Tuesday, June 8, 2021 – California Healthline

Los Angeles Times: FDA OKs New Alzheimer’s Drug After 20 Years. Experts Disagree 
In a decision based as much on hope as on science, the Food and Drug Administration on Monday approved a drug designed to treat Alzheimer’s disease despite scant evidence that it improved the symptoms of patients who tested it. The lack of a clear clinical benefit after two late-stage clinical trials prompted an FDA advisory panel to urge that the drug, called aducanumab, be rejected. The agency acknowledged the uncertainties about the medication but said its approval was justified by the seriousness of the disease and the dearth of options for treating it. (Khan and Kaplan, 6/7)

Stat: FDA Grants Historic Approval To Alzheimer’s Drug From Biogen
The Food and Drug Administration on Monday approved the first new treatment for Alzheimer’s disease in nearly two decades, a landmark decision that has been eagerly awaited by millions of Americans diagnosed with the condition but that will be hotly contested by some in the scientific community who doubt the drug’s effectiveness. While other drugs treat symptoms of Alzheimer’s, the new medicine, called Aduhelm, is the first to attack what some believe is an underlying cause of the disease and slow cognitive decline, albeit marginally. (Feuerstein and Garde, 6/7)

AP: FDA Approves Much-Debated Alzheimer’s Drug Panned By Experts
It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia. The decision, which could impact millions of Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits. (Perrone, 6/7)

Stat: A Twist In FDA’s Alzheimer’s Decision: No Limits On Which Patients Can Get It 
As if the saga of aducanumab needed another twist, the Food and Drug Administration tossed in an extra curveball Monday as it approved the Alzheimer’s therapy by specifying who would be eligible for the treatment. Or rather, not specifying. Doctors had anticipated that if the FDA gave the green light to the therapy now called Aduhelm, it would endorse its use for patients like those who qualified for clinical trials: people in the earliest stages of Alzheimer’s disease, who also had the plaques of amyloid protein that the therapy aims to clear. (Joseph, 6/7)

AP: How Will Insurers Cover A New Alzheimer’s Drug?
[Insurers] will likely request some documentation first that the patient needs the drug. Many plans will require doctors to submit records and other paperwork justifying the treatment before they agree to cover it. Insurers also will likely require pre-approval for brain scans needed to determine that the patient is a candidate for treatment, said Lance Grady of Avalere Health consultants. (Murphy, 6/8)

Stat: The Price Of Biogen’s Alzheimer’s Drug May Lead Payers To Erect Roadblocks
The Food and Drug Administration’s approval on Monday of an Alzheimer’s drug developed by Biogen is raising fresh questions about the financial implications for millions of families, insurers, and American taxpayers. But the drug maker is already scrambling to mitigate the fallout. At a wholesale price of $56,000 per year, the company exceeded some Wall Street expectations, and greatly surpassed the $8,300 threshold that a nonprofit determined was the price at which the medication could be considered cost-effective. That assessment reflected intense controversy over study data that prompted numerous experts to question the extent to which the drug actually helps patients. (Silverman, 6/7)

Axios: FDA Signals Watered-Down Drug Standards With Aduhelm Approval 
Following the FDA’s approval of Biogen’s Alzheimer’s treatment Aduhelm, experts fear the approval — based on weak scientific data — is a sign the agency is putting speed over rigor. “A general signal being sent to the rest of the drug industry is: If you can get uncertain, maybe suggestive data and a post-hoc analysis — get that threshold to us — we may approve your drug,” said Peter Bach, a drug researcher at Memorial Sloan Kettering Cancer Center. (Herman, 6/8)

CNBC: Biogen Alzheimer’s Drug: Dementia Expert Says Evidence ‘Wasn’t Sufficient’ For Approval
Dementia expert Dr. Jason Karlawish told CNBC he’s skeptical of the Food and Drug Administration’s approval of Biogen’s Alzheimer’s disease drug, Aduhelm, saying “the evidence to approve the drug wasn’t sufficient.” “Another study is needed to establish whether this drug, in fact, is effective. Unfortunately, the FDA approved the drug for marketing, although they also do want another study,” the co-director of the Penn Memory Center at the University of Pennsylvania said on Monday following the agency’s formal OK. (DeCiccio, 6/7)

