Recent highly publicized withdrawals of drugs from the market because of safety concerns
raise the question of whether these events are random failures or part of a recurring pattern …

THE CENTRAL THEME OF THE INSTITUTE OF MEDICINE report on the US drug safety
system was the need for a life cycle approach to drug evaluation: both the benefits and the …

Two alarming trends have surfaced in the pharma ceutical industry these past two decades.
The first is a surge in ethics violations. Despite journalists, researchers, bloggers, and lately …

ABSTRACT A recurring, foundational issue for evidence-based regulation is deciding
whether to extend governmental approval from an existing use with sufficient current …

Drawing on economic theory and institutional analysis, this paper reframes Akerlof's theory
of how a market for lemons operates and argues that each of the many markets for lemons …

" Smart, funny, clear, unflinching: Ben Goldacre is my hero."—Mary Roach, author of Stiff,
Spook, and Bonk We like to imagine that medicine is based on evidence and the results of …

If not randomized, biases can make determination of causation difficult will be used for
patients on whom it has not been studied or for whom it is cost-ineffective. In these …

Results of randomized clinical trials are the preferred “evidence” for establishing the benefits
and safety of medical treatments. We present evidence suggesting that the conventional …

Pharmaceutical manufacturers must conduct extensive research to prove the safety and
efficacy of a new drug before it can be sold to the public. However, once the Food and Drug …

Independent review panels plus a major industry review conclude that only 10-15% of" new"
drugs provide a significant therapeutic breakthrough over existing drugs and involve a new …