On Tuesday morning, the controversial and experimental coronavirus treatment program being run by a Hasidic doctor who claimed he had kept more than 500 symptomatic patients out of the hospital was shut down. By afternoon, after intervention from the White House, it was up and running again.

The doctor, Vladimir Zelenko, has been in isolation because he is immunocompromised. But he is directing perhaps the world’s most extensive, unsanctioned medical experiment related to coronavirus — the use of the anti-malaria drug hydroxychloroquine to treat Covid-19, a something President Donald Trump has been touting for days as a “game changer” in the fight against the virus.

The experiment is controversial: Trump’s top medical adviser, Dr. Anthony Fauci, has cautioned against use of the drug to treat the virus, calling evidence of its effectiveness “anecdotal.” On Monday evening, New York banned off-label use of the drug, which is also used to treat lupus and rheumatoid arthritis, outside state-approved clinical trials.

But on Tuesday afternoon Vice President Mike Pence announced on Fox News that the Food and Drug Administration was approving off-label use of the drug “right now.”

“Doctors can now prescribe chloroquine for that off-label purpose of dealing with the symptoms of coronavirus,” Pence said.



__

As a public service during this pandemic, the Forward is providing free, unlimited access to all coronavirus articles. If you’d like to support our independent Jewish journalism, click here.





Zelenko, 46, a Russian immigrant who became Hasidic as a young adult. and runs a medical practice in Orange County, N.Y., has been doing that for more than a week. His self-reported success — no deaths among any of his clients, who are almost all Hasidic Jews — has given him an audience on Fox News and across conservative news sites, as supporters of the president look to bolster Trump’s attempts to curtail coronavirus — and the economic repercussions — as soon as possible.

Though he has been operating in uncharted medical territory, backed up by only a small number of studies, Zelenko has attracted interest from other doctors looking for ways to stem the growing wave of Covid-19 hospitalizations.

“I’m not claiming any miracle cures,” Zelenko said in a telephone interview Tuesday morning. “I’m creative, and I think out of the box. We have an unprecedented health crisis — it requires unique thinking.”

Zelenko has been urging people in the ultra-Orthodox world to stay calm, even as he has sounded the alarm about potentially high rates of infection in Hasidic villages and neighborhoods. In a video message shared on WhatsApp, he said that the majority of people infected with the virus will require no treatment.

“You gotta relax,” he said, speaking from the driver’s seat of his car. “There is no room for young people to get nervous or cause hysteria, you will all be fine.”

Dr Zev Zelenko says that young people need to relax in the face of the Coronavirus pandemic, as even those of them that are affected will likely get better without any treatment. #Coronavirus#COVID19pic.twitter.com/SeHjKA2hJq— J News 24 (@JNEWS245) March 22, 2020

Zelenko has been directing his medical staff from quarantine in his home in Englewood, N.J., because he had his right lung removed last year during treatment for lung cancer. He said he is taking a low dose of hydroxychloroquine himself, prophylactically.

Zelenko said that he has been using a cocktail of drugs on his patients: hydroxychloroquine, in combination with azithromycin — an antibiotic to treat secondary infections — and zinc sulfate, which studies have suggested slows down virus replication in the body. He said he had been administering the cocktail to patients with shortness of breath of any age, and those over 60 years old or who are immunocompromised and exhibiting milder symptoms. He said he is not treating asymptomatic people under 60 who are healthy or low risk.

He acknowledged that his regimen was new and untested, and that it was too soon to assess its long-term effectiveness. But he said he thinks the rewards of implementing his treatment method are much greater than the risks of waiting to verify its efficacy, and he insisted that he is seeing only positive results from using hydroxychloroquine, in combination with two other drugs, on an outpatient basis for patients at higher risk of dying from the virus.

His patients in Kiryas Joel are facing a potentially high rate of infection, due to their density and to the village’s slowness to shut down all of its institutions in the wake of government-ordered school closures and restrictions on social gatherings. Their spiritual leader, Rabbi Aharon Teitelbaum, has been diagnosed with the virus.

Zelenko declined to say whether he was treating Teitelbaum with the regimen, but said that he could confirm that there was a “high” number of infections among the religious and spiritual leadership of the town.

Zelenko said that about 350 of the roughly 500 patients he has treated for coronavirus symptoms are from Kiryas Joel, while the other 150 live in the Monsey area, where his second clinic is located. He said he has largely not had his patients tested for coronavirus, because he worried that waiting for test results to begin treatment would compromise the treatment’s effectiveness.

Shlomo Polachek, the patient representative for Hatzalah, the Orthodox paramedic service, in Monroe, N.Y., which borders Kiryas Joel, said that the Hasidic community there has seen three hospital admissions: two on Monday afternoon and one on Saturday who was released within 24 hours.

“Here in Monroe, it seems to be an indication that it works for the people,” Polachek said of Zelenko’s experimental treatment. “It’s hard to say for sure.”

Trump has been pushing for broader use of hydroxychloroquine since last week. On Sunday he said the drug “would be a gift from heaven, this would be a gift from God if it works.”

But the experimental use of the drug goes against public-health officials’ more cautious approach. Fauci, a top doctor at the National Institutes of Health, suggested that he would only make the drug available under the auspices of a controlled clinical trial.

