PH 3860 PHARMACEUTICAL POLITICS AND POLICY
Spring 2010
TIME: Mondays noon- 3PM
PLACE: School of Public Health: Room E605
Syllabus Version – April 5, 2010
Professors :
Pauline Vaillancourt Rosenau (Un. of Texas School of Public Health
And
Lincy Lal ( MD Anderson Cancer Center – UT Houston)
PVR Office E915; Telephone 713-500-9491,
email: Pauline.Rosenau@uth.tmc.edu
Course readings include online materials and articles from peer reviewed journals.
Access the most recent version of the course syllabus at www.prosenau.com where
you can click on the live links and browse materials – some, not all of these readings
are required. The annotations to the readings were prepared by Chin-Fun (Sandra)
Chu, and Pauline Rosenau.
Evaluation: This course is given on a pass/fail basis. Satisfactory performance on all
of the course requirements is required to pass the class. The requirements include
one term paper on a topic that is covered in the class approved by the professors (40%
- 10-15 pages); weekly attendance and participation (20%); presentation of articles
from the readings to the class from time to time (20%). Term paper topics are to be
chosen by January 25th. A bibliography is due on February 8th. The tentative outline
of the paper is due on February 22nd and the final term paper must be submitted by
April 26th . A brief oral presentation should be given the day that a student’s term
paper topic is covered in class (20% oral presentation).
A self-evaluation sheet will be filled out by each student and submitted at the end of
term to help the professor write future recommendation letters and in filling out SPH
comment cards.
Class participation: attendance is required. If you anticipate two or more unexcused
absences please consider withdrawing from the course. Approximately 25 pages of
reading are assigned per week but expect wide variation. There is a lot of material to
cover- sometimes summaries or abstracts are assigned rather than full text. Feel free
to read the entire article if you wish. Topics are designated as “special report
opportunities” on the syllabus. The date of the presentation depends on the topic
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chosen – see the course syllabus below. The special opportunities are not required
reading for the other students though they are of course, not prohibited from doing
these readings.
All assigned readings should be read prior to the class for which they are
scheduled, as they will be discussed on the indicated date. Expect readings
assignments to be amended as the course proceeds so do not read too far in advance
of the assignments.
School of Public Health Competencies: PH 3810 fulfills a few competencies in all
fields, but it covers almost all the competencies in the following areas:
Professionalism (ethics), Communication & Informatics, Systems Thinking, and
Diversity & Culture.
Objectives of the course
Students will learn about the content of pharmacy policy in the US and other
countries. At the end of the course they will be able to explain: the difference between
brand and generic medications, how pharmacy policy is made, the role of the FDA,
the approval process, the function of patents, how prices of pharmaceuticals can be
controlled, and why pharmaceuticals are switched from prescription to OTC status.
Students will be able to critically assess: direct to consumer marketing, detailing, and
the ethical/conflicts-of-interest inherent in pharmacy research. They will be able to
compare and evaluate pharmacy policy in both the industrialized and developing
countries. They will be able to assess the role of globalization and the difficulties in
regulating pharmacy products in the global marketplace. The impact of the ongoing
US health system reform on pharmaceuticals will be a special focus of the course so
that students will be able to analyze it for themselves by the end of the term.
Abbreviations on this course syllabus:
Wall Street Journal = WSJ
New York Times = NYT
Journal of the American Medical Association = JAMA
The New England Journal of Medicine = NEJM
January 11th; Introduction and Definitions, Context, Players, and Significance;
Drug Approval and Regulation
Overview: http://www.youtube.com/watch?v=HhbK9qA-jU8&NR=1
Introduction:
January 18th – no class; Martin L. King Day
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January 25th; Pharmaceutical Research, Development, Approval Process, and
Patents in the US and Abroad
Topics:
Definitions : Brand Name Drugs, Generic Drugs, Over-the-Counter Drugs
Context: The “Players” and Vested Interests
Congress and government
Pharmaceutical industry, industry
Insurance
Hospitals, physicians, and pharmacists
Patients and consumer representatives (AARP) etc.
Employers’ view
History of Major Pharmaceutical Regulations
How the Pharmaceutical Policy is driven by the Structure of the U.S. Healthcare
System
Pharmaceuticals are the fastest growing component of U.S. health care costs
Policy Makers vis-à-vis The New Technologies
The Approval Process and the various stages. Is It Too fast, too slow, or just right?
OTC vs. Brand Approval Process; generic versus brand
Generics vs. brand name pharmaceuticals (ethical drugs)
Orphan Drug Act
*Rice, Tom, The Economics of Health Reconsidered – selected pages xeroxed for
the class that related to pharmaceuticals
*Ugalde, A., and Homedes, N. 2006. From scientists to merchants: the transformation
of the pharmaceutical industry and its impact on health. Societies Without Borders.
1(1): 21-40.
The article offers several reasons and explanations of why the pharmaceutical
companies’ expenditure keeps rising over the years.
Congressional Budget Office. (A CBO Study) 2006. Research and development in the
pharmaceutical industry: introduction and summary. Available at
http://www.cbo.gov/ftpdocs/76xx/doc7615/10-02-DrugR-D.pdf
This CBO study discusses several issues related to pharmaceutical R&D: cost of
developing new drugs, roles of federal and private investments, industry’s
performance, and relationship between industry’s profits and R&D investment.
Light, Donald “Misleading Congress about Drug Development” Journal of Health
Politics, Policy and Law, vol 32, #5 October 2007.
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http://web.ebscohost.com.www5.sph.uth.tmc.edu:2048/ehost/pdf?vid=4&hid=112&si
d=d9c9fa16-4574-4748-9be4-f120135da123%40sessionmgr110
Light and Lexchin (2004) Will Lower Drug Prices Jeopardize Drug Research?” The
American Journal of Bioethics, 4 (1); W3-W6
Light and Lexchin, “Foreign Free Riders and the High Price of US Medicines”
British Medical Journal vol 331, 22 October 2005.
Shurin, S.B., and Nabel, E.G. 2008. Pharmacogenomics- ready for prime time? New
England Journal of Medicine. 358(10):1061-1063. Available at
http://content.nejm.org.ezproxyhost.library.tmc.edu/cgi/reprint/358/10/1061.pdf
Pharmacogenomics, a novel therapy that emphasizes on personalized medicine,
requires many more clinical trials to ensure its safety and effectiveness for medical
treatments. This is particularly important for general public since each individual has
different genomic make-up that reacts specifically to certain personalized medicines.
