Bulletin criticises MHRA and industry for “epidemic of misleading adverts”
The Medicines and Healthcare products Regulatory Agency (MHRA) is failing to control the marketing activities of the pharmaceutical industry, according to the Drug and Therapeutics Bulletin.
Professor Joe Collier, editor of the bulletin, said this week: “We
are seeing an epidemic of misleading advertisements and this probably
reflects a level of incompetence by the regulatory authority coupled
with an irresponsible stance by the industry. This position needs rectifying.”
Professor Collier’s comments follow the publication of this month’s
bulletin which calls for Lundbeck to withdraw claims made about memantine
(Ebixa). Memantine is licensed for patients with moderately severe to
severe Alzheimer’s disease. The bulletin assessed the company’s
claim that memantine results in “improvements in activities of
daily living [that] help patients to maintain a degree of independence
and be easier to care for, potentially avoiding the need for nursing
home care”.
The bulletin concluded that the claim is not scientifically robust. “On
published evidence, memantine produces, at best, only a small reduction
in the rate of deterioration in global, functional and cognitive scales
in such patients. Whether this translates into important changes in quality
of life or how long the effects last is unclear,” it states. The
evidence that treatment with memantine reduces the amount of care needed
or helps prevent institutionalisation is “unconvincing”,
it adds (2003;41:73).
A spokesman for Lundbeck said that the company disagreed with the bulletin
in a number of areas and suggested that it had not reviewed the evidence
properly. In terms of the bulletin’s specific criticism of the
company’s claims about avoiding nursing home care, he said that
it was a question of wording, pointing out that “potentially” was
used rather than “definitely”.
A spokesman for the MHRA told The Journal that it has contacted Lundbeck
about the claim and asked that any material containing the claim is withdrawn.
The company has done so. The MHRA has also asked the company to write
to all health professionals in receipt of advertising material containing
the promotional claim to correct any misunderstanding. |
