felt certain areas were extremely sensitive, such as the use of behaviorcontrolling drugs. We wanted some representation from that group. Then we wanted another group of people who are in the medical (I hate to use the word) establishment-teachers, funders, and others who are instrumental in direct or indirect ways. As you can see, when you try to balance in this way, at every point some group is underrepresented.

We were very gratified at the response we got from invitees, since we were making an imposition on busy people in a short time. If we could have kept this to a group of 15, we would have had no formal agenda. But because we simply couldn't conceive of fewer than 50 people achieving any kind of representation, we have a program which sounds very formal and heavy. It is not so intended. We have asked all the presenters to be as informal as possible, and the respondents are rigidly limited to five minutes. We have left open Saturday morning for anyone here who would like to make a statement.

Now, as to our expectations: I really don't feel we expect any answers. We hope that certain kinds of questioning will take place. We hope that perhaps by the last day there will be a sense of whether a dialog of this sort should be ongoing. Perhaps there will be some ideas from the group as to how best to continue an easy conversation among legislators, representatives of the public interset and the biomedical community. We hope for the end of a certain kind of rhetoric. There is recognition, I think, on the part of the senators who brought us here and all the participants, that these are not issues that ought to be approached in an adversarial fashion or exploited for rhetorical purposes. We've seen a lot of crises, and we have a feeling that if some easy access to communication can occur, perhaps some of these problems can be better handled ahead of time than after the fact, in newspapers and magazines.

THE CONGRESS AND BIOMEDICAL RESEARCH: THE CHANGING RELATIONSHIP

DANIEL CALLAHAN. We thought we'd begin with some history. Stephen Strickland will address the question of the historical relationship between Congress and the biomedical research community, with emphasis on what seems to be happening now. The respondents will be Robert Marston and André Hellegers. We'll then move on to Ruth Hanft, who will try to lay out some of the economic issues.

STEPHEN STRICKLAND. For about 15 years, from the early 1950's through the middle 1960's, national medical research policy has formulated in a friendly environment. Those were the good old days, when a few members of the United States Congress specifically including Senator Lister Hill (D-Ala.) and Representative John Fogarty (D.-R.I.) assumed responsibility for seeing to it that the biomedical research enterprise flourished. In that era, policy makers-especially those in Congress were predisposed to accept on face value assessment of research possibilities and resource needs advanced by medical scientists or their spokesmen.

In those golden days of federal support, the operating imperatives of the U.S. medical research enterprise-scientific, political, and ethical-were roughly in balance. And the managerial imperative had not come strongly to the fore.

The scientific imperative of which I speak is simply that which impels the researcher forward from his latest finding and enlarged understanding via the most recent clue, to the next problem. It is an unceasing quest for fact and truth. As it relates to biomedical science, the scientific imperative, for many researchers, has as a premise a view stated by Lewis Thomas: that disease is "fundamentally unnatural" and that therefore disease mechanisms are "quite open to intelligent intervention and reversal whenever we learn more about how they operate."

The political imperative is that which makes public officials inevitably think in terms of practical effects and benefits. It seeks the greatest good for the greatest number, which sometimes gets interpreted as the quickest good for the most visible number. It encompasses considerations of cost and efficiency as well as results, and the less obvious and immediate the results, the more weight given to costs and efficiency-in short, to management.

This imperative has been articulated in a number of ways, for example in President Johnson's provocative question of 1965, as to whether any practical medical secrets remained locked up behind laboratory doors. It is illustrated in what Science magazine described last year as the prevailing philosophy at the Office of Management and Budget: "that science, like everything else, should pay off if it is going to get public support."

The ethical imperative as it relates to biomedical science traditionally has been more generalized, seeking to assure that the ends be beneficient and the means harmless.

The management imperative is the fuzziest in definition-with attendant controversy not only over its proper role but over what it means vis-a-vis science. At the very least, the management imperative in almost anyone's terms implies systems for insuring that funds are spent wisely and well in accordance with authorized mission and stated policy goals.

In recent years, new questions have been raised as to whether we have been sufficiently conscious of ethical issues relating to biomedical innovations and even biomedical research. The management imperative has been asserted more strongly than ever, perhaps because scientific progress has seemed slow to those reviewing budgets and trying to "manage by directive." Meanwhile, the very concept of managing science is derided by some scientists. The political and scientific imperatives are sometimes in conflict.