Topol, E.J., Murray, S.S., and Frazer, K.A. 2007. The Genomic Gold Rush. JAMA.
298(2): 218-221. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1001/jama.298.2.218
The studies of human genomics have helped uncover the benefits and development of
genomic medicine, a useful and promising medical treatment for the near future.
However, more gene-based clinical trials are still needed to confirm the validation of
this type of therapy for diseases with complicated conditions. Additional issues
related to genomic medicine include patent, licensure, and cost.
Jack, A. 2008, June 16. GSK leads pack in affordable drugs for the poor. Financial
Time. P12. Available at http://www.ft.com/cms/s/0/4d1f87fe-3b3e-11dd-b1a10000779fd2ac.html?nclick_check=1
The Access to Medicine index, which ranks companies based on independent
assessment of their business activities, reveals that GSK outperformed many USbased drug companies to make drugs available and affordable to the poor.
Zhang “Push to Compare Treatments Worries Drug, Device Makers” WSJ April 14,
2009
February 1st, The FDA, more funding, more responsibility, divide into several
smaller organizations, patents, safety, post marketing surveillance, and approval
Time
Approval Times Are Not Getting Longer
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Post-Market Monitoring
Individual Liberty and Pharmaceuticals
Withdrawal of approved medication from market
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/ Dangerous
Prescription – Novembe 2003
Wood et al “A Sad Day for Science at the FDA” NEJM Sept 22, 2005
Berlin, “Examination of the Relationship between Oncology Drug Labeling Revision
Frequency and FDA Product Categorization” AJPH Sept 2009.
Dhruva et al “Strength of Study Evidence Examined by the FDA in Premarket
Approval of Cardiovascular Devices,” JAMA Dec. 23/30 2009
Wolf et al “Improving Prescription ‘Drug Warnings to Promote Patient
Comprehension” Arch. Intern. Med/ vol 170 ( #1) Jan 11, 2010.
Engelberg “Balancing Innovation , Access, and Profits – Market Exclusivity for
biologics” NEJM 2009.
Hamburg, M.A., and Sharfstein, J.M. 2009. The FDA as a public health agency. The
New England Journal of Medicine. 360(24): 2493-2495. Available at
http://content.nejm.org.ezproxyhost.library.tmc.edu/cgi/reprint/360/24/2493.pdf
Hamburg and Sharfstein are the newly appointed commissioner and principal deputy
commissioner of the FDA by the Obama’s administration. Their avid interest in
public health is greatly emphasized in this article.
Keyhani, S. Diener-West M., and Powe, N. 2006. Are developing times for
pharmaceuticals increasing or decreasing? Health Affairs. 25(2): 461-468. Available
at http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.25.2.461
This study found that drug development times and regulatory review periods have
decreased in the past few years. The authors concluded that longer clinical trials
should not be one of the contributing factors for rising drug prices.
Gottlieb, S. 2005. Opening Pandora’s pillbox: using modern information tools to
improve drug safety. Health Affairs. 24(4):938-948. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.24.4.938
This article suggested that more resources and updated information technology (IT)
tools for postmarketing surveillance and collection of medication safety data can
greatly improve the drug development approval process in the United State.
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Kesselheim, A.S. 2007. The role of litigation in defining drug risks. JAMA.
297(3):308-311. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1001/jama.297.3.308
Pharmaceutical safety litigation can have both advantageous and disadvantageous
impacts on drug regulatory policies. This is especially important for the availability of
data related to clinical trials and the cost of research and development for innovative
medication.
Anderson, G.M., Juurlink, D., and Detsky, A.S. 2008. Newly approved does not
always mean new and improved. JAMA. 299(13): 1598-1600. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1001/jama.299.13.1598
Regulatory reform alone is an insufficient step to improve drug safety. Physicians,
patients, industries, third party payers, and regulatory agencies need to work together
to enhance the efficiency of information sharing. Post marketing studies are urgently
required to provide essential information about safety of the drugs.
Armstrong, D. 2006, May 15. How the New England Journal missed warning signs
on Vioxx. The Wall Street Journal. Available at http://www.postgazette.com/pg/06135/690336-114.stm
The editor of the New England Journal of Medicine was criticized in the midst of the
recall of Vioxx, an unsafe drug manufactured by Merck. The Vioxx article published
in this prestigious journal misled healthcare professionals into thinking this painkiller
was safe to treat their patients.
Trenton, L.A. 2009. J&J focusing research on cancer, other unmet needs. Business
Week.
Johnson & Johnson has decided to devote a good portion of their investment to drug
research with improved diagnostic tests in order to meet the unmet medical needs for
the upcoming future, in keeping with the Obama administration’s priorities for healthcare reform.
Mundy, A. June, 25, 2008. Drug industry boosts lobbying. The Wall Street Journal.
Available at http://www.greenchange.org/article.php?id=2844
Big pharmaceutical companies spent enormous amount of money on lobbying
members of Congress. They focused on finding ways to block the importation of less
expensive foreign drugs and to support the protection of drug patents in the U.S. and
overseas.
Kaiser family foundation “Pharmaceutical Manufacturers Increase Lobbying” Aug 21
2009 – see also “opensecrets.com”
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February 8th Controlling Costs of Prescription Drugs in the United States
Formularies to control costs
Federal Government Cost Cutting Measures
State Government Efforts to Control Costs: seeking discounts
FDA Measures
Federal Retirees
Veterans Drug Benefits
Pill Splitting
Generics: as a cost saver, as a cost driver
Interest groups and lobbying increase costs
Using formularies, user fees, co-insurance, deductibles
Would research suffer if pharmaceutical prices in the US were lower because
of aggressive price controls
The new US health system reform and pharmaceuticals costs
Prescription drug trends. September, 2008. Kaiser Family Foundation.
Available at http://www.kff.org/rxdrugs/upload/3057_07.pdf
Recent statistics has shown the rising expenditure for prescription drugs and
the factors that drive the prescription spending to go up are studied. Some of
the mechanisms that are used by private health insurance companies and
health programs funded by public money to control the cost for drugs are
briefly mentioned.
