October 6, 2021
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While countries in Asia are distributing home-care kits with antivirals to combat COVID-19, physicians from other parts of the world have declared their profession to be at a crossroads. Australia is one of many countries where health professionals face restrictions in their treatment of COVID-19; a recent ban against Australian doctors prescribing their patients with ivermectin caused a great uproar. In the United States, doctors seeking to treat their patients face similar pressures. TrialSite covers the latest development where physicians unite to declare their right to treat their patients.
Australia, the U.S.A, and other countries in similar positions are concerned that agencies such as the World Health Organization (WHO) impose a ‘one size fits all’ approach, impeding the ability of doctors to care for their patients and provide treatment at their discretion. TrialSite is familiar of several situations where the WHO has actively pressured a national government to ultimately dissuade doctors from embracing ivermectin, for example, as an off-label approach to help care for COVID-19 patients. Licensing boards declare in America that doctors may lose their right to practice—their livelihood—if they pass “misinformation.” But who defines the term? What if those defining the term are also promulgating misinformation?
This issue voluntarily brought scientists, doctors, and even COVID-19 survivors worldwide to the International COVID Summit (ICS) in Rome, Italy, to sign the petition called the Physicians Declaration. There they shared their positive experiences and evidence when using safe and effective medicines that proved to counter the early effects of COVID-19. The summit’s outcome was in stark contrast to the G20 Health and Ministers Summit, also held in Rome less than 10 days before the ICS; WHO’s central role in driving health policy guidelines was reinforced, and ministers committed to ensuring its ongoing funding.
Physicians Declaration
The Physicians declaration is a document signed by doctors and scientists on September 14, 2021, during the ICS, aiming to restore the right of physicians to treat patients by prescribing early treatments to patients with mild and severe symptoms. As of October 5, 2021, over 10,000 doctors and scientists have signed the document.
Current Practice
The recommendation of the World Health Organization (WHO) in treating COVID-19 patients depends on the severity of the symptoms.
Patients with mild to moderate symptoms will be isolated at home with no immediate treatments.
Those with severe symptoms can be admitted and treated in the hospital.
Although limited resources constrain hospitals to prioritize severe cases of COVID-19, treatment for others showing early signs of COVID-19 is delayed, putting them at risk.
Early Intervention
Since the onset of the pandemic, some physicians and scientists have discussed the effectiveness of certain drugs as early intervention treatments for COVID-19. However, this idea has been continuously shut down by multiple organizations and agencies, citing limited data. The European Medicines Agency, Department of Health, and WHO have imposed a severe strain on doctors’ abilities to prescribe effective treatments.
Dr. George Fareed is a Harvard Medical School graduate and HIV/AIDS medicine specialist family medicine doctor with the F. Plesner Award for Rural Doctor of the Year and Border Hero Award. In his ICS speech, he claimed that the greatest medical failure is the “wait and see” protocol for COVID-19 treatment, asserting that deaths could have been prevented with early intervention and treatment. He discussed the onset of flu-like symptoms during the replication of the virus in the first stage of COVID and explained that the goal is to stop the viral replication.
Dr. Peter McCullough, a clinical cardiologist in preventive cardiology and advanced lipidology, explained the function of ionophore drugs that allow zinc into the cell, which interferes with viral replication. Currently, the two main ionophore drugs used in treating COVID-19 are hydroxychloroquine and ivermectin.
COVID-19 Drugs Suggested at the ICS
The COVID-19 virus has been continually demonstrated by the media as an incurable monster, putting great fear of the virus into the world. However, scientists and doctors worldwide believe that the virus does not need to be demonized in this way, given that there are effective treatments available to use. TrialSite has followed the stories of doctors advocating for a number of drugs, which include hydroxychloroquine and ivermectin. The antivirals discussed at the ICS are briefly summarized here.
Hydroxychloroquine
The use of hydroxychloroquine was pioneered by Dr. Luigi Cavanna, the head of the oncology ward in Piacenza hospital in Italy. He became a candidate for the Nobel Prize in 2021 after realizing that the severe symptoms of seriously ill COVID-19 patients could have been prevented if treated early.
Dr. Brian Tyson, a family medicine doctor in the Urgent Care Covid Clinic, Imperial Valley, California, worked with Dr. Fareed on potential treatments in 2020. They treated patients with a combination of hydroxychloroquine and azithromycin or doxycycline on top of the usual zinc, vitamin D, and C given to patients. This is similar to the treatment used by Dr. Ira Bernstein, the co-founder of the Canadian Covid Care Alliance and lecturer of the Department of Family and Community Medicine University of Toronto.
