Remdesivir VIII
There is a severe Remdesivir shortage
On March 2 2020, I warned you that this was going to happen.
I did not warn about the opaque and arbitrary Trump administration policy, because the Trump administration is always “worse than you imagine possible even taking into account the fact that it is worse than you imagine possible” Brad DeLong 2003 or so referring to the last Republican presidency.
When are Americans going to notice the pattern ?
All Americans notice the pattern, half don’t care.
Robert:
I do and I do not understand your complaint. In the seventies I was a part of the introduction of a new dialyzer for Kidney Dialysis. Indeed I was planning the limited pilot production of it and its components. We ran the hell out of the pilot production line, component manufacturing, and were flying 747s of kuprophan fiber in from Germany as they made it weekly. The need was great. I had hands on control on the process planning and could walk out on the production line (garbed) and see what the hell was going on there. If I were still at this and if safe, I would be boarding a plane and flying to China or ? to do the same thing. Even if manufacturing was in the US, we would still have ramp up issues as capacity increases do not increase that fast.
We receive(d) 1.5 million doses or enough to treat 300,000 people at 5 doses for a crowd of 3 million globally. It is staying in the US and screw the others?
The pattern to this, in USDA/FDA regs and Good Manufacturing Practices to regulate the introduction and the use of new and current drugs. That “big business” located the manufacturing outside of the US to avoid Overhead in the US is not really a political question while the disbursing of 1.5 million doses is. Sounds like someone is making “Sophie’s Choice?” You get it or you die or we use this other drug.
I am not surprised at this.
Robert,
I gather that you are doing your best to demonstrate the Dunning-Kruger effect, first with your nonsense about hydroxychloroquine and now about Remdesivir (and about epidemiology and about science-based medicine, and who knows how many other topics?). But really, why do you continue to spout this nonsense after already having established yourself as a poster child for D-K?
I suggest you read
regarding Remdesivir.
Bob:
Thank you for the link. Read it and added it to my library of other info. As they stated and I agree, this is a “yuge” gift to Gilead by Fauci.
“Doctors lambaste federal process for distributing Covid-19 drug remdesivir”.
Gilead Sciences and not Jared Kushner should determine who gets their treatment.
“Bob Michaelson
May 7, 2020 11:41 am”
Your link goes to a rant by some person named “Tim” which appears to be Instagram. This is your source for reliable medical information? Seriously?
I appreciate that my post on the pricing issue for Remdesivir was posted on AB. I added this relevant update:
https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-remdesivir-global-supply
Gilead is in discussions with some of the world’s leading chemical and pharmaceutical manufacturing companies about their ability, under voluntary licenses, to produce remdesivir for Europe, Asia and the developing world through at least 2022. The company is also negotiating long-term voluntary licenses with several generic drug makers in India and Pakistan to produce remdesivir for developing countries. Gilead will provide appropriate technology transfers to facilitate this production. Finally, the company is in active discussions with the Medicines Patent Pool, which Gilead has partnered with for many years, to license remdesivir for developing countries. To further facilitate access in developing countries during this acute health crisis, Gilead is in advanced discussions with UNICEF to utilize their extensive experience providing medicines to low- and middle-income countries during emergency and humanitarian crises to deliver remdesivir using its well-established distribution networks.
PGL:
I should not have to tell you this. You are always welcome here.
“Pgl”: My link goes to an article by “Orac” (there are rants by a “Tim” responding to Orac, but so what?). Orac, aka David H. Gorski, has far more credentials than does Waldmann to address medical questions, or for that matter questions relating to science-based medicine.
Bob:
To be clear, I do not believe Robert disputes credentials and he openly admits he lacks knowledge on certain topics.
If we are citing David H. Gorski as a source, could we do so in full?
Bob/pgl:
Thank you for finding the article. Saved it too. Here is the score plus the comforting verbiage afterwards (article) as I understand it.
HCL plus any chaser does not work. Anecdotal info, my neighbor’s father was given HCL plus AZT and it worked. Southern France reported in the news (running scorecard here: https://www.mediterranee-infection.com/covid-19/), Didier’s concoctions worked (my French is terrible in comparison to my understanding German). My daughter the NP has seen successful use of this in Colorado. The hazard of HCL “could” perhaps be controlled by dosage?
