NCATS in Limbo

Back in May, Richard Shelby’s opening statement to a Senate subcommittee hearing on the NIH FY12 budget hinted that getting Congressional 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. Will NCATS be the right mechanism for taking valuable discoveries that the taxpayer has funded and giving it a greater opportunity to make it into the marketplace? As we review this proposal, we need to consider the fact that NIH is not a drug developer or an expert in the therapeutics world.

Indeed, Shelby urged more deliberative consideration of what actions should be taken, akin to the advice given by Jeremy Berg and countless others:

Dr. Collins, I believe that NCATS is a matter we should contemplate, but we must ensure that the steps forward are measured and in the best interest of all stakeholders, especially those who are in need of treatment and care.

All the while, the NIH has been actively moving ahead with the redistribution of NCRR programs and personnel … though sans detail with regard to space, staffing, or budgets.

Then a month later, Sebelius wrote to Tom Harkin with the NIH FY12 budget request ($31.7B), including a line item (several, actually) for NCATS and listings on how the NCRR dollars would be reallocated. These are all based on the President’s requested FY12 budget, which of course will likely bear little resemblence to what is finally appropriated (especially since the House passed an appropriation bill that reduced the President’s request for Labor, HHS, and Education by $41.6B). Sebelius describes the process of establishing NCATS as one in which an NIH taskforce:

carefully identified and evaluated program placements that would improve organizational efficiencies and provide scientific synergies. To aid in the decision-making, the taskforce implemented a transparent process to collect and consider input from a wide range of internal and external experts, as well as stakeholders ranging from members of the public to members of the extramural research community.

Efficiencies, synergies, adjacencies. I guess the process to collect input could be described as transparent, though I worry a bit about the metrics that will be used to benchmark progress in achieving her stated mission for NCATS to “advance translational sciences by accelerating the development and delivery of new and more effective diagnostics and therapeutics.”

However, Sebelius and Collins have a more immediate concern facing them, such as the June 15th letter by Rep. Denny Rehberg (R-MT):

If the President decides to submit a formal budget amendment and provides answers to my questions to allow us to review the proposal fully, we will be happy to consider the request. However, until such information is provided we cannot responsibly take any action on this matter.

Therefore, I am very troubled by reports that the NIH has already taken steps to start the search for a new director of NCATS in advance of congressional action. I understand that during public discussion of NCATS to the Advisory Council to the Director of NIH on June 9, 2011, NIH announced it has begun the search process for a director and the process to notify current employees of reassignments to be effective on October 1, 2011 in anticipation of NCATS standing up on October 1, 2011.

It seems premature to take these steps in advance of an official presidential request, let alone required congressional action. I suggest NIH cease all action related to establishing NCATS until the President submits a formal request and congressional action is completed.

… It is unclear based on the scant level of information provided to the Appropriations Committee thus far how NCATS is the answer to advance translational research.

What sort of information is Rep. Rehberg looking for? The sort requested last January by John Bartrum.

Science notes that other Representatives also have concerns about NCATS and the NIH reorganization:

Several other House members, including Representative Michael Capuano (D-MA), who represents the Boston area, also wrote NIH recently with concerns about how the reorganization would affect CTSAs. Last week Capuano sent NIH another letter. “Several of Congressman Capuano’s constituents have expressed concerns that the NIH’s priorities may be shifting away from basic research,” explained Capuano spokesperson Alison Mills, who declined to release the letter until NIH responds.

I like the concern over the shift in NIH priorities away from basic research.

Indeed, Congressional members are not the only ones wondering if NCATS is the solution to the myriad problems in bringing promising diagnostic and therapeutic agents to market:

But others are unconvinced that the public sector’s contributions stretch much beyond basic science. Benjamin Zycher, a senior fellow at the Pacific Research Institute, a conservative economic think-tank in San Francisco, says industry contributions dominate throughout applied phases of drug development (that is, beyond target discovery identified in basic research).

… Zycher, for instance, predicts the center will flop because the NIH isn’t set up for applied research. Moreover, he worries that by enhancing public sector contributions, the center could invite congressional meddling in pricing, fast-track approval decisions and other business-related concerns.

For the biotech industry in particular, USDA’s Toole [research economist] pictures two outcomes arising from the establishment of NCATS. On the one hand, companies could benefit from being relieved of some of the upfront R&D groundwork. On the other hand, it’s also possible that publicly funded scientists could seek more patent protection for their work, continue to overestimate the commercial value of their intellectual property and slow down tech transfer from academia to industry, turning them into competitors as much as collaborators, he says.

