Spring Semester 2006
Monday, 1-4 p.m., SON 380 requested, 3 Units

Syllabus Updated on: October 1, 2005

This course syllabus was prepared with the assistance of Yu F Lee,

Pauline Vaillancourt Rosenau, Ph.D.
E915, 713-500-9491 Pauline.Rosenau@uth.tmc.edu

Course Overview

This course will introduce students to pharmacy policy, an essential aspect of public health. The approval of new medications, the differences between brand name drugs, generic, and over-the-counter drugs is considered along with the “shift movement,” (prescription to OTC status). The development, distribution, marketing and consumption of pharmaceuticals are influenced by policy. All aspects of these processes are influenced by the pharmaceutical industry, government (the FDA), congress, insurance companies, pharmacists, hospitals, physicians, consumer representatives and patients. Regulatory issues, controlling the cost of prescription, state – federal relationships as well as the global market place weigh heavily on pharmacy policy today. Cross border issues will be discussed. Conflict of interests, normative choices, and ethical dilemmas of pharmaceutical policy will be studied. Guest lecturers will particpate throughout the course.

Course Requirements and Grading

If any Rice University students are enrolled, please note that this class will observe the University of Texas, School of Public Health, academic calendar. The first class is January 9, at 1-4 PM in SON 380.. There are 3 components of the course, which carry weight as follows: a) term paper (50%) b) Class presentations of articles and the term paper (20%) c) Participation in class discussion (30%).

Course Paper: Students are expected to write a comprehensive review paper on a topic related to a policy aspect of pharmaceuticals. This review paper has a suggested length of 15 double spaced pages of text (not including abstract, tables, and references), and should include a discussion section which explicitly elucidates the implications of the evidence in the literature for policy making or delivery of health care services. The methods section in the paper should cover the databases used for the literature search, years of search, and the keywords. Students will submit a one double spaced page proposal outlining their paper topic, and its importance for health policy on March 1st.

Since the paper accounts for 50% of the course grade, it must be an original work of the student prepared for this course. If there is evidence of dishonesty or plagiarism (instructor may use www.turnitin.com ), the student will automatically receive an F grade in the class. The class paper is due on or before the last day of the class but incompletes will be given if special arrangements are made in advance with the professor for good reason..

Class Presentation of Course Paper: Each student is expected to make a 15 minute presentation of the findings and implications of their course paper during one of the last two class sessions. A brief (2-3 minute) presentation of the topic will be made by the student on February 27., 2006. they will received feedback from the professor and the class. Students are encouraged to make extra copies of their 1 page paper proposal for class distribution.

Course Attendance and Discussion: Students are expected to attend all class sessions. Absences (other than emergencies) are unacceptable. Students are expected to familiarize themselves with the course readings before the class, and participate actively in class discussions. Copies of course readings and other class handouts will be provided to the students whenever possible.

Course Schedule, Topics, and Assignments

Week 1 (January 9, 2006): Introduction and Distribution of Course Syllabus: Definitions, Context, Players, and Significance

Topics:

Definitions (Brand Name Drugs, Generic Drugs, Over-the-Counter Drugs)

Context: The “Players” and Vested Interests – The Pharmaceutical Industry, Government, Congress, Insurance, Industry, Pharmacists, Hospitals, Physicians, Patients, Consumer representatives (The AARP) etc.

History of Major Pharmaceutical Regulations

How the Pharmaceutical Policy is driven by the Structure of the U.S. Healthcare System

What is Policy?

Why This Course Matters for Health Services:

Cost Fasting growing component of health care costs

Policy Makers V is-à-vis The New Technologies

The Human Genome: Personalizing Drug Treatment and universal health insurance

Improvements in Methods of Prescribing Drugs – Reducing Errors.

Learning from experience from other countries to make US better

Readings :

 Farley, D. Benefit vs. Risk: How CDER Approves New Drugs. Available Online at: http://www.fda.gov/fdac/special/newdrug/benefits.html .

FDA Consumer. Generic Drugs: What You Need to Know. September/October 2002.

Slater, E.E. Today’s FDA. NEJM 352(3): 293-7 (2005).

Kaiser Family Foundation (2005). Medicaid: A Timeline of Key Developments. Available online at: http://www.kff.org/medicaid/medicaid_timeline.cfm

Kaiser Family Foundation (2005). Medicare: A Timeline of Key Developments.

Available online at: http://www.kff.org/medicare/medicaretimeline.cfm

Week 2 (January 16, 2005): Holiday

Topics:

The Process and the various Stages

FDA :

Who pays and is this a problem?

