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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

#171

Earlier quoted context omitted.

If the patents relating to likely avenues of that research are tied up, it makes it much harder.

How can you patent if there is open prior art?

You patent the necessary later steps, not the prior art itself. Companies have a pretty good method.

Re: FDA approves first monthly injectable to treat HIV infection

#172
post #63

Earlier quoted context omitted.

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It was a generic ideological flamewar tangent. That includes several good reasons for downvoting. https://news.ycombinator.com/newsguidelines.html

Thanks for pointing that out. Sorry for adding to an offtopic, flamewar inspiring subthread. I hoped providing some sources for the GP's comment might spur on some more productive discussion and i genuinely thought the other commenter was asking in good faith about sources for discussion. I was also genuinely curious as to the harsh reaction

I do see now the flamewar aspect to it and didn't really stop to consider the initial topic of the article when I responded. I was just trying to focus on the actual topic of the commenter's statement and kinda got lost in searching up articles. I was hoping to maybe bring some data and information into the discussion that might steer it in a more productive direction.

It is an issue that could productively be discussed. It seems it didn't end up being the case though and probably wasn't the most appropriate comment thread to do so on.

Re: FDA approves first monthly injectable to treat HIV infection

#173
post #108

Earlier quoted context omitted.

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 genuinely takes a massive amount of labor using mostly highly paid professionals like doctors, nurses, and research scientists. Even before any trials start, the support materials for a premarketing application for a drug are usually in the thousands of pages and include clinical trial protocols that describe minutiae like how blood samples will be drawn so data is comparable between hospitals. Then you have to fi…

And getting FDA approval is not the finish line. It's just the start of the roll-out. Now employ teams of reps to get the drug covered by every commercial insurance company and all Medicare/Medicaid parties so that patients have access to this life-saving treatment, get policies and authorization forms and billing codes created and implemented. Do outreach to make sure doctors and patients even know that a drug has been approved and how it compares to existing options.

Re: FDA approves first monthly injectable to treat HIV infection

#174
post #162
post #142

Earlier quoted context omitted.

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…

Globally there are ~50 new drugs per year. Total public and private spending on drug R&D hits ~190B per year. So even including government and charity donations your only up to 4 billion per drug. Private companies nominally cover ~60% of that dropping their investment to ~2.3 billion per successful drug. However, that’s overly generous as a great deal of tax breaks etc indirectly subsidize that 2.3 Billion. So, it’s…

This is not a bad back of the envelope analysis. Forbes did one a while back that looked at 10 year R&D spend and then 10 year approvals (to account for the delay). Numbers vary wildly between companies.

But one thing to keep in mind is using your number, there are plenty of drugs that get approved that only have a few billion in sales over their lifetime. So either break even or not even breaking even. It’s a massive blockbusters like Lipitor ($10B in sales per year) that pays for all the mediocre drugs.

Re: FDA approves first monthly injectable to treat HIV infection

#175

Earlier quoted context omitted.

3k month sounds about right for a chronic condition. Many many people pay at least this to stay alive. That said , Universal Health Care is needed for stuff like this to work. At 3k a month it makes the most sense to try and emigrate to a better country.

> At 3k a month it makes the most sense to try and emigrate to a better country. Countries won't let you in if you're going to cost taxpayers too much. For example, New Zealand won't let you emigrate there if you have serious psoriasis, since treatment can cost thousands of dollars/month.

For biologics, sure, but steroid creams are the standard treatment and work quite well, and are much cheaper - maybe $100/year.

Re: FDA approves first monthly injectable to treat HIV infection

#176

Earlier quoted context omitted.

How can you patent if there is open prior art?

You patent the necessary later steps, not the prior art itself. Companies have a pretty good method.

What is "prior art" when we're talking about profiting off of research if not the necessary steps to do something?

Re: FDA approves first monthly injectable to treat HIV infection

#177

Earlier quoted context omitted.

Ok... and 10.6 million use birth control pills according to the CDC. Also, just because something appears convenient doesn’t mean that it actually is. Have you looked up how many women use one of those invasive contraceptive implants? Technically, a woman only has to get a new implant once every 4 years+. But have you not read the horror stories about the implants becoming dislodged and causing internal bleeding and…

You seem to be implying that IUDs are much less popular than the pill. That is not the case. They are just behind the pill in popularity. Also, people on PrEP already need to do regular bloodwork, so needles and appointments are already involved every few months. Doing an appointment every 2 months instead of every 3 and not needing to take a daily pill as well is a huge win in level of effort. https://www.cdc.gov/nc…

“You seem to be implying that IUDs are much less popular than the pill. That is not the case. They are just behind the pill in popularity.”

Your first sentence makes no sense. You say that I’m implying that pills are more popular yet you confirm that indeed they are.

Unless, you’re saying that I was implying that they’re _heavily_ more popular, which is also not what I implied.

You’re completely missing the point. I’m gay and on prep myself for several years.

The grandfather post mentioned that 2 million people are doing an injection as if that implies that many people prefer that over pills.

I could write more and explain more but I’m tired of talking to so many morons for today.

Re: FDA approves first monthly injectable to treat HIV infection

#178
post #108

Earlier quoted context omitted.

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 has to do with the time value of money and long development timelines. Here is a great blog post from a scientist trying to find investors for drug to cure his wife's terminal disease.[1] >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/20…

[deleted]

Re: FDA approves first monthly injectable to treat HIV infection

#179
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…

This is a brand new treatment. All things that are the product of cutting edge research and are difficult to get to market will be expensive.

I'm taking an orphan drug that was approved in 2002/3 and costs more than this per month and last I checked the company that developed the drug was still in the red.

This idea that drugs should be cheap and accessible the moment they are approved is incompatible with economic reality. You need a system with a profit motive so that many people and investors are motivated to invest their lives, careers and money in that market so we get progress year after year.

This is a trolley car problem. On one track are all the people you can save in the present by making something immediately accessible to all regardless of the economic reality of those that produced the drug. On the other track all the the people that you can save long term by having an economically viable industry that can continue making advances that save lives in perpetuity.

Re: FDA approves first monthly injectable to treat HIV infection

#180
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…

I'm not one to lead the cancel brigade but you could have just said "some communities". There are plenty of white communities that frown on homosexuality so I don't know what is gained by citing demographics. Since there's no purpose in calling out race, but you did anyway, I can see how some might see this as an unprovoked attack.
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