Harris, Gardiner “Large Price Jumps Reported for Small but Vital Drugs”
NYT January 11, 2010. http://www.nytimes.com/2010/01/11/business/11price.html
What accounts for these cost increases heading into health system reform in
the USA? It isn’t just the pharmaceutical manufacturers; it is the middlemen
as well.
Rubin, R. June, 2009. FDA has a lot on its plate as new chief takes over. USA
Today. Available at http://www.usatoday.com/news/health/2009-06-16hamburg-fda_N.htm
Newly appointed commissioner of FDA, Margaret Hamburg, laid out plans
for the upcoming tasks: tobacco product control, drugs, medical products, and
direct-to-consumer advertising.
Catlin, A., Cowan, C., Hartman, M., Heffler, S., and the National Health
Expenditure Accounts Team. 2008. National health spending in 2006: a year
of change for prescription drugs. Health Affairs. (27)1:14-29. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.27.1.14
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A major change of public health programs, Medicare and Medicaid, and the
implementation of Medicare Part D had a huge impact on how the money was
spent on drugs. Under Medicare Part D, the national health spending has
increased rapidly for drug purchase while other health service spending
remained stable or experienced slow growth rate.
Hartman, M., Martin, A., McDonnell, P., Catlin, A., and the National Health
Expenditure Accounts Team. 2009. National health spending in 2007: slower
drug spending contributes to lowest rate of overall growth since 1998. Health
Affairs. (28)1: 246-260. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.28.1.2
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The drug spending in 2007 experienced a slower growth rate in comparison
with the previous growth rate in 2006. In this case, more retailed prescription
drugs with high demand of generic dispensing were purchased and there was
an even slower growth rate for prescription drug price with consumer safety
concern.
Lee, T.H., and Emanuel, E.J. 2008. Tier 4 drugs and the fraying of the social
compact. The New England Journal of Medicine. 359(4):333-335. Available
at http://content.nejm.org.ezproxyhost.library.tmc.edu/cgi/reprint/359/4/333.pdf
Different types of copayments are being used as strategies to contain the cost
for prescription drugs; especially for biologic drugs with therapeutic purpose.
The idea of co-insurance, which ignores effectiveness and cost-effectiveness,
is proposed to offset the high cost of certain drugs for certain population.
Robinson, J. 2008. Value-based purchasing for medical devices. Health
Affairs. (27)6: 1523-1531. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.27.6.1
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Conflict of interest is still an unresolved issue for hospitals and health service
providers to purchase medical devices. Practicing physicians and hospitals
have a complicated relationship when it comes to acquire new instrument for
patients’ needs. More information is still needed for the performance of
medical device and the disclosure of the sale price.
Edward Owens and Jean Hynes , “Vanguard Health Care Fund: Comanagers'
view of the market”, The outlook on health care reform and the Vanguard
Health Care funds’ portfolio's positioning.
http://www.vanguard.com/health_care_video
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*Donald W. Light, “Global Drug Discovery: Europe Is Ahead: Health
Affairs, August 25, 2009,
http://content.healthaffairs.org/cgi/reprint/hlthaff.28.5.w969v1
It is widely believed that the United States has eclipsed Europe in
pharmaceutical research productivity. However, a comprehensive data set of
all new chemical entities approved between 1982 and 2003 shows that the
U.S. never overtook Europe in research productivity, and in fact Europe is
pulling further ahead – an expanded list of responses and rejoinders….
Healthcare Reform bill Positive to Net Neutral for Pharmaceuticals Industry
According to Analysis by Morningstar Expert – Yahoo Finance , November
30, 2009 http://finance.yahoo.com/news/Healthcare-Reform-Bill-twst2122905458.html/print?x=0
Wilson “Drug Makers Raise Prices in Face of Health Care Reform” NYT,
Nov. 16, 2009.
Kleinke “Dot-Gov: Market Failure and the Creation of a National Health
Information Technology System;” Health Affairs Sept/oct 2005
February 15th – no class; Presidents Day
February 22; Direct to Consumer Marketing: Marketing, and Detailing,
(DTCA: direct to consumer advertising), Switching to Over-the-Counter and
Rational Drug Use – a Public Health Perspective.
II. Direct to Consumer Ads
Video: “Pfizer to Pay Record Penalty Over Promotions” Nesley and Adams,
September 2, 2009 PBS – News Hour story
http://www.npr.org/templates/story/story.php?storyId=112488287&sc=emaf
Direct-to-consumer ads increase costs of health care.
http://video.google.com/videoplay?docid=2984454276714900562
http://www.youtube.com/watch?v=rdh9_Uz6cIs&NR=1
PBS Frontline – “ The Other Drug War”
http://www.pbs.org/wgbh/pages/frontline/shows/other/
CBO “Promotional Spending for Prescription Drugs” Economic and ‘Budget
Issue Brief, December 2, 2009
NJPIRIG Law and Policy Center; “Turning Medicine into Snake Oil; How
Pharmaceutical Marketers Put Patients at Risk,” May 2006
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Woloshin and Schwarz, “Bringing the FDAs Information to Market” Arch of
Internal Medicine, vol 169 (#21) Nov 23, 2009.
Steel “Drug Makers to Press for Guidance on Web Marketing” WSJ, Nov 12,
2009.
Law, Soumerai et al “Costs and consequences of Direct-to-Consumer Advertising
for Clopidogrel in Medicaid, Arch of Internal Medicine/ vol 169, November 23,
2009
Berndt, E.R., and Donohue, J.M. Direct-to-consumer advertising in health care:
an overview of economic issues., ppp 131-163 in Incentives and Choice in
Health Care; Edited by Frank A. Sloan and Hirschel Kasper, 2008,July 2008,
MIT Press
Direct-to-consumer advertising (DTCA) in the field of health care still
remains one of the difficult problems to be resolved. Based on the economics
models, the DTCA can have both good and bad influences on physician and
patients’ decisions. Today, FDA still needs to face many challenges to
regulate the ads being promoted by pharmaceutical companies.
Schwartz and Woloshin, “Lost in Transmission – FDA Drug Information that
Never Reaches Clinicians” NEJM October 29,2009
It is hard to get accurate information to Clinicians – what does this say about
consumers?
FDA warns 14 pharmaceutical companies about short internet ads that do not
contain risk information. April, 2009. Kaiser Daily Health Policy Report:
Prescription Drugs. Available at
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=57874
Several pharmaceutical companies such as GSK, Johnson & Johnson, Bayer,
Novartis, receive warning from FDA for their inappropriate internet ads that
contain misleading information on uses beyond those approved by FDA. The
companies that support internet search engines are not contacted by the
agency because of the current policy.
