FDA crackdown on alternative health
From fringes, growing distrust of feds’ motives
Operation Quack Hack, the federal government’s initiative to clamp down on fake coronavirus medications and cures, has exposed a health underground in America brimming with distrust not only of mainstream medicine but the government itself.
It’s a Tea Party for COVID-19 times. Its members are angry at government warning letters that many perceive as an infringement on their right to free speech, free trade and people’s control over their health care – and some are ready to fight back.
A common refrain: How can we trust the same government that signed off on opioids?
The most radical believe that wealthy globalists – including Bill Gates and Anthony
Fauci – created the coronavirus, unleashed it from Wuhan, China, along with immune-system-weakening 5G wireless technology; and intend to install digital ID chips in our bodies at the same time they give us the vaccine.
For them, the two agencies behind Operation Quack Hack – the Food and Drug Administration and the Federal Trade Commission – are sinister organizations. Their objective is to force everyone to take the vaccine, and the only way to do that is to convince us there’s no other choice.
“We’re not your slaves, we’re not in your cult,” right-wing talk show host Alex Jones shouted in June at an anti-mask rally in Austin. “If you want war, you’d better believe you got war.”
Jones got in trouble with the FDA in April for peddling a line of silver products, including silver-laced toothpaste, as a COVID-19 cure.
The majority of alternative health
providers that received warning letters are less extreme, but many still think the FDA and FTC are out to get them. The goal as they see it? To protect Big Pharma from competition as their market share grows.
“The healthcare system in this country is rigged against inexpensive, safe, and effective natural remedies in favor of expensive pharmaceutical drugs,” said Clark Hansen, a naturopathic medical doctor in Arizona, in an email message to USA TODAY. “The US medical system is ignoring any treatment that is not patentable and therefore cannot provide a multi-billion profit for some giant healthcare company.”
The FTC warned Hansen in May to stop implying that a combination of elderberry, echinacea and the herb andrographis could prevent coronavirus infection.
In an email to USA TODAY, the FDA said its goal actually is to protect consumers from scammers and products that harm them. The agency added that it doesn’t want consumers wasting their time on remedies that “may lead to delays in getting proper diagnosis and medical care for COVID-19 and other potentially serious diseases and conditions.”
Its sister agency was more succinct. “The FTC has taken aggressive action against marketers who want to take advantage of the anxiety caused by the current health crisis,” the agency said in an email. “We have done so to prevent consumer injury. There is no other motivation.”
Under the law, supplement suppliers are not allowed to use some words – “cure,” “treat,” “prevent,” “mitigate” or “diagnose” – in promotional materials.
Though many providers openly declare their products won’t cure COVID-19, the mention of “treat” or “prevent” in the same sentence as “coronavirus” has been enough to trigger a letter from the FTC and FDA.
Recognizing the power of these agencies, most of the more than 300 companies and individuals that got warning letters have responded by removing or changing marketing materials on their websites, then they’ve quietly gotten back to the business of addressing customer ailments.
Kate Tietje, who runs the Modern Alternative Mama website and ran afoul of the government for touting Elderberry Elixir, vitamin C and vitamin D as remedies for the virus, had this to say about government regulators in a post she later removed from her website:
“Seeing that the FDA allows ‘approved drugs’ to harm and even kill millions of people, while badgering natural companies that have fewer than 10 reports of unproven adverse effect claims, shows us definitively that it’s not about keeping people healthy.”
‘A magic bullet’
Since the onset of the pandemic seven months ago, the FDA and the FTC have sent out an average of 13 letters a week warning companies and individuals to stop making false claims about their ability to prevent or cure COVID-19.
Many of the recipients have a history of fraud and malfeasance.
They include televangelist Jim Bakker, who spent five years in prison for defrauding his own ministry back in the 1980s; Gordon Pedersen, who wears a lab coat and stethoscope and calls himself a doctor even though he holds no medical degree; and Matthew Martinez, who agreed to give up his chiropractor’s license in 2016 after being accused of having sex with clients and suggesting that a patient with multiple sclerosis could be cured by drinking breast milk.
Both Bakker and Pedersen told their followers that Silver Solution was the antidote to COVID-19 and were sued by the government for failing to address allegedly false claims outlined in warning letters.
If the government does not receive an adequate response to its warning letter it can file suit, seek a restraining order to shut down the company’s web sites and operations, command it to recall and destroy its products and raw materials and refund its customers.
Pedersen refused to participate in court proceedings and could not be reached for comment. Bakker battled back, claiming religious exemption. Court documents filed on his behalf state that his product is a sacrament, as important to his ministry as soliciting donations and preaching the second coming of Christ.
As for Martinez, the FTC faulted him for claiming that high doses of vitamin C “have a significant impact on treating coronavirus” and that stem cells help in the healing process. After receiving his warning letter from the FTC, he also boasted that the ultraviolet light in his company’s octagon-shaped “Blue Room” provided “virus-killing” benefits.
Another warning letter recipient with a history of breaking the law was Richard Marschall. A naturopathic physician, he got busted twice between 2011 and 2017 for introducing misbranded drugs into interstate commerce and spent 60 days in jail. That didn’t stop him from marketing a product called “the dynamic duo” that he said could “crush 30 different viral infections including those in the Corona family.”
