Bad Drug Applications: “Katastrophex” Critique

  • Judith K. Jones
Part of the NATO Advanced Study Institutes Series book series (NSSA, volume 39)


The following arguments were made in favor of the drug application as presented to the Registration Committee.
  1. 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. 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.



Adverse Reaction Placebo Control Alcohol Withdrawal Clinical Trial Design Randomize Placebo Control Trial 
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Copyright information

© Springer Science+Business Media New York 1981

Authors and Affiliations

  • Judith K. Jones
    • 1
  1. 1.Division of Drug Experience Office of Biometrics and EpidemiologyBureau of Drugs, Food and Drug AdministrationRockvilleUSA

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