Back to the one hand, industry has long been relieved of the “upfront R&D groundwork” through the NIH’s longstanding support of basic discovery research, which is too risky for profit-maximizing companies to pursue. The shift of NIH dollars to help academic researchers take their discoveries to market would come at the price of fewer fundamental mechanisms and potential targets identified.

In the meantime, the clock is ticking:

Rehberg chairs the House appropriations labor/HHS subcommittee, which oversees NIH’s budget. On 26 July, it will introduce a spending bill that would need to fund NCATS if it is to launch by 1 October, the start of the 2012 fiscal year.

At the aforementioned June 9th ACD meeting during which the search for an NCATS Director was “prematurely” announced, Larry Tabak (Deputy Director, NIH) rather than Barbara Alving (Director, NCRR) presented the NCRR Update. In fact, the entire afternoon session was devoted to NCATS. Perhaps any champagne uncorked at the end of the day may have been premature.

17 Comments »

  1. iGrrrl said

    Writing from the NIH regional meeting in Ft. Lauderdale, here. I asked twice what the attending NIH staff thought would happen to the shape of the CTSAs under NCATS, and in both cases got a fairly politic answer that the CTSAs were important programs. I’ll be very interested to see the RFA in the fall, if there is one. The third round centers are up for competing renewal.

  2. curie said

    my take is still to make each specialty institute devote separate budget for translation research without creating this one giant institute. who better to identify which translation projects to fund than the institute whose focus is to advance that area. more jobs and more funds for each institute.

  3. einstein said

    Unnoticed by many, the NCATS issues seem to have also tossed a monkey wrench into the Addiction Institute plans. What was scheduled for October 2012 (FY ’13) has now been moved to October 2013 (FY ’14), with the extra time devoted to getting “strategic planning input” for the new IC from affected stakeholders. Probably in the hopes of silencing any outcries like those encountered with NCRR/NCATS. Unfortunately however, those of us who will become orphan children (alcoholic liver disease, and others) shunted to other ICs rather than moving with the rest of our current institute to the new one, are not being offered any input opportunity there — neither on the move itself, nor on the “strategic planning” for our areas in their new homes. Obviously, the powers-that-be do not understand that it is US from whom the outcries will come. And we WILL be loud.

  4. NCI or Bust said

    The idea of an institute devoted to translational research has bothered me for some time. After discussing this with several of my colleagues my concern is that this is a mechanism to shove larger and larger fractions of the NIH budget to fewer and fewer scientists who have little incentive to innovate. First, this seems to fit with the background of F. Collins, who has mainly been involved in and seems to have a strong affinity for big science. Second, there seems to be a natural proclivity for agencies to follow this path and essentially replace innovation with large bureaucratic structures that at best do engineering on existing technologies. For instance, NASA never replaced the Space Shuttle program which was mainly based on tech from the 60s. Similarly, the genome project spent billions engineering existing technologies and using brute force methods that ignored shotgun sequencing etc which in my opinion allowed Collins to co-finish the genome and avoid what otherwise would have been a much less successful effort. Another good example is “the alliance for cellular signaling” which did not anticipate RNAi and thus chose poor model systems in hindsight. The common failure is that most of the ideas in these projects came from a few highly established scientists that were resistant to a change in direction but who secured funding long after their approaches became outdated. Third, I can see this becoming a vehicle whereby researchers who have moved on to more administrative roles at their institutions can effectively control increasingly larger percentages of external funding as such funding will only go to PIs who can marshal the resources required for the appearance of a “credible” translational infrastructure. Specifically, funding will increasingly be determined by the ability to fulfill the administrative requirements/paperwork while the science is an afterthought. I remember an instance in Canada about 6-7 years ago where some VERY large grants from CFI were given mainly to the groups that could pass administrative review i.e. fill out the 3-4 large binders of paperwork which was a hurdle that came before any scientific review. This effectively made it impossible for anyone with a great idea but without an army of administrators to compete.

    • writedit said

      All very good points – kudos on your attention to and astute take on science history. Your last point is particularly well taken as Collins is planning the next round of $25M Roadmap grants, which will likely only be competitive to the big players with tremendous administrative and core infrastructure resources, not to mention track records established with years of high levels of funding. But administrative support is increasingly important for funding at any level and will only become more so: the House has a bill in the works that would apply the reporting requirements for ARRA funding (i.e., quarterly) to all federal research funding (HR 2146, http://thomas.loc.gov/cgi-bin/bdquery/z?d112:h.r.2146🙂.

