(Reuters) - The European Medicines Agency (EMA) is investigating Novo Nordisk's diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland's health regulator flagged three cases of patients thinking about suicide or self-harm.
Shares of the Danish drugmaker fell 1% on Monday following the news.
An EMA safety committee is looking into adverse events raised by the Icelandic Medicines Agency, including two cases of suicidal thoughts in those who used Ozempic, which contains the active ingredient semaglutide, and Saxenda, the regulator said.
Another patient on Saxenda, Novo's earlier and less effective weight-loss drug that contains the active ingredient liraglutide, reported thoughts of self-injury, the agency said.
Iceland's drugs regulator did not immediately respond to requests for details.
Novo Nordisk said patient safety was top priority and it treated all reports about adverse events very seriously. Its own safety monitoring so far found no "causal association" between the self-harming thoughts and the drugs, it said in a statement.
The EMA's investigation centres on medicines that contain either semaglutide or liraglutide. Novo's obesity treatment Wegovy, for which demand has surged in the United States, contains semaglutide.
The review was announced weeks after the regulator raised a thyroid cancer safety signal, a means to monitor potentially adverse effects, on several of Novo's products containing semaglutide.
Suicidal thoughts are not listed as a side effect in the EU product information for either drug.
In the United States, however, prescribing instructions for Wegovy recommend that patients are monitored for suicidal thoughts or behaviour.
According to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard, there have been at least 60 reports of suicidal ideation since 2018 from patients on semaglutide or their health care providers.
FAERS has received at least 70 such reports since 2010 from users of liraglutide or their health care providers.
Information in these reports has not been verified and the existence of a report is not proof of causation, the FDA says.
The FDA said it monitors safety of drugs throughout their life cycle. Wegovy's trials did not suggest increased risk of suicidal behavior, but the drug's label contains a warning for suicidal behavior and ideation because of risks associated with other weight management drugs, the regulator said.
SENSITIVE
Although Iceland's regulator has flagged only three cases, the issue of suicidal thoughts linked to weight-loss drugs is sensitive and has hobbled previous attempts by the drug industry to develop lucrative weight-loss drugs.
In clinical trials for Ozempic and Saxenda, Novo excluded people with a history of psychiatric disorders or recent suicidal behavior.
Sanofi's Acomplia, which never won U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts.
Acomplia was designed to modify parts of the nervous system that regulate appetite. New weight-loss drugs such as Wegovy regulate appetite by mimicking a gut hormone, and not directly interfering with brain chemistry.
Diet pills Contrave by Orexigen Therapeutics and Qsymia by Vivus Inc, approved in the U.S. in 2014 and 2012, respectively, carry warnings on their labels about increased risk of suicidal thoughts.
Markus Manns, senior portfolio manager at Union Investment and a Novo shareholder, said that a low incidence of suicidal thoughts might be acceptable for a drug against Type 2 diabetes but not for a weight-loss drug.
The EMA said on Monday it would consider whether the review should be extended to other medicines of the same class, known as GLP-1 receptor agonists.
The EMA's ongoing thyroid cancer investigation includes all GLP-1s.
Other drugs in the class include Eli Lilly and Co's Mounjaro. Lilly did not respond to a question from Reuters on whether the EMA had contacted them to provide data for the new investigation.
Penny Ward, a visiting professor in pharmaceutical medicine at Kings College in London and an expert on EU drug safety monitoring, said the most likely outcome of the investigation would be a change in the drug's label in the EU to carry a warning of the possible side effect of suicidal thoughts.
Another drug safety expert, who spoke on condition of anonymity, said the small size of Iceland's population might have led regulators to consider only a few adverse event cases were a significant proportion and worth investigating.
(Reporting by Ludwig Burger in Frankfurt and Maggie Fick in London; Additional reporting by Bhanvi Satija in Bengaluru, Michael Erman and Patrick Wingrove in New York, Robin Respaut in San Francisco, Louise Breusch Rasmussen in Copenhagen and Jennifer Rigby in London; Editing by Savio D'Souza, Nivedita Bhattacharjee, Sriraj Kalluvila and Barbara Lewis)
There are other alternative articles and podcasts regarding this remarkable drug...listen here:
Inhaling Pleasant Scents During Sleep Tied to a Dramatic Boost in Cognition
Batya Swift Yasgur MA, LSW
August 08, 2023
Inhaling a pleasant aroma during sleep has been linked to a "dramatic" improvement in memory, early research suggests.
