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Tuesday, March 1, 2022

Biden to blame social media for ‘mental health crisis’ at State of the Union

 President Biden plans to castigate social media companies for contributing to “a national mental health crisis” Tuesday night in his first State of the Union speech — while noting other factors such as the COVID-19 pandemic, which has been blamed for fueling record-high numbers of drug overdose deaths over the past two years.

Biden will host former Facebook worker Frances Haugen, who accused the company of failing to censor misinformation and content harmful to teens, as one of his guests to underscore his attack on tech giants.

“The president believes tech companies should be held accountable for the harms they cause,” a White House official told reporters on a call previewing the portion of his speech.

A White House release said Biden “will announce a strategy to address our national mental health crisis,” including funds for federal programs that promote mental health at colleges and other communities.

Frances Haugen
Facebook whistleblower Frances Haugen will be a guest of President Biden at his State of the Union.
Drew Angerer
Social Media
The White House is accusing social media companies of gender bias that discourages women from pursuing jobs in fields like engineering.
stnazkul

Biden also wants “to ban excessive data collection on and targeted advertising online for children and young people,” the release said.

The president’s forthcoming annual budget will request $5 million for “research on social media’s harms, as well as the clinical and societal interventions we might deploy to address them,” according to a fact sheet that also accuses companies of gender bias by delivering pornographic results when people search for “girls” of various races.

Biden wants to “stop discriminatory algorithmic decision-making that limits opportunities for young Americans,” the White House said.

House of Representatives
President Joe Biden will propose $5 million in funding toward researching the harms social media inflicts on society and ways to combat them.
J. Scott Applewhite

When a girl searches for jobs online, platforms will too often push her away from fields like engineering that historically have excluded women,” the fact sheet contended. “Searches for ‘Black girls,’ ‘Asian girls,’ or ‘Latina girls’ too often return harmful content, including pornography, rather than role models, toys, or activities.”

The White House statement acknowledged other causes of mental health issues but didn’t specifically mention drug overdose deaths, which surpassed 100,000 in a 12-month period ending in April 2021. The 28.5 percent spike was driven by illicit fentanyl coming largely from China. The potent compound is increasingly cut into non-opioid drugs and pressed into counterfeit prescription pills while also wiping out a generation of addicts unwittingly hooked on painkillers by Purdue Pharma’s OxyContin.

“Our country faces an unprecedented mental health crisis among people of all ages,” the White House statement said.

“Two out of five adults report symptoms of anxiety or depression. And, Black and Brown communities are disproportionately under-treated — even as their burden of mental illness has continued to rise. Even before the pandemic, rates of depression and anxiety were inching higher. But the grief, trauma, and physical isolation of the last two years have driven Americans to a breaking point.”

Although criticism of Big Tech platforms often is bipartisan — with both Biden and former President Donald Trump supporting changes to Section 230 immunity for third-party content — Republicans are more likely to blame US mental health woes on issues such as the mandatory masking of students and remote learning due to COVID-19.

Pills
The White House failed to specifically mention overdoses as part of the mental health crisis.
BackyardProduction

“If you’re a parent of a child with asthma, as one parent shared with me, wearing a mask for now close to two years has been just a very difficult experience,” Virginia GOP Attorney General Jason Miyares said in a recent interview.

“I had another parent who shared with me [that] their daughter, they used to be an all-A student, is now a mostly ‘C’ student because they wear glasses and the school has gone from a joy to complete misery,” Miyares added. “And another parent of a schoolage child said how excited their child was, their daughter was, that for the very first time, they could see what their best friend from school actually looks like. I mean, think about the mental health crisis as well [and the effect] that we’re having on our kids.”

https://nypost.com/2022/03/01/biden-to-blame-social-media-for-mental-health-crisis-at-state-of-the-union/

Gemini Axes 80% of Workforce, Names Interim CEO, in Restructuring

 Gemini Therapeutics, a clinical-stage biopharma company dedicated to developing treatments for genetically defined age-related macular degeneration (AMD), announced a series of corporate updates Monday. Among these is a corporate restructuring that will see a drastic 80% of the company's workforce laid off. 

The Cambridge, Massachusetts-based company has seemingly been struggling for a while. When Gemini announced its Q2 financial updates in August 2021, it showed a net loss of $16.4 million, compared to a net loss of $6.8 million during Q2 2020. 

