by Meg Hansen
Since the emergence of a mysterious respiratory disease in Wuhan, scientists have determined that COVID-19 is a profound inflammatory disease caused by a novel coronavirus named SARS-CoV-2. The virus triggers abnormal immune responses resulting in extensive inflammation and blood clots in the lungs and occasionally other organs, as evidenced by patient autopsies.
Phase Specific Intervention
The disease has a median incubation phase of five days from exposure to the onset of symptoms, after which it progresses in two distinct phases. During the first “Symptomatic Phase” (around eight to ten days), active viral replication occurs and manifests as upper respiratory symptoms, body aches, malaise, brain fog, and occasionally gastro-intestinal problems. Early treatment should consist of antiviral drugs that inhibit SARS-CoV-2 replication and diminish the enormous viral load, along with immune boosting supplements.
After the eighth day from onset of symptoms, the viruses are dead. Most patients with mild disease develop an appropriate immune response that results in viral clearance and recovery. However, the viral debris could trigger a hyper-immune response leading to cytokine storm (i.e. abrupt, severe internal inflammation) and respiratory failure. Risk factors for such complications include increased age, male gender, comorbidities (e.g. obesity, diabetes, cardiovascular disorders), immunosuppressed states, and Vitamin-D deficiency. If the disease progresses into the pulmonary phase, it occurs nine to twelve days after symptoms appear.
In the “Pulmonary Phase,” patients experience prolonged immune dysregulation characterized by a sharp drop in blood oxygen saturation, impaired ability to eliminate damaged cells and viral debris, pulmonary microvascular injury, increased disposition to clotting, and lung inflammation. In-patient treatment should consist of supplemental oxygen to overcome hypoxia, anticoagulants to limit blood clotting, and corticosteroids to prevent multiorgan inflammation and its potentially fatal consequences.
Phase-specific intervention is the key to success. It makes no sense to give antiviral drugs during the late pulmonary phase, when live and replicating viruses are absent. Yet, the National Institutes of Health (NIH) approved an antiviral drug for hospitalized patients on the basis of a study sponsored by its division, the National Institute of Allergy and Infectious Diseases (NIAID).
Turning Pathogen to Profit
In April 2020, NIAID Director Anthony Fauci announced that antiviral remdesivir (sold by Gilead Sciences at $3,120 per patient for a treatment course) would become the standard of care for hospitalized COVID-19 patients. This decision came in spite of international studies proving that remdesivir does not provide significant clinical benefits and the WHO’s recommendation against its use. Note that eight members of the NIH COVID-19 Treatment Guidelines Panel have disclosed financial ties to Gilead, which spent more money lobbying Congress last year than in its history.
When a regulatory body like the NIH, entrusted with protecting the public, throws in with the industry it is supposed to regulate, people get hurt. This phenomenon, known as regulatory capture, enables companies to co-opt the government’s regulatory power to block competitors from entering the market or succeeding. The pandemic created a new global market for COVID-19 prophylaxis and treatment. Our public health agencies have been helping corporations to exploit it, demonstrating the extent to which Big Pharma has captured them.
Bringing new drugs to market is expensive and takes decades. The process is more complex for vaccines that have higher costs and regulatory barriers. However, a new genetic technology called synthetic messenger RNA (mRNA) offered a speedy solution to vaccine makers. Conventional vaccines contain a live-attenuated germ, or an inactivated/ killed germ (whole organism or part of it), or an inactivated germ toxin that does not cause infection but induces immunity via antibody-production. In comparison, an mRNA vaccine injects the molecular code of SARS-CoV-2’s spike protein (with which the virus infects host cells) and teaches the body to recognize and attack the spike protein. Synthetic mRNA can be rapidly synthesized in a laboratory.
Using mRNA experimental technology, Pfizer-BioNTech produced a vaccine in record-shattering time. The company struck an initial $1.95 bn advance purchase deal with the US government, followed by subsequent contracts totaling $6 bn. A gold rush ensued as President Trump’s Operation Warp Speed spent upwards of $18 bn for vaccine development. Moderna, a secretive biotech firm that had never created a product, received $6 bn in federal funds. NIH Director Francis Collins revealed that the agency owns a part of the Moderna vaccine’s intellectual property and has a financial stake in it.