In a small, randomized control trial researchers found that when cognitively normal individuals were exposed to the scent of an essential oil for 2 hours every night over 6 months, they experienced a 226% improvement in memory compared with a control group who received only a trace amount of the diffused scent.
In addition, functional magnetic resonance imaging (fMRI) showed that those in the enriched group had improved functioning of the left uncinate fasciculus, an area of the brain linked to memory and cognition, which typically declines with age.
"To my knowledge, that level of [memory] improvement is far greater than anything that has been reported for healthy older adults and we also found a critical memory pathway in their brains improved to a similar extent relative to unenriched older adults," senior investigator Michael Leon, PhD, professor emeritus, University of California, Irvine, told Medscape Medical News.
The study was published online July 24,2023 in Frontiers of Neuroscience.
The Brain's "Superhighway"
Olfactory enrichment "involves the daily exposure of individuals to multiple odorants" and has been shown in mouse models to improve memory and neurogenesis, the investigators note.
A previous study showed that exposure to individual essential oils for 30 minutes a day over 3 months induced neurogenesis in the olfactory bulb and the hippocampus.
"The olfactory system is the only sense that has a direct 'superhighway' input to the memory centers areas of the brain; all the other senses have to reach those brain areas through what you might call the 'side streets' of the brain, and so consequently, they have much less impact on maintaining the health of those memory centers."
When olfaction is compromised, "the memory centers of the brain start to deteriorate and, conversely, when people are given olfactory enrichment, their memory areas become larger and more functional," he added.
Olfactory dysfunction is the first symptom of Alzheimer's disease (AD) and is also found in virtually all neurological and psychiatric disorders.
"I've counted 68 of them — including anorexia, anxiety, [attention-deficit/hyperactivity disorder], depression, epilepsy and stroke. In fact, by mid-life, your all-cause mortality can be predicted by your ability to smell things," Leon said.
Leon and colleagues previously developed an effective treatment for autismusing environmental enrichment that focused on odor stimulation, along with stimulating other senses. "We then considered the possibility that olfactory enrichment alone might improve brain function.”
Rose, Orange, Eucalyptus…
For the study, the researchers randomly assigned 43 older adults, aged 60 - 85 years, to receive either nightly exposure to essential oil scents delivered via a diffuser (n = 20; mean [SD] age, 70.1 [6.6] years) or to a sham control with only trace amounts of odorants (n = 23; mean age, 69.2 [7.1] years) for a period of 6 months.
The intervention group was exposed to a single odorant, delivered through a diffuser, for 2 hours nightly, rotating through seven pleasant aromas each week. They included rose, orange, eucalyptus, lemon, peppermint, rosemary, and lavender scents.
All participants completed a battery of tests at baseline, including the Mini-Mental State Examination (MMSE), which confirmed normal cognitive functioning. At baseline and after a 6-month follow-up, participants completed the Rey Auditory Verbal Learning Test (RAVLT) as well as three subsets of the Wechsler Adult Intelligence Scale–Third Edition (WAIS-III).
Olfactory system function was assessed using "Sniffin Sticks," allowing the researchers to determine if olfactory enrichment enhanced olfactory performance.
Participants underwent fMRI at baseline and again at 6 months.
Brain imaging results showed a "clear, statistically significant 226% difference between enriched and control older adults in performance on the RAVLT, which evaluates learning and memory (timepoint × group interaction; F = 6.63; P = .02; Cohen's d = 1.08; a "large effect size").
They also found a significant change in the mean diffusivity of the left uncinate fasciculus in the enriched group compared with the controls (timepoint × group interaction; F = 4.39; P = .043; h2p = .101; a "medium-size effect").
The uncinate fasciculus is a "major pathway" connecting the basolateral amygdala and the entorhinal cortex to the prefrontal cortex. This pathway deteriorates in aging and in AD and "has been suggested to play a role in mediating episodic memory, language, socio-emotional processing, and selecting among competing memories during retrieval."
