A Problem with the NIH Roadmap and Cross-Institution Research

Last week, I attended a talk by Alan Krensky, who is the Director of the NIH Office of Portfolio Analysis and Strategic Initiatives (OPASI).

First, OPASI is a superb acronym (Krensky has OPASI--it works better if you actually say it). One of OPASI's tasks is to oversee the NIH Roadmap and other cross-institute initiatives (more about that in a bit). The other priority is to assess how effective various programs are and to use this information to determine what future priorities should be. That sounds dry, but re-read that sentence: when Krensky speaks, you should listen.

Much of his talk dealt with OPASI, but there were some other interesting points he made. One concern he raised was the "overexpansion of medical centers." While someone in his position will rarely make a very blunt public utterance, it was very clear that there is a strong belief that the increase of funds that went to medical centers was spent far too much on increasing faculty positions, and not nearly enough on translational research (i.e., research that results in medical progress). Given the recent recommendations that grants spend less on 'soft money' salary support for researchers, it's pretty clear that NIH is not happy with a lot of the medical centers--I would expect lots of soft money cuts.

The second thing is that NIH is very aware that they need to standardize their clinical research networks. Translated into English, what this means is that various large scale trials, sample collection networks, and data information centers need to start communicating with each other and standardizing, well, everything (when possible). This would have powerful ramifications for drug development and safety. NIH would be able to conduct more Phase IV trials (even 'accidentally') to assure drug safety. Phase IV trials are the post-release assessments of drug efficacy and safety, and, currently, most of these trials are conducted by drug companies themselves. Needless to say, the current system has some conflict-of-interest problems....

Finally, it was very useful to hear Krensky talk about the NIH Roadmap Initiative. The Roadmap accounts for five percent of the NIH budget, and is designed to sponsor cutting-edge science that often crosses boundaries between the various NIH institutes. For example, the Human Microbiome Project, which examines how the microorganisms that live on and in us affect and influence our health, deals with everything from obesity, to Crohn's disease, lung and skin disease, infectious disease, and autoimmune disease. No one NIH institute could possibly 'own' this, or have the budget to do without massively cutting its other core activities (an aside: This isn't bureaucratic infighting: the Cancer Institute isn't going to fund research in eye disease or vice versa).

The funding for the Roadmap, because it doesn't have a permanent home and is supposed to stimulate new lines of research, only lasts for five years (in some cases, ten years), at which point, the various institutes are supposed to incorporate the relevant components into their agendas. One wonders how, in an era of flat or shrinking budgets, this is supposed to happen. Thank goodness the Mad Biologist is around when you need him.

During the Q&A, I asked Krensky about the long-term funding of Roadmap-initiated science. I wanted to know how NIH and OPASI will determine whether a Roadmap initiative has been successful and what pressure can and will be brought to bear on the various institutes to support sucessful Roadmap science. Also, I asked what happens if the institutes don't want to 'own' a particular Roadmap initiative.

Krensky began his response with, "That's a good question." Having used that exact phrase myself, I knew that NIH doesn't have an answer. And NIH doesn't so far. Krensky said that there is concern over what they call "the off-ramp." Of course, the office involved in assessing NIH programs could play hardball if it wanted to...

Granted, not all Roadmap initiatives will succeed. But other successful programs will involve so many players, that no one will want to step forward and allocate funds to it (I think the Molecular Libraries Screening Center Network (MLSCN) initiative is in real danger of this occurring).

Oh well, I could be at a medical center....