II. Switching to Over-the-Counter and
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
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Cohen, J.P., Paquette, C., and Gairns, C.P. 2005. Switching prescription drugs to
over the counter. BMJ 330:39-41. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1136/bmj.330.7481.39
In order to curb the cost of prescription drugs, many insurers adopted
switching to encourage patients to purchase over-the-counter drugs instead of
prescription drugs by increasing the amount of co-payments that patients need
to pay. Examples given in this article include United Kingdom, United States,
and Sweden. The switching to over-the-counter also motivates pharmaceutical
companies to file for switching before their patent protection expires and
compete for market share ahead of other generic entries.
Rational Drug Use
Lal, Lincy and PV Rosenau “Evaluation of Rational Use of Medications in
the United States” Journal of Primary Care & Community Health, April 2010
March 1. Begin ; “International Issues: Industrialized Countries compared” – to
be completed in April
OECD, “Pharmaceutical Pricing Policies in a Global Market: executive
summary” 2008, http://www.oecd.org/dataoecd/36/2/41303903.pdf
Mossialos, Marazek, Wallley et al., Regulating Pharmaceuticals in Europe (2004)
http://www.euro.who.int/document/E83015.pdf
This edited work provides a comprehensive view of the topic.
Ess, S.M., Schneeweiss, S., and Szucs, T.D. 2003. European healthcare policies for
controlling drug expenditure. Pharmacoeconomics 21(2):89-103. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://web.ebscohost.com/ehost/pdf?vid
=53&hid=5&sid=f6cad70f-c468-4fd8-931b-7e3c0ec31b69@sessionmgr14
Ess et al. categorize and discuss several different methods that are used by
OECD countries to regulate their rising pharmaceutical costs in respond to the
intention of maintaining the dynamics in the industry and ensuring the need of
the citizens and healthcare providers are met.
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March 8th – no Class ; Spring Break
March 15th: Who Pays for Medications in the US: – Lincy Lal lead professor for
this week.
High Cost of Prescription Drugs
Government Insurance Programs
Medicare – the new prescription drug plan; too complicated and too much
choice?
Medicaid Federal Retirees
Veterans
Private Insurance
The Uninsured and the Poor
Out of Pocket Payments
Access
The pharmaceutical Industry’s Charity
Medical research charity (AMRC-UK based), joint research initiatives,
donations from interest groups (cancer association or heart association….etc.)
Medicare part D and other insurances
Rational Drug Use; Lal and Rosenau
READINGS:
Lal, Lincy and PV Rosenau “Evaluation of Rational Use of Medications in the
United States” Journal of Primary Care & Community Health, April 2010
READINGS:
Wessel, David “The Lessons of Medicare Part D” WSJ, January 7, 2010 ppA
2. Available at http://online.wsj.com/article/SB126282080941818727.html
Stubbings J, DePue RJ Jr. 2009. Medicare Part D: selected issues for plan
sponsors, pharmacists, and beneficiaries in 2009. Am J Manag Care 15
(9):645-9. Available at
http://www.ajmc.com/media/pdf/AJMC_09sepStubbings645to649.pdf
This paper reviews the changes to the Part D benefit 2009. Changes include
coverage amounts in the standard drug benefit, outreach to vulnerable
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populations, evidence based compendium use, standards for e-prescribing, and
guidance for medication therapy management.
Zhang Y, Donohue JM, Lave JR, e tal. 2009. The effect of Medicare Part D on
drug and medical spending. N Engl J Med 361(1):52-61.
http://www5.sph.uth.tmc.edu:2048/login?url=http://content.nejm.org/cgi/repri
nt/361/1/52.pdf
This paper compared spending for prescription drugs and other medical care 2
years before the implementation of Part D in January 2006 with such
expenditures 2 years after in 4 groups of elderly beneficiaries.
West JC, Wilk JE, Rae DS, et al. 2009. Medicaid prescription drug policies
and medication access and continuity: findings from ten states. Psychiatr
Serv. 60(5): 601-10. Abstract at:
http://psychservices.psychiatryonline.org/cgi/content/abstract/60/5/601
This study compares medication access problems among psychiatric patients
in ten state Medicaid programs, assess adverse events associated with
medication access problems, and determine the impact of drug utilization
management on access and adverse reactions.
Kennedy J, Morgan S. 2009. Cost-related prescription nonadherence in the
United States and Canada: a system-level comparison using the 2007
International Health Policy Survey in Seven Countries. Clin Ther 31(1): 2139. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1016/j.clint
hera.2009.01.006
This study compared rates of cost-related non-adherence across major
financing systems (insurance coverage status) for prescription drugs in the
United States and Canada.
Schneeweiss S, Patrick AR, Pedan A, et al. 2009. The effect of Medicare Part
D coverage on drug use and cost sharing among seniors without prior drug
benefits. Health Aff (Millwood) 28(2): w305-16. Epub 2009 Feb3. Available
at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.2
8.2.w305
This study evaluates the effect of Medicare Part D among seniors who
previously lacked drug coverage, using time-trend analyses of pateint-level
dispensing data from pharmacy chains.
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Kaiser Family Foundation: Prescription Drug Trends. September 2008.
Available at http://www.kff.org/rxdrugs/upload/3057_07.pdf
This report covers the trend of rising expenditures for medications, the factors
driving the changes in prescription spending, the insurances coverage for
prescriptions, and selected strategies aimed at containing the rising costs.
Neuman, P., and Cubanski, J. 2009. Medicare Part D update- lessons learned
and unfinished business. N Engl J Med 361(4):406-414. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://content.nejm.org/cgi/repri
nt/361/4/406.pdf
The enacted Medicare Part D prescription –drug plan in 2006 seemingly
helped more Medicare enrollees to gain more accesses to the needed
medication compare to the poor drug coverage before the program had been
implemented. However, there are still some other unresolved issues
accompanying this drug plan such as the coverage gap (dough nut hole),
coverage for low-income beneficiaries, and complicated choices of plans that
can influence the beneficiaries’ selection of plans and utilization of the
medications. In addition, the cost of pharmaceuticals is still rising. It is highly
suggested that the government should have negotiating power to bargain with
the drug manufacturers to bring the drug cost down.