No significant differences were found between the groups in olfactory ability.
Limitations of the study include its small sample size. The investigators hope the findings will "stimulate larger scale clinical trials systematically testing the therapeutic efficacy of olfactory enrichment in treating memory loss in older adults."
Exciting but Preliminary
Commenting for Medscape Medical News, Donald Wilson, PhD, professor of child and adolescent psychiatry and of neuroscience and physiology, the Child Study Center, NYU Langone Medical Center, New York, said that multiple studies have "demonstrated that problems with sense of smell are associated with and sometimes can precede other symptoms for many disorders, including AD, Parkinson's disease, and depression."
Recent work has suggested that this relationship can be "bidirectional" — for example, losing one's sense of smell might promote depression, while depressive disorder might lead to impaired smell, according to Wilson, also director and senior research scientist, the Emotional Brain Institute, Nathan Kline Institute for Psychiatric Research, who wasn't involved with the study.
This "two-way interaction" may raise the possibility that "improving olfaction could impact non-olfactory disorders."
This paper "brings together" previous research findings to show that odors during bedtime can improve some aspects of cognitive function and circuits that are known to be important for memory and cognition — which Wilson called "a very exciting, though relatively preliminary, finding."
A caveat is that several measures of cognitive function were assessed and only one (verbal memory) showed clear improvement.
Nevertheless, there's "very strong interest now in the olfactory and nonolfactory aspects of odor training and this training expands the training possibilities to sleep. This could be a powerful tool for cognitive improvement and/or rescue if follow-up studies support these findings," Wilson said.
Front Neurosci. Published online July 24, 2023. Full text
Speaking our truth may involve risking rejection, but when we allow ourselves to follow the flow of life, we are supported.
As children most of us learn that honesty is better than dishonesty, and we may not question this beyond whether or not to do what we’re told. As adults, however, we can go deeper to examine our choices as investments of energy with predictable risks and returns. When we speak the truth, we affirm what already is. This is like using a paddle when the stream is already moving the same direction. We are already supported by the universe and its energy flow, so we don’t need to exert much energy, leaving more for other pursuits. But dishonesty redirects a portion of our energy against the flow, which requires extra effort. In addition, it creates an alternate reality that requires further energetic input to be maintained. So we can easily see that we are best served when we work with the flow of the universe.
Life is not always clearly defined, so we may find it useful to follow our choices to their logical conclusions. We may feel that little untruths are harmless, but they can be like small cracks that weaken an overall structure over time. Even giving someone a compliment or trying to protect them can create problems later when the alternate reality we’ve created becomes the basis for further actions. Even if the actions that follow are honestly done, the underlying unstable foundation of dishonesty will threaten to topple things eventually. This can lead to further energy being spent on keeping things hidden, working to remember the tales we’ve spun and fearing the consequences of being found out. Life doesn’t need to be this draining, but we can make the choice to free ourselves from the bonds of dishonesty at any time.
Speaking and living our truth may involve risking, among other things, the possibility of rejection. But when we allow ourselves to follow the flow of life, we are supported. We can then use our energy to cultivate physical, emotional, and spiritual well-being and to create our dreams, rather than leaving ourselves too drained to even maintain our existence. Today we can make honesty our choice in every interaction, bringing the nurturing power of the universe’s energy into our lives to bring positive, lasting results.
The Cochrane Library - the gold-standard independent research organization - has been reviewing the use of physical interventions to reduce respiratory illnesses like COVID and influenza since 2010. Here's what their 2023 updated report has to say about medical and surgical masks.
STORY AT-A-GLANCE
Dr. Anthony Fauci is making the media rounds again, saying he hopes people will comply if mask recommendations return
In January 2021, the U.S. Centers for Disease Control and Prevention ordered the wearing of masks on public transportation. A court order issued in mid-April 2022 ultimately blocked enforcement of the order. So, it has now been legally clarified that the CDC cannot mandate anything. They can only make recommendations, which Fauci also recently confirmed
The 2023 Cochrane review of “Physical Interventions to Interrupt or Reduce the Spread of Respiratory Viruses” found masking had no effect on confirmed infection rates. The review also found no difference between medical/surgical masks and N95/P2 respirators
Fauci is still doubling down on masking, saying masks work “on an individual level” even though randomized controlled trials show it makes no difference on the population level
If mask recommendations are renewed this fall, do not comply
From the start of the COVID-19 pandemic, health experts have been unable to unify around a cohesive message about face masks. A virtuoso of contradiction, Dr. Anthony Fauci — then-director of the National Institute of Allergy and Infectious Diseases (NIAID) and a prominent face of the White House COVID-19 response team — publicly flip-flopped on the usefulness and need for masks multiple times.
