25X Growth in Ivermectin Sales & NY Times Declares the Drug ‘Doesn’t Work’
Ivermectin sales have skyrocketed worldwide as many populations across many nations are using the FDA-approved anti-parasite medication as a proactive early treatment against SARS-CoV-2 infection, the virus behind COVID-19. According to a recent New York Times (NY Times) piece, prescriptions across America have increased nearly 25-fold from the beginning of the pandemic until mid-August 2021. Ivermectin is currently being studied in two major Phase 3 trials in the United States; one, called the COVID-OUT study, is led by the University of Minnesota in partnership with UnitedHealthcare. Another National Institutes of Health (NIH)-sponsored study is being conducted by Duke University, called ACTIV-6. Another prominent study at University of Oxford (PRINCIPLE) included the drug. Over 63 studies around the world involving over 26,000 patients indicate some positive impact. At the same time, dozens of nations have used ivermectin during the pandemic, some quite successfully, such as India’s Uttar Pradesh, a heavily populated state with over 220 million people that proactively used the drug as part of a home-based home healthcare regimen caring for those with COVID-19. Ivermectin is still used pervasively across parts of India, Brazil, Bangladesh, and even Slovakia, where health regulators provisionally authorized it. In America, Dr. Jacques Rajter led the successful ICON study in Broward County, Florida. The results of which were published in the peer-reviewed journal Chest. While sales have skyrocketed, so has the criticism, warnings not to use the animal version of the drug, and most recently a New York Times declaration that there is, “No evidence it works.” TrialSite concurs with the recent Times piece that any self-medication and/or use of veterinary products represents a real problem. Moreover, we agree that some of the research indicates neutral to no benefit. Yet numerous studies indicate positive data points as does considerable real-world evidence in various parts of the globe. Additionally, with nearly three dozen ongoing studies, why would the New York Times journalist, Emma Goldberg, issue a declarative statement proclaiming there is “No evidence that the drug works” when she acknowledges there are over 30 ongoing studies with more data to review? Such positioning and placement of the language indicate an agenda.
Huge Demand Leads to Shortages
The mainstream media doesn’t differentiate between the skyrocketing demand for ivermectin determined by the source. Reading much of the press leads one to believe that the demand is driven by the veterinary product, fueled by misinformed people who self-medicate. However, most of the demand is from physicians prescribing the product off-label. At least as of this writing, this is perfectly legal, although frowned upon by many physicians. Then, of course, there is veterinary use and abuse if the consumption involves self-medicating humans.
The recent Times piece reports on the huge demand for the drug across the United States, indicating that prescriptions have risen to over 88,000 per week in mid-August. Goldberg writes that this is markedly up from the average of 3,600 per week at the pandemic baseline, according to researchers from the Centers for Disease Control and Prevention CDC). That’s just about a 25-fold increase since the baseline of the pandemic.
In many communities, Ms. Goldberg reports pharmacists declaring shortages of the drug. For example, in places such as Kuna, Idaho, pharmacist Travis Walthall cannot get enough product in stock.
A Problem: Self Treatment & Animal Product
Goldberg follows several mainstream media reports on the growing calls to poison control centers due to rising ivermectin use. TrialSite has tried to secure such data before, which has been difficult. According to the New York Times, the CDC cited data from the American Association of Poison Control Centers that declares a five-fold increase in calls about the drug. But we don’t doubt that people are abusing the drug based on what they read on social media.
Growing reports account for dangerous self-medication, often embracing the animal version of the product. While TrialSite’s Ivermectin Fact Check indicates the drug can lawfully be prescribed off-label (assuming full disclosure to the patient), individuals buying and consuming the animal variety are the real topic of the NY Times piece.
Goldberg reports that, according to the Mississippi health department, about 70% of the calls associated with the state poison control center involve “…people who ingested ivermectin from livestock supply stores.”
One toxicologist down in Texas, Dr. Shawn Varney, reports the number of calls involving ivermectin at the South Texas Poison Center have tripled—the vast majority associated with the veterinary product.
TrialSite concurs with the NY Times reporter that if these reports are accurate, they reflect a growing problem with self-medication and a deep chasm between many people and their health care systems.
Journalism That Doesn’t Include the Other View
Ms. Goldberg shared in her piece that ivermectin “has not been shown to be effective in treating COVID,” yet people are “clamoring to get the drug.” Citing the FDA’s “You are not a horse” marketing effort cautioning against the use of the veterinary drug, Goldberg uses select information for her declaration that the drug doesn’t work at all for COVID.
