Federal Whistleblower Says Boss Pushed Him to Purchase Drugs That Hadn’t Been Tested in Humans

In November, Rick Bright, then head of the Biomedical Advanced Research and Development Authority, was asked to spend millions of taxpayer dollars purchasing a drug that was presented as a “miracle cure” for viral diseases. BARDA, a division of the Department of Health and Human Services, is responsible for purchasing treatments, vaccines, and other medical products to protect the U.S. during public health emergencies. And the drug could be “a great asset to national security,” as one of the drug’s developers, George Painter, told Bright at the time.

But as Bright detailed in a whistleblower complaint filed last week, he didn’t think that BARDA should purchase the drug, known as EIDD-2801. A trained virologist who has decades of experience in government disaster preparedness, Bright had reason to worry that EIDD-2801 might be dangerous. The antiviral hadn’t undergone basic safety testing in humans, as is typically required of drugs that BARDA purchases. And similar drugs in the same class had caused serious reproductive problems in animals, with animals exposed in the womb born without teeth and with partially formed skulls.

Bright stood his ground, according to the complaint, which alleges that he was forced out of his job in April because of his resistance to pressure that BARDA purchase EIDD-2801 and other drugs pushed by industry consultants. Because of his insistence that the drug needed to be proven safe before he would discuss its purchase, the issue was temporarily tabled at the end of last year.

The episode shines a light on the muddy intersection of the pharmaceutical industry and government. It also underscores how longstanding greed and business concerns seem to have shaped the office tasked with equipping the U.S. to confront public health crises. Bright is scheduled to testify before a House committee on Thursday.

Central to Bright’s whistleblower complaint is Robert Kadlec, the assistant secretary for disaster preparedness, who proved to be a major obstacle in Bright’s efforts to ramp up the production of N95 masks. Before joining HHS in August 2017, Kadlec served as a consultant for more than a dozen companies, including Emergent BioSolutions, which received a contract worth up to $36 million for a plasma-based treatment for Covid-19 in April.

In 2018, Kadlec helped Emergent get a deal worth up to $2.8 billion for a smallpox vaccine, as the Washington Post recently reported. That contract covered a longer period of time than a previous contract and charged an increased price per dose for the vaccine, according to the story.

The basis for the pricing of the plasma-based Covid-19 treatment, for which Emergent received $14.5 million, is unclear. At press time, HHS had not responded to an inquiry about the contract.

Painter’s enthusiasm for EIDD-2801 is perhaps understandable. He had helped develop the drug and, as president and chief executive officer of Drug Innovation Ventures at Emory University, known as DRIVE, stood to profit handsomely if Bright OK’d its purchase with federal dollars.

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A consultant named John Clerici, who was also central in a campaign to promote a drug made by Aeolus, a company run by an associate of Jared Kushner, had his own personal stake in the EIDD-2801 deal. Clerici was representing DRIVE as a consultant, according to the complaint, which describes him as persistently pushing for BARDA to adopt it.

Clerici’s bio on the website of Tiber Creek Partners, a firm he co-founded that helps biotech companies obtain government contracts, identifies him as both “instrumental in the passage of legislation” that created BARDA in 2004 and central in helping pharmaceutical companies obtain funds made available through the law.

“He has assisted more than three dozen companies in obtaining over four billion dollars in funding for the research, development, and procurement of public health countermeasures to the federal government,” according to the page, which also specified Clerici’s critical role in getting funding for “the majority of awards” under Project BioShield, a $5.6 billion program designed to accelerate the development and purchase of medical products that could be needed in the case of biological, chemical, radiological, and nuclear crises.

“I am saddened that during this crisis that critical public heath leaders are being distracted by politically motivated allegations, dangerously and needlessly taking attention off of the pandemic response,” Clerici wrote in a statement to The Intercept. “I unequivocally deny the reckless insinuations in Dr. Bright’s complaint.”

Painter and Clerici weren’t the only people whose business interests seemed to be driving efforts to get BARDA funding for EIDD-2801 despite the health concerns. Kadlec, described in the complaint as a friend of both Painter and Clerici, also insisted that Bright didn’t need to wait for human safety studies before purchasing doses of the drug for the American public. Kadlec “repeatedly called” Bright and another member of his staff to ask whether BARDA was going to support EIDD-2801, according to Bright’s complaint, and brought the drug up in various staff meetings, asking if BARDA had taken any steps to move forward with it and making it clear “that he intended to push the funding through for this contract despite Dr. Bright’s objections.”

The case of EIDD-2801 is just one of several instances in which Bright faced pressure not just from lobbyists, but also from Kadlec and others on his staff described in the whistleblower’s complaint as “all well-connected, having worked with or for Republican members of Congress.” Kadlec served as staff director of North Carolina Republican Sen. Richard Burr’s Subcommittee on Bioterrorism and Public Health Preparedness from 2005 to 2007. Jennifer Alton, before serving at HHS under Kadlec while the Aeolus contract was under consideration, had also worked for Burr and for Bavarian Nordic while Kadlec was a consultant to the biotech company. Chris Meekins, who left HHS for the private sector last year, worked on biodefense stockpiles for Rep. Andy Harris, R-Md., before serving as Kadlec’s chief of staff.

The coronavirus crisis has brought long-simmering conflicts of interest in the defense preparedness realm to the fore. Disputes about hydroxychloroquine, which Trump has hyped as a treatment for Covid-19, seem to have spurred Bright’s damning complaint. The public health emergency has also dramatically increased the number of products BARDA is considering. One of them is EIDD-2801. According to the whistleblower report, although human testing had still yet to be completed, Painter again sought federal funding for the drug from BARDA in late February, this time as a treatment for Covid-19.

In an emailed statement, Emory spokesperson Laura Diamond acknowledged that Painter met with BARDA in both November and February. While the whistleblower complaint described Painter as “deliberately circumventing” a submissions process designed to streamline Covid-19-specific funding requests, Diamond wrote that Painter followed BARDA guidelines and process and noted that DRIVE has not received funding as the result of either meeting.