Idaho Doctor Makes Baseless Claims About Safety of COVID-19 Vaccines

SciCheck Digest

A viral video features a doctor making dubious claims about COVID-19 vaccines and treatments at a forum hosted by Idaho’s lieutenant governor. Dr. Ryan Cole claims mRNA vaccines cause cancer and autoimmune diseases, but the lead author of the paper on which Cole based that claim told us there is no evidence mRNA vaccines cause those ailments.

How do we know vaccines are safe?

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Update, Aug. 27, 2021: The Pfizer/BioNTech COVID-19 vaccine, which was previously authorized by the Food and Drug Administration for emergency use, received full approval from the agency on Aug. 23 for people 16 years of age and older.

Update, Feb. 10, 2022: The Moderna COVID-19 vaccine received full approval from the FDA on Jan. 31 for individuals 18 years of age and older. 

More than 565,000 people have died from COVID-19 in the U.S., but two effective mRNA vaccines are now available. Some treatments for certain patients, such as those hospitalized or receiving oxygen, have also been approved or authorized by federal agencies, and they continue to be studied.

Since the pandemic began, however, politicized social media posts have featured doctors, some looking authoritative in white coats, spreading dubious claims about both vaccines and treatments for COVID-19. The most recent example in this misinformation niche is Dr. Ryan Cole, who owns a medical lab in Idaho.

Cole is featured in a video that has amassed more than a million views. He makes a variety of claims, some of which we’ve addressed before.

The video was recorded while he spoke at a forum on March 4 hosted by Idaho’s lieutenant governor, Janice McGeachin, a Republican, and it was posted by a Libertarian organization called the Idaho Freedom Foundation.

McGeachin was featured in an October post by that group, posing with a Bible and a gun in a video that advocated against public health measures related to the pandemic and asked viewers to sign a statement saying that “any order issued in the future will be ignored.”

Cole said in an interview with FactCheck.org that he’s “not affiliated with any political party, group or organization.” According to the Idaho Secretary of State’s office, Cole is registered as a Republican.

In the March 4 video, Cole makes claims suggesting that federal agencies have acted nefariously, as well as claims that undermine vaccines and promise miracle treatments.

We’ll address his four main claims.

• Although there is no evidence to support this, Cole suggested that some of the COVID-19 vaccines could cause cancer or autoimmune diseases.
• Again, without evidence, Cole suggested that the federal government withheld a treatment for COVID-19 in order to “vend” a vaccine.
• Studies haven’t proved that ivermectin is effective in treating COVID-19, but Cole claimed that federal agencies “have suppressed this life-saving medication.”
• Cole said public health officials should encourage people to take vitamin D supplements rather than wear masks or stay physically distant from others.

Vaccine Safety

Two of the COVID-19 vaccines available in the U.S. use messenger RNA, or mRNA, to train recipients’ immune systems to make antibodies that fight the virus that causes COVID-19. (See SciCheck’s articles on those vaccines: “A Guide to Moderna’s COVID-19 Vaccine“ and “A Guide to Pfizer/BioNTech’s COVID-19 Vaccine.”)

These are the first vaccines using mRNA technology authorized in the U.S., but scientists have been developing and testing mRNA vaccines for years, including in people during clinical trials. Still, misinformation exploiting fears of this new technology has been common online.

To those bogus claims, Cole has now added: “mRNA trials in mammals have led to odd cancers. mRNA trials on mammals have led to autoimmune diseases — not right away, six, nine, 12 months later.”

We asked Cole to provide support for those claims, and he referred us to a 2018 paper published in the journal Nature Reviews Drug Discovery that reviewed trials and studies of various, earlier mRNA vaccines.

But that paper doesn’t support his statement.

Norbert Pardi, a research assistant professor of medicine at the University of Pennsylvania, was the lead author of the paper. He told us in an email, “No publications demonstrate that mRNA vaccines cause cancer or autoimmune diseases.”

Pardi’s 19-page paper does make one passing reference to autoimmune diseases, which is what Cole highlighted to us.

The paper says: “A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity. Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken.”

But, Pardi explained, he and the other researchers included that passage because they wanted to note some potential concerns. However, he emphasized that “no scientific evidence has confirmed that these concerns are real.”

It’s also worth noting that the paper predated the COVID-19 pandemic by two years, so it doesn’t include any information specifically about the COVID-19 vaccines.

