USA buys up world stock of remdesivir(theguardian.com)
theguardian.com
USA buys up world stock of remdesivir
https://www.theguardian.com/us-news/2020/jun/30/us-buys-up-world-stock-of-key-covid-19-drug
126 comments
1. remdesivir is not a cure for COVID and not as valuable to the rest of the world. We need vaccine
2. there is plenty of generic remdesivir in India
Until recently people were buying it from India to treat FIV (a previously fatal disease in housecats). There was a whole network of people supplying it through Facebook groups and mailing it to the US.
To fill in slightly more detail, that's GS-441524 instead of remdesivir. It's closely related but a lot easier to manufacture. Here's a good article on that:
https://www.statnews.com/2020/05/14/gilead-should-ditch-remd...
And a fascinating tale how cat owners are buying the black market version to treat FIP:
https://www.theatlantic.com/science/archive/2020/05/remdesiv...
https://www.statnews.com/2020/05/14/gilead-should-ditch-remd...
And a fascinating tale how cat owners are buying the black market version to treat FIP:
https://www.theatlantic.com/science/archive/2020/05/remdesiv...
Last I read, the trial results for Remdesvir were disappointing. Much less encouraging that the trials using steroids. Is remdesvir actually that valuable?
2. there is plenty of generic remdesivir in India
How does this go together with the claim that "Remdesivir is patented by California-based Gilead"?
How does this go together with the claim that "Remdesivir is patented by California-based Gilead"?
> How does this go together with the claim that "Remdesivir is patented by California-based Gilead"?
India does not recognize patents on medicine.
See, for example: India: Patents And The Indian Pharmaceutical Industry [1]
> With regard to pharmaceuticals, in the case of substances intended for use or capable of being used as food, drugs or medicines or substances produced by chemical processes, patents are granted only for the processes of manufacture of such substances and not for the substances themselves. Hence, pharmaceutical products are currently not granted patent protection under Indian law.
(And note that the "process of manufacture of such substances" is in practice interpreted so tightly that it covers very little.)
[1] https://www.mondaq.com/india/patent/865888/patents-and-the-i...
India does not recognize patents on medicine.
See, for example: India: Patents And The Indian Pharmaceutical Industry [1]
> With regard to pharmaceuticals, in the case of substances intended for use or capable of being used as food, drugs or medicines or substances produced by chemical processes, patents are granted only for the processes of manufacture of such substances and not for the substances themselves. Hence, pharmaceutical products are currently not granted patent protection under Indian law.
(And note that the "process of manufacture of such substances" is in practice interpreted so tightly that it covers very little.)
[1] https://www.mondaq.com/india/patent/865888/patents-and-the-i...
I think that law was changed in 2005 to allow product patents.
The law might have been changed, but the practice of the law has not. India still does not honor practically any foreign patents on medicine.
this practice helped so many people from low-income countries survive form life-threatening conditions by just importing drugs from India.
A relative of mine from a very low income country got Hepatitis C treatment, thanks to India.
https://www.expresspharma.in/covid19-updates/remdesivir-in-i...
> To expand the supply of remdesivir across the globe, Gilead Sciences has signed non-exclusive voluntary licensing agreements with four Indian generic pharma manufacturers, namely; Cipla, Hetero Labs, Jubilant Lifesciences and Mylan as well as a Pakistani firm, Ferozsons Laboratories to manufacture and distribute remdesivir in 127 countries.
They basically gave away licenses to generics manufacturers- gilead has been very reasonable.
Also, not all countries respect patents.
Also, not all countries respect patents.
This is exceptionally important to mention, too.
Imagine "doing the right thing", and then people lamblasting you, upset at you, and even actively working against you.
Imagine "doing the right thing", and then people lamblasting you, upset at you, and even actively working against you.
I expected the backlash from pharma publications going on about how the incredibly low price gilead set for the drug is going to set a precedent that might force the entire industry to cut prices and destroy profits[1]. I didnt expect the backlash from the public. The message that gilead and friends would be getting is that people will hate pharma for the sake of hating pharma, amd that the hate they get has nothing to do with their behavior, so might as well charge high prices since the anti-pharma crowd is not acting in good faith.
[1]https://www.statnews.com/2020/06/29/gilead-remdesivir-price-...
[1]https://www.statnews.com/2020/06/29/gilead-remdesivir-price-...
Fun Fact: it's perfectly legal to photocopy a textbook for educational purposes in India. Supreme Court threw away the court case when somebody tried to sue them.
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If it helps patients to recover faster, it does make a huge difference by having more beds available in the hospital.
The wonder drug that supposedly can cut two whole days off a case! Wow I am surely sad that MY goverment didn't hoard all those pills, I mean they are only 2000USD per treatment...
First the US buys all the chloroquin, now this. Next they will come for all our sugar pills too!
First the US buys all the chloroquin, now this. Next they will come for all our sugar pills too!
I thought studies include Remdesivir and Hydroxycloroquine showed negative results. Why would we be buying up Remdesivir when Dexamethasone is the new hot drug with good clinical results?
Remdesivir reduces hospital stay but does not reduce mortality. It costs a lot and is hard to make.
Dexamethasone is cheap, easy to make, and reduces mortality. We don't want remdesivir, which is why you're not seeing regulatory action to seize control of the rights.
https://www.nihr.ac.uk/news/first-drug-to-reduce-mortality-i...
Dexamethasone is cheap, easy to make, and reduces mortality. We don't want remdesivir, which is why you're not seeing regulatory action to seize control of the rights.
https://www.nihr.ac.uk/news/first-drug-to-reduce-mortality-i...
