Course Syllabus:
Business of Healthcare

Faculty

Professor Donald P. Conway

Objectives

COURSE OBJECTIVES
This course focuses on the intersection of business and medicine. As the U.S. population ages, an entirely new demographic stress will be put on our healthcare system. Within this context, new business opportunities will emerge. The demand for health care will increase significantly over the next 25 years. New forms of delivery systems must be initiated to minimize the pressure on our fragile hospital system.

The course will be framed within the context of the U.S. employer-based system. The issue of 47 million Americans who are uninsured must be addressed in developing any solution. The U.S. system will be compared against other single-payer and universal coverage systems in terms of costs, quality and health outcomes. The course will focus on real world business opportunities for health care providers, doctors, and hospital systems, products (e.g. pharma, biotech and medical devices) and health care services.

LEARNING OBJECTIVES
As healthcare is a highly regulated industry worldwide. Emphasis will be put on understanding regulation and formal requirements which impact commercial success of an enterprise. Variations in strategies for development and commercialization will be highlighted.
The primary objective will be to understand the business side of health care and be able to answer the following questions:
• At which point and what data would you require to invest in a health care product/company? • What factors would you consider and which variables would have the most impact upon your investment decision the most?
These fundamental questions will be analyzed from both a venture capital and also an entrepreneurial point of view.
Overall, this course is intended to prepare managers, investors, and consultants in the healthcare field for success in an important industry which is in flux.

Requirements

Materials

The syllabus & course pack contains all prescribed readings and cases.

NOTE:
Required readings (including all case materials) are clearly identified as such under "REQUIRED" headings.
Optional readings are grouped together and listed last for each class session under "OPTIONAL READINGS BELOW".

Attendance

Since the material in this class builds session by session, attendance at each session is important. Please notify me before class by any means available if you are unable to attend a session due to illness, family emergency, or an unavoidable conflict. If you must miss a class session for any reason, please notify me by e-mail in advance of class.

Tuck Honor Code

The Honor Code Principle applies to this course.

Office Hours

My office hours are Wednesdays, 12:00 Noon to 5:00 pm and Thursdays, 9:00 am to 5:00 pm. You may also make an appointment to meet with me at another time by contacting me directly via email, phone, or at the end of class.

Classroom Time & Preparation

Classroom time will predominantly revolve around the class presentation and associated readings. For the class to work well, and for you to benefit from it to the greatest possible extent, preparation for each class meeting is essential. All students are expected to arrive at class prepared to discuss the readings and case(s) assigned for that day.

Grading

Class Participation - 50%

The classroom is a chance for you to test and challenge new ideas and concepts. Participation in class will be evaluated on the quality and intellectual rigor of the discussion. As students have varied backgrounds, every question is encouraged.

Mid-term Paper - 10%

A three-page paper on a current healthcare topic of interest to you is due by close-of-business Monday, April 27, 2009. An analysis of any case we will cover would also be sufficient to meet this requirement. Again, that is, any one of the cases in the course packet. I am always available to discuss potential topics and scope for your papers. Please submit your papers to my assistant, Marcia Diefendorf, in 310 Woodbury by close-of-business on business Monday, April 27, 2009.

OPTION: Either Group Project OR Final Exam - 40%

Project (40%)
The optional Project is focused on applying the concepts and principals you learn in class at a real world situation in which you have a stake. Ideally, this would relate to work you plan to pursue in your internship or after graduation. This can be an individual or group effort. Groups should consist of no more than 3 people. I am always willing to discuss ideas and alternatives for your projects at any time. Executive summaries of the project are due by close-of-business on Tuesday, April 28, 2009.

Projects are due Tuesday, May 19, 2009. The project can be a slide deck sufficient for a 15-minute presentation or a 3,000 word research paper with citations.
Please give your projects to my assistant, Marcia Diefendorf, in 310 Woodbury Hall by close of business Tuesday, May 19, 2009.

Final Exam (40%)
The optional Final Exam with instructions will be distributed on Tuesday, May 19, 2009 in class. It is due on Friday, May 22, 2009.

Schedule

Class 1
Tues. 3/24
Overview of the U.S. Healthcare System and Managed Care Organizations

The U.S. spends twice as much gets worse health outcomes.


SPEAKER: Donald P. Conway, MD/MBA, T’72

OBJECTIVE: To frame the challenge of managing in the evolving health care environment.

TOPICS: Industry Analysis; Quality; Supply & Demand Setting; United States; Health Care Industry

REQUIRED READINGS:

The Challenge Facing the U.S. Healthcare System (Richard Bohmer and Carin-Isabel Knoop) (HBS 9-606-096)

Uwe E Reinhardt "Is There Hope For The Uninsured?" Health Affairs: WEB EXCLUSIVES (July 1, 2003): W376-W390. See Weblink:

"Health Costs: Symptom or Disease?:[Letter], The New York Times, June 10, 2007, Late Edition (East Coast), See Weblink:

Nigel Hawkes, INTERVIEW: Frontline, WGBH, April 15, 2008. See Weblink:

“Uninsured Put a Strain On Hospitals,” by Reed Abelson, The New York Times, Thursday, December 9, 2008, pp. B1, B7. See Weblink:

Julie Rovner,, “Obama: Crushing Health Care Costs Must Be Fixed,” NPR, March 10, 2009. See Weblink:

Laura Meckler, “Obama Emphasizes Controlling Health-Care Costs,” The Wall Street Journal, Friday, March 6, 2009, p. A4. See Weblink:

Optional:

OPTIONAL READINGS BELOW:

Wilhelmine Miller, Elizabeth Richardson Vigdor, Willard G Manning. "Covering The Uninsured: What Is It Worth?" Health Affairs: WEB EXCLUSIVES (January 1, 2004): W157-W167. See Weblink:

Optional: Richard Wolf, “Social Security Hits First Wave of Boomers,” USA Today, Tuesday, October 9, 2007, See Weblink:

Class 1 (cont'd)

Optional: OPTIONAL READINGS BELOW: (continued)

The New York Times-"The High Cost of Health Care," EDITORIALS/LETTERS, November 25, 2007. See weblink:

Optional: “Obama’s smart play on healthcare,” by Doyle McManus, Los Angeles Times, March 1, 2009. See Weblink:

Optional: “Obama principles for health care reform,” Psyche, Science, and Society. (Blog of Stephen Soldz: Psychoanalyst, Psychologist, Researcher, and Activist). See Weblink:

Optional: “Health-Care Spending Slows in U.S. as Recession Curbs Coverage,” by Aliza Marcus. Bloomberg, February 24, 2009. See Weblink:

Optional: “For Uninsured Young Adults, Do-It-Yourself Medical Care,” by Cara Buckley, The New York Times, Wednesday, February 18, 2009, See Weblink:

Optional: “The Hunt for Health Insurance For Those Who Are Self-Employed,” by Marci Alboher, The New York Times, Thursday, March 27, 2008. P. C5. See Weblink:

Optional: “Health Insurers, Poised for Round 2,” by Reed Abelson, The New York Times, March 1, 2009, See Weblink:

Optional: Dan Bilefsky, “Medical Care in Romania Comes at an Extra Cost,” The New York Times, Monday, March 9, 2009, p. A8. See Weblink:

Optional: “Sick around the world,” [PBS FRONTLINE’S Interview with Karl Lauterbach). See Weblink:



Class 2
Wed. 3/25

SPEAKER: Donald P. Conway, MD/MBA, T’72


Case: Cleveland Clinic (HBS 9-607-143)

REQUIRED READINGS:

“Building a Strong Services Brand” [BH230-Kelley School of Business -(HBS)]

Alan Murray (2006, February 1). The Economy; BUSINESS: “Health-Care Fixes Should Focus on Quality”. Wall Street Journal (Eastern Edition), p. A.2. See Weblink:

“Building a strong services brand: Lessons from Mayo Clinic´by Leonard L. Berry and Kent D. Seltman. Business Horizons, Vol. 50, (2007) pp. 199-209. See Weblink:

Optional:

OPTIONAL READINGS BELOW:

“AMERICA'S Best Hospitals,” (cover story) U.S. News & World Report, July 10, 2008, following pp. 40-41. See Weblink:

Optional: “Rating Doctors Like Restaurants,” EDITORIAL: The New York Times, February 18, 2009, Editorial Desk, SECTA, Late Edition, Final. See Weblink:

Optional: “Late Approval of Drugs Linked To Safety Issues,” by Keith J. Winstein, Wall Street Journal, March 27, 2008. pp. D1, D6. See Weblink:

Optional: “Doctors Show Their Hand,” by Reed Abelson, The New York Times, Wednesday, December 3, 2008, pp. B1, B8. See Weblink:

Optional: Jo-Ann Byrne, Sigrid Schreiner, Emad Rizk and Laura Sokolowski, “Clinical Quality Benchmarking: Here’s How to Do It and Why,” Trustee, May 1, 1998. See Weblink:



Class 3
Mon. 3/30

Objective:
The class will focus on:
• the basics of current health care payment mechanisms including role of government and private payors
• how these reimbursement systems impact provider and payor behavior including the issues of cost shifting, payor mix and clinical program mix
• the strategic issues and dilemmas caused by the current organization and financing of the health care in the US • impact on the overall health care industry and US economy

GUEST SPEAKER:
Paul B. Gardent (MBA /CPA, T’76)
Senior Associate,
Center for Leadership and Improvement
The Dartmouth Institute for Health Policy and Clinical Practice

Paul B. Gardent is a Senior Associate at the Center for Leadership and Improvement at The Dartmouth Institute for Health Policy and Clinical Practice. Prior to that he served as Executive Vice President, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire where he worked for twenty-seven years.

Prior to DHMC, he worked as Senior Vice President, The Memorial Hospital, Pawtucket, Rhode Island, and as a Senior Consultant for Price Waterhouse Company in Boston, Massachusetts. Mr. Gardent also worked as Administrator, Maternal and Child Health Services for the State of New Hampshire.

Mr. Gardent is a graduate of the University of New Hampshire with degrees in Business Administration and Sociology and was awarded a Masters of Business Administration degree from the Tuck School of Business at Dartmouth College where he was an Edward Tuck Scholar. Mr. Gardent is a Certified Public Accountant.

Among his current professional activities, Mr Gardent is on the Board of Directors of Mascoma Financial Service Corporation and chairs their Audit Committee and is Trustee of Trust Funds for Hanover NH. Mr. Gardent has served as a trustee of the New Hampshire Foundation for Healthy Communities, was on the Board of Directors for the Accreditation Council for Graduate Medical Education (ACGME) and has been active in the Council of Teaching Hospitals of the Association of American Medical Colleges (AAMC). He has served on a number of AAMC and ACGME national committees. He also served on the Board of Trustees of the New Hampshire Hospital Association and served as Chairman of the Board (2006).

Mr. Gardent is on the faculty of the Dartmouth Medical School in the Department of Community and Family Medicine Department. He is the past Chair of the Executive Committee of the Quality Management Network. Mr. Gardent has given many lectures and presentations on leadership and quality improvement.

