While TrialSite reported that a Brazilian rural state recently passed a law allowing the use of ivermectin and hydroxychloroquine for COVID-19, now in the United States, Republican lawmakers from New Hampshire, Kansas, and Indiana push to ensure access to such repurposed drugs in those states, despite a stance by the U.S. Food and Drug Administration (FDA) that such drugs should only be used for COVID-19 in clinical trials. In Concord, New Hampshire, some politicians seek to make it easier for patients to access ivermectin as an early-onset treatment for COVID-19. In the ‘Live Free or Die’ state, House Bill 1022 would enable pharmacists to dispense ivermectin via what’s known as a standing order, reports local media WMUR 9, despite the FDA’s declaration on the drug for off-label use against COVID-19. In Kansas, a growing Republican-led movement calls for a similar bill for early treatment to include ivermectin and hydroxychloroquine, while similar calls are heard in Indiana. Will 2022 be the year of the push for repurposed therapies at the state level? Prominent U.S. government-backed clinical trials that include ivermectin may help or hinder the momentum for state-level initiatives. Meanwhile, with record COVID-19 infection counts, health authorities become more intent on educating people about the benefits of vaccination versus the risks of COVID-19. A lack of early treatments combined with the concern that monoclonal antibodies may not work as well against Omicron leaves the sick fewer choices, as it appears only Sotrovimab works well against the latest variant of concern, according to some critical care doctors.
What to do?
With an explosion of Omicron COVID-19 cases across America, concerns grow that vaccination does not stop viral transmission, as observed with mounting breakthrough infections. TrialSite covered the recent study from Denmark’s Statens Serum Institut which reported in an uploaded preprint study that the second doses of Pfizer and Moderna mRNA-based vaccines may actually increase the likelihood of SARS-CoV-2 infection after 90 to 150 days.
It would be misleading to declare that the vaccines are not effective against Omicron. Rather, the investigators from Denmark found them to be effective, but the durability of the vaccines raised concerns. The study authors declared, “In light of the exponential rise in Omicron cases, the findings highlight the need for a massive rollout of vaccinations and booster vaccinations.” The latter was emphasized with the Pfizer vaccine, due to waning effectiveness but an identified rebound in positive efficacy with a booster.
Regardless, “booster fatigue” becomes a growing topic, as a confluence of forces increasingly indicate countries such as the USA, the UK, and perhaps soon Israel’s health authorities will signify a transition to an endemic stage of COVID-19.
Authorized Treatments in Short Supply
While both Pfizer and Merck have antiviral-like medications now coming to market there are still limited supplies amidst the historic rises in new infections due to the highly transmissible nature of Omicron.
Concerns with Merck’s Molnupiravir are mounting in some parts of the world—so much so that in the world’s second most populated nation, India, the apex research organization ICRM has cautioned against the use of the drug.
The antivirals, key for many as a tool to end the pandemic, are hard to come by in many locations. With Omicron raging, the timing of the shortages couldn’t be worse.
In the meantime, although monoclonal antibodies have helped infected Americans fight off COVID-19, a crisis emerged with this class of treatment as well. A confluence of factors, including product shortages in part due to federal meddling of the supply chain combined with the fact that only one of the mAb products appears to work well with the new mutant version of SARS-CoV-2 (GSK and Vir’s Sotrovimab), makes access to these products exceedingly elusive.
Meanwhile, with vaccinated persons becoming infected all over America due to the highly transmissible mutant, concern and fear associated with breakthrough hospitalizations become a daily fear. Yes, it appears that the vaccines still protect people from more severe Omicron-based disease, but again, the effectiveness wanes and booster fatigue become a growing reality. What about other treatments?
Moves to Ivermectin?
Despite the incredible controversy surrounding ivermectin, TrialSite reports that elected officials are proposing bills to ensure access to this FDA-approved repurposed drug. Even though the FDA recommends only in clinical trials, a medical freedom movement thrusts forward with what is supposed to culminate in a large march in the nation’s capital Sunday, January 23. TrialSite follows proposed legislation involving ivermectin, and the even more controversial hydroxychloroquine.
