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Pharmaceutical manufacturer Merck announced today the company is seeking FDA emergency-use authorization for its experimental antiviral treatment for COVID-19, molnupiravir.
On Oct. 1, Merck released a statement that said, “At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients.”
So impressed was it with the results of Merck’s study, the independent board of experts monitoring the trial recommended that it be interrupted, according to The Washington Post.
This drug, which comes in capsule form, if administered during the first five days of the onset of COVID is intended to “prevent mild and moderate cases of covid-19 … from turning into dire episodes.”
On the same day, Axios reported that the development of this drug was delayed by seven or eight months due to infighting among Trump administration officials. In an article entitled “Before Merck backed COVID antiviral, Trump admin turned it down,” Axios wrote that “Trump administration officials fought over whether — and ultimately declined — to fund” molnupiravir.
According to Axios:
At the beginning of the pandemic last year, one group of HHS officials was pushing for the federal government to fund what they saw as a promising new drug. Another group was skeptical of the data available, and the process by which the funding was being requested.
What happened is described in detail in a whistleblower complaint filed by former BARDA director Rick Bright, who led the skeptical point of view.
They quote an anonymous “former senior Trump administration HHS official who was present for portions of the dispute” as saying, “You could have theoretically had this seven, eight months ago maybe.”
Allysia Finley, a member of The Wall Street Journal’s editorial board, reported a slightly different version of the story today. In an article entitled “Who Slowed Merck’s Covid Remedy? A ‘whistleblower,’ not Trump officials, delayed funding for molnupiravir,” she sets the record straight.
Finley writes (emphasis mine): “In fact, Trump officials pushed for government funding to accelerate the development of the drug, molnupiravir. They were opposed by a career official, Rick Bright, whom Democrats praised as a ‘whistleblower.'”
Bright was the director of the Biomedical Advanced Research and Development Authority, which is part of the Department of Health and Human Services. Its responsibilities include “preparing for and responding to public-health threats.”
According to the Journal:
After Mr. Bright repeatedly clashed with HHS officials, he was reassigned in April 2020 to a lower-level job at the National Institutes of Health. Mr. Bright then filed a complaint accusing Trump officials of pressuring him to fast-track unsafe drugs and award contracts “based on political connections and cronyism.”
He claimed that even before the pandemic, they were inappropriately pressing BARDA to fund clinical studies of molnupiravir, which had shown promise against other viruses in lab experiments at Emory University. Mr. Bright’s complaint alleged that George Painter, CEO of Drug Innovation Ventures at Emory, and Trump HHS official Robert Kadlec had urged BARDA in November 2019 to “invest millions of dollars into their ‘miracle cure.’” It noted that “similar experimental drugs in this class had been shown to cause reproductive toxicity in animals, and offspring from treated animals had been born without teeth and without parts of their skulls.” But similar effects hadn’t occurred with molnupiravir. Mr. Bright rejected the Emory funding request; the decision “clearly frustrated Dr. Kadlec and further strained their relationship,” according to the complaint.
After the pandemic struck, the results of a combined study from researchers at Emory University, Vanderbilt University, and the University of North Carolina at Chapel Hill “showed molnupiravir was highly potent against Covid-19 in human cells and prevented other coronaviruses, including SARS, from causing severe lung damage in mice.“
The author of the study, UNC’s Ralph Baric, whose name we’ve heard before in connection with gain of function research, saw molnupiravir as a potentially promising drug for the treatment of COVID.
The Journal continued:
Emory had licensed molnupiravir to Ridgeback, which in April 2020 requested $100 million from the government to fast-track studies in humans. Mr. Bright says Trump officials ordered BARDA officials “to fund the Ridgeback proposal as quickly as possible, and preferably within 24 hours.” But he [Bright] said “Ridgeback had not followed the proper procedure for receiving BARDA funding.” BARDA declined the request, and Ridgeback collaborated with Merck, which put its own capital at risk.
After Mr. Bright’s reassignment, BARDA funding for trials, manufacturing and advance purchases of monoclonal antibodies proved critical in accelerating their development. Molnupiravir would likely have been available much sooner had Barda provided funding as Trump officials urged last spring.
Mr. Bright’s allegation that Trump officials promoted molnupiravir because of ties to Mr. Painter wasn’t borne out.
This tweet from Sen. Elizabeth Warren hasn’t aged particularly well.
The Trump administration ignored warnings from Dr. Rick Bright, the country’s top vaccine scientist, and then fired him after he wouldn’t go along with the President’s reckless push of a miracle cure for COVID-19. The Senate needs to hear from Dr. Bright. https://t.co/GaYKJ6AFiy pic.twitter.com/Fy3qX3QSbS
— Elizabeth Warren (@SenWarren) May 14, 2020
So, the answer is no Axios, no Sen. Warren. Bright was fired because he obstructed the development of a drug that could potentially have saved the lives of tens of thousands of Americans if it had come sooner.
But it’s so much more fun to blame it on Trump, isn’t it?
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