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?

https://www.zerohedge.com/markets/40-californians-are-considering-moving-another-state-due-cost-living

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

Chemours stock drops nearly 2% after final 'forever chemicals' deal announced

 Shares of Chemours Co. (CC) dropped nearly 2% in the aftermarket Friday after the chemicals company, alongside DuPont de Nemours Inc. (DD) and Corteva Inc. (CTVA), said it has reached a final $1.85 billion deal in principle to settle claims they are responsible for so-called "forever chemicals" in drinking water in the U.S., hewing close to what the companies announced in early June. The $1.185 billion will go into a settlement fund the three companies will establish, with Chemours contributing about 50%, or about $592 million, and DuPont, with about $400 million, and Corteva, with about $193 million, contributing the remaining 50%. The settlement amounts will be funded by the companies in full and deposited into the water district settlement fund within ten business days following preliminary approval of the settlement by the court system, they said. Shares of DuPont fell 1.3%, while Corteva's were up 0.1%. Chemours and Corteva were spun off from DuPont's predecessor in the past few years. Last week, 3M Co. (MMM) announced its own "forever chemicals" proposed settlement.

https://www.morningstar.com/news/marketwatch/202306301196/chemours-stock-drops-nearly-2-after-final-forever-chemicals-deal-announced

US businesses operating in China face new risks under updated PRC law

 American businesses that are operating in China will face new risks under a revision to a counter-espionage law by the PRC, warns the National Counterintelligence and Security Center.

The center, which is part of the Office of the Director of National Intelligence, issued a memo on Friday outlining the new risks for American businesses operating in China under a recently passed revision to a counter-espionage law in the PRC.

According to the National Counterintelligence and Security Center, the law, which goes into effect on Saturday, expands "the definition of espionage from covering state secrets and intelligence to any documents, data, materials, or items related to national security interests, without defining terms."

The law also "Broadens the scope of the PRC’s counterespionage law."

Intelligence officials are warning that any "documents, data, materials, or items" could now be "considered relevant to PRC national security due to ambiguities in the law."

Additionally, the law also has the "Potential to create legal risks or uncertainty for foreign companies, journalists, academics, and researchers."

Mirriam-Grace MacIntyre, who leads the National Counterintelligence and Security Center, told the Wall Street Journal that the law expands the definition of espionage without defining terms in a manner that's "deeply problematic for private sector companies."

The counter-espionage law which was recently revised is part of a group of more laws which could give the Chinese government "legal grounds for accessing and controlling data held by U.S. firms in China."

https://www.foxbusiness.com/politics/us-businesses-operating-china-face-new-risks-revised-prc-law-intelligence-officials-say

U.S. Physical Therapy started at Buy by B of A

 Target $138

https://finviz.com/quote.ashx?t=USPH&p=d

Kraken Ordered to Turn Over Its Users’ Information to the IRS

 

• Cryptocurrency exchange must provide wide swath of user data
• Court order comes amid deepening digital currency crackdown

Cryptocurrency exchange Kraken was ordered by a judge to provide a wide swath of information about its users to the Internal Revenue Service for the agency’s investigation of underreported tax liability.

The IRS has said it wants information on Kraken accounts that did at least $20,000 of cryptocurrency trading in any single year, from 2016 to 2020. Kraken had called the agency’s summons an “unjustified treasure hunt,” arguing it went well beyond the boundaries set in a similar fight with Coinbase about six years ago. 

https://www.bloomberg.com/news/articles/2023-06-30/kraken-ordered-to-turn-over-its-users-information-to-the-irs

Goldman in talks to offload Apple credit card, savings products to American Express

 Goldman Sachs

 is in talks to offload its Apple credit card and high-yield savings account products to American Express, a source told CNBC’s Leslie Picker.

Goldman Sachs and Apple declined to comment. CNBC has also reached out to American Express.

The talks come amid a broader retreat by Goldman from its largely failed consumer banking initiatives, for which CEO David Solomon has taken a great deal of heat. Last week, CNBC reported that the Wall Street giant is preparing to take a huge writedown on its 2021 acquisition of fintech lender GreenSky.

The Wall Street Journal first reported the Goldman talks with American Express. The newspaper said there’s no assurance of a deal, nor is an agreement close.