From Gorski’s article (I assume Gorski) and down near the end (consequences of bypassing EBM/SBM): “When it comes to remdesivir, based on one trial and ignoring a negative trial, Dr. Fauci has declared remdesivir to be, in essence, the de facto standard of care for treating hospitalized patients with COVID-19. That premature adoption means we might never know how well it actually works or if it even does work.” As I understand it, remdesivir has its hazards also and there is gold in this drug to be mined due to the pandemic which is also why Gilead pursued having it removed from orphan drug status (smart move on their part).
Lenzer and Brownlee’s: “As always, it is the patient who suffers the harms of using a drug first and doing the right scientific studies later. In the case of hydroxychloroquine, potential side effects are not trivial. The drug can affect heart rhythm, potentially triggering a rare condition known as torsades de pointes, which can end in sudden cardiac death.” This is the “no shit” moment of the article as read by someone who may have to use “something” and everyone is arguing how you are going to die. Pick one; HCL plus a chaser not working or causing other medical issues, remdesivir not working, getting either too late in the treatment protocol, no treatment, ventilator, being given a saline drip and being lied to that the drug in it will cure you (does anyone tell the relatives?). The epiphany appears to be, the patient pays in any of these scenarios and the good doctors are arguing which is the better one.
I wish Trump had never spoken of HCL or the Gilead drug. It ignited a political sh*t storm. Out of this the only ones who should be outraged are the patients as they will pay the ultimate price. Most of them do not know it yet.
Robert is an economist as is PGL. I am a drive by in economics. Took enough courses (BA and MA) to understand the issues. Worked in the hospital supply, pharma, and food industries over the years. Bob we had a conversation about Chicago electric buses a ways back. I used to take these buses which ran on Irving Park Road and I referenced them during an exchange with you. You appear to have a medical background (guessing).
@Pgl,
That link is gold. Thanks.
““When it comes to remdesivir, based on one trial and ignoring a negative trial, Dr. Fauci has declared remdesivir to be, in essence, the de facto standard of care for treating hospitalized patients with COVID-19. That premature adoption means we might never know how well it actually works or if it even does work.”
Fauci was sitting to the King of Hyperbole but that is no excuse for hyping what Fauci really said. He called remdesivir an important proof of concept followed by precisely what he meant by that. No sane person has said remdesivir is a “game changer”. No sane person has declared the need for more research over.
The discussion was a thoughtful one covering lots of topics but this quote was a bit over the top.
pgl:
If you are =referencing Trump as sitting next to Trump, it was a dumb comment to make in front of him as he will take it to the bank. The thrust of that commentary was by Gorski citing Fauci. But if you must know, here is the entire paragraph which contains that quote:
I do not see “game changer” in my comment. And as we know, Gorski has far more credentialing than the three of us together. I accept such, pgl and I also believe Gorski was not happy with the comment by Fauci.
The missing crux of this article which has not been discussed is “how many more people will be used in placebo study and given a saline drip or ringlets?” 3-4 studies globally incorporating a few hundred here or there. How many more will pass on while waiting for affirmation from the good doctors on a new agreed upon standard?
Is it acceptable to do nothing while we wait?
Dr. Gorski and Dr. Fauci agree on one thing:
https://www.thedailybeast.com/plandemic-the-viral-coronavirus-documentary-stars-a-discredited-doctor-and-sham-science
Judy Mikovits is a nut case.
run75441:
I don’t have a medical background, just chemistry, and that long enough ago that I no longer claim credentials even there; although I did learn the need to be somewhat skeptical when reading papers. But my biologist friends taught me that plausible early results are very far from clinical applications; most discoveries touted in the press should run under the headline “Good News for Mice.”
I do credit Waldmann for having the sense to eventually recognize the spurious nature of hydroxychloroquine claims, and for noticing how few “promising” drugs pan out in the end. Which makes it all the more annoying that he continues to advocate dubious positions.
