Francis Collins, the director of the US National Institutes of Health (NIH), found himself on the defensive today before a House of Representatives subcommittee intent on scrutinizing the NIH’s shiny new translational-medicine centre.
The National Center for Advancing Translational Sciences (NCATS), launched in January, aims to shrink the time it takes to get new drugs, devices and diagnostics to the bedside by attacking obstacles in drug development, from poor toxicology to inefficient clinical trials. Members of the House Appropriations Committee’s Labor, Health and Human Services, Education and Related Agencies subcommittee pressed Collins on whether his plans for the NCATS will jeopardize basic research at the biomedical agency.
“Can you ensure that the development of NCATS will not take resources away from basic sciences?” asked Representative Michael Simpson (Republican, Idaho), echoing subcommittee chairman Denny Rehberg’s opening comments.
Collins noted that the NIH’s support for basic research has held steady at about 54% of the agency’s budget for decades. “I do not expect that percentage to change,” he said. He added repeatedly that all but 2% of the US$575 million in funding for the translational medicine centre this year comes from pre-existing NIH programmes and is not “new” money. (The exception is the new $10 million that are launching the Cures Acceleration Network.)
“The amount of new funds going to NCATS is a very small amount indeed,” he said. “We are trying to be very careful about this. We believe we could do a lot with modest resources at this point simply by putting the focus on bottlenecks” in the drug-development pipeline.That view was challenged later in the hearing by Roy Vagelos, the former chief executive of Merck, who said that the pharmaceutical industry spends about $50 billion annually, or roughly 100 times the NCATS budget, without solving the problems — such as inadequate toxicology — that cause so many failures in drug development . “Does anyone in the audience believe that there is something that NCATS is going to do that the industry thinks is critical and that they are not doing? That is incredible to think that. If you believe that you believe in fairies.”
Vagelos added that, with success rates for applicants for NIH grants at historic lows, “we would be doing a lot more good for getting important new drugs on the market” by funding more young investigators.
But another drug-company executive, Scott Koenig, who was senior vice-president of research at MedImmune, and testified at the hearing on behalf of the Biotechnology Industry Organization, took issue with Vagelos. (Koenig is now president and chief executive of MacroGenics, a private biotechnology company.) He called NCATS a “unique opportunity” to fill gaps in drug development that industry is not addressing, and is not incentivized to address. Predictive toxicology, for example, he said, “is not an issue that drug companies would be working on”, nor is the identification of biomarkers that won’t deliver clinical benefits until years down the line. “This is not something that the drug industry spends a lot of time and money on,” he said.
Separately, several of the members of the subcommittee focused on whether NIH was shortchanging another programme to boost funding for NCATS next year.
Representative Cynthia Lummis (Republican, Wyoming) interrupted Collins to insist that he explain how the $64-million increase proposed for NCATS in 2013 can’t be seen as being largely funded by a cut to the Institutional Development Award (IDEA) programme. The NIH has proposed a cut in 2013 of $50.5 million from the programme, which funds biomedical investigators, trainees and infrastructure in 23 largely rural states that have historically experienced low application-success rates for NIH grants.
“I would not want you to see a direction connection between the IDEA programme and NCATS. Those are not the same dollars that just got moved from one box to another,” Collins responded.
“Dollars are dollars,” Lummis replied.
Rehberg, whose rural state is also a recipient of IDEA funds, said that, for his part, “I can’t imagine supporting NIH’s request to reduce the base of the IDEA programme”, which the subcommittee in 2012 boosted to $276 million from $229 million.
Collins replied that NIH had interpreted that boost as a “much-needed”, but one-time event.
“We [the subcommittee] did not suggest…that these were one-year funds,” Rehberg retorted.
Rehberg raised another controversial topic in his opening statement, but did not return to it when he asked questions of Collins. The National Children’s Study has been in the spotlight because of a recently announced shift in its goals and strategy. It initially aimed to recruit a nationally representative sample of 100,000 children, but now has abandoned that ambitious goal, as its leaders note in this 2013 budget document they recently submitted to Congress (see pages 34 and 35). Two of its external advisers have resigned in the last two weeks.
In his opening remarks, Rehberg said that NIH’s budget document “provides vaguely described changes to the study and an unanctipated (15%) reduction to the cost. A transparent discussion is needed ensure the proposed changes do not undermine the scientific value of the study,” he said.
Collins warned lawmakers that a set of budget cuts mandated as part of a budget deal struck by Congress last August would be damaging to the NIH if they were to go into effect as scheduled in January 2013. The so-called “sequestration” — a set of across-the-board cuts in discretionary spending slated to come into effect if Congress does not act to avert them — would translate to a 7.8%, $2.5-billion loss to the agency. As a result, he said “2,300 grants we had planned to give in fiscal year 2013 would not be able to be awarded. It would be devastating.”