ABSTRACT
Benoxaprofen, a propionic acid derivative, was developed by Eli Lilly (Lilly) during the 1970s. In the uk it was approved under the tradename Opren to treat the symptoms of arthritis, in hospitals in April 1980 and marketed to general practitioners in August/September 1980. In the us it was marketed to all doctors under the tradename Oraflex with the same basic indications to all doctors in May 1982. By 5 August 1982 Lilly had withdrawn the drug worldwide following its suspension on 4 August 1982 by the British regulatory authorities on the advice of the csm, and in the centre of a growing controversy about the drug’s safety and efficacy. This chapter examines in detail the production and use of scientific knowledge pertinent to benoxaprofen safety and efficacy by Lilly and the regulatory authorities. Throughout the chapter I refer to the generic name, benoxaprofen, unless wishing to emphasize the use of the drug specifically in the uk or the us, in which case I refer to Opren or Oraflex, respectively. Similarly, I refer to the drug’s manufacturers as Lilly, unless I am specifically discussing the actions of the British subsidiary, Dista Products Ltd (Dista).
