When marketing and science intersect: do patients with MS benefit?

MS entered the treatment era a scant 9 years ago with US Food and Drug Administration (FDA) approval of interferon β-1b. Since then, two interferon β-1a preparations, an amino acid polymer, glatiramer acetate; and a chemotherapeutic agent, mitoxantrone, have received regulatory approval in the United States and many other countries for various forms of relapsing MS. Approval is based on modest but clear-cut efficacy and acceptable toxicity. The details of the studies leading to these approvals are well described in a review article in the January 22, 2002 issue of Neurology .1 Although we now have a fuller treatment armamentarium, our understanding of the mechanisms of action of these agents is speculative, with much of what we think we know “reverse engineered” from the outcomes of the clinical trials. Equally important, information as to optimal dose, route of administration, and dosing frequency is quite limited for any of the agents, to say nothing about their comparative efficacy and safety. Thus, there is little in the way of science to inform …