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Pharmacology and Toxicology
PHAR 100
Hisham Elbatarny

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) Example: • 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. Advertising Techniques • 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 Drug Trials • 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 • comparator ◦ 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 • randomiz
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