Harris’s LA neighborhood ordered to evacuate as wildfires blaze through area

 Vice President Harris’s neighborhood in Los Angeles was ordered to evacuate Tuesday night as wildfires blazed through the area, her spokesperson said Wednesday.

“Last night, the Vice President’s neighborhood in Los Angeles was put under an evacuation order. No one was in her home at the time,” spokesperson Ernie Apreza said on social platform X.

“She and the Second Gentleman are praying for the safety of their fellow Californians, the heroic first responders, and Secret Service personnel,” Apreza added.

Harris, a lifelong Californian who served as the state’s U.S. senator and attorney general, said in a statement Tuesday that she was briefed about the state of the wildfires and would continue to be updated regularly “about these damaging wildfires and the coordinated efforts to contain them.”

“I am also urging residents in the affected areas to listen to local officials, remain vigilant, and evacuate immediately if told to do so,” Harris continued in her statement Tuesday evening.

Harris said she and President Biden “are committed to ensuring that no community has to respond to this disaster alone” and that they have mobilized federal resources “to help suppress the fires, provide overhead support, and begin assisting those impacted.”

She said the Federal Emergency Management Agency (FEMA) has already approved a Fire Management Assistance Grant to reimburse the state for some of the firefighting costs.

“As a proud daughter of California, I know the damage that wildfires have on our neighbors and communities. I also know that the impact is often felt long after the fire is contained. As we respond and as Californians recover, I will ensure that our administration is in constant contact with state and local officials,” Harris added.

Harris’s statement comes as the Pacific Palisades wildfire and three other fires burn through the area surrounding Los Angeles, prompting California Gov. Gavin Newsom (D) to declare a state of emergency. The fires have also forced some residents to evacuate and caused significant damage to structures in the area.

The Palisades fire, which started as a brush fire at approximately 10:30 a.m. local time Tuesday, has grown to almost 3,000 acres with zero containment, according to Cal Fire.

The second fire, the Eaton fire, also started Tuesday near Altadena Drive and Midwick Drive in Pasadena. The Hurst fire, the third fire, started burning Tuesday night, spreading rapidly with high winds and burning at least 500 acres. A fourth one, the Tyler fire, began Wednesday morning in Coachella, Riverside County.

https://thehill.com/homenews/state-watch/5073912-vice-president-harris-neighborhood-evacuated-wildfires/

Los Angeles Fires to Top $50 Billion in Damage, AccuWeather Says

 The wildfires raging out of control around Los Angeles will likely cause between $52 billion to $57 billion in damages and economic loss, according to a preliminary estimate by AccuWeather Inc.

The blazes burning around Santa Monica and Malibu are consuming some of the most expensive real estate in the US, affecting areas where the median home value is more than $2 million, the company said. Fires fanned by hurricane-force wind gusts may spread flames deeper into these neighborhoods destroying more homes.

In addition to the human costs and property damaged, there will likely be longer-lasting health impacts due to acrid smoke, as well as a dent in the region’s lucrative tourism business, the company said.

“This is already one of the worst wildfires in California history,” said Jonathan Porter, AccuWeather’s chief meteorologist. “Should a large number of additional structures be burned in the coming days, it may become the worst wildfire in modern California history based on the number of structures burned and economic loss.”

https://finance.yahoo.com/news/los-angeles-fires-top-50-212424334.html

Maduro Says Americans & Ukrainians Among Group Of 'Mercenaries' Detained

 This kind of bizarre headline seems to only keep coming out of Venezuela: President Nicolás Maduro says that US nationals are among a group of 'mercenaries' detained by authorities.

Maduro claimed in a Tuesday announcement that seven foreign mercenaries, including Ukrainians and Americans, were caught in the act of plotting to attack and destabilize the country's leadership. "Just today we've captured seven foreign mercenaries, including two important mercenaries from the United States," he said.

He described that the group also included two Colombian hitmen captured "in different places" as well as "three mercenaries who came from Ukraine, from the war in Ukraine, to bring violence to the country."

Via AFP

The two Americans were characterized as "very high level" and "important" mercenaries; however, no further details of the identities of the detained have been released.

Maduro claimed the group had planned "to carry out attacks on the leaders of the revolution" - in reference to Bolivarian socialism popularized which goes back to his mentor and prior leader Hugo Chavez.

It's possible the group is being subject to severe interrogation, or even torture: "I am sure that in the next few hours, they will confess," Maduro additionally stated.

Key context for all this is the Biden administration recognizing and welcoming into the US a new Venezuelan 'interim president':

The announcement of the detention of the foreign nationals comes just hours after US President Joe Biden welcomed exiled Venezuelan opposition candidate Edmundo Gonzalez Urrutia to the United States.

