Search This Blog

Monday, June 17, 2024

LA Studying Removing Police From Traffic Enforcement

In another step toward complete and total lawlessness on the West Coast, Los Angeles is reportedly studying the idea of removing police from traffic enforcement altogether as a way to reform policing. 

A new report from the LA Times says that this week, the City Council approved a study aimed at determining how to implement additional speed bumps, roundabouts, and other modifications to streets to curb speeding and improve driving safety.

This would come in the place of traffic enforcement by officers after reform advocates argued for "the city to limit how often police pull people over for low-level offenses and to start imagining a future in which unarmed city workers would take over most traffic duties". 

Councilmember Marqueece Harris-Dawson commented: “I think the city of Los Angeles can lead the nation.” 

In what, is the real question. 

In a unanimous 13-0 decision, the council ordered city transport staff to deliver feasibility studies within 90 days on proposals such as setting up unarmed civilian teams for specific traffic issues and accident investigations, reducing fines in less affluent areas, and halting stops for minor violations like expired tags, according to the LA Times report

Advocates from the Push L.A. coalition expressed cautious optimism about the vote, acknowledging it as a significant step but remaining concerned about potential bureaucratic obstacles.

Before the council meeting, dozens of organizers rallied outside City Hall, displaying signs and chanting slogans like “The People united, will never be defeated.”

Activist Leslie Johnson from Community Coalition pledged to maintain pressure on officials to prevent the study's findings from being ignored. The rally in downtown L.A. served both as a celebration of anticipated success and a reminder to the council of their vigilance.

Speakers referenced individuals like Keenan Anderson who died during traffic incidents involving police, and shared personal stories about the traumatic impact of traffic stops.

Interim chief Dominic Choi said: “Our job is public safety, and we’re going to use the tools that are given to us in the best way we can to improve public safety. So if restrictions are put on us, I’m going to visit roll calls, and I’ll talk about this policy change or this law and encourage our officers.”

Chauncee Smith of advocacy group Catalyst California commented: “From our perspective, having another feasibility study is not necessary; there’s numerous cities around the country that have already adopted a variety of these reforms. We’re focusing on changing the conditions, as opposed to punishing a person for something that they did or did not do.”


2 New Immunotherapy-Chemo Options Approved for Endometrial Cancer

 Two new immunotherapy-chemotherapy options are now approved for patients with primary advanced or recurrent endometrial cancer, the FDA announced.

On Monday, the agency approved the PD-1-directed immune checkpoint inhibitor pembrolizumabopens in a new tab or window (Keytruda), in combination with carboplatin and paclitaxel, for patients with either mismatch repair (MMR)-deficient or MMR-proficient disease, based on results of the KEYNOTE-868/NRG-GY018opens in a new tab or window trial.

And on Friday, the agency approved the PD-L1 inhibitor durvalumabopens in a new tab or window (Imfinzi) in combination with the same chemotherapy regimen for women with MMR-deficient disease only based on results of the DUO-Eopens in a new tab or window trial.

Both phase III trials met their primary endpoints, demonstrating improvement in progression-free survival (PFS) with the addition of immunotherapy.

Last summer, dostarlimab (Jemperli)opens in a new tab or window become the first checkpoint inhibitor to be approved for primary advanced or recurrent endometrial cancer, with the indication limited to MMR-deficient or microsatellite instability-high tumors.

Pembrolizumab Approval

The randomized KEYNOTE-868/NRG-GY018 trial had two separate cohorts, including 222 patients with MMR-deficient tumors and 588 with MMR-proficient tumors. All were randomized to standard chemotherapy plus either pembrolizumab or placebo. Patients received carboplatin-paclitaxel plus concurrent pembrolizumab (200 mg) or placebo every 3 weeks for six cycles, followed by a single-agent treatment with either the checkpoint inhibitor (400 mg) or placebo every 6 weeks for up to 14 cycles.

