Health official warns of potential COVID-19 vaccine problems

Whistleblower says Trump administration response carries risks

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Posted May 14, 2020 at 12:28pm

Trump administration whistleblower Rick Bright, who served until recently as director of the Biomedical Advanced Research and Development Authority, told lawmakers Thursday that tragic consequences could occur if science is ignored in the national response to the COVID-19 pandemic. 

“If we fail to improve our response, based on science, I fear the pandemic will get worse and be prolonged,” Bright testified before the House Energy and Commerce Health Subcommittee. “We have the world’s greatest scientists. Let us lead. Let us speak without fear of retribution.”

Bright, who oversaw vaccine development investments in his BARDA role, warned that the distribution of an eventual vaccine could be delayed by the same supply chain issues that led to mass shortages of personal protective equipment. 

“If you can imagine a scenario, this fall or this winter or early next spring, when a vaccine becomes available … there’s no one company that can produce enough for the country or for the world. There are going to be limited supplies,” Bright said. “We need to have a strategy in place now.”

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He also raised concerns that the Trump administration’s messaging on a vaccine for the novel coronavirus may be overly optimistic. National Institute of Allergy and Infectious Diseases Director Anthony Fauci has said a vaccine could be administered as soon as next year.

“A lot of optimism is swirling around a 12- to 18-month time frame, if everything goes perfectly. We’ve never seen everything go perfectly. My concern is if we rush too quickly and consider cutting out critical steps, we may not have a full assessment of the safety of that vaccine,” Bright said. “I still think 12 to 18 months is an aggressive schedule, and I still think it will take longer than that.”

Bright said the Trump administration ignored early warnings about supply chain issues affecting N95 respirators and he was excluded from meetings about preparedness because he insisted that the United States should ramp up supply. 

“I was told I was starting a commotion and I was removed from those meetings,” he said. 

The administration's response had significant consequences, he said. “Lives were endangered, and I believe lives were lost,” Bright said.

Bright’s testimony was challenged by Republicans on the panel, and President Donald Trump tweeted Thursday morning that Bright should be fired. 

“I don’t know the so-called Whistleblower Rick Bright, never met him or even heard of him, but to me he is a disgruntled employee, not liked or respected by people I spoke to and who, with his attitude, should no longer be working for our government,” Trump said, using words he later repeated in comments to reporters.

Bright filed a formal whistleblower complaint with the Office of Special Counsel last week charging that the Trump administration retaliated against him. Bright said he was reassigned from his position overseeing BARDA to a lesser role at the National Institutes of Health for challenging the administration’s promotion of hydroxychloroquine and chloroquine as COVID-19 treatments without a controlled clinical trial.  

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Bright shared his concerns about hydroxychloroquine and chloroquine with the press and said that was the “straw that broke the camel’s back,” spurring his removal.

Hydroxychloroquine and chloroquine are antimalarial drugs favored by Trump but are not proven to be safe and effective against COVID-19, and in some cases cause heart rhythm problems.

Bright’s concerns were “escalated,” he said, when he learned of attempts by the Trump administration to make it available to patients who were not diagnosed with COVID-19 and were not under the supervision of a physician in order to “flood New York and New Jersey” with this drug.

“There wasn’t sufficient evidence,” he said.

HHS rebuttal

Department of Health and Human Services Secretary Alex Azar challenged Bright’s testimony in comments outside of the White House on Thursday afternoon.

“Everything he’s complaining about was achieved,” Azar said.

In a lengthy rebuttal to Bright, HHS said in a statement the government has “procured contracts for the delivery of hundreds of millions of N95 respirators from a host of suppliers.”

The HHS statement did not specify how many of those masks have been manufactured and delivered. Nurses unions report hospitals are still suffering from a shortage of N95 respirators.

Azar and the HHS statement also downplayed Bright’s role at HHS.

HHS said initiatives to procure needles and syringes were underway but Bright was not aware of them, though these supplies remain in shortage.

“This is like somebody who was in a choir and is now trying to say he was a soloist back then,” Azar said.

Azar also questioned Bright’s credibility because he ultimately requested the emergency use authorization that made a large donation of chloroquine available to the national stockpile.
“Dr. Bright literally signed the application for an FDA authorization of it," Azar said, adding, "His allegations do not hold water."

Bright contended in his testimony that he signed the emergency use authorization to stave off a much broader request for an expanded access protocol requested by Azar’s office. Bright said the EUA ensured “guardrails” around prescribing that would have not been available under the “compassionate use” Azar sought.

Patients would need to take the drug in a hospital setting under close supervision of a physician under an EUA. The administration sought to get around those guardrails, Bright said, ultimately prompting his decision to speak out.

Energy and Commerce ranking Republican Greg Walden of Oregon and Health Subcommittee ranking Republican Michael C. Burgess of Texas raised a number of parliamentary concerns at Thursday’s hearing. They expressed frustration that the hearing was announced before the minority party received notification.

View into deliberations

Bright’s testimony provides a rare window into the inner workings of the Trump administration’s readiness. The White House has limited the ability of health experts on its coronavirus task force to testify on Capitol Hill, and Trump has downplayed warnings about the pandemic that threaten to depress the economy.

Energy and Commerce Health Subcommittee Chairwoman Anna G. Eshoo, D-Calif., said the Trump appointees named in Bright’s complaint — HHS Secretary Alex Azar, Assistant Secretary for Preparedness and Response Robert Kadlec and White House Director of Trade and Manufacturing Policy Peter Navarro — all declined to testify at Thursday’s hearing. 

Members of the coronavirus task force and their deputies cannot testify to Congress throughout May without the express permission of White House Chief of Staff Mark Meadows, according to a White House directive sent to congressional staff on May 4. 

Departments central to responding to the COVID-19 pandemic, HHS and the departments of Homeland Security and State, could each only testify at four hearings related to the crisis for the month, the directive stated. 

Eshoo said she had asked several Trump administration health officials to testify on Jan. 30, but Azar rejected the request.

“It was Secretary Azar who said they cannot come; I’m the top person. And when I come, they will come with me,” Eshoo said. 

Bright’s testimony comes as the administration is still reviewing the Centers for Disease Control and Prevention’s detailed guidance on resuming business and community life without stoking a rash of new cases. Trump administration officials delayed its release, according to The Associated Press.