Dubious COVID-19 Treatments and Preventives


The U.S. Food and Drug Administration and the U.S. Federal Trade Commission have stated:

There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19).

Advertising that a product can prevent, treat, or cure COVID-19 without rigorous scientific evidence sufficient to substantiate the claims violates the federal FTC Act. Nevertheless, various products and services have been touted as being effective in treating or preventing COVID-19. Most lack a plausible rationale for any potential benefit against COVID-19 or are nonsensical. Some hyped treatments and preventives are known to present hazards. For others, evidence of safety is lacking. Consumers of dubious COVID-19 treatments and preventives waste their money and time.

Hyped treatments and preventives for COVID-19 are discussed in these expandable sections:

The Federal Trade Commission and/or the U.S. Food and Drug Administration have sent letters to these marketers warning them to stop making unsubstantiated claims that their acupuncture, moxibustion, traditional Chinese medicine (TCM), or Chinese herbal offerings can treat or prevent COVID-19:

 

Submitted by William M. London.

First published August 28, 2020.

Last updated September 4, 2020.

Cannabidiol (CBD) is a chemical compound found in marijuana and hemp that does not produce a high. In 2018, the U.S. Food and Drug Administration (FDA) approved a cannabidiol preparation (brand name Epidiolex) to treat two rare, severe forms of epilepsy. In 2020, the FDA approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Although there is great interest in potential medical uses for CBD, the evidence for its safety and effectiveness falls far short of the marketing hype for many available products. Since 2015, the FDA has ordered many companies to stop making unapproved claims. The market for unapproved CBD products is nevertheless burgeoning as marketers have claimed the products have value in treating a variety of diseases. The FDA and others have found that some CBD products have not contained dosages claimed by marketers. Dangerous chemicals have been found in popular CBD vaping liquids.

The FDA and/or the Federal Trade Commission have sent warning letters to these businesses who have marketed their CBD products with unsubstantiated COVID-19-related claims

Under an administrative settlement with the Federal Trade Commission (FTC), Marc Ching, the California-based marketer of a supplement called Thrive, which consists mainly of Vitamin C and herbal extracts, is barred from: (a) continuing to make baseless claims that Thrive can treat, prevent, or reduce the risk of COVID-19, and (b) making unsupported cancer treatment or prevention claims for products containing cannabidiol (CBD). In April, the FTC announced that Ching agreed to a preliminary federal court order that imposed similar terms. The order also requires Ching to send written notices to customers and retailers of Thrive, that: (a) clearly explain that it will not treat, prevent, or reduce the risk of COVID-19, (b) CBD-EX, CBD-RX, and CBD-Max will not treat cancer, and (c) informs customers and retailers of Ching’s settlement with FTC. According to the FTC’s federal district court complaint and administrative complaint seeking temporary relief, Ching:

  • since at least December 2018 advertised and sold Thrive online, through his Whole Leaf Organics website
  • began in March 2020 marketing Thrive as an “anti viral wellness booster” that treats, prevents, or reduces the risk of COVID-19
  • advertised and sold Thrive online, with a 50-capsule bottle selling for $36.99
  • falsely stated that these benefits of Thrive were clinically proven
  • used his Whole Leaf Organics Web site to advertise and sell three CBD-containing products, CBD-EX, CBD-RX, and CBD-Max, falsely claiming they were effective cancer treatments

Ching’s administrative case is scheduled to begin on January 7, 2021. [FTC order stops the marketer of “Thrive” supplement from making baseless claims it can treat, prevent, or reduce the risks from COVID-19. FTC press release. July 10, 2020]

For more information:

Submitted by William M. London

First published May 26, 2020.

Last updated October 20, 2020.

Many chiropractors have been falsely advertising that chiropractic care can boost the immune system and thereby prevent novel coronavirus (SARS-CoV-2) infections. A study of Twitter activity showed that messages linking spinal manipulative therapy, an intervention most commonly used by chiropractors, with enhancing immunity increased dramatically in the United States since the COVID-19 pandemic began. During the pandemic, the International Chiropractors Association (ICA) posted reports on its website to buttress those claims. However, more than 140 chiropractic researchers around the globe reviewed those reports and concluded that the ICA provided no valid clinical scientific evidence that chiropractic care can impact the immune system. Their conclusion is consistent with a message to chiropractors from the World Federation of Chiropractic.

The College of Chiropractors of BC, the regulatory body of British Columbia chiropractors, issued a public notice, which states that it is inappropriate for chiropractors to promote treatment or supplements as a means to boost the immune system and imply that this will prevent infection from the novel coronavirus. On April 27, 2020, the president of the College of Chiropractors of Ontario reported that the regulatory body sent 74 cease and desist orders to chiropractors making such claims in their advertising.

In the United States, the Federal Trade Commission issued warnings to:

  • Active Lifestyle Clinic (Phoenix, Arizona) to stop making unsubstantiated coronavirus-related prevention or treatment claims for chiropractic adjustments and ozone treatments.
  • Back 2 Health Family Wellness Center (Little Silver, New Jersey) to stop making unsubstantiated coronavirus-related prevention or treatment claims for chiropractic services.
  • Fuller Life Chiropractic (Peachtree City, Georgia) to stop making unsubstantiated claims on its website about raising “Innate Immunity” through chiropractic in order to defend against coronavirus.
  • Epigenetics Healing Center in Overland Park, Kansas (operated by Jay Goodfinder, D.C.) to stop claiming that intravenous treatments of vitamin C, vitamin D and glutathione and supplements of garlic, pycnogenol, and vitamin B12 are effective against COVID-19.
  • Hackbart Chiropractic (Seward, Nebraska) to stop making unsubstantiated coronavirus-related prevention or treatment claims for chiropractic services.
  • Mathew Martinez, D.C., who operates the Absolute Health Clinic in Bristol, Washington, to stop advertising that stem cell therapy, intravenous vitamins C and D, and various other “immune-boosting” supplements can treat or protect against COVIUD-19 infections.
  • Natural Health Center of Clifton (Clifton, New Jersey) to stop making coronavirus-related prevention or treatment claims for chiropractic adjustments, acupuncture, and nutritional supplements.

