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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

Key Democrat Manchin Bashes FDA Leader on Alzheimer’s Approval (Bloomberg):

Senator Joe Manchin, a moderate Democrat considered a crucial vote within the party’s slim Senate majority, said Janet Woodcock, the temporary head of the Food and Drug Administration, should be quickly replaced with a permanent leader.

Manchin blasted an FDA decision to approve the controversial Alzheimer’s therapy Aduhelm despite conflicting evidence that the Biogen Inc. drug works and an overwhelmingly negative vote against the therapy by agency advisers. The FDA ruling led three members of that panel to quit in protest…

Manchin urged U.S. President Joe Biden to nominate “acceptable permanent leadership to ensure Americans are protected from harmful drugs and that scientific recommendations are considered when approving new medications.” … Manchin wrote Biden a letter earlier this year ripping into the agency for its “long track record approving dangerous opioids without considering public health.” On Thursday, he wrote that

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Ten days left to submit proposals to the Wellcome Trust for Workplace Mental Health 2021

Dear Colleagues,

Wellcome are delighted to announce the launch of our Workplace Mental Health 2021 Request for Proposals.

Businesses all over the world are increasingly thinking about how they can most effectively support the mental health of their staff, even more so in light of the Covid-19 pandemic. However, despite growing interest and investment in workplace mental health, we still have so much to learn about what works.

In 2020, we asked ten global research teams to review the evidence behind a sample of promising approaches for preventing anxiety and depression in the workplace, focusing on younger workers. The research spanned a broad range of approaches ranging from employee autonomy to breaking up excessive sitting to financial wellbeing interventions. You can read a summary of the findings from this commission on our website.

Now we are looking to commission up to 20 research teams to review the evidence behind other … Read the rest

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First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all

6 ways the FDA’s approval of Aduhelm does more harm than good (STAT News):

Like many people, I was shocked when the Food and Drug Administration ignored the advice of its neurological drugs advisory panel and broadly approved Biogen’s new drug, Aduhelm, even for populations never included in the clinical trials to assess the drug.

I am not a casual bystander to this controversial decision. I am a physician who has been treating people with Alzheimer’s since 1982; an early researcher into the biology of amyloid, the brain protein that Aduhelm targets; someone with a strong personal family history of dementia … As I formulate my responses to my own patients, here are six recurring themes:

  1. Pull of desperation
  2. Elbowing aside existing treatments
  3. Amyloid reduction alone is no help
  4. An uninterpretable trial
  5. Trials and labeling disconnect
  6. Cost and equity issues

Bottom line. The FDA’s approval of Aduhelm raises more

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Growing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen

ICER Issues Statement on the FDA’s Approval of Aducanumab for Alzheimer’s Disease (Institute for Clinical and Economic Review):

The Institute for Clinical and Economic Review (ICER) believes that the FDA, in approving aducanumab (Aduhelm™, Biogen) for the treatment of Alzheimer’s disease, has failed in its responsibility to protect patients and families from unproven treatments with known harms.

Our review of the evidence was concordant with that of many independent experts: current evidence is insufficient to demonstrate that aducanumab benefits patients. The avenue forward has seemed clear: another study would be needed to reduce the substantial uncertainty about the drug’s effectiveness, a requirement of even greater priority because of the drug’s common and potentially serious side effects.

However, instead of waiting for such a trial, the FDA chose to move the goalposts and approve aducanumab based on the surrogate outcome of removing amyloid from the brain rather than the patient-centered outcome

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Study in China finds that retirement may accelerate cognitive decline, even for those with stable income

People who retire early suffer from accelerated cognitive decline and may even encounter early onset of dementia, according to a new economic study (Note: opens PDF) I conducted with my doctoral student Alan Adelman.

To establish that finding, we examined the effects of a rural pension program China introduced in 2009 that provided people who participated with a stable income if they stopped working after the official retirement age of 60. We found that people who participated in the program and retired within one or two years experienced a cognitive decline equivalent to a drop in general intelligence of 1.7% relative to the general population. This drop is equivalent to about three IQ points and could make it harder for someone to adhere to a medication schedule or conduct financial planning. The largest negative effect was in what is called “delayed recall,” which measures a person’s ability to remember something … Read the rest

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DARPA-funded nonsurgical neurotechnologies push the frontier of brain-machine interfaces

Credit: J Robinson and Rice University

Rice University Charges Into the Future with Magnetics and Bioimplants (All About Circuits):

Advances in self-generating drug delivery systems, brain-to-brain communication, and injury mitigation technologies are just some of the newest research coming down the pipeline from Rice University.

