December 19, 2018
“Any physician, or panel of hospital-based physicians, claiming that vitamin C is experimental, unapproved, and/or posing unwarranted risks to the health of the patient, is really only demonstrating a complete and total ignorance or denial of the scientific literature. A serious question as to what the real motivations might be in the withholding of such a therapy then arises. Ignorance of medical fact is ultimately no sound defense for a doctor withholding valid treatment, especially when that information can be easily accessed.”
Thomas E. Levy, M.D., JD
Vitamin C by IV and an FBI raid. How hope, rather than proof, sent the antioxidant’s sales soaring during COVID-19.
Wearing face masks and protective Tyvek suits with yellow boots, FBI investigators recently raided a medical building in metro Detroit to gather evidence about an alleged fake treatment being sold for COVID-19.
It looked like a drug bust. Authorities sealed off the building’s entrance, carried away boxes and enlisted local police to secure the area. But this wasn’t a rogue lab getting seized for illicit substances. In this case, agents were investigating a suspected scheme involving an essential nutrient found in orange juice, broccoli and strawberries:
Otherwise known as ascorbic acid, this powerful antioxidant has become the subject of faith, controversy and even frequent government crackdowns during the pandemic. It’s also become more popular than ever, benefiting from religious-like claims and beliefs about its effectiveness against COVID-19 despite not even having the power to cure the common cold.
“I am aware of no other nutrient that causes such emotion,” said Dr. Daniel Monti, chair of Integrative Medicine at Thomas Jefferson University in Philadelphia.
Consumers have shown that with their wallets, including some who mainline it into their veins or just load up on tablets. Vitamin C supplement sales soared to about $209 million during the first half of 2020, up 76% compared with the same period last year, according to Nielsen research.
In the federal case near Detroit, Dr. Charles Mok has been charged with health care fraud and is accused of using the pandemic as an opportunity to bill insurers, including Medicare, for high-dose vitamin C intravenous infusions that authorities say were “fraudulently represented as COVID-19 treatments and preventative measures.”
His case drew investigators from the U.S. Department of Health and Human Services and the FBI, who wore protective gear during the raid in April to guard against exposure to COVID-19. Mok's next court date is scheduled for September.
Since April, the Federal Trade Commission also has issued at least 37 warning letters to health clinics and wellness centers across the nation, accusing them of overhyping similar high-dose IV infusions of vitamin C. The FTC regulates against deceptive business practices and accused the clinics of unlawfully marketing such therapies to prevent or treat COVID-19, a disease without a proven cure or prevention.
Some claims were brazen. “Research shows that high dose Vitamin C is effective against COVID-19,” said the website of the LaCava Center for Integrative Medicine in St. Charles, Ill., according to the FTC's warning in April. “GIVE US A CALL TODAY TO SCHEDULE YOUR VITAMIN C IV AT 50% OFF!"
The FTC told the firm and others to cease such claims because they lacked sufficient scientific evidence. The businesses since have taken down their COVID claims, but many generally still offer such IV treatments to boost immunity and overall health despite being considered dubious by many experts.
Such treatments often sell for about $200 and are generally considered safe for patients to receive under proper medical oversight. But there are risks. They're not scientifically proven, meaning customers might be spending their money on a service that may or may not work.
History of misunderstanding
So why all the fuss over a household vitamin that can be squeezed out of a grapefruit? Because it’s a form of hope against the fear of the deadly coronavirus, medical experts say. And that hope has surged even though claims about its powers generally are unreliable, false or premature at best without more evidence from experimental clinical trials, according to experts in nutrition and medicine.
Vitamin C still has its champions. Take the case of movie and TV stuntman Greg Fitzpatrick, the longtime double of actor Ben Stiller. Fitzpatrick attributes his recovery from a prostate cancer diagnosis in 2016 to a change in diet and regular intake of high-dose vitamin C. He also continues to get 75 grams of IV therapy weekly because he said he believes it boosts his immune system and "keeps me healthy during COVID."
"Can you prove it? I guess not," Fitzpatrick told USA TODAY. He said he believes in it "wholeheartedly."
Vitamin C “has not been studied with much rigor,” said Alexander Michels, research coordinator at the Linus Pauling Institute at Oregon State University, which studies the role of vitamins in human health. “The molecule – ascorbic acid – is not easy to work with and has properties that make it difficult to understand. Therefore, it has a long history of misunderstanding in the scientific community and medical practice.”
Clinical trials involving COVID-19 vitamin C treatments are pending and could take years before reaching conclusions. Monti’s team at Thomas Jefferson aims to see whether IV vitamin C can help prevent progression of the disease and avoid the need to put patients on a ventilator.
“If I ever had to be treated for COVID, I would definitely push to be put on my own trial to get IV vitamin C – not because there is current proof it would do anything but because I believe there is a plausible mechanism that it might,” Monti said. Monti and other health care experts say most people generally get all the vitamin C they need by eating a good amount of fruits and vegetables, which helps boost their immune system and overall health.
