Daniel Levy, MD, Susan Brink
247 pages. New York, NY: Alfred A. Knopf; 2005. $26.95. ISBN 0-375-41275-1
For most health professionals, “Framingham” means a body of data that guides cardiovascular risk prediction. Lost to most of us is the story of an era when the medical establishment was bewildered by and impotent in a rising tide of arteriosclerotic vascular disease. The Framingham Heart Study began in this setting. The results have been dramatic changes in the practice of cardiology and medicine in general. This fascinating story is told by the current Director of the Study, Dr Daniel Levy, and his coauthor, Susan Brink, in their book, A Change of Heart. The result of Framingham is trusted information on the relationship between common measures made in our patients and the probability of their having a heart attack or stroke. The national guidelines for treatment of cardiovascular risk factors have been built on the relationships found over some 50 years of observation in this Massachusetts community. Indeed, the term “risk factor” was invented to describe the results of the findings from this study. Although full of information about how the science developed, this book is well written and entertaining, meant for the layperson as well as the health professional. Once started, it will not be lying unfinished on your bookshelf.
The book provides a description of the state of our knowledge about vascular disease during the early half of this century. The method of high blood pressure management in President Franklin D. Roosevelt is used to illustrate the confusion and ignorance among medical practitioners as they either ignored this disease, rationalized its importance, or simply hid its existence from the public and the president himself. There was honest disagreement about the significance of his blood pressure and its potential consequences. The medications that were available were unwieldy and gave adverse consequences unacceptable to most patients. There was no concept of the effect of the blood pressure distribution on the population. Values that we now know predict stroke and other vascular disease were considered “normal,” and in fact both benign and essential with aging. Cigarette smoking and blood cholesterol were not considered to be related to heart attack.
As World War II ended and the thoughts of our government and university leadership turned toward domestic problems, the rising incidence of vascular disease got the attention it deserved. The leadership at the newly formed National Heart Institute in Bethesda, Md, conceived the idea of a community-based study of vascular disease. This received the strong support of Paul Dudley White, a renowned cardiologist in Boston and one of the founders of the American Heart Association. Other supporters included David Rutstein of the Harvard School of Public Health, who was instrumental in choosing a suburb of Boston as the sight for the study. He correctly believed that strong ties to a nearby academic institution would be needed for the success of the project. Initially, there were conflicting ideas as to the goal of this program. Some viewed Framingham as a place to study patients with heart disease and to determine environmental features that might have contributed to the disease and to its progression in such patients. This was to be combined with interventions to test the benefit of dietary change and other newly discovered treatments. Others thought that the study should not focus on those with disease because heart attack often appeared suddenly and in apparently healthy people. To discover the causes, an evaluation of a cross-section of the community, with a focus on middle-aged adults, was the appropriate design. This would provide detailed study of those who would develop heart disease during the planned 20 years of observation and would allow distinction from those remaining free of the disease. The hunt should be for characteristics that would allow prediction of the clinical disease before its manifestation in the doctor’s office or hospital. It was the latter concept that won out and was strongly defended by its second and long-time director, Roy Dawber. Dawber saw the trial through many uncertain days and lived to the age of 92 years to enjoy seeing the fruits of his labor have such important and far-reaching impact.
Because the nature of the program was new, not only the goals but also the execution of this study generated conflict over the best methods and procedures. Fortunately, wisdom, good will, and the absolute necessity of practicality in the community setting shaped the study into a steady generator of new information. What is often forgotten is that Framingham was and is a free-living American community of real people who were well aware of the study that was born and evolved in their town. The initial staff, Dr Gilcin Meadors and Nell Mckeever, RN, was able to reach into the community and find those action-oriented citizens, like Evelyn Langley, who became lifelong supporters and recruiters of their fellow townspeople. Perhaps through a combination of luck and guidance from the National Institutes of Health, the sequence of leaders seemed to bring the right talent to the job at the right time. Dawber reshaped the study to make it clear to the suspicious local medical community that this was not a socialistic and competitive enterprise and acquired the Framingham physicians’ strong support in the observational tasks that were the real business of the study. William Kannel was a prolific writer and made certain that the data reached the medical and scientific world. This work has been extended by William Castelli and now Dan Levy. The management of the huge data sets continuously acquired and constantly expanding required new methods and the superhuman dedication provided by Pat McNamara.
The book A Change of Heart not only tells the story of how findings in Framingham have changed the practice of medicine, stimulated the development of new treatments, and driven public health policy in the United States and throughout the world but also relates the fascinating personal interactions of the investigators who lived among the subjects of their study for decades. The author (Dr Levy) has known many of the original volunteers and their children, who continue to participate in the study. In the book, he relates many of their stories, putting a human face on the scientific experiment. As a result, the reader is left with admiration and gratitude for the altruism and tenacity of the Framingham citizens that made the study possible. The final form of the Framingham Heart Study was shaped by scientists, public health experts, and physicians, as well as the very people who were the subjects of the study. All deserve much credit for adherence to the goals of uncovering the causes of vascular disease while accepting what was possible in an observational study.
The Framingham Heart Study was scheduled to end after 20 years of federal funding, and indeed, after 20 years, many of the predictive relationships that we now recognize were being documented and published. However, it was obvious to the investigators that important information was yet to flow from the experiment. In 1969, a letter from Paul Dudley White to then-President Richard Nixon secured funding until Boston University could establish a contractual relationship with the National Institutes of Health. That relationship has provided for support and supervision since. Observation of the remainder of the 5209 original subjects and an even larger study of their offspring continues some 57 years after its beginning in the summer of 1948. Without the involvement of the National Institutes of Health, visionary academic leaders, and the Framingham community, the world would certainly have been delayed in receiving factual guidance that saves lives every day. This is a story worth reading.