Several research projects funded by the Defense Advanced Research Project Agency’s (DARPA) N3 program might herald a future of highly advanced human-machine interfacing that expands the capabilities of soldiers and first responders.

This article will first overview the DARPA program and the basics of these three programs. Then, a look at the common electronics technologies that are being used in biotechnology at Rice University. Keep reading excellent article HERE, over at All About Circuits.

About DARPA’s N3 program:

Six paths to the nonsurgical future of brain-machine interfaces (DARPA):

Back in 2019, DARPA awarded funding to six organizations to support the Next-Generation Nonsurgical Neurotechnology (N3) program, first

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Debate: What is the role of financial advisors and platforms in detecting and addressing cognitive decline among older clients?

Baby Boomers’ Biggest Financial Risk: Cognitive Decline (The Wall Street Journal):

For baby boomers who manage their own nest eggs, a risk is looming that has nothing to do with stock prices or interest rates.

The risk is cognitive decline, which can rob them of their judgment, often without much warning. One big mistake—or a series of smaller ones—can go unnoticed by loved ones, and potentially ravage a lifetime of hard-earned savings.

To mitigate these risks, there are things baby boomers and others can do now to prepare for any problems. In addition, 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

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Don’t worry, be happy: How excessive worrying may influence the rate of neurodegeneration

Worrying and the Aging Brain (Dana Foundation):

Over the past decade, scientists and clinicians have noted a significant association between common mental health conditions and accelerated brain aging—the changes to brain structure, physiology, and function that are thought to lead to later cognitive decline. Both depression and anxiety disorders, for example, are strongly correlated with the development of dementias including Alzheimer’s disease later in life, yet it has been unclear why. Neuroscientists and gerontologists around the globe have diligently worked to investigate which particular symptoms might contribute to age-related cognitive decline.

New research from the University of Pittsburgh, using a machine learning model to predict a person’s “brain age,” suggests that excessive worrying and rumination may influence the speed of neurodegeneration and the memory and attention deficits that come along with it. Keep reading the excellent article Worrying and the Aging Brain over at Dana Foundation’s website.

Recent Study:

Affective … Read the rest

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Eye-tracking pioneer Smart Eye acquires MIT spin-off Affectiva to augment driver monitoring systems and more

Emotion-detection software start-up Affectiva acquired for $73.5M (TechCrunch):

Smart Eye, the publicly traded Swedish company that supplies driver monitoring systems for a dozen automakers, has acquired emotion-detection software startup Affectiva for $73.5 million in a cash-and-stock deal.

Affectiva, which spun out of the MIT Media Lab in 2009, has developed software that can detect and understand human emotion, which Smart Eye is keen to combine with its own AI-based eye-tracking technology. The companies’ founders see an opportunity to expand beyond driver monitoring systems — tech that is often used in conjunction with advanced driver assistance systems to track and measure awareness — and into the rest of the vehicle. Together, the technology could help them break into the emerging “interior sensing” market, which can be used to monitor the entire cabin of a vehicle and deliver services in response to the occupant’s emotional state … The opportunity will initially be

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On building better brains at any age, treating Depression vs. Dementia, emerging neurotechnologies, psychedelics, and more

Welcome to a new edition of SharpBrains’ e‑newsletter, featuring eleven new research findings and innovative resources for lifelong cognitive and brain health.

#1. Debate: Are depression and dementia two sides of the same coin? And, if they are, how to best approach treatment?

#2. Either way, the earlier the better, but it’s never too late: New book outlines the five lifestyle pillars to “build a better brain at any age”

#3. “If I were a cardiologist evaluating a patient’s chest pain, for instance, I would speak with the patient, but then I would listen to their heart and measure their pulse and blood pressure. I might order an electrocardiogram or a cardiac stress test, tools that weren’t available a century ago. Because I’m a psychiatrist, however, I evaluate patients in precisely the same way that my predecessors did in 1920…” Reading Our Minds: New book issues strong call to action to … Read the rest

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