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Healthy Skepticism Library item: 1201

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

Kocs D, Fendrick AM.
Effect of off-label use of oncology drugs on pharmaceutical costs: the rituximab experience.
Am J Manag Care 2003 May; 9:(5):393-400
http://web.archive.org/web/20070527141019/http://www.cbc.ca/disclosure/archives/040217_adr/resources.html


Abstract:

BACKGROUND: While the off-label use of oncology interventions is widespread, the factors influencing off-label use and the resultant influence on oncology drug expenditures are not well understood. STUDY DESIGN: To assess the indications for rituximab use, a retrospective review was undertaken at a single academic center between September 1998 and June 2001. METHODS: Patient diagnoses were linked to pharmacy records, and each administration of rituximab was classified as either on-label or off-label as defined by FDA-approved indications. The resultant utilization patterns were the foundation for a conceptual model designed to identify factors that influence off-label use of oncology-related therapeutics and forecast the effect of off-label use on aggregate oncology drug expenditures. RESULTS: One hundred one patients received a total of 428 rituximab administrations during the study period. Most (320, 75%) of the administrations were for off-label indications. Although the extent of off-label and on-label use grew at a similar rate initially, off-label utilization increased nearly exponentially over time as on-label uses lessened. A conceptual model that describes factors that promote, inhibit, or have a mixed influence on off-label use may help predict future patterns of off-label utilization and allow better forecasting of oncology drug expenditures. CONCLUSIONS: The off-label use of rituximab is substantial. Projections of oncology-related patterns of care and drug expenditures must account for the potential for off-label use.

Keywords:
Academic Medical Centers Antibodies, Monoclonal/adverse effects Antibodies, Monoclonal/economics Antibodies, Monoclonal/therapeutic use* Antineoplastic Agents/adverse effects Antineoplastic Agents/economics Antineoplastic Agents/therapeutic use* Cancer Care Facilities Drug Approval Drug Costs* Drug Labeling* Drug Utilization Review* Education, Pharmacy, Continuing Female Health Services Research Hospital Costs* Humans Male Middle Aged Neoplasms/classification Neoplasms/drug therapy* Retrospective Studies United States

 

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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