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Saturday, July 1, 2023

First trial over Zantac cancer claims set for November

 The first U.S. trial over claims that discontinued heartburn drug Zantac causes cancer is now expected to take place in California state court on Nov. 13, a lawyer for plaintiffs in the litigation said Friday.

Plaintiffs in the litigation claim that Zantac causes nine forms of cancer, including colorectal, breast and bladder cancer.

A trial in a case brought by a different plaintiff had been expected next month, but it was called off after the pill's British drugmaker GSK Plc, the only defendant in the case, settled for an undisclosed amount without admitting liability.

Thousands of lawsuits over Zantac have been filed in California against GSK, Sanofi SA, Pfizer Inc and Boehringer Ingelheim, which all sold the drug at various times.

The trial is meant to serve as a test of the claims' strength, and its outcome could shape negotiations toward a broader settlement.

Not all the companies, which have repeatedly denied that Zantac can cause cancer, are named in each lawsuit. Which specific case will go to trial in November has not yet been determined, according to a spokesperson for GSK.

First approved in 1983, Zantac became the world's best selling medicine in 1988 and one of the first-ever drugs to top $1 billion in annual sales. It was originally sold by a forerunner of GSK.

In 2019, some manufacturers halted Zantac sales over concerns that its active ingredient, ranitidine, degraded over time to form a chemical called NDMA. While NDMA can be present in low levels in food and water, research has found it causes cancer in larger amounts.

The FDA in 2020 withdrew from the market all remaining brand name Zantac and generic versions.

The drugmakers scored a major victory in December, when a federal judge threw out all of the Zantac cases in U.S. federal court, some 50,000, after finding the opinions of the plaintiffs' expert witnesses linking the drug to cancer were not backed by sound science.

The remaining cases are in state courts, most of them in Delaware, where more than 70,000 cases are pending.

https://www.marketscreener.com/quote/stock/GSK-PLC-9590199/news/First-trial-over-Zantac-cancer-claims-set-for-November-44245890/

Sandoz: An Unbranded Version Of Humira Is Also Available At Discount

 SANDOZ: AN UNBRANDED VERSION OF HUMIRA IS ALSO AVAILABLE AT AN 81% DISCOUNT BELOW CURRENT HUMIRA LIST PRICE ALONGSIDE HYRIMOZ

https://www.marketscreener.com/news/latest/SANDOZ-AN-UNBRANDED-VERSION-OF-HUMIRA-IS-ALSO-AVAILABLE-AT-AN-8-8230--44246673/

Disney accused in lawsuit of 'systematically' paying women less than men in California

 Walt Disney has been accused of systematically underpaying women in California in a lawsuit that alleges the company's female employees in the state earned $150 million less than their male counterparts over an eight year period.

The Friday filing in Los Angeles County Superior Court seeks to persuade the judge to certify a four-year-old civil suit as a class action, covering some 12,500 current or former fulltime female Disney employees who held positions below the level of vice president.

An analysis of Disney's human resource data from April 2015 through December 2022 has found female Disney employees were paid roughly 2% less than male counterparts, the filing said. It was conducted by David Neumark, a University of California Irvine professor and labor economist.

Disney disputes the findings.

"The plaintiffs' assertions about an alleged pay gap between women and men are simply false, which we will demonstrate through the litigation," said Shawna M. Swanson, associate general counsel and head of the employment law function for Disney.

The original suit was filed by LaRonda Rasmussen in 2019, after she learned that six men with the same job title earned substantially more, including one recent hire with several years less experience, who earned $20,000 more, according to the complaint. Nine current or past Disney employees have joined the suit.

"Several of the named plaintiffs, they do love the Disney brand, they just want to be paid fairly," said Lori Andrus, the plaintiffs' lead attorney.

Lower pay for women in California would breach the state's Equal Pay Act and the Fair Employment & Housing Act. 

https://www.marketscreener.com/quote/stock/WALT-DISNEY-COMPANY-THE-4842/news/Disney-accused-in-lawsuit-of-systematically-paying-women-less-than-men-in-California-44246568/

EV charging firms oppose Texas' 'premature' plan to mandate Tesla standard

 A group of EV charger makers and operators is pushing back against Texas' plan to mandate the inclusion of Tesla technology in charging stations, saying it is "premature," according to a document seen by Reuters and a source aware of the matter.

Reuters reported last week that Texas would require charging companies to include both Tesla's North American Charging Standard (NACS) as well as the nationally recognized rival Combined Charging Standard (CCS) technology to be eligible for a state program to electrify highways using federal dollars.

Washington followed suit, and standards organization SAE International has said it aims to make an industry standard configuration of Tesla's charging connector in six months or less, adding momentum to Tesla CEO Elon Musk's hope of making NACS the national charging technology.

But five electric vehicle charging companies, including operator ChargePoint Holdings and manufacturer ABB , and a clean energy association have written to the Texas Transportation Commission, calling for more time to re-engineer and test Tesla's connectors.