Many chiropractors have been involved in the promotion of unproven stem cell treatments for a variety of health problems. It is not surprising to find a chiropractor involved in the promotion of unproven stem cell treatment of COVID-10. In September, Arkansas’s attorney general accused the Arkansas Regenerative Medical Center LTD (ARMC), the firm’s medical director Sarah Knife Chief, M.D., and chiropractor Serge Francois, D.C. of marketing fraudulent COVID-19 treatments including ozone therapy. The lawsuit alleges:

  • In early 2020, ARMC, Chief, and Francois used a popular Hispanic radio station and employed the station’s DJ in an effort to reach Latino consumers, who were being disproportionately affected by the coronavirus.
  • ARMC advertised on its website and Facebook page stem cell treatments and ozone therapy, claiming that they were “very effective” against COVID-19 and would allow employees to return to work more quickly.
  • Consumers were charged upwards of $3,000 for the useless treatments.

 

Other regulatory actions in the United States have included:

  • The Oregon Department of Justice secured a consent agreement that prohibited Sandra Johnson, D.C., of Bend Oregon from making promotional claims about products that refer to coronavirus or COVID-19.
  • The U.S. Attorney’s Office for the Northern District of Texas has obtained a temporary restraining order to stop Ray L. Nannis, D.C., d/b/a Optimal Wellness Solutions from advertising that his sublingual homeopathic products can prevent and treat COVID-19 infections.
For more information:

Submitted by William M. London

First published May 26, 2020.

Last updated October 7, 2020.

Dietary supplements are broadly defined under current federal law. According to the 1994 Dietary Supplement Health and Education Act (DSHEA) dietary supplements include any products that contain at least one of the following: (1) a vitamin, (2) a mineral, (3) an herb or botanical, (4) an amino acid, (5) a dietary substance “for use to supplement the diet by increasing total dietary intake,” or (6) any concentrate, metabolite, constituent, extract. Under DSHEA, dietary supplement products go through no premarketing approval process as do new drug products. DSHEA enables dietary supplement marketers to state how their products may influence body structure or function, but such statements must be accompanied by a disclaimer that they have not been evaluated by the US Food and Drug Administration (FDA) and that the products are not intended to “diagnose, treat, cure or prevent any disease.” Going beyond structure/function claims to disease claims turns dietary supplements into unapproved drugs. There are currently no FDA-approved drug products for preventing or treating COVID-19. The Federal Trade Commission (FTC) has regulatory authority over advertising claims made for dietary supplement products and may take action when claims are deceptive.

According to the Therapeutic Research Center’s Natural Medicine database, COVID-19-related claims have been made for dietary supplement products said to contain ingredients such as: astragalus, Baikal skullcap, boneset, cannabidiol (CBD), Ceylon cinnamon, colloidal silver, cordyceps, danshen, dong quai, Echinacea, elderberry, fulvic acid, green tea, halotherapy (salt), hu zhang, humic acid, kudzu, licorice, New Jersey tea, rhodiola, quercetin, traditional Chinese medicine, vitamin C, and zinc.

Claims of immune system boosting or support are often made for dietary supplements, but there is no good evidence that taking dietary supplements help people without nutrient deficiencies fight off or resist infections such as from the coronavirus that causes COVID-19. There is also no good evidence that any dietary supplement product can fight off coronavirus infection through anti-viral activity. Some dietary supplement products promoted for use against COVID-19 have contained ingredients in doses that can be harmful.

Vitamin D has received significant media attention for being potentially protective against COVID-19, but a protective effect has yet to be established in randomized controlled studies. Researchers have strongly cautioned against both potentially harmful vitamin D supplement doses “(greater than the upper limit of 4000 IU/day (100 µg/day))” and becoming vitamin D deficient.

According to the National Institutes of Health:

There are insufficient data to recommend either for or against the use of vitamin D for the prevention or treatment of COVID-19.

Silver products sold as dietary supplements and hyped as treatments or preventives for COVID-19 are discussed in a separate expandable section below.

The FTC and/or the FDA sent letters to these businesses warning them to stop making unsubstantiated claims that their food products, dietary supplements, and herbal treatments can treat or prevent COVID-19, making them unapproved drugs:

Federal authorities issued a civil injunction to stop Marc “White Eagle” Travalino’s sale of fraudulent COVID-19 cures through his business and his website, “whiteeaglenativeherbs.net,” which has been shuttered by the action. Travalino allegedly sold an undercover special agent a treatment for COVID-19 on May 5, 2020 after guaranteeing that the agent’s hospitalized grandmother would not die from COVID-19 if given the medicine. On May 14, 2020, the FDA and the FTC sent Travalino a warning letter requiring him to cease and desist sales of unapproved and unproven COVID-19 cures and treatments. Almost a week after he was warned to stop, Travalino again sold his COVID-19 treatments to another undercover agent.

