Tag Archives: Food and Drug Administration (FDA)

Changing The Dynamic On Vaccines

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Robert F. Kennedy, Jr., is known to be somewhat skeptical on vaccines–very skeptical on the Covid-19 vaccine. In the end, that may be a good thing for America’s children.

On Thursday, Hot Air posted an article about one possible impact of Kennedy’s tenure as Secretary of Health and Human Services.

The article reports:

I have an unusual perspective on RFK Jr. I think that his skeptical approach to the current vaccination schedule will turn out to be a good thing, not because he will enhance skepticism about the safety and efficacy of vaccines, but because it will do the opposite–for safe and effective vaccines.

The current establishment chant is that any and all vaccines are an unalloyed good for everyone, always. To put it mildly, that simply cannot be true. It is a mantra, not a scientific conclusion, and the reason why the mantra is repeated so persistently is that public health officials are so scared that people will mistrust vaccines that they feel the need to force a unified message and brainwash people.

That was made obvious during COVID. You can even go read the transcripts of meetings within the CDC and FDA discussing the pros and cons of the mRNA vaccines, and the officials kept talking about ensuring that all messaging was simplified and unified. No nuance, no discussion, no informed consent. The belief was that keeping people UNinformed was crucial.

That’s why the FDA’s top two vaccine officials eventually bolted–right in the middle of the pandemic. The propaganda being put out was so deceptive that they couldn’t stand behind it.

The article notes:

Between birth and six years old, children are supposed to receive at least 30 different vaccinations, excluding the multiple mRNA COVID-19 shots. What is the likelihood that there are no downsides, side effects, interactions, immune system effects, or other unintended consequences? It’s an interesting question, and one that isn’t really studied in a systematic way. Many of these vaccines are barely tested before being rolled out.

My suspicion is that the safety and effectiveness vary quite a bit among the various vaccines out there, and I am absolutely certain that the vaccine schedule is unlikely to be suboptimal at the very least.

The article explains the upside of Kennedy’s skepticism:

Everybody who is worried that RFK, Jr. is undermining faith in vaccines seems to have missed the fact that people have lost trust in public health officials for very good reasons. We demand that it is the skeptics, not the pro-vaccine fanatics, who examine the evidence and tell us the good, the bad, and the ugly.

Do I assume RFK, Jr. is right about his opinions about vaccines? No. But it’s not like he has ripped all the vaccines off the market–he’s hired good scientists to delve into the evidence and report to all of us what they find. Inform us. I suspect that the answers will differ from vaccine to vaccine, and that each vaccine has different risk and benefit profiles.

I am looking forward to those answers.

A Welcome Change In Policy

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On Wednesday, Legal Insurrection reported that the HHS has discontinued the Centers for Disease Control and Prevention (CDC) recommendations that children, teenagers, and pregnant women receive routine COVID-19 vaccinations. On Friday, the Food and Drug Administration (FDA) approved the Novavax Covid-19 vaccine with the unprecedented demand that Novavax conduct a new clinical trial of its shot after approval,

The article reports:

Health and Human Services Secretary Robert F. Kennedy, Jr., may be pulling ahead in the race to be the most active agency head during President Donald J. Trump’s second term.

Last week, Kennedy appeared before both the House Appropriations Committee and the Senate Health, Education, Labor, and Pensions (HELP) Committee and gave a masterclass in how to answer inane Democratic narrative-based questioning. He also ordered a review of abortion pill safety data, worried that the real statistics indicated more adverse effects than originally advertised.

Now, the HHS has discontinued the Centers for Disease Control and Prevention (CDC) recommendations that children, teenagers, and pregnant women receive routine COVID-19 vaccinations.

The article notes:

This marks a significant shift in federal health policy, moving away from the universal vaccination guidance that has been in place since September 2023. The new rules also promote a new framework for the testing of annual vaccines.

According to a report published Tuesday morning by The Associated Press, the Food and Drug Administration (FDA) would recommend annual booster shots for adults over the age of 65 in addition to younger adults and children whose pre-existing conditions or health concerns put them at greater risk of hospitalization or death from contracting COVID-19.

An article published on Tuesday by the New England Journal of Medicine provides a framework for developing and testing annual vaccines that might eventually be offered to generally healthy people who don’t fall into the currently recommended age and risk categories.

“For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted,” the article read. “Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment.”

These are welcome changes. Let’s go back to the day when parents decided what shots they or their children would receive.

Protecting Women’s Health

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This is not an article to debate abortion. I believe abortion is wrong for a number of reasons, but that is not what this article is about. The link between Planned Parenthood and Margaret Sanger is troubling at best. The fact that the majority of abortion clinics are located in low-income neighborhoods is also troubling, but more troubling is the fact that the dangers of the abortion pill are being overlooked.

On Thursday, The Federalist reported:

More than 100 pro-life, pro-women, and pro-family organizations sent a letter to President Donald Trump’s top drug and health agencies asking them to “put the safety of women first” by reinstating the abortion pill safeguards stripped away by the Obama and Biden administrations.

“The danger this drug poses to women and girls is clear,” the letter states.

In the request to U.S. Food and Drug Administration Commissioner Martin Makary and U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the coalition of concerned advocates warned that data shows “chemical abortion is neither safe nor effective.”

“In short, the FDA’s purpose is to safeguard the health and safety of Americans. In the case of mifepristone, these bedrock principles—necessary not only for the trust of Americans, but also for the safety of women—have been undermined by political whims that obscured the growing evidence of mifepristone’s harm,” the letter continues.

The letter highlighted a new landmark study, which determined that mifepristone, a key part of the drug regimen used to complete more than half of the nation’s abortions, has a rate of life-threatening or serious complications that is at least 22 times higher than what the FDA and the pill’s manufacturer suggest.

Corporate media tried to blackout and undermine the study with smears that it is “bogus,” relies on “bad data,“ and amounts to “junk science” because it was not peer reviewed. The Washington Post even claimed that the discovery of mifepristone’s high injury rate is no big deal because it has a warning label.

Researchers Ryan Anderson and Jamie Bryan Hall told The Federalist they were careful to exclude certain data, including 72 percent of emergency room visit diagnoses, to avoid overstating the risks of the drug. Even with that added caution, they found “11 percent of women who have a chemical abortion suffer a serious adverse event.”

Obviously, pregnancy is a natural reaction to a certain activity. It is a natural function of a woman’s body–it is not a disease that needs to be cured, and it is not simply a lump of cells to be destroyed. When you use a drug to interfere with the body’s natural function, there are going to be consequences. When that drug kills something that is attached to the body, there may be complications.

It’s time that the Food and Drug Administration actually worked for the benefit of Americans rather than for the benefit of drug companies. We have seen the scandals with tobacco, Oxycontin, the Covid-19 vaccine, and now the abortion pill. The agency needs either to go away or to change its paradigm.

