Remember Hydroxychloroquine or HCQ? The drug that the previous POTUS improperly touted; the drug that was rushed by the U.S. Food and Drug Administration (FDA) to Emergency Use Authorization (EUA) only to be later revoked by the agency once a growing consensus deemed the drug not effective and representing adverse event risks for at least certain populations? Remember, the FDA issued a caution against the drug last summer, reporting that there were reports of “serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries and liver problems and failure.” However, the drug has been used for malaria and those with lupus for a long time and continues to be used for those purposes. What’s happened to this drug in the context of COVID-19? Did the world stop using it for this new indication? What about HCQ clinical trials involving COVID-19? TrialSite reported back in November 2020 that a major African clinical trial called “ANTICOV” not only featured HCQ as its primary study drug but the announcement emphasized the importance of therapeutic prevention as vaccine coverage will take months or years in many parts of developing Sub-Saharan Africa. Moreover, a review of active HCQ trials involving COVID-19 in Clincaltrials.gov reveals that there are at least 131 clinical trials ongoing. TrialSite surveys reveal that the drug is widely used in Africa, the Middle East, Asia, and even parts of Eastern Europe and Turkey. Why are there still so many studies and actual real-world use of HCQ in relation to COVID-19, when here in the West, it seems banished as a topic associated with COVID-19? A prominent Yale Physician, public health epidemiologist and investigator shares his perspective with the TrialSite Community in a new paper under consideration for peer-review publication. While TrialSite doesn’t take any particular “sides” in the debate about HCQ, this platform most certainly exists as an unbiased and objective forum to introduce, discuss, and debate research.
According to a recent survey written by Dr. Risch, MD, PhD, every one of the now nine (9) studies of high-risk outpatient HCQ studies reveals a significant 2-fold or better risk reduction for hospitalization or mortality. Moreover, the Yale physician and researcher shows in his recent work that numerous systematic case-series studies reveal a solid treatment benefit versus mortality.
Suggesting that contrary to popular belief among elite academic medical centers of the West, the drug has already saved “many thousands of lives” and argues that the “natural experiment” investigations of population medication responses suggest material evidence of progressive interaction between HCQ use and mortality reduction.
Moreover, Dr. Risch’s research results reveal that the randomized controlled trials purported by detractors as offering definitive evidence of no benefit of HCQ use in outpatients are based overwhelmingly on low-risk subjects with nearly no hospitalization or mortality events. He suggests in his paper that these results are “uninformative and irrelevant for bearing upon these risks according to HCQ use in high-risk outpatients.”
But what about Safety?
According to Risch, the drug has been used safely for 65 years by hundreds of millions of individuals around the world, taking in the aggregate billions of doses by those with autoimmune disorder as well as other chronic diseases. Risch counters that this drug is actually one of the safer ones around.
Moreover, he counters, and perhaps challenges, the FDA to produce the data backing their claims, going on the record: “The FDA has no systematic evidence of fatal adverse events from HCQ prophylaxis or outpatient treatment use and has invalidly used evidence in hospitalized patients to create a false public warning by extrapolating to outpatient use.”
Without forming judgement one way or the other, TrialSite suggests a review of Dr. Risch’s report—he is an expert in the field of public health epidemiology. Also, readers should review studies countering its efficacy and assess the logic and underlying assumptions in Dr. Risch’s argument. Regardless, an unbiased, censor-free discussion is merited during these crisis times. The entire manuscript can be reviewed here.
Harvey A. Risch, MD, PhD, Professor of Epidemiology, Yale School of Public Health
Profile: Harvey Risch is Professor of Epidemiology in the Department of Epidemiology and Public Health at the Yale School of Public Health and Yale School of Medicine. Dr. Risch received his MD degree from the University of California San Diego and PhD from the University of Chicago. After serving as a postdoctoral fellow in epidemiology at the University of Washington, Dr. Risch was a faculty member in epidemiology and biostatistics at the University of Toronto before coming to Yale. Dr. Risch’s research interests are in the areas of cancer etiology, prevention and early diagnosis, and in epidemiologic methods. He is especially interested in the effects of reproductive factors, diet, genetic predisposition, histopathologic factors, occupational/environmental/medication exposures, infection and immune functioning in cancer etiology. His major research projects have included studies of ovarian cancer, pancreas cancer, lung cancer, bladder cancer, esophageal and stomach cancer, and of cancers related to usage of oral contraceptives and noncontraceptive estrogens. Dr. Risch is Associate Editor of the Journal of the National Cancer Institute, Editor of the International Journal of Cancer, and was for six years a Member of the Board of Editors, the American Journal of Epidemiology. Dr. Risch is an author of more than 330 original peer-reviewed research publications in the medical literature and those research papers have been cited by other scientific publications more than 40,000 times. Dr. Risch has an h-index of 93 and is a Member of the Connecticut Academy of Sciences and Engineering.
Call to Action: Find the link to the manuscript here.