Too fast, too slow or just right?

Patents – too long, too short or just right?

OTC vs. Brand Approval Process

Testing in Foreign Countries and the approval process

Pharmaceutical Industry Position on Research Costs

Video: ” Rush to Market-Bad Medicine” — June 22,1998

Readings :

 Pisano, D.J., Chapter 2: U.S. Drug Regulation. In: Essentials of Pharmacy Law. CRC press, 2003. (17 pages)

 Anonymous. The stalling game: sweetheart deals and patent extensions keep lower-cost cost generic drugs from consumers. Available at ConsumerReports.org, July 2001. Accessed at Jun. 14, 2003.

Berenson, A. Blockbuster Drugs Are So Last Century. The New York Times, July 3, 2005.

Di Masi, J; Hansen, RW; Grbowski, HG. "The Price of Innovation: New Estimates of Drug Development Costs." Journal of Health Economics, 22:151-185, 2003.

Light, D; Warburton, RN."Extraordinary Claims Require Extraordinary Evidence." Journal of Health Economics, 24:1030-1033, 2005.

Week 4 (January 30, 2006): Safety, Post Marketing Surveillance, and Approval Time
Guest Lecturer:
Grace Kuo, Pharm. D.
Baylor College of Medicine
Program Director of the Southern Primary Care Urban Research Network (SPUR-Net)
Houston, TX

 Topics

Withdrawal from the market: a case study of vioxx, bextra, and Celebrex etc.

Video: ” FDA Drug Screening Measures Under Intense Scrutiny” — Nov. 23, 2004

 Readings :

 Fontarosa, P.B. et al. Postmarketing Surveillance— Lack of Vigilante, Lack of Trust . JAMA 292 (21): 2647-50 (2004).

Okie, S. What Ails the FDA? NEJM 352(11): 1063-66 (2005).

Harris, G. At F.D.A., Strong Drug Ties and Less Monitoring. The Wall Street Journal. December 6, 2004.

(Analysis of the relationship between the FDA and the pharmaceutical industry)

Okie, S. Safety in Numbers- Monitoring Risk in Approved Drugs. NEJM 352(12): 1173-76 (2005).

(Possible role of the IOM in the monitoring of drug safety)

Gottlieb, S. Opening Pandora’s Pillbox: Using Modern Information Tools to Improve Drug Safety. Health Affairs 24(4): 938-48 (2005).

(How the FDA can improve drug safety monitoring with more/better tech)

Mathews, A. and S. Hensley. FDA Targets a Surge in Fake Drugs in the U.S.The Wall Street Journal Online. September 11, 2003

(Raise the problem of counterfeit drugs)

Rudolf, P.M. et al. Counterfeit Drugs . NEJM 350(14): 1384-86 (2005).

(Analysis of the counterfeit drug problems)

Kaiser Family Foundation. FDA Should Allow Patients ‘Freedom To Choose’ To Take Medications With Potential Safety Risks, Oped Says. August, 2, 2005. Available online at:

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=3&DR_ID=31782

Week 5 (February 6, 2006): Who Pays for Medications in the US
Guest Lecturer:
Lincy Lal
Texas Southern University-College of Pharmacy and Health Sciences
Houston, TX

Topics:

High Cost of Prescription Drugs

Government Insurance Programs

Medicare – the new prescription drug plan and senior discount card

Medicaid -

Federal Retirees

Veterans

Private Insurance

The Uninsured and the Poor

Out of Pocket Payments

Video:

Readings :

Martinez , B. Drug Co-pays Hit $100. The Wall Street Journal. June 28, 2005

Kaiser Family Foundation. Fact Sheet: Prescription Drug Trends. October 2004. Available online at:

http://www.kff.org/rxdrugs/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=48305 .

The Kaiser Commission on Medicaid and the Uninsured. Fact Sheet: Medicaid at a Glance. January 2005. Available online at:

http://www.kff.org/medicaid/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=50450 .

Pear, R. Report Says Medicaid Overpays for Drugs. The New York Times. March 8, 2005.

The Kaiser Family Foundation. Fact Sheet: Medicare at a Glance. April 2005. Available online at:

http://www.kff.org/medicare/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=52974 .

Anonymous. Medicare Drug Plan. April 30, 2004. Available online at:

http://www.pbs.org/now/science/drugplan.html

Altman DE . The New Medicare Prescription-Drug Legislation. NEJM 350(1): 9-10 (2004).

