Day: February 3, 2023

• The 2023 omnibus appropriations bill includes 19 lines that could give the U.S. Food and Drug Administration the power to ban off-label use of approved medications

• If the little-noticed provision is passed, doctors’ ability to freely treat patients, and patients’ ability to use all available treatments after making an informed decision, will be lost

• The amendment puts the FDA, and by proxy Big Pharma, at the helm of powerful health care decisions that should be made on an individual, personalized level between a patient and their health care provider

• In California, law AB 2098, which went into effect January 1, 2023, gives the state power to take away doctors’ medical licenses if they spread “misinformation” that goes against the standard COVID-19 rhetoric

• The trend to allow a Pharma-controlled government to silence your doctor and dictate basic components of your medical care is not confined to the U.S. — it’s happening globally

In the U.S., 1 in 5 prescriptions is written for an off-label use.

While sometimes this allows medications to be overused or misused, it also protects doctors’ ability to freely treat patients, and patients’ ability to use all available treatments after making an informed decision.

That 20% of medications are used off-label also indicates “a degree of freedom physicians currently have that will be foreclosed,” notes English comedian and actor Russell Brand,

if a little-noticed provision in the omnibus spending bill is passed. “Literally, this will mean that your doctor will not be able to do what’s best for you because they’ll work for Big Pharma now,” Brand says.

The 2023 omnibus appropriations bill — a 4,155-page tome involving $1.7 trillion in spending — includes 19 lines that could give the U.S. Food and Drug Administration the power to ban off-label use of approved medications. In a commentary for The Wall Street Journal, Dr. Joel Zinberg wrote:

“Physicians routinely prescribe drugs and employ medical devices that are approved and labeled by the Food and Drug Administration for a particular use. Yet sometimes physicians discern other beneficial uses for these technologies, which they prescribe for their patients without specific official sanction.

The new legislation amends the Food, Drug and Cosmetic Act, or FDCA, to give the FDA the authority to ban some of these off-label uses of otherwise approved products. This unwarranted intrusion into the physician-patient relationship threatens to undermine medical innovation and patient care.”

“The new provision was enacted at the FDA’s urging,” Zinberg says,

in response to a 2021 legal ruling that limited the FDA’s power to meddle with the practice of medicine. In March 2020, the FDA banned the use of electric shock devices for particular uses, namely to treat patients engaging in self-harm or aggressive behaviors that could harm others.

The devices are FDA approved, and while the FDA banned their use for certain contexts, it still allowed them to be used for smoking addiction and other purposes.

This led to a lawsuit — Judge Rotenberg Education Center v. FDA — in which the Judge Rotenberg Education Center, a school for people with severe behavioral and intellectual conditions, sued the FDA over the ban.

The court ruled in the school’s favor, stating that the FDA’s ban violated federal law because it interfered with health care practitioners’ authority to practice medicine. As it stands, the FDA does not have the power to ban medical devices for a particular use.

The school’s attorney, Mike Flammia, who also represented students’ parents in favor of the device’s use, told CNN the decision “protects what all of us cherish, and that is the ability to go to our doctor and have our doctor decide what is the best treatment.”

As it stands, Section 360f of the FDCA

only gives the FDA authority to ban a medical device if it poses “an unreasonable and substantial risk of illness or injury.” It can ban the device outright, but it can’t pick and choose when it can and can’t be used.

“Barring a practitioner from prescribing or using an otherwise approved device for a specific off-label indication would violate another FDCA section, which bars the FDA from regulating the ‘practice of medicine,'” Zinberg says.

The FDA is trying to change that.

The omnibus amendment would change Section 360f so that the FDA could ban a medical device if it poses an unreasonable risk for “one or more intended uses” while leaving it approved for others. “Since the new provision lets the FDA skirt the ban on interfering with the practice of medicine by banning devices for particular uses, the agency will likely claim this as a precedent allowing it to ban off-label uses of drugs as well,” according to Zinberg.

This puts the FDA, and by proxy Big Pharma, at the helm of powerful health care decisions that should be made on an individual, personalized level between a patient and their health care provider.

Remember that in 1992, the Prescription Drug User Fee Act (PDUFA) was created, which allows the FDA to collect fees from the drug industry. “With the act, the FDA moved from a fully taxpayer funded entity to one supplemented by industry money,” a BMJ article written by investigative journalist Maryanne Demasi explains.

Now, significant portions of regulatory agencies’ budgets come from the pharmaceutical industry that these agencies are supposed to regulate. In 1993, after PDUFA was passed, the FDA collected about $29 million in net PDUFA fees. This increased 30-fold — to $884 million — by 2016.

