Medical Writing, Editing & Grantsmanship

Nature seeks comments on a proposed effort to hold co-authors accountable for a manuscript’s scientific integrity. Specifically:

We suggest that journals should require that every manuscript has at least one author per collaborating research group who will go on record in a way that collectively vouches for the paper’s standards. Each would sign a statement with reference to Nature’s publication policies as follows:

“I have ensured that every author in my research group has seen and approved this manuscript. The data that are presented in the figures and tables were reviewed in raw form, the analysis and statistics applied are appropriate and the figures are accurate representations of the data. Any manipulations of images conform to Nature’s guidelines. All journal policies on materials and data sharing, ethical treatment of research subjects, conflicts of interest, biosecurity etc. have been adhered to. I have confidence that all of the conclusions presented are based on accurate extrapolations from the data collected for this study and that my colleagues listed as co-authors have contributed and deserve the designation ‘author’.”

Perhaps such discussion of author accountability will come up in some of the RCR training programs recently funded by the National Postdoctoral Association Bring RCR Home project.

Talk about the perfect embodiment of the CTSA concept …

The Washington Regional Institute for Clinical and Translational Science (WRICTS) comprises 7 DC-area hospitals and universities: Children’s Hospital, Georgetown University, George Washington University, Howard University, MedStar Health and MedStar Research Institute, the Veterans Administration Hospital, and the University of Maryland, College Park.

Très bien. And how cool that this amazing regional consortium was announced on the day the CTSA U54 applications were originally due … I’m guessing their application is so polished you need shades to read it.

Looks like the PRISM pit bull lost out … UPDATE … or maybe not, despite the good news below. And further discussion on open access in general can be found in The Scientist.

The US Senate approved the FY2008 Labor, HHS, and Education Appropriations Bill (S.1710), including a provision that directs the NIH to strengthen its Public Access Policy by requiring rather than requesting participation by researchers. The bill will now be reconciled with the House Appropriations Bill, which contains a similar provision.

The current voluntary NIH Public Access Policy, begun in 2005, has a low level of participation (deposit rate of less than 5% by individual investigators). Under a mandatory policy, NIH-funded researchers will be required to deposit copies of eligible manuscripts into NLM PubMed Central. Articles will be made publicly available no later than 12 months after publication in a peer-reviewed journal (NIH expects that only in limited cases will authors deem it necessary to select the longest delay period).

Last week’s issue of Circulation includes a report that further fuels my tirade against the tobacco industry as a funder of “scientific” research. Tong & Glanz describe “how the tobacco industry initiated and funded scientific work to counter epidemiological and biological conclusions that secondhand smoke causes cardiovascular disease. The industry pursued this work initially to fight smoke-free regulations; later, the work also was done to promote allegedly “reduced-harm” products.”

The scientific consensus is that frequent exposure to secondhand smoke increases the risk of cardiovascular disease by 30%. The industry has gone so far as to attribute the effects on blood and vascular function to “an unproven epinephrine-related stress response from odor” … not the toxic smoke itself. After detailing the subtle and not so subtle shortcomings of tobacco-funded study designs, Tong & Glanz conclude that “industry interest in preserving corporate viability has affected the design and interpretation of their cardiovascular studies”.

Specifically, they caution: “The question of whether cardiovascular disease effects, not just carcinogens, can be eliminated with the large number of chemicals in tobacco smoke must be on the forefront in the ongoing “reduced-harm” product debate, a debate that will intensify if the federal Food and Drug Association is granted authority to regulate tobacco products. The industry’s past and recent cardiovascular scientific activities indicate the need for great caution in current debates about future tobacco industry regulation and development of “reduced-harm” tobacco products.”

In commenting on this report, a spokesperson for Philip Morris USA stressed that the company continues to research ways to reduce the health risks from smoking, creating a $350 million center for research and technology in Richmond, Va. Oh joy.

A friend asked me this weekend to look over & take my axe to a bloated manuscript destined for a high-impact journal. Oof. The manuscript arrived about 40% over the word limit and covering data from two experimentally distinct but thematically linked projects (well, they brought in a third project, which I quickly amputated). Exceedingly interesting theories & data, so I can understand the enthusiasm and desire for a unifying theory manuscript. However, there are those pesky word count boundaries.

Some brief all-purpose advice (some already shared here) comes to mind as I slog through this. Please …. Keep the introduction concise and laser-focused. Don’t restate data from figures & tables in the text (highlight most significant findings, sure), and don’t interpret or comment on data in the results. And take a scapel to interesting data that are not immediately & directly applicable to the discussion in which you intend to engage the reader. Discussions are meant for discussing the significance of results & their place in the current state of the science, not introducing new concepts or plugging other work in your lab (relevant lit citations okay, paragraphs rehashing methods & results not okay). Consider what is most important to convey to your peers and do so in a straightforward, modest manner.

