Medical Writing, Editing & Grantsmanship

Update: Contrast Meredith Wadman’s portrayal of the recent SMRB teleconference in Nature with the summary posted on the NIH Feedback site.

Or not.

According to the agenda posted for the SMRB meeting tomorrow (800-779-1545, pass code “NIH), we’ll get a 15-min update on what’s happening with NCRR, a 15-min update on what’s happening with NCATS, a 15-min discussion among SMRB members, and 20 min of public comment. Just that quickly, we will learn the results of the “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”.

A hint of what this transparent process has wrought can be found on the NCATS feedback page, where Larry Tabak has posted an NCRR Task Force recommendations (aka updated straw model) for where NCRR programs will be redistributed. Perhaps most important is the name change from “Interim Infrastructure Unit” to “Infrastructure Entity”, which I am sure will reassure many concerned constituencies.

Former SMRB member and not-yet-former NIGMS Director Jeremy Berg has submitted a public comment urging his former fellow Board members to:

recommend to the NIH Director, to the Secretary of Health and Human Services, and to Congress that NCRR not be abolished at this time, pending an appropriately transparent process, following the principles outlined in the SMRB report, Deliberating Organizational Change and Effectiveness.

Bold typeface is used in the submitted comment. He goes on to explain and cross reference his case for this recommendation and includes an e-mail he sent in advance of the December 7th SMRB meeting raising critical questions about what might happen to NCRR and the need to consider these issues before voting on any proposal to create a new center for translational science and therapeutics.

One wonders if the 15-min presentations to be made this teleconference will address the many questions raised by House staffer John Bartrum. Well, at least it won’t take long to find out.

News updates in Science and Nature highlight the pushback the NIH is getting for its hasty plans to abolish NCRR.

Update: The teleconference was very short on detail (no detailed analysis certainly), and the comments reflected concerns from specific NCRR constituencies for their programs (everyone wants to be put in the OD rather than an IC) as well as patient/disease advocacy groups telling the NIH to hurry up and deliver cures. SMRB member Tom Kelly (Sloan-Kettering) asked why the rest of NCRR wasn’t just left intact after taking out the CTSA program (which only began in 2006, whereas NCRR has been around since 1962). Larry Tabak talked about being left with an IC that looked like a coat of many colors and perhaps the time was right to consider whether better places – better adjacencies – could be found for all these programs.

Of course, the SMRB has been considering the merger of NIAAA and NIDA since its inception in 2009, and in September 2010 recommended the creation of a single new IC devoted to substance use, abuse and addiction. However, after nearly two years of deliberation, Collins has indicated the need for more thoughtful analysis and has not (apparently) transmitted this request to Sebelius, whereas, in the absence of even a cursory impact study, he transmitted the request to both create a new Center (as recommended by the SMRB) and to abolish NCRR (which was not recommended by the SMRB) less than two weeks after the December 7th meeting.

What’s next? Jocelyn Kaiser’s recap in Science suggests it’s all over but the shoutin’.

Hopefully members of the House and Senate will do a little shoutin’ of their own if there is any hope for this precedent-setting reorganization of the NIH to follow a reasonable, deliberative, transparent process.

Obama released his FY12 budget blueprint today, with NIH coverage in the HHS section starting on page 16 (of PDF … p 452 of document). Total budgetary authority requested for FY12 is $31.994 B, for a gain of $740M over FY10. The submitted budget request includes:

NATIONAL CENTER FOR RESEARCH RESOURCES
For carrying out section 301 and title IV of the Public Health Service Act with respect to research resources and general research support grants, $1,297,900,000.

and no mention of specific funding for NCATS in the budget tables (no doubt too late) or the Cures Acceleration Network (which was authorized by the Patient Protection and Affordable Care Act, CAN starts on p 978 of PDF), but Obama does acknowledge the new Center in his budget overview for HHS:

Invests in Science for a Healthy Economy
Supports Biomedical Research at the National Institutes of Health (NIH). Biomedical research is essential to the health of the American people and the health of our economy. Innovation in this field creates and sustains companies, products, and jobs. The Budget includes $32 billion for basic and applied biomedical research supported by NIH both on-campus and at academic and independent research institutions across the country. Through implementation of the National Center for Advancing Translational Sciences and the Cures Acceleration Network, NIH will increase its focus on bridging the translational divide between basic science and therapeutic applications. By fostering novel collaborations among government, academia, and industry, NIH will accelerate the development of treatments for diseases and disorders that affect millions of Americans. NIH will continue to pursue the leading edge of discovery in basic cancer science, development of new cancer treatments, and prevention and early detection of cancer, focusing on recent discoveries regarding cancer genomes. For Alzheimer’s disease, NIH is partnering with the private sector to find new methods for early diagnosis and to support early drug discovery and preclinical drug development. Ongoing research into environmental factors, early detection, and novel treatments will transform our understanding and care for those with autism spectrum disorders.

So, we’ll see how this all shakes out, particularly with the rest of the FY11 budget (well, CR) debate ahead of us still.

Nature has a nice summary of where the NIH currently stands on the Republican cutting block (a cut of $1.629 B from vs Obama’s increase of $740 M over FY10 levels), as does Science, and I’ll post their reviews of the Obama budget blueprint as the dust settles.