  5. Spiny Norman said

    Collins interviewed about NCATS on Bloomberg: http://www.washingtonpost.com/business/collins-says-nihs-budget-is-in-a-terrible-squeeze/2011/06/27/AGkbtynH_video.html

    • writedit said

      Yes, I saw this. His blithe remarks about safety testing were a bit worrisome, also his confidence that creating NCATS will lead to a re-engineering of the process by which therapeutics are discovered and evaluated. I think the bean counters in industry would have figured out if there were some way within FDA regulations to streamline the process. Instead, big pharm seems to be shifting away from internal R&D toward acquiring or licensing products from smaller drug companies (often launched from academic discoveries). The NYT has little piece on the emphasis on acquisitions and licensing deals as a means for launching new drugs: http://prescriptions.blogs.nytimes.com/2011/06/27/acquisitions-not-research-fuels-new-drugs/ Industry is no doubt excited about the concept of NCATS (i.e., taxpayers) taking over their expensive R&D responsibilities.

      • guess said

        IMHO, Collins’s “blithe remarks” don’t necessarily mean/prove “his confidence” that creating NCATS -in the way being proposed by a very few NIHers and big pharma supporters- will lead to a re-engineering of the process by which therapeutics are discovered and evaluated.

        I think that Collins is, simply, voicing their opinions and desires (very strong voices without a doubt). As he voices the opinions of the majority embedded in his own opinions. He is a listener.

  6. guess said

    Does anyone know if the latest ACD meeting will be posted at NIH website?

  7. […] doubt to counter a less than enthusiastic response from Congress, Francis Collins has published a commentary in Science Translational Medicine addressing specific […]

  8. AH said

    Writedit,

    It called my attention at NCRR website under News and Events that “Barbara Alving to step down as NCRR Director”. There is a mild reference to NIH reorganization and everything belonging to NCRR will continue to be administered by NCRR. This is what I understood.
    Hopefully, and I say it vehemently, Barbara Alving stays at NIH. She is a superb leader.

    Have you heard anything?

    • einstein said

      FROM: Director, NIH

      SUBJECT: Transition in Leadership at the National Center for Research Resources

      I am writing to share information about an NIH transition. Barbara Alving, M.D., Director of the National Center for Research Resources (NCRR), will be leaving the NIH on September 30. I want to thank Barbara for her stalwart service to the National Institutes of Health. Since coming to NIH in 1999 from the Washington Hospital Center, Barbara has served in leadership positions in two NIH institutes. From September 2003 until February 1, 2005, she was the acting director of the National Heart, Lung, and Blood Institute (NHLBI). In March 2005 she became the acting director of NCRR. She was named the Director of NCRR in 2007. During 2002-2006, she also served as the director of the Women’s Health Initiative. She has guided both NHLBI and NCRR through challenging times of transition. We are all grateful for Dr. Alving’s dedication and commitment, and wish her well in her next pursuits.

      I am pleased to announce that Dr. Louise Ramm, who is the Deputy Director and the Director of Extramural Activities for NCRR, has agreed to be Acting Director for NCRR starting October 1. Dr. Ramm received her Ph.D. in microbiology at the University of Virginia in 1974. After post-doctoral training in biochemistry, also at the University of Virginia, she became a faculty member at the Johns Hopkins School of Medicine in the Microbiology Department. She joined the Division of Research Resources, the predecessor organization of NCRR, in 1987 as a Health Scientist Administrator in the Biological Models and Materials Program and subsequently became the Director of the Program. She has served in her current position since 1994. I greatly appreciate her willingness to take on this new role at such a critical time, and I ask for all members of the NIH community to give her their support.

      Francis S. Collins, M.D., Ph.D.

    • writedit said

      I have been waiting to post about the Alving resignation, which is no surprise (it will be a thankless, frustrating mess to manage come Oct 1 no matter what Congress does), until I could find out more about whether NCRR or NCATS would be in the CR for FY12. We might not know until Sept whether the CR budget authority, which will be based on a prior FY, includes Collins’ shiny new Center or not. If NCATS does replace NCRR in the CR, then the NCRR programs that have been being shuffled around all summer will sit down in whatever IC chair they are at when the music stops and be administered by whatever personnel are assigned in the IC or OD office that serves as the new programmatic home.

  9. whimple said

    I want to thank Barbara for her stalwart service to the National Institutes of Health.

    Yeah, good job on all that stalwartiness. At a minimum Collins isn’t sad she’s leaving, but this reads more like a successful force-out to me.

  10. […] the legislative branch has been publicly enthusiastic about Collins’ proposed changes, which remain in limbo under a cloud of voiced concerns. Stay tuned. Advertisement GA_googleAddAttr("AdOpt", "1"); […]

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