A trio of influential medical professional associations issued a press release to express their strong opposition to the “ordering, prescribing, or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial.” TrialSite suggests the medical establishment, including the FDA, CDC, and growing numbers of medical societies, are now circling the wagons on the independent physicians who have followed and interpreted positive research results predominantly in low-to-middle-income countries (LMICs). On the record, the American Medical Association (AMA), American Pharmacists Association (APhA), and American Society of Health-System Pharmacists represent the next attack on what could be the forthcoming surrender of the use of ivermectin as a tool in the war against COVID-19. TrialSite suspects movements are in the works to 1) punish physicians or pharmacists that dispense and prescribe the drug for the COVID-19 off-label indication and, if that doesn’t work, 2) potentially criminalize the use of the drug off label for use against COVID-19.
TrialSite offers a breakdown of the logic behind this recent strong declaration.
What spooks these preeminent physician and pharmacist associations?
A 24-ild increase since the pandemic commenced, increasing exponentially over the past few months.
What are the associations calling for?
The immediate end to all prescribing, dispensing, and use of ivermectin for the prevention of COVID-19 outside of a clinical trial. They also call for all “trusted health care professionals in their communities” to become proactive about warning patients not to use ivermectin outside of FDA-approved indications and guidance.
What dangers do they share?
First, AMA and the others established that the animal varieties of ivermectin “are highly concentrated for large animals” and thus “pose a significant toxicity risk for humans.”
What authority do they cite?
The medical associations refer to advisories indicating that ivermectin isn’t authorized or approved for the treatment of COVID-19 outside of clinical trials. They share that both the U.S. Centers for Disease Control and Prevention (CDC) and the FDA have cautioned, especially emphasizing the animal version and the risks posted in self-medication.
The group also sites Merck as an authority here, noting they are a “manufacturer of the drug” and indicate the lack of evidence to support the use of the drug to treat COVID-19. Of course, they don’t mention Merck’s material interests in clearing ivermectin use around the world. They have been given $356 million in taxpayer money to develop what could be considered in part at least a competitive product targeting COVID-19. Merck has also been guaranteed a $1.2 billion purchase from the Biden Administration, should their Molnupiravir gain emergency use or formal approval.
Edenbridge Pharmaceuticals is also a major producer they do not reference.
Finally, the AMA and others cite that the Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19 recommend against using ivermectin outside of a clinical trial.
What data do these prominent associations use to back their strong declarations?
Very little. They do refer to “Calls to poison control centers” that have increased “five-fold” from their pre-pandemic baseline. But how many are there? 50 calls is a lot different than 500,000.
What do they want patients to do?
Use the FDA’s Consumer update explaining why one should not use ivermectin to treat or prevent COVID-19 as well as the CDC Health Alert Network Advisory on the Rapid Increase in Ivermectin Prescriptions and Reports of Severe Illness Associated with Products Containing Ivermectin to Treat COVID-19. While this report provides some anecdotal data, it lacks any total numbers and speaks in generalities that calls to poison centers have increased five-fold. But it would appear there hasn’t been any formal study on the matter, at least not yet.
What does the AMA, APhA, and ASHP declare is the more effective way to limit the spread of COVID-19?
Vaccination followed by wearing face masks, social distancing in public spaces—avoidance of large crowds—and frequent hand washing. In their press release, they also “strongly urge eligible unvaccinated individuals to get vaccinated.”
Want to read an objective fact check for ivermectin?
See the TrialSite fact check for more information
Why are doctors prescribing ivermectin off-label?
Because doctors have followed many of the ivermectin studies worldwide, including a handful of meta-analyses, pointing to positive data points in targeting COVID-19. TrialSite has reported on this topic for a long time. See a listing of the studies and the TrialSite fact check.
Why don’t the preeminent associations agree with these studies?
They believe they are not of sufficient quality and hence discount dozens of them.
Will this ever-tightening pressure and possibly eventual band increase pharmaceutical and vaccine sales?
Absolutely. Many are using ivermectin (human version) as a prophylaxis as a handful of studies show some positive data. The medical establishment doesn’t believe it works at all and wants it banned.
What lies ahead?
TrialSite suspects the Biden Administration considers physicians prescribing ivermectin and the patients consuming it as a hindrance to universal vaccination. Of course, any illicit use, such as self-medication with the animal variety, is wrong and should be stopped. While prescribing off-label ivermectin for COVID-19 is legal now between a licensed physician, for example, and their consenting patient, don’t be surprised if some significant moves are made first to pressure pharmacies and doctors to shun the drug. If that fails, conditions may intensify, including executive actions under the PREP Act or other federal edict to essentially criminalize the use off-label—yes, criminalize even the use of the human variety directed by a licensed doctor and their consenting patient. Note this is what happened in South Africa until a push back by civil society groups and a lawsuit led to the acceptance of the drug off-label.
Starting this week, powerful medical associations will put a progressively tighter squeeze on any independent-minded physicians that deviate from the party line.