Biden expressed his support for a "peaceful transfer back to democratic rule" in Venezuela and cautioned against further repression.

The US and other neighboring countries believe Gonzalez Urrutia won a July presidential election by a landslide and that official results were fudged.

The opposition is in the meantime calling for "millions" of Venezuelans to protest Maduro's Friday inauguration to a third six-year term, which the US says was based on a rigged election.

But as the AP points out, opposition leadership has been in shambles: "Whether people will protest against Maduro on Friday remains to be seen since the government’s post-election repression campaign, including the arrests of more than 2,000 people, has had a chilling effect. And even if opposition supporters decide to demonstrate, it is unclear who would lead them," it writes.

The timing is also interesting given that in less that two weeks, Maduro's archnemesis Donald Trump returns to the White House. Maduro has already accused Trump of seeking to orchestrate regime change in his country in order to take the oil.

https://www.zerohedge.com/geopolitical/maduro-says-americans-ukrainians-among-group-mercenaries-detained

Ukraine Says Ready To Replace 'Putin-Friendly' Hungary In EU & NATO

 The long-running war of words and denunciations exchanged between Kiev and Budapest has shown no signs of abating. This week Ukraine is now saying it can replace Hungary in the European Union and NATO if Viktor Orbán keeps cozying up to Putin.

The bombastic statement was issued by Ukraine's Ministry of Foreign Affairs of Ukraine on Wednesday, and was also made available on X. The statement was formulated in response to the "latest manipulative statements from the leadership of Hungary regarding Ukraine’s decision not to extend the transit agreement with the aggressor state, Russia, from 2025 onwards."

Via Shutterstock

Ukraine said it "would be ready to fill any vacant space in the EU and NATO if Hungary chooses to vacate it" in favor of its membership in the Commonwealth of Independent States (CIS), or the Collective Security Treaty Organization (CSTO).

Formed in 2002, the CSTO has of late been overseen by Putin and originally consists of the six post-Soviet states of Russia, Belarus,  Armenia, Kazakhstan, Kyrgyzstan, and Tajikistan.

"If Hungary genuinely wishes to contribute to ending the war, it should start by not undermining unity within the EU and instead work to strengthen the energy security and independence of its own country and citizens alongside the rest of Europe and the United States," the statement said further.

Prime Minister Orbán has made himself known as a constant vocal critic of Ukraine ever gaining access to NATO membership. He has further demanded more serious diplomatic efforts to negotiate an end to the war, standing with Slovakia's Fico in this regard.

All of this also comes amid the backdrop of the gas row triggered by Ukraine's refusal to renew a 5-year transit deal with Moscow. Orban's government has blamed Kiev for a some 20% rise in natrual gas prices on the European market.

Slovakia and Austria in addition to Hungary remain heavily reliant on Russian gas purchased through Gazprombank, despite its being under US and European-led sanctions.

Hungarian Foreign Minister Péter Szijjártó has charged Ukraine with intentionally putting Europe in an economic bind by not renewing the gas transit deal with Russia.

https://www.zerohedge.com/geopolitical/ukraine-says-ready-replace-putin-friendly-hungary-eu-nato

Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review

 As previously reported, Vanda has sought approval from the U.S. Food and Drug Administration (FDA) for tradipitant for the treatment of patients with gastroparesis. FDA declined to approve Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis, providing Vanda with a Complete Response Letter (CRL) on September 18, 2024.

Today, Vanda issued a letter to FDA Commissioner Robert M. Califf, MD, regarding the September 18, 2024 CRL in reference to Vanda's NDA for tradipitant for the treatment of gastroparesis. The full letter is shown below:

_____________________________________________________________________

Dear Dr. Califf:

We are writing to bring your attention to a disturbing pattern of conduct at FDA that impairs the credibility of the agency and harms the American public. In an interview last year you stated that you would not overrule decisions made by civil servants at the Agency except in certain cases of "corruption" or "temporary insanity" of the decision maker.1 Neither the public nor regulated entities like Vanda are able to determine what instances of "corruption" or "temporary insanity" would in your view merit overruling lower-level FDA employee decisions. This opacity in decisionmaking and oversight has allowed a culture of obfuscation and closemindedness to fester at FDA. And your agency's review of our application to market tradipitant is no exception.

Three months ago, Vanda received a complete response letter (CRL), dated September 18, 2024, in response to the new drug application (NDA) Vanda submitted on September 18, 2023, for the use of tradipitant for the treatment of symptoms of gastroparesis, a serious and debilitating gastrointestinal disorder. We wrote to Dr. Nikolov expressing our surprise "by the sheer disregard for the facts, evidence, and basic scientific principles contained in the complete response"—a letter that could not "possibly reflect a legitimate regulatory review" as it did not "provide reasoned explanations or engage with the evidence we presented on its merit—including voluminous evidence from experts."

