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‘Reckless in the Extreme’: FDA Panel Recommends New RSV Shot for Use in Healthy Infants
By Michael Nevradakis, Ph.D. | The Defender | June 9, 2023
Advisors to the U.S. Food and Drug Administration (FDA) on Thursday recommended approval of AstraZeneca’s new monoclonal antibody, which the drugmaker said is designed to protect infants and toddlers up to age 2 from respiratory syncytial virus (RSV).
The drug, nirsevimab, would be delivered to newborns in a single shot at birth or “just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable,” CNN reported.
Members of the independent committee, which includes several pediatricians, “were enthusiastic about the potential” of the antibody, STAT reported, as was Thomas Triomphe, executive vice president of vaccines at Sanofi, which will market the drug in the U.S.
In a statement, Triomphe said:
“Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact.
“We are encouraged by the advisory committee’s positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden.”
But medical experts interviewed by The Defender raised a number of concerns, including what they said was inadequate safety testing.
“It’s preposterous to give this drug prophylactically, especially without adequate safety testing,” said Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense (CHD).
AstraZeneca reported only 48% efficacy for the drug. And Hooker noted that the “circulating half-life of the antibodies is probably less than one month so the protection would be minimal at best.”
Hooker also commented on the fact that 12 infant deaths were recorded during the clinical trial, which the FDA committee claimed were “unrelated” to the antibody:
“It appears that this vote was meant to bolster uptake and popularity of the RSV vaccines that are now approved for maternal use. The very low rate of effectiveness for such a therapy is troubling as the conservative estimate is below 50%, which is usually a hard metric for drug approval.
“Also, it seems odd that four infants in the trial would die of cardiac arrest — with no information given, it leaves one to wonder why these children would die in such a way. Also, there should be further investigation into the two SIDS [sudden infant death syndrome] deaths that occurred during the trial.”
Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of CHD’s scientific advisory committee, told The Defender,“It is reckless in the extreme to inject very young babies with an inadequately tested monoclonal antibody drug to prevent a condition that for most of them will be no more than a cold.”
Cardiologist Dr. Peter McCullough told The Defender that while monoclonal antibodies are “generally safe” for children, he questioned the benefit of such a treatment for what he called a “mild” infection. He said:
“Monoclonal antibodies are generally safe in children and adults; however, I am concerned broad infant population uptake may disrupt normal thymus and immune system development that easily handle infections such as RSV, influenza, rhinovirus, adenovirus and SARS-CoV-2.
“RSV is a characteristically mild infantile infection easily resolved with conventional nebulizers. I believe nirsevimab would not be clinical-indicated for all infants and likely would be utilized in high-risk babies with congenital heart or lung disease, such as cystic fibrosis, or those with prior thoracotomies for heart surgery, where respiratory mechanics would be compromised.”
The FDA committee’s positive recommendation for nirsevimab, also known as Beyfortus, comes just weeks after the agency approved GlaxoSmithKline Biologicals’ Arexvy, the first-ever RSV vaccine for older adults, and recommended Abrysvo, Pfizer’s RSV vaccine for pregnant women.
According to CNBC, the FDA is expected to make a final decision on nirsevimab in the third quarter of this year.
Nass told The Defender that while the FDA is not obligated to follow the panel’s advice, “it almost always does so.”
FDA: Infant deaths during clinical trial ‘unrelated’ to the treatment
CNBC reported that the FDA review identified no safety concerns with nirsevimab, but also reported that 12 infants died during the trials.
According to CNBC:
“Four died from cardiac disease, two died from gastroenteritis, two died from unknown causes but were likely cases [of] sudden infant death syndrome, one died from a tumor, one died from COVID, one died from a skull fracture, and one died of pneumonia.”
Dr. Melissa Baylor, who according to CNBC is “an FDA official,” said, “Most deaths were due to an underlying disease. None of the deaths appeared to be related to nirsevimab.”
But according to STAT, “There are questions that remain to be answered” about nirsevimab that require “further study.”
For instance, no data are available “about whether giving nirsevimab to a baby whose mother was vaccinated against RSV during pregnancy would give the infant more protection or would be a waste of the product.”
STAT noted that several members of the FDA committee “worried that the dose given in the first year of life might be too small to benefit a baby who was 8 months or older when receiving the injection, depending on the size of the baby.”
Baylor also expressed concerns about how nirsevimab would interact with vaccines in development — such as Pfizer’s Abrysvo — that confer protective antibodies to the fetus by administering the shot to the mother.
CNBC reported that “Other monoclonal antibodies have been associated with serious allergic reactions, skin rashes and other hypersensitivity reactions.”
According to Baylor, the FDA did not identify “any cases of serious allergic reactions in the nirsevimab trials,” while “cases of skin rash and hypersensitivity reactions were low in infants who received the antibody.” She added that cases of such side effects are expected to be observed if the treatment receives FDA approval.
Manish Shroff, AstraZeneca’s head of patient safety, said, “Safety is of utmost importance” to the drugmaker and that it will “keep a close eye” on the safety of nirsevimab via a “global monitoring system,” CNBC reported.
According to Endpoints News, nirsevimab has already received regulatory approval in the EU, U.K. and Canada, but “it has not yet launched in any of those markets.”
According to CNBC, “Nirsevimab is administered as a single injection with the dose depending on the infant’s weight.”
Infants weighing less than 5 kilograms will receive a 50 mg dose for their first RSV season, while those over 5 kilograms will receive a 100 mg injection. Children under age 2 who “remain at risk for severe RSV” in their second season would then receive an additional 200 mg injection of the antibody.
Nirsevimab is not the first monoclonal antibody for RSV. According to STAT, AstraZeneca’s Synagis (palivizumab) is approved in the U.S. and EU, and “protects against infection in high-risk infants.”
According to CNBC, it is intended “only for preterm infants and those with lung and congenital heart conditions that are [at] high risk of severe disease” and is administered monthly, whereas nirsevimab “would be administered to healthy infants.”
Endpoints News reported that “AstraZeneca leads all development and manufacturing activities” for nirsevimab, “while Sanofi is responsible for marketing activities and revenue recognition” — for which the drugmaker paid $129 million “to be part of the collaboration.”
Is RSV really a danger for most infants?
CNBC previously reported that the U.S. “suffered an unusually severe RSV season” this past winter. The New York Times reported on a “tripledemic” involving RSV, flu and COVID-19, “that swamped children’s hospitals and some I.C.U. wards.”
One U.S. county — Orange County, California — declared a local health emergency and issued a proclamation of local emergency in November 2022, citing rising RSV cases among children in the region, and the Biden administration subsequently declared a public health emergency that month.
According to the U.S. Centers for Disease Control and Prevention (CDC), nearly all children are infected with RSV before the age of 2.
While CNBC characterized RSV as a “public health threat” that “kills nearly 100 babies in the United States every year,” Nass questioned the danger it poses to most infants.
In May, Nass wrote that the CDC published a paper on RSV deaths in infants between 2009 and 2021, which found “were only a total of 300 deaths in children less than one year over the 12 years, or 25 on average per year.”
Nass added that the number of injuries that may be caused by vaccines or other treatments during pregnancy “is almost certainly going to outweigh the loss of 25 babies a year from RSV.”
In her remarks to The Defender, Nass drew comparisons with the hepatitis B vaccine for children, saying that adverse effects from the treatment may appear later in childhood and are not likely to be connected to the drug:
“The hepatitis B vaccine, recommended for all children at birth in the US, and received by about 75%, was never tested for babies’ safety — over more than a few days — before the program started, or since.
