Biotech Syllabus
From Cyberlaw
Interactions and Tensions
Mp3 audio from Class One is now available here (right click to save a copy to your machine)
Instructors: Charles R. Nesson, Bruce A. Leicher and Gary A. Cohen
Administrative Support: Arielle Silver
Education Technology Support: Dustin Boyer
Harvard Law School
Spring 2006
Classes meet on Mondays, 4:45 to 6:45 PM
Pound Hall 204, Harvard Law School Campus
(see campus map and directions)
About this Course
Advances in medical research, particularly in biopharmacology, are pushing the boundaries of thinking on previously-unimaginable issues. What defines a human life? What are the proper uses of genetic information, by researchers, physicians and, perhaps, insurers and employers? In our post-genomic world, with clinical studies having expanded to less-developed countries, what constitutes ethically tenable research? At the same time, government, academia and industry are struggling to develop, and work within, sound and sustainable public health policies. Is the private, for-profit biopharmaceutical industry capable of conducting ethically-defensible clinical studies, both within and outside of the developed world? Do intellectual property protections add to, or detract from, individual and public health? How should biopharmaceutical corporations balance ethical obligations (if any) to make drugs affordable and accessible, with their ethical and legal obligations to shareholders? Are national governments and international organizations prepared to effectively regulate medical research? Are research universities still part of the academy, or are they "big business," too? If our overall healthcare delivery and financing system is "broken," is it ethically defensible to "blame" (via over-regulation) the scientists and businesspeople who start, finance and build the biopharmaceutical industry? Given present tensions – economic, legal and ethical – can academia, private healthcare providers, payers, government and industry adequately serve their disparate stakeholders and advance public health? This course will focus on the ethical, legal and social issues raised by new developments at the frontiers of bioscience. The course will provide students with an opportunity to investigate recent legal and bioethical controversies arising out of the proliferation of medical scientific developments; and will explore the use of – and limits to – law as a means of regulating medical research. Using an interdisciplinary approach and involving expert guest lecturers from industry, government and academia, the course offers students an opportunity for fresh, interesting, rigorous analyses of a host of issues related to health law policy, biotechnology and bioethics.
Students will be expected to write a twenty-page paper (12-point font, double-spaced, not including references, footnotes or appendices) on a subject of their choosing (to be discussed with and pre-approved by an instructor), and to contribute actively to class discussions and the class "wiki" (more information to be provided at the first class session).
Syllabus
Class One (Feb 06) – Setting the Stage: Health Law, Bioethics and Human Rights
Guest Lecturer: George J. Annas, Edward R. Utley Professor, BU School of Public Health
Reading:
- Annas, "American Bioethics after Nuremberg: Pragmatism, Politics, and Human Rights," University Lecture, Boston University, December 2005 (available here)
Class Two (Feb 13) – Industry: From Start-Up to Products
Guest Lecturer: T. Forcht (Teo) Dagi, M.D., Managing Director, Cordova Ventures
Readings:
- Understanding the Industry:
- Biotechnology Industry Organizaion (BIO) 2005-2006 Guide to Biotechnology (available here) (pages 1-49; 123-131)
- Biotechnology Industry Organization Timeline (available here)
