- The Trump administration's push to expand use of the malaria drug hyrdoxychloroquine to treat COVID-19 "was distracting to dozens of government scientists" trying to advance vaccines and other experimental therapeutics, the ousted director of the Biomedical Advanced Research and Development Agency told a congressional panel Thursday.
- The official, Rick Bright, said government scientists pushed back against a White House effort to "flood" coronavirus hotspot New York City with hydroxychloroquine because they were concerned with the drug's cardiovascular side effects and other safety worries.
- Bright was recently removed as BARDA director and reassigned to a position at the National Institutes of Health following conflicts with senior administration health figures. He has filed a whistleblower complaint seeking to be returned to his job at BARDA.
Bright's first appearance before a congressional subcommittee since his removal and subsequent whistleblower complaint focused on missteps in preparing for the onslaught of the new coronavirus.
Hydroxychloroquine, a generic malaria drug, drew early attention from the White House as a potential treatment because of small studies emerging from China and France. Top officials pushed for quick approval of an expanded access plan that would make it widely available, prompting scientists at NIH, the Food and Drug Administration and other agencies to scramble to develop an alternative plan, according to Bright.
"It was extremely distracting to dozens of government scientists," Bright said in response to questions from members of the House Energy and Commerce Committee heath panel.
He claimed the scientists had to "put aside all other" work to address the request from top administration officials. "It distracted from their efforts in developing other vaccines and drugs."
In his whistleblower complaint, Bright said he worked with Janet Woodcock, a top FDA official, to draft an Emergency Use Authorization request, which the FDA signed off on March 29. Under the EUA, the FDA specified hydroxychloroquine use be limited to treating patients hospitalized with COVID-19 who are unable to join a clinical trial.
Keeping hydroxychloroquine's use restricted to a hospital setting was intended to ensure that patients would be under close medical supervision when they used it, Bright said. The FDA has warned the pill can lead to heart rhythm irregularities and, because it hadn't been studied in coronavirus patients, there could be other safety risks in that population, Bright added.
"When I spoke about my concerns, that was the straw that broke the camel's back and led to my removal," he told the committee.
The Department of Health and Human Services, of which BARDA is part, pushed back strongly Thursday, saying Bright was responsible for identifying hydroxychloroquine as a potential treatment, securing supplies and pushing for the Emergency Use Authorization.
"Dr. Bright literally signed the application for FDA authorization," HHS Secretary Alex Azar said at the White House Thursday.
President Donald Trump, speaking with reporters alongside Azar, said there was a "tremendous response" to hydroxychloroquine and characterized Bright as a "disgruntled person."
Before the committee, Bright also cast doubt on a federal timetable of 12 to 18 months to advance a vaccine through clinical testing and into broader use, calling it an "aggressive schedule."
"It's critical to note that 12 to 18 months doesn't mean an FDA approved vaccine," he said. "You may have enough information on safety and immunogenicity, but not on efficacy, to use it on an emergency basis."
BARDA has funded vaccine development efforts by Moderna, Johnson & Johnson and Sanofi, committing to spend hundreds of millions of federal money to jumpstart manufacturing while testing is still ongoing.