SCIENTIST: CONCERNS GOT HIM MOVED
Says he raised health questions about use of drug
A former top vaccine official removed from his post last month alleged in a whistleblower complaint on Tuesday that he was reassigned to a less prestigious role because he tried to “prioritize science and safety over political expediency” and raised health concerns over a drug repeatedly pushed by President Donald Trump and other administration officials as a possible cure for coronavirus.
Rick Bright, former director of the Biomedical Advanced Research and Development Authority, was removed from his post on April 20 after having served as BARDA director for nearly four years. He was reassigned to a narrower role at the National Institutes of Health that the Department of Health and Human Services touted as part of a “bold new plan” to defeat COVID-19, the disease caused by the novel coronavirus.
Bright portrays himself in the 89-page complaint as one of the administration’s health officials trying to sound the alarm about the virus as early as January. He said he called for the rapid development of treatments and vaccines, as well as the stockpiling of additional N95 masks and ventilators, at a time when HHS political leadership, including Secretary Alex Azar, appeared to him to be underestimating the threat.
He offers copies of emails that suggest he repeatedly pressed the Trump administration in January to obtain samples of the virus from China so that scientists could get to work on a vaccine and diagnostic treatments, but was met with indifference by top administration officials.
He also notes that he clashed with his boss, assistant secretary for preparedness and response at HHS Robert Kadlec, for at least two years, according to the complaint. Bright alleged that Kadlec and others pressured him to buy drugs and medical products for the nation’s stockpile of emergency medical equipment from companies that were linked politically to the administration and that he resisted such efforts.
HHS did not immediately respond to a request for comment on Tuesday.
On a call with reporters on Tuesday, Bright’s lawyers, Debra Katz and Lisa Banks, said Bright came under pressure from Kadlec to award contracts “based on political connections and cronyism,” and that he was met with indifference from top HHS officials when he tried to sound the alarm about the coronavirus in
January.
“Dr. Bright’s removal from BARDA was retaliation, plain and simple,” Katz said. Bright’s lawyers are requesting a stay of HHS’S decision to remove him from his post and to reinstate him as BARDA director while the complaint is investigated.
Bright asserts in the complaint that he resisted pressure from HHS political leadership to make “potentially harmful drugs widely available,” including chloroquine and hydroxychloroquine, which Trump has repeatedly heralded as a treatment for COVID-19, and from his Twitter account and the White House podium urged people to take both. The president’s associates, including Fox host Laura Ingraham and Trump’s personal attorney Rudy Giuliani have also pushed the drug in private Oval Office meetings and phone calls.
The document describes one such clash that occurred after Bayer offered to donate 3 million chloroquine pills to the national stockpile, which is run by HHS’S Office of the Assistant Secretary for Preparedness and Response. BARDA officials raised concerns over the donation because of a lack of evidence over the drug’s safety or efficacy.
The Bayer pills came from facilities in Pakistan and India that were not approved by the FDA and therefore were not approved for use in the United States, the complaint states.
“Government leadership was rushing blindly into a potentially dangerous situation by bringing in non-fda approved chloroquine from India and Pakistan from facilities that had not been inspected by the FDA,” Bright said on the call with reporters. “I could not in good conscience ignore the scientific recommendations to limit access to those drugs under the direct care of a doctor and instead allow political ambition and timelines to override scientific judgment.”
“That was one of the many things I pushed back on with senior leadership with HHS,” he added.
In an email as part of the exhibits of Bright’s complaint, a BARDA official wrote, “there are safety liabilities associated with the drug . . . accepting the donation could send a signal that we are not concerned about the risk.”
The official added: “I do not believe we should accept the donation [of chloroquine from Bayer] until we have an understanding on the clinical utility of the drug. Accepting the donation could lead to widespread use that is not supported by any clinical data.”
The Bayer donation ultimately went forward. Bright received an “urgent directive” from HHS general counsel Bob Charrow to make the drug widely accessible, outside of hospital settings and without close physician supervision, according to the complaint.
Bright said that he worked with the Food and Drug Administration to craft an emergency use authorization that was narrower than what HHS had sought. The FDA authorization, which applies to chloroquine from the national stockpile, is limited to hospitalized patients who cannot participate in a clinical trial.
Bright acknowledged in the complaint that his concerns over the drug’s safety led him to provide emails and information to a reporter working on a story about Bayer’s donation to the national stockpile, which further exacerbated tensions with his bosses.
Bright also said in the complaint that he raised repeated objections to the “outsized” role Kadlec allowed industry consultants to play in securing contracts for drugs that Bright and other scientists viewed as “not meritorious.” One of those mentioned was John Clerici, a pharmaceutical consultant with ties to Kadlec. Bright said he was pressured to extend a contract with one of Clerici’s clients.
Clerici, in a statement, said he “unequivocally” denied the allegations by Bright. He added, “It’s sad that during this crisis Dr. Bright and his team have chosen to launch politically motivated allegations against me and other people. The allegations are false and will be proven so.”
Officials at HHS who have spoken on the condition of anonymity have said that Bright’s departure had been discussed for months because of dissatisfaction with his job performance. Yet a 2019 performance review obtained by The Washington Post showed Bright received glowing marks.
“I rightly resisted efforts to provide an unproven drug on demand to the American public,” Bright said in his statement on April 22. “I also resisted efforts to fund potentially dangerous drugs promoted by those with political connections.”
The dangers of hydroxychloroquine have become more clear in recent weeks. A Veterans Affairs study released April 21 found that COVID-19 patients who were treated with hydroxychloroquine were more likely to die than those who were not. Three days later, the FDA warned that doctors should not use the drug to treat COVID-19 patients outside a hospital or clinical trial because of reports of “serious heart rhythm problems.”