Editorials

Failures of the therapeutic chain as a cause of drug ineffectiveness

BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7395.895 (Published 26 April 2003) Cite this as: BMJ 2003;326:895

Promotion, misinformation, and economics work better than needs

  1. Albert Figueras, assistant professor of pharmacology,
  2. Joan-Ramon Laporte, professor of pharmacology (jrl@icf.uab.es)
  1. Fundació Institut Català de Farmacologia, World Health Organization Collaborating Centre for Research and Training in Pharmacoepidemiology, Universitat Autònoma de Barcelona, Hospital Universitari Vall d'Hebron, 08035-Barcelona, Spain

    Failure of drug treatment may be due to wrong diagnosis, selection of an inappropriate drug or dosage, use of an adulterated or fake drug, the patient's non-adherence, a drug's poor bioavailability or lack of efficacy, medication error, or occurrence of an adverse reaction. The potential causes of therapeutic failure depend on a complex interplay of social and medical factors. Failures can occur at every step of the therapeutic chain, which is the process describing the life of medicines in a community. This process includes development, regulation (including registration), marketing, distribution, prescription, dispensing, and use of the drug.1

    The following are only some examples of failures in drug treatment. In 2001 the top five best selling medicines globally were atorvastatin, omeprazole, simvastatin, lansoprazole, and amlodipine, although available evidence indicates that only two of these drugs are first choice in their class. In recent years, various non-essential non-innovative drugs had to be withdrawn from the market because of serious adverse effects after a few years of growth in sales. One of these drugs, troglitazone, was associated with a risk of liver failure, which had been played down by the manufacturing company.2 More recently, serious flaws in the published pivotal trial that served as the basis for the global promotion of celecoxib were made public,3 and alosetron was reapproved by FDA amid accusations that the FDA had become a servant of the …

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