Healthy Skepticism Library item: 16363

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Wilkinson JJ, Force RW, Cady PS.
Impact of safety warnings on drug utilization: marketplace life span of cisapride and troglitazone.
Pharmacotherapy 2004 Aug; 24:(8):978-86
http://www.ncbi.nlm.nih.gov/pubmed/15338846

Abstract:

STUDY OBJECTIVE: To evaluate the impact of safety alerts on the volume of cisapride and troglitazone usage. DESIGN: Retrospective database analysis. SETTING: University research center. MATERIAL: Idaho Medicaid claims data from January 1994—July 2000. MEASUREMENTS AND MAIN RESULTS: Monthly counts of total and new prescriptions filled for cisapride and troglitazone were analyzed graphically over time as a function of all prescriptions. New prescriptions were defined as those filled by patients who had not received the drug within the previous year. A binomial comparison of the 5 months before and after each safety alert was conducted by Poisson distribution. Overall and new cisapride usage increased after the first alert, which occurred in February 1995 (p<0.05). After the second alert, in September 1995, growth in new prescriptions ended but total prescriptions continued to grow (p<0.05). After the third alert, in June 1998, growth in total use ended and the number of new prescriptions declined (p<0.05). The final two alerts (June 1999 and January 2000) were met with significant declines (p<0.05 for both). Troglitazone was the subject of two alerts in October and December 1997. After these, overall usage increased (p<0.05), whereas the number o new prescriptions decreased (p<0.05). The third alert, in July 1998, caused no change as total prescription use continued to grow (p<0.05), whereas the number of new prescriptions decreased (p<0.05). A fourth alert, in June 1999, resulted in a decrease of overall usage and new prescriptions (p<0.05 for both). CONCLUSION: Numerous safety alerts were required for each drug before drug usage declined. The decline in overall use was slower than the decline in new prescriptions, possibly indicating a need for increased assessment of refilled prescriptions after the release of new safety data.

Keywords:
Chromans/adverse effects*nCisapride/adverse effects*nDatabases, FactualnDrug Labeling*nGastrointestinal Agents/adverse effects*nHumansnHypoglycemic Agents/adverse effects*nPharmacoepidemiologynProduct Surveillance, Postmarketing/methods*nRetrospective StudiesnThiazolidinediones/adverse effects*nUnited StatesnUnited States Food and Drug Administration*

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909