With COVID-19 vaccines working and restrictions lifting across the country, it’s finally time for those now vaccinated who’ve been hunkered down at home to ditch the sweatpants and reemerge from their Netflix caves. But your brain may not be so eager to dive back into your former social life. [Read more…] about The neuroscience behind why our brains will need time to adjust to ‘un-social distancing’
Welcome to a new edition of SharpBrains’ e‑newsletter, providing this time a summary of the saga around the FDA approval of aducanumab (Aduhelm) as a supposed treatment for Alzheimer’s Disease, plus a range of timely research findings and resources for lifelong brain health.
First, below are some key reads to navigate “probably the worst drug approval decision in recent U.S. history” — Dr. Aaron Kesselheim, the Professor of Medicine at Harvard Medical School who resigned rom the FDA Advisory Committee in protest.
“The Institute for Clinical and Economic Review (ICER) believes that the FDA, in approving aducanumab (Aduhelm by Biogen) for the treatment of Alzheimer’s disease, has failed in its responsibility to protect patients and families from unproven treatments with known harms.”
“The FDA’s approval of Aduhelm raises more questions and creates more problems than a new drug approval should. It’s time for governmental, professional, and advocacy entities to step in where Biogen and the FDA have failed and explain to patients, caregivers, and clinicians how this drug is not the “new day” in the fight against Alzheimer’s disease and needs to be approached cautiously, if at all.” — Dr. Sam Gandy, Professor of Neurology and Psychiatry at the Icahn School of Medicine at Mount Sinai, where he holds the Mount Sinai Chair in Alzheimer’s Research
“In short, while the amyloid hypothesis has faltered, the approval of aducanumab, which is based primarily on this theory, suggests that the theory may once again dominate research, and could reduce the chances of finding more promising treatments. For example, tau protein, which also accumulates in the brains of Alzheimer’s patients — long before the amyloid protein does — has been shown to be closely associated with the cognitive impairment resulting from the disease … we must not interrupt research on biomarkers and new therapeutic approaches.”
#4. US Senator Joe Manchin calls for a new FDA Commissioner to replace current (acting) one who “has repeatedly ignored public health concerns and shown a dereliction of duty” over opioids and aducanumab:
“I write today concerning the lack of permanent leadership at the Food and Drug Administration (FDA), and the continued tenure of Dr. Janet Woodcock as interim commissioner. Just last week, the FDA granted approval for Aduhelm (aducanumab), a treatment for Alzheimer’s, despite its advisory panel voting nearly unanimously against its approval, with no panel member voting in favor of approval”
(Let’s hope something useful emerges from this very unhealthy FDA decision. Quite disturbing, though, to notice the links between the opioid epidemic and the recent Aduhelm approval.)
“Under the broad label that FDA approved, the drug is available to all Alzheimer’s patients, and the agency did not place limits on treatment duration suggesting that patients could remain on the drug indefinitely. We are troubled by reports that those factors could lead the drug to command “somewhere between” the $37 billion we currently spend on Medicare Part B and the $90 billion we currently spend on Medicare Part D. This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resiliency.”
The stakes couldn’t be higher.
Now let’s review other important developments in June.
” … big do-it-yourself investing and trading venues like Vanguard Group, Fidelity Investments and Charles Schwab Corp. are strengthening some of the ways they detect possible signs of decline. Among other things, all three firms check for clients’ difficulty navigating security protocols or need for frequent password resets. In such cases, a designated family member might be informed.
Vanguard also checks client-call recordings for keywords—such as “confused” and “dementia”—that might signal trouble.”
“While retirement schemes like the 401(k) and similar programs in other countries are typically introduced to ensure the welfare of aging adults, our research suggests they need to be designed carefully to avoid unintended and significant adverse consequences. When people consider retirement, they should weigh the benefits with the significant downsides of a sudden lack of mental activity. A good way to ameliorate these effects is to stay engaged in social activities and continue to use your brains in the same way you did when you were working.
In short, we show that if you rest, you rust.”
“Digital mental health can be viewed as a way to extend the mental resources that we have,” said David Mohr, who directs the Center for Behavioral Intervention Technologies at the Northwestern University Feinberg School of Medicine. A step-care model, for example, would allow patients with milder symptoms to be treated via technology while reserving in-person care for patients who need something more.
“Pear is one of nine companies invited to participate in the U.S. Food and Drug Administration’s (FDA) Precertification Pilot Program. Pear has developed and commercialized the first three FDA-authorized PDTs, has 14 product candidates, and is scaling its platform for third-party product distribution opportunities. The Company’s three FDA-authorized products, reSET®, reSET‑O® and Somryst®, address large market opportunities with more than 20 million patients suffering from substance and opioid use disorders and more than 30 million from chronic insomnia, in the U.S. alone, respectively.”