Recently read about This. theoretically doesn’t look like the cure
https://scopeblog.stanford.edu/2020/06/29/how-remdesivir-wor...
https://scopeblog.stanford.edu/2020/06/29/how-remdesivir-wor...
"The drug, which was invented for Ebola but failed to work, is under patent to Gilead, which means no other company in wealthy countries can make it."
Sorry, but if the one blessed company with the patent can't keep up with demand, and millions are going to die because there are patent restrictions, then ignore the patent laws and save some lives. It wouldn't look too good if the American government tried to stop it, essentially saying "It's against the law to save their lives, and we're going to punish you for saving them."
Sorry, but if the one blessed company with the patent can't keep up with demand, and millions are going to die because there are patent restrictions, then ignore the patent laws and save some lives. It wouldn't look too good if the American government tried to stop it, essentially saying "It's against the law to save their lives, and we're going to punish you for saving them."
The last studies I saw showed Remdesivir didn't actually save lives. Unless some very different studies have come out, this is just a politically connected pharma company using the pandemic to get a fat check from the US government. This is just your standard every day corruption.
One of my friends is an anaesthetist dealing with Covid patients day in day out in India. She works for a Government hospital and they started trying Remdesivir 3 days ago. She said all three patients that they have given the drug to have died of arrest - she does insist though that its not because of the drug but she was saying that it isn't improving things if the patient is in late stages of Covid.
This is a worthless 2nd hand hearsay anecdote.
Remdesivir has a minor beneficial impact when delivered VERY EARLY.
No need to spread FUD when there's clinical data available.
Remdesivir has a minor beneficial impact when delivered VERY EARLY.
No need to spread FUD when there's clinical data available.
>Remdesivir has a minor beneficial impact when delivered VERY EARLY.
There's still a couple of problems though:
* It has to be delivered by IV drip
* It's in short supply
* It's expensive
Which means that realistically, the only way to get a positive impact from it would be to send high-risk patients who were very likely to have just been exposed to the hospital for the injection. Even then, the risk-value proposition does not seem that great.
There's still a couple of problems though:
* It has to be delivered by IV drip
* It's in short supply
* It's expensive
Which means that realistically, the only way to get a positive impact from it would be to send high-risk patients who were very likely to have just been exposed to the hospital for the injection. Even then, the risk-value proposition does not seem that great.
None of these three points is the bottleneck. It's still easy to give someone an IV early on if they're in a high-risk group, it's not in that short supply, and at ~$2500 per treatment regimen it's not that expensive compared to an extended hospital stay.
The bottleneck is that it's only slightly effective.
The bottleneck is that it's only slightly effective.
It’ll be a means for the rich to lessen their pain. Nothing more. Let’s be honest.
No hospital would take you in on slight symptoms. The drug alone costs $3,000+, it’s basically US-only and thus needs to be administered there, which will end up costing about as much again.
See the top 0.01% hold some remdesivir in their mansions for their private physician to administer.
No hospital would take you in on slight symptoms. The drug alone costs $3,000+, it’s basically US-only and thus needs to be administered there, which will end up costing about as much again.
See the top 0.01% hold some remdesivir in their mansions for their private physician to administer.
Can you point me to the results from the clinical trial?
I wasn't trying to spread FUD. I did state that the arrests weren't because of the drug.
I wasn't trying to spread FUD. I did state that the arrests weren't because of the drug.
Yes a minor impact, that doesn't really show that it saves lives at all. Just that generally those who take the drug early on are out of bed a couple of days earlier than others. Not really worth 2000USD a pop. Sounds like a big pharma scam to me. Same with the Chloroquin
I have no idea if remdesivir works or not, but that is the problem with drugs in a shortage scenario like we're currently seeing. If there aren't enough of them, you're going to save them for the most critical patients. But those patients are the most likely to die anyway. That's why randomized controlled trials are so important. Data from a hospital that's not randomizing distribution of the drug is not really helpful.
Same here. I swear Covid has been bringing out the WORST in information recycling I've ever seen.
They use some medical mumbo jumbo to show that patients spend less time at hospitals compared to other drugs and therefore Remdesivir works. They know how to lobby the scientific community so we will never know the truth. Sick patients will use and pay out of fear. I would love to see an unbiased study at some point if at all that shows the relative efficacy of Hydroxychloroquine with and without zinc and Remdesivir and other drugs.
The Tamiflu hustle.
Remdesivir can change the disease so people are in the hospital for a less days. Accounting for only the basic cost of a hospital bed at least financially this is a big improvement. And of course if one of the major problems is a shortage of beds this helps a lot.
It seems to reduce the number of days spent in the hospital, which would save lives if hospitals are over-capacity. But only if given early.
So in theory it could save lives if it keeps Karen and Becky out of the ER.
So in theory it could save lives if it keeps Karen and Becky out of the ER.
This Twitter thread explains in detail how the pharmaceutical pricing works: https://twitter.com/chimeracoder/status/1278041777883303936
What about India? Aren't they famous for having laws that ignore pharmaceutical patents?
One would think this would be a rather large opportunity for them.
One would think this would be a rather large opportunity for them.
Trust me Canada, India and most likely the EU too won't be waiting for anyone.
As a Canadian, I've seen our government repeatedly threaten to bypass US drug patents in the last trade war we had with the US.
And frankly, the cheaper drugs are for the consumer, generic or otherwise, the better. I'm certain that a life-saving drug won't be getting skipped because of a patent dispute.
As a Canadian, I've seen our government repeatedly threaten to bypass US drug patents in the last trade war we had with the US.