Under an administrative settlement with the FTC, Marc Ching, the California-based marketer of a supplement called Thrive, which consists mainly of Vitamin C and herbal extracts, is barred from: (a) continuing to make baseless claims that Thrive can treat, prevent, or reduce the risk of COVID-19, and (b) making unsupported cancer treatment or prevention claims for products containing cannabidiol (CBD). In April, the FTC announced that Ching agreed to a preliminary federal court order that imposed similar terms. The order also requires Ching to send written notices to customers and retailers of Thrive, that: (a) clearly explain that it will not treat, prevent, or reduce the risk of COVID-19, (b) CBD-EX, CBD-RX, and CBD-Max will not treat cancer, and (c) informs customers and retailers of Ching’s settlement with FTC. According to the FTC’s federal district court complaint and administrative complaint seeking temporary relief, Ching:

  • since at least December 2018 advertised and sold Thrive online, through his Whole Leaf Organics website
  • began in March 2020 marketing Thrive as an “anti viral wellness booster” that treats, prevents, or reduces the risk of COVID-19
  • advertised and sold Thrive online, with a 50-capsule bottle selling for $36.99
  • falsely stated that these benefits of Thrive were clinically proven
  • used his Whole Leaf Organics Web site to advertise and sell three CBD-containing products, CBD-EX, CBD-RX, and CBD-Max, falsely claiming they were effective cancer treatments

Ching’s administrative case was scheduled to begin on January 7, 2021. [FTC order stops the marketer of “Thrive” supplement from making baseless claims it can treat, prevent, or reduce the risks from COVID-19. FTC press release. July 10, 2020] On October 19th, the FTC announced that it approved a final administrative consent order settling charges against Ching individually and also d/b/a Whole Leaf Organics. The order:

…bars Ching’s false and unsubstantiated health claims and requires him to send written notices to customers and retailers of Thrive explaining that it will not treat, prevent, or reduce the risk of COVID-19. He also must tell customers and retailers that the three CBD-containing products will not treat cancer. Finally, the letters must inform customers and retailers of his settlement with the FTC.

The FTC has charged Golden Sunrise Nutraceutical, Inc. of Porterville, California with deceptively advertising a $23,000 treatment plan as a scientifically proven way to treat COVID-19. As alleged in the FTC’s complaint, Golden Sunrise:

  • began marketing its Emergency D-Virus plan as a treatment for COVID-19 in March 2020.
  • falsely claims in advertising on billboards, their websites, and on social media that the company’s supplements—ImunStem, Aktiffvate, and AnterFeerons—are “uniquely qualified to treat and modify the course of the Coronavirus epidemic in CHINA and other countries,” and that users can expect the “disappearance of viral symptoms within two to four days
  • continued to market the treatment plan after FTC sent Golden Sunrise a letter in April 2020 warning the company to immediately remove all advertising claims that the products could prevent, treat, or cure COVID-19
  • falsely claim their products and treatment plans have been reviewed and accepted by the FDA, and designated safe and effective
  • promoted and sold a range of dietary supplements as treatments for cancer and Parkinson’s disease, as well as many other different serious health conditions and diseases
  • offered some treatments costing as much as $170,000 to $200,000
For more information:

Submitted by William M. London

First published May 27, 2020.

Last updated October 20, 2020.

The Federal Trade Commission has sent a letter warning this marketer to stop making unsubstantiated claims that its electromagnetic field blocking patch can treat or prevent COVID-19:

 

 

Submitted by William M. London.

First published August 28, 2020.

The practice of administering plant-derived essential oils on the skin, via inhalation of vapors, or internally via ingestion for supposed healing power is commonly called aromatherapy. The oils for aromatherapy are described as “essential” to refer to the volatile, aromatic components that some people describe as the “essence” of the plant source, which supposedly represents the plant’s “life force,” “spirit,” or soul. The use of essential oils for aromatherapy is not essential for health. A wide variety of unsubstantiated health claims have been made for essential oils including for use against COVID-19. Product potency is not standardized. Marketers don’t do enough to advise users about potential risks. Some marketers promote risky ways of administering essential oils.

The U.S. Food and Drug Administration and/or the Federal Trade Commission have sent warning letters to these firms for selling essential oil products with unsubstantiated claims to prevent, treat, mitigate, or cure COVID-19:

For more information:

Submitted by William M. London

First published May 27, 2020, last updated July 30, 2020.

Many people believe that homeopathy is simply a fancy term for natural or herbal medicine. It is actually a superstitious, spiritual approach to medicine based on the notion that diseases can be effectively treated with substances that would, if given to healthy people, cause the disease symptoms. Proponents of homeopathy believe that the substances become increasingly potent as remedies through a process involving successive dilutions and vigorous shaking called succussion. Some homeopaths falsely claim that “nosodes” (products made from pathological organs or tissues; causative agents such as bacteria, fungi, ova, parasites, virus particles and yeast; disease products; or excretions) are as effective as vaccines for disease prevention.

No currently marketed drug products labeled as homeopathic have been approved by the FDA for any use.

The U.S. Attorney’s Office for the Northern District of Texas has obtained a temporary restraining order to stop Ray L. Nannis, D.C., d/b/a Optimal Wellness Solutions from advertising that his sublingual homeopathic products can prevent and treat COVID-19 infections.

The Federal Trade Commission and/or the U.S. Food and Drug Administration (FDA) have warned these marketers to stop making unsupported claims that their homeopathic and related products can effectively prevent or treat COVID-19:

For more information:

Submitted by William M. London

First published May 26, 2020, last updated July 1, 2020.

President Trump, Elon Musk, Dr. Mehmet Oz and Brazilian President Jair Bolsonaro have all touted hydroxychloroquine (brand name Plaquenil) as an effective drug treatment for COVID-19. Several hosts of Fox News programs have also fueled hydroxychloroquine hype.

