Transcript Viribash
Benefit and harm: Effectiveness and risk • Key concepts in therapeutics • Key issues in communication I Ralph Edwards Marie Lindquist With acknowledgements to Andrew Herxheimer ' Effectiveness' and 'risk' • Effectiveness is an indication that a drug works: this is not the same as benefit 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 Perception of effectiveness and risk from medicines Mild stroke Hypertension 160/100 Insurance medical Hypertension 160/100 Difference? Treatment Same treatment Not only pathology, but also in PERCEPTIONS of what chances one will take Viribash The new natural antiretroviral 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 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 Viribash • Media treats this as a break through. • Much demand and consumer activism • Controversy over high cost 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? 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?