And frankly, the cheaper drugs are for the consumer, generic or otherwise, the better. I'm certain that a life-saving drug won't be getting skipped because of a patent dispute.
The real scandal is that the drug doesn't really work the well. But the government can certainly sell this as a victory, especially since Trump was accused for promoting chloroquine and now he has access to both competing "solutions".
Gilead has already announced that they won’t enforce the patent for coronavirus treatment. That doesn’t mean it’s easy to make, but the patent is not the issue.
Actualy Gilead is allowing generics manufacturers to produce remdesivir
https://www.gilead.com/purpose/advancing-global-health/covid...
https://www.gilead.com/purpose/advancing-global-health/covid...
Except they declare the terms of who gets to produce it and where they can be distributed. Conveniently they reserve the exclusive rights for the 'rich' countries to themselves.
Is that supposed to make someone angry? Because this seems like an okay solution to make back investments and still allow cheaper access for poorer nations.
Still if they can't keep up with demand and there are many lifes at stake, we should probably legislate a compensated invalidation of such a patent.
Still if they can't keep up with demand and there are many lifes at stake, we should probably legislate a compensated invalidation of such a patent.
The US is not the entirety of the countries they reserve to themselves. This process was not decided on as the most efficient by any sort of entity with an interest in public health - it's a private company performing a "goodwill" gesture.
"goodwill"
I'm certain that the CEO knows just how fickle the patent is and wants to maintain as much control, gain as much money, favors etc while reducing risks, liability, losses etc.
I'm certain that the CEO knows just how fickle the patent is and wants to maintain as much control, gain as much money, favors etc while reducing risks, liability, losses etc.
> The US is not the entirety of the countries they reserve to themselves.
Sorry, my statement on legislation was ambigious. First, "we" was meant as "we the people of our respective countries," not limited to the US in any way. Secondly, it would probably create some international problems, so a combined effort would be nice. But I think companies should be compensated in such a case (hence "compensated invalidation") in a way that a company can reasonably accept.
> This process was not decided on as the most efficient by any sort of entity with an interest in public health - it's a private company performing a "goodwill" gesture.
I didn't claim that. I said it seems like an okay solution to that challenge (to me). This is independent from who came up with the idea.
As I felt it was phrased in a whay to supposedly make a reader angry, I questioned why that should be the case. Maybe that was over-interpreted by me. For the same reason I would accept this as an actual goodwill gesture. I have no trouble with the idea that richer countries have to pay more for making the development worthwhile and poorer countries benefiting from that at a cheaper price, as it seems like the humane thing to do to me.
Sorry, my statement on legislation was ambigious. First, "we" was meant as "we the people of our respective countries," not limited to the US in any way. Secondly, it would probably create some international problems, so a combined effort would be nice. But I think companies should be compensated in such a case (hence "compensated invalidation") in a way that a company can reasonably accept.
> This process was not decided on as the most efficient by any sort of entity with an interest in public health - it's a private company performing a "goodwill" gesture.
I didn't claim that. I said it seems like an okay solution to that challenge (to me). This is independent from who came up with the idea.
As I felt it was phrased in a whay to supposedly make a reader angry, I questioned why that should be the case. Maybe that was over-interpreted by me. For the same reason I would accept this as an actual goodwill gesture. I have no trouble with the idea that richer countries have to pay more for making the development worthwhile and poorer countries benefiting from that at a cheaper price, as it seems like the humane thing to do to me.
> Because this seems like an okay solution to make back investments
The investment was made by the American people paying taxes. The profits will be privatized.
https://www.washingtonpost.com/business/2020/05/26/remdesivi...
The investment was made by the American people paying taxes. The profits will be privatized.
https://www.washingtonpost.com/business/2020/05/26/remdesivi...
Pandemic aside, the US government shouldn’t get a better deal than any other investor. If you invest “tens of millions” into drugs that will cost “billions” to bring to market, you don’t get to get the drug for free. Imagine a Silicon Valley investor proposing those terms: we’ll invest $1 million in your startup for 75% of the equity. But that’s exactly what people are proposing when they say a few tens of millions of government funding should buy free access to patented technology that takes hundreds of millions to bring to market.
I don’t think people are asking for “free”, they’re asking for “at cost”, or some sort of bulk deal. There is actually a lot of precedent for that in SV deals, for one people get some return on investment (the bulk order discount / profit cut deal). Second you get deal modifiers like facebooks sweetheart ad deal for Microsoft’s 240M funding round, which might be akin to “if we fund this thing we need you to work with us if we’re all about to die without it”.
Truly good/fair solution probably exists between nationalizing Gilead and Gileads opening bid.
Truly good/fair solution probably exists between nationalizing Gilead and Gileads opening bid.
At cost is highly problematic when your investor is also your largest consumer by a huge margin.
Also, if you donate no-strings grants and services, you are not a investor in the traditional sense. You are providing charity.
Based on your link, various American government agencies contributed $70MM to the R&D of remdesivir. While I can't find the total R&D cost for this particular drug, the average R&D cost for bringing a new drug to market is about $1BN [1]. Draw your own conclusions.
[1] https://www.biopharmadive.com/news/new-drug-cost-research-de...
[1] https://www.biopharmadive.com/news/new-drug-cost-research-de...
It's disingenious to frame like the public paid for the whole research. This articles talks about 70 million dollars in public money invested. Bringing a drug to market has a total R&D bill on the order of billions of dollars.
the US government intentionally gives away money with no strings attached for R&D. The explicit purpose of this funding is to help companies make products and profit. If the outcome you want is different, we need to look at different research vehicles.