The US government gave $1.2 bn to AstraZeneca for developing a vaccine with Oxford University. Other recipients include Johnson and Johnson ($2 bn), Merck ($38 mm), Novavax ($1.6 bn), and Sanofi-GlaxoSmithKline ($2.1 bn). By February 2021, the FDA had issued an Emergency Use Authorization (EUA) for the Pfizer, Moderna, and Johnson and Johnson vaccines.
Suerie Moon (Co-Director of the Global Health Centre, Geneva) explains that these vaccine makers exert a “high amount of market power” and can demand higher prices compared to generic drugs that can be made by several competitors. The disproportion between vaccine sellers and consumers renders it a captive market, enabling the former to reap exorbitant profits. Pfizer expects to earn up to $61 billion in 2021 from vaccine sales (beating the $42 billion it made last year).
Although Operation Warp Speed allocated $6 bn for antiviral therapeutics, no new drugs were investigated. Could the politico-economic landscape, conquered by vaccines, have disincentivized antiviral drug development? One of the FDA’s statutory requirements for issuing an EUA is that “no adequate, approved, and available alternative to the product” should exist for “diagnosing, preventing, or treating the disease.” The ability to administer vaccines is thus contingent on the absence of drugs that treat COVID-19. Is it any wonder that treatment remains elusive twenty months into the pandemic?
No Treatment for Active Infection
The NIH and the Centers for Disease Control and Prevention (CDC) advise patients to avail of supportive care (Tylenol and Motrin), isolate to prevent transmission, and seek medical attention if they turn blue. Dr. Paul Marik (Chief of Pulmonary and Critical Care Medicine, Eastern Virginia Medical School) calls this “do nothing” approach therapeutic nihilism; I prefer medical negligence. Providing no treatment puts the patient at risk for developing life-threatening complications and long-term injuries. Most hospitalized patients that need ventilators either die or if they survive, become respiratory cripples unable to breathe without the machine.
Moreover, fifty to eighty percent of those that recover from acute infection face persistent illness in its aftermath. Post-COVID Syndrome or long haul COVID presents as a wide spectrum of on-going symptoms like fatigue, cough, shortness of breath, headache, and joint pains. The NIH can offer no guidance despite having launched an initiative to study the condition six months ago. Meanwhile, the CDC advises healthcare professionals to share information about patient support groups and online forums to “long haulers.”
Unsatisfied with the status quo, Marik and a group of maverick clinicians formed the Front Line COVID-19 Critical Care Alliance (FLCCC). They applied their expertise, as pulmonologists and I.C.U. specialists, to create phase-specific treatment protocols that use generic drugs. Ivermectin is central to these regimens and it is recommended with other synergistic drugs that have potent anti-inflammatory, antioxidant, and immune-modulating properties. For example, melatonin, vitamin supplements, heparin, antihistamines, statins, and corticosteroids.
Public health and pharmaceutical industry leaders were not impressed. New products deliver a massive payoff to multiple stakeholders, whereas an off-patent drug like ivermectin makes no money in addition to jeopardizing the vaccine emergency use authorization. Consequently, Big Pharma and the regulatory agencies have been vilifying a drug that cures COVID-19.
The Story of Ivermectin
Ivermectin is an anti-parasitic drug approved by the Food and Drug Administration (FDA) and classified as “Essential Medicine” by the WHO. In 1978, Japanese biochemist Satoshi Omura extracted avermectin compounds from a soil sample, which were then developed by William C. Campbell of Merck Research Laboratories into ivermectin as a cure for river blindness. Endemic in Sub-Saharan Africa, this parasitic infestation had affected eighteen million people at that time. In some West African villages, sixty percent of the population over the age of fifty-five years was blind.