Texas' plan "risks the successful deployment" of the first phase of federal funds being rolled out, they said in the letter sent to the chairman of the commission on Thursday, which was seen by Reuters.

"Time is needed to properly standardize, test, and certify the safety and interoperability of Tesla connectors across the industry," they said.

The source directly aware of the matter told Reuters that some of these organizations are planning to reach out to the federal government with the issue soon.

The Texas Department of Transportation, ChargePoint, ABB and other signatories FreeWire, EVBox and FLO did not immediately respond to Reuters' requests for comment.

Another signatory, Americans for Affordable Clean Energy, an association of truck stops and convenience stores, could not be reached immediately.

Tesla, the dominant EV maker in the United States, has scored a string of victories for its charging technology in recent weeks, starting with Ford Motor saying it would adopt NACS. General Motors, Rivian Automotive and a raft of auto and charging companies did the same, on concerns of losing out on customers if they offer only CCS.

Tesla's Superchargers account for about 60% of the total number of fast chargers in the United States, according to the U.S. Department of Energy, and the deals will allow non-Tesla users to use the company's large charging network.

But concerns remain about how smoothly the two charging standards would talk to each other and whether having both standards in the market would raise costs for vendors and customers.

Charging companies have to re-work several aspects of NACS connectors, including extending the cable length and ensuring adequate temperature ranges, as well as get certifications for specific parts, the companies said in the letter.

The companies also highlighted the need for a strong supply chain of NACS cables and connectors that comply with the requirements.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/EV-charging-firms-oppose-Texas-premature-plan-to-mandate-Tesla-standard-letter-44246329/

Friday, June 30, 2023

Stanford Study of Paxlovid for Long COVID Stopped Early

 Enrollment into a small trial of nirmatrelvir/ritonavir (Paxlovid) for long COVID -- one that previously garnered attention for investigators not wearing masks

opens in a new tab or window -- has been stopped early after an interim analysis, Stanford University confirmed to MedPage Today.

Two sources familiar with the STOP-PASC studyopens in a new tab or window told MedPage Today that trial enrollment had been halted. One was told by a study coordinator that a preliminary review found "inconclusive evidence" for the primary outcome of the study. Another said their first appointment was canceled just a few days before it was supposed to take place, and they were later told that all future enrollment had been halted.

"I've had neurological long COVID for more than 2 years and this was the first time I had an opportunity to participate in a trial testing a potential drug therapy," the participant whose visit was canceled told MedPage Today. "I was so eager to give it a try, I spent money from my dwindling savings account to pay for [my] trips."

Stanford Medicine spokesperson Lisa Kim confirmed that "new enrollment is closing slightly earlier than original projections based on a planned interim analysis reviewed by an external monitoring committee."

"There are no safety concerns with the study and enrolled participants are encouraged to complete follow-up activities as planned," she added.

Kim did not provide further comment on what was found during the interim analysis and did not comment on the "inconclusive" results mentioned by the study coordinator to the source.

In May, MedPage Today reportedopens in a new tab or window that some participants were concerned that some investigators were not wearing masks during clinic visits, potentially putting the participants at risk.

According to ClinicalTrials.govopens in a new tab or window, the study design specified two-way masking, for both investigators and participants. Neither Stanford nor study sponsor Pfizer would comment on whether or not the masking issue factored into the decision to stop the study early.

Pfizer spokesperson Jerica Pitts said Pfizer "funded the study and provided clinical supplies of Paxlovid and the placebo comparator at no cost." She also confirmed that new enrollment is closed at this time, "and the investigators plan to share final results as soon as the study is completed. We look forward to reviewing these results once available and will use the insights gathered to help inform planned and future studies."

STOP-PASC is a phase II study that sought to enroll 200 participants. It is not clear how many enrolled before recruitment closed.

Participants would receive a 15-day course of either nirmatrelvir/ritonavir or placebo plus ritonavir. Stanford and Pfizer did not comment on why the placebo group also received a protease inhibitor.

The study called for five patient visits over a total of 15 weeks, with the therapy or placebo given for the first 15 days. The estimated completion date was November 2023, according to ClinicalTrials.gov. The study's primary outcome is the difference at 10 weeks between the nirmatrelvir/ritonavir and placebo arms for any of six core symptoms of post-acute sequelae SARS-CoV-2 infection, or PASC: "fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms."

Stanford spokesperson Kim said the results of the STOP-PASC trial "will be shared as soon as the study is completed," and that the study should be published "sometime before the end of the year" but that there is no definite timeline.

ClinicalTrials.gov currently lists the status of the study incorrectly as "recruiting."

https://www.medpagetoday.com/special-reports/exclusives/105295

40% Of Californians Are Considering Moving To Another State Due To Cost Of Living

 Just when you though the exodus from California to places like Florida and Texas may have slowed....you can guess again.

That's because a recent poll called the California Community Poll, administered at the beginning of June, showed that roughly 43% of residents in California think the state is heading in the wrong direction. 