“Because no one can know what a very young baby will become at birth, it is impossible to attribute a lower IQ, hyperactivity, less nimble limbs or any other problem that shows up later, to an injected drug given shortly after birth. So those connections, if any, are unlikely to be identified.”
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Beware of Studies Concluding Autism is Not Associated with Childhood Vaccination
By Peter A. McCullough, MD, MPH | Courageous Discourse | June 3, 2023
As an epidemiologist, I can tell you it takes considerable training and scholarship to determine whether or not a study is valid and to determine if the conclusions are supported by the data. When it comes to childhood vaccines, the world is becoming skeptical of the vaccine industry since the CDC ACIP panel has added the EUA unsafe, ineffective mRNA COVID-19 vaccines for infants starting at 6 months of age.
With the ever expanding ACIP schedule of vaccine quantity and intensity of injections there has been a skyrocketing rate of autism. This has triggered scientists to go back and look at the studies published at the time to reassure parents that routine vaccines did not cause autism. Because so many shots are given at once, it is probably not any individual product that is the culprit, rather “hyper-vaccination” of a bundle of vaccine products that invokes a neurotropic, cytokine mediated inflammatory reaction that in some causes febrile seizures, autism, and immediate death. There are factors related to susceptibility including older parents and siblings with autism, but it remains that hyper-vaccination is a likely provocateur.
Madsen et al used Danish automated health data to evaluate the association of the MMR at age 15 months and autism. Only 40/422 had charts reviewed to verify the diagnosis of autism. Because it is an important diagnosis, all 422 cases should have been adjudicated by two blinded expert child psychiatrists. This study was unlikely to find an association from the outset since not all the vaccines where considered as a “bundle” and compared to children who went “natural” meaning completely unvaccinated with any product.
Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med. 2002 Nov 7;347(19):1477-82. doi: 10.1056/NEJMoa021134. PMID: 12421889.
To make matters worse, the authors found 18% had missed the MMR at 15 months. That proportion seemed high to me so I checked another source. In 2015-2016 Holt et al performed a chart review and found that 55% of those MMR “unvaccinated” in the Danish system were indeed received the MMR documented in the medical record. Hence the Madsen analysis is invalid since both groups had largely received the MMR shot at age 15 months and there was no reporting of the true control group of interest—completely unvaccinated children.
Holt N, Mygind A, Bro F. Danish MMR vaccination coverage is considerably higher than reported. Dan Med J. 2017 Feb;64(2):A5345. PMID: 28157059.
In studies that are using unadjudicated, automated sources of data, misclassification often biases the results to the null hypothesis making a Type II error, that is, failing to find an association when indeed it is present.
Here is a summary of why Madsen does not rule out MMR or hyper-vaccination as a cause of autism:
- non-randomized study with no true placebo group
- all 442 cases of autism were not adjudicated by at least two independent child psychiatrists to confirm the diagnosis
- Danish automated data due no capture all the MMR vaccinations; some (~55%) of the “unvaccinated” had received the MMR vaccine
- MMR was not considered as part of the multi-injection bundle of hyper-vaccinated children compared to completely natural unvaccinated kids, which is the real control group of interest for autism
A similar paper using the same data sources, nearly identical study design, and equally flawed analysis was published similarly in Annals of Internal Medicine in 2019 (Hviid et al). In summary, we cannot rely on the Madsen or Hviid studies to rule out the MMR as a partial determinant of autism. Moreover, studies that make strong conclusions with such faulty data are suspect for investigator bias—meaning the authors intentionally wanted to rule out the association perhaps to advance the vaccine agenda, appease their institutions or research sponsors, or otherwise wished to be willfully blind to the possibility that childhood hyper-vaccination is a determinant of autism.
FDA admits it has no records indicating covid-19 vaccine safety protocols were followed
By Aaron Siri | ICAN | June 9, 2023
From early in the pandemic, the government has been promising the public that it was taking COVID-19 vaccine safety “very seriously,” and that the vaccines had been subject to “the most intense safety monitoring program in U.S. history.” ICAN likes to confirm these claims for itself but when it tried to do just that, it uncovered that the FDA actually deviated from long-standing protocols concerning vaccine safety.
Since May 9, 2008, the FDA has had vaccine safety procedures in place detailed in a Standard Operating Procedures and Policies (SOPP) document. This document “describes the procedures that the [FDA] staff should routinely follow to coordinate rapid responses to complex vaccine safety issues,” and discusses a Vaccine Safety Team whose “key purpose” is to “coordinate [FDA] rapid responses to vaccine safety issues … and to serve as a resource [] to identify data and policy needs pertaining to vaccine safety.”
One office in the FDA is crucial to this goal and acts as the “official contact for VAERS and is responsible for processing and review of the reports,” as well as “for forwarding those reports to the appropriate contacts within CBER for further action and follow-up.” For example, its staff members identify VAERS adverse event reports that “need a rapid response and complex coordination,” after which they are supposed to “immediately” inform certain FDA management who then alert other sub-agencies.
Given the lofty talk by federal health agencies claiming that COVID vaccines were subject to “the most rigorous – and accurate – review processes globally,” one would think that the FDA, at a minimum, subjected them to at least these already ridiculously weak pre-existing standards for vaccine safety monitoring.
But, after ICAN’s attorneys submitted records requests to the FDA seeking documents on the FDA’s policies concerning the identification of VAERS reports requiring a “rapid response,” as well as documents showing that the FDA had actually followed up on the individual VAERS reports that required a “rapid response,” the FDA replied more than year later with an incredible response: “A search of our records did not locate any documents responsive to your request.”
In a nutshell, the FDA has essentially admitted that it is not following even its own set of already watered-down procedures for vaccine safety monitoring that were in place prior to COVID.
When the curtain is pulled back on the purported “thorough” and “intense” safety monitoring, there is yet again nothing to see. So much for the FDA’s promise to look out for the American people. ICAN will continue to monitor the FDA and share any important updates.
See below for more instances where ICAN uncovered instances where “health” agencies made unsupported claims to the public:
‘Medical Gaslighting’: Physicians Speak Out Against COVID Policies, Call for Reform
By Brenda Baletti, Ph.D. | The Defender | June 5, 2023
The Global Health Project last week released a video titled “The Oath,” in which physicians describe the effect on doctors, patients and the healthcare system of silencing dissent during the COVID-19 pandemic.
The filmmakers also called on doctors to commit to making foundational changes so that what happened during the pandemic never happens again.
The film features six doctors — Elizabeth Lafay, D.O., Steven Klayman, D.C., Timothy Stonesifer, D.O., Molly Rutherford, M.D., MPH, Michael Turner, M.D., and Amy Offutt, M.D. — who said they are “saying what tens of thousands of silenced medical professionals from all over the world have not been able to say.”
Throughout the video, they respond to a series of questions.
Responding to the first question, “When did you begin to have doubts?” they described how they lost faith in institutions such as the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Lancet and the pharmaceutical companies as they saw well-respected doctors silenced, articles retracted and corrupted clinical trials exposed.
It became clear the agencies were not acting in the public interest, Turner said, because “they’re captured, they’re paid off, they’re corrupt.“
In response to the second question, “How have people been harmed?” they discussed spiking levels of anxiety and depression that began with the fearmongering at the start of the pandemic.
Lafay described working in the ER during the early days of the pandemic when the hospitals emptied out and there were few COVID-19 patients — but many people arriving with “horrible, debilitating anxiety and depression.”
People stuck at home in front of the television absorbed the message “Stay home, don’t be with your family, don’t be with your friends. Isolate, hibernate,” Offutt said. “It’s really taken its toll.”
“People are fearful and I think that was the goal, to make people fearful and be forced into taking this vaccine,” Klayman added.
