Ethical Issues in Drug Testing, Approval, and Pricing: The Clot-Dissolving Drugs

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.

Dr. Brody offers a series of solutions based upon philosophical principles such as respect for individual differences in a liberal society. An insightful critique of the current process of approving drugs by the FDA in the United States is also provided. The book offers a new way to deal with questions about the cost of drugs. And it gives a complete history of a major medical development that saves thousands of lives each year, the use of clot-dissolving drugs for patients with heart attacks. This illuminating 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.