It’s also revealing that at the FDA, 9 out of 10 of its former commissioners between 2006 and 2019 went on to work for pharmaceutical companies.

As Brand noted:

“What they’re looking for is a crafty, sly, insidious way to be able to intercede in your relationship with your physician. And as usual, it’s for your ‘safety’ and for your ‘benefit’ … Why would you want Big Pharma and a regulatory body that they fund interfering in your relationship with your doctor about your health?

Have they not found enough ways to extract revenue from you, to put your health second, to put your well-being way, way behind their profits and their list of priorities? Why is the bias moving even further in that direction? … This is not about medicine. This is about licensing. This is about profits, patents, the ability to extract revenue.”

During the pandemic, it became clear how patients suffer when health agencies are allowed to dictate what medications doctors are allowed to prescribe to their patients. Ivermectin — a generic medication that doctors had success treating COVID-19 with early on — was quickly vilified, as were the doctors who attempted to prescribe it for COVID-19 patients.

In his book, “The War on Ivermectin: The Medicine That Saved Millions and Could Have Ended the COVID Pandemic,” Dr. Pierre Kory details Big Pharma’s suppression of this drug when it was found to work against COVID-19. When he and colleagues first spoke out about the drug’s potential, however, he was naïve. He said during our 2022 interview:

“I worked a lot and I got deeply expert on ivermectin. But what happened in the next few months is that everything started going sideways, and I could not figure it out. I saw hit pieces … The thing is, I didn’t know. I didn’t know that what I was really doing — bringing forth data supporting the efficacy of a generic drug — that is poking the bear.

And when I say poking the bear, what is anathema to the pharmaceutical industry and their whole business model is they cannot have generic off-patent drugs become standard of care. It obliterates the market for their pricing new pills.

I didn’t know I was stepping into a war. In the history of pharma, I don’t think any single medicine threatened as many [drug] markets and campaigns. The only other medicine that did that was hydroxychloroquine, but they already killed hydroxychloroquine in 2020.

I was coming out now with ivermectin, and it threatened hundreds of billions of dollars in perpetuity for these insanely lethal vaccines, monoclonal antibodies, remdesivir, paxlovid, molnupiravir — all of the markets for their novel new pills to enter. I mean, I don’t think any medicine has ever threatened that much of a market.”

If the FDA is allowed to ban medications for certain uses, we’ll see more of what happened with ivermectin. It’s a “problem for many reasons,” Zinberg explains:

“The statute gives the FDA the power, without any public input, to prevent patients’ access to off-label therapies even though their physicians and their patients have found the treatments to be beneficial or even essential.

… Allowing the FDA to ban certain off-label uses will impair clinical progress. Off-label use enables physicians to assess their patients’ unique circumstances and use their own evolving scientific knowledge in deciding to try approved products for new indications.

If the treatment proves useful, formal studies are performed and published. If enough evidence accumulates, the treatment becomes the standard of care, even if the manufacturer didn’t submit the product for a separate, lengthy and costly FDA review.

… Substituting regulators’ wisdom for the cost-benefit judgment of physicians and their patients will discourage attempts to use approved products in new and beneficial ways and deprive patients of valuable treatments. Congress should reconsider this ill-advised legislation.”

In California, regulators are also interfering with the practice of medicine. Law AB 2098, which was signed into law September 30, 2022

and went into effect January 1, 2023,

gives the state power to take away doctors’ medical licenses if they spread “misinformation” that goes against the standard COVID-19 rhetoric.

Specifically, those who “disseminate or promote misinformation or disinformation related to COVID-19, including false or misleading information regarding the nature and risks of the virus, its prevention and treatment; and the development, safety, and effectiveness of COVID-19 vaccines” could be “disciplined,” which includes loss of their medical license.

It’s akin to putting shackles on their wrists, forcing them to conform to a narrative intent on pushing dangerous gene therapies and ineffective medications. It’s also a potential warning of darker things to come.

What constitutes “misinformation” or “disinformation” worthy of taking away a person’s medical license? It’s anyone’s guess, really, but doctors afraid of being punished are likely to steer clear of anything that could possibly fit under this definition — to the detriment of their patients.

Bill 2098 itself is packed with misinformation and ignores the scientific truths about COVID-19,

such as the fact that prior infection with COVID-19 results in natural immunity — immunity that’s superior to that achieved via a COVID-19 shot.