Simply put, “there is no scientific evidence that shows that mRNA vaccines cause autoimmune diseases,” Pardi said. “Multiple clinical trials have been performed with mRNA vaccines in the past 10 years and none of them found that mRNA vaccination caused autoimmune diseases. Further, we are not aware of any studies showing an autoimmune disease appearing many months after vaccination as Dr. Cole inaccurately suggests.”

Likewise, Dr. Roger Shapiro, associate professor of immunology and infectious diseases at Harvard’s T.H. Chan School of Public Health, told us in an email that he was unaware of any study that would support Cole’s claim that the vaccines are carcinogenic.

“There is nothing in the science of mRNA vaccines that would suggest carcinogenicity, and they have been tested in humans for other diseases before COVID-19,” Shapiro said. “mRNA rapidly breaks down in the body, and probably does not last long enough to act as a carcinogen.”

“Regarding autoimmunity,” he said, “this is always a concern with any medical product, but there is no evidence to date suggesting it, and it does not seem any more likely than with other vaccines. mRNA is made all the time in our bodies, and delivering it by vaccine should not be different.”

Dr. Dean Winslow, an infectious disease physician at Stanford Health Care, concurred with the other experts with whom we spoke. In a phone interview, he characterized Cole’s claims about cancer as “fearmongering” and said, “There’s just no scientific basis for that.”

“We’re talking about these very small fragments of messenger RNA that don’t hang around for long at all,” he said, noting that the mRNA vaccines have been in use for almost six months and have been “very safe, very well-tolerated vaccines.”

Winslow recognized that some people are concerned that the mRNA from the vaccine might persist in their bodies and somehow change their genetics or cause long-term effects. So he emphasized that the vaccines have small fragments of RNA, which survive only briefly and carry information about the virus that causes COVID-19.

Similarly, Pardi told us, “COVID-19 mRNA vaccines do not alter our DNA and they get rapidly degraded so they do not promote cancer formation.”

Treatments, Vaccines Can Both Be Approved

Cole also suggested in the video that the federal government had suppressed a treatment for COVID-19 in order to “vend” a vaccine. (We’ll address his claims about the supposed treatment in the next section.)

“If there’s a treatment for a disease, the federal government cannot approve a vaccine by law, by rule,” Cole falsely claimed, suggesting that federal agencies were withholding access to a treatment for COVID-19 so that they could instead profit from vaccines.

“So, the NIH, who, you know, is involved in approving medications, they co-hold the patent on the ‘vaccine’ with Moderna,” Cole said, referring to the National Institutes of Health, an agency that does not approve medications. “If the fox is not guarding the henhouse there, I don’t know who is. That also is insanity to have the government in bed with a private company vending a product that they want to give to everybody.”

There are several problems with this statement.

First, there is no law barring vaccines if treatments are available for a given disease, said Jorge Contreras, a professor in the College of Law at the University of Utah who specializes in intellectual property and genetics and the law. He asked, “Why would there be such a law?”

Clearly there isn’t, Contreras pointed out, since the Food and Drug Administration authorizes a flu vaccine every year while Tamiflu, an antiviral drug used to treat the flu, has been available since the FDA approved it in 1999.

“It’s certainly true that many diseases that we vaccinate for, there is no known cure for,” he said, noting that this is often the case with viral diseases, which are hard to treat.

“But that’s not a legal requirement. That’s a scientific reality,” he said.

As for Cole’s claim about the NIH, that agency conducts and funds research. It doesn’t approve drugs, medical devices or vaccines — that’s a function of the FDA.

The NIH did collaborate with Moderna on the development of its COVID-19 vaccine. As we’ve explained, government researchers had previously been working with scientists at Moderna on an investigational vaccine to protect against MERS, another disease caused by a coronavirus. The team was able to apply that knowledge to design a COVID-19 vaccine.

Since the NIH does research, it also files and receives patents, many of which it licenses to pharmaceutical companies. So, Contreras said, NIH’s patents stemming from research on mRNA vaccines are to be expected, and use of those patents by pharmaceutical companies is also to be expected. Similarly, scientists from government-funded labs sometimes share credit on patents with scientists from privately funded labs. That’s normal, too, Contreras said.

Generally, he explained, there are two reasons that the NIH licenses its patents to companies. First, the NIH is a taxpayer-funded institution, and it can recoup some of its investment in research by lending out the use of its discoveries. Second, the clinical trials required to bring a drug or vaccine to market are risky and expensive, so, theoretically, making its discoveries available to companies can encourage the private sector to take the risk and create products.