Widespread interest in hydroxychloroquine was initially generated by Didier Raoult, the senior author of a paper reporting a small, substandard, uncontrolled clinical study of the drug used alone and in combination with the antibiotic azithromycin on COVID-19 patients. The paper purported to show the treatments reduced the presence of the novel coronavirus in the body, but the study design was inadequate for demonstrating that drug treatment was helpful and has been harshly criticized. Serious concerns about the safety and effectiveness of hydroxychloroquine in treating COVID-19 emerged soon after Raoult’s paper was published. Raoult’s reputation as a scientist has since suffered.

Some scientists thought that hydroxychloroquine can act to both keep the virus from entering cells of the body and disrupt viral protein production. However, it doesn’t seem to work in lung cells that are infected by the novel coronavirus. Several rationales have been proposed for using azithromycin, but its effectiveness against COVID-19 remains unsubstantiated. Over 100 relevant clinical trials were started.

Hydroxychloroquine is an approved drug for either prevention or treatment of certain types of malaria. Its anti-inflammatory action makes it effective in treating patients with lupus, rheumatoid arthritis, and some other health problems. The promotion of hydroxychloroquine for COVID-19 has threatened supplies of the drug for patients who rely on it to manage their inflammatory diseases.

Hype for hydroxychloroquine and chloroquine, a chemically similar drug, led to a tragic mistake in March. The Centers for Disease Control and Prevention (CDC) reported that two individuals consumed non-pharmaceutical chloroquine phosphate, a chemical for aquarium use that is commercially available for purchase at stores and through internet websites:

One of the individuals died shortly after arrival to the hospital. The second individual was critically ill with severe gastrointestinal symptoms and cardiac conduction abnormalities. Upon recovery, the surviving individual reported to the media that they ingested the product to prevent infection with SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), after seeing information on the medical use of chloroquine on television. The product in their possession was in powder form inside a 2.2-lb. container and labeled “for Ornamental Fish Use Only”.

Hydroxychloroquine has not been approved by the U.S. Food and Drug Administration (FDA) for treating COVID-19, but, in April, it granted an emergency use authorization (EUA) for its use to treat adults and adolescents who weigh at least 110 pounds and who are hospitalized with COVID-19, but who are unable to participate in a clinical study. That EUA was later revoked as new, discouraging evidence emerged.

On May 18, 2020, President Trump announced that he had been taking hydroxychloroquine every day for about a week despite having tested negative for the coronavirus and having no symptoms. A statement from Trump’s physician Sean P. Conley, D.O. released that day noted that, two weeks prior, one of the president’s support staff had tested positive. Dr. Conley wrote:

After numerous discussions [President Trump] and I had regarding the evidence for and against the use of hydroxychloroquine, we concluded that the potential benefit from treatment outweighed the relative risks.

On May 24th, President Trump announced that he had finished his hydroxychloroquine regimen. If Dr. Conley had prescribed the drug for him and President Trump had taken it as he said he did, we would still have no way of knowing from his anecdote whether the drug made any difference for him. Before concluding that hydroxychloroquine is evidence-based medicine against COVID-19, favorable findings from well-designed, properly conducted clinical trials will be needed.

On June 15th, the FDA revoked the EUA because the legal criteria for initiating it were no longer met. It announced:

Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.

Moreover:

Recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit.

In a separate announcement on June 15th, the FDA warned that co-administering either hydroxychloroquine sulfate or chloroquine phosphate with the investigational antiviral drug remdesivir may result in reducing remdesivir’s antiviral activity. Remdesivir has received an EUA for treating hospitalized COVID-19 patients with severe disease.

The FDA’s chief scientist wrote on June 15th:

FDA has concluded that…it is no longer reasonable to believe that oral formulations of [hydroxychloroquine] and [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.

The FDA has cautioned against use of hydroxychloroquine and chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of potentially life-threatening heart rhythm problems.

In June, the World Health Organization announced that its ongoing Solidarity Trial’s hydroxychloroquine treatment arm had been been discontinued based on disappointing interim findings, signals of safety problems, evidence from the UK’s Recovery Trial, and a Cochrane Review of other evidence about the drug.

On June 20th, the National Institutes of Health announced that a clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) had been halted because a Data Safety Monitoring Board had determined that drug was very unlikely to be beneficial to hospitalized patients with COVID-19.

On July 6th, President Trump tweeted:

The highly respected Henry Ford Health System just reported, based on a large sampling, that HYDROXYCHLOROQUINE cut the death rate in certain sick patients very significantly. The Dems disparaged it for political reasons (me!). Disgraceful. Act now.

The president was referring to a research paper published in the International Journal of Infectious Diseases. Letters to the editor of the journal noted multiple errors, flaws, and biases in the research. Days after the paper was published, the Henry Ford Health System sought an EUA to treat COVID-19 patients with hydroxychloroquine, but the FDA denied the request.

In late July, NBC News reported that Facebook, YouTube, and Twitter each removed a 45-minute video that violated their standards by falsely claiming that business and school closings, social distancing, and masks were not needed because the drug hydroxychloroquine could both prevent and cure COVID-19. The claims were made by a group presented as “America’s Frontline Doctors” at a July 27th event in front of the U.S. Capitol with a small audience that had been livestreamed by the far-right website, Breitbart News. The Tea Party Patriots, a right-wing nonprofit group, hosted and funded the event. Madonna’s Instagram post about the video was flagged for spreading misinformation. She called Immanuel her hero. Donald Trump Jr.’s Twitter account was temporarily suspended after he tweeted the video stating “This is a must watch!!! So different from the narrative everyone is running with.” President Trump retweeted a clip of the video and later defended doing so, saying that one of the doctors, Stella Immanuel, was impressive and that he thought her voice was “important.”