The bill, if it passes, will stop doctors from practicing medicine the way they deem best for the individual patient. It will also stop dissent — even when dissent is necessary and beneficial, and coming from people with expertise. And that’s precisely the point.

In December 2022, Physicians for Informed Consent sued the state of California, arguing that AB 2098 violates the U.S. Constitution.

According to a news release, “The lawsuit argues that the State has weaponized the vague phrase ‘misinformation,’ thereby unconstitutionally targeting physicians who publicly disagree with the government’s public health edicts on COVID-19.”

It’s important to note that the trend to let a Pharma-controlled government silence your doctor and dictate basic components of your medical care is not confined to the U.S. — it’s happening globally.

Proposed amendments to the 2005 International Health Regulations (IHR), for instance, aim to erase the concepts of human dignity, human rights and fundamental freedoms from the equation.

The first principle in Article 3 of the 2005 IHR states that health regulations shall be implemented “with full respect for the dignity, human rights and fundamental freedoms of persons.” The amendment strikes that sentence.

Instead, international health regulations will be based on “principles of equity, inclusivity and coherence” only. This means they can force you to undergo whatever medical intervention they deem to be in the best interest of the collective.

Individuals won’t matter. Human dignity will not be taken into consideration. Human rights will not be taken into consideration, and neither will the concept that human beings have fundamental freedoms that cannot be infringed. Autonomy over your body will be eliminated. You’ll have no right to make personal health decisions.

While it may start slowly, such as with Pharma’s quiet move to ban off-label usage of medications for certain uses, it will soon expand, chipping away at your sovereignty until it’s gone. This is why it’s imperative to share this knowledge and support measures that protect our human rights and individual freedoms.

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Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked.

The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional. The subscription fee being requested is for access to the articles and information posted on this site, and is not being paid for any individual medical advice.

If you are pregnant, nursing, taking medication, or have a medical condition, consult your health care professional before using products based on this content.

• Children eating vegan diets faced an increased risk of nutritional deficiencies and lower bone mineral content (BMC), and were shorter by about 3.15 centimeters (1.2 inches) than omnivores

• Concerning nutrient deficiencies were also found in the vegan children fed a nutritionist-planned diet

• Nutrient deficiencies in vegan children included vitamin A insufficiency and “markedly low” levels of total, HDL and LDL cholesterol, essential amino acids and the omega-3 fat DHA

• One of the pitfalls of a vegan (or vegetarian) diet is that many people end up relying on ultraprocessed foods such soy infant formula, soy milk or fake meat products

• In most cases, infants and children do best with whole, animal foods in their diet to meet their complex nutritional needs

The debate over the healthiest diet for children is almost as controversial as the debate over plant- versus meat-based diets. And, no vegan parent wants to be told that feeding their baby a vegan diet is dangerous. However, it could, in fact, be damaging to children’s health.

While it’s true that most people, children included, could benefit from adding more whole foods to their diets — including certain plant-based foods — there are risks involved when you move from eating a diet rich in plant foods to one that is strictly plant-based.

While the U.K.’s National Health Service (NHS) compiled a guide to feed vegan infants and children ages 5 and under, it noted:

“We are not recommending a vegan diet. It is important to note that meeting the nutritional requirements of babies and young children will be challenging on a vegan diet, and using fortified foods and some supplements will be essential. Animal sourced foods provide good sources of many nutrients to the diet.”

A study of Polish children between the ages of 5 and 10 years evaluated body composition, cardiovascular risk and micronutrient status of vegetarian and vegan children compared to omnivores.

The study claimed vegan diets were associated with a healthier cardiovascular risk profile, but this was largely based on lower levels of LDL cholesterol — a flawed marker of heart health. The children eating vegan diets also faced an increased risk of nutritional deficiencies, lower bone mineral content (BMC) and were shorter by about 3.15 centimeters (1.2 inches). According to the study:

“Our data suggest that restriction of animal-based foods could prevent children from achieving optimal height or bone mineral status and could lead to selected nutritional deficiencies. The shorter height of children consuming PBDs [plant-based diets] may have mixed implications for long-term health. Taller height is associated with higher social status, and this association may be causal rather than just an artifact of social correlates.”

The researchers called the lower bone mineral content among those eating a vegan diet “concerning,” since maximizing bone mineral content in childhood is recommended to reduce the risk of osteoporosis and fractures later in life:

“We found that vegans have lower BMC even after accounting for smaller body and bone size. It does not seem optimal to enter adolescence, a phase when bone-specific nutrient needs are higher, with a BMC deficit already established. If such deficits are caused by a diet that persists into adolescence, this might increase the risk of adverse bone outcomes later in life.”

