FDA Approved 65 Percent of New Drugs in 2022 Based on a Single Study

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The 21st Century Cures Act (Cures Act), signed into law in December 2016, was created to help accelerate medical product development and “bring new innovations and advances” to patients quicker and more efficiently. Yet some researchers suggest the law is being used to bypass the once rigorous and evidenced-based standards for new drug approvals, allowing novel drugs to flood the market without adequate data and public transparency.

According to a research letter published on August 8 in the Journal of the American Medical Association Network Open (JAMA), 24 of the 37 drugs approved in 2022 by the U.S. Food and Drug Administration (FDA) were based on a single study, with only four drugs having more than three studies to support their approval. . .

According to the research letter, most of the 413 studies evaluating the 37 drugs approved in 2022 were sponsored by the industry—meaning they were manufactured, funded, and analyzed by the company producing the product, seeking FDA approval, and standing to benefit financially from the drug.

Of the studies available for analysis, only 25 percent of study results have been made publicly available, with the results of six percent of those studies published after the FDA had already approved the drug for use.

Furthermore, researchers found that only 55 percent of studies evaluating drugs in 2022 consisted of randomized clinical trials—the “gold standard” of evidence-based medicine—despite the FDA justifying most approvals based on randomized clinical trial data. (Read more from “FDA Approved 65 Percent of New Drugs in 2022 Based on a Single Study” HERE)

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Biden Says He’s Traveled ‘Tens of Thousands of Miles’ Across War Zones

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President Joe Biden claimed Thursday that he traveled “tens of thousands of miles” in war zones while speaking to veterans in Utah.

Biden made the comments during a three-day trip to Arizona, New Mexico and Utah to tout his policy accomplishments, during which he signed an order declaring a national monument around the Grand Canyon Tuesday, barring new uranium mining projects. “There is no difference between having a mental health problem and breaking your arm or your leg,” Biden said.

“No difference. And you should not be worried about, asking for help, any more than you would if you broke your leg. There‘s nothing to be ashamed of in seeking that help,” Biden continued. “Think about this: I don‘t know how many in my tens of thousands of miles that I‘ve traveled through war zones, I don‘t know anybody who would not wonder whether or not what these veterans have seen cause post-traumatic stress — its enormous. It‘s an enormous problem.” (Read more from “Biden Says He’s Traveled ‘Tens of Thousands of Miles’ Across War Zones” HERE)

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Biden Admin’s New Climate Rule Would Cause Rolling Blackouts in Huge Swath of America, Analysis Finds

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Proposed Environmental Protection Agency (EPA) rules regulating carbon dioxide emissions for power plants would lead to blackouts in a large slice of the Midwest and impose costs of nearly $250 billion, according to new analysis by the Center of the American Experiment (CAE).

The EPA’s proposed regulations would require fossil fuel-fired power plants to adopt developing technologies, such as carbon capture and sequestration (CCS) and hydrogen blending, in order to significantly bring down their greenhouse gas emissions over the coming decades. CAE filed comments this week in response to the EPA’s proposals, highlighting in its analysis that the EPA has overestimated the efficacy of wind and solar while exposing the 45 million people living in the area served by the Midcontinent Independent System Operator (MISO) power grid to elevated blackout risks.

The EPA “does not appear to have the expertise necessary to enact such a sweeping regulation on the American power sector,” CAE wrote in its comments.

CAE’s analysis found that the EPA’s modeled MISO grid could result in massive blackouts across the 15 states it serves, with one stress test scenario estimating that nearly one in five MISO-served households would be without power. Additionally, CAE calculated that building up enough capacity to avoid its projected blackouts in the MISO region would cost $246 billion in total by 2055. (Read more from “Biden Admin’s New Climate Rule Would Cause Rolling Blackouts in Huge Swath of America, Analysis Finds” HERE)

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Hunter Biden’s ‘Sugar Brother’ Attorney Could Be on the Hook Next

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Entanglements with President Joe Biden’s embattled son Hunter Biden could potentially bring down high-powered California attorney Kevin Morris — who was recently spotted reportedly smoking a bong on the balcony of his Malibu home.

Morris, a longtime Democrat donor who was best known for throwing money around in Hollywood — helping to broker a licensing deal for “South Park,” among other things — has been linked to Hunter Biden since 2019 in what the New York Post called “more of a bromance than an attorney-client relationship.”

According to the Post’s report, Morris earned a reputation as Hunter’s “Sugar Brother” — in addition to allegedly acting as a “fixer” for the president’s son, Morris may have assisted in marketing and selling some of his paintings and reportedly loaned him the money when he needed to pay back $2 million in federal tax debt.

