1. Benefit and harm: Effectiveness and risk Key concepts in therapeutics Key issues in communication I Ralph Edwards Marie Lindquist With acknowledgements to Andrew Herxheimer

2. 'Benefit' and its opposite 'Harm' "To be an advantage to" –Societal "Something that contributes to or increases one’s wellbeing" –Individual A BENEFIT TO SOCIETY MAY NOT BE A BENEFIT TO AN INDIVIDUAL AND VICE VERSA NEITHER IS HARM TO SOCIETY THE SAME AS HARM TO AN INDIVIDUAL AND VICE VERSA There are individual and general definitions possible for benefit and harm

3. 'Benefit' in societal terms Benefit –Increased overall population health 'Fitter' working population –Decreased expenditure on health Increased efficiency Shift to less costly options Harm –Increased longevity without health –More costly health care Costs shifted or hidden Diversion of funding from more 'effective' areas

4. 'Benefit' in societal terms Benefit –Measles vaccine –Total abolition of tobacco advertising –Discontinuation of the NSAIDS that cause the most GI bleeding Effective only –The prolongation of life in diabetics –Treatment of HIV –The use of 'Viagra' Which shows that decisions on health are not only based on public health BENEFIT but also EFFECTIVENESS

5. ' Effectiveness' and 'risk' Effectiveness is an indication that a drug works: this is not the same as benefit

6. The true balanced concepts Efficacy v. hazard –Pre-clinical/clinical study Effectiveness v. risk –Post-marketing clinical use studies Benefit v. harm –What is actually experienced by a patient or patients

7. Perception of effectiveness and risk from medicines Mild strokeHypertension 160/100Treatment Insurance medicalHypertension 160/100Same treatment Difference? Not only pathology, but also in PERCEPTIONS of what chances one will take

8. Communication challenges Different audiences: different perceptions –Doctors, patients, media, lawyers How to express the effectiveness/ risk balance How to compare between treatments How to handle changes in knowledge –HRT - myocardial infarction –Blood pressure therapy (ALLHAT)

9. Communication challenges Expression of message –Retention of information: reference Complexity –Impact Confidentiality v. openness –Access –Information flow (Learned intermediary) Seriousness of issue –speed of communication

10. Effectiveness/risk communication The correct message To the right audience By the right medium ConsequencesConsequences –Message received? –Message understood? –Followed up? –Acted upon appropriately?

11. Communication challenges Message sent Message understood Follow up Message acted upon Message received Action appropriate Studies More messages ! ! New!

12. Benefit and harm from medicines Edwards, IR., Wiholm, B-E., Martinez C. (1996) "Concepts in Risk-Benefit Assessment" Drug Safety 15(1): 1-7CIOMS 4 Compare like-with-like –Principle of 3's Disease; effect of drug; ADRs Seriousness; duration; frequency Three worst and three most frequent ADRs –Then consider cost...