John W. Swanson, an 81-year-old farmer from Stafford, New York, a rural area east of Buffalo, was infected with COVID-19, on a ventilator, and according to a legal affidavit, ‘on death’s doorstep’ at United Memorial Medical Center (part of Rochester Regional Health). Apparently, the patient was given one dose of ivermectin, which immediately had a positive impact, as he started breathing again. But in what is becoming a similar New York State story, the hospital’s doctors then refused to give follow-up doses of ivermectin. And the patient’s family moved swiftly for justice. Swanson’s wife Sandra hired the same attorneys that were able to convince other New York State judges to compel other hospitals to administer ivermectin to dying patients, which as TrialSite reported on has appeared to save lives. In this case, it appears to be working again as Sandra Swanson recently told the Buffalo News: “I definitely think the ivermectin is helping him.” She also told the local press that the hospital has been denying her any visitation with her husband. Veronica R. Chiesi, a spokesperson for United Memorial Medical Center, declined to comment on the Swanson case. Read below about the unfolding ivermectin saga, including growing evidence of censorship and an introduction to the rapidly advancing TrialSite platform for biomedical research-oriented social engagement.
Thanks to the reporting of Dan Herbeck at the Buffalo News, TrialSite learned of yet another New York State case where rural or regional hospitals are denying COVID-19 patients ivermectin treatment at the request of families and their doctors. Thanks to a savvy law firm there, Judges are ruling on the side of the patient.
What’s going on in New York?
There is at least three cases now that TrialSite has reported on in New York State where the family of elderly or seriously ill COVID-19 infected patients were denied ivermectin treatments. While dozens of studies from around the world show overwhelmingly positive results, regulatory authorities and apex research bodies are hesitant to accept any of the positive data yet and have pounced on any data that shows neutral results.
In New York, TrialSite is aware that the ongoing reporting by this media platform, the outspoken Front Line COVID-19 Critical Care Alliance (FLCCC) and other reports of the accumulating positive data associated with ivermectin research around the world, have been reviewed by family members.
Not easily dismissed by hospitals that refuse to treat the elderly patients, New York families have turned to a couple of attorneys, including Ralph C. Lorigo and Jon F. Minear, both with West Seneca, New York-based Law Office of Ralph C. Lorigo.
In one case, Lorigo’s firm got to work to secure a Judge’s declaration that the Millard Fillmore Suburban Hospital treat an 80-year-old New York State patient staring at death from COVID-19 with ivermectin. Thanks to this lawyering work, Supreme Court Judge Henry J. Nowak aligned with the family and compelled the providers to care for Judith Smentkiewicz. The additional treatments helped as she rapidly improved thereafter.
TrialSite followed this patient: thanks to the ivermectin-based intervention, she was able to recover and go home. TrialSite asked why did it resort to this?
TrialSite reported for a second time that a New York judge made a similar order to help save a patient. In this case, Judge Frank Caruso, New York Supreme Court, Orleans County, made a preliminary move for the plaintiff, Robert Dickinson—a physician and husband of the plaintiff—in his perfectly legal request to use ivermectin off label. Rochester General Hospital was compelled to follow the physician and allow the ivermectin treatment.
Hospital Won’t Let Wife See Husband
Sandra Swanson’s next obstacle is to see her husband. She told Mr. Herbeck recently, “They held the phone to his ear, and I read to him a long list of people who are praying for him every day, about 20 people,” she said. “But I need to see him.” At this stage, there’s no way to allow the patient’s wife to at least come to the door to see her husband.
Off Label Use
Ivermectin, a medicine for parasites, has been around for four decades. While not authorized for use against COVID-19, dozens of studies show materially positive results. At well-established human dosage levels, the drug is safe: hundreds of millions of people are treated with it every year mostly in the tropics for various parasite-borne diseases, such as River Blindness in Nigeria.
The National Institutes of Health (NIH) in 2020 smartly changed their position on the drug to neutral—meaning they don’t recommend for or against in the context of COVID-19. Importantly (and humanely), TrialSite applauded their position: while they won’t accept the compounding positive data from dozens of studies, they also saw enough to adjust their recommendations. While on the one hand, NIH conveniently hedges its position on the other given what other agencies and regulatory bodies are doing, TrialSite acknowledges NIH as indicating to the market the off-label use scenario. For that, they are to be commended.
Censorship of Ivermectin & other Repurposed Candidates
TrialSite affiliated journalists, such as Mary Beth Pfieffer, have reported on the growing censorship afflicting the land.
The social media companies are at work, possibly in concert with government agency interests and industry to thwart any mention of this drug to the public. Why would that be? The drug is approved for many years as an antiparasitic treatment and very safe. In fact, the two academics that discovered the drug won Nobel Prizes in medicine.