Good News For America

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On Saturday, Just the News posted an article about a recent announcement from the U.S. Food and Drug Administration.

The article reports:

Butterfly pea flower extract, Galdieria extract blue, and calcium phosphate have now received approval or expanded approval for use in a variety of snacks and beverages, the latest step forward in Health and Human Services Secretary Robert F. Kennedy’s plan to substitute synthetic dyes.

“For too long, our food system has relied on synthetic, petroleum-based dyes that offer no nutritional value and pose unnecessary health risks,” Kennedy said in a statement. “We’re removing these dyes and approving safe, natural alternatives – to protect families and support healthier choices.”

In April, the FDA and HHS announced a phaseout timeline for petroleum-based food additives – which are correlated with several health problems in children – and promised to accelerate the approval process of natural alternatives to assist the transition.

The American food industry has until the end of 2025 to remove Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1 and Blue No. 2 from their products, as The Center Square reported.

A website called foodbabe.com has a few pictures showing labels of American foods and the labels of those same foods in other countries. There are a lot of ingredients in American foods that are banned in other countries.

Here are two examples:

I consider ketchup one of the basic food groups. It is available locally with sugar instead of high fructose corn syrup. However, generally speaking, the stuff you get in restaurants is the high fructose corn syrup variety.

The article at Just the News concludes:

Calcium phosphate, a natural compound found in bones and teeth, is now approved for use of white colorant in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.

“On April 22, I said the FDA would soon approve several new color additives and would accelerate our review of others,” FDA Commissioner Martin Makary said Friday. “FDA staff have been moving quickly to expedite the publication of these decisions, underscoring our serious intent to transition away from petroleum-based dyes in the food supply and provide new colors from natural sources.”

I am looking forward to having to read fewer labels when I shop!

This Is Wonderful News

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On Sunday, Breitbart reported:

Dr. Jay Bhattacharya, President Donald Trump’s director of the National Institutes of Health (NIH), announced the closure of the agency’s last remaining beagle experiment lab over the weekend after former NIH physician Dr. Anthony Fauci’s horrific beagle-testing scandal was exposed.

“It’s very easy, for instance, to cure Alzheimer’s in mice. But those things don’t translate to humans,” Bhattacharya told Fox News host Rachel Campos-Duffy on Sunday:

…“So we put forward a policy to replace animals in research with technological advances, AI and other tools, that actually translate better to human health.”

When he made the announcement that “We got rid of all of the beagle experiments on NIH campus,” Campus-Duffy said, “Amen.”

NIH confirmed the move on social media, saying it has enacted an “initiative to expand innovative, human-based science while reducing animal use in research, including getting rid of all the beagle experiments on the NIH campus.”

A years-long investigation by medical watchdog group White Coat Waste revealed that the NIH killed over 2,100 beagles in “brutal septic shock experiments” since 1986.

The article concludes:

The Trump administration has been stepping away from animal testing within other agencies as well, with animal rights group PETA praising the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) for “helping spare tens of thousands of animals each year.”

There are better ways of gathering information than torturing animals. The experiments carried out on beagles during the time Dr. Fauci was in charge were horrific. I am truly glad to see experiments on animals end. Scientists need to find better ways to collect the information they need.

We Have Reached Peak Ridiculousness

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On November 11th, Breitbart posted an article about a recent recall by the Food and Drug Administration.

The article reports:

The U.S. Food and Drug Administration (FDA) ordered the recall of nearly 80,000 pounds of butter produced in Texas for Costco. The agency ordered the recall because the product packaging contained no “Contains Milk” allergy statement.

Food & Wine reported that the FDA issued a Class II recall on November 7 for 79,200 pounds of Kirkland Signature Sweet Cream Butter (salted and unsalted). The FDA claimed the butter packaging lists “cream” as an ingredient but does not bear the “Contains Milk” allergy statement.

The American Heritage Dictionary defines butter as follows:

People who are allergic to milk are generally allergic to cream. People who are allergic to milk have probably learned to read labels in order to avoid setting off their milk allergy.

The article includes some interesting screen shots:

As someone who is lactose intolerant (someone who has problems digesting milk), I think this is the dumbest recall ever. People who have the problem have learned to read labels.

How Safe Is The Manufacturing Of The Vaccine?

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On Sunday (updated Monday), The Epoch Times posted an article about manufacturing violations in the production of the Moderna Covid-19 vaccine.

The article reports:

U.S. Food and Drug Administration (FDA) inspectors uncovered problems at a Moderna plant used to manufacture a substance that is part of the company’s COVID-19 vaccine, according to a newly released document.

Moderna failed to meet multiple requirements, including rules aimed at minimizing the potential for contamination, according to the document.

FDA inspectors performed inspections at the plant in Norwood, Massachusetts from, Sept. 11 to Sept. 21, visiting nine times in total.

They found that equipment used to manufacture the substance was not cleaned properly before usage, that a mock cleaning done for manufacturing did not adequately simulate the actual process, that written alarm procedures were not followed, and that neither the equipment nor the plant were designed in a way that would make contamination less likely.

Inspectors also learned that Moderna used materials beyond their expiration date.

“There are more than two thousand expired items stored in your … warehouse and cold storage at time of inspection,” Unnee Ranjan, the FDA’s lead investigator, wrote in a summary of the inspections.

The article concludes:

Another part of the FDA report, dated Sept. 21, described how the Norwood facility did not have adequately designed air handling systems to “assure appropriate air quality in the … cleanroom in which the mRNA drug substance is manufactured.”

Inspectors also said they found positive air pressure was not “consistently maintained” between cleanrooms and airlocks and that monitoring data showed the cleanroom pressure turned negative between January and September. That development was “not assessed for potential impact,” they said.

“At face value, it appears multiple controls designed to prevent contamination were deficient,” Mr. Lynn said.

Another recently released document, produced by the nonprofit Informed Consent Action Network on orders from a federal judge, showed the FDA detected in Andover, Massachusetts, issues with the manufacture of a substance used in the Pfizer-BioNTech vaccine. Pfizer said in response it had taken actions to correct the issues.

The government is still putting ads up on television encouraging Americans to take the vaccine, even after there have been numerous reports of serious side effects. Now we find out there are manufacturing problems also? It’s time for the Covid vaccine to go away.

 

 

It’s A Little Late

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On Thursday, The Epoch Times reported that the Food and Drug Administration (FDA) has now approved the use of Ivermectin for the treatment of Covid-19.

The article reports:

Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.

“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.

The government is defending the FDA’s repeated exhortations to people to not take ivermectin for COVID-19, including a post that said “Stop it.”

The case was brought by three doctors who allege the FDA unlawfully interfered with their practice of medicine with the statements. A federal judge dismissed the case in 2022, prompting an appeal.

