A recent news release from Al Jazeera, the Middle Eastern media out of Qatar, stepped into the COVID-19 discussion with a special on ivermectin. Reported on by Jonah Hull in the U.K., the reporter shares that the drug has been approved as an anti-parasitic medication in both animals and humans (different drug products), with the human variety in use safely since 1988. Of course Merck, one of drug’s producers, years ago made an incredibly positive humanitarian move giving away at least hundreds of millions of doses of ivermectin but have taken a different track for COVID-19. This news video shares that trials completed around the developing world—all the ones TrialSite has covered since late April—points out that the overall results have tallied positive in the aggregate—that the generic drug appears to be an effective treatment for COVID-19. Meta-analyses undertaken by at least four different groups in the U.S. and the U.K. show that the drug can reduce symptoms and mortality by up to 75% and can even inhibit transmission, with some prophylaxis like properties. Others, such as the U.S. National Institutes of Health (NIH), counter however that these studies design must be factored in, inhibiting any final conclusions. As reported by TrialSite, in parts of India, such as Uttar Pradesh, the drug has been credited with bringing the cases down to more manageable levels while health authorities will offer protective doses to every attendee of a prominent forthcoming religious festival.
A Tour of Some Familiar Names
Mr. Hull’s special elicited quotes from Dr. Wasif Ali Khan, investigator with clinician with ICDDRB Hospital in Dhaka, Bangladesh, who shared that “for countries like us, it is a wonder drug because it has a long history of use in Asia and Africa,” going on to share that in these developing parts of the world, the living conditions and demographics don’t support the same measures that are taken in Europe and North America (e.g. social distancing, self-quarantine, etc.). ICDDRB has conducted at least a couple studies published in the TrialSite.
Dr. Pierre Kory from the Front Line COVID-19 Critical Care Alliance (FLCCC) shared in the special that their meta-analysis revealed that the drug should be put to immediate global use. The drug works at each stage, serving as an anti-viral and anti-inflammatory elements. But others, such as the NIH, counter that there is not yet enough data to make such a call.
The focus in the wealthy world has centered on vaccine development, and Mr. Hull emphasizes that there has been a significant reluctance of regulators in this part of the world to accept studies from developing nations, pointing to study design, etc.
However, with the rapid mutations and the need to possibly develop continuous updated vaccine products (e.g. boosters), vaccines alone may not be the full long-term answer, suggests the newscast. In fact, that is absolutely the case in the United States as TrialSite has demonstrated that the NIH continues to fund clinical trials in various therapies, even as prophylaxis, such as AstraZeneca’s AZD7442, a powerful long-acting monoclonal antibody first discovered at Vanderbilt and licensed by the Anglo-Swedish global pharmaceutical company. AZD7442 has the potential to be a prophylaxis and therapy targeting COVID-19.
Hull, reporting for Al Jazeera, shares that the worldwide interest is building in ivermectin with its potential to contribute as a prophylaxis and treatment for those already infected. Mentioned is the Principle trial sponsored by University Oxford as one that is conducting an ivermectin study; however, TrialSite has information that Oxford hasn’t yet included ivermectin and in fact is still deciding whether they will or not.
Dr. Pierre Kory is again quoted that ivermectin could be included in a strategy to treat at least people in the developing world that are awaiting mass vaccination. As TrialSite has discussed, in Africa while the African Union seeks to work with bankers to underwrite a several billion dollar “vaccine bond,” and in fact, a half-billion dollar vaccine bond has already been underwritten for COVID-19, the gap between when mass numbers in Africa will be vaccinated for COVID-19 and the present represents a material amount of time. How will people protect themselves until then?
The news report pointed to Slovakia becoming the first EU country to formally authorize ivermectin for this particular indication (COVID-19).
Circling the Wagon in the U.S.
Ironically, or perhaps not so, just as interest in ivermectin grows worldwide, in America, a confluence of economic, political, and social interests have converged to express intensified concern about ivermectin and its safety profile. Based on nebulous reports of growing numbers of self-medicated-driven hospitalization or calls to poison centers, the U.S. Food and Drug Administration issued a cautionary statement declaring that ivermectin should not be taken for COVID-19. This, not surprisingly, aligned nicely with Merck’s recent messaging. TrialSite revealed that the great American pharmaceutical company had just spent over $400 million on COVID-19 M&A target and that a month later the company received over $300 million in taxpayer money.
While the NIH has officially stated it cannot recommend against, or for, this particular therapy for COVID-19; at this point, that’s left any off label usage up to physician discretion and consenting patient. The FDA’s statement, according to the FLCCC, is misleading and serves to alarm physicians not to prescribe off label despite the fact that the many studies around the world have used what is considered a safe dosage range.
