For five fraught days in mid-July, Karen Downey’s husband lay dying of COVID-19 at Cleveland Clinic Indian River Hospital while she fought in court to force doctors to give him what she believed was a last shot at keeping him alive: the controversial drug ivermectin.
The anti-parasitic is used legitimately to treat lice and mites in people, and has saved so many millions from disfiguring diseases in poor countries that its discoverers were awarded the Nobel Prize.
The FDA has neither authorized nor approved its use in treating COVID-19. But in February, the agency changed its recommendation against use of the drug to a statement saying it could recommend neither for or against using it. The NIH is conducting a large Phase III clinical trial of the drug with results reportedly expected early next year.
In the meantime, the government’s messaging continues to be dominated by warnings of people using the veterinary formulation of the drug and poisoning themselves.
Cleveland Clinic Indian River said in a statement it does not offer ivermectin to coronavirus patients “at this time,” citing FDA and CDC precautions about ivermectin’s risks and “insufficient data supporting its use.
Nevertheless, ivermectin has been promulgated as a treatment for COVID-19 by a group of doctors well outside the mainstream.
Families of patients dealing with severe COVID-19 are an increasingly vocal cohort. Fueled by doubts about mainstream medicine and energized by unproven alternatives, they are taking their pleas for last-ditch efforts like ivermectin from the bedside to the bench, asking courts to intervene when hospitals balk.
In a small town like Vero, the controversy quickly turned personal in July after the Cleveland Clinic refused the wishes of a family living here since the 1980s, whose patriarch was on a ventilator.
Karen Downey married her husband Ron 50 years ago after he came home to Rhode Island from Vietnam. A marine mechanic who once repaired watercraft with the Navy SEALs, Ron opened his own shop, Midway Marine, when the couple moved to Vero in 1983. They chose Vero because it seemed a good place to raise their two daughters, Karen said. Karen started a business in home decorating.
At 75, Ron Downey was healthy but had a stent for heart disease. He also had some aches and pains from a very bad motorcycle wreck two years ago, when he was slammed by a truck on S.R. 60. It was 8:30 on a Sunday morning; Ron was on his way to church. It took months of rehab at Palm Garden before he was back home, watching Red Skelton reruns again with his five grandchildren. That was Ron’s idea of bliss, his family says.
Then came COVID-19. The Downeys mostly stayed home during lockdown. After things opened up, they wore masks in crowded places, Karen said. When vaccines became available, they were in the first group to be eligible. But they turned them down, skeptical of the speed with which they were developed, and also the way they were developed.
Devout Roman Catholics, they objected to the use of fetal cell lines in developing or testing the vaccines. They are not used in the production of vaccines, though Karen is not convinced of that.
“I don’t want dead babies’ DNA in my body,” she said.
In May, the Downeys’ son-in-law, Tim Perenich, 56, got COVID. So did his wife and son. None of them were vaccinated and all of them used ivermectin. According to the son-in-law, he had the worst case of the three and was out of commission for two weeks. “I don’t know if the ivermectin had much of an effect, but I know I didn’t end up on a ventilator,” he said.
That common dovetailing of resistance to vaccination and the demand for off-label treatments like ivermectin frustrates Dr. Gerald Pierone, an infectious disease specialist. He says the misplaced trust that unproven treatments can save people encourages them not to be vaccinated.
Pierone is founder of Whole Family Health, where the Downeys went to get tested when Ron suddenly became so exhausted he needed Karen’s help to get from the bed to the bathroom.
Karen had already been sick with vomiting and fever for a week. She believes she may have given COVID-19 to Ron, and that she may have gotten it from their trip to the V.A. in West Palm, where Ron went for a check-up.
That was in late June. COVID infections had dipped in Indian River County, a welcome lull before Delta hit in full force in August. Numbers were still low when the Downeys both found out on July 6 an hour after a rapid test that they were positive for COVID. Karen was already through the worst of her symptoms. But Ron’s acute fatigue, his only symptom, just kept getting worse.
A day after the positive tests, Dr. Pierone gave Ron an infusion of monoclonal antibodies, an approved treatment aimed at avoiding hospitalization.
As he was getting the infusion, Ron’s oxygen levels suddenly plummeted to 45 percent. Karen rushed him to the ER at Cleveland Clinic Indian River. Six hours later, Ron had a room on the COVID ward. The next morning, by the time Karen got a call from the hospital, he had been taken to the ICU, sedated, intubated and placed on a ventilator.