- Pharmaceutical Research and Manufacturers of America (PhRMA) Pharmaceutical Industry Profile 2005 – From Laboratory to Patient: Pathways to Biopharmaceutical Innovation (available here)
- Joppi, Roberta, “Disappointing Biotech,” British Medical Journal, Volume 331(7521), 15 October 2005, pp 895-897 (available here)
- Avidor, Yoav, et al, “Biotechnology and Drug Discovery: From Bench to Bedside, Southern Medical Journal, Volume 96, Number 12, December 2003 (available here)
- Understanding the Technology: (Read briefly)
- John M. Wozney, “Overview of Bone Morphogenetic Proteins,” SPINE, Volume 27, Number 16S (2002), pp S2–S8 (available here)
- Vukmirovic, Ognjenka et al., “Exploring genome space,” Nature, Volume 405(6788), 15 June 2000, pp 820-822 (availabe here)
- Kieny, Marie Paule et al, “Research and Development of New Vaccines Against Infectious Diseases,” American Journal of Public Health, Volume 94(11), November 2004, pp 1931-1935 (available here)
- Alzheimer Disease Case Study: (Read briefly)
- Linda J. Van Eldik et al., “Barriers to Alzheimer Disease Drug Discovery and Development in Academia,” Alzheimer Disease and Associated Disorders, Vol. 16, Suppl. 1 (2002), pp. S18–S28 (available here)
- L. D. Altstiel et al., “Barriers to Alzheimer Disease Drug Discovery and Development in the Biotechnology Industry,” Alzheimer Disease and Associated Disorders, Vol. 16, Suppl. 1 (2002), pp. S29–S32 (available here)
- Howard M. Fillit, “Commentary: Barriers to Drug Discovery and Development for Alzheimer Disease,” Alzheimer Disease and Associated Disorders, Vol. 16, Suppl. 1 (2002), pp. S1–S8 (available here)
Optional Background Readings:
- Selkoe, Dennis J. et al, “Defining Molecular Targets to Prevent Alzheimer Disease,” Archives of Neurology, Volume 62(2), February 2005, p 192-195 (available here)
- T. Forcht Dagi, “Resource Material and General Bibliography: Biotechnology” (available here)
- Hampton, JR, "Clinical trial safety committees: the devil's spoon," British Medical Journal, Volume 320(7229), 22 January 2000, pp 244-245 (available here)
- Fukuyama, “How to Regulate Science,” The Public Interest, no. 146 (Winter 2002) (available here)
Class Three (Feb 20) – Industry: Private Control of Science and Medicine
Guest Lecturer: Sheldon Krimsky, Professor, Department of Urban and Environmental Policy & Planning, Tufts University
Readings:
- Complaint, Gelsinger v. Trustees of the Univ. of Pennsylvania (Court of Common Pleas, Philadelphia County) (available here)
- Danforth Report (available here) and University of Pennsylvania Response (available here) to Gelsinger Death
- Sheldon Krimsky and Ruth Hubbard, "The Business of Research," Hastings Center Report, Jan-Feb 1995 v25 n1 p41(3) (available here)
- Sheldon Krimsky, The Funding Effect in Science and its Implications for the Judiciary Journal of Law and Policy Vol. XIII, No.1 (2005) (available here)
- Sheldon Krimsky, "From Asilomar to Industrial Biotechnology: Risks, Reductionism and Regulation," Science as Culture 14(4):309-323 (December 2005) (available here)
- [Further Reading – Optional] Sheldon Krimsky, Science and the Private Interest. Rowman-Littlefield Publishing Co., 2003 (information available here)
Class Four (Feb 27) – Academia: Licensing Discoveries, Selling Itself?
Lecturer: Charles R. Nesson, Weld Professor of Law, Harvard Law School
Readings:
- Derek Bok, Universities in the Marketplace – The Commercialization Of Higher Education (2003) (Princeton University Press) (read Chapter One, available here)
- Risa L. Lieberwitz, The Marketing of Higher Education – The Price of the University's Soul, 89 Cornell L. Rev. 763 (2004) (reviewing Derek Bok's book) (Lexis or Westlaw)
Class Five (Mar 06) – Academia: Tech Transfer and the Bayh-Dole Act
Lecturer: Bruce A. Leicher, Vice President and General Counsel, Antigenics, Inc.