“The fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does it then have the authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no,” Jared Kelson, representing the doctors, told the appeals court.

The FDA on Aug. 21, 2021, wrote on X, formerly known as Twitter: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The post, which linked to an FDA page that says people shouldn’t use ivermectin to prevent or treat COVID-19, went viral.

In other statements, the FDA said that ivermectin “isn’t authorized or approved to treat COVID-19” and “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”

The article concludes:

Dr. Marik has noted that a number of studies support using ivermectin against COVID-19, as the FDA itself has acknowledged. Some other studies show little to no effect.

Federal law enables the FDA to provide information, such as reports of adverse reactions to drugs, but not medical advice, Mr. Kelson said.

“This is something the FDA has never been able to do. And it’s a bright line,” he told the court, adding later: “The clearest examples of where they have gone over the line are when they say things like, ‘You are not a horse, you are not a cow. Seriously, y’all. Stop it.’”

Judges indicated they agree that the FDA lacks the power to give medical advice; Judge Clement said, “You’re not authorized to give medical advice.”

But Ms. Honold said the government “isn’t conceding that in this case.”

She also argued that Congress has empowered the FDA to protect public health and make sure regulated products are safe and effective, giving it the “inherent authority to further its mission by communicating information to the public about safe uses of drugs.”

A ruling in favor of the doctors would prevent the FDA from reporting on consumers suffering after cooking chicken with NyQuil or that opioid addiction is a problem, she claimed.

Mr. Kelson said that wasn’t accurate. “It’s when they step beyond that [and] start telling people how they should or should not be using approved drugs,” he said.

Ms. Honold also said that the courts can’t hold agencies accountable when they provide false or misleading information: “The FDA is politically accountable, just like all other executive agencies.”

Check the statistics on Covid deaths in countries where people routinely take Ivermectin to prevent parasites. There are very few deaths in those countries.

While We Were Watching Other Things

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On Wednesday, KTVZ in Bend, Oregon,  reported the following:

Cultivated meat, also known as lab-grown meat, has been cleared for sale in the United States.

Upside Foods and Good Meat, two companies that make what they call “cultivated chicken,” said Wednesday that they have gotten approval from the US Department of Agriculture to start producing their cell-based proteins.

Good Meat, which is owned by plant-based egg substitute maker Eat Just, said that production is starting immediately. Cultivated or lab-grown meat is grown in a giant vat, much like what you’d find at a beer brewery.

Wednesday’s move follows a series of previous approvals which have paved the way for sales of cultivated meat in the US.

Last week, Good Meat and Upside said they had received approval for labels for its product from the USDA. In March, Good said it had received a so-called “no questions” letter from the Food and Drug Administration. That letter states that the administration is satisfied that the product is safe to sell in the United States. The FDA issued a similar letter Upside Foods in November.

The nascent cultivated meat sector is being overseen by both the USDA and the FDA.

Good Meat, which has been selling its products in Singapore, advertises its product as “meat without slaughter,” a more humane approach to eating meat. Supporters hope that cultured meat will help fight climate change by reducing the need for traditional animal agriculture, which emits greenhouse gases.

This is the latest move by the climate extremists to separate Americans from their hamburgers and steaks. I suspect that we will reach a point where farming and raising cattle are looked upon as undesirable activities, and those professions will gradually be phased out to be replaced by fake food. I really think this is a bad idea.

The article concludes:

Upside founder and CEO Uma Valeti on Wednesday called the approval “a giant step forward towards a more sustainable future,” adding that it will “fundamentally change how meat makes it to our table.”

Upside is planning to introduce its product at Bar Crenn, a San Francisco restaurant, but did not share a launch date yet. Selling at Bar Crenn should help Upside learn more about how chefs and diners feel about the product, a representative said. Eventually, the company plans to work with other restaurants and make its products available in supermarkets.

For now, Upside is holding a contest to allow curious customers to be among the first to try the product in the US.

Don’t mess with my steak!

Disturbing Information On Covid Vaccines

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On Thursday, The Conservative Review posted an article about one aspect of the Covid vaccine that was kept from the public.

The article reports:

No wonder Pfizer and the FDA sought to hide these documents from the public for 75 years. To this day, the medical field is pressuring pregnant women to get these terrible shots, but now we know that Pfizer was tracking safety concerns for these women from day one. As we observe plummeting birth rates and skyrocketing fetal losses throughout the world, it is now clear that Pfizer and the FDA were aware that the vaccine could spread through the placenta and breast milk, as later studies seemed to confirm. Where is the action from Congress? This affects all of humanity, including a generation yet to be born.

The eight-page confidential document was dated April 20, 2021, but tracked 458 pregnant women and 215 lactating women from the time the shots were released until February 28, 2021. That was the same date that Pfizer already recorded over 1,200 deaths and over 1,000 categories of serious adverse events.

The article concludes:

How can Congress continue to allow multiple DOD and HHS agencies to funnel billions of dollars to Pfizer to continue producing similar biologics that are so harmful at the same time they are indemnified from liability? The company is able to use the taxpayer-funded revenue to then funnel money to powerful organizations to promote mandates. Earlier this week, Lee Fang posted on his Substack a copy of the disclosures showing some of the top medical and civic organizations took Pfizer funding before pushing the mandates.

These organizations included the Chicago Urban League, the American Academy of Pediatrics (AAP), the National Consumers League, The Immunization Partnership, the American Pharmacists Association, the American College of Preventive Medicine, the Academy of Managed Care Pharmacy, the American Society for Clinical Pathology and the American College of Emergency Physicians.

Thus, it’s quite evident that none of the decisions of “private” institutions to mandate or even endorse the shots were driven by free market factors, but by government funding, coercion, and denying those initially injured during the early weeks an ability to sue Pfizer, which is a gross violation of the Seventh Amendment.

In many respects, this “public-private” partnership is more fascistic than pure unvarnished government action because we cannot vote out the leadership of Pfizer. To that end, either the subsidies or the liability exemptions need to be repealed. Yet Congress hasn’t even precluded mandates in the future. What a disgrace!

Is anyone in the Government or in the medical or civic community actually looking out for the health of Americans?

The Pause In The Mandate

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On Friday The Conservative Review posted an article about mandatory Covid vaccine shots.

The article reports:

Some of you might have jumped with elation on Tuesday after hearing the news that the FDA had de-authorized the original series of COVID shots. What the agency is really doing, however, is reloading so it can enshrine the shots into the permanent immunization schedule and mix them with an ever-growing list of respiratory viral vaccines they are rolling out over the coming months. Now is the time for Congress to step on the gas pedal in opposing these shots, not tabling the issue as if it’s over.

