University of Minnesota

“It Isn’t Always Fun.” – A Generation of Preventive Trials

A generation of preventive trials to lower cardiovascular disease (CVD) risk may be said to have begun at the Makarska Conference in fall of 1968 [see Volume I]. A stellar group of experts gathered at the site of the Seven Countries Study 10-year follow-up survey in Dalmatia to outline future strategy and tactics of heart attack prevention. National Institutes of Health (NIH) leaders were present, along with participants from the American Heart Association, the International Society of Cardiology, and the World Health Organization, all focused on prevention trials to test the effects of modifying risk factors. The outline developed there was detailed. It included separate, definitive, large-scale experiments for reducing high blood pressure and high blood cholesterol and for multiple elevated risk factors combined. These were focused on people at special risk before and also after onset of manifest CVD, that is, both primary and secondary prevention.

The broad actions proposed at Makarska were soon bolstered and detailed in other major reports, the Report of the Task Force on Arteriosclerosis of the National Heart and Lung Institute, and the Report of the Joint Commission on Heart Disease Resources, appearing respectively in 1970 and 1971. The nation had begun a remarkably broad program of prevention research that for the first time addressed pragmatic questions about the feasibility and extent of prevention as well as explanatory researches on the “why and how.” New staffing and funding were set aside at the National Heart and Lung Institute for prevention, expressly to complement bench and clinical researches on heart attacks.

A major new operational strategy was also put into place in which NIH staff, with consultation, basically designed the national studies and then controlled them. This was carried out through a system of requests for proposals, responses and central review, and of cooperative agreements or contracts for research, in which NIH appointed the chairpersons and steering committees for the projects and assigned project officers to oversee each from Bethesda.

This tight central organization and direction of prevention researches by the NHLI, later the National Heart, Lung, and Blood Institute (NHLBI), succeeded in recruiting virtually all the competent and experienced investigators in the field; its programs became “the only game in town.” The entire field moved forward briskly and appeared to flourish as this strategy developed and took over cardiovascular disease prevention research nationally. NHLBI led all the national institutes of health in preventive undertakings. But thereafter, for some years, the originators of the research ideas had progressively less opportunity to submit viable independent initiatives, prepared among experienced and compatible investigators. Instead they were increasingly locked into contractual collaborations, often with people of different backgrounds, ideas, experience, and motivations, who had no history of working together, and had their researches supervised by youngish Project Officers in Bethesda who were sometimes, happily not always, overly-impressed with their authority.

But, at least, most investigators in the 1970s were busily occupied with good works. And we could dream of and plan for other more original things to do — one day, on our own — things that would surely be more fun.

Millennial Commentary

The Great Leap Forward in prevention research had many successes among the observational studies and preventive trials of these years,1970-2000. NHLBI led all the national institutes, and others worldwide, in prevention studies and programs. A remarkable NIH operation, The Lipid Research Centers, dominated the field for a decade and more, even having branch operations in the Soviet Union. Its Primary Prevention Trial, a core activity of the heavily vested NHLBI and its directors, was the most successful and influential of them all. The preventive action counterparts of the Institute’s research, the High Blood Pressure Education Program and the National Cholesterol Education Program became central to the national picture of prevention. But there were unhappy effects of central NIH administrative control of most prevention research for cardiovascular diseases, the effects of which are still being felt today. In fact, the direction of prevention research from Bethesda Central, if anything, has increased over the decades. The outcome has been mixed.

Moreover, there has been a shift away from the long-successful balanced structure and funding of investigator-initiated and programmatic NHLBI researches, once partitioned deliberately among bench, clinical, and population researches, to a program dominated today by molecular biology, genetics, and technology. The consequences for epidemiological and prevention research, its staffing, infrastructure , and spirit, were keenly felt in the late 1990s; the damage to prevention research is still felt despite improved overall funding of NIH by Congress early in the millennium.

This nation came close, it seemed, in the 1980s and early 1990s, to putting research and policy strategies in place for the virtual elimination of premature illness from hypertension and atherosclerosis in industrial society. In the late 1990s and early aughts, however, coincident with the shift in NIH research policy, the population experienced a backsliding in risk behavior and in disease rates; a significant backlash developed against healthy sociocultural change. Large segments of western society, moreover, failed to share equitably in the diminished risk of cardiovascular and cancer deaths. Huge reservoirs of these diseases arose, moreover, in developing countries, where the high rates of tobacco use and hypertension still wait patiently for blood cholesterol levels and multi-factor risk to catch up, thereby creating, we anticipate, monstrous new epidemics in the foreseeable future.

In the end, the larger research issues in prevention, in health behaviors and health promotion, and in the public health, have quite lost their priority in academia and at NIH. Their current elite now have, it maintains, “more interesting and important things to do.” And, since September 11, 2001, the whole nations’ energies and resources are focused on a bizarre war against clandestine terrorists and a battle for the minds of oppressed peoples and failed nations around the world.

Again, I am ahead of my story. Let us once more return to details of the preventive trials, in particular, MRFIT, launched in 1972. I describe it to the exclusion of other important studies such as the HDFP and the Lipid Research Centers Program, because my involvement in MRFIT was early and intimate.

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