- - Thursday, November 11, 2021

Those of us working for the last two years to defeat the Covid-19 pandemic and get the world back on track have witnessed only portions of the actors at play, the proverbial elephant’s legs or trunk.  

An important aspect of the pandemic response has been internal governmental functions, not well known outside the individuals involved.  

Peter Navarro, President Trump’s Director of Trade and Manufacturing Policy and Policy Coordinator of the National Defense Production Act, was the administration’s response catalyst and his diary-based memoir of the last 18 months, “In Trump Time,” reveals the degree to which much of what former President Donald J. Trump, guided by Mr. Navarro, tried to accomplish was subverted both by political opponents and by certain Trump appointees.  It confirms why various obvious methods to understand and control the pandemic never became operationalized.

One of these methods was the Strategic National Stockpile distribution of 60 million doses of hydroxychloroquine (HCQ) for early Covid treatment.  Mr. Navarro ends his chapter on HCQ with a quote from Victor Davis Hanson that HCQ lost support because Donald Trump endorsed it.  The partisan loathing was easy to see at that time. Still, it is not why Anthony Fauci, head of the NIAID of NIH and nominal Covid “czar,” described HCQ as having no benefit, risky, and supported only by “anecdotal evidence.” It is not why forces were already afoot in October 2019 to undermine HCQ use in early Covid treatment.

In that month, the French Minister of Health, Agnès Buzyn, reclassified HCQ from over-the-counter to prescription only. She had no evidence to do this.  She claimed that chloroquine was “genotoxic,” and since HCQ is similar in structure to chloroquine, it should be limited.  This was despite 65 years of safe use of HCQ by hundreds of millions of people in tens of billions of doses worldwide, in children, pregnant women, infants, and frail elderly.  The reclassification appears to have been made public on January 13, 2020, but had occurred before there was much public knowledge of the likelihood of a pandemic happening.

Then on February 13, 2020, the New England Journal of Medicine published an outrageous article entitled “The Magic of Randomization versus the Myth of Real-World Evidence,” authored by four people whose primary work involves pharma-funded drug trials.  This article ignored all the ways that it is easy to subvert randomized trials, asserted that randomization automatically solves all trials problems, and was in effect an entire screed against my discipline of epidemiology.  

Without going into all the technical details, the most problematic feature of this essay is that for randomization to work reliably, the groups of patients in the trials need to be large enough to have hundreds of outcome events in each group.  You may have noticed that even the Covid vaccine trials have not been large enough to do this.  With smaller trials, there is no guarantee that the groups are balanced under randomization.  And in fact, we know from a major 2014 analysis by Andrew Anglemyer and colleagues for the Cochrane Commission, involving some ten thousand study comparisons, that nonrandomized controlled trials produce on average almost identical answers as randomized ones.

The question is why the “Magic” paper was published in February 2020, before Mr. Trump had said anything.  In my opinion, the threat of HCQ benefit for early Covid treatment was already understood, and it is well known that generic drugs do not have sufficient financial backing for mounting the expensive randomized trials that the FDA still demands despite stipulation otherwise in the 21st Century Cures Act passed by Congress in 2016.  

This paper set the stage for Dr. Fauci to claim that only randomized studies are valid and thus block HCQ use while patent medications and vaccines were being developed and tested.  We know from the ten controlled trials of outpatient HCQ use across the world, involving more than 40,000 patients, that early HCQ cuts mortality by at least 75%, thus that Dr. Fauci’s evidence denialism abetted the needless deaths of more than half a million Americans.

The co-actors in these events, Rick Bright and Janet Woodcock, are well described by Navarro and fleshed out in a published essay by Dr. Steven Hatfill, who was medical advisor to Mr. Navarro.  Dr. Hatfill describes: “On March 23, Rick Bright, Ph.D., Health and Human Services (HHS) Deputy Assistant Secretary for Preparedness and Director of the Biomedical Advanced Research and Development Authority (BARDA) received notice that HHS Secretary Alex Azar directed him to establish an Expanded Access Investigational New Drug (IND) authorization for HCQ through BARDA. This would have legitimized use of the drug stored in the Strategic National Stockpile for treatment of COVID-19 outside a hospital setting. On March 24, Janet Woodcock, M.D., then-FDA Director of the Center for Drug Evaluation and Research and now FDA acting commissioner, quickly reached out to Rick Bright. In place of obtaining an IND as directed by his superiors, she advised Bright to submit an application for an Emergency Use Authorization (EUA) for hydroxychloroquine instead.”

This EUA, which was approved quickly after midnight, restricted HCQ use to hospital patients only and thus explicitly blocked HCQ from use in outpatients, the very patients in whom HCQ works the best.

Mr. Navarro lays out all of these nefarious deeds and many others. “In Trump Time” is fascinating and chilling reading as to how villainous personalities indifferent to the massive pandemic death toll obstructed numerous actions that could have dramatically reduced the human and economic damage that has occurred in our country.

• Harvey A. Risch, MD, Ph.D., is a Professor of Epidemiology at Yale School of Public Health.

• • •

In Trump Time: A Journal of America’s Plague Year
By Peter Navarro
All Seasons Press, October 2021, 326 pages, $28

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