ARKADELPHIA -- A few months ago, William Burks, owner of Clark County Livestock Feed, had enough veterinary-grade Ivermectin on his shelves to cover sales of the anti-parasitic drug for at least the next two years.
[LINK: Click here to read the FDA's report on Ivermectin for covid » arkansasonline.com/1031fda/]
Now, he's almost sold out.
All Burks has left are a few containers of the topical version of the de-worming medication, which farmers ordinarily buy to rub on horses, cows or hogs to get rid of parasites.
Like the bottles of injectable Ivermectin, the containers of the topical solution, Burks said, are also selling out fast.
"I've had people buy that, too," he said. "Rub it on their chest or their stomachs."
To be sure, some who are visiting Burks' farm supply store, which sells everything from pig feed and bales of hay to fertilizer and propane tanks, could be purchasing Ivermectin to treat livestock.
But Burks said he suspects otherwise. He said many customers are buying it to treat covid-19.
"I would say this last rush, 90% of them [sold] was for personal use, for people usage," Burks said. "I probably sold what I would sell in two years in a month."
"Some of the people taking it are well-educated people," Burks said, adding that he's saving one 1,000-milliliter bottle for himself -- just in case.
He said he's heard stories of people buying tubes of Ivermectin paste and "licking it off the end of the tube." Others who go to Burks' store buy bottles of the liquid, normally injected into animals, and "pour it in water or tea or coffee normally and then drink it."
Only one bottle has been returned by a customer who told Burks he "felt like doctors knew more than he knew about this." The customer said he decided to get a covid vaccination, Burks said.
"My theory is the reason it got so popular is that evidently it worked for somebody," Burks said. "I don't see how it could get so popular and not be helping somebody as many people who has took it."
The reason for its popularity is that some believe Ivermectin can prevent or even cure the coronavirus. So they've been flocking to stores that sell animal products to buy the anti-parasitic to take themselves.
No comprehensive data is available to indicate how widespread the use of Ivermectin to treat the coronavirus is in Arkansas. Anecdotal evidence from farm supply stores, doctors and pharmacists suggest that while its consumption may not be rampant, it's also not uncommon.
The frenzy for the medication began about a year ago after news spread on social media and via other information channels that studies, conducted in countries like South Africa, Australia and Nigeria, indicated that the drug is effective in curing the coronavirus.
Multiple organizations, as well as regulatory bodies, have said otherwise, citing faulty data in studies that have been conducted, resulting in inconclusive evidence as to whether the medication, also available in a U.S. Food and Drug Administration-approved form to treat parasites in humans, has any efficacy in treating covid-19.
In Arkansas, similar agencies, including the Arkansas Department of Health and the state Medical Board have not taken a hard-line stance.
The Arkansas Medical Society "does not have a policy statement on the use of Ivermectin," said David Wroten, executive vice president of the physician advocacy group.
The Arkansas Hospital Association "does not make recommendations on courses of treatments for patients, as that would interfere with doctor-patient relationships," Bo Ryall, head of the trade association, said in a statement.
"The FDA has not authorized or approved Ivermectin for the treatment or prevention of covid-19 in people or animals," the agency said on its website. "Ivermectin has not shown to be safe or effective for these indications."
On its Twitter feed, the FDA issued a more concise warning: "You are not a horse. You are not a cow. Seriously, y'all. Stop it."
In a joint statement released in September, the American Medical Association, the American Society of Health-System Pharmacists and the American Pharmacists Association said they "strongly oppose the ordering, prescribing or dispensing of Ivermectin to prevent or treat covid-19 outside of a clinical trial."
"We are alarmed by reports that outpatient prescribing for and dispensing of Ivermectin have increased 24-fold since before the pandemic and increased exponentially over the past few months," the associations said.
"There is good consensus among all of the infectious disease doctors and all other expert organizations advising on covid that we should not be using Ivermectin outside of a clinical trial because there is not a predominance of evidence that shows that it is effective," said Dr. Robert Hopkins Jr., chief of the division of general internal medicine at the University of Arkansas for Medical Sciences.
"There have been a couple of very small studies that have shown potential benefit, but there have been more studies that have shown no benefit," Hopkins said. "I can't fathom that somebody who really is a thoughtful and a caring physician would [prescribe] this given the lack of data that we have supporting it."
SALES RISE
Retailers across the state that sell Ivermectin for veterinary use report they've been out for months. About 45 minutes away from Clark County Livestock Feed, an employee at the Garland County Farmers Association in Hot Springs said the product is on back-order until sometime next year.
"There's definitely been an uptick [in sales]," said David Lipsmeyer, a founder of the Tontitown-based K&K Vet Supply, which sells products to stores like Clark County Livestock Feed. "We have highly, highly told everyone it's not for human use."
"I've even got some customers who have decided not to handle it," Lipsmeyer said. "I don't blame them."
Overdoses of the animal form of the medication have been on the rise -- yet another indication of its increased use.