Hurley, J. et al. US Medicare Reform: Why Drug Companies and Private Insurers Are Smiling. CMAJ 170(4): 461-2 (2004).

Stuart, B. et al. Riding the Rollercoaster: the Ups and Downs in Out-Of-Pocket Spending Under the Standard Medicare Drug Benefit. Health Affairs 24(4):1022-31 (2005).

The Kaiser Family Foundation. Estimates of Medicare Beneficiaries’ Out-Of-Pocket Drug Spending in 2006. November 2004. Available online at:

http://www.kff.org/medicare/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=48947 .

Week 6 (February 13, 2006): Controlling Costs of Prescription Drugs in the United States
Guest Speaker:
Dr. Hua Chen, PhD
University of Houston School of Pharmacy
Texas Medical Center Campus
Houston, TX

Topics:

Formularies

Federal Government Cost Cutting Measures

FDA Measures

Medicare Reform and Prescription Drug Benefits

Federal Retirees

Veterans Drug Benefits

State Government Efforts to Control Costs

Medicaid Programs: Negotiating for a Lists of Preferred Drugs –

State Discounting

Senior Drug Assistance Programs

Readings :

Altman, S.H. and C. Parks-Thomas. Controlling Spending for Prescription Drugs. NEJM 346(11):855-856 (2002).

Thomas, C.P. Incentive-Based Formularies. NEJM 349(23): 2186-88 (2003).

Huskamp, H.A.et al. The Effect of Incentive-Based Formularies of Prescription-Drug Utilization and Spending. NEJM 349(23): 2224-32 (2003).

The Reforming States Group. State Initiatives on Prescription Drugs: Creating A More Functional Market. Health Affairs 22(4):128-36 (2003).

Modern, N.E. et al. States’ Control of Prescription Drug Spending: A Heterogeneous Approach . Health Affairs 24(4): 1032-38 (2005).

Week 7 (February 20, 2004): Holiday

Topics:

Direct-to-consumer Advertising

Legislation Regulating Generic Drugs

The Switch Movement: Prescription to OTC Movement

Switching and Its Function:

A Means to Reduce Costs of a doctor visit for patients

A Means for Insurance Companies to Lower Costs

Competitive Measure by Drug Industry

Use of Sales Representatives – Marketing to Physicians and Hospitals

Web-sites Sponsored by Drug Companies as a Marketing Tool

Paper Assignment: Brief (2-3 minutes) students to present their topics to the class

Video: ” A Second Opinion-Narc Siegal on Drug Advertising”— Aug. 9, 2002

Readings :

Harris, G. Fractured Image in Need of Mending for Drug Makers. The New York Times, July 8, 2005.

 Avorn, J. Torcetrapib and Atorvastatin- Should Marketing Drive the Research Agenda? NEJM 352(25): 2573-76, June 23(2005).

Wolfe, S.M. Direct-to-Consumer Advertising – Education or Emotion Promotion? NEJM 346(7):524-526 (2002).

Holmer, A.F. Direct-to-Consumer Advertising – Strengthening Our Health Care System. NEJM 346(7):526-528 (2002).

Berndt, E.R. To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs. NEJM 352(4):325-8, January 27(2005).

Anonymous. Myth: DirectTto-Consumer Advertising Is Educational for Patients. Canadian Health Service Research Foundation, 2004.

Hollon, M.F. Direct-to-Consumer Advertising: a Haphazard Approach to Health Promotion. JAMA 293(16): 2030-33, April 27(2005).

Waxman, H.A. Ensuring That Consumers Receive Appropriate Information from Drug Ads: What is the FDA’s Role? Health Affairs Web Exclusive April 28 (2004).

Mathews, A.W. FDA to Review Drug Marketing to Consumers. The Wall Street Journal. August 2, 2005.

Kaiser Family Foundation. 23 Drug Companies Agree to New Guidelines on Advertising. August 3, 2005. Available online at:

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=3&DR_ID=31804

Harris, G., and A. Berenson. 10 Advisers Voting on Pain Pills’ Sales Have Industry Ties. The New York Times, February 25, 2005.

Reynolds, T. Switching From Prescription to Over the Counter. Annals of Internal Medicine. 136(2):177-180, January 15 (2002).

Cohen, J.P. et al. Switching Prescription Drugs to Over the Counter. BMJ 330: 39-41, January 1 (2005).

Strom, B.L. Statins and Over-the-Counter Availability. NEJM 362(14): 1403-05, April 7 (2005).

