Posted originally on the conservative tree house on May 5, 2022 | Sundance
The FDA has limited the use of the Johnson and Johnson COVID vaccine to only those over 18-years-old due to blood clotting issues. [Press Release Here] Johnson & Johnson’s Covid-19 vaccine is now limited to adults due to the risk of a rare blood clotting syndrome.
FDA – “Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.” (read more)
WHAT CHANGED? – “The FDA and CDC have continuously monitored for and investigated all suspected cases of TTS reported to VAERS. In an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.”
Posted originally on the conservative tree house on May 3, 2022 | Sundance
Previously a federal judge overturned the federal mask mandate for transportation, thereby allowing travelers to make their own choices. The DOJ has appealed that decision after the CDC said it wanted the mask mandate to remain in place. The status of that litigation is unknown.
Today, the CDC has announced a semi-permanent extension of the federal transportation mask mandate with no expiration date noted. [Announcement Here] That means all travelers on airplanes, trains, busses and ridesharing will be required to wear facemasks again, including inside the terminals and operational hubs of those transportation nodes, pending the outcome of the DOJ appeal to the federal court.
CDC Announcement – “At this time, CDC recommends that everyone aged 2 and older – including passengers and workers – properly wear a well-fitting mask or respirator over the nose and mouth in indoor areas of public transportation (such as airplanes, trains, etc.) and transportation hubs (such as airports, stations, etc.).
[…] This public health recommendation is based on the currently available data, including an understanding of domestic and global epidemiology, circulating variants and their impact on disease severity and vaccine effectiveness, current trends in COVID-19 Community Levels within the United States, and projections of COVID-19 trends in the coming months.
[…] “CDC continues to recommend that all people—passengers and workers, alike—properly wear a well-fitting mask or respirator in indoor public transportation conveyances and transportation hubs to provide protection for themselves and other travelers in these high volume, mixed population settings. […] Additionally, it is important for all of us to protect not only ourselves, but also to be considerate of others at increased risk for severe COVID-19 and those who are not yet able to be vaccinated. Wearing a mask in indoor public transportation settings will provide protection for the individual and the community.” ~ Rochelle Walensky, CDC Director
If the Biden administration lose the court appeal to reinstitute the mask mandate, this announcement by the CDC would appear to be moot, they couldn’t enforce it. However, if the Biden administration is successful in their appeal, the mandatory mask wearing returns.
Put another way….. If the Biden administration lose the appeal, the people wearing masks will be the COVID worshippers. If the Biden administration win their appeal we all have to wear them.
The mandate created by Joe Biden did not have legal structure. It was a dictatorial fiat that exceeded the capacity of the executive branch to create. U.S. District Judge Kathryn Kimball Mizelle found the CDC exceeded its statutory authority with the mask mandate and violated the rules that guide CDC regulations. {LINK} After Joe Biden arbitrarily announced the federal transportation mandate, the CDC triggered enforcement of the mask mandate without any required time for public feedback on a new regulation.
Congress could easily write a law authorizing mechanisms for the CDC and TSA to use in enforcement of a federal Transportation mask mandate; but they won’t – because the public doesn’t support it. However, the Biden administration doesn’t care about majority public opinion, they are fine-tuned to push virtue signaling as a political strategy.
The White House is very committed to all their mandates around COVID-19, the mask mandate is no different. From the perspective of the professional political left, the theater of forced mask wearing represents the visible power and authority of government to rule the lives of the irrelevant proles.
Any pesky legal rulings, that seek to reduce or remove the power of government, are viewed by the left as arbitrary and insignificant efforts to block their almighty power of government. They can choose to wear a mask if they want, but that’s not really the issue behind the mask mandate. The true power of the left is in the ability to force everyone to comply to their whims regardless of individual freedom.
The Covidians who define themselves by their adherence to the dictates of the U.S. government, will be happy with this position from the CDC today. They worship at the altar of COVID science and use masks as an expression of their sanctimonious feeling of superiority. However, in an election year where the overwhelming majority of the American people have had enough of this political science, this CDC position may fuel an even more angry response.
