The ongoing devastation wrought by the Covid-19 pandemic creates an understandable allure for a quick-fix or magic-bullet solutions. But it is painstaking scientific testing — not magical thinking — that reveals what works and how well. For example, clinical trials involving tens of thousands of patients across multiple continents were needed to demonstrate the enormous value of Covid-19 vaccines.
Early in the pandemic, hydroxychloroquine was touted by Trump as one of those quick fixes, with the absence of supporting data.
Now it’s ivermectin, an anti-parasitic drug.
Granted, the drug was awarded a Nobel Prize in 2015 for its effectiveness against river blindness and other tropical diseases, and is widely used by veterinarians as an anti-parasitic.
Now promoters are doing just that — promoting. Without knowing.
Knowing requires testing in well-designed clinical trials.
One example of this came in December of 2020 when a physician who formerly worked for a health care system in Wisconsin, Pierre Kory, described the immense potency of the drug before a Homeland Security and Governmental Affairs committee, saying, “All studies are positive,” he testified, “with considerable magnitude benefits, with the vast majority reaching strong statistical significance.”
The gold standard in drug development is the randomized controlled trial. These maximize the chance that the group receiving a treatment and the control group not receiving it are alike in all other respects. But even such trials must be properly conducted with adequate sample sizes, investigators and participants blinded to who is getting what, and rigorous data collection and analysis. But Kory cited several non-randomized observational studies, in which patients can receive non-standardized treatments, as well as many poor-quality controlled trials.
Kory was citing a trial study in Egypt in which one group of COVID-19 patients was treated with ivermectin and a second group was treated with hydrochloroquine — instead of a placebo. NOT a controlled study.
According to those researchers, there was a 90% reduction of death in the ivermectin group. However, a British student and an Australian epidemiologist investigated the study and found a plethora of data fabrication and plagiarism.
The study from Egypt was retracted.
Higher quality data is sought out by a group called the Cochrane Collaboration, who excluded dozens of studies on ivermectin with “high risk of bias.”
Their statement: “Based on the current very low- to low-certainty evidence, we are uncertain about the efficacy and safety of ivermectin used to treat or prevent Covid-19.” The group recommended that ivermectin use be restricted to clinical trials that might actually generate high quality data.
Even Merck, a manufacturer of ivermectin, concurs with WHO and the Infectious Diseases Society of American with this statement: “….No meaningful evidence for clinical activity or efficacy in patients with Covid-19.”
The University of Oxford’s rigorously designed PRINCIPLE trial is now trying to determine if ivermectin actually benefits people with Covid-19. But until those results come in, I urge people to heed the lessons of hydroxychloroquine, bleach, and all the other purported Covid-19 cures: effective treatments will be identified through systematic scientific study, not by wishful thinking, fabrication, or miracles.
Now, as with hydroxychloroquine, the increased demand for ivermectin due to unsubstantiated promotion, has caused a shortage of the drug, and a spike in calls to Poison Control Centers because of misuse.
This opinion piece can be read in its entirety at STAT.
The author is Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner of the FDA.