Tucker Carlson: You Are Not Supposed To Notice Psychiatric Drugs Are Driving Young Men Insane

 

FNC's Tucker Carlson asked the question about whether mind-altering SSRI drugs have a connection to the massive increase in mass murders and suicides, particularly among young American men.

"Did it work? Let's see. Over the very same period, the suicide rate in the United States jumped by 35%. Did it work? Well, millions of people got on anti-suicide drugs and we wound up with many more suicides. So, maybe it's not working."

TUCKER CARLSON: They're numbed by the endless psychotropic drugs that are handed out in every school in the country by crackpots posing as counselors and of course, they're angry. They know that their lives will not be better than their parents. They'll be worse. That's all but guaranteed. They know that. They're not that stupid and yet, the authorities in their lives, mostly women, never stops lecturing them about their so-called privilege. You're male. You're privileged. Imagine that. Try to imagine an unhealthier, unhappier life than that.

So, a lot of young men in America are going nuts. Are you surprised? And by the way, a shockingly large number of them have been prescribed psychotropic drugs by their doctors, SSRI or antidepressants and that would include quite a few mass shooters and keep in mind, again, these drugs are meant to prevent crazy behavior and yet there seems to be a connection.

Eric Harris, the columbine killer was on Zoloft and Luvox. A year earlier, a 15-year-old called Kip Kinkel shot his parents and dozens of classmates. He was on Prozac. In 2005, a 16-year-old called Jeff Weise killed his grandfather and ten kids in Minnesota. He was on Prozac, too. So was 27-year-old Steven Kazmierczak who murdered six people at Northern Illinois University. In 2012, you may recall when 25-year-old James Holmes walked into a movie theater and shot 82 people. He was on Zoloft.

The list goes on and on and on and on. It includes the shooter at the Washington Navy Yard in 2013. That would be 34-year-old Aaron Alexis. It also includes Dylan Roof. He's the 21-year-old who shot up the church in Charleston. Now, he was apparently a racist, and we've heard a lot about that. Fine, but we've heard next to nothing about the fact that he was taking SSRIs, he and many, many others. You're not supposed to notice, but some have.

The Journal of Political Psychology once assembled a list of dozens more mass killings, all committed by young people, young men on prescription drugs. So, is there a connection? Well, we don't know definitively. We do know there are a whole lot more of these drugs being taken by kids than ever before and by the entire population. Who's not taking some prescription medication at this point? Between 1991 and 2018, total SSRI prescriptions in the United States rose by more than 3,000%. 3,000%!

3,000% of anything is a massive change. You don't see changes like that, but the point of this change was to make Americans calmer, saner, happier. Take these drugs and your problems will go away. Yes, you will become numb. You will lose part of yourself. You no longer experience deep joy. You'll become part robot, but at least you won't want to kill yourself or harm other people. That was the promise.

3,000%. Did it work? Let's see. Over the very same period, the suicide rate in the United States jumped by 35%. Did it work? Well, millions of people got on anti-suicide drugs and we wound up with many more suicides. So, maybe it's not working. Is it possible it's making the problem worse, you think? Well, let's see. Mass shootings also increased dramatically over the very same period. Here's a chart that shows it. Now the halfwits on Twitter always scream the same thing. Correlation is not causation. All right. Whatever that means, but tell us, halfwits. What is going on exactly? What does that chart mean?

We know that SSRIs are dangerous. It says so right on the label. They increase "the risk of anxiety, agitation, irritability, hostility, aggressiveness, impulsivity and mania." Oh, not a big deal. That's not causation. Then what is it? According to one meta study by the FDA, young people who've been prescribed SSRI have an increased rate of suicide. Oh, wait. More suicides? Weren't they supposed to reduce suicide, but we're getting more suicide? Let's stop right there, but we're not stopping. We're accelerating.

Between 2015 and 2019, the use of SSRI drugs by teens in the United States rose by nearly 40%. So, it's not working? Let's do a whole lot more of it.