Dr. Immanuel, a pediatrician and religious minister in Houston, Texas, has a history of making bizarre medical claims. She has repeatedly attributed gynecological problems to people having sex in their dreams with demons and witches. She claims that alien DNA is used in medical treatments. Investigators of the featured doctors found that “none of the most vocal members have practices that would place them on the actual front lines of the COVID-19 pandemic. Some don’t currently practice at all.”

On July 31st, the Texas Medical Board issued a press release objecting to “a widely published claim of a ‘cure’ for COVID-19.” It stated in part:

A physician must provide full disclosure of treatment options, side effects, obtain informed consent, and there cannot be false, misleading or deceptive advertising or statements made regarding any therapies, including a cure for COVID-19.

President Trump has touted a journal paper published in July about a retrospective observational study of 2,541 hospitalized patients with COVID-19 that found reduced mortality among those who received hydroxychloroquine alone or in combination with azithromycin. Such a study cannot control for confounding factors the way properly designed randomized clinical trials can. Letters to the editor of the journal identified multiple flaws, errors, and biases in the study.

On August 3rd, President Trump continued to hype hydroxychloroquine against COVID-19. He said that it has tremendous support despite contrary views from his own experts. He claimed that his support for it is “politically toxic.”

Trump’s enthusiasm for hydroxychloroquine is inconsistent with recommendations from the National Institutes of Health’s COVID-19 Treatment Guidelines Panel. The panel’s guidelines include these summary statements:

  • The COVID-19 Treatment Guidelines Panel (the Panel) recommends against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19, except in a clinical trial. [The panel characterized this recommendation as strong and based it on one or more well-designed, nonrandomized trials or observational cohort studies]. (This recommendation is part of a statement last updated June 16, 2020.)
  • The Panel recommends against the use of high-dose chloroquine (600 mg twice daily for 10 days) for the treatment of COVID-19. [The panel characterized this recommendation as strong and based it on one or more randomized trials with clinical outcomes and/or validated laboratory endpoints.] (This recommendation is part of a statement last updated June 16, 2020.)
  • The COVID-19 Treatment Guidelines Panel recommends against using hydroxychloroquine plus azithromycin for the treatment of COVID-19, except in a clinical trial. [The panel characterized this recommendation as strong and based it on expert opinion.] (This recommendation is part of a statement last updated July 17, 2020.)

On August 20th, the Infectious Disease Society of North America updated its recommendation statement for treatment and management of patients with COVID-19 regarding the use of hydroxychloroquine:

Recommendation 1. Among hospitalized patients with COVID-19, the IDSA guideline panel recommends against hydroxychloroquine*. (Strong recommendation, Moderate certainty of evidence)

  • Remark: Chloroquine is considered to be class equivalent to hydroxychloroquine.

Recommendation 2. Among hospitalized patients with COVID-19, the IDSA guideline panel recommends against hydroxychloroquine* plus azithromycin. (Strong recommendation, Low certainty of evidence)

  • Remark: Chloroquine is considered to be class equivalent to hydroxychloroquine.

The last literature search was conducted on August 7, 2020. The summary of evidence is based on five RCTs and eight non-randomized studies.

The FDA has sent warning letter to these sellers of unapproved/misbranded hydroxychloroquine or chloroquine products intended to mitigate, prevent, treat, diagnose, or cure COVID‐19:

For more information:

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. FDA, updated July 1, 2020.

Gorski D. Hydroxychloroquine to treat COVID-19: Evidence can’t seem to kill it. Science-Based Medicine, July 27, 2020.

Hydroxychloroquine ineffective for COVID-19, demon sperm, and zombies. Skeptical Raptor, July 30, 2020.

Submitted by William M. London

First published June 3, 2020.

Last updated September 8, 2020.

The Federal Trade Commission has sent a letter warning this marketer to stop making unsubstantiated claims that its infrared radiation device can treat or prevent COVID-19:

Submitted by William M. London.

First published August 28, 2020.

Intravenous vitamin C is an unproven treatment for COVID-19 and for the complex, often-deadly bodily reaction of sepsis that can result from infectious diseases including COVID-19. Nevertheless, TruthInAdvertising.org has identified more than 40 clinics (or “medical spas” as they sometimes call themselves) promoting “immunity drips” for treatment or prevention of  COVID-19. The drips may contain, in addition to megadoses of vitamin C, B vitamins, zinc and an antioxidant called glutathione. Many clinics promoting intravenous drips also promote unproven ozone treatments.

On April 1, 2020, the American Association of Naturopathic Physicians, a trade group devoted to advancing naturopathic medicine as a profession, issued a press release prematurely promoting intravenously administered vitamin C as an adjunctive treatment for moderate to severe cases of COVID-19.

Dr. Charles Mok, who operates Allure Medical Spa, PLLC in Shelby Township, Michigan has been charged in a criminal complaint for health care fraud scheme that included allegedly submitting false and fraudulent claims to Medicare for high-dose intravenous vitamin C infusions to patients at risk of contracting COVID-19, especially those working on the frontlines, and to those who tested positive for COVID-19. Dr. Mok made unsubstantiated claims in multiple launch videos that vitamin C reduces the severity of symptoms, duration of illness, and therefore the contagiousness of COVID-19 and significantly increases the immunity system of those who have a high risk for contracting the virus.

TruthInAdvertising.org has identified more than 40 clinics advertising deceptive COVID-19 prevention and treatment claims for intravenous nutrient therapies in violation of federal law.

The Federal Trade Commission has warned these companies to stop making unsubstantiated claims that their intravenous nutrient drips can treat or prevent COVID-19:

For more information:

Submitted by William M. London

First published May 26, 2020.

Last updated September 4, 2020.

