Communicating the risks and benefits of medicines.

Pharmaceutical innovation, together with rising education, sanitation and wealth, prolonged life expectancy in industrialised countries throughout the 20th century. At the turn of the 21st century, with many, formerly common, lethal diseases confined to the developing world, the benefits of medical intervention are taken for granted in industrialized countries, and the expectations of safety have risen considerably. The perception and tolerance of risk has changed largely in the absence of immediate, population-wide health threats. Here, we review selected examples of drug withdrawals and adverse drug effects, and their impact on public perception. We analyse the role of major players, such as the media, patients, prescribers, regulators and pharmaceutical companies, and what actions are needed to better describe and communicate the risks and benefits of medicines to the public.

Biomarkers in the prevention and treatment of atherosclerosis: need, validation, and future.

Cardiovascular disease (CVD) remains one of the leading causes of morbidity and mortality in the developed world, and there is a clear need to develop novel therapeutic strategies to reduce cardiovascular risk further than is currently possible. Traditionally, the effectiveness of new cardiovascular drugs has been evaluated in clinical trials using cardiovascular outcomes as endpoints. However, such trials require large numbers of patients followed over long periods of time. Clinical trials using surrogate markers for CVD may be shorter in duration and involve fewer participants. Measurement of atherosclerotic progression is an ideal surrogate marker as it is predictive of future cardiovascular events. The "gold standard" for detecting and defining the severity, extent, and rate of atherosclerotic progression has been quantitative coronary angiography. However, this technique has fundamental limitations. More recently, measurement of carotid intima-media thickness using B-mode ultrasound and measurement of atheroma volume using intravascular ultrasound have emerged as more accurate techniques for detecting atherosclerotic progression. Both of these techniques have potential utility as surrogate endpoints in place of cardiovascular outcomes in clinical trials. Their use might facilitate the more rapid development of novel, safe, and effective therapies.