But I would question any assumption that a direct tension is building between the general public on one side and biomedical scientists on the other. Some small, particular publics undoubtedly have discrete concerns about the application of new medical technologies stemming from science, but overall there is considerable evidence the public is supportive of both the political and scientific imperatives. And the public is willing to leave to scientists and elected officials decisions about funding levels, program priorities, and organizational mechanisms. This posture puts them in the middle when political and scientific forces pull in different directions.

Concerted efforts to line up public support-meaning support from various publics-is tantamount to political activity, whether those

engaging in it are scientists or senators. Yet I also do not believe that the difference between today's research policy arena and that of yesterday is simply "politics." In the Nixon years, there were clearly more decisions at more levels that were more political than formerly was the case. But it is not the essential nature of the process that has changed. Instead, what has changed are: a) the particular actors and their special predilections, b) the fiscal or budgetary situation of the federal government, and c) the balance among the operating "imperatives" scientific, political, managerial, and ethical-all of which affect research policy and the research enterprise.

Clearly, many of the recent tensions in the biomedical research community and among the decision makers in Washington-tensions. concerning policy premises, program directions and priorities-are the inevitable result of shrinking budgets. The potential conflicts invited by the National Institutes of Health (NIH) charter of 1930 and the National Cancer Institute charter of 1937 were for many years avoided because rapidly growing budgets permitted wide latitude about what research to support and how to support it.

Beyond these factors, NIH has always had to operate within a political context and always will, basically because the allocation of public resources is always a political process in a democracy. This means among other things that resources are assigned to given activities or areas of endeavor according to convictions about how much those endeavors will contribute to the public good. It is of course not a perfect process, and may sometimes seem to produce results that are unwise or inequitable. Overall, however, I think most of us would favor the fundamental process above any other alternative, even as it functions in relation to biomedical science.

Second, while it is true that biomedical research has fewer unquestioning friends holding high policy positions today-in Congress and the Executive-than in the past, the basis on which important friends of former days made favorable decisions was not purely Platonic or passive. Decisions of the 1950's and '60's, which added millions of additional dollars to the federal commitment to medical research, including programs for biomedical training and research facilities, were clearly affected by a generous spirit. But those decisions were firmly grounded in pragmatism. In the early '60's John Fogarty made sure the National Institute of Arthritis and Metabolic Diseases (as it was then called) got an extra few hundred thousand dollars to begin a program in ulcerative colitis. He was persuaded that this particular enlargement of the budget was desirable not just because he had empathy for the thousands of victims of the disease, but also because the director of the institute certified to him (in response to a Fogarty query), that the research field was ready for fuller investigation, that there were specific research lead that needed greater attention, and that good people could be attracted to do good work.

Friendly policy makers in the good old days, like less friendy ones today, naturally had one eye focused on potential constituencies. So cancer and heart disease always had an easier time than microbiology and gastroenterology, and they probably always will. Yet policy makers also had an eye out for good ideas, which were justified by scientists. There were no millions dying of Tay-Sachs disease, and the

number of infants afflicted by retrolental fibroplasia was not enormous, but key Members of Congress encouraged spending research funds on problems relating directly or indirectly to those afflictions. There are some similarities in the medical research policy arena of the present and that of 15 years ago Congress, then as now, tends to dominate the Executive. For the first several years of the Nixon Presidency, the Secretary of Health, Education and Welfare, like earlier secretaries in the Eisenhower administration, was largely outside the decision-making process when it came to the big issues-for example the launching of the new war against cancer. As in the earlier period, executive influence over medical research policy was, with the exception of cancer, exerted through budgetary controls.