So, Cole mischaracterizes the relationship between the NIH and the vaccine manufacturers when he says that it’s a “conflict of interest” to have the “federal government in bed with a vaccine company.”

It’s actually normal to have pharmaceutical companies use government-owned patents.

And he’s wrong when he says of federal agencies, “they don’t want a therapy to work because then they can vend their vaccine.”

There’s nothing that would prohibit the use of vaccines if there were an effective treatment for COVID-19.

Not Enough Data on Ivermectin

Neither the World Health Organization nor the National Institutes of Health has recommended the use of ivermectin — a common anti-parasitic medication — in the treatment of COVID-19.

Merck, the pharmaceutical company that manufactures ivermectin, has similarly noted that there is “[n]o scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and; A concerning lack of safety data in the majority of studies.”

But Cole claimed in the video that ivermectin is a “treatment” for COVID-19.

He suggested that federal agencies have stifled its use so that they could profit from vaccines, as we explained above.

“We’re in farm country, horse country — you know, you give it to your dogs, your cats, your horses,” Cole said in the video, addressing an audience in Idaho.

Ivermectin is used to treat parasites in animals, but crossover use in humans can be dangerous. While Cole may have only been emphasizing the ubiquity of the drug, not suggesting that people should take veterinary medicine, the FDA has said that patients have been hospitalized after taking ivermectin intended for horses as interest in the drug as treatment for COVID-19 has grown.

Ivermectin does have antiviral properties, but the FDA hasn’t approved it to treat any viral infections. It is being studied with regard to COVID-19, though, according to both the WHO and NIH.

“Treating COVID-19 with Ivermectin is still being evaluated in clinical trials, but at present there is not enough evidence to support its use,” said Shapiro, the Harvard professor. “My understanding is that the inhibitory dose needed for it to work is extremely high and trying to take enough to suppress the virus could lead to other problems.”

The trials so far have “showed no benefit or worsening disease, some showed shorter time to disease resolution or viral clearance, and some did show a possible mortality benefit; but there were problems with most of these trials that include small sample size and different outcome measures and other possible biases,” he said.

Winslow, from Stanford, cautioned that “there have been many claims for miracle cures” over the course of the pandemic and said that ivermectin would need more rigorous study before we know how useful it would be in treating COVID-19.

“Ivermectin truly is a wonder drug for parasitic diseases,” he said, “but my suspicion is that it will be a lot like hydroxychloroquine.”

Hydroxychloroquine is an antimalarial drug that was touted by former President Donald Trump as a treatment for COVID-19, although studies found that it wasn’t an effective treatment and may cause serious side effects in some patients, as we’ve explained before.

The problem with drugs like ivermectin and hydroxychloroquine, which are promoted as having broad-spectrum antiviral properties, is that the quantity of inhibitor required to effectively kill off the virus also sickens the host cells, Winslow said.

Even potent versions, like remdesivir, which Winslow referred to as the “gold standard” of specific antiviral therapy in COVID-19 treatments, only accelerates the time to recovery, but doesn’t significantly reduce death rates or mortality from COVID-19. Remdesivir is the only drug approved by the FDA to treat COVID-19; the approval is for patients requiring hospitalization.

So, Cole’s claim that “there is blood on the hands of bureaucrats in Washington who have suppressed this life-saving medication,” is unfounded. Ivermectin hasn’t been proved to be effective.

Overstating Effect of Vitamin D

Another of the major points that Cole emphasized in the video is the role vitamin D could have in fighting COVID-19.

“If you do not supplement with vitamin D in the wintertime, you are immune suppressed. Most insurance companies in Idaho and northern states do not pay for a vitamin D test, unfortunately,” said Cole, whose lab offers several vitamin D tests.

After eschewing public health guidelines that recommend staying six feet apart and wearing masks to slow the spread of the virus, Cole said, “What should public health message number one, two, and three be? Vitamin D, vitamin D, vitamin D.”

It’s true that vitamin D, which is mostly associated with bone health, plays a part in the immune system. But that doesn’t mean it’s a panacea for COVID-19, as we’ve explained before.

While a lot of basic research points to vitamin D having a role in the immune system, it is less clear if these mechanisms are applicable in clinical practice and to what degree they would benefit COVID-19 patients, as we’ve written. Studies assessing whether vitamin D can treat or prevent infectious diseases have generally been inconsistent.

