Joe Mercola warned by FDA about quack COVID-19 treatments

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One of our favorite alternative medicine quacks, Dr. Joe Mercola, DO, has been warned by the FDA to cease promoting useless COVID-19 treatments. This is not the first time that Dr. Mercola has run afoul of the FDA, and given his past activities, I doubt it’s his last.

The FDA told Joe Mercola that three products he markets with COVID-19 treatment claims are are “unapproved new drugs” and “misbranded drugs” being sold in violation of the Food, Drug, and Cosmetic Act. The three products are – Liposomal Vitamin C, Liposomal Vitamin D3, and Quercetin and Pterostilbene Advanced.

In case you don’t feel like reading what Joe Mercola has done this time, I’ll save you a bit of time. There is no evidence that any of these products do anything to treat COVID-19. But let’s take a look at Mercola and his quack treatments.

joe mercola
Photo by Anna Shvets on Pexels.com

Who is Joe Mercola?

I have tried to avoid writing about Joe Mercola because others have done it so much better. In case you don’t who he is, Mercola is an American proponent of pseudoscientific alternative medicine, an osteopathic physician (see Note 1), an internet salesman, and an anti-vaccine advocate.

Mercola is also a member of the right-wing medical group, the Association of American Physicians and Surgeons, which promotes scientifically discredited views about medicine and disease.

In 2005, 2006, and 2011, the U.S. Food and Drug Administration warned Mercola and his company that they were making illegal claims for their products’ ability to detect, prevent, and treat disease.

Orac has been writing about Mercola for over a decade. In one of his earliest articles, he explains that Mercola has gotten filthy rich selling his quackery over the internet:

What I also now know is that Joe Mercola is rich, as in filthy rich, as in “rolling in the dough” rich, as in “raking it in hand over fist rich.” After all, he has $1 million to give away to the NVIC and various other quackery-promoting groups. Many people never make $1 million over the course of their entire lives. And how did Mercola make all this money? Here’s a hint: It wasn’t through practicing standard medicine. Oh, no. He made his millions selling and practicing what I consider to be quackery.

Of course, he now has the chance to make more money with this pandemic. Of course, he does.

What is “liposomal” vitamin C and D3?

I don’t want to waste too much of your time on these things, but “liposomal” seems to be one of the new pseudoscience claims that wrapping the vitamin C or D3 with a fatty membrane (or liposome) makes it easier for the uptake of these vitamins.

I can’t find any overwhelming evidence that this is true for these vitamins (given that vitamin D is a “fat”) but assuming that in some biologically plausible manner it does increase uptake of these vitamins, does it really matter? Does vitamin D or C have any effect on treating COVID-19?

Joe Mercola

Vitamin C and COVID-19

The history of using vitamin C to treat the common cold traces back to Linus Pauling‘s 1970 book, Vitamin C and the Common Cold. That book set off a huge run on vitamin C, which became the go-to supplement for those who wanted to prevent or treat colds. A few years later, Pauling updated the book to claim that it also was good for the flu.

Even back then there was criticism of the science behind it, which continues to today. And now we have real scientific evidence that should make you quite skeptical of Pauling’s claims. As common cold treatments go, vitamin C is not supported by much evidence.

According to a systematic review in the Cochrane Reviews,

The failure of vitamin C supplementation to reduce the incidence of colds in the general population indicates that routine vitamin C supplementation is not justified, yet vitamin C may be useful for people exposed to brief periods of severe physical exercise. Regular supplementation trials have shown that vitamin C reduces the duration of colds, but this was not replicated in the few therapeutic trials that have been carried out.

Admittedly, the researchers did find some evidence, never in the form of a double-blind or randomized clinical trial, that vitamin C may reduce the length of a cold.

I examined the research for vitamin C and COVID-19, and other than bad opinion articles in junk predatory journals, the one article published in a respected journal stated the evidence supporting its use in treating COVID-19 is “lacking.”

Oh wait, there was a randomized, double-blind clinical trial with vitamin C to treat COVID-19. The researchers found that high-dose zinc and vitamin C (ascorbic acid) had no impact on the course of symptoms in patients with mild COVID-19.

The study was stopped early for futility after an interim analysis conducted when 214 patients were enrolled; the researchers planned to include 520 patients.