The company chalked up the losses to an increase in operating expenses, which were $5.5 million for the quarter (compared to only $1.1 million for the same quarter in 2020). Gemini said the increased expenses were due to becoming a public company and from increasing headcount. 

After such dismal updates, it wasn't a surprise when Gemini announced it was cutting 20% of its staff in October 2021. In the press release, the company said it was reducing its research and non-clinical programs to better focus on GEM103, a precision medicine for geographic atrophy secondary to dry AMD. Gemini called the pivotal clinical trial of GEM103 "resource-intensive." 

And resource-intensive it must have been because a week later, Gemini began offering inducement grants to purchase more than 217,000 shares of the company's common stock under NASDAQ Listing Rule 5635(c)(4).

By the time 2021's Q3 financial report came around in November, Gemini's net losses were $18.6 million, and operating expenses were $5.0 million. 

Still, the company had a few rays of hope. Its ongoing Phase IIa, multi-center study of GEM103 was going well. At the AAO meeting in November 2021, Gemini presented GEM103 study data which showed the drug was well-tolerated across 510 intravitreal injections with no ocular serious adverse events. The company also still had $150.1 million in cash assets. 

But the losses kept coming, and now Gemini is cutting 24 of its employees—around 80% of its remaining workforce. The company said these layoffs are designed to keep it focused on developing GEM307, a new antibody for human complement factor H protein, a protein essential for retinal health. Gemini plans to continue working on clinical development for GEM307. 

The corporate update included other announcements related to restructuring. Jason Meyenburg, the CEO, president and director of Gemini, is stepping down, although he will remain an advisor to the company. Meyenberg will be succeeded by Georges Gemayel, Ph.D., as interim president and CEO. Gemayel was appointed as Gemini's chair of the board of directors in May 2021. 

Gemayel, who has more than 30 years of experience in the pharmaceutical industry, had expressed excitement in joining the company.

"Gemini has a very exciting approach to treat dry AMD that could bring to the market a best-in-class product," he had said when he was appointed as chair. 

Now that Gemayel will be serving as interim CEO and president, he said he is evaluating "strategic alternatives." Gemini has not set a timeline for these alternatives, and the company says it will not offer further comments until the board of directors has decided which route they will pursue. 

"We have decided to reduce the Company's operations to preserve financial resources until the strategic evaluation process concludes," Gemayel said. 

https://www.biospace.com/article/gemini-therapeutics-corporate-updates-include-layoffs-new-leadership/

AbbVie Bolsters Neuro Platform with $1B Syndesi Buy

 AbbVie has bolstered its neuropsychiatric and neurodegenerative portfolio with the acquisition of Belgium-based Syndesi Therapeutics in a deal valued at up to $1 billion. 

With an upfront payment of $130 million, AbbVie gains Syndesi's portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118. SV2A plays a central role in synaptic transmission, the communication between neurons in the brain. Improved regulation of SV2A could play a role in approaching treatment of Alzheimer’s disease, major depressive disorder and other disorders with cognitive impairment. 

Tom Hudson, AbbVie’s head of R&D and chief scientific officer, noted that there is a “major unmet need” for new therapeutics and treatments that can improve cognitive function in patients with hard-to-treat neurologic diseases. Through the acquisition of Syndesi, AbbVie hopes to advance the research of the first-in-class SDI-118 for the treatment of cognitive impairment associated with neuropsychiatric and neurodegenerative disorders, Hudson said in a statement. 

A small molecule, SDI-118, is currently in Phase Ib studies. In the study, the asset targets nerve terminals to enhance synaptic efficiency. In its announcement, AbbVie said that synaptic dysfunction is believed to be an underlying issue in cognitive impairment that is associated with multiple disorders.  

Last year, Syndesi initiated dosing in the proof-of-principle study about eight months after results from two small Phase I studies showed the drug was safe and well-tolerated in trial participants. The studies also included promising data in electroencephalogram (EEG) recordings of brain activity. 

Syndesi said SDI-118 produced a “unique profile of changes in quantitative EEG relative frequency power,” which was consistent with a novel mechanism of action. The company said that the data complemented the PET target engagement data that had previously been seen. 

Jonathan Savidge, chief executive officer of Syndesi, said the company has been impressed with AbbVie and its shared view of the potential of SDI-118 in a range of neurologic diseases. 