Carey, M.A. January, 2009. Democrats announce bill allowing Medicare to
offer government-run drug plan. Commonwealth Fund. Available at
http://www.commonwealthfund.org/Content/Newsletters/Washington-HealthPolicy-in-Review/2009/Feb/Washington-Health-Policy-Week-in-Review--February-2--2009/Dems-Announce-Bill-Allowing-Medicare-to-OfferGovernment-Run-Drug-Plan.aspx
Senate and House Democrats introduced a new bill that will allow Medicare
to negotiate the drugs prices with the drug manufacturers. This legislation,
once implemented, can greatly help the government-run programs to save
more money for pharmaceutical expenditure.
Levinson, W., and Laupacis, A. 2006. A call for fairness in formulary
decisions. Arch Intern Med 166: 16-18. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://archinte.amaassn.org/cgi/reprint/166/1/16
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Irrational drug prescription reimbursement policy leads to undesirable clinical
practice to prescribe medications. Countries such as United Kingdom,
Canada, and the United States utilize guidelines to include a drug formulary
list that will include drugs that public insurance scheme will pay for.
Typically, cost-effectiveness is one important factor for the drugs to be
included in the list, but public interest is seldom involved in the process. This
article proposes to find an innovative approach to incorporate public opinion
into decision-making process.
Madden, J.M., Graves, A.J., Zhang, F., Adams, A.S., Briesacher, B.A., RossDegnan, D., Gurwitz, J. H., Pierre-Jacques, M., Safran, D.G., Adler, G.S., and
Soumeria, S.B.. 2008. Cost-related medication nonadherence and spending on
basic needs following implementation of Medicare part D. JAMA
299(16):1922. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1001/jama.29
9.16.1922
The cost-related medication non-adherence (CRN) is a common problem in
the elderly and disabled patients. This study found that there was small, yet
significant, decrease in CRN after the implementation of Medicare Part D in
2006 compared to previous year. However, there was still no net decrease in
CRN among the sickest beneficiaries. Also, the data was inconclusive for the
nonelderly disabled individuals.
Abelson, R. July, 31, 2004. Schering case demonstrates manipulation of drug
prices. New York Times Available at
http://www.nytimes.com/2004/07/31/business/schering-case-demonstratesmanipulation-of-drug-prices.html?pagewanted=1&pagewanted=print
A government Medicaid investigation revealed the scheme that had
overcharged the state and federal programs by Schering-Plough, a
pharmaceutical company that poured tens of millions of dollars into consumer
advertising, for a popular allergy medicine – Claritin.
March 22nd ; Ethics, Research / Development and Conflicts of Interest
Guest Lecturer – Ground Rounds on ethics and Pharmaceuticals by Beatrice Manning
Issues:
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Doctors and Practitioners: financial connections, industry funded educational
and research grants, ghost writers, and” targeted detailing”
Pharmaceutical Companies; fraud, fixing the results of research, manipulating
investors, fudging the data, and misleading research results
Universities; setting standards
Researchers, Scientists, and Medical Journals: who writes the article or the
guidelines? Who pays? Where are they invested? Who is really the author?
Who omits information from the report? Who fails to disclose conflicts of
interest when publishing?
Should pharmacists be required to fill all prescriptions submitted?
Human genome project
Wilson, C.R. 2008. Redefining the relationship: ethical prescribing in a
pharmaceutical world. Canadian Family Physician. 54:1341. Available at
http://www.cfp.ca/cgi/reprint/54/9/1341
In order to influence physicians’ prescribing behavior, the pharmaceutical
companies persistently attempt to establish a relationships with physicians by
funding their continuing medical education, offering gifts and kickbacks, and
financing some medical meetings…..etc. Today, new standard of guidelines
will be needed to prevent any inappropriate interactions between doctors and
the industry.
Mello, M.M., Studdert, D.M., and Brennan, T.A. 2009. Shifting terrain in the
regulation of off-label promotion of pharmaceuticals. New England Journal of
Medicine 360(15):1557-1566. Available at
http://content.nejm.org.ezproxyhost.library.tmc.edu/cgi/reprint/360/15/1557.pdf
The environment of the regulation of off-label promotion of pharmaceuticals
in U.S. has changed dramatically since 1980. Prior 1980, there was only a
few regulations imposed by FDA to regulate the off-label drug uses. After
1980, the public awareness of this drug uses began to increase and there were
more Congressional hearings regarding this matter. Distribution of the peerreviewed journal articles by the industry is still a major issue. The judicial
ruling from both Supreme and federal district courts has reached several
ambiguous decisions on whether there should be a requirement for the
company to submit the reprint for FDA review and how the information needs
to be disseminated. Currently, the regulatory agencies will need to primarily
focus on how to prevent any illegitimate activities of off-label prescription
promotion.
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Sismondo, S. 2008. How pharmaceutical industry funding affects trial outcomes:
causal structures and responses. Social Science & Medicine 66:1909-1914. Available
at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1016/j.socscimed.2008.01.
010
Recent qualitative reviews and two major studies of meta-analyses provided
evidences that the pharmaceutical industry funding had a substantial effect on
the outcomes of the clinical trials. Industry adopted a strategy called
“publication planning” to influence the process of research and development,
and the data results from clinical trials. It was strongly recommended that
too-close interaction between pharmaceutical industry and researchers should
be eliminated.
Rothman, D.J., and Chimonas, S. 2008. New developments in managing physicianindustry relationships. JAMA 300(9):1067-1069. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1001/jama.300.9.1067
To discourage the behaviors endorsed by PhRMA code and laxed guidelines
by some of the government bodies, ABIM and IMAP published its own policy
recommendations on conflict of interest in January, 2006. Subsequently,
AAMC approved a new set of policies based on these guidelines in June,
2008. While some of the prominent medical centers decided to follow these
newly-revised rules, other health organizations seemed hesitated to adopt the
same path due to unforeseen interactions with the pharmaceutical companies
as they needed the industrial sponsorship for their research funding. At this
moment, it is still too early to conclude the effect and impacts that the new
guidelines have created, but this action is required to ameliorate the
deteriorating situation of conflicts of interest in the healthcare field.
