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Ivermectin: Why are there lawsuits over this unproven drug

People are suing hospitals over the controversial pill.

Some people continue to take ivermectin even though it's unproven to treat COVID-19

Ivermectin continues to stir controversy. 

Getty Images

Ivermectin is a drug some doctors tested to see if it could be repurposed for a COVID-19 treatment. The anti-parasitic had seemingly positive effects on some patients, however, more studies showed it has little to no effect when it comes to treating the disease. There has also been an increase in the use of the animal version of ivermectin leading to people getting sick and dying. 

In recent months, there has been a dramatic increase in calls to poison centers in Mississippi, Oklahoma, Utah and Alabama from people who are taking ivermectin intended for animals. Meanwhile, emergency rooms are seeing more patients who consumed a version of the medicine intended as a horse dewormer and two New Mexicans died from ivermectin toxicity. The drug has stayed in the headlines following podcaster Joe Rogan saying he used it after he tested positive for COVID.

There's also been an increase in legal action over the drug. Some families of COVID-19 patients have sued hospitals for not administering ivermectin. The wife of a man in Ohio sued the hospital he was being treated in for not providing him the drug. Similar stories happened in Indiana, Illinois and Kentucky

On one side, there are some doctors who have said that ivermectin could help ease the pandemic if used globally. On the other, public health officials who have reviewed the data and who say the drug's effectiveness against COVID-19 isn't conclusive.

Here's what you need to know about ivermectin and its use for COVID-19. 

What is ivermectin?

Ivermectin is an anti-parasitic medicine that cures diseases such as river blindness and scabies by paralyzing and killing the parasites. It can also inhibit some viruses from infecting cells, thus preventing the virus from spreading like with dengue fever. 

The drug isn't common in the US. There were 146,212 prescriptions written for ivermectin in 2019 according to the drug database ClinCalc. In comparison, the cholesterol-lowering atorvastatin ,better known under the brand name Lipitor, has 112 million prescriptions that same year. Ivermectin was primarily prescribed as a topical or lotion, which are common to treat lice and scabies. 

Where ivermectin is used more frequently is in developing countries where parasites are more common and deadlier. 

"Ivermectin provides significant health benefits in treating parasitic diseases, especially in areas of extreme poverty in low middle-income countries," said Dr. Gerald W. Parker, associate dean for Global One Health, College of Veterinary Medicine and Biomedical Sciences at Texas A&M University.

Scientists at pharmaceuticals giant Merck discovered ivermecin in 1975 and began using it to treat scabies, river blindness and other parasitic diseases carried by worms and lice starting in 1981. It's on the World Health Organization's list of essential medicines for a basic health care system. More than 250 million people take the drug across the globe each year, and it's effective for animals as well. The researcher who developed ivermectin received the Nobel Prize for their work in 2015

The drug is considered safe when taken in appropriate dosages. Side effects for the ivermectin vary depending on whether it's taken orally to treat intestinal infections or topically for skin infections. Oral tablets can cause drowsiness, nausea, vomiting and, in very rare cases, an increase in heart rate and seizures. Side effects for the topical ivermectin can include skin rash and irritation, while dry skin and stinging pain are severe and rare.

Can ivermectin be used to treat COVID-19?

This is where things get complicated. Public health agencies, including the Federal Drug Administration, the National Institutes of Health and the World Health Organization, don't suggest ivermectin's use to treat COVID-19. They cite the lack of data from large, randomized trials confirming the drug's effectiveness to treat the disease. 

Some doctors who cite multiple smaller studies and firsthand experience say otherwise. They claim ivermectin does work to prevent people from developing symptoms from COVID-19 and can shorten recovery time for those already infected.  

What do public health agencies say about ivermectin as a COVID-19 treatment?

The discussion isn't new. The FDA said back in March that it hadn't approved the use of ivermectin to treat COVID-19. It warned that large doses of the drug are "dangerous and can cause serious harm." The agency also advised against human use of ivermectin produced for animals, such as cows and horses, as the doses aren't the same and could contain ingredients intended only for animals. 