They said many people no longer trust the medical profession because doctors have been silent on what happened and that many doctors felt they could not speak out.
As the names of pharmaceutical giants such as Novartis, Merck, Pfizer, GSK (formerly GlaxoSmithKline), the Bill & Melinda Gates Foundation and others flashed across the screen, Lafay said:
“It’s really tough because we’re all owned at this point. It’s easier for me to come on camera maybe and say some things like this because I am an independent practitioner now. If you don’t have your [own] practice, then you really can’t help people.
“And I think that is where a lot of [practitioners’] fear comes from, the fear of not being employed.”
But there are larger moral issues at stake, too, Klayman said, adding: “Are you going to give in to what is wrong? Or are you going to fight for what is right?”
Offutt said she thought “fixing the broken system” begins with rebuilding the doctor-patient relationship. Doctors used to spend more time with patients, she said, but then, “It became a business, and I was just one of the employees.”
“There is uniformity and conformity that’s encouraged, and the decision-makers at the top usually are not physicians, and this is a big problem, right?” Turner asked. Instead, they are lawyers looking to minimize risk and accountants looking to maximize profits.
When doctors work for these corporations, Lafay said, insurance and pharmaceutical companies are calling the shots:
“We don’t really have a voice anymore. We’re not really making choices that are best for our patients. We’re checking boxes.
“Unless we fight for the doctor-patient relationship and work to maintain privacy and decision-making that is based on an individual patient scenario, then that will be lost. The art of medicine will be gone, and we may as well be replaced by artificial intelligence.”
The doctors said in order to heal, you should “own your health” — eat well, get sunshine, move around, connect in person and to other people.
“I think doctors who maybe did some things that they regret should come out and acknowledge what they did and assure patients that they’re going to learn from it and change,” Rutherford said. “And then I think we need the truth. We need to investigate, why did all of this happen and how can we keep this from ever happening again?”
Turner said people from across the political spectrum and all walks of life are starting to come together around principles such as “accountability, honesty, respect, self-determination, bodily autonomy, freedom.”
“There’s an awakening going on, so it’s exciting and we’re gonna come out the other side,” he said.
The video closes with the oath:
“I solemnly swear to listen to my patients, respect their wishes, and together make the best choices for that individual and to do no harm.”
Video marks launch of Global Health Project
The video release marked the launch of the Global Health Project, an organization hoping to raise awareness of the coercive power exerted on society by global health agencies during the COVID-19 pandemic and to build a movement to create a better system.
The group began as a conversation among physicians and health researchers about what happened during the pandemic and how to make sure it doesn’t happen again, Andrea Nazarenko, Ph.D., a spokesperson for the organization, told The Defender.
The group hopes the video will open the door for conversation, Katarina Lindley, D.O., family physician and another group spokesperson, said.
A doctor might hear the physicians’ stories and say, “That’s exactly how it happened to me,” she said. Or, patients can go to their doctors and raise these issues with them.
Lindley also said that statements by global leaders, the World Health Organization’s proposed pandemic treaty and amendments to the International Health Regulations, and other evidence point to the fact something like the COVID-19 pandemic can happen again, and if it does, the Global Health Project wants to build an informed and connected public. She continued:
“So our hope is that by sharing these stories, by empowering the public as well, we want them to question things … when new things come along. And if they feel in their gut something is wrong, they need to trust their gut, then they really become advocates for themselves, for their family, for their friends.
“And I’m hoping that physicians will remember why they took the Hippocratic oath … And there’s lots of things that we need to start questioning that maybe we didn’t question before.”
While the changes they are talking about are systemic, Lindley said it starts in the doctor-patient relationship.
When someone’s car breaks down, she said, they usually try to find a good mechanic by asking friends and shopping around.
“I think when it comes to medicine and healthcare, we kind of almost need to do the same thing. Shop around … interview your doctor. Even if you have insurance and you’re assigned to a doctor, you don’t have to accept the doctor.”
People can find doctors who are independent, who have “stepped away from the matrix, as I call it,” Lindley said, so they can build great relationships with patients.
Nazarenko added:
“Ultimately, what we experienced during the pandemic was traumatic. We are suffering from collective trauma at a societal level. Just like any other trauma, this trauma will not disappear by ‘moving on’ and ‘forgetting about it.’ Trauma must be processed.
“Unfortunately, what we are facing right now is the mainstream narrative telling us to ‘forget about it,’ to ‘just move on,’ and to ignore our feelings (‘just let it go’). This is medical gaslighting at a population level. In any other relationship, we would identify this as the behavior of an abuser.
“If we want to move on and create a world of togetherness, we need to talk about it. We don’t all need to agree on everything — but we need to have the conversation.
“Silence leaves us vulnerable to this happening again. They separated us for a reason. This video is about bringing people together again and engaging in authentic conversations.”
Watch here:
Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Deaths from the flu – do not seek and ye shall not find
By Professor Martin Neil | TCW Defending Freedom | June 7, 2023
The flu vanished from the UK in the winter of 2020/21 and did not return for another year, as I wrote in TCW here. The official reason is that the novel and deadly SARS-CoV-2 virus ‘outcompeted’ flu and replaced it as a primary cause of death during that time. However there appears to have been a collective and systemic failure in flu surveillance and flu death reporting systems in the UK during 2020 and into 2021. Thus, it is possible that the failure to detect and report flu (and deaths recorded as due to it) may better explain the mystery of vanishing flu rather than viral interference from SARS-Cov-2.
A mix of surveillance systems consistently reported on flu before 2020 and continued to have some role to play post-spring 2020 until flu returned at the end of 2021. In the UK, flu surveillance is performed via clinical surveillance by primary care (based on networks of GPs), the FluDetector and the FluSurvey systems.
Credence has been given to the idea of tracking pandemics using machine learning via Google Trends data, the UK’s FluDetector system being one such system. FluDetector reported that flu disappeared in 2020/21, yet this is totally at odds with Google’s own data and UKHSA reports, both of which report a clear signal for flu in the UK in 2020/21. What the Google data does show is that people were concerned enough about flu that they searched for flu on the internet in significant numbers, even when apparently in the middle of a deadly pandemic caused by SARS-CoV-2, a virus they were told was more novel and more deadly than the flu. It is also notable that the number of searches for flu in 2020 were not significantly different from those conducted in previous years in the UK.
The UK FluSurvey system was originally conceived to survey a panel of self-selecting participants for signs and symptoms of influenza-like illnesses (ILIs). In March 2020 it was repurposed to cover both Covid-19 and flu symptoms, and the routine questionnaire was adapted to capture Covid-19 specific information. The FluSurvey system tracked ILI incidence only until week 20 of 2020, and never updated this data. It was decided no longer to track both flu and Covid from November 2020 but report this change in policy only in January 2021. The FluSurvey then stated it (presciently) knew in January 2021 that the flu season had now begun and did so after (supposedly) witnessing the near eradication of flu from March 2020 to May 2020. Fever and cough symptoms were still tracked and peaked in the same way as in previous years and this continued, but tracking ILI incidence was abandoned, thus reducing the strength of the flu signal.
The Office for National Statistics (ONS) have a legal duty to report mortality statistics for each year. The 2020 statistics for England and Wales exclude any report on influenza and pneumonia deaths, and instead are wholly focused on deaths ‘involving’ Covid-19. In contrast, their 2021 statistics report on influenza and pneumonia deaths, starting on January 8. So, for 2020 any reporting of flu deaths was completely abandoned in favour of Covid-19 reports, and flu is included only in surveillance reports from 2021, thus giving the impression flu had disappeared in the intervening period.