This section of your WaPo article hits the nail on the head:
>“Without incentivizing some of these companies to stay attached to emerging disease, I think they will walk away, even after this one,” he said. “In this situation [filing for a government patent] would have caused more harm with Gilead and not been worth it. “The government’s job is to make sure industry is successful, and if industry is successful, then we all benefit from it.” “Although USAMRIID performed extensive and critical screening and testing for Gilead, testing a compound and finding that it is indeed an effective antiviral compound does not qualify USAMRIID as a joint inventor of the compound,” Leigh Callander, chief patent counsel for the U.S. Army Medical Research and Development Command, said in an email.
This section of your WaPo article hits the nail on the head:
>“Without incentivizing some of these companies to stay attached to emerging disease, I think they will walk away, even after this one,” he said. “In this situation [filing for a government patent] would have caused more harm with Gilead and not been worth it. “The government’s job is to make sure industry is successful, and if industry is successful, then we all benefit from it.” “Although USAMRIID performed extensive and critical screening and testing for Gilead, testing a compound and finding that it is indeed an effective antiviral compound does not qualify USAMRIID as a joint inventor of the compound,” Leigh Callander, chief patent counsel for the U.S. Army Medical Research and Development Command, said in an email.
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Canada already did that once in regards to Cipro (anthrax antidote patented by bayer) back in 2001. The Bush gov forced Bayer to sell it for way cheaper, by threathing to buy generics instead.
https://www.nytimes.com/2001/10/24/business/a-nation-challen...
https://www.nytimes.com/2001/10/24/business/a-nation-challen...
I was curious about this, so did a little search:
Other interesting results were:
Canada forced to honour Bayer's patent on ciprofloxacin (BMJ. 2001 Oct 27; 323(7319): 956. PMCID: PMC1172996)
> In an embarrassing mix-up, Canada's federal government will pay twice for a supply of the antibiotic ciprofloxacin (marketed as Cipro) that it ordered to protect Canadians in case they are faced with an outbreak of anthrax, as has happened in the United States.
...
> After a meeting of officials from the health department and both companies on Monday, the government announced it will still pay the generic firm the amount of its contract— $C1.3m (£580 000; $824 000)—and will buy another 900 000 tablets from Bayer. Bayer's price is said to be $C2.50 a tablet, compared with Apotex's $C1.50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1172996/
Canadian government almost swamped by ciprofloxacin (BMJ. 2001 Nov 3; 323(7320): 1026. PMCID: PMC1173010)
> Canada's federal government has narrowly avoided having to pay for twice as much of the antibiotic ciprofloxacin (Cipro) as it thinks it needs to protect its citizens in the case of an outbreak of anthrax.
> The federal health department circumvented its own drug patent rules when it ordered about 900 000 tablets of the medication from a generic drug manufacturer, Apotex. The patent, held by Bayer AG, does not expire until 2004. Bayer reportedly threatened to sue. But after an announcement by the government that it would both pay the generic firm the amount of its contract—$C1.3m (£574 000; $825 000)—and buy another 900 000 tablets from Bayer, both drug companies let the health minister, Allan Rock, off the hook.
...
> Under the patent act, the government could have obtained authorisation to have a non-patented version of ciprofloxacin on a non-commercial basis, but it failed to ask for this.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1173010/
Other interesting results were:
Canada forced to honour Bayer's patent on ciprofloxacin (BMJ. 2001 Oct 27; 323(7319): 956. PMCID: PMC1172996)
> In an embarrassing mix-up, Canada's federal government will pay twice for a supply of the antibiotic ciprofloxacin (marketed as Cipro) that it ordered to protect Canadians in case they are faced with an outbreak of anthrax, as has happened in the United States.
...
> After a meeting of officials from the health department and both companies on Monday, the government announced it will still pay the generic firm the amount of its contract— $C1.3m (£580 000; $824 000)—and will buy another 900 000 tablets from Bayer. Bayer's price is said to be $C2.50 a tablet, compared with Apotex's $C1.50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1172996/
Canadian government almost swamped by ciprofloxacin (BMJ. 2001 Nov 3; 323(7320): 1026. PMCID: PMC1173010)
> Canada's federal government has narrowly avoided having to pay for twice as much of the antibiotic ciprofloxacin (Cipro) as it thinks it needs to protect its citizens in the case of an outbreak of anthrax.
> The federal health department circumvented its own drug patent rules when it ordered about 900 000 tablets of the medication from a generic drug manufacturer, Apotex. The patent, held by Bayer AG, does not expire until 2004. Bayer reportedly threatened to sue. But after an announcement by the government that it would both pay the generic firm the amount of its contract—$C1.3m (£574 000; $825 000)—and buy another 900 000 tablets from Bayer, both drug companies let the health minister, Allan Rock, off the hook.
...
> Under the patent act, the government could have obtained authorisation to have a non-patented version of ciprofloxacin on a non-commercial basis, but it failed to ask for this.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1173010/
Fortunately, it's possible millions will not die in this case because remdisivir is most likely a quality-of-life therapeutic for people in the recovery phase. Your intuition is real though and my existential terror is that a real viral entry treatment will be developed, and that it may become unavailable or means-tested in an exclusionary way.
newsbinator(2)
Countries can nationalize the patent in times of pandemics and produce it locally. But this drug is hard to make.
This, I work in specialty pharmacies and Remdesivir is a complicated drug to produce.
Currently Gilead believe they can bring down their production time from 8-12 months 6-8 months, that means we won't see a large supply of this drug until 2021.
Currently Gilead believe they can bring down their production time from 8-12 months 6-8 months, that means we won't see a large supply of this drug until 2021.
