Monday, June 4, 2012

drug marketing undermines patient safety and public health

Am J Public Health. 2011 Mar;101(3):399-404. Epub 2011 Jan 13.

The inverse benefit law: how drug marketing undermines patient safety and public health.


Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.
http://www.ncbi.nlm.nih.gov/pubmed/21233426?dopt=Abstract

disease-mongering activities companies can use to stimulate drug sales

  • Promotion of anxiety about future ill-health in healthy individuals
  • Inflated disease prevalence rates
  • Promotion of aggressive drug treatment of milder symptoms and diseases
  • Introduction of questionable new diagnoses—such as PMDD or social anxiety disorder—that are hard to distinguish from normal life
  • Redefinition of diseases in terms of surrogate outcomes (i.e., osteoporosis becomes a disease of low bone density rather than fragility fractures)
  • Promotion of drugs as a first-line solution for problems previously not considered medical, such as disruptive classroom behaviour or problematic sexual relationships.
Ray Moynihan and colleagues describe disease mongering as, “widening the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments” [ 1].
The rationale for regulation of drug promotion is health protection, encouragement of appropriate medicine use, and prevention of deceptive advertising. The European community code on medicinal products for human use states that advertising of medicinal products “must encourage the rational use of the product and may not be misleading” [ 34]. Canada's Food and Drugs Act prohibits advertising of a drug that is “false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, merit or safety” [ 35]. The World Health Organization's Ethical Criteria for Medicinal Drug Promotion states that advertisements, “…should not take undue advantage of people's concern for their health” [ 36].
Disease mongering by definition creates erroneous impressions of the condition a product aims to treat and the merit and safety of treatment, and frequently provokes undue anxiety or exaggerates prevalence rates.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1434509/?tool=pubmed