In response to a freedom of information request about flu in 2020 the ONS obfuscated its answer by using a different death code, ‘respiratory disease’ rather than flu, for the period up to May 2020, and may have done so to hide the deaths that should have been attributed to flu. This FoI request shows that there were 2,287 flu deaths in March 2020, which is not greatly different from the 3,324 Covid-19 deaths that same month; yet SARS-CoV-2 was considered to be a significantly greater threat to public health. Furthermore, in January 2021 the ONS reported that there were almost as many deaths involving flu (5,719) as there were involving Cc
Evidence for the presence of flu is available from other data sources. Data for pneumonia and flu deaths can be extracted from the UK NOMIS (official census and labour market statistics) system. When we queried this system, we were quite shocked to find that it returns 20,130 influenza and pneumonia deaths for 2020, at a rate consistent with previous years (eg 26,342 in 2019). The presence of flu deaths in 2020 in the UK is repeated elsewhere. In the US, influenza and pneumonia numbers are similar in 2020 to previous years, as reported by the CDC, with 53,544 deaths in 2020 compared with between approximately 50-60k deaths in each year from 2015 to 2019.
Despite these facts, the WHO’s international flu surveillance system, FluNet, shows no significant flu for 2020/21 in either the UK or US.
The fact that these failures cut across all parts which comprise the UK flu surveillance and reporting system suggests that this failure is not coincidental, as do the observed inconsistencies in changing patterns of flu surveillance and reporting across different branches of UK public health.
In a previous article we pointed out the dearth of virological evidence for viral interference causing SARS-CoV-2 to ‘outcompete’ flu. These new findings relating to reporting systems also strongly suggest that viral interference between SARS-CoV-2 and the flu is a myth. Flu was present in 2020 and some of the respiratory deaths attributed solely to SAR-CoV-2 may have also involved flu in some significant way.
This is based on an original article co-authored with Professor Norman Fenton, Nick Hudson and Jonathan Engler. The extended version is available from the substack Where are the Numbers?
Mayo Clinic Suspended Professor Over Comments On Covid And Transgenderism
By Ben Squires | Reclaim The Net | June 8, 2023
The Mayo Clinic College of Medicine and Science suspended a professor for deviating from “prescribed messaging” and placed a gag order on him, Foundation For Individual Rights and Expression (FIRE) says. The college handed down the punishment despite its free speech promise to faculty and students.
On March 5, professor Michael Joyner was suspended without pay for speaking to the press, which is common for him as he is a prominent academic.
After he commented about plasma treatment for Covid and transgender sports performance on The New York Times, CNN, and other outlets, Mayo Clinic said he “failed to communicate in accordance with prescribed messaging.”
Administrators said that “reflect[ed] poorly on Mayo Clinic’s brand and reputation” and led them to “question whether … [he is] able to appropriately represent Mayo Clinic in media interactions.”
However, Joyner did not speak on behalf of the college, he spoke for himself. In letters to the college, FIRE explained that faculty members have the right to speak as private citizens.
After suspending him without pay, Joyner was told he must vet “each individual media request through Public Affairs … [to] determine what topics are appropriate and are responsible for protecting Mayo Clinic’s brand and reputation” and cease “engagement in offline conversations with reporters.”
In simpler terms, he was told to shut up. When he does speak, he must discuss “approved topics only and stick to prescribed messaging.”
Mayo Clinic is in violation of the institution’s Freedom of Expression and Academic Freedom Policy, which promises “academic freedom and freedom of expression for all learners and faculty … which includes the right to discuss and present scholarly opinions and conclusions without fear of retribution or retaliation” even “if those opinions and conclusions conflict with those of the faculty or institution.”
In response to a letter from FIRE about upholding free speech and academic freedom, Mayo Clinic said disciplinary “action taken against Dr. Joyner did not involve a gag order and did not violate our academic freedom policy.”
Querying the existence of a covid ‘pandemic’
Health Advisory & Recovery Team | June 6, 2023
Covid-19 has been described as a global pandemic but does this title give it a severity and indeed fear factor way beyond its actual impact?
The word pandemic used to have a very specific meaning. It was used to describe a scenario where there was extensive incapacitation of key workers and large numbers of deaths, including young people. A genuine pandemic is not something that would have needed billions of dollars in advertising for people to even notice and fear. Using this long-established definition of the word, we conclude that there was in fact no global pandemic in 2020. The word was deliberately misapplied and weaponised against an unsuspecting public. Let us be clear, this article is not questioning the existence of a virus SARS-CoV-2 or an illness named Covid-19, but even the choice of ‘SARS’ (Severe Acquired Respiratory Syndrome) as the name for this coronavirus was already setting the scene for systematic fear-mongering.
The notion of a ‘pandemic’ was relentlessly promulgated through mainstream media to ramp up fear in the population, to help enforce unprecedented lockdowns and other extremely harmful policies (e.g school closures and universal mask wearing) and to push through Emergency Use Authorisations of novel technology mRNA and viral vector DNA products.
This would not have been possible were it not for three false premises that covid was:
- novel;
- extremely lethal; and
- unprecedented.
It was none of these things. It was no more novel than numerous other viruses which emerge each year in terms of the ability to be recognised by our immune systems. It was no more lethal than bad influenza viruses of the past and was less lethal than seasonal influenza for the young. Intensive care stays were longer than have been observed with flu, though whether that was due to a virus directly or caused by our changed response to how we treated respiratory infections is unclear. Overall it was a treatable, seasonal respiratory virus mostly affecting the old and infirm.
HART has written previously on how similar the mortality was to the bad influenza winter of the year 2000. The mortality data for 2020 is unremarkable globally when compared to previous influenza seasons except perhaps in New York City and Northern Italy. In both of these outliers, the data emerging is raising uncomfortable questions about the relative contribution of the virus versus the impact of policy-related responses when considering the extraordinary number of deaths reported. In spite of these outliers, global mortality data shows no evidence of a global pandemic. It could be argued that a once in every 20 year event should not be minimised, but nor does it justify an all of society emergency response or the institution of a permanent biosecurity surveillance state.
Figure 1 showing ONS crude mortality rates since 1840
Without the highly flawed PCR case data and draconian global restrictions on doctors’ freedom to treat their patients as they saw fit, there would be nothing particularly notable about this year. Outside of PCR driven data, a small rise in the number of calls to ambulances for breathing difficulties was observed, though it is possible that hysteria and fear may be responsible for at least part of this. We might have noticed an unusually late spike in influenza-like illness but not much more. Mortality-wise, it would appear as a mid-range ‘bad flu’ year. It is worth reading the work of Professor Denis Rancourt on mortality data, who has been pointing out this inconvenient truth since early 2021.1,2
Interestingly, the WHO quietly altered the accepted definition of ‘pandemic’ in 2009, just before the so-called H1N1 ‘pandemic’. The rushed-to-market Pandemrix vaccine which was pushed hard in the face of the imaginary ‘pandemic’ was subsequently pulled from the market due to life-changing side effects (often in children), a signal picked first up in Finland but later found elsewhere.
In essence, they used exactly the same playbook in 2020, but seemed to have ironed out some of the ‘problems’ encountered the first time round. Vicious behavioural psychology tactics were the main tools used to ‘correct’ these ‘problems’. Shaming people into believing they may ‘kill granny’ was a master-stroke. They used guilt, shame and the threat of ostracism, these being some of the most powerful drivers of human behaviour. There was even an identical cast of characters; Fauci, Drosten and Gates, all reporting for duty, aided and abetted by the bought and paid for media machine working on 24 hour overdrive.
In 2003, an influenza pandemic was defined as follows:
“An influenza pandemic occurs when a new influenza virus appears against which the human population has no immunity, resulting in several simultaneous epidemics worldwide with enormous numbers of deaths and illness.”