Moderna is officially coming for toddlers and infants under five. The company submitted a formal request with the Food and Drug Administration (FDA), claiming the vaccine is 51% effective among toddlers under two and 37% effective in the two to five-year-old range. Instead of the standard two-100 microgram doses, the youngest among the population will receive two 25-microgram doses.
“I think it is likely that over time they will need additional doses. But we’re working on that,” Moderna’s Chief Medical Officer Dr. Paul Burton stated.
They will continue to force vaccines on everyone in the population. There is no telling the long-term effects of injecting a gene-altering medication into a baby, but Big Pharma is willing to risk lives for profits and government is will risk lives to retain control over a scared and uninformed population. Only 475 children under five have died from COVID, according to the Associated Press. There is absolutely no need for a vaccination for this demographic.
There are reports of babies dying through breast milk contaminated with the vaccination. Countless top doctors have warned against vaccinating children in general. Even the World Health Organization has even admitted that healthy adolescents do not need boosters, despite Pfizer filing a claim to have theirs approved for the five to twelve-year-old kids. Not to be outdone, Pfizer said it will have a vaccine for babies by the summer.
Since parents are reluctant to destroy their child’s development, the powers that be will continue to force mandates. They will push for universal passports to document everyone, including the youngest, most vulnerable members of society. They want us to inject ourselves repeatedly from birth until death for a virus that even Fauci no longer calls a pandemic.
Democrats in Rhode Island have prepared legislation that could double taxes for parents of unvaccinated children. Senator Sam Bell, who is championing the bill, claims that there is a need for a universal mandate. Under the proposed law, unvaccinated residents would face a $50 monthly fine for noncompliance. Employers would also be required to mandate vaccines for all employees or face a $5,000 fine per violation. The biggest burden – “Any person who violates this chapter shall be required to pay a monthly civil penalty of fifty dollars ($50.00) and shall oweTWICE THE AMOUNT OF PERSONAL INCOME TAXES.”
To receive an exemption for a minor, three separate doctors must confirm that the child is “not fit for immunization.” Then the state would need to investigate each claim and determine whether or not the parents should be financially ruined. So even if three different doctors say that a child should not be vaccinated, the state may override them.
Biden lost his bid to implement a federal vaccine for employers last year, but the battle is not over. State lawmakers still have the capabilities to force compliance through any means possible. Bell wants to make the state of Rhode Island unlivable for the unvaccinated. While this is unlikely to pass, the fact that they are still attempting to force vaccinations in April 2022 shows that the war on medical freedom has not ceased.
A March 16 opinion piece in The BMJ raises some serious questions about what they call, “The illusion of evidence based medicine.” Authors Jon Jureidini and Leemon B. McHenry posit that the prominence of evidence-based medicine constituted a paradigm shift, meant to give a solid foundation in science for our medical care system. But the validity of the paradigm depends of accurate data from clinical trials, and most of these are conducted by the pharma industry and then published under the name of “senior academics.” Public release of what had been confidential pharma industry documents gives the medical world key insights into the level to which pharma-sponsored trials are mischaracterized. Getting a bit philosophical, The BMJ argues that critical rationalism is key for both the integrity of science and the role of science, “in an open, democratic society.” But this ideal is under threat by corporate power, a world in which, “financial interests trump the common good.” The dominance of massive pharma firms involves some competition, but all these players are united in working to expand the general pharma market. And while what the authors call, “free market champions” have embraced privatization, “the unintended, long-term consequences for medicine have been severe.”