The First Recommendation Was the Correct One
In January 2020, he said "Americans shouldn’t be wearing masks because they don’t work." This stance was reiterated in March 2020, when he stated1 that "people should not be walking around with masks" because "it’s not providing the perfect protection that people think that it is."
At the time, the U.S. Centers for Disease Control and Prevention and the U.S. Department of Health and Human Services agreed, as did Dr. Amesh Adalja, a Johns Hopkins Public Health expert,2 and Surgeon General Jerome Adams, who took to Twitter urging Americans to stop buying masks, saying they are "NOT effective,"3 and that if worn or handled improperly, face masks might actually increase your risk of infection.4
Logically, only symptomatic individuals and health care workers were urged to wear them. However, by June 2020, universal mask mandates had become the norm and we were told we had to wear them because there may be "asymptomatic super-spreaders" among us — another lie.
By July 2020, Fauci claimed his initial dismissal of face masks had been in error and that he’d downplayed their importance simply to ensure there would be a sufficient supply for health care workers, who need them most.5
Triple Masking and Other IQ Tests
Fast-forward a few weeks, and by the end of July 2020, Fauci went to the next extreme, flouting the recommendation to wear goggles and full face shields in addition to a mask, ostensibly because the mucous membranes of your eyes could potentially serve as entryways for viruses as well.6
This, even though a March 31, 2020, report7 in JAMA Ophthalmology found SARS-CoV-2-positive conjunctival specimens (specimens taken from the eye) in just 5.2% of confirmed COVID-19 patients (two out of 28).
Toward the end of November 2020, the asymptomatic spread narrative was effectively destroyed by the publication of a Chinese study8 involving nearly 9.9 million individuals. It revealed not a single case of COVID-19 could be traced to an asymptomatic individual who had tested positive. Still, the propaganda machine churned on, ignoring the evidence at hand.
Around December 2020, recommendations for double-masking emerged,9 and this trend gained momentum through extensive media coverage as we moved into the first weeks of 2021.10 That two masks would be more effective than one is just "common sense," Fauci told CNBC in January 2021.11
Undeterred by scientific evidence and logic, by the end of January 2021, "experts" started promoting the use of three12,13 or even four14 masks, whether you were symptomatic or not.
The suggestion to self-asphyxiate turned out to be one step too far, however. In the face of public ridicule, other experts encouraged the return to common sense, as impaired respiration can worsen any number of health conditions.
True to form, while promoting the concept of double-masking as recently as January 29, 2021,15 by February 1 that year, Fauci conceded, "There is no data that indicates double-masking is effective," but that "There are many people who feel … if you really want to have an extra little bit of protection, ‘maybe I should put two masks on.’"16 In other words, the suggestion is based on emotion, not actual science.
Fauci also went from promising a mask-free existence once the vaccine rolled out, to insisting that mask-wearing was still necessary after vaccination because vaccine-resistant variants might pop up, to proposing we might need to wear masks every flu season in perpetuity.
The fact is, Fauci knew masks cannot block viruses and that claiming otherwise was unscientific. He told the truth in a private email to a colleague back in February 2020, in which he stated that masks are "not really effective in keeping out viral particles, which are small enough to pass through material."17 Masking people up reinforced the idea that we were living in dangerous times though. It fed people’s fears, and that’s the effect they were after.
Fauci Hopes People Will Mask Up Again
As we head into fall, Fauci is now making the media rounds again, saying he hopes people will comply if mask recommendations return. Why media still believe that people will listen to Fauci is a mystery of its own. In a September 2, 2023, CNN interview, Fauci said:18
"I would hope that if we get to the point that the volume of cases is such and organizations like the CDC recommends — CDC does not mandate anything — recommends that people wear masks, I would hope that people abide by that recommendation ..."