This seems like a massive and extremely obvious problem, extremely obvious. People aren't themselves. They're taking drugs that appear to be causing the behavior that drugs are designed to prevent. Why don't they talk about this on TV? Oh, let's see. In 2020, the pharmaceutical industry spent more than $4.5 billion advertising on national television in this country. Now, how much is that? Well, to put it in some context, Pfizer spent more on advertising in 2020 than it did on research and development.

But it wasn't a bad decision. It was a great decision. Pfizer's revenue doubled last year to more than $81 billion. Now, how do they do that? Well, the ad campaign paid off. It helped convince politicians to require the entire population take Pfizer products, products that don't work as advertised, that have killed large numbers of people and whose side effects are indemnified against lawsuits by the United States Congress. That's quite a business model. You might think it could be a subject of a media story, but no. No stories on Pfizer. They're paid to be fanboys of Pfizer. Therefore, they are.

Here's a tweet, for example, from CNBC, which is ostensibly a news organization and we're quoting, "Pfizer is uniquely positioned to advance MRNA, which could be a breakthrough for other infectious diseases, genetic diseases and cancer. (Paid post for Pfizer) #ad." It was on their Twitter account, a news organization. They're admitting it's a paid post for Pfizer. But in CNBC's defense, they're not alone. Pretty much all the news coverage you see in the United States is a paid post for Pfizer.

...

Oh, it's all brought to you by Pfizer. Now, why is that? Because TV channels don't prescribe drugs. Doctors do. So, why would Pfizer, a drug company, be advertising on television? Well, we're not sure the answer. Let's put it this way. Don't hold your breath waiting for CNN or Good Morning America to do a hard-hitting investigative piece on the potential connection between prescription drugs and violence. Probably not going to happen since they sponsor those channels. They're going to keep telling you it's all about guns. It's all about guns.

Does anyone really believe it's all about guns? No one thinks that. If you really thought that guns caused violence, you would, for example, demand far harsher prosecution of gun possession in the cities. That's where most of the shooter’s shootings are taking place, but no one's doing that. Why? Because that's where Democratic voters live. So, there's no chance anyone's going to crack down on them. Instead, politicians are using these tragedies to do what they've always wanted to do, which is disarm their political opponents. Here's someone who's kind of dumb enough to say it out loud. This is the governor of Illinois, J.B. Pritzker.

https://www.realclearpolitics.com/video/2022/07/06/tucker_carlson_are_you_surprised_young_american_men_are_going_nuts.html

ADHD Drugs May Treat Alzheimer's Cognitive Symptoms Effectively

 Drugs with principally noradrenergic action -- including ones prescribed for attention deficit-hyperactivity disorder (ADHD) or to treat hypertension or depression -- may effectively treat cognitive symptoms and apathy in Alzheimer's disease, a systematic review and meta-analysis suggested.

Noradrenergic drugs showed a significant small positive effect on global cognition with a standardized mean difference (SMD) of 0.14 (95% CI 0.03-0.25, P=0.01), according to Michael David, MBBS, PhD, of Imperial College London, and colleagues.

These drugs also showed a large positive effect on apathy (SMD 0.45, 95% CI 0.16-0.73, P=0.002), they reported in the Journal of Neurology, Neurosurgery, and Psychiatry. The effect persisted after removing outliers to account for heterogeneity across studies.

Noradrenergic drugs target noradrenaline, also called norepinephrine, which is predominantly synthesized and released by noradrenergic neurons in the locus coeruleus in the brainstem. A common mechanism is inhibition of noradrenaline reuptake, preventing synaptic clearance and prolonging its effect.

"This analysis shows there's potential for repurposing medication already known to be safe and effective at improving certain symptoms in other patient populations for use in Alzheimer's disease," David told MedPage Today.

"Current Alzheimer's treatments largely focus on boosting the acetylcholine system and have modest effects," David pointed out. "Drugs that work on the noradrenergic system, like the ones in our analysis, have the potential to improve symptoms such as inattentiveness which, in turn, can improve memory and apathy."

