Open Mike

Helping connect you with the NIH perspective, and helping connect us with yours

Welcome to the Open Mike Blog at the NIH

Peter H. Schuck, the former deputy dean of the Yale Law School, recently published the book, Why Government Fails So Often: and How It Can Do Better,1 a rather depressing explanation of how public regard for government has steadily declined since the 60s and 70s.

After 10 chapters that detail why the US Federal Government fails and fails again, along comes Chapter 11. No, not a chapter on bankruptcy, but on “Policy Successes.” And one of the several policy successes he mentions include an agency that you and I are well familiar with … the National Institutes of Health. The author notes, “Even small-government advocates generally concede an important role to the Federal Government [in] basic research – the creation of knowledge – in areas where private actors lack incentives to invest.” NIH-funded research has yielded important discoveries that have led to new treatments; has enabled excellent institutions of learning to flourish; has created cutting-edge job opportunities; and has forged strong collaborations with the private sector.

Yet, not all is well with the NIH extramural science enterprise. The growth of the NIH budget has stalled over the past decade2 and not kept pace with inflation, or our biomedical research purchasing power3. We live in a hypercompetitive environment, with a number of associated problems: a peer review system that must distinguish among many excellent proposals in light of restraints on resources and capacity4, 5, 6; unstable funding; administrative burdens; and trainees and young investigators who fear for their future. A number of recommendations7,8, 9, some of which may have been considered radical even a few years ago, have been put forth – cap salaries, cap support for individual labs, support people as opposed to projects, be more judicious about support for big science projects, support more staff scientists, train young scientists for non-academic careers, and re-align incentives to enable more efficient spending (e.g., on core facilities10,11,12) and to encourage workplaces in which diversity and collaboration are less the exception, more the norm.7, 13

While I was the lead of the NIH cardiovascular program division (within the NIH’s National Heart Lung and Blood Institute), I had the chance to work closely with NIH Director Francis Collins on unique programs and initiatives that explore innovative ways to support research, such as fostering NIH-funded comparative effectiveness research14, on making PCORnet a reality15 and on building the Precision Medicine Initiative.16 I also have had the opportunity to work with colleagues throughout NIH on a number of analyses and publications resulting from data-driven approaches to look at issues facing the research community. And more and more I have been drawn to the national — indeed international — conversation.

It’s a conversation that concerns itself with nothing less than how to save the American biomedical research enterprise. To be successful, NIH must nurture, foster, and develop a learning culture of “results-based accountability.”17 Accountability means deep and sometimes painful conversations about valid metrics, about stories that underlie metrics, about the economics of science, about evidence-based considerations of what kinds of partnerships and strategies are most likely to “turn the curve” – really about applying the scientific method to ourselves at NIH. And it means that we have to be willing to talk, even in public, about our shortcomings and our ignorance. In a strange way, my greatest pleasure about working at NIH is that I can work at an agency that “admits” that its cardiovascular trials don’t publish18; that its program staff may be failing by relying too much on peer review percentile scores for making funding decisions5, 19; that other models (e.g., PCORI) for funding research have something worthwhile to teach us20, and that it may be putting too much money into “big science.”21 But I’m also excited and optimistic about NIH, because its extramural leadership has been so willing to embrace rigorous methodologies to think about its own work – its successes and its failures. And NIH leadership is willing, indeed eager, to seriously consider wholly new ways of doing business.

I look forward to working with you, the extramural community, in my new role as the NIH deputy director for extramural research. I believe that by building upon the outstanding work of Dr. Rockey and her team, and by building upon the data-driven work my colleagues and I have had the fortune to conduct over the past few years, we can take the nation’s biomedical research enterprise to the highest level it’s ever seen.

I am also very much looking forward to carrying on and building upon Dr. Rockey’s tradition of blogging. I plan to use the blog to help connect you with the NIH perspective, and, even more importantly, to help connect us with yours. So … welcome to the Open Mike Blog at the NIH. I look forward to hearing from you.

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12 thoughts on “Welcome to the Open Mike Blog at the NIH

  1. I look forward to reading more about your work, especially if it is written in plain and accessible language, the way results based accountability would suggest.

    • Indeed I can’t understand most of what Dr. Lauer wrote especially the part about result-based accountability. Time for some plain talking. Dr. Lauer, are you saying that NIH-sponsored research programs are not providing sufficient bang for the buck in terms of finding new ways to combat disease? If so how can we do better? De-emphasize peer-review scores in funding decision?

  2. What struck me about your description of the strategies being discussed to deal with current state of things at NIH is that none of the strategies involved garner public support for NIH. My understanding is that $2 billion has been cut out of the NIH budget due to sequestration. Plus there has been inflation.

    The process of getting society to be willing to spend more on public health research will at the same time be a process that visibly enhances human wellbeing. But if you read Atul Gwande’s latest book, you see that a sizable amount of medical care is not well aligned with reasonable operational definitions of human wellbeing.

    I think NIH’s efforts have to be measured against the increase or decrease in the prevalence of people who are healthy, prosocial, and caring toward others. If the last two seem beyond the purview of NIH, I would argue that they are conditions that have a huge impact on public health.