Doucet, M., and Sismondo, S. 2008. Evaluating solutions to sponsorship bias. J Med
Ethics 34:627-630. Available at
http://jme.bmj.com.ezproxyhost.library.tmc.edu/cgi/reprint/34/8/627
A strong association between pharmaceutical industry funded clinical trials
and pro-industry results has been revealed by many of primary studies and
systematic reviews. To eliminate these biased clinical trials influenced by
drug manufacturers, effective strategies and valuable tools are immediately
needed to improve the validity of these outcomes of the clinical trials. Some
of the current mechanisms used to discourage any biased clinical studies
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include financial disclosure, guidelines by CONSORT, and trial registries,
however, more rigorous actions need to be applied to ensure the conflict
between science and marketing is avoided.
Freudenheim,”And You Thought a Prescription Was Private” NYT August 9, 2009
http://www.nytimes.com/2009/08/09/business/09privacy.html
Steinbrook, R. 2009. A higher bar – Vermont’s new law on marketing prescribed
products. New England Journal of Medicine 361:8-9. Available at
http://content.nejm.org.ezproxyhost.library.tmc.edu/cgi/reprint/361/1/8.pdf
A newly passed law in Vermont, effective in July, 2009, includes a very
comprehensive scheme to regulate pharmaceutical company marketing to
doctors and other medical professionals. The enacted law restricts almost all
forms of contributions offered by the pharmaceutical companies to healthcare
workers in Vermont. For the gifts and other expenditures that are allowed,
such information will have to be disclosed and become publicly searchable
data on the internet.
March 29th; Cross-border Issues, purchasing medication abroad and Health
System Reform 2009-10 (effect on pharmaceuticals)
Topics: Health System Reform 2009-10 (impact on pharmaceutical access, cost,
quality, manufacturing and distribution)
Lecture by Pauline Vaillancourt Rosenau
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: To Reduce Costs by Importing from Canada
The role of Internet Pharmacies in the future?
Cross Border Sales (Canada, Mexico, Australia, New Zealand, Hong Kong,
etc.)
Public Policy Consistency— enforcement and the Supreme Court
Safety of imports
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Kesselheim, A.S., and Choudhry, N.K. 2008. The international pharmaceutical
market as a source of low-f prescription drugs for U.S. patients. Annals of Internal
Medicine. 148(8):614-619. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://web.ebscohost.com/ehost/pdf?vid
=42&hid=5&sid=f6cad70f-c468-4fd8-931b-7e3c0ec31b69@sessionmgr14
U.S. has a drug price that is relatively high compared to other industrialized
countries. To increase the accessibility and affordability of the drugs needed
for the patients, the FDA permits individuals to acquire 90-day supplies of
drugs for personal use from other countries, but large-scale prescription drug
imputation is still illegal. Currently, the drug importation from low and
middle-income countries is problematic since the drug product integrity and
legal status of such products are not warranted. While American citizens can
save money by purchasing from other countries, safety is still an unresolved
issue and many customers will face the counterfeit problems of the
prescription drugs.
Woo, J., Wolfgang, S., Batista, H. 2008. The effect of globalization of drug
manufacturing, production, and sourcing and challenges for American drug safety.
Clinical Pharmacology & Therapeutics. 83(3):494-497. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1038/sj.clpt.6100493
Globalization has created opportunities for the pharmaceutical companies to
obtain their pharmaceutical products and active pharmaceutical ingredients
(API) from other international markets; mainly China and India. The
complexity of this supply chain is increasing as the trend is getting more and
more popular. Experts suggest new scheme to monitor the import life cycle
and electronic pedigree to ensure the sources of ingredients and the safety of
the products. In the end, the industry should be ultimately held accountable for
the safety of their manufactured drugs.
Simon, R.J., Maxwell, J., and Webb, D.J. 2008. Internet pharmacy: a web of mistrust?
Br J Clin Pharmacol 66(2):196-198. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1111/j.13652125.2008.03215.x
As the annual drug sales on the internet steadily increased, for example, $726
million from Canada in 2005, U.S. consumer tend to use the cyber doctors and
self-diagnose to obtain their prescription drugs from internet pharmacies. To
make this matter worse, some of the less reputable websites are openly
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engaged in illegal on-line trafficking of controlled substances. The task to
control the commercial trading of the pharmaceuticals over the internet might
seem daunting, but it is an indispensable action that the law enforcement
should take to protect their citizens.
Alkire, M. 2009. Purchasers beware: better oversight of foreign pharma plants just the
first step. Modern Healthcare. 39(22):19. Available at
http://www.modernhealthcare.com/article/20090601/SUB/306019996#
A great deal of efforts is still needed for FDA to conduct necessary inspection
of overseas facility to make pharmaceutical products. Especially consumers
tend to purchase their prescription drugs on the internet from dubious websites
from other countries. The idea of group purchasing organization (GPO) is
proposed for the hospitals to acquire their pharmaceutical products in order to
ensure the safety and the quality of the drugs.
April 5th: International Issues; Developing Countries ; Lincy Lal lead professor for
this week.
Vaccines and low incentives- global market, advanced commitment market
Developing countries and payment for medications developed and produced
elsewhere
Patents in the US and abroad
(REQUIRED **) Cameron et al, Medicine prices, availability, and affordability in 36
developing and middle-income countries; a secondary analysis The Lancet vol 373,
January 17, 2009 (attached)
Essential
Medications.pdf
Crager SE, Guillen E, Price M. 2009. University contributions to the HPV vaccine and
implications for access to vaccines in developing countries: addressing materials and
know-how in university technology transfer policy. Am J Law Med 35 (2-3): 253-79.
The initial development of the currently available HPV vaccines took place at
a number of universities and other publically funded institutions, however
there is little low-cost access to the vaccine in developing countries when
access would be crucial. Some mechanisms to overcome to barrier to access
to discussed in the paper.
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Beaglehole R, Ebrahim S, Reddy S, et al. 2007. Prevention of chronic diseases: a call to
action. Lancet 370 (9605): 2152-7. Epub 2007 Dec 11.
Chronic diseases are leading causes of death and disability, but are not given
much attention in the global-health agenda. This paper provides evidence that
cost-effective interventions exists aims at whole populations and individuals
to reach this goal.
Clement et al “Using Effectiveness and cost-effectiveness to Make Drug Coverage
Decisions; a comparison of Britain, Australia, and Canada. JAMA Oct 7, 2009.
Bart TN. 2008. Parallel trade of pharmaceuticals: a review of legal, economic, and
political aspects. Value Health 11(5) 996-1005. Epub 2008 May.
