In response to intensifying demand, Gilead Sciences (GILD) has been ramping up production of its experimental remdesivir treatment that is being tested to combat the novel coronavirus.
The drug maker now has 1.5 million individual dosages that could be used for more than 140,000 patients and is supplying the medicine, which is being made available through clinical trials and special access programs, at no charge.
“Providing our existing supplies at no charge is the right thing to do, to facilitate access to patients as quickly as possible and in recognition of the public emergency posed by this pandemic,” Gilead chief executive officer Daniel O’Day wrote in an open letter released Saturday night. He added the 1.5 million doses will be donated for “broader distribution” following any potential future regulatory approvals.
About the Author Reprints
Ed Thank you!
Since there was no to dose, I would call Gilead info also sensationalizing news. It is normal and to be expected when cart is put before the horse. That is the case here. Gilead’s GREED is more important that the public NEED. By giving half information, stock spikes up and that is more critical to some folks.
Well such behavior is normal. People should be reminded what George Merck, founder of Merck US said
“We try to remember that medicine is for the patient. We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.”
Thank you!
Hi Steve White:
Thank you! There are many unanswered questions. Just printing news without facts (what is the dose, how many per patient and how many days) causes more confusion.
Thus printing news without facts is more SENSATIONALISM than public service. Thank you!
Hi Girish,
Nice to hear from you.
Gilead disclosed dosing in two trials back in February, which you can read here in their statement…
https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-initiates-two-phase-3-studies-of-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19
The dosing was not mentioned here because the dosing was not an issue in this instance. But the story does contain facts.
Sorry if you felt otherwise.
Regards
ed at pharmalot
Ed:
Has the effective dose for Remdesivir been established. In your write up there is no mention. Thank you!
Girish – I have no answer to your question but I note they say they have 1.5M doses, enough to treat 140,000 patients – so, it appears they give them ten doses each – do you know anything about why they need ten doses and how they would plan to time the doses? One per day for ten days, all the same? Or double doses at the beginning? Is there toxicity such that they can not give it in fewer doses? Just wondering.
So Sig,
You claim to have expertise in natural resources and are a mathematician and an economist. Let me judge your comment! First of all, what is your view and what have you written n global warming? Care to share your links? What is you background and expertise in natural resources, mathematics, and economy? Degrees? Institutions?
When are you getting your PhD in economics?
https://www.linkedin.com/in/sigmund-silber-40a36719/
You did NOT do your homework about Gilead, clearly and obviously. The fact that you were totally clueless for the pricing of Gilead’s HCV drugs is astounding! Just simply look them up (sofosbuvir, Harvoni, Epclusa, etc.) in Google.
It is pretty simple Sig, as to how Ed treated Gilead.
if a reporter is too critical or negative about a company, he would not get too far the next time when he tries to talk to the company (CEO or the spokesperson). You must/should know that as a fact?
This is IMO an outstanding and much needed article providing hopes for so many dying or severely ill coronavirus patients.
I would hasten to add that despite all the criticism of Ed’s from his recent and previous articles, it is important to note that this one does NOT require any superfluous medical knowledge nor expertise and is simply the result of pure and dogged pursuit thus a great example of investigative journalism. Pulitzer (yes Ed was a finalist a few years ago) always trumps MD or PHD IMO. The case study is that the now famous Catholic Diocese Scandal covered by the Boston Globe Spotlight story and the Oscar winning story and reporters did not need any divinity degree nor expertise.
So shame on those totally self-centered and grand-standing critics!! I did notice most of them were US based. To those, I urge you to swallow your pride, check your ego, and try to learn something from this exceptional NYT article below on the now famous first-hand account of the recovered Chinese-American HCP patient James Cai in NYC. Yes Gilead’s Remdesivir is again prominently featured.
https://www.nytimes.com/2020/04/05/magazine/first-coronavirus-patient-new-jersey.html
The only question I do have for Ed is the patent status of Remdisivir, globally.
The only plea I have for Ed is that next time he speaks to Gilead’s CEO O’Day, make sure to ask something about approximate timing of Remdisivir NDA submission to the FDA (later this year, early next year) and very importantly acessibility and price when (not if) is approved.
I have no objections to the article at all and wanted to thank the author and Stat for it.
As a layman I am trying to understand this. It seems to me, if Gilead put the drug into orphan status (which apparently it really WAS, since it had not been proven effective against anything, including this virus, and might have truly remained if not found to work on this) not only was that legal, but, in the absence of abusing their position, that is perfectly fine.
Sitting on medical patents seems like a terrible abuse – but were they going to do that? Seems more likely, whatever the status of the drug, they were going to go into large scale production, if it would not bankrupt them, betting that they will sell all they can make.
As another poster pointed out, the million treatments are maybe 1/100th of what we need. Instead of blaming Giliead for doing nothing wrong (I am not saying the author did that, but people were apparently) why not blame the Feds?
Not for the drug’s status – for not ordering all the drug Gilead can make as fast as they can make it, pending the results of all the trials. At a price which gives Gilead a huge windfall, but with the understanding if they try to price gouge the public the Feds will step in and force production or licensing at affordable prices.
In other words, we guarantee they get a windfall, and we also guarantee we have a lot of medicine.
What I read here is very, very disturbing . A drug touted as one of our best hopes will not be available to millions of people who will need it by the time we know if it works or not.
Great story. I want to support stat
If remdesivir is proven safe and effective, these production numbers 1-2 orders of magnitude too small. If it is approved for severe covid, 1% of the world population will need access to this antiviral, which means we’ll need 70 million courses of treatment, in other words 70 times more than the capacity Gilead is planning for.