In the MMR-deficient cohort, median PFS was not reached in the pembrolizumab arm, as compared with 6.5 months for the group assigned to placebo (HR 0.30, 95% CI 0.19-0.48, P<0.0001). In the MMR-proficient cohort, median PFS reached 11.1 months with the addition of pembrolizumab versus 8.5 months with chemotherapy alone (HR 0.60, 95% CI 0.46-0.78, P<0.0001).

Overall survival (OS) data were immature at the time of the analysis, but recently reported results showed a trendopens in a new tab or window favoring the immunotherapy arms in both cohorts:

  • MMR-proficient: HR 0.79 (95% CI 0.53-1.17)
  • MMR-deficient: HR 0.55 (95% CI 0.25-1.19)

Adverse events (AEs) in the trial increased with the addition of pembrolizumab (grade ≥3 in 55-63% vs 45-47% with placebo). Toxicities were in line with the known safety profiles of pembrolizumab, carboplatin, and paclitaxel, the FDA stated, with the exception of a higher incidence of rash.

Durvalumab Approval

DUO-E was a three-arm trial testing two investigational combinations added to standard carboplatin-paclitaxel chemotherapy.

Regardless of MMR status, the addition of durvalumab to carboplatin-paclitaxel, followed by durvalumab maintenance, improved PFS versus chemotherapy plus placebo, but exploratory analysis suggested the MMR-deficient group drove most of the benefit.

In the 95 patients with MMR-deficient tumors, median PFS was not reached in the durvalumab arm versus 7 months in the placebo arm (HR 0.42, 95% CI 0.22-0.80). OS data were immature.

"With the incidence and mortality of endometrial cancer expected to continue to increase significantly in the coming decades, it is more important than ever that we bring new treatment options to patients at the earliest possible moment in their care," DUO-E investigator Shannon Westin, MD, of the University of Texas MD Anderson Cancer Center in Houston, said in a press releaseopens in a new tab or window from drugmaker AstraZeneca. "This approval underlines clear evidence that durvalumab plus chemotherapy followed by durvalumab monotherapy delivers important clinical benefits for patients with mismatch repair-deficient endometrial cancer."

Common AEs with durvalumab included "peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, diarrhea, vomiting, and cough," the FDA said. Serious AEs occurred in 30%, most commonly rash or constipation (4.5% for each). Overall, AEs leading to discontinuation of durvalumab occurred in 11% of patients.

https://www.medpagetoday.com/hematologyoncology/othercancers/110692

Community-Based Interventions for Opioid Overdoses Fail to Reduce Deaths in Trial

 There was little improvement in opioid-related overdose deaths with community-based interventions, according to a multisite cluster randomized trial, although the study was met with several obstacles.

In an intention-to-treat analysis, rates of opioid-related overdose deaths were similar between the intervention group and the control group (47.2 deaths vs 51.7 per 100,000 population) across 67 study communities over a 12-month comparison period, reported Jeffrey H. Samet, MD, MPH, of Boston Medical Center, and colleagues in the HEALing Communities Study at the National Institute on Drug Abuse (NIDA).

Those rates corresponded to an adjusted rate ratio of 0.91 (95% CI 0.76-1.09, P=0.30), they stated in the New England Journal of Medicineopens in a new tab or window. The findings also were reported at the College on Problems of Drug Dependenceopens in a new tab or window annual meeting.

The study's evidence-based practices focused on "increasing opioid education and naloxone distribution, enhancing access to medication for opioid use disorder, and safer opioid prescribing and dispensing. The intervention also included a series of communication campaigns to help reduce stigma and increase the demand for evidence-based practices," according to a NIDA press releaseopens in a new tab or window.

The authors found that intervention effectiveness on the rate of opioid-related overdose deaths did not appear to differ based on location or participant demographics, including age, sex, and race or ethnic group.

They had prespecified a 40% reduction in the rate of overdose deaths related to opioids between the two groups, but conceded post-study that such a target was "clearly ambitious. The trial may have been underpowered to detect substantially smaller yet clinically meaningful differences."

