Should a decades-old lice medication be used to treat COVID-19? These Florida doctors are

Several South Florida doctors are using an anti-parasitic drug for lice and pinworms to treat COVID-19 patients. The drug has not been given the green light to treat the novel coronavirus, although trials are underway, and the National Institutes of Health recommends against using it that way.

Despite the skepticism and the red flag, a Florida Keys physician who runs three clinics along the island chain says more than a dozen of his patients have recovered after getting doses of ivermectin. Dr. Bruce Boros of Key West said he has been giving it to COVID patients for months and said they are encouraged by the results.

“It stopped them from the downward slide they were on,” Boros said.

But national medical researchers aren’t on board.

The National Institutes of Health’s COVID-19 Treatment Guidelines Panel two weeks ago recommended against using ivermectin, first approved as an anti-parasitic drug in 1975, to treat the coronavirus outside of clinical trials.

And the U.S. Food and Drug Administration posted on its website in May that the use of ivermectin to treat or prevent COVID-19 “should be avoided as its benefits and safety for these purposes have not been established. Data from clinical trials are necessary for us to determine whether ivermectin is safe and effective in treating or preventing COVID-10.”

The FDA also warned against self-medicating with invermectin that is prescribed for veterinary purposes. It’s used as a prophylactic against heartworm.

The NIH, in its recommendation against prescribing ivermectin as a COVID treatment, mentioned a Broward County doctor’s study, saying the document lacked enough information to conclude the drug was a significant factor in the sampled patients’ recoveries. “The limitations of this retrospective analysis make it difficult to draw conclusions about the efficacy of using ivermectin to treat patients with COVID-19,” the NIH statement reads.

Clinical trials

Despite what some consider its promise in treating COVID-19, not only in South Florida, but in India, Bangladesh, Peru and Colombia, many doctors and pharmacists globally have warned against prescribing ivermectin until more peer-reviewed clinical trials are conducted.

Andrew McLachlan, dean of pharmacy at the University of Sydney in Australia, wrote in an article published this month in The Conversation that so far, the study that started the fervor for ivermectin as a possible COVID treatment used monkey cells in a test tube, and the doses of the drug used would be dangerous to humans.

“This means ivermectin’s virus-killing powers would be unlikely to be harnessed inside the human body,” McLachlan wrote.

There are more than 30 clinical trials being conducted worldwide researching the drug’s potential as a COVID-19 treatment.

Broward hospital approval

Broward Health has approved the anti-parasite drug for its “portfolio” of medications its doctors can use to treat COVID-19 after one of its physicians theorized dozens of his patients beginning in April recovered after taking it, said Dave Lacknauth, executive director of pharmacy services and system integrative at the four-hospital network.

“We think of it as helping stop the viral replication early on in the process,” Lacknauth said.

However, even proponents of the drug stress it is not a cure, and Lacknauth said years of peer-reviewed clinical trials will likely be needed to conclude if ivermectin was truly instrumental in patients’ recoveries, or if they would have gotten better without taking it.

“The reason why we use it is we don’t know what’s working and what’s not working because there are so many variables. We consider it part of our portfolio of success for patient recovery,” Lacknauth said. “We won’t know for sure if it works for about two or three years after there are more controlled trials.”

The other drugs in the “portfolio” are hydroxychloroquine and remdesivir. All three are used for their potential to stop the novel coronavirus from replicating itself in human lungs, Lacknauth said. And, they are usually given in a cocktail that includes vitamin C and zinc.

Hydroxychloriquine, an anti-malaria drug, became controversial after President Donald Trump touted its unfounded efficacy against COVID in March, and because of its potential risk for causing dangerous heart rhythm problems.

But Lacknauth said unlike hydroxychloroquine, ivermectin causes few side effects, and they are usually “pretty benign,” he said.

“We haven’t seen any negatives with it,” Lacknauth said. “If it could help, we want to have it.”

Florida Keys treatment

Boros, a cardiologist who owns and operates all three of the Keys’ Advanced Urgent Care clinics, was one of the earliest healthcare professionals along the island chain to sound the alarm about the dangers of the novel coronavirus, urging social distancing and mask-wearing.

He was also a vocal proponent of the highway checkpoints that went up in late March to keep tourists outside the Keys in what turned out to be a successful effort to stop the disease from spreading throughout the archipelago.

Soon after the checkpoints came down June 1, COVID-19 cases spiked in the Keys. By July, there were hundreds of cases. There are now more than 1,700.

