Fact Checking the Fact Checkers: The Case of Ivermectin for Publicly-Subsidized Research

Fact Checking the Fact Checkers The Case of Ivermectin for Publicly-Subsidized Research

On December 11, TrialSite reported on a US Senate hearing at which, among other things, there was testimony urgently calling for more research and an EUA for ivermectin as both a prophylactic against and an early treatment for COVID-19. As we recently covered, there is mounting evidence in support of these uses, and definitely for government-sponsored research, for this cheap and safe drug. One media account we did not address was a December 10 “fact check” by the Associated Press (AP) in collaboration with Facebook titled, “No evidence ivermectin is a miracle drug against COVID-19.” In this piece, the AP relies on old protocols and also ignores newer evidence, showing an excessive deference to official edicts over honestly looking at the medical evidence. The AP author doesn’t do her homework as is elaborated on below. Based on accumulating data and growing evidence, the case for publicly-funded investigation into ivermectin is compelling. Does AP represent a particular agenda in that particular piece? Does power, politics, and money influence which research gets funded in the midst of the pandemic?

Errors in Argumentation

The AP, via author Beatrice Dupuy, indulges in both a straw-man argument and bait-and-switch tactic in its key finding; the former by asking whether ivermectin is “miraculous” (while a doctor may have used such language, common sense dictates that an inquiry more relevant to the public health would be whether ivermectin is “effective”), and the later by offering an “Assessment” that answers a different question than the one in the “Claim.” Quoting AP, “CLAIM: The antiparasitic drug ivermectin ‘has a miraculous effectiveness that obliterates’ the transmission of COVID-19 and will prevent people from getting sick—-AP’S ASSESSMENT: False. There’s no evidence ivermectin has been proven a safe or effective treatment against COVID-19.” The claim is about ivermectin as a prophylactic to prevent getting COVID-19 illness, but the assessment’s language states that it is not an effective “treatment against COVID-19.” Since prophylactic prevention is for the well, and treatment is for the sick, confusing these medical uses appears to be sloppy journalism or worse. 

Errors in Fact

AP relies heavily on the fact that the FDA and NIH, “have said that [ivermectin] is not approved for the prevention or treatment of COVID-19.” It is key to remember that official guidelines are often updated as evidence comes to light, and to rely on authority without looking at the evidence is yet another fallacy when searching for the truth. The most up-to-date (as of December 7) summary of the evidence regarding ivermectin is the FLCCC Alliance’s, “A Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19.” Much of the chronicling of the accumulation of evidence to date was accomplished by TrialSite. FLCCC member Dr. Pierre Kory pointed out that a good amount of reporting worldwide for this breakthrough story was in fact led by the TrialSite, an online media and information exchange platform committed to clinical trial accessibility and transparency. After all, this is necessary to nurture and build trust in research, critical in the aim to advance overall biomedical research. 

Dr. Kory’s review includes 90 sources to various studies and evidence, and lists what could be the “top 11” data points to use (and continue to collect data on) ivermectin and footnoted in the Review:

  • From 2012 on in-vitro studies have showed viral replication inhibition from ivermectin.
  • Ivermectin inhibits SARS-CoV-2 replication in-vitro and thereby removes all virus within 48 hours (University of Monash)
  • Ivermectin is anti-inflammatory with strong data showing an inhibition of both cytokine production and a key inflammation mediator. 
  • Ivermectin substantially shrinks viral load and prevents organ damage in animal models using SARS-CoV-2 or other coronaviruses. 
  • Ivermectin as a prophylactic stops viral transmission and development of COVID-19 illness in exposed persons. 
  • Ivermectin both quickens recovery and stops deterioration in people with mild or moderate COVID-19. 
  • The drug, “hastens recovery and avoidance of ICU admission and death in hospitalized patients.”
  • Mortality in critically ill patients is reduced with ivermectin. 
  • Regions with widespread use show major reductions in fatality rates 
  • Safety, availability, and cost are unparalleled with minimal drug interactions or side effects seen over almost four decades and billions of doses of use.
  • WHO’s List of Essential Medicines has included ivermectin for many years. 

Also cited by the FLCCC Alliance, the International Journal of AntiMicrobial Agents recently published an analysis of, “data using the prophylactic chemotherapy databank administered by the WHO along with case counts obtained by Worldometers, a public data aggregation site used by among others, the Johns Hopkins University.” They compared the data from nations with mass ivermectin use for parasite prevention with other countries and found that the ivermectin countries had significantly lower COVID-19 case counts “to a high degree of statistical significance.”

