Medical Writing, Editing & Grantsmanship

The NIH is seeking comments on its new National Center for Advancing Translational Sciences. Of course, some of the accompanying FAQs are a bit leading (e.g., Why is now the time to establish such a Center?).

The Center, recommended by the SMRB within a month of the Nov 10th TMAT Working Group presentation on how to advance translational research and therapeutics development, is projected to be online by October 1, 2011 with a budget (based on an initial estimate of $650M) exceeding that of NIAMS, NHGRI, NIAAA, NIDCD, NIDCR, NLM, NIBIB, NCMHD, NINR, NCCAM, and FIC.

The solicitation of comments suggests input is being sought on both the Center and the future of NCRR, though with regard to the latter, Collins has showed his cards in an interview with Nature:

What happens to the rest of the NCRR’s programmes?

Again, the strong assurance is that these programmes are valued, that they will be supported, that the people involved in them are doing great work. There is no intention here to dismantle them. But if there are opportunities to reorganize and reassign these programmes in ways that make them more interactive with what we are trying to do in this new centre, well, that seems like a good thing to consider.

Hopefully the NIH will take more than a month to consider this course of action.

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.

Update: It’s official … see my comment below for details on the SMRB’s recommendation that Collins establish a new Center at the NIH dedicated to translational medicine and therapeutics.

First, another Continuing Resolution continues FY10 funding levels until Dec 18th. According to the AAMC, seems most likely these CRs will be the high-point of FY11:

During debate on the measure, Rep. Jerry Lewis (Calif.), the ranking Republican on the House Appropriations Committee, again expressed opposition to “any potential omnibus spending bill the Democratic leadership may be planning to bring to the House floor before the end of the year.” He also opposed extending the CR for the balance of FY 2011 at current level, which he described as “frankly, too darn high.”

Second, see the opening line of the post below. On Dec 7, the Scientific Management Review Board, which has issued a report recommending the merger of NIAAA and NIDA (under consideration by Collins, with a decision likely by summer 2011), will discuss the possible creation of a new center on translational medicine and therapeutics.

In November, Arthur Rubinstein, in a presentation on workings of the Translational Medicine and Therapeutics (TMAT) Working Group, proposed that:

a new TMAT program be established at NIH in the form of 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
• Serve as a catalyst, resource, and convener for collaborative interactions, capitalizing on the relative strengths of the extra-and intramural communities, private sector, government, and academia, to promote quick-win, fast-fail paradigms and further develop the pre-competitive space.

Let’s see … “process engineering of the therapeutics development pipeline” … “quick-win, fast-fail paradigms” … “pre-competitive space.”

What happened to the mission “to seek fundamental knowledge about the nature and behavior of living systems”?

Why not just say, we need a place (other than NCRR apparently) to house CAN (Cures Acceleration Network), the CTSAs, NIH-FDA projects (regulatory science), perhaps comparative effectiveness research, and some other big Roadmap initiatives in partnership with the NIH Clinical Center (to enhance its own use & sustainability)? Of course, the next question is what happens to funding levels at the 25 ICs that currently support translational research and therapeutics development (see first news bulletin above).

Okay … what are they smoking in DC?

An NAS Research Universities “blue-ribbon committee” has been asked to write a report on “the top ten actions that Congress, the federal government, state governments, research universities, and others could take to assure the ability of the American research university to maintain … excellence in research and doctoral education…” The commmittee met in late November to address concerns about shrinking federal investment in academic research. As Science reports,

At the top of the list, university leaders want changes in the formula used to reimburse universities for the ancillary costs of conducting federally funded research on campus.

You might think, wow, they finallly recognize that they need to stop floating their research enterprises on soft money and instead ask “universities to use existing resources in the most efficient manner,” as Science reported when the committee was first announced. Maybe a consistent but modest level of F&A reimbursement for all institutions, not individually negotiated rates.

Um, not quite.

The negotiated reimbursement rate is too low … What if, he [James Duderstadt, UMich] said, the community abandoned its perennial request for more … and accepted flat funding in return for the government allowing universities to be reimbursed fully for what they consider the true cost of hosting federally funded research?

“Hosting federally funded research”? Sounds like a damn Tupperware party.

But in other words, universities want all the $ they consider necessary for building new buildings, running their research administration machine, and keeping the lights on, even if it means less money for actual research and training. And they seem to think their faculty will be pleased as punch about all this:

At the same time, Duderstadt acknowledged that increasing reimbursement for overhead costs, in a flat budget, would leave agencies with less money for research grants. That would increase competition among faculty members already bemoaning low success rates on their applications. “Would your faculty support that approach?” wondered panelist Walter Massey, president of Morehouse College in Atlanta and a former director of the National Science Foundation. “They want a grant with lower, not higher, indirect costs. Could you bring them around?”

Several university administrators thought they could, provided the changes were explained properly. “The challenge is to be consistent and understandable,” said Kim Wilcox, provost and vice president for academic affairs at Michigan State University in East Lansing. “If we can do that, then it’s up to us to explain it to the faculty.”

Like I said, what are they smoking?