"It's known that the area of the brainstem that produces noradrenaline is damaged early in Alzheimer's disease, leading to a low noradrenergic state in some patients," he added. "Adequate and appropriate brain noradrenaline is important in modulating attention, in particular through its action in the prefrontal cortex."

The review included clinical trials published between 1980 and 2021 involving noradrenergic drugs that had been used to potentially improve cognitive or neuropsychiatric symptoms in people with neurodegenerative disease.

Overall, the researchers included 19 randomized controlled trials involving 1,811 participants that focused on noradrenergic drugs in Alzheimer's disease or mild cognitive impairment. Six trials were judged to be good quality; seven were considered fair and six were considered poor. Nine studies involved norepinephrine reuptake inhibitors, with five of them assessing methylphenidate (Ritalin).

In 10 trials, cognition was assessed across 1,300 participants by the Mini-Mental State Examination or Alzheimer's Disease Assessment Scale-Cognitive Subscale. Apathy outcomes were assessed in eight trials and 425 people; these studies often used the Apathy Evaluation Scale or the Neuropsychiatry Inventory-Apathy.

The effect size on global cognition of 0.14 was between that of cholinesterase inhibitors in Alzheimer's disease (SMD 0.38, 95% CI 0.28-41.1) and mild cognitive impairment (SMD 0.06, 95% CI -0.08 to 0.20), David and colleagues noted. The overall pooled effect was not significant for measures of attention.

Pooled data also provided no support for noradrenergic drugs on agitation or general measures of neuropsychiatric symptoms.

"There were limitations to our study," David acknowledged. "Most notably is the fact that the medications included in our analysis work in a variety of ways, and it is not currently clear what mechanism of action is likely to be most effective in this context."

"More trials are needed to confirm these results and established what medications in which patients are most likely to be effective," he said.

In the NorAD clinical trial, researchers are evaluating adjunctive extended-release guanfacine (Intuniv), a drug approved for ADHD in the U.S., versus standard cholinergic treatment in Alzheimer's disease.

"Guanfacine was selected on the basis of promising data on its effects in animal studies and healthy volunteers as well work in other patient groups," Paresh Malhotra, PhD, also of Imperial College London, told MedPage Today.

"Previous studies using guanfacine in Alzheimer's disease had been relatively underpowered and at a relatively low dose," added Malhotra, who is a co-author on the current study and NorAD principal investigator. "We felt there was justification for a powered trial with the modified-release version in combination with standard cholinesterase inhibitors to assess cognition and aspects of attention."

Disclosures

Researchers disclosed funding from the U.K. Medical Research Council, University College London Hospitals' National Institute for Health Research (NIHR) Biomedical Research Centre, the Wellcome Trust, and NIHR Cambridge Biomedical Research Centre.

Malhotra disclosed leading the NIHR-funded NorAD study, with investigational medicinal product provided through a drugs-only grant from Takeda.

Primary Source

Journal of Neurology, Neurosurgery, and Psychiatry

Source Reference: David MCB, et al "Cognitive and neuropsychiatric effects of noradrenergic treatment in Alzheimer's disease: systematic review and meta- analysis" J Neurol Neurosurg Psychiatry 2022; DOI: 10.1136/jnnp-2022-329136.

https://www.medpagetoday.com/neurology/alzheimersdisease/99583

FDA Getting Tougher on Birth Tissue Companies

 The FDA may be getting tougher on birth tissue injection companies, experts in stem cells and regenerative medicine said.

In its most recent warning letter to one such company, Re-Gen Active Lab, FDA stated outright that use of its products for "orthopedic diseases or conditions" would not be considered homologous use of human tissue -- and thus would need to be regulated in the more stringent class of biologics.

"The key is the blunt, 'You can't deploy these products for ortho applications' statement because it's non-homologous use. The FDA is rarely that clear, so this is refreshing," Paul Knoepfler, PhD, a stem cell expert at the University of California Davis, told MedPage Today.