Medical Schools Take Neo-Liberal Approach
Knowledge and data ownership hamper progress in science due to the fact that the pharma industry tends to suppress negative trial outcomes, not report adverse events, and not share their raw data with the research community. To quote The BMJ, “Patients die because of the adverse impact of commercial interests on the research agenda, universities, and regulators.” And duty to shareholders’ “hierarchical power structures” prioritizes both product loyalty and public relations over integrity. Further, while our fancier universities face influence from their endowments, “they have long laid claim to being guardians of truth and the moral conscience of society.” And facing reduced government funding, these schools have taken the, “neo-liberal market approach,” seeking out pharma funding, with strings attached.
Doctors as “Product Champions”
And thus, science departments at a broad swath of our universities can be seen as “instruments of industry.” When you combine firm-level control of the research agenda and the “ghosting writing of medical journal articles and continuing medical education,” scholars can transform into promotors of commercial products. Further, media reports of “industry-academe partnerships[s]” add to a general mistrust of our academic institutions that betrays the very vision of an open society. And what The BMJ calls the “corporate university” itself undermines the idea of academic leadership. Where once deans were folks with “distinguished contributions to their disciplines,” now they are more of fundraisers/academic managers who must show their “profitability” and ability to attract corporate sponsorship. And medical academia’s stars, who tend to be opinion leaders, advance their careers via industry opportunities. These folks are hired based largely on their influence on the “prescribing habits” of other doctors. The opinion leaders are also often well-paid by pharmaceutical advisory boards and speakers’ bureaus in the context of presenting results of pharma industry trials. And instead of being “independent, disinterested scientists,” they can become “product champions,” in the parlance of marketing executives.
Reforms Called For
Proposals for reform can include, “liberation of regulators from drug company funding; taxation imposed on pharmaceutical companies to allow public funding of independent trials; and, perhaps most importantly, anonymized individual patient level trial data posted, along with study protocols, on suitably accessible websites so that third parties, self-nominated or commissioned by health technology agencies, could rigorously evaluate the methodology and trial results.” For readers seeking more information, the American Medical Association’s Code of Medical Ethics Opinion 7.1.4 sets out that organization’s policies on conflicts of interest in industry-funded research.
A March 16 opinion piece in The BMJ raises some serious questions about what they call, “The illusion of evidence based medicine.” Authors Jon Jureidini and Leemon B. McHenry posit that the prominence of evidence-based medicine constituted a paradigm shift, meant to give a solid foundation in science for our medical care system. But the validity of the paradigm depends of accurate data from clinical trials, and most of these are conducted by the pharma industry and then published under the name of “senior academics.” Public release of what had been confidential pharma industry documents gives the medical world key insights into the level to which pharma-sponsored trials are mischaracterized. Getting a bit philosophical, The BMJ argues that critical rationalism is key for both the integrity of science and the role of science, “in an open, democratic society.” But this ideal is under threat by corporate power, a world in which, “financial interests trump the common good.” The dominance of massive pharma firms involves some competition, but all these players are united in working to expand the general pharma market. And while what the authors call, “free market champions” have embraced privatization, “the unintended, long-term consequences for medicine have been severe.”
TrialSite recently shared that a handful of states have proposed bills to ensure ivermectin is available to treat COVID-19 via a legitimate physician’s prescription. Those states include Indiana, Kansas, and New Hampshire. Recently, a leading proponent of the use of ivermectin, Dr. Paul Marik, one of the co-founders of the Front Line COVID-19 Critical Care Alliance (FLCCC), discussed the pending New Hampshire ivermectin legislation with conservative news platform, America’s Voice Network.
Marik, board certified in Internal Medicine, Critical Care Medicine, Neurocritical Care, and Nutrition Science, is a key opinion leader who has worked in numerous hospitals and health systems from South Africa, UK, and of course, the United States where he is most recently affiliated with Eastern Virginia Medical School (EVMS) as well as other medical institutions. Not a stranger to controversy, or for that matter, pushing the comfort boundaries of the medical establishment, Marik isn’t a lightweight, with over 400 peer-reviewed journal articles, 50 book chapters, and author credits for four critical care books.