NPR: Fisher-Price Ignored Safety Warnings Even After Infants Started Dying: Report 
Executives at Fisher-Price ignored repeated safety warnings about the company’s once popular Rock ‘n Play sleeper, even after infants began to roll over and die in the now-recalled product, according to a new report. An investigation by the House Committee on Oversight and Reform alleges that the New York-based children’s products giant didn’t adequately vet the sleeper for safety before putting it on the market in 2009 and then batted away criticism of the Rock ‘n Play for a decade before recalling it in 2019 after more than 50 infants had lost their lives. “What we found is absolutely shocking,” said the committee’s chairwoman, Rep. Carolyn B. Maloney, D-N.Y. “It is a national scandal.” (Hernandez, 6/7)

The Washington Post: Fisher-Price Criticized By House Panel For Infant Deaths In Its Rock ‘N Play Inclined Sleepers 
Two company executives were sharply criticized Monday by a House panel over Fisher-Price’s decision to keep its Rock ’n Play inclined sleeper on the market for a decade while waiting until 2019 to recall a product tied to dozens of infant deaths. Members of the House Oversight Committee seemed to struggle to find new ways to describe their outrage and incredulity with the well-known maker of toys and baby products, with Rep. Raja Krishnamoorthi (D-Ill.) saying Fisher-Price showed “a shocking lack of corporate integrity.” (Frankel, 6/7)

San Diego Union-Tribune: San Diego County Tops 2 Million With At Least One Vaccine Dose 
San Diego County’s vaccine tracker passed the 2 million mark over the weekend, indicating that nearly two-thirds of the region’s population have received at least one dose. Now listed at 2,071,589 on the county’s COVID-19 vaccine tracking website, the total puts the region in easy striking distance of the 2.1 million goal that is 75 percent of the 2.8 million eligible residents age 12 and older, the “herd immunity” goal set by the county health department. (Sisson, 6/7)

Bay Area News Group: California’s Rising Tide Of COVID Vaccination Records Raise Privacy Concerns 
When California Gov. Gavin Newsom announced cash incentives to spur coronavirus vaccine-hesitant residents to get their shots, he emphasized everyone who received a dose was automatically entered into state databases. “We have your information in our system,” he said, referring to the millions of vaccination records in the California Public Department of Health’s confidential, digital Immunization Information System, reassuring anyone concerned about missing their opportunity to qualify for a $1.5 million grand prize for taking a vaccine. But not everyone is so reassured. (Moore, 6/7)

Southern California News Group: CSUN Coronavirus Vaccine Site Closes As LA County’s Effort Shifts To Smaller, More Focused Efforts
Public health officials took steps to shut down the mammoth vaccination site at California State University Northridge on Monday, June 7, as the county morphs its operations to smaller, more-focused sites, in the latest sign that the pandemic is waning in Los Angeles County. Three other sprawling parking-lot clinics will close next week. On Monday, L.A. County reported nine additional deaths, bringing the county’s overall death toll to 24,354. The county reported 120 new cases, bringing the total number of cases to 1,244,254. The number of people hospitalized with the virus dropped from 254 on Sunday to 232 on Monday, according to the state dashboard, with 37 in intensive care. (Grigoryants, 6/7)

Sacramento Bee: Can Coronavirus Antibody Test Prove If COVID Vaccine Worked? 
For the cautious and vulnerable, such as those with weakened immune systems, taking a coronavirus antibody test after vaccination might offer some assurance that their bodies built immunity against COVID-19. But the tests are unnecessary and unreliable, and should not be used to determine how much protection someone gains from the vaccines, the U.S. Food and Drug Administration says. That’s because the tests weren’t designed to reveal that kind of information; they should only be used to determine if a person had a coronavirus infection in the past, not a current one. What’s more, the test may provide false confidence that could put people in harm’s way. (Camero, 6/7)

Sacramento Bee: Fact Check: Can COVID Vaccines Make Your Arm Magnetic?
Social media videos of COVID-19 vaccinated people sticking coins and refrigerator magnets to their arms have been spreading a popular conspiracy that the coronavirus shots contain microchips or other metals supposedly used by the government to track Americans. But instead of facts, all these people have are oily arms and some tape, experts say. (Camero, 6/7)

