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FDA Weighs Approval of a Lucrative Alzheimer’s Drug, but Benefits Are Iffy

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.


This story also ran on The Daily Beast. It can be republished for free.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But … Read the rest

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Analysis: Mounting Pressure on China About Covid ‘Lab Leak’ Could Backfire

President Joe Biden has ordered U.S. intelligence agencies to determine whether the covid virus, or a near ancestor, emerged from a cave, a live-animal market, a farm — or a secretive Chinese laboratory.

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But it’s doubtful this probe will yield definitive insights, and it could even backfire.

Some experts hypothesize that global pressure could prompt a Chinese scientific whistleblower to come forward with evidence of a lab leak. After all, it is unlikely such an accident could have occurred without dozens of people finding out about the leak, or an ensuing cover-up.

But the growing political pressure to discover Chinese malfeasance or a lab accident at the root of the pandemic could make a definitive answer less, rather than more, likely, according to virologists and experts on U.S.-China scientific exchanges.

“We have to reduce the political tension and let the scientists … Read the rest

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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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Newsom Wants to Spend Millions on the Health of Low-Income Mothers and Their Babies

Amid a pandemic that has pushed millions of mothers out of the workplace, caused fertility rates to plunge and heightened the risk of death for pregnant women, California Gov. Gavin Newsom and Democratic lawmakers are seeking a slate of health proposals for low-income families and children.

Newsom, a self-described feminist and the father of four young children, has long advocated family-friendly health and economic policies. Flush with a projected budget surplus of $75.7 billion, state politicians have come up with myriad legislative and budget proposals to make poorer families healthier and wealthier.

They include ending sales taxes on menstrual products and diapers; adding benefits such as doulas and early childhood trauma screenings to Medi-Cal, the state’s Medicaid program; allowing pregnant women to retain Medi-Cal coverage for a year after giving birth; and a pilot program to provide a universal basic income to low-income new parents.

“COVID-19 laid inequity bare for … Read the rest

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From Racial Justice to Dirty Air, California’s New AG Plots a Progressive Health Care Agenda

California Attorney General Rob Bonta, a longtime Democratic state lawmaker, comes to his new role well known for pursuing an unabashedly progressive agenda on criminal justice issues. He has pushed for legislation to eliminate cash bail and to ban for-profit prisons and detention centers. But Bonta also has a distinctive record on health care, successfully advancing legislation to protect consumers from so-called surprise medical bills when they inadvertently get treatment from out-of-network providers and framing environmental hazards like pollution as issues of social justice.

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He was among the Democratic lawmakers leading the charge at the California Capitol to take on Big Soda, pushing to cut consumption of sugary drinks through taxes and warning labels. Such proposals so far have faltered under the influence of the soda industry.

Bonta, 49, was an infant when his family, in 1971, moved to California from … 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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Behind The Byline: Finding a ‘Superstar’ to Interview

KHN has never been busier ― and health coverage has never been more vital. The Behind The Byline series on YouTube and Instagram TV offers an insider’s view.

Journalists and producers from across KHN’s newsrooms take you behind the scenes in these bite-size videos to show the ways they are following the story, connecting with sources and sorting through facts.

Jenny Gold — Finding a ‘Superstar’ to Interview

Senior correspondent Jenny Gold started her yearlong project with a question: How will covid shape the next generation of doctors? In June 2020, more than 30,000 new doctors graduated from medical school and started their training on the front lines of the pandemic.

Dr. Paloma Marin-Nevarez — a woman from Los Angeles whom Gold describes as thoughtful and outgoing — stood out from the beginning. She was about to start her residency in Fresno, California, a city in the state’s agricultural Central … Read the rest

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Opioids Like ‘Lean’ Permeate Hip-Hop Culture, but Dangers Are Downplayed

Nykerrius Williams knows about the close relationship between hip-hop and opioid use. Williams, 27, an independent rapper from Gibsland, Louisiana, who goes by the name Young Nyke, took oxycodone pills for the first time when he was 16 and has continued patterns of misuse of those pills, as well as Lortabs, Xanax and codeine cough syrups, until recently. To him, it’s part of the business.

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“If you ain’t rapping about being on no drugs, or you out here in the streets selling some drugs,” he said of his chosen profession, “you ain’t got some of that going on — like, don’t nobody wanna hear what you talking about.”

This snapshot of Williams’ hip-hop life doesn’t seem all that different from that of musicians of other genres for whom the mix of drugs and addiction is a recurring storyline, claiming the lives … Read the rest

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Mississippi’s Black Communities Turned Around Their Covid Rates. Next Up: Make Strides on Vaccines.

At its first pop-up vaccination event on April 10, the Northeast Mississippi Coalition Against Covid 19 gave shots to nearly 40 people in Shannon, a town where roughly 60% of some 1,800 residents are African American.


This story also ran on NBC News. It can be republished for free.

Though a fraction of the doses typically given out at large mass vaccination sites, the event was a success, say organizers — a coalition of health care providers and elected officials. Held outdoors, it allowed for a physically distant, communal atmosphere that many have missed over the past year.

“People would get their shot, and then say, ‘I’m going to get my wife or my daughter,’” said Dr. Vernon Rayford, a Tupelo internal medicine physician and coalition member.

The group has held two more events and administered a total of 110 doses, Rayford said. More pop-ups are scheduled.

Mississippi had already … Read the rest

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Biden Administration Signals It’s in No Rush to Allow Canadian Drug Imports

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The Biden administration said Friday it has no timeline on whether it will allow states to import drugs from Canada, an effort that was approved under President Donald Trump as a key strategy to control costs. 

Six states have passed laws to start such programs, and Florida, Colorado and New Mexico are the furthest along in plans to get federal approval.   

The Biden administration said states still have several hurdles to get through, including a review by the Food and Drug Administration, and such efforts may face pressures from the Canadian government, which has warned its drug industry not to do anything that could cause drug shortages in that country.  

“Although two proposals have been submitted to FDA, no timeline exists for the agency to make a decision. Thus, the possible future injuries to Plaintiffs’ members are overly speculative and not … Read the rest

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