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Physician Specialists Urge CDC to Consider A Safe & Powerful Treatment For COVID-19
As Covid-19 infection and death rates continue their climb, public opinion is consolidating around our health agencies’ guidance and directives. Resolution of the pandemic could be around the corner given the recent announcements around their initial observations of volunteers in Pfizer and Moderna Phase III trials of their novel vaccine based on an mRNA (messenger RNA) platform. Both vaccine manufacturers claim an initial 90-95% efficacy rate of their experimental vaccines.
The vaccines are in fact experimental as Phase III trials take a full 24 months to complete. Nevertheless widespread deployment of the vaccine will move ahead under the Emergency Use Authorization (EUA) policy. This policy does not indemnify vaccine manufacturers from legal action if their products cause harm. That protection has been in place for over thirty years under the National Childhood Vaccine Injury Act passed in 1986 in response to vaccine manufacturers refusal to produce vaccines without legal protection. The EUA goes a little further by allowing this particular vaccine to be administered to the public prior to the completion of safety and efficacy trials.
Given the unprecedented situation we find ourselves in, such bold measures seem justifiable in the interest of saving lives. After all, there aren’t any other potential options. At least that is what we are and have been told.
In reality, several relatively inexpensive and effective measures have been suggested based on anecdotal and even experimental evidence. These include the use of corticosteroids, Vitamin D and hydroxychloroquine among others. Physicians on the front line have been urging FDA approval for these medicines to treat Covid-19 since the beginning of the pandemic. These medicines have been reliably effective in treating other conditions and have shown promising benefit with symptomatic Covid-19 patients. Despite the completion of preliminary studies in June, 2020 that demonstrated seriously ill COV patients had ample benefit from steroid administration, the CDC position against this treatment did not relent even a month later according to this article in the British Medical Journal.
As of today, the CDC recommended treatment guidelines continue to uphold the use of Remdesivir, an antiviral agent (that manufacturer Gilead charges $2,340 for a five day treatment) and bamlanivimab, casirivimab and imdevimab, monoclonal antibodies to the SARS-COV-2 spike protein (which medicare pays on average $340 per hour long infusion). Inexpensive, well known medicines like hydroxychloroquine and Vitamin D that have generous safety profiles when given judiciously remain conspicuously absent from their recommendations.
Could Ivermectin be the "miracle cure"?
Just this week, Pulmonary and Critical care specialist, Dr. Pierre Kory made this emphatic plea at the Senate Homeland Security and Governmental Affairs Committee on “Early Outpatient Treatment of Covid-19”. Dr. Kory is an academic physician and part of a larger group of critical care clinicians, the Frontline Covid Critical Care Alliance, that have been researching all treatment options since the onset of the pandemic. Recently they are attempting to bring awareness to the results of controlled studies involving the use of Ivermectin in the prevention and treatment of Covid-19.
If you have a dog or cat this medicine may be familiar to you. Ivermectin is a first line remedy for heartworm. It has also been widely and successfully used to treat various parasitic and roundworm infections in humans for nearly four decades. Discovered in 1975, it was first prescribed in 1981 and is on the W.H.O.’s list of essential drugs. This medicine has been instrumental in fighting infections from river blindness and filariasis to scabies and head lice.
Ivermectin paralyzes parasites by blocking nerve conduction in their cellular membranes leading to their death. Why then would it be useful in SARS-COV-2 infection (Covid-19)? It has been demonstrated, in both in vivo and in vitro studies, to be effective in arresting the replication of certain viruses by blocking nuclear transport of various viral proteins required for the manifestation of disease in Dengue, West Nile Virus (WNV), Venezuelan Equine Encephalitis Virus (VEEV) and Influenza. It has also been shown to stop the replication of SARS-COV-2 in this study from June of this year. Furthermore, Ivermectin has anti-inflammatory properties. The attenuation of an inflammatory response, especially in the late stages of the covid-19 disease process, is instrumental in improving outcomes as well. The possibility that this 40 year old heartworm medicine may have a role in treating Covid-19 is therefore not so far-fetched.
Despite the rigid and limited treatment guidelines offered by the CDC, physicians like Dr. Kory have been exploring all possible treatment options for months. As more study results get published it is becoming increasingly clear that this remarkable medicine may be more effective than any other in treating covid-19.
Their conclusions are based on numerous studies from around the world. They have made them all available on their website and provide an excellent summary of the studies to date here. Admittedly, few of the studies have been peer-reviewed. As Dr. Kory points out, the peer-review process takes months. Given the fact that we are moving forward with vaccines that are nearly two years from completion of Phase III trials, granting some latitude to these studies is not necessarily out of step with the breakneck pace we are on to find a treatment. In any case, Ivermectin studies have been completed, Covid vaccination studies haven’t.
What does the evidence suggest?
Ivermectin is being shown to be remarkably effective in treating patients with both mild and severe symptoms. For the purposes of this article I will explore what is perhaps the most intriguing aspect to this medicine’s application: prevention of the disease. This is particularly relevant as millions of healthcare providers and school aged children are getting ready to roll up their sleeves to receive an experimental vaccine.