Funny he should say that. Recall the CDC not only mandated but ORDERED the wearing of masks on public transportation in January 2021. However, as noted on the CDC’s website,19 the order became unenforceable due to a court order, issued in mid-April 2022.
Remember that when the CDC renews its mask recommendations. They can’t mandate or order you to do anything. Also remember that Fauci just confirmed the CDC has no authority to do anything but make recommendations.
Gold Standard Science Review Found No Benefit
Cochrane Reviews have long been recognized as the gold standard in evidence-based health care as their analyses look at the whole body of published science, and every few years, reviews are updated to include the latest research findings.
For example, reports on "Physical Interventions to Interrupt or Reduce the Spread of Respiratory Viruses" — which includes mask wearing — were published in 2009,20 2010,21 2011,22 202023 and January 2023.24
During 2020 and most of 2021, mask proponents tried to cast doubt on studies showing that masks had no impact on the spread of respiratory viruses because they weren’t specific to COVID-19.25
This was actually irrelevant because masks cannot block viruses that are much smaller than the gaps in the fabric, and SARS-CoV-2 is even smaller than the flu virus. Still, the lack of COVID-specific trials kept the counterarguments going. That all changed in January 2023 however. By then, COVID-specific mask trials had been conducted, and all were included in the Cochrane Library’s systematic review.26
In all, the 2023 update added 11 new randomized controlled trials (RTCs) and cluster-RCTs to their previous 2020 analysis, bringing the total number of RCTs to 78. Six of the 11 were conducted during the COVID pandemic, and three looked at the spread of COVID-19 specifically.
Yet, as in previous reviews, there was no evidence to support mask wearing. The SARS-CoV-2 virus, it turns out, behaves just like other influenza viruses and easily penetrates these barriers. As noted by the authors:27
"Medical or surgical masks — Ten studies took place in the community, and two studies in healthcare workers.
Compared with wearing no mask in the community studies only, wearing a mask may make little to no difference in how many people caught a flu-like illness/COVID-like illness (9 studies; 276,917 people); and probably makes little or no difference in how many people have flu/COVID confirmed by a laboratory test (6 studies; 13,919 people)."
Type of Mask Makes No Difference
In summary, the 2023 Cochrane review found that surgical masks did not significantly reduce the risk of flu-like/COVID-like symptoms in the general population. Surgical masks also did not affect the risk of laboratory-confirmed influenza and COVID.
So, masking had no effect on confirmed infection rates (which are more important than self-reported symptoms). The review also found no difference between medical/surgical masks and N95/P2 respirators. So, none of the new studies changed anything. Masks failed to prevent influenza transmission before the pandemic, and they still fail to prevent respiratory infections, including COVID.
By late February 2023, The New York Times even allowed the publication of an opinion piece by conservative columnist Bret Stephens titled, "The Mask Mandates Did Nothing. Will Any Lessons Be Learned?"
"When it comes to the population-level benefits of masking, the verdict is in: Mask mandates were a bust," Stephens wrote. "Those skeptics who were furiously mocked as cranks and occasionally censored as ‘misinformers’ for opposing mandates were right. The mainstream experts and pundits who supported mandates were wrong.
In a better world, it would behoove the latter group to acknowledge their error, along with its considerable physical,28 psychological,29 pedagogical30 and political31 costs ... The Cochrane report ought to be the final nail in this particular coffin."
CDC Director Made False Statements About Cochrane Review
It has not become the final nail in the coffin, though. In her February 2023 congressional testimony, then-director of the CDC Dr. Rochelle Walensky doubled down on the CDC’s mask orders, arguing that the Cochrane analysis only relied on a "small number" of COVID-specific trials — as if more would somehow change the results.
It’s rare to be able to say that science has conclusively shown something to be true, but we’re as close as we can get to absolutes when it comes to mask wearing. On top of that lame argument, she falsely claimed the Cochrane Library editor-in-chief had "retracted the summary of that review,"32 which never happened.33
The editor, Karla Soares-Weiser, did however add a comment to the review stating, "The original Plain Language Summary for this review stated that ‘We are uncertain whether wearing masks or N95/P2 respirators helps to slow the spread of respiratory viruses based on the studies we assessed.’ This wording was open to misinterpretation, for which we apologize."34
But nothing was retracted. The plain language summary states that to this day. Moreover, while Soares-Weiser claimed that interpreting the results as "masks don’t work" was an "inaccurate interpretation," and that an accurate interpretation would be that "the results were inconclusive," the lead author, Dr. Tom Jefferson, insists the findings were unequivocal.
