Healthy Skepticism Library item: 19892

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Publication type: Journal Article

Prescrire on 'commercial' drug launches
SCRIP 1994 Jun 21; 1933:29

Full text:

The French drug bulletin, Prescrire, has criticised the launch in France of two pharmaceutical products: a 67mg micronised formulation of Fournier’s hypolipaemic, Lipanthyl (fenofibrate), and Pierre Fabre’s anorectic, Incital (mefenorex).

…Lipanthyl 67M
The launch of Lipanthyl 67M to replace Laipanthyl 100mg, which was withdrawn from the market at the end of 1993, is a “purely commercial operation”, according to Prescrire. The cost per capsule of Lipanthyl 67M is Fr1.11 56% more than a capsule of Lipanthyl 100, it notes.

The clinical evaluation dossier for fenofibrate is still very limited, Prescrire says, describing the product information for Lipanthyl 67M, published in November 1993, as “skeletal”. It includes a pharmacokinetic study of the bioequivalence of the two products in 24 healthy volunteers, and three other pharmacokinetic studies from 1982, 1986 and 1989. These last three studies concluded that age or average/moderate renal insufficiency had no effect on the pharmacokinetics of fenofibrate, but none of them actually studied Lipanthyl 67M, Prescrire says.

Fenofibrate has been marketed for 20 years, but has never been tested in clinical trials in terms of mortality and morbidity, and the bioquivalence data are “minimal”, according to the drug bulletin. Lipanthyl 67M is reimbursed at 65%. Prescrire criticises both the company for launching the product, and the “complicity, if only passive”, of the health authorities and reimbursement bodies.

…Incital
Incital is not really a new product: mefenorex was approved in France in 1966 and launched by Roche in 1970 as Pondinil, although it was withdrawn from the market in 1987, according to Prescrire. The clinical trials cited in the product information for Incital were all published between 1963 and 1970; mefenorex has never been tested in long-term clinical trials, and “has not been compared with other anorectics in clinical trials which meet current scientific requirements”, it says. “To our knowledge, mefenorex has never been marketed in countries with an active pharmacovigilance system (the Nordic and ‘Anglo-Saxon’ countries).”

In terms of its risk/benfit profile, mefenox cannot be seen as anything but an amphetamine-type anorectic, and is described as such in Martindale, Prescrire says. The risk/benefit profile of such anorectics is “unfavourable” overall, given their limited short-term efficacy, their “no doubt zero long-term efficacy”, and their “relatively frequent” side-effects, it declares.

The use of amphetamine-type anorectics is generally not recommended for the treatment of obesity, and the relaunch of mefenorex “has no justification in terms of public health”, Prescrire says. This launch too is a “purely commercial operation” given the high price of the product (Fr120 for 24×40mg tablets, non-reimbursed), it adds. The health authorities “have not been consistent in allowing such an operation” it adds.