FDA obstruction: Patients die, while Trump gets the blame

In a recent Washington Post op-ed, seven former FDA commissioners claimed that the agency has lost credibility with the public, and they blamed it on President Trump.

Jumping on the same bandwagon, an editorial in the once-venerable New England Journal of Medicine accused the president of “failing at every step” to stop the COVID-19 pandemic, thus enabling more than 220,000 deaths to date.

In reality, these charges are driven by craven politics and Big Pharma conflicts of interest. They divert attention from the FDA’s despicable efforts to block access to effective and inexpensive generic medications. Foremost among these is hydroxychloroquine.

Let’s take this in steps.

First, who is bringing these charges? The seven commissioners include David Kessler — adviser for the Biden campaign; Scott Gottlieb — board of directors of Pfizer and consultant to many pharmaceutical companies; Mark McClellan — board of directors of Johnson & Johnson; Robert Califf — extensive ties with many of the largest pharmaceutical companies; Andrew von Eschenbach — board of directors of the biotech company BioTime and director of Viamet Pharmaceuticals; and Jane Henney — who has served on the board of directors of AstraZeneca.

Many of these companies manufacture patented COVID-19 vaccines and medications. These products are in direct competition with generic, low-cost drugs that FDA has been asked to approve for outpatient COVID-19 use, but that it has refused.

Not to be outdone, the New England Journal of Medicine editorial was led by Deputy Editor Lindsey Baden, who disclosed that he is involved in COVID-19 vaccine clinical trial work conducted in collaboration with the National Institutes of Health, COVID-19 Vaccine Prevention Network, and Crucell/Janssen, Moderna, the Gates Foundation, and the Ragon Institute.

Baden is also chair of the Antimicrobial Drug Advisory Committee of the FDA. Not only is Baden, because of his role with the FDA, motivated to deflect blame from the agency, but he appears to be incentivized financially to tilt the COVID-19 response away from inexpensive generic medications and toward patented and massively profitable vaccines.

The reality is that the FDA has undermined its own credibility, and it has done so brazenly in plain sight. No president was needed for that, as I’ll explain.

As background, one must understand that COVID-19 patients are typically hospitalized because they have developed a severe and life-threatening pneumonia, one that fills the lungs with inflammatory debris and causes abnormal blood clotting in the lungs and small blood vessels. This advanced and dangerous condition, often described as acute respiratory distress syndrome, or ARDS, is entirely different from early “outpatient” (that is, outside the hospital) manifestations of COVID-19, which typically consist of a self-limiting, flu-like illness. We are thus speaking of two very different groups of patients. This distinction between COVID-19 outpatient and inpatient, of course, is well known to the FDA.

And yet, on July 1, the FDA posted on its website a large, black-letter warning against using hydroxychloroquine, or HCQ, to treat outpatients: “FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting.” The FDA justified this warning — stated on the website, just beneath the warning itself — by referring to safety concerns among hospitalized patients.

The FDA does not mention the crucial distinction between evidence for outpatients and inpatients. It does not mention the large body of evidence that HCQ is safe when used in COVID-19 outpatients. It does not mention that HCQ is currently being used safely by millions of outpatients with lupus and other rheumatological conditions. Nor does the FDA mention that HCQ has been safely used worldwide by hundreds of millions of persons, equaling tens of billions of doses, over more than half a century.

And finally, the FDA does not mention that it has no data showing adverse events in outpatient use. In short, among relatively healthy outpatients, HCQ has amassed one of the deepest and most extensive safety records of any drug in history, and the FDA’s warning implication of general harm is an outright lie….


Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.