The FDA and CDC had a problem. There was no way to continue marketing the shots any longer as an imminent and urgent need for an ongoing pandemic. After all, even the president has said the pandemic is over. Were they to continue packaging the shots as a continual series for protection against the pandemic, they’d be left with fewer than 1% of the public getting them. So rather than simply canceling them, as Switzerland and other countries are doing, the FDA pulled a bait-and-switch. Officials de-authorized the original series of shots to signal the pandemic is over. But now they have established a system that will allow them to enshrine the newer bivalent shot or some future version, perhaps mixed with flu and RSV, as an annual single shot.

Why is this so significant? With the public already groomed into thinking they need an annual flu shot, officials now hope to treat COVID like the flu shot.

The article notes:

Indeed, the FDA’s announcement was designed to signal to Republicans that they can tell their base the issue is over, when in fact it’s just beginning. For example, given that Congress and the president have terminated the public health emergency, why did HHS Secretary Xavier Becerra announce last week an extension of the PREP Act liability waivers for all COVID-related products all the way through the end of 2024? Why is there such a need to continue suspending the Seventh Amendment’s guarantee of a jury trial by absolving Pfizer and Moderna of all liability?

Clearly, they are not done. Which is why Republicans must use reauthorization bills to rectify the dozen or so atrocities committed against the people using pandemic authority.

There are still a lot of questions about the vaccine and about boosters. I personally know someone who developed Bell’s Palsy after a booster. Her doctor advised her not to get any more boosters. I suspect she is not the only one who reacted to the shot that way. If nothing else, the continuing liability waivers are a concern–if the vaccine is totally safe, why do we need the waivers?

Investigating Government Policies On Covid-19

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I seriously doubt that there was a perfect solution for handling Covid-19 when it appeared in 2020. However, I also wonder if the government actually got anything rights. An investigation into the government’s handling of the pandemic would be very useful in developing a template for handling future pandemics.

On January 19th, The Daily Signal posted a checklist for the House of Representatives committee that is investigating the government’s handling of the pandemic.

The article notes:

After three years, and more than 1 million deaths in the U.S. associated with COVID-19, a comprehensive, sober, and detailed investigation into the federal government’s response is a necessary precondition for restoring Americans’ trust in federal public health agencies.

Specifically, that includes the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, and the Office of the Secretary at the Department of Health and Human Services.  

A Heritage Foundation analysis of the federal public health performance identified 13 pandemic-related topics that deserve detailed congressional inquiry. (The Daily Signal is the news outlet of The Heritage Foundation.)

Here are some of the things that need to be investigated:

  • Why did the CDC, despite statutory requirements dating back to 2006, fail to modernize and upgrade its systems of data collection and dissemination? Dr. Deborah Birx, former coordinator of the White House Coronavirus Task Force under Trump, has already told Congress that “the No.1 public health issue in the United States today is that there is no comprehensive database or integration of data from laboratories, public health institutions, and clinics.”  
  • Why did federal public health authorities send out confusing messaging on the value of masks and mask mandates? Dr. Anthony Fauci and Dr. Nancy Messonnier of the CDC and then-Surgeon General Jerome Adams initially insisted, very publicly and sometimes vehemently, that masking was unnecessary or ineffective. Previous studies on masking indeed failed to provide strong support for cloth masking, let alone mask mandates. Between February and April 2020, however, top federal officials did a U-turn, and insisted on the value of a masking policy that they previously opposed. What was the new scientific evidence, then available in the professional literature, for such a dramatic policy reversal in that brief period? Congress should find out.
  • Why did federal officials attempt to impose a set of unprecedented vaccine mandates on tens of millions of Americans without weighing the risks and benefits of vaccination for different cohorts of the population, based on age, the acquisition of natural immunity, or an underlying vulnerability to the virus?  Young and healthy persons faced little danger of severe illness or death from COVID-19. Robust findings in the professional literature demonstrated the strength of natural immunity. Recent research on vaccine boosters for young adults concludes that potential harms outweigh the benefits of the vaccination.

Please follow the link to read the entire article. America is supposed to be a representative republic–our elected officials are supposed to represent us and answer to us–it’s time they did.

Playing Word Games With Americans’ Health

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On Saturday, The Epoch Times posted the following headline:

FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommendation

The article reports:

The U.S. Food and Drug Administration (FDA) telling people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation, government lawyers argued during a recent hearing.

“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the lawyers, told the court during the Nov. 1 hearing in federal court in Texas.

“They use informal language, that is true,” he also said, adding that, “it’s conversational but not mandatory.”

The hearing was held in a case brought by three doctors who say the FDA illegally interfered with their ability to prescribe medicine to their patients when it issued statements on ivermectin, an anti-parasitic that has shown positive results in some trials against COVID-19.

Ivermectin is approved by the FDA but not for COVID-19. Drugs are commonly used for non-approved purposes in the United States; the practice is known as off-label treatment.

This is a link to a CDC Health Advisory put out on August 26, 2021. I suspect that as this case moves forward, this Advisory may disappear, so I will quote some of it here:

Recommendations for the Public
• Be aware that currently, ivermectin has not been proven as a way to prevent or treat COVID–19.
• Do not swallow ivermectin products that should be used on skin (e.g., lotions and creams) or are
not meant for human use, such as veterinary ivermectin products.
• Seek immediate medical attention or call the poison control center hotline (1–800–222–1222) for advice if you have taken ivermectin or a product that contains ivermectin and are having
symptoms. Signs and symptoms include gastrointestinal effects (nausea, vomiting, abdominal pain, and diarrhea), headache, blurred vision, dizziness, fast heart rate, and low blood pressure.
Other severe nervous system effects have been reported, including tremors, seizures, hallucinations, confusion, loss of coordination and balance, decreased alertness, and coma.
• Get vaccinated against COVID–19. COVID–19 vaccination is approved by FDA and is the safest and most effective way to prevent getting sick and protect against severe disease and death from SARS–CoV–2, the virus that causes COVID–19, including the Delta variant.
• Protect yourself and others from getting sick with COVID–19. In addition to vaccination, wear masks in indoor public places, practice staying at least six feet from other people who don’t live in your household, avoid crowds and poorly ventilated spaces, and wash your hands often or use hand sanitizer that has at least 60 percent alcohol.

The article at The Epoch Times concludes:

“The government engaged in a singularly effective campaign here to malign a common drug that has been used for a very long time and has been dispensed in billions of doses. It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the ivermectin,’ I don’t understand how that would not be traceable back to the FDA,” Kelson said.

U.S. District Judge Jeffrey Brown, a Trump appointee overseeing the case, said that he was most concerned about the social media statements because they did not include any qualifiers.

Belfer argued the statements were aimed at consumers and that the Twitter posts linked to one of the pages, which does include the qualifier.

“So it was predictable that if you include the link to the article, people will click on the link and will see the full article, which includes that disclaimer that if your doctor writes you a prescription, you should fill it exactly as prescribed,” he said.

