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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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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909