None
header-image

Looking past concerns about the drug’s safety, not to mention his own agency’s recommendations, Stephen Hahn took time during the COVID-19 crisis to lend a helping hand to Dr. Vladimir Zelenko, a hero among fringe Trumpworld figures.

It was Sunday, April 5, and Dr. Stephen Hahn, the commissioner of the U.S. Food and Drug Administration, faced a world of problems. Less than two months after the first American death from COVID-19, the U.S. health care system was under siege, with more than 300,000 confirmed cases of the new disease—the most of any nation in the world—and almost 10,000 deaths. Hahn was under fire over faulty test kits the FDA had approved, and angry members of Congress were demanding that his agency prevent the hoarding of an old malaria drug called hydroxychloroquine, which President Trump was hyping without evidence as a miracle cure.

Nevertheless, Dr. Hahn found time that afternoon to carry out an unusual mission. He contacted an obscure family practitioner in Monroe, New York, with whom he had never before been in touch, to ask if the doctor had “time for a quick call.” Once on the phone with Dr. Vladimir Zelenko, Hahn posed a question: How could he—the commissioner of a federal health agency with a $5.7 billion annual budget and the responsibility to safeguard the nation’s drugs, medical devices, and food supply—be of help?

Zelenko was a 46-year-old “simple country doctor,” as he described himself to the New York Times, who claimed to have witnessed positive results after prescribing a cocktail of drugs including hydroxychloroquine to patients in the Orthodox Jewish community of Kiryas Joel, New York. His message aligned perfectly with the pronouncements Trump had been making from the White House podium: that hydroxychloroquine, when used early and liberally, was a game-changing treatment for COVID-19. That, in turn, had earned Zelenko a growing platform on right-wing media.

Two days after that first phone call, in a series of text messages obtained by Vanity Fair, Zelenko returned to Hahn for help setting up a clinical trial of some 750 outpatients at St. Francis Hospital in Roslyn, New York. “The Catholic Health System (St. Francis Hospital) / Dr Zelenko COVID-19 trial is ready to go,” Zelenko wrote to Hahn, copying one of the hospital’s doctors involved in the trial. “We need ASAP 1. Hydroxychloroquine 200mg. 10000 pills 2. Azithromycin 500mg 5000 pills 3. Zinc sulfate 220 mg 5000 pills This treatment will be deployed in outpatient primary care.”

Hahn responded, “Not sure what the ask of FDA is.” To which Zelenko replied, “We need the medication to run the study.” Hahn then asked, “Do you have IRB approval?” This referred to an institutional review board that hospitals use to oversee clinical trials and research. The doctor answered, “Hopefully this week.”

“Congratulations,” Hahn offered. “Really well done.” He then advised the doctor to reach out to the Federal Emergency Management Agency (FEMA) to obtain hydroxychloroquine from the Strategic National Stockpile, a federal cache of emergency equipment and supplies managed by the Department of Health and Human Services (HHS). When the doctor expressed uncertainty over how to do that, Hahn offered, “I’ll send you the contact.”

Federal agency chiefs normally focus on high-level problems and solutions, delegating any ground-level efforts through the chain of command. Assisting with a lone clinical trial hardly seemed worthy of the commissioner’s time. More troubling, perhaps, was the question of why Hahn—whose agency two weeks earlier had established restrictions on the use of certain chloroquine drugs in the national stockpile to hospitalized patients, as a way to avert potential risk to patients—appeared to be bending over backward to assist a doctor who, in line with President Trump, was advocating unfettered use of the drug.

Hahn, 60, a radiation oncologist who previously served as chief medical executive of the University of Texas MD Anderson Cancer Center, has repeatedly insisted that he has felt no political pressure while carrying out his agency’s pandemic response. “I can assure you 100% that the president has never pressured me to make a decision regarding any regulatory aspect of the FDA’s work,” he recently told the Washington Post.

