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Last year I described in this journal1 an unacceptable influence of a pharmaceutical company on the off-label use of one of its products. Now I would like to report on an acceptable and even praiseworthy initiative of a pharmaceutical manufacturer in monitoring the use of its drug. The devastating action of thalidomide on the human embryo caused its withdrawal from the market in the early 1960s. This teratogenic drug began, however, to be used again when it was found that it had a favourable effect on patients suffering from various diseases.2–4 One of the companies producing this drug was aware that it had a moral responsibility to prevent (accidental) abuse of its product.5 The scientists of this company have developed a number of criteria: STEPS, that is, a System for Thalidomide Education and Prescribing which includes a registry of all treated patients (under a code number). The authors show that they are aware of possible mishaps when they write: “Despite all the checks and balances in the STEPS programme, the system will work only if it makes intuitive sense to its participants and they adhere to program requirements”.5 An even more stringent attitude is taken by Bousvaros and Mueller6 when they write: “Given the ethical complexities of thalidomide use, we recommend that individuals planning to precribe thalidomide consult with their hospital’s institutional review board and develop their own formal protocols, independent of the consent provided by the manufacturing company. Such a consent should include information about the efficacy in the condition being studied and review adverse effects of sedation, constipation, erythroderma, neuropathy, and teratogenicity”. Strangely enough none of the authors appear to have reserved a task for the governmental safety evaluation agencies. In my opinion they should be kept informed of all clinical trials with off-label administered drugs. These administrative authorities should be allowed to intervene, if necessary at all stages of the treatment.
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