Billions of doses have been allocated to people around the world for parasite control, and the safety record since its first use in humans in 1988 has been good. In fact, in just several months, significant health concerns have been raised in relation to drugs such as remdesivir, the only approved drug for COVID-19; the World Health Organization’s Solidarity trial has led to the conclusion that it shouldn’t be used for COVID-19.
Yet demand for the product is strong, with now over a $3 billion turnover. With up to a couple hundred billion dollars in revenue to be had in just the next handful of years, a biopharmaceutical program will be employed to get COVID-19 under control, and cheap generics are not included, at least not in the lucrative rich markets in North America, Europe, Australia, etc.
U.S. Regulatory Notice
The FDA is the law of the land when it comes to food and drugs. About 50% of the TrialSite Network resides in that jurisdiction. And the recent FDA declaration, while there is indication that it may be for reasons more than just health concern, must be acknowledged and understood. The edict doesn’t criminalize the off-label use per say, but the agency has taken a Merck-like stance against the drug. While they refer to no data, no public health agency reports, no warning letters (at least any that they thought was necessary to share with the public), the Gold Standard regulatory body has declared its concern; and they are the executive branch agency that was created in 1906 to enforce the original Food and Drug Act, and, of course, all the additions to the act since then. The FDA has served as a vital enforcement authority helping to protect the public from all sorts of illicit products peddled to the American people and hence serve an absolutely critical purpose.
This media source has definitely been involved with its fair share of controversy. Backed by the Qatar government, it has taken on views that this media platform certainly doesn’t support. TrialSite carefully reviewed the content and points out that the newscast produces verifiable information.
They do not, however, provide the pharmaceutical or regulatory perspective from the developed world, so the overall broadcast could be deemed biased. The reality is that there are biases on all sides here.
Governments in the rich world are in fact responding to the pandemic in a resolute manner, unleashing the biopharma sector to dramatically advance medicinal development. COVID-19 represents one of the most significant biomedical-based research and development bursts in history.
There are examples abound, such as the development of an mRNA based vaccine with 95% efficacy in just months is heretofore just not imaginable. TrialSite has several reports from individuals that have been given the Lilly and Regeneron monoclonal antibody products that served to clear up the virus within days—that such products can be developed so fast boggles the mind. To date, hindering this class of product are a number of issues, including the fact that they are not easy or straightforward to administer, especially for home use. Although, interesting programs such as the one from UnitedHealth to treat people at home shows some promise.
While billions of taxpayer dollars are now invested, hundreds of billions of dollars in just a few years is at stake. The challenge is that the government haven’t served to effectively protect the masses of people, and TrialSite is here to tell all that that is not their actual role at the federal level. It is of paramount importance that during this pandemic wherever and whenever possible, people, families, extended family and community must empower themselves with knowledge and know-how to help protect themselves accordingly.
The federal government will offer some support via ongoing financing for vaccine and therapy research as well as support for mobilization and distribution of such treatments as well as regulatory oversight to monitor for safety and efficacy. The CDC and other agencies do what they can to help keep the public and health agencies informed and updated. State and local public health authorities, depending on the level of financing, organizational prowess and talent, do what they can to help their populations during this pandemic—and during normal times. And health systems, non-profit to for-profit to publicly funded, provide in many cases the most sophisticated care of any in the world.
But what has become apparent in this pandemic is how many people are left with no recourse. How many elderly in long-term care had to die? The growing obesity, diabetes and other chronic disease crises in America make the population extra vulnerable to the novel coronavirus. The social determinants of health indicate that those from lower income or ethnic and racial minorities may face graver risk.
What’s clear is that in America and beyond, a commitment to health at the individual, family and community level—from the ground up—must be a high priority. Despite trillions spent on federal health care, the overall health of the nation struggles with mounting chronic conditions, from myriad causes, including ones associated with the social determinants of health. Thus the vital importance of a new health-centered agenda for all the people.
This includes a commitment to one’s personal and family health and for matters that effect broader interests—political organization. After all, if change is what one wants in a democratic market-based economy, that’s how its achieved.
So after a spirited tour into a number of related subjects, although Al Jazeera doesn’t produce any misinformation, it precludes other vantages to the evolving and unfolding story. For example, it didn’t interview the NIH or FDA or EMA for that matter. So, it can be deemed bias but in fairness other media sources are just as biased as well, but in the other direction—think CNN, MSNBC, and Fox. The people must find their information from a myriad of diversified sources and in the process develop a more critical eye for what is in the interests of themselves, their families and their communities.