Drug Advertising, Drug Trials and Placebo effects
Advertising is BAD for your health!
• US Pharma
◦ spent $57.5 billion on marketing in 2004 (Canada: $2.8 billion)
◦ spent $31.5 billion on research and development on new meds (Canada: $1.2 billion)
• market is flooded with “me too” drugs which maximize profits while offering little or no
improvement to health care
◦ use same structure, but add a methyl group, or change a tiny bit of structure
◦ then market it as a new drug
• for every $1 spent on prescription meds, $0.25 goes to promotion
◦ of which nearly all is used to entice MDs
• evidence suggests that prescribing practices are influenced by enticements
• are prescription choices being driven by solid test results or robust promotion?
◦ mostly robust promotion
• Dr. Marc-Andre Gagnon, University of Quebec, Public Library of Sci Med, Jan 2008
(MACLEANS: Jan. 2008)
• Pfizer pays record fine in 2009 (2.1 Billion USD)
• promoting drugs for indications where they did not have approval
◦ cannot promote drug for helping anything but what it has approval for
• wined and dined physicians to encourage prescribing of 4 drugs.
• purpose of advertising: persuade the public to buy
• advertising drugs to the public: not appropriate
• instead: consult w/ physician and collaborate on what prescribe
• advertising techniques:
◦ catch attention; use of authorities to endorse products ; fear
◦ offer easy solution to a problem ; before/after techniques
• two episodes lead to improved regulations:
◦ 1938 – Sulfonamide prepared as a solution, but the solvent was toxic – deaths
◦ Thalidomide – 1961– Administered during pregnancy, resulted in phocomelia teratogenic
▪ improper development of limbs, flipper like arms
• to conduct a trial, manufacturer must **randomized, controlled trial:
◦ submit proof of efficacy and safety (animal data)
◦ methods to be used in the trial
◦ drug given to qualified investigators Preclinical Trial
• show on smooth muscle; test on animals, etc.
• toxicity screens: in vitro, in vivo, carcinogenic, teratogenic, etc.
Phases of a Clinical Trials in Drug Development
• Phase I – One or two doses in healthy volunteers
◦ absorption, distribution, elimination and adverse effects (limited)
• Phase II – Try on limited number of subjects: short-term efficacy study. Determine dose for
phase III. Safety. Proof of concept.
• Phase III – Long-term study for efficacy and safety. (2000, 20 000) depending
◦ Randomized controlled trials.
• Phase IV – Often referred to as post-market surveillance – look for possible rare toxicities.
Confounding Factors in Clinical Trials
• try to eliminate:
◦ the variable nature of most diseases
◦ the presence of other diseases and risk factors
◦ subject bias
◦ observer bias
• record everything that happens to subjects, even if seems not related
• how: randomized controlled trial. anecdotal data inappropriate
Elements of a Phase III Trial
◦ placebo: no drug
◦ standard of care: best available treatment of that condition
• patient selection
◦ spectrum of severity of condition, generally rigid set of exclusion and inclusion criteria