In 2009, the WHO decided, in their infinite wisdom, to get rid of the words “enormous numbers of deaths and illness.” from the definition. You would think deaths and serious illness were the only meaningful characteristics of a ‘deadly pandemic’.
To successfully fight against the globalist mission creep of tyrannical public health measures, we must collectively stop stoking the ‘deadly pandemic’ fire. If we continue to allow this falsehood to embed in public consciousness, all of the unethical horrors enacted will simply be repeated for the next non-pandemic-pandemic.
Without the requirement for excess deaths and widespread serious illness, malevolent profit-driven interests can simply will a ‘pandemic’ into existence on finding any new mutation amongst the global virus population. A strategy to force countries to invest heavily in searching for genetic anomalies will fuel the pandemic creation industry. Once one is found, the response can be fuelled by using fraudulent test data and media advertising, as they did very successfully in 2020. We cannot allow this to happen again and must therefore reclaim the word ‘pandemic’ to ensure it is only applied in the correct way.
We expect a reflexive objection to this article from some quarters on the basis that the case has not been adequately argued that covid had minimal impact on overall mortality in 2020. This fact is irrelevant when challenging the terrifyingly inappropriate global response. The world’s population was sold a serious lethal deadly pandemic which – we were told – necessitated the reordering of society. The ‘new normal‘ as it was affectionately called by so many perfectly in-sync global leaders. In the event, we did not have a serious lethal deadly pandemic, and what has happened (and continues to happen) is based on a lie. Arguing about whether or not some bits of the lie might have a modicum of truth in them is a distraction from much bigger questions which need addressing.
Footnotes
Missouri v. Biden might be most important legal case in U.S. history
From what I’ve read, proof our federal government wants to kill free speech is overwhelming.
BY BILL RICE, JR. | JUNE 7, 2023
Until yesterday, I’d not read any documents in the lawsuit brought by the states of Missouri, Louisiana et al vs. President Biden. Because of this, I didn’t fully grasp the stunning claims made by the plaintiffs, nor realize how overwhelming the evidence is that supports this case.
Yesterday, I read the first 54 pages of a 354-page legal document that was filed with a federal district court in Louisiana on March 3, 2023.
I now better understand why some people believe this might be the most important legal case in U.S. history.
In a nutshell, attorneys for the plaintiffs are compiling and presenting a mountain of evidence that shows actors for the U.S. government have conspired to nullify the First Amendment to the U.S. Constitution.
This Amendment was first for an important reason.
It states that “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.”
The core issue at stake is should American citizens be allowed to have genuine “freedom of speech.”
In my view, the evidence already presented in this legal case proves beyond a reasonable doubt that a cadre of officials in government (and organizations working “in partnership” with government agencies) despise, fear and want to end “free speech.” In fact, they’ve already effectively blocked the free speech of millions of Americans.
In a democracy, free speech is vitally important as it makes dissent from prevailing narratives possible and thus protects the “natural rights” of citizens who may hold minority views. That is, without “free speech,” only the views of those who embrace “authorized” opinions would be allowed to participate in any meaningful way in democratic debates.
One can parse this lengthy document a thousand ways, but the bottom-line conclusion is that the U.S. government believes only its views should be allowed to be widely disseminated.
Even more terrifying, virtually all the important institutions in contemporary society defend and seemingly support the efforts of the federal government to censor any speech labeled “mis-“ or “disinformation.”
A few of my main take-aways from my (partial) reading of this must-read legal document:
All Hope is Not Lost
The fact that attorneys general from at least two U.S. states have filed such a lawsuit provides hope that the entire country has not yet become disciples and enforcers of Big Brother.
It is also significant that the push-back to mass censorship comes from the state level of our “republic” and not from the federal government itself. That is, the Attorney General of the United States should have brought this case. Instead, representatives of the U.S. government are vigorously defending mass censorship, and the effort to “abridge the freedom of speech.”
The Legal System Can Work
This document is 354 pages because it’s replete with transcripts from legal depositions and exhibits that the public would have not seen absent the commencement of this legal proceeding.
The document also proves the power of legal “discovery” wherein defendants have to turn over all relevant evidence such as emails, meeting records, etc. (although plaintiffs argue that the defendants have still not turned over every piece of “discovery” requested).
A healthy democracy hinges on “fact-finding” and a “search for the truth.” This lawsuit has made it possible for the people who are following this case (not enough people) to learn more about the activities of the most powerful individuals who work for the most powerful government on the planet.
A quick aside ….
In reading this summary of evidence, I was struck by how easy it was for plaintiffs’ attorneys to build their case.
The attorneys, investigators and staffers bringing this case are clearly intelligent professionals who’ve been very thorough in developing their evidence and trying to prove their case. That is, if they get a fair hearing (which I’m not sure they will), they should win this case with ease.
However, this example made me think of all the lawsuits and “fact-finding” exercises that have NOT occurred with any of the litany of crimes and scandals of our Covid times (and even before Covid).
One strongly suspects that if other teams of competent litigators and investigators had employed the same tools of discovery and depositions, every scandal of our times would also be just-as-easily exposed.
Just like I think about all of the mainstream news articles that are off limits to alleged “watchdog” journalists, I also think about all the lawsuits and prosecutions that are apparently off limits to the people and organizations who could bring such cases.
What’s the core issue in this case?
The first paragraph of the “motion for the injunction” describes what the plaintiffs are trying to prove (and have already proven as far as I am concerned).
- “Federal officials, including Defendants, have made a long series of public statements since at least 2018 demanding that social-media platforms increase their censorship of speech and speakers disfavored by these officials, and threatening adverse consequences – such as repeal or reform of Section 230 immunity under the Communications Decency Act (CDA), antitrust scrutiny or enforcement, increased regulation, and other measures – if the platforms do not increase censorship …. “ (emphasis added).”
Note: For more excerpts from the document, see Reader Comments (under “most recent.”)
Comments:
Laymen and legal scholars alike agree that the First Amendment does not compel any publisher to print any and all speech. For example, a private company like The New York Times can publish, or not publish, whatever speech it wants for whatever reason it wants.
The issue in this case is whether citizens living in the “town square” can use Facebook, Twitter, YouTube, etc. to share their opinions or facts.
Or, more specifically, can the government use its immense power to compel private companies to censor speech the government doesn’t like (speech labeled by the government as dangerous, extremist, false or basically “misinformation” or “disinformation” as the government defines these terms).
Plaintiffs argue that the federal government is using its power to abridge free speech. The federal government is doing this by threatening to effectively shut down social media companies who don’t comply with the government’s wishes.
The federal government could harpoon these companies by “reforming” or “amending” Section 230 of the CDA. This section grants legal immunity to such companies, meaning social media companies can’t be sued or criminally tried because of the speech of citizens who make posts on their platforms.
Paragraph 3 of the document explains the power of this “threat.”
“3. The threat of antitrust scrutiny or enforcement is also a major motivator to social-media platforms. For example, Facebook CEO Mark Zuckerberg has stated that the threat of antitrust enforcement is “an ‘existential’ threat” to his platform.”
The evidence – presented on scores of pages – clearly reveals this “threat” was made explicitly, implicitly, publicly and privately over and over and over by myriad employees of the U.S. government, including the President of the United States.
This makes one (almost) feel empathy for these social media companies, which have had a symbolic bazooka pointed at their heads by the U.S. government dating to the day “Joe Biden” allegedly won the presidential election over Donald Trump.
I write that I “almost” feel empathy for these companies because if anyone skims this document, he will quickly see that virtually every employee and key executive of these companies was eager and happy to accede to the demands of their pro-censorship rulers.
