1 / 10

Benefit and harm: Effectiveness and risk

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.

micah
Download Presentation

Benefit and harm: Effectiveness and risk

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 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

  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?

More Related