Ethical Problems of Clinical Trials in Long Term Studies of Patients with Diabetes Elizabeth Barrett Connor, MD, Epidemiology Link to paper: http://cardiometabolic.cardiosource.org/Article-of-the-Month/2013/09/LookingBack-on-the-Look-AHEAD-Trial.aspx In the first BSS of the New Year, we focused in on the ethics of diabetes research, an issue that influences the lives of thousands of Americans every year. Due to a decrease in activity levels and increase in unhealthy eating, more and more people are affected with type 2 diabetes every year. This seminar focused on some of the research projects and the issues that arise when doing clinical trials with diabetic patients. The main question raised by one of Reena Wing’s projects was “How can we find out if treating diabetes (for a diabetic patient) can reduce heart disease rates?” The problem with studying diabetes in this way is that it takes about 10 years for a patient with type 2 diabetes to develop heart disease. Another study called DPP investigated diabetes prevention. The study was performed by Dr. Elizabeth Barrett- Connor’s group. Some problems that arose were control group issues, blindness issues, randomization and study length. The ethical issues that arose in discussion of the projects are as follows: 1. Exclusion Criteria: Reena Wing’s study excluded diabetic patients that might develop heart disease via a graded exercise tolerance test. a. This meant that anyone who might potentially get a cardiovascular disease is excluded from the study. This presents a problem because the study aims to see whether diabetes treatment can reduce heart disease. b. The point was raised that people shouldn’t be excluded from a study as a result of their health problems. 2. Control group issues a. If a patient with diabetes who enrolled in an intervention study is not allowed to do ANYTHING about their diabetes, an ethical issue is raised. Not treating an existing illness is blatantly unethical. 3. Justice Issue: It is the duty of a physician to protect the safety of the patient. a. Limiting the population to those who are most suitable for a research study via the results of an exercise test doesn’t seem fair b. The patient should have the right to decide if they would like to engage in the study, even if the exercise test indicates that heart disease may occur in the future. 4. Beneficence and Non-maleficence a. There’s a social responsibility to provide continuing education for patients and physicians about nutrition and healthy living. Notes and summary by: Nitya Rao