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A new whistleblower complaint from a former U.S. health official describes how the Trump administration's COVID-19 response was hampered by cronyism and rejection of the severity of the virus. The 89-page complaint from Rick Bright, an immunology expert who led the Biomedical Advanced Research and Development Authority (BARDA) until he said he was forced out of his position, provides insight into the Trump administration's approach at Public health area before and during the pandemic.
From spring 2017 until his "involuntary removal" last month, the leadership of HHS (Health and Human Services) Dr. Bright and BARDA are under pressure to ignore expert recommendations and instead award lucrative contracts based on political ties and cronyism, "the complaint said." Dr. Bright has spoken to Kadlec (Assistant Secretary for Readiness and Response) and other HHS executives about the oversized role of John Clerici, an industry advisor to pharmaceutical companies with a longstanding relationship with Dr. Kadlec, disputed when awarding the government contracts. "
For example, in 2017 Bright declined to "extend a contract with Mr. Clerici's customer, Aeolus Pharmaceuticals, who had completed an in-process review (IPR) without further funding expiring Justification for Renewal Regarding this failed contract, Clerici emphasized that Aeolus' chief executive officer was a "wild card" and friend of Jared Kushner, President Trump's son-in-law and president's senior advisor, in which Dr. Bright asserted himself Contract, which led to a certain discord between him and the HHS leadership. "
In the fall of 2019, Bright said he "rejected Dr. Kadlec's pressure to invest millions of dollars in EIDD-2801, a drug developed at Emory University by a long-time friend of Dr. Kadlec. EIDD-2081 was presented as a "miracle cure" for influenza, Ebola and almost every other virus, although the developer has not yet conducted clinical trials and no data has been compiled to demonstrate either the efficacy or safety of the drug in humans. "
In February 2020, the manufacturers of EIDD-2801 "again sought funding for the drug – this time to treat COVID-19". Bright said he partially fought the $ 100 million request because "Emory had not yet completed the nearly $ 30 million in clinical trials for which NIH and DOD funds had been received." Ultimately, "the award was not given before Dr. Hell's departure from BARDA."
In a statement to the New York Times, Clerici said he "clearly" denied any wrongdoing and "it is sad that during a pandemic, Dr. Bright and his team decided to distract people like Dr. Kadlec who were critical of the response are with politically motivated accusations. It is clear that his accusations are false and will be proven. "
Trump's urge for chloroquine
Bright's whistleblower complaint, citing many internal emails and events from face-to-face meetings, was filed with the US Office of Special Counsel. The complaint addresses, among other things, the strange case of hydroxychloroquine, a malaria drug that President Donald Trump has repeatedly advertised as coronavirus treatment despite the lack of evidence. (The FDA has since issued a warning about the drug that it "should be limited to clinical trial settings or to the treatment of certain hospitalized patients.")
"In an obvious effort to provide the government with a short-term political victory during the escalating health crisis, the office of ASPR (Assistant Secretary for Readiness and Response) pressured BARDA to promote chloroquine as a therapeutic agent for COVID-19, despite one clear lack of scientific support, "says the whistleblower complaint.
Bright and another concerned colleague have reached a compromise where the drug would remain "in the hands of healthcare professionals and out of the public eye" to ensure that "the drugs are administered to patients only under strict medical supervision and." who are known to be infected with the virus. "
"Despite the compromise brokered, the government continued to push for expanded, unattended access to chloroquine and hydroxychloroquine, which is an apparent violation of the EU's Emergency Use Authorization, issued by its own FDA, and regardless of the risk to the American public . " Complaint said.
Bright's complaint continued:
On April 4, 2020, hours after President Trump again touted hydroxychloroquine as a treatment for COVID-19 during a White House press conference, HHS Deputy Minister of Health, Brett Giroir, MD, instructed FEMA administrator Peter Gaynor, vice director of logistics Joint Chiefs of Staff Rear Adm. John Polowczyk and Dr. Kadlec to mobilize the country's supply chain to "flood NY and NJ with treatment courses (of hydroxychloroquine)". Admiral Giroir gave this order on the orders of the White House. Mr. Gaynor also had instructions from FDA Commissioner Dr. Stephen Hahn received to distribute hydroxychloroquine to pharmacies nationwide, even though the EUA did not provide for outpatient use of the drug.
HHS announced a donation of 3 million Bayer’s hydroxychloroquine pills. The drug was "imported from factories in Pakistan and India that were not controlled by the FDA," the complaint said.
Bright revealed details to the journalist
Bright finally concluded that "he had exhausted all available means to alert government officials who refused to listen or take appropriate measures to keep the public informed," and "his only remaining option was his To share concerns with a journalist who has contacted and understood the specific problem and risks associated with these drugs and who have already gathered extensive information from multiple sources. "
Bright "informed a reporter of the specific public health and safety threat posed by the government's decision to release these untested drugs to 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.
"The HHS leadership, including (HHS) Secretary (Alex) Azar and Dr. Kadlec, had already become aware of Dr. Bright's removal because of other issues he had raised regarding fraud, waste and abuse, however, chose to remove him as BARDA director within a few days of the chloroquine article being published because they suspected he was the source, "Bright & # 39; s complaint said.