Drug Safety - A Billion Dollar Story

Abstract

In 1997, American Home Products (AHP) withdrew its diet drugs Redux (dexfenfluramine) and Pondimin (fenfluramine) from the market. Studies by the US Food and Drug Administration (FDA) had linked the drugs, commonly known as Fen-phen, to potentially fatal heart valve damage and pulmonary hypertension. Six years and one name change later, Wyeth is still struggling to shake off the impact of Fen-phen on its earnings (Source: Financial Times, "Drug Companies Hit by Charges", Oct. 23, 2003). Fen-phen and other high profile cases show that drug safety is not just a backroom activity performed to satisfy the reporting requirements of the regulators; it can have a major bearing on a company's profit and market capitalisation. Sanofi-Synthé labo learned the same thing with its anti-platelet agent Plavix - in reverse. Clinical trials have shown that although Plavix is only marginally more effective than aspirin in reducing the risk of myocardial infarction, stroke and vascular death in patients with atherosclerosis, it is less likely to cause gastrointestinal bleeding. A better safety profile, as distinct from greater efficacy, was enough to knock the cheap and cheerful aspirin off its perch, and turn Plavix into a blockbuster - helping to boost the company's overall sales by 14.8% in 2002. The cost of selling drugs with damaging side effects is considerable, as are the rewards for making drugs that are safer than comparable medications, even if they do not work any more effectively. Yet many pharmaceutical companies continue to develop drugs that show signs of causing serious side effects rather than spiking them at an early stage in the clinical testing process. In doing so, they waste millions of dollars, as well as potentially jeopardising the lives of patients and their own reputations. With proper risk management - the early detection an understanding of risk, and subsequent management of that risk throughout the product lifecycle - it is possible both to make drugs with an acceptable risk/benefit profile and to ensure that those drugs are profitable.