But since then, the FDA has tellingly moved to warn about the dangers of the drug. And now, in its most significant walk-back to date, it has pulled that emergency use authorization (EUA) altogether.
The decision Monday by the FDA now lends credibility to persistent suspicions that all of this was politicized from the beginning.
In its decision, the FDA said, “It is no longer reasonable to believe that oral formulations of [hydroxychloroquine] and [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”
In making its case, it cited a large, randomized study that it said showed “no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation.”
The ruling from Trump’s own administration comes after he has spent months playing up the promise of the drug and has, according to the White House, taken the drug himself in hopes of preventing the disease. (Trump took the drug despite there being no evidence of its prophylactic benefits.) The president has also repeatedly cast the drug as utterly safe — a harmless proposition. “What do you have to lose?” he said repeatedly.
The initial FDA decision was fraught. Health officials questioned its speed and raised suspicions that the agency had bent to pressure from a president who was keen on finding a quick fix — whether it was this or anything else — for the country’s coronavirus outbreak.
“The recent issuance of the chloroquine/hydroxychloroquine EUA, in the midst of political pressure and with scant and conflicting supporting evidence, should be of serious concern,” former FDA chief scientists Luciana Borio and Jesse Goodman wrote at one point. “When EUA status is sought or granted seemingly under pressure, it may also open a floodgate of efforts to promote unfounded use of other unproven treatments, risking a perception that special interests can influence FDA decisions.”
Rick Bright, a leading health official in the Trump administration, emerged as a whistleblower, saying he was transferred to a new position for raising concerns about how the administration was handling the drug.
“I believe part of the removal process for me was initiated because of a pushback that I gave when they asked me to put in place an expanded access protocol that would make chloroquine more freely available to Americans that were not under the close supervision of a physician and may not even be confirmed to be infected with the coronavirus,” Bright said in congressional testimony.
Bright alleged that the drug was being pushed along to allow the president a “short-term political victory” as questions about his handling of the coronavirus outbreak proliferated.
All along, health officials and FDA Commissioner Stephen Hahn have denied that political pressure weighed on the initial decision. Hahn’s current and former colleagues have defended him, too.
“I have not felt political pressure,” Hahn told the Stat news outlet. “I have not exerted political pressure on FDA.”
The FDA also said that the emergency-use authorization “was prepared by expert FDA career staff and reflects extensive discussions with experts at CDC, NIH and BARDA who are involved in pandemic response,” referring to the Centers for Disease Control and Prevention, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority.
But Trump’s comments paint a somewhat different picture. At given junctures, he has suggested that he and Hahn pushed along the process because of Trump’s belief in the drug — even claiming that it was done at record pace.
“It was only the fast approval by FDA that allowed us to do that,” Trump said March 19 of early testing of the drug in New York. “It was a really rapid approval.”
Hahn “got it approved very quickly,” Trump added. “I won’t even tell you how quickly, but let’s put it this way: It’s approved.”
After the drug was approved for emergency use in late March, Trump again nodded to Hahn’s — and this time his — involvement in making it happen so quickly.
Trump told “Fox & Friends” on March 30 that “hydroxychloroquine is something that I have been pushing very hard. I got the very early approval from the FDA. It was going to take a long time, and Dr. Stephen Hahn, the head of the FDA, gave us an early approval, a very quick approval, a 24-hour approval.”
He added in the same interview: “And I got it done, because I said: ‘Look, some of these people are very sick and they’re not going to make it. Let’s do it. Let’s get it done.’ ”
Right there is Trump saying he personally exerted pressure on the process — whether undue or otherwise. You could dismiss it as the characteristic bluster of a president seeking to defend his stewardship of the outbreak, but it doesn’t exactly paint a picture of a politics-free decision. By Trump’s admission, he was “pushing very hard,” and he credited himself with making it all happen. He even suggested it was a “24-hour” process.
Those comments and Bright’s testimony take on new significance now that the FDA has acknowledged that its initial, rapid decision no longer applies — that it now agrees with the more skeptical views of health officials who have, from the beginning, questioned Trump’s promotion of the drug.
How that now-reversed decision was made in the first place would seem to be of significant concern, especially given Trump’s demonstrated history of bending supposedly nonpolitical portions of the federal bureaucracy to his will — and, in many cases, to his whims.