I have a noobish question. Looking at Remdesivir wiki page to try to get a feeling for why it's hard to make, their are some really odd chemicals used like this https://en.wikipedia.org/wiki/Trimethylsilyl_triflate
Why is something like this, with its silicon and sulphur atoms as part of the backbone, needed? Why wouldn't the same but with a more typical fully-carbon backbone work? If it's too complex a question, skip it, but thanks if you can shed light.
Why is something like this, with its silicon and sulphur atoms as part of the backbone, needed? Why wouldn't the same but with a more typical fully-carbon backbone work? If it's too complex a question, skip it, but thanks if you can shed light.
The short “answer” is that the reaction step needs to form a carbon-carbon bond, which isn’t always trivial to make. A fully carbon backbone is likely not reactive in the way they need it to be here.
Certain “weird” metals like zinc, tin, and silicon (And these are the more normal ones) have been found to be able to help with this type of chemistry. The reason for why these metals are useful gets into orbital mechanics, but the core idea is that they can facilitate carbon-carbon bond formation.
The sulphur and fluorine are standard as part of the triflate functional group — it is a stable leaving group based on wanting electrons and being stable once it grabs those electrons (The sulphur can facilitate reasonable stabilisation).
Certain “weird” metals like zinc, tin, and silicon (And these are the more normal ones) have been found to be able to help with this type of chemistry. The reason for why these metals are useful gets into orbital mechanics, but the core idea is that they can facilitate carbon-carbon bond formation.
The sulphur and fluorine are standard as part of the triflate functional group — it is a stable leaving group based on wanting electrons and being stable once it grabs those electrons (The sulphur can facilitate reasonable stabilisation).
That compound in particular is used to help replace a C-OH bond with a C-CN bond. It may seem like a weird chemical but it's very commonly used in organic synthesis.
> Why wouldn't the same but with a more typical fully-carbon backbone work?
Because a fully carbon backbone would not be as reactive and would not attach/detach from the intermediate as needed
> Why wouldn't the same but with a more typical fully-carbon backbone work?
Because a fully carbon backbone would not be as reactive and would not attach/detach from the intermediate as needed
[deleted]
[deleted]
I'm not even an armchair doctor, but is there any truth to it being overcomplicated in a way that offers no benefit in this specific situation? My incredibly lay interpretation of the article below is that Gilead purposely designed something much more complicated to synthesize, that ends up being less effective than its predecessor. It reads as if all the over engineering of Remdesivir ended up having no positive result.
https://www.statnews.com/2020/05/14/gilead-should-ditch-remd...
>The company has also developed GS-441524, another pro-drug that, as its name suggests, the body also converts into GS-441524 triphosphate, but in just in three steps. GS-441524 is easier to synthesize than remdesivir, requiring three steps instead of the seven needed for remdesivir.
>Researchers initially thought that remdesivir would be activated more quickly than GS-441524 in human cells infected with the SARS and MERS coronaviruses. Yet data from primary human airway epithelial cells — one of the most clinically relevant cell-based models of the human lung — showed no statistically significant difference in potency between the two compounds. When GS-441524 was used to treat cats with feline infectious peritonitis, a progressive and usually fatal disease caused by a coronavirus, it displayed remarkable safety and therapeutic efficacy, with 96% of cats recovering after treatment.
>Recent research in coronavirus-infected nonhuman primates demonstrated problems with remdesivir that inadvertently showed the antiviral effectiveness of GS-441524. In multiple studies testing remdesivir in coronavirus-infected mice or rhesus macaques, it was rapidly converted to GS-441524 in the bloodstream.
>Take the latest controlled study conducted in rhesus macaques infected with SARS-CoV-2: After remdesivir was administered intravenously, GS-441524 was present in serum samples at concentrations 1,000-fold greater than remdesivir. Upon completion of the study, the researchers found that only GS-441524 — not remdesivir — was detected in the macaques’ lungs, yet they exhibited no signs of respiratory disease, significantly reduced viral loads, and a distinct reduction in damage to lung tissue. Such results reinforce those obtained from a prior study, also in macaques, and data from other species that GS-441524 exhibits strong antiviral activity.
>The first step in the bioactivation of GS-441524 is the rate-limiting step, something that remdesivir was designed to avoid. But that doesn’t matter clinically because of remdesivir’s rapid transformation to GS-441524 in the bloodstream.
There is also a black market for GS-441524, which could be a reason Gilead doesnt want to promote it?
https://www.theatlantic.com/science/archive/2020/05/remdesiv...
https://www.statnews.com/2020/05/14/gilead-should-ditch-remd...
>The company has also developed GS-441524, another pro-drug that, as its name suggests, the body also converts into GS-441524 triphosphate, but in just in three steps. GS-441524 is easier to synthesize than remdesivir, requiring three steps instead of the seven needed for remdesivir.
>Researchers initially thought that remdesivir would be activated more quickly than GS-441524 in human cells infected with the SARS and MERS coronaviruses. Yet data from primary human airway epithelial cells — one of the most clinically relevant cell-based models of the human lung — showed no statistically significant difference in potency between the two compounds. When GS-441524 was used to treat cats with feline infectious peritonitis, a progressive and usually fatal disease caused by a coronavirus, it displayed remarkable safety and therapeutic efficacy, with 96% of cats recovering after treatment.
>Recent research in coronavirus-infected nonhuman primates demonstrated problems with remdesivir that inadvertently showed the antiviral effectiveness of GS-441524. In multiple studies testing remdesivir in coronavirus-infected mice or rhesus macaques, it was rapidly converted to GS-441524 in the bloodstream.
