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Sunday, January 7, 2024

AARP Just Told Its 38 Million Members To Get An 8th (Yes, Eighth!!) Shot Of mRNA

 by Alex Berenson via 'Unreported Truths' substack,

AARP? Or AARPfizer?

The lobbying group for older Americans just told its nearly 38 million members to “hustle” for another Covid jab, even if they have already had five boosters.

See for yourself. The following question-and-answer column ran in the organization’s December “AARP Bulletin”:

AARP is open to anyone 50 or older.

The column does not specify a narrower or higher age range for its recommendation.

Thus it implies that even a 50-year-old who has not already had six “Covid boosters” needs to “catch up” with another immediately.

Keep in mind that someone who has had “five Covid boosters” has actually received seven mRNA jabs - the initial two-shot primary vaccination regimen, followed by five boosters.

Thus AARP is suggesting its members should be taking their eighth jab of mRNA in the last three years.

Yet scientists have essentially no safety data beyond a third shot, much less a fourth or more, and thus no way of knowing if the risks of repeated mRNA dosing rise with each shot.

AARP’s unbelievably bad advice doesn’t end there.

The column then goes on to tell members that “the most recent shot, which was released in September 2023, isn’t actually a booster. It’s a new vaccine that targets the latest variants.”

A what-now? A new vaccine?

Wow.

Guess it must have gone through the randomized trials that are required in the United States for any new drug or vaccine.

No?

Let’s just call it a new vaccine anyway, since our elderly readers have gotten kinda suspicious of the failure of the Covid shots they’ve already taken.

But the article ends on a happy note: Researchers are even working on a combined COVID-flu vaccine, so a few years from now, a single shot from your doctor or pharmacy may be all you need to protect yourself fully...

If the side effects from the 23 mRNA jabs you’ve taken by then don’t kill you first!

(No, you shouldn’t. REALLY.)

https://www.zerohedge.com/covid-19/aarp-just-told-its-38-million-members-get-8th-yes-eighth-shot-mrna

Joe Biden: the medications and vacations aren't working

 Poor Joe Biden. He had a hard day at Valley Forge telling us “democracy is on the ballot,” and “I understand power.” No one knows what he meant by that. It was a day so hard he was badly confused thereafter as Fox New reports:  

President Biden appeared perplexed upon his arrival in Delaware following an anti-Trump speech in Blue Bell, Pennsylvania, on Friday.

President Biden garnered the attention of some social media users on Friday after he delivered a speech in Pennsylvania and appeared "confused" landing in Delaware later that evening.

It’s becoming increasingly hard to tell Biden’s normal, daily level of confusion from confusion worthy of more than passing mention.

After delivering the address, first lady Jill Biden quickly approached the podium and hugged the president before taking him by the hand and leading him off the stage. The couple appeared to whisper something to one another, but what [they] said wasn't discernible based on the angles of the main camera.

After embracing his wife, Biden turned back to the mic and spoke over the loudspeakers that had already begun playing exit music.

"I understand power. Thank you all so very much," he said before slowly leaving the stage.

Jill Biden is Joe’s constant companion, particularly when it comes time to guide him off stage in the hope of avoiding more video of him trying to shake hands or speak with invisible people or haplessly stumbling in circles, trying to find a way to exit the stage.

Highlighting the instance in a post to social media, one user noted that Jill Biden helped the president "off the stage following his remarks lest he get confused, and/or lost, or falls."

When he got off the helicopter, his confusion was far above “normal”:


"After two weeks of vacation and a 32-minute speech, Biden is back in Delaware for a weekend respite. He was VERY confused upon landing," RNC Research, an account managed by the Republican National Committee, remarked on X.

Sharing the same clip, conservative commentator Benny Johnson wrote in a post to X, "Biden is lost again."

He’s lost more or less constantly, even after two weeks of vacation keeping him out of the public eye.

Brennan Gorman, an Independent voter, joined "FOX & Friends Weekend" in November and offered his perspective on why he finds Biden's age a problem for not only his campaign, but the entire country.