“The plaintiffs, by their own admission, have continued to prescribe ivermectin. So they always had the authority. It may be that patients were not able to fill prescriptions, but the doctors themselves always had the authority,” he added later.

Brown said he appreciated the briefing from the parties and that he would rule “as quickly as we can for ya’ll.” As of Nov. 19, he has not issued a ruling.

The government did everything it could to prevent the use of Ivermectin. The problem with Ivermectin is that it is cheap and the pharmaceutical companies do not make a lot of money on it. The medical profession has sold its soul for money, and people around the world have did because of it. Accountability is in order.

Is Accountability Coming?

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On September 30, Yahoo News posted the following headline:

The FDA Misled the Public About Ivermectin and Should Be Accountable in Court, Argues the Association of American Physicians and Surgeons (AAPS)

Wow. I have no idea what the motive of the FDA was (although I could make some educated guesses), but people died because of their actions. They do need to be held accountable.

The article reports:

The Association of American Physicians and Surgeons (AAPS) filed its motion and amicus brief Thursday evening with the federal district court in Galveston urging it to allow the lawsuit to proceed against the FDA for its misleading statements against ivermectin. In Apter v. HHS, a group of physicians sued to hold the Food and Drug Administration, a federal agency within the Department of Health & Human Services (HHS), accountable for its interference with physicians’ ability to treat Covid-19.

“Defendant FDA has improperly exploited misunderstandings about the legality and prevalence of off-label uses of medication, in order to mislead courts, state medical boards, and the public into thinking there is anything improper about off-label prescribing,” AAPS writes in its amicus brief to the court. “Not only is off-label prescribing fully proper, legal, and commonplace, but it is also absolutely necessary in order to give effective care to patients.”

Yet the FDA published multiple statements and sent letters to influential organizations to falsely disparage ivermectin, implying that it was not approved for treating Covid-19. Many, including courts and state medical boards, were misled by the FDA into thinking that its lack of approval for this treatment meant that ivermectin should not be used to treat Covid-19.

“It has never been proper for the FDA to interfere with that essential part of the practice of medicine, and the FDA knows it,” AAPS informed the court. The FDA “insisted and continues to insist on interfering with the prescription of this safe medication by physicians in treating Covid-19,” AAPS added.

The article notes that AAPS General Counsel Andrew Schlafly stated that once the FDA approves a medication as safe, then physicians have full authority to prescribe it to treat any illness.

People died because of the actions of the FDA.

Is Anyone Comfortable With This?

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On Sunday, The U.K Daily Mail posted the following headline, “FDA set to authorize updated COVID-19 booster shots for newer Omicron strains without completed human tests: Agency will assess new jabs based on mice research and older vaccines.”

The article reports:

New COVID-19 booster shots are set to be authorized this week by the Food and Drug Administration (FDA) and will be available to most Americans before human testing has even been completed.

The shots have been modified to target the latest Omicron variant, but won’t have finished testing in humans when the FDA makes the decision. Instead, the FDA is relying on data from other sources – like research in mice and older vaccines, the Wall Street Journal reported.

‘Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,’ FDA Commissioner Robert Califf said in a tweet last week. 

This is insane.

The article notes:

WILL THEY WORK BETTER?

No one knows. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and an FDA vaccine adviser, said the antibody jump from that earlier BA.1-tweaked candidate was ‘underwhelming.’

‘What the administration is asking us to do is to accept this bivalent vaccine as significantly better’ than another dose of today’s vaccine, he said. ‘It would be nice if there were data to support that.’

But while FDA hasn’t made a final decision, Marks said there’s evidence that the updated boosters are safe and that waiting for more study of their effectiveness would risk another mutant appearing before they could roll out.

They ‘essentially refresh the immune response,’ he said. ‘Granted, it’s still a bit of a guess how long it will last but, this is doing our best.’

Given how outdated the current shots are, an update makes sense, said Dr. Walter Orenstein of Emory University, a former vaccine director at the Centers for Disease Control and Prevention. While he’d like to see more data, he plans to get the new booster.

 A large percentage of Americans have had Covid. They have natural immunity. The shots did not prevent people from getting or spreading Covid, so why in the world should they get the booster. The current variant of Covid is not a danger to most Americans. The only reason to continue with the nonsense of creating vaccines that don’t work is financial, and that is not a valid reason to inject people with an untried vaccine.

Lied To Again

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On Wednesday, The Epoch Times posted an article about the connection between the Covid-19 vaccines and heart inflammation.

The article reports:

The U.S. Centers for Disease Control and Prevention (CDC) has claimed that there was no known association between heart inflammation and COVID-19 vaccines as late as October 2021.

CDC officials made the claim, which is false, in response to a Freedom of Information Act request for reports from a CDC team that is focused on analyzing the risk of post-vaccination myocarditis and pericarditis, two forms of heart inflammation. Both began to be detected at higher-than-expected rates after COVID-19 vaccination in the spring of 2021.

The team focuses on studying data from the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system co-run by the CDC and the U.S. Food and Drug Administration.

The date range for the search was April 2, 2021, to Oct. 2, 2021.

“The National Center for Emerging Zoonotic Infectious Diseases performed a search of our records that failed to reveal any documents pertaining to your request,” Roger Andoh, a CDC records officer, told The Epoch Times. The center is part of the CDC.

No abstractions or reports were available because “an association between myocarditis and mRNA COVID-19 vaccination was not known at that time,” Andoh added.

Reports of heart inflammation after COVID-19 vaccination were first made public in April 2021 by the U.S. military, which detected the issue along with Israeli authorities well before the CDC.

While Dr. Rochelle Walensky, the CDC’s director, said that month that the agency had looked for a safety signal in its data and found none, by the end of June CDC researchers were saying that the available data “suggest an association with immunization,” and in August described (pdf) the issue as a “harm” from vaccination.

The claim that the link wasn’t known “is provably false,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times via email. “Either the right hand does not know what the left hand is doing at CDC, or federal health officials are disseminating misinformation about what they knew about myocarditis following mRNA COVID vaccines and when they knew it.”

Sen. Ron Johnson (R-Wis.) said that the FOIA response “raises even more questions about the agency’s honesty, transparency, and use, or lack thereof, of its safety surveillance systems, such as VAERS, to detect COVID-19 vaccine adverse events.”

I do not claim to understand the technical aspect of this article. However, I do believe that the CDC and vaccine manufacturers have not been honest about the long-term effects of the Covid vaccines. I am not sure that they understand the long-term effects of the vaccines. I do think the time has come to do away with vaccine mandates (the vaccine is still supposedly experimental and only to be authorized in a state of emergency) and get on with our lives.

When The Government Interferes With Medical Treatment

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On Monday, Townhall reported on a lawsuit filed by a group of doctors against the Food and Drug Administration.