"The language in this warning letter and the multi-year trend of more untitled and warning letters in this specific space suggests the FDA, finally, is moving to shut this down," he added.

Though the Re-Gen Active Labs warning letter was issued in late May, it recently garnered attention when Chris Centeno, MD -- a physician who owns stem cell clinics across the U.S. and who was sued by the FDA about a decade ago over certain stem cell treatments -- posted about it on his blog.

"The FDA this week hopefully put the final nail in this coffin with new language that should make anybody selling these products very nervous," Centeno wrote.

In order to be considered a "361" human tissue product rather than a "351" biologic drug -- which requires more substantial regulation -- a company must show that its product is used the same way in the patient as it is in the donor, and that it's been minimally manipulated.

Centeno noted that previously, FDA warning letters to birth tissue companies were vague, and focused on manufacturers' use of terms such as "cushioning" to promote the appearance of homologous use. But now, he said, the language is much more focused.

In the letter, FDA wrote, "Your products are not intended to perform the same basic function or functions of umbilical cord or amniotic membrane in the recipient as in the donor, such as serving as a conduit (for umbilical cord); or serving as a selective barrier for the movement of nutrients between the external and in utero environment, protecting the fetus from the surrounding maternal environment, and serving as a covering to enclose the fetus and retain fluid in utero (for amniotic membrane)."

The letter also stated that the product fails to meet criteria for minimal manipulation, "because your processing alters the original relevant characteristics of the umbilical cord and/or amniotic membrane related to their utility for reconstruction, repair, or replacement."

Finally, the agency stated specifically that use of the products in orthopedic indications would not be considered homologous use.

Centeno called the new language "epic" on his blog. "This eliminates all orthopedic marketing for these tissues, which is one of their biggest markets."

"If I were a birth tissue company focusing on the orthopedic space, I would either fold up shop or raise tens of millions of dollars for a clinical trial," he wrote.

Centeno said he would expect more warning letters to follow, now that FDA has "very narrowly defined what homologous use is for these products."

FDA's new regenerative medicine guidelines went into effect in May 2021 after a 3.5-year compliance period. While the agency has done "surprisingly little" on stem cell clinics since the regulations took effect, Knoepfler wrote on his blog, "a pattern seems to be emerging of warnings and other actions targeting birth-related cell manufacturers."

He pointed to a February warning letter to Idaho-based Smart Surgical, as well as earlier letters to Utah Cord Bank, Predictive Biotech, and Liveyon.

"I think we'll see more aggressive action in the coming year, but it may continue to be slower than many of us would have hoped," Knoepfler said. "COVID and other issues have really slowed the agency down on the stem cell clinic front."

Leigh Turner, PhD, executive director of the bioethics program at University of California Irvine, agreed that there does appear to be a "general pattern of FDA enforcement activity" aimed at birth tissue companies.

"It looks as though the FDA is investigating and issuing warning letters to a subset of businesses selling non-compliant birth tissue-derived 'stem cell' products," Turner told MedPage Today. "There are many more suppliers and direct-to-consumer clinics still selling such products, and so what I see is a laudable uptick in FDA enforcement activity that is still nowhere close to making a significant dent in what by now is a very large marketplace."

"I hope FDA, FTC, and state Attorney General offices continue to pursue such businesses and get more aggressive in their enforcement actions," Turner added, "because all signs indicate that limited enforcement actions encourage such companies and clinics to proliferate with little fear of being investigated or disciplined in any way."

https://www.medpagetoday.com/special-reports/exclusives/99603

DOJ makes 1,500 arrests in 10 cities during violent crime crackdown

 The Justice Department (DOJ) has made more than 1,500 arrests across 10 cities in the past month as part of an operation to crack down on violent crime, according to a Wednesday news release.

The release says that the U.S. Marshals Service completed a 30-day initiative at the end of last month, called Operation North Star, to arrest sex offenders, “violent criminals” and self-identified gang members. 

