Regulation of medicines

These detectorists are responsible for an important aspect of post-marketing surveillance of safety of medicines. They supplement the system of licensing of medicines. To obtain a licence for a medicine, the applicant has to satisfy the regulator as to its quality, efficacy and reasonable safety in the indication proposed for it. A drug with even modest benefits can be identified in relatively small placebo-controlled clinical trials. Often the ‘benefits’ are changes in a biochemical measure, such as serum cholesterol concentration, which is a surrogate measure of the clinically important effect. It is much harder to know about potentially important adverse effects. This is important, since rational therapeutics demands that both the potential benefit and the possible harm that could result from treatment are weighed in the balance. By contrast, common adverse effects of treatment occur even with placebo (the ‘nocebo’ effect) and confuse the picture. A rare adverse drug reaction can be difficult to detect, but serious enough to alter the balance between benefit and harm. How can the prescriber make proper decisions or give proper advice if the possible harm is undefined, and serious adverse drug reactions remain to be discovered?