Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.
Dear TrialSite News Readers,
Below are emails to one of the sites of the ACTIV-6 study and Dr. Carolyn Bramante, director of COVID-OUT. There is nothing the enemies of ivermectin will not stoop to including calling ivermectin “horse dewormer,” making it unavailable at pharmacies, failing to report Uttar Pradesh, publishing bias, biased newspaper reporting, and “fake” randomized trials. The “fake” randomized trial has been weaponized by ivermectin’s opponents. There isn’t the slightest doubt that behind the scenes our government health care agencies, drug companies, and others have conspired to make ivermectin appear ineffective in Lopez-Medina, Together, ACTIV-6 and COVID-OUT.
How else is it that the Together, ACTIV-6, and COVID-OUT studies all use basically the same protocol, 3 days of ivermectin 0.4 mg/kg or less on an empty stomach? ACTIV-6 and COVID-OUT are giving a slightly lower dose than in the Together study after the higher dose of ivermectin failed to show statistical benefit in Together. That only makes sense if they are trying to make ivermectin fail. There were lots of problems with Together which appear intentional. Lead investigator, Edward Mills basically works for Bill Gates. Analysis of Ivermectin in Together
NIH and FDA stand to be humiliated if the NIH-sponsored ACTIV-6 or the University of Minnesota COVID-OUT trial show significant benefit of ivermectin. Why would the University of Minnesota, who should be independent, choose to treat patients with about the same dose that failed in Together? No one knowledgeable about ivermectin would in real life use it that way for the delta variant.
The Lopez-Medina study, published 3/4/21 in JAMA, was sponsored by pharma companies including Gilead, and Merck. It appears JAMA was complicit, ignoring a host of problems including identical side effects in the treatment and placebo groups and in publishing deceptive conclusions, saying ivermectin was not effective in “adults” with mild COVID. They also failed to mention that the patients ages averaged 37 years old. The WHO said it was their most important article in recommending against ivermectin. The AMA just came out stating that ivermectin should only be used in trials. They are supposed to be a private organization that represents physicians, not the FDA.
Would you put it past Merck to provide underdosed pills of stromectol, Merck’s generic ivermectin which is being used in ACTIV-6 and COVID-OUT?
I spoke with a physician on the ACTIV-6 committee at one of the sites for ACTIV-6. I was concerned about the dose of ivermectin. They were receptive to changing it and offered me to write to their committee. I was very impressed that they were fair and honorable. I was told they were giving it on an empty stomach at the advice of the FDA. They didn’t know where the dose came from. I thought they were also underdosing fluvoxamine at 50 mg twice a day when 100 mg twice a day was successful in Together, but it turns out 50 mg twice a day was used in the racetrack study and the EUA that was submitted was for 50 mg. twice a day. I emailed them my concerns about ivermectin, and fluvoxamine dosing then wrote that after further research, my concerns about fluvoxamine dosing were unfounded.
I have the idea that the people involved in running ACTIV-6 at the individual sites and those at the University of Minnesota are honest and want to be involved in good science. I hope they do not want to be offering patients a dose of ivermectin that is known to be ineffective or a placebo. I hope they do not want to be part of a trial that will falsely brand ivermectin as ineffective, helping to prevent it from reaching the billions around the world who need to have it available.
I would suggest that readers reach out to all the ACTIV-6 trial sites and the COVID-OUT team, expressing your concerns about ivermectin dosing in ACTIV-6 and COVID-OUT and asking that ivermectin be properly dosed. We need ivermectin experts to reach out to them with evidence that the correct treatment on the delta virus is ivermectin 0.4 mg/kg with food for at least a week.
Board members of the AMA, American College of Physicians, the Infectious Disease Society of America, the American Thoracic Society, American Lung Association, and Society of Critical Care Medicine need to be contacted with your concerns about irrational ivermectin dosing involved with these trials. So far major medical organizations have lined up behind the government healthcare agencies or remained silent. What is happening is obvious and we need to know where they stand. Many medical leaders are fearful of retribution by drug companies and government healthcare agencies. Those who cannot stand up for honest research that could affect billions of human beings should stand down.
Few people on television who have discussed how ivermectin has been demonized. CNN has authored “hit pieces.” The only ones saying the truth are the personalities on FOX, i.e., Tucker Carlson, Maria Bartiroma, Laura Ingraham and others. The only politician doing anything is senator Ron Johnson. They need to know of the blatant misconduct in these studies regarding ivermectin treatment as well as what happened in Uttar Pradesh.
I would also suggest reaching out to the NIH ACTIV-6 committee. I would imagine that many committee members have no idea what the correct ivermectin dosage is but unfortunately, the possibility exists that the committee has agreed to intentionally give ivermectin incorrectly as part of the NIH strategy of suppressing repurposed drugs. This is the same committee that last year recommended against a large, randomized trial of famotidine, an over-the-counter H2 blocker of mast cells. This was cancelled despite the high probability that mast cells are involved in cytokine storm. Multiple published studies show the benefit of over-the-counter mast cell therapies, including one out of Harvard that showed individuals who regularly took famotidine did not get very sick from COVID-19. The Promise of Famotidine for COVID-19
Readers need to spring into action or more “fake” ivermectin data is coming. It might be enough to bury ivermectin for good. If we want things to change, we need to be activists and go to the people running these trials and those who will stand up for honesty in medicine. I hope that after being presented with the obvious evidence of deceit, they will act appropriately. All the anti-ivermectin forces involved with the “fake” studies read Trialsite News. They will do their best to prevent ivermectin from getting a fair shake. We must fight hard and dirty like them to prevail.