Co-author Redonna Chandler, PhD, director of the HEALing Communities Study, told MedPage Today that the study had a January 2020 start-date, so just 2 months before the COVID-19 shutdowns. "The COVID pandemic had a huge impact on our community members and all the settings where we were trying to implement the evidence-based interventions," she stated.

Chandler explained the researchers had just 10 months before the comparison period to establish community partnerships and to implement evidence-based practices. As a result, the time frame did not allow them to properly initiate many proposed programs with the intervention groups, which required recruiting new staff, updating clinical practice workflows, and developing new collaborations within community groups.

And Chandler noted that effects of the interventions may have also been tempered by the rapidly evolving illicit drug market, especially with the emergence of new drug mixtures such as fentanyl and xylazineopens in a new tab or window. NIDA Director Nora D. Volkow, MD, stressed in the press release that in "the era of fentanyl and its increased mixture with psychostimulant drugs, it's clear we need to continue developing new tools and approaches for addressing the overdose crisis."

To conduct the 4-year HEALing (Helping to End Addiction Long-Term) Communities studyopens in a new tab or window, the researchers selected 806 evidence-based practice strategies to be implemented in communities across Kentucky, Massachusetts, New York, and Ohio. The communities were randomly assigned to receive selected interventions (n=34) or to be added to a wait-list control group (n=33). The communities in the intervention group then selected the strategies they wanted to implement.

Strategies were put in place using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIMopens in a new tab or window) framework and the Practical, Robust Implementation and Sustainability Model (PRISMopens in a new tab or window) implementation-science framework.

The interventions were implemented into the assigned communities between January 2020 and June 2022, then a 12-month comparison period was conducted from July 2021 to June 2022. In total, the intervention group implemented 615 out of the 806 strategies: 254 involved overdose education or naloxone distribution, 256 involved the use of opioid use disorder medications, and 105 involved prescription opioid safety.

However, only 38% of these strategies were underway before the comparison period began in July 2021, the researchers said, and during that comparison year (July 2021 through June 2022) across communities, 4,517 deaths were linked with opioid overdoses. After the comparison period, the control communities received interventions from July 2022 through December 2023.

Still, the intervention did yield some benefits. First, Samet's group found that the risk for adverse events (AEs) -- defined as the number of opioid-related emergency medical service runs -- were similar in the two groups, with none of the AEs, serious or otherwise, attributed to the study intervention.

Then, Chandler highlighted that "we found ways to build partnerships between healthcare, behavioral health and criminal legal systems. The hospital and the primary care providers and the jail and the mental health provider and the substance abuse treatment programs were all working together in a harmonized way."

"We feel like we have a game plan," she noted.

Chandler said that longer-term implementation, along with ongoing quality improvement, could have led to better results. In fact, she noted many of the states with intervention communities have seen noticeable declines in overdose deathsopens in a new tab or window. The researchers are conducting follow-up analysis to determine whether the trial's interventions may have played a role in those declines.

"Those takeaways are still evolving," Chandler said. "We're going to have hundreds of findings from this trial -- some have been published and some are in process."

"In terms of the main study finding, we did find that we were able to implement the study and that we were able to get evidence-based practices -- with known ability to reduce overdose fatality -- into communities," she added.

Miriam E. Delphin-Rittmon, PhD, HHS Assistant Secretary for Mental Health and Substance Use, emphasized in the press release that the "implementation of evidence-based interventions is critical to addressing the evolving overdose crisis. This study recognizes there is no quick fix to reduce opioid overdose deaths. Saving lives requires ongoing commitment to evidence-based strategies."

Disclosures

HEALing Communities was supported by NIDA and the Substance Abuse and Mental Health Services Administration through the NIH HEAL Initiative. Several co-authors are NIH employees.

Co-authors in Kentucky disclosed support from the University of Kentucky Office of the President and Office of the Vice President of Research. Co-authors disclosed relationships with Pear Therapeutics, Merck Company Foundation, Boehringer Ingelheim Pharmaceuticals, and Amgen.

