By Mary Beth Pfeiffer
It took two court hearings, frantic medical and legal maneuvers, and a wrenching 80-hour delay. But finally at 8:53 p.m. on Monday May 3, a COVID-19 patient got the ivermectin that her doctor — and a judge, twice — had ordered.
Whether the comatose patient, Nurije Fype, 68, will survive is a still in question. But Ralph Lorigo, the attorney who is fighting for her life, is not done yet.
The Buffalo, N.Y., lawyer won court orders on Friday May 1 and, after the first was ignored, again on Monday May 3, telling Elmhurst Hospital to give Fype ivermectin “immediately”. But despite the long delay, Lorigo lost his bid on Tuesday May 4 to make the Chicago-area hospital pay a $25,000 fine and court costs, and to stop it from insisting Fype’s guardian sign away any hospital responsibility for her treatment.
Those twin decisions – to allow the drug on one hand, but let the hospital off on costly delays – shows the promise and limits of using courts to get desperately needed care.
“The whole purpose was to let this drug be administered and it’s being administered,” DuPage County Judge James Orel told the parties. “There’s nothing left for this court to hear.”
Left hanging was the implication if the waiver isn’t signed. “If they don’t continue her treatment,” Lorigo told me, “I’ll be in court again tomorrow.”
Significant Wins. Rare Cases
Fype’s case and others shed a light on how hospitals are resisting a drug which shows great promise to quell COVID-19 – and the pain that obstinacy causes to patients and families.
Courts are helping in the rare instances that legal challenges can be mounted — and afforded. In another decision on Tuesday May 4, a New York State judge also upheld ivermectin treatment for a patient at Mount Sinai Nassau South Hospital in Long Island. In all, five judges have now accepted Lorigo’s argument that ivermectin could work where nothing else had.
In the Chicago case, the Elmhurst attorney, Joseph Monahan, had argued that ivermectin was “not ethical to use…an outlier…not standard of care.” He boasted that the hospital saved 92 percent of its COVID patients.
Judge Orel’s response was pointed. “There’s still 8 percent” who died, he said. “If there’s a medicine out there that can assist a patient … and nothing else is working and she’s regressing to the point of near death, then, yes, I balance the equities.” Meaning he weighed the evidence and sided with what many doctors call the “right to try.”
The Long Island case involved patient Deborah Bucko, 52, who was hospitalized Feb. 28. Like Fype, her family’s struggle to get ivervectin was not easy or quick, involving pleas to hospital doctors and administrators, and, finally, two court hearings. These delays undoubtedly threaten deterioration of ICU patients tethered to ventilators, like Bucko and Fype.
The court papers and testimony in these cases, and my conversations with Lorigo, Dr. Pierre Kory, the leading physician on ivermectin, and family members of Fype and Bucko reveal maddening ignorance and denial of the positive effects of ivermectin in 53 trials, including 27 randomized controlled trials.
Guidelines That Don’t Work
Scott Mantel, Deborah Bucko’s husband, studied the research when the family became ill in February. His wife was prescribed an antibiotic and inhaler but deteriorated and was admitted to the hospital. Then in day six of COVID and worried he would follow, Mantel tracked down Dr. Zev Zelenko, an early treatment pioneer. He suggested ivermectin, hydroxychloroquine, azithromycin, zinc and a steroid pill.
Within hours, Mantel said, “I was 100 percent better. It was almost like completely eradicated. I’d never been treated with medicine that worked that fast in my life.”
He was not convinced it was the ivermectin that the made the difference until his daughter, 17, took everything but the ivermectin and took longer to recover.
Mantel’s attempts to share these experiences with hospital physicians fell on deaf ears. Their response: “There’s no real research, no conclusive studies, not peer-reviewed — whatever the terminology, they threw it out,” he said.
Hundreds of miles away at Elmhurst, Desarada Fype received a similar response when she suggested ivermectin for her mother Nurije. “They don’t have it in the protocol. They are not willing to use it. They think it is experimental drug,” she said. “Not approved from FDA to treat COVID. And the list goes on and on.”
Indeed, medical personnel seem unwilling to consider anything but rote protocols. In the court papers, the hospital said ivermectin “was not consistent with the Mount Sinai Health System Guidelines,” which were based on “recommendations of professional societies, international government agencies and infectious disease expert opinions…”
While public health agencies haven’t accepted cheap, generic ivermectin, for reasons I think are unrelated to the evidence, they can offer nothing else. Mantel watched his wife decline on a ventilator for three weeks until he confronted doctors. “You guys are treating her with the normal standard of care, and she’s getting worse,” he told them. “What is it we are going to do differently this time?”
That’s when he handed an infectious disease physician the protocols of Front Line COVID Critical Care Alliance, which included ivermectin. To his surprise, one infectious disease doctor, who had no clue of the quicksand he was treading, said OK and prescribed the drug. Red flags were raised within the hospital. That led to the first court case, a judge’s order for five days of treatment, and a second court case that, decided Tuesday, to allow it to continue.
“Doing the same thing and expecting different results is insanity,” Mantel said. choking up with he recalls the lifeline that Lorigo and FLCCC’s president and ivermectin expert, Dr. Pierre Kory, offered. “I get emotional just thinking about it.”
Fearful Doctors, Disinformation
Lorigo, a lawyer for 46 years, has received hundreds of calls about his ivermectin cases. At one point, he spoke to a doctor in Pennsylvania who wanted “a letter saying my license will not be in jeopardy,” if he prescribed ivermectin. Lorigo told the doctor that the National Institutes of Health, which is officially not for or against ivermectin, “protects you.” That wasn’t enough.
How about saving a patient’s life? The response: “That’s one life. I have a license to protect.”
While they may not know the emerging science of ivermectin, many frontline doctors and nurses are aware of how ivermectin is portrayed and, unfairly I believe, demonized. They know it’s not FDA-approved for COVID, though are unconcerned that convalescent plasma, though widely used, isn’t either. They may know that the World Health Organization has said ivermectin should only be used in clinical trials, but may not know that WHO advises against the use of hugely popular remdesivir.
Indeed, in opposing treatment for Nurije Fype, Elmhurst Hospital cited, as Exhibit A, the FDA statement entitled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” The statement conflates animal with human formulations, pinning its assertion that the drug can to be dangerous to “multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.” When I asked FDA to define “multiple,” I was told there were four reported cases, some of which “had been lost to follow up.”
Step Aside. Allow This Drug.
In his pitch to shoot down the Fype request for ivermectin, Elmhurt’s Dr. Daniel Sullivan repeated the mantra that ivermectin “is routinely used to treat or prevent parasitic worms,” “is not an anti-viral medication,” and “not approved by the FDA … for use in treating COVID-19.”
No mention is made that it has been used so successfully in people since the 1980s that it won two scientists the Nobel Prize in Medicine in 2015. Or, as Dr. Kory noted in his response, 20 percent of medications approved for one purpose are used for another. Kory noted that the FDA has acknowledged it “has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19.”
Several times in the Chicago hearing Tuesday, Judge Orel said a variation of the following statement, which might be advised of hospitals and public health agencies as well.
“Step aside and allow this medication,” he said. “Let this medication be administered.”
Mary Beth Pfeiffer is an author and journalist.
Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.