NIH agonizes over research directions - C&EN Global Enterprise (ACS

Jan 22, 1979 - But most did their best to go along with the exercise, which is being coordinated by Dr. Joseph G. Perpich, NIH associate director for ...
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NlH agonizes over research directions Proposal to develop a set of principles for establishing a five-year plan of research has biomedical scientists frustrated and angry An important debate about the goals of basic research is taking place at the National Institutes of Health. The issues are complex and controversial and may resolve nothing. But the aim is to develop a set of principles for establishing a fiveyear plan of research for an era of "limits." Almost no one is comfortable with the whole idea. NIH director Donald Fredrickson has begun mailing out the report of a conference held at NIH last fall on refining a tentative list of those principles. The conference was arranged in a hurry, attendees from the biomedical research community complained of its haste, and many went home in a huff. But most did their best to go along with the exercise, which is being coordinated by Dr. Joseph G. Perpich, NIH associate director for program planning and evaluation. The hope is to preserve and perhaps even increase federal funding for basic biomedical research while integrating its results with the Department of Health, Education & Welfare's gargantuan mission of improving health care and lowering its costs. Most think the ideal is an impossibility and wish HEW Secretary Joseph Califano would leave basic research to its own concerns. The thinking is that it thrives best when left alone. Meanwhile, the biomedical research community is angry and frustrated. Its main spokesman, the Federation of American Societies for Experimental Biology, is saying that President Carter is not delivering on his promises to raise the research budget and declares that "things will get worse before they get worse." And in its December newsletter it ridiculed the planning and performance of the fall principles meeting. The tentative list of these principles was spelled out last year by Califano before the annual meeting of the American Federation of Clinical Research when he spoke of his agony over setting priorities. His agony, he essentially said, was science's agony, too. Now, nine months later, everyone still appears to be hurting all over. These principles for a five-year plan as further developed at the conference are:

Fredrickson: more logic and meaning • In fundamental research: "A national commitment to fundamental research is essential to meet a full range of public health expectations." • In clinical applications and health services research: "To improve the quality of health care, prevent disease, and contain health care costs, the health care system requires, in addition to new knowledge developed at the fundamental level, the support of applied, problemoriented health research." • In health regulation and promotion: "The knowledge base necessary to protect the public health through the establishment of preventive measures, the conduct of health education and promotion activities, and the formulation of regulations must be further developed." • In research capability: "Present research capabilities must be sustained and enhanced to assure future health gains." A fifth category, "unifying concepts," considered the "need to reaffirm the federal support of health research; to fulfill public expectations regarding a return on the public's investment in health research; to communicate effectively the nature of the scientific process, its limitations and benefits; to develop bridges between fundamental and applied research; and to explore new interactions and processes." It's the last concept—new interactions and processes—that is the key to the whole exercise. Medicine, like the rest of society, is composed of special interest groups each clamoring for its own slice of

the budget. Nevertheless, the Institute of Medicine has been given a contract by NIH to criticize the report and emerge with an even better set of principles. "Many people in the scientific community doubt whether science lends itself to planning," says research psychiatrist Leon Eisenberg of Harvard University. Eisenberg headed the panel on health regulation and promotion. Eisenberg says his concern is that the October conference was staged mainly as a media event "rather than as a serious scholarly exercise." He says there was no attempt to build on previous efforts to establish health research policies, such as the work of the President's Panel on Biomedical Research. "I'm not impressed that it was terribly helpful," he says. "I think it should be a study done over several years by several people." The same sentiment was echoed to C&EN by Dr. Mildred Cohn, biochemistry professor at the University of Pennsylvania. Cohn is president of the American Society of Biological Chemists. She was a member of the fundamental research panel. Perpich, who is running the exercise from beginning to end, also has the job of producing by the end of the year the outlines of HEW's research plan. As a research planner, he must contend with not only a basic hostility to planning but antipathy toward the idea that basic research must fall within the same limits as, say, health services research. "What you see from this report," Perpich says, "is the development of two tracks. One is in fundamental science, the other is in applications. What we want to see develop is better coordination and integration between the two." But' the sense of the exercise remains vague, subject mainly to the way one wants to see it. NIH director Fredrickson wants more logic and meaning put into planning at NIH and, with Perpich, has introduced what they call the SATT system of analysis. The SATT system— which stands for Science, Applications, Technology transfer, and Training—is an attempt to divide the programs of NIH's 10 institutes along those four categories. The same method is being applied to the programs of other HEW agencies. A model of research-applications-regulation integration has emerged in the toxicology program, which is an interagency group formed after the vinyl chloride episode took regulators and scientists by surprise. What they discovered was that the regulators didn't know what the scientists long had known about vinyl Jan. 22, 1979 C&EN

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chloride and that ways had to he found to share information better. One adviser to Califano thinks the ex-, ercise is well worth it, despite its long struggle to achieve a comprehensive logic. "It has set in motion a process that will he worthwhile and more productive than anything like this that has gone on in the past," he says. "Each agency has to impose a S A T T framework on its activities. This will force a discussion and analysis where things have heen rightly or wrongly emphasized." Nevertheless, the exercise resembles a hydra, with many different attitudes competing, just as in politics. As Eisenberg declared in remarks at the conference, "We do not accept the premise that resource limitations preclude any significant expansion of the health research budget. T h a t is a political judgment, not a reflection of economic necessity." In short, agreement will come hard. Wil Lepkowski, C&EN Washington

Product liability model law drafted The Commerce Department has drafted a model law that it hopes will help unsnarl the legal tangle surrounding product liability litigation. As the department notes, liability law is "fraught with uncertainty." Rules vary among jurisdictions and courts, and are in a constant state of flux. In the past year and a half, 18 states have enacted their own product liability legislation widening already existing disparities in the law, Commerce says. T h e uncertainties in these laws have been blamed for soaring product liability insurance rates, which on the average increased 210% between 1974 and 1976. These, in turn, according to Commerce, have led to increased prices for consumer and industrial products; acted as a disincentive to the development of high-risk but potentially beneficial products; and led to many, particularly small, businesses going without product liability insurance coverage. After a $500,000, 18-month study of product liability problems, a federal interagency task force recommended changing the tort-litigation system more than a year ago. Among other changes, the task force recommended that any new law provide basic standards of responsibility, making distinctions among problems relating to defects in construction, defects in design, and defects based on failure to warn; define a time period after which a manufacturer's duty to product users terminates; set a duty limitation for unavoidably unsafe products; and set up a no-fault compensation system for damages caused by products. Many, but not all, of these suggestions have been incorporated in the proposed model law. For example, under the model law, product sellers would be held strictly liable for defects in construction or mismanufactured products. 18 C&EN Jan. 22, 1979

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