Three months later, Dr. Nikolov has not even acknowledged that letter, let alone provided a response. This is unacceptable, and stems from the seriously misguided nature of your position that you will not overrule decisions made by civil servants at the Agency except in extreme situations such as "corruption" or "temporary insanity" of the decision maker. As a political appointee and head of the agency, you are the only person accountable to the American public—a public that needs to know that the agency will follow the law and ensure courteous and civil behavior by agency employees.

In addition, FDA has denied our request to convene an Advisory Committee to consider our application for tradipitant, a process by which experts and the public can voice their opinion on our application. As you are no doubt aware, the number of Advisory Committee meetings convened by the agency has drastically declined over the last few years. See Cheri Banks, The Future of Voting for FDA Advisory Committees, Federation of American Scientists (Sept. 9, 2024), perma.cc/L8R3-2FJD (noting that in 2021, 6% of drug applications were referred to advisory committees, down from 55% in 2010). You have stated separately that there should be "less voting" by advisory committees, and that you don't believe in "gladiator votes" because "votes don't matter."  These statements compound a sentiment that the agency avoids public scrutiny of its decisions, which is dangerous both for public health and agency credibility.

I understand that you may be leaving the agency in the new administration, but I hope that you will consider this letter, and I would welcome your thoughts in response. FDA's policies, practices, and culture must be evaluated and corrected so as to align with scientific evidence and the law.

Sincerely,

Mihael H. Polymeropoulos, M.D.
Chief Executive Officer
Vanda Pharmaceuticals Inc.

1.   MedPage Today, Politics and Controversy in the FDA, YouTube (Apr. 11, 2023) (statement of Commissioner Robert Califf, M.D.), available at https://www.youtube.com/watch?reload=9&app=desktop&v=zGrnzM51Jrs.

______________________________________________________________________

The text of the letter to Dr. Nikolov, referenced in the second paragraph of the letter above, is available at: https://assets.vandapharma.com/pdfs/vanda-letter-to-dr-nikolov.pdf

https://www.prnewswire.com/news-releases/vandas-letter-to-fda-commissioner-highlights-faulty-gastroparesis-nda-review-302346357.html

Controversial fluoride analysis published after years of failed reviews

Federal toxicology researchers on Monday finally published a long-controversial analysis that claims to find a link between high levels of fluoride exposure and slightly lower IQs in children living in areas outside the US, mostly in China and India. As expected, it immediately drew yet more controversy.


The study, published in JAMA Pediatrics, is a meta-analysis, a type of study that combines data from many different studies—in this case, mostly low-quality studies—to come up with new results. None of the data included in the analysis is from the US, and the fluoride levels examined are at least double the level recommended for municipal water in the US. In some places in the world, fluoride is naturally present in water, such as parts of China, and can reach concentrations several-fold higher than fluoridated water in the US.



The authors of the analysis are researchers at the National Toxicology Program at the National Institute of Environmental Health Sciences. For context, this is the same federal research program that published a dubious analysis in 2016 suggesting that cell phones cause cancer in rats. The study underwent a suspicious peer-review process and contained questionable methods and statistics.



The new fluoride analysis shares similarities. NTP researchers have been working on the fluoride study since 2015 and submitted two drafts for peer review to an independent panel of experts at the National Academies of Sciences, Engineering, and Medicine in 2020 and 2021. The study failed its review both times. The National Academies' reviews found fault with the methods and statistical rigor of the analysis. Specifically, the reviews noted potential bias in the selection of the studies included in the analysis, inconsistent application of risk-of-bias criteria, lack of data transparency, insufficient evaluations of potential confounding, and flawed measures of neurodevelopmental outcomes, among other problems.




After the failing reviews, the NTP selected its own reviewers and self-published the study as a monograph in August.
High risk of bias

The related analysis published Monday looked at data from 74 human studies, 45 of which were conducted in China and 12 in India. Of the 74, 52 were rated as having a high risk of bias, meaning they had designs, study methods, or statistical approaches that could skew the results.

The study's primary meta-analysis only included 59 of the studies: 47 with a high risk of bias and 12 with a low risk. This analysis looked at standardized mean differences in children's IQ between higher and lower fluoride exposure groups. Of the 59 studies, 41 were from China.