However, as the delta variant created yet another wave of the pandemic this summer, a growing number of people began taking ivermectin intended for animals as word spread on social media about the medication's possible use against COVID-19. Apparently, they were unable or unwilling to get prescriptions intended for humans.

The use of livestock ivermectin has resulted in some people calling state poison centers after taking the drug and experiencing negative and sometimes disturbing side effects. On Aug. 20, the Mississippi State Department of Health sent out an alert regarding the number of calls its poison center received, with 70% related to the "ingestion of livestock or animal formulations of ivermectin purchased at livestock supply centers." Similar stories came from other states including OklahomaUtah and Alabama where poison centers have been receiving more calls from people who took too much of the drug. On Thursday, the New Mexico Department of Health confirmed two ivermectin-related deaths

On Aug. 21, the FDA tried a different approach to get people's attention, tweeting: "You are not a horse. You are not a cow. Seriously, y'all. Stop it."  

Back in April, the FDA reaffirmed in a post on its website that ivermectin isn't approved to treat COVID-19 nor has it been given emergency use authorization

The NIH said in February that there was insufficient data to "recommend either for or against the use of ivermectin for the treatment of COVID-19." It did say lab tests found the drug stopped the reproduction of the SARS-CoV-2 virus that cause the disease. However, to be effective, the dosages would need to be "100-fold higher than those approved for use in humans." 

While some clinical studies showed ivermectin to have no benefit, the NIH said other studies saw a lower mortality rate among patients. However, those studies were incomplete or had methodological limitations such as small sample sizes or patients receiving additional medicine along with ivermectin, according to the NIH. 

The WHO said in March that the current evidence on the use of ivermectin for treatment of COVID-19 was "inconclusive." 

The American Medical Association (AMA), American Pharmacists Association (APhA) and American Society of Health-System Pharmacists (ASHP) say they "strongly oppose the ordering, prescribing, or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial."

A doctor in Arkansas who prescribed the drug to patients is under investigation by the state medical board, according to a report from CNN. He reportedly gave ivermectin prescriptions to prisoners at the county jail where he was contracted to provide medical services. 

Who says ivermectin is a treatment, and what information do they have? 

Ivermectin's potential use as a COVID-19 therapeutic made headway in December during a US Senate Homeland Security Committee meeting called Focus on Early Treatment of COVID-19. Dr. Pierre Kory, a pulmonary and critical care specialist, testified about the drug's use for the treatment of the disease. 

"Ivermectin is highly safe, widely available, and low cost," Kory said in the Senate meeting. "We now have data from over 20 well-designed clinical studies, 10 of them randomized, controlled trials, with every study consistently reporting large magnitude and statistically significant benefits in decreasing transmission rates, shortening recovery times, decreasing hospitalizations, or large reductions in deaths. These data show that ivermectin is effectively a 'miracle drug' against COVID-19." 

During his testimony, Kory referred to a paper he authored -- Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19 -- that was published in the May edition of the American Journal of Therapeutics. 

The paper was also included in the Frontiers of Pharmacology journal in January but was then removed in March. Dr. Frederick Fenter, chief executive editor of the journal, said the paper was removed due to "strong, unsupported claims based on studies with insufficient statistical significance, and at times, without the use of control groups." Fender also said the authors promoted their own specific ivermectin-based treatment, which goes against editorial policies. 

The studies listed in Kory's paper tend to be for a small number of participants and have a questionable methodology. For example, a study of 234 uninfected health care workers in Argentina found those who received the drug were far less likely to be diagnosed with COVID. A Buzzfeed News report was unable to find confirmations that this trial even occurred as the hospital it was conducted in says its health care workers were not included in a test. 

An Iraq study saw a quicker recovery time with using ivermectin, but the test was done on only 70 patients. In a small double-blind, randomized placebo-controlled trial in Israel with a group of 89 patients, those taking ivermectin saw lower viral loads than those who didn't receive the drug. 

There are also studies that show otherwise. A clinical trial of 476 patients found ivermectin didn't improve the recovery time in patients who had COVID-19. A review of 10 random clinical trials, with more than 1,000 participants, also didn't find improvements with ivermectin. One Egyptian study claimed to show positive results, but it's since been redacted over ethical concerns. Another study, of 1,500 patients, found that ivermectin had "no effect whatsoever."