28% have mixed feelings about the direction and 28% think it is going in the right direction, a summary from Just the News/The Center Square reported this week. The survey interviewed 1,354 people. 

56% of respondents were "totally dissatisfied" with the state's cost of healthcare and another 56% said they were dissatisfied with the cost of homes in the state. More than 50% of residents also were dissatisfied with safety in their local communities, the report says.

Californians also seem to be unhappy with the state's economy, with 68% of those polled saying they were "totally dissatisfied" and a stunning 81% of respondents saying that the cost of everyday expenses was unsatisfactory. 

61% of those polled also said the cost of living is the key reason that they are considering leaving the state, with about 40% of respondents saying they are considering moving to another state, even with 68% of respondents saying California is "part of how they identify themselves". 

Also focused on the economy, 46% of residents surveyed said they can't pay for an unexpected expense and don't have the ability to save. 

The report was quick to note that, despite the stunning response from the more than 1,300 people surveyed, many residents were "by and large" still happy to live in the state because it “brings people together around new ideas and vibrant communities.”

So, we'll see you in Texas and Florida then, right?

NYC Now Sheltering More Illegal Immigrants Than Homeless Citizens: Deputy Mayor

 by Ryan Morgan via The Epoch Times (emphasis ours),

New York City is now providing more shelter to non-citizens than to its own homeless resident population, according to the latest assessment from a city official.

At a Wednesday press conference, New York City Deputy Mayor For Health and Human Services Anne Williams-Isom said the city is currently sheltering more than 100,000 people, the majority of whom are illegal immigrants and other non-citizens who are seeking to stay in the United States for the long-term.

With over 50,000 asylum seekers currently in our care at this point, we now have more people seeking U.S. asylum than longtime unhoused New Yorkers in our shelter system,” New York City Williams-Isom said.

Many of the non-citizens being sheltered in the city are people who illegally crossed the U.S. southern border but made asylum claims or otherwise requested legal status in the U.S. and are now awaiting a ruling in their immigration cases.

Since last year, Republican Texas Gov. Greg Abbott has been busing illegal immigrants away from his border state to other areas of the country; particularly Democratic districts like New York City that have designated themselves as immigration “sanctuary cities.” New York City has been one of the main receiving points for tens of thousands of these illegal immigrants and many have stayed in the city since their arrival.

Williams-Isom called the ratio of illegal immigrants to resident homeless people in the city’s shelter system “sobering.” She said New York City has taken in 81,200 illegal immigrants and asylum seekers since the Spring of 2022, including “2,500 new asylum seekers” in the past week.

“You see from today’s numbers that we have reached a tipping point,” she said. “We now have more asylum seekers in our care than longtime New Yorkers from when we first came in and who are in our existing [New York City Department of Homeless Services] system.

NYC Mayor’s Shelter Strategy

Williams-Isom said New York City has opened 176 new shelter sites, including 12 humanitarian relief sites since last spring, but indicated the city has virtually exhausted its capacity to shelter people.

“We will continue to do our part. I might say we’re doing more than our part,” she said on Thursday. “But this is a national humanitarian crisis and we need sustained and profound support from the federal government in the form of financial aid and in the form of a national coordination.”

Following a 1984 court decision known as the “Callahan consent decree,” New York City has had to provide shelter for virtually all homeless people who apply. Last month, New York City Mayor Eric Adams requested that a court suspend this “Right to Shelter” rule. New York City is also one of many locations throughout the U.S. that consider themselves “sanctuary cities,” meaning they do not cooperate with federal immigration authorities that might arrest or deport illegal immigrants.

Abbott has said his busing strategy has shone a spotlight on the hypocrisy of sanctuary cities that balk at the prospect of having to actually take, and share responsibility for, illegal immigrants.

In May, Adams began trying to relocate some illegal immigrants from New York City to neighboring areas of New York, with a commitment to cover the costs of their shelter, food, counseling, and other services for up to four months. Many of these neighboring communities have rejected the relocation efforts, even issuing emergency declarations to block Adams’ administration from busing illegal immigrants to their communities.

Earlier this month, the Adams administration filed a lawsuit against 30 New York counties, seeking a court order overriding any emergency orders blocking his efforts to move illegal immigrants to those neighboring communities.

Adams has also called on President Joe Biden’s administration to provide New York City with more federal funding for its shelter system. In a May 21 interview with CBS News, host Margaret Brennan noted the federal government has pledged about $30 million in assistance to deal with the influx, but Adams insisted his city’s shelter expenses would far exceed that level of federal support.

We’re projected to spend close to $4.3 billion, if not more. This estimate was based on a number of migrants coming to the city, and those numbers have clearly increased,” Adams said. “When you look at the price tag, $30 million comes nowhere near what this city is paying for a national problem.”

https://www.zerohedge.com/political/new-york-city-now-sheltering-more-illegal-immigrants-homeless-citizens-deputy-mayor