>Take the latest controlled study conducted in rhesus macaques infected with SARS-CoV-2: After remdesivir was administered intravenously, GS-441524 was present in serum samples at concentrations 1,000-fold greater than remdesivir. Upon completion of the study, the researchers found that only GS-441524 — not remdesivir — was detected in the macaques’ lungs, yet they exhibited no signs of respiratory disease, significantly reduced viral loads, and a distinct reduction in damage to lung tissue. Such results reinforce those obtained from a prior study, also in macaques, and data from other species that GS-441524 exhibits strong antiviral activity.
>The first step in the bioactivation of GS-441524 is the rate-limiting step, something that remdesivir was designed to avoid. But that doesn’t matter clinically because of remdesivir’s rapid transformation to GS-441524 in the bloodstream.
There is also a black market for GS-441524, which could be a reason Gilead doesnt want to promote it?
https://www.theatlantic.com/science/archive/2020/05/remdesiv...
Even if this wasn't the case, a country could ignore the patent anyway and deal with the consequences later. A fine or sanctions by another country is preferable to a lot of dead citizens.
That said, patent restrictions are arguably the only reason the drug exists in the first place. So let's not get out over our skis here.
Remdesivir was developed with public funds. Shouldn't the fact that the public shouldered the risk of development be factored into any of this?
https://www.uab.edu/news/health/item/11082-investigational-c...
https://www.uab.edu/news/health/item/11082-investigational-c...
Technically true, but completely misrepresents the issue.
Discovering (100s of)compounds in a lab (which is what the public funds pay for) is the easy and much cheaper part.
Testing it in humans and modifying it for that purpose is hard, expensive, and time consuming. Pretending like these drug companies do nothing and just take all the benefit from public research is incorrect.
Discovering (100s of)compounds in a lab (which is what the public funds pay for) is the easy and much cheaper part.
Testing it in humans and modifying it for that purpose is hard, expensive, and time consuming. Pretending like these drug companies do nothing and just take all the benefit from public research is incorrect.
I never said they did nothing. I'm pointing out that they aren't the John Galt story that people are lead to believe when people mention "recouping cost". And like any other shareholder, shouldn't we see something of a benefit for putting up our own capital?
Here on HN, we should easily be able to see through this trope. The government made a $37.5 million grant to study a range of drugs. How much equity should the government get for what basically amounts to seed funding for the $1 billion cost of bringing a drug to market? (Account for dilution and the fact that the “investor” here doesn’t put more money into subsequent funding rounds.)
That's a good point.
That said arguably that there are many kinds of methods for funding the creation of drugs. The existing system isn't the only way. Your statement is literally, "stick with the status quo". The NIH should fund and produce these drugs, no patents, free for all to produce.
What second or third order effects might happen? I’m not saying the status quo is the only reasonable equilibrium, but if you take the profit motive out of something (anything), I worry that you’ll get fewer of society’s resources directed towards that area. Maybe that’s money, attention of the brightest/most creative thinkers, willingness to do the outright drudgery required to invent, perceived status of the field, etc.
If you want a lot of drug research, you probably want to ensure that successful drug research is lucrative. (Maybe less than today, maybe making unsuccessful research or negative reproduction more lucrative than today.)
If you want a lot of drug research, you probably want to ensure that successful drug research is lucrative. (Maybe less than today, maybe making unsuccessful research or negative reproduction more lucrative than today.)
The scientists doing the work could be getting paid the exact same by the government as opposed to investors looking to make 1000x returns.
In fact, I’m pretty sure the taxpayers are subsidizing investors with all the free research and knowledge they get from taxpayer funded higher educational facilities.
In fact, I’m pretty sure the taxpayers are subsidizing investors with all the free research and knowledge they get from taxpayer funded higher educational facilities.
Lol if you think investors are getting 1000x returns then why aren’t you investing in all the pharma companies :)
I wrote looking to make 1000x returns, not getting 1000x returns. If I was investing into pharma R&D, I would also be looking for commensurate returns and there’s nothing wrong with that.
Developing medicines is a high risk venture. But the rewards are extremely high also, so maybe it merits the resources of all of society. This is ignoring that US taxpayers already pay for a significant portion of the R&D via universities.
Developing medicines is a high risk venture. But the rewards are extremely high also, so maybe it merits the resources of all of society. This is ignoring that US taxpayers already pay for a significant portion of the R&D via universities.
Your original argument basically applies to everything, why shouldn’t the government just pay everyone’s salary since we’ve all benefited from some subsidy. 80-90% of drugs are discover by private companies doing research. Also, i think you would find that those scientists that you claim could just be paid by the government would leave those jobs when they inevitably have an idea that their risk adverse bureaucratic boss doesn’t want to pursue. Then they will find some rich fiends to invest and start companies themselves and we will be back to where we are now :). Unless you force everyone to work for the state... Anyway, I don’t feel like getting into the capitalism vs socialism but if you do a bit of research I’m sure you can discover why the current model works.
> The NIH should fund and produce these drugs, no patents, free for all to produce.
There is nothing to stop that under the current model. It just isn't happening.
There is nothing to stop that under the current model. It just isn't happening.
Creating drugs is usually not the big cost. Regulatory compliance is.
Reforming the FDA process could save an large amount of lives and money.
Reforming the FDA process could save an large amount of lives and money.
What are the other kinds of methods
Gilead can still be paid for the treatments produced, but if they cannot create supply to meet demand during an unprecedented crisis, they should not be allowed to become the bottleneck.
They have offered to let generics produce it without royalty fees.