"There is just no evidence that they (masks) make any difference. Full stop," he told investigative journalist Maryanne Demasi.35 And N95 masks are no better. "Makes no difference," Jefferson said.
Did Cochrane Library Editor Succumb to Pressure?
Soares-Weiser added her "apology" to the review after being contacted by New York Times columnist, Zeynep Tufekci, who’d rebuked Jefferson’s statements in a March 10, 2023, article titled "Here’s Why the Science Is Clear that Masks Work."36
"Tufekci argued that despite no high-quality data, we could conclude, based on poor evidence, that masks DO work," Demasi wrote.37 In a September 8, 2023, Substack article, science journalist Paul Thacker added:38
"In my own communication with Cochrane scientists, they find Tufekci’s behavior boorish and unprofessional.39 In retrospect, it’s clear that Tufekci colluded with Cochrane’s Soares-Weiser, who runs the organization, but was not involved in the mask review.
After the two canoodled earlier this year, Soares-Weiser rushed out a public statement to please Tufekci and New York Times editors, but has had to hire the pricey consulting firm Envoy to deal with the fallout and scientists’ concerns over her leadership style.
Scientists have demanded that Soares-Weiser explain why she talked to Tufekci about their review, and published a statement criticizing it, without first consulting them ...
It’s obviously embarrassing to Cochrane that they are now spending money on a consulting firm to clean up the mess Soares-Weiser created with review scientists. Her actions have even caught the attention of Johns Hopkins researcher Marty Makary, who tweeted40 that Cochrane is now caving to political pressure from partisans who want the science to conclude that masks work ...
At the time that Tufekci published her essay, Jefferson sent her editors a letter pointing out numerous errors. The paper chose to ignore this. But Jefferson set the record straight yesterday during an interview with Michael Smerconish, who hosted Jefferson on his radio program.41
Jefferson pointed out in the interview that powerful people in public health, like Anthony Fauci, could have ended all the controversy over mask use by funding large studies to draw more conclusive results on masks.
‘The whole story of the pandemic, since 2020, is that nobody (or very few people) have stepped forward and filled that gap,’ Jefferson said.
Institutions in the United States are now starting to implement mask policies, Jefferson noted, without offering any proof to people that they work. ‘How are they going to justify this?’... ‘We could find no evidence that masks make a difference,’ Jefferson told Smerconish ..."
Smerconish also interviewed Jefferson in a CNN segment, September 9, 2023, asking him point blank, "Do masks work, in your opinion, in stopping the spread of COVID?"
Jefferson pointed out that none of the three COVID-specific trials found a beneficial effect of masking. "It is impossible to show that something DOESN’T work," he added. The science of masking looks at "is it more likely than not" for it to work, "and at the moment, there’s no evidence of that being the case" Jefferson said, adding:
"I can’t tell you if they work or not, but it’s more likely than not that they don’t work."
Fauci, the Science Denier
Smerconish also interviewed Fauci,42 asking him to comment on the Cochrane review’s findings, and Jefferson’s comment to Demasi, that policymakers were basing their mask recommendations on "nonrandomized studies, flawed observational studies."43
Indeed, the primary piece of "evidence" for the CDC’s original mask recommendation was an anecdotal story about two symptomatic hair stylists who interacted with clients while wearing masks in the salon. Of the 67 clients who agreed to be interviewed and tested, none tested positive for SARS-CoV-2, which according to the CDC was evidence that the masks prevented spread of infection in a real-world setting.44
"How do we get beyond the finding of that [2023 Cochrane] review?" Smerconish asked Fauci. Fauci’s response? There are "other studies" that show masks work "at an individual level," Fauci said, adding, "When you’re talking about the effect on the epidemic ... as a whole, the data are less strong."
