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Healthy Skepticism Library item: 389

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Melzer D.
New drug treatment for Alzheimer's disease: lessons for healthcare policy.
BMJ 1998 Mar 7; 316:(7133):762-4
http://bmj.bmjjournals.com/cgi/content/full/316/7133/762


Abstract:

The launch of donepezil (Aricept), a specific treatment for patients with mild or moderate Alzheimer’s disease, attracted intense interest. Clinicians and others were quoted in the media as being optimistic about the drug’s effectiveness, but concerned that NHS funding would be withheld or uneven. However, reaching consensus on the clinical rather than statistical importance of this drug requires open debate, given the relatively small effect sizes and uncertainty over side effects in typical patients. Debate has been hampered because publication of the full results of the main clinical trials has been delayed. This episode highlights several issues of general policy importance that must be resolved if access to the information needed for clinical and other decision making is to be improved.

Keywords:
*analysis/United Kingdom/journal advertisements/new drugs/donepezil (Aricept)/INFLUENCE OF PROMOTION: JOURNALISTS/INFLUENCE OF PROMOTION: PRESCRIBING, DRUG USE/PROMOTIONAL TECHNIQUES: JOURNAL ADVERTISEMENTS/REGULATION, CODES, GUIDELINES: JOURNALS AND MASS MEDIA Advertising Aged Alzheimer Disease/drug therapy* Cholinesterase Inhibitors/therapeutic use* Clinical Trials Decision Making Drug Approval Drug Industry Editorial Policies Evidence-Based Medicine Government Regulation Great Britain Health Policy Humans Indans/therapeutic use* Information Dissemination* Piperidines/therapeutic use* Risk Assessment* Therapeutic Human Experimentation* United States Publication Types: Review Review, Tutorial MeSH Terms: Advertising Aged Alzheimer Disease/drug therapy* Cholinesterase Inhibitors/therapeutic use* Clinical Trials Decision Making Drug Approval Drug Industry Editorial Policies Evidence-Based Medicine Government Regulation Great Britain Health Policy Humans Indans/therapeutic use* Information Dissemination* Piperidines/therapeutic use* Risk Assessment* Therapeutic Human Experimentation* United States Substances: Cholinesterase Inhibitors Indans Piperidines donepezil


Notes:

(Limited to parts of article dealing with promotion.) Licensing trials on highly selected patients may provide insufficient information on which to base clinical decisions, especially where effect sizes are small and comorbidity is common. All trial evidence should be published before new drugs are marketed and medical journals should not carry advertisements referring to unpublished data.

 

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