INDICE: Foreword.Acknowledgement.Introduction.Chapter 1.What is Off–label Medicine? .Scope of the issue.Chapter 2.Examples where products have been through regulatory approval for a secondary use.Finasteride: pseudohermaphroditism and hair growth.Sildenafil: re–tasking the blue pill for a life–threatening illness.Doxycycline: from killing bugs to protecting gums.Raloxifene: from cancer to bone disease and back again.Galantamine: using snowdrops to improve memory.Cyclosporine: preventing immune attack on organs and skin.Dimethyl fumarate: a remarkable drug for multiple sclerosis.Botox: a drug to kill or cure you.Examples where evidence is uncertain and not to regulatory standards.Tricyclic anti–depressants : for curing more than emotional pain.Aspirin for cancer.Retrospective data: looking back to create future therapies.Chapter 3.Viewpoint of the patient.Viewpoint of the prescriber.Professional guidelines.Patient awareness.Practitioner attitudes.Diagnosis.Chapter 4.Normal drug development and drug repurposing development.Gaming the system.Orphan use.Pharmaceutical marketing.Expanding uses for non–pharmaceuticals.Direct–to–Consumer Advertising.Patents and genericisation.Conclusion.Chapter 5.Relative safety.Different therapeutic uses.Chronic vs acute dosing.Different dose.Differences between children and adults.Other patient populations.Fatal adverse drug reactions.Quality of evidence.Strong evidence.Poor evidence.Doctors do not know evidence.Proximity of off–label to on–label.Debunking medical myths.Chapter 6.A prescriber s ethical and professional duties.Medical professional participating in off–label promotion.A prescriber s legal position.Consent.Liability.Reimbursement.Compendia.NICE.Compassionate access.Cost.Chapter 7.Regulators do not regulate medical practice.Off–label marketing.Off–label fines.Whistle–blowers.European situation.Tip of the Iceberg.Free speech.Chapter 8.Constraints on making changes.Moves to enhance off–label medicine.Diagnosis shifting.A partial solution: Clinical trial transparency.A Solution based on Increased Regulatory Supervision.My Solutions.Professional standards.Reimbursement and Pricing.Outcomes.Conclusion.References
- ISBN: 978-1-118-91207-2
- Editorial: Wiley–Blackwell
- Encuadernacion: Cartoné
- Páginas: 216
- Fecha Publicación: 20/02/2015
- Nº Volúmenes: 1
- Idioma: Inglés