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November 14, 2022
Medical research is supposed to båe non-biased and professional to insulate legitimate scientific inquiry from personal and financial interests. The recently published “Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients with Mild to Moderate Covid-19” shows the consequences of erosion of scientific integrity by political and financial biases.
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The study, performed between June 2021 and February 2022, concluded that Ivermectin was no better than placebo (sugar pills) for treating mild to moderate Covid-19 illness in outpatients.[i] Touted as the definitive protocol to silence Ivermectin promoters, the article was published in the American Medical Association’s journal JAMA on 21 October 2022. Without explanation, the AMA did not allow online comments on the publication. The media predictably hyped the article and simultaneously continued to criticize the drug, something it had done since early 2020. CNBC published “Ivermectin – a drug once touted as a Covid treatment by Conservatives – doesn’t improve recovery much, clinical trial finds” 3 days after the publication was released online.
The second-in-command of the trial, Dr David Boulware, has shown contempt for Ivermectin before, during, and after the study. The Star-Tribune interviewed him on June 13, 2022.
“Ivermectin is not an effective therapy for COVID-19 at this dose and duration, regardless of what the people promoting or selling ivermectin say,” said Dr. David Boulware, a U infectious disease researcher who oversaw the design of ACTIV-6 as co-chair of its protocol committee. “This is now the second very large trial to show no benefit of ivermectin.”
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Boulware said he expects ivermectin proponents to dismiss the latest results because of the lower dosage, but that they are “moving the goalpost” because he consulted with some of them at the outset of ACTIV-6 in early 2021 and they supported the dosage at that time.” Front Line Covid-19 Critical Care Alliance (FLCCC), one of the largest proponents of ivermectin, disagreed and released a June 2022 paper stating the trial used too low of a dose too late in the course.
This trial used lower doses and shorter durations of treatment that were not being used by Ivermectin prescribers. Worse, the Ivermectin treatments were begun after the known peak viral load in patients. It is well known that anti-virals must be started earlier. Flu medication (within 2 days or less) and Paxlovid (within 5 days or less). As a practicing ER physician, most of my covid treatments were begun within 2-3 days of symptom onset, not the 6-day lag time in the trial. The delay is critical to understanding the drug effects and raises the question if the researchers intentionally delayed treatment for so long to minimize effects of the investigated drug. With the authors’ obvious bias, this is entirely plausible.
Dr Boulware has been involved in the 2 biggest trials that ‘proved’ that Ivermectin was ineffective. With his bias, could he have sabotaged both trials for gain?
During the course of the ACTIV-6 trial, Dr Boulware was active on his professional Twitter account to bash Ivermectin. In November 2021 he tweeted, ““Yet another Ivermectin study retracted. I’m losing count of the retractions. How many thousands of Americans have taken Ivermectin.” Openly criticizing the drug he’s studying and American patients in general is both unethical and unprofessional and should call his entire protocol that he co-authored into question.
Medicine and science have taken a disturbing turn since the start of Covid-19. After a very brief period of willingness to explore all possible treatment modalities for the worrisome virus, the medical community quickly condemned most if not all off-the-shelf therapies including steroids, Motrin, hydroxychloroquine, and ivermectin. The establishment did this before any meaningful trials had proven or disproven their efficacy. Worse, the medical community, governments, and social medial synchronized their efforts to suppress discussion of off-the-shelf therapies and socially and professionally punished doctors to prevent intellectual discussions.
Ivermectin may be effective. It may not. The problem is that it was vilified before any scientific data could objectively and sufficiently weigh its merit. A sustained and deliberate multidisciplinary public relations campaign was waged to turn the American public against both off-the-shelf treatments and the doctors who dared to discuss them. Once-distinguished physicians saw their careers ruined and some had their licenses revoked.
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Large studies were not started until the end of the pandemic when covid was far less lethal and very few were dying or being hospitalized anymore. The Boulware research ‘study’ increasingly appears to be a propaganda tool with a preconceived conclusion. It was done too late in the pandemic to confirm or deny early case reports of efficacy.
The major danger is that this tactic will be repeated in the next pandemic and doctors will again be told to prescribe nothing until an expensive designer drug from the company that has provided more ad revenue to TV than any other company saves the day. Research must be done as soon as a virus or disease emerges when there are no alternatives or vaccines available and the true effect to decrease hospitalization and death can be seen.
Research for profitable drugs frequently had unethical protocol changes, shifting outcomes, and extrapolation of results that did not fit the study. Ethics were loose. The same treatment was not afforded off the shelf (unprofitable) treatments. Data on adverse reactions from research on vaccines and expensive drugs was suppressed by force. Judges were required to obtain adverse event information. California’s governor recently obliterated the concept of informed consent, a central pillar of ethical research. Most troubling, criticism of the new paradigm by physicians was not tolerated.
Just a few short year ago, protocols executed by openly biased and unprofessional doctors would have likely been dismissed as invalid due to egregious researcher bias and financial conflict of interest. The simultaneous rise of online censorship with unprecedented influence of pharmaceutical corporations has created a new era of medicine and medical research. It will be good for drug profits and politicians leveraging medical crises for power. It will not be good for American patients.
Dr Boulware’s Twitter posts sum up the dangerous direction the new generation of doctors are taking America. It is a place devoid of the Hippocratic Oath.
[i] Naggie, Susanna, et al. “Effect of Ivermectin vs Placebo on Time to Sustained Recovery In Outpatients With Mild to Moderate Covid-19.” Jamanetwork.com 21 October 2022.
Photo credit: Bundesministerium für Finanzen CC BY 2.0 license
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