New Hampshire’s Move
The medical freedom movement takes on steam in anticipation of a forthcoming march in Washington, DC (January 23), as several groups testified against the proposed New Hampshire Bill while others “say there should be more research.”
Recently tracked on local media, New Hampshire Republicans seek to guarantee access to the repurposed drug. Recently showcased on WMUR 9, a Hearst Media-owned station, Dr. Nick Perencevich, a retired surgeon was filmed on television declaring, “I would like to think that the standard of care in New Hampshire is that a patient can certainly have ivermectin prescribed off-label if that patient, ideally, gets put into some clinical trial, whether it’s a drug company, or whether it’s an academic institution like Dartmouth.”
Now before the House Health and Human Services Committee, the WMUR 9 report shared [the Bill] is expected to make it to the House floor for a vote in the weeks ahead. The broadcast ended with a segment on ivermectin indicated for horses. TrialSite notes that the media didn’t bother to interview the proponents of the bill nor hear their argument, indicating the possibility of bias.
Kansas Callings
Meanwhile, In Kansas, Sen Mark Steffan recently announced forthcoming bills to promote off-label use of approved FDA prescription drugs including hydroxychloroquine and ivermectin for COVID-19 patients.
The bill was introduced in a special session, however, has not yet been acted upon in a recent Kansas Senate committee resolution, reports the Kansas Reflector, an independent non-profit-based media.
In the recent report, reporter Noah Taborda referred to the proponents of the forthcoming bill as driven to appease “anti-vaxxers,” and that would “undermine local health officials and promote off-label use of prescription drugs.”
An anesthesiologist, Sen. Steffen has been critical of the medical establishment’s efforts to block use of off-label early care treatments such as ivermectin and hydroxychloroquine. Taborda writes that “the Hutchinson Republican advocated for more avenues to use these treatments,” even though the FDA is on the record that ivermectin, for example, should only be used for COVID-19 in clinical trials. TrialSite reports a couple of sizable clinical trials including ivermectin have been underway in the United States.
Meanwhile, COVID-19 continues to rage in Kansas, breaking new daily case counts. The issue of off-label drug use continues to be positioned as an “anti-vaxxer” issue, yet this clearly isn’t the case for all proponents. In the case of Steffen, he is on the record that the risk-benefit analysis associated with the COVID-19 vaccine products favors avoidance for children who rarely end up hospitalized. Yet, according to the Kansas Reflector, while the movement for medical freedom gains momentum in parts of this plains state, there has been an explosion of cases, many of which are either Delta or Omicron-based, with a total of 7,162 deaths in a state with a population of 2.93 million residents.
Tragically, Tim Carpenter writing for the local media reported child deaths—three children under ten years old and three additional adolescents between the age of 10 and 17. Hence, medical establishment proponents argue the risks of hospitalization and death are too high, justifying universal vaccination.
Hoosier Hope?
In the meantime, in the midwestern state of Indiana, Rep. Curt Nisly, R-Goshen, authored a bill that would allow for use of ivermectin to treat COVID-19. Like Kansas, this agricultural state has more access to the animal variety of the drug. Nisly went on the record for the Indy Star in an email declaring, “Why wouldn’t we make this available, especially if we want Hoosiers to stop using horse paste. Hoosiers should be able to care for their health safely and effectively.”
The proposed House Bill 1372 allows for a physician or advanced practice registered nurse to write a standing order for ivermectin ensuring the pharmacist would dispense the drug while stipulating that the pharmacist couldn’t try to dissuade the patent from accessing the drug.
Conclusion
The surge in Omicron cases, in a way, is the perfect bad storm, as a combination of vaccine booster fatigue and antiviral and monoclonal antibody shortages along with the rising medical freedom movement lead to state legislatures pushing for new bills to make economical repurposed drugs like ivermectin available on demand.
An imminent march on Washington this Sunday, January 23 possibly intensifies the medical freedom movement which very well may influence midterm elections. TrialSite predicts within a couple of weeks more proposed off-label bills will contribute to a growing clash of interests. Luckily, thus far, omicron infections appear milder but exponential numbers of cases, hospitalization rates, and deaths move higher, regardless.