"Observational Medicine" should be replaced by "Real Science"

Abstract

Science is defined by fundamental principles that can be modeled to explain observations and predict new findings. Clinical trials have not achieved this status. The trials generate new observations and lack the ability to predict future outcomes. The following hypotheses are generated: 1. Biology has no defined fundamental principles that can be modeled to explain observations and predict new findings. 2. Observational Medicine has advanced our knowledge but has not elicited fundamental principles that could predict future outcomes in individual patients. 3. A biologic model of regeneration/degeneration moderated by inflammation framed by 6 laws of biology can make predictions. 4. Biology can be quantified. Observational Medicine from Hippocrates, through Framingham and the Women's Health Initiative are examined. These trials have advanced our knowledge but have not elicited fundamental principles that could predict future outcomes. A set of fundamental principles of biology and a model based on regeneration/degeneration modified by inflammation has been previously reported. These laws represent empirical facts and no exceptions to these laws have been realized. The model suggests the observations from Framingham could be explained by the quantity of circulating stem cells and the inflammatory status of the patient. Clinical trials that select patients by their quantity of stem cells and inflammatory status would be more efficient than selection by risk factors. This same model can explain the inability of the Women's Health Initiative to determine the female advantage over men in coronary heart disease. This model is exploited to make predictions in coronary disease, heart failure, and is used to explain disease processes, paradoxes and make predictions. Mechanical statistical entropy is method that can quantify biologic processes.