July/August 1999 Vol 17 No 7/8 ISSN 1321-571X
Contents
Eisai’s promotion of Aricept (donepezil).
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Eisai promotes Aricept (donepazil) in Thailand for Alzheimer’s disease.
This month’s edition focuses on an advertisement which illustrates several classic techniques for misleading promotion including:
A copy of the advertisement appears below.
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August 1999
Chief Executive Officer
Eisai Co. Ltd
4-6-10 Koishikawa, Bunkyo-ku
Tokyo 112
Japan
re: the promotion of Aricept (donepezil)
Dear Sir,
We are concerned about your company’s promotion of Aricept in Thailand. An advertisement in the MIMS Thailand 1998 Vol 27 No 2 asserts:
"New, once a day Aricept
For the well-being of Alzheimer’s Patients and Families
Already, over 192,000 patients and more than 10 million patient days worldwide experience with Aricept
Over 80% of Aricept-treated patients in clinical trials showed either improvement or no further decline in cognitive function (ADAS-cog assessment)2"
The number 2 in superscript gives the impression of a citation but no references are provided in the advertisement.
Comparison of your claims with initial conclusions based on the evaluations available to MaLAM<1>, summarised below, raises some questions. This letter is intended to give you the opportunity to express your point of view so that we can assess whether your claims assist appropriate therapy. We hope that you will either provide evidence to support your claims or reconsider the promotion of Aricept. We are optimistic that dialogue can lead to improvements in drug promotion to the benefit of the public, health professionals and your company.<2>
Initial conclusions.
MaLAM's analysis of Aricept is based on reviews by the French
Prescrire International <3> and the British Drug and
Therapeutics Bulletin.<4>
We are concerned both about what the advertisement says and fails to say. The advertisement does not mention that Aricept only provides symptomatic treatment for Alzheimer's dementia and does nothing to reverse the underlying course of the disease. Any treatment effects that may occur do not persist after the drug has been withdrawn.
The advertisement claims that Aricept has been used in over 192,000 patients. However the published studies for this drug have had very strict exclusion criteria which are not mentioned in the advertisement. Patients were excluded if they were taking anticholinergic, anticonvulsant, antidepressant or antipsychotic drugs. Other drugs with CNS activity were either prohibited or "partially restricted." Other exclusion criteria included evidence of insulin-dependent diabetes, asthma or chronic obstructive lung disease and
clinically significant GI, hepatic or CVS disease. The Drug and Therapeutics Bulletin states that: "A consequence of excluding such a potentially wide variety of patients is that the trial population is unlikely to be representative of the patients with Alzheimer's disease likely to be met in routine clinical practice. . . It would, for instance, be relatively uncommon for a patient with Alzheimer's disease not to be taking a drug with CNS activity."
Finally, the advertisement does not provide any safety information. While Aricept may be a relatively safe product, there have been recent reports of psychiatric disturbances, including hallucinations, agitation and aggressive behaviour. Recognition of these side effects has necessitated a change in the Summary of Product Characteristics in the United Kingdom.
The advertisement asserts that Aricept is "For the well-being of Alzheimer's patients and families." [Emphasis added.] However, there is no evidence from controlled trials that Aricept has any effect on the quality of life for caregivers.
According to the advertisement "Over 80% of Aricept-treated patients… showed either improvement or no further decline in cognitive function." However, the average improvement in the cognitive score with Aricept compared with placebo never exceeded 3 points. Experts in the United States FDA consider that at least a 4-point reduction is required to consider a dementia treatment as effective.
Although there is data showing that Aricept results in an improvement in clinicians' global rating scores of overall dementia, most of the improvements were rated as minimal. Prescrire International estimates that only about 10% of patients can be expected to obtain a clinical benefit from Aricept. Furthermore, these small positive changes have to be balanced against Aricept's unproven effects on quality of life for both patients and caregivers and on day-to-day functioning.
Prescrire International concludes that Aricept should only be used on a case by case basis and only after warning the family and other caregivers that the benefit is, at best, only moderate. The Drug and Therapeutics Bulletin is unconvinced of the value of Aricept in routine clinical practice.
Questions
1. Does Eisai have any evidence that Aricept affects the
underlying process in Alzheimer's disease? If not, will Eisai
undertake to mention this limitation in future advertisements?
2. Does Eisai have any evidence that Aricept is effective for
patients with Alzheimer's disease beyond those included (not
excluded) from published clinical trials?
3. What percent of patients does Eisai believe will benefit from
Aricept?
What is the evidence for this estimate?
4. Does Eisai have any evidence that Aricept improves the quality
of life
of caregivers of patients with Alzheimer's disease?
5. Does Eisai believe that safety information should be given the
same emphasis as evidence of effectiveness?
6. What quality control mechanisms does Eisai have in place to
ensure that its advertisements are scientifically accurate and
balanced?
Yours sincerely,
Dr Joel Lexchin MD, CCFP (EM), DABEM
Secretary, MaLAM Inc www.camtech.net.au/malam
August 1999
Chief Executive Officer
Eisai Co. Ltd
4-6-10 Koishikawa, Bunkyo-ku
Tokyo 112
Japan
re: the promotion of Aricept (donepezil)
Dear Sir,
I have read the MaLAM International edition about the promotion of Aricept by Eisai in Thailand.
q
(Please tick where appropriate)
I am a: doctor q
pharmacist q
nurse q
……………………….. q
and would appreciate receiving a personal copy of your reply. q
Yours sincerely,
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