Recently, he filed a lawsuit against his hospital over the institution’s ban on various therapies including ivermectin, which happens to be a core therapy in his and his colleagues MATH+ Hospital Treatment Protocol for COVID-19. He and colleagues such as Dr. Pierre Kory experienced what they declare is censorship, as key journals had reviewed and accepted manuscripts, such as with the Journal of Intensive Care Medicine, only to see the approvals retracted. Physicians such as those affiliated with the FLCCC represent prominent figures at this weekend’s medical freedom march.
The alternative media reporter, Heather Mullins, shared that New Hampshire’s bill is now “sponsored” and must still “go through some hurdles to get passed,” but if done so will “essentially make ivermectin available over the counter.” According to the TrialSite report, the proposed bill would authorize access at the pharmacy via a “standing order” which generally indicates authorization for nurses, pharmacists, and other appropriately credentialed health care professionals that if directed by state law, empowers the direct care and admonition of a vaccine or therapy (in this case ivermectin) based on an approved medical doctor-based approved protocol.
TrialSite didn’t report that Paul Marik testified for the proposed bill in New Hampshire. Mullins reports that Marik and other front-line physicians have been on the record that if ivermectin had been allowed for use as an early at-home prophylactic treatment targeting COVID-19, hundreds of thousands of lives could have been saved.
The Interview
Prior to the testimony in New Hampshire, Dr. Marik shared that 3.7 billion doses of ivermectin have been administered around the world, “changing the face of parasitic diseases on this planet.” Marik declared that ivermectin “is probably the second most important drug ever invented” [the drug’s inventors did win a Nobel Prize and the drug is on the World Health Organization Essential Drug List].
Declaring that the drug is cheap, safe, and “highly effective against SARS-CoV-2, and if used more widely this drug could have saved hundreds of thousands of lives.”
Referring to its use in many other countries, the critical care physician went on the record that it’s a “lifesaving drug.”
Why the pushback against ivermectin? Marik, now somewhat liberated given he isn’t dependent on his employer Sentara, let loose declaring, “There are multiple reasons, and this is probably generated by Big Pharma, government, and big corporations who don’t like cheap repurposed drugs.” He continued, “So this is a war on cheap, repurposed drugs.” Emphasizing the goals of ivermectin’s adversaries, Marik stated, “They want you to use expensive designer drugs which in fact don’t work.”
In clarifying his understanding of the New Hampshire bill, Marik declared it is proposing to make ivermectin available over the counter [again via standing order] and according to the critical care doctor, it makes sense given the drug’s safety profile— “the drug is safer than Tylenol,” stated Marik. Repeating again the drug’s safety profile makes it safer than Tylenol, he went on the record “People should be given access to this drug in order to prevent and treat COVID.”
Marik espoused the critical FLCCC view that early treatment for COVID-19 absolutely represents a critical care strategy: simply waiting at home for a symptomatic phase, prompting a trip to the hospital raises significant danger for severe disease and worse.
The Controversy
According to Heather Mullins’ report, there has been a coordinated effort to censor the robust data pointing to at least some ivermectin-based efficacy around the world. Ivermectin study watchers often point to the website which tracks all ivermectin studies in a clean, orderly series of tables and graphs. While the majority of the 75 completed studies point to positive data points, the mainstream media and medical establishments in North America, Europe, and Australia have limited the number of studies within the research portfolio that they even acknowledge to just a handful. The others? These studies are dismissed because of bad quality.
A couple of prominent studies showed no benefit, yet, at least one of them became surrounded with controversy and allegations among some industry watchers of conflict of interest. TrialSite notes this hasn’t been proven, and one study in Egypt that was part of a couple of meta-analysis studies turned out to have manipulated data. Yet even with the questionable Egyptian study, TrialSite’s Sonia Elijah’s investigation raised some disturbing questions in “How Ivermectin became a Target for the Fraud Detectives.”
