Abstract
To assess the potential damage to patients from the inappropriate use of placebo. Pivotal clinical trials of new drugs were evaluated for the treatment of multiple sclerosis following effective treatment with beta interferons and glatiramer acetate. The differences in the relapse rate between the experimental arms of the trials with interferons and glatiramer and the placebo groups were calculated. In ten pivotal trials, 2,752 patients were given placebo instead of the best proven treatments. The annualized relapse rate was reported for 2,405 of these patients. Patients receiving placebo suffered 630 more relapses than those treated with interferons or glatiramer. The inappropriate use of placebo in clinical trials unduly harms patients. The use of standard active comparators would preserve patients' rights and better define the respective clinical value of new medicines.
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