On a completely different topic – I’m impressed that you remembered our brief discussion some time ago about Chicago electric buses; I didn’t recall it at all until you mentioned it!
Bob:
Thank you for the return. I can talk at different levels. I just do not want to over or underwhelm. I try to gauge my conversation. I also remember the people I talk to. Finding someone who knows about Six Corners with the newspaper stands on the corners and the Sears at Irving and Cicero is rare as is knowing about the electric buses on Irving Park Road and Cicero.
Grew up in Chicago, graduated Lane Tech in 67. Kicked off from South Jefferson for a stint in the Marines. Brought back a wife from NYC in 71. Graduated Lewis in 3 years for my BA. Finished my Masters at Loyola-Chicago in 80 going at night for 3 years.
Feel free to contribute here at AB. Robert is a pretty nice Prof. I like reading him as well as PGL. My name is Bill. I have been using run75441 for decades now so it has been my moniker. Few drugs do pan out and I have worked on some of them as well at supplies. Thank you for the reply.
Good news from Gilead:
https://www.dawn.com/news/1554986/gilead-sciences-in-talks-with-pharma-companies-in-pakistan-india-to-start-remdesivir-production
Gilead Sciences “is negotiating long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries. Gilead will provide appropriate technology transfers to facilitate this production”. The statement adds that the company’s goal “is to make remdesivir both accessible and affordable to governments and patients around the world” and it plans to continue the production of the drug for “Europe, Asia and the developing world through at least 2022”.
Of course I noted this over at Econospeak.
“studies (at least of hospitalized COVID-19 patients) can’t be carried out with a placebo control anymore because it would be considered unethical.”
WTF? Yes double blind tests can still be run. Fauci was just saying that once the test results are in, those that had been given the placebo should be given the option to taking the actual treatment. The misrepresentations of what Fauci said are just weird.
pgl:
That was “Gorski.”
https://www.euroweeklynews.com/2020/04/23/costa-del-sols-malaga-hospital-participates-in-new-drug-trial-to-fight-covid-19/
Costa del Sol’s Hospital Clinico de Malaga has announced that it is participating in a drug trial for coronavirus (Covid-19), with the University Hospital of Virgen de Sevilla. THE study will analyse an anitiviral drug called Remdesivir to treat Covid-19 patients. According to the hospital, the trial will analyse the efficiency and safety of the drug on patients who have moderate and serious Covid-19 infections. The trial forms part of a much larger international study, and involves at least 13 Spanish hospitals, including the Malaga’s Virgen de la Victoria University Hospital.
This was 2 weeks ago. The buzz is the results are out and look favorable. I don’t want to get ahead of this but saying what Robert write is “dubious” strikes me as ignoring that there are lots of studies like this.
The news from Malaga on Remdesivir for anyone who speaks Spanish:
https://www.diariosur.es/malaga-capital/hospital-regional-participa-20200508113652-nt.html
I don’t so an English summary from someone who does would be appreciated.
Bangladeshi firm makes generic remdesivir
https://www.seymourtelegraph.com.au/world/2020/05/09/1165433/bangladeshi-firm-makes-generic-remdesivir
A Bangladeshi company says it has produced the first generic version of the anti-viral drug remdesivir, which is currently being tested as a possible treatment for COVID-19. “We have successfully completed all the steps in the manufacturing of remdesivir,” Simeen Hossain, head of Eskayef Pharmaceuticals Bangladesh Limited, said on Friday about the production of the drug developed and patented by Gilead Sciences in the US.The announcement comes as Gilead negotiates with pharmaceutical manufacturers in India and Pakistan over the production of remdesivir for developing countries. Remivir, the brand name of remdesivir manufactured by Eskayef, will be available for use in hospitals “in a few days” after it has been approved by Bangladesh’s regulator, the company’s marketing chief Mujahidul Islam told DPA. Eskayef is one of eight companies which the Bangladeshi government has approved to produce remdesivir, after the US Food and Drug Administration issued an Emergency Use Authorisation for the drug. Bangladesh, as a UN Least Developed Country, is allowed to produce any patented medicine without obtaining prior permission under World Trade Organisation agreements.