  3. There is also some disquiet about recent “big science” projects that have drained money away from the real jewel of US biomedical research, the investigator initiated hypothesis testing project. The human genome project and the Decade of the Brain over-promised on the benefits for curing disease. The National Children’s Study was a catastrophic waste of money as is the whole alternative medicines area. NIH has been driven by congressional whims and not so much by good science

  4. There is no evidence to support that a cumbersome bureaucracy improves on efficiencies of the market. This money is better spent offering private enterprise tax benefits for research. A recent article in the WSJ articulates this view: “The Myth of Basic Science”.

    If the NIH resources are competent, they would be better utilized “doing” versus “reviewing”. If they are not competent, sitting in judgement of the huge expenditures allocated (capriciously) to the “doers” is the worst possible implementation.

    The chief beneficiaries of these funds are universities. They squander resources on writing research requests that appeal to the bureaucrats. The drive for grants overwhelms practical research considerations.

  5. I like your emphasis on the past success of NIH in building up the biomedical research and education enterprise in the USA through its support of fundamental, basic research, but the following statement of yours troubles me…

    “…my greatest pleasure about working at NIH is that I can work at an agency that “admits”…that its program staff may be failing by relying too much on peer review percentile scores for making funding decisions.”

    Maybe I’m not reading this correctly, but to me this has a very disturbing ring to it! Are you saying that NIH would rather not rely on peer review rankings to make funding decisions?? Does that indicate a preference at NIH to just minimize or effectively eliminate peer review and have program staff instead just decide who and what to fund? This is not good at all!!!

  6. To cut to the chase, the money for NIH funding comes from Congress and much of our research infrastructure is created and maintained by our Universities (indirect costs). Finally, partnerships with venture industry and Pharma partners is another important outlet for additional funding.

    Bottom line: I see the failure to budge the dial on the NIH total funding for a decade as a simple failure of NIH leadership. There is no CEO in any industry that could maintain their position in a similar situation and there is no private entity that would survive such a situation (albeit there are always exceptions to such black and white statements). Change things now.

    NIH funding comes from Congress: The Congress can spend 17 months investigating Benghazi but can’t convene an investigation to determine our Country’s investment in biomedical research and then act on it? Ridiculous. Do it now. Bring the stakeholders to the table first to make a strong recommendation to Congress.

    Institutional roles in biomedical research: The truth is that for some reason we have given a pass to the institutions that are critical partners in the biomedical research endeavor. There is no mention of this in the present discussion so far despite the fact that indirect costs are 50-90% of NIH outlays for each research grant! Why is that? The answer from Congress is that we are always looking to Government for money (i.e. handouts) while we just want to do what we are doing. First, our Institutions happily took their piece of the brief largess of the Obama decision to infuse the NIH with additional funding to build more medical research buildings and hire new faculty or steal existing faculty (at ridiculous costs in some cases) to fill them and then depend on this increased base to apply for more NIH funding that simply strained the system further. That makes no sense in terms of taking responsibility for these new and existing faculty. But pretty research buildings look good for administrators and Deans. And if they have the money to suddenly build and recruit, why not start by investing in their existing faculty? The institutions also sit on huge endowments and make decisions on philanthropy. There is no reason that these advantages cannot be looked as leverage for additional funding and also send a clear message to Congress that we are involved too. We need to bring Institutions to the table and we need to hold them responsible for their roles.

    Venture investment and Pharma: This is too long an issue for this blog but suffice to challenge everyone with a controversial statement: a pure clinical trial (supported by NIH funding at very high costs compared to most basic and translational research R01 grants), if it really has clinical value, should be supported by a partnership with venture investors and Pharma. The point is obviously to raise the pressure on decisions for NIH funding as the only source for selected clinical grants and create novel opportunities to work with venture investors. We need to lose the fantasy that we create these amazing new discoveries (according to us) in our academic studies and then angels appear from the heavens to take our work, enter the long and complicated process of translating it to commercial value and delivering it to patients. Create a fund of $500 million dollars from VC investors and Pharm and give them input on funding any new clinical grant. Again, this discussion raised the issue of whether we are delivering our advances to patients and no one mentions how complicated and challenging and unprepared most academics are to do any such thing. It can and is being done, however. The NIH needs to step up and take advantage of what some academics and their Institutions have done successfully.

  7. I plan to use the blog to help connect you with the NIH perspective, and, even more importantly, to help connect us with yours.

    I do hope you are sincere on this point. Many of us in the extramural community have greatly appreciated the communication of the Rock Talking blog (and Director Berg’s pioneering communicative work at NIGMS when he was Director). Nevertheless there has been a sense (you can see this in the more contentious RT comment threads) that when the community is in disagreement with what NIH has decided to pursue, all of a sudden a deaf ear is turned. I would ask that you strive to show in the future that you have heard and understand the issues being raised in opposition to your plans. Even if your response is to tell us to go take a hike, it is much better received when we can see that our position is actually understood and has been rejected. This is preferable to ignoring the points, pretending to not understand, re-directing the critique to a less opposing one, etc.

  8. There is also some disquiet about recent “big science” projects that have drained money away from the real jewel of US biomedical research, the investigator initiated hypothesis testing project.

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