(WGHP) — An organization that champions the use of ivermectin as a treatment for COVID-19 has updated its treatment plan to include medications commonly used by transgender women. Much like ivermectin, the medical community has not supported using any of these medications for COVID-19.
Where is this coming from?
Fox News’s Maria Bartiromo interviewed Dr. Pierre Kory, president of the “Frontline COVID-19 Critical Care Alliance,” on Sunday. During the interview, he touted his organization’s guidelines and protocols for the treatment of COVID-19, primarily focusing on the use of ivermectin.
Kory has been a vocal advocate for the antiparasitic medication ivermectin, calling it a “wonder drug” during his testimony before the U.S. Senate in December 2020.
The U.S. Food and Drug Administration and the National Institutes of Health, however, have countered those claims and said that the drug is not approved for the prevention or treatment of COVID-19. The FDA posted a full article explaining “why you should not use ivermectin to treat or prevent COVID-19.”
Kory and others had an article of theirs retracted from the Journal of Intensive Care Medicine in November 2021 after a hospital noted miscalculations in a study of “MATH+” therapies, which includes “dual anti-androgen therapy” as a first-line treatment.
In the complaint, Sentara Norfolk General Hospital in Virginia said that, while the study reported patients receiving the “MATH+” therapies saw a mortality rate of 6.1% at the hospital, the actual mortality rate was much higher.
According to the complaint:
Of 191 patients, only 73 patients (38.2%) received at least 1 of the 4 MATH+ therapies, and their mortality rate was 24.7%. Only 25 of 191 patients (13.1%) received all 4 MATH+ therapies, and their mortality rate was 28%.’
What is “anti-androgen therapy”?
In the FLCCC’s protocols, the organization recommends what they refer to as “second-line agents” in the event of “poor response to therapies above” or “significant comorbidities.” These protocols specifically promote “anti-androgen therapy” for preventative treatment of COVID-19.
The NIH’s National Cancer Institute defines anti-androgen therapy as “treatment with drugs to block the action of androgens (male hormones) in the body. Androgens, such as testosterone, bind to proteins called androgen receptors, which are found in prostate cancer cells and in cells of some other tissues. Antiandrogen therapy keeps androgens from binding to these receptors and may keep cancer cells from growing. It is used to treat prostate cancer.”
The FLCCC alleges that “androgens exacerbate COVID-19 and that anti-androgen therapy improves clinical outcomes. The anti-androgens dutasteride, proxalutamide and spironolactone have been demonstrated to reduce time to viral clearance, improved time to recovery and reduced hospitalization as well as reduced mortality in both men and women.” The FDA and NIH do not support these claims.
The guidelines recommend 10-day cycles of three drugs, specifically:
- Dutasteride OR Finasteride
It also recommends a nonsteroidal-antiandrogen called proxalutamide, which has only been approved for use in Paraguay and is still in trial stages in the United States for use in the treatment of metastatic prostate cancer.
When asked, representatives from Cone Health could not find anyone on staff who had heard of this as a treatment for COVID-19.
What are these drugs usually for?
The Mayo Clinic describes Spironolactone as “used to diagnose and treat hyperaldosteronism, a condition in which the adrenal gland produces too much hormone called aldosterone. … This medicine may also be used to treat fluid retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome.”
Dutasteride is “used alone or in combination with tamsulosin to treat men who have symptoms of an enlarged prostate gland. … Dutasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate to grow.”
Finasteride is “used to treat men with benign prostatic hyperplasia (BPH) and male pattern hair loss, also called androgenetic alopecia. … Finasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate to grow or hair loss in males.”
It should be noted that pregnant women should not even touch Dutasteride or Finasteride due to the risk of birth defects.
Two of these drugs are commonly used, in addition to the above-described functions, as treatments for people going through the process of medically transitioning.
Spironolactone is a drug used in “feminizing hormone therapy” by transgender women, according to the Mayo Clinic.
“Typically, you’ll begin feminizing hormone therapy by taking the diuretic spironolactone at doses of 100 to 200 milligrams daily. This blocks male sex hormone (androgen) receptors and can suppress testosterone production,” the Mayo Clinic explains.
Finasteride is also used during feminizing hormone therapy, often to treat or prevent hair loss.
Are these drugs approved to treat COVID-19?
No. The FDA has only granted full authorization to one drug for the treatment of COVID-19: remdesivir. Nor has the agency granted an Emergency Use Authorization for any of these treatments.
According to experts from Novant Health, “Dual anti-androgen therapy is not currently endorsed by any national guidelines for the treatment of COVID-19 including the National Institutes of Health (NIH) or Infectious Diseases Society of America (IDSA).”
There have been no clinical studies that found Spironolactone, Dutasteride or Finasteride to be effective in combatting COVID-19 infection. While researchers have suggested that spironolactone may be able to alleviate certain COVID-19 symptoms, no clinical trials have released results to prove those theories.
“Alternative treatments that are not endorsed by national guidelines do not have clear clinical benefit and increase the risk of side effects of the medications that may be harmful to some patients,” a statement from Novant Health read.
“Vaccination offers the best protection against COVID-19,” the North Carolina Department of Health and Human Services said in a statement. “Treatments used for COVID-19 should be prescribed by your health care provider. People have been seriously harmed or even died after taking products not approved for treatment of COVID-19, including products approved or prescribed for other uses.”