- Rick Bright, who was last month removed as director of the Biomedical Advanced Research and Development Agency, filed a whistleblower complaint on Tuesday alleging he was punished for raising warnings about the Trump administration's response to the coronavirus pandemic.
- In particular, Bright claimed his involuntary transfer to a reduced role at the National Institutes of Health was retaliation for his pushback against plans by the Trump administration to widely distribute unproven drugs like hydroxychloroquine to treat COVID-19.
- Bright is seeking to be returned to his position as head of BARDA, which is central to the U.S. government's coordination and funding of private sector efforts to develop new drugs and vaccines for infectious diseases like the new coronavirus. Bright also called for the Office of Special Counsel to conduct a full investigation into his dismissal.
The complaint, made public Tuesday by Bright's lawyers, casts the controversy over hydroxychloroquine as a tipping point leading to his ouster.
But the expansive 89-page document also details Bright's objections to what he saw as improper pressure from administration officials, including Bright's boss at the Department of Health and Human Services, Robert Kadlec, to award BARDA contracts to firms with political connections.
The complaint describes rising tensions between Bright and Kadlec over the course of several years, during which Bright claims he repeatedly resisted pressure to use BARDA funding for projects backed by well-connected companies, including one with alleged ties to the president's senior advisor and son-in-law, Jared Kushner.
"I was pressured to let politics and cronyism drive decisions over the advice of the best scientists in the government," Bright said on a call with reporters Tuesday.
COVID-19, and the Trump administration's efforts to curb its spread in the U.S., brought those tensions to the surface, Bright alleges, resulting in a series of confrontations with Kadlec and others at the Office of the Assistant Secretary for Preparedness and Response, a division within the Department of Health and Human Services that oversees BARDA.
"Dr. Kadlec's frustration with and animus towards Dr. Bright reached its breaking point when, after the emergence of COVID-19, Dr. Bright resisted efforts to fall into line with the Administration's directive to promote the broad use of chloroquine and hydroxychloroquine and to award lucrative contracts for these and other drugs even though they lacked scientific merit and had not received prior scientific vetting," the complaint states.
Beginning in mid-March, when President Donald Trump began touting chloroquine and hydroxychloroquine as effective against COVID-19, ASPR pushed BARDA to more strongly consider the decades-old malaria pills.
Around that time, ASPR had received an offer from Bayer to donate 3 million chloroquine pills to the federal stockpile, which one ASPR official wrote could be "a big immediate win," according the complaint. Several other companies, including Novartis, Mylan and Teva, would subsequently pledge to donate enormous quantities of the drugs and related variants.
Scientists at BARDA and the Food and Drug Administration concluded there wasn't enough evidence to show the drugs were safe and effective, even as Bayer announced its donation and ASPR officials began discussing how to distribute the supplies.
On March 23, the top HHS lawyer, Bob Charrow, directed Bright and BARDA to quickly make the Bayer drugs widely available through what's known as an expanded access program.
Bright claims he was was concerned about the treatment's side effects, which can include potentially serious heart irregularities, and hesitant to use drugs supplied from facilities in Pakistan and India which had not been inspected by the FDA.
Doing so, Bright said on the Tuesday call, would be "rushing blindly into a potentially dangerous situation."
Looking for an alternative, Bright said he worked with Janet Woodcock, the influential head of the FDA's chief drugs division, to push for an Expanded Use Authorization that would restrict the drug's use to within hospitals and to patients who couldn't otherwise join a clinical trial.
While the FDA did clear emergency use of two types of hydrocxychloroquine, the agency later issued a formal warning of the drug's safety risks that was made public, coincidentally, on the same day Bright was removed from his position.
The rapid elevation of chloroquine and hydroxychloroquine to the top of government officials' lists for prospective COVID-19 treatments was surprising, in part because it's not clear exactly how the drugs would work to curb the infectious disease.
Small clinical trials in China and France suggested a potentially powerful benefit, although the latter study has been heavily criticized for flaws in its design and conduct. Evidence collected since has been, at best, inconclusive, or, more concerning, suggestive the drugs may be causing harm.
Bright has worked at BARDA since 2010, previously serving as the agency's division head for influenza and emerging infectious diseases. He was replaced by ASPR's Gary Disbrow on an acting basis.