But his relationship with the younger Biden could potentially get him into trouble with the California State Bar. (Read more from “Hunter Biden’s ‘Sugar Brother’ Attorney Could Be on the Hook Next” HERE)

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Kentucky Gov. Backs Transgender Procedures Linked to Negative Health Outcomes for Children

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Kentucky Governor Andy Beshear has maintained that he doesn’t support sex change surgeries on minors, but that he does support access to other so-called “gender-affirming” treatments, procedures that have been linked to negative health outcomes for children.

The issue has come to the forefront of the Kentucky gubernatorial race with Beshear saying in recent weeks that he doesn’t support transgender surgeries on kids, and that they don’t happen in the commonwealth. He has openly voiced support for non-surgical procedures. In his veto message of a bill banning all transgender procedures, including surgeries, on children, Beshear said that the bill would “cause an increase in suicide among Kentucky’s youth.”

This message is disputed by “detransitioners” and medical associations who say that transgender treatments on minors do not actually help mental health or reduce suicide rates, as well as medical groups that have warned of potential health risks from non-surgical gender procedures.

“There is not a single long term study to demonstrate the safety or efficacy of puberty blockers, cross-sex hormones and surgeries for transgender-believing youth. This means that youth transition is experimental, and therefore, parents cannot provide informed consent, nor can minors assent to these interventions. Moreover, the best long-term evidence we have among adults shows that medical intervention fails to reduce suicide,” the American College of Pediatricians says.

The American College of Pediatricians is a medical association group founded in 2002 that is composed of over 600 physicians and other health care workers across the U.S. “who are dedicated to the well-being of children.” (Read more from “Kentucky Gov. Backs Transgender Procedures Linked to Negative Health Outcomes for Children” HERE)

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FBI Gunned Down Utah Man Accused of Threatening Joe Biden; Who Was Craig Robertson? What We Know About the Armed Trump Supporter Shot Dead in Raid

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By Breitbart. The FBI gunned down a Utah man accused of making death threats against President Joe Biden during a raid on his home on Wednesday morning.

Seventy-five-year-old Craig Deleeuw Robertson was being charged with three counts of interstate threats, threats against the president, and influencing, impeding, and retaliating against federal law enforcement officers by threat, according to a criminal complaint. . .

“PERHAPS UTAH WILL BECOME FAMOUS THIS WEEK AS THE PLACE A SNIPER TOOK OUT BIDEN THE MARXIST,” one of his Facebook posts allegedly read.

“IN MY DREAM I SEE JOE BIDEN’S BODY IN A DARK CORNER OF A DC PARKING GARAGE WITH HIS HEAD SEVERED AND LYING IN A HUGE PUDDLE OF BLOOD. HOORAH,” another post said. . .

The FBI deemed these threats “credible,” and attempted to serve arrest and search warrants at Robertson’s home in Provo, Utah, but ended up shooting and killing him around 6:15 a.m. local time. (Read more from “FBI Gunned Down Utah Man Accused of Threatening Joe Biden” HERE)

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Who Was Craig Robertson? What We Know About the Armed Trump Supporter Shot Dead in Utah FBI Raid

By New York Post. The Utah man shot dead by FBI agents Wednesday morning after making online assassination threats to President Biden and other top Democrats was a staunch Donald Trump supporter, Air Force veteran, Second Amendment advocate and twice-widowed father of three adult children. . .

The registered Republican and self-proclaimed “MAGA Trumper” wrote online Sunday that he heard Biden was coming to Utah so he was digging out his camouflage hunting suit and “cleaning the dust off the M24 sniper rifle.”

Robertson had a collection of firearms that he frequently showed off in photos posted to his social media profiles, where he described himself as an “Air Force Vietnam Era vet, retired welding inspector, gunsmith and woodworker. NRA Life Member, 2A advocate and owner of many AR rifles + many other rifles, shotguns, and handguns.” . . .

Clark said Robertson was an “established icon” in their neighborhood and was often outspoken about his political views.

“He was a boomer, and he was very political and sometimes made off-color jokes … but nothing that indicated it was a threat,” he said, adding that he was “frail of health.” (Read more from “Who Was Craig Robertson? What We Know About the Armed Trump Supporter Shot Dead in Utah FBI Raid” HERE)

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Drug User Cannot Be Barred From Owning Guns, U.S. Court Rules

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A federal appeals court on Wednesday ruled that a decades-old law prohibiting users of illegal drugs from owning firearms was unconstitutional as applied to the case of a marijuana user, the latest fallout from a U.S. Supreme Court ruling last year that expanded gun rights.