That is related to my comment that to be effective the injection needs to be made before it is clear that it is needed.
But if it is effective and other treatments are not, I am confident that that problem can be overcome. But there will be an issue of who pays for it.
Other than in the trials, those in this first wave of cases will not benefit from these new treatments.
If we are lucky there will be marked slowdown in cases after this peak and that will allow time to ramp up production of that which sees to be useful
I agree with you totally Joey. I believe the Feds should step in and order millions of doses now, so that if it does work well, we will have them (hopefully the world will have them too) on hand so that no one goes without a life-saving treatment which is proven to work.
I realize drugs do not magically appear, and there may be production limitations which can not be easily overcome, but it sounds like the limiting factor now is Gilead’s finances, how much they can/are willing to put into creating a stockpile. That should not be the case, the Feds should be ordering up every reasonable candidate drug and vaccine in huge numbers IMO. If they do not pan out, we lost some money but the cost of not having them – not just in lives but in the economic shutdown which could be ended sooner if people were not scared of the virus – is so great, it is worth slinging some money around.
Sounds like a hit piece on Gilead. They so far to me have done nothing wrong. Why gang up on them. They can not distribute what they do not have and it is appropriate that those getting it be participants in trials where data is collected
I do not like this author.
Hi Mr. Silber,
Thanks for your note.
You’re correct that Gilead can’t distribute what it does not have. But I did not accuse Gilead of doing anything wrong.
I did recount some of the recent controversy over access, which has been an issue or, in some cases, there is concern might become an issue.
These concerns are out there and – whether one likes it or not – are part of the larger story of how the drug is tested, possibly approved and, later, distributed.
If access ceases to be a concern, that will get noted.
Meanwhile, Gilead should certainly get credit for its development efforts and willingness to address access concerns.
Hope this helps and stay safe,
ed at pharmalot
Yes you did cover it all but your tone was not IMO appropriate.
I have seen other things you have written which are better.
On average the companies who work on this stuff will lose money. No one who worked on the SARS vaccine as an example even had a chance to take it to Phase III I may not have the terminology correct but the virus went away before they could get approval and have a market.
So we should be careful to not make it more difficult for companies to move forward. Whether their decisions are always the best can be debated that is for sure. But to vilify a company is not constructive.
As a journalist, providing the background and history is legitimate. But you could have properly added a sentence that the current actions seem reasonable. You didn’t.
You should have.
You focused a lot on someone who was hurt by a decision they made. Perhaps they could have handled that differently but there will be shortages of human resources in these times.
You are the writer. I am the reader. So you write and I judge.
I am also a journalist and write mostly about the weather under the name Sig Silber. You can find me. I sometimes write about other things as I have a background in natural resources and I am a mathematician and an economist. The same rules apply. I write, the reader judges.
Get used to it.
Hi Mr. Silber.
Nice to hear from you again.
Rather than tone, perhaps you objected to what I emphasized, which were the most recent developments.
I agree that it’s rather remarkable Gilead had an existing antiviral drug that was ready for Phase 3 testing for a pandemic. And the company has been rightfully lauded for its quick response and willingness to further invest. Other than what I mentioned in the story, these are not new points, though.
Although Gilead has a different chief executive and management now, it also has a history of controversy over pricing and access. And what is new is that three times in the past week, this issue came up.
First, when dozens of advocacy organizations issued a letter about patents and data. The second instance involved complaints from some families (which a few other outlets covered more extensively). And third, the EMA, a regulator, referenced the access issue in its own statement.
These developments all occurred in the past week and were sandwiched between two unusual open letters from the Gilead ceo, which appear to have largely been prompted by access concerns.
This is why I noted what I did in the story.
That said, if the drug does prove effective, Gilead will face a herculean effort – providing as much medicine as possible. And this will be an enormous undertaking, of course.
Assuming the drug is approved, a complicated and delicate dance will unfold. First and foremost is satisfying the public health benefit. The company may also be able to recognize this financially as a longer term, recurring business. However it plays out, every move by the company will be picked apart.
But I wasn’t writing a column, in this instance, just passing along the most recent events. I’m actually happy for readers to judge for themselves, though.
I’m quite used to it, actually. And I also enjoy the give and take.
For now, I think we’ll have to agree to disagree.
Regards
ed at pharmalot
We do not totally disagree. You did a good job of covering all aspects of the issue and I give you credit for that. I just found the tone wrong given the circumstances. I accept your alternative explanation as I think the two are equivalent.
You know more about this than I do but I have been both a consultant to pharma and an investor and I know that sometimes there are bad things that happen. We see the black market in medical equipment now and that informs us of some aspects of human nature that are not ideal.
But this did not look like that to me.
Did you include this in the original article? I do not remember. “Although Gilead has a different chief executive and management now, it also has a history of controversy over pricing and access.”
That is very important. They have a different management so beating them with a stick over prior actions to me is in appropriate but it was not inappropriate for you to document that. I think we have a lot of troublemakers in this world and although I am an amateur journalist (management consulting is my profession) I do not like the Media one bit.
I do not think Gilead’s approach will be successful. You need an injection early on so that may be unwieldy. They certainly have the right to make a profit but many in the industry are putting profit as Job #3 but you can not survive without a profit and resources used in one area are not being used in other areas. So I want these companies to survive.
I am sorry I gave you such a hard time as you clearly are trying to do a good job. So I hope you are safe and I hope you are observant and have a Seder and this is the Hebrew month of miracles and we need one. It is not an accident that Passover and Easter occur pretty much at the same time. The path may be different but the concept is very very similar.
Thanks for the give and take. I give you credit for that.
I am going to try to read more of what you write.
But let’s hope we end up with a mutitude of useful treatments.