In particular, how easy will distribution be, considering that HIV is extremely easily preventable but it still spreads, because of lack of distribution of knowledge, I assume.
This is a huge problem in the US. Truvada must be taken everyday to prevent HIV, and in 2015, it cost $1400 for a 30 day supply. In 2021, it costs between $1900 and $2500+ for a 30 day supply in the US.
Elsewhere in the world, Truvada might cost $40. In Australia, Truvada costs $8 for a 30 day supply[1].
The only other drug approved for PrEP in the US is Descovy, which is manufactured by Gilead, too, and costs $2300+ minimum for a 30 day supply.
[1] https://www.independent.co.uk/news/world/americas/us-politic...
An epilepsy medication I took, once the patents completely expired (both on the regular and extended release versions), the generics ended up costing me more to pick up while the branded version rose in price as well.
https://www.fda.gov/drugs/abbreviated-new-drug-application-a...
The US has some of the lowest cost generics in developed nations - prices tend to be lower than the EU. The US has some of the highest generic drug penetration of developed nations. [1] That's because of things like the 180 generic drug exclusivity and mandatory generic substitution laws.
The 180 exclusivity is a big part of that. If you open the flood gates to any generic manufacturer, the margins disappear so quickly that some manufacturers won't even bother to try. By dangling a massive carrot whereby the generic manufacturers can quickly recoup costs and make a large profit, it drives generic companies to compete to the enter the market.
When Lipitor went off patent, eleven generic companies entered the market and prices dropped 95%.
The US generic market is one of the best functioning in the world.
AUD 6.60 in Australia is the cost for those eligible for the concession PBS rate (those that are on welfare, pension etc.). It's AUD 41.30 for everyone else.
This is all thanks to our government negotiating a good rate with the manufacturer and then subsidizing the costs. This is not what all governments do, unfortunately.
Also, can't help but wonder if your insurance company has an ownership interest in Descovy...somewhere. $2200 is cheap if you're paying it to yourself. And the pie grows.
Yeah, that's my mildly paranoid writing for the week, methinks.
https://www.hhs.gov/about/news/2020/11/20/fact-sheet-trump-a...
Democrats have some options they'd like to do that might help but cannot because of the filibuster. Reconciliation which is the only way around the filibuster guaranteed is pretty limited in scope due to the rules around it. Whether those could pass a vote if there was no filibuster is unknown because they all get completely blocked by Republican filibuster.
Which itself was a state level implementation of a program the insurance industry and national Republicans were talking up as an alternative in the 90s when, i the wake of the failure of Clinton’s healthcare reform, it seemed there was enough residual demand for something to be done in that regard nationally that they thought they needed to bring something to the table.
Repetitively, issues are raised and forgotten by politicians, and never actually solved by the party in power. For various reasons, many people have come to believe propaganda about the filibuster. For example, Sen. Warren and others say that the filibuster is racist and a relic of the past, yet Democrats (including Warren) filibustered the Republican's $500 billion coronavirus relief bill in September of last year. They were really saving their votes to send you money after the election. They also filibustered a Republican police-reform bill last year.
While the parties do not necessarily hold the same platforms as each other, many of the Senators literally went to school in order to become politicians. They are not your friends. They are prevaricating in order to remain in power and make money. Not all - but many of them. Warren has some redeeming qualities, but facts are facts. She has been a Senator since 2013 and has had her own share of "clarified statements".
Definition: A wedge issue is a divisive political issue, especially one that is raised by a candidate for public office in hopes of attracting or alienating an opponent's supporters.
These wedge issues are used to keep people's emotions going, so as to vote for one party and hate the other. Then, the issues are not solved a the times they could. There is a reason for the existence of an actual term, wedge issue, for the concept - because it constantly happens.
That very power is a reason I think there's a few hold outs on the Democrat side that don't want to get rid of it. The senate is naturally stacked against the democrats as the parties are currently aligned so a few don't want to risk giving up that power. There's also a number who (at least claim to) believe that the unlimited debate is an important part of the Senate.