TrialSite has chronicled ivermectin studies all over the world, including the ICON study done in Broward County early on during the pandemic. Of course, this study wasn’t a randomized controlled trial, thus limiting its impact. Interviews with the head of the largest hospital in the Dominican Republic as well as a well-respected investigator in Dhaka, Bangladesh, and interactions with doctors in Nigeria, Zimbabwe, South Africa, and India found positive data points. TrialSite even sponsored an objective documentary in Peru, one of the first nations to accept the use of the drug for the novel coronavirus.
After numerous interviews, study write-ups, and real-world observations, the case for ivermectin should be taken seriously. The U.S. National Institute of Health is financing an ivermectin-based study called ACTIV-6, while the University of Minnesota led one of the largest ongoing ivermectin studies called COVID-OUT.
The drug does have a proven safety profile at doses currently approved for parasitic indications. However, claims that higher dosages are just as safe as Tylenol might be a stretch—rather that claim would be associated with currently approved indications. Yet, it’s not a stretch to declare the drug is generally safe if taken off-label under the guidance of a licensed, competent physician.
The FDA’s behavior during this pandemic in association with ivermectin has been questionable, to say the least. Issuing warnings to the public not to use the animal variety of the drug, they emphasized that for the human version, it should be used only in clinical trials. TrialSite’s Sonia Elijah’s piece on obtaining FDA emails suggested the possibility of some form of disinformation campaign emanating from the world’s most respected food and drug regulatory body—an activity, if true, is beneath this organization.
FDA letters to medical and pharmacy boards and medical societies have led to considerable pressure on doctors employed by health systems and pharmacies not to allow ivermectin prescriptions off-label for COVID-19. In addition to a survey substantiating this trend, TrialSite chronicles plenty of instances evidencing efforts to block access. The TrialSite survey evidenced the effectiveness of an ongoing purge.
While there has been much controversy following the drug, Marik, Kory, and others actually visited the National Institutes of Health COVID-19 Treatment Guidelines Panel to discuss the evidence of efficacy against SARS-Cov-2 in early 2021.
from use only in clinical trials to the following recommendation:
There is insufficient evidence for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.
Yet if the drug is generally safe and a licensed physician along with an appropriately consenting patient agree to an off-label regimen, why would this vary from other standard off-label use cases that no one makes a fuss about? What is it about COVID? TrialSite has observed based on the severity and intensity of the pandemic, more federal involvement, and intervention in healthcare. Concerns of ivermectin took off when government, industry, and regulators discovered that prescriptions skyrocketed from 3,000 per week pre-pandemic to nearly 90,000 per week during the second year of the pandemic.
TrialSite recently reported on a study led by a University of Michigan doctor showing that at least $130 million in insurance claims for the drug treating COVID-19 in 2021—that figure is probably more than double when counting all the cash-based prescriptions.
Call to Action: What are your thoughts? Is the federal government simply trying to protect people by blocking access to ivermectin or is this part of some regulatory capture movement? Does this mean industry’s interest supersedes patients? Perhaps, the truth is more nuanced. While this TrialSite fact check on the fact checkers (Ivermectin) could be updated, its core arguments are sound.
TrialSite recently shared that a handful of states have proposed bills to ensure ivermectin is available to treat COVID-19 via a legitimate physician’s prescription. Those states include Indiana, Kansas, and New Hampshire. Recently, a leading proponent of the use of ivermectin, Dr. Paul Marik, one of the co-founders of the Front Line COVID-19 Critical Care Alliance (FLCCC), discussed the pending New Hampshire ivermectin legislation with conservative news platform, America’s Voice Network.
Posted originally on the conservative tree house on April 21, 2022 | Sundance
Someone might want to knock Anthony Fauci down a few pegs from his high-horse position. In this brief video, Fauci was asked for his opinion on the recent federal court ruling that the CDC exceeded its authority with a federal transportation mask mandate.