It would mark an abrupt reversal for the two corporate giants. In October, the Journal reported Goldman and Apple renewed their partnership through 2029. And in April, Goldman Chief Financial Officer Denis Coleman touted a deepening of the partnership.

“This week, we announced the launch of a savings account for Apple Card users. We are excited to deepen our partnership with Apple through this additional offering and to introduce another source of deposit funding for the firm,” Coleman said at the time.

The Journal also reported Friday that Goldman is talking about unloading its General Motors card partnership. GM declined to comment to CNBC.

https://www.cnbc.com/2023/06/30/goldman-in-talks-to-offload-apple-financial-products-to-american-express-source.html

Tide Is Turning On Transgender Tolerance

  by Patricia Tolson via The Epoch Times (emphasis ours),

Over the past few years, the transgender movement has pushed its way into every nook and cranny of American culture, and major institutions and authorities have tried to force all people to go along with it.

But now, the tide is turning.

It started quietly, with biological science and objective reality being given a backseat to internal feelings and chosen identity. To become a member of the opposite sex, all one needs to do is declare it to be so and others will be forced to acknowledge it is so.

Next came the reengineering of language. The word “sex,” which defines a man or a woman, has been replaced by the word “gender,” which can be anything.

Then came the new terms and pronouns.

To help people keep up with the growing list of terms and pronouns, Trans Student Educational Resources provides a tutorial, advising that “these are not the only pronouns” and that “there are an infinite number of pronouns as new ones emerge in our language.”

For those who struggle to differentiate and understand the new terms and pronouns, there’s an “LGBTQ+ Glossary” explaining all of the gender terms, acronyms, initialisms, and pronouns on their ever-evolving and expanding list.

Even the National Institutes of Health under the Department of Health and Human Services provides instruction and guidance on the proper use of “Gender Pronouns & Their Use in Workplace Communications,” warning that “intentional refusal to use someone’s correct pronouns is equivalent to harassment and a violation of one’s civil rights.”

Refusal to use a colleague’s preferred pronoun at work can result in punishment or termination.

Erasing Women

Then came the effort to erase womanhood itself.

Females are no longer “women.” Those promoting gender ideology cannot define the term “woman,” and women are instead referred to as “birthing people” or “people with uteruses.” There are also claims that “men can have periods” and “women have penises.”

Last year, a biological male named Brían Nguyen won the title of Miss Greater Derry in a local New Hampshire pageant that’s part of the Miss America organization, and another biological male, Dr. Rachel Levine, was named Woman of the Year by USA Today.

Sports Illustrated, a magazine known for featuring female models on the cover, recently included a transgender singer, who is a biological male, in its cover photos.

Men are also claiming titles, trophies, scholarships, and accolades in women’s sports.

Then there’s Fallon Fox, a man who identifies as a woman and became a mixed martial arts fighter. After knocking out two women in the ring and breaking one of their skulls, Fox boasted about how much Fox “enjoyed” it, calling it “bliss.” Fox was later named “the bravest athlete ever” and given the Pioneer Triumph Award by Out Sports.

A recent Gallup survey shows the vast majority of Americans believe transgender athletes “should only be allowed to compete on sports teams that conform with their birth gender.”

Targeting Youth

Then they came after children.

As previously reported by The Epoch Times, the progression of the trans movement began in 2015 with the introduction of drag queen story hour, which evolved into “family-friendly” drag shows where men scantily clad in a garish guise of womanhood perform sexually charged dances in front of children. They moved from pride parades to restaurants, amusement parks, theme parks, regular bars, gay bars, schools—and churches.

Laws were passed to facilitate the transitioning of children against the will of parents. Washington state passed a law (pdf) that would enable the staff at shelters where a runaway was seeking “gender-affirming care” to contact the state’s Department of Children, Youth, and Families rather than the parents so the child can obtain that “care” without the parent’s knowledge or consent. California is pushing legislation to take children away from parents who refuse to enable their minor-aged children to obtain sex change operations.

Children are given puberty blockers and hormones. Young girls are having their breasts removed. Then there’s the “painful” truth about sex change surgery.