But Hahn’s previously unreported intervention on behalf of Zelenko—who was both promoting a COVID-19 treatment that the government’s top medical experts had warned against and seeking drugs that the FDA’s own rules restricted—calls his claims of independence into doubt. “I am pretty appreciative to Stephen Hahn,” Zelenko told Vanity Fair in an interview. “I think he helped in this process.”

The FDA declined Vanity Fair’s request to interview Dr. Hahn. FDA spokesman Michael Felberbaum instead provided a statement: “Throughout the pandemic, the FDA has heard from people across all levels of government, academia, industry, and the public interested in providing or seeking assistance or information from the agency. In that vein, Dr. Hahn and others at the FDA have connected with a variety of entities on ways to combat COVID-19 and put them in touch with the appropriate people for follow-up, including agency staff who assess the science and the data regarding potential prevention and treatment options.”

But experienced observers of the FDA find Hahn’s conduct troubling. “The primary import of his action is to add the agency’s scientific weight to these unproven claims put forth by Trump and Zelenko,” said Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former associate FDA commissioner. “It feels like so much about Trump and this epidemic. You say one thing and you encourage something else. ‘We’re providing it under restricted conditions, but—wink-wink—you have little to fear in providing it in situations beyond that.’”

In the weeks following their first phone call, as Hahn continued to assist Zelenko, the commissioner found himself a party to Zelenko’s growing political entanglements. By April 26, Hahn had been copied on an email alongside Trump chief of staff Mark Meadows and former New York City mayor turned Trump lawyer Rudy Giuliani. The email was sent to Zelenko by Jerome Corsi, a right-wing conspiracy theorist who had been investigated as part of the Mueller probe. In it, Corsi—who is involved in a for-profit telemedicine platform where doctors prescribe hydroxychloroquine—expressed his anxieties about the “heavy legal scrutiny” facing the drug.

A growing body of clinical studies indicates that hydroxychloroquine is ineffective in treating COVID-19 and may actually increase mortality. The World Health Organization, the National Institutes of Health, the FDA, and the pharmaceutical company Sanofi, which sells hydroxychloroquine under the brand name Plaquenil, have all issued guidelines cautioning against the kind of early, prophylactic use of the drug that Trump has hyped and Zelenko advocates. On Friday a retrospective study of 96,000 COVID-19 patients on six continents, published in the medical journal The Lancet, found that hospitalized patients treated with hydroxychloroquine and an antibiotic—part of the drug combination Zelenko has plugged—were 45% likelier to die.

Zelenko claims that clinical trials of hydroxychloroquine with poor outcomes are part of a political conspiracy from a “corrupted” medical establishment, and are “clearly designed to fail and to substantiate a false narrative.” Last week Trump claimed, honestly or not, that he himself had been taking hydroxychloroquine.

President Trump began touting hydroxychloroquine from the White House podium on March 19, claiming there were “very, very encouraging early results.”Dr. Hahn, who was also present, offered a more measured assessment, stating that “a large, pragmatic clinical trial” could help answer the question of the drug’s effectiveness.

His caution reflected the doubts of top federal clinicians and scientists. In early March, the director of the influenza and emerging infectious diseases division within HHS’s Biomedical Advanced Research and Development Authority (BARDA) wrote to a colleague that the drug had “not panned out to clinical benefit,” according to an internal email obtained by Vanity Fair. Others flagged the drug’s well-established risk of cardiac arrhythmias.

Nonetheless, the White House was moving ahead with a plan to promote the drug and launch a vast clinical trial. On March 19, Trump alluded to that plan when he declared that the government would be “quickly studying this drug…as it’s given out to large groups of people, perhaps in New York and other places.”