The article reports:

In a lawsuit filed earlier this month, a group of doctors sued the Food and Drug Administration and Department of Health and Human Services for “unlawfully” interfering with their ability to practice medicine and prescribe ivermectin for use in Covid-19 patients.

Specifically, the three doctors—Robert L. Apter, Mary Talley Bowden and Paul E. Marik—argue the FDA can’t ban use of an approved human drug for “off-label” use. 

“The FDA also can not advise whether a patient should take an approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient relationship,” the complaint says. “Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is — and always has been — reserved to states.”

The article concludes:

In a statement, Bowden said “fighting the system has been a much bigger challenge than fighting the disease.“

“Despite my excellent track record treating COVID patients, the FDA’s smear campaign against ivermectin continues to be a daily hurdle to overcome,” she said. “I am fighting back – the public needs to understand what the FDA has done is illegal, and I hope this suit will prevent them from continuing to interfere in the doctor-patient relationship.”

The government’s handling of the use of ivermectin in concerning. It was proven early on that if you administered ivermectin to Covid patients early, the results were positive. The fact that the government opposed the use of ivermectin is puzzling. Hopefully the disclosure portion of this lawsuit will shed some light on that.

Information We All Need

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On Tuesday, The Washington Examiner posted an article about Monkeypox. The article provides a brief summary of the things the public needs to know.

Here are some excerpts:

In total, 92 cases of monkeypox have been confirmed so far, with another 28 suspected cases, according to the World Health Organization. Most of the cases in the U.K. and Europe have been in young men with no history of travel to Africa and who were gay, bisexual, or had sex with men.

…All of the cases that have been confirmed through a PCR test were infected by the strain native to West Africa, but only one case has a direct tie to the region. The first to be confirmed in the U.K. was a person who had traveled from the U.K. to Nigeria and back. The person was immediately isolated upon return, and “the risk of onward transmission related to this case in the United Kingdom is minimal,” the WHO said. But that still leaves open the question of where the dozens of other cases came from.

A leading adviser to the WHO, Dr. David Heymann, told the Associated Press that sexual transmission at two raves in Belgium and Spain appear to have been major catalysts for the spread of the virus in Europe.

…There is not currently a vaccine made specifically to prevent monkeypox infection, but smallpox vaccines have proven to be at least 85% effective in preventing monkeypox. Experts also believe that administering a smallpox vaccine after a monkeypox exposure may help prevent the disease or make it less severe.

The article concludes:

Infectious disease experts said this outbreak is very different from COVID-19, which caught the U.S. public health infrastructure off guard. Unlike symptoms of COVID-19 infection, symptoms of monkeypox are visual and cases are easier to trace. Monkeypox is also far less transmissible than COVID-19. And unlike COVID-19, monkeypox is not an airborne pathogen.

“Contact tracing COVID-19 is a nightmare, and I don’t want to say it’s a piece of cake, but it’s a much more straightforward proposition [to trace monkeypox],” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development.

The Food and Drug Administration has also approved several antiviral medications to treat smallpox and diseases like it.

“That’s why I’m pretty optimistic that we’ll be able to contain it because the overall level of transmissibility is low, the incubation period is longer, and in about two weeks, the characteristic rash makes contact tracing easier, and we already have vaccines and antiviral drugs ready to go. … [COVID-19 is] really just the opposite of monkeypox,” Hotez told the Washington Examiner.

At least there is some good news.

Somehow The Mainstream Media Missed This Story

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On Friday, The Epoch Times reported the following:

Pfizer hired 600 employees in the months after its COVID-19 vaccine was authorized in the United States due to the “large increase” of reports of side effects linked to the vaccine, according to a document prepared by the company.

Pfizer has “taken a multiple actions to help alleviate the large increase of adverse event reports,” according to the document. “This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.”

At the time when the document—from the first quarter of 2021—was sent to the U.S. Food and Drug Administration (FDA), Pfizer had onboarded about 600 extra full-time workers to deal with the jump.

“More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021,” Pfizer said.

The document was titled a “cumulative analysis of post-authorization adverse event reports” of Pfizer’s vaccine received through Feb. 28, 2021. It was approved by the FDA on April 30, 2021.

The document was not made public until the Public Health and Medical Professionals for Transparency sued the FDA after the agency claimed it needed decades to produce all the documents relating to the emergency use authorization granted to the company for the vaccine.

Under an agreement reached in February, the FDA must produce a certain number of pages each month.

The article concludes:

Pfizer did not respond to emailed questions, including how many workers it has onboarded to deal with adverse events.

The companies that manufacture the other two COVID-19 vaccines that U.S. regulators have cleared, Moderna and Johnson & Johnson, did not respond when asked if they have seen an increase in adverse events and if they have hired more employees to deal with reports.

The number of post-vaccination adverse event reports to the Vaccine Adverse Event Reporting System, jointly run by the FDA and the Centers for Disease Control and Prevention, has spiked since the vaccines were first cleared.

Problems linked to the vaccines include heart inflammation, blood clotting, and severe allergic shock.

Federal officials say the vaccines’ benefits outweigh the risks, but some experts are increasingly questioning that assertion, particularly for certain populations.

People should have been made aware of this as the vaccine was being pushed by the government. A vaccine that doesn’t prevent the illness and has serious side effects does not seem to be the answer to the pandemic. Please follow the link above to read the entire article. If you are not yet vaxxed, you might not want to rush out to receive the vaccination.

Do The Fact-Checkers Actually Check The Facts?

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On Sunday, Forbes posted an article about fact checkers. The article specifically focuses on the fact-checkers who ‘check facts’ in the areas of Covid-19 and climate change, two of the more controversial topics of the day.

On the subject of Covid-19, the article notes:

Over two years into the pandemic, some of the most basic questions remain contentious, and even questions of data integrity remain mired in controversy. Are covid deaths over-reported since many may have died with covid rather than of covid? Did lockdowns and masks make any discernible difference to public health? Are there viable early treatments for the disease available or are vaccines approved under Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) the only way to go? Are covid vaccines safe and effective? To each of these questions, the overwhelming majority of the fact checking sites (or fact checking departments of the legacy media) support the reigning narrative articulated by big pharmaceutical companies, government agencies such as the Centers for Disease Control and Prevention (CDC) and the FDA, and key government officials such as Dr. Anthony Fauci. The Biden administration welcomes this, and goes further in calling social media companies such as Facebook to partner with the White House to “fight misinformation” about covid-19.

When three distinguished medical people released the Great Barrington Declaration which contradicted the administration’s policies, their ideas were immediately squelched without debate. That’s not how science is supposed to work.