Those who read this document will see never-ending examples of government officials brow-beating and intimidating social media companies for NOT censoring MORE.
To me, these companies appear almost masochistic – as in they seemingly enjoyed their incessant scoldings. For example, social media employees often thanked their government minders for pointing out their transgressions, which they seem overly-eager to correct. (Here, the Stockholm Syndrome comes to mind).
The “stick” of repealing Section 230 is not the only motivation social media companies have for complying with Big Brother.
Numerous “carrots” also exist as almost every one of these companies also profits from big contracts with the federal government and/or receives large sums of money (such as vaccine advertising spends) for supporting the authorized narratives (or, more precisely, silencing the non-authorized narratives).
The Virality Project
The document makes many references to the Virality Project, an influential project commissioned by academics at Stanford University.
As I’ve written previously, the most important goal of the world’s real rulers in Covid times was/is the effort to fight “vaccine hesitancy.”
If people were hesitant about getting their Covid vaccines, the mRNA project would be a bust. Big Pharma and all the many entities that receives massive amounts of money from Big Pharma would not be pleased.
One thing that might make half the world skeptical of the “safe and effective” non-vaccines would be if the views of vaccine skeptics actually “went viral.”
This, very possibly, could have happened … absent mass censorship.
In my last article, I discussed several of the key “chess moves” our rulers have made to make sure they win this “game.”
Arguably, the most important move was making sure dissenting views did NOT go viral, a result which didn’t happen by chance … but by a coordinated effort to censor hundreds of millions of potential skeptics and critics.
Since the government doesn’t own Facebook (where two billion people share speech), the government had to “persuade” Facebook (Meta) to do their censoring for them.
This was a conspiracy, a massive one …
In reading this document, I was also stunned when I thought about all the employees and organizations that were involved in the effort to defeat the threat of “vaccine hesitancy” (and protect all the other many untrue Covid narratives).
I stopped reading after 54 pages, but this was enough to see that the actors in this conspiracy (a cover-up of the truth) included the President of the United States, all his key White House employees, the CDC, the Census Bureau, The Surgeon General and his staff, officials in the NIH (such as Anthony Fauci), many of the key members of Congress, all the new “fact checkers” and probably the White House chef.
Time and again, plaintiff’s attorneys present examples where government officials cite articles written by “journalists” at The New York Times or Washington Post that were used as a weapon to demand even more censorship among social media companies.
Surreally, this means our “free press” has been one of government’s key allies in suppressing free speech.
Government contractors, non-profits and think tanks were also brought in to help with the vital censorship chess moves.
Another hallmark of a conspiracy would be any evidence proving a coordinated initiative. The plaintiff’s attorneys have done an excellent job proving this happened. For example, the authors of the legal brief repeatedly show how the words “accountable” and “transparency,” were used ad nauseam by all the censorship conspirators.
When government actors told social media companies they would be “held accountable,” this was a not-too-subtle threat that they better do as told … Which, sadly and not surprisingly, they did.
The conspirators also incessantly demand “transparency” from social media companies.
The government didn’t just ask social media companies to do a little more censorship for the good of the country, they demanded access to all the algorithms, data bases, search queries, content-moderation policies, etc. that would prove companies were censoring the content the government said must be censored.
Amazingly, companies like Meta complied …. so, apparently, officials at the CDC and The Census Bureau (which for some reason took a lead role in enforcing censorship) and key White House staffers were looking at the same tools Meta used to see what Covid topics were trending on their platform.
The government would then tell the companies to ban such speech on their platforms.
Not only did government actors hold a gun to the social media companies’ heads, they wanted to see (and even use) the very tools that allow these companies to know what their users were posting.
As we’ve learned from the “Twitter files,” government officials also repeatedly zeroed in on key “disinformation super-spreaders” and made sure they were banned and punished.
Victims/targets of these censorship efforts include high-profile Covid skeptic like Alex Berenson, Steve Kirsch and Robert Kennedy, Jr., but they might as well have included Bill Rice, Jr, whose Facebook account has also been suspended (for no known or stated reason) multiple times.
Per the copious evidence in this legal brief, every time Meta banned someone or said some topic was now taboo, government officials were rarely placated, and demanded even more censorship. And, again, government officials kept demanding “transparency” to see that thy’s will was being done.
The irony of course is that the U.S. government is the least transparent entity on the face of the earth.
To be clear and to state what should be perfectly obvious by now, the multi-faceted censorship and “disinformation” programs (which pre-date Covid) were created and enforced to make sure no real government “transparency” is/was possible.
For our government officials, transparency is like sunlight or a silver crucifix to a vampire.
What will be the result of this lawsuit?
I actually don’t know what the plaintiffs are demanding except for the government to cease and desist with its efforts to compel censorship.
Speaking for myself, I’ve already seen enough evidence where this U.S. citizen won’t be mollified unless we have criminal prosecutions, the impeachment of President Biden and the censure of all the members of Congress who bullied these social media executives.
Also, the companies that went along with this need to be boycotted by every citizen that still cares about the First Amendment.
I’d also note that while Twitter has (largely) turned over a new leaf under the ownership of Elon Musk, the rest of the social media companies are censoring left and right just like they’ve been doing since “Joe Biden” was sworn into office. (This tells me these companies are betting on “Biden” prevailing in this lawsuit).
It’s not just Covid issues subject to mass censorship ….
For those who think the censorship regime only deals with Covid topics, I say you better think again … as this document also proves.
Plenty of sections of this document provide evidence showing that “disinformation” about Climate Change, election fraud and woke issues like “gender identification” will also continue to be subject to the whims of the government’s arbiters of truth.
For my part, I’m now convinced that what shouldn’t happen … will probably happen. This means, “Joe Biden” will probably win re-election and this case will probably be thrown out or the Supreme Court led by (captured?) John Roberts will ultimately side with the defendants.
If this happens, perhaps more Americans will belatedly understand the new legal precedent that has been set.
In the future, any speech that’s deemed “misinformation” by unelected bureaucrats (at say the CDC or EPA) can indeed be censored and banned.
It will be perfectly fine for presidents, Congressmen and surgeon generals to demand that social media companies censor unauthorized or “dangerous” speech. Furthermore, the government will be granted that “transparency” that tells them Meta or Google are following their orders.
Strangely, Substack wasn’t mentioned …
In reading this document, I was struck by the fact Substack (as far as we know) has yet to be targeted by the Censorship Czars.
My guess is that if this case is decided in favor of the defendants, this will no longer be the case. The “dangerous misinformation” I’ve been posting (and my readers in the Reader Comments) will suddenly be fair game for censorship as well.
Substack is replete with writers challenging the false Covid narratives, but this speech platform is also full of skeptics of Climate Change, writers who might not support the Ukraine War or central bank digital currencies … authors who think election fraud is real and correspondents who don’t like the “woke” transgender and pronoun malarky.
For the past 240 years, Americans thought the First Amendment gave them the “freedom” to share their views on controversial topics. If Biden and the U.S. government win this case, I suspect we’ll soon learn otherwise.
A new cholesterol drug for ‘statin intolerant’ people
But what is the evidence?
By Maryanne Demasi, PhD and Robert DuBroff, MD (Cardiologist, New Mexico) | June 5, 2023
For years, researchers have tried to convince patients that statins don’t cause muscle aches and pains. They’d say that people in trials who took statins experienced muscle aches at the same rate as people on placebo, and that if they did experience muscle pain, it was “rare.”
But now, researchers have had a change of heart. Statins do cause muscle aches in about 20% of people, a problem known as ‘statin intolerance.’ Why the change of heart?
