Dr. McCullough presents a rebuttal to Dr. Jha's statement advocating for randomized trials for COVID-19 treatments, arguing that observational studies shown to have significant reductions in hospitalization and death rates demonstrate valid efficacy. A new analysis indicates randomized trials may yield lower effect size estimates, supporting the value of clinical judgment and observational data in pandemics instead of waiting years for trial results.
Randomized Trials Found Only Modest Reduction in Effect Size Compared to Non-Randomized Studies New Analyses Suggests the Early COVID-19 Treatment Benefits Were Valid Thu, 03 Oct 2024 09:26:28 GMT https://petermcculloughmd.substack.com/p/randomized-trials-found-only-modest By Peter A. McCullough, MD, MPH
I was rebutted in the US Senate on November 19, 2020, by Dr. Ashish Jha who was at the Brown School of Public Health at the time and later became the White House Coronavirus Coordinator. In response to my presentation of the McCullough Protocol for the early treatment of high-risk patients with acute COVID-19, he told America that his patients and doctors would only accept results from large, prospective randomized trials. By the way, the only COVID-19 products with such trials were mRNA vaccines.
Now a new analysis from Salcher-Konrad et al has found for drug therapies, that randomized trials yield a slightly more conservative estimate of effect size, specifically 19% lower. That means for observational, comparative studies with large effect sizes done in the field, the results are likely to be valid. For example, through 2020 Procter et al reported their results with early multidrug therapy for acute COVID-19: 87.6% and 74.9% reductions in hospitalization and death, respectively. That means at worst, the real effects were 70.9% and 60.7%—huge public health benefits were thrown aside by the soon-to-be vaccine promoter Jha.
If we have learned anything through the pandemic, we cannot wait for large randomized trials that will take years to complete and likely just confirm what doctors are observing in the field. Clinical judgment, empiricism, and observational data have crucial roles to play in future pandemics.
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Peter A. McCullough, MD, MPH
President, McCullough Foundation
Salcher-Konrad M, Nguyen M, Savovic J, Higgins JPT, Naci H. Treatment Effects in Randomized and Nonrandomized Studies of Pharmacological Interventions: A Meta-Analysis. JAMA Netw Open. 2024 Sep 3;7(9):e2436230. doi: 10.1001/jamanetworkopen.2024.36230. PMID: 39331390.
Procter, MD, B. C., APRN, FNP-C, C. R. M., PA-C, MPAS, V. P., PA-C, MPAS, E. S., PA-C, MPAS, C. H., & McCullough, MD, MPH, P. A. (2021). Early Ambulatory Multidrug Therapy Reduces Hospitalization and Death in High-Risk Patients with SARS-CoV-2 (COVID-19). International Journal of Innovative Research in Medical Science, 6(03), 219–221. https://doi.org/10.23958/ijirms/vol06-i03/1100