Personally I think it's a relic that's getting in the way of passing the exact legislation that will make Democrats more popular (and make it easier to vote to counteract some extremely blatant voter suppression happening in red states).
[0] consider 3 senators working 8 hour shifts of 8 on 16 off. That would be maintainable for a very long time.
The power of the minority was a crappy compromise to get the less densely populated states (not coincidentally southern slave owning states) to sign on to the constitution. The original Articles of Confederation were even worse requiring basically unanimity to pass federal laws and taxes. The whole job of the Senate was to appease those same states. Do any other countries have this kind of explicit carve out for land (essentially) getting an equal weight?
I think a government where the majority party can't actually implement any kind of agenda is a fundamentally broken government.
> I dont understand why states have to wait around for the federal government to solve healthcare.
Because they're ironically forbidden by federal law. Several legislators in CA would love to bring a statewide single-payer healthcare bill forward, but funding it would require using federal Medicare dollars in ways that require permission from the US Congress. Guess how likely that'll be forthcoming?
I think this is a big sustaining source of disillusion with the US government. Cynical minorities have a pretty easy way to make people hate the opposition by just blocking everything, this was even explicitly acknowledged by McConnel as their strategy. Block everything no matter how small.
Now, it’s also possible that we’re suffering from the two party hell we’ve created and that we have an overstated (too large) minority party that doesn't reflect the wishes of any reasonable fraction of our people... I tend to think this is more of a problem than people realize. We need voting reform to bring more plurality into govt operations and lawmaking.
Republican Senators don't seem to care if an agenda is supported by a majority of registered Republican voters.
Anyhow, the Senate must be reformed or abolished. Land does not require representation. Give every state a guaranteed 2 senators, I suppose, but some reasonable formula should be implemented that apportions more populous states additional senators.
Harry Reid previously lowered cloture threshold for non SCOTUS appointments, but only after Republicans act(ed) in bad faith and refused to "Advice and Consent."
They refused to confirm 2 very important seats for 'cost savings' and claimed that the DC circuit was 'underworked.' This is in the context of anti-Obama everything and no matter how milquetoast the nominee was.
https://en.wikipedia.org/wiki/Nuclear_option#Use_in_2013_and...
The bit about Manchin is fact, though. They can't change the rule without him, and he doesn't want to eliminate the filibuster. He did say that he would consider modifying it to make it more difficult, however.
He's being far more cooperative than, say, Liebermann was while passing the ACA, and his actual goal is to say he's fighting those out of control big city liberals by keeping the filibuster, but the changes he'll allow will make it completely different and more or less how it was in the 90s.
Sinema also wants to keep it and seems to actually be a true believer, which is dumb and not even what her voters want, so who knows what's up with that.
I don't think we can be too charitable towards Manchin considering his other stances. That said, you raise a good point: changing the filibuster doesn't really change his position; he's still an essential vote to pass any legislation in a tied senate, so he benefits from either outcome. I suppose, all other things being equal, it makes sense for him to nominally oppose ending the filibuster for the sake of his base.
With two parties both jockey for position in being as close to center as possible while still appearing unique. To leave the center is to sacrifice those voters to the opposition. This is why first past the post voting is stable yet nearly useless.
Democrats consist of actual liberals, marxists, authoritatians, etc.
Republicans consist of actual fiscal conservatives, the religious, libertarians, etc.
Both are unhappy alliances and occasionally fracture and spill one of these constituencies and the opposition rushes to appeal to them.
Sure, that is still pretty high, but it basically saved my life. If not for Obamacare I would need to come up with over 300k per year to not get very sick.
This isn't an either party is the same situation. One party would let me be seriously ill. One would give me a possible solution.
I am on an orphan drug myself (subcutaneous immunoglobulin, which I am self-infusing at the moment...) which costed $278,000/year under contract, when I lived in the US. Of course the provider bills a much higher amount. But the figure I gave is the one that is paid out, over the course of a year.
You should know that the third leading cause of death in the US is believed to be preventable medical errors. This has been corroborated via multiple follow-up studies