The Limits of Evidence in Drug Approval and Availability: A Case Study of Cilostazol and Naftidrofuryl for the Treatment of Intermittent Claudication

The history of the evaluation, approval, and marketing of these drugs illustrates the limitations of data in the regulatory approval and marketing of agents whose benefit is subjective and difficult to quantify. Implementation of a standardized protocol with strict eligibility criteria, objective quantifiable measurement of drug effect, and validated endpoints will eventually allow development of an ideal pharmacotherapy for IC.