A three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals concluded that the federal law violated a Mississippi man’s right to “keep and bear arms” under the U.S. Constitution’s Second Amendment.

The man, Patrick Daniels, had been convicted under that law after law enforcement found a pistol and a semi-automatic rifle in his vehicle during a traffic stop along with marijuana cigarette butts.

The U.S. Drug Enforcement Administration did not administer a drug test, though Daniels admitted he sometimes smoked marijuana, which federal law prohibits. He was sentenced to nearly four years in prison.

While his case was pending, the conservative-majority Supreme Court in June 2022 declared for the first time that the Second Amendment protects an individual’s right to carry a handgun in public for self-defense. (Read more from “Drug User Cannot Be Barred From Owning Guns, U.S. Court Rules” HERE)

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Religious Group Blasts FBI Memo: ‘Unconstitutional Effort to Surveil Catholics’

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A Catholic advocacy group tore into the FBI on Wednesday over revelations that an effort from the bureau’s Richmond, Virginia, office to target certain “traditionalist” Catholics may have been more widespread.

CatholicVote referenced a less redacted version of an FBI document released by the House Judiciary Committee that revealed involvement from the bureau’s Portland and Los Angeles offices in an initiative that had initially appeared isolated to the Richmond office.

“The FBI has finally acknowledged what we have long suspected, namely that FBI efforts to spy on Catholic churches went far beyond a single field office and a so-called rogue agent,” CatholicVote President Brian Burch said in a statement.

Burch added, “Further, these new FBI admissions raise even more questions now about the intent, purpose, and scope of this illegal and unconstitutional effort to surveil Catholics inside of churches across America.”

The document, which was first leaked soon after its internal issuance by the FBI’s Richmond field office in January, functioned as a threat assessment of “radical-traditionalist Catholics.” The FBI determined they made up a “small minority of overall Roman Catholic adherents” and that there existed an “increasingly observed interest” of violent extremists within that particular group of Catholics. (Read more from “Religious Group Blasts FBI Memo: ‘Unconstitutional Effort to Surveil Catholics’” HERE)

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Perverters in Chief: Jill Biden Goes on Grotesque New Mission

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First Lady Jill Biden’s campaign role is to go where the 2024 votes are for her octogenarian husband – and for Democrats that means the symbolic “queer” capital of the world, San Francisco, where she posed last week with a bevy of homosexual drag queens.

Mrs. Biden ventured to the LGBT mecca for an event at Manny’s, a community gathering “space” that boasted on Instagram in a post about her visit as being “unapologetically queer and unapologetically political.”

The Manny’s Instagram post shows Jill Biden posing with what appears to be five drag queens, men dressing up as pretend women. Such “queens” usually come off as crude caricatures mocking the fairer sex. The post’s caption reads: “This photo says it all – San Francisco queens meeting the First Lady of the United States of America in a civic meeting space in the Mission District of my fair city of San Francisco.” . . .

Underneath the Manny’s photo with Mrs. Biden in the Libs of TikTok tweet is another photo from a different pro-LGBT Instagram account (“sweetestmilksf”) showing a drag queen posing with a bunch of young children, along with an adult dressed as the Easter Bunny. In the space of just a few years, establishment Democrats have fully embraced the idea that homosexual drag queens – who in their adult “drag show” performances usually revel in crude sexual humor – are appropriate role models for innocent kids. . .

In June, Mrs. Biden held a Democrat fundraiser at Manny’s. Politico reporter Dustin Gardiner quoted her at the event as saying about the 2024 election: “Remember how hard it was last time? This time, it’s going to be even harder… The fight for freedom doesn’t end. This is the most important election of our lives.”

(Read more from “Perverters in Chief: Jill Biden Goes on Grotesque New Mission” HERE)

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Biden Rips Reporter’s ‘Lousy Question’ About Speakerphone Calls With Hunter

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President Biden insisted Wednesday that he “never talked business with anybody” after his son Hunter’s former business partner Devon Archer told Congress last week that he was on speakerphone during roughly 20 business meetings and even met his son’s foreign patrons at in-person events.

“There’s this testimony now where one of your son’s former business associates is claiming that you were on speakerphone a lot with them, talking business,” Fox News correspondent Peter Doocy told Biden after a wind-power event in New Mexico.

“I never talked business with anybody. I knew you’d have a lousy question,” Biden scoffed.

“Why is that a lousy question?” Doocy asked.

“Because it’s not true,” the president replied as he walked away. (Read more from “Biden Rips Reporter’s ‘Lousy Question’ About Speakerphone Calls With Hunter” HERE)

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