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Schizophrenia: no to placebo-controlled
clinical trials!

In a serious illness such as schizophrenia, for which there are effective drugs, conducting placebo-controlled clinical trials is not ethically acceptable.

The September issue of la revue Prescrire expresses outrage at the marketing authorisation granted to a "new" neuroleptic, paliperidone, which is no other than the active metabolite of risperidone. This authorisation was granted on the basis of paliperidone’s clinical evaluation dossier which did not include a single trial comparing it with risperidone, or with haloperidol (the first-line treatment), but simply with a placebo, which means that patients suffering acute illness were deliberately recruited for these trials and deprived of the best available treatment.

The launch of paliperidone ahead of the release of risperidone generics appears to be a purely commercial operation offering no tangible benefits for patients. Thus a pharmaceutical firm raced to commercialise a new drug; the drug regulatory agencies mechanically applied legislation which regrettably does not focus on therapeutic advances; and doctors whose conscience has been numbed chose not to bother to relieve patients’ suffering for the benefit of short-sighted "research".

For la revue Prescrire, the drug regulatory agencies need urgently reminding of their public heath remit, while healthcare professionals need to be reminded that their duty is first and foremost to patients.

©Prescrire Septembre 2007

Source: "palipéridone-Invega°. Rien qu’un métabolite de la rispéridone, un neuroleptique bientôt copié" Rev Prescrire 2007 ; 27 (287) : 651-652.

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