Among the 47 studies with a high risk of bias, the pooled difference in mean IQ scores between the higher-exposure groups and lower-exposure groups was -0.52, suggesting that higher fluoride exposure lowered IQs. But, among the 12 studies at low risk for bias, the difference was slight overall, only -0.19. And of those 12 studies, eight found no link between fluoride exposure and IQ at all.

Among 31 studies that reported fluoride levels in water, the NTP authors looked at possible IQ associations at three fluoride-level cutoffs: less than 4 mg/L, less than 2 mg/L, and less than 1.5 mg/L. Among all 31 studies, the researchers found that fluoride exposure levels of less than 4 mg/L and less than 2 mg/L were linked to statistically significant decreases in IQ. However, there was no statistically significant link at 1.5 mg/L. For context, 1.5 mg/L is a little over twice the level of fluoride recommended by the US Environmental Protection Agency for US community water, which is 0.7 mg/L. When the NTP authors looked at just the studies that had a low risk of bias—seven studies—they saw the same lack of association with the 1.5 mg/L cutoff.




The NTP authors also looked at IQ associations in 20 studies that reported urine fluoride levels and again split the analysis using the same fluoride cutoffs as before. While there did appear to be a link with lower IQ at the highest fluoride level, the two lower fluoride levels had borderline statistical significance. Ten of the 20 studies were assessed as having a low risk of bias, and for just those 10, the results were similar to the larger group.

Criticism

The inclusion of urinary fluoride measurements is sure to spark criticism. For years, experts have noted that these measurements are not standardized, can vary by day and time, and are not reflective of a person's overall fluoride exposure.

In an editorial published alongside the NTP study today, Steven Levy, a public health dentist at the University of Iowa, blasted the new analysis, including the urinary sample measurements.

"There is scientific consensus that the urinary sample collection approaches used in almost all included studies (ie, spot urinary fluoride or a few 24-hour samples, many not adjusted for dilution) are not valid measures of individuals’ long-term fluoride exposure, since fluoride has a short half-life and there is substantial variation within days and from day to day," Levy wrote.

Overall, Levy reiterated much of the same concerns from the National Academies' reviews, noting the study's lack of transparency, the reliance on highly biased studies, questionable statistics, and questionable exclusion of newer, higher-quality studies, which have found no link between water fluoridation and children's IQ. For instance, one exclusion was a 2023 study out of Australia that found "[e]xposure to fluoridated water during the first 5 [years] of life was not associated with altered measures of child emotional and behavioral development and executive functioning." A 2022 study out of Spain similarly found no risk from prenatal exposure.




"Taking these many important concerns together, readers are advised to be very cautious in drawing conclusions about possible associations of fluoride exposures with lower IQ," Levy concluded. "This is especially true for lower water fluoride levels."
Another controversial study

But, the debate on water fluoridation is unlikely to recede any time soon. In a second editorial published alongside the NTP study, other researchers praised the analysis, calling for health organizations and regulators to reassess fluoridation.

"The absence of a statistically significant association of water fluoride less than 1.5 mg/L and children’s IQ scores in the dose-response meta-analysis does not exonerate fluoride as a potential risk for lower IQ scores at levels found in fluoridated communities," the authors argue, noting there are additional sources of fluoride, such as toothpaste and foods.

The EPA estimates that 40 to 70 percent of people's fluoride exposure comes from water.

Two of the three authors of the second editorial—Christine Till and Bruce Lanphear—were authors of a highly controversial 2019 study out of Canada suggesting that fluoride intake during pregnancy could reduce children's IQ. The authors even suggested that pregnant people should reduce their fluoride intake. But, the study, also published in JAMA Pediatrics, only found a link between maternal fluoride levels and IQ in male children. There was no association in females.

The study drew heavy backlash, with blistering responses published in JAMA Pediatrics. In one response, UK researchers essentially accused Till and colleagues of a statistical fishing expedition to find a link.

"[T]here was no significant IQ difference between children from fluoridated and nonfluoridated communities and no overall association with maternal urinary fluoride (MUFSG). The authors did not mention this and instead emphasized the significant sex interaction, where the association appeared for boys but not girls. No theoretical rationale for this test was provided; in the absence of a study preregistration, we cannot know whether it was planned a priori. If not, the false-positive probability increases because there are many potential subgroups that might show the result by chance."

Other researchers criticized the study's statistics, lack of data transparency, the use of maternal urine sampling, and the test they used to assess the IQ of children ages 3 and 4.

https://arstechnica.com/health/2025/01/controversial-fluoride-analysis-published-after-years-of-failed-reviews/

Facebook’s Fact-Checkers Changed the Way I See Tech—and Speech—Forever

 When I first heard that Mark Zuckerberg was shutting down Facebook’s fact-checking department, my first thought was: Too little, too late.