Week 9 (March 6, 2004): Spring Break

Week 10 (March 13, 2004): Cross-border Issues, Federalism and Medication (the states versus the Federal government )

Topics

What is federalism in the US compared to other countries?

Differences between Federal and State Health Care Systems:

Who is the Ultimate Payer?

What the federal government wants

What the states want: Facing Budget Deficits, States Strive To Reduce Costs

Importing from Canada

The role of Internet Pharmacies

Cross Border Sales ( Canada, Mexico, Australia, New Zealand, Hong Kong, etc.)

Public Policy Consistency— enforcement and the Supreme Court

Video: “The Other Drug War”— Nov. 13, 2003

Readings :

 Mello, J.D. et al. The Pharmaceutical Industry versus Medicaid- Limits on State Initiatives to Control Prescription-Drug Costs. NEJM 350(6): 608-13 (2004).

 Zuger, A. R x: Canadian Drugs. NEJM 349(23):2188-2190 (2003).

 Simon, B. Pfizer Moves to Try to Stop Drugs from Canada. The New York Times. January 14, 2004.

Parkes, D. Crackdown on Net Pharmacies. The Gazette, Montreal. February 19, 2005.

Choudhry, N.K., and A.S. Detsky. 2005. A perspective on US Drug Reimportation. JAMA 293(3): 358-62, January 19 (2005).

Zimm, A., and J. Lauerman. U.S.Drugmakers Have New Foe: Europe. The Gazette, Montreal. April 2, 2005.

Topics

Changing Pharmaceutical Market

Public and Private Sector Financing of Pharmaceuticals

Determination and Measurement of Drug Prices in other countries

Global Pricing Comparisons

Are funds for Research and Development in jeopardy

Globalization, No International Regime, and the “Enforceability” of Laws

Laws and Regulations Controlling Cross-border Sales

Free Trade Issue, Regional Trading Areas and the WTO—Theory and Reality

What the US Can Learn From Other Countries to Control Rx Prices

Efforts to Reduce Costs of Drugs in Germany

How Canada Does It So Well

European Drug Approval Process

Readings :

 Anderson , G.F. and J. Poullier. Health Spending, Access, And Outcomes: Trends In Industrialized Countries. Health Affairs 18(3): 178-92 (1999). (Abstract and Exhibit 5)

Dougherty, K. Minister ‘just say no’ to higher drug costs. The Gazette, Montreal. January 10, 2004.

Sancton, D. Drug-price hike would be first in 10 years. The Gazette, Montreal. January 13, 2004.

Whalen, J and V. Sprothen. German Curbs on Drug Costs Rile Big Brands. The Wall Street Journal. May 2, 2005.

Ess, S.M. et al. European Health Care Policies for Controlling Drug Expenditure. Pharmacoeconomics 21(2): 89-103 (2003).

Kanavos, P. and U. Reinhardt. Reference Pricing For Drugs: Is It Compatible With U.S. Health Care? Health Affairs 22(3): 16-30 (2005). (Abstract and Exhibit 1)

Anonymous. International Experience with Prescription Drug Policy. Health Affairs 22(3):15 (2003)

Maynard, A. and K. Bloor. Dilemmas in Regulations of the Market for Pharmaceuticals. Health Affairs 22(3):31-41 (2003).

Towse, A. The Efficient Use of Pharmaceuticals: Does Europe Have Any Lessons for A Medicare Drug Benefit? Health Affairs 22(3):42-45 (2003).

Frank, R.G. Government Commitment and Regulation of Prescription Drugs. Health Affairs 22(3):46-48 (2003).

Morgan, S. et al. Outcomes-based Drug Coverage in British Columbia. Health Affairs 23(3):269-76 (2004).

Light, D.W. and J. Lexchin. Will Lower Drug Prices Jeopardize Drug Research? A Policy Fact Sheet. The American Journal of Bioethics 4(1): W3-W6 (2004).

Schwartz, K. Filling Prescriptions Abroad. PBS Online News Hour, February, 2004. Available online at: http://www.pbs.org/newshour/health/importation/pricing.html

Patents and domestic production

Pricing and Distribution

Safety Issues in the international arena

(Counterfeit Drugs, Contaminated Medications, Poor Quality

Control at Point of Production)

Drug Availability; Manipulating Demand and Creating Shortages

Drug Approval Process

(Taxpayers)

Donations; foreign aid and pharmaceutical companies

North American Free Trade Agreement and other regional trade agreements

Readings :

Glennerster, R., Kremer, M., and H. Williams. The Price of Life. Foreign Policy, May/June 2005, p.26-7.

