Research Catalog

Title

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

Author

Brody, Baruch A.

Publication

New York : Oxford University Press, 1995.

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Holdings

Details

Description

x, 268 pages : illustrations; 25 cm

Summary

• . 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.
• 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.

Subjects

• Ethics, Pharmacy
• Fibrinolytic Agents
• Drugs > Prices > Moral and ethical aspects
• Drug Approval
• Drug Costs
• Drugs > Testing > Moral and ethical aspects
• Fibrinolytic agents
• Ethics, Medical

Bibliography (note)

• Includes bibliographical references and index.

Contents

• 1. The Development of Thrombolytic Therapy. The Medical Background. The Years of Promise. 1982: A Year of Consolidation and Further Initiatives. Biotechnology, Genetech, and tPA. The Great Clinical Trials. 1987: The Year of FDA Approval. Money Issues. The End of the Story. Final Considerations -- Appendix A. Timetable of Initial Clinical Trials of Thrombolytic Agents -- Appendix B. Estimates of Additional Short-Term Deaths in Placebo Control Groups -- Appendix C. Backup Calculations for Estimates of Additional Deaths in Placebo Control Groups -- 2. Troubling Ethical Issues in the Conduct of Clinical Trials. A Selected Survey of Statements of Principles and Regulations. The Use of Placebos in Clinical Trials. Consent in the Emergency Room. Conflicts of Interests and the Validity of Clinical Trials -- 3. Troubling Ethical Issues in the Approval of New Drugs. The Development of the FDA Regulatory Scheme in the United States. Alternative Regulatory Schemes in Other Countries.
• The Ethical Foundations of an Appropriate Drug Regulation Scheme -- 4. Troubling Ethical Issues in Drug Adoption. Prices, Clinical Choices, and Reimbursement Policies. The Prices of Drugs.

ISBN

019508831X

LCCN

94004479

Owning Institutions

Columbia University Libraries