But here’s the big point – people have been making all kinds of ludicrous claims about vitamin C and disease for over 50 years, and yet, there is no plausible biological mechanism for it doing anything to prevent any disease except scurvy. You’d think someone would have figured out something by now.

Vitamin D and COVID-19

Two terrible papers that I recently reviewed had tried to show some effect of vitamin D supplementation on the course of COVID-19. The problem was that neither paper came close to being scientifically robust – in fact, they were ridiculed by real scientists. Neither article provided any convincing clinical evidence that vitamin D could prevent or treat COVID-19.

However, because there is always a “however.”

Individuals with low blood levels of vitamin D who present to the hospital with COVID-19 need to have vitamin D supplements. It isn’t to treat COVID-19 directly (it’s not going to boost your immune system), it’s to reduce certain comorbidities that can make COVID-19 outcomes much worse.

Also, infections like COVID-19 can reduce vitamin D levels in many people. But we have no data on whether the drop in vitamin D levels has any effect on outcomes.

But don’t worry, science does move on. There are 78 studies listed in the clinical trial database that are examining any links between vitamin D supplementation and COVID-19. Maybe in a couple of years, we will know whether it is useful or not.

On the other hand, if you have been diagnosed with a vitamin D deficiency and you take a proper dose of the vitamin, it won’t hurt. But megadoses will not help and will cause harm.

Stay tuned. Maybe there will be a well-designed, large, randomized, double-blind, clinical trial that might give us some evidence as to whether it works or not. Oh, there is one.

The FDA tells Joe Mercola to stop

It’s not just me who says these things don’t work to treat, cure, or prevent COVID-19, it’s the FDA. They wrote this to Joe Mercola:

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses [redacted] and [redacted] (see Note 2) on February 8, 2021. We also reviewed your social media site at https://www.twitter.com/mercola, where you direct consumers to your website [redacted] to purchase your products. The FDA has observed that your website offers “Liposomal Vitamin C,” “Liposomal Vitamin D3,” and “Quercetin and Pterostilbene Advanced” products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 2pt1 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

The letter to Mercola lists out all of his outlandish and unsupported claims about these supplements. And they concluded by stating:

FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.

This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

We all know that Joe Mercola won’t stop selling quackery and anti-vaccine disinformation to the public because he makes a boatload of cash from shilling his quack treatments. Orac recently wrote:

Joseph Mercola, DO has been a frequent topic of discussion on this blog over the last 15 years. The reason is simple. He runs one of the largest repositories of misinformation about health on the entire Internet, including social media. He promotes antivaccine pseudoscience, the rankest of cancer quackery (e.g., the idea that cancer is a fungus and that baking soda can cure it), and pseudoscience and quackery of every imaginable variety, all while presenting himself as “moderate” and “reasonable” compared to those “real crazies,” like Mike Adams. It’s not just his website and social media activity, though. Selling supplements and all manner of woo, Mercola has become fabulously wealthy and has been using that wealth to support antivaccine groups, such as Barbara Loe Fisher’s National Vaccine Information Center to run antivaccine ads in various outlets , promoting a fake holiday known as Vaccine Injury Awareness Week over the last decade, and in general try to spread disease by discouraging vaccination. How wealthy has Joe Mercola become with his online quackery empire? His net worth is now over $100 million!

Over $100 million. I wish being a Big Pharma Shill paid that well.

Notes

  1. In the USA, a DO, or Doctor of Osteopathic Medicine, is functionally equivalent to an MD. Osteopathy schools, which have a dash of pseudoscience thrown into the curriculum, have highly competitive entrance standards, much like medical schools. The quality of students and their training is barely different than what is found in an average medical school. Once a student receives their DO, they can compete for the same residency and post-residency training programs as an MD. They can train to enter any medical specialty from pediatrics to surgery to psychiatry to anything they want. They are licensed as physicians as opposed to chiropractors, homeopaths, and naturopaths. From a purely practical standpoint, patients rarely know if their physician is an MD or DO. This is generally not true in any other country – and a US DO may not be able to be licensed as a physician in other countries.
  2. I do not place links to quack websites anymore. If you want to find his nonsense, you can easily google it.

Citations


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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!