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Ethical Issues Related to Compassionate Use. RDLA, February 26, 2014. Michael J. Werner. Overarching Principles. The situation usually arises because someone is very sick and wants access to an unapproved product outside of a clinical trial

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ethical issues related to compassionate use

Ethical Issues Related to Compassionate Use

RDLA, February 26, 2014

Michael J. Werner

overarching principles
Overarching Principles

The situation usually arises because someone is very sick and wants access to an unapproved product outside of a clinical trial

FDA has policies designed to provide access to such patients

Companies are confronted with an ethical dilemma

ethical points to consider bio
Ethical Points to Consider (BIO)
  • Companies have an ethical responsibility to develop and market products as fast as possible
    • Patient autonomy does not supercede
    • Autonomy means cannot be forced to receive treatments/informed consent – not an absolute right to an unapproved product
  • Company ethical priority is not jeopardizing clinical program that will help many patients
  • Providing a product through compassionate use could put clinical program at risk
points to consider con t
Points to Consider (con’t)
  • Early access could hurt the integrity of clinical trial process
    • Diminish incentive for patients to participate
  • Can a patient in this situation provide truly informed consent?
    • By definition, there is likely insufficient safety data
      • Can the company be sure such data exists?
  • How can a company ensure equity in distribution of a product outside a clinical trial?
    • Which patients get the product (best lawyer? Most Twitter followers?)
      • Can the company develop inclusion/exclusion criteria
other issues for companies
Other Issues for Companies

Life threatening condition?

Other treatment options (including clinical trials)?

Are they confident product has sufficiently demonstrated safety?

Is there any efficacy data for the product?

Legal liability?

Opinion of patient’s treating physician?

concluding points
Concluding Points
  • Companies/sponsors have an ethical obligation to get products to the market as soon as possible
  • Actions that put a clinical program at risk are counter to that obligation
  • Other options to provide products to patients are potentially fraught with other ethical challenges
  • There could be situations where patients get access to unapproved products outside of trials
  • Many companies try to balance these ethical issues and develop compassionate use policies