“(Research findings) suggest that cognitive function may need to be monitored closely in individuals with affective disorders, as these individuals may be at particular risk of greater cognitive decline.”
#11. Smarter cars are coming soon … : Eye-tracking pioneer Smart Eye acquires MIT spin-off Affectiva to augment driver monitoring systems and more
Finally, a quick cognitive exercise. Given the universal beauty of math, you don’t need to speak Spanish to try this quick teaser: Brain teasers en español: ¿cuál es el número que falta en el cuarto triángulo?
Wishing you a happy and healthy summer,
The SharpBrains Team
(Same brain teaser in English here)
Es viernes y quizás algunos necesitemos un pequeño empujón cognitivo para abordar el fin de semana…
Aquí va un breve desafío matemático: ¿Qué número que falta en el cuarto triángulo?
Aviso a tod@s esos sharp brains: Sí, puede haber más de una respuesta … pero asegúrate de que tu solución funciona bien en todos los triángulos!
[Read more…] about Brain teasers en español: ¿cuál es el número que falta en el cuarto triángulo?
Space Between the Ears (Cerebrum):
A few short months ago, news programs around the globe showed NASA engineers and scientists celebrating as a robot named Perseverance successfully landed on the surface of Mars. The mission: capture and share images and audio that have never been seen or heard before. As impressed as most observers were of this major milestone, many couldn’t help but wonder when we might be ready to someday send humans. While it seems the stuff of science fiction and almost inconceivable, the answer—according to recent NASA planning—is before the end of the 2030s, less than two decades away. [Read more…] about Next in NASA’s path to Mars: Overcoming astronauts’ cognitive and mental health challenges
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring a life well lived, the latest news on brain health and innovation, and some brain teasers in honor of International Brain Teaser Month.
#1. Thank you, Sharon. We won’t. “Never stop wondering” — Sharon Begley, science journalist, RIP
#2. Write injuries in sand, kindnesses in ____________.
Milk the cow, but do not pull off the ___________.
Enjoy these 5 US and 7 international proverbs to test your cognitive skills.
#3. Beware the snakes as you tease your mind with this optical illusion.
#4. The blood-brain barrier is hopefully hard at work: Can COVID-19 coronavirus “invade” human brain tissue? (Quick answer: evidence so far is mixed)
#5. Yes, a bit circular…but that’s the point: To manage stress, sleep better. To sleep better, keep a good routine and manage stress.
#6. Excellent article for those interested in state-of-the-art neurotech. The Promise of Big Data Imaging for Mental Health
#7. We’d much rather see the NIH or a fitness or nutrition company sponsor such a promising study, rather than a pharma company, but this is great news anyway: The new frontier in neurocognitive monitoring and dementia screening: the Apple Watch
#8. “I am encouraged by Cognito’s innovative approach,” said Allan Levey, M.D., Ph.D., Professor and Chairman of the Department of Neurology at Emory University and Director of the Emory Goizueta Alzheimer’s Disease Research Center. “This strategy translating recent advances in non-invasive modulation of brain activity with sensory stimulation with light and sound has the potential to be an urgently needed safe, non-invasive, and effective treatment for millions of individuals with Alzheimer’s disease.” Neurostimulation device GammaSense by Cognito Therapeutics secures FDA Breakthrough Device Designation to explore Alzheimer’s Disease applications
#9. This can help a ton of people, given that “Currently, video EEG is the gold standard for seizure detection, but it requires a hospital stay, is often costly, and can be stigmatizing.” Study: Wearable sensors and machine learning may well (one day) help detect a broad range of epileptic seizures
#10. “While 66% accuracy may not sound high, it is an improvement on current accuracy levels of diagnosis by human clinicians, particularly general physicians who aren’t trained in psychiatry.” Machine learning study finds standardized brain scan biomarker to detect depression with 66% accuracy
#11. FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation. Two of the priorities are the “issuance of draft guidance on a predetermined change control plan (for software’s learning over time)” and “Developing methods to evaluate and improve machine learning algorithms.” Both are crucial given that data-driven innovation is in flux by definition, unlike drug-driven innovation.
#12. The law of averages suggests 2021 will be a good year … Here’s a toast to a Healthy, Happy & Meaningful New Year.
The SharpBrains Team
To celebrate this quite-challenging Thanksgiving, here are five fun brain teasers and games that readers have enjoyed the most this year so far. It is always good to learn more about (and appreciate) that most precious resource we all (yes, all) have up there!
#1. First of all, these days it’s always important to test your stress level
#2. You say you know the colors? Try the Stroop Test
#3. Check out this classic attention experiment
#4. What do you know about mental self-rotation?
#5. Last but not least, here are ten classic illusions to tease your mind.
Thank you in advance for trying them, enjoying them, and sharing them 🙂