The operation prioritized arresting those who used a firearm in their crime or exhibited risk factors associated with violence. The Marshals Service made 230 arrests for homicide and 131 for sexual assault and seized 166 firearms, more than $53,600 in currency and more than 33 kilograms of illegal narcotics, the release states. 

The arrests occurred in Baltimore, Chicago, Houston, Indianapolis, Los Angeles, Memphis, New Orleans, New York City, Philadelphia and Washington, D.C. 

“The Justice Department is committed to doing everything we can to protect our communities from violent crime and end the plague of gun violence,” Attorney General Merrick Garland said in the release.

“Operation North Star reflects the approach we are taking across the Department to work in partnership with law enforcement agencies and communities to identify and hold accountable those responsible for the greatest violence.” 

The release states that the Marshals Service pooled resources and expertise with federal, state and local agencies.

“By partnering with our local and state partners, we are able to hone in on the most dangerous criminals who cause the most harm,” Marshals Service Director Ronald Davis said in the release. 

Some of the arrests noted in the release were a man wanted for homicide after a hit-and-run that killed a 10-year-old girl, a man wanted in connection with a drive-by shooting that injured a seven-year-old girl and a man wanted for two first-degree murder counts stemming from a cold case in 2003.

https://thehill.com/blogs/blog-briefing-room/news/3547819-doj-makes-1500-arrests-in-10-cities-during-violent-crime-crackdown/

Federal agencies warn health sector against North Korean ransomware

 U.S. federal agencies issued a joint advisory on Wednesday regarding North Korean state-sponsored cyber actors using Maui ransomware to target the health sector.

The FBI, the Cybersecurity and Infrastructure Security Agency (CISA) and the Department of the Treasury said that particular ransomware has been used by North Korean government-backed hackers since at least last spring to target health care and public health sector organizations.

“This malicious activity by North Korean state-sponsored cyber actors against the healthcare and public health sector poses a significant risk to organizations of all sizes,” said Eric Goldstein, CISA’s executive assistant director for cybersecurity.

The advisory also provides steps the health sector can take to mitigate and prevent ransomware attacks. Some of the recommendations include regularly installing and updating antivirus and antimalware software, implementing user training programs and phishing exercises, and avoiding using public Wi-Fi networks.

The agencies also discouraged health sector organizations from paying ransoms because doing so does not guarantee the recovery of stolen data. Businesses should instead adopt and improve cybersecurity best practices and report ransomware attacks to law enforcement. 

“The North Korean state-sponsored cyber actors likely assume healthcare organizations are willing to pay ransoms because these organizations provide services that are critical to human life and health,” the advisory said. 

“Because of this assumption, the FBI, CISA, and Treasury assess North Korean state-sponsored actors are likely to continue targeting [health care and public health] sector organizations.”

This is the latest joint advisory related to North Korean government-backed hackers. In April, the same federal agencies warned of increasing cyber threats involving cryptocurrency from a North Korean group.

The agencies said the group targeted various organizations in the cryptocurrency industry such as play-to-earn crypto video games, crypto trading companies and individual holders of valuable non-fungible tokens, often referred to as NFTs. 

The April advisory followed an FBI press release alleging that North Korean hackers were responsible for stealing about $620 million in cryptocurrency in March from Axie Infinity, a virtual video game that uses NFTs.

https://thehill.com/policy/cybersecurity/3547548-federal-agencies-warn-health-sector-against-north-korean-ransomware/

FDA working to allow overseas formula makers to stay in US market

 The Biden administration is working on a plan that will allow foreign manufacturers of infant formula to keep their products on the market in the U.S. long term, the Food and Drug Administration (FDA) announced Wednesday.

The move would diversify the supply chain and is aimed at preventing another situation like the current shortage, which occurred after the country’s largest manufacturing plant was shut down for months over safety concerns.

The FDA since May has allowed overseas manufacturers to temporarily ship their products to the U.S. as a way to ease the shortage.