The U.S. Food and Drug Administration (FDA) has warned consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom affects the same opioid brain receptors as morphine and appears to have properties that expose users to the risks of addiction, abuse, and dependence. There are no FDA-approved uses for kratom. The agency has received concerning reports about its safety. The FDA has also warned consumers not to use any products labeled as containing kratom’s psychoactive compounds, mitragynine and 7-hydroxymitragynine.

The FDA has issued a letter warning against selling kratom products in the United States intended to mitigate, prevent, treat, diagnose, or cure COVID-19 to:

 

For more information:

FDA and Kratom. FDA Public Health Focus. September 11, 2019.

Kratom Drug Facts. National Institute on Drug Abuse. April 2019.

 

Submitted by William M. London.

First published August 28, 2020.

Miracle Mineral Solution (MMS) contains a 28% solution of sodium chlorite. which, when mixed with an acid such as citrus juice, produces chlorine dioxide (ClO2), a potent bleach used for stripping textiles and industrial water treatment. Sodium chlorite is not legal to sell for human consumption, and legitimate suppliers of the chemical include a warning sheet stating that it can cause potentially fatal side effects if swallowed.The U.S. Food and Drug Administration (FDA) has strongly urged consumers not to purchase or use MMS, explaining that drinking MMS is the same as drinking bleach and can cause dangerous side effects, including severe vomiting, diarrhea, and life-threatening low blood pressure. The FDA has received reports of people requiring hospitalizations, developing life-threatening conditions, and dying after drinking MMS. Health Canada has warned consumers not to use MMS and stated: “Ingestion of water treated with Miracle Mineral Solution (28% sodium chlorite solution) has been associated with two adverse reactions in Canada, including one life threatening reaction.”

In April, a federal court entered a temporary injunction halting the sale of MMS by Genesis II Church of Health and Healing and its principals, Mark Grenon, Joseph Grenon, Jordan Grenon, and Jonathan Grenon. This action followed a warning letter issued by the U.S. Food and Drug Administration stating that MMS is an unapproved new drug sold in violation of federal law.

On July 8th, the U.S. Attorney’s Office for the Southern District of Florida announced that the four Grennons had been charged with conspiracy to defraud the United States, conspiracy to violate the Federal Food, Drug and Cosmetic Act, and criminal contempt. According to the criminal complaint affidavit, the Grenons allegedly:

  • directed their customers to ingest MMS, a solution that contains sodium chlorite and water, which causes the solution to become chlorine dioxide, a powerful bleach
  • claimed that MMS can treat, prevent, and cure COVID-19
  • marketed MMS as a miracle cure-all for dozens of other serious diseases and disorders, including cancer, Alzheimer’s, autism, multiple sclerosis, and HIV/AIDS, even though the FDA had not approved MMS for any use
  • sold tens of thousands of bottles of MMS nationwide under the guise of Genesis II Church of Health and Healing, an entity they allegedly created to avoid government regulation of MMS
  • willfully violated civil court orders to halt distribution of MMS
  • sent letters to the judge presiding over the civil case saying that they would not comply with the Court’s orders and that the judge should be “taken out.”

The judge ordered that all websites selling MMS be immediately removed from the Internet and that all supplies involved in the product creation be confiscated and destroyed.

As reported by 23WIFR, multiple agencies were called to the “church” location in Bradenton, Fla. in connection with search warrants and the federal order. Hazmat crews were reportedly called to assist with the warrants.

On August 3rd, the FDA and the Federal Trade Commission jointly issued a warning letter to the operators of MMSTabs.com because the site offers MMS products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

On August 11th, the FDA announced that a U.S. District Court in Florida entered permanent injunctions that prohibit the Grenons and their “church” from selling or distributing unapproved or misbranded products such as Mineral Miracle Solution (MMS). Afterwards, the perpetrators’ main websites stated: “Due to US Dept. of Justice permanent injunction against the Genesis II Church, this site is closed. —Bishop Mark S. Grenon.”

On August 13th, Associated Press reported that Colombian officials said they arrested Mark Grenon and his son Joseph, who were shipping their products from the beach town of Santa Marta to clients in the United States, Colombia, and Africa.

For more information:

Submitted by William M. London

First published May 26, 2020, last updated August 20, 2020.

The Federal Trade Commission has sent letters warning these multilevel marketing companies tto remove and address claims that they or their participants are making about their products’ ability to treat or prevent coronavirus disease or about the earnings people who have recently lost income can make, or both:

Both Health and Earnings Claims:

Earnings Claims:

Health Claims:

For more information:

Sutherland D. Multi-level menace. Skeptical Inquirer 42(5):44-46, September/October 2018.

How MLMs exploit consumers during a pandemic. TruthInAdvertising.org, April 27, 2020.

MLM Watch: The Skeptical Guide to Multilevel Marketing.

Multi-level marketing businesses and pyramid schemes. Federal Trade Commission, October 2019.

Submitted by William M. London

First published September 27, 2020.

The U.S. Food and Drug Administration and/or the Federal Trade Commission sent warning letters to these sellers of nasal or inhaler products making unsubstantiated claims for for preventing or treating COVID-19:

Submitted by William M. London

First published August 17, 2020.

Updated September 8, 2020.

Oleandrin is the chemical from the plant Nerium oleander (oleander) that is responsible for the toxic effects that the plant parts have on the heart. The Therapeutic Research Center’s natural medicines database rates oleander as “LIKELY UNSAFE” to take by mouth and identifies no health problems that oleander can effectively treat. Oleander is the supposedly active ingredient in several homeopathic products. (See section on homeopathy above.) It has been inappropriately included as an ingredient is some herbal concoctions. According to the U.S. Food and Drug Administration, oleandrin may not be marketed as or in a dietary supplement.