The article also discusses the climate-change fact-checkers:

Like the media coverage of covid-19, climate change headlines in the mainstream media for the past three decades have been overwhelmingly one-sided. The basic premise is that the “science is settled” as in a tweet by then U.S. President Barack Obama in 2013: “Ninety-seven percent of scientists agree: climate change is real, man-made and dangerous” with the obvious subtext: “Who are you to challenge this?” And, as in the covid-19 context, the marginalization of climate sceptics has a long track record.

Two examples suffice how fact checks and editorializing serve to ensure that sceptics need not apply for access to the wider public. The first relates to the London-based BBC, fondly known as “beebs”, for its authoritative news broadcasts around the world as it emerged from the ashes of World War II. The British media giant was known and praised not only for its balanced news features but also for its nature documentaries. And in this space, two celebrities with the same first name – David Bellamy and David Attenborough – emerged in the 1970s, directing fascinating TV programs on nature and the environment from every corner of the globe into tens of millions of homes. As British commentator James Dellingpole wrote in his eulogy to Bellamy who died in 2019, “both were superstars…both were well on their way to becoming national treasures.”

Yet, while one, Attenborough, basks in the glow of international fame and is invited to many of the climate conferences as star speaker and delegate, the other claimed he had become a pariah as soon as he rejected group-think on global warming – describing climate change as “poppycock”. Though his climate scepticism killed his media career he remained utterly unrepentant. The BBC itself has made it clear to its staff that it will not invite climate sceptics to its interviews and panel discussions to balance debates because the “science is settled”

The article concludes:

Without getting into details about the claims of the so-called factchecker, the key point here is to note the perversions of truth in representing the arguments critiqued in such “fact checks”. Perhaps this is best revealed by the fact that Facebook argued in its legal defence that its cited fact check was “just opinion” when faced by a lawsuit brought by celebrated journalist John Stossel who had posted two climate change videos.

Readers and viewers beware of this peculiar twist to the caveat emptor clause: the “fact checks” used by the mainstream news outlets and social media to police what you read and watch are just opinions.

Please follow the link above to read the entire article. We are being played.

A Constitutional Republic Will Only Stand As Long As Its Citizens And Voters Are Able To Stay Informed

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On Tuesday, The Western Journal posted an article about the lack of transparency and misinformation coming out of the Centers for Disease Control and Prevention (CDC) during the past two years or so.

The article notes:

The Centers for Disease Control and Prevention is being called out for not sharing the vast quantities of data it had been gathering during the COVID-19 pandemic.

Some medical experts are speculating that the reason why is the fear the data will be “misinterpreted” and used as justification not to follow the agency’s guidelines regarding vaccination and other matters.

“Tell the truth, present the data,” said Dr. Paul Offit, a vaccine expert and adviser to the Food and Drug Administration, The New York Times reported.

…Kristen Nordlund, a spokeswoman for the CDC, told the news outlet the reason much of the data has been withheld is “because basically, at the end of the day, it’s not yet ready for prime time.”

Bureaucracy is another reason.

The CDC is weighed down by multiple layers of bureaucracy, including a requirement to first run information to be released through the Department Health and Human Services and the White House.

“The CDC is a political organization as much as it is a public health organization,” said Samuel Scarpino, managing director of pathogen surveillance at the Rockefeller Foundation’s Pandemic Prevention Institute, the Times reported.

“The steps that it takes to get something like this [covid data] released are often well outside of the control of many of the scientists that work at the CDC.”

The article concludes:

In an opinion piece in The Wall Street Journal last month, Makary (Dr. Marty Makary, a professor and researcher at the Johns Hopkins University School of Medicine) contended that another topic the CDC has been reluctant to address is natural immunity.

“For most of last year, many of us called for the Centers for Disease Control and Prevention to release its data on reinfection rates, but the agency refused,” he wrote.

“Finally last week, the CDC released data from New York and California, which demonstrated natural immunity was 2.8 times as effective in preventing hospitalization and 3.3 to 4.7 times as effective in preventing Covid infection compared with vaccination,” he continued.

Makary further noted the National Institutes of Health resisted acknowledging natural immunity.

“Because of the NIH’s inaction, my Johns Hopkins colleagues and I conducted the study. We found that among 295 unvaccinated people who previously had Covid, antibodies were present in 99 percent of them up to nearly two years after infection,” he wrote.

Makary argued the failure of the CDC to release the data sooner meant many who had previously recovered from COVID and had better immunity than those were just vaccinated needlessly lost their jobs.

He concluded that they should be hired back.

There was a political agenda here and a monetary agenda here. The CDC is too closely tied financially to the drug companies. There was more money in vaccines than there ever was in ivermectin!

The Case Against Vaccine Mandates

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On Wednesday, The Epoch Times posted an article about a recent statement by Dr. Peter McCullough.

The article reports:

COVID-19 vaccine mandates “have to be repealed” as the vaccines are “still in research” and “people cannot be mandated to participate in research,” says Dr. Peter McCullough.

McCullough, a cardiologist, epidemiologist, and internist who manages COVID-19 patients with heart-related complications and patients who become ill after receiving a COVID-19 vaccine, contends that COVID-19 vaccine mandates violate the Nuremberg Code.

“When it comes to research, research can only be voluntary. And under no circumstances can anyone receiving pressure, coercion, or threat of reprisal cannot violate the cornerstone of ethics unethical, is immoral to do that,” he says.

McCullough notes that the CDC and FDA have yet to publish “their first monthly safety report” on the vaccines, and that as of Dec. 17, the CDC’s VAERS (Vaccine Adverse Events Reporting System) has reported 20,622 deaths post-vaccination globally and over 983,000 adverse events.

The article includes a statement about the accuracy of the VAERS data:

…a June 2021 analysis of VAERS COVID-19 vaccine death reports led by the University of London’s Scott Mclachlan. Mclachlan found that “contrary to claims that most of these reports are made by lay-people and are hence clinically unreliable,” health service employees were the reporters at least 67 percent of the time, and “there were only 14 percent of the cases for which a vaccine reaction could be ruled out as a contributing factor in their death.”

The article concludes:

A lawsuit was recently filed against the FDA by a medical transparency group, Public Health and Medical Professionals for Transparency (PHMPT) formed by a group of doctors and scientists, including Harvey Risch, a professor of epidemiology at the Yale School of Public Health.

The FDA has asked a judge to grant it 75 years to fully release the documents in its possession tied to the approval of the Pfizer-BioNTech COVID-19 vaccine.

Aaron Siri, a lawyer working on the case, on Dec. 8 wrote, “If you find what you are reading difficult to believe—that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.”

Since its initial announcement of vaccine mandates in both the federal and private sectors, the Biden administration has emphasized that “vaccines are safe, free, and the most effective way for workers to be protected from COVID-19 transmission at work.”

The Epoch Times reached out to the CDC and the White House for comment.

