Biomedical Research, Technology, and Assessment

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Biomedical Research, Technology, and Assessment

• Chapter 10
• Dr. Tracey Lynn Koehlmoos

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Introduction

• US enjoys reputation as world leader of
  biomedical research and health services
  technology
• US government actively supports research and
  advancement
• 1) Review the role of research
• 2) Developmental procedures
• 3) Use of technological assessment and its impact
  on expenditures

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Biomedical Research

• Government interest and funding started in 1945
  with 5 million dollars
• 2000, US government spent 25.3 billionexcludes
  drug company and private research funds!

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National Institutes of Health

• NIH is controls much of the federal funds
• Comprised of 19 disease or condition specific
  institutes (ex. NCI)
• Focus shift from infectious to chronic disease
• Although Federal support of biomedical research
  is less than 4 of total health expenditures, the
  NIH budget has grown more than 100 between 1998
  to 2003.
• Up to 27 billion in 2003

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Health Services Technology

• Development of technology
• Dissemination
• Application

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Steps in Development

• McKinleys Development Model
• 1) Promising Report
• 2) Professional Organizational acceptance
• 3) Public, state and 3rd party payer endorsement
• 4) Standard procedure observational reports
• 5) Randomized clinical trials
• 6) Professional denunciation and
• 7) Erosion and discreditation
• NOT ALL TECHNOLOGIES FOLLOW ALL STEPS

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Effect of Technology on

• We pay for having the most advanced health
  services system on the planet.
• 16 GDP in 2005
• 50 of annual increase due to new tech.
• Examples
• Treated AIDS and End Stage Renal Disease
• Coronary Artery Bypass Grafts
• Clinical progress into other areas psych
  disorders, substance abuse

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Pharmaceuticals

• Drug development is important but not a huge
  proportion of US healthcare expenditures (as in
  France and Germany)
• Widely regulated industry
• Food and Drug Administration (1906)
• Regulates the production dissemination of all
  drugs and medical devices
• Controls the approval and marketing of Over The
  Counter (OTC) and prescription drugs

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Criticism of FDA Review

• Review process always underfire
• Public and press clamor for new drugs without the
  lengthy waiting period (average from start to
  approval 7 years)

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New Drug Development

• New drug development can take 12 years and is
  expensive (gt800 million from start to market)
• To protect health interest in unprofitable areas
• Orphan Drug Act 1983 Ensures that essential but
  low demand drugs remain available
• National Childhood Vaccine Injury Act 1986
  Limits legal actions and allows for review of
  vaccines that cause adverse reactions

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Personal Health Drug Expenditures

• About 10 of total personal health expenditures
  (2005)
• 60 prescription drugs
• 40 OTC drugs
• Medicare Part D is specifically designed to
  reduce the financial impact of prescription drug
  purchases on senior citizens (2006)

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Medical Devices

• Defined Any item promoted for medical purpose
  that does not rely on a chemical action to
  achieve its desired effect.
• Most devices are used by providers (medical
  equipment, surgical tools)
• New products must have FDA approval

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Durable Medical Equipment Supplies

• Often overlooked, lt2 of health expenditures
• Wheelchairs, dressings, prostheses
• Growth of elderly population brings increase
  expense
• Medicare and Medicaid are instituting controls in
  this area
• Waste, fraud and abuse (controls and checks)

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Technology Assessment (TA)

• How do we know when a new procedure is ready for
  general application?
• Randomized Clinical Trials (RCT)the Gold
  Standard in Research!
• Whose job is TA?
• No centralized authority (parts to FDA, AHRQ)
• Private sector? HmmmPeriodic and more likely if
  it is cost effective

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NIH Consensus Conferences

• Recommending treatment changes since 1976
• NIH convenes panel of experts
• Develop and disseminate reports
• Example Switch from radical mastectomy to
  Modified Radical mastectomy AND switch from MRM
  to BCS for ESBC.

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Technological Reassessment

• Period Reassessment is necessary
• Variability by physician training and specialty
  (new field of research!)
• Why do some out-dated technologies linger?
• Physician training
• Lack of a good alternative
• 3rd Party Payer continues to reimburse for it

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Changes in Healthcare System

• Managed Care Emphasis on cost savings
• Focus on new outpatient technologies
• Threats to drug industry (formularies, limits)
• Ethical Concerns
• Misapplication or overuse (MRI for every
  headache?)
• Futile care providing care without benefit
• Genetic research (Stem Cell)

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Summary

• Technology and biomedical research make the US
  the world leader in healthcare services
  innovation
• Research, drugs, medical devices and surgical
  procedures are all part of the growing
  contributors to healthcare expenditures.