The proposed DoD Science & Technology FY08 budget of $10.8 billion is 2.2% of the total DoD budget, a decline of $311 million (whereas total DoD budget grew by $42 billion in FY08). This is about a third of the NIH budget, but it’s spent on significantly fewer initiatives (I like the 3rd category - perhaps the vomit flashlight?):

Foundational Sciences - $300-500M
Active & Conventional Armor Technology - $50M
Defeat of Speed of Light Weapons Systems - $50-100M
Adaptive, Interactive, Full Immersion Training of the Soldier/Marine - $50-100M
Metamaterials - $30-50M
Information Warfare - $100-200M
Information Assurance - $100-200M
Networking Technology - $40-70M
Organization, Fusion, & Mining Large Data Sets for Enhanced Decision Making - $40-60M
Energy - $50-100M
Manufacturing Science Technology - $50-70M
Software Development Technology - $40-70M
Combatting Weapons of Mass Destruction - $50-100M
Neuro-ergonomics - $30-50M
Advanced Medical Research - $100-150M
Autonomous Operations of Networks of Unmanned Vehicles in Complex Environments - $100M
Disparate Sensors, Communications, & Spectrum Management - $500M
Biometric-Based Tactical Threat Identification Demonstration - $190M
Monitoring the Marine Environment for Marine Mammals During Active Sonar Operations - $150M
Specialty Materials for Airships - $30M

Given the crowd who probably reads this blog, I’ll add that the Advanced Medical Research initiative includes such topics as … tissue regeneration, traumatic brain injury, post-traumatic stress disorder … [okay, all these make sense] … and …

“Off-head neurophysiologically-based brain activity sensing” [I get the gist - but there must be a better title] and
“Universal Antigens” [hmmm]

And yes, I realize these don’t add up to $10.8B. These are the major priorities - there will be others, and demonstration projects as well. UPDATE: Science is reporting a request to increase the S&T budget by 11% (1.2B) for FY09, though the likelihood of such an increase is slim. Additional resources would go primarily toward “foundational sciences, covering areas such as biosensors, photonic crystals, and the computing sciences.”

Those overachievers at NIAID already have their FY07 data out, including a perky suggestion that young investigators would do well to apply for K (career development) funding due to the (relatively) high success rates. For all K mechanisms, the rate is 22%, with a highly variable range of 6% for K99s (post doc) to 17% for K24s (mid career) to 50% for K25s (mentored quantitative).

My immediate thought was - whoa - what about the unfunded Ks in the 150s and even the 140s these days?

Key qualifier for the success rate calculation: “Applications that have one or more amendments in the same fiscal year are only counted once” [in the denominator ... total number funded in the numerator].

Update: And the winners have been announced (I have links to each site’s description here):

Albert Einstein College of Medicine of Yeshiva University (New York City)
Boston University (Boston)
Harvard University (Cambridge, Mass.)
Indiana University School of Medicine (Indianapolis)
Northwestern University (Chicago and Evanston, Ill.)
The Ohio State University (Columbus, Ohio)
The Scripps Research Institute (La Jolla, Calif.)
Stanford University (Palo Alto, Calif.)
Tufts University (Boston)
The University of Alabama at Birmingham (Birmingham, Ala.)
University of Colorado Denver (Aurora, Colo.)
The University of North Carolina at Chapel Hill (Chapel Hill, N.C.)
The University of Texas Health Science Center at San Antonio (San Antonio)
The University of Utah (Salt Lake City)

And I only missed Scripps, but they have a lot of collaborating sites (including, oddly, CHOP - Children’s Hospital of Philadelphia …)

Update: The roster for the CTSA SEP meeting on Feb 19-20 has been posted. The roster for the panel meeting on Feb 12-13 is available as well. Lots of anxious institutions out there, I know.

Not as complex as March Madness brackets, but I’ve been thinking about the remaining Clinical & Translational Science Award (CTSA) sites. If they stick with the 12 sites per cycle trend, that leaves just 3 submission dates, including the one in a few weeks (or 4 submission cycles if they drop back to the original intent to make 8 awards per RFA).

