Coronavirus

“Political Connections and Cronyism”: In Blistering Whistleblower Complaint, Rick Bright Blasts Team Trump’s Pandemic Response

Two weeks after being pushed out of his post, the former head of a $1.5 billion federal health agency formally accuses top officials of pressuring him to approve unproven chloroquine drugs and award pricey contracts to friends of the administration.
Image may contain Tie Accessories Accessory Coat Suit Clothing Overcoat Apparel Human Person Crowd and Audience
Photo illustration by Alicia Tatone. Photos from Getty Images.

He was pressured to invest in drugs and vaccines that lacked scientific merit, because the people selling them had friends in the Trump administration, up to and including the president’s son-in-law, Jared Kushner. He was forced to transfer funds to acquire drugs for the Strategic National Stockpile, America’s most important reserve of lifesaving medications, based not on health needs but on “political connections and cronyism.” He was instructed to use his department’s budget to purchase flu medications of questionable efficacy. And when the COVID-19 crisis erupted, he was pressured to approve a plan that would “flood” cities with unproven and untested doses of chloroquine drugs, from uninspected manufacturing plants in Asia. When his efforts to work through the system failed, he decided he had a “moral obligation to the American public” to ring the alarm about the plan, “which he believed constituted a substantial and specific danger to public health and safety.” In retaliation, he was “smeared,” with officials unfairly accusing him of dropping the ball on vaccine development and PPE preparation.

These are just some of the allegations contained in a blistering, 63-page complaint that Dr. Rick Bright, former head of the Biomedical Advanced Research and Development Authority (BARDA), filed today with the U.S. Office of Special Counsel. According to his lawyers, Bright will testify before Congress next week.

Vanity Fair has submitted requests for comment to the White House and the Food and Drug Administration, and will update this article with any responses. In a statement, Department of Health and Human Services spokesperson Caitlin Oakley said: “Dr. Bright was transferred to NIH to work on diagnostics testing—critical to combatting COVID-19—where he has been entrusted to spend upwards of $1 billion to advance that effort. We are deeply disappointed that he has not shown up to work on behalf of the American people and lead on this critical endeavor.”

Bright has become the first high-level federal whistleblower to publicly allege that the Trump administration has responded to the COVID-19 crisis by unduly pressuring health officials, and putting politics and profit ahead of science. Bright, the government’s top coronavirus vaccine developer, had spent a decade at BARDA, a small but powerful agency within the Department of Health and Human Services (HHS), whose mandate is to partner with private companies to help accelerate the development of vaccines, drugs, and diagnostics. According to Bright’s complaint, BARDA manages almost $50 billion worth of contracts and acquisitions, on an annual budget of just over $1.5 billion. He was named director in 2016.

On April 22, after HHS reassigned him to a smaller role at the National Institutes of Health, Bright alleged in a fiery statement that he had been sidelined because he “resisted efforts to fund potentially dangerous drugs promoted by those with political connections.” One of the drugs Bright identified in his statement was the malaria medication hydroxychloroquine, which President Trump had promoted extensively as a “game changer.” Bright said he had “rightly resisted efforts to provide an unproven drug on demand to the American public.”

His original statement prompted an immediate call for investigations. Rep. Frank Pallone Jr. (D-N.J.), chairman of the House Energy and Commerce Committee, asked the HHS inspector general to probe Bright’s departure, and Rep. Anna G. Eshoo (D-Calif.) announced that her subcommittee on health would hold congressional hearings.

Today’s complaint goes much further, enumerating a series of instances in which politics encroached on science. According to the complaint, Bright’s superiors at the Department of Health and Human Services began pressuring him to “ignore expert recommendations and instead to award lucrative contracts based on political connections and cronyism,” starting around the spring of 2017. Bright says he “repeatedly clashed” with his boss, Dr. Robert Kadlec, the assistant secretary for preparedness and response, over the “outsized role” played by Kadlec’s friend John Clerici, a pharmaceutical consultant. That year Clerici tried to get Bright to renew a contract with one of his clients, Aeolus Pharmaceuticals, that was set to expire. “In attempting to justify the extension of this failed contract,” Bright says in his complaint, “Mr. Clerici emphasized that Aeolus’s Chief Executive Officer was a ‘wildcard’ and a friend of Jared Kushner, President Trump’s son-in-law and a Senior Advisor to the President.”

