TrialSite Staff | Quality Journalism Jan. 21, 2022

TrialSite recently shared that a handful of states have proposed bills to ensure ivermectin is available to treat COVID-19 via a legitimate physician’s prescription. Those states include Indiana, Kansas, and New Hampshire. Recently, a leading proponent of the use of ivermectin, Dr. Paul Marik, one of the co-founders of the Front Line COVID-19 Critical Care Alliance (FLCCC), discussed the pending New Hampshire ivermectin legislation with conservative news platform, America’s Voice Network.

Marik, board certified in Internal Medicine, Critical Care Medicine, Neurocritical Care, and Nutrition Science, is a key opinion leader who has worked in numerous hospitals and health systems from South Africa, UK, and of course, the United States where he is most recently affiliated with Eastern Virginia Medical School (EVMS) as well as other medical institutions. Not a stranger to controversy, or for that matter, pushing the comfort boundaries of the medical establishment, Marik isn’t a lightweight, with over 400 peer-reviewed journal articles, 50 book chapters, and author credits for four critical care books.

Recently, he filed a lawsuit against his hospital over the institution’s ban on various therapies including ivermectin, which happens to be a core therapy in his and his colleagues MATH+ Hospital Treatment Protocol for COVID-19. He and colleagues such as Dr. Pierre Kory experienced what they declare is censorship, as key journals had reviewed and accepted manuscripts, such as with the Journal of Intensive Care Medicine, only to see the approvals retracted. Physicians such as those affiliated with the FLCCC represent prominent figures at this weekend’s medical freedom march.

Background

In a recent interview DR. PAUL MARIK | NEW HAMPSHIRE IVERMECTIN BILL – Good News | 45 | Data Matter (tvwfc.co.uk) with the conservative media platform America’s Voice Network, Marik shared his opinions on pending legislation, the importance of repurposed therapeutics, and who he thinks has been involved in the attack on ivermectin as an off-label treatment option.

The alternative media reporter, Heather Mullins, shared that New Hampshire’s bill is now “sponsored” and must still “go through some hurdles to get passed,” but if done so will “essentially make ivermectin available over the counter.” According to the TrialSite report, the proposed bill would authorize access at the pharmacy via a “standing order” which generally indicates authorization for nurses, pharmacists, and other appropriately credentialed health care professionals that if directed by state law, empowers the direct care and admonition of a vaccine or therapy (in this case ivermectin) based on an approved medical doctor-based approved protocol.

TrialSite didn’t report that Paul Marik testified for the proposed bill in New Hampshire. Mullins reports that Marik and other front-line physicians have been on the record that if ivermectin had been allowed for use as an early at-home prophylactic treatment targeting COVID-19,  hundreds of thousands of lives could have been saved.

The Interview

Prior to the testimony in New Hampshire, Dr. Marik shared that 3.7 billion doses of ivermectin have been administered around the world, “changing the face of parasitic diseases on this planet.” Marik declared that ivermectin “is probably the second most important drug ever invented” [the drug’s inventors did win a Nobel Prize and the drug is on the World Health Organization Essential Drug List].

Declaring that the drug is cheap, safe, and “highly effective against SARS-CoV-2, and if used more widely this drug could have saved hundreds of thousands of lives.”

Referring to its use in many other countries, the critical care physician went on the record that it’s a “lifesaving drug.” 

Why the pushback against ivermectin? Marik, now somewhat liberated given he isn’t dependent on his employer Sentara, let loose declaring, “There are multiple reasons, and this is probably generated by Big Pharma, government, and big corporations who don’t like cheap repurposed drugs.”  He continued, “So this is a war on cheap, repurposed drugs.” Emphasizing the goals of ivermectin’s adversaries, Marik stated, “They want you to use expensive designer drugs which in fact don’t work.”

In clarifying his understanding of the New Hampshire bill, Marik declared it is proposing to make ivermectin available over the counter [again via standing order] and according to the critical care doctor, it makes sense given the drug’s safety profile— “the drug is safer than Tylenol,” stated Marik. Repeating again the drug’s safety profile makes it safer than Tylenol, he went on the record “People should be given access to this drug in order to prevent and treat COVID.”

Marik espoused the critical FLCCC view that early treatment for COVID-19 absolutely represents a critical care strategy: simply waiting at home for a symptomatic phase, prompting a trip to the hospital raises significant danger for severe disease and worse.