REQUIRED READINGS:

Porter ME, Teisberg EO. Redefining Competition in Health Care. Harvard Business Review, 2004. 82(6): p. 64-76. See Weblink:

Herzlinger RE. Why Innovation in Health Care Is So Hard. Harvard Business Review, 2006. 84(5): p. 58-66. See Weblink:

Reinhardt UE. The Pricing of U.S. Hospital Services: Chaos behind a Veil Of Secrecy. Health Affairs (Project Hope), 2006. 25(1): p. 57-69. See Weblink:

"Hospitals Wage Ad War", Sharon Terlep; The Detroit News, May 22, 2005. See Weblink:

Assignment:
Read and study the WSJ Armstrong article below. Analyze the competitive situation in this article using the Porter Analysis (5-forces).

Choose either Rapid City Regional Hospital (RCRH) or Black Hills Surgery Center (BHSC) for your analysis. Based on your analysis prepare a short summary of your conclusions regarding this case. Be prepared to present and defend your analysis and conclusions in class.

REQUIRED READING FOR ASSIGNMENT:
Armstrong D. Skillful Operation: A Surgeon Earns Riches, Enmity, by Plucking Profitable Patient; The Wall Street Journal. August 2, 2005, p. A1. See Weblink:

Optional:
OPTIONAL READINGS BELOW:

“I.R.S. Study Seeks to Assess If Hospitals Earn Tax Breaks,” by Stephanie Strom, The New York Times, Friday, February 13, 2009, p. A17. See Weblink:

Optional: AUDIOLINK: “Web Sites Compare How Hospitals Measure,” NPR: Talk of the Nation, August 26, 2008. AudioPlayer at Weblink: http://www.npr.org/templates/player/mediaPlayer.html?action=1&t=1&islist=false&id=93987412&m=93987408
LISTEN at Weblink Below:

Class 4
tues. 3/31

GUEST SPEAKER: William B. Weeks, MD/MBA


Dr. Weeks is the Director, Field Site, for the VA National Center for Patient Safety. A practicing psychiatrist, he has helped contribute to systemic improvements in patient safety in the VA through delivery of collaborative learning projects focused on patient safety and by studying the efficacy of these efforts. His research interests are economic and business aspects of health care, patient safety and quality improvement. In addition to this work, Dr. Weeks is an Associate Professor in the Department of Psychiatry and the Department of Community and Family Medicine at Dartmouth Medical School, a core faculty member at Dartmouth Medical School’s Center for the Evaluative Clinical Sciences where he teaches “Financial and Strategic Management of Healthcare Organizations”, Senior Scholar for the VA Quality Scholars Program and the VA Patient Safety Fellowship Program, national fellowship programs designed to produce future healthcare leaders in quality improvement and safety in healthcare.

Cases:
Turnaround at the Veterans Health Administration (A)(HBS 9-608-061)
and
Turnaround at the Veterans Health Administration (B)(HBS 9-608-062)

REQUIRED READINGS:

Malcolm Gladwell (January 2005), Blink. The Power of Thinking Without Thinking, Little, Brown and Company:New York, New York, (from Chapter Four), pp. 125-136.) ON COURSE RESERVE AT FELDBERG LIBRARY

“The VA Drug Pricing Model: What Senators Should Know,” by Greg D’Angelo. WebMemo published by The Heritage Foundation, No. 1420, April 11, 2007. See Weblink:



Class 5
Mon. 4/6

GUEST SPEAKER:
Ken Kaitin, Ph.D.

Tufts Center for the Study of Drug Development

Dr. Kaitin is Director of the Tufts Center for the Study of Drug Development, an academic drug policy research group providing strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of the drug development process. He is also Associate Professor of Medicine at Tufts University School of Medicine. In addition, he serves on the faculty of the European Center for Pharmaceutical Medicine at the University of Basel. Dr. Kaitin received a B.S. from Cornell University and an M.S. and Ph.D. in pharmacology from the University of Rochester.

Dr. Kaitin conducts research, lectures, and writes on pharmaceutical development, regulation, and public policy. He has written extensively on factors that contribute to the slow pace and high cost of pharmaceutical R&D and the impact of regulatory and legislative initiatives to speed new drug development and review. Dr. Kaitin has provided public testimony before the U.S. Congress in hearings on pharmaceutical innovation and FDA reform, and he has worked closely with the U.S. Council on Competitiveness. He is on the Board of Directors of the New England Institute for Health Care Research and Innovation, and he served on the Center for Strategic and International Studies’ bioterrorism task force “National Strategy for Anti-Biothreat Vaccines, Therapeutics, and Diagnostics.” Dr. Kaitin is a former president of the Drug Information Association and editor-in-chief of the Drug Information Journal. He also serves on the editorial boards of the American Journal of Therapeutics, Clinical Research and Regulatory Affairs, Drug Discovery and Development, and the Food and Drug Letter.

REQUIRED READINGS:

“The Continued Need for Independent Research on Prescription Drugs,” (J. Hoadley), HEALTH AFFAIRS, Jan./Feb. 2004, Vol. 23, No. 1, pp. 244-249. See Weblink:

“Biotechnology Advances Have Improved R&D Success Rates, According to Tufts CSDD,” TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT. Web Site 3/7/2005. See Weblink:

“Innovative R&D Strategies Remain Key to Developing New Medications” TUFTS CENTERFOR THE STUDY OF DRUG DEVELOPMENT. See Weblink:

“Outlook 2009,” TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, Tufts University, 2007.) See Weblink:

Optional:

OPTIONAL READINGS BELOW:

“A Methodology for Counting Costs for Pharmaceutical R&D,” See Weblink:

Optional: “The Political Economy of FDA Drug Review: Processing, Politics, and Lessons for Policy,” (D. Carpenter), HEALTH AFFAIRS, Jan./Feb. 2004, vol. 23, No. 1, pp. 52-63. See Weblink:

Optional: “Guinea Pigging,” (Carl Elliot), The New Yorker, 1/7/2008, Vol. 83, Issue 42, pp. 36-41. See Weblink:

Optional: “The U.S. Remains Preferred Market for Launching New Products,” TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, (News & Events/Recent News) November 12, 2008. See Weblink:

Optional: “New Drug Development Still Takes Eight Years Despite Faster FDA Review,” TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, (News & Events/Recent News) January 8, 2009. See Weblink:

Class 5 (cont'd)

Optional: OPTIONAL READINGS BELOW: (continued)

“A Study Faults Overseas Drug Trials,” by Natasha Singer, The New York Times, p. B7, February 19, 2009. See Weblink:



Class 6
Tues. 4/7

SPEAKER: Donald P. Conway, M.D., T’72

Optional: REQUIRED:

Case: Merck: Conflict and Change (HBS 9-805-079)

REQUIRED READINGS:

: The Life Sciences Revolution: A Technical Primer (HBS 9-602-118)

“How New Drugs Move through the Development and Approval Process,” TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, See Weblink:

“TheVytorin Hangover,” by Matthew Herper, Forbes.com, (Healthcare) December 08, 2008. See Weblink:

“Delays in Drug’s Test Fuel Wider Data Debate,” by Ron Winslow and Sarah Rubenstein, The Wall Street Journal, (Trial and Error), March 24, 2008, p. A1, A11. See Weblink:

Class 7
Mon. 4/13

SPEAKER: Donald P. Conway, M.D., T’72

REQUIRED:
Case: Product Team Cialis: Getting Ready to Market (HBS 9-505-038)

REQUIRED READINGS:

Marjorie E Ginsburg "PERSPECTIVE: Cost-Effectiveness: Will The Public Buy It Or Balk?" HEALTH AFFAIRS: WEB EXCLUSIVES (January 1, 2004): W297-W299. See Weblink:

Alex Berenson, "Minky Viagra? Pfizer Doesn't Want You to Understand It, Just Buy It," The New York Times, April 30, 2007, Late Edition (east Coast) See Weblink:

“No Lipitor Mug? Drug Makers Cut Out Goodies for Doctors,” by Natasha Singer, The New York Times, Wednesday, December 31, 2008, pp. A1, A18. See Weblink:

Optional:

OPTIONAL READINGS BELOW:

Gardiner Harris, “Senators Seek Public Listing Of Payments To Doctors,” The New York Times, September 7, 2007, Late Edition (East Coast) See weblink:

Optional: Daniel Carlat, “Dr. Drug Rep,” The New York Times Magazine, November 25, 2007, 64-69. See Weblink:



Class 8
Tues. 4/14


Specialty Pharma

GUEST SPEAKER:
Michael D. Landsittel (T’02)
Director, Business Development
Genzyme Corporation

Mike Landsittel has worked in business development for Genzyme's Biosurgery business unit since 2002. In his position, Mike is responsible for assessing both internal and external business opportunities for the company. He also plays an integral role in helping define Genzyme's strategy for its emerging Biosurgery business. Prior to working at Genzyme, Mike interned as a financial analyst for ICOS Corporation in 2001 and worked as a manager in the healthcare practice for Arthur Andersen from 1994 until 2000. Mike received his MBA from the Tuck School of Business at Dartmouth and his BA in Business Administration from the University of Michigan.


REQUIRED
Case: Genzyme/Geltex Pharmaceuticals Joint Ventures (9-UVO-086), Version 2)

REQUIRED READINGS:

“Commissioning for Rare Diseases: View from the Frontline,” (A. Burls et al.), BMJ, October 29, 331(7523), 2005, pp. 1019-1021. See Weblink:

“Orphan Drugs and the NHS: Should We Value Rarity?,” (C. McCabe et al.), BMJ, October 29, 2005, pp. 1016-1018. See Weblink:

“Ahead of the Tape,” by Mark Gongloff, The Wall Street Journal, February 11, 2009, p. C1. See Weblink:

Optional:

OPTIONAL READINGS BELOW:

Editorial, The New York Times OPINION, "When a Drug Costs $300,000," Published: March 23, 2008. See Weblink:

Optional: Draft second edition of: Social Value Judgments: "Principles for the Development of NICE guidance,” (consulted on 1 December 2007 - 7 March 2008). See Weblink:

Optional: “Cutting Dosage of Costly Drug Spurs Debate,” by Andrew Pollack, The New York Times, March 16, 2008, A1, A18. See Weblink:

Optional: “Genzyme Set Back On Plans For Drug,” by David Armstrong, The Wall Street Journal, Tuesday, March 3, 2009, p. B3. See Weblink:



Class 9
Mon. 4/20


Medical Devices Development

GUEST SPEAKER:
Aaron Kaplan, MD, FACC
Associate Professor of Medicine (Cardiology)
Dartmouth-Hitchcock Medical Center

Dr. Kaplan completed his medical training at Stanford after which he was appointed to the Stanford faculty. Dr. Kaplan joined the Dartmouth faculty in September, 2002, where he splits his time between clinical activities primarily on the Interventional Cardiology Service and early device development. Combining his clinical background in interventional cardiology with his medical device start-ups experience, Dr. Kaplan focuses on early device development. Along with Drs. John Simpson and Thomas Fogarty, Dr. Kaplan founded LocalMed, a venture-backed start-up which developed technology to medicate the arterial wall during angioplasty. He was also on the founding team of Perclose, Inc., a start-up company pioneering arteriotomy closure. He has consulted to numerous medical device companies including: CVA, Corazon, Endobionics, Radiant, ACS/Guidant and Cordis, JnJ as well as leading medical device venture capital firms. For the past three years, Dr. Kaplan has convened a closed symposium on medical device development. Attendance at this invitation only meeting includes FDA staff, medical professionals and members of the investment community. For example: Accelerated Tech, Boston Scientific, Cordis Corporation, Cutlass Capital, Edwards Lifesciences, Fresh Tracks Capital, GlyCoFi, Guidant Corporation, Highland Capital, Hogan & Hartson, Innovation Factory, Lehman Brothers, Magenta Medical, Med-Tel, Medtronic, NMT Medical, Inc., Polaris Venture Partners, St. Jude Medical, Sanford Bernstein, Spray Venture Partners, UBS, Versant Ventures and WFD Ventures.


