Too soon to market

[...]donepezil, a recently licensed drug for Alzheimer's disease, is supported by only one randomised controlled trial published in full, with follow up of just 12 weeks. 1 This is long enough to show a treatment effect but hardly useful for routine clinical practice, where the issue is one of...

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Published inBMJ Vol. 315; no. 7118; pp. 1248 - 1249
Main Authors Dent, Thomas H S, Hawke, Simon
Format Journal Article
LanguageEnglish
Published England British Medical Journal Publishing Group 15.11.1997
BMJ Publishing Group LTD
BMJ Publishing Group
EditionInternational edition
Subjects
Alzheimer's disease
Communication
Decision Making
Drug Approval
Drug Information Services
Editorials
Funding
Humans
Licenses
Pharmaceutical industry
Practice Patterns, Physicians
Prescription drugs
United Kingdom
United Kingdom > UK
United Kingdom
UK
Online AccessGet full text

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Abstract [...]donepezil, a recently licensed drug for Alzheimer's disease, is supported by only one randomised controlled trial published in full, with follow up of just 12 weeks. 1 This is long enough to show a treatment effect but hardly useful for routine clinical practice, where the issue is one of longer term efficacy and safety. Riluzole, licensed recently for use in amyotrophic lateral sclerosis (a form of motor neurone disease), clearly has some efficacy, but because this is at best modest and the drug has no effect on muscle function, 3 its role in treatment is uncertain. 4 The unpublished data seen by the licensing authorities have not been scrutinised by the scientific community and may not have been peer reviewed, which limit their suitability for use in prescribing and funding decisions.
AbstractList [...]donepezil, a recently licensed drug for Alzheimer's disease, is supported by only one randomised controlled trial published in full, with follow up of just 12 weeks. 1 This is long enough to show a treatment effect but hardly useful for routine clinical practice, where the issue is one of longer term efficacy and safety. Riluzole, licensed recently for use in amyotrophic lateral sclerosis (a form of motor neurone disease), clearly has some efficacy, but because this is at best modest and the drug has no effect on muscle function, 3 its role in treatment is uncertain. 4 The unpublished data seen by the licensing authorities have not been scrutinised by the scientific community and may not have been peer reviewed, which limit their suitability for use in prescribing and funding decisions.
In an editorial, Dent and Hawke discuss the present system by which new drugs enter Britain's National Health Service, which is harmful to patients and clinicians. A new apprach to approving drugs needs to take into account relative effectiveness and cost utility.
Author Hawke, Simon
Dent, Thomas H S
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Snippet [...]donepezil, a recently licensed drug for Alzheimer's disease, is supported by only one randomised controlled trial published in full, with follow up of...
In an editorial, Dent and Hawke discuss the present system by which new drugs enter Britain's National Health Service, which is harmful to patients and...
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SubjectTerms Alzheimer's disease
Communication
Decision Making
Drug Approval
Drug Information Services
Editorials
Funding
Humans
Licenses
Pharmaceutical industry
Practice Patterns, Physicians
Prescription drugs
United Kingdom
Title Too soon to market
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