Claims that oleandrin has anti-viral activity are based on a single pre-clinical study that has not been peer-reviewed and merely found that oleandrin has activity against the virus in a test tube. Nevertheless, after meeting with two oleandrin enthusiasts—MyPillow CEO Mike Lindell and Housing and Urban Development Secretary Ben Carson, MD—President Trump expressed interest in permitting oleandrin to be marketed as a dietary supplement or approved as a COVID-19 drug. In August, Lindell reportedly joined the board of Phoenix Biotechnology, which makes oleandrin, and received a financial stake in the company. In a televised interview with Anderson Cooper, Lindell claimed that 1,000 people took oleandrin in 2016 without having adverse reactions, but he was unable to cite the supposed study.  Phoenix Biotechnology has referred to studies carried out at University of Texas M.D. Anderson Cancer Center that supposedly showed a lack of toxicity. However, the studies have not been published. Joe Schwarcz, PhD concluded:

There are many cases of animals and people having been poisoned by oleander, sometimes on purpose. In Sri Lanka, unfortunately, the plant has become a common means for suicide, prompting the government to take steps to eradicate it and prohibit its cultivation as an ornamental plant. At this point, it is totally irresponsible to recommend any oleander product as having efficacy against COVID-19. When I hear this kind of nonsense, I feel like putting a pillow over my head. And it will not be “MyPillow.” [Schwarcz J. Planting a toxic oleander seed. McGill Office for Science and Society, Aug 19, 2020]

For more information:

Quave C. Oleandrin is a deadly plant poison, not a COVID-19 cure. The Conversation, Aug 18, 2020.

Novella S. Oleandra—the new COVID snake oil. Science-Based Medicine, Aug 19, 2020.

Swan J. Trump eyes new unproven coronavirus “cure”. Axios, Aug 16, 2020.

Lutz E. The MyPillow guy wants to bring Trump’s COVID miracle cure to life. Vanity Fair, August 17, 2020.

Klein B. Trump ‘enthusiastic’ over unproven coronavirus therapeutic, MyPillow creator says. CNN, Aug 17, 2020.

Cilizza C. Anderson Cooper just exposed the coronavirus quackery of one of Donald Trump’s most loyal allies. CNN, Aug 18, 2020.

Novella S. FDA decision on oleandra. Science-Based Medicine, September 9, 2020.

***

Submitted by William M. London

First published September 10, 2020.

Ozone (a molecule consisting of 3 oxygen atoms) is a toxic gas that has been promoted by naturopaths and other non-science-based health hucksters as a therapy for chronic diseases, Lyme disease, viral infections, chronic fatigue syndrome, autoimmune diseases, “detoxification,” and “boosting the immune system” despite the lack of substantiating evidence of safety and effectiveness. Practitioners of ozone treatment administer ozone through several different routes. It is most commonly administered by infusing it into blood drawn from a patient and then re-injecting the blood.

Various drinkable water products are deceptively promoted as being able to enhance health by increasing in the body  oxygen in the form we need to breathe in (molecules consisting of two oxygen atoms).

Hydrogen peroxide administered orally or intravenously is also deceptively promoted as a health enhancing oxygenation therapy.

Hyperbaric oxygen therapy HBOT involves breathing oxygen in a pressurized chamber. The Food and Drug Administration (FDA) has cleared hyperbaric chambers for certain medical uses, such as treating decompression sickness suffered by divers, air or gas embolism (dangerous “bubbles” in the bloodstream that obstruct circulation), thermal burns (caused by heat or fire), and carbon monoxide poisoning, However, many promoters advertise the chambers with unproven claims for effectiveness in treating a wide variety of injuries and diseases including COVID-19. Risks of HBOT include sinus pain, ear pressure, painful joints, paralysis, and air embolism. The oxygen-rich environment of hyperbaric chambers pose a risk of fire.

The U.S. District Court for the Northern District of Texas has entered a permanent injunction halting Purity Health and Wellness Centers of Dallas, Texas, which fraudulently promoted “ozone therapy” as a COVID-19 treatment, from offering unproven treatments for the disease.

In September, Arkansas’s attorney general accused the Arkansas Regenerative Medical Center LTD (ARMC), the firm’s medical director Sarah Knife Chief, M.D., and chiropractor Serge Francois, D.C. of marketing fraudulent COVID-19 treatments including ozone therapy. The lawsuit alleges:

  • In early 2020, ARMC, Chief, and Francois used a popular Hispanic radio station and employed the station’s DJ in an effort to reach Latino consumers, who were being disproportionately affected by the coronavirus.
  • ARMC advertised on its website and Facebook page stem cell treatments and ozone therapy, claiming that they were “very effective” against COVID-19 and would allow employees to return to work more quickly.
  • Consumers were charged upwards of $3,000 for the useless treatments.

The Federal Trade Commission has warned these businesses to stop making unsubstantiated claims for ozone, hydrogen peroxide, and/or other oxygen for treating or preventing COVID-19:

For more information:

Submitted by William M. London

First published May 26, 2020.

Last updated October 7, 2020.

The Federal Trade Commission has sent letters warning these marketers to stop making unsubstantiated claims that their pulsed electromagnetic field devices can treat or prevent COVID-19:

 

 

For more information:

Novella S. Pulsed electromagnetic field snake oil. Science-Based Medicine, June 8, 2016.

 

Submitted by William M. London.

First published August 28, 2020.

Evidence is lacking to support claims that silver products can be used safely or effectively treat or prevent infections. Although silver products are sold as dietary supplement, silver has no dietary function. Silver products are often sold as colloidal silver, a suspension containing microscopic silver particles. According to the Natural Medicines Comprehensive Database (NMCD):

Despite claims to the contrary, there is no good evidence to support using colloidal silver for COVID-19.