The vegan children in the group were more likely to suffer from vitamin B12 deficiency, low HDL levels and lower vitamin D levels,

each of which could have implications for their current and future health.

Vitamin B12, also known as cobalamin, is necessary for your body to make red blood cells as well as for proper nerve function and DNA synthesis. Without adequate levels, a number of physical symptoms, ranging from numbness to fatigue, can occur. Mental health can also suffer significantly, as vitamin B12 plays an important role in neurological function.

It’s been shown, for instance, that people with depression and high B12 levels have better responses to treatment,

while up to 30% of patients hospitalized for depression may be B12 deficient.

While choline, a B vitamin known for its role in brain development, wasn’t covered in the featured study, it’s another essential nutrient that humans must get from dietary or supplement sources. Animal foods are a major contributor of choline to the diet, and it’s difficult to get enough of this essential nutrient if you don’t consume them, particularly eggs, according to a study published in the journal Nutrients.

Additionally, important nutrients such as carnitine, carnosine and creatine are also very low in a plant based diet and ideally need to be supplemented. In another example, researchers followed 40 children with a median age of 3.5 years who attended a Finnish daycare.

There, they received nutritionist-planned vegan or omnivore meals designed to meet their nutritional needs.

However, even then, concerning nutrient deficiencies were found in the vegan children, including vitamin A insufficiency and “markedly low” levels of total, HDL and LDL cholesterol, essential amino acids and the omega-3 fat DHA. According to the researchers:

“The markedly low cholesterol in vegan infants and children in our study raises the question of whether such levels are healthy, as cholesterol is essential for cellular growth, division, and development of physiological systems due to its major role in the synthesis of cell membranes, steroid hormones, bile acids, and brain myelin …

DHA and active vitamin A are both important for eyesight, and the low statuses of both in [vegan] children may raise a concern for the visual health.”

NHS also states that, from the age of 1, “you can give your baby unsweetened, calcium-fortified, plant-based drinks (such as soya, oat and almond drinks) as part of a healthy balanced diet.”

However, not only is most soy genetically engineered (GE) and sprayed with toxic pesticides and herbicides like Roundup, with its dangerous active ingredient glyphosate, but soy products contain phytoestrogens such as genistein, which may affect the development of the reproductive system.

When it comes to soy formula, I believe it’s unsuitable for all children. But soy-based beverages should also be avoided later in childhood, and you’ll definitely want to steer clear of ultraprocessed foods like Soylent.

Soylent is a Silicon Valley creation, dreamed up by a group of software engineers

with no education in nutrition or human biology. The primary premise behind Soylent is that you can drink your complete nutritional requirements and never have to eat real food again. But this GE concoction, which is heavily promoted as a panacea to fill in nutritional gaps in those following plant-based diets, will not propel you, or your children, to optimal health.

Its products contain ingredients like soy protein isolate, canola oil — a major dietary source of toxic linoleic acid — artificial flavors and the artificial sweetener Sucralose.

Unfortunately, one of the pitfalls of a vegan (or vegetarian) diet is that many people end up relying on ultraprocessed foods such as this, mistakenly believing them to be healthy.

Raising children on a diet of plant-based “burgers” isn’t doing their health any favors either. Swapping traditional, whole foods grown by small farmers for mass-produced fake foods grown in a laboratory is, unfortunately, part and parcel of The Great Reset.

The EAT Forum, co-founded by the Wellcome Trust, developed a Planetary Health Diet that’s designed to be applied to the global population and entails cutting meat and dairy intake by up to 90%, replacing it largely with foods made in laboratories, along with cereals and oil.

Sadly, this is not what you or your children need to thrive, but it’s being pushed as a healthy, green and sustainable alternative to animal foods. As such, lab-grown, animal-free milk proteins are becoming all the rage.

The process to make these concoctions is far from natural, but one company, Perfect Day, is trying to get around that, describing their process as involving “nature’s code,” which is another way of describing the DNA that they are manipulating.

They use GE fungi microflora, which they go so far as to say “grazes” on plant-based inputs, hoping your mind’s eye will revert to a cow grazing in a field, rather than the tanks in which their GE fungi are actually grown.

It’s quite telling that, while the healthiest dairy products come from grass fed cows that are integrated into their surrounding environment, Perfect Day’s fake milk proteins can only be produced in a system that’s isolated from the outside world.

