The powerful Alzheimer’s Disease lobby is fighting a multi-billion-dollar battle on two fronts. It is quietly trying to limit restrictions the Food and Drug Administration puts on the use of new drugs aimed at slowing the progression of the brain disease. And it is publicly pressing Medicare to pay for the widespread use of the monoclonal antibodies FDA already has conditionally approved as well as others in the pipeline. [Read more…] about Growing controversy over role of FDA and Medicare in promoting anti-amyloid drugs given limited benefit, high cost, severe side-effects
Attention is being focused on a side effect of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab). Even before its controversial approval on June 7, there were cases of amyloid-related imaging abnormalities (ARIA‑E), or cerebral edema, observed in the trials. [Read more…] about Amyloid-related imaging abnormalities (ARIA) found in approximately 40% of patients taking “Alzheimer’s drug” Aduhelm
While the chatter surrounding Biogen’s controversial Alzheimer’s med Aduhelm has largely been centered on a pivotal Medicare reimbursement decision as of late, analysts are pointing to one new study that suggests there may be “room for surprises” when it comes to the treatment’s safety. [Read more…] about Study: Fewer than 1% of geriatric patients with cognitive complaints met Aduhelm research trial criteria. What can we expect about its real-world safety?
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring this time nine scientific reports and industry developments to help promote lifelong brain and mental health.
“… venting likely doesn’t soothe anger as much as augment it. That’s because encouraging people to act out their anger makes them relive it in their bodies, strengthening the neural pathways for anger and making it easier to get angry the next time around. Studies on venting anger (without effective feedback), whether online or verbally, have also found it to be generally unhelpful … To get out of that, you can ask the person to step back and help you reframe your experience by asking, “How should I think about this differently?” or “What should I do in this situation?”
“The new company would find it pushing well beyond its current mindfulness focus to, “provide the full spectrum of proven, effective virtual support – from mindfulness and meditation, to text-based behavioral health coaching, to video-based therapy and psychiatry – for all types of patient populations.”
12 good tips for students and everyone else
Their independent review concludes that “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal, we recommend against offering this agent to patients with Alzheimer’s dementia (mild or otherwise) or mild cognitive impairment.”
A strong call to “learn how this regulatory failure occurred and to ensure that it doesn’t occur again”
Addressing the ongoing controversy about conservatorships, a USC Professor of Law, Psychology, and Psychiatry shares a great article to debunk these all-too-common myths
If you have not encountered the “Linda brain teaser” before, please give it a try! If you have, you’ll enjoy the new paper titled Tversky and Kahneman’s Cognitive Illusions: Who Can Solve Them, and Why?
Fascinating approach to gait training.
Neuralink vs. Paradromics vs. non-invasive platforms — quite a stimulating space to track
Wishing you and yours a happy and healthy back-to-school and month of September,
The SharpBrains Team
VA Health System Won’t Cover Biogen’s Alzheimer’s Drug (The Wall Street Journal):
The Department of Veterans Affairs won’t cover Biogen Inc.’s new Alzheimer’s drug, the latest rebuke of the controversial treatment since it was approved earlier this summer.
The VA decided not add the drug, called Aduhelm, to its formulary list of available medicines because of the drug’s risk of causing serious side effects and a lack of evidence that it improves cognitive function, an agency spokeswoman said. [Read more…] about Veterans Affairs won’t cover Biogen’s new “Alzheimer’s drug” given concerns over safety and lack of evidence
Top researchers who advised the U.S. Food and Drug Administration on Biogen Inc.’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.” [Read more…] about Alzheimer’s & Dementia researchers challenge FDA’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker