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  • Commentary
    Open Access

    Offshore Pharmaceutical Trials: Evidence, Economics, and Ethics

    Mayo Clinic Proceedings: Innovations, Quality & Outcomes
    Vol. 2Issue 3p226–228Published online: June 5, 2018
    • Y. Tony Yang
    • Brian Chen
    • Charles L. Bennett
    Cited in Scopus: 0
      Backed by a group of wealthy investors and an American university, a US pharmaceutical company recently flouted United States Food and Drug Administration (FDA) safety protections by testing an experimental herpes vaccine offshore.1 More than 20 American patients with herpes were flown to St Kitts several times to be vaccinated.1 By participating in a study that was not monitored by the FDA or a safety panel, patients forewent mandated layers of protection against dangerous adverse effects or even death.

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