Since the beginning of this year, the Arkansas Poison Center at UAMS Medical Center had 45 cases of Ivermectin overdoses as of the end of September.
That's a dramatic increase given that the center had only 25 calls for Ivermectin toxicity over a four-year period before this year, said Dr. Howell Foster, head of the Arkansas Poison Center.
Of the overdose cases this year, "only one of those was an accidental exposure that had nothing to do with covid treatment," Foster said, adding that two of the overdoses involved children.
So far, none of the cases have been fatal, he said.
That one Ivermectin overdose this year occurred after someone made a sandwich with the medication to feed to a pig, then placed the sandwich on a countertop and "grandma came by and ate the Ivermectin sandwich," Foster said.
"I think the public is going after Ivermectin with some ferocity," he said. "The majority of what we deal with are veterinary products, so they are not going to a doctor, not getting prescribed a dose."
PRESCRIPTIONS UP
There are some who are going to doctors and being prescribed Ivermectin for coronavirus treatment, according to pharmacists and physicians who spoke to the Arkansas Democrat Gazette, citing examples of records from covid-positive patients who've been transferred from other medical facilities where the drug is listed as a medication.
"There are many more prescriptions for Ivermectin," John Vinson, head of the Arkansas Pharmacists Association, said. "The usage was very low before. A pharmacist might dispense [Ivermectin] once or twice a year."
"Now they might have four or five patients a day," Vinson said.
Doctors prescribing Ivermectin to treat or prevent covid-19 has become more controversial, particularly as some experts say they are concerned that physicians may be promoting the anti-parasitic instead of coronavirus vaccines or other treatments, like monoclonal antibodies, which have shown to be effective at preventing severe, even deadly cases, of the virus.
There are questions of whether physicians prescribing Ivermectin are doing anything wrong.
It's not illegal for physicians to prescribe FDA-approved medicines for off-label use.
Where the situation becomes murky with Ivermectin is that it is a FDA-approved drug -- to treat parasites in humans.
"Is it wrong? Legally wrong?" Dr. Joe Thompson, head of the Arkansas Center for Health Improvement, said of prescribing it. "I think probably because the FDA has come out saying it shouldn't be used [to treat covid-19], that carries some restriction on [a physician's] prescription authority."
Thompson added: "An inappropriate practice of a physician would be to be prescribing Ivermectin and not advocating for vaccines and providing vaccines. That clearly is putting patients at a disadvantage and an increased risk of dying from covid."
Questions are emerging in Arkansas and elsewhere as to whether physicians should face disciplinary action from licensure agencies, such as state medical boards, for prescribing Ivermectin or spreading misinformation about the medication when it's unclear whether it works to treat the virus.
In July, the Federation of State Medical Boards said "physicians who generate or spread covid-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license."
The Mississippi State Board of Medical Licensure issued guidelines in September supporting the Federation of State Medical Boards' stance.
"These principles are not limited to covid-19 vaccine issues," the Mississippi State Board of Licensure said in a document, adding that doctors have "an ethical obligation" to make sure medical information they provide is accurate and "based on valid scientific evidence and insight gained from professional experience."
In October, the Washington Medical Commission suspended a doctor's license after "allegations against" the physician for "a public campaign promoting Ivermectin as a curative for covid-19" and prescribing it "without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating covid-19," the agency said.
Still it appears that many state medical boards have not taken action against physicians prescribing Ivermectin for the coronavirus or for spreading misinformation about its efficacy directly to patients or via public platforms such as social media.
"What you are finding are the medical boards unwilling to make a stand against their doctors who are behaving inappropriately," said Brian Castrucci, president and CEO of the de Beaumont Foundation, a public health advocacy group. "The medical boards, at some point, are going to not be able to kick the can down the road anymore."
"I would argue that we have to take a very hard look at those who are spreading misinformation or using off-label medication and how that could impact their license," Castrucci said. "This is a question that we, as a society, are going to have to confront."
DISCIPLINARY ACTION?
In Arkansas, it remains unclear whether physicians who are prescribing Ivermectin or touting it as a pandemic panacea before more clinical trials are completed, will face disciplinary action from the Arkansas state Medical Board.
In an online document concerning the use of Ivermectin for covid-19, the Arkansas Department of Health, the umbrella agency over the state Medical Board, includes a link to the FDA's website where the federal agency explains why it has not authorized the medication to treat the virus.
"Ivermectin is not approved by the FDA for use and treatment in covid-19, but it is approved for other illnesses and physicians have the ability to prescribe medications for off-label use," Danyelle McNeill, a spokesperson for the Health Department, said in an email. "ADH does not track the use of prescription Ivermectin."
Hospitals across Arkansas have issued statements against the drug's use for covid-19.
National Park Medical Center in Hot Springs said it "does not recommend the use of Ivermectin for covid-19 patients."