REQUIRED:
Case: Drug Eluting Stents: A Paradigm Shift in the Medical Device Industry (Stanford OIT-50 – HBS)

REQUIRED READINGS:

“Angioplasty’s golden era may be fading,” by Steve Sternberg, USA TODAY, (Cover Story), pp. 1A-2A. See weblink:

“Is That Device Safe?,” (Opinion): The New York Times, January 27, 2009, (p. A30 of January 26, 2009 edition). See Weblink:

“Life, Death and Liability,” by Barry Meier, The New York Times, Friday, February 20, 2009, pp. B1, B4. See Weblink:

Optional:

OPTIONAL READINGS BELOW:

“Cramer ‘Blown Away’ by St. Jude Medical,” CNBC, Wed. February 11, 2009. See Weblink:

Optional: “That Must Be Bob at the Door. I Hear His New Hip Squeaking,” by Barnaby J. Feder, The New York Times. (Late Edition (East Coast), New York, N.Y.: May 11, 2008. pg. A.1. See Weblink:

Optional: “Study Finds More Failure of Heart Device,” by Barry Meier, The New York Times, Monday, February 23, 2009 and February 24, 2009. p. B9. See Weblink:

Optional: “A Health-Tech Monopoly,” The Wall Street Journal, (Editorial), February 11, 2009. See Weblink:



Class 10
Tues. 4/21

SPEAKER: Donald P. Conway, MD/MBA, T’72

REQUIRED:
Case: Fred Khosravi and AccessClosure (HBS 9-806-044)

REQUIRED READINGS:

Endius Inc.: Alternatives for Developing a New Medical Device (HBS - DMI011)

Medicare and Drug-Eluting Stents (Ivey 905M53-HBS)

“Medical Technology & Spending: The Next Market Bubble?,” EDITORIAL, HEALTH AFFAIRS, Vol. 27, no. 6 (2008): pp. 1464-1465. See Weblink:

“Drugs v. Devices,” [OPINION - EDITORIAL], The New York Times, Sunday, March 15, 2009. See Weblink:

“A Win for Injured Patients,” [EDITORIAL], The New York Times, March 5, 2009, p. A30. See Weblink:

Optional:

OPTIONAL READINGS BELOW:

A.V. Kaplan, D.S. Baim, J.J. Smith et al, “Medical Device Development. From Prototype to Regulatory Approval’” Circulation, June 29, 2004, pp. 3068-3072. See Weblink:

Optional: R. Mehran, M.B. Leon, D.A. Feigal et al, “Post-Market Approval Surveillance. A Call for a More Integrated and Comprehensive Approach,” Circulation, June 29, 2004, pp. 3073-3077. See Weblink:

Optional: Alex Berenson (2006, January 11), “Just 20 New Products Are Approved, Despite Biotechnology's Hope,” The New York Times, (January 11, 2006, p. C.1. See Weblink:

Optional: “New Focus Of Inquiry Into Bribes: Doctors,” by Barnaby J. Feder, The New York Times, March 22, 2008. See Weblink:



Class 11
Mon. 4/27

SPEAKER: Donald P. Conway, MD/MBA, T’72

REQUIRED:
Case: Abbott Laboratories and HUMIRA: Launching A Blockbuster Drug (Stanford Case: OIT-44 Condensed)

REQUIRED READINGS:

“Is Biotechnology Losing Its Nerve?,” (A. Pollack), The New York Times, February 9, 2004, pp. 1-3. See Weblink:

What You Can Learn from Managers in Biotech (HBS-U9705A)

F.M. Steinberg and J. Raso “Biotech Pharmaceuticals and Biotherapy: An Overview,” Journal of Pharmacy & Pharmaceutical Sciences, 1(2), pp.48-59. See Weblink:



Class 12
Tues. 4/28


Biotech: A New Model

SPEAKER: Donald P. Conway, M.D., T’72

REQUIRED:
Case: Amgen Inc.’s Epogen—Commercializing the First Biotech Blockbuster Drug (HBS 9-706-454)

REQUIRED READINGS:

DiMasi JA, Grabowski HG. “Economics of New Oncology Drug Development” Journal of Clinical Oncology, Vol. 25, No 2 (January 10), 2007: pp. 209-216 © 2007. DOI: 10.1200/JCO.2006.09.0803). See Weblink:

ALEX BERENSON and ANDREW POLLACK "Doctors Reaping Millions for Use of Anemia Drugs." The New York Times, May

Optional:

OPTIONAL READINGS BELOW:

James J. Cramer, New York Magazine, “Crash Insurance,” THE BOTTOM LINE, March 12-19, 2007, pp. 42, 44. See Weblink:

Optional: Heather Won Tesoriero and Avery Johnson, “Suit Details How J&J Pushed Sales of Procrit,” The Wall Street Journal, May 10, 2007. See Weblink:

Optional: Andrew Pollack, “Duel Over a Monopoly,” The New York Times, October 17, 2007, Late Edition (East Coast) See weblink:

Optional: “All The Wrong Numbers,” (Matthew Herper), Forbes, 03/14/2008 online. See Weblink:



Class 13
Mon. 5/4


Medicare Part D

GUEST SPEAKER:
Greg Butz T’06
Morgan Stanley
Investment Division

Greg is an Associate in Morgan Stanley's Western Region Healthcare Practice. He joined Morgan Stanley in 2006 and focuses on the biotechnology, emerging pharma and medical technology sectors. Prior to Morgan Stanley, Greg was a Senior Equity Research Associate at Banc of America Securities and Robertson Stephens, where he followed mid cap and large cap biotechnology companies. In addition, Greg worked in Specialty Biotherapeutics Commercial Strategy at Genentech. Greg has a degree in Economics from Williams College and an M.B.A.in 2006 from the Tuck School of Business at Dartmouth.brbrbr

REQUIRED:
Case: Genentech’s Dilemma: Avastin Vs. Lucentis (IMD-3-2004)

REQUIRED READINGS:

“Dreaming Of Deals In Pharma,” by Natasha Singer and Duff Wilson, (Marketplace), The New York Times, pp. 1-2, Wednesday, February 25, 2009. See Weblink:

“The Pfizer Drug Warning,” The Wall Street Journal, (Opinion Journal), January 28, 2009. See Weblink:

“Make way for biogenerics,” The Boston Globe, [EDITORIAL], Sunday, March 8, 2009. See Weblink:

Optional:

OPTIONAL READINGS BELOW:

“Genentech Still Aserts Roche Bid Is Too Low,” by Andrew Pollack, The New York Times, March 2, 2009, p. B6. See Weblink:

Optional: “Bristol-Myers’s Heavy Reliance on 3 Drugs Puts Its Prospects for Growth in Doubt,” by Natashing Singer, The New York Times, Wednesday, January 38, 2009. See Weblink:

Optional: “Roche Seeks to Buy Rest of Genentech,” by Andrew Pollack, The New York Times, February 10, 2009. See Weblink:

Optional: “The High Cost of a Cancer Drug,” (EDITORIAL), The New York Times, March 10, 2008. See Weblink:

Optional: “MS Drug, Cost Cuts Help Elan Swing to Profit,” by Quentin Fottrell, The Wall Street Journal, February 10, 2009. See Weblink:



Class 13 (contd)

Optional: OPTIONAL READINGS BELOW: (continued)

“Novartis Has Proof of Concept For New R&D Model, And NMEs To Show It,” Dartmouth College, The Pink Sheet, Vol. 70, Number 049, December 08, 2008,page 13. See Weblink:

Optional: “Weighing the outcomes,” by Michael J. Russo & David Balekdjian, Nature Biotechnology, Vol. 26, pp 173-182 (2008). See Weblink:

Optional: “Biotech as Bush bows out,” by Aaron Lorenzo, Nature Biotechnology, Vol. 26, pp 15-18 (2008). See Weblink:

Class 14
Tues. 5/5

GUEST SPEAKER:
Kristen Maynard, MBA (T’01)

Administrative Director in the President’s Office.
The Administrative Director is the liaison between the President and administrative and clinical leadership on senior level projects and other day-to-day responsibilities; reporting strategy and progress to the President. Kristen also acts as the primary liaison and support for the BWH and BW/F Boards of Trustees, and Board Committees, working in conjunction with the Board Chairman. As Director, she also works closely with Partners senior management and senior representatives of the Harvard Medical School, to facilitate institutional specific initiatives. She also manages the Brigham's one-year administrative Fellowship program, the Deland Fellowship, oversees special projects on behalf of the President, and manages all financial and human resource matters related to the President's Office.

Assignments:

Case: Brigham and Women’s Hospital: Shapiro Cardiovascular Center (HBS 9-608-175)

REQUIRED READINGS:

David Whelan, “BAD MEDICINE. Why Are Patients Forced to Get Care at Big, Dangerous Hospitals? The Heart of the Health Care Industry Has Failed the Consumer,” Forbes, Vol. 181, No. 5, March 10, 2008, (pp. 86-87, 90, 95-96,98). See Weblink:

“Disrupting the Hospital Business Model,” (FEATURE) by Clayton M. Christensen, Jason Hwang, MD and Jerome H. Grossman, MD; Strategy & Innovation, December 10, 2008. See Weblink:

“Hospitals raise perk ante to draw, treat patients,” by Tom Murphy, AP Business Writer, Associated Press, San Francisco Chronicle, Wednesday, December 3, 2008. See Weblink:

Class 15
Mon. 5/11

GUEST SPEAKER:
Debbie Brooks, T’86


Deborah W. Brooks is co-founder of The Michael J. Fox Foundation for Parkinson’s Research (MJFF). As such, Ms. Brooks spearheads principal-gifts fundraising and advises on strategic and programmatic direction. In addition, she serves as the senior spokesperson for new and existing external audiences.

Ms. Brooks served as MJFF’s president and chief executive officer from October 2000 to February 2007, during which period the Foundation funded over $90 million in research either directly or through partnerships and became the single largest funder of Parkinson’s disease research outside the U.S. government.

Prior to co-founding MJFF with actor and Parkinson’s advocate Michael J. Fox, Ms. Brooks spent nine years at Goldman, Sachs & Co. as vice president in the Fixed Income and Asset Management Divisions. Seeking to apply her strategic background and business acumen to the nonprofit sector, she then shifted focus and led several not-for-profit organizations through start-up and turnaround efforts before joining Mr. Fox to launch the Foundation in late 2000.