Two days after that press conference, Dr. Zelenko uploaded a video to YouTube in which he addressed the president directly. Zelenko claimed that he had used hydroxychloroquine early on hundreds of patients, not a single one of whom had been hospitalized. He even advocated treating patients with his regimen of hydroxychloroquine, zinc, and azithromycin before confirming a diagnosis, as he believed clinical intuition was more important than a positive test. In the video, he told Trump, “I am suggesting that you please advise the country that they should be taking this medication in an outpatient setting.” He added, “I personally love you.”

The day after Zelenko uploaded the video, Trump’s chief of staff, Mark Meadows, contacted him to ask for his patient data. Meadows did not respond to an email seeking comment.

Two days later, on March 24, the federal government’s top interagency medical countermeasures group recommended that chloroquine-based COVID-19 treatments should be studied only in controlled, hospital-based clinical trials, as their safety and efficacy were “not supported by data from reliable clinical trials” and carried “potential risks.” On March 28, the FDA issued its EUA allowing chloroquine drugs from the Strategic National Stockpile to be administered only to hospitalized COVID-19 patients who could not access clinical trials.

Remarkably, the recommendation did nothing to curb the Trump administration’s ambition to “flood New York and New Jersey” with treatment courses obtainable even at drugstores, as spelled out in a series of internal emails first obtained by Vanity Fair. Inside the federal government, career officials had been pushing back for weeks against a White House plan they considered dangerous, but by the evening of Saturday, April 4, it was clear that Hahn had fallen in line with the administration. “Hahn asked to distribute to hospitals and the drug stores,” FEMA administrator Peter Gaynor wrote to colleagues in an internal email.

It was the following day when Hahn first reached out to Zelenko.

Hahn’s services on behalf of Zelenko included a personal introduction to the director of the National Library of Medicine, a division of the National Institutes of Health that oversees clinicaltrials.gov, the website where any legitimate clinical trial must be listed in order to publish study results in a peer-reviewed journal. In a statement, a spokesperson for the National Library of Medicine said that Zelenko had contacted the director, Patricia Flatley Brennan, and “shared lessons learned from treating patients that he thought would be valuable to others. Dr. Brennan suggested that he write up a case report for publication.”

As Zelenko worked with St. Francis Hospital to hammer out the details of a clinical trial that would test his preferred cocktail of hydroxychloroquine, zinc, and one of two antibiotics— azithromycin or doxycycline—on COVID-19 outpatients, Hahn intervened. He shared the contact information for a FEMA official with hospital investigators, so St. Francis could obtain hydroxychloroquine directly from the Strategic National Stockpile.

“Stephen Hahn helped us get medication,” Zelenko said. “We were having trouble—he advised us who to talk to in FEMA.”

One current HHS official said of Hahn’s intervention to help a single hospital get stockpiled drugs, “That is way outside what one would consider normal for a commissioner to do…. I have never heard of anyone at FDA doing anything like that.”

Dr. Avni Thakore, a cardiologist at St. Francis Hospital and the study’s principal investigator, told Vanity Fair that the study of hydroxychloroquine in COVID-19 patients seemed like a natural fit for the hospital, which has a national reputation in cardiac care. “It is a safety protocol,” she said of the study, which plans to remotely monitor the heart rhythms of trial enrollees by providing them with mobile electrocardiogram devices. She also emphasized that the trial was inspired not only by Zelenko’s clinical observations, but also by other sources: “early results from some small studies, and observational reports, doctors sharing their observations, all of that combined.”

As Zelenko’s celebrity grew, he became a fixture on podcasts hosted by Jerome Corsi and, through him, Rudy Giuliani. Before long, Corsi himself would contact Hahn.

Corsi, who obtained a Ph.D. in political science from Harvard in 1972, is the best-selling author of books questioning John Kerry’s war record and Barack Obama’s citizenship. He briefly served as the Washington, D.C., bureau chief of Infowars, the conspiracy website run by Sandy Hook truther Alex Jones, though he later sued Jones for defamation. He became a target of the Mueller investigation as a result of his contacts with Roger Stone and his alleged foreknowledge of WikiLeaks document dumps. The Mueller team eventually declined to press charges, and Corsi sued Stone for defamation.

