The Wall Street Journal Sets Axios Straight on What Delayed the Development of Molnupiravir

 

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.

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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Published in Healthcare
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  1. DrewInWisconsin, Oaf Member
    DrewInWisconsin, Oaf
    @DrewInWisconsin

    Am I correct in guessing that molnupiravir is basically a patented (and therefore more expensive) ivermectin?

     

    • #1
  2. Percival Thatcher
    Percival
    @Percival

    But if molnupiravir had proven to be safe and effective, Orange Man Bad might have won the election and we would have worsened our relationships with the UK and France, our key allies. We would have eased pressure on our opponents; China, Russia, Iran, al Quaeda, and the Taliban. Worst of all, we would have been deprived of the dizzying power and scope of Joseph Biden’s intellect and his sure hand on the helm of the ship of state.

    Let’s go, Brandon!

    • #2
  3. DonG (CAGW is a hoax) Coolidge
    DonG (CAGW is a hoax)
    @DonG

    DrewInWisconsin, Oaf (View Comment):

    Am I correct in guessing that molnupiravir is basically a patented (and therefore more expensive) ivermectin?

    No.   It works differently.  It also costs 1000x the price. 

    • #3
  4. DrewInWisconsin, Oaf Member
    DrewInWisconsin, Oaf
    @DrewInWisconsin

    DonG (CAGW is a hoax) (View Comment):
    It also costs 1000x the price. 

    Well, yeah . . .

    • #4
  5. Jerry Giordano (Arizona Patriot) Member
    Jerry Giordano (Arizona Patriot)
    @ArizonaPatriot

    DrewInWisconsin, Oaf (View Comment):

    Am I correct in guessing that molnupiravir is basically a patented (and therefore more expensive) ivermectin?

    My impression is that it’s more complicated than this.  They are both antivirals, I think, though as I understand it, ivermectin is an antiparasitic drug that also may have antiviral properties.

    The efficacy studies of ivermectin are mixed and somewhat dubious, as far as I can tell.  There may be broader studies ongoing, and perhaps it will prove effective in the end.  I think that there have been a lot of poorly supported claims of effectiveness.  Here and here are two double-blind studies that found ivermectin ineffective. 

    These are just two that I found by searching for “double blind study ivermectin.”  It looks like there are a number of studies, and it’s hard to tell who to believe in the overall reporting of results.

    On the other hand, it looks like the molnupiravir study is a good, double-blind study that is showing effectiveness.

    On the other other hand, ivermectin has been used for many years, and has a pretty good safety record, as I understand it.  This would not necessarily be true of a new drug like molnupiravir.  So even if the new drug has stronger evidence of effectiveness, it has the downside that safety data will be more limited.

    I’d really appreciate it if one of the docs would comment on this.

    • #5
  6. KCVolunteer Lincoln
    KCVolunteer
    @KCVolunteer

    Jerry Giordano (Arizona Patrio… (View Comment):

    The efficacy studies of ivermectin are mixed and somewhat dubious, as far as I can tell. There may be broader studies ongoing, and perhaps it will prove effective in the end. I think that there have been a lot of poorly supported claims of effectiveness. Here and here are two double-blind studies that found ivermectin ineffective.

    In the second study sighted, ivermectin was administered for 5 days, and states,

    There was no significant (this word may not mean what they think it means) difference in the proportion of patients who required escalation of care in the 2 treatment groups (2% with ivermectin, 5% with placebo; absolute difference.

    One patient in the placebo group died during the study period.

    That looks to me like a 60% reduction in the number of patients, by those who received ivermectin, that didn’t proceed to a higher level of care, compared to the placebo group. With only one death in either group, it being in the placebo group, at could be risky to extrapolate to a larger population. Although some doctors that have prescribed ivermectin have claimed the have had no deaths among their patients.

    Stopping the study at 400 subjects seems premature and dubious. Are there other broader studies? There is the experience in the Indian state of Uttar Pradesh 199.8 million population(distributed ivermectin) versus the Indian state of Kerala 34.8 million population, that did not.

    • #6
  7. Jay Tuck Coolidge
    Jay Tuck
    @JayTuck

    Ivermectin has pretty good data supporting it’s use, though not from RCTs (what does the NIH do around here?). It also has an excellent safety profile and is cheap, so it has no elite marketing or organizational advocacy. Front Line Critical Care Alliance is a group of health care professionals advocating for its use.

    I’m glad Molnupirivir seems effective. But that efficacy was proven on rodents with engrafted human embryonic lung tissue. 

    https://gab.com/hhtuck/posts/106252318795833582

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6776695/

    • #7