"I'm absolutely concerned," he said at the time. "He exhibits many issues when it comes to physical and cognitive abilities, but also it's difficult for him to connect with the younger generation. Our electorate is getting younger and younger, and we're electing people who are older and older."

Seventy-six percent of voters agreed Biden is "too old" to serve a second term, compared to just 48% who said the same about Trump, according to the poll.

It’s becoming increasingly obvious the medications Biden is taking to have even an hour or two of relative lucidity aren’t working as well as they once did. Doctors generally don’t diagnose patients they haven’t seen, but Rep. Ronny Jackson (R-TX) has unique qualifications to do just that. He was White House physician for Presidents Obama and Trump:

"I've been saying for quite some time now, when he was candidate Joe Biden, that I didn't think that he had the cognitive ability to do the job," Jackson said on "FOX & Friends."

Jackson emphasized that Biden has "degenerated" over the last three years.

That’s obvious even to non-physicians.

"He's got these people that surround him that are inappropriately encouraging him to continue to run, because it builds up who they are and what they do. But our border, our wars overseas, our economy, you know, it's just a disaster right now. And he just can't do the job. And it's just on display every day that he's not capable of doing this job anymore," Jackson warned.

People like Jill Biden and the Obama retreads handling him. Will Joe Biden withdraw? Considering his public statements about refusing to recognize his age and its limitations, that’s unlikely. Will the Democrat/socialist/communist Party push him aside for…Kamala Harris? That’s unlikely too. As long as they think they can prop him up without him doing little but muttering and drooling, they’ll run a second basement campaign. They have their mummified meat puppet. They don’t need another…yet. They also realize Kamala Harris is even more unpopular than Biden, but pushing aside a semi-black woman would cripple their voting base, an impossibility for a party based on identity politics. Another problem is Harris won’t read briefing books or listen to handlers. She really seems to believe she’s on top of things.

Hang on for a wild, and potentially destructive, ride from now until the election and beyond.

https://www.americanthinker.com/blog/2024/01/joe_biden_the_medications_and_vacations_arent_working.html 

NH House Passes Bill Banning Genital Transgender Surgery On Children

 by Tom Ozimek via The Epoch Times (emphasis ours),

The New Hampshire House of Representatives has passed a bill that prohibits some transgender surgeries on minors, though the measure falls short of the initial intent of the measure that sought to ban all so-called “gender reassignment” procedures for children.

Twelve Democrats joined nearly all Republicans to pass House Bill 619 by a vote of 199-175 on Jan. 5, in a move that came amid a series of other transgender-related bills that the House voted on earlier in the day.

The bill that passed was a watered-down version of the original proposal, which, if passed as introduced, would have banned giving puberty blockers and cross-sex hormones to children and would have prohibited the surgical removal of breasts in girls who identify as boys.

The current version of the bill prohibits the carrying out of “genital gender reassignment surgery” on anyone under 18 while also banning health care workers from referring minors for such producers to out-of-state facilities.

Genital gender reassignment surgeries are defined in the bill as surgical procedures to alter the genitalia of children who have no sex development disorders or whose genitals are not “malignant,” meaning cancerous or otherwise dangerous to their physical health.

Banned procedures include removal of the penis and testicles or surgically creating a penis from other parts of the body, with the exception of reconstructive surgery to restore normal form and function to tissue affected by physical pathologies like malformation or trauma.

Male circumcision is also exempt from the ban.

The bill now heads to the GOP-controlled Senate and, if it passes there, then to the desk of New Hampshire Gov. Chris Sununu, a Republican.

Reactions and Other Bills

Proponents of the bill argued that children should be protected from irreversible gender reassignment surgeries—especially since there’s not much data about their impact and claimed benefits—while opponents said it goes against parental rights and medical freedom.

Rep. Erica Layon, a Republican and co-sponsor of the bill, said that genital reassignment surgeries should be prohibited—at least until more data is available.

We need to wait,” she said, according to the New Hampshire Bulletin, a local news outlet.

