Doctor who promoted malarial drug draws scrutiny of federal prosecutors

A federal prosecutor has opened a preliminary inquiry into whether an obscure New York doctor who won White House attention by claiming he could treat the coronavirus broke the law by falsely claiming that a hospital study of drugs he had promoted had won federal approval.

Sharon LaFraniere and Kevin RooseThe New York Times
Published : 2 May 2020, 09:33 AM
Updated : 2 May 2020, 09:33 AM

The doctor, Vladimir Zelenko, wrongly claimed that the Food and Drug Administration had backed a study of a drug cocktail that he asserts is effective in treating COVID-19, the disease caused by the virus. Through a misdirected email, that claim came to the attention of Aaron Zelinsky, a federal prosecutor in Baltimore working on fraud cases arising out of the pandemic.

Zelenko, known as Zev, had claimed the study had the FDA’s approval to Jerome Corsi, a conservative commentator who figured in the special counsel’s investigation of Russian interference in the 2016 election. Corsi then repeated that claim in an email he mistakenly directed to Zelinsky instead of to the physician, he said in a podcast this week.

Zelinsky, a former member of the special counsel’s team that investigated Russian interference in the 2016 presidential election, had dealt with Corsi while working on a criminal case that led to the conviction of Roger Stone, President Donald Trump’s longtime friend.

Corsi said that Zelinsky promptly checked and discovered that the study was not FDA-approved, then requested all Corsi’s communications with the doctor. Corsi’s lawyer, David Gray, said Corsi voluntarily turned over the information. The inquiry was first reported by The Washington Post.

In an interview Friday, Zelenko said that he was guilty of nothing more than sloppy wording.

“I’m a clinician, not a researcher,” he said. “I don’t understand fully the language of clinical research.”

He said the misunderstanding stemmed from a lecture he gave last month to a group of physicians over the videoconferencing app Zoom, which Corsi attended. During the lecture, Zelenko claimed that the clinical trial he was helping organise, sponsored by St Francis Hospital in New York, had been approved by the FDA. In fact, only the hospital’s internal review board had approved it.

Zelenko said he had the impression that his study had the government’s seal of approval because he had spoken with Stephen Hahn, the FDA’s commissioner, who discussed the findings with him and helped him locate medicine for the trial, he said.

“In my mind, that led me to think it was FDA-approved,” Zelenko said. “In reality, it was a mistake.”

Zelenko said that he had not been contacted by the Justice Department and that he learned of the inquiry from Corsi’s public statements.

Corsi said he believed that the doctor never intended to deceive anyone. “He can’t speak precisely about something he doesn’t understand,” he said.

A self-described “simple country doctor,” Zelenko proposed a three-drug cocktail of an antimalarial medication called hydroxychloroquine, the antibiotic azithromycin and zinc as a treatment for COVID-19 after seeing numerous patients with symptoms of the disease. He is not the first, nor the only, doctor to propose antimalarial drugs as a treatment.

But his claims that he could cure the disease by treating it aggressively in the early stages, which he played up in a YouTube video that he addressed to Trump, caught the attention of the president’s inner circle. After the video went viral, Mark Meadows, the White House chief of staff, contacted him. Rudy Giuliani, Trump’s personal lawyer, also publicly praised the doctor. The video has been taken down.

For weeks, Trump himself promoted hydroxychloroquine as “very effective” and possibly “the biggest game changer in the history of medicine.” The right-wing news media also seized on the potential of antimalarial drugs as a treatment.

Since then, more evidence has emerged that hydroxychloroquine and azithromycin may not be effective at treating the coronavirus and may in fact be harmful because of the risk of severe side effects. The FDA warned in April that hydroxychloroquine, either on its own or in combination with azithromycin, should not be administered to treat COVID-19 outside a hospital setting or in a clinical trial, saying it could cause heart rhythm problems.

But Zelenko has remained firm in his conviction, sending regular updates about new studies and patient testimonials to a contact list that includes reporters and government officials in several countries. “I am more emboldened,” he said in a voice memo April 22.

Hydroxychloroquine and azithromycin are now being used in several clinical trials to determine their efficacy against the virus, including a trial conducted by the Rutgers Cancer Institute of New Jersey and another by the pharmaceutical company Novartis, which is studying the effect of hydroxychloroquine alone.

© 2020 New York Times News Service