Ethical issues in drug testing, approval, and pricing : the clot-dissolving drugs / Baruch A. Brody.

New York : Oxford University Press, 1995.

x, 268 pages : illustrations ; 25 cm

Includes bibliographical references and index

Development of thrombolytic therapy -- Medical background -- Years of promise -- 1982: a year of consolidation and further initiatives -- Biotechnology, genentech and tPA -- Great clinical trials -- 1987: the year of FDA approval -- Money issues -- End of the story -- Final considerations -- Timetable of initial clinical trials of thrombolytic agents -- Estimates of additional short-term deaths in placebo control groups -- Backup calculations for estimates of additional deaths in placebo control groups

Troubling ethical issues in the conduct of clinical trials -- Selected survey of statements of principles and regulations -- Use of placebos in clinical trials -- Consent in the emergency room -- Conflicts of interests and the validity of clinical trials -- Troubling ethical issues in the approval of new drugs -- Development of the FDA regulatory scheme in the U.S. -- Alternative regulatory schemes in other countries -- Ethical foundations of an appropriate drug regulation scheme -- Troubling ethical issues in drug adoption

Prices, clinical choices and reimbursement policies -- Prices of drugs.