The trachea transplant scandal and “compassionate use”

The synthetic trachea transplantations performed at the Karolinska Hospital1 were undertaken under “compassionate use.” The transplantations were an unproven intervention performed in the absence of safety and efficacy data from animal studies and without any scientific foundation.Article 37 of the Declaration of Helsinki indicates the circumstances under which “compassionate use” could apply: “In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health, or alleviating suffering.”In the original trial of the Macchiarini case in 2022, the court ruled that Macchiarini was justified in using trachea transplants in two of the three patients because they were in an emergency situation (that is, about to die). But the…
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