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Implications for Therapeutics

Richard A. Rudick, MD

Arch Neurol. 1994;51(2):125-128.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

FOLLOWING AN open hearing in March 1993, an advisory panel to the US Food and Drug Administration (FDA) recommended approval of a new therapy for exacerbating-remitting multiple sclerosis (MS). Betaseron, it was reported, not only reduced the annual exacerbation rate by about 35% but also significantly slowed increasing plaque burden measured by serial magnetic resonance imaging (MRI). The atmosphere at this extraordinary hearing was a bizarre combination of medicine, politics, and finance. The room was filled with patient advocates, neurologists, biotechnology and pharmaceutical industry representatives, and financial analysts armed with cellular telephones. Stock prices for Chiron, the manufacturer of Betaseron, fluctuated during the hearing, along with the hopes and fears of patients; but by the end of the day, the advisory panel had determined that Betaseron was both safe and effective for the treatment of exacerbating-remitting MS. Significantly, approval was heavily supported by an objective test—MRI—that corroborated the clinical findings. . . . [Full Text PDF of this Article]

Author Affiliations
Cleveland, Ohio

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