In the foreword to Navdanya International’s report “False Solutions That Endanger Our Health and Damage the Planet,” Vandana Shiva also details how lab-grown foods are catastrophic for human health and the environment, as they are repeating the mistakes already made with industrial agriculture:

“In response to the crises in our food system, we are witnessing the rise of technological solutions that aim to replace animal products and other food staples with lab-grown alternatives. Artificial food advocates are reiterating the old and failed rhetoric that industrial agriculture is essential to feed the world.

Real, nutrient-rich food is gradually disappearing, while the dominant industrial agricultural model is causing an increase in chronic diseases and exacerbating climate change. The notion that high-tech, “farm free” lab food is a viable solution to the food crisis is simply a continuation of the same mechanistic mindset which has brought us to where we are today — the idea that we are separate from and outside of nature.

Industrial food systems have reduced food to a commodity, to “stuff” that can then be constituted in the lab. In the process, both the planet’s health and our health have been nearly destroyed.”

Breastmilk is the healthiest food for babies, one that can’t be replicated in a lab. But that didn’t stop Bill Gates from announcing the startup company Biomilq in June 2020. It’s using biotechnology to create lab-made human milk for babies.

Using mammary epithelial cells placed in flasks with cell culture media, the cells grow and are placed in a bioreactor that the company says “recreates conditions similar to in the breast.”

Another company, Helaina, aims to create glycoproteins “identical to those found in breast milk,”

which can then be added to a variety of infant formulas. They may also be used in seniors’ nutrition and, eventually, all sorts of foods.

Many familiar globalists are invested in these faux dairy ventures. Biomilq investors, for example, include Bill Gates, Jeff Bezos, Mark Zuckerberg, Richard Branson, SoftBank CEO Masayoshi Son, Chinese business magnate Jack Ma, Michael Bloomberg and Salesforce Co-CEO Marc Benioff.

The first Biomilq product is expected to be ready for the market within the next three to five years.

Other animal-free milk products are expected to hit the shelves sometime between 2023 and 2024.

That includes ice cream made with lab-grown dairy, slated to go into Ben & Jerry’s product line.

But don’t be fooled. Fake meat and dairy cannot replace the complex mix of nutrients found in grass fed beef and dairy — or in human breastmilk — and it’s likely that consuming ultraprocessed meat and milk alternatives may lead to many of the same health issues that are caused by a processed food diet. So if you’re vegan, or raising vegan children, do not base your diet around these pseudofoods.

Breastmilk is the healthiest food for babies, but if you’re a strict vegetarian or vegan, be sure you make a point to supplement where needed, including for choline, omega-3s, folate and vitamin B12. If you’re unable to breastfeed or obtain human breastmilk for your baby, I do not recommend using commercial infant formula — and especially not soy-based varieties.

Instead, you can find my preferred recipe for healthy homemade infant formula here. You’ll notice it’s not vegan — it’s filled with nutrient-rich animal foods, such as raw grass fed cow milk, organic cream and beef hydrolysate gelatin, along with some items that many vegans will be familiar with, such as nutritional yeast flakes and organic, virgin coconut oil.

In most cases, infants and children do best with whole, animal foods in their diet to meet their complex nutritional needs.

Subscribe to Mercola Newsletter

Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked.

The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional. The subscription fee being requested is for access to the articles and information posted on this site, and is not being paid for any individual medical advice.

If you are pregnant, nursing, taking medication, or have a medical condition, consult your health care professional before using products based on this content.

• A Chinese trial comparing clinical outcomes of COVID-19 patients treated with the antimalarial drug hydroxychloroquine and those receiving standard of care alone reports “disappointing” result

• The hydroxychloroquine group only had a 28-day negative conversion rate of 85.4% compared to the control group’s rate of 81.3%. No difference in the alleviation of symptoms was observed between the two groups

• The study did not, however, use supplemental zinc, which helps prevent viral replication. Evidence suggests hydroxychloroquine works for COVID-19 because it acts as a zinc ionophore, meaning it shuttles zinc inside your cells

• A Brazilian chloroquine trial stopped the high-dose arm of the study early due to patients developing ventricular tachychardia, a dangerous heart rhythm problem. Chloroquine is known to be more toxic than hydroxychloroquine

• Quercetin is a naturally occurring zinc ionophore. Taken with zinc, it may be helpful to prevent and potentially treat COVID-19. Research is currently underway to assess quercetin’s effectiveness against COVID-19

ℹ️ From Dr. Joseph Mercola

Since COVID-19 first entered the scene, exchange of ideas has basically been outlawed. By sharing my views and those from various experts throughout the pandemic on COVID treatments and the experimental COVID jabs, I became a main target of the White House, the political establishment and the global cabal.