Ms. Brooks is a member of the Advisory Board for FasterCures Philanthropy Advisory Service and sits on the External Advisory Board for Emory University’s Collaborative Center for Parkinson’s Disease Environmental Research. Ms. Brooks serves on the Board of Overseers of the School of Social Policy and Practice at the University of Pennsylvania. She serves on the MBA Advisory Board of the Tuck School of Business at Dartmouth as well as the Advisory Board for Women in Business at Tuck. She is a past member of the National Advisory Environmental Health Sciences Council of the National Institutes of Health and director of the Parkinson’s Action Network.

Ms. Brooks holds a BA in economics from the College of William and Mary, an MBA from the Tuck School at Dartmouth College and an MS in marital and family therapy from Northwestern University.


Required Assigments:

The Kinetics and Michael J. Fox Foundations (A) (HBS - SM163A) and The Kinetics and Michael J. Fox Foundations (B) (HBS - SM163B)



Class 16
Tues. 5/12

SPEAKER: Donald P. Conway, MD/MBA (T’72)


REQUIRED READINGS:

“Medicare Rules Set Off a Battle on Drug Choices,” (R. Pear), The New York TimesSee Weblink:

“Priorities In The Pharmaceutical Industry,” (2004). HEALTH AFFAIRS, 23(1), p. 9. See Weblink:

“Designing a Prescription Drug Benefi,” (2004). HEALTH AFFAIRS, 23(1), p. 123. See Weblink:

“The Challenges of a Medicare Drug Benefit,” (2004). HealHEALTH AFFAIRS<.i>, 23(1), 88. See Weblink:

“Medicare Blow to Virtual Colonoscopies,” by Andrew Pollack, The New York Times, Friday, February 13, 2009 p. A18 See Weblink:

Joanne Silberner, “For IV Meds, Medicare Forces Costlier Hospital Trip,” NPR, (HEALTHCARE), March 11, 2009. See Weblink:

Optional:

OPTIONAL READINGS BELOW:

Bruce E Landon, James D Reschovsky, David Blumenthal (2004), “Physicians' Views Of Formularies: Implications For Medicare Drug Benefit Design,” HEALTH AFFAIRS, 23(1), 218-226. See Weblink:

Optional: “How Much Should Medicare Pay for Drugs?,” (J. Newhouse), HEALTH AFFAIRS, Jan./Feb. 2004, Vol. 23, No. 1, pp. 89-102. See Weblink:

Optional: “Medicare Law’s Costs and Benefits are Elusive,” (R. Pear), The New York Times, December 9, 2003, pp. 1-3. See Weblink:

Optional: “Deciphering the Drug Benefit (12/08/2003)” (TABLE), The New York Times, December 9, 2003.
See TABLE Weblink at: http://www.nytimes.com/imagepages/2003/12/08/national/09MEDI_CHART.gif.ready.html
See Weblink for Article at:

Class 16 (cont'd)

Optional: OPTIONAL READINGS BELOW: (cont'd)

“Drug Therapy Gains Favor To Avert Stroke,” by Thomas M. Burton, The Wall Street Journal, Tuesday, March 3, 2009, pp. D1, D5. See Weblink:

Optional: “Medicare Costs Rise Unevenly Across U.S.,” by Reed Abelson, The New York Times, Wednesday, February 25th, 2009. See Weblink:

Optional: “Medicare Widens Drugs It Accepts For Cancer Care,” by Reed Abelson and Andrew Pollack, The New York Times, Monday, January 26, 2009, pp. A1, A22 See Weblink:

Optional: “Dissidents At F.D.A. Complain Of Inquiry,” by Gardiner Harris, The New York Times, Tuesday, January 27, 2009. See Weblink:

Optional: “U.S. to Study Effectiveness of Treatments,” by Robert Pear, The New York Times, Monday, February 16, 2009, p. A1. See Weblink:

Optional: “Effort Largely Fails to Improve Aging Medicare Users’ Health,” by Lindsey Tanner (AP writer), Chicago Defender, Wednesday, February 18, 2009. See Weblink:



Class 17
Mon. 5/18


Health Care Reform Insights from an Insider

GUEST SPEAKER: Susan Dentzer

Susan Dentzer is the editor-in-chief of Health Affairs, the nation’s leading journal of health policy, and an on-air analyst on health with The NewsHour with Jim Lehrer on the Public Broadcasting Service (PBS). Dentzer assumed the job of editor-in-chief on May 1, 2008, after a decade as the on-air health correspondent for The NewsHour. Health Affairs, which has been called the nation’s health policy “Bible,” is a peer-reviewed journal that appears bimonthly in print with additional online entries published weekly at www.healthaffairs.org. The journal and website, based in Bethesda, Maryland, are published by Project Hope, the health education and humanitarian assistance organization that operates programs in 36 countries around the world.

Before joining Health Affairs, Dentzer led the NewsHour’s health unit, providing in-depth coverage of healthcare and health policy. The unit, begun in 1998, was funded by grants from the Henry J. Kaiser Family Foundation and, beginning in 2005, from the Robert Wood Johnson Foundation.

Dentzer is the recipient of multiple journalism awards. In 2007, she received the American Society on Aging’s National Media Award for a two-part series on our current understanding of the causes of Alzheimer’s disease, efforts underway to speed treatments to patients, and the enormous burden faced by caregivers of Alzheimer’s patients. The NewsHour Health Unit's December 2005 and April 2005 pieces, "Wounded Soldier" and "Wounded Warrior," about a paralyzed and brain damaged soldier who was severely wounded in Iraq, won the 2005 Award for Excellence in Health Care Journalism from the Association of Health Care Journalists. The same pieces also earned both a CINE Golden Eagle and New York Festival award.
Dentzer's October 2004 Health Unit piece, "Osteoporosis," received a first-place Gracie Allen award for public television news from American Women in Radio and Television. Her two-part investigative series on importation of prescription drugs, broadcast in March 2004, earned a second-place prize for radio and television programming from the American Health Journalists Association. Coverage in 2002 of the "Eden Alternative" approach to nursing home reform garnered a 2003 Gabriel Award from the Catholic Academy for Communication Arts Professionals. And a 1999 report on schizophrenia earned the 2000 Robinson Electronic Media Award from the American Psychiatric Association.