According to Fauci, the CDC bureaucratic science should supersede any constitutional, legal or limiting positions by the legislative or judicial branches of government. In essence he’s saying the CDC is above the law. WATCH:
The CDC is a subservient regulatory agency just like every other agency within government and is just as subject to the laws and legal limitations of the constitution as any other agency would be. However, in the worldview of Fauci and the Branch Covidians, the power of science puts them above the law.
In semi-related news…. “Philadelphia will end its COVID-19 indoor mask mandate less than a week after reinstating it, city health officials said Thursday night.” {LINK}
Posted originally on the conservative tree house on April 20, 2022 | Sundance
Ideological leftism is contingent upon appeasing the most insane elements of the extreme left.
As a consequence, the Biden political CDC has announced they need the Biden political DOJ to try and get the federal mask mandate put back into place.
CDC Announcement: “To protect CDC’s public health authority beyond the ongoing assessment announced last week, CDC has asked DOJ to proceed with an appeal in Health Freedom Defense Fund, Inc., et al., v. Biden, et al. It is CDC’s continuing assessment that at this time an order requiring masking in the indoor transportation corridor remains necessary for the public health.” (LINK)
According to NBC News, “the Justice Department said that it has filed a notice of appeal “in light of today’s assessment by the CDC” in a statement late Wednesday afternoon.” (LINK)
The Covidians who define themselves by their adherence to the dictates of the U.S. government, are happy. However, in an election year where the overwhelming majority of the American people have had enough of this political science, this decision fuels an angry rebuke.
Posted originally on the conservative tree house on April 19, 2022 | sundance
Obviously, the office of White House Chief of Staff Ron Klain is urgently contacting pollsters to measure how the base of the party would feel if the administration did not challenge the federal court ruling that overturned the federal mask mandate for transportation.
The far-left is on its heels after a Tampa judge overturned the CDC’s legal framework for the mask mandate rule, and the TSA changed their guidance. Most of the Biden support base, the Covidians, define themselves through the virtue signaling of wearing a mask. However, all of the airlines quickly abandoned rules for masks during travel, and the overwhelming majority of Americans cheered.
Now, the Biden DOJ finds themselves in a hot political place. Biden is stuck between the mentally and emotionally unstable Covidians (10%) and the normal Americans (90%). If the DOJ doesn’t challenge the ruling, the Covidians will be even more mad. [Psaki Transcript Here]
(WASHINGTON DC) – […] White House press secretary Jen Psaki, speaking to reporters aboard Air Force One en route to New Hampshire, said the Justice Department was still reviewing the ruling and noted that these reviews typically take a few days. She pointed out that the CDC had said previously it needed 15 days to evaluate public health data related to the mask mandate.
“Public health decisions shouldn’t be made by the courts. They should be made by public health experts,” Ms. Psaki said.
Republicans and some Democrats praised Monday’s ruling by the judge, who was appointed by former President Donald Trump, a Republican. “It’s about time,” said Rep. Sam Graves, the top Republican on the House Transportation and Infrastructure Committee. “This hypocritical and overreaching mandate was never about health or science.” (read more)
Arriving in New Hampshire today, Biden was asked what should travelers do about wearing masks? Biden said, “It’s up to them”.
By Matt Walsh originally Published on Rumble on April 18, 2022
Today on the Matt Walsh Show, leftists are fighting passionately to defend the profit margins of the pharmaceutical industry, even as Big Pharma uses an entire generation of children as lab rats. Also, federal officials hunt for the murderer of a dolphin, while letting the murderer of five infant children off the hook. Plus an MSNBC analyst explains why it’s a threat to free speech to allow people to say whatever they want on social media. And a Democrat candidate for congress aborted her child to save the planet. Finally in our daily cancellation, Ilhan Omar is upset because Christians were singing on a plane. We’ll talk about all of that and more today on the Matt Walsh Show.
NBA star Jonathan Isaac has withstood immense pressure to conform to popular social issues. He’s now writing a book about his experience and is publishing with the Daily Wire. Pre-order your copy now: https://utm.io/ud96e.
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