Propaganda and pervasive censorship have been deployed to seize control over every part of your life, including your health, finances and food supply. The major media are key players and have been instrumental in creating and fueling fear.

I am republishing this article in its original form so that you can see how the progression unfolded.

Originally published: April 27, 2020

The debate about whether the antimalarial drug hydroxychloroquine is an effective treatment for COVID-19 continues, as a Chinese trial

comparing clinical outcomes of those treated with the drug and those receiving standard of care alone reports “disappointing” results.

Seventy-five COVID-19 patients at 16 Chinese treatment centers received 1,200 milligrams of hydroxychloroquine in addition to standard of care for the first three days of treatment, followed by a maintenance dose of 800 mg per day for two weeks in mild to moderate cases and three weeks for severe cases. Another 75 patients received standard of care only.

The primary endpoint was a 28-day negative conversion rate of SARS-CoV-2 (viral load reduction). Secondary endpoints included improvement rate of clinical symptoms and the normalization of C-reactive protein and blood lymphocyte count within 28 days.

According to the authors, the hydroxychloroquine group only had a 28-day negative conversion rate of 85.4% compared to the control group’s rate of 81.3%. No difference in the alleviation of symptoms was observed between the two groups.

Adverse events were also higher in the hydroxychloroquine group (30%) compared to controls (8.8%). You can find a listing of the adverse events in Table 2 of the study.

The most common adverse event, at 10%, was diarrhea. That said, the authors point out that:

“A significant efficacy of HCQ [hydroxychloroquine] on alleviating symptoms was observed when the confounding effects of anti-viral agents were removed in the post-hoc analysis (Hazard ratio, 8.83, 95%CI, 1.09 to 71.3).

This was further supported by a significantly greater reduction of CRP (6.986 in SOC [standard of care] plus HCQ versus 2.723 in SOC, milligram/liter, P=0.045) conferred by the addition of HCQ, which also led to more rapid recovery of lymphopenia, albeit no statistical significance.

Conclusions: The administration of HCQ did not result in a higher negative conversion rate but more alleviation of clinical symptoms than SOC alone in patients hospitalized with COVID-19 without receiving antiviral treatment, possibly through anti-inflammatory effects. Adverse events were significantly increased in HCQ recipients but no apparently increase of serious adverse events.”

A few things are worthy to note about this study. Aside from its small size, the patients received a far higher dose of hydroxychloroquine than typically used in the U.S. — 1,200 milligrams for the first three days, followed 800 mg per day for two to three weeks, compared to the U.S. Food and Drug Administration’s suggested dosage of 800 mg on Day 1, followed by 400 mg per day for four to seven days, depending on severity.

Secondly, most patients had mild disease with little hypoxemia, and thirdly, treatment was administered quite late, on average 16 to 17 days after the onset of disease. Commenting on the findings, Josh Farkas, associate professor of pulmonary and critical care medicine at the University of Vermont writes:

“Much of the pathogenesis of critical illness seems to result from dysregulated inflammation, rather than direct viral cytopathic effect. This raises a question of whether any antiviral treatment will be beneficial for late-presenting patients with severe illness.

Of course, it is possible that earlier use of hydroxychloroquine could be beneficial (e.g., perhaps at the first signs of illness on an out-patient basis). This is under investigation and additional data is likely to be forthcoming soon. Even if this does work in the outpatient clinic, it would probably have little impact on the management of these patients within the intensive care unit.”

Editor’s note: This blog was deleted and wiped clean from the internet later. I am leaving it here to illustrate how something controversial can quickly disappear, even when well-documented and sourced at the time it’s used.

Perhaps most importantly, however, is the absence of zinc, which Farkas does not mention. We now know that chloroquine and hydroxychloroquine act as zinc ionophores,

meaning they shuttle zinc into your cells, and zinc appears to be a “magic ingredient” required to prevent viral infection.

If given early, zinc along with a zinc ionophore should, at least theoretically, help lower the viral load and prevent the immune system from becoming overloaded. Without zinc, hydroxychloroquine may be more or less useless.

So, in my view, I doubt this study is worth placing too much stock in, seeing how it did not administer supplemental zinc. As noted in the preprint paper, “Does Zinc Supplementation Enhance the Clinical Efficacy of Chloroquine / Hydroxychloroquine to Win Todays Battle Against COVID-19?” published April 8, 2020:

“Besides direct antiviral effects, CQ/HCQ [chloroquine and hydroxychloroquine] specifically target extracellular zinc to intracellular lysosomes where it interferes with RNA-dependent RNA polymerase activity and coronavirus replication.

