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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. 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

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  1. Ethical Issues Related to Compassionate Use RDLA, February 26, 2014 Michael J. Werner

  2. 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

  3. 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

  4. 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

  5. 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?

  6. 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

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