Anonymous, Poor Markets, Rich Rewards. The Economist, October 2 nd 2004, p.65.

Attaran, A. How Do Patents and Economic Policies Affect Access to Essential Medicine in Developing Countries? Health Affairs 23(3): 155-66 (2004).

Hale, V.G., Woo, K., and H.L. Lipton. Oxymoron No More: The Potential of Nonprofit Drug Companies to Deliver On the Promise of Medicine For the Developing World. Health Affairs 24(4): 1057-63 (2004).

Week 13 (April 3, 2006): The Employer's Point of View
Guest Speaker:
| Ira L. Winsten
Director of Compensation and Health & Welfare Benefits
CenterPoint Energy
Houston, TX

Employer’s Point of View:

CenterPoint’s Rx Strategy

Total Rx spending as a part of total medical expenses

Co-pay design and rationale

Top twenty drugs by utilization and cost

PBM services

Future Issues – bio meds, Medicare Rx benefit.

Week 14 ( April 10, 2006): Ethics, Research / Development and Conflicts of Interest

Conflict of Interest as Regards Advertising Direct to Public:

Use of Sales Representatives and various incentives; is there a conflict of interest

Research/Development and Conflict of Interests

Financial Ties between Faculty Researchers and Private Drug Companies –

Role of FDA/NIH

Financing Research;

Conflict of Interest in Drug Research

Hospital Stake in Drug Maker – Is this a Conflict of Interest?

Role of Research in Approval Process

Pharmaceutical Companies Influence Publications – Need for Disclosure

Does the pharmacist have an ethical obligation to follow their conscientious?

Video: ”Science for Sale”— Nov. 15, 2002

“Pill Protest”— Jun. 30, 2005

Readings :

 Fountain, H. Does Science Trump All? The New York Times, May 29, 2005.

Als-Nielsen, B., Chen, W., Gluud, C. and L.L. Kjaergard. Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events? The Journal of the American Medical Association. 290(7):921-928 (2003).

Als-Nielsen, B., Chen, W., Gluud, C. and L.L. Kjaergard. Results of Clinical Trials Sponsored by For-Profit vs. Nonprofit Entities, Letter. The Journal of the American Medical Association. 290(23):3071-3072 (2003) (relates to Als-Nielsen JAMA article).

Palmer, R.H. Results of Clinical Trials Sponsored by For-Profit vs. Nonprofit Entities, Letter. JAMA 290(23):3070 (2003) (relates to Als-Nielsen JAMA article).

Rosefsky, J.B. Results of Clinical Trials Sponsored by For-Profit vs. Nonprofit Entities, Letter. The Journal of the American Medical Association. 290(23):3070-3071 (2003) (relates to Als-Nielsen JAMA article).

Steinbrook, R. Gag Clauses in Clinical-Trial Agreements. NEJM, 352(21): 2160-62 (2005).

Kolata, G. Companies Facing Ethical Issue As Drugs Are Tested Overseas. The New York Times, March 5, 2004.

Peterson, M. Science Journals Tighten Rules for Disclosure of Financial Ties. The New York Times, Sep. 27, 2003

Mathews, A.W. Worrisome Ailment in Medicine: Misleading Journal Articles. The Wall Street Journal, May 10, 2005.

Willman, D. NIH Inquiry Shows Wide Spread Ethical Lapses, Lawmaker Says. The L.A. Times, July 14, 2005.

Hoey, J. The Truth About the Drug Companies: How They Deceive Us and What to Do About It. NEJM 351: 1580-1 (2004).

Angell, M. Big Pharma Is a Two-Faced Friend. Financial Times, July 19, 2004.

Blurnenthal, D. Doctors and Drug Companies. NEJM 351(18): 1885-90 (2004).

Chimonas, S. and D.J. Rothman. New Federal Guidelines for Physician-Pharmaceutical Industry Relations: The Politics of Policy Formation. Health Affairs 24(4): 949-60 (2005).

Steinbrook, R. Financial Conflicts of Interest and the Food and Drug Administration’s Advisory Committees. NEJM 353(2): 116-8 (2005).

Anonymous. In Search of Plan C. The Economist, April 9, 2005.

Week 15 (April 17, 2006): Review, Summary, and Conclusion

Week 16 (April 24, 2006): Student Paper Presentations

Papers Due

Course Evaluation (April 24th)