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Queen's University
Pharmacology and Toxicology
PHAR 100
Bill Racz

Lesson A.2 – Drug Advertising, Drug Trials & Placebo Effects Drug Advertising Techniques:COB FUD 1. Catch audience (physician’s) attention 2. Use of celebrities or authority to endorse products 3. Fear 4. Offering easy solution to problem 5. Before-after technique 6. Discredit drugs produced by other manufacture and praise your own Drug Trials: • Prior to 1938, the regulations for introducing drugs into therapeutic use were not well defined o 1938 – antibacterial drug turned out to be toxic and killed ~100 people  regulations for introduction of new drugs included a requirement to show that the new drug was non-toxic or at least had an acceptable toxicity profile o 1962 – sleeping pill later discovered to cause fetal malfunctions in pregnant women  pharmaceutical company was required to show evidence of both safety and efficacy (effectiveness) for a drug  safety testing widened to test drug in several animal species 1. The manufacturer is required to submit proof of both the safety and the efficacy of the drug in several animal species to the government regulatory agency in the particular country concerned 2. detail methodology for the proposed clinical trial in humans 3. pharmaceutical manufacturer’s detailed submission is carefully evaluated by qualified scientists in the regulatory agency Phases of Clinical Trial • Phase 1 – study conducted in a limited number of healthy volunteers and effects are studied Lesson A.2 – Drug Advertising, Drug Trials & Placebo Effects • Phase 2 – determine whether the drug is effective in treating the condition it is recommended for. Careful attention is paid to proof of concept/safety of the drug. • Phase 3 – tested in larger number of people (~1000+). Safety and efficacy is studied. • Phase 4 (“postmarketing surveillance”)– surveillance of the effects of drugs is required after the drug is released for general use as risks that are delayed or less frequent than 1 in 1,000 administrations may be missed in the Phase 3 trial Placebo Effect • Placebo – an inert substance which masquerades as a drug • Physicians sometimes use placebos when a patient demands a certain drug when none is available • Placebo effect – occurs as a result of drug administration and have nothing to do with the pharmacological effects of the drug • Beecher • conducted one of the most comprehensive studies of placebo effects in 1955 • found satisfactory relief in 35% of ~1000 patients suffering from various conditions (ex. common cold, anxiety, mood changes, headaches, etc) • adverse effects are also possible (ex. headaches without having taken a drug) • likelihood of placebo effect is greater in sick, anxious patients under stress • since 35% of patients respond to placebo, we must either compare a new drug with a placebo or with an older drug of proven value. So we can compare: if the groups respond to the real drug in a percentage significantly higher than the 35%, then it is actually effective. Design of a Phase 3 Study (Comparative Efficiency Trial) Method of Comparison of New Drug with an Older Drug (or with a placebo if there is no older drug available) Cross-Over Design We may administer a new drug to all individuals on one occasion and study the effect of the drug, and then administer an older drug (or placebo) to the same individuals on another Lesson A.2 – Drug Advertising, Drug Trials & Placebo Effects occasion. This method is flawed since there may be differences in the individual groups when studied on the second occasion. Group A receives new drug and Group B receives older drug (or placebo) – effects of treatments are compared. On the second occasion, Group A receives older drug (or placebo) and Group B receives new drug – effects of treatments are compared. The treatment of the two groups should be compared at the same time in order to be valid. This type of trial can be used in disease states which are chronic and stable. It has limited application for most drugs and this design is not used very often. Parallel Design Subjects are divided into two groups and one group receives the new drug and the other group the placebo or an established drug. Most Phase III studies are parallel design Randomization Subjects assigned to different experimental groups must be assigned in a strictly random manner. The best method is to use a table of random numbers where a sequence of digits is generated randomly by a computer. Consider that 24 subjects, whose initi
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