US biomedical scientists should support bold plans to transform the process of drug development. Now is not the time for disunity.
At an open meeting at the US National Institutes of Health (NIH) next Monday, agency director Francis Collins will outline his timely vision for a new centre dedicated to translational medicine and therapeutics. Collins sees the new National Center for Advancing Translational Sciences (NCATS) as an incubator for potentially promising nascent therapeutics, to help them through the drug-development pipeline to the point where a risk-averse industry will license them and bring them to the clinic. He wants it to recharge a dwindling cadre of experts in clinical pharmacology. And he sees it as a way of reinventing the woefully inefficient drug-development process itself. But not everyone at Monday's meeting will share Collins's enthusiasm for the project. Establishing the centre will entail breaking up the NIH's National Center for Research Resources (NCRR). More than 1,200 comments, mainly from NCRR constituents fearful for the future of their programmes, have poured into an NIH feedback website.
Collins is right to seek to accomplish quickly what otherwise threatens to become a drawn-out period of necessary change.
The process to set up the centre, with an initial budget of more than US$600 million, has certainly been hasty, and has by its nature alienated a significant element of the NIH-funded community. But Collins is right to seek to accomplish quickly what otherwise threatens to become a drawn-out and even more disruptive period of necessary change. Band-Aids are best torn off quickly.
Dissent has largely focused on how Collins plans to make that change. The largest piece of the proposed new centre, the $490-million Clinical and Translational Science Awards, will be transferred from the $1.3-billion NCRR. In what can only be termed an executive decision, taken quickly in December and presented to the NIH community effectively as a fait accompli, Collins wants to dismantle the remaining 60% of the NCRR and move its programmes elsewhere — for example, to the National Institute of General Medical Sciences, the National Institute of Biomedical Imaging and Bioengineering, and to his own office. There, an 'infrastructure entity' will, among other things, administer primate and non-primate disease-model research resources, grants for shared and high-end instrumentation, and training and career development for animal medicine. There have been many calls for a slower, more considered and analytical process to decide the future of the NCRR, including a letter from 16 senators concerned for a $229-million NCRR programme that supports biomedical infrastructure in mainly rural states that have historically received relatively little NIH money.
It is certainly risky to dismember a $1.3-billion centre and scatter its programmes without the months of analysis that, for instance, went into the decision to create a new addictions institute at the NIH in 2013. And grant recipients of NCRR-supported programmes have been forced to settle for verbal promises from Collins that the money, staff and commitment will remain unchanged in their new institutional homes. In dire budget times for the agency, such assurances are understandably cold comfort. The new NCATS will also take tremendous institutional investment to make it work, far more than is reducible to dollars and cents. The learning curve for all involved will be steep.
But Collins was hired to lead, and leading he is. What's more, he has reason to hurry. It is entirely possible that he will be out of a job 18 months from now if Republicans capture the White House in next year's presidential election. It's worth noting, too, that the new 'infrastructure entity' in his office will be overseen by James Anderson, a thoughtful manager with a reputation for being smart, effective and organized — and with a keen eye for checking that programmes are well run. The NIH should certainly make sure in two or three years that, whoever is in charge, Collins's promise to protect NCRR programmes has been kept — provided they are performing.
But the arguments about the NCRR's dissolution must stop here. They risk becoming a distraction and, what's worse, a political liability on Capitol Hill, where lawmakers with their knives out for expendable programmes may find disunity an invitation. The real driver of the angst about the future of NCRR programmes is the precarious position of NIH funding in 2011 and beyond. All those involved should turn their energies to doing everything possible to secure its budget in these extraordinarily difficult times.
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Embrace change. Nature 471, 135 (2011). https://doi.org/10.1038/471135a