Caroline Chang

1
The Ethics of Drug Eluting Stents
Final Presentation 5/12/03

• Caroline Chang
• Maya Dobuzhskaya Manish Gaudi
• Mark Sellmyer

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Overview

• What are Ethics?
• Ethics of Clinical Trials
• Clinical Trial Results
• Ethics vs Reality
• Rationing of Stents
• Consequences of Rationing
• Conclusions

3
Ethics Who Cares?

• Ethics a set of principles of right conduct
• Rightness is a subjective measure
• The information and opinions expressed in this
  presentation are only one view of rightness, and
  should not be treated as ethical law.

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What Are Clinical Trials?

• Extensive laboratory testing to find a safe and
  effective treatment in the shortest amount of
  time
• Studies are carefully designed to
• -answer the research questions
• -protect participants

http//www.nlm.nih.gov/medlineplus/tutorials/clini
caltrials/hc019101.html
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What Makes Clinical Trials Ethical?

• Social or scientific value
• Scientific validity independent review
• Favorable risk-benefit ratio
• Fair subject selection
• Informed consent
• Respect for potential and enrolled subjects

Emanuel, Ezekiel, et. al. What Makes Clinical
Research Ethical?
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They are Ethical. But..

• Clinical trials are necessary but need to be
  carefully monitored and regulated
• Need a single, legally-binding set of ethical
  guidelines
• Most clinical trials in the United States are
  considered ethical

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Clinical Trial Disclaimer

• Clinical trials are not necessarily
  representative of a real-world population
• However, its all we have

8
Results of Relevant Clinical Trials
New England Journal of Medicine
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Ranking the Options

• 1. Drug-Eluting Stent
• 2. Minimally Invasive Bypass
• Surgery
• 3. Bare Metal Stent
• 4. Balloon Angioplasty

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Ethics v. Reality

• Ethically Since Drug-eluting stents are the most
  effective treatment, everyone should get them
• Realistically This is not possible because
  resources are limited

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What are the limitations of implementing DES?

• Demand gt Supply
• Money DES are 3x as expensive as BMS
• Insurance Reimbursement Issues
• Hospitals must make up the difference leading to
  conflicts of interest.

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Why do DES cost so much?

• - Stent processes already established
• - Polymers and drugs are relatively inexpensive
• Where does all the money go?

PROFIT!
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The Options

• Ration the stents according to
• -severity of case
• -first come first serve
• -financial status of patient
• -worth of patient
• Do not offer stenting procedures

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The Options

• Ration the stents according to
• -severity of case
• -first come first serve
• -financial status of patient
• -worth of patient
• Do not offer stenting procedures

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If You Ration..

• Ethical Problem
• Not everyone will get optimal therapy
• (ie drug-eluting stents)
• Our Ethical Solution
• Have every patient evaluated using a single set
  of guidelines (ex SAHA)

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Ways of Determining Severity

• Evidence Based medicine
• Firm proof that treatment is effective. However
  this makes it difficult to deny treatment.
• Cost benefit analysis
• X-axis is percentile of risk. Y-axis is amount of
  benefit. Not a direct relationship.

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Rationing by SeverityHigh-Risk vs Low-Risk
Approach

• High risk patients (get DES)
• -Hypertension
• -Diabetes
• -Angina
• -Increased age
• Low risk patients (get BMS)
• Goal Use DE stents only in circumstances in
  which a significant clinical benefit for the
  patient can be anticipated. (SAHA)

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Responsible Parties For Rationing

• Cardiologists
• Evaluate patients according to guidelines
• Distributors (hospitals)
• Keep track of DES supply
• Insurance Agencies
• Peer review of doctors not following guidelines
• Patients
• - Patient Bill of Rights

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Conclusions

• Because DES are beneficial, they should be given
  to all stenting patients
• Due to economical constraints, DES must be
  rationed
• We recommend rationing based on severity of
  circumstance
• A set of universal guidelines should be used
  determine the severity

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References
Thanks to all the other Ethics Group Members.

• http//eduserv.hscer.washington.edu/bioethics/topi
  cs/consent.html
• Gunn, J. et al. Heart. 2003 89127-131
• http//www.saheart.org/guidelines_stents_eluting.h
  tml
• Report by Daniel Callahan P.h.D, Medical
  Technology, Innovation, and the Nature of Medical
  Progress, NIHCM Conference, Washington D.C.
  January 27-28th 2003.
• Degertekin, M. et al. JACC. 2003 41(2)184-189
• Dzavik, V. Am J Cardiol. 200391(suppl)27A-33A
• Diegeler A, Thiele H, Falk, V, et al. Comparison
  of stenting with minimally invasive bypass
  surgery for stenosis of the left anterior
  descending coronary artery. N Engl J Med 2002 Aug
  22347561-6.
• N Engl J Med 2002 Jun 63461773-80.
• Coronary Stent System Potential Adverse Effects.
  www.guidant.com.
• De Luna AB, ONeill WW. Drug-coated stents for
  everyone or for selected use in high-risk
  populations.
• www.cardiosource.com.
• Morice, M. et al. NEJM. 2002 346(23)1773-1780
• Virmani, R. et al. Heart. 200389 133-138

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• QUESTIONS?

ETHICS IS 1!
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