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ICER: FDA failed to protect patients from unproven Alzheimer's treatment with known harms


Food and Drug Administration (FDA) drew criticisms after granting Alzheimer’s disease drug Aduhelm a conditional approval. It allows the drug scientifically known as aducanumab to be prescribed and used while its maker Biogen conducts a post-marketing, phase 4 confirmatory study that could take years to complete.
Aduhelm is the first Alzheimer’s medication approved by the FDA since 2003.
According to the influential Institute for Clinical and Economic Review (ICER), the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Aduhelm.
ICER questions Aduhelm’s effectiveness
The FDA, which announced the approval on June 7, said that the drug was the first to treat the underlying mechanism in Alzheimer’s. But ICER didn’t see it that way. ....

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Mysterious "Havana syndrome" affects more American diplomats, soldiers and spies than previously thought


Department of State and the
Department of Defense spurred broad concern in the Biden administration.
Initially, there were only around 60 publicly confirmed cases, concentrated in China and Cuba. This did not include a group of injured CIA officers, whose total isn’t public.
The new total now includes cases from Europe as well as elsewhere in Asia. The expanded number reflects the administration’s efforts to more thoroughly review other incidents amid concern over a spate of them in recent months.
At least three CIA officers have reported serious health effects from episodes overseas since December, including one that happened within the past few weeks. All have been required to undergo outpatient treatment at the Walter Reed National Military Medical Center or other facilities. ....

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