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FDA approves first monthly injectable to treat HIV infection

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Re: FDA approves first monthly injectable to treat HIV infection

#141

Post by reimertz »

lotsofpulp wrote: post #132
reimertz wrote: post #127

Earlier quoted context omitted.

Independent non-profits trying to fight for individuals in a capitalist-driven society seems to be doomed to fail. An depressing example; Insulin and how the inventors made sure to make the the process available to anyone; > The patent would not be used for any other purpose than to prevent the taking out of a patent by other persons. When the details of the method of preparation are published anyone would be free to…

> where corporations and their boards are legally bound to maximize profit, ignoring morals for profit. Where is this true? It’s not even a definable legal standard.

You are definitely correct and thanks for pointing it out. Generalizations and miss-information doesn't help at all.

I obviously need to go out for a walk before I comment on these type of news. It's super exciting but also extremely depressing since the ones who'd need this the most likely wont afford it.

Re: FDA approves first monthly injectable to treat HIV infection

#142

Post by timr »

akiselev wrote: post #99
timr wrote: post #83

Earlier quoted context omitted.

> My understanding is the funding for the trials was partly from NIAID. I have no particular insight into the pricing of this drug, but in general, NIAID funding doesn't get anywhere close to the level of investment needed to bring a drug to market (NIAID's total budget is something like $5Bn. A single drug can easily require that much money to go to market). Moreover, it isn't a bright-line distinction between publi…

> I have no particular insight into the pricing of this drug, but in general, NIAID funding doesn't get anywhere close to the level of investment needed to bring a drug to market (NIAID's total budget is something like $5Bn. A single drug can easily require that much money to go to market). According to [1] "the estimated median capitalized research and development cost per product was $985 million, counting expendit…

Yeah, $5Bn may be a bit of an exaggeration, but it's not off by an order of magnitude; this review, based on data from Eli Lilly, put the fully capitalized R&D number at $1.8Bn in 2010:

https://www.nature.com/articles/nrd3078

(one can certainly quibble over the "cost of capital" assumptions these days, but the model isn't wildly wrong.)

> That billion dollar figure is risk adjusted per product meaning that's the cost of all R&D and clinical trials against the number of products that hit the market.

Yes, but as you know, you can't simply separate the successful products from the ones that fail. The former pay for the latter.

> A lucky startup can pull off a successful trial for a few hundred million (i.e. Sofosbuvir), if not tens of millions for an orphan drug.

Sure, one can always hit the lottery. But unlike startups (where the N-independent-failures model works OK), drugs don't make it to market without a deep-pocketed company willing to set huge piles of money on fire in the final phases.

Your other comment below does a good job of explaining why trials are insanely expensive...which is why lucky startups almost never run their own. So you're dependent on a system where deep-pocketed mega-corporations need to exist simply to get the drugs on the market, and they are reliant on massive returns to take the risk in the first place.

Re: FDA approves first monthly injectable to treat HIV infection

#143

Post by damnyou »

daniel957 wrote: post #128
damnyou wrote: post #123

Earlier quoted context omitted.

I'm pretty sure that "easier" is a subjective determination. But no, I don't have a hard time swallowing pills. It's just that doing something once a week is easier than having to remember to do something everyday. The injections are also more effective for me, as they are here. And finally there's an aesthetic aspect to plunging a needle into one's muscle that I appreciate.

Yes, it’s subjective to some extent, hence why I asked in what way is it easier beside you just saying that it is? I left out “to you” but I thought the HN community was a bit smarter than that. Even if you had said “it’s easier to me. Full stop,” I still would have written the same reply... All you said was “it’s easier” in your original point. You obviously felt the need to clarify yourself in your most recent comm…

I did not downvote you, for the record. I thought your questions were useful and I hope I answered them to the best of my ability.

This pandemic has been hard on all of us. Take care.

Re: FDA approves first monthly injectable to treat HIV infection

#144

Post by SargeZT »

tyingq wrote: post #71
perardi wrote: post #68

As someone who is in this high-risk community: good news. (Well, except for that price tag.) People, to a first approximation, are just terrible at pill compliance. Doesn’t matter the demographics, people just aren’t perfect at taking a pill, every day, at the same time, forever and ever. Having that injection where you can set it and forget it? Nice advance. Not game-changing, but still a nice move forward. And I th…

It's a shame that PrEP is still so expensive.

