US Health Agency Calls for Inquiry into Alzheimer's Drug Review
Voice of America
WASHINGTON - The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between her agency's drug reviewers and the maker of a controversial new Alzheimer's drug.
Dr. Janet Woodcock announced the extraordinary step via Twitter. It's the latest fallout over last month's approval of Aduhelm, an expensive and unproven therapy that the agency OK'd against the advice of its own outside experts. Woodcock made the request to the Department of Health and Human Services' inspector general, the watchdog agency that oversees the FDA and other federal health agencies. The move comes after numerous calls for a probe into the approval from medical experts, consumer advocates and members of Congress. Two congressional committees have already launched their own review. "We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency's review staff were inconsistent with FDA's policies and procedures," Woodcock wrote on Twitter. Biogen pledged to cooperate with the inquiry.A Korea Institute of Machinery and Materials researcher controls a wheelchair with stiffness-variable "morphing" wheels in Daejeon, South Korea, Nov. 5, 2024. The "morphing" wheel can roll over obstacles up to 1.3 times the height of its radius. Inspired by the surface tension of water droplets, it goes from solid to fluid when it encounters impediments.
FILE - Part of the temples of Baalbek, a UNESCO world heritage site in Lebanon's eastern Bekaa Valley, illuminated in blue light, Oct. 24, 2015. FILE - This picture shows closed shops on an empty street in the eastern Lebanese city of Baalbek on Oct. 19, 2024. FILE - People walk near the Roman ruins of Baalbek, Lebanon, Jan. 5, 2024. FILE - A man sits amidst the rubble at a site damaged in the aftermath of an Israeli strike on the town of Al-Ain in the Baalbek region, amid the ongoing hostilities between Hezbollah and Israeli forces, in Lebanon, Nov. 6, 2024.
Dr. Jaafar al Jotheri, shown here Nov. 10, 2024, holds satellite images and explores the site of the Battle of al-Qadisiyah, which was fought in Mesopotamia -- present-day Iraq -- in the 630s AD. A desert area with scattered plots of agricultural land with features that closely matched the description of the al-Qadisiyah battle site described in historic texts, Nov. 10, 2024.