The text of the bill states: “Adolescent genital gender reassignment surgery generally lacks both adequate information for informed consent and involves a high risk of coercion for parental consent when parents believe that they are faced with a choice between their child committing suicide or consenting to their child’s genital gender reassignment surgeries.”

Rep. Jonah Wheeler, a Democrat who voted with most Republicans in favor of the measure, explained his reasoning in a speech ahead of the vote.

This is a question of whether or not you believe children should be able to get an irreversible surgery,” Mr. Wheeler said, per the New Hampshire Bulletin.

“Despite being a liberal who believes in human rights, I do not think that children should be able to get irreversible surgery. So I’ll take all the heat that comes from this,” he added.

Rep. Dan Hynes, a Republican who switched to an Independent, said the bill “goes against parental rights and goes against medical freedom.”

Passage of the genital gender reassignment surgery bill came alongside House votes on other transgender-related measures.

Earlier on Jan. 4, the House voted in favor of House Bill 396, which would allow the state and public schools to differentiate based on sex in “places of intimate privacy” such as bathrooms, as well as in prisons and sports competitions.

Also, the House voted against House Bill 264, which would have allowed people to get a new birth certificate reflecting the gender they identify with without having to get a court order.

Medically Necessary?

A number of mental health and pediatric organizations in the United States and abroad advocate for so-called gender-affirming care, saying that medically transitioning children and adults will alleviate suicidal tendencies.

Professionals often dismiss objections to transitioning children by telling parents that a transgender son or daughter is better than a dead child.

About a half-dozen U.S. federal courts have blocked bans on so-called gender-affirming care for children, which proponents argue is “medically necessary” to lower the likelihood that people suffering from gender dysphoria will commit suicide.

Opponents have pushed back on the claim that transgender procedures reduce suicidality, with a research review in March that purports to be the first ever to evaluate mental health outcomes solely from the standpoint of likelihood of suicide, finding that the results are inconclusive.

That’s in part because most of the underlying research failed to control for the time elapsed after transgender procedures, with the researchers suggesting that people who get such procedures may be subject to an initial “honeymoon period” that evaporates over time as they revert to similar levels of suicidal ideation as before.

“There may be implications for the informed-consent process of gender-affirming treatment given the current lack of methodological robustness of the literature reviewed,” the study authors wrote.

Meanwhile, a recent Finnish study found that mental health issues for people who medically transition continue despite “treatment.”

The need for psychiatric care was greater both before and after medical transitioning compared to a control group, the data showed.

The results of the peer-reviewed study also showed that more individuals are seeking help for gender dysphoria and that it is happening at ever younger ages, with a marked increase in female patients.

Darlene McCormick Sanchez contributed to this report. 

https://www.zerohedge.com/political/new-hampshire-house-passes-bill-banning-genital-transgender-surgery-children

FDA ordered to reconsider denial of approval for vape products

 A federal appeals court on Wednesday ordered the U.S. Food and Drug Administration to reconsider its decision barring two makers of flavored liquid for e-cigarettes from marketing their products, saying the agency had been arbitrary and capricious in refusing to consider the companies' marketing plans.

The 9-5 decision by the New Orleans-based 5th U.S. Circuit Court of Appeals reversed a July 2022 decision by a three-judge panel of that court.

Circuit Judge Andrew Oldham, who was appointed to the court by Republican former president Donald Trump, wrote for the majority that the FDA had first asked e-cigarette companies for detailed plans about how they would market their products to prevent abuse by youth, saying those plans were crucial, but then denied their applications without looking at them. He said that fell short of the agency's obligation to "turn square corners," or deal straightforwardly with companies.

"No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people," he wrote, apparently likening executive branch agencies such as the FDA to a separate branch of government. "And FDA's regulatory switcheroos in this case bear no resemblance to square corners."

Eric Heyer, a lawyer for liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make "a significant course correction by communicating with specificity" what companies must do to get approval.

The FDA declined to comment.