One thing to note is that many of these studies on both sides have yet to be peer-reviewed. 

Merck, the company that created ivermectin, released a statement in February saying there was "no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies" and "no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease." It also cited a lack of safety data from major studies. 

Why is there a controversy over ivermectin?

The debate about ivermectin's usage to treat COVID-19 has gone from the hospital to social media, exacerbating the discourse as well as the vitriol. While those in support of the drug appear to want an end to the pandemic, their arguments in favor of ivermectin have become fodder for anti-vaccine activists and conspiracy theorists. 

Groups that have spread misinformation about COVID-19 throughout the pandemic latched onto ivermectin's use following Kory's Senate testimony. Anti-vaccine groups on social media and messaging app Telegram share misinformation about the vaccine while asking where they can buy the drug. Rumble, an alternative video platform to YouTube, has pages of videos falsely saying vaccines are ineffective while advising people to also take ivermectin. 

Ivermectin box

One study on the effectiveness of ivermectin took place at the Center for Pediatric Infectious Diseases Studies, in Cali, Colombia.

Luis Robayo/AFP via Getty Images

Anti-vaccine posts and videos can also be found on YouTube, Facebook and Twitter, although the companies are attempting to take these posts down or make them harder to find. 

Kory was a guest on the Dark Horse Podcast hosted by Bret Weinstein, a former professor at Evergreen State College, on June 1 to talk about ivermectin. That video was eventually demonetized on YouTube and Weinstein's channel received a strike, which prevented him from posting content for one week and could lead to its removal if he receives two more strikes within 90 days. 

YouTube says its actions on Weinstein's videos were part of its policies. 

"While we welcome open discussions of potential treatments and clinical trials related to COVID-19 on YouTube, based on guidance from the CDC, FDA and other local health authorities, we don't currently allow content that recommends ivermectin as an effective treatment or prevention method for the virus," said Ivy Choi, a YouTube spokesperson. "We craft our policies to prevent the risk of egregious real-world harm, and update them as official guidance evolves. We do allow exceptions to our policy about ivermectin, including content that also gives viewers the full context of the FDA's current position."

Because of YouTube's decision, the controversy over ivermectin grew and became tied to what some claim to be "big tech censorship." 

Joe Rogan, the comedian, mixed-martial arts commentator and podcaster, said on Instagram that he tested positive for COVID-19 and threw "all kinds of meds" at the illness, including ivermectin. Rogan has been criticized in the past for spreading COVID-19 misinformation. He has since confirmed he recovered from COVID.

Two New Mexicans died due to ivermectin, as first spotted by Albuquerque news station KOB on Sept. 22 and confirmed by the state's department of health. One of the individuals who died was reportedly battling a serious case of COVID-19. 

"Drugs should only be used as directed, and ivermectin is not a viable treatment for COVID-19," said David Morgan, New Mexico Department of Health media and social media manager. 

What's required for ivermectin to get approved for treating COVID-19? 

For the public health agencies, it's going to come down to the results of large clinical studies being conducted around the world. 

"There is a large, ongoing randomized, placebo-controlled trial in the United Kingdom, so officially the jury is still out to see if ivermectin may offer clinical benefit," said Dr. Parker. "But so far there is no indication to use Ivermectin as a patient or prescribe as a physician, other than in an approved clinical trial."

The Oxford University Principle Trial is seeking to work with more than 5,000 participants and give a three-day course of oral ivermectin treatment to individuals randomly and compare their results to individuals who receive standard care. 

In the US, the NIH is evaluating therapeutics for COVID-19 with its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) master protocol. Ivermectin was added in phase three of ACTIV-6, which will test the effectiveness of repurposed drugs. 

"The ACTIV prioritization group, trial team and trial oversight groups continuously track new data on any agent we are studying in our trials and evaluate that data for how it might influence our testing of that agent and the safety/well being of the participants in the trial," said Dr. Sarah Dunsmore, a program director at the National Center for Advancing Translational Sciences that is part of the NIH. 

What's unclear is how long the whole process will take. The studies need time to be completed, and then the agencies will require more time to come up with conclusions based on the data. 

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.