Dr. McCullough also promotes the use of hydroxychloroquine. It is worth noting, however, that Dr. Peter McCullough is currently facing a lawsuit due to his illegitimate affiliation with Baylor Scott & White Health, or so they claim. TrialSite suggests that these doctors during the pandemic have sought out to do nothing but help patients. To viciously attack doctors, the ultimate providers of health is a shame that will be overcome. Dr. McCullough has expressed his concerns about vaccine safety and efficacy, suggesting that healthy people under 50 and COVID survivors have no scientific reason to get the vaccine.
Despite some early success of hydroxychloroquine as an early intervention for the virus, the WHO still does not recommend the drug as an effective COVID-19 treatment based on the drug’s failure to reduce mortality and need for mechanical ventilation in 30 trials with more than 10,000 COVID-19 patients. There was also a tremendous backlash in mainstream media surrounding statements made by then-President Trump, who declared that the drug was proving to be an excellent preventive for COVID-19 among the “thousands and thousands of front-line workers” who were using hydroxychloroquine so that “they don’t catch the horrible disease.”
President Trump’s remarks sparked a huge controversy, as the American Medical Association (AMA) disclaimed any record of tracking the use of the drug among health care workers. The drug trials came under immediate scrutiny and polarized the scientific community, many of whom questioned the methodologies adopted by ongoing clinical trials. Subsequently, the Food and Drug Administration (FDA) laid out restrictions on drug supplies, cautioning that hydroxychloroquine could cause heart rhythm issues when used outside of hospital settings.
This chain of events discredited the drug’s use in preventing COVID-19, and hydroxychloroquine continues to be reported with tremendous skepticism in the media. However, studies on the drug are still ongoing and are interpreted variously with contentious results. In May, TrialSite interviewed preeminent Yale physician Dr. Risch, who reviewed nine COVID-19 patient case studies to reveal that hydroxychloroquine reduced the risk of hospitalization and death two-fold.
Ivermectin
Ivermectin, aspirin, and budesonide were added to the hydroxychloroquine treatment protocol of Dr. Fareed. This similar combination therapy was used by other doctors as well, such as Dr. Jackie Stone from Zimbabwe, who discussed the importance of combination therapy and the addition of ivermectin to treatment protocols. Her data shows a decrease in mortality of up to 10-fold upon the addition of ivermectin, supporting her point that combination therapy is more effective than monotherapy.
Although results are promising, New Zimbabwe reported in January 2021 that the Medical and Dental Practitioners Council of Zimbabwe (MDPCZ) warned that Dr. Stone does not have a valid license to practice medicine in Zimbabwe and that she has been working with unregistered people to dispense the drugs to patients, conducting unapproved clinical trials.
Faced with formidable opposition, Dr. Stone continued to stand by her treatment regimen and was eventually validated by an abrupt change in Zimbabwe’s stance toward ivermectin. TrialSite interviewed Dr. Stone, who shared that the combination treatment regimen with ivermectin significantly reduced mortality by 1.5% in a community setting.
Canada’s Dr. Ira Bernstein, the co-founder of the Canadian Covid Care Alliance and lecturer at the University of Toronto, believes in the ability of hydroxychloroquine and ivermectin in treating COVID-19 early.
With the majority of 65 clinical trials exhibiting positive data points and a few published meta-analyses—from the U.S.A, U.K, Italy, and India all calling out positive study data, the possibility of an orchestrated suppression of the drug’s positive attributes against COVID-19 is a distinct possibility.
Delegates from England, Croatia, Spain, Brazil, Peru, France, and the USA had their fair share of experiences that prompted them to firmly promote the use of Ivermectin. However, its use is still under debate due to lack of data as defined by a combination of agencies from the World Health Organization (WHO), the U.S.A National Institute of Health (NIH), the Food and Drug Administration (FDA), and Centre for Disease and Control (CDC).
Currently, the WHO and nearly all regulatory bodies only recommend the use of ivermectin in clinical trials. A couple of major studies on ivermectin in the U.S.A include COVID-OUT (NCT04510194), from the University of Minnesota and UnitedHealthcare, and the NIH’s ACTIV-6 (NCT04885530).
Proponents of ivermectin argue, however, that the protocols include underdosed regimen, much like they highlight in the McMaster University Together trial headed by Dr. Ed Mills. Critics also point out that insufficient duration of ivermectin dosage and lack of adapting the treatment protocol to a virulent variant could also play a role in disappointing results. Dr. Ira Bernstein raised a concern regarding the Together trial design: the study did not exclude those who had previously used ivermectin. Therefore, there was a likelihood that the treatment group did not show substantial differences from placebo due to previous ivermectin exposure in participants.
The Physicians Declaration highlights the widespread frustration at the steps being taken to limit doctors’ abilities to treat their patients on a global scale. There is also a need for further coverage and research about ongoing clinical trials on antivirals which could very well control the transmission of COVID-19 in its early stages, reducing case numbers and deaths. Doctors must be able to care for their patients—it’s an intimate, very localized affair…not one that was designed for federal or international health agency oversight, even in a pandemic.