The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act, and said manufacturers of the products would need to apply for approval to continue selling them.

It initially considered e-cigarettes as having some promise in helping adult smokers transition from conventional cigarettes, but faced pressure from anti-smoking groups to restrict flavored e-cigarettes amid a rise in youth vaping.


Fatal NYC migrant stabbing was over woman — in tent city filled with armed rivals, split ‘camps'

 The fatal migrant stabbing at the Randall’s Island tent city was over a woman, law-enforcement sources said Sunday — while asylum-seekers described life in the shelter as full of armed rivals and divisive “camps.”

The 24-year-old victim was inside the cafeteria tent at the sprawling shelter around 7:30 p.m. Saturday when he got into a beef with a fellow asylum-seeker who had been talking to the man’s girlfriend, sources told The Post.

During the dispute, the victim was assaulted by four people, sources said. One of the suspects, 26, then whipped out a knife and stabbed the victim in the neck and chest area, sources said.

The victim was rushed to Harlem Hospital, where he was pronounced dead.

Police recovered the knife at the scene and arrested the suspected stabber, while his three accomplices are in the wind, sources said.

Venezuelan immigrant Roger Castillo said of the dead man, “He was a good person, he was a good friend.

“There is not much security, and they are far away,” Castillo said of guards. “It happens so fast.”

A migrant stabbed to death on Randall’s Island was killed after a scuffle over his girlfriend at the site, sources said.Peter Gerber

Migrants at the makeshift shelter, which was erected last year to house the overflow of migrants flooding into the five boroughs from the US border, have been problematic, some asylum-seekers said.

They said some of the migrants around them have split into “camps” based on their ethnicity and native countries, with Hispanics, Africans and Haitians occasionally at odds, while many are armed with knives and typically petty crimes can be rampant.

“Everyone has a knife,” migrant Mauricio Pinto said.

Moroccan migrant Nabil Jajhlaq added, “There is a lot of stealing.

“If you put your phone down or your charger for a moment, they take it immediately. Any of your stuff that you don’t have they will take.

“There is definitely camps,” he said.

New York City officials erected a massive tent city on Randall’s Island to handle the overflow of migrants in the city.Paul Martinka
Migrants at the Randall’s Island tent city said they have broken up into ethnic “camps” — and everyone has a knife.Peter Gerber

The migrants said tensions are high particularly because there is only one cafeteria facility on the site, which forces members of each camp to rub elbows.

The stabbing incident came hours after a rumble at a migrant intake center in the East Village led to two arrests and a pair of cops getting injured when a man tried to cut into the line of 400 asylum-seekers.

The fight broke out around 8:30 a.m. outside the center on East Seventh Street near Tompkins Square Park in Manhattan, after the culprit allegedly spilled coffee on others while cutting the line, witnesses said.

The cops suffered minor knee and facial injuries in the scuffle.

https://nypost.com/2024/01/07/metro/fatal-migrant-stabbing-on-randalls-island-was-over-woman-sources/

Ultragenyx prelims, guidance, updates, milestones

 Preliminary 2023 Total Revenue of $430 million to $435 million, Crysvita® Revenue of $325 million to $330 million and Dojolvi® revenue of $70 million to $71 million

2024 expected Total Revenue guidance between $500 million to $530 million, Crysvita revenue of $375 million to $400 million, and Dojolvi revenue of $75 million to $80 million

Year-end 2023 cash balance of approximately $776 million and 2024 guidance for net cash used in operations expected to be less than $400 million

Ultragenyx will present at the 42ᵗʰ annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 3:00 p.m. PT. The live and archived webcast of the presentation will be accessible from the company’s website at https://ir.ultragenyx.com/events-presentations.

https://www.globenewswire.com/news-release/2024/01/07/2805007/20739/en/Ultragenyx-Reports-Preliminary-2023-Revenue-Guidance-for-2024-Revenue-and-Cash-Usage-Pipeline-Updates-and-2024-Milestones.html

Vertex Pipeline and Business Updates

 -Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced multiple program updates ahead of upcoming investor meetings in January, including the company’s scheduled webcast from the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 11:15 a.m. ET/8:15 a.m. PT.

