Ethics and the business of bioscience / Margaret L. Eaton.

Format:

Book

Author/Creator:

Eaton, Margaret L.

Language:

English

Subjects (All):

Medical ethics.

Medicine--Research--Economic aspects.

Medicine.

Business ethics.

Biomedical Research--ethics.

Ethics, Business.

Commerce--ethics.

Equipment and Supplies.

Industry--ethics.

Research Design.

Medicine--Research.

Medical Subjects:

Biomedical Research--ethics.

Ethics, Business.

Commerce--ethics.

Equipment and Supplies.

Industry--ethics.

Research Design.

Physical Description:

xv, 534 pages ; 23 cm

Place of Publication:

Stanford, Calif. : Stanford Business Books, 2004.

Summary:

" The stakes in bioscience, both moral and financial, are high. While each of the landmark cases depicted in Ethics and the Business of Bioscience" offers distinct lessons, in aggregate it becomes clear that those engaged in bioscience and business must learn to exercise moral reasoning as scientific adn financial decisions are being made. Eaton' s accessible text should prove to be a useful resource for those learning to do so." --Journal of the American Medical Association"

Contents:

Why study bioscience business ethics? 5

Benefits of addressing ethical and social issues 13

Tour of the book and suggestions for use of the material 14

Part II Ethics and Industry Overview

2 Ethics and Business Activity 23

Benefits of incorporating ethics into business decision making 26

Moral systems 31

Utilitarianism 33

Kantian ethics, rights, and duties 39

Justice and fairness 46

Formal and material principles of justice 47

Distributive justice 47

Compensatory justice 55

Method for ethics analysis and decision making 57

3 Ethics Analysis Applied to Monsanto and the Labeling of rbST 70

Case study: Monsanto and the labeling of rbST 70

Utilitarian analysis 88

Rights analysis 94

Justice 99

Ethical reasoning conclusions 101

4 Research Ethics 106

Human research 106

Animal research 119

5 Industry Regulation and the Product Approval Process 129

Striking a balance between speed and safety 130

Stages of FDA product review 132

Clinical trials process 137

Medical device regulation 143

6 Research Collaborations Between Academia and Industry 151

Benefits and risks of collaboration 152

Assessing the impact of university-industry research relationships 156

Changes in industry-academic relationships and the federal response 159

Case study: Novartis-U.C. Berkeley research collaboration 161

7 Industry-Sponsored Clinical Research and the Use of Placebo Controls 195

Placebo controls 196

Ethical issues in placebo-controlled studies 200

Changing views on placebo controls 202

International debates 203

Case study: Genzyme Tissue Repair and the NeuroCell-PD clinical trials 207

8 Mitigation of Harm to Subjects Injured in Clinical Research 235

History of attempts to develop compensation policies 236

Industry research practice 242

Tentative responses and renewed calls for mandatory compensation programs 244

Case study: Adiana, Inc., and the development of a female sterilization device 246

9 Conducting Clinical Research in Developing Countries 276

HIV transmission research in Haiti 278

AZT studies in pregnant African and Thai women 280

HIV transmission trial in Uganda 282

Cardiac drug trials in Argentina 284

Case study: VaxGen, Inc., fighting the AIDS epidemic 288

10 Anticipating and Managing Postmarket Problems 329

Medical and social uncertainties associated with marketing medical products 329

Uncertainty about product safety and efficacy 330

Product misuse 332

Public acceptance 333

Evolving medical information 333

Case study: Myriad and OncorMed and the marketing of the first genetic tests for breast cancer susceptibility 337

11 Access to Medical Products 377

AIDS activists and the Food and Drug Administration 378

Early access: Compassionate use, treatment INDs, and parallel track programs 380

Personal use import exemption 382

Accelerated drug approval 384

Pharmaceutical companies and drug pricing 386

Case study: Merck's U.S. managed distribution program for the HIV drug Crixivan 391

12 Advertising Prescription Drugs Directly to Patients 427

Development and enforcement of FDA's DTC broadcast ad guidelines 429

Cost effectiveness of DTC prescription drug advertising 431

DTC prescription drug advertising expenditures 434

Medical community reactions to DTC prescription drug advertising 436

Case study: Zeneca's direct-to-consumer advertising of Nolvadex 443

13 Using Corporate Ethics Advice 480

Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts 482

Affymetrix, Inc., Santa Clara, California 484

The Institute for Genomic Research, Rockville, Maryland 484

DNA Sciences, Mountain View, California 485

Advanced Cell Technologies, Worcester, Massachusetts 486

Case study: Geron Corporation and the role of ethics advice 490.

Notes:

Includes bibliographical references and index.

ISBN:

0804742499

0804742502

OCLC:

52813825