Prior to joining The NewsHour in 1998, Dentzer was chief economics correspondent and economics columnist for U.S. News & World Report, where she served from 1987 to 1997. In a series of columns and stories for U.S. News, she reported extensively on the debate over reforming and partially "privatizing" Social Security and over such health policy issues as regulation of managed care. Before joining U.S. News, Dentzer was at Newsweek, where she was a senior writer covering business news until 1987. Dentzer's work in television has included appearances as a regular analyst or commentator on CNN and The McLaughlin Group.
Dentzer's writing has also earned her several fellowships. A Nieman Fellow at Harvard University for the 1986–87 academic year, she studied health economics and other disciplines. A U.S.-Japan Leadership Program Fellow in 1991, Dentzer conducted research on U.S.-Japan economic relations and the effects of the aging Japanese population.

Dentzer is a member of the Council on Foreign Relations, and the Chair of the Board of Directors of the Global Health Council, the world's largest membership organization of groups involved in global health. Dentzer also serves on the Board of Directors of the International Rescue Committee (IRC), the nonprofit organization that works in relief, rehabilitation, protection, post-conflict development, and resettlement services for those uprooted or affected by violent conflict and oppression worldwide. At IRC, Dentzer heads the Board's Health Committee, which oversees the organization's health programs in 25 countries. In February 2008, she traveled to Syria and Jordan as part of an IRC delegation reviewing the situation of Iraqi refugees who have fled to these countries as a result of the ongoing war in Iraq.


She serves on the Kaiser Commission on Medicaid and the Uninsured as well as the advisory board of the California Health Benefits Review Committee and is a member of the National Advisory Committee for the Robert Wood Johnson Foundation's Investigator Awards in Health Policy Research. Dentzer is also on the board of directors of the Friends of the National Institute for Nursing Research.
A graduate of Dartmouth, Dentzer holds an honorary master of arts degree from Dartmouth and an honorary doctorate of humane letters from Muskingum College, New Concord, Ohio. She is a member of the Board of Overseers of Dartmouth Medical School. Previously, she served on the Dartmouth College Board of Trustees from 1993 to June 2004, and was the first woman ever to serve as Chair of Dartmouth's board, from 2001 to 2004. She is also a former trustee of the Dartmouth-Hitchcock Medical Center, having served in that capacity until 2004. In 2007 she received the Dartmouth Alumni Award, the highest honor given to Dartmouth alumni for service to the college.
Dentzer, her husband, and their three children live in the Washington, D.C. area.

REQUIRED READINGS:

“Evidence and Health Care Reform,” (EDITORIAL), The New York Times, Saturday, February 28, 2009 p. A22. See Weblink:

“New U.S. Health Insurance Program Envisioned,” by Will Dunham, WASHINGTON (Thomson Reuters), February 19, 2009. See Weblink:

“A Push to Spell Out a Drug’s Risks and Benefits,” by Natasha Singer, The New York Times, Thursday, February 26, 2009, p. B3. See Weblink:

“A Start on Health Care Reform,” [EDITORIAL], The New York Times, Sunday Opinion, March 7, 2009. See Weblink:

Optional:

OPTIONAL READINGS BELOW: “A Hurdle for Health Reform: Patients and Their Doctors,” by Tara Parker-Pope, The New York Times, WELL, March 3, 2009, p. D1,D6. See Weblink:

Optional: “Liberal Groups Flexing Muscle In Lobby Wars,” by Jim Rutenberg, The New York Times, NATIONAL, Sunday, March 1, 2009, p.1, 13. See Weblink:

Class 17 (cont'd)

Optional: OPTIONAL READINGS BELOW: (continued)

"Health Care Now," by Paul Krugman, The New York Times, p. A23. See Weblink:

Optional: "Health Care Industry In Talks to Shape Policy," by Robert Pear, The New York Times, Friday, February 20, 2009, p. A16. See Weblink:

Optional: "Tough Questions Dog Health-Care Overhaul," by Laura Meckler, The Wall Street Journal, March 3, 2009, p. A5 See Weblink:

Optional: "Obama¡¦s Health Plan, Ambitious in Any Economy, Is Tougher in This One," by Robert Pear, The New York Times, (NATIONAL), Monday, March 2, 2009, p. A14. See Weblink:

Optional: "Slowing the Growth of Health Care Costs--Lessons from Regional Variation," Elliott S. Fisher, Julie P. Bynum, and Jonathan S. Skinner, The New England Journal of Medicine, (Perspective), Vol. 360, No. 9, February 26, 2009, pp. 849-852. See Weblink:

Optional: Steven Spear (Brookline), "What we need is to rate the providers," Letter to the Editor, The Boston Globe, Tuesday, March 10, 2009. See Weblink:

Optional: Alicia Mundy, "FDA Backs Knee Device After Long Lobby Effort," The Wall Street Journal, p. A1, A12. See Weblink:



Class 18
Tues. 5/19


Course Wrap-up and Project Presentations

REMINDERS:

Final Projects are due by close of business on Tuesday, May 19, 2009.

Final Exam with instructions will be distributed today in class. It is due this Friday, May 22, 2009.