Just because it is doesn't mean it ought to be. This, in fact, seems to be a pretty clear indication of why alternative funding methods should be considered.
Alternative funding methods already exist. Nothing is stopping governments or nonprofits from funding or developing new drugs. So what's your proposal here?
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If there is already alternative suppliers of this drug in India (as claimed by the article) under generic brands, can't they do a licensing deal for the drug and use that production while still not ignoring patent laws?
can't tell if this is a supply chain (production) problem or patent laws dilemma.
can't tell if this is a supply chain (production) problem or patent laws dilemma.
I think the problem is that gilead has already announced that they’re planning on charging something in the order of $3k per treatment, which won’t work in most of the world, and is a sure fire way to get countries to start asking questions about the value proposition of drug patents.
Basically if you have a company in India willing to manufacture for say $200, Gilead will still charge the same amount, so licensing is likely to end up being at cost for 3rd party manufacturers with all profits going to Gilead.
But if Gilead does do that then a whole lot of countries will suddenly start asking why they’re having to pay so much to a US company that isn’t manufacturing the drug, and is getting a 80-90% cutof the revenue.
It’s better for gilead to try to maintain a veneer if “quality productions costs this much” in order to justify their pricing.
Basically if you have a company in India willing to manufacture for say $200, Gilead will still charge the same amount, so licensing is likely to end up being at cost for 3rd party manufacturers with all profits going to Gilead.
But if Gilead does do that then a whole lot of countries will suddenly start asking why they’re having to pay so much to a US company that isn’t manufacturing the drug, and is getting a 80-90% cutof the revenue.
It’s better for gilead to try to maintain a veneer if “quality productions costs this much” in order to justify their pricing.
Most drugs have different prices in different countries so this is nothing new.
Also, My understanding is that 3rd party manufactures are not paying any royalties to Gilead, which is very generous and they should be applauded.
The good news is that the drug that actually works is a generic one.
The optics of this are terrible and the US should be working with other countries. But my guess is even if the US worked with Europe on distribution >90% of it would go to the US anyway. The need stateside is exponentially greater.
My guess is that Gilead played Trump and will now backtrack to make a licensing deal so that the EU can produce its own at a lower price.
There’s nothing stopping Gilead from allowing more licensing now that it has squeezed all it can from its best customer.
My guess is that Gilead played Trump and will now backtrack to make a licensing deal so that the EU can produce its own at a lower price.
There’s nothing stopping Gilead from allowing more licensing now that it has squeezed all it can from its best customer.
Interestingly, Gilead apparently has a standing agreement with Europe to deliver remdesivir. It should be interesting to see how this agreement can be fulfilled if 100% of all doses have already been sold to the U.S.
Currenly, remdesivir is not approved for the treatment of COVID-10 in the EU, but a decision along these lines is expected this week.
Currenly, remdesivir is not approved for the treatment of COVID-10 in the EU, but a decision along these lines is expected this week.
Sounds like the Guardian isn't happy its home country got out-bid. Did it expect that America would buy less of a potentially life-saving drug, effectively prioritizing the welfare of foreigners over her own? I'd expect any government to act in such a manner.
I agree media is making a big deal out of this.
But, would our reaction be still the same if Guardian's headline said China or Russia did this? Probably not. Perhaps we would even talk about putting new sanctions.
I think the right move would be allowing other companies to produce enough of it. If that means financially supporting Gilead, let's do that. Then nobody has to take all the stockpile.
But, would our reaction be still the same if Guardian's headline said China or Russia did this? Probably not. Perhaps we would even talk about putting new sanctions.
I think the right move would be allowing other companies to produce enough of it. If that means financially supporting Gilead, let's do that. Then nobody has to take all the stockpile.
> But, would our reaction be still the same if Guardian's headline said China or Russia did this? Probably not. Perhaps we would even talk about putting new sanctions.
Nope. There are about a billion other reasons both should be sanctioned to the point of embargo, but this isn't one. Nations have been fighting each other for resources for months now. That's to be expected in a high-demand, low-supply environment where each wants to save as many of her citizens as possible, and I wouldn't blame China or Russia for taking similar actions. For instance, I don't really blame China for having restricted exports of PPE because of greater need at home. I'd rather America get her hands on more stuff, but I'd expect any competent government to act in the interests of her citizens and so can't fault China (at least, not for this).
> I think the right move would be allowing other companies to produce enough of it. If that means financially supporting Gilead, let's do that. Then nobody has to take all the stockpile.
This is definitely a good approach, but this drug is pretty hard to make, so I'm not sure another company could just start making it easily [0]. However, Gilead has already been working with partner companies to ramp up production [1], which will allow them to benefit from all the work Gilead has put in to figuring out how to produce it at scale.
[0]: https://www.acsh.org/news/2020/03/26/problem-remdesivir-maki...
[1]: https://www.statnews.com/2020/04/30/gileads-remdesivir-has-s...
Nope. There are about a billion other reasons both should be sanctioned to the point of embargo, but this isn't one. Nations have been fighting each other for resources for months now. That's to be expected in a high-demand, low-supply environment where each wants to save as many of her citizens as possible, and I wouldn't blame China or Russia for taking similar actions. For instance, I don't really blame China for having restricted exports of PPE because of greater need at home. I'd rather America get her hands on more stuff, but I'd expect any competent government to act in the interests of her citizens and so can't fault China (at least, not for this).
> I think the right move would be allowing other companies to produce enough of it. If that means financially supporting Gilead, let's do that. Then nobody has to take all the stockpile.
