FINAL Feinberg Lecture - Slater - 11-21-2002

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Fostering Innovation in Medicine and Research
Eve E. Slater, M.D., F.A.C.C.Assistant Secretary
for HealthDepartment of Health and Human Services
2002 Charles C. Leighton, M.D., Memorial
LectureUniversity of PennsylvaniaOctober 18,
2002
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1900-presentA Century of Innovation

• Increased Life Expectancy
• Increased Cancer Survival Rate
• Decreased Cardiovascular Mortality
• Advent of Vaccines
• Human Genome Project
• . . . . . . . . . . . . . . . . . . . . .and so
  much more

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Investment in Medical Research and Care

Receiving more in improved health than we pay
in treatment costs implies that medical care is a
more productive investment than the average use
of our funds outside the medical sector.

Cutler, McClellan, and Newhouse1998
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Federal Funding for National Institutes of
Health (NIH)

• Doubling of NIH budget in 5 years (1998-2003) to
  27 billion in Fiscal Year 2003
• NIH budget in 1960 182 million
• Clinical research funding 32 of budget (Fiscal
  Year 2001)

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Selected Federal Legislative Milestones

• Bayh Dole Act (1980) removed barriers to patent
  ownership from federally supported research
  40 billion/260,000 jobs (1999)
• Stevenson Wydler Act (1980) stimulated
  public-private partnerships
• Orphan Drug Act (1983) encouraged research and
  development for drugs for orphan diseases
• National Cooperative Research Act (1984) eased
  antitrust concerns
• Waxman Hatch Act (1984) protected intellectual
  property
• Federal Technology Transfer Act (1986)
  stimulated technology transfer
• Clinical Research Enhancement Act (2000)
  encouraged funding for clinical research

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These new paradigms will require a
reexamination of the structure of the U.S.
medical research institutions and government to
ensure that they reflect and accommodate new
multidisciplinary research and development
processes.

Senator William H. Frist, M.D. Journal of the
American Medical Association, May 2002
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Institute of Medicine Reports on Quality

• Medical Errors approximately 45,000-100,000 per
  year
• Cost approximately 17-29 billion per year
• Hospital Drug Errors approximately 2 billion
  per year

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The Administration supports your (U.S. House
of Representatives) efforts to pass ... and enact
legislation to remove the liability barriers to
improving quality and safety of health care.

Secretary Tommy G. ThompsonSeptember 10, 2002
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Drug Development Costs (source Tufts CSDD)

• 2002 cost 802 million
• 19 reduction in all phases length 100
  million saved
• 21.5 to 25.5 increase in clinical success rate
  100 million saved
• If phase III studies decrease by 1 year 71.4
  million saved
• If 33 decrease in development and regulatory
  review time 1.7 million saved

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Innovation and Cost
Memory Federal Funding and Key
Legislation ReasonTranslational Research
Prioritization and Dialogue ImaginationInfrastr
ucture for Quality Availability and Access