Whistleblower Report Details FDA Hydroxychloroquine Role
A whistleblower report by ousted Biomedical Advanced Research and Development Authority (BARDA) director Rick Bright details the roles of senior FDA officials involved in allowing the broader use of malaria drugs chloroquine and hydroxychloroquine during the Covid-19 pandemic. Bright says he filed the complaint after being removed from his post and reassigned to NIH for opposing the drugs’ expanded use for Covid-19 because such use lacked scientific merit, among other issues. He was concerned over the Trump Administration’s promotion of the drugs as a “panacea” and its demands that New York and New Jersey be “flooded” with them, “which were imported from factories in Pakistan and India that had not been inspected by the FDA.”ֺ
Bright painted a favorable picture of CDER director Janet Woodcock’s role in allowing the malaria drugs’ use in Covid-19 patients. With Administration officials urging a broader-use “Expanded Access IND protocol,” Woodcock strongly recommended that BARDA submit an application for an emergency use authorization (EUA) instead. “Given the uncertainty about the risks of chloroquine, an EUA would better protect patients by enabling physicians to closely monitor their progress in a hospital setting and treat any side effects of the drug,” the complaint said. “A small Chinese clinical study released that same day, and which Dr. Bright discussed with Dr. Woodcock, produced statistically insignificant results about the therapeutic benefits of hydroxychloroquine and provided no more compelling reason to make the drug available nationwide without also requiring the close supervision of a physician when administered.”
The whistleblower complaint said that despite the brokered compromise by Woodcock, “the Administration nevertheless continued to push for expanded, unsupervised access to chloroquine and hydroxychloroquine, in blatant violation of the EUA issued by its own FDA and regardless of the risk to the American public.” Based on discussions with the White House, FDA commissioner Stephen Hahn agreed that hydroxychloroquine should be distributed to pharmacies nationwide, even though the EUA did not provide for outpatient use of the drug, the complaint said.
Bright’s complaint also documented how FDA and the Administration dropped the ball on securing masks and respirators after being warned that “America’s fragile, foreign controlled mask and respirator supply was a national security problem. In January, Prestige Ameritech had repeatedly warned the government about the imminent mask shortage, and invited them to discuss with a company official ways to address the issue, but it had received no response other than a form email five weeks later.”
In March, Bright said, CDRH dismissed concerns about swab shortages because two primary manufacturers had “huge manufacturing capacity.” Bright called CDRH director Jeffrey Shuren to learn where the swabs were manufactured, which he identified one as being in the Lombardy region of Italy – the epicenter of Italy’s coronavirus outbreak which had been placed under lockdown. Bright and others contacted the Defense Department to determine whether military flights could be used to transport swabs from Italy to the U.S. in the event that commercial planes could not because of the lockdown.