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FDA approves first monthly injectable to treat HIV infection

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131–140 of 220 posts

Re: FDA approves first monthly injectable to treat HIV infection

#131
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…

If, as a company, you have the option of charging $X if you accept gov’t funding or 400% * $X, doesn’t that sound like a great way to disincentivized taking govt funding?

And as others have said gov’t funding tends to be a small fraction of total cost of R&D.

And the funding tends to come very early - some professor is researching a new anti-viral and stumbles across a new molecule. It’s still several hundred million and a decade or more away from market.

Re: FDA approves first monthly injectable to treat HIV infection

#132
post #105

Earlier quoted context omitted.

> can we create an independent non-profit which receives ownership, and whose charter aligns with actually treating as many people as possible? There is a proposal for such an entity: https://en.wikipedia.org/wiki/Health_Impact_Fund

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.

Re: FDA approves first monthly injectable to treat HIV infection

#133
post #82

Earlier 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.

Anyone can’t use the research. Bayh-Dohl Act basically passes ownership of any IP to the person who received the grant.

https://en.m.wikipedia.org/wiki/Bayh–Dole_Act

Re: FDA approves first monthly injectable to treat HIV infection

#134
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…

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.

Re: FDA approves first monthly injectable to treat HIV infection

#135

Pharmacy (i.e. the cost of drugs) is a big contributor to rising healthcare costs and injectables are an increasingly more popular and very expensive way to deliver drugs. This is a good example of how R&D and drug development works in the US. Invest time and energy in a much more profitable form of treatment for a disease that is already managed.

Pharmacy is about 10% of total healthcare costs so not a major driver of rising healthcare costs, but it gets a lot of media attention.

And no, they didn’t create an injectable drug because it’s “popular”. They did it because it address compliance of oral therapies.

Re: FDA approves first monthly injectable to treat HIV infection

#136
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…

Great interview on problems with intellectual property rights in the drug market. https://www.youtube.com/watch?v=u6OpapwQOks

Re: FDA approves first monthly injectable to treat HIV infection

#137
post #30

Earlier quoted context omitted.

> we at least must allow them to profit as much or more from a cure as they would from a treatment I think that’s where you go wrong. There are huge profit incentives for a cure. If a biotech company comes up with a cure they will instantly have the business of every afflicted person on the planet. The market for that and price they can charge will be way larger than a slightly different treatment. Beyond that, there…

There are indeed huge profit incentives for a cure. There are even larger profits to be had from a monthly treatment that the patient has to take for the rest of their lives. Are you saying people that aren’t taking a monthly biologic injection for example will start coming out of the woodwork for a cure when normally they wouldn’t seek treatment for their malady?

People don't buy medical treatments in most of the world. Countries do.

And countries will always pick the best priced possible treatment.

Re: FDA approves first monthly injectable to treat HIV infection

#138
post #67

Earlier quoted context omitted.

> I'm curious what evidence there is on either side of this claim Looking at the list of the most deadly non-tropical infectious diseases [1], most can be vaccinated against and/or cured. The standouts remain lower respiratory infections, e.g. influenza, and HIV/AIDS. When confronted with a novel coronavirus, it took a few months for the world's medical systems to devise various treatments and a vaccine. Neither of t…

The Hep C cure wasn't all that profitable, from what I understand. On paper it was a clear win-win - the cure would save the various healthcare services lots of money compared with treatment, whilst still raking in boatloads of money. The trouble is that healthcare services everywhere balked at buying it regardless of their structure and despite the fact that not doing so would cost them money in the long term, and e…

The hepatitis C cures was massively profitable. Gilead paid $11B for Pharmasset’s portfolio and everyone said they were dumb.

They then had sales of $10.4B in the first year on the market. That’s one year and one drug (they’ve developed newer drugs and launched those too).

Re: FDA approves first monthly injectable to treat HIV infection

#139
post #108

Earlier 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 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 find participating hospitals, PIs, and patients which means lots of negotiation and patient screenings and TV/radio/web advertising. Then you have to manufacture the drugs in small to medium quantities. Then you have to actually run the trials which means paying a lot of people and most if not all of their medical care related to the clinical trial.

Phase I trials, for example, are usually carried out under constant medical supervision and push the dosage as high as they can until 50% of the cohort will no longer tolerate it. That alone is usually thousands or tens of thousands per day per patient.

By the time you get to phase III where you have hundreds to thousands of patients, you're shelling out up to $1k per patient for the incentive and $100-1k per checkup for the length of the trial. A 1k person phase III can easily cost tens of millions in labor just to administer the drug and collect samples once a month for a year. Data provenance and normalization is important so a not insignificant chunk of this time is largely unavoidable paperwork.

Re: FDA approves first monthly injectable to treat HIV infection

#140

> 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?

Why is it spreading? Because ACCESS TO CARE is extremely unevenly distributed. It can be extremely difficult for people with limited resources to get proper care.

Canada, with universal healthcare has about the same number of new cases per capita.

So it’s not access to care.

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