FDA Push for Fake Brain Surgery Trial Spurs Ethical Concerns

Katie Jackson desperately wants a new treatment for Huntington’s disease. Her husband died from the devastating brain disorder. And because the disease runs in families, her three children have a 50% chance of inheriting the condition. She’s pinned her hopes on a cutting-edge gene therapy from UniQure NV.

But Jackson says Huntington’s patients have no desire to meet a new demand from the US Food and Drug Administration: to enroll in a new clinical trial where some people will undergo fake brain surgery without getting UniQure’s treatment. The FDA’s request, intended to conclusively determine the therapy’s potency, has raised concerns the trial would be both unethical and impractical.