In late April, Corsi was planning a promotional campaign for a telemedicine platform on his website, corsination.com, that enabled doctors to conduct video consultations with patients and directly prescribe them hydroxychloroquine and other drugs. According to Corsi’s marketing materials, Dr. Zelenko would serve as the program’s medical director.

But on April 20, Corsi accidentally emailed those marketing plans not to Zelenko but to Aaron Zelinsky, a U.S. prosecutor who’d worked on the Mueller investigation—a mishap first reported by the Washington Post. Zelinsky, now spearheading a COVID-19 fraud-fighting task force out of the Maryland U.S. Attorney’s Office, scrutinized the materials and zeroed in on Corsi’s claim that “Zelenko has an FDA approved randomized test of HCQ under-way.” No such trial was listed on clinicaltrials.gov, raising the prospect of fraud.

Zelenko said he had mistakenly made the claim to a group of physicians in the telemedicine program, having confused approval from the hospital’s institutional review board with FDA approval. “I kind of misspoke,” he told Vanity Fair. He also said he had agreed to serve as an unpaid medical adviser, not a paid director, for Corsi’s telemedicine program.

When Zelinsky inquired about the erroneous claim, Corsi and Zelenko panicked. Zelenko appealed for help to a doctor at St. Francis Hospital who was one of the study’s principal investigators. The doctor wrote a “To Whom It May Concern” letter on April 22, stating: “Dr. Zelenko not only embraced the idea of a controlled trial, but has been instrumental in helping us develop the trial to the point where, in less than two weeks, we are ready to initiate it.”

On Sunday, April 26, Corsi expressed his concerns in an email to Zelenko that Vanity Fair obtained. Corsi cc’d the message to a large and unlikely group: Dr. Hahn; Mark Meadows (via his personal email); Giuliani; a volunteer paramedic director in Orange County; a rabbi; the lawyers for Corsi and Zelenko; and two of the doctors involved in the fledgling St. Francis clinical trial. (Reached by Vanity Fair, Corsi declined to comment on his decision to copy Hahn and the others on the email.)

Corsi noted in the email that the “HCQ issue is under heavy legal scrutiny.” Taking Zelenko to task for making inflated scientific claims about his protocol, Corsi wrote, “I am concerned that you have to speak very precisely.” He went on to stress how scrupulous he had been about following the letter of the law in setting up the TeleMD program: “under advice by legal counsel, emphasizing that we are marketing a teleconference with an MD who can legally write prescriptions for HCQ.”

The email had the quality of skywriting, as if it were intended to telegraph to the email recipients, and to any federal prosecutor, Corsi’s commitment to scientific legitimacy. It is not clear what impact the email had. But one recipient of the email described it as a “CYA” effort.

The doctors at St. Francis Hospital, who were copied on the email, submitted their clinical trial design to clinicaltrials.gov that same day, though it is unclear whether they did so before or after receiving Corsi’s email. Within six days the trial was posted on the website, complete with what appeared to be an imprimatur of legitimacy, a National Clinical Trial number.

In an interview, Corsi was keen to assert his view that the posting of the clinical trial “makes legitimate what Dr. Zelenko was saying…on a government website, a government-recognized clinical trial.”

— Trump Whines About His COVID-19 Victimhood as Campaign Flails
— Why Creating the Post-Coronavirus New Normal Is a Job for Individuals
Massive Corporate Deals Are Making Hospitals’ PPE Shortages Worse
— The United States Is Woefully Unprepared for a COVID-19 Election
— In a Secret Superrich Session, Barry Sternlicht Sketches an Optimistic New Normal
— Coronavirus Has Recast America as a Global Chump
— From the Archive: Exposing Wall Street’s Pharmaceutical Problem

Looking for more? Sign up for our daily Hive newsletter and never miss a story.

From: VANITYFAIR