“2023 was marked by continued strong performance in the cystic fibrosis business and acceleration of our development stage pipeline, propelling the company into 2024 with tremendous momentum," said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “We continue to reach more patients than ever before with our CF medicines; we’ve launched CASGEVY™ in the U.S., UK and Bahrain following the historic approvals of this gene editing therapy late last year, and we are well positioned to advance our mission of bringing additional transformative medicines to people with serious diseases.”

Disease Areas with Approved Medicines

Cystic Fibrosis

  • Next-in-class triple combination: Completed three pivotal studies evaluating the next-in-class, triple combination CFTR modulator therapy vanzacaftor/tezacaftor/deutivacaftor compared to TRIKAFTA® in patients with CF ages 6 years of age and older (ages 12+ in SKYLINE 102 and 103 studies; ages 6-11 in the RIDGELINE study). Vertex expects to share the results of all three studies in early 2024.
  • VX-522: Completed dosing in the single ascending dose (SAD) portion of the Phase 1/2 study of VX-522 in patients with CF and initiated the multiple ascending dose (MAD) portion of the study. VX-522 is a CFTR mRNA therapeutic that Vertex is developing in collaboration with Moderna for the >5,000 patients with CF who do not make any CFTR protein and cannot benefit from CFTR modulators.
  • Epidemiology update: Vertex revised its estimates for the number of patients living with cystic fibrosis from ~88,000 to ~92,000 in the U.S., Europe, Australia, and Canada.

Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT) – CASGEVY

  • Received regulatory approvals for CASGEVY in the fourth quarter of 2023 in the U.S. for sickle cell disease, and in Great Britain and Bahrain for the treatment of both SCD and TDT; also received positive CHMP opinion for CASGEVY for both SCD and TDT from the European Medicines Agency (EMA).
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2024, for CASGEVY in TDT. Additional regulatory submissions for CASGEVY are currently under review in Switzerland and the Kingdom of Saudi Arabia, with submission in Canada planned for the first half of 2024.
  • Completed enrollment in two global Phase 3 studies of CASGEVY in patients 5 to 11 years of age with SCD or TDT.
  • Signed an agreement with Synergie Medication Collective, a medication contracting organization founded by a group of Blue Cross and Blue Shield affiliated companies covering approximately 100 million people, to provide access to CASGEVY.
  • Activated 9 authorized treatment centers (ATCs) in the U.S. and 3 in Europe, with an ultimate goal of activating approximately 50 ATCs in the U.S. and 25 in Europe.
  • Epidemiology update: Vertex revised its estimates for the number of patients living with severe sickle cell disease, from ~25,000 patients to ~30,000 patients in the U.S. and Europe, with additional patients in Bahrain and the Kingdom of Saudi Arabia. Vertex’s updated estimate for patients with transfusion-dependent beta thalassemia is revised from ~7,000 to ~5,000 patients in the U.S. and Europe, with additional patients in Bahrain and the Kingdom of Saudi Arabia.

Pipeline Disease Areas

Acute Pain

  • VX-548: Completed three Phase 3 studies of VX-548 for the treatment of moderate to severe acute pain, including two randomized placebo-controlled studies: one following abdominoplasty and one following bunionectomy surgery, as well as a third single-arm safety and effectiveness study, which enrolled both surgical and non-surgical patients with moderate to severe acute pain. Vertex expects to share the results of all three studies in early 2024.
  • VX-993:
    • Completed a Phase 1 study of an oral formulation of VX-993, a next-generation NaV1.8 inhibitor, and anticipates initiating a Phase 2 study for the treatment of moderate to severe acute pain in 2024.
    • Vertex also anticipates initiating a Phase 1 study of an intravenous formulation of VX-993 for the treatment of moderate to severe acute pain in 2024.