While throughout the piece, Goldberg explicitly and implicitly communicates that the drug doesn’t work—that there is absolutely no evidence that it could be a possible tool to use in the fight against COVID-19—she doesn’t mention that over 63 completed studies evidence at least some positive data points. However, the journalist doesn’t look at all of the studies or even discuss a contrarian viewpoint with medical professionals who prescribe the drug off-label. Instead, she follows a careful script meant to offer up the negative answer.
For example, she cites a few sources, including a recent Cochrane review of 14 ivermectin studies involving over 1,600 participants declaring there was no apparent benefit. This particular meta-analysis doesn’t include studies that other meta-analyses use to come up with a positive finding.
Goldberg points to the recent McMaster University-led Together Trial showing the drug didn’t produce any better than the placebo. Although PI Dr. Edward Mills was declarative that the drug doesn’t work, many knowledgeable experts are critical of the study design, as TrialSite recently shared. TrialSite reported that several researchers expressed concern about the Together Study protocol, indicating challenges with dosage, the timing of dosage, and other factors such as the fact that many were already taking ivermectin in the region of Brazil where much of the study commenced.
The NY Times writer also emphasized a questionable study led by Eduardo Lopez Medina, which indicated no statistical significance based on the results. Dozens of researchers and physicians have protested that study, as Dr. Michael Goodkin indicates in a recent article published by TrialSite.
Many of these critics authored a complaint letter to the publisher, sharing several concerns, including the fact that this obscure Colombia trial site received numerous pharmaceutical payments during the study, including ones from Merck, the company that happens to be developing a competitive pharmaceutical therapeutic called molnupiravir.
Not mentioned by Goldberg was a faulty Egyptian study that certainly looks to be problematic. Although this study showed a positive ivermectin outcome, the results are in question due to what appears to be unacceptable fudging of data, among other things.
Moreover, she precludes material information that other major institutions have embraced the drug for Phase 3 studies—these are the studies that lead to approvals. A study drug cannot make it to this late stage without showing that there is at least some evidence to justify the investment in the clinical trials process. Thus she omits any discussion of pivotal Phase 3 studies investigating ivermectin, including the COVID-OUT and the NIH ACTIV-6 study.
Why not Present Other Data?
Although Goldberg acknowledges there are “another 31 studies…still underway to test the drug,” she doesn’t bother to provide any countervailing points of view, and this is a real problem observed with what we call the “special interest” journalism of today. There appears to be ever more biased (usually industry-centric) content that frankly is turning off readers. Goldberg just reinforces that problem with this piece.
She doesn’t seek out any other points of view on the matter. For example, the authors of at least two (2) meta-analysis indicating the drug shows some effect, including Bryant et al. and Kory et al.
TrialSite’s library includes meta-analyses from Italy and India, indicating some positive data points.
But the NY Times writer doesn’t bother to look into any opposing views domestically and demonstrates no curiosity into massive use cases in places like India. For example, millions of people used the drug as part of the Uttar Pradesh state public health regimen to beat back the Delta variant-driven surge in the spring and early summer.
While media industry “fact-checkers” have attempted to shoot down the Indian information, TrialSite’s investigations reveal irrefutable activity, evidenced by dozens of interviews and articles in mainstream media in India. Recently, an Indian doctor’s interview highlights some of the positive outcomes involved.
What About the Methodology Behind the Evidence?
Many of the critics of the ivermectin-based studies declare that there just aren’t enough studies yet and that the many dozens of studies revealing positive results unfortunately derived from suspect-designed studies from the Third World.
Out of these 63 studies comes a significant amount of supportive clinical trials evidence associated with COVID-19, including randomized (31) and observational (32) studies, over 26,000 patients, and a near majority of all studies finding at least some important benefit with treatment.
TrialSite suggests a comparison with the average amount of evidence relied upon to formulate the treatment guidelines of the Infectious Disease Society of America (IDSA):
In a 2010 review of 65 of its most recent guidelines, the IDSA found that 50% of guideline recommendations were made without any trials evidence in support and were termed “expert opinion only.”
Another 31% of guideline recommendations were based solely on observational studies, while only 16% of all recommendations were based on at least one randomized controlled trial.
In other words, the number of legitimate clinical trials for ivermectin have been superior to those for the IDSA’s treatment guidelines if one assumes appropriate underlying study design (which we recognize many don’t).
Interestingly, ivermectin was approved for the treatment of scabies by the WHO based only on ten randomized controlled trials, including 852 patients. This is despite the fact that the trials found ivermectin was actually inferior to the permethrin cream it was being tested against. It essentially won approval based largely on its low cost and use of administration.
The WHO arrived at such a bold recommendation without the pressure of a pandemic, given it was based on such a seemingly small evidence base.