Michael B. Goodkin MD, FACC
Sent: Tue, Oct 12, 2021 9:47 pm
Subject: Fwd: Problems with dosing of Ivemectin in COVID-OUT
Dear ACTIV-6 team,
Below is an email I sent to Dr. Carolyn Bramante at University of Minnesota who is running the COVID-OUT trial. They are using a dose of ivermectin very similar to Together and slightly higher than in ACTIV-6. It seems quite a coincidence that all 3 studies are using about the same treatment strategy even though in Together ivermectin showed statistically insignificant benefit.
It appears that investigators in Together deliberately tried to make ivermectin not succeed . Comments by lead investigator, Dr. Edward Mills, who ran the trial, were very unprofessional and prejudicial against ivermectin. Initially Dr. Mills was going to use a single dose of ivermectin until ivermectin advocates complained loudly and he reluctantly agreed to 3 doses. There were many problems with the trial which I hope will be investigated when the study is peer reviewed.
Why would NIH choose to give half the patients in ACTIV-6 less ivermectin than in Together? The FDA has shown blatant bias against ivermectin. Dr. Gentile told me it was the FDA who told you to give it on an empty stomach. Ivermectin experts always give it with a meal. Where did the arbitrary 3 days of treatment come from? It did not come from world experts who use ivermectin often.
Ivermectin is not the only repurposed drug for which NIH’s actions are questionable. It is highly probable that mast cell activation is responsible for much if not most of the inflammation in COVID. The NIH ACTIV committee chose to do nothing with mast cell therapies which include famotidine(pepcid), certirizine(zyrtec), luteolin and quercetin, all over the counter. A randomized trial showing statistically significant benefit from famotidine 80 mg orally 3 times a day will be reported soon. 3 trials of famotidine plus celecoxib will be starting shortly. The promise of famotidine for COVID-19
There is something very wrong with this series of trials of ivermectin. A great amount of academic dishonesty is going on. I hope you will look into my allegations and try to find a way for ivermectin to get a fair shake.
Michael B. Goodkin MD, FACC
Dr. Carolyn Bramante
University of Minnesota
Director COVID-OUT Trial
Dear Dr. Bramante,
I’m Dr. Michael Goodkin, retired cardiologist. I am concerned about the dosing of ivermectin in the COVID-OUT study. The vast majority of patients will be getting 0.39 mg/kg on an empty stomach for 3 days. I have no idea how that dose was arrived at. In Together, patients got 0.4 mg/kg on an empty stomach for 3 days and it showed statistically insignificant benefit. In ACTIV-6 patients will be getting 0.3-0.4 mg/kg on an empty stomach for 3 days. It seems odd that all 3 studies are using basically the same dosing strategy, with ACTIV-6 and COVID-OUT using the same dosing strategy even after it failed in Together.
A coordinator of ACTIV-6 told me the FDA gave them the dose and advised them to give it on an empty stomach. There is clear data that the blood level is 2.6 times greater with a meal and no evidence of toxicity from giving it with meals. Pharmacokinetics of Ivermectin in Healthy Volunteers
Much higher doses of ivermectin have been given safely.
1 Guzzo CA, Furtek CI, Porras AG, et al. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. J Clin Pharmacol. 2002;42(10):1122-1133
2. Navarro M, Camprubí D, Requena-Méndez A, et al. Safety of high-dose ivermectin: a systematic review and meta-analysis. Journal of Antimicrobial Chemotherapy. 2020;75(4):827-834.
3. Krolewiecki A, Lifschitz A, Moragas M, et al. Antiviral effect of high-dose ivermectin in adults with COVID- 19: A proof-of-concept randomized trial. EClinicalMedicine. 2021;37.
Most ivermectin experts believe it should be used for at least 7 days and that ivermectin should be given with food. Dr. Pierre Kory has an enormous worldwide experience and is as expert as anyone in the world. His meta analysis was published in the American Journal of Therapeutics. Dr. Kory Ivermectin American Journal of Therapeutics
I would like to see ivermectin put to a fair test. I don’t think Together was fair. Here is an analysis.
Analysis of Ivermectin in Together ACTIV-6 and COVID-OUT will be nearly identical, will likely show similar results and not satisfy the question of whether ivernectin can be effective to early COVID.
Ivermectin worked extremely well in a very large population, possibly by preventing COVID transmission. as evidenced by Uttar Pradesh, India where in 230 million people ivermectin has almost eliminated COVID. Unfortunately the american press and US healthcare agencies have not reported it.
The FDA has been overly aggressive against ivermectin. They recommended against it when NIH was neutral. Their “horse dewormer” campaign shows their blatant bias. They have gotten pharmacists to stop ordering and selling it. They got the AMA to say it should only be used in trials. Ivermectin has no significant toxicity at even very high doses and many believe the evidence clearly shows that it works.The FDA cannot be trusted on dosing due to the obvious bias. Very positive results for ivermectin would be an enormous black eye for them but a tremendous boon for COVID patients all over he world where vaccines will not be used in many places any time soon. Cheap generic treatments are badly needed. I think you owe it to the COVID patients of the world to make sure you are giving an adequate dose of ivermectin.
I hope you will rethink what your strategy.
Merck has a long track record of doing anything for money, ie. vioxx. Merck’s deadly vioxx playbook
Their public statement 2/4/21, Merck Ivermectin statement 2/4/21 was all lies. They had terrible conflict of interest as they had gotten $356 million from HHS and were working on a competitor for ivermectin which has turned out to be molnupiravir, a mutagen, on which they hope to make many billions. Ivermectin is in the way of their huge profits.
Merck is capable of anything. I don’t know where your stromectol came from but I would have it analyzed.
I hope to hear from you.
Michael B. Goodkin MD, FACC