TrialSite’s documentary about ivermectin use in Peru, a balanced, totally unbiased film shot completely in that South American nation, was recently taken down by YouTube. Up for ten months with no problems, this documentary is apparently clear that all the physicians involved declared more research was needed.
A TrialSite investigation into its rapidly growing YouTube content library found that Google is actually hand selecting videos involving ivermectin for de-emphasis and hence less or no advertising remuneration. Moreover, Facebook has systematically identified any news coverage of ivermectin as misinformation. But its Facebook that’s now the culprit of propagating misleading information by not letting their viewers hear the truth.
For example, when TrialSite reported on Slovakia’s health authority approving off label use of the ivermectin for COVID-19 as a fact, which it is, Facebook punished those that posted that news link. Now, they claim that the news item was misleading, but it isn’t at all—it was and is fact.
This means that there is a significant misinformation agenda now underway, led by social media companies but reinforced by the interests of at least some pharmaceutical companies and kindred spirit in the regulatory bodies.
The U.S. Food and Drug Administration’s (FDA) recent warning targeting ivermectin referred to reports of safety problems but didn’t share any examples. TrialSite acknowledges the FDA as not only representing the law of the land when it comes to food and drugs but also the Gold Standard for research quality and controls. It was disappointing as they included no details in their edict—the timing and the lack of substance raised more questions than answers for many. It was timed close to the report from the Missouri Poison Center (picked up by Business Insider) that there was an increased reporting of overdoses or abuse of the drug. TrialSite pondered all of this in “FDA Now Cautions against Ivermectin: The Vested Interests are Circling the Wagons.”
TrialSite on multiple occasions tried to reach the medical lead and communications director employed by the Missouri Poison Center to find out more information. Like how many calls relating to ivermectin did they receive? What was the nature of the calls? What was the result or outcomes? We recieved crickets in response.
Of course, TrialSite’s position is that ivermectin needs more research and that a licensed physician and consenting patient should be able to make a decision on their own if ivermectin is an acceptable treatment for a particular COVID-19 case. Based on mounting data, the regulatory authorities should have considered some form of emergency use—but they didn’t.
TrialSite’s disappointment with the regulatory and research institute’s lack of interest in ivermectin despite so many positive studies doesn’t damper the spirit at all. Any good and just cause, taking on special interests for example in a highly influenced and compromised society, won’t be easy nor popular. But life’s too short to not take a stand.
The vaccination program has been amazing and truly is testimony to the incredibly potential of the life science industry. The previous POTUS, while undoubtedly guilty of numerous mistakes—for example, withholding to the American public the severity of the contagion per the Woodward interview—did in fact drive Operation Warp Speed (OWS), which TrialSite called out as a brilliant move. Of course, the logistics of fulfillment wasn’t sufficiently in place, and the current POTUS has done a good job so far mobilizing government agencies and the broader society toward vaccination.
Thanks to OWS, never before have effective vaccines been developed at such speed. Imagine if the industry, regulators and government agencies took this approach to cures for cancer!
But vaccines are not by any means the entire solution. The National Institutes of Health acknowledges that therapies must be coupled with vaccines to overcome COVID-19 as well as other measures, such as personal protective equipment, social distancing in hotspots, etc.
The NIH is now supporting therapy studies, such as AstraZeneca’s AZD7442 as a prophylaxis and post-contact treatment. Other possible investigational products in clinical development for use at early onset, mild-to-moderate cases include those from Pfizer, Merck and others. The government funded ACTIV-2 program shows some examples.
Repurposed Drugs: Where are they?
But repurposed generic drugs show significant promise. For example, TrialSite showcased the fluvoxamine research led by Washington University School of Medicine in St. Louis. This included an interview on the TrialSite Podcast show with the principal investigator Dr. Eric Lenze.
They now lead a Phase 3 contactless clinical trial using fluvoxamine to treat COVID-19. Profiled on CBS 60 Minutes the effort has been supported by successful technology entrepreneur Steve Kirsch and his COVID-19 Early Treatment Fund (CETF). https://www.treatearly.org/
Proponents of fluvoxamine now believe that the existing trial data speaks for itself—the drug should be used at least on an emergency basis as it may benefit COVID-19 patients by slowing the progression of symptoms.
A healthy market-based democracy requires open and honest discussion and debate about the various potential therapies in development. TrialSite’s mission from the start was more transparency and accessibility for research with an emphasis on the trial site and study participant when the venture was launched toward the end of 2018. With a diversified pool of vaccines combined with a healthy competitive therapeutic marketplace (including branded and generic) plus smart measures to reduce transmission, this will lead American society out of the current crisis.
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Check out the documentary here.