Posts Push Unproven ‘Spike Protein Detoxification’ Regimen

SciCheck Digest

Serious side effects after COVID-19 vaccination are rare, and there isn’t evidence people need to undergo a “spike protein detoxification” regimen after getting vaccinated, contrary to claims made online. Nor has such a regimen been shown to help people recover from long COVID, or long-term health problems after having COVID-19.

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For the vast majority of people, any side effects from COVID-19 vaccines are mild and temporary, such as a sore arm or fever. There isn’t reason to believe people need to undergo any sort of detoxification procedure following vaccination. Some people have persistent symptoms after COVID-19, referred to as long COVID. But there aren’t any proven treatments for this condition.

Despite this, Dr. Peter A. McCullough, a cardiologist with a history of spreading false or misleading claims about COVID-19 and vaccines, has been promoting an unproven “spike protein detoxification” protocol, which has been widely shared on Instagram.

“Just like I brought the world the very first treatment protocol for COVID-19 … the McCullough Protocol, yesterday I published the very first detoxification protocol for people who have had multiple rounds of COVID or vaccines or both. And that is to get the body to start to clear the spike protein out of its system,” McCullough said in a video clip in one of the posts.

SARS-CoV-2, the virus that causes COVID-19, has spike protein on its surface and uses it to enter cells. The COVID-19 vaccines approved or authorized in the U.S. either contain spike protein or instruct a person’s cells to make spike protein. The immune system mounts a response to the spike protein, better preparing it to recognize and respond to the virus if it encounters it in the future.

The “McCullough Protocol” recommends treatments for COVID-19 that have been shown not to work, including hydroxychloroquine and ivermectin. The new “Base Spike Detoxification” protocol, described in the fall 2023 issue of the Journal of American Physicians and Surgeons, suggests taking a combination of curcumin, bromelain and nattokinase.

The Journal of American Physicians and Surgeons, where McCullough and his colleagues described the unproven protocol, is published by the Association of American Physicians and Surgeons, a small organization of physicians known for putting forward fringe medical views. The publication is not indexed by Medline, a database of the National Library of Medicine that includes journals that have met certain basic requirements, including passing a scientific quality review.

There isn’t evidence that the trio of substances presented by McCullough would help clear spike protein from the human body. And while treatments for long COVID are sorely needed, there aren’t studies in humans to suggest McCullough’s regimen would be effective.

“There are no clinical trials that I’m aware of demonstrating efficacy for individuals with Long COVID, either individually or in combination,” Dr. Benjamin Abramoff, a physician specializing in physical medicine and rehabilitation and director of the Post-COVID Assessment and Recovery Clinic at the University of Pennsylvania, told us in an email about the substances McCullough touts.

“There is no evidence that these supplements work for long COVID,” Dr. Kristin Englund, an infectious disease physician and director of the Long COVID reCOVer Clinic at Cleveland Clinic, said.

“I haven’t seen any published peer-reviewed data that indicates these interventions have any effect,” David R. Walt of the Wyss Institute at Harvard University, told us in an email, in response to a question about whether McCullough’s protocol can help people with “spike protein detoxification.” Walt is an expert in analysis of proteins and other biomolecules.

Another Instagram post sharing the unsupported protocol implied that McCullough has credibility because he “is putting out the information – he is not telling you ‘I have the formula buy it from me.’ You can get this anywhere. He’s letting you know what the deal is – so watch who is making money and who is just giving you the information for free to help you.”

It is possible to buy the substances McCullough mentions from a variety of companies. But McCullough is chief scientific officer of The Wellness Company and promotes the company’s Spike Support product, which contains nattokinase — so he stands to gain financially from his recommendation. According to the disclosure in his new protocol article, McCullough receives “partial salary support and holds an equity position in The Wellness Company.”

“The Wellness Company has brought the best news to those who suffer from long COVID or regret COVID-19 vaccination,” McCullough is quoted as saying in a recent sponsored post on the website Vigilant News. “Our Spike Support product is the bedrock of the recently-published ‘Base Spike Detoxification Protocol,’ the first and only regimen to help people recover from post-acute sequelae after COVID-19 and vaccination,” he continued, repeating the unsubstantiated claim that the regimen has benefits.

While there are no evidence-based treatments for long COVID, also sometimes called post-acute sequelae of COVID-19, there are some measures people can take to possibly reduce their risk of getting it in the first place. This includes getting vaccinated against COVID-19.