Los Angeles Times: California COVID Transmission Rate Among Lowest In The U.S. 
California continues to record one of the lowest COVID-19 case rates in the nation, underscoring its sustained progress toward extinguishing the pandemic a week ahead of the state’s planned reopening. As of Monday, California’s seven-day case rate per 100,000 people was 11, tied with Nebraska for the third-lowest among all states, according to data from the Centers for Disease Control and Prevention. California is behind only Vermont, with a 6.9 seven-day case rate, and South Dakota, with 9.2. (Money and Lin II, 6/7)

The Bakersfield Californian: Kern Public Health Reports 23 New Coronavirus Cases Monday 
Kern County Public Health Services reported 23 new coronavirus cases Monday morning, and no new deaths. That brings the county’s case count since the pandemic began to 110,395. There have been 1,398 deaths. Public Health reports that 39,642 people have recovered from the illness, and 68,293 people are presumed to have recovered. (6/7)

Orange County Register: Orange County Reported 19 New Cases And No New Deaths, June 7 
The OC Health Care Agency reported 19 new cases of the coronavirus on Monday, June 7, increasing the cumulative total in the county to 255,473 cases since tracking began. There have been 403 new infections reported in the last 14 days. No new deaths were reported Monday. In Orange County, the count of those who have died from the virus is reported at 5,083. (Goertzen, 6/7)

Southern California News Group: L.A. County Reported 134 New Cases And Three New Deaths, June 7 
Los Angeles County public health officials reported 134 new cases of the coronavirus, bringing the total number of cases to 1,245,253 as of Monday, June 7. Officials reported three new deaths linked to the coronavirus, for a total 24,392 deaths since tracking began. There were five fewer hospitalizations reported since Sunday, decreasing the official count of hospitalizations to 254, with 17% in ICU. (Goertzen, 6/7)

Los Angeles Times: L.A. County Reopening: COVID-19 Vaccine, Mask, Testing Rules 
Los Angeles County is eagerly awaiting a full reopening June 15. But despite the excitement, it won’t be a complete return to a pre-pandemic normal. Here are five things to expect as L.A. County fully reopens. (Lin II and Money, 6/7)

KQED: 99% of California’s Public Schools Plan to Fully Reopen In-Person This Fall, State Says
According to data released by the state Monday, 99% of the California public school districts that provide data to the state say they will fully reopen for in-person instruction this fall. The state also rolled out a series of interactive tools on its Safe Schools web portal Monday, which allow parents and educators to track school reopenings, summer instruction and COVID-19 resources for both public school districts and charter schools in real time. (McEvoy, 6/7)

Los Angeles Times: How Schools Can Reopen Safely In The Fall 
The masks, the social distancing, the stick-up-the-nose testing: Those unpleasant coronavirus-controlling measures are far from over for K-12 kids returning to in-school learning after summer vacation ends.It’s unlikely that a COVID-19 vaccine will be available for children under 12 before classes resume in the fall. But a new study has found that when elementary-school children mask up and maintain some distance from one another over the course of the school day, a single infected child will likely pass the infection to fewer than one other student, on average, over the course of 30 days. (Healy, 6/7)

Los Angeles Times: Black Parents See Less Bullying, Racism With Online Learning 
Some parents of Black Los Angeles school students opted to keep their children in distance learning after schools reopened in April because they wanted to shield them from inequitable and sometimes harsh treatment on campus, according to a report from a local advocacy group. Among Black parents surveyed, 82% cited COVID-19 as one factor for keeping their children home and 43% said they were concerned about bullying, racism and low academic standards, according to the report by Speak Up, which conducted focus groups, analyzed district data and conducted its own survey. (Newberry and Blume, 6/8)

Sacramento Bee: Gallup Poll: Less Than Quarter Of Americans Social Distancing 
Fewer Americans are social distancing and wearing masks during the COVID-19 pandemic after the Centers for Disease Control and Prevention released its updated guidance on masks. A new Gallup poll released Monday found that 22% of Americans are social distancing from non-household people, which is down from 30% in April and 48% in January. (Lin, 6/7)