We also emphasize that the NIH Guidelines for COVID-19 have multiple strength levels of recommendation available to them, from weak or “consider” to making use near mandatory. TrialSite suggests that the public should demand from the IDSA and NIH credible explanations for the anomaly of not arriving at even a weak recommendation for ivermectin, one of the safest, affordable, and widely available medicines known. The safety record of the drug is well known and doesn’t need to be defended here.
Finally, no credible physician or journalist recommends that people self-prescribe with veterinary forms of ivermectin. Experts such as the Front Line COVID-19 Critical Care Alliance have been working tirelessly for months to persuade the public health agencies to provide more specific guidance to physicians on using ivermectin to treat patients with COVID-19.
The FLCCC suggests that increasing calls to poison control centers directly result from their failure to provide such guidance and education to U.S citizens.
The Real Concern
TrialSite suggests a real concern of the research and medical establishment is that the use of ivermectin is perceived to be:
Getting in the way of the vaccination program.
Not monetizable at the levels possible with this pandemic.
Exhibit implicit if not explicit bias of academia and research elites to the research and care initiatives in low-and middle-income countries (LMICs).
The mainstream media, including the NY Times, position that vaccine-hesitant people are using ivermectin as an alternative to the vaccine. But early treatments, whether they be ivermectin or some pharmaceutical, are necessary to combat COVID-19. A vaccine-centric strategy isn’t sufficient for society to overcome this virus.
The NIH is fully aware of this fact—that is, that antivirals will be key moving forward. With over $3 billion in new antiviral pharmaceutical clinical research, the apex research body knows all too well that a vaccine-centric strategy to overcome COVID-19 isn’t sufficient.
Rather, the war against COVID-19 is won via a combination of tools from safe and effective vaccines to therapeutics (both branded pharmaceuticals and low-cost generics) paired with sound, rational and data-driven, risk-based public health measures ongoing. Antivirals, or drugs that behave like antivirals, serve an important role, and if ivermectin eventually fits into that category, it should be accepted by health authorities.
Because drug development is a risky, competitive business requiring enormous capital outlay and a high probability of failure, the race is on during this pandemic for rich monetization. Gilead generated $3 billion during the first nine months of the pandemic thanks to remdesivir pandemic-driven sales. Moderna has transformed from a money loser to market power, while Pfizer may generate tens of billions per year from its vaccine.
Of course, there are exceptions, as Merck showcased with its ivermectin-based Mectizan program, a notable effort to eradicate river blindness in tropical areas. But generally, as University of California Hastings College of the Law professor Robin Feldman writes in “Drugs, Money and Secret Handshakes,” that prescription drug prices continue to grow is no accident.
And because much of the ivermectin research and care evidence has occurred in low-to-middle-income countries (LMICs), much of the medical establishment in places like America and England aren’t that interested in results, regardless of the outcome. They do have a point. The studies aren’t nearly as well-funded and well-designed as pharmaceutical industry studies. Groups within the NIH and academia have low confidence levels in some small studies in places from Bangladesh to Brazil. They will refer to those studies that don’t yield results, when convenient but the reality is that mostly poorer countries have used ivermectin during the pandemic. Of course, that’s changing now based on the sales number reported by the NY Times.
Where Does the Truth Lie?
TrialSite suggests Ms. Goldberg’s employer directs the one-sided view, not the reporter herself. TrialSite concurs with Ms. Goldberg and the NY Times that self-medication with any prescription drug, or improper use of a veterinary product, represents a real societal problem.
As an independent media and social network platform, we strive to provide a more objective point of view. Read TrialSite’s “Ivermectin Fact Check—An Independent TrialSite Breakdown” for our assessment of ivermectin at this point.
We declare therein that ivermectin is not a cure for COVID-19 nor a silver bullet but instead could represent one of several tools a physician may use to combat the virus. That’s up to the licensed medical professional and their consenting patient. And, of course, more data is always needed for greater understanding.
Mindful that the situation is complex, dynamic, and unfolding, we stand ready to adjust and update our position as data is available. While we are disappointed yet again with another one-sided mainstream media write-up concerning ivermectin, Ms. Goldberg at least doesn’t sink to the low levels of Michael Hiltzik, the Los Angeles Times hack for hire—read his “hit piece” here. Ms. Goldberg does at least try to contain herself, sparing the readers the features of the all-too-obvious hit piece.
Call to Action: Regardless of one’s view on ivermectin, in the United States, one can only legally access the drug via an off-label prescription from a licensed and competent medical professional, and of course, the patient must consent. No one should self-medicate with the veterinary version of the drug. This is a dangerous and legally questionable activity.