“Promoting unproven Long COVID treatments can lead to wasted time, money, and possibly even adverse effects of the treatments,” Abramoff said. “Stoking fears about vaccination can not only lead to increased risk from acute COVID but also the risks of Long COVID.”

Englund recommended that people “be cautious of spending a lot of money on unproven claims of effectiveness.”

We reached out to McCullough and The Wellness Company with questions but did not receive a reply.

Spike Detox Protocol Not Shown to Work in People

McCullough and his co-authors themselves wrote in the Journal of American Physicians and Surgeons that their protocol has not been tested in humans sufficiently to make therapeutic claims.

“The duration of therapy and the impact on clinical outcomes such as quality of life, symptom scores, hospitalization, and death are unknown,” they wrote. “Thus, no therapeutic claims can be made until large prospective randomized double-blind placebo controlled trials are completed.”

Yet McCullough makes statements in video clips suggesting dosage and duration of therapy and says that his protocol will help people. “Now here are the doses: nattokinase, 2,000 units twice a day, bromelain, 500 mg a day, and curcumin, 500 mg twice a day. How long? About three to 12 months to detoxify the body,” he said in one clip shared on Instagram. “I’ve had enough experience with this in my clinic that I know that this will help,” he added, before repeating the statement that he can’t make therapeutic claims.

The nattokinase-containing Spike Support product is $65.99 for 120 capsules, according to The Wellness Company website.

McCullough and co-authors theorized in their article that their regimen can target the spike protein based on studies in which researchers found that nattokinase or natto extract could degrade spike proteins or pieces of them. Nattokinase is derived from natto, a food made from fermented soybeans. The studies were done in vitro, meaning they were done in lab dishes. They did not show whether nattokinase can degrade the spike protein in humans, nor even in animals.

They also referred to research indicating that bromelain, which is derived from pineapple stems, cleaves the spike protein, again shown only in vitro. And they referred to computer modeling that they say indicates curcumin, found in turmeric, could block the interaction of the spike protein with cells.

Dr. Igor Koturbash, co-director of the Center for Dietary Supplements Research at the University of Arkansas for Medical Sciences, told us via email that in vitro evidence does not mean a substance will work as intended as a treatment.

“Many phytochemicals and other natural and synthetic products have been tested in vitro to be effective against viral infection, including COVID,” he said. “I do not recall many of them demonstrating effectiveness in animal systems, not to mention in humans.”

McCullough and his colleagues provided an extensive summary of other research into the three substances, some of which repeats verbatim the text of a 2020 paper by a separate group of researchers. None of this research was done in people with long COVID, nor does it show the effects of the substances on the spike protein.

Unsupported Claims Stoke Fear About Spike Protein

McCullough and The Wellness Company often repeat the idea that the spike protein persists in the body and harms people after vaccination or COVID-19.

This idea is based on some hypotheses about the origins of long COVID and a very rare vaccine side effect. But McCullough and his company take these theoretical ideas and use them to make unsupported pitches for his protocol and the Spike Support product.

“Get back to that pre-COVID feeling. Vaccinated or not, toxic spike proteins pose a long-term threat to your health,” reads the page selling the Spike Support product on The Wellness Company website.

“So yesterday was a historic day as the very first detoxification protocol was published in the U.S. medical literature that gives people a chance to take this whole issue into their own hands and use natural substances to begin to help the body clear this very dangerous protein from its cells and tissues,” McCullough said in a video clip shared on social media.

Experts told us that spike detoxification is not a term generally used by medical professionals.

“Completely unnecessary,” said Walt of the concept of spike detoxification. “Almost all individuals clear the protein. There are a few rare individuals who have persistent spike protein but very rare.”

Walt said that after vaccination or infection, people develop an antibody response to the spike protein, leading to its clearance. This antibody response kicks in three days after vaccination and three days to a week after a person is infected, he told us.

Walt co-authored a paper published earlier this year in Circulation theorizing about a possible but unconfirmed role for persistent circulating spike protein in myocarditis, or inflammation of the heart muscle, a rare vaccine side effect. The researchers found spike unbound by antibodies circulating in the blood of teens and young adults with myocarditis after vaccination, but not in the blood of healthy vaccinated people.

“Although the implications of this finding must be better understood, these results do not alter the risk-benefit ratio favoring vaccination against COVID-19 to prevent severe clinical outcomes,” the researchers wrote.

Other work has suggested a different, inflammation-related mechanism for this rare heart problem.

