The FDA’s mass murder of more than half a million Americans

OPINION:

The Democrat-controlled House Select Subcommittee on the Coronavirus Crisis has accused us of constantly pressuring then-FDA Commissioner Stephen Hahn and his agency to make the antiviral drug hydroxychloroquine (HCQ) available to outpatients in early treatment use.  We, in turn, accuse Mr. Hahn, his successor Janet Woodcock, Anthony Fauci, and the broader FDA bureaucracy, of the mass murder of more than half of million Americans who needlessly perished from the effects of COVID-19 because they were denied early access to HCQ.

During the early stages of the pandemic in the Spring of 2020 when the battle over HCQ was being fought – Mr. Hahn graphically describes it as a “knife fight” with the White House – Mr. Hahn and his FDA minions never realized or acknowledged that COVID-19 has two-stages. 

Stage One is typified by an initial four- to seven-day early phase of upper respiratory tract infection.  At this early stage, COVID-19 is normally self-limiting (although unpleasant) in healthy adults less than 50 years old.  It is also poorly transmitted in children with no co-morbidities. Infected children do not readily pass COVID-19 to adults, or each other.

In the 50- and-over population with co-morbidities, however, approximately 15% of cases progress into a more severe late phase of the disease within 7-8 days from symptom onset. Stage Two is typified by shortness of breath, falling oxygen saturation levels, heart damage, and later septic shock (cytokine storm) requiring ventilation support, and possible death.  

What the preliminary science told us then – and why we engaged so vigorously with Mr. Hahn and the FDA on behalf of President Donald J. Trump – is that HCQ offers a very powerful and safe therapeutic effect during the early phase of the disease. In this Stage One, HCQ has the ability to dramatically curtail its viral replication and block the transition of patients into the potentially lethal late, second stage of the disease.

We now know that what we hypothesized based on preliminary data is true. In fact, the evidence that HCQ could have taken death off the table for over half a million Americans is now overwhelming.

Consider that as of August 2022, there have been 354 studies of HCQ as a treatment for COVID-19 involving 5,764 scientists and 482,120 patients in 51 countries. Meta-analysis across these studies demonstrates a resounding 57-81% improvement in mortality when given in early treatment and a 41% reduced hospitalization. 

To put this in “blood on the FDA’s hands” terms, this meta-analysis indicates that if physicians had been allowed to freely prescribe HCQ off-label to outpatients within the first seven days of their symptoms, anywhere from 570,000 to 810,000 Americans would still be alive today of the million Americans who lost their lives.  Here, we must be reminded that these lost souls were our parents or grandparents or friends or lovers or (very rarely) children who turned out to be nothing more than dust in the political and partisan winds fanned not just by the FDA but by the Faucites across the U.S. health bureaucracy and a “hydroxy hysteria” CNN and New York Times.   

Must this grim past continue to be a prologue?  Must the FDA continue to suppress HCQ’s use either because it continues to refuse to follow the science – or simply can’t afford to acknowledge that Donald Trump and his White House advisors were right all along to push for early treatment HCQ use?

Here, it may be useful to point out that the FDA has at least backtracked on the use of another “controversial” therapeutic in ivermectin and now allows physicians to prescribe it off-label for COVID-19.  Latest studies indicate a regular use of Ivermectin as prophylaxis for COVID-19 yields up to a 92% reduction in mortality in an observational study of 88,012 individuals in a strictly controlled population.  However, HCQ remains the Voldemort of America’s medicine cabinet – the COVID-19 therapeutic that must not be named.

Remember, here, too, that we were repeatedly and wrongly warned that HCQ was dangerous when in fact it had been used safely by both lupus and arthritis patients and as an anti-malarial treatment for decades, and it can be used by pregnant women and nursing mothers.  And this high safety factor has likewise been borne out by the growing mound of overwhelming evidence in support of HCQ. The FDA never once distinguished between early use and late use of HCQ in COVID-19 or acknowledged that it was the virus causing fatal cardiac events in late-phase COVID-19 patients, not HCQ.

Ironically, we’d like to end this piece by thanking the Select Committee’s Chair Rep. James Clyburn and his churlish band of partisan idiots for raising the HCQ debate like Lazurus back from the dead.  His witch hunt report has allowed us to remind America and the world – along with a bankrupt corporate media that refuses to cover HCQ fairly – that HCQ offers one of the most potent and affordable treatments for COVID-19 today.  If only the FDA would look at the actual data gathered from almost half a million patients, and allow its use.

• Peter Navarro served as the Defense Production Act Policy Coordinator in the Trump White House and is the author of Taking Back Trump’s America: What We Lost the White House and How We’ll Win It Back.  Dr. Steven Hatfill is a specialist physician and virologist with a military background and author of Three Seconds to Midnight.