WASHINGTON — 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 as a possible cure for coronavirus.
Rick Bright, former director of the Biomedical Advanced Research and Development Authority, was removed 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 improve testing to defeat COVID-19, the disease caused by coronavirus.
Bright portrays himself in the 89-page complaint as an administration health official trying to sound the alarm about the virus beginning in early January. He said he called for the rapid development of treatments and vaccines, as well as the stockpiling of additional N95 face masks and ventilators, at a time when HHS political leadership, including Secretary Alex Azar, appeared to him to be underestimating the threat.
He also notes that he clashed with his boss, assistant secretary for preparedness and response at HHS Robert Kadlec, for at least two years. Bright alleges 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 issued a brief comment Tuesday afternoon that did not address Bright’s allegations.
“Dr. Bright was transferred to NIH to work on diagnostics testing — critical to combating COVID-19 — where he has been entrusted to spend upwards of $1 billion to advance that effort,” said HHS spokeswoman Caitlin Oakley. “We are deeply disappointed that he has not shown up to work on behalf of the American people and lead on this critical endeavor,”
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.”
“Dr. Bright’s removal from BARDA was retaliation, plain and simple,” Katz said. Bright’s lawyers are requesting that HHS reinstate him as BARDA director while his 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, and urged people to take both from his Twitter account and the White House podium. The president’s associates, including Fox host Laura Ingraham and Trump’s personal attorney Rudy Giuliani, have also pushed the drug as a treatment for COVID-19 in private Oval Office meetings and phone calls.
The document describes one such clash in mid-March after Bayer offered to donate 3 million chloroquine pills to the national stockpile, which is run by HHS’ 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 included 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.
But that raised safety alarms with certain FDA officials, according to the complaint. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, urged Bright to request an emergency use authorization from the FDA that was far narrower than what HHS sought. The authorization that was issued, which applies to chloroquine and hydroxychloroquine from the national stockpile, is limited to hospitalized patients with COVID-19 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.
Another issue he raises in the complaint is the administration’s response on N95 face masks. He alleges in the complaint that for nearly five weeks, HHS leadership failed to head warnings the country was facing a massive shortage of protective equipment for health care workers. In that time, a major U.S. manufacturer contacted Bright, offering to activate mothballed production lines, but Bright could not get traction with superiors to fund the effort, the complaint states. Instead, sensing no urgency from the U.S., Prestige Ameritech proceeded to export a million masks to China, according to the complaint. Prestige Ameritech did not immediately respond to a request for comment.
Bright also says 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 first public 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.”
Bright includes emails in his filing to document that he repeatedly pressed top HHS officials in January to obtain samples of the virus from China so that scientists could get to work on a vaccine and diagnostic treatments, but got no traction.
In another email provided as part of the complaint, Brett Giroir, the administration’s testing czar, wrote, “Really want to flood Ny (sic) and NJ with treatment courses,” referring to hydroxychloroquine.
Bright’s removal last month drew criticism from congressional Democrats. Rep. Anna Eshoo of California, is chairwoman of the House subcommittee on health, called Bright a “thoroughbred professional” and vowed to hold a hearing on the matter.
Bright is represented by the whistleblower attorneys retained by Christine Blasey Ford, who alleged that Supreme Court Justice Brett Kavanaugh sexually assaulted her when they were teenagers.
At the time of his departure from BARDA, several senior administration officials expressed dismay, saying the change was disruptive, especially in the middle of the government’s coronavirus response, and would cause further turmoil at the health agency. Others, however, said BARDA was moving too slowly on COVID-19 treatments and vaccines, and that the agency had problems that predated this crisis.
Bright’s statement, nevertheless, has made him a hero among some in the scientific community, who have expressed concern for weeks about the president’s claims about hydroxychloroquine and chloroquine.
The Washington Post’s Aaron Davis and Ellen Nakashima contributed to this report.