San Francisco Chronicle: Oakland’s Guaranteed Income Program To Start Accepting Applications. Who’s Eligible?
Oakland will open the first round of applications Tuesday for the city’s guaranteed income program — one of the largest of its kind in the country. The program, Oakland Resilient Families, will send $500 cash payments with no strings attached for 18 months. The first round of applications will be for 300 families who live in East Oakland, who must live within a one square-mile boundary. Applications will open citywide for an additional 300 families later this summer. Low-income families, with at least one child under 18, are eligible for the program. Applicants who are Black, indigenous or people of color will be prioritized. The application is open to anyone whose income qualifies — a shift after the program’s initial announcement spurred criticism that white residents wouldn’t be eligible. (Ravani, 6/7)

CBS News: 36 Million Families May Start Receiving Child Tax Credit Deposits On July 15 
The IRS is sending letters to more than 36 million families who may qualify for monthly payments under the federal Child Tax Credit. Under the expanded tax benefit, families may be eligible to receive up to $300 per child on a monthly basis from July 15 through December 15. … The IRS said it will [send] a second letter that will estimate their monthly payment amount, which will begin hitting bank accounts on July 15. (Picchi, 6/7)

Modesto Bee: West Stanislaus County Needs Food, Housing And Utility Assistance 
Help with utility payments, food and rent are top priorities for West Stanislaus County residents, according to a recent survey. Grayson Neighborhood Council, a nonprofit focused on social equity and environmental issues, conducted the survey, which was presented by five residents during the Stanislaus County Board of Supervisors meeting May 18. Prior to that, the organization presented the results to the Patterson and Newman city councils. John Mataka, Grayson Neighborhood Council president, said during the presentation that between October 2020 and March, 617 residents of Grayson, Westley, Vernalis, Patterson, Newman and Crows Landing were surveyed on what their top needs were as a result of the pandemic. (Briseño, 6/8)

Los Angeles Times: Tiny Homes Plan For Homeless People Divides Affluent Arcadia 
Away from the streets of downtown L.A.’s skid row and gentrifying Echo Park, the debate over tiny homes in Arcadia offers a stark lesson in the challenges of finding shelter for unhoused people. Over the last decade, Los Angeles County’s homeless problem has spread from urban hot spots to the suburbs. While Arcadia has relatively few homeless people, the idea of providing them a place to live is stoking anger and fear in some quarters, compassion in others. (Campa, 6/8)

The Bakersfield Californian: Dignity Health Responds To SEIU-UHW Accusations Regarding PPE For Security Officers 
Service Employees International Union-United Health Care Workers West is claiming leadership with Mercy Hospital Downtown directed security officers to share face coverings with each other during the COVID-19 pandemic. But the hospital is saying that’s completely false. In a Monday advertisement, the union claimed the healthcare provider put patients and workers at risk during the COVID-19 pandemic. Robin Mangarin-Scott, vice president of marketing and communications for Dignity Health Central California, responded to those assertions on Monday. (Feinberg, 6/7)

San Diego Union-Tribune: San Diego Oncologist Treats Maladies With Melodies 
The recent books “Compassionomics” and “The Empathy Effect” extol the healing power of caring. That comes as no surprise to San Diego physician Steven Eisenberg. He co-founded an oncology practice called uCARE and acts as an official medical director and unofficial CEO — Chief Empathy Officer. (Bell, 6/8)

Stat: Apple Announces New Feature To Share Health Data With Doctors
Apple is making it easier than ever for users to make the most of the mountains of health data already in the palm of their hands. At its annual technology showcase known as the Worldwide Developers Conference on Monday, Apple revealed a new feature for users who have opted to share their medical records on their devices. Users can now choose the types of information they would like to share — such as an elevated cholesterol level or their physical activity history — and identify specific people to send it to, such as family members or clinicians. (Brodwin, 6/7)

Stat: Onduo’s New Exec On Google’s Data Skills And Moving The Needle On Health
After leading the charge at Duke University to free health care data from its silos, physician-scientist Erich Huang is jumping to Onduo where, as its chief science and innovation officer, he’ll help generate that kind of health information. In his new role at the virtual care platform created by Verily, Alphabet’s life science division, Huang will focus on generating evidence through case studies and clinical trials, with the aim of learning what kinds of digital health interventions work for patients and why. (Brodwin, 6/7)

