Author Description

Although most developed countries have extensive regulations governing the testing, approval and marketing of new drugs, there are major gaps in these regulations. In this compelling new volume, Dr. Brody uses the example of the development of thrombolytic drugs to identify several such gaps. Issues addressed include the use of placebo control groups in clinical trials, the importance of determining the type of consent that should be obtained for emergency research, and ways to avoid conflicts of interest in clinical trials. He also discusses topics such as deciding to continue clinical trials or to approve a drug quickly, maintaining a proper balance between efficacy and safety in drug approval, the pricing of new drugs and considering prices when ordering drugs. This work offers the first comprehensive analysis from an ethical perspective of the entire drug development process, and it does so while comparing American and European approaches to the process.