As zinc deficiency frequently occurs in elderly patients and in those with cardiovascular disease, chronic pulmonary disease, or diabetes, we hypothesize that CQ/HCQ plus zinc supplementation may be more effective in reducing COVID-19 morbidity and mortality than CQ or HCQ in monotherapy. Therefore, CQ/HCQ in combination with zinc should be considered as additional study arm for COVID-19 clinical trials.”

In related news, a Brazilian chloroquine trial

stopped the high-dose arm of the study early due to patients developing ventricular tachychardia, a dangerous heart rhythm problem. As reported by Live Science:

“The Brazilian researchers planned to enroll 440 people in their study to test whether chloroquine is a safe and effective treatment for COVID-19. Participants took either a ‘high dose’ of the drug (600 milligrams twice daily for 10 days) or a ‘low dose’ (450 mg for five days, with a double dose only on the first day) …

However, after enrolling just 81 patients, the researchers saw some concerning signs. Within a few days of starting the treatment, more patients in the high dose group experienced heart rhythm problems than did those in the low dose group. And two patients in the high dose group developed a fast, abnormal heart rate known as ventricular tachychardia before they died.”

As explained in my previous article, “Antimalarial Medications: A COVID-19 Treatment Option?” chloroquine and hydroxychloroquine have been shown to be effective in the lab against the SARS coronavirus that appeared in 2003.

Laboratory testing also suggests chloroquine is effective in cell cultures against COVID-19 when combined with an antiviral drug, remdesivir.

However, chloroquine (Aralen) appears to be a more hazardous choice than hydroxychloroquine (Plaquenil), which is a derivative of chloroquine.

Both use the same pathway, but hydroxychloroquine is thought to be about 40% less toxic

and, overall, has a safer side effect profile.

Considering the risks of chloroquine and hydroxychloroquine, and the evidence suggesting the reason these drugs work for COVID-19 is because they act as zinc ionophores, it’s worth questioning whether other more natural zinc ionophores can be used.

One prime example would be quercetin, which is a naturally occurring zinc ionophore.

As reported by the Green Stars Project,

“Researchers from Oak Ridge National Lab used the world’s most powerful supercomputer, SUMMIT, to look for small molecules that might inhibit the COVID-19 spike protein from interacting with human cells and, interestingly, quercetin is fifth on that list.”

Quercetin is one of only three natural products found to inhibit the SARS-CoV-2 spike protein. The only natural product found to be slightly more effective is luteolin, a polyphenol found in radicchio, green peppers, serrano and green hot chili peppers, chicory, celery and many other foods.

Quercetin is another flavonols compound found in a variety of foods, including apples, Brassica vegetables, capers, onions, tea and tomatoes, just to name a few. It’s also contained in medicinal products such as Ginko biloba, St. John’s Wort (Hypericum perforatum) and elderberry (Sambucus canadensis).

Research has already demonstrated that quercetin is a powerful immune booster and broad-spectrum antiviral. As noted in a 2016 study

in the journal Nutrients, quercetin’s mechanisms of action include the inhibition of lipopolysaccharide (LPS)-induced tumor necrosis factor α (TNF-α) production in macrophages.

TNF-α is a cytokine involved in systemic inflammation, secreted by activated macrophages, a type of immune cell that digests foreign substances, microbes and other harmful or damaged components. Quercetin also inhibits the release of pro-inflammatory cytokines and histamine by modulating calcium influx into the cell.

According to this paper, quercetin also stabilizes mast cells and has “a direct regulatory effect on basic functional properties of immune cells,” which allows it to inhibit “a huge panoply of molecular targets in the micromolar concentration range, either by down-regulating or suppressing many inflammatory pathways and functions.”

Another 2016 study

concluded it helps modulate the NLRP3 inflammasome, an immune system component involved in the uncontrolled release of pro-inflammatory cytokines that occurs during a cytokine storm.

In vitro studies

have shown quercetin exerts antiviral activity against SARS-CoV, and preliminary findings

suggest quercetin can inhibit the SARS-CoV-2 main protease as well. You can get even more details about the anti-inflammatory and antiviral powers of quercetin in “Quercetin Lowers Your Risk for Viral Illnesses.”

The good news is researchers are in fact planning to study the use of quercetin against COVID-19.

