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Drug company accused of breaking advertising regulations

Fabian Waechter BMJ

The Drug and Therapeutics Bulletin has accused the drug company Novartis of breaching advertising regulations in its advertisement for pimecrolimus, a new cream for treating dermatitis (2003;41(5):33-6).

A recent review by the bulletin resulted in three criticisms. The main concern was that while the licence limits the use to patients aged 2 years and older, the recent advertisement, published in many medical journals, shows a baby who looks younger than 2 years, implying that the cream could be used on babies below that age. The bulletin is consequently demanding that the drug’s licence be withdrawn.

But a spokesman for Novartis, which market the drug as Elidel, said that the child used in the advertisement was not younger than 2.

Dr Richard Chiswell, medical adviser to the company, said: "The boy used for the advertisement was actually 2 years and 5 months old." But he admitted that the Medicine and Healthcare Products Regulatory Agency had recently drawn their attention to the fact that "the boy looks younger to many people."

He said that Novartis was "sorry for this misunderstanding" as it was "not our intention to give the impression that pimecrolimus should be prescribed to children younger than 2 years." The company has stopped the advertising campaign and is going to publish a correction in all the journals where the advertisement appeared.

The bulletin also raised another point. It questioned the scientific validity of the studies that backed the launch of the drug. It argued that it was inappropriate to use non-effective treatment (placebo) as a control group against pimecrolimus. It said that the cream should have been compared with the treatment of choice, which was the application of topical steroids. By comparing the cream with a placebo, the trial might have made the drug seem more beneficial than it actually was.

Dr Chiswell said that the company compared pimecrolimus with placebo rather than a topical steroid, because it was "not primarily intended to be used instead of topical steroids" but rather in cases where patients "refuse steroids" or would not take them for other reasons.

A statement from the company said: "Elidel (pimecrolimus) has not been compared with mild to moderate strength corticosteroids in clinical trials. Studies were designed to evaluate the efficacy of Elidel (pimecrolimus) in the prevention of flares of atopic eczema. There are no other potential comparator treatments that are specifically licensed for this indication."

The third issue raised by the bulletin concerned the safety of the drug. The bulletin said that there was not enough information on its possible harmful effects, with a special emphasis on its local immune suppressive effect.

A statement from Novartis said: "With regards to safety, Elidel (pimecrolimus) has only a low potential to affect systemic immune responses, as shown in standard pre-clinical models of systemic immunosuppression. Topical Elidel (pimecrolimus) penetrates similarly into, but permeates much less through human skin (in-vitro) than corticosteroids, and in clinical studies the systemic absorption was very low."
 
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