Ivermectin (brand name Mectizan) was so effective that Merck established the Mectizan Donation Program (MDP) in 1987 to distribute the miracle drug free of charge. MDP continues today as the longest-running, disease-specific drug donation program. Over the past three decades, 3.7 billion doses of ivermectin have been administered globally. In 2015, Campbell and Omura won the Nobel Prize in Medicine for discovering ivermectin.
Subsequent analyses showed that ivermectin has antiviral activity against a broad range of viruses (e.g. dengue virus). Noting the structural similarities between SARS-CoV-2 and many viruses that are susceptible to ivermectin, Australian researchers tested the drug and found that it inhibits SARS-CoV-2 replication in vitro. Further, French scientists studied the drug’s effect in an animal model and found that it “greatly attenuated” SARS-CoV-2-associated pathology. These findings encouraged clinical trials around the world to investigate ivermectin’s repurposing potential in COVID-19.
Unitaid (WHO) commissioned an international team, led by Andrew Hill (University of Liverpool), to analyze all active ivermectin trials. The meta-analysis of eighteen randomized control trials/ RCTs (2, 282 patients) found that ivermectin led to faster viral clearance, favorable clinical recovery, and reductions in hospitalization and mortality rates (by seventy-five percent). However, the study’s conclusion did not reflect its findings and instead deemed the data as inconclusive. In March 2021, the WHO declared that ivermectin should not be used for COVID-19 – a recommendation that US agencies have followed. Hill later revealed that the study’s conclusion was “not his own” and had been informed by its sponsors.
Though numerous studies have since attested to ivermectin’s efficacy and safety, regulatory agencies remain irrationally impervious.
In a review of global clinical studies of ivermectin in COVID-19 (Japanese Journal of Antibiotics, March 2021), Yagisawa et al. wrote that the results of forty-two clinical trials (15,000 patients) had been conducted by February 2021, and the data showed that the drug brought an eighty-three percent improvement in the early phase and a fifty-one percent improvement during the pulmonary phase.
Kory et al. concluded that meta-analyses, based on eighteen RCTs evaluating ivermectin, found large and statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance (American Journal of Therapeutics, May-June 2021).
In a meta-analysis of twenty-four RCTs (3,328 patients), Hill et al. found that ivermectin decreased inflammation and cleared the viral load faster. In eleven RCTs of moderate-to-severe infection, there was favorable clinical recovery, reduced hospitalization, and a fifty-six percent reduction in mortality (Open Forum Infectious Diseases, July 2021).
Bryant et al. conducted a meta-analysis of fifteen trials and found that ivermectin reduced the risk of death (American Journal of Therapeutics, July-August 2021).
Data analyst Juan Chamie has converted epidemiological analyses of ivermectin intervention in various countries (Argentina, Brazil, India, Mexico, Paraguay, and Peru) into graphs that illustrate the drug’s efficacy in reducing deaths and the number of cases.
By dismissing this mountain of evidence as insufficient, regulatory bodies have imposed arbitrary standards on ivermectin. In contrast, the FDA approved remdesivir based on three small RCTs.
Moreover, the FDA insists that ivermectin is a dangerous drug on which you can overdose. The WHO global database (www.vigiaccess.org), which compiles reported side effects of medicinal products, reports sixteen deaths and 4,700 total adverse events related to ivermectin use since 1992. Ivermectin is indisputably safe. Why then would the authorities allege otherwise? Merck recently secured a $1.2 bn advance purchase agreement with the US government for an antiviral drug called molnupiravir that it is currently developing. The pharmaceutical giant issued a statement denouncing ivermectin as having no scientific basis or meaningful clinical evidence for efficacy against SARS-CoV-2. It also warned about the drug’s “concerning lack of safety.” What was once Merck’s miracle drug is now nothing but a threat to its bottom line.
Only in a morally diseased society would the politics of profit take precedence over the public’s well being, even as the pandemic has infected 196 million people worldwide and claimed the lives of four million and counting.
Meg Hansen is a Bennington County resident, writer and former executive director of a VT health policy think tank. She holds a medical degree from a university in India and a Master’s Degree from Dartmouth College. She ran for state-level public office in 2020.