About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline

LOG IN
LOG IN


46 Food Drug Cosm. L.J. 487 (1991)
Adverse Drug Reactions: Finding Sharp Safety Signals in a Noisy Haystack

handle is hein.journals/foodlj46 and id is 517 raw text is: Adverse Drug Reactions: Finding Sharp Safety Signals in a Noisy Haystack W. LEIGH THOMPSON* I. INTRODUCTION Thomas Sydenham (1624-1689) founded clinical epidemiology on the principles of detailed observations and accurate records. He defined dis- ease as the struggle between noxious influences and natural healing capa- bilities. The indications of that struggle he divided into: symptoma essen- tialis (direct effects of the noxious influences), symptoma accidentalia (reaction of the body to those noxious influences), and symptoma artifi- cala (effects of physicians and treatments). The epidemiology of therapeu- tic safety is simply distinguishing symptoma artificalia arising during or after one treatment among many others in complex patients from hetero- geneous populations. This analysis is facilitated by detailed observations and accurate records of many patients. The mixed metaphor of this article focuses attention on the two chal- lenges in epidemiology of therapeutic safety. These are related and may appear identical, but are subtly distinct. First, there are voluminous data-often 1,000,000,000 characters in a new drug application (NDA) haystack with only a few sticky safety concerns. Validating a large data base and combing it repeatedly for needles, especially with multivariate analyses, is a new and challenging discipline. Second, most descriptions of body dysfunctions are vague and imprecise noise. Clinical data are not as precise and orderly as the notes of Beetho- ven's Ninth. Everyone in the audience perceives the event when the tubist drops his instrument, but in a patient with recurrent esophageal spasm it is difficult to distinguish the pains of heart attack. Clinical information specialists are trying to convince physicians to improve definition of their language to enhance precision of the healing arts. II. BODY LANGUAGE How can symptoma artificalia be recognized and described? Evolution has provided a rich language by which our external environment is sensed. We perceive pain and temperature at thousands of points on our skin, distinguish hundreds of colors and sounds, and recall scores of tastes and smells. Much of our energy is spent to minimize unpleasant signals * Dr. Thompson is Group Vice President, Lilly Research Laboratories, Eli Lilly and Company. A previous version of this article was presented at The Food and Drug Law Institute's seminar ADR Reporting: Current Issues and Future Developments, Washington, D.C. (July 19, 1990).