By Kevin Stawicki

Law360 (May 5, 2020, 9:42 PM EDT) -- The doctor booted from his job leading the federal agency developing a coronavirus vaccine filed a whistleblower complaint Tuesday asking the U.S. Office of Special Counsel to reinstate him and investigate whether he was pushed out for advocating scientific solutions over unproven drugs touted by the Trump administration.

Dr. Rick Bright said officials at the U.S. Department of Health and Human Services retaliated against him by removing him as director of the Biomedical Advanced Research and Development Authority and deputy assistant secretary for preparedness and response. Bright said he was transferred after he resisted providing the malaria drugs chloroquine and hydroxychloroquine "on demand to the American public" to treat COVID-19 even though their broad use lacked scientific merit.

While Bright's resistance to those drugs ultimately triggered his ouster on April 20, he said his push for vaccine and drug development as early as January was met with "indifference which then developed into hostility from HHS leadership," according to the complaint. 

"I was removed from my position because of my continued insistence that the government invest funds allocated by Congress — hard earned taxpayer dollars — to address the COVID-19 and invest them into safe and scientifically vetted solutions instead of funding projects that were promoted by cronies or politically connected companies," Bright said in a phone call with reporters on Tuesday.

Dr. Robert Kadlec, assistant secretary for preparedness and response, removed Bright from his powerful position at BARDA and shifted him to a post with less sway at the National Institutes of Health in what Bright described as a move fueled by the agency's contempt for his resistance to the Trump administration's politicization of and reckless disregard for scientific research.

Bright said he was prepared to consider all options and think outside the box, but insisted chloroquine and hydroxychloroquine be provided only to hospitalized patients with confirmed cases of COVID-19 while under the supervision of a physician.

"I witnessed government leadership rushing blindly into a potentially dangerous situation by bringing in a non-FDA approved chloroquine from Pakistan and India from facilities that had never been approved by the FDA," Bright said Tuesday. "Their eagerness to put blindly forward, without sufficient data, to put this drug into the hands of Americans was alarming to me and my fellow scientists."

Bright's attorney Debra Katz of Katz Marshall & Banks LLP called her client's removal "retaliation, plain and simple."

"We are confident that an investigation will show that Dr. Kadlec treated Dr. Bright with hostility from the very start of the COVID-19 pandemic because of Dr. Bright's insistence that the government invest billions of dollars allocated by Congress into safe and scientifically vetted solutions and not on drugs, vaccines and other technologies that lack scientific merit," Katz said.

The complaint asks for Bright's termination to be temporarily paused as the special counsel investigates the complaint. But the OSC cannot unilaterally compel the agency to reinstate Bright, said Nick Schwellenbach, a senior investigator at the Project On Government Oversight who was previously the OSC's communications director, who was also on the call.

"If they determine a stay is warranted, which we believe it is, they will approach the office of general counsel at HHS and seek to negotiate a stay with them. This happens fairly often," he said. "It's not unusual for OSC to obtain these negotiated stays."

Bright's removal on April 20 came on the same day that researchers unveiled the results of a nationwide study of hydroxychloroquine treatment at veterans hospitals indicating the drug doesn't help patients combat the novel coronavirus and instead is associated with more deaths than standard care. 

Three days later, the U.S. Food and Drug Administration issued a warning telling patients and caregivers that those drugs had been reported to have serious and life-threatening side effects when used to treat COVID-19.

Bright said the agency's contempt for him started as early as 2017 when he began challenging political influence on government contracts with BARDA. In one instance, Bright said he experienced pushback when he challenged attempts by a pharmaceutical industry consultant with ties to Kadlec to warn Bright that the CEO of a company seeking an extension of a failed government contract was friends with Trump's son-in-law, Jared Kushner, and had "Hollywood connections."

HHS spokesperson Caitlin Oakley told Law360 in an email that it was Bright himself who requested an emergency use authorization from the FDA for using donations of chloroquine in the strategic national stockpile to treat COVID-19 patents.

"Dr. Bright was transferred to NIH to work on diagnostics testing – critical to combatting COVID-19 – where he has been entrusted to spend upwards of $1 billion to advance that effort," Oakley said. "We are deeply disappointed that he has not shown up to work on behalf of the American people and lead on this critical endeavor."

The White House did not immediately respond to requests for comment.

Bright is represented by Debra Katz and Lisa Banks of Katz Marshall & Banks LLP.

--Additional reporting by Hailey Konnath. Editing by Jill Coffey.

Updated: This article has been updated with comment from HHS. 

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