Donald C. Pompan, MD Michael M. Jacobs, MD, MPH
Dr. Jha testified that his opinions are derived from his review of the scientific literature, stating that none of the ostensibly “high-quality, randomized control trial studies” concluded that HCQ is effective in treating COVID-19 illness. He stated that observational studies were not of sufficient quality to conclude that HCQ is effective. He pointed out that his opinions are in line with the consensus of experts in academia, and are also in accordance with the opinions of the CDC, NIH, and FDA.
Unlike Dr. McCullough, Dr. Jha never discussed the science of COVID-19 illness. In fact, he did not dispute Dr. McCullough’s description of the different stages of the illness, and the rationale for early treatment. Oseltamivir/Tamiflu, by example, interferes with viral replication, disrupting progression of influenza illness. Accordingly, as Dr. McCullough explains, if treatment can interfere with viral replication early in the course of COVID-19 illness, we can confidently prevent progression to higher-morbidity stages of the disease. Again, Dr. Jha did not challenge Dr. McCullough on the science, pathophysiologic, and pharmacologic basis of early treatment for all three facets of the disease: viral replication, cytokine storm, and thrombosis.
Dr. Jha and other recognized national “experts” such as Dr. Fauci, do not offer any recommendations regarding early outpatient treatment of COVID-19 illness, which was the subject of the meeting. Dr Jha’s intention was to deny the overwhelming evidence supporting early treatment with HCQ and ivermectin (IVM)-based protocols. Indeed, outpatient treatment extends far beyond the use of only HCQ. Dr. Jha did not address other aspects of Dr. McCullough’s outpatient treatment protocol targeting the progression of COVID-19 illness to cytokine storm and microthrombosis.
There is an obvious flaw with Dr. Jha’s argument against HCQ and IVM: none of the randomized, control trials that he cited involved early treatment, within 5 to 7 days, of high-risk patients with the full HCQ or IVM cocktail. A cocktail, not just HCQ and/or IVM, is used by doctors around the world to interfere with viral replication in order to prevent progression to cytokine storm and microthrombosis. Dr. Jha, however, never addressed the science of the virus and well-described aspects of COVID-19 pathophysiology.
Dr. Jha, moreover, did not cite a single study disproving the approach of early treatment of high-risk patients. Dr. Jha’s statement that “all the experts are in agreement” is not remotely sufficient medical science polemics. Clinical conclusions and recommendations are based on rigorous data analysis and not merely consensus opinion.
Dr. McCullough has over 600 peer-reviewed publications, including two dozen on COVID-19 disease. He has chaired many high-risk data safety monitoring boards and knows all the inner workings of large-scale clinical trials. Dr. Risch’s expertise is in analyzing data from the literature, and his renowned scholarship has resulted in over 300 peer-reviewed articles. As Dr. Risch emphasizes, all the studies involving early treatment of high-risk patients with HCQ have shown positive outcomes in reducing hospitalization and death.
In the Recovery study cited by Dr. Jha, patients received HCQ when they were hospitalized with evolving or florid cytokine storm; the majority were on supplemental oxygen. Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19 | NEJM
The authors of another widely cited randomized control trial from Brazil on hospitalized patients (Cavalcanti et. al) concluded that if HCQ were given earlier, the results could have been different. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 (nejm.org)
Timing of pharmacological intervention is paramount when the goal is disruption of viral replication; it is all about the science, which Dr. Jha did not address in his testimony.