Ethics and the Pharmaceutical Industry

Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Government officials and social critics have questioned whether the multibillion-dollar industry is fulfilling its social responsibilities. This doubt has been fueled by the national debate over drug pricing and affordable healthcare, and internationally by the battles against epidemic diseases, such as AIDS, in the developing world. Debates are raging over how the industry can and should be expected to act. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, and marketing.

Table of Contents:
Charting a sustainable path for the 21st century pharmaceutical industry Michael A. Santoro; Part I. Profits, Patients' Rights, and Scientific Progress: The Ethics of Clinical Research Conducted in Private Enterprises: 1. Drug research: between ethical demands and economic constraints Jurgen Drews; 2. Emerging international norms for clinical testing: good clinical trial practice Juhana E. Idanpaan-Heikkila and Sev S. Fluss; 3. The regulatory and ethical challenges of pediatric research M. Dianne Murphy and Sara F. Goldkind; 4. Including children in research: participation or exploitation? Robert M. Nelson; 5. Racial and ethnic inclusiveness in clinical trials Valentine J. Burroughs; 6. The rights of patients to participate in clinical trials Glenna Crooks; 7. How should government regulate stem-cell research? Perspectives of a scientist-legislator The Hon. Rush Holt; Part II. Marketing and the Efficient Utilization of Healthcare Resources: Ethical and Public Policy Challenges: 8. Ethics and prescribing: the clinician's perspective Charles L. Bardes; 9. Direct-to-consumer advertising of prescription drugs: a policy dilemma Meredith B. Rosenthal and Julie M. Donohue; 10. Regulation of prescription drug promotion Thomas Abrams; 11. Off-label communications in marketing prescription drugs Scott D. Danzis; 12. The need for better health information: advancing the informed patient in Europe Don E. Detmer, Peter Singleton and Scott C. Ratzan; 13. Who should get access to which drugs? An ethical template for pharmacy benefits Norman Daniels, James E. Sabin and J. Russell Teagarden; 14. The application of cost-effectiveness and cost-benefit analysis to pharmaceuticals Joel Hay; Part III. Patents, Pricing, and Equal Access: 15. Intellectual property rights, access to life-enhancing drugs, and corporate moral responsibilities Patricia H. Werhane and Michael Gorman; 16. A future agenda for government-industry relations William Weldon; 17. AIDS activism and the pharmaceutical industry Martin Delaney; 18. The campaign against innovation Sidney Taurel; 19. Third world perspectives on global pharmaceutical access James Thuo Gathii; 20. The promise of vaccines and the influenza shortage of 2004: public and private partnerships Gary R. Noble; Part IV. Charting a Sustainable Path for the 21st Century: 21. Evolving approaches to healthcare challenges Thomas M. Gorrie; 22. Property rights in crisis: managers and rescue Nien-he Hsieh; 23. Blurring the lines: public and private partnerships addressing global health William Foege; 24. Renegotiating the grand bargain: balancing prices, profits, people, and principles Greg Koski.

About the Author :
Michael A. Santoro is Associate Professor with tenure in the Business Environment Department at Rutgers Business School, where he teaches courses on business ethics, public policy, labor and human rights, law, ethical issues in the pharmaceutical industry, and China business strategy. Professor Santoro holds a Ph.D. in Public Policy from Harvard University and a J.D. from the New York University School of Law. As a Research Associate at Harvard Business School, he wrote or co-authored nearly 30 case studies and teaching notes on ethical and legal topics such as global protection of intellectual property, insider trading, the Federal Sentencing Guidelines, and the Fair Credit Reporting Act. Professor Santoro has also published numerous journal articles, op-ed articles, and book chapters on these topics in publications such as Foreign Policy, and Human Rights Quarterly. He is the author of Profits and Principles: Global Capitalism and Human Rights in China (2000). Thomas M. Gorrie is Corporate Vice President, Government Affairs & Policy at Johnson & Johnson, with responsibility as Corporate Officer for all federal, state, and international government affairs and policy. He has over 30 years of worldwide health care experience. He has worked with various Johnson & Johnson companies in research and development, marketing and sales, business development, strategic planning, general management, international venture capital, and health policy. Dr Gorrie received his Ph.D. in chemistry from Princeton University. He completed post-doctoral studies at the Swiss Federal Institute of Technology in Zurich. He serves on numerous non-profit boards, including Duke University Health Care System, Robert Wood Johnson University Hospital, the Dean's Advisory Board of the Rutgers Business School, and the Hun School of Princeton.

Review :
'... Michael Santoro and Thomas Gorrie have compiled a series of essays that provide a fair, balanced and insightful examination of an increasingly troubled relationship between the pharmaceutical industry and society.' Journal of the American Medical Association