The Pushback

The backlash that followed transgender activist Dylan Mulvaney’s Bud Light endorsement was swift and costly, and the subsequent efforts by Anheuser-Busch to recover the extraordinary losses it continues to suffer have failed miserably.

The company’s first statement didn’t work. Neither did the second. The patriotic follow-up commercial was ripped as “pandering,” and the manly camo cans were “mocked.” As reported by The Epoch Times, the latest mea culpa commercial striving to reclaim the all-American image it once had is being met by responses that the company is now “trying too hard.”

The Epoch Times reported how two Los Angeles Dodgers pitchers spoke out after the team announced it would honor the drag queens who call themselves the Sisters of Perpetual Indulgence during a “pride night” event on June 16.

In the National Hockey League, the number of players who refused to play the “Pride Night” games grew to such an extent that the league’s board of governors ruled on June 22 that none of the players will wear special jerseys for pregame warmups during themed nights next season.

There’s been similar backlash to Target’s “Pride Month” displays and merchandise and to Mulvaney’s ads for Tampax and Nike women’s sports bras, prompting the “Burn Bra Challenge” online.

Now there’s a movement to reclaim “the rainbow.” Conservative rapper Bryson Gray released a new song called “Reclaim the Rainbow,” with thousands of views on YouTube.

‘Taking the Rainbow Back’

Rabbi Kirt Schneider, a self-described “Jewish believer in Jesus” and host of “Discovering the Jewish Jesus,” is the leader and founder of a new movement called “Taking the Rainbow Back.”

Rabbi Kirt Schneider in an undated photo. (Courtesy of Rabbi Schneider)

The objectives of his movement include “restoring the rainbow’s meaning to its original God-given purpose and message,” and removing “the stigma associated with the rainbow being exclusively an LGBTQ symbol.”

As described in Genesis 9:14-16, the first rainbow was set in the sky by God after the great flood as a reminder of the “everlasting covenant” between God and man “and every living creature.” The rainbow is God’s promise that “never again will the waters become a flood to destroy all life.”

https://www.zerohedge.com/political/tide-turning-transgender-tolerance

Most kale contains ‘disturbing’ levels of ‘forever chemicals’: report

 Haters of kale, rejoice!

A new survey of kale samples taken from several US grocery stores found that seven out of eight samples had “disturbing” levels of per- and polyfluoroalkyl substances.

Ironically, kale was chosen as a test subject because scientists wanted to look at a vegetable that has a reputation for being healthy.

It’s perhaps even more ironic that the kale labeled “USDA organic” had higher levels of PFAS than conventional kale.

That was “a bit of a shock finding,” Robert Verkerk, founder of the Alliance for Natural Health, told the Guardian.

Kale was chosen as a test subject because of its reputation as a “healthy” vegetable.

Getty Images

The Alliance for Natural Health produced the survey report and published it on its website.

PFAS are often referred to as “forever chemicals” because they don’t break down easily and are found in soil, water and air worldwide.

PFAS are a group of synthetic chemicals widely used in packaging, clothing, carpets, firefighting foam and even toilet paper since the 1950s.

Research has linked the chemicals to cancer and other health problems, such as issues with the immune system, liver and fertility.

And scientists are still learning about PFAS, including how best to detect and measure them, remove them from air and water and determine their long-term effects.

For the survey, the kale samples were sent to a lab certified by the Environmental Protection Agency and were then tested with the same method used by the Food and Drug Administration.

The FDA conducted kale analyses between 2019 and 2021 and found no evidence of PFAS contamination.

There are no established safe limits for PFAS in food in the US.

Getty Images

The new survey found PFAS levels going up to 250 parts per trillion. There are no established limits for PFAS in food in the US.

But the EPA has determined that no amount of exposure to PFAS compounds in drinking water can be considered safe.

It’s not known how the kale was contaminated with PFAS, but it could have been grown with PFAS-tainted irrigation water or in fields where contaminated sludge had been spread.

“It’s pretty scary, and there’s no easy solution,” Verkerk said. He also called upon the FDA to implement a better PFAS testing program for America’s entire food supply.

https://nypost.com/2023/06/30/most-kale-contains-disturbing-levels-of-forever-chemicals/