But the president left out the crux of Bright’s allegation. In a detailed whistleblower complaint, Bright says that he was sounding the alarm about hydroxychloroquine early, that he was “directed” to sign an emergency application for the drug’s use in hospitals despite his reservations, and that he did it as a compromise with Trump appointees who were pushing to release the drug even more widely.
The Food and Drug Administration warns against using hydroxychloroquine to treat covid-19 patients outside of hospitals or clinical trials, citing a risk of heart problems. Clinical trial results, academic research and scientific analysis indicate that the danger is a significantly increased risk of death for certain patients. Evidence showing the effectiveness of hydroxychloroquine in treating covid-19 has been scant.
Trump for two months has promoted the drug as a safe and effective treatment for the novel coronavirus, and on Monday he doubled down, saying he had been taking one pill a day for more than a week despite showing no symptoms. (Sean P. Conley, the White House physician, issued a vague statement saying he and the president “concluded the potential benefit from treatment outweighed the relative risks,” though he did not provide any details on the “treatment” or specifically confirm Trump is taking the drug.)
In his former position as director of the Biomedical Advanced Research and Development Authority (BARDA), Bright signed an emergency request asking the FDA to approve the use of hydroxychloroquine on hospitalized patients who could not participate in clinical trials. The FDA granted it March 28.
Now, all of a sudden, he’s a hydroxy-skeptic, Trump observed in a tweet, skewering Bright for supposedly changing his views. “Dr. Bright literally signed the application for FDA authorization of it — literally, he’s the sponsor of it,” Alex Azar, health and human services secretary, said in responding to Bright’s allegations.
But the story is not so clear-cut. Bright’s 57-page whistleblower complaint describes in detail how Azar initially called for a much broader authorization for use of the drug, not limited to hospitals.
Bright received an “urgent directive” from HHS general counsel Bob Charrow to make the drug widely accessible, outside of hospital settings and without close physician supervision, but that raised safety alarms with certain FDA officials, according to the complaint he filed with the Office of Special Counsel on May 5.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, urged Bright to request an emergency use authorization (EUA) from the FDA that was far narrower. The authorization that ultimately was issued, which applies to chloroquine and hydroxychloroquine from the national stockpile, is limited to hospitalized patients with covid-19 who cannot participate in a clinical trial.
The complaint describes one clash in mid-March, after Bayer offered to donate 3 million chloroquine pills to the national stockpile. BARDA officials raised concerns over the donation because of a lack of evidence over the drug’s safety or efficacy for covid-19.
The Bayer pills came from facilities in Pakistan and India that were not FDA-approved and therefore not approved for use in the United States, the complaint states.
“Implementing the EUA was a compromise position, to rein in HHS leadership’s initial campaign to make the drugs available to the public outside of a hospital setting and without physician supervision,” Bright says in his complaint. “Dr. Bright and Dr. Woodcock ultimately prevailed upon their colleagues, and the FDA assisted BARDA in drafting an EUA request and provided it to Dr. Bright on the evening of March 28, 2020. Dr. Bright reviewed and edited the request letter to clarify that although he was being directed to sign the EUA request, it was not at his or BARDA’s behest.”
The FDA has approved hydroxychloroquine to treat malaria, lupus and rheumatoid arthritis, but recent studies have cast doubt on its effectiveness as a covid-19 treatment. Many hospitals have stopped using the drug outside of clinical trials.
“We no longer are keeping large quantities and have returned most of it,” Nishaminy Kasbekar, director of pharmacy for the Penn Presbyterian Medical Center in Philadelphia, previously told The Washington Post. “I think they should revoke the EUA because clearly based on the data it is no longer considered a treatment for covid.”
“You did sign the EUA,” CBS News’s Norah O’Donnell told Bright on “60 Minutes.”
“I was given a directive,” he said. “I didn’t have a choice. ... I went along and signed that letter knowing that we had contained access to that drug.”
Azar representatives have disputed Bright’s claims. In a statement quoted on-air by “60 Minutes,” HHS officials said Bright’s account was “filled with one-sided arguments and misinformation.” HHS officials also have sent reporters a document noting that Bright “praised the members of his team for their work to acquire chloroquine on multiple occasions” and had worked to acquire hydroxychloroquine from Teva Pharmaceuticals.
We asked HHS representatives whether Bright was directed to sign the emergency application as part of a compromise but didn’t get a response.
The Office of Special Counsel last week said it found “reasonable grounds to believe” that administration officials retaliated against Bright by moving him to a different position at the National Institutes of Health. The office recommended that Bright be reinstated to his role at BARDA while its investigation continues.
The Pinocchio Test
Trump suggests Bright is being hypocritical because he was the federal health official who requested the emergency authority to use hydroxychloroquine in hospitals, and now is warning about the drug’s dangers.
But the circumstances under which Bright signed the document matter. We’ve yet to see anyone in the Trump administration knock down the relevant facts from his detailed whistleblower complaint.
Bayer offered 3 million chloroquine pills. Trump administration officials directed that the malaria drug — which had not been tested for its covid-19 efficacy — be authorized for widespread use outside hospitals. Bright and other officials were concerned and successfully bargained a more limited scope, only within hospitals, according to the complaint, and Bright was “directed” to sign the emergency request.
Trump told half the story, and he earns Two Pinocchios.
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