Well, there’s a new drug for people with statin intolerance, one that lowers cholesterol like a statin, but without the muscle aches.
The drug is called bempedoic acid. It acts on the same cholesterol biosynthesis pathway as statins and reduces the amount of cholesterol made by the liver.
The drug is being touted as “revolutionary.” Recently, Stephen Nicholls, cardiologist, and co-investigator on a major trial of the drug said:
“This drug provides another option for lowering cholesterol and is particularly important for patients that cannot tolerate statins. That’s a real problem in clinical practice which limits our ability to effectively lower cholesterol in many patients.’’
Bempedoic acid on trial
Almost 14,000 participants across 32 countries took part in a clinical trial of bempedoic acid and the study was published in the New England Journal of Medicine.
All the trial participants had statin intolerance — half were given placebo and the other half were given 180 mg bempedoic acid daily, and followed for a median duration of 3.3 years.
The drug lowered LDL-cholesterol by about 20%, as well as a marker of inflammation called C-Reactive Protein (CRP) – but did that translate into less major cardiovascular events?
The primary outcome analysed was a composite of four outcomes: heart attack, stroke, revascularisation, and cardiovascular death.
After taking bempedoic acid daily for an average of 3.3 years, the relative risk reduction of the composite outcome was 13% and the absolute risk reduction was 1.6%.
However, in terms of individual categories within the composite endpoint, bempedoic acid had no significant effect on fatal or non- fatal stroke, death from cardiovascular causes, and death from any cause.
The small risk reduction of a cardiovascular event (1.6%) must be weighed up against the increased risk of gout (1%), gall stones (1%) and other drug interactions.
Is the push to lower cholesterol futile?
In 1996, Nobel laureates Brown and Goldstein wrote an editorial in Science titled, “Heart attacks: gone with the century?”
The authors surmised that “proof of the cholesterol hypothesis, discovery of effective drugs, and better definition of genetic susceptibility factors – may well end coronary disease as a major public health problem early in the next century”.
But over a quarter of a century later, drugs to lower cholesterol have made virtually no impact on ending heart disease.
As we published in the journal, Preventative Medicine, over the past 10 years cholesterol levels have been falling, while the number of Americans dying of heart disease has been steadily climbing.
If high cholesterol was “causal” in heart disease, as the prescribing guidelines suggest, then we’d expect to see an opposite trend.
Our most recent meta-analysis of 21 statin trials was unable to find a consistent relationship between lowering LDL-cholesterol and death, heart attack or stroke, following statin therapy.
And despite the widespread use of cholesterol-lowering statins in Europe, observational studies indicate that there has been no accompanying decline in coronary heart disease deaths.
A review of 29 major randomised controlled trials of cholesterol reduction published between 2004 and 2018, found that only two reported a mortality benefit while nearly two-thirds reported no cardiovascular benefit at all.
Further, other types of cholesterol lowering medications like niacin, fibrates and cholesteryl ester transfer protein (CETP) inhibitors, which do ‘everything right’ by lowering LDL, raising HDL (the good cholesterol) and reducing triglycerides, have failed to save lives or reduce cardiovascular events in randomised clinical trials.
This should underscore the limitation of targeting LDL-cholesterol, a surrogate marker. By concentrating almost exclusively on lowering cholesterol, we have diverted our attention from more important drivers of atherosclerosis like metabolic syndrome and insulin resistance.
The simplicity of just taking a statin pill has also fuelled patients’ complacency about being ‘protected’ from heart disease, at the expense of engaging in more protective lifestyle interventions like regular exercise and eating a nutritionally complete diet.
In the field of science, the accumulation of contradictory evidence should lead to a rejection or modification of the prevailing hypothesis – yet the cholesterol hypothesis lives on.
It leads us to the inescapable conclusion that cholesterol-lowering medications are not the miracle drugs we had hoped for.
*NB: Bempedoic acid (oral pill 180mg) has been approved in the US, Canada, UK, and Europe – but not in Australia (possibly in 2yrs).
Bempedoic acid may also be prescribed in combination with another non-statin drug called ezetimibe for additional LDL-C lowering.
‘Failing Our Children’: Weight-Loss Surgeries for Kids and Teens on the Rise, Study Says
By Suzanne Burdick, Ph.D. | The Defender | June 7, 2023
As obesity rates among U.S. kids and teens continue to soar, more children and adolescents in the U.S. are undergoing weight-loss surgery, a new peer-reviewed study concluded.
According to the JAMA Pediatrics study, severe obesity is the “fastest-growing obesity subcategory in the US pediatric population.”
The researchers — including Sarah Messiah, Ph.D., MPH, professor of epidemiology at UTHealth School of Public Health in Houston, Texas — said the rate of invasive medical procedures on the gastrointestinal tract among 10- to 19-year-olds has been on the rise since 2016 and jumped by nearly 20% between 2020 and 2021.
“This analysis shows that families are making the decision to pursue bariatric surgery more frequently year-over-year,” Messiah said in a news release. The increase was most pronounced “among those from racially and ethnically diverse backgrounds,” she said.
Commenting on the new study, pediatrician Dr. Lawrence Palevsky said, “Our medical community is failing our children by deciding that the best way to treat them [for obesity] is through medication and surgery.”
These measures do nothing to address the underlying factors that are negatively impacting the children’s health, such as “their psychology, their home environment, their diet, and the overall sociological issues with which they’re dealing,” Palevsky told The Defender.
Palevsky said many medical professionals refuse to acknowledge the role that diet and the environment both play in the health and welfare of children.
Palevsky’s first medical school instructor “within the first five minutes of introducing himself to the class, made it a point to let us know that nutrition is not a field of medicine,” he said.
The prevailing mentality is that “We, in the medical world, solve your problem by cutting you up and fixing you” — and then patients can go back to their lives and make the dietary and environmental choices they were just making all along.
“So go ahead, drink your beverages with high-fructose corn syrup … and play as many video games and computer games as you want so that you’re not physically active and we will just take you to the operating room and solve your problem.”
Palevksy said although he was “conventionally trained,” his approach to medicine is “to get to the root cause and to the contributing factors that are bringing on symptoms” — rather than using pharmaceuticals to suppress or treat symptoms — and “to educate parents and their children so they can resolve illness more easily.”
An increase in weight-loss surgeries among youth likely could lead to more medical errors — which researchers say is a leading cause of death in the U.S.
In a 2016 analysis published in the BMJ, John Hopkins University School of Medicine researchers said that more than 250,000 deaths per year were due to medical error — making medical error the third leading cause of death in the U.S.
‘Too quick to reach for a pill or surgical solution’
Earlier this year, the American Academy of Pediatrics (AAP) issued new clinical guidelines for treating childhood obesity that endorsed weight-loss pharmaceuticals and — for the first time ever — more weight-loss surgeries as “safe and effective” treatments for childhood obesity.
The two AAP-approved methods of weight-loss surgery for children — sleeve gastrectomy or gastric bypass — entail removing or rendering permanently dysfunctional a large percentage of the stomach.
“Our analysis suggests that these access channels are being utilized, and more frequently, even during the COVID-19 pandemic,” Messiah said.
Meanwhile, critics — including Dr. Paul Thomas, an integrative pediatrician — said the increased “market” for weight-loss surgeries performed on children fails to address the root cause of children’s obesity.
“We are too quick to reach for a pill or a surgical solution,” Thomas said. “Addressing the root cause and underlying conditions that have resulted in obesity will give lasting results that will also promote physical, emotional and spiritual healing.”