But when the pandemic hit, people wanted to believe that consuming larger doses could defend the body against the novel coronavirus, echoing a similar theory that spread in the popular culture starting around 1970. That’s when vitamin C evangelist Linus Pauling published his book “Vitamin C and the Common Cold,” which made the case that a bigger dose could build up a better defense, a notion now considered to be debatable at best and discredited at worst. Fifty years later, the belief was again dispersed rapidly and globally.
►In January, misinformation already was transmitting on social media before the pandemic shut down the U.S. economy. In one example, a Facebook user advised people in the Philippines to “load up” on vitamin C to prevent COVID-19, among other advice. That post was shared at least 15,000 times but ultimately was flagged for false information.
►By early March, 21% in the U.S. thought that taking vitamin C “probably” or “definitely” prevents infection and 26% were unsure, according to a national probability survey cited in a study of misinformation on the disease by the Harvard Kennedy School.
On Instagram, actress Marla Maples, the former wife of President Donald Trump, has been among those vouching for it.
"Now I’m getting a vitamin C drip (IV)," she said in a March 13 post that showed her getting an infusion. "I've done this off and on for a few years, but right now I feel like it’s really more important because of the spread of the coronavirus and flus and other viruses we may not even know of that are in our world. Do all you can to build your immune system right now. Take your liposomal vitamin C. if you have the chance and can find someone that does vitamin C drips, I would look it up."
Maples didn't respond to a message seeking comment through her website.
►By late March, the Australian government decided to make a public statement about an unspecified report that said intravenous high-dose vitamin C may be beneficial in the management of a COVID-19 infection.
“We have investigated this report and found there is no robust scientific evidence to support the usage of this vitamin in the management of COVID-19,” said Australia’s Therapeutic Goods Administration.
►In the U.S., health-related businesses started trying to cash in with IV therapies, citing reports of positive results from China in the treatment of COVID-19. After the FTC cracked down on it, many cut the claims.
In the Detroit area case, Dr. Mok's Allure Medical spa based in Shelby Township "submitted at least 98 claims to insurance companies, including Medicare, related to Vitamin-C infusion therapy services offered to patients as purported COVID-19 treatment and preventative care," according to the federal criminal complaint against him. His attorney declined comment.
Such firms generally are for-profit and are not taking part in experimental clinical trials seeking to establish scientific evidence on vitamin C. In those clinical trials, intravenous vitamin C has shown promise in treatments for sepsis and some tumor types, Monti said. By contrast, many wellness centers and naturopathic firms still offer unproven intravenous vitamin C therapies, saying they boost immunity and health with antioxidants.
“Higher blood levels of vitamin C can be achieved with IV infusion than with oral intake, and that would be the argument for IV administration: a rapid spike in blood levels that exert some acute anti-microbial effect,” said Dr. David Katz, a preventative medicine specialist and founding director of Yale University’s Yale-Griffin Prevention Research Center. “I am aware of no actual evidence of benefit, so this is hope and wishful thinking on the part of the recipient, and opportunism and exploitation on the part of the provider.”
Only one injection product cleared
The manner in which these injectable vitamin C products are sold and distributed also is murky under the law. Only one vitamin C injection product has been approved for use in the U.S. by the Food and Drug Administration, which regulates drug safety and effectiveness. That product is Ascor by McGuff Pharmaceuticals and is approved only for the short-term treatment of scurvy, a disease caused by vitamin C deficiency.
Yet the wellness firms that sell IV therapies are not treating scurvy and don’t necessarily require a prescription, depending on the dosage. Several said they obtain the vitamin C from compounding pharmacies, which don’t appear to be selling Ascor and might get the vitamin C from elsewhere, sometimes derived from corn.
Last October, the FDA even took the step of issuing a warning that said, “All other ascorbic acid injection products are unapproved new drugs that should not be distributed in interstate commerce without a new drug application approved by FDA. ”So then how are these other vitamin C injection products compliant with the law?
"This is a very complicated question and has been at the heart of various changes and the evolution of compounding pharmacy laws and regulations for many years," said Nicholas Hoang of McGuff Pharmaceuticals, the maker of Ascor.
The FDA didn’t answer a request for clarity. Pharmacies that were identified as providing these products to wellness firms didn’t immediately return messages, nor did naturopathic doctors with expertise in IV therapies.
Compounding pharmacies do have some legal leeway when tailoring drugs for individuals, as do doctors who can make approved drugs available for off-label uses. But how the vitamin C IV business jibes with the FDA isn’t clear, nor is much of the science surrounding vitamin C for consumers. In general, Monti said, vitamin C has provoked strong claims from famous scientists for decades, as well as strong counter-arguments from others.
“If (consumers) take it and see a positive effect, who can really discount their experience?” Michels of the Pauling Institute said in an e-mail. “On the other hand, the science is lagging far, far behind. Consumers, doctors, and scientists alike often think they know everything there is to know about vitamin C, but most of them have an incomplete picture. Even those who have dedicated their lives to studying this vitamin admit that they know very little.”
W. O. Belfield, Jr.