BY: PIERRE KORY
Omicron emerging in the United States and news of the first reported death in the United Kingdom remind us how little we understand the novel coronavirus, and with vaccines less effective against the new variant, how much we are in need of additional ways to fight it. To broaden our knowledge of COVID-19 and identify the best ways to treat and prevent it, doctors should be able to use every possible safe means at their disposal to help patients. Unfortunately, that is impossible in our current political climate.
Since the summer of 2020, U.S. public health agencies have continually shut down the use or even discussion of generic treatments that are minimally profitable. The National Institutes of Health (NIH) funded 20 large research studies of patented pharmaceutical industry drugs before only recently (and slowly) agreeing to study repurposed generic medicines.
The Food and Drug Administration and the Centers for Disease Control have recommended next to none. Instead, the Biden administration has thrown its political weight almost solely behind mass vaccinations, and hospitals and pharmacies have dogmatically followed suit. But this approach is proving insufficient to arrest COVID-19.
Repurposed Generic Medicines That Help Fight COVID
Just look at the evidence on fluvoxamine, a widely used generic antidepressant. A randomized controlled trial (RCT) published in November 2020 showed that the drug led to far less clinical deterioration in treated patients. Another, larger, double-blind RCT, published in The Lancet in October of this year, found fluvoxamine reduced COVID-19 mortality rates by up to 91 percent and hospitalizations by two-thirds. This is an FDA-approved drug. Dosed correctly and for such short periods, it is safe. And it costs about a dollar a pill.
These findings have since been further reinforced by another study published by the Journal of the American Medical Association in November, which showed a strong “class effect” of benefits from anti-depressants very similar to fluvoxamine against COVID-19. Yet, despite the large double-blind, placebo-controlled trial, neither the NIH nor the Infectious Diseases Society of America (IDSA) has arrived at a recommendation for routine use of these drugs to treat COVID-19.
The NIH to date has ignored the study. Its last update on fluvoxamine dates back to April, more than seven months ago. More disturbing is the fact that the IDSA recently reviewed this high-quality trial, yet still held fast to its recommendation of “do not use outside of a clinical trial.” Why do repurposed drugs require numerous trials prior to an agency recommendation, while high-profit, novel, patented drugs get routinely approved after only a single trial?
A recent and most brazen example is Merck’s expensive new anti-viral COVID-19 drug, molnupiravir. The FDA rapidly approved it based on a single study of modest benefits in mildly ill outpatients, and the Biden administration swiftly agreed to pay $700 per course of treatment. That was all despite the fact the medicine costs about $20 per course to manufacture, according to a World Health Organization consultant, and may prove less effective or even harmful in practice.
With our national debt registering at $2.77 trillion and inflation rampant, building the capacity in our federal government to study cheap, generic medicines would be a smart economic move. But there appears to be no appetite for fiscal prudence or scientific inquiry beyond the expensive, newly minted solutions churned out by our nation’s pharmaceutical industry.
Hospital Bans Proven Treatment
Doctors who don’t toe the line are subjected to censorship and threatened with the loss of their livelihood, regardless of their clinical experience. My colleague Dr. Paul Marik, a scientist-physician practicing in Norfolk, Virginia, is among them. He has treated patients throughout the COVID outbreak and was an early advocate for the use of steroids to treat COVID patients — a practice initially discouraged by federal health officials that has since proven effective.
When evidence first emerged about fluvoxamine, we began studying the medicine and sharing clinical data with physicians in the Frontline COVID-19 Critical Care Alliance (FLCCC), a non-profit physician group we run together. We added it to our FLCCC protocol seven months ago. Marik began treating his patients with the medicine in addition to steroids and a number of repurposed generic medicines, which contributed to halving deaths in his hospital.
That progress is now in jeopardy: Marik’s employer, Sentara Norfolk General Hospital, has forbidden the use of fluvoxamine as well as several other FDA-approved generic drugs to treat COVID-19 — and mortality rates are already rising.
What is the hospital’s justification for denying patients a treatment that’s proving effective in clinical trials? It sounds a lot like the NIH’s website, and rings equally hollow: “Many [of these medicines] do not have published peer-reviewed, RCT [randomized controlled trial] available to assess both efficacy and safety in COVID-19.”
Over the last two years, our political and public health authorities have talked often of trusting science to guide an effective response to this terrible virus, but their actions have more often been dictated by tribalism and greed.
We will surely face new COVID-19 variants after Omicron, and other infectious disease outbreaks in the future. We can prepare by building the capacity in our government to study cost-effective treatments quickly and efficiently, and by empowering doctors to pursue every possible treatment that can help patients.
Leave a Reply