Medical Writing, Editing & Grantsmanship

Back in May, Richard Shelby’s opening statement to a Senate subcommittee hearing on the NIH FY12 budget hinted that getting Congressional approval for NCATS might not be as easy as Collins had thought … certainly not as easy as fluffing it past the SMRB last December:

The question remains, however, as to whether NCATS is the right approach to solving this issue. Will NCATS be the right mechanism for taking valuable discoveries that the taxpayer has funded and giving it a greater opportunity to make it into the marketplace? As we review this proposal, we need to consider the fact that NIH is not a drug developer or an expert in the therapeutics world.

Indeed, Shelby urged more deliberative consideration of what actions should be taken, akin to the advice given by Jeremy Berg and countless others:

Dr. Collins, I believe that NCATS is a matter we should contemplate, but we must ensure that the steps forward are measured and in the best interest of all stakeholders, especially those who are in need of treatment and care.

All the while, the NIH has been actively moving ahead with the redistribution of NCRR programs and personnel … though sans detail with regard to space, staffing, or budgets.

Then a month later, Sebelius wrote to Tom Harkin with the NIH FY12 budget request ($31.7B), including a line item (several, actually) for NCATS and listings on how the NCRR dollars would be reallocated. These are all based on the President’s requested FY12 budget, which of course will likely bear little resemblence to what is finally appropriated (especially since the House passed an appropriation bill that reduced the President’s request for Labor, HHS, and Education by $41.6B). Sebelius describes the process of establishing NCATS as one in which an NIH taskforce:

carefully identified and evaluated program placements that would improve organizational efficiencies and provide scientific synergies. To aid in the decision-making, the taskforce implemented a transparent process to collect and consider input from a wide range of internal and external experts, as well as stakeholders ranging from members of the public to members of the extramural research community.

Efficiencies, synergies, adjacencies. I guess the process to collect input could be described as transparent, though I worry a bit about the metrics that will be used to benchmark progress in achieving her stated mission for NCATS to “advance translational sciences by accelerating the development and delivery of new and more effective diagnostics and therapeutics.”

However, Sebelius and Collins have a more immediate concern facing them, such as the June 15th letter by Rep. Denny Rehberg (R-MT):

If the President decides to submit a formal budget amendment and provides answers to my questions to allow us to review the proposal fully, we will be happy to consider the request. However, until such information is provided we cannot responsibly take any action on this matter.

Therefore, I am very troubled by reports that the NIH has already taken steps to start the search for a new director of NCATS in advance of congressional action. I understand that during public discussion of NCATS to the Advisory Council to the Director of NIH on June 9, 2011, NIH announced it has begun the search process for a director and the process to notify current employees of reassignments to be effective on October 1, 2011 in anticipation of NCATS standing up on October 1, 2011.

It seems premature to take these steps in advance of an official presidential request, let alone required congressional action. I suggest NIH cease all action related to establishing NCATS until the President submits a formal request and congressional action is completed.

… It is unclear based on the scant level of information provided to the Appropriations Committee thus far how NCATS is the answer to advance translational research.

What sort of information is Rep. Rehberg looking for? The sort requested last January by John Bartrum.

Science notes that other Representatives also have concerns about NCATS and the NIH reorganization:

Several other House members, including Representative Michael Capuano (D-MA), who represents the Boston area, also wrote NIH recently with concerns about how the reorganization would affect CTSAs. Last week Capuano sent NIH another letter. “Several of Congressman Capuano’s constituents have expressed concerns that the NIH’s priorities may be shifting away from basic research,” explained Capuano spokesperson Alison Mills, who declined to release the letter until NIH responds.

I like the concern over the shift in NIH priorities away from basic research.

Indeed, Congressional members are not the only ones wondering if NCATS is the solution to the myriad problems in bringing promising diagnostic and therapeutic agents to market:

But others are unconvinced that the public sector’s contributions stretch much beyond basic science. Benjamin Zycher, a senior fellow at the Pacific Research Institute, a conservative economic think-tank in San Francisco, says industry contributions dominate throughout applied phases of drug development (that is, beyond target discovery identified in basic research).

… Zycher, for instance, predicts the center will flop because the NIH isn’t set up for applied research. Moreover, he worries that by enhancing public sector contributions, the center could invite congressional meddling in pricing, fast-track approval decisions and other business-related concerns.

For the biotech industry in particular, USDA’s Toole [research economist] pictures two outcomes arising from the establishment of NCATS. On the one hand, companies could benefit from being relieved of some of the upfront R&D groundwork. On the other hand, it’s also possible that publicly funded scientists could seek more patent protection for their work, continue to overestimate the commercial value of their intellectual property and slow down tech transfer from academia to industry, turning them into competitors as much as collaborators, he says.

Back to the one hand, industry has long been relieved of the “upfront R&D groundwork” through the NIH’s longstanding support of basic discovery research, which is too risky for profit-maximizing companies to pursue. The shift of NIH dollars to help academic researchers take their discoveries to market would come at the price of fewer fundamental mechanisms and potential targets identified.

In the meantime, the clock is ticking:

Rehberg chairs the House appropriations labor/HHS subcommittee, which oversees NIH’s budget. On 26 July, it will introduce a spending bill that would need to fund NCATS if it is to launch by 1 October, the start of the 2012 fiscal year.

At the aforementioned June 9th ACD meeting during which the search for an NCATS Director was “prematurely” announced, Larry Tabak (Deputy Director, NIH) rather than Barbara Alving (Director, NCRR) presented the NCRR Update. In fact, the entire afternoon session was devoted to NCATS. Perhaps any champagne uncorked at the end of the day may have been premature.