Primary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowSamet JH, et al "Community-based cluster-randomized trial to reduce opioid overdose deaths'" N Engl J Med 2024; DOI: 10.1056/NEJMoa2401177.


https://www.medpagetoday.com/publichealthpolicy/clinicaltrials/110672

Russian official says Ukraine pouring troops into contested Kharkiv region

 A Russian official said on Monday that fighting was gripping parts of Ukraine's northeastern Kharkiv region which Moscow has been trying to seize and added that Ukraine's military was pouring men and equipment into the contested area.

Ukrainian President Voldodymyr Zelenskiy said Kyiv's forces were gradually pushing Russian troops out of the contested area. His top commander predicted that Moscow would try to press forward pending the arrival in Ukraine of sophisticated Western equipment, including U.S-made F-16 fighter jets.

Russian forces crossed into parts of Kharkiv region last month and officials say they have seized about a dozen villages.

Vitaly Ganchev, Russia-appointed governor of the areas of Kharkiv region controlled by Moscow, said Russian forces were beating back Ukraine's latest counter-attacks in areas near Vovchansk, five kilometres (three miles) inside the border.

"There is fighting still going on in the Kharkiv sector. The fiercest clashes are in Vovchansk and near Lyptsy," Ganchev told Russian news agencies.

"The enemy is sending reserves and trying to counter-attack but is meeting a fierce response from our armed forces."

Russian President Vladimir Putin said the incursion sought to create a "buffer zone" to prevent Ukraine from shelling border areas, including Belgorod region, opposite Kharkiv.

Over the past week, Ukrainian officials have said the Russian advance is firmly under control.

Zelenskiy, in his nightly video address, said Ukrainian troops were "gradually pushing the occupiers out of the Kharkiv region". The military's General Staff reported 10 Russian attacks were repelled near Vovchansk and Lyptsi.

Ukraine's top military commander, Oleksander Syrskyi, said on Telegram that Moscow's commanders "were building intensity and expanding the geography of military activity.

"The enemy clearly understands that the gradual arrival of weapons and equipment from our partners, the arrival of the first F-16s, strengthens our air defences," he wrote. "Time is one our side and their chances of success will diminish."

Ukrainian military bloggers said Kyiv's forces were holding positions around Vovchansk and trying to break through Russian lines to consolidate units around the town.

Russian forces seized much of Kharkiv region in the early weeks of the February 2022 invasion, but Ukraine recaptured large swathes of territory later that year.

Kharkiv, Ukraine's second largest city, 30 km (18 miles) from the border, stayed out of Russian hands, and months of Russian attacks have eased, Ukrainian officials say, thanks to the arrival of new weaponry.

https://www.yahoo.com/news/russian-official-says-ukraine-pouring-210027273.html

Apple to discontinue 'buy now, pay later' service in US as it plans new loan program

 Apple on Monday said it will discontinue its "buy now, pay later" (BNPL) service in the United States as it launches a new loan program.

Users will be able to access installment loans offered through credit, debit cards and lenders when checking out with Apple Pay, starting later this year, the company said in a statement.

"This solution will enable us to bring flexible payments to more users, in more places across the globe in collaboration with Apple Pay-enabled banks and lenders," the company said.

The existing users of the BNPL service, Apple Pay Later, with open loans will still be able to manage and pay them via the Wallet app, the company said.

Apple Pay Later was unveiled to select users in March last year, allowing users to split purchases into four payments spread over six weeks with no interest or fees.

https://finance.yahoo.com/news/apple-discontinue-buy-now-pay-202259550.html

Kansas accuses Pfizer of misleading public about COVID vaccine in lawsuit

 The U.S. state of Kansas on Monday sued Pfizer, accusing the company of misleading the public about its COVID-19 vaccine by hiding risks while making false claims about its effectiveness.

In a lawsuit filed in the District Court of Thomas County, the state said the New York-based drugmaker's alleged false statements violated the Kansas Consumer Protection Act. It is seeking unspecified money damages.