“I am delighted with the closing of this deal. It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Now, as part of AbbVie, the program is well-positioned to move into later stages of clinical development,” Savidge said in a statement. 

Under terms of the deal, AbbVie forked over $130 million. The remaining $870 million in the back-end heavy deal will be paid to Syndesi shareholders based on the achievement of certain established milestones.  

Backed by Novo Holdings, Syndesi launched in 2017 to develop novel SV2A modulators. In 2018, the company licensed SDI-118, which had been discovered by UCB Biopharma SRL, one of the organizations that helped launch Syndesi.  

For AbbVie, the acquisition of Syndesi is expected to complement its ongoing neurodegenerative disease collaboration with Mission Therapeutics. Last fall, the two companies nominated two deubiquitinating enzyme (DUB) targets to advance as potential therapies for Alzheimer’s and Parkinson’s.  

The company previously had an Alzheimer’s partnership with Voyager Therapeutics, but that partnership was dissolved in 2020. The two companies initially hooked up in 2018 in a tau and alpha-synuclein vectorized antibody collaboration with a goal to develop vectorized antibodies against the tau protein. 

https://www.biospace.com/article/abbvie-acquires-belgium-s-syndesi-therapeutics-and-its-neurodegenerative-disease-assets-/

RedHill Upamostat Shows 100% Efficacy In Non-Hospitalized COVID-19 Patients

 RedHill Biopharma Ltd 

 (Get Free Alerts for RDHL) has announced topline results from the Phase 2 part of the Phase 2/3 study of RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients.

  • The study showed promising efficacy results delivering a 100% reduction in hospitalization due to COVID-19, with zero patients on RHB-107 hospitalized with COVID-19 compared to 15% on the placebo-controlled arm requiring hospitalization. 
  • Furthermore, the study showed an 87.8% reduction in reported new severe COVID-19 symptoms, with only one patient on RHB-107 (2.4%, 1/41) compared to 20% (4/20) of patients on the placebo-controlled arm experiencing new COVID-19 related severe symptoms.
  • The study met its primary outcome measure, demonstrating a favorable safety and tolerability profile of RHB-107.
  • RHB-107 is an orally-administered antiviral targeting human serine proteases that prepare the spike protein for viral entry into target cells. 

Kids With Cancer in Ukraine Take Shelter, Wait for Evacuation

 Young cancer patients in Ukraine's children's hospitals have taken shelter in hospital basements that are serving as temporary bomb shelters.

Amid the Russian invasion of Ukraine, doctors and nurses are trying to provide limited treatment when possible, though supplies of necessary food, water, and medications are dwindling, according to NBC News.

"These children suffer more because they need to stay alive to fight with the cancer — and this fight cannot wait," Lesia Lysytsia, a doctor at Okhmatdyt, the country's largest children's hospital in Kyiv, told the news station.

Some kids only have access to a basic form of chemotherapy right now, while other treatments have been interrupted. Doctors have expressed concerns about relapses if the interruption of treatment continues for an extended  period.

At Kyiv Regional Oncology Center, some kids' blood counts grew so low, and supplies became so sparse, that doctors started blood transfusions from parents to their kids, NBC News reported.

"Our patients, they will die," Lysytsia said. "We will calculate how many people or soldiers have died in attacks, but we will never calculate how many patients weren't diagnosed of disease in time, how many patients died because they didn't receive treatment. It's an epic amount of people."

Hospital staff members want to evacuate the families, but it can be a difficult process, NBC News reported. They don't know how long the travel will take, what medical supplies are needed, or what obstacles they could face on the road.

"Patients and their parents ask me if it's safe, and I say, 'I don't know,'" Lysytsia said. "I don't even know if it's safe to go outside. It's possible they go out near the hospital and they'll be attacked."

For now, medical professionals across Ukraine have been discussing ways to move patients with the most severe cancer and other medically vulnerable residents in Kyiv to medical centers in Lviv and western Ukraine, where supplies are better and conditions are safer. From there, some of the sickest children could be transported to Poland, where officials have promised medical care.

On Monday, 14 children in Kyiv were put on a bus to Lviv, which is typically a 3- or 4-hour trip, NBC News reported. But after 8 hours of winding routes and checkpoints, they likely had 5  more hours to go. The group will be joined in Lviv by another bus of 20 children, and police will escort both across the border.