In a statement to the New York Times, Clerici said, “I unequivocally deny all of the allegations lodged by Dr. Bright and his lawyers.”

Tensions escalated over the course of the next year, the complaint alleges, as Bright objected repeatedly to Kadlec’s efforts to award multimillion-dollar contracts to Clerici clients. Last fall Bright “rejected pressure by Dr. Kadlec to invest millions of dollars in EIDD-2801, a drug developed at Emory University by a longtime friend of Dr. Kadlec. EIDD-2081 was presented as a ‘miracle cure’ for influenza, Ebola and nearly every other virus, even though the developer had not yet conducted clinical trials and no data had been compiled to demonstrate either the efficacy or safety of the drug in humans.” That incident, the complaint says, further strained Bright’s relationship with Kadlec, setting the scene for their eventual rupture over COVID-19. “The fact that Dr. Kadlec and his staff repeatedly made decisions to benefit those like Mr. Clerici and his clients, but which were not in the best interest of the health or safety of Americans, continued to be of tremendous concern to Dr. Bright,” the complaint states.

The COVID-19 crisis only magnified the brewing conflict between scientific safeguards and political expediency. In a January 23 meeting, Bright demanded urgent access to funding, personnel, and clinical specimens necessary to develop lifesaving medicines for use in a possible pandemic. He was met with reassurances from HHS brass that the virus’s spread was under control, according to the complaint. Also in January, Mike Bowen, the co-owner of a leading mask manufacturer named Prestige Ameritech, offered to scale up production of N95 masks. “U.S. mask supply is at imminent risk,” Bowen told Bright, according to the complaint. Bowen reached out again and again in the coming days, but Bright was unable to get Kadlec and HHS to take the threat seriously, the complaint states, leading Bowen to write to Bright, saying, “Rick, I think we’re in deep shit.”

Bright’s allegations, and his refusal to accept his demotion quietly, come as the Trump administration continues to muzzle scientists and remove government watchdogs. On Friday, House Democrats said that the White House had blocked the government’s top infectious disease expert, Dr. Anthony Fauci, from testifying at an upcoming appropriations panel hearing. That same day Trump nominated a new Health and Human Services inspector general, effectively replacing the acting official who had issued a report in early April confirming that hospitals around the country were experiencing widespread shortages of critical medical supplies and protective equipment. The administration had denied that such shortages existed.

The crisis at BARDA came to a boiling point after top agency health officials found themselves under immense pressure to fulfill a vision that Trump had outlined from the White House podium: to build a stockpile of repurposed malaria drugs, hydroxychloroquine and chloroquine, that he claimed had “very, very encouraging early results.”

There was scant evidence of the drug’s utility—and plenty of questions about its safety as a treatment for COVID-19. Chloroquine drugs, which are used to treat malaria as well as autoimmune conditions such as lupus, can have serious side effects, including heart arrhythmias. One infectious disease doctor described hydroxychloroquine as a “zombie drug,” advanced as a possible treatment for acute respiratory distress in various outbreaks, including the H5N1 and H7N9 strains of avian flu, with disappointing results. “It’s back every seven years.”

It is unclear what, exactly, drew Trump administration officials to double down on hydroxychloroquine as a potential game-changing cure. On March 13, a Google Doc on the use of chloroquine drugs, which had been cobbled together by a cryptocurrency investor and a New York City lawyer, drew the attention of billionaire inventor Elon Musk, who tweeted about it on March 16.

By March 17, according to documents obtained by Vanity Fair, officials within HHS were already working to corral donations of the drug, though they seemed to know it was unlikely to amount to a miracle cure. “Not a blockbuster drug for this fight, but a good drug” is how Joe Hamel, the manager of strategic innovation and emerging technology at the Assistant Secretary of Preparedness and Response (ASPR), a division within HHS, described chloroquine treatments in an email to colleagues.

The next day a health scientist at BARDA noted to colleagues that the guidance from two HHS working groups was to “wait for clinical data on the numerous clinical trials that are ongoing before making recommendations on the use of chloroquine for COVID-19. Currently, there is no data available to support that chloroquine provides clinical benefit in the treatment or prevention of COVID-19.”

But Trump did not wait. On March 19, he first touted the drug at a White House press conference, setting off a crisis that ricocheted from the Food and Drug Administration (FDA) to HHS to BARDA, as staff looked to circumvent safeguards and load up the Strategic National Stockpile with millions of doses, procured from far-flung manufacturing plants around the globe. (The Strategic National Stockpile is a cache of equipment and supplies managed by HHS that can be accessed in the event of medical emergencies.)

This left Dr. Bright, and other top administration health officials, scrambling for answers to urgent questions about the quality, safety, and efficacy of the drugs. The debate played out inside contentious White House coronavirus task force meetings and a flurry of emails, as documents obtained by Vanity Fair reveal.

According to Dr. H. Clifford Lane, deputy director for clinical research and special projects at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), the administration proposed that the NIH launch a massive study involving as many as tens of thousands of patients. It was an idea that the NIAID flatly rejected. “We were very keen to do some studies, to figure out what effect the drug does have,” Lane says, “but in the traditional way we do it”—meaning via smaller-scale studies on hospitalized patients who could be closely monitored and evaluated.

Nonetheless, on or around March 23, administration officials devised a plan for Bright’s agency, BARDA, to sponsor a new experimental drug study, under which the chloroquine drugs could be widely disseminated.

The scheme set off a furious round of debate within HHS, as BARDA officials pushed back, concerned that broad use of the drug could pose a clinical danger to the American public.

By late March, health officials across multiple agencies had settled on an alternate plan, which they viewed as safer for patients. On March 28, the FDA issued an emergency use authorization (EUA) to allow chloroquine drugs from the Strategic National Stockpile to be administered to hospitalized COVID-19 patients who could not access clinical trials. As Bright said in a statement on his firing, “I insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician.”

But top officials appear to have ignored the restriction that Bright fought to insert into the FDA’s emergency rule. As Trump continued to expound on the benefits of hydroxychloroquine from the podium, they worked behind the scenes to move thousands of doses from the stockpile into the nation’s retail pharmacies, where patients could access the drug with a simple doctor’s prescription. In part, this was intended to assist non-COVID-19 patients struggling with shortages prompted by the president’s promotion of the drug, but there was also discussion of “off-label” prescriptions for treatment of the novel coronavirus.

On April 5, Navy Rear Admiral John Polowczyk, who leads a supply-chain task force at FEMA, spelled out the distribution plan in an email to top administration colleagues: “Distro to Hospitals and retail pharmacies and geography: NYC area - 100k to hospitals, 150k to retail Detroit - 50k to hospitals, 100k to retail Chicago - 50k to hospitals, NO - 20k hospitals - 50k retail Total hospitals - 220k hospitals, 400kretail. Total 620k first shipments.”

This resulted in a query from an official within ASPR’s Strategic National Stockpile division: “All, just wanted to assure everyone is aware that the EUA,” the FDA’s emergency rule, “for hydroxychloroquine and chloroquine (see attached) appears to limit use to the treatment of hospitalized patients.” A FEMA spokesperson referred questions about the distribution plan described by Polowczyk to HHS and the FDA.

But with Trump cheerleading wide use of the drug, his top appointees appeared uninterested in the more restrictive fine print. Only after a study of veterans with COVID-19 found that patients treated with chloroquine died at twice the rate of those who didn’t get the drug did Trump scale back his cheerleading. By then Rick Bright had fought all he could within the system to limit the drug’s use. Within a week of the study’s publication, Bright had been pushed out of BARDA and decided to blow the whistle.

More Great Stories From Vanity Fair

— Inside Donald Trump and Jared Kushner’s Two Months of Magical Thinking
— How Andrew Cuomo Became the Coronavirus Trump Antidote
— What Do Your Genetics Have to Do With Your Chances of Dying From Coronavirus?
— Trump’s Scientific Ignorance Is Crippling His Coronavirus Response
— How to Work From Home, According to Neuroscience
— From the Archive: The Untold Story of Dallas’s Heroic Ebola Response

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