The Controversy

According to Heather Mullins’ report, there has been a coordinated effort to censor the robust data pointing to at least some ivermectin-based efficacy around the world. Ivermectin study watchers often point to the website which tracks all ivermectin studies in a clean, orderly series of tables and graphs. While the majority of the 75 completed studies point to positive data points, the mainstream media and medical establishments in North America, Europe, and Australia have limited the number of studies within the research portfolio that they even acknowledge to just a handful. The others? These studies are dismissed because of bad quality. 

A couple of prominent studies showed no benefit, yet, at least one of them became surrounded with controversy and allegations among some industry watchers of conflict of interest. TrialSite notes this hasn’t been proven, and one study in Egypt that was part of a couple of meta-analysis studies turned out to have manipulated data. Yet even with the questionable Egyptian study, TrialSite’s Sonia Elijah’s investigation raised some disturbing questions in “How Ivermectin became a Target for the Fraud Detectives.”

TrialSite has chronicled ivermectin studies all over the world, including the ICON study done in Broward County early on during the pandemic. Of course, this study wasn’t a randomized controlled trial, thus limiting its impact. Interviews with the head of the largest hospital in the Dominican Republic as well as a well-respected investigator in Dhaka, Bangladesh, and interactions with doctors in Nigeria, Zimbabwe, South Africa, and India found positive data points. TrialSite even sponsored an objective documentary in Peru, one of the first nations to accept the use of the drug for the novel coronavirus.

After numerous interviews, study write-ups, and real-world observations, the case for ivermectin should be taken seriously. The U.S. National Institute of Health is financing an ivermectin-based study called ACTIV-6, while the University of Minnesota led one of the largest ongoing ivermectin studies called COVID-OUT.

The drug does have a proven safety profile at doses currently approved for parasitic indications. However, claims that higher dosages are just as safe as Tylenol might be a stretch—rather that claim would be associated with currently approved indications. Yet, it’s not a stretch to declare the drug is generally safe if taken off-label under the guidance of a licensed, competent physician.

The FDA’s behavior during this pandemic in association with ivermectin has been questionable, to say the least. Issuing warnings to the public not to use the animal variety of the drug, they emphasized that for the human version, it should be used only in clinical trials. TrialSite’s Sonia Elijah’s piece on obtaining FDA emails suggested the possibility of some form of disinformation campaign emanating from the world’s most respected food and drug regulatory body—an activity, if true, is beneath this organization.

FDA letters to medical and pharmacy boards and medical societies have led to considerable pressure on doctors employed by health systems and pharmacies not to allow ivermectin prescriptions off-label for COVID-19. In addition to a survey substantiating this trend, TrialSite chronicles plenty of instances evidencing efforts to block access. The TrialSite survey evidenced the effectiveness of an ongoing purge.

While there has been much controversy following the drug, Marik, Kory, and others actually visited the National Institutes of Health COVID-19 Treatment Guidelines Panel to discuss the evidence of efficacy against SARS-Cov-2 in early 2021.

Just weeks after that meeting the NIH changes its ivermectin recommendation.

 from use only in clinical trials to the following recommendation:

• There is insufficient evidence for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

Yet if the drug is generally safe and a licensed physician along with an appropriately consenting patient agree to an off-label regimen, why would this vary from other standard off-label use cases that no one makes a fuss about? What is it about COVID? TrialSite has observed based on the severity and intensity of the pandemic, more federal involvement, and intervention in healthcare. Concerns of ivermectin took off when government, industry, and regulators discovered that prescriptions skyrocketed from 3,000 per week pre-pandemic to nearly 90,000 per week during the second year of the pandemic.

TrialSite recently reported on a study led by a University of Michigan doctor showing that at least $130 million in insurance claims for the drug treating COVID-19 in 2021—that figure is probably more than double when counting all the cash-based prescriptions.

Call to Action: What are your thoughts? Is the federal government simply trying to protect people by blocking access to ivermectin or is this part of some regulatory capture movement? Does this mean industry’s interest supersedes patients? Perhaps, the truth is more nuanced. While this TrialSite fact check on the fact checkers (Ivermectin) could be updated, its core arguments are sound.

TrialSite recently shared that a handful of states have proposed bills to ensure ivermectin is available to treat COVID-19 via a legitimate physician’s prescription. Those states include Indiana, Kansas, and New Hampshire. Recently, a leading proponent of the use of ivermectin, Dr. Paul Marik, one of the co-founders of the Front Line COVID-19 Critical Care Alliance (FLCCC), discussed the pending New Hampshire ivermectin legislation with conservative news platform, America’s Voice Network.