An overview of parallel trade of pharmaceuticals, which exists in both
industrialized countries, as well as in the developing world, is provided, as
well as, the health economics and political context in which the parallel trade
is set in currently, especially in the EU and U.S.
Cohen-Kohler JC. 2008. The morally uncomfortable global drug gap. Clin Pharmacol
Ther 82 (5): 610-4. Epub 2007 Sep.
World Health Organization notes that one-third of the global population lacks
regular access to essential medicines and that in some parts of Africa and
Asia, it is even more severe. Slowly, there is a paradigm shift and access to
essential medicines is increasingly viewed as a fundamental human right and
policy implications are discussed in this paper.
Rodriguez-Monguio R, Rovira J, Seoane-Vazquez E. 2007. Analysis fo the World
Bank’s pharmaceutical lending. Health Policy 81(1): 102-16. Epub 2006 Jul7.
This article analyzes the World Bank’s lending activity on pharmaceuticals and
medical products during the fiscal years 1999-2001 by regions, borrower and
supplier country, and procurement method.
Smith, R.D., Correa, C., and Oh, C. 2009. Trade, TRIPS, and pharmaceuticals. The
Lancet 373: 684-691
While the Trade Related Aspects of Intellectual Property Rights (TRIPS)
intents to help the developing countries to obtain needed pharmaceutical
products, the TRIPS-plus requirement in public-health area present a barrier
that would not easily allow the developing countries to exercise their right to
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use the flexibilities built in TRIPS to overcome pharmaceutical patent law to
manufacture or import essential medicines based on their needs. The TRIPSplus indeed increases the price of medicines and raises the expenditure for
these countries’ health-care system.
Stercks S. 2004. Patents and Access to Drugs in Developing Countries: An
Eithical Analysis. Developing World Bioethics 4 (1): 58-75.
The ethical principles and public health guidelines are applied to analyze the
significance of Doha declaration on Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS) and its underlying implication for the
greater good to assist developing countries to gain access to essential
medicines and the right to manufacture these pharmaceutical products.
Phillips, M.M. 2009, June 12. Vaccine plan aims to spur drug development for poor
nations. The Wall Street Journal.
The governments of some industrialized countries and the Bill and Melinda
Gates Foundation vow to assist the developing countries with the purchase of
vaccines for pneumococcal disease. They also guaranteed the drug companies
that the future market would be large enough to justify developing and
manufacturing new vaccines.
Measuring medicine prices, availability, affordability and price components. 2nd
edition, 2008. World Health Organization. (BOOK)
This manual is published for the purpose to provide a standardized method to
measure medicine prices, the availability and affordability of such essential
medicines. Many aspects including regulatory and delivery systems for drugs,
procurement prices in public and private sector, and taxes applied to
pharmaceutical products are considered in this measuring tool. The evidence
can be served as national and international comparisons and can be used for
better policy development and implementation.
The Lancet: essential medicines out of reach of most people. December, 2008. Health
Action International. http://www.haiweb.org/medicineprices/28012009/MPM-Issue4.pdf
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WHO/HAI price measurement tool was used to assess the price of essential
medicines in low- and middle- income countries where high drug price
hinders people’s access to life-saving medicines. Possible solutions include
better financing and distribution system, promotion of the use of generic
products and controlling supply chain cost.
Improved availability of essential medicines needed. . July, 2009. Health Action
International. http://www.haiweb.org/medicineprices/15072009/Bulletin5final.pdf
Several medicine policies are implemented in countries where the there is low
availability for essential medicines in the public sector. The sick and the poor
simply cannot afford to purchase expensive pharmaceutical products from
private sector. These policies aim to improve the availability and affordability
of essential medicines to the people.
April 12th ; International Issues: Industrialized Countries compared
Topics:
Pharmacy Policy for Public Health
Changing Pharmaceutical Market
Public and Private Sector Financing of Pharmaceuticals
Global Pricing Comparisons
Are funds for Research and Development in jeopardy?
Laws and Regulations Controlling Cross-border Sales
Can the US Learn From Other Countries to Control Rx Prices?
Efforts to Reduce Costs of Drugs in Germany
How Canada Keeps Pharmaceutical Prices Down
European Drug Approval Process
Context: The “Players” and Vested Interests – The Pharmaceutical Industry,
Government, Congress, Insurance, Industry, Pharmacists, Hospitals,
Physicians, Patients, Consumer representatives (The AARP) etc.
Determination and measurement of drug prices in other countries
(**REQUIRED for all to read) Thomson and Mossialos “Primacy Care and
Prescription Drugs: Coverage, Cost-Sharing, and Financial Protection in Six
European Countries" March 10, 2010 Commonwealth fund :
http://www.commonwealthfund.org/Content/Publications/IssueBriefs/2010/Mar/Primary-Care-and-Prescription-Drugs-Coverage-Cost-Sharing-andFinancial-Protection.aspx
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“The Cost of Drugs Issues,” Five countries examined by experts from each
including Professor Uwe Reinhardt.
http://www.pbs.org/wgbh/pages/frontline/sickaroundtheworld/themes/drug.html
Morgan, S.G., McMahon, M., Mitton, C., Roughead, E., Kirk, R., Kanavos, P., and
Menon, D. 2006. Centralized drug review processes in Australia, Canada, New
Zealand, and the United Kingdom. Health Affairs 25(2):337-347. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.25.2.337
The structures and the significant components –rigor process, clarity of roles,
and transparency of rationale- of centralized drug review performed by the
regulatory agencies in Australia, Canada, New Zealand, and the United
Kingdom were discussed and evaluated. Their methods to conduct the initial
assessment of evidences submitted by the drug makers and appraisal of such
evidences, while not perfect, can provide practical and valuable information
for the policy makers to make informed and evidence-based decisions.
Morgan, S., Bassett, K, and Mintzes, B. 2004. Outcomes-based drug coverage in
British Columbia. Health Affairs 23(3):269-276. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.23.3.269
In British Columbia, Canada, the provincial drug benefit program –
PharmaCare- adopted an outcome-based drug coverage plan to help its
citizens to gain access to therapeutically effective pharmaceuticals while
controlling the public drug plan’s costs. The program received academic
advices from a university-based group of experts (Therapeutic Initiative) to
establish a framework to evaluate all drugs that the manufacturers sought
public coverage. Evaluation data from this PharmaCare policy for public drug
plan proved to save the province approximately $35 million annually.