Keeping in mind the current Consortium sites (& their partners), we still have NCRR K12 sites that haven’t received CTSA U54s as yet. I suspect NCRR would like to get these off the books already (they make a big deal about subsuming existing award programs), and all these K12ers will almost certainly be submitting new or amended full CTSA applications. Plus, they all also have K30 and M01 awards (the K12, K30, & M01 programs are integral components of CTSA site infrastructure - hence their relevance). This would be Einstein/Yeshiva, Northwestern, UCLA, UMd, UMinn, and UNC (also a Roadmap interdisciplinary ctr) … the only the latter 3 have official Roadmap K12s, but the others are NCRR-funded clinical research scholar programs.

{UMinn in particular is no doubt counting on an award this coming round given the fact that, based on their comprehensive & highly entertaining presentation at the AAMC GRAND meeting, they were probably expecting to pop champagne corks a few weeks ago.}

We still have 45 institutions that received P20 awards to plan for a full CTSA application. Among these, UMd and UNC are listed above, which leaves 43 sites making big plans this fall, many of whom better go with the buddy system rather than apply alone if they want to be assured Consortium membership.

Among the P20 sites, several also have both a K30 and an M01 award: Georgetown (excellent chance of success), Harvard, Medical College of Wisconsin, NYU, SUNY Stony Brook, U Alabama, U Cinncinnati, U Colorado, U Florida (also a Roadmap interdisciplinary ctr), U South Florida, and U Tennessee. So 17 likely sites with multiple awards available to be subsumed.

How about just a K30 and M01? More strong candidates: Baylor (also a Roadmap interdisciplinary ctr), Boston University, Indiana U, Penn State, Tufts University, UCSD (also has Roadmap T32), UT San Antonio, U Utah (LDS Hospital is part of the Roadmap Clinical Research Network), and U Vermont. Now we’re up to 26 sites with good odds … perhaps depending in part on whether they skipped versus applied for but did not receive a CTSA P20.

Let’s see … among the other CTSA planning grant awardees, U Illinois-Chicago has a K30; MUSC has a Roadmap T32 & M01; Stanford has a Roadmap T90 & M01 (& a Roadmap U01); U Missouri has a Roadmap T90 & M01; and UNM has an M01 & Roadmap Clinical Research Network site.

That’s 31 sites with a reasonable amount going for them on paper … which eats up most of the 36 spots left at the table. Of course, not all of these sites are necessarily applying - or applying on their own. And one could argue that if the NIH wants to encourage more/new institutions to provide these comprehensive clinical research-training programs that sites other than current awardees in these areas be considered for CTSAship … but I suspect NCRR can’t afford to go that route.

So what about the institutions not yet cited that received CTSA P20s (n=32)? Most if not all of these have M01s so are on relatively equal footing in that regard. The need for geographic diversity (i.e., the need to spread the wealth to more Congressional districts) should bring sites like Dartmouth, LSU, U Arkansas, U Hawaii, U Kansas, U Kentucky or Louisville, U ND, U Oklahoma, and/or UVa into the mix. Some could even displace strong candidates listed above that are located in CTSA-laden areas (i.e., Pa, NYC, upper midwest, Texas, Calif).

My money is on institutions with established & well organized biorepositories linked with EMR (electronic medical record) and supported by solid bioinformatics … those with robust & comprehensive biostatistics capabilities (need a big stable of seasoned biostatisticians to manage the increased work load) … some more pediatric powerhouses … sites that feature genuine leadership roles outside the School of Medicine … some really creative public-private partnerships … those with excellent training track records (& the ability to attract outstanding trainees, especially minorities) … plus those institutions willing & able to put up more than a dollar-for-dollar match (it’s NPR station pledge time after all) - and real dollars, not existing space etc.

Still to come: what CTSAs can do for investigators at their institutions and beyond … and for public health in general.

An article by Campbell et al. in tomorrow’s issue of JAMA presents data from a national survey of department chairs about the nature, extent, and consequences of institutional–academic industry relationships for medical schools and teaching hospitals. Among the 459 department chairs who responded, 60% had a personal relationship with industry, and 67% of their departments did. Of note is the finding that “72% viewed a chair’s engaging in more than 1 industry-related activity (substantial role in a start-up company, consulting, or serving on a company’s board) as having a negative impact on a department’s ability to conduct independent unbiased research.”

Yes, the Department of Energy prides itself in “Advancing the Energy, Economic, & National Security of the US.” Four years into its 20-year plan, Facilities for the Future of Science: A Twenty-Year Outlook, the DOE has released an interim report.

You may recall that the DOE was the originator of and longtime partner in the Human Genome Project. They’ve since transitioned to a Genomics:GTL (genomics to life) program and support for Bioenergy Research Centers.