"Pfizer made multiple misleading statements to deceive the public about its vaccine at a time when Americans needed the truth," Kansas Attorney General Kris Kobach, a Republican, said in a statement.

The lawsuit claims that, beginning shortly after the vaccine's rollout in early 2021, Pfizer concealed evidence that the shot was linked to pregnancy complications, including miscarriage, as well as inflammation in and around the heart, known as myocarditis and pericarditis.

"The representations made by Pfizer about its COVID-19 vaccine have been accurate and science-based," Pfizer said in a statement, adding that it believed the lawsuit had no merit.

The U.S. Food and Drug Administration in June 2021 added a warning about myocarditis and pericarditis to the vaccine's label. The side effects are rare and most often occur in adolescent boys and young men.

A 2023 review of 21 studies by the U.S. National Institutes of Health concluded that COVID vaccines were not linked to miscarriage.

Kansas also said Pfizer falsely claimed that its vaccine, which was developed with German partner BioNTech for the original strain of the virus, retained a high effectiveness against mutated variants, and that it would prevent not only illness but transmission.

Texas Attorney General Ken Paxton filed a similar lawsuit against Pfizer last year, which remains pending. Pfizer has also called that case meritless.

Kobach said on Monday that other states had been collaborating with Kansas in its investigation and are expected to file lawsuits as well.

BioNTech is not a defendant in the case.

https://finance.yahoo.com/news/kansas-accuses-pfizer-misleading-public-185122000.html

Xi Said US Is Trying To 'Goad Beijing' Into Attacking Taiwan

 China’s President Xi Jinping told European Commission head Ursula von der Leyen that the United States was trying to "goad Beijing into attacking Taiwan," according to officials aware of the exchange, which took place a little over a year ago but is just now being revealed.

Xi has also been warning his own officials, at a moment tensions are high across the Taiwan Strait particularly given Beijing sees newly inaugurated Taiwan President Lai Ching-te as a pro-independence hawk.

"Xi issued the warning in a meeting with von der Leyen in April 2023 that was described to the Financial Times by several people," according to a weekend report in FT. "He said the US was trying to trick China into invading Taiwan, but that he would not take the bait. Another person said he had issued similar warnings to his officials."

"Xi’s remark to von der Leyen is the first known case of him making the claim to a foreign leader," the report continued. "Xi also said that a conflict with the US would destroy many of China’s achievements and undermine his goal of achieving a 'great rejuvenation' by 2049."

The revelation follows on the heels of Chinese Defense Minister Dong Jun telling the Shangri-La Dialogue in Singapore this month that the People's Liberation Army (PLA) is ready to "forcefully" stop Taiwan’s independence.

China's Foreign Ministry has also recently said that those supporting independence for the island would find themselves "crushed." Much of this is in response to remarks of US President Joe Biden on multiple different occasions seen as ultra-provocative and representing as possible shift from Washington's long-standing 'One China' policy.

"The U.S. is standing up for peace and stability in the Taiwan Strait," the president declared at West Point on May 25th of this year. He added that "I’ve always been willing to use force when required to protect our nation, our allies, our core interests." 

He has actually articulated this commitment publicly on no less than six occasions: August 2021October 2021May 2022September 2022, at the West Point commencement address, and in interview remarks to TIME magazine.  

Without doubt, Beijing has picked up on every comment, and is monitoring carefully. It has of late also launching encircling military drills around the island in response to President Lai's coming to power.

Beijing likely sees other US allies in the region as being prepped by Washington for a future hot conflict with China...

As for Lai, he said while visiting a military academy in the south of Taiwan this weekend, "The biggest challenge is to face the powerful rise of China, [which is] destroying the status quo in the Taiwan Strait and regards Taiwan’s annexation and the elimination of the Republic of China as the great rejuvenating cause of its people."

https://www.zerohedge.com/geopolitical/xi-said-us-trying-goad-beijing-attacking-taiwan