The Impact of the TrialSite

TrialSite spent the last eight months at the founders’ expense chronicling studies involving ivermectin. The Monash University in vitro study that demonstrates that ivermectin absolutely zapped SARS-CoV-2 caught the initial attention of the Salt Lake City, Utah-based online venture.  

But it was only an in vitro study; much work had to be done (animal studies, toxicology, dosage studies, etc.). TrialSite expected at least a few genetic companies to pick up and explore this medical pathway—after all, Ivermectin is an FDA approved drug with a widely known safety profile—but no major generic companies bothered. 

Rather, a global community of physicians responded in an unprecedented health crisis in the modern era; community physicians, hospitals and various health systems’ personnel dealing with a pandemic, started exploring ways to save lives. Although this is certainly not the proper sequential order for repurposing existing FDA approved medicines, these were no ordinary times at all.

Interestingly, Peru was the first nation, or one of them, to embrace ivermectin. On this topic, TrialSite interviewed international ivermectin expert Dr. Carlos Chaccour now residing in Spain and conducting ivermectin research on his own. In Peru, Dr. Chaccour made the case that the scandalous Surgisphere papers were the reason for Peru embracing ivermectin.

However, based on the documentary TrialSite produced in Peru titled TrialSite News Original: Documentary in Peru about Ivermectin and COVID-19,” the explanation for the wide use of ivermectin more than likely resulted from an urgent direct response to the Monash findings. Again, during the height of the pandemic in a third world country, there wasn’t the capacity or wherewithal for extensive clinical trials although all interviewed in the TrialSite documentary acknowledged the importance of, and need for randomized controlled studies. 

Meta-Analysis of Ivermectin Studies

Dr. Pierre Kory and the FLCCC started researching ivermectin a few months ago as the pandemic raged.  Over a phone call in November, Dr. Kory explained to TrialSite founder Daniel O’Connor that the online media platform was an incredibly important resource for he and his colleagues’ research. 

In fact, it’s the only media platform dedicated to covering clinical trials sites and breakthroughs that systematically covered this important topic. Few else would touch it.  

TrialSite’s search function can be used to find most of ivermectin-focused studies referred to in Dr. Pierre Kory’s meta-analysis, which includes the following:

Existing Prophylaxis Trials Data

Author/Country/SourceStudy Design/SizeIvermectin DoseClinical Outcomes
Shouman W. Egyptwww.clinicaltrials.govNCT0442256RCTN=30440-60kg: 15mg60-80kg: 18mg>80kg: 24mg7.4% vs. 58.4% developed COVD19 symptoms; p<.001
Carvallo H, Argentinawww.clinicaltrials.govNCT04425850RCTN-229200 mcg drops0.0% vs. 11.2% contracted COVID-19;P<.001
Behera, P IndiamedRxivdoi:org/10.1101/2020.10.29.20222661OCTN=186 case controlPairs300 mcg/kg2 doses reduced odds of contracting COVID-19 (OR 0.27 95% Cl 0.16-0.53)

 Existing Early Outpatient Data Showing High Efficacy

Author/Country/SourceStudy Design/SizeIvermectin DoseClinical Outcomes
Carvallo, H ArgentinamedRxivdoi.org/10.1101/2020.09.10.20191619Case seriesN-16724mg=mild36mg=moderate48mg=severeAll 135 with mild illness survived; 1/32 (3.1% of hospitalized patients died)
Mahmud R Bangladeshwww.clinicaltrials.govNCT0452383RCTN=36312mg+doxycyclineEarly improvement:60.7% vs. 44.4%, p,.03, deterioration 8.7% vs. 17.8% p<0.2
Podder, CS BangladeshIMC J Med Sci 2020:14(2)RCTN=62200 mcg/kgRecovery time 10.1 vs 11.5 days (NS), average time 5.3 vs. 6.3 (NS)
Alam T BangladeshBangladesh College of Phys and Surg, 2020; 38:10-15Doi.org/10.3329/jbcps.v.38i0.47512Case SeriesN=100200 mcg/kg + doxycycline All improved within 72 hours
Chowdhury A, BangladeshResearch SquareDoi:10.21203/rs.3.rs-38896/v1RCTN=116200 mcg/kg + doxycyclineRecovery time 5.93 vs. 9.33 days (p = .071)
Morgenstern J, Dominican RepublicmedRxivdoi:https://doi.org/10.1101/2020.10.29.2022205Case SeriesN=3,099Outpatients:0.4 mg/kgHospitals & patients: 0.3mg/kgMortality = 0.03% in 2688 outpatients, 1% in 300 non-ICU hospital patients, 30.6% in 111 ICU patients 

