What does the public think of placebo use? The Canadian experience.
Part of the National Placebo Initiative in Canada included public consultations, based on the belief that the views of the public should inform Canadian policy development on what constitutes appropriate placebo use. Public consultations took place nationally in 2003. A deliberative dialogue approach was used, or a structured discussion format designed to facilitate the consideration of complex issues and build consensus. The placebo debate was characterized as having 3 distinct approaches and each were explored. The first approach "Maximize Patient Protection" identified the need for experts to determine appropriate placebo use and that placebos should only be allowed under very restricted conditions. The second approach "Maximize Medical Knowledge" identified that placebos give essential information about the safety and efficacy of new drugs, and are appropriate when the rights, safety and well-being of research participants are ensured. The third approach "Maximize Patient Autonomy" identified that the current system of regulating placebo use is paternalistic and that patients should be able to define what is in their best interests and have more leeway to determine for themselves if they wish to participate in a placebo-controlled trial. Advantages and disadvantages of each approach were considered and feedback on what constitutes appropriate placebo use was sought. The major findings were that: PCTs were considered a valuable and acceptable part of advancing medical knowledge, research using placebos must be valid and justifiable; a patient-centred approach needs to be fostered; patient autonomy (choice) should be a first consideration and take clear precedence in trials of low to medium risk, patient protection (or health) may need to "trump" patient autonomy at higher levels of risk and/or patient vulnerability; placebos are not a violation of the duty of care as duty of care is best met by identifying a choice for patients, whenever a choice is available. These consultations clearly were not designed to produce conclusive evidence, but rather to provide some useful insights into what the public may think about placebo use; additional studies are indicated.
Therapeutic Products Directorate, Health Canada. patricia.huston@ottawa.ca
Patricia
P
Huston
D000293:Adolescent; D000328:Adult; D000368:Aged; D001294:Attitude to Health; D002170:Canada; D018849:Controlled Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D004341:Drug Evaluation / Q000941:ethics* / Q000592:standards; D005260:Female; D006291:Health Policy; D006805:Human Experimentation / Q000941:ethics* / Q000592:standards; D006801:Humans; D008297:Male; D008875:Middle Aged; D026684:Personal Autonomy; D010919:Placebos; D011639:Public Opinion
D010919:Placebos