FDA Push for Fake Brain Surgery Trial Spurs Ethical Concerns
Bloomberg • • business
Key Points:
- Katie Jackson, whose husband died from Huntington’s disease and whose children face a 50% risk of inheriting it, is hopeful about a new gene therapy developed by UniQure NV.
- The US Food and Drug Administration (FDA) has requested a new clinical trial requiring some participants to undergo sham brain surgery without receiving the actual treatment to conclusively assess the therapy's effectiveness.
- Huntington’s patients, including Jackson, strongly oppose the FDA's demand, viewing the sham surgery as unethical and impractical given the disease's severity and the urgent need for effective treatments.
