The National Institutes of Health will establish by October its new center for helping pharmaceutical companies make drugs from university research discoveries, NIH leaders said Wednesday. They are moving ahead with the plan despite protests from scientists, lawmakers, and some agency officials.
"Change requires action," the director of the NIH, Francis S. Collins, said after meeting with advisers he described as committed to the creation of the NIH's proposed new National Center for Advancing Translational Sciences.
No matter which way it goes, the decision on whether to create the center, known as Ncats, carries potentially major implications for universities and their researchers. Even critics of Dr. Collins's initiative said they recognize that too many scientific discoveries in university laboratories are not finding their way to the stage of industry development necessary to improve and save lives. At the same time, university scientists have warned that the proposed organizational changes could endanger more than $500-million a year in critical existing NIH programs. The proposed budget for Ncats is $700-million a year.
Those who are concerned include Jeremy M. Berg, director of the National Institute of General Medical Sciences, an NIH division that would inherit several programs in the reorganization. "To do that rush, without any process to decide whether it's a good idea or a bad idea, does seem to be the wrong way to go," Mr. Berg said in an interview. "There are plenty of ways of advancing translational sciences over the next year while you wait to figure everything out."
The NIH is the single largest source of money for academic research in the United States. It has an annual budget of about $31-billion, with nearly $17-billion of that amount spent at universities. But Dr. Collins, since taking office as NIH director in August 2009, has suggested some of that spending may be wasted as research results languish. He has therefore put a priority on improving "translational research," meaning the process of converting basic scientific discoveries financed by the NIH into drugs and medical devices.
Resistance to Program Shifts
The NIH, however, has so far received more than 1,100 comments on the plan to create Ncats, much of it centered on the idea that Dr. Collins is moving too fast, reshuffling his agency without having fully considered all the implications. Many of the published comments have come from university researchers describing important medical research that they feel might be left without a clear source of NIH support.
That's largely because the NIH, by law, cannot exceed its current number of 27 divisions. Under Dr. Collins' plan, the creation of Ncats would be achieved by eliminating the NIH's National Center for Research Resources and redistributing that center's programs to Ncats and to other parts of the NIH. The research-resources center has an annual budget of about $1.2-billion, about half of which would become part of Ncats. The rest of the division's programs have not yet been assigned permanent homes, and so far have been provisionally slated by Dr. Collins for distribution among at least five other NIH units.
Dr. Collins, describing his plans to reporters by telephone conference Wednesday, said much of the opposition appears to reflect a natural human tendency to fear the unknown. "People are often unsettled by change," he said.
The critics include William M. Southerland, a professor of biochemistry at Howard University, who told the NIH he worries about the fate of the NIH's Research Centers in Minority Institutions program, which is among those units housed at the research-resources center. The minority-institutions program led to the creation of the National Human Genome Center at Howard, which "has played a pivotal role in better understanding the role of genetics in diseases which disproportionately impact minorities," Mr. Southerland wrote in a comment submitted to the NIH.
Another researcher, James R. Allen, a professor of psychology at the University of Alaska at Fairbanks, said the Institutional Development Award program—another unit that would be left seeking a new home within NIH—made possible the creation of the Center for Alaska Native Health Research at his university. That has made possible a series of projects investigating "significant health disparities among Alaska Natives in mortality due to suicide, alcohol abuse, and stroke," Mr. Allen wrote.
Such concerns are widespread at the Federation of American Societies for Experimental Biology, or Faseb, which is the nation's largest coalition of biomedical-research associations, said the group's president, William T. Talman, a professor of neurology at the University of Iowa.
The federation is "very, very supportive of the whole concept of translational research," Dr. Talman said. But, he said, "careful thought needs to be given to the impact on excellently run and very productive and extremely helpful programs."
The protests are already being reflected in Congress, which was notified on January 14 of the planned reorganization and has 180 days from that date to take any action. Sen. Daniel K. Inouye of Hawaii, the chairman of the Senate Appropriations Committee, joined a fellow Democrat, Sen. Mark P. Begich of Alaska, in writing to the NIH expressing "concern and opposition" over Dr. Collins's plan, especially as it affects the Institutional Development Award program.
But such fears are already showing signs of diminishing, Dr. Collins said Wednesday, as critics learn more about his plans. The NIH is committed to maintaining current staffing and financing levels for all affected programs, at least in the short term, Dr. Collins said. No program can have long-term guarantees, but the changes are being proposed with the intent of strengthening all programs rather than diminishing them, he said.
Promoting Drug Development
In his first major effort on translational research, a year ago, Dr. Collins announced a partnership with the federal Food and Drug Administration to help the FDA rule more quickly on the safety and effectiveness of new medical products and procedures. At the time, he said he had tallied 128 instances in which researchers identified a compound that showed some promise for medical use but then faced difficulty in winning FDA approval.
Statistics cited by the NIH show that drug-company investment in research and development has increased for most of the past 15 years, while the annual number of new drug approvals by the FDA over that period most often declined or stayed flat.
Drug companies are now spending about $45-billion a year on research and development, while getting no more than about 25 new FDA drug approvals during each of the past several years. In the late 1990s, however, annual investment levels of about $20-billion led to about 40 new drug approvals a year, the statistics show.
Dr. Collins said the idea for Ncats stems from the recognition that the various units of the NIH have an assortment of programs for encouraging companies to make drugs out of research discoveries. Those programs, however, could benefit from being pulled together into a single unit that is designed to study ways in which their work could be more effective, Dr. Collins said.
Mr. Berg said he agrees with the need identified by Dr. Collins. He said there are too many instances in which a university research project gives a company odds of less than 10 percent that a discovery will lead to a commercial product. If some additional process of investigation—such as further testing to establish the safety of a substance or to develop better methods for producing it—could raise the odds to around 30 percent or 40 percent, a company might take a chance at making the substance into a drug, Mr. Berg said. Drugs that have many potential customers in wealthy nations will do better in most circumstances, but companies could still be led by NIH to see value in producing medicines for use by poorer patients and in impoverished countries, he said.
An NIH overhaul, however, might not be necessary to accomplish that, he said. "I'm not so convinced that you really need to create a new entity, as opposed to just bringing things together in way that NIH does all the time in other ways," Mr. Berg said. "If NIH reorganized every time there was a new scientific opportunity, we would be constantly reorganizing and never doing very much."
The research-resources center is too important a part of the NIH to risk disrupting it, said Mark O. Lively, a professor of biochemistry at Wake Forest University and past president of Faseb. Its roles include running a grant program that helps university scientists with NIH grants obtain high-end research equipment.
"It is a research-resource provider," he said of the center. "It's like the department in a city that does your roads and manages the pickup services for your garbage."
"They've got to get the money from somewhere to do this," he said of the NIH and its planned creation of Ncats, and many of the programs in the research-resources center, he said, "are concerned that they may be tapped or sacrificed in some way."