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

Bibliographic Details
Main Author:	Brody, Baruch A.
Format:	Book
Language:	English
Published:	New York : Oxford University Press, 1995.
Subjects:	Bioethics > United States. Drug Evaluation. Drug Approval > economics > United States. Drug Costs. Fibrinolytic Agents. Clinical Trials as Topic > economics > United States.

Table of Contents:

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.