He remained on the ventilator for four weeks, including through a court-ordered course of ivermectin. On Aug. 4 he died, with Karen and their daughter Cheryl at his side.
The Downeys had won their case to get ivermectin, but it was only for five days, not “until recovered” as a doctor’s prescription had read. Apart from a brief decrease in lung inflammation at the start of the course, it appeared to have no effect, family said.
The prescription also called for more treatments. Written by a doctor listed on a pro-ivermectin website, Front Line Covid-19 Critical Care, or FLCCC, it called for a protocol spelled out on the same website, one that involved 15 therapies, supplements and drugs, many of them used off-label.
Karen still believes that Ron might have had a chance with what she called “the full protocol.”
But in the final back-and-forth at the hearing, all that was discussed was ivermectin.
In the end, the hearing, like the ivermectin, had no effect, other than marking a couple’s last tandem act in a half-century long union. Together they had fought one of the top hospital systems in the world over a handful of pills that in the end changed nothing.
“It was heartbreaking that they wouldn’t listen to me,” said Karen.
The Delta surge had put an end to visitation in the middle of Ron’s ordeal, but eventually, the hospital allowed family to visit him again. The daily hour at his bedside was a struggle for Karen, as she prayed the rosary over Ron, with one of her two daughters who took turns driving from Tampa to support her.
Karen Downey hesitated for weeks to tell her story, though she was eager to get her message out about ivermectin and all it took to get it for her husband. When she was finally able, she told it mostly at the brink of tears.
Unlike some other unvaccinated COVID victims, she did not mention regret at not pushing Ron to get the shot, or not getting it herself.
Whether either one was vaccinated was one of the first questions the hospital asked when they got to the ER.
“They admitted they were not,” said son-in-law Perenich. “I’m suspicious that the hospital then placed them in Column B, if you know what I mean.” Column B, he explained, meant lesser quality care.
“We provide the same high-quality level of care to every patient we serve,” Cleveland Clinic said in response.
“This situation is incredibly tragic,” said Pierone, an infectious disease specialist and tireless practitioner in the community’s fight against COVID. “I feel for anyone who has lost a loved one to this disease.”
But Pierone, who for years has been involved in clinical trials including of COVID-19 treatments, is convinced that ivermectin has no place in the pandemic arsenal.
“I have reviewed much of the data on ivermectin and do not believe that it helps treat COVID-19 patients,” he said flatly.
Pierone pointed out that in August, just a day after Downey died, the largest placebo-controlled trial to date, at McMaster University in Canada, was stopped because of futility after 1,300 people were enrolled.
The AMA and two pharmacists’ associations have asked practitioners not to prescribe ivermectin, and the FDA urges people not to use it.
Yet within weeks of Downey’s death in early August, ivermectin prescriptions were soaring to more than 80,000 a week compared to the usual pre-pandemic 3,600, the New York Times reported. That despite a review of 14 studies involving 1,600 people showing no evidence that ivermectin prevented or effectively treated COVID-19, nor that it reduced deaths from the disease.
Why do so many people claim that ivermectin has been shown to work against COVID-19?
Survival after a COVID-19 infection is already at 99 percent, Pierone says, with the elderly and those with comorbidities making up most of the 1 percent who die.
That means when doctors claim dozens of their patients taking ivermectin have pulled through, they are telling the truth – those patients are not among the 1 percent who die.
Pierone says 10 percent to 15 percent of the patients showing up at his infusion clinic for monoclonal antibodies are already taking ivermectin, and they have continued to worsen.
“The delay in referral to proven life-saving treatment – monoclonal antibody treatment – has been one of the most frustrating aspects of our response to this disease,” Pierone said.
“Patients have been newly diagnosed and are often given various combinations of vitamins, ivermectin, hydroxychloroquine and corticosteroids without monoclonal cocktails even being mentioned.”
Pierone says his clinic has treated more than 500 patients since November 2020. “A small number have died, all unvaccinated of course, and all of them came to us late in the course of the 10-day eligibility window.”
Today, more than two months after her husband’s death, Karen Downey tears up frequently talking about the case.
In the end, going to court “was something I needed to do,” Karen said. “We needed to do anything we could. We prayed and we prayed, and we went to court and fought.”