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

3. 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

4. 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

5. Viribash The new natural antiretroviral

6. Viribash Derived from Tibetan moss Used traditionally by monks for long life and at higher doses to cause euphoria –Accidentally found to control AIDS by some addicts who were taking higher doses Registered in the EU as a herbal and given orphan drug status for HIV

7. Viribash Three hundred patients treated in trial –Rapid, sustained response to one year on daily dose mono-therapy –ADR s Common: Rash, fever –early, mild, but sometimes recurrent. Euphoria-mild, no confusion etc. Also: Retinitis (2), Colitis (1), Thyrotoxicosis (1), Pain in hands (2) –Regarded as residual underlying disease or chance

8. Viribash Media treats this as a break through. Much demand and consumer activism Controversy over high cost

9. Viribash Would you register this? –How do you see the comparative effectiveness-risk for this drug? What would you put in the package insert? What precautions? Monitoring?

10. Viribash 18 months after launch there are increasing number of reports, worldwide, of –thyrotoxicosis, –retinitis, –multiple sclerosis, –arthritis Some patients (20) at 3 years showing resistance What would you do?