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.
FDA approves first monthly injectable to treat HIV infection
111–120 of 220 posts
Re: FDA approves first monthly injectable to treat HIV infection
#112Earlier quoted context omitted.
> So even in a rich country, this is like 50% more than the income of a typical person. Generic versions of expensive American drugs tend to be released by Indian pharmaceutical companies into developing countries after a while.
They do it after the patent expires.
https://link.springer.com/chapter/10.1007/978-981-13-8102-7_...
Re: FDA approves first monthly injectable to treat HIV infection
#113Earlier quoted context omitted.
It's a shame that PrEP is still so expensive.
It’s frustrating that it’s so expensive for the most at-risk communities in the US. Because you can totally work the systems to get it affordably. Besides insurance, there are clinics, there are coupons, there are programs…but you have to have the information literacy and the time to figure out how to jump through all those hoops. Me, I work remotely, I have insurance, I live on the north side of Chicago, I can get m…
Re: FDA approves first monthly injectable to treat HIV infection
#114As someone who grew up in the 80s with the fullblown AIDS crisis, this really is a testament to human ingenuity. When we were kids, this sounded like the end of the world: a virus that attacks the immune system itself. It was so terrifying to hear about such a horrible disease that had no cure, and was so insidious that we couldn't even create a vaccine to stop it. In a few decades we as a species have found a way no…
I was born in '86. Even into the 90's this line of thinking hadn't changed all that much. The attitude around most diseases and the like that had a 'social' component was best described as "shock and shame" - e.g, you're screwed long-term and society blamed you.
> In a few decades we as a species have found a way not only to completely eradicate it to undetectable levels (it still hides in cells to protect itself) but now we are at a monthly injection.
I was going to ask how this works until you answered the question for me (if it's undetectable, why isn't this considered cured?) Last I heard research is still trying to figure this out. At the same time, I can remember hepatitis C having a similar wrap in the 90's - 'you have it, and probably always will' - Mavyret/Epclusa changed that. It still blows my mind that the problem is pretty much solved at this point.
Hail Science.
Re: FDA approves first monthly injectable to treat HIV infection
#115Earlier quoted context omitted.
Or to approach the same issue from the other direction: Does public funding for research of this type self-sabotage, if it enables pharmaceutical companies to set pricing at a level which meaningfully limits the use of the results of that research?
How exactly are is big pharma limiting the result of that research? Anyone can use the research.
Re: FDA approves first monthly injectable to treat HIV infection
#116> 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…
>Or, if you think that the government itself shouldn't own IP for a product on the market, can we create an independent non-profit which receives ownership, and whose charter aligns with actually treating as many people as possible?
The current model of government funded research is like backing a Kickstarter because you want to see the product made, but get no direct benefit. It is made because we as a people think the world will be better off with the product, than without, and are willing to pay to make that happen.
I think government co-venture is also great option, as long as it is negotiated up front and we can keep political corruption out of it. However, the question then becomes if drug development will dry up once the the government has locked down all the IP and nobody wants to partner with them.
I think another good model would be seed support for independent non-profit pharmaceutical(s) charted to balance reinvested profits with social benefit (without government owning the IP). The question and risk here becomes one of oversight and accountability.
Re: FDA approves first monthly injectable to treat HIV infection
#117Earlier quoted context omitted.
Yikes. There's absolutely no reason to do this. You get equally useful results by comparing to current standard of care, and that's the thing you ultimately need to measure for approval of a treatment for which existing treatments exist anyway (the FDA wouldn't approve a drug that's better than nothing but markedly worse than the current standard of care, so that's the benchmark).
Then why isn't it done as such in all instances? It seems that whenever a perfect placebo be permissible, that is what is being used rather than the current standard of care. Soldiers can be sent to their death for oil and other resources that benefit the larger majority? but this is “yikes”?, not a phrase I find to occur in conjunction with rational decisions often.
It is. Control groups are no-treatment if no approved treatment exists, or current standard of care if there's an approved treatment. That's standard practice.
> It seems that whenever a perfect placebo be permissible, that is what is being used rather than the current standard of care.
If by "perfect placebo," you mean "no treatment," that's not correct, and is considered unethical.
Re: FDA approves first monthly injectable to treat HIV infection
#118Earlier quoted context omitted.
I believe that the government does own a portion of the IP. If you read patents filed by defense contractors and pharma/universities they often say something like this "This invention was made with Government support under Contract no. F29601-03-C-0191 awarded by the Air Force Research Laboratory, Kirtland AFB, N. Mex. The Government has certain rights in the invention." https://patentimages.storage.googleapis.com/f9…
So then why is the government letting the company reap so much of the benefits of their IP?
Re: FDA approves first monthly injectable to treat HIV infection
#119Earlier quoted context omitted.
> 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…
Genuinely curious - why do these drugs cost so much? Can we make it cheaper? I know there’s a lot of hit & miss and that the cost of the drug also covers the misses, but it feels like we should be able to do this for millions, not billions.
and
http://sitn.hms.harvard.edu/flash/2020/modern-drug-discovery...
are decent reads.
Mostly it's the complexity of the compounds involved, the supply chain, and regulatory costs.
Re: FDA approves first monthly injectable to treat HIV infection
#120Earlier quoted context omitted.
> 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…
Genuinely curious - why do these drugs cost so much? Can we make it cheaper? I know there’s a lot of hit & miss and that the cost of the drug also covers the misses, but it feels like we should be able to do this for millions, not billions.
>it takes a hundred dollars of drug revenue 17 years from now to motivate someone to invest one dollar today. No wonder drugs are expensive.
That is a 10,000% return on investment required to break even.
http://www.cureffi.org/2019/04/29/financial-modeling-in-rare...