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.
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“It is inconceivable to us,” said Jackson, chief executive officer of Help 4 HD International, a Huntington’s advocacy organization. “Subjecting participants to invasive procedures without the prospect of therapeutic benefit is unjustifiable.”
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Performing a fake surgery would involve patients undergoing anesthesia for about 10 hours. … They would also have their head shaved and have a hole drilled into their skull without going through the bone.
Depending on how long the trial goes, the patients in the placebo group may not be eligible to get treated because their disease might have progressed.
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