Readings:
- Bayh-Dole Act, Dec. 12, 1980, Pub. L. No. 96-517, 94 Stat. 3015-28 (codified, as amended, 35 U.S.C. §§ 200-212, 301-307 (2003))
- Rights to Inventions Made By Nonprofit Organizations and Small Business Firms Under Government Grants, Contracts, and Cooperative Agreements, 37 C.F.R. § 401 (2003)
- U.S. General Accounting Office, Technology Transfer: Administration of the Bayh-Dole Act by Research Universities (1998) (available here)
- Wendy H. Schacht, A Discussion on the Bayh-Dole Act and the Stevenson-Wydler Act (2000) (available here)
- Joshua A. Newberg & Richard L. Dunn, Keeping Secrets in the Campus Lab – Law, Values and Rules of Engagement for Industry-University R&D Partnerships, 39 AM. BUS. L.J. 187 (2002) (Lexis or Westlaw)
- MIT Technology Transfer Guide (available here)
- 2005 Model PHS Cooperative Research and Development Agreement (available here)
- 1998 Model NIH Materials Cooperative Research and Development Agreement (available here)
- Sample Biotech Sponsored Research Agreement (available here)
Class Six (Mar 13) – Government: Regulating the Marketplace
Guest Lecturer: Beverly Lorell, M.D., Chief Medical and Technology Officer, Guidant Corporation
Readings:
- U.S. Food and Drug Administration, "FDA History" (available here)
- U.S. Food and Drug Administration, "Benefit versus Risk: How the FDA Approves New Drugs" (available here)
- Marilyn J. Field and Hugh Tilson, Eds., Safe Medical Devices for Children, Committee on Postmarket Surveillance of Pediatric Medical Devices, The National Academy of Medicine (2005):
- Chapter 3: Regulatory Framework for Postmarket Surveillance of Medical Devices (available here)
- Chapter 4: Identifying and Understanding Adverse Medical Device Events (available here)
- Chapter 5: Monitoring of Postmarket Study Commitments Involving Medical Devices (available here)
- Regulatory Glossary and Acronyms (available here)
Class Seven (Mar 20) – Government: The Importance – and Challenge – of Patents
Guest Lecturer: Scott A. Brown, Vice President-Intellectual Property and Deputy General Counsel, Millennium Pharmaceuticals, Inc.
Readings:
- Merck v. Integra Lifesciences, 125 S. Ct. 2372 (June 13, 2005) (available here)
- Integra Lifesciences v. Merck, 2003 U.S. App. Lexis 27796 (June 6, 2003) (available here)
- Embrex v. Service Engineering Corp. , 216 F.3d 1343 (June 28, 2000) (available here)
- Madey v. Duke, 266 F. Supp. 2d 420 (June 15, 2001) (available here)
- Madey v. Duke, 307 F.3d 1351(October 3, 2002) (available here)
- Roche v. Bolar Pharmaceutical Co., 733 F.2d 858 (April 23, 1984) (available here)
- 35 USCS § 271 (2005) (available here)
- US Patent 6747150 B2 (Boronic Ester and Acid Compounds) (available here)
- US Patent 6696550 B2 (Humanized Anti-CCR2ab) (available here)
- "The Ethics of Patenting DNA," Nuffield Council on Bioethics (2002)(available here)
No Class (Mar 27) – Spring Recess
Class Eight (Apr 03) – Tensions: Ethics and Biotechnology
Guest Lecturer: Michael J. Sandel, Bass Professor of Government, Harvard University
Readings:
- "What Money Can’t Buy: The Moral Limits of Markets," Michael J. Sandel, The Tanner Lectures on Human Values, Delivered at Brasenose College, Oxford, May 11 and 12, 1998 (available here)
- "The Case Against Perfection," Michael J. Sandel, Atlantic Monthly, April 2004 (available here)
- Staff Background Paper on "Enhancements," President's Bioethics Council (2002) (available here)
- Staff Working Paper -- Distinguishing "Therapy" and"Enhancement," President's Bioethics Council (2002) (available here)
- Bostrom, "Human Genetic Enhancement: A Transhumanist Perspective" (2004) (available here)
- Baylis and Robert, "The Inevitability of Human Genetic Enhancements" (2003) (available here)
Class Nine (Apr 10) – Tensions: Financial and Other Conflicts of Interest
Lecturer: Bruce A. Leicher, Vice President and General Counsel, Antigenics, Inc.
