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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.
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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 Treatment Insurance medical Hypertension 160/100 Same treatment • Difference? • 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?