Of course, Fauci didn’t cite any of the "individual level" studies he’s referring to, but with that comment he basically confirmed Jefferson’s conclusion that decisions were indeed based on nonrandomized studies and flawed observational studies — like the anecdotal hair salon "study" — not gold-standard RTCs.
Despite that, Fauci again doubled down, telling Smerconish "There is no doubt masks work. Different studies give different percentages of advantage of wearing it, but there's no doubt that the weight of the studies … indicate the benefit of wearing masks."45
Jefferson Responds to Fauci’s Comments
At Demasi’s request, Jefferson responded to Fauci’s comments:46
"So, Fauci is saying that masks work for individuals but not at a population level? That simply doesn’t make sense. And he says there are ‘other studies,’ but what studies? He doesn’t name them so I cannot interpret his remarks without knowing what he is referring to.
It might be that Fauci is relying on trash studies. Many of them are observational, some are cross-sectional, and some actually use modelling. That is not strong evidence. Once we excluded such low-quality studies from the review, we concluded there was no evidence that masks reduced transmission."
As mentioned earlier, Fauci went from disparaging mask wearing in January through March 2020, only to make an abrupt about-face weeks later. At the time, he defended his flip-flopping saying, "When facts change, I change my mind." But as Jefferson told Demasi, none of the facts had changed:47
"There were no randomized studies, no new evidence to justify his flip-flop. That’s simply not true ... What Fauci doesn't understand is that cloth and surgical masks cannot stop viruses because viruses are too small and they still get through."48,49,50
In conclusion, Demasi writes:51
"As it stands, the Cochrane review will continue to be the subject of attacks because it presents a major roadblock for implementing masking policies. Jefferson says he doesn’t know what motivates people to ignore the facts.
‘Could it be part of this whole agenda to control people’s behavior? Perhaps,’ he speculated. ‘What I do know ... is that Fauci was in a position to run a trial, he could have randomized two regions to wear masks or not. But he didn’t and that’s unforgivable.”
Mask Harms Revealed
While we have no evidence showing masks prevent the spread of COVID, we do have evidence showing mask wearing can cause harm. For example, in its December 2020 interim guidance on masks,52 the WHO noted that mask disadvantages included "a false sense of security," and that:
"Several studies have demonstrated statistically significant deleterious effects [of masks] on various cardiopulmonary physiologic parameters during mild to moderate exercise in healthy subjects and in those with underlying respiratory diseases."
A German registry of reported effects among children found 68% experienced some sort of impairment, such as irritability, headache, poor concentration, reduced happiness, reluctance to go to school, general malaise, impaired learning and fatigue.53
Other investigations have revealed children are exposed to potentially dangerous elevations in carbon dioxide when wearing a face mask,54 and health care workers who wear masks for six or more hours have been found to be at higher risk of respiratory infections due to mask contamination.55 A dozen different volatile and potentially hazardous chemicals have also been identified in medical masks.56
Research57 by German physician Dr. Zacharias Fögen has also linked mask mandates to significantly higher COVID-19 case fatality rates. "These findings suggest that mask use might pose a yet unknown threat to the user instead of protecting them, making mask mandates a debatable epidemiologic intervention," he concluded.
He proposed this as-yet unidentified threat might be related to a phenomenon called the "Foegen effect." The general idea is that breathing through a face mask forces deep re-inhalation of virions, which might make COVID-19 infection more likely and/or more severe. He suspects mask wearing may also exacerbate the effects of long-COVID for the same reason. In addition to the above, prolonged mask wearing has been linked to:58
Facial alkalinization, dehydration and enhanced skin barrier breakdown, which can increase your risk of bacterial infections
Increase in headaches and sweating
Decreased cognitive precision
Medical errors
Interference with social learning in children
Obscured nonverbal communication
Distorted verbal speech
Removal of visual cues, which is detrimental to people with hearing loss
Do Not Comply
In closing, Florida Gov. Ron DeSantis has already vowed to not enforce any federal mask mandates that might come down the pike, and hopefully, other states will follow suit.
But even if they don’t, remember that CDC can only make recommendations. They cannot order you to do anything. At this point, it’s imperative that everyone simply say "no" and peacefully refuse to comply with mask wearing, because it’s impossibly to comply your way out of tyranny, which is what the COVID spectacle has always been about.