Peripheral Neuropathic Pain (PNP)

  • VX-548:
    • Following the December 2023 release of positive Phase 2 results with VX-548 in diabetic peripheral neuropathy, which represents ~20% of peripheral neuropathic pain patients, Vertex plans to meet with regulators in the first quarter of 2024 and anticipates advancing VX-548 into pivotal development.
    • Initiated a Phase 2 study of VX-548 in lumbosacral radiculopathy, another type of peripheral neuropathic pain and the largest patient segment (over 40%) within the PNP category.
  • VX-993: Vertex also anticipates initiating a Phase 2 study with an oral formulation of VX-993 for the treatment of PNP in 2024.

APOL1-Mediated Kidney Disease (AMKD) – Inaxaplin (VX-147)

  • Completed enrollment in the Phase 2B dose-ranging portion of the study of inaxaplin for the treatment of patients with AMKD.
  • Vertex expects to select the inaxaplin dose for the Phase 3 portion of the Phase 2/3 pivotal trial and begin Phase 3 in the first quarter of 2024.

Type 1 Diabetes (T1D)

  • VX-880: Completed enrollment in Parts A, B, and C of the Phase 1/2 study of VX-880, an allogeneic, stem cell-derived, fully differentiated, insulin-producing islet cell therapy, used in conjunction with standard immunosuppression, in patients with T1D and impaired awareness of hypoglycemia and recurrent hypoglycemic events.
    • Efficacy:
      • As of the last data cut, all 14 patients dosed with VX-880 demonstrated islet cell engraftment and production of endogenous insulin.
      • All Part A and B patients, except for one patient who withdrew consent from the study, demonstrated glycemic control to target ADA recommended levels with HbA1C <7% and no longer required exogenous insulin. Part C patients have trajectories similar to Part A and B patients.
    • Safety:
      • The safety profile of VX-880 to date is consistent with immunosuppressives, the perioperative period and past medical history.
      • Two patient deaths, both unrelated to VX-880, have occurred. Vertex has placed the study on a protocol-specified pause, pending review of the totality of the data by the independent data monitoring committee and global regulators.
  • VX-264: The clinical trial for VX-264, which encapsulates the same VX-880 cells in a device that is designed to eliminate the need for immunosuppressants, is a multi-part, Phase 1/2 study.
    • Part A has initiated, enrolled and dosed multiple patients.
    • The study remains ongoing in multiple centers and countries as Vertex prepares for Part B initiation.

Myotonic Dystrophy Type 1 (DM1) – VX-670

  • Received clearances from Health Canada and Medicines and Healthcare Products Regulatory Agency (MHRA – UK) for Clinical Trial Applications (CTA) for VX-670 for patients with DM1. Vertex initiated the Phase 1/2 clinical trial in patients with DM1 in Canada and will initiate the study in the UK near-term.
  • Vertex also submitted an Investigational New Drug (IND) application to the FDA for VX-670. The FDA requested additional information, which resulted in a clinical hold. Vertex is working to address FDA comments and initiate the study in the U.S.
  • VX-670 is an oligonucleotide that targets the underlying cause of DM1, linked to a cyclic peptide that promotes effective delivery into cells. DM1 is the most prevalent muscular dystrophy in adults with ~110,000 people living with the disease in the U.S. and Europe.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) – VX-407

  • Completed IND-enabling studies of VX-407 for the treatment of ADPKD and anticipates beginning a Phase 1 clinical trial in healthy volunteers this year.
  • VX-407 is a first-in-class small molecule corrector that targets the underlying cause of ADPKD in a subset of patients with responsive PKD1 mutations, estimated at ~25,000 (or ~10%) of the overall ~250,000 ADPKD patient population. ADPKD is the most commonly inherited kidney disease.

J.P. Morgan Healthcare Conference Presentation and Webcast

Dr. Kewalramani will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 11:15 a.m. ET/8:15 a.m. PT.

A live webcast of management's remarks will be available through the Vertex website, www.vrtx.com, in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company's website.

https://www.businesswire.com/news/home/20240107188174/en/