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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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Colors Of The World: Legacy Community Health Southwest Clinic

The southwest side of Houston is home to two adjoining and struggling neighborhoods: Gulfton and Sharpstown, where more than 30 percent of residents live below the poverty line and high rates of chronic disease persist. Legacy Community Health, a full-service Federally Qualified Health Center that operates 40 clinics in southeast Texas, sought to address those challenges. “We began seven years ago by purchasing a building with an existing practice to serve those neighborhoods,” says Joel Kalmin, director of facilities planning at Legacy Community Health. “Over time, we put that building through three extensive renovations to accommodate our growth there and provide expanded services.”

When a plot of vacant land adjacent to the clinic became available, Legacy saw its chance to expand in a major way and continue to meet growing demand for health services in the area. To accomplish that while keeping the existing 14,000-square-foot building open during construction, the … Read the rest

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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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Safe Space

One of the many ways The Center for Health Design works to make research and practical tools accessible is through the creation of Topic Toolboxes. We’ve produced more than a dozen of these toolboxes on both micro and macro issues, relating to everything from technology to emergency department throughput. Each toolbox contains a wide array of resources to fit every learning style, such as issue briefs, executive summaries, webinars, industry expert interviews, and design strategies. Within each toolbox, some of the resources are open to all and then some are available only to Affiliate+ members.

Creating easy access to the research and resources that design and healthcare professionals need to make informed decisions has never been more important than during this last year. Thanks to a partnership with industrial supply company Grainger, all of the resources in the Safety Toolbox are being made available to everyone until the end of … Read the rest

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Penn Medicine, Interventional Support Center

Seeking new solutions to improve efficiency and increase quality, Penn Medicine envisioned a new offsite Interventional Support Center (ISC) as a comprehensive facility to support multiple facilities throughout the Philadelphia region. The ISC centralizes sterilization of surgical instruments, sterilization of linens, and storage of surgical supplies and soft goods. The consolidation of services at the ISC will standardize instrument processing, instrument sets, and soft goods across the health system. The ISC will allow storage space for extended inventory of supplies on hand. Case carts will be transported to and from the ISC from various facilities in temperature controlled trucks on a prescribed schedule to facilitate maximum efficiency.

Stantec’s team integrated healthcare planners, architects, designers, engineers, and industrial designers to design the new facility. Solutions were tested and validated using time motion studies and simulation modeling to identify gaps and bottlenecks in the flow.

The facility supports a one-way forward flow … Read the rest

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