Morgan et al “Influencing Drug Prices throught Formulary-Based Policies; Lessons
from New Zealand” Healthcare Policy, 2007.
Rx Atlases. UBC’s Centre for Health Services and Policy Research; Canada and
British Columbia
Morgan, Raymond, Mooney and Martin, The Canadian RX Atlas, 2nd edition,
2008,http://www.chspr.ubc.ca/rxatlas/canada 2008
Steve Morgan, Colleen Cunningham, Gillian Hanley, and Dawn Mooney, The BC
Rx Atlas, 2nd Edition (2009)
http://www.chspr.ubc.ca/rxatlas/bc/2009 2009
http://www.chspr.ubc.ca/files/publications/2009/BCRxAtlas/intromethodskeyfindings.pdf
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Sood, N., de Vries, H., Guteirrez, I., Lakdawalla, D.N., and Goldman, D.P. 2009. The
effect of regulation on pharmaceutical revenues: experience in nineteen countries.
Health Affairs 28(1): w125-w137. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1377/hlthaff.28.1.w125
This study was based on the analysis of the impacts brought on by the
pharmaceutical regulations implemented in nineteen OECD countries in
relation to the pharmaceutical revenues. The authors found that direct price
control has the largest impact on controlling the drug cost and economic
evaluation appeared to be the fastest-growing trend for policy development.
These policies, when implemented together, can have tremendous effects on
cutting down the pharmaceutical expenditure in the unregulated market such
as the US.
Siva, N. 2009. The drug price is right – or is it? The Lancet 373: 1326-1327.
Available at http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1016/S01406736(09)60756-X
The previous version of Pharmaceutical Price Regulation Scheme (PPRS) in
U.K. was deemed to be impractical when it comes to negotiating drug price
with the pharmaceutical manufacturers and to determine the real effectiveness
of drugs based on the need of patients’ quality of life. Unlike the old PPRS,
the updated PPRS will adopt value-based approach to set the drug price wisely
while actually taking the therapeutic benefits into consideration.
Berton, E. 2008, October 15. Glaxo drug hits U.K. insurance hurdle. The Wall Street
Journal. Available at http://online.wsj.com/article/SB122401726179533727.html
The U.K.’s National Institute of Clinical Excellence (NICE) rejected the
public coverage of GlaxoSmith Kline’s breast-cancer drug – Tyverb. NICE
claimed that Tyverb was not proven to be a clinically cost-effective medicine
to treat the patients.
July, 09, 2009. NICE to reconsider GSK’s Tyverb. www.pharmafocus.com
July,10, 2009. NICE upholds GlaxoSmithKline appeal for advanced breast
cancer treatment, Tyverb (lapatinib). Available at
http://www.medicalnewstoday.com/articles/157009.php
NICE is giving the cancer drug, Tyverb manufactured by GSK, a second
chance that it might be included in their formulary list. Under the newer and
more lenient guidelines, the agency is re-reviewing the cost-effectiveness of
Tyverb for women with aggressive form of advanced breast cancer based on
“end-of-life” criteria.
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Kanter, J. 2008, November 29. Europe accuses drug makers of padding health care
costs. The New York Times. Available at
http://www.nytimes.com/2008/11/29/business/worldbusiness/29drugs.html
Evidences found by the European Union investigators suggested that the
pharmaceutical companies purposely and strategically delayed the availability
of less expensive generics and new medicines on the market in order to gain
lucrative profits for their own businesses. The drug makers even paid the
generics maker to postpone the introduction of their products for the
consumers. Their corporate actions caused additional billions of dollars to the
health system in the European countries.
Horton, R. 2009. The UK’s NHS and pharma: from schism to symbiosis. The Lancet
373:435-436. Available at
http://www5.sph.uth.tmc.edu:2048/login?url=http://dx.doi.org/10.1016/S01406736(09)60148-3
For the welfare of the patients who require access to important medicines, big
pharma, clinicians, and medical researchers should strive for a harmonious
collaboration to establish a system to produce effective and affordable
medicines for the patients. As the interactions among these three parties are
unavoidable, moral compass should be applied to guide them through this
complicated conflict-of-interest pathway.
Jerah Thomas. 2009. Pharmaceutical pricing and reimbursement: procedures and
strategis in Germany, the United Kingdom, Canada, and Australia. Student Term
Paper
Drug approval and regulation, pricing and reimbursement by the public
healthcare system, and cost containment strategies utilized by Germany, the
United Kingdom, Canada, and Australia were well-briefed and compared.
Sandra Chu. 2009. Pharmaceutical policy activity in France, United States, Japan, and
New Zealand.
Policies implemented and methods to control pharmaceutical costs in France,
United States, Japan, and New Zealand were summarized and compared.
Among these countries, the United States appears to have different scheme
dealing with rising drug cost compared to other three countries.
Gordon and Forelle, ”EU Ordered to Reconsider Glaxo Request on Its Prices” WSJ,
October 7, 2009
April 19th; Globalization, no international regime, and the “enforceability” of
laws
Free trade issue, regional trading areas and the WTO – theory and reality
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Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)
Healthcare systems and pharmaceutical policies in other countries
Ethic issues – tainted drugs, clinical trials
Vaccine issues – global market, advanced commitment market
Drug safety issues – counterfeit drugs
Drug re-importation
TRIPS – free trade agreement, World Bank, TRIPS-plus
Fullar, T. July, 21, 2009. Using scientific tools in an international war on fake drugs.
New York Times. Available at http://www.nytimes.com/2009/07/21/science/21coun.html
With the soaring number of evidences shown that counterfeit pharmaceutical
drugs have been circulating around the global market, a phenomenon mostly
seen in the third-world country where regulation towards drug safety is more
lax, members from the science community and international law enforcement
engage in the collaborative work to combat this fake drug business by using
cutting-edge technology that allows them to identify the counterfeits in a very
short amount of time. In the future, the experts hope that consumers will be
able to verify the genuineness of their pharmaceutical goods in the local
pharmacies.
April 26th ; Student term papers due and 10 minute summary of paper to be
presented to the class.
ACKNOWLEDGEMENT:
The first draft of this course syllabus was prepared by Chin-Fun (Sandra) Chu,
August 2009 as part of the fulfillment of an Independent Study for her MPH at the
School of Public Health, University of Texas – Houston
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