Academia,
Healthcare Providers, and
the Industry
Three Different Worlds?
Three Different Sets of Goals?
Sheldon Kong, PhD
Senior Director, Outcomes Research
Merck & Co., Inc., NJ, USA
December 17, 2002
CHEBS Seminar, University of Sheffield
Outline
• Introduction to Merck & Co., Inc.
• Personal interpretation of Outcomes Research
• Opportunities and challenges for collaboration
among academia, healthcare providers &
pharmaceutical manufacturers
• Afterthought:
– A pharmaceutical manufacturer’s perspective
– 3win leads to better healthcare decision making
2
Merck & Co., Inc.
• More than 70,000 employees worldwide
– > 11,000 employees in Merck Research Labs
– 2001 R&D spending - $2.5 billion (up 14% from 2000)
• Conduct business in about 150 countries
• Market more than 100 medicines and vaccines
• Clinical trials: one protocol, one standard, worldwide
2001
U.S.
Int’l (ex-US)
TOTAL
Trials
261
74
335
Countries
1
59
60
Sites
5,168
3,637
8,805
Patients
106,539
49,504
156,043
• No. 1 corporate giver in US (e.g., Mectizan Donation
Program, $100 million of Recombivax HB)
3
Our Values
“We try never to forget that medicine is
for the people. It is not for the profits.
The profits follow, and if we have
remembered that, they have never failed
to appear… How can we bring the best of
medicine to each and every person? We
cannot rest till the way has been found,
with our help, to bring our finest
achievements to everyone.”
— George W. Merck, 1950
4
Our Mission
• Provide society with superior products and services
to improve the quality of life and satisfy customer
needs
• Provide employees with meaningful work and
professional growth and development
• Provide investors with a superior rate of return
5
Our Strategy for Growth
• Discover important
new medicines through
breakthrough research
• Demonstrate the
value of our medicines
to patients, payors
and providers
6
Outcomes Research
• Flourishing definitions and fields
– Outcomes research
– Pharmacoeconomics/Health economics
– Health technology assessment
• Understanding the inputs and end results (clinical,
economic and quality of life value) of health care
interventions
7
Personal Interpretation of Outcomes
Research: Three Key Components
Health Care
Input
COSTS
(Resources
consumed)
Health Care
Program or
Procedure
PROGRAM
Surgery
Hospital
Drug Therapy
• What do we do?
• How much does it cost?
• What are the outcomes?
Output or
Outcomes
OUTCOMES
Clinical effects
Quality of life
Economic benefits
Is this a better (or the best)
program given the amount of
money (resources) we spend
and the outcomes we get?
8
What Do Researchers Need to Support
Outcomes Research Activities?
•
•
•
•
Research expertise
Data (new or existing)
Funding
Understanding of applications/impact of research
projects
–
–
–
–
–
Advancement of science
Health care policies: national/regional
Clinical decision making
Marketing effort (capitalism system)
Self interest/actualization: e.g, curiosity, funding
9
Collaborations Among Different Parties:
Not a New Phenomenon
• Long history of collaboration between academia and
pharmaceutical manufacturers on “basic” research
(e.g., pharmaceutics) and clinical studies (e.g.,
clinical trials)
• Examples of excellent collaboration exist among
academia, healthcare providers & pharmaceutical
manufacturers (e.g., Heart Prevention Study)
• Barriers exist for close collaboration between
healthcare providers and pharmaceutical
manufacturers (e.g., legal, financial, cultural)
10
Collaboration Among the Three Parties:
Perfect Match?
• Pharmaceutical manufacturers need information to
make decisions related to regulatory application,
reimbursement and promotion
• Healthcare providers have (potential) data to offer
and need to analyze/interpret these data in the
context of broader healthcare systems
• Universities have skilled researchers and data
processing capacity, and require research projects to
provide revenues, research training and experience
opportunities, and publications
11
Challenges Facing Academia
(More Relevant in the US)
• Pressure for grants amid increasing competition for
federal funding
• Need to accommodate academic/research freedoms
• More federal money goes to “basic” research
• Many outcomes research projects require large,
longitudinal, up-to-date databases
• Recruitment and employment opportunities for
graduate students
• Real life applications of research & influencing
policy and clinical decision making
12
Challenges Facing Healthcare Providers
(More Relevant to US MCOs)
• Increasing competition for customers (US managed
care organizations)
• Improving quality of health care with affordable
price (outcomes assessment)
• Lack of expertise in outcomes research
• Conflict between long-term commitment to research
and short-term financial goals
• Lack of well-built database infrastructure (e.g.,
clinical status, integration of different segments of
information)
13
Challenges Facing Pharmaceutical
Manufacturers
• It’s getting more difficult to get innovative medicines
to market and more resources are needed
• Pressure for more data (beyond safety and efficacy
for regulatory approval) at launch
– Required before 'real life' usage data is available
– Increasingly required for reimbursement or formulary
listing
– Formation of a "fourth hurdle"
• Shift in medical decision making for selection of
therapy: from primarily individual physicians to
large payors/groups (with collective expertise)
14
Collaboration Among the Three Parties
to Provide the Best Patient Care
How to overcome
barriers for a mutually
beneficial collaboration?
Challenges exist
with such endeavors,
but collaboration
can be beneficial in
satisfying the needs of
all parties
15
How to Improve Collaboration
• Understand each other’s “business”
• Learn to communicate with each other (three distinct
cultures)
• Set reasonable expectations (funding, confidentiality,
deliverables, publications, timelines)
• Be clear and specific at the very beginning
• Be proactive
16
Potential for Conflict of Interest
• Outcomes Research is a new field & research results
may have major impact on policy, formulary, and
clinical decisions
• Questions may arise regarding study conclusions due
to lack of certain variables in provider databases
• Perceived problems with decisions based on
“clinical” versus “economic” considerations
• Desire for publication versus need for proprietary
information
• Funding from different sources: different sets of
conflicts of interests?
17
3win Collaboration: A Pharmaceutical
Manufacturer’s Perspective
• Ensure patients access to innovative medicines
• Quality of clinical evidence should be used as the key
criterion in evaluating innovative medicines
• OR studies can help in making decisions about more efficient
healthcare resource utilization while also providing evidence
for the importance of appropriate use of innovative medicines
• Merck studies should be held to the same standards as any
other studies in the peer-reviewed literature
• Merck is committed to publishing results to contribute to the
advancement of the field of OR
– Undertake research using patient-centered outcome measures
– Communicate with healthcare providers and regulators to enable
understanding of available data
18
A Perfect Example of Collaboration:
3Win Leads to Better Healthcare Decision Making
Healthcare
Providers
Pharmaceutical
Manufacturers
Patients
Academia
(CHEBS)
19