"We will do everything that is important for our patients," Lysytsia said. "And we will stay until the end."

SOURCE:

NBC News: "Kids with cancer in Ukraine shelter in hospital basements, hoping to evacuate."

https://www.medscape.com/viewarticle/969414

Russian-backed investment fund tied to influential U.S. corporate consulting firm Teneo

 

  • LetterOne has multiple links to Teneo, which was founded by two Democratic consultants who worked for former Presidents Bill Clinton, Barack Obama and former Secretary of State Hillary Clinton.
  • Under the contract, which was viewed by CNBC, LetterOne was on track to pay Teneo more than $3.6 million since September 2020. The discovery of these ties comes as Russia is getting hit with sanctions from around the world following their initial invasion of Ukraine.
  • The Department of Justice’s FARA Unit, which monitors U.S. lobbying and consulting work for foreign representatives, said it believes the contract between Teneo and LetterOne “remains active.”
  • An investment fund backed by Russian oligarchs sanctioned by the European Union following the invasion of Ukraine has ties to Teneo, an influential corporate-advisory firm based in the United States.

The public relations and strategy giant was hired in 2020 by LetterOne, a private equity firm based out of Luxembourg that counts sanctioned billionaires Mikhail Fridman, who is a native of Ukraine, and Petr Aven among its cofounders. The contract, which was viewed by CNBC, appears to have paid Teneo more than $3.6 million to line up interviews and consult on media strategy in the U.S.

LetterOne was founded by Fridman, Aven, Alexei Kuzmichev, Andrei Kosogov and German Khan — all of whom are some of the wealthiest business leaders with interests in Russia. All five founders have been on LetterOne’s board, with Fridman as the chairman, according to data from PitchBook reviewed by CNBC. The executives launched the firm in 2013 after establishing Alfa Group, one of the largest conglomerates in Russia.

Fridman and Aven have been sanctioned by the EU, and accused of having ties to Russian President Vladimir Putin, claims that were denied in an emailed statement to CNBC. The statement did not answer any of CNBC’s questions on LetterOne’s work with Teneo or how the investment fund is planning to move ahead now that two of its founders have been sanctioned. Fridman’s bank, Alfa Bank, has also been sanctioned by the United States. He’s called for an end to the Russian invasion of Ukraine.

After CNBC asked a LetterOne representative on Monday about their business, including their relationship with Teneo, several pages of their website, including the “our people” section, appear to have been wiped as of Tuesday morning. An error message now appears on that section which listed the founders and executives at the firm. The LetterOne board section is still active, but it no longer shows Fridman and Aven as members of the board.

Joshua Hardie, a spokesman for LetterOne, said Fridman and Aven resigned from the board on Tuesday. CNBC first contacted the private equity firm on Monday.

Though emails to Teneo were not returned, Kathleen Lacey, a company senior managing director who was listed in a document as working the LetterOne account, told CNBC in a brief phone call on Monday that LetterOne was no longer one of her clients and she believed her firm wasn’t representing it anymore.

The Department of Justice’s FARA Unit, which monitors U.S. lobbying and consulting work for foreign representatives, told CNBC on Tuesday that it believes the contract between Teneo and LetterOne “remains active.”

LetterOne has multiple links to Teneo, which was founded by two Democratic consultants who worked for former Presidents Bill Clinton, Barack Obama and former Secretary of State Hillary Clinton. The private equity firm has been involved in almost a dozen deals estimated to be worth over $1 billion, according to PitchBook. Uber, for example, saw a $200 million investment from LetterOne in 2016.

Teneo has since grown into a consulting giant, with past clients including Dow Chemical and Coca-Cola. Foreign clients have included Neom, a company backed the juggernaut Public Investment Fund with the goal of creating a megacity in Saudi Arabia, and a foundation led by an Emirati princess.

Their listed senior advisors is a who’s who of political and business leaders including former Republican House Speaker Paul Ryan, former IBM CEO Ginni Rometty, former Dow Chemical CEO Andrew Liveris and Harvey Pitt, a former chairman of the Securities and Exchange Commission.

Doug Band, who was once one of Bill Clinton’s closest aides, founded Teneo with Declan Kelly and Paul Keary. Kelly worked as the special envoy to Northern Ireland in the Obama administration and helped Hillary Clinton run for president in 2008. Band and Kelly have since left the firm, with the latter resigning from being Teneo’s CEO after reports of him drunk and acting inappropriately at an event organized by the Global Citizen nonprofit. Keary became the CEO after Kelly’s resignation.

