Only in the age of COVID-19 have drugs become so politicized. For example, the story of Hydroxychloroquine: drug that was promoted early on across the board as considered at least one early-stage option to attempt to treat the novel coronavirus. Some of the world’s largest studies, such as University of Oxford’s COPCOV, embraced the anti-malarial drug. But with the controversial Trump promotion as well as intense scrutiny on the data thereafter, came the emergence of medicinal “camps” and, of course, such polarization tends to produce the data that fits into the convenient paradigm or world view. Thereafter, a wave of data finding and evidence indicated the drug was either not safe or not effective. On the other hand, some studies evidenced real benefit, such the Henry Ford Healthcare system’s’ study suggesting it can reduce the death rate. Regardless, in today’s hyper-polarized and political world, investigational drug products can actually be associated with a movement, a cause, and even a political ideology. Now an Ohio Governor brings the Hydroxychloroquine conflict to the next level in Ohio; Mike DeWine, in response to a band on the drug by the Ohio Board of Pharmacy, declared the ruling should be reconsidered. Two days later, that same board flipped and reversed its decision after the Governor’s urge for reconsideration. And while Hydroxychloroquine’s jury isn’t done deliberating, Remdesivir cleans house with a projected $1-$3 billion in Blockbuster-style sales for a drug not even officially approved by the U.S. FDA. What is going on here?
Ohio Board of Pharmacy Makes it move
Perhaps influenced by Dr. Anthony Fauci, director of NIAID and the nation’s most influential infectious disease expert, as he has repeatedly declared that trials reveal “consistently” that the drug is “not effective” in treating SARS-CoV-2, the Ohio Board of Pharmacy issued a surprising draconian rule. Beginning last Thursday, all pharmacies, clinics and other medical institutions couldn’t dispense or sell Hydroxychloroquine/Chloroquine to treat COVID-19. However they could be used in clinical trials, reported Cameron McNamee, director of policy and communications for the board. But, moving forward, if a private doctor wanted to use off label with a private patient, they were effectively banned from doing so, reported the Columbus Dispatch.
Hence, on Thursday July 30, the rule effectively banning the dispensing of the anti-malarial drug for the treatment of COVID-19 went into effect. This rule stopped all pharmacies from selling or dispensing the drug (hydroxychloroquine or chloroquine) for use as a SARS-CoV-2 treatment without the prior approval from the executive director of the board. It emphasized that any and all prior approvals for the drug would not be held invalid.
The Governor’s Position
In an immediate response, Governor DeWine, a Republican, issued the following statement:
“I agree with the statement from Dr. Steven Hahn, Commissioner of the Food and Drug Administration, that the decision about prescribing hydroxychloroquine to treat COVID-19 should be between a doctor and a patient. Therefore I am asking the Ohio Board of Pharmacy to halt their new rule prohibiting the selling or dispensing of hydroxychloroquine or chloroquine for the treatment or prevention of COVID-19. The Board of Pharmacy and the State Medical Board of Ohio should revisit the issue, listen to the best medical science and open the process up for comment and testimony from experts.”
The New Rules Immediately Rescinded
As recently updated on the State of Ohio Board of Pharmacy’s website, the new rule went into effect and then was immediately rescinded after the Governor’s remarks, and undoubtedly, the outcry by many concerned physicians, health care professionals and citizens in Ohio.
With Governor DeWine’s declaration and citizen uproar, the State of Ohio Board of Pharmacy withdrew its ruling. According to local news, WFMJ, the board’s decision came after the Governor’s request that they reconsider this rule. Hence, the Board stated, “This will allow the Board to reexamine the issue with the assistance of the State Medical Board of Ohio, clinical experts, and other stakeholders to determine next steps.”
Who is the State of Ohio Board of Pharmacy?
According to their website, the State of Ohio Board of Pharmacy is responsible for “administering and enforcing drug laws of Ohio, which includes the licensing of pharmacists, pharmacy interns, terminal and wholesale distributors and dangerous drugs.”
The first five-member Board of Pharmacy was appointed by the Governor at that time, which was 1884. As declared on their website, the Board is “the single State agency in Ohio responsible for administering and enforcing laws governing the practice of pharmacy and the legal distribution of drugs.” With nine members appointed by the Governor for a four year term, eight of the members are actually licensed pharmacists who are supposed to represent, “to the extent practicable, each phase of pharmacy practice” as well as a member from the public. Additionally, the Board employs a 57-person staff responsible for day-to-day operations.
Hydroxychloroquine/Chloroquine: The Politicized New World
The reality is that the data points for these drugs are mixed. The World Health Organization (WHO), for example, put a pause on any hydroxychloroquine studies, only to announce it would resume global trials of hydroxychloroquine after the drug safety monitoring committee found no evidence that there was increased risk of death for COVID-19 patients.
An article was published in The Lancet on May 22, 2020, claiming that hospitalized COVID-19 patients treated with the drug (with or without macrolide) didn’t benefit from treatment and rather were at greater risk of death. However, the article was retracted due to serious questions about data integrity. How could The Lancet just blindly accept such a study as the observational one from the very questionable Surgisphere? Who was behind all of that?
But highly respected investigators, such as Peter Horby at University of Oxford Professor of Emerging Infectious Diseases and Global Health and chief investigator of the RECOVERY Trial have come out and declared that the evidence from the trial reveals that hydroxychloroquine isn’t effective for patients hospitalized with COVID-19. But critics note that the drug wasn’t supposed to be used on hospitalized patients but rather that if it was to be effective, it would be used immediately on disease onset as a measure to try to reduce the chances of the infection progressing.
In the meantime, the U.S. FDA revoked the emergency use authorization for the drug while the agency updated the fact sheets for the emergency use authorization of remdesivir (again, only for cases of hospitalized patients and intravenous administration) to warn that combining hydroxychloroquine with remdesivir may reduce antiviral activity of remdesivir.
However, the TrialSite reported that the Henry Ford Health system study, which looked at 2,400 hospitalized patients and uncovered a 50% lower death rate in the Hydroxychloroquine group and “no safety problems.” Critics contend still that the study was not a randomized controlled study.
Back on July 12, TrialSite introduced a Hydroxychloroquine roundup and expressed concerns about the politicization of our public health decisions. Meanwhile, that pollicization was on full display in the State of Ohio.
In the meantime, Remdesivir is granted exceptional status, so much so that actual trial endpoints are changed last minute by NIAID and the sponsor; with data that the drug reduces COVID-19 hospitalization by a few days, it’s had a full embrace and acceptance by the U.S. FDA. Thanks to that move, top analysts forecast the drug maker, Gilead, will generate between $1 billion and $3 billion in 2020 alone on a drug that isn’t even officially approved by the FDA (it’s under emergency use authorization). Hence, the first blockbuster of a drug that wasn’t even approved. TrialSite understands while many start to become a little paranoid about intentions.
Call to Action: For concerned citizens and residents of communities that care about the public health, TrialSite is here for you. Send us information about any concerns or issues, and we will investigate.