Every member of Congress will be getting an earful about just about every proposed cut, but that doesn’t mean you shouldn’t contact your Congress person and Senators to voice your concerns about protecting biomedical and other scientific research in the US.

Update: Science has both a letter from 14 Senators dated Feb 14 questioning the NIH’s plans to abolish NCRR as well as Collins’ response, dated Feb 16. It seems, looking at the Science piece, that Collins decided to move the IDeA program from NCRR to NIGMS without a clear go-ahead from NIGMS director Jeremy Berg … and certainly with no deliberate, transparent process of assessing the implications of such a move.

Pursuant to P.L. 109-482, the NIH Reform Act, Congress has 180 days to act on Kathleen Sebelius’ request to abolish the NCRR. It only took Senators Inouye (Hawaii) and Begich (Alaska) 18 days to voice their firm opposition to “the changes currently under deliberation” via a letter to Sebelius and Collins.

Ouch.

As Nature, which released the Senators’ letter notes, Inouye chairs the Senate Appropriations Committee.

Having worked with the exceptional staff at NCRR, I completely concur with the Senators regarding their concern that “disruption of the placement and expertise at NCRR will only serve to dismantle the laudable work that has been accomplished.” NCRR folks will not be rushing to help Collins with his “Interim Infrastructure Unit“, which means these very special and complex (and currently well-managed) programs will at best stall until a more permanent home is found again, whether at an IC or in the OD or in … hmmm … perhaps a new (novel!) freestanding center to again manage such infrastructure programs in the extramural research community.

Of course, in her letters to Congress, Sebelius was acting on “information provided to me by the NIH Director” … which clearly included absolutely no detailed (or even cursory) assessment of the impact of either the abolition of NCRR or the establishment of NCATS on the rest of the NIH (or the extramural research community). Perhaps, given a bit more information after the February 23 SMRB meeting, she will realize that her determinations were premature and that more careful examination of the repercussions of both actions is needed prior to their recommendation to Congress and implementation at the NIH.

Perhaps. One can hope. And one can submit comments on the Feedback page and in advance of the SMRB meeting.

I thought this might show up on the SMRB Website by now, but as announced in the Federal Register, the next meeting of the SMRB, which is open to the public, will be held Wednesday, February 23rd, from 11:30 a.m. to 1:30 p.m. The toll-free number to participate in the teleconference is 1-800-779-1545 (pass code is “NIH”). You can also submit written comments by Feb 22nd. An agenda will be posted on the SMRB Website, but the Federal Register announcement notes that:

Agenda: Presentation and discussion will focus on NIH activities related to the Board’s recommendations to create a new center for advancing translational medicine and therapeutics development. As requested by the Board in its Report on Translational Medicine and Therapeutics, NIH will provide an update on the proposed creation of a new center and its evaluation of the impact of such a center on other relevant extant programs at NIH, including the National Centerfor Research Resources. The Board will also discuss next steps regarding future SMRB activities. Time will be allotted on the agenda for public comment. To sign up for public comment, please submit your name and affiliation to the contact person listed below by February 22, 2011. Sign up will be restricted to one sign up per e-mail. In the event that time does not allow for all those interested to present oral comments, anyone may file written comments using the contact person address below.

Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

Contact Person: Lyric Jorgenson, Office of Science Policy, Office of the Director, NIH, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, smrb@mail.nih.gov, (301) 496-6837.

Should be a fun 2 hours filled with a lot of fast talking, unless they do not anticipate any impact on the rest of the NIH that will merit discussion or many public comments. Lunchtime no less. No talking with your mouths full.

In the meantime, you can also continue to leave comments at the NCATS feedback page, including your thoughts on the NCRR redistribution straw model and about NCATS itself. I’m not sure why this page does not include the notices sent to Congress about the proposed formation of NCATS and abolition of NCRR or the list of questions from staffer John Bartrum, but you can find all of these items here.

The Rock posted nonexclamatorily today about the the future of the biomedical workforce, including data on funding trends to various classes of institutions. (most awardee types hold steady over the 25 y of data … noticeable though small increases in Research Institutes and For-Profits … it seems Virginia Tech was right on the money in realizing they needed to launch a med school to get a bigger share of the NIH pie)

Anyhoo, Collins has charged an ACD subcommittee to develop a workforce model to “help inform NIH in implementing policies to facilitate a vibrant and diverse future biomedical research workforce.” I didn’t realize such a thing could be facilitated, but there you go.

Fortunately, our man Jeremy Berg is all over this one. Last year at this time, he sought input on the planning process for their strategic plan for training and career development … and you all indeed did put out. He now seeks input – by February 15th – on the draft of the NIGMS Strategic Plan for Biomedical and Behavioral Research Training. Perhaps his draft report (which is truly a pleasant read) and your comments could help inform facilitation on a larger scale. Jeremy presents you with a usable document. Clear action bullets. Nice quotes and sidebars. For example,

We all know that being a professional scientist is more than simply doing experiments.”

I’m sure he can’t wait to hear from you about it. I’m sure you can’t wait to read and comment on it. Just do it! Hey, we’re all WTF – together!