The Bakersfield Californian: Teen Brothers Top International Science Fair With Their Biomedical Designs
Bakersfield isn’t known for its high-tech laboratories but the Brar brothers haven’t let that get in the way of their scientific experiments. The Stockdale High School students turned their home into a laboratory where they each tried to solve different problems in the medical field. It paid off for both at the recent Regeneron ISEF, an international science fair where high school students from 75 countries compete against one another. Harjaisal Brar, a freshman, earned second place in the biomedical engineering division for his 3D printed COVID-19 ventilator. He was bested only by his older brother Ishaan Brar, a senior, who won first place in the same division for designing a catheter that includes valves that aims to decrease the risk of infection and death. (Gallegos, 6/6)

San Francisco Chronicle: Water Shortage Emergency Declaration, Mandatory Restrictions Coming In Santa Clara County
The Bay Area’s most populous county likely will soon face mandatory water use restrictions, as officials from its main provider announced Monday they would declare a water shortage emergency this week. With drought conditions worsening in California, the Santa Clara Valley Water District said it planned to make the declaration and urge water companies and city and county officials to impose mandatory water use rules at a meeting Wednesday. (Flores, 6/7)

Sacramento Bee: CA Drought Depletes Reservoirs Of Critical Water Supplies 
Water levels at Lake Oroville have plunged to the point that its giant hydropower plant could be idled for the first time ever this summer, putting additional strain on California’s troubled electric grid. At massive Shasta Lake, which feeds the Sacramento River watershed and much of the Central Valley, conditions are so bad that major cities are drawing up conservation plans, farmers have scaled back plantings and environmentalists are angrily warning of massive fish kills. California’s reservoirs, normally the bulwark of the state’s elaborate water system, have been left defenseless by a drought that seems to worsen by the day. (Kasler, Sabalow, and Reese, 6/8)

EdSource: Orange County Schools Join With Children’s Hospital To Address Student Mental Health Needs 
Faced with rates of adolescent suicide and self-harm that have been among the fastest-rising in the country, schools in Orange County have teamed up with a local hospital to boost mental health services on campuses. The partnership between Children’s Hospital of Orange County and the Orange County Department of Education will include a streamlined connection between the schools and the hospital system, and “well spaces” on every campus where students can visit counselors, do yoga or meditate, and generally relax. (Jones, 6/8)

CalMatters: With Anti-Asian Hate Rising, California Group Keeps Track 
Stop AAPI Hate, a California-based coalition, has recorded nearly 7,000 hate incidents involving Asian Americans and Pacific Islanders nationwide since the beginning of the coronavirus pandemic. It’s become a key source of information for the media and for advocates looking to stop the surge of racist attacks. (Seshadri, 6/7)

San Francisco Chronicle: S.F. City Hall Reopens To The Public With Pride Festivities And Weddings
The front steps of San Francisco City Hall were full Monday, with politicians and a marching band, all there to mark the beginning of Pride month, a few days belated, with a flag-raising ceremony. It was standard fare: The Lesbian and Gay Freedom Band — the city’s official band — banged out the classics, like “Dancing Queen” by Abba, while somebody in the crowd passed out mini Pride flags and politicos made speeches. But it also marked a turning point — San Francisco City Hall was finally open to the public for the first time since shelter-in-place orders were issued in March 2020. After more than a year spent at home and over Zoom, a group had gathered in joy looking very much to the future while acknowledging the past. (Kost, 6/7)

KQED: UC Berkeley Launches NFT Auction Of Nobel Prize-Winning Cancer Research
UC Berkeley says it is the first academic institution in the world to use a non-fungible token (NFT) to auction off the science and correspondence behind a Nobel discovery. Bidding began at 12:03 p.m. today on “The Fourth Pillar,” which includes the scientific findings behind James P. Allison’s invention of cancer immunotherapy. The first bid was for 12.00 ETH (Ether), or just over $31,000. The piece includes 10 pages of disclosure documents and related correspondence from 1995 detailing the invention of the cancer treatment developed by Allison, an immunologist who was then based at Berkeley. (Veltman, 6/7)