"CHI St. Vincent does not offer Ivermectin as a treatment for covid-19, even when occasionally requested by patients," Dr. Douglas Ross, CHI St. Vincent chief medical officer, said in a statement. "At present, there are no large scale, randomized prospective studies of quality that prove Ivermectin's efficacy in the prevention or treatment of covid-19."
"Contrary to seeing any benefit from its use, our healthcare providers have seen some patients get sick and present with serious side effects from the inappropriate use of Ivermectin, particularly with veterinary doses," Ross said.
Troy Wells, the president and CEO of Baptist Health, also said his hospital system "does not endorse" the medication to treat covid-19.
Mercy, which also has hospitals and clinics across the state, said in a statement that the health care system doesn't "promote the use of any form of Ivermectin" to treat covid.
St. Bernards Healthcare in Jonesboro "recently revised its covid policy to say that the hospital will not use Ivermectin to treat covid-positive patients," Mitchell Nail, a spokesperson, said via email.
"Because our healthcare system incorporates hundreds of physicians at three hospitals and numerous clinics, it's possible that one or more doctors have prescribed it at some point during this pandemic," Nail said. "Our flagship hospital's formal policy now precludes physicians working there from using it to treat patients."
COMPLAINTS FILED
The Arkansas state Medical Board has received complaints surrounding several physicians prescribing Ivermectin for the coronavirus or spreading misinformation about the drug, according to documents obtained by the Democrat Gazette.
Amy Embry, director of the state Medical Board, said the board "has no position on Ivermectin."
"The Arkansas Medical Practices Act does not prohibit off-label [use of prescriptions]," Embry said. "If anyone has a complaint against a physician, they need to go through the complaint process."
Dr. Sylvia Simon, chairman of the state Medical Board, said in a phone interview that Ivermectin is a "sticky issue."
Simon declined to comment further. "I have no comment whatsoever on this," she said, referring questions to attorneys who represent the board.
Those attorneys declined to speak on the record to the Democrat Gazette.
The state Health Department "does not have jurisdiction over the practice of medicine or medical licenses," McNeill, the agency spokesperson, said, citing Arkansas Code §20-7-109(c)(1), which states that the state Health Department is prohibited from such regulation.
Two of the complaints to the state Medical Board remain under investigation. One surrounds Dr. Robert Karas who reportedly prescribed Ivermectin to inmates at the Washington County jail, as well as other patients.
Documents obtained from the state Medical Board pertaining to the investigation via a Freedom of Information Act request include testimony from inmates who said they were not informed that they were receiving the medication, and in some instances, were told that their treatment regimen for covid-19 was vitamins.
Other documents in the case include letters from the public expressing concern over social media posts from Karas that spread misinformation about covid-19 treatments.
The Arkansas Democrat Gazette could not reach Karas for comment.
A second investigation surrounds a physician prescribing Ivermectin to treat covid-positive nursing home patients, the complaint said.
The state Medical Board is still investigating the allegations.
A third complaint, also obtained by the Democrat Gazette via a Freedom of Information Act request, involved a member of the public who said Dr. Amy Beard shared "a lot of disinformation around covid and the vaccine" on a Facebook site.
"In the middle of a global pandemic, her words and actions are extremely unsafe, not only for those she is treating, but also to the general population at-large," the complaint said.
In a written response to the complaint, Beard said she has "treated approximately 250 patients for covid with hydroxychloroquine and/or Ivermectin."
In June, the FDA revoked emergency use authorization to use hydroxychloroquine, an anti-malaria drug, to treat covid-19 after studies showed that it provided no benefit in "decreasing the likelihood of death or speeding the recovery" from covid, the agency said.
"Not one person I've treated has died from covid, and only one patient has required hospitalization," Beard continued in her response. "That patient has fully recovered."
Beard said she follows standard of care practices, provides informed consent and "does not discriminate based on [covid] vaccination status."
Beard said the "true issues" of the individual who complained "are with the First Amendment, telemedicine laws, and the use of proven, viable therapeutics for the treatment of covid."
During its Oct. 7 meeting, the state Medical Board said the Facebook post referred to in the complaint letter against Beard could not be found.
"I don't see we have anything we can follow up on then because it is a he-said-she-said," Simon, the chairman of the board, said.
The board voted to take the case as information, which means members did not feel like the evidence presented indicated a violation of the Arkansas Medical Practice Act.
The Arkansas Democrat Gazette could not reach Beard for comment.
On Beard's Facebook page, which has more than 13,000 followers, there are posts containing questions as to whether the National Institutes of Health "funded the creation of the pandemic."
Another post contains information for physicians who don't want to get covid vaccinations to find alternative avenues to treat patients via telemedicine. On the post, dated Oct. 14, Beard wrote, "Helping however I can."
In another post, dated Oct. 11, Beard said she could no longer respond to questions on Facebook since she'd "been placed in Facebook jail for 28 more days."
She directed her followers to another social media platform called Telegram where her username is "@redneckdoc."