CHEM 183 Lecture Notes - Lecture 5: Nuremberg Code, Rofecoxib, Informed Consent

• School: McGill University
• Department: Chemistry
• Course: CHEM 183
• Professor: David Noble Harpp

Document Summary

Clinical trials: must be cross over doube blind study, nuremberg code. No physical and mental suffering: a) phase i, done on 20-100 healthy individuals, to show that it is not toxic on humans; show that it is safe. Subjects get paid; thus mostly students volunteered: b) phase ii, done on patients that you want to treat. 100-300 patients: c) phase iii, done on patient you want to treat. Marketing laws: how much a drug is charged, bill 102 (1969) Any drug that put drug on the market had to license it to other companies: the other company had to pay for the royalties (4% royalties) But other companies can copy the drug: you can sell it but you had to give 4% to the originator who created it. Advertising of drugs: billion usa, billion spent on advertising on doctors.