This is definitely a good approach, but this drug is pretty hard to make, so I'm not sure another company could just start making it easily [0]. However, Gilead has already been working with partner companies to ramp up production [1], which will allow them to benefit from all the work Gilead has put in to figuring out how to produce it at scale.
[0]: https://www.acsh.org/news/2020/03/26/problem-remdesivir-maki...
[1]: https://www.statnews.com/2020/04/30/gileads-remdesivir-has-s...
exactly.
Imagine if there were excess stockpiles or capacity what the headline would have been! "Trump's fails to save US population with readily available medication!"
The media...just...suck...
The media...just...suck...
The drug that looked very promising for the last pandemic, yet turned out to have no benefit, and now looks very promising as a treatment for this pandemic...
Smells to me like someone in the remdesivir marketing department is doing very well... Are there any scientific studies that don't have vested interests and show it's a good treatment?
Smells to me like someone in the remdesivir marketing department is doing very well... Are there any scientific studies that don't have vested interests and show it's a good treatment?
There is a lot of competition. I think everything is on the table right now.
https://covdb.stanford.edu/compound-list/
https://covdb.stanford.edu/compound-list/
This smells an awful lot like the Tamiflu story.
Rumsfeld was chairman of Gilead until he was nominated as Secretary of Defense. He refused to sell his shares in the company and thus was forced to leave the room whenever discussions that might impact the company happened. A few years later the Pentagon starts stockpiling billions of dollars worth of Tamiflu. By the time Rumsfeld left the white house, Gilead shares were up from $7 in 2001 to $67 in 2006.
I'm confused. Are you saying he had an ulterior motive? Tamiflu is effective when given early. The stockpiles (which I doubt amounted to the billions) were for the general US population in case of a super-flu. ...so it was a good idea.
Clinicians more-or-less agree that Remdesivir has some minor beneficial anti-viral impact if given at the earliest moments of infection (like within 12 hours of infection), and some lesser beneficial impact later in cases where the body has trouble getting rid of the virus.
Covid-19 doesn't kill you. Those most sick in their 2nd and 3rd weeks are usually made very sick by their immune system's own inflammatory immune response (cytokine storm).
What this means is that Remdesivir could be very effective for patients that have known exposures and are in high risk categories.
...but, for most clinicians, since it needs to be given intravenously, it's not usually part of the clinical response (for the moment).
This is why the manufacturer (Gilead) is working on an oral delivery system. ...and we should all be supportive of that, because a broad use anti-viral might be very useful for covid-19 as well as other future viral diseases.
Still - what's going to save us from covid-19 is going to be a vaccine (and some degree of herd immunity).
Covid-19 doesn't kill you. Those most sick in their 2nd and 3rd weeks are usually made very sick by their immune system's own inflammatory immune response (cytokine storm).
What this means is that Remdesivir could be very effective for patients that have known exposures and are in high risk categories.
...but, for most clinicians, since it needs to be given intravenously, it's not usually part of the clinical response (for the moment).
This is why the manufacturer (Gilead) is working on an oral delivery system. ...and we should all be supportive of that, because a broad use anti-viral might be very useful for covid-19 as well as other future viral diseases.
Still - what's going to save us from covid-19 is going to be a vaccine (and some degree of herd immunity).
According to the article 500,000 doses are the production of July, and 90% of August and September. Three full months would be 500,000 / 2.80 * 3 = 535,714 doses. A full treatment is made of six doses. There are 89,285 treatments in there. Less than 30,000 per month. Too bad for the rest of the world that all of them will happen in the USA but they are way too few to matter globally. Split them proportionally with the population and how many of them are going to be assigned to any European country? Maybe we need a x10 in the production or more. Better, local production, which I understand is neither quick nor easy.
Gilead is not the only producer because it has licensed numerous other companies to manufacture the product.
See this post:
https://news.ycombinator.com/item?id=23700736
See this post:
https://news.ycombinator.com/item?id=23700736
> Better, local production, which I understand is neither quick nor easy.
There is patent. So, it is not legal unless countries change patent law.
There is patent. So, it is not legal unless countries change patent law.
> Better, local production, which I understand is neither quick nor easy.
I know nothing about the patent law, but according to the article, drug is patented. Assuming the process is not open-source, I'd argue that other countries would be looking for alternative vaccinations.
From the article:
> The drug, which was trialed in the Ebola epidemic but failed to work as expected, is under patent to Gilead, which means no other company in wealthy countries can make it. The cost is around $3,200 per treatment of six doses, according to the US government statement.
I know nothing about the patent law, but according to the article, drug is patented. Assuming the process is not open-source, I'd argue that other countries would be looking for alternative vaccinations.
From the article:
> The drug, which was trialed in the Ebola epidemic but failed to work as expected, is under patent to Gilead, which means no other company in wealthy countries can make it. The cost is around $3,200 per treatment of six doses, according to the US government statement.
This is a terrible waste of money. Hydroxychloroquine is less expensive, seems to be more effective according to the research, and backed by more science. You just have to look beyond your mainstream media to find the truth.
Hydroxychloroquine is not effective, but Remdesivir is not very effective either, so I would agree that it's a terrible waste of money.
That's OK. Apparently HCQ works too.
After working in the emergency room for three years now, I can firmly say no treatment even comes close to prevention.
The rest of the world already uses HCQ + Zinc prophylactically for about $20 instead. The pharma complex did a great job along with their zombie mob of amrchair biochemists (the ones downvoting me to hades right now) of discrediting HCQ with BS studies of almost dead people with 10x the normal dose of HCQ without Zinc. All HCQ is in this protocol is a Ionophore to get the zinc into the cells. Lancet had to retract one of the studies which they almost never do.