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- Anthony N. DeMaria, MD, MACC, Editor-in-Chief, Journal of the American College of Cardiology⁎ ()
- ↵⁎Address correspondence to:
Dr. Anthony N. DeMaria, Editor-in-Chief, Journal of the American College of Cardiology, 3655 Nobel Drive, Suite 400, San Diego, California 92122.
Everyone is aware of the enormous progress that has been made with regard to cardiovascular disease over the past half century. Percutaneous intervention, defibrillators, heart transplant, and a variety of pharmaceutical agents have reduced the morbidity and prolonged the life of patients with coronary disease and/or heart failure. No one could deny that the field of cardiovascular medicine has been a hotbed of innovation and advancement.
The credit for the progress in cardiovascular medicine must be attributed to a number of groups. Researchers are, of course, the first group that comes to mind. The process of discovery is fundamental to the progress of any field of medicine. Vision and inquisitiveness, coupled with hard work, perseverance, and often a little luck, are required to develop important new knowledge. Since, by definition, research deals with the unknown, investigators must be prepared not only for the possibility that their experiment will fail, but also that it may render a negative answer that does not lead to an important clinical advance. For every study that provides a major breakthrough, there are many, many others that render small increments of knowledge or provide the groundwork for others to move forward. Enormous credit must be given to those in the research community who endure intellectual uncertainty and professional insecurity to define new mechanisms and therapies for cardiovascular disease.
Investigators, of course, cannot perform their work without considerable assistance. Whether it is molecular biology or a randomized multicenter clinical trial, quality research requires financial and administrative resources. We have been fortunate to have a supportive infrastructure throughout the industrialized world which has nurtured investigators and facilitated our efforts. Society has usually been generous in providing financial support for medical investigation. Private industry, while a possible beneficiary of the results, must also be acknowledged for the investment they have made in research. We are very likely living in a time of unprecedented support for the research enterprise.
However, there is one group without whom important medical advances could not occur, and who I believe are often overlooked when assigning credit. I am referring to the patients who participate in medical research. I must admit, I became anxious and diaphoretic when reading the side effects on the package insert of approved medications that I take. Research participants voluntarily expose themselves to an uncertain degree of discomfort and risk, often with little or no expectation of benefit for themselves. These individuals generally make more of a commitment to the research project in terms of their own discomfort and potential adverse events than do even the investigators.
My appreciation of research subjects has been reinforced by a recent study we have undertaken involving the administration of stem cells to postinfarct patients. As with any phase one safety and dosing trial, the unknowns are considerable. This uncertainty is amplified somewhat by the nature of the agent being evaluated—that is autologous mesenchymal stem cells. Patients participating in the protocol must undergo extensive screening for undetected subclinical disease and be hospitalized for 72 h. This is for the possibility of a benefit which must be weighed against receiving a placebo, or ineffective therapy, or a possible adverse event. Nevertheless, nearly every patient we have approached thus far has shown a genuine interest in being able to participate. Certainly, it would be hard to argue that they do not understand the risks which are explained to them in great detail.
In the foregoing study, the patients have at least some chance of benefit. I have conducted imaging studies in the past where the patients would receive no clinical benefit themselves. In fact, the data are often blinded until after a therapeutic decision is made. Nevertheless, these patients typically agree to participate in the study in the unselfish hope that it will “help someone else.” There is no question that both we as investigators and society as a whole owes these individuals a large debt of gratitude.
Werner Forssman set a good example for us when he demonstrated the feasibility of catheterization by passing a catheter to his own right heart. Perhaps we as physicians should follow the example by being more proactive in participating in research protocols. The necessity of a pathophysiological state likely excludes us from many protocols. However, there are many procedures inside and outside of cardiology for which we would qualify. This would provide a clear statement that our own commitment to increasing knowledge is equal to that of our patients.
The worldwide research effort in cardiovascular disease has begotten fantastic benefits for society. While the profession basks in the glow of achievement, we must not forget the contributions of the research participants who made the advancements possible. The courage and selflessness of the individuals who voluntarily enroll in investigational protocols should serve as both an example and inspiration for the rest of us. In my opinion, they are the unsung heroes of our research enterprise.
- American College of Cardiology Foundation