“For some companies, the agency’s flexibility has resulted in their ability to use a greater breadth of their existing, global manufacturing footprint, creating more resiliency in the U.S. infant formula supply chain and reducing the risk of reliance on too few production facilities supporting the United States,” FDA Commissioner Robert Califf and Susan Mayne, the director of the agency’s Center for Food Safety and Applied Nutrition, said in a statement. 

The agency said it will develop a new framework that will be more streamlined and allow companies to meet U.S. requirements and keep their products on the market past November, when the current enforcement flexibility ends.

The FDA said it will issue further guidance in September to show companies that have already received temporary enforcement discretion how they can meet FDA requirements to continue to supply infant formula to the U.S. 

In the meantime, the FDA said it will provide a single point of contact for any company aiming to enter the U.S. infant formula market and will host meetings with companies that import, sell or distribute formula under the FDA’s temporary policy to help determine what additional steps should be taken to ensure uninterrupted marketing of products.

“The FDA expects that our continued efforts will help infant formula manufacturers who are new entrants to the U.S. market better understand their options to continue producing and supplying formula to the U.S. in the weeks, months and years ahead,” Califf and Mayne said

Just four companies are responsible for about 90 percent of the U.S. formula market. When a manufacturing plant in Michigan operated by Abbott Nutrition was shut down by regulators in February, the effects cascaded down a supply chain already strained because of the pandemic. 

The FDA has come under fire for failing to realize the severity of the problem until it was too late. 

Administration officials have been working to boost existing supply by easing federal import regulations, as well as by reopening Abbott’s plant. The plant reopened June 4 after the company committed to additional sanitizing and safety protocols but closed again less than two weeks later after severe weather caused damage and flooding to the plant.

The company has not said when the facility will resume production and did not respond when asked on Wednesday.

https://thehill.com/policy/healthcare/3547964-fda-working-to-allow-overseas-formula-makers-to-stay-in-us-market/

FDA issues limited authorizations for pharmacists to prescribe Paxlovid

 The Food and Drug Administration (FDA) on Wednesday issued a revision to its emergency use authorization (EUA) for Pfizer’s COVID-19 antiviral Paxlovid that will allow pharmacists to prescribe the treatment with certain limitations.

Under the original EUA from the FDA, only physicians, advanced practice registered nurses and physician assistants were permitted to prescribe Paxlovid to patients. The FDA said in its announcement that state-licensed pharmacists would now be able to prescribe Paxlovid, meaning many more pharmacy locations will now be able to provide coronavirus antivirals to patient sooner.

According to the FDA’s revised authorization, people who have tested positive for COVID-19 and are seeking antiviral treatment should bring pharmacists their “electronic or printed health records less than 12 months old,” “the most recent reports of laboratory blood work” and a list of current medications they are taking so pharmacists can be aware of possible drug interactions.

“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” Cavazzoni said.

The FDA said pharmacists should refer patients for clinical evaluation if there is insufficient evidence to assess renal and hepatic function, potential drug interactions, the need for modification of other drugs or if Paxlovid is determined to not be an appropriate treatment due to potential drug interactions.

The initial exclusion of pharmacists from the providers able to prescribe the antiviral treatment was a point of contention in the White House’s “Test to Treat” initiative, with pharmacists arguing that leaving them out severely limited the initiative’s effectiveness.

While most, if not all, pharmacies have licensed pharmacists on staff, not all locations necessarily have health care providers like physicians and advanced practice registered nurses who can issue prescriptions, leading many patients to experience a delay in obtaining Paxlovid, which must be administered within five days of symptoms onset to be effective.

In many “medical deserts,” pharmacists may be the only health care providers easily accessible to rural residents.

Pharmacists’ organizations argued it was misstep by the Biden administration to exclude pharmacists, as they specialize in understanding drug interactions and risks. Pharmacists had also been included in previous EUAs for COVID-19 treatments, such as for monoclonal antibodies.

In March, around a dozen pharmacy organizations called on the White House to remove limits on prescribing the antiviral.

https://thehill.com/policy/healthcare/3547743-fda-issues-limited-authorizations-for-pharmacists-to-prescribe-paxlovid/