A new whistleblower complaint by a former US health official details how the Trump administration's COVID-19 response was hampered by cronyism and denial about the virus's severity. The 89-page complaint filed by Rick Bright, an immunology expert who led the Biomedical Advanced Research and Development Authority (BARDA) until he says he was forced out of his position, provides an inside look at the Trump administration's approach to public health before and during the pandemic.
From spring 2017 until his "involuntary removal" last month, "HHS [Health and Human Services] leadership pressured Dr. Bright and BARDA to ignore expert recommendations and instead to award lucrative contracts based on political connections and cronyism," the complaint said. "Dr. Bright repeatedly clashed with [Assistant Secretary for Preparedness and Response Robert] Kadlec and other HHS leaders about the outsized role played by John Clerici, an industry consultant to pharmaceutical companies with a longstanding connection to Dr. Kadlec, in the award of government contracts."
For example, Bright in 2017 objected to a push "to extend a contract with Mr. Clerici's client, Aeolus Pharmaceuticals, which an IPR [in-process review] had concluded should be allowed to expire without further funding. In attempting to justify the extension of this failed contract, 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. Dr. Bright stood his ground on this contract, which led to some discord between him and HHS leadership."
In fall 2019, Bright says he "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."
In February 2020, EIDD-2801 makers "were once again seeking funding for the drug—this time, as a treatment for COVID-19." Bright says he fought the request for $100 million in part because "Emory still had not completed the clinical trials for which it had received nearly $30 million in NIH and DOD funds." Ultimately, "the award was not made prior to Dr. Bright's departure from BARDA."
In a statement to The New York Times, Clerici said he "unequivocally" denied any wrongdoing and that "it's sad that during a pandemic, Dr. Bright and his team have chosen to distract people like Dr. Kadlec, who are critical to the response, with politically motivated allegations. The record is clear that his allegations are false and will be proven so."
Trumps push for chloroquine
Bright's whistleblower complaint, which cites many internal emails and events from in-person meetings, was filed with the US Office of Special Counsel. Among other things, the complaint delves into the curious case of hydroxychloroquine, a malaria drug President Donald Trump repeatedly promoted as a coronavirus treatment despite a lack of evidence. (The FDA has since issued a warning about the drug, saying it "should be limited to clinical trial settings or for treating certain hospitalized patients.")
"In an apparent effort to score a short-term political victory for the Administration during the escalating health crisis, the Office of the ASPR [Assistant Secretary for Preparedness and Response] pressured BARDA to promote the malaria drug chloroquine as a therapeutic for COVID-19, despite a clear lack of scientific support," the whistleblower complaint said.
Bright and another concerned colleague brokered a compromise in which the drug would remain "in the hands of healthcare professionals, and out of the hands of the public," ensuring that "the drugs were administered to patients only under close physician supervision and who were known to be infected with the virus."
"Despite the brokered compromise, the Administration nevertheless continued to push for expanded, unsupervised access to chloroquine and hydroxychloroquine, in blatant violation of the EUA [Emergency Use Authorization] issued by its own FDA and regardless of the risk to the American public," the complaint said.
Bright's complaint continued:
On April 4, 2020, hours after President Trump once again touted hydroxychloroquine as a treatment for COVID-19 during a White House press conference, HHS Assistant Secretary for Health Adm. Brett Giroir, M.D., instructed FEMA Administrator Peter Gaynor, Vice Director for Logistics of the Joint Chiefs of Staff Rear Adm. John Polowczyk, and Dr. Kadlec to mobilize the nation's supply chain to "flood NY and NJ with treatment courses [of hydroxychloroquine]." Admiral Giroir issued this instruction based on orders from the White House. Mr. Gaynor likewise had received instructions from FDA Commissioner Dr. Stephen Hahn to distribute hydroxychloroquine to pharmacies nationwide, even though the EUA did not provide for outpatient use of the drug.