A contract between Teneo and LetterOne reviewed by CNBC shows that the consulting firm was hired in 2020 for a retainer of $150,000 per month to advise the fund on their media strategy. Teneo, according to the contract, was expected to “provide strategic counsel and stakeholder engagement advice to the company and its board members (including, without limitation, scheduling media interviews, assisting with media briefings, coordinating stakeholder engagements and related activities).”

Under the contract, LetterOne was on track to pay Teneo more than $3.6 million since September 2020. There were at least four Teneo representatives who worked the account, according to other documents filed to the DOJ.

Further documents show that through last year, Teneo took credit for trying to set up interviews for LetterOne leaders with producers and television anchors, including those at CNBC, Bloomberg and Fox Business. A document shows that a Bloomberg representative was contacted almost a dozen times to see whether LetterOne could sponsor one of their Bloomberg Invest events.

There are other ties between Teneo and LetterOne.

LetterOne’s nonexecutive chairman is Evan Davies, a British businessman who was once the U.K. minister of state for trade, investment and small business. He’s also a senior advisor at Teneo.

VEON, a telecommunications company operating in Russia and Ukraine is listed on LetterOne’s website as one of its active investments. Ursula Burns was chairman of the VEON board for almost three years before stepping down in 2020. She later became the chairwoman of Teneo.

Meanwhile, VEON announced on Tuesday that Mikhail Fridman resigned from their board.

https://www.cnbc.com/2022/03/01/russian-backed-investment-fund-tied-to-influential-us-corporate-consulting-firm.html

Doctors Shelter in Place at Ukrainian Heart Hospital

 As Russian troops occupy the space just a few kilometers away from his hospital, Borys Todurov, MD, director of the Heart Institute of the Ministry of Health of Ukraine in Kyiv, has remained focused on supporting the patients -- and staff -- who have taken shelter at the facility.

Missiles, tanks, and cannons deployed by the Russian military have destroyed parts of Kyiv, creating major obstacles for transportation to and from healthcare facilities throughout the city. Patients and staff at the Heart Institute have remained in place since the start of the invasion, since it's unsafe for people to enter or leave hospital grounds. Most of the patients, staff, and family members at the facility have stayed in the basement -- where they have been since Russia threatened to bomb Kyiv.

"The Heart Institute is totally blocked," Todurov told MedPage Today through a translator. Nurses and doctors at the hospital have worked for several days straight, he said, completing their shifts without any staff changes.

Some of the staff have gathered their family members to take shelter in the basement at the Heart Institute, including Todurov's children, grandchildren, and pregnant daughter-in-law. But other doctors and nurses are completely disconnected from their families, unsure of where they are or how to contact them. "Our nurses, our doctors are worried about their families," Todurov said. "It is very critical."

image
At the Heart Institute in Kyiv, nurses take a short break in the basement. Photo by the Heart Institute.

Nearly all of the patients, including children, have also been moved to the basement for their protection. However, Todurov said in a video on Sunday (which was translated for MedPage Today) that not all of the patients, including five who were intubated, could be moved underground.

As of Sunday, the Heart Institute had 98 admitted patients, 28 of whom are in the ICU, Todurov said. Prior to the invasion, the hospital might have as many as 170 admitted patients. But because transportation is inaccessible, hospital admissions have come to a halt.

"We cannot admit people with active coronary disease," Todurov said, because there are no ambulances, no other ground transportation, and it is not safe to move around the city. The facility has not yet admitted any patients wounded from the war, but Todurov said that they are ready to do so.

Todurov said he doesn't anticipate being able to restock medications or other medical supplies once they exhaust their short-term supply. He is particularly concerned for patients who have kidney issues, because they may not be able to continue their dialysis treatments if the hospital does not get access to supplies.

Neighbors and volunteers are making food deliveries to the hospital to sustain patients, healthcare workers, and their families. "We are trying our best to keep everyone happy and healthy," Todurov said. "It's very important to listen, to talk and to give hope to people and to say that it will pass," Todurov said. "We will be happy."

"This is our reality," he added. "It's very hard, but at the same time, people in Ukraine have never been so united to fight for freedom."

https://www.medpagetoday.com/special-reports/exclusives/97417