Stevens, a senior research fellow at Lilly Research Laboratories in Indianapolis, also questioned the rationale behind the new center: “If there is any organization that is slower and less agile than industry, it’s the federal government.”

    Leaving aside that debate, the big issue facing NIH and the biomedical community is whether Collins’s plan is the best use of NIH’s large but still finite budget and the possible threat to existing research activities supported by NCRR that affect the rest of the 27 institutes and centers.”Is there a management logic to splitting them?” asked council member Howard Garrison, who heads up the policy shop for the Federation of American Societies for Experimental Biology in Bethesda, Maryland. “It seems wasteful and destructive without a vision of why.”

    Garrison volunteered to draft a letter describing the council’s concerns about how NIGMS would be affected. It would be sent to Collins and the NIH management board as well as to Collins’s boss, U.S. Health and Human Services Secretary Kathleen Sebelius, and to the congressional panels that set NIH’s budget. A House of Representatives spending panel has already asked for information on the proposed changes, which would go into effect in 180 days unless Congress intervenes.

  15. writedit said

    Jocelyn Kaiser’s recap of the Feb 23 SMRB teleconference suggests this body has become and will continue to do little more than rubber stamp whatever the Director wants.

  16. [...] FY12 appropriations bill Conference Report includes its own assessment of the process by which NCRR was replaced by NCATS: The conference agreement includes language to eliminate the NCRR and create the National Center [...]

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