HHS announced its acceptance of a donation of 3 million hydroxychloroquine pills from Bayer, and the drug was "imported from factories in Pakistan and India that had not been inspected by the FDA," the complaint said.
Bright revealed details to journalist
Bright eventually concluded that "he had exhausted all avenues to alert government officials, who refused to listen or take appropriate action to accurately inform the public" and that "his only remaining avenue was to share his concerns with a journalist who had contacted him and understood the specific issue and risks associated with these drugs and who had already gathered substantial information from multiple sources."
Bright "provided information to a reporter about the specific danger to the public health and safety caused by the Administration's decision to release these untested drugs for use by the general public," the complaint said. The journalist was Katherine Eban, whose Reuters article on April 16 revealed internal emails about the Trump administration's chloroquine push.
"HHS leadership, including [HHS] Secretary [Alex] Azar and Dr. Kadlec, were already gunning for Dr. Bright's removal because of other issues he had raised about fraud, waste, and abuse, but they chose to remove him as BARDA Director within days of publication of the article about chloroquine because they suspected that he was the source," Bright's complaint said.
House hearing next week
US Rep. Anna Eshoo (D-Calif.), chair of the House Energy and Commerce health subcommittee, yesterday announced plans to hold a hearing next week to examine Bright's complaint. "Dr. Bright's whistleblower complaint raises serious concerns about the Administration's COVID-19 response including alleged gross mismanagement, waste of funds, abuse of authority, and scientific censorship," Eshoo said. "This complaint alleges that the Administration has put cronyism and internal bickering ahead of protecting the health of Americans during a pandemic."
Eshoo said she looks forward to hearing Bright's testimony "and, if possible, testimony from Health and Human Services (HHS) Secretary Alex Azar and the HHS Assistant Secretary for Preparedness and Response Robert Kadlec."
Some administration officials have said planning for Bright's departure began before the pandemic. That time frame isn't necessarily inconsistent with Bright's allegations, because he says he has been clashing with Trump administration officials since 2017.
"[P]eople familiar with the discussions said department officials had been talking about moving him out of his role for several months," The New York Times wrote on April 23.
"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," according to Politico.
Supply shortages ignored
In addition to pursuing questionable chloroquine treatments, the Trump administration was accused in Bright's complaint of ignoring warnings about the seriousness of the virus and ignoring warnings of shortages of medical supplies like masks and the drug remdesivir.
Bright provided numerous examples of his early warnings about the pandemic not being taken seriously. For instance, on January 23, 2020, "Dr. Bright attended a meeting with HHS senior leadership across all agencies to brief Secretary Azar on COVID-19. Anticipating the urgency and magnitude of the threat and knowing the lead times needed to develop new drugs, diagnostics, and vaccines, Dr. Bright pressed for urgent access to funding, personnel, and clinical specimens, including viruses, which he emphasized were all critically necessary to begin development of lifesaving medicines needed in the likely event that the virus spread outside of Southeast Asia. Secretary Azar and Dr. Kadlec responded with surprise at Dr. Bright's dire predictions and urgency, and asserted that the United States would be able to contain the virus and keep it out of the United States. Secretary Azar further indicated that the CDC would look at the issue of travel bans to keep the virus contained. Dr. Bright responded that [the] virus 'might already be here. We just don't have the tests to know one way or the other.' Dr. Bright's comments were met with skepticism and were clearly not welcome."
Instances of Bright warning about a mask shortage included a meeting on February 7, when "Dr. Bright and Dr. Anita Patel from the CDC reminded DLG [Disaster Leadership Group] members of previous FRMM [Flu Risk Management Meeting] reviews, models and publications which cited a need for up to 3.5 billion N95 masks to respond to a pandemic." The complaint continued:
Dr. Bright reiterated that the United States had a significant shortage and raised concerns that the exportation of masks further depleted an already inadequate supply. He insisted that the federal government urgently needed to place orders to ramp up productiRead More – Source
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