Last year, the FDA received 1,262 requests from drug companies, on behalf of desperate patients, to use unapproved drugs outside of clinical trial programmes. The number of 'compassionate use' requests has risen by nearly 25% since 2010, with no sign of abating. Yet, while companies carry most of the onus of deciding which cases to support and which to deny, they typically make their decisions on an ad hoc basis. Social media campaigns and personal connections can sway the outcomes. Arthur Caplan, a medical ethicist at New York University School of Medicine, believes that a fairer decision-making process is needed. He told Asher Mullard about a pilot project that he ran with Johnson & Johnson's pharmaceutical company Janssen to equitably and transparently distribute an experimental drug outside of its clinical trial programme.
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Arthur Caplan. Nat Rev Drug Discov 15, 226–227 (2016). https://doi.org/10.1038/nrd.2016.61
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DOI: https://doi.org/10.1038/nrd.2016.61