That’s because I’ve had my own experience with his team of fact-checkers.

Back in February 2020, when I was the Sunday editor of the New York Post, China expert Steven Mosher pitched me a theory about how the coronavirus started. Back then, it was believed it came from a wet market in Wuhan, but Steven was unconvinced. He said it was much more likely it had leaked from the Wuhan Institute of Virology, which had been doing experiments with the coronavirus for years.

This was before the lockdowns, and before Covid had spread across America and killed millions worldwide. Some experts had just started talking about the possibility of a global pandemic.

I was happy to publish Steven’s piece, because I figured the world would want to hear an alternative idea at an important moment from a social scientist who had lived in China and written books about the country.

I was right about the story. (In fact, the lab leak theory is now seen as the most likely explanation for Covid’s origins.) But I was wrong—and naive—to think anyone in power would want to hear it.

We published the piece on February 22, under the headline “Don’t Buy China’s Story: The Coronavirus May Have Leaked from a Lab.” It immediately went viral, its audience swelling for a few hours as readers liked and shared it over and over again.

I had a data tracker on my screen that showed our web traffic, and I could see the green line for my story surging up and up. Then suddenly, for no reason, the green line dropped like a stone. No one was reading or sharing the piece. It was as though it had never existed at all.

Seeing the story’s traffic plunge, I was stunned. I thought, How does that even happen? How does a story that thousands of people are reading and sharing suddenly just disappear?

Later, the Post’s digital editor gave me the answer: Facebook’s fact-checking team had flagged the piece as “false information.”

I was shocked—and embarrassed. Never in my life had a story I worked on been deemed “false information.” For a moment, I second-guessed myself. I was worried I’d done something wrong, and that I had caused reputational damage—and possible financial damage—to the Post. If your outlet gets dinged three times by Facebook, the digital editor told me, they pretty much censor all your stories from the platform. No media outlet could afford that.

In the meantime, I kept seeing stories by legacy media outlets parroting the wet market theory, turning the idea of a lab leak into a “conspiracy theory.” The message was clear: The Post was irresponsible for even suggesting such hogwash.

I feel ridiculous admitting it now, but even after more than 25 years as a journalist, even though I worked at a more irreverent newspaper, I strongly believed that our most prestigious outlets believed in seeking the truth. I trusted them. Now, I realized, they were pushing a singular narrative and squelching all other discussion. I was seeing Big Tech censorship of the American media in real time, and it chilled me to my bones.

What happened next was even more chilling. I found out that an “expert” who advised Facebook to censor the piece had a major conflict of interest. Professor Danielle E. Anderson had regularly worked with researchers at the Wuhan Institute of Virology, and even done her own experiments at the institute—and she told Facebook’s fact-checkers that the lab had “strict control and containment measures.”

Well, of course she did.

Facebook’s “fact-checkers” took her at her word. An “expert” had spoken, Wuhan’s lab was deemed secure, and the Post’s story was squashed in the interest of public safety. Zuckerberg’s team wasn’t going to challenge the party line on the pandemic—especially after, as was reported last year, President Biden started pressuring Facebook to censor certain stories about Covid. It was strange to think the suppression of other stories like mine could have come straight from the White House.

Thankfully, the Post won the battle to have Facebook’s “false information” flag removed after a few months. But other outlets didn’t seem to care. In the years that followed, I watched as the elite media happily continued to dismiss the Post as a purveyor of false information on stories like Hunter Biden’s laptop and Joe Biden’s fitness to run the free world. Outlets like Politico, The Washington Post, and The New York Times sneered at the Post as a “far-right” tabloid with a political axe to grind, trying to convince their readers that nothing the paper reports is true.

But these outlets have been grinding their own axe, aided and abetted by Zuckerberg and other tech overlords who wish to decide what we all believe. In 2021, in the wake of a lawsuit, Facebook admitted that its “fact checks” are just “opinion,” used by social media companies to police what we watch and read.

I applaud Zuckerberg for admitting he was wrong and eradicating his fact-checking department. It’s not easy to deliver such a public mea culpa. But still, I wonder how much it will help. Once you’ve shut down a toxic waste dump that’s been poisoning a landfill for years, the ground is never the same.

Margi Conklin is the managing editor of The Free Press, overseeing the editorial team and our investigative reports, features, opinion pieces, and more. Previously, she held various senior roles at the New York Post, including editor of the Sunday edition, managing editor of news features, and features director. She has also worked as an editor at multiple national magazines in both the UK and the U.S., including Elle and Harper’s Bazaar.

https://www.thefp.com/p/facebook-fact-checkers-shut-down-my-story-on-covid-lab-leak-theory