But the differences in the two eras are really more striking then the similarities. Recent congressional support of NIH has largely been restricted to interceding to protect it against executive politicization. And the fundamental difference between the present period and that when Lister Hill and John Fogarty were the chief congressional policy makers is that there was then, but recently there has not been, strong mutual feelings of trust and confidence among Congress, medical science administrators, and the medical research community. In a sense, those who led NIH and Congress in medical research in the earlier period reached their maturity together. A new set of actors in both camps inherited a legacy of cooperation, but have sometimes felt constrained to assert independence from it. Some members of Congress who have been most interested in medical research, namely Senators Edward Kennedy (D-Mass.) and Jacob Javits (R-NY) and Representative Paul Rogers (D-Fla.), in essence have attempted to change congressional rules and traditions, in order more strongly to assert a strong congressional-medical research relationship. Specifically, to exercise the supportive and protective leadership they think Congress should have, they have sought to reclaim jurisdiction over medical research for their legislative committees, and away from the appropriations committees.

It is inevitable that the distinctive thrusts of the scientific, political, management, and ethical imperatives will continue occasionally to result, as they have in the past, in a practical pulling and tugging over the direction and pace of a biomedical scientific enterprise. It should not be inevitable that they be manifested in fights between scientists and policy makers, in disjointed policies and contradictory programs, in dysfunctions in scientific progress. For they are not inherently theoretically incompatible.

Now is the time for a new maturity on the part of all those who take part directly and indirectly in the making of medical research policy for our nation. A maturity involves, first, recognition that each of the operating imperatives-political, scientific, managerial and ethical-is legitimate, and, second, recognition that medical science is most likely to progress when these imperatives are operating in relative harmony.

ROBERT MARSTON. I'll reply by adding a couple of emphases I think deserve some attention, which Stephen Strickland either didn't touch on, or didn't touch on very heavily. The first one has to do with the relationship of national biomedical research and the institutions in which research is done. When I first went to NIH as an associate direc

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tor in 1965, the major concern was the impact of the Fountain committee. The people at NIH had the feeling that the scientific community did not rise up to defend NIH at that time. Also, the Fountain committee's impact on NIH exemplified particularly well the public's difficulty in understanding how science is done, and the scientist's difficulty in explaining in a short period of time what takes his whole life to work out.

The second point is the impact of that critical 1968 budget, the Nixon-Johnson budget. All of a sudden, the scientific community (as well as the rest of the country) faced the necessity of expenditure containments. We all thought it was a one-year event, but the next year we found we were still negotiating downward. It really wasn't until 1970, in a very dramatic four-hour discussion, that Elliot Richardson, then Secretary of Health, Education, and Welfare said, "OK, all of the fat that was in there is out now, and we will go back to 100 percent funding of moral commitments." That immediately raised the question of what you do about the percentage of new grants. It was about that time that the question of training grants came up, and I've never known in my own mind whether that came up as a matter of policy, or a matter of trying to find a big hunk of money once the moral commitment on it was closed off.

I think Strickland has correctly pointed out the third major event; that is, the cry from the public and Congress for more relevance. It was an increasing call, if not for practical results, then at least for results in highly visible areas. Examples are the National Science Foundation's Research Applied to National Needs program, and the national cancer program.

I don't agree quite as much with Strickland on Congressional personalities. Although there have been personnel changes in the appropriations committees, I think the big thing was development of interest by the health committees, by Kennedy and Javits in the Senate, and by Rogers and his committee in the House.

Working with them is a different ball game from working under open-ended, no-dollar limitations with the appropriations committees. First, it requires rejustification in greater detail of ongoing research, and second, it eats into the directors' time. The amount of time the director of NIH and the directors of the institutes spend, year after year, before committees is completely out of balance with the magnitude of the money appropriated.

There is only one other point I will comment on, and I really don't know what can be done about it. When one starts talking about really serious science, then I think almost always there is an opportunity for an awful lot of miscommunication.

I think one sees in almost every discussion of this type a question of priorities, a difference between talking about whether one is going to

2 In the early '60s, the House Government Operations Intergovernmental Relations Subcommittee, headed by Representative L. H. Fountain (D.-N.C.), expressed criticism of some facets of NIH policy and administration. In a report issued in 1961, the subcommittee argued that NIH was not organized to administer its grant programs adequately, and that it failed to provide proper review of research and to maintain enough contact with grantees to determine the proper degree of continuing support. In 1962, a second report found little improvement. It concluded "Congress has been over-zealous in appropriating money for health research." NIH subsequently issued new policy regulations, many of which affected the ways in which grant money may be spent. See Congressional Quarterly Almanac, Vol. XIX, p. 154, 1963.