On Aug. 5, Marschall was indicted for the third time on the same charge: introducing misbranded drugs into interstate commerce.
An insistence to keep selling supposed coronavirus cures after being told not to is also what got Marc “White Eagle” Travalino in trouble.
A self-proclaimed medicine man and shaman who runs website and folksy trading post in Fort Davis, Texas, Travalino got nabbed by the FDA for saying his Kolon Kleen, Maska Miakoda and Shar Mar products were “proven to work and destroy” the coronavirus. Instead of ceasing his marketing activities after receiving his warning letter, he tried to sell more treatments – this time to an undercover agent.
The government responded by shutting down all Travalino’s operations, both online and brick-and-mortar.
‘Emptying our pockets’
Some coronavirus treatments exposed by Operation Quack Hack were more outlandish.
Face Vital LLC swore by a batterypowered silicon brush used for cleaning facial pores. Mypurmist argued that its hand-held steam machine was the answer. BioElectric Shield offered a golfball-sized pendant to block immunesystem-sapping 5G electromagnetic waves.
“5G appears to be the straw that broke the camel’s back when it comes to the spread of the Coronavirus,” the company said on its website. “An extremely intense rollout of 5G was launched initially in Wuhan City, China.
“Is it a coincidence that this is also where the coronavirus outbreak started?” the company asked. “We are urging you to get protection from EMF radiation.”
Three companies suggested sound waves or music could defeat the virus. Musical Medicine, headed by Dr. Suzanne Jonas, advertised new music “designed to boost your immune system.” Spooky2 Scalar, a New York company headed by Matt Forrest, said its new sounds “would protect you and your family,” and Bioenergy Wellness in Miami said it had found a COVID-attacking frequency and that sound frequencies were better at penetrating cells than chemicals.
These treatments and others subject to the warning letters have no ability to help anyone with COVID-19, said professor Arthur Caplan, who heads the medical ethics division at the NYU School of Medicine.
“They’re just emptying our pockets for their own gain and greed,” he said.
Caplan added that if companies receiving warning letters had any real virus fighting abilities, Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, would be talking about them on TV.
“If I’m going to bet on the future,” Caplan said. “I’m still betting on the infectious disease guys over the vitamin purveyors to work our way out of this,”
‘You can’t report anything about COVID that’s positive’
Peddling potions, balms and tinctures for ailments as varied as erectile disfunction and Parkinson’s disease, alternative health providers targeted by Operation Quack Hack do most of their business over the Internet.
About four in 10 also operate naturopathic, holistic, acupuncture or chiropractic clinics where practitioners meet with clients to help with pain management or plan healthy alternatives for living on an increasingly toxic planet.
For nearly a third, go-to products for fighting coronavirus virus have been simple – the kind of thing any mother might suggest to ward off the flu: vitamin C, vitamin D and zinc. Another 26% offered some mixture of herbs or essential oils that might include elderberries, echinacea, ginger, garlic, licorice, turmeric, peppermint, astragalus root, reishi mushrooms, blackseed oil, olive leaf, dandelion.
But it’s not always clear for whom these supplements will work and under what circumstances. To some, that alone justifies the government clamping down on those that make a definitive statement about the a cure or treatment for COVID-19.
“They need to have competent scientific evidence that something works – and no one has that,” said Mitchell Katz, spokesman for the FTC.
Alternative health care providers say that doesn’t mean they should be silenced. That’s where Dr. David Brownstein, who believes in the basic mission of the FDA and FTC, says the two agencies have gone too far.
Brownstein said he found a new way of looking at health care less centered on medications than on treatments that support the immune system.
Brownstein said one of his patients gave him a book on nutrition, which led him to wean his father off nitroglycerin pills in favor of natural supplements. Within 30 days, he said, his father’s cholesterol fell from 300 to 200, his 20year history of angina ended and his skin turned from pasty gray to pink.
That led Brownstein to seek out natural therapies for his patients, including an anti-viral strategy that he regularly turns to during flu season. The regimen involves high doses of vitamins A, C, D and iodine for four days, followed, if necessary, by nebulizer treatments of hydrogen peroxide and iodine, then intravenous treatments of hydrogen peroxide, vitamin C and ozone. Brownstein said he used the same regimen on more than 100 COVID-19 patients during the outbreak in the Detroit suburbs in March and April.
“My partners, nurses and I were going out to see patients in their cars in the parking lot in 30-degree weather in March,” Brownstein said. “We were giving them IVs in their cars, and as soon as we started treating them they got better. We saw 107 patients. Only one was hospitalized. No one died and no one had to be ventilated.”
Instead of drawing praise, Brownstein said he got in trouble with the FTC for posting the results of his 107-person study on his website and including YouTube testimonials from patients who recovered. Brownstein said the FTC faulted his study because it wasn’t randomized, meaning he had no untreated control group.
“I just couldn’t sleep at night if I did that,” he said. “How could I not have people receive a therapy that I thought could help them?”
Brownstein’s study was peer-reviewed by three medical doctors and an academic and contained more than 90 citations to scholarly articles and texts. But the FTC still made him pull it off his website. “It sends a chill out that you can’t report anything about COVID that’s positive,” Brownstein said. “You can’t report anything that doesn’t fit the narrative that all you can do is wear a mask, social-distance and wait for a vaccine.”