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After Charlie Gard: ethically ensuring access to innovative treatment

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540 www.thelancet.com Vol 390 August 5, 2017 July 24, 2017, marked the end of the long-running legal battle over treatment for UK infant Charlie Gard. International medical experts, invited by… Click to show full abstract

540 www.thelancet.com Vol 390 August 5, 2017 July 24, 2017, marked the end of the long-running legal battle over treatment for UK infant Charlie Gard. International medical experts, invited by the High Court to examine Charlie, concluded that proposed innovative treatment could no longer offer even theoretical benefit. His parents accepted that it was time to allow Charlie to die, while bitterly lamenting that he had missed a potential window of opportunity for treatment. Charlie Gard died 4 days later, after withdrawal of intensive medical treatment. This emotionally and ethically fraught case has divided experts and the wider community. It is time now to seek common ground about the key issues this case has raised (panel). We focus here on the questions raised around innovative treatment. In particular, when should parents be allowed to access desired innovative treatment that offers a potential benefit to their child? The standard answer to that question is that a treatment should not be provided or permitted if it would impose a clinically significant risk of serious harm. But that raises questions about what risks are significant and which harms are serious. We also need to balance harms against benefits—more unpleasant or risky treatment would be acceptable if the benefits are greater or more likely. In the Gard case, the requested treatment had never been tried in animal models or in other patients with his rare illness. That makes it extremely hard to know just what the risks or benefits could be. Clinicians are understandably loath to approve untested therapies in gravely ill patients who cannot give consent. However, it is not always possible or ethical to test treatments in patients with less severe forms of a disease. For patients who are dying, without other treatment options, there may be little to lose and everything to gain, especially when side-effects are minimal or can be controlled. In such situations, parents should potentially be allowed to access treatment even if there is some risk and little direct evidence of benefit (figure). Expeditious assessment is important to avoid patients missing out on the chance of benefit. At the same time, it is vital to protect dying children from interventions that have no realistic prospect of helping them, and that would cause them to suffer. In the face of uncertainty, particularly if a child is deteriorating, one option could be to allow strictly timelimited trials of therapy, with clear termination criteria and agreement that the treatment would be stopped (and palliative care provided) if severe side-effects arise, or if no substantial benefit is seen within the trial period. How should hospitals and professionals decide whether treatment offers a realistic benefit, or would cause suffering? Clinical ethics or similar committees could—and sometimes already do—play a role in gathering and considering scientific evidence and expert opinion about proposed treatment. (Great Ormond After Charlie Gard: ethically ensuring access to innovative treatment

Keywords: gard ethically; benefit; innovative treatment; treatment; charlie gard; access

Journal Title: The Lancet
Year Published: 2017

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