Safe Drugs and the Cost of Good Intentions

Abstract

In recent years, the pendulum of opinion on the health benefits and risks of drugs has swung back from what were often unrealistically high hopes to much grimmer expectations. This shift has resulted from several high-profile incidents related to the drugs' risks and the perception that drug companies downplayed safety findings. Not only has the reputation of the pharmaceutical industry become tarnished as a result, but the performance of drug-regulatory agencies has also come under renewed scrutiny. Some observers have concluded that the entire regulatory system must be revamped because regulators have failed to apply sufficient counterpressure on companies.