If someone wants to get the vaccine, let them. However, vaccine mandates are simply not the right thing to do. They are unconstitutional and violate the civil rights of Americans. The government has no right to tell you that you have to take a drug or put something into you body against you will.

 

Actually Following The Science

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On December 21st, The New York Post posted an article titled, “Biden needs to tell the FDA to stop blocking lifesaving COVID treatments.”

The article lists a number of treatments for COVID that have been tested scientifically and proven to be effective:

Fluvoxamine, a commonly available medication, reduced COVID deaths by 91 percent in a randomized controlled trial conducted with impeccable methodology and recently published in The Lancet. This study affirms another trial on the drug published last spring in the Journal of the American Medical Association. The drug is safe, has a plausible mechanism of action, costs $10 and has no contrary studies that might challenge the breathtaking results published. Yet I’ve never heard our public-health officials mention fluvoxamine.

…Merck’s lifesaving drug molnupiravir received an up-vote from the FDA’s external experts three weeks ago, yet the agency has not authorized the drug. Pfizer’s Paxlovid drug cut COVID deaths to zero (compared with 10 deaths in the control group), yet in the five weeks the FDA has been sitting on the application the agency has not even scheduled an advisory meeting to review it. Maybe functionaries don’t want to change their holiday plans.

The article also notes that the outbreak of the Omicron variant of COVID may actually contain some good news:

We also need straight talk when it comes to Omicron. Now 73 percent of new US COVID infections are from Omicron, a strain resulting in more mild illness. A University of Hong Kong study found that Omicron is one-tenth as infective in lung cells compared with the Delta variant. That explains why Omicron patients report far fewer cough and fever symptoms and far fewer people develop severe illness. Instead, the vast majority of Omicron-infected people get common-cold symptoms.

The fear headline is that Omicron partially evades antibody immunity. That’s true; so did Delta. But, also like Delta, Omicron does not escape existing T-cell immunity, according to a new Johns Hopkins study, which is consistent with mounting population data. Cases from the epicenter in Gauteng, South Africa, are plunging, down 44 percent Monday from the prior day. According to South African Health Minister Dr. Joe Phaahla, only 1.7 percent of COVID cases were hospitalized the second week of the Omicron-dominant wave, compared with 19 percent the same week of the Delta wave.

We now have laboratory data, epidemiological data and bedside observations to conclude that Omicron is a milder variant. We are witnessing how pandemics end — a virus mutates down and becomes endemic as population immunity increases.

There is a light at the end of this tunnel, but our government bureaucrats keep putting it out.

The Facts Are Slowing Coming Out

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On Thursday, The Patriot Daily Wire reported that the Food and Drug Administration (FDA) has released more information about the possible side effects of the Pfizer coronavirus vaccine.

The article reports:

As the FDA prepares to approve Pfizer’s new pill for treating high-risk patients infected with COVID, more information about dangerous side effects tied to its vaccine are coming to light.

Just yesterday, we reported another death tied to the vaccine in New Zealand. Now, documents released by the FDA reveal that drugmaker Pfizer recorded nearly 160K adverse reactions to its COVID vaccine in the initial months of its rollout.

The data were obtained by a group of doctors, professors, and journalists calling themselves Public Health and Medical Professionals for Transparency. They filed a Freedom of Information Act request with the FDA asking for their release. And the first tranche of documents revealed that, as of February 2021, when Pfizer’s shot was being rolled out worldwide on an emergency basis, the drugmaker had compiled more than 42K case reports detailing nearly 160K individual adverse reactions to the vaccine.

The data show the bulk of the adverse event cases, both serious and non-serious, were classified as “general disorders”.

You shouldn’t have to file a Freedom of Information request to get this data–it should be given to everyone who is considering getting the vaccine.

Please follow the link above to read the entire article. It includes the complete breakdown of data from Public Health and Medical Professionals For Transparency. There has to be a risk/benefit analysis when considering getting the vaccine. There also needs to be a discussion about how effective the vaccine actually is.

A Professional Stating The Obvious

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Despite being part of the Trump administration, Dr. Ben Carson is not a political animal. He tends to speak his mind regardless of the political winds. On Thursday, The Epoch Times posted an article about his views on the coronavirus pandemic.

The article notes:

“We’ve been having tunnel vision” dealing with the COVID-19 pandemic, Dr. Ben Carson told EpochTV’s “American Thought Leaders” program.

“Let’s throw the politics out. We could solve this problem pretty quickly,” he stated in an interview that will premiere on Dec. 18 at 7 p.m. New York time.

…“Let’s look around the world at things that work. Let’s look at the fact that on the western coast of Africa, there’s almost no COVID. And let’s ask ourselves, why is that? And then you see, it’s because they take antimalarials, particularly hydroxychloroquine. Let’s study that. Let’s see what’s going on there.

“Let’s listen to these physician groups who’ve had incredible success with ivermectin. Let’s look at the results with monoclonal antibodies. Let’s look at all of these things. Let’s put them all in our armamentarium so that we don’t have a one-size-fits-all system.”

The U.S. Food and Drug Administration (FDA) at one time had authorized hydroxychloroquine for treating certain COVID-19 patients but quickly revoked the emergency use authorization (EUA) in June 2020, claiming no data showed its effectiveness.

The FDA hasn’t approved or issued an EUA for ivermectin to treat COVID-19, citing the same reasons.

Using hydroxychloroquine or ivermectin to treat COVID-19 patients has been highly controversial. Some studies show, and some doctors claim, that hydroxychloroquine or ivermectin can effectively treat COVID-19 patients. A vaccine confidence insight report (pdf) from the Centers for Disease Control and Prevention (CDC) labeled such claims as misinformation or disinformation.

“COVID is a virus. Viruses mutate. That’s what they do. And they will continue to mutate,” Carson said.

Carson pointed out that fortunately, most of the time, viruses become a little weaker with each mutation.

The article concludes:

“We have a situation where you have the government advocating that children be vaccinated, even though the risk for death for a child with COVID is 0.025 percent, essentially the same as it is for seasonal flu. You don’t see us doing all this every year for seasonal flu,” Carson stated.

“The risk of mortality for a healthy child is approaching zero, and yet we’re saying do this without knowing what the long-term risks are?” he said. “And why would you subject an innocent child to a lifetime of unknown risk? It just makes absolutely no sense.

“We need to have faith in our government. We need to have faith in our health care systems. And by injecting politics into it, I think we have put ourselves behind the eight ball. It’s going to take a while to reestablish that trust,” he said.

“Why not learn how to look at what’s logical and what makes sense? And why not encourage discussion of those things, rather than everybody getting their respective corners and shooting hand grenades at each other?”

The way out is real leadership, he said.

“The only path is strong leadership. We don’t have that.”

As I have previously stated, “How many of our CDC officials and government officials own stock in pharmaceutical companies?”