Existing Data Showing High Efficacy in Hospitalized Patients

Author/Country/SourceStudy Design/SizeIvermectin DoseClinical Outcomes
Rajter, JC FloridaChest 2020Doi.org/10.1016/j.chest.2020.10.009OCTN=280200 mcg/kg +azithromycinOverall mortality 15% vs. 25.2%, p =.03, Severe illness mortality 38.8% vs. 80.7%, p=.001
Khan X, BangladeshArch Bronconeumol, 2020Doi.org/10.1016/j.arbres.2020.08.007OCTN=24812 mgMortality 0.9% vs. 6.8%, p<.05 LOS 9 vs. 15 days, p<.001
Goria, FL IraqmedXrivdoi.org/10.1101/2020.07.07.20145979OCTN=87200 mcg/kg + HCQ + azithromycinLOS 7.6 vs. 13.2 p<.001. 0/15 vs. 2/71 died
Soto-Beccerra P, PerumedRxivdoi.org/10.1101.2020.10.06.20208066OCTN=5683IVM, N=563Unknown dose <48 hours after admissionNo benefits found
Hashim H, IraqmedXrivdoi.org/10.1101/2020.10.26.20219345RCTN=140200 mcg/kg + doxycyclineRecovery time 6.3 vs. 13.6 days (p<.001), 0% vs. 27.3% mortality in severely ill, (p=.052)
Portman-Baracco A, BrazilArch Bronconeumol, 2020Doi.org/10.1016/j.arbres.2020.06.011OCTN-1408150 mcg/kgOverall mortality 1.4% vs. 8.5%, HR 0.2, 95% Cl 0.11-0.37

AP’s Hit Job: Why are they Attempting to Distort Reality?

TrialSite has spent several months, at founders’ expense, chronicling various research associated with COVID-19, and many other conditions. TrialSite has no agenda other than to bring clarity and transparency to research. This is an incredibly important mission as greater trust must be infused into the research process should it grow into clinical research as a care option, as we believe this seamless reality is the way forward to improve overall healthcare for all.

AP’s piece unfortunately wasn’t authored to convey the truth, hence it’s not even complete journalism but rather propaganda, or a representation of a particular material agenda. 

The author uses a comment from Amesh Adalja, a Johns Hopkins professor and respected infectious disease expert, who declared that all that has been put forth is “anecdotes” and studies not reflective of “gold standard” research. This is an unfortunate position given the truly substantial material amount of evidence accumulating that undoubtedly justifies NIH research support, for example. Dr. Adalja has earned significant revenues from pharmaceutical companies as reported here. Clearly, the research that TrialSite has chronicled and that FLCCC has focused on isn’t good enough for him. 

Over $2 billion of tax payer money has been injected into just three pharmaceutical companies to develop completely novel monoclonal antibodies. TrialSite applauds these great companies, including Regeneron, Eli Lilly and AstraZeneca. It’s frankly amazing what they have accomplished thus far in the midst of pandemic conditions. We have reported heavily on these important monoclonal antibody investigational products. We can also declare the NIH’s NIAID has accomplished some amazing things as well under the direction of Dr. Anthony Fauci during this pandemic. It was their scientists that helped co-discover the Lilly product, for example, in association with a spinoff from the University of British Columbia called Abellera.

Our position is that this is not an “either or” false dilemma type of situation. The marketplace needs multiple treatments at various price points, levels of accessibility and effectiveness given any number of conditions. This includes both novel, branded treatments as well as generic products. 

Hence, should there be compelling evidence for action, the importance of investigating the use of off-label, FDA approved drugs for helping to treat COVID-19 is of paramount concern. And we now have the case for ivermectin.

That is, the amount of data justifies such public research expenditure. In any other time, regulatory authorities would embrace this opportunity. After all, this was the very point of FDA’s Real World Evidence program in association with the 21st Century Care Cures Act.  

In the aggregate, dozens of studies—from case series to observational studies to randomized controlled trials—reveal plenty of data to justify serious investigations into ivermectin, one of many treatment considerations associated with COVID-19. This of course doesn’t contradict a major vaccination program but actually complements such an effort. While the vaccination programs ramp up, no person in their right mind would stand against safe and effective low-cost options to help combat a pandemic should they be proven safe and effective. Moving forward, AP journalists should do a little more homework before making such broad and conclusive claims.