Thomas, the subject of a book on how he lost his medical license after publishing a controversial study on the health of his vaccinated patients versus those unvaccinated, told The Defender :
“While there may be rare special circumstances where bariatric surgery for morbid obesity in children may make medical sense, the major focus should be lifestyle changes after endocrine etiologies have been ruled out.
“The AAP endorsement of this surgery may create a market for surgeries in children that could easily be avoided by proper attention to the underlying cause of the obesity, which in many cases is related to stress, poor nutritional choices, lack of exercise, inadequate sleep and psychological and emotional duress.”
1 in 5 American kids are obese
The Centers for Disease Control and Prevention (CDC) defines obesity as “a body mass index (BMI) at or above the 95th percentile of the CDC sex-specific BMI-for-age growth charts.”
According to the CDC, the most recent national statistics show that 14.7 million children and adolescents ages 2-19 are obese. That equates to a child obesity rate of 19.7% — meaning roughly 1 in 5 kids is obese.
Obese children are at greater risk of developing related functional, metabolic and psychological conditions, experiencing pervasive weight bias and stigma and having greater healthcare costs.
Childhood obesity also is strongly correlated with the risk of adult obesity and poor health, with considerable social and economic consequences.
The proportion of U.S. children who are overweight or obese surged to unprecedented levels during the COVID-19 pandemic, according to CDC data.
Public health experts cited economic hardship, school closings, shutdowns, limited physical activities and increased food insecurity for many families caused by COVID-19 mitigation measures as reasons for the surge.
Palevsky noted that many children living in inner cities do have access to fresh food.
Dr. Hooman Noorchashm, a general and cardiothoracic surgeon with more than 20 years of experience, commented on the same problem.
In the area of Philidelphia where Noorchashm lives, he said, “You can go to McDonald’s and buy a thousand calories worth of food for 4 or 5 bucks at McDonald’s [but] you can’t get a healthy salad for less than 20 bucks.”
Surgeon: ‘I personally would never subject my child … to bariatric surgery’
Childhood obesity is a “real clinical problem,” Noorchashm said — but it’s a “multifactorial problem” that has a great deal to do with “access to healthy food and people’s relationship to food.”
And when it comes to addressing the problem, an ounce of prevention is worth a pound of treatment, he added.
Noorchashm said there was “no question” that severely obese children “need effective treatments.”
However, when treatments — like weight-loss surgeries and weight-loss medications — are “so lucrative,” it creates an economic incentive to focus research and government funds on treatments rather than on prevention, he said.
Within the AAP, there is a society of pediatric surgeons and pediatric bariatric surgeons, Noorchashm said. “These organizations have lobbying power.”
“It’s a problem of economy,” he said, adding:
“In other words, because the Bandaid costs so much and so many special groups are making money off it, regulatory incentive decreases to actually solve the root cause …
“I personally would never subject my child or any child that’s related to me to bariatric surgery.”
According to Palevsky, government and food industry leaders — including the U.S. Department of Agriculture (USDA) — should be held responsible for providing kids with nutritious foods.
Instead, as The Defender recently reported, more highly processed foods will be on the menu for children in public schools this fall thanks to a “major new initiative” to get Kraft Heinz’s “Lunchables” products into U.S. public school cafeterias.
Two styles of Lunchables ostensibly meet the federal nutritional guidelines set for the USDA National School Lunch Program, which provides meals to nearly 30 million kids across the country.
Commenting on the AAP’s new guidelines for treating childhood obesity, Mary Lou Singleton, midwife and family nurse practitioner, said they “offered no meaningful analysis or explanation of what is driving the childhood obesity epidemic.”
Singleton added:
“I found no mention of the massive changes in the U.S. food supply that correlate with the skyrocketing rates of obesity among children and adults alike …
“The document fails to address the school lunch program, which is providing a significant amount of the calories U.S. schoolchildren are eating weekly. Most schoolchildren in the U.S. are fed plastic-wrapped, chemically-preserved, pesticide-laden food made in factories months or years earlier.
“In addition to the sugar, the chemicals in these foods have endocrine-disrupting obesogenic properties.”
Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa. She holds a Ph.D. in Communication Studies from the University of Texas at Austin (2021), and a master’s degree in communication and leadership from Gonzaga University (2015). Her scholarship has been published in Health Communication. She has taught at various academic institutions in the United States and is fluent in Spanish.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
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Alarmist climate science as a textbook example of groupthink
By Paul MacRae | May 1, 2012
A while ago, I received an email from a friend who asked:
How can many, many respected, competitive, independent science folks be so wrong about [global warming] (if your [skeptical] premise is correct). I don’t think it could be a conspiracy, or incompetence. … Has there ever been another case when so many ‘leading’ scientific minds got it so wrong?
The answer to the second part of my friend’s question—“Has there ever been another case where so many ‘leading’ scientific minds got it so wrong?”—is easy. Yes, there are many such cases, both within and outside climate science. In fact, the graveyard of science is littered with the bones of theories that were once thought “certain” (e.g., that the continents can’t “drift,” that Newton’s laws were immutable, and hundreds if not thousands of others).
Science progresses by the overturning of theories once thought “certain.” … continue
Blog Roll
Aletho News- New US shipment of 6,500 tons of military aid arrives in Israel
- Military aid to Ukraine vital for ‘US hegemony’ – Republican senator
- Zelensky’s favorite drone company at center of Ukrainian corruption alert
- The Broken Contract
- US CENTCOM’s Request for Dark Eagle Missiles Shows Shortage of Weapons and Limited Options
- Iran consolidates Strait of Hormuz control in post-war power shift, leaving US in dark
- A pause, not a ceasefire: Washington stalls, Tehran recalibrates
- US blockade crumbles as Iran turns to overland routes
- Hidden costs of US Iran war push total far beyond $25bn Pentagon claim
- Iran Will Respond With Long-Term Strikes to US Attack, Even If It Is Short-Term – IRGC
- If Americans Knew
- Former Tik Tok official describes massive pressure from Israel lobby
- Amid ceasefire violations and genocide, Israel commits piracy – Daily Update
- Five Laws and Standards That Require the US Cut Off Weapons to Israel
- Israel’s diabolical killing machine and how it targets journalists.
- The Global Sumud Flotilla to Gaza — A cry at sea to the world’s dormant conscience
- Politico’s powerful parent company tells Politico they must support Israeli narrative
- How Tony Dokoupil Became the Face of ‘Zionist Fanatic’ Bari Weiss’s CBS
- Far Right Israeli Settler Movement Enters Syria in a Push for “Greater Israel”
- ‘People Have the Right to Be Buried’: In Gaza, Thousands of Palestinians Remain Trapped Under Rubble
- Born during Israel’s genocide: Gaza’s child survivors bear the scars of war
- No Tricks Zone
- Oversupply Of Volatile Solar Energy Leads To Record NEGATIVE Prices!
- New Study: Extreme Heat Records, Heatwaves, Extreme Cold Records Declining Across US Since 1899
- It’s The Cold, Stupid! Cold 20 Times More Lethal Than Heat, Multiple Studies Show
- European Institute For Climate And Energy: “Climate Debate is Seldom About Science”
- New Study: The Climate May Be 5 Times More Sensitive To Solar Forcing Than Commonly Assumed
- EV Industry Reached $70 Billion In Losses In 2024 Due To Delusional Green Ideologies
- Reality Check: Maldives Have Actually Grown In Size Or Remained Stable Over Recent Decades
- Abrupt Climate Change Also Occurred NATURALLY In The Past …25 Times During Last Ice Age
- Cave Discovery Reveals Today’s Desert Climates Were Recently Far Warmer, Wetter, Teeming With Life
- German Expert: Heat Dome Led To Record Temps In Western USA…Warmer In 1934, 1936
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