Four different studies are summarized on their above referenced page, all of which demonstrate a statistically significant reduction in infection rates of healthy people. Of note, a recently published randomized controlled study of 217 patients in Argentina demonstrated a 0% infection rate of healthy patients taking prophylactic Ivermectin compared to an 11% rate of infection of those with no treatment. Healthy people with regular contact with a known COVID positive person also had a greater than eight fold reduction in contracting the disease compared to those who received no treatment in a different randomized controlled study with 304 subjects.
Perhaps even more interesting are the retrospective observations of large populations who received prophylactic Ivermectin compared to similar populations that didn’t. Here I am referring to a paper submitted by Alan Cannell, an engineer that has lived in Mozambique, who noticed that the Covid Rates in Mozambique and Ethiopia where Ivermectin is commonly used to combat the endemic parasitic infections were much lower than in South Africa where the drug is less frequently taken.
His interest piqued, he compiled Covid infection rates from three large towns in Brazil that instituted prophylactic Ivermectin to their population in mid July and compared the number of new cases in these towns in August to three other towns in Brazil of comparative size and geographical location that didn’t use the medicine during the same time period. When comparing each town’s August rates to their June and July rates, the towns that used Ivermectin fared 50 to 200% better. Of course this does not represent a controlled study, but we are looking at a combined population of over 3 million people with roughly the same demographics. His observations in East Africa seemed to play out in South America too.
Are the CDC and NIH biased?
Where does this leave us? Dr. Kory is making a direct and impassioned plea to the CDC and NIH to immediately form a taskforce to review and research the enormous amount of new information regarding this inexpensive, tried and true medicine that has been available around the world for decades. Despite all the convincing findings, these institutions have not changed their position from August 27 when they decreed that Ivermectin should not be used outside of a controlled trial. As a physician who has “cared for more dying Covid patients than anyone could imagine”, he finds the CDC’s seeming lack of interest in a safe and potentially game-changing regimen dumbfounding. This is in stark contrast to their resounding support given to a vaccine solution even though any meaningful study on their efficacy and safety cannot even begin for another 2 years. The implications here are hard to overlook.
I am a physician however I am not qualified to offer an authoritative opinion on the quality of the large amount of clinical data now available around this topic. Dr. Kory is. Nonetheless, he and all other medical professionals that directly care for Covid-19 patients ultimately must abide by the guidelines that are set forth by the CDC. His request to the CDC and NIH for an immediate assessment of the data and reevaluation of their position is more than reasonable. It is my personal opinion that any reluctance or refusal to do so should be considered negligent given these circumstances. I echo Dr. Kory’s plea and request that all my colleagues in clinical medicine consider the evidence and if so moved, join in this petition for an updated set of recommended treatment guidelines.
The Pandemic is NOT a Hoax
If you believe this group of clinicians is sincere, it is worthwhile to closely consider what Dr. Kory has to say about Covid-19 itself. “It is not the flu.” Here he is indicating his frustration with the continued comparisons with death rates between the flu and Covid-19 that demonstrate little difference in most age groups. That has not been his or his colleagues personal experience. Once a Covid patient arrives in the intensive care unit, he feels there is very little that can be done, especially using the treatment guidelines from the CDC. This is much different than a serious bout with influenza. Prevention and early treatment go a long way.
As we negotiate the widely divergent narratives about this complicated disease and sometimes perplexing response to it, it is very easy to succumb to polarization ourselves. Just because the death rate in the relatively young and healthy is very small doesn’t mean we should dismiss the disease as harmless. Just because little can be done to treat the critically ill does not mean we should look no further than a vaccine that is yet to be fully tested when other, safe and efficacious alternatives are available. Though there is controversy about the origins of this virus, it is most definitely not a “hoax”. Neither are the alternative treatment regimens we have to combat it. Dr. Kory notably is not suggesting that Ivermectin is a replacement for a vaccine. He believes it would serve in tandem with one.
Medical Therapies are often found in Nature
Ivermectin is itself a variation of a product of a species of bacteria called Streptomyces avermectinius. If you are familiar with pharmacology you will not find this surprising. Many of our most potent pharmaceuticals, especially antibiotics, were first found in nature serendipitously and later isolated, purified and synthesized. In that sense the “cure” often comes from the same source as the “disease”.
Indeed, the vaccines we have manufactured over the decades are often bits and pieces of the very same pathogens we seek to eradicate. Often they are grown in cell lines of other species. Now we are slowly turning away from nature and synthesizing the solution ourselves. The advent of the mRNA-based vaccine platform is perhaps the biggest step towards a “man-made” solution. Rather than presenting the “enemy” to our immune systems for future recognition, we are now programming our cellular machinery to synthesize a portion (the full length SARS-COV-2 spike protein) of the enemy itself, peptide by peptide.
We cannot know with any certainty which approach is better or safer at this moment. However, doubt doesn’t seem to exist in the institutions that are governing our response to this pandemic. They seem to be inexplicably offering us a synthetic solution to a natural problem at all costs.
Update: December 14, 2020. We have corrected the previously described mechanism of the mRNA vaccine. The mRNA codes for the spike protein (the antigen) and not an antibody to the spike protein.