A recent article from NPR looked at the research on vitamin D with respect to COVID-19 over the last year and found, essentially, the same thing. It also noted that some studies have shown that low vitamin D levels are associated with a higher risk of contracting COVID-19 or with becoming seriously ill.

“While these studies raised hopes among some researchers, others are skeptical, noting that most of these are observational studies, not the gold-standard randomized, controlled trials,” the story said.

“Much of the available evidence only shows association — not causation — and even those results are mixed,” Walter Willett, a professor of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health, told NPR.

In September, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in an Instagram Live interview that for those who are deficient in vitamin D, “I would not mind recommending, and I do it myself, taking vitamin D supplements.” But, as we wrote before, excessive doses should not be used.

Sources

Johns Hopkins University & Medicine. Coronavirus Resource Center. Accessed 16 Apr 2021.

Harvard Health Publishing. “Treatments for COVID-19.” Harvard Medical School. Updated 5 Apr 2021.

Fichera, Angelo. FactCheck.org. “Texas Doctor Spreads False Claims About COVID-19 Vaccines.” 26 Mar 2021.

Hale Spencer, Saranac. FactCheck.org. “Video Uses Bogus Claims to Stoke Race-Based Fears of COVID-19 Vaccine.” 2 Feb 2021.

Idaho Secretary of State’s Office. Email to FactCheck.org. 9 Apr 2021.

Centers for Disease Control and Prevention. “Understanding mRNA COVID-19 Vaccines.” CDC.gov. Updated 4 Mar 2021.

McDonald, Jessica. FactCheck.org. “A Guide to Moderna’s COVID-19 Vaccine.” Updated 9 Apr 2021.

McDonald, Jessica. FactCheck.org. “A Guide to Pfizer/BioNTech’s COVID-19 Vaccine.” Updated 9 Apr 2021.

Jaramillo, Catalina. FactCheck.org. “No Evidence Vaccines Impact Fertility.” Updated 3 Mar 2021.

Pardi, Norbert, et al. “mRNA vaccines — a new era in vaccinology.” Nature Reviews. 12 Jan 2018.

Pardi, Norbert. Research assistant professor of medicine, University of Pennsylvania. Email exchange with FactCheck.org. 12 Apr 2021.

Shapiro, Roger. Associate professor of immunology and infectious diseases, T.H. Chan School of Public Health, Harvard University. Emailed responses to FactCheck.org. 8 Apr 2021.

Winslow, Dean. Infectious disease physician, Stanford Health Care. Telephone interview with FactCheck.org. 12 Apr 2021.

Contreras, Jorge. Professor, college of law, University of Utah. Telephone interview with FactCheck.org. 15 Apr 2021.

U.S. Food & Drug Administration. “FDA’s Critical Role in Ensuring Supply of Influenza Vaccine.” FDA.gov. 28 Sep 2020.

U.S. Food & Drug Administration. “Tamiflu: Consumer Questions and Answers.” FDA.gov. 14 Nov 2017.

U.S. Food & Drug Administration. Drug Approval Package — Tamiflu. FDA.gov. Approval date 27 Oct 1999.

National Institutes of Health. About the NIH. NIH.gov. 7 Jul 2015.

National Institutes of Health. “How are drugs approved for use in the United States?” NIH.gov. 1 Dec 2016.

World Health Organization. “WHO advises that ivermectin only be used to treat COVID-19 within clinical trials.” WHO.int. 31 Mar 2021.

National Institutes of Health. COVID-19 Treatment Guidelines — ivermectin. NIH.gov. 11 Feb 2021.

Merck & Co. “Merck Statement on Ivermectin use During the COVID-19 Pandemic.” Merck.com. 4 Feb 2021.

U.S. Food & Drug Administration. “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” FDA.gov. 5 Mar 2021.

McDonald, Jessica and Eugene Kiely. FactCheck.org. “Azar, Trump Mislead on FDA’s Hydroxychloroquine Decision.” 18 Jun 2020.

Centers for Disease Control and Prevention. Things to Know about the COVID-19 Pandemic. CDC.gov. 17 Mar 2021.

McDonald, Jessica. FactCheck.org. “Does Vitamin D Protect Against COVID-19?” 8 Jun 2020.

Stone, Will. NPR. “A Year In, Here’s What We Know About Vitamin D For Preventing COVID.” 14 Apr 2021.

Miller, Korin. Prevention. “Can Vitamin D Reduce Your Risk of COVID-19? Doctors Say the Answer Isn’t Simple.” 15 Sep 2020.