The emergence of Omicron in the United States and the announcement of the first reported death in the United Kingdom reminds us of how little we understand about the new coronavirus, and with less effective vaccines against the new variant, how much we have need additional resources to combat it. To expand our knowledge about COVID-19 and identify the best ways to treat and prevent it, physicians should be able to use all the safe means available to them to help patients. Unfortunately, this is not possible in our current political climate.
Since the summer of 2020, US public health agencies have continuously shut down the use or even discussion of unprofitable generic treatments. The National Institutes of Health (NIH) funded 20 large pharmaceutical industry patented drug research studies before only recently (and slowly) agreed to study reused generic drugs.
The Food and Drug Administration and the Centers for Disease Control have not recommended any recommendations. Instead, the Biden administration threw its political clout almost solely behind mass vaccinations, and hospitals and pharmacies dogmatically followed suit. But this approach is not enough to stop COVID-19.
Reused Generic Drugs 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 caused much less clinical deterioration in treated patients. Another larger, double-blind RCT, published in The Lancet in October this year, found that fluvoxamine reduced COVID-19-related death rates by up to 91% and hospitalizations by two-thirds. This is an FDA approved drug. Dosed correctly and for such short periods of time, 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 the benefits of antidepressants 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) have come up with a recommendation for the routine use of these drugs to treat COVID-19.
The NIH to date has ignored the study. His last update on fluvoxamine was in April, over seven months ago. More troubling is the fact that the IDSA recently reviewed this high-quality trial, while staying true to its recommendation “not to use outside of a clinical trial”. Why do reused drugs require multiple trials before an agency’s recommendation, while new, high-profit, patented drugs are routinely approved after just one trial?
A recent and more cheeky example is Merck’s expensive new COVID-19 antiviral drug, molnupiravir. The FDA quickly approved it based on a single study of modest benefit in mildly ill outpatients, and the Biden administration quickly agreed to pay $ 700 per treatment. This was all despite the fact that the drug costs around $ 20 per course to manufacture, according to a consultant to the World Health Organization, and may prove to be less effective or even harmful in practice.
With our national debt standing at $ 2.77 trillion and skyrocketing inflation, strengthening our federal government’s capacity to study inexpensive generic drugs would be a smart economic move. But it seems there is no appetite for fiscal prudence or scientific research beyond the expensive and newly created solutions by our country’s pharmaceutical industry.
Hospital bans proven treatment
Doctors who don’t respect the line are subject to censorship and threatened with losing their livelihood, regardless of their clinical experience. My colleague Dr Paul Marik, a medical scientist practicing in Norfolk, Virginia, is one of them. He has treated patients throughout the COVID epidemic and was one of the early advocates of the use of steroids to treat COVID patients – a practice initially discouraged by federal health officials who turned since proven effective.
When evidence first emerged about fluvoxamine, we began to study the drug and share clinical data with doctors from the Frontline COVID-19 Critical Care Alliance (FLCCC), a group of doctors for the purpose non-profit that we run together. We added it to our FLCCC protocol seven months ago. Marik began treating his patients with the drug in addition to steroids and a number of reused generic drugs, which helped halve the number of deaths in his hospital.
This progress is now at risk: Marik’s employer Sentara Norfolk General Hospital has banned the use of fluvoxamine along with several other generic drugs approved by the FDA to treat COVID-19 – and death rates are already increasing.
What is the hospital’s rationale for denying patients treatment that has proven to be effective in clinical trials? It sounds a lot like the NIH website and sounds just as hollow: “A lot [of these medicines] have not published peer reviewed, RCT [randomized controlled trial] available to assess both the efficacy and safety of COVID-19. “
Over the past two years, our political and public health authorities have spoken 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 variants of COVID-19 after Omicron and other infectious disease outbreaks in the future. We can prepare by strengthening our government’s ability to study cost-effective treatments quickly and efficiently, and by empowering physicians to pursue all possible treatments that can help patients.
Pierre Kory, MD, is President and Chief Medical Officer of the Front-Line COVID-19 Critical Care Alliance.