As we will discuss below, there is some evidence that people with long COVID have persistent virus or viral components in their body such as spike protein, leading to hypotheses that this could contribute to their symptoms. But even if this indeed turns out to be a contributor to long COVID, it hasn’t been shown that McCullough’s protocol would help with the problem.

Lack of Long COVID Treatments

Experts told us that they worry about bad actors taking advantage of a situation in which people with long COVID are suffering and do not have evidence-based treatment options.

People can do a few things to reduce their risk of getting long COVID. “The best way to prevent Long COVID is to avoid getting acute COVID through things like masking and vaccination,” Abramoff said.

For people who do get COVID-19, having been vaccinated likely reduces risk of long COVID and also possibly its severity, he said. There have also been studies that indicate a possible role for taking the antiviral Paxlovid or metformin, an antidiabetic medication, while sick with COVID-19 to lower long-COVID risk.

“There are still a lot of questions about long COVID, so as a result, we don’t have treatments for long COVID,” Englund said. “We know how to treat people’s symptoms, but we don’t know how to treat the underlying problem.”

A National Institutes of Health initiative called RECOVER will run at least four trials testing long COVID treatments — either aimed at addressing the theorized underlying biology of the disease or at alleviating symptoms. Various other clinical trials are planned or are underway.

Researchers hope to test treatments aimed at different possible long COVID causes or mechanisms. One of these is that there is persistent virus, viral protein or viral mRNA. Abramoff said there is “interesting preliminary evidence” that viral persistence could contribute to long COVID, adding that “[w]hile this is one compelling theory, it has yet to be proven.”

A number of clinical trials are testing Paxlovid as a long COVID treatment, with the theory that this antiviral medication could help deal with residual virus, said Dr. Upinder Singh, an infectious disease physician at Stanford University. Singh is a principal investigator for the Stanford site of the RECOVER trial and is also involved in other research into Paxlovid for long COVID.

Some patient advocates and researchers have expressed concern about the pace of research and the designs of planned studies. In the meantime, some people and groups have run surveys or gathered anecdotal reports from patients with long COVID of benefits from supplements, including nattokinase.

But clinical data are still lacking.

“We don’t have a treatment, and so people often are desperate for help, and I feel like some of this unfounded stuff really preys on that desperation and that fear and that anxiety,” Singh said during an interview about McCullough’s spike detoxification protocol.

“I understand how desperate people are to feel better and get back to their pre-COVID health, but that doesn’t mean that we just reach for anything that is out there, because it can be a waste of time and a lot of money and have potential harms,” Englund said.

Potential Legal Issues with Spike Support Claims

The Wellness Company’s Spike Support product is labeled as a supplement. Unlike new drugs, supplements do not need to gain U.S. Food and Drug Administration approval — a process that includes an evaluation of safety and efficacy — before being marketed.

But to label their product as a supplement, companies cannot claim that it prevents or treats a disease. Legal experts told us that statements about the product tied to the company, such as on the company’s website and in sponsored content, may be running afoul of limits on claims about treatment.

“In this case, the FDA could determine that the products are misbranded drugs,” Allison Whelan, an expert on the FDA and a professor at Georgia State University College of Law, told us via email.

If the FDA determines that products are misbranded drugs, Whelan said, its first step “would likely be to send a ‘warning letter’ to the company requesting that [it] amend its statements about the products so as not to make any disease claims.”

Whelan said that statements on the page from The Wellness Company selling the Spike Support product alone would give the FDA authority to send a warning letter to the company.

The page says, “Buy daily Spike Support and protect you and your family against the effects of COVID, vaccines, and shedding,” for instance.

Claims in sponsored content could also be viewed by the FDA as drug claims, Alexandra Roberts, a professor of law and media at Northeastern University School of Law, also told us in an email. As we mentioned earlier, McCullough is quoted in one sponsored post linking to Spike Support as saying the product is the “bedrock” of “the first and only regimen to help people recover from post-acute sequelae after COVID-19.”

Roberts, who has expertise in false advertising law, said that claims about Spike Support also could be in the jurisdiction of the Federal Trade Commission, which “has primary responsibility when it comes to the regulation of the truth or falsity of the advertising (besides labeling) of foods, non-prescription drugs, devices, and cosmetics.”

“So if the claims about Spike Support or nattokinase are false, or if the data does not adequately substantiate those claims, FTC could take action,” she said.

When asked whether the FDA had taken any actions related to The Wellness Company or its Spike Support product, a spokesperson told us that the “FDA does not discuss possible or ongoing investigations, except with the party involved.”

“The FTC has not announced any public actions related to this product,” an FTC spokesperson said.

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