It is expensive, but it is accessible. Truvada for PrEP has a program both for insured patients that covers co-pays up to $7,200 per year (I pay zero dollars a year because of this), and a medication assistance program for uninsured patients where after signing up and meeting eligibility requirements (which are basically 'are you at risk of getting HIV' and 'are you not wealthy to the point where you should definitely be able to afford insurance') you receive the medication at zero cost.

This is true of many medications, but Truvada is especially famous for it. As a gay man I have a lot of friends on it, and because of the aforementioned program, only two of the thirty+ pay any co-pay at all, and it's something like 20 bucks for them.

Re: FDA approves first monthly injectable to treat HIV infection

#145

Post by thisrod »

ed25519FUUU wrote: post #28

> In 2018, for instance, there were approximately 36,400 newly infected patients living with HIV in the U.S. This number seems insane to me in the USA . Why is a well known deadly disease, with well understood transmission vectors, still spreading so prominently here?

I was about to reply: because no one ever recovers from HIV infection. Then I realised it isn't true. People being treated for HIV are not contagious, so they "recover" in the epidemiological sense the moment they start treatment. The only way that can happen is if a lot of people have HIV but don't know it.

Re: FDA approves first monthly injectable to treat HIV infection

#146

Post by daniel957 »

daniel957 wrote: post #104
damnyou wrote: post #101

Earlier quoted context omitted.

It is in fact much easier and less of a hassle (for me) than taking a pill everyday, which is what I used to do before I switched to injectables. Injectables seemed scary right until the moment when I started taking them, after which they became a normal part of my life.

In what way is it easier besides you saying that it’s easier? You have a hard time swallowing pills I guess? Or do you remember to take injections more because they stand out more in your mind than pills do? EDIT: Not sure why this is getting downvoted. Since when on HN is it acceptable for someone to say “I think this way so it must be a fact” without providing an explanation? Even when it comes to subjectivity, the…

He edited his comment to say “(for me)” after I had replied.

Also, if you click damnyou@‘s comment history, you’ll clearly see that he loves using the phrase “in fact” without supporting his assumptions. I didn’t deserve to be downvoted.

Re: FDA approves first monthly injectable to treat HIV infection

#147

Post by tyingq »

SargeZT wrote: post #144
tyingq wrote: post #71

Earlier quoted context omitted.

It's a shame that PrEP is still so expensive.

It is expensive, but it is accessible. Truvada for PrEP has a program both for insured patients that covers co-pays up to $7,200 per year (I pay zero dollars a year because of this), and a medication assistance program for uninsured patients where after signing up and meeting eligibility requirements (which are basically 'are you at risk of getting HIV' and 'are you not wealthy to the point where you should definitel…

That's better than I had imagined it was, though I wonder about those on really lousy insurance, or no insurance. Or perhaps those on their parent's insurance that aren't "out" yet, etc.

Re: FDA approves first monthly injectable to treat HIV infection

#148

Post by daniel957 »

damnyou wrote: post #143
daniel957 wrote: post #128

Earlier quoted context omitted.

Yes, it’s subjective to some extent, hence why I asked in what way is it easier beside you just saying that it is? I left out “to you” but I thought the HN community was a bit smarter than that. Even if you had said “it’s easier to me. Full stop,” I still would have written the same reply... All you said was “it’s easier” in your original point. You obviously felt the need to clarify yourself in your most recent comm…

I did not downvote you, for the record. I thought your questions were useful and I hope I answered them to the best of my ability. This pandemic has been hard on all of us. Take care.

? I’m not sure what the pandemic has to do with this.

I looked at your comment history and you say “in fact” without supporting your opinions _often_ to the point that I laughed.

Also, you edited your original comment which probably led to the downvotes.

I’m assuming you must also correlate the pandemic with your immaturity then.

Re: FDA approves first monthly injectable to treat HIV infection

#149

Post by jklein11 »

abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

Does anyone actually end up paying the 47,500 a year for the drug or is this some sort of gimmick on the part of the drug company when they negotiate reimbursement rates with CMS or other payers?

Re: FDA approves first monthly injectable to treat HIV infection

#150

Post by lwhi »

jklein11 wrote: post #149
abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

Does anyone actually end up paying the 47,500 a year for the drug or is this some sort of gimmick on the part of the drug company when they negotiate reimbursement rates with CMS or other payers?

I'd imagine this cost would generally be borne by insurers or a government health care body.
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