One of those ill with the virus earlier this summer was Kyle Carter, a 45-year-old music promoter living in Key West.

Carter is a big man. He stands six feet, four inches and weighs around 290. He’s had several surgeries in his life, but is otherwise healthy. On July 3, he was helping a friend empty out a trailer in the summer heat. He felt a little weak, but he didn’t think too much about it.

“The sun in Key West is enough to do it to you,” he said. “COVID crossed my mind, but I didn’t think it was a big deal.”

For about three days, he felt like he had the flu. By Day 5, he had a fever of more than 103 degrees, “and I’m really feeling pretty awful,” Carter said. Five days later, he had a bad cough and trouble breathing. On the 11th day of the illness, Dr. Boros’ staff X-rayed his lungs and the right one was filled with fluid. He tested positive for COVID-19 and had developed viral pneumonia.

Boros told him about ivermectin, which he had been reading about as a possible treatment for COVID, and asked him if he wanted to try it. He did.

“By that point, I would try anything,” Carter said.

Boros said that Carter was on the verge of having to go on a ventilator, which he said is when most deaths occur.

“He was really sick,” Boros said. “He was going down the tubes fast and was going to wind up on a ventilator.”

Starting around 4 p.m. that day, Boros gave Carter a large dose of ivermectin, 18 3-milligram pills over the next four hours. Carter took nine pills at first, five more about two hours later, and the rest of the dose early the next morning. Boros was worried at first about how much to give Carter since there are no established guidelines about using the drug to treat COVID. But he was more concerned about how fast his patient’s condition was deteriorating.

“There’s nobody to tell us about what to do here,” Boros said.

“Within 12 hours, I’m starting to feel better. Twenty-four hours later, I’m out of the hospital and my actual symptoms have gone away,” he said. “I could speak entire sentences without having to cough.”

Other than a slight malaise, Carter said last week he is symptom free.

Boros believes in ivermectin’s effectiveness so much that he gives it to all his patients showing signs of COVID-19, especially since the drug has few known negative side effects.

“It’s really the answer,” he said.

And, more importantly, the sooner patients start treatment, the better the outcome, he said. That’s because COVID-19 is a virus that is built on ribonucleic acid, which allows it to quickly reproduce itself inside the human body. Boros and other advocates of ivermectin believe the drug stops the RNA replication of the virus.

Boros isn’t the only, and not the first, South Florida to treat patients with ivermectin.

In Fort Lauderdale

Dr. Jean-Jacques Rajter, a Fort Lauderdale pulmonologist with the Broward Health system, began prescribing ivermectin in April, and his reported patients’ outcomes led the hospital system to approve it as a COVID-19 treatment.

Early that month, one of his patients in the hospital was very ill with COVID-19. She required 50 percent oxygen to breathe. The woman’s son was persistent that more could be done for his mother before she would have to go on a ventilator.

Rajter’s wife, Dr. Juliana Cepelowicz-Rajter, also a pulmonologist, had read a recent study out of Australia where high doses of ivermectin killed COVID cells in the lab. The woman’s son read about the same study and asked Rajter if his mother could be treated with the drug.

But Rajter said the levels used in the study could be toxic if given to a person. The son then asked about the approved dose for humans, which is 200 micrograms per kilogram of weight.

“I said, ‘I’m not sure if it’s going to work or not.’ He said, ‘Any drawbacks of trying it out with my mom?’ ” Rajter said in an interview Thursday.

The woman agreed to the treatment, and the results were almost immediate. Within 48 hours, she showed significant improvement. Rajter was so encouraged that he successfully treated two more critically ill patients with ivermectin that month.

And, at around $7 a pill, it’s an inexpensive protocol.

Rajter co-authored a retrospective study in June that he has submitted to scientific journals for publication that assessed 280 adult COVID-19 patients. One-hundred-seventy-three of the participants were given ivermectin and 107 were treated with standard care.

The overall mortality rate of those given the drug was 15 percent, compared to 25 percent of the other sample group, Rajter said.

More importantly, he said, was that of the high-risk patients participating in the study, who were suffering from severe pulmonary disease, 81 percent of those not receiving ivermectin died, compared with 39 percent of those taking the drug.

Rajter and Boros said they don’t dispute the need for more studies. They both say the positive results they attribute to ivermectin in their patients beg the need for more clinical trials.

“This is not the final chapter,” Rajter said. “It indicates that this needs extensive study.”