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The depiction of Judgment Day on the façade of the Cathedral of Notre Dame shows an angel weighing the good and evil of souls to determine whence they go. Hanging on one side are devils tilting the scale in the wrong direction. In making decisions about treating multiple sclerosis (MS) with immunotherapies, we weigh risks and benefits. For us, the devil is in the details of those risks and benefits. If we underestimate risks or overestimate benefits, the scales can tilt in the wrong direction.
In 2000, the Food and Drug Administration (FDA) registered the chemotherapy drug, mitoxantrone, for the treatment of aggressive relapsing-remitting MS and secondary progressive MS (SPMS). The FDA based its decision largely on the results of a placebo-controlled trial conducted by the Mitoxantrone for Multiple Sclerosis (MIMS) Study Group. FDA approval came when the only published data from the trial were in abstracts.1,2 When the complete report of the MIMS trial was finally published in 2002,3 neurologists were already using mitoxantrone to treat SPMS.
In 2003, the Therapeutics and Technology Assessment (TTA) Subcommittee of the American Academy of Neurology (AAN) reviewed the evidence on mitoxantrone for the treatment of MS.4 The TTA subcommittee noted that there were blinding problems with the MIMS trial, the study …
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