On Monday evening, New York Gov. Andrew Cuomo released an executive order that effectively ended pharmacists’ ability to prescribe hydroxychloroquine for use in treating Covid-19, and prohibited any experimental use of the drug outside of state-approved clinical trials. On Tuesday morning, at a press conference, he said that New York hospitals would begin using the drug that day, after Trump had encouraged him to try hydroxychloroquine on patients already admitted to hospitals.

“He sent it to me, I’m using it, today,” Cuomo said. “If it works, great.”

Zelenko said the idea behind his approach is to treat the spread of the virus in the body before it damages the lungs beyond repair. Once the lungs of a Covid-19 patient exhibit what’s called acute respiratory distress syndrome, according to WHO, the patient’s likelihood of death is about 50%, according to early estimates.

His method is based on very rough data presented in recent studies. One, from China, found that hydroxychloroquine was effective at stopping the spread of the novel coronavirus in petri dishes. A study from France released last week, based on a sample size of 40 patients, and only 26 of whom received the treatment, suggested the combination of the drug with azithromycin, a common antibiotic, appeared to be helpful in lowering the amount of coronavirus the body, and therefore buying time to treat the disease.

However neither study was comprehensive or done in a controlled setting, which is why health officials have pushed back against the use of the drug. But Zelenko said that his method, despite being untested, is necessary, as health officials predict more than 1 million deaths across the United States. He said he believes it is safe, because so far he has recorded minimal side effects.

“It’s a no brainer — in the right subset of patients,” he said.

Already, public health officials in India and Jordan have authorized use of hydroxychlorquine for treating Covid-19. Some doctors in the U.S. are using the drug to treat the disease as well, as well as using it themselves to stave off infection as they treat coronavirus patients.

Trump has latched onto it as a “game changer” in fighting coronavirus as he pushes to reopen the American economy sooner than many health experts are advising. He wrongly stated last week that the FDA had approved the drug for treating the coronavirus. FDA Commissioner Stephen Hahn said the drug would only be available “in the setting of a clinical trial — a large, pragmatic clinical trial.”

Zelenko said that he felt that hydroxychloroquine was not being taken seriously as a treatment due a combination of factors, including conservativeness on the part of the government’s medical establishment in requiring a controlled clinical trial, as well as the fact that Trump himself has been pushing for the use of the drug.

“And this is a political year, with a presidential election, and there are forces at play that would prefer to see the economy collapse rather than President Trump to look good, in my opinion,” Zelenko said.

Zelenko has already taken his message to Fox News commentator Sean Hannity’s news program. On Monday evening, on his cable TV program, Hannity also read from a letter that Zelenko said he sent to Mark Meadows, Trump’s chief of staff, and praised Zelenko’s methods.

“I’m just blown away by all this,” Hannity said in the radio interview.

STUNNING! NY Doctor Vladimir Zelenko Finds 100% Success Rate in 350 Patients Using Hydroxychloroquine with Z-Paks (VIDEO) https://t.co/Yhhnr5jgXO via @gatewaypundit— Bill Mitchell (@mitchellvii) March 24, 2020

Zelenko said that his regimen is also being studied by medical officials in Israel and Brazil.

He said that he has also been contacted by dozens of doctors interested in his regimen. One doctor who called him, Dr. Avery Knapp, a neuroradiologist with a practice in Florida, said that he realizes Zelenko’s method is untested, but wants the government to investigate to see if his results are real.

“It seems to me to be a very interesting approach,” said Knapp, who said he is not involved in treating coronavirus patients. “There’s not a lot of US studies, but he’s taking basically what a lot of hospitals are doing for inpatient, and he’s taking it one step further, which is taking it to higher risk outpatients.”

Zelenko has already been accused of exaggerating claims about the extent of coronavirus infections in Kiryas Joel. Last week, in a video shared on WhatsApp, he estimated that 90% of the village would become infected, based on receiving nine positive results from 14 tests conducted for the virus.

The video resulted in criticism from the health commissioner for Orange County, who called Zelenko’s comments “highly irresponsible” — as well as a harsh rebuke from Kiryas Joel’s Office of Emergency Management.

In a statement released on social media Tuesday afternoon, the consortium of emergency response teams linked Zelenko’s statements to anti-Semitic incidents related to coronavirus. The statement appeared to refer to an incident that occurred near Kiryas Joel Monday, in which a Hasidic man was refused service on his car at a Toyota dealership.

“The exploitation of a crisis and a community is unacceptable because it fuels Antisemitism and only exacerbates a problem, making it more difficult to manage,” the statement read.

In his interview with the Forward Tuesday morning, Zelenko acknowledged his initial estimate was wrong, but insisted that data from testing sites in Hasidic neighborhoods suggests that the community is seeing an infection rate of over 60%.

Gilman did not immediately respond to an emailed request for comment. Zelenko declines to comment on the statement from the Office of Emergency Management.

Important urgent message pic.twitter.com/f9A4XgRQnk— 𝙔𝙤𝙨𝙚𝙛 𝙍𝙖𝙥𝙖𝙥𝙤𝙧𝙩 (@YosefRapaport) March 24, 2020

Ari Feldman is a staff writer at the Forward. Contact him at feldman@forward.com or follow him on Twitter @aefeldman