Bad Drug Applications: “Katastrophex” Critique

Abstract

The following arguments were made in favor of the drug application as presented to the Registration Committee.

• 1. The Belloni Study of 1860 patients studied a wide range of patients which reflected the actual setting of use. Even though moderate, there was some effect in most patients, and no adverse reactions were observed.

• 2. With respect to other studies, the drug has been shown in the animal and clinical trials to have a wide variety of effects, including an anti-anxiety effect, anti-convulsive effect, and a possible anti-hypertensive and anticholesterolemic effect, as well as a possible use for alcohol withdrawal. No toxicity is seen in high doses as indicated by the anti-convulsant study and post-marketing surveillance in one country has shown no serious adverse effects. Placebo controls were not carried out in any of the studies because in most cases this was felt to be unethical.