Readings:
- Food and Drug Administration, Department of Health and Human Services (DHHS), Financial Disclosure Regulations (21 C.F.R. § 54 (2003))
- Moore v. The Regents of the U. of Cal., 51 Cal.3d 120 (Cal. 1990) (excerpts available here)
- Jennifer A. Henderson & John J. Smith, Financial Conflict of Interest in Medical Research – Overview and Analysis of Institutional Controls, 58 FOOD & DRUG L.J. 251 (2003) (Lexis or Westlaw)
- U.S ex re Franklin v. Parke-Davis, Case No. 96-11651-PBS (D. Mass. 2003) (Lexis or Westlaw); Franklin Amended Complaint and Summary Judgment Decisions
- PhRMA, Code on Interactions with Health Care Professionals (2002) (available here)
- Office of Inspector General, Compliance Program Guidance for Pharmaceutical Manufacturers (April 2003) (available here)
- Corporate Integrity Agreement Signed by Schering Plough (available here)
- Neurontin Case Materials:
- "Whistleblower Tells of 'Illegal' Tactics," Boston Globe, March 12, 2003 (available here)
- "Pfizer Nears Drug Settlement," New York Times, March 12, 2003 (available here)
- United States v. Parke-Davis, Memorandum and Order, August 22, 2003 (available here)
Class Ten (Apr 17) – Tensions: Interactions Among Companies, Healthcare Providers and Patients
Guest Lecturers: Harris Berman, M.D., Former CEO, Tufts Health Plan; Dean for Public Health and Professional Degree Programs, Tufts Medical School; and Jim Roosevelt, CEO, Tufts Health Plan
Readings:
- Marcia Angell: The Truth About the Drug Companies (excerpt) (available here)
- TCS News: “The Truth About Marcia Angell” (available here)
- TCS News: “Saving Marcia Angell From Herself” (available here)
- Nature Medicine: “Taking aim at Pharma” (available here)
- ACCME: Standards For Commercial Support – Standards to Ensure the Independence of CME Activities (available here)
- American College of Physicians: “Physician–Industry Relations. Part 1: Individual Physicians” (available here)
- American College of Physicians: “Physician–Industry Relations. Part 2: Organizational Issues” (available here)
- American College of Physicians: “Too close for comfort? How some physicians are reexamining their dealings with drug detailers” (available here)
- JAMA: “Health Industry Practices That Create Conflicts of Interest – A Policy Proposal for Academic Medical Centers” (available here)
- Medical News Today: “Medical Schools Should Ban Drug Company Gifts, Samples, Contributions To Continuing Education, JAMA Paper States” (available here)
- JHU Online Newsletter: “When Drug Reps Come Calling: To Protect The Integrity Of Prescribers, A New Hospital Policy Restricts The Activities Of Those Pushing New Therapies” (available here)
Class Eleven (Apr 24) – Tensions: Technology, Personhood, Politics and Regulation
Lecturer: Gary A. Cohen, Former Vice President of Ethics & Corporate Responsibility, Millennium Pharmaceuticals, Inc.
Slides: (available here)
Readings:
- Elliott, “Where Ethics Comes From” (available here)
- Shiavo Case: Selected Briefs:
- Brief of Michael Schiavo/ACLU (Pinellas County) (available here)
- Brief of Governor Jeb Bush (Florida Supreme Court) (available here)
- Reply Brief of Michael Schiavo (Florida Supreme Court) (available here)
- Reply Brief of Governor Jeb Bush (Florida Supreme Court) (available here)
- Amicus Terri Schiavo’s Parents (Florida Supreme Court) (available here)
- Amici 55 Bioethicists (Florida Supreme Court) (available here)
- Amicus Family Research Council Bioethics Group (Florida Supreme Court) (available here)
- Amici Not-Dead-Yet et al. (Florida Supreme Court) (available here)
- Amicus Academy of Florida Elder Law Attorneys (available here)
- Amicus Elder Law Section of Florida Bar (Florida Supreme Court) (available here)
- Amicus Association of American Physicians and Surgeons (11th Circuit) (available here)
- Amicus Congressman Weldon (11th Circuit) (available here)
- Background:
- Schiavo Timeline (available here)
- Transcript: For the Relief of the Parents of Terri Marie Schiavo (House of Representatives, March 20, 2005)(available here)
- Kass, "Is there a Right to Die?" (available here)
- Articles on Death and Dying: From DNR Orders to Active Euthanasia (available here)
- Dresser, "A Hard Case Makes Questionable Law" (available here)
- Annas, "'Culture of Life' Politics at the Bedside" (available here)
Class Twelve (May 01) – Tensions: Balancing Ethical and Economic Imperatives
Discussion: The Value of Acedia – A Roundtable Discussion of the Role of Ethics in Biotechnology Drug Pricing
Moderator: Charles R. Nesson
Panelists: Six Volunteers from Class
Reading:
- "The Value of Acedia: Ethics and Industry Decision-Making: Access to and Affordability of Breakthrough Biotechnology Products" (Case Study)(available here)