NMCD considers colloidal silver to be:

Likely unsafe when used orally, topically, or intravenously. Side effects may include silver deposition in the skin and mucous membranes, seizures, liver and kidney toxicity, and others.

The Office of the Missouri Attorney General filed a lawsuit against Jim Bakker and Morningside Church Productions, Inc. for misrepresentations about the effectiveness of “Silver Solution” as a treatment for 2019 novel coronavirus (COVID-19).

In April, the U.S. District Court for the District of Utah has halted the sales of silver products touted as COVID-19 cures by Gordon Pedersen of Cedar Hills, Utah, and his companies, My Doctor Suggests LLC and GP Silver LLC.

In July, the U.S. Department of Justice announced that:

  • Pedersen was indicted by a federal grand jury for posing as a medical doctor to sell silver-based products for ingestion as a cure for COVID-19 despite having no evidence that his products could treat or cure the disease.
  • The company Pedersen previously co-owned, My Doctor Suggests LLC (My Doctor Suggests): (1) agreed to plead guilty to a one-count criminal information related to its false and misleading marketing of ingestible silver products as a drug treatment for COVID-19, and (2) severed ties with Pedersen and agreed to cooperate in his prosecution.

U.S. District Judge Ronald A. White for the U.S. District Court for the Eastern District of Oklahoma entered a temporary restraining order against Xephyr LLC, doing business as N-Ergetics and three individuals associated with the entity, requiring them to immediately stop distributing colloidal silver products.

The U.S. Food and Drug Administration and/or the Federal Trade Commission have warned several companies to stop making unsubstantiated claims that their silver products can treat or prevent COVID-19 including:

For more information:

Submitted by William M. London

First published May 26, 2020.

Last updated September 8, 2020.

The Federal Trade Commission and/or the U.S. Food and Drug Administration have sent letters warning these marketers to stop making unsubstantiated claims that their skincare products can prevent or treat COVID-19:

 

Submitted by William M. London.

First published August 20, 2020.

Updated September 8, 2020.

The Federal Trade Commission has sent a letter warning this marketer to stop making unsubstantiated claims that its offerings using sound can prevent or treat COVID-19:

 

Submitted by William M. London.

First published August 28, 2020.

In September, Arkansas’s attorney general accused the Arkansas Regenerative Medical Center LTD (ARMC), the firm’s medical director Sarah Knife Chief, M.D., and chiropractor Serge Francois, D.C. of marketing fraudulent COVID-19 treatments including stem cell treatments. The lawsuit alleges:

  • In early 2020, ARMC, Chief, and Francois used a popular Hispanic radio station and employed the station’s DJ in an effort to reach Latino consumers, who were being disproportionately affected by the coronavirus.
  • ARMC advertised on its website and Facebook page stem cell treatments and ozone therapy, claiming that they were “very effective” against COVID-19 and would allow employees to return to work more quickly.
  • Consumers were charged upwards of $3,000 for the useless treatments.

The Federal Trade Commission and/or the U.S. Food and Drug Administration sent letters warning these marketers to stop making unsubstantiated claims that their stem cell treatments can treat or prevent COVID-19:

For more information:

 

Submitted by William M. London.

First published August 28, 2020.

Last updated October 7, 2020.

In April, the Washington State Office of the Attorney General sent a cease and desist letter to Redmond-area resident Johnny T. Stine and his company, North Coast Biologics to stop selling an unapproved “vaccine” product without testing and evidence. The product was sold for $400. In June, the Attorney General filed a lawsuit against Stine and his company. The lawsuit resulted in the filing of a consent decree that:

  • prohibited Stine and his company from marketing future vaccines without rigorous testing and sound scientific evidence
  • required Stine to pay $8,500 to the state for the cost of bringing the case, with another $30,000 suspended based on his compliance with the agreement
  • entitled as many as 30 victims of the scam to refunds

 

Submitted by William M. London.

First published September 8, 2020.

The U.S. Food and Drug Administration has issued warning letters to these sellers because their tests were adulterated and/or misbranded:

 

Submitted by William M. London

First published August 19, 2020.

Last updated September 8, 2020.

The Federal Trade Commission sent letters warning these marketers to stop making unsubstantiated claims that their Zapper devices can prevent or treat COVID-19:

 

For more information:

Barrett S. The bizarre claims of Hulda Clark. Quackwatch, October 23, 2009.

Orac. Requiem for a quack. Respectful Insolence, September 9, 2009.

Orac. Requiem for a quack, Part II: Hulda Clark, author of The Cure for All Cancers died of cancer. Respectful Insolence, October 27, 2009.

Chavez P. How Hulda Clark victimized my parents. Cancer Treatment Watch, August 11, 2007.

Barrett S. Hulda Clark associate barred from making false claims about “Zappers” and other products. Casewatch, November 30, 2004.

FTC sues Dr. Clark Association.

FTC prohibits marketers of herbal products and the “Zapper” from making unsubstantiated claims. FTC news release, December 28, 2001. Posted at Casewatch on November 20, 2005.

Swiss company to provide refunds to U.S. customers. FTC press release, December 3, 2004.

Warning letter to W&W International Medical Research. Casewatch, December 1, 1998. (Posted August 20, 2006.

 

Submitted by William M. London

First published October 20, 2020.

Inoculation Against Misinformation

Drawing upon the unique expertise of institutions such as the Committee for Skeptical Inquiry and Quackwatch, the Center for Inquiry is doing what we do best: confronting and exposing pseudoscience and misinformation. View our resources page on the coronavirus and slow the spread of misinformation: