The TPA Controversy and the Drug Approval Process
The View of the Cardiovascular and Renal Drugs Advisory Committee
- Peter R. Kowey, MD;
- Lloyd Fisher, PhD;
- Elsa-Grace Giardina, MD;
- Carl V. Leier, MD;
- David T. Lowenthal, MD, PhD;
- Franz H. Messerli, MD;
- Craig M. Pratt, MD
- From the Medical College of Pennsylvania, Philadelphia (Dr Kowey); the University of Washington, Seattle (Dr Fisher); Columbia College of Physicians and Surgeons (Dr Giardina) and Mount Sinai Medical Institutions (Dr Lowenthal), New York; Ohio State University, Columbus (Dr Leier); Ochsner Medical Institutions, New Orleans (Dr Messerli); and Baylor College of Medicine, Houston (Dr Pratt).
Since this article does not have an abstract, we have provided the first 150 words of the full text.
Excerpt
SEVERAL months ago, our panel considered two applications submitted to the Food and Drug Administration (FDA) for the approval of thrombolytic agents for treatment of patients with acute myocardial infarction. One of these was intravenous (IV) streptokinase and the other was IV recombinant tissue plasminogen activator (rt-PA). We recommended approval of IV streptokinase and postponement of approval of IV rt-PA. There followed considerable public debate in which we were accused of "deciding to sacrifice thousands of American lives on an altar of pedantry" (The Wall Street Journal, June 2,1987). In essence, many observers opined that we had elected to debate picayune, unsolvable issues rather than make an important and lifesaving therapy available to the American public. Editorialists demanded that FDA Commissioner Frank Young repudiate the panel's suggestion and grant immediate approval of rt-PA. In response to one of the editorials in the lay press, we attempted to explain the issues
Footnotes
-
Reprint requests to Cardiology Division, Medical College of Pennsylvania, 3300 Henry Ave, Philadelphia, PA 19129 (Dr Kowey).