As reported by Maclean’s,

Canadian researchers Michel Chrétien and Majambu Mbikay began investigating quercetin in the aftermath of the SARS epidemic that broke out across 26 countries in 2003.

They discovered a derivative of quercetin provided broad-spectrum protection against a wide range of viruses, including SARS.

The Ebola outbreak in 2014 offered another chance to investigate quercetin’s antiviral powers and, here too, they found it effectively prevented infection in mice, “even when administered only minutes before infection.”

So, when the COVID-19 outbreak was announced in Wuhan City, China, in late December 2019, Chrétien contacted colleagues in China with an offer to help. In February 2020, Chrétien and his team received an official invitation to begin clinical trials. According to Maclean’s:

“The Canadian and Chinese scientists would collaborate on the trials, which would include about 1,000 test patients. Chrétien and Mbikay plan to join colleagues from the non-profit International Consortium of Antivirals — which Chrétien co-founded with Jeremy Carver in 2004 as a response to the SARS epidemic — in manning a 24/7 communications centre as soon as clinical trials go ahead.

The U.S.-based Food and Drug Administration has already approved quercetin as safe for human consumption, which means the researchers can skip testing on animals. If the treatment works, it’ll be readily available … Chrétien’s team says their treatment would cost only $2 a day.”

While the COVID-19 pandemic is in full swing — and for any future influenza season — supplementing with quercetin and zinc may be a good idea for many, in order to boost your immune system’s innate ability to ward off infectious illness. As for dosage, here are some basic recommendations:

• Quercetin — According to research from Appalachian State University in North Carolina, taking 500 mg to 1,000 mg of quercetin per day for 12 weeks results in “large but highly variable increases in plasma quercetin … unrelated to demographic or lifestyle factors.”

• Zinc (and copper) — When it comes to zinc, remember that more is not necessarily better. In fact, it can backfire. When taking zinc, you also need to be mindful of maintaining a healthy zinc-to-copper ratio. As noted by Chris Masterjohn, who has a Ph.D. in nutritional sciences,

  in an article and series of Twitter posts:

  “In one study, 300mg/day of zinc as two divided doses of 150 mg zinc sulfate decreased important markers of immune function, such as the ability of immune cells known as polymorphonuclear leukocytes to migrate toward and consume bacteria.

  The most concerning effect in the context of COVID-19 is that it lowered the lymphocyte stimulation index 3 fold. This is a measure of the ability of T cells to increase their numbers in response to a perceived threat. The reason this is so concerning in the context of COVID-19 is that poor outcomes are associated with low lymphocytes …

  The negative effect on lymphocyte proliferation found with 300 mg/day and the apparent safety in this regard of 150 mg/d suggests that the potential for hurting the immune system may begin somewhere between 150-300 mg/d …

  It is quite possible that the harmful effect of 300 mg/d zinc on the lymphocyte stimulation index is mediated mostly or completely by induction of copper deficiency …

  The negative effect of zinc on copper status has been shown with as little as 60 mg/d zinc. This intake lowers the activity of superoxide dismutase, an enzyme important to antioxidant defense and immune function that depends both on zinc and copper …

  A study done with relatively low intakes of zinc suggested that acceptable ratios of zinc to copper range from 2:1 to 15:1 in favor of zinc. Copper appears safe to consume up to a maximum of 10 mg/d.

  Notably, the maximum amount of zinc one could consume while staying in the acceptable range of zinc-to-copper ratios and also staying within the upper limit for copper is 150 mg/d.”

Masterjohn goes into even greater detail in his zinc article, discussing maximum absorption rates and much more.

In summary, he recommends taking 7 mg to 15 mg of zinc four times a day, ideally on an empty stomach, or with a phytate-free food.

The recommended dietary allowance in the U.S is 11 mg for adult men and 8 mg for adult women, with slightly higher doses recommended for pregnant and breastfeeding women,

so we’re not talking about taking significantly higher dosages.

Additionally, you can take one zinc acetate lozenge per day, which will provide you with an additional 18 mg of zinc. If you’re exposed to the virus, take one additional lozenge after the exposure.

Masterjohn stresses that you’ll want to keep your total zinc intake below 150 mg per day to avoid negative effects on your immune system. He also recommends getting at least 1 mg of copper from food and supplements for every 15 mg of zinc you take.

Keep in mind that there are many food sources of zinc, so a supplement may not be necessary. I eat about three-fourths of a pound of ground bison or lamb a day, which has 20 mg of zinc. I personally don’t take any zinc supplement other than what I get from my food, which is likely in an optimal form to maximize absorption.

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