Vaccine expert battle

Ousted vaccine expert battles with Trump team over his abrupt dismissal

Former head of HHS vaccine office claims he was transferred for opposing hydroxychloroquine.

By DAN DIAMOND

The abrupt ouster of a top vaccine expert at HHS has split officials who see it as either a boon for the nation’s Covid-19 response or the latest indication of a dysfunctional health department.

Rick Bright, the director of the Biomedical Advanced Research and Development Authority, was transferred to a new, more narrow role at the National Institutes of Health this week, an HHS spokesperson confirmed. The move was more than a year in the making — Bright had clashed with department leaders about his decisions and the scope of his authority — but came abruptly, said five current and former HHS officials.

One person familiar with the situation said Bright was frozen out of his email and learned about the reassignment only when his name was removed from the BARDA website this weekend. As of Tuesday, Bright had not accepted the reassignment to NIH, where he was tapped to work on efforts to deploy point-of-care Covid-19 testing. Gary Disbrow, Bright’s former deputy, is now BARDA’s acting leader.

Bright told The New York Times on Wednesday that he believed his removal was because of his internal opposition to pursuing investments in malaria drugs as potential treatments for Covid-19, which President Donald Trump has touted without scientific evidence. Three people with knowledge of HHS' recent acquisition of tens of millions of doses of those drugs said that Bright had supported those acquisitions in internal communications, with one official saying that Bright praised the move as a win for the health department as part of an email exchange that was first reported by Reuters last week, although Bright's message was not publicly reported.

"If Bright opposed hydroxychloroquine, he certainly didn't make that clear from his email — quite the opposite," said the official, who has seen copies of the email exchanges.

In a statement late Wednesday, an HHS official directly linked Bright's decisions to the health department's acquisition of the malaria drugs.

"As it relates to chloroquine, it was Dr. Bright who requested an Emergency Use Authorization from the Food and Drug Administration for donations of chloroquine that Bayer and Sandoz recently made to the Strategic National Stockpile for use on COVID-19 patients," spokesperson Caitlin Oakley said. "The EUA is what made the donated product available for use in combating COVID-19."

Bright did not respond to multiple requests for comment on Tuesday and Wednesday. In a statement released by his lawyers, Bright said that he will ask the HHS’s inspector general to “investigate the manner in which this administration has politicized the work of BARDA and has pressured me and other conscientious scientists to fund companies with political connections and efforts that lack scientific merit.”

Asked about Bright's claims at Wednesday's press briefing, Trump denied knowledge of his role and his abrupt ouster.

"I never heard of him," Trump said. "The guy says he was pushed out of a job, maybe he was, maybe he wasn't. You'd have to hear the other side."

Inside HHS, Bright's ouster is being positioned as a way to improve a crucial disease-fighting arm at a time of national crisis, amid some officials’ complaints that BARDA moved too slowly, focused on the wrong investments and took too long to award its contracts.

“BARDA was not as responsive during the crisis” as it could have been, said one former official. “Rather than prioritizing therapeutics that could be available in weeks, Bright focused on products that would take weeks or months.” For instance, BARDA didn’t make what’s known as a broad agency announcement to solicit potential investments in diagnostics, vaccines or treatments until March, five weeks after HHS Secretary Alex Azar declared a public health emergency over the Covid-19 outbreak.

Health officials have warned that the coronavirus crisis will plague the United States for months, with some predicting a second, more damaging outbreak of the virus this fall. Meanwhile, Food and Drug Administration Commissioner Stephen Hahn on Wednesday warned CBS News that a vaccine is at least a year away, if not longer.

HHS on Wednesday did not respond to questions about Bright’s leadership of BARDA or whether he had accepted his new role, referring instead to an earlier statement.

"Dr. Rick Bright will transfer the skills he has applied as Director of the Biomedical Advanced Research and Development Authority to the National Institutes of Health, as part of a bold plan to accelerate the development and deployment of novel point-of-care testing platforms," an HHS spokesperson said on Tuesday. "Dr. Bright brings extensive experience and expertise in facilitating powerful public-private partnerships that advance the health and well-being of the American people."

Bright, a career official, first joined BARDA in 2010 and was named as director of the $1.5 billion organization in November 2016, where he played a central role in the nation’s vaccine development, such as last year’s drive to develop a new flu vaccine, and response to biomedical hazards. BARDA also received a funding infusion from Congress as part of the Covid-19 response and has steered hundreds of millions of dollars for potential vaccines, including more than $450 million for a collaboration with the drug firm Johnson & Johnson to speed vaccine development.

But the Trump administration’s leadership team long faulted Bright for an array of management problems, including complaints about BARDA’s pace and strategy, concerns echoed by outside observers. For instance, Bright steered multiple investments with companies like Roche and Sanofi to develop what are known as IL-6 inhibitors, which target potential drivers of inflammation in Covid-19 patients with severe disease; scientists have found evidence that the IL-6 agents could prevent some of the ravages of Covid-19. But leaders and observers thought the decisions were duplicative, noting that Eli Lilly is also pursuing a government-backed investigation into IL-6 inhibitors too.

“That’s three bets on basically the same mechanism of action,” said one outside analyst with knowledge of BARDA operations. “To do it to the exclusion of all else was insane.”

Bright clashed with his boss, Robert Kadlec, the Trump administration’s assistant secretary of emergency and preparedness, over his leadership style and specific issues like whether BARDA was hewing to its mission of research and development or inappropriately expanding its portfolio into procurement too, said three people.

Two of Bright’s supporters said that BARDA was perceived to be slow because Bright — a career scientist — insisted on reviews of ideas that raised scientific concern, like the Trump administration's recent focus on hydroxychloroquine. That drug, a malaria treatment, has been widely touted as a therapy for Covid-19 despite scant evidence that it’s been helpful, but HHS officials were told last month to prioritize it.

“BARDA is a terrific organization — both Dr Bright and its staff have a lot of experience in moving quickly in emergency situations,” said Nicole Lurie, who served as assistant secretary of emergency and preparedness under the Obama administration. “Rick has a lot of integrity, which is also especially important in pressured situations where everyone is panicked.”

An individual with knowledge of BARDA operations suggested that criticism of Bright’s investments in IL-6 was wrongheaded, given that the organization continues to have flexibility in how it crafts its response. The health department also has been plagued with broader questions about its responsiveness that go beyond BARDA, such as whether its agencies appropriately coordinated with each other on Covid-19 testing.

Other current and former health officials — including a prominent Trump appointee, former FDA Commissioner Scott Gottlieb — praised Bright’s work as the organization’s leader.

“At BARDA, Rick Bright was an outstanding partner to me, to FDA, and to our shared public health goals; including the approval of a historic treatment for smallpox and a vaccine for Ebola,” Gottlieb tweeted. “I look forward to his continued contributions to advance the health and safety of our nation.”

Bright’s abrupt ouster and comments to The New York Times have sparked fears that the health department — already wracked by years of high-level fights that may have hindered the Covid-19 response — will see more turf wars, specifically within HHS' emergency-response division between supporters of Bright and Kadlec.

“It’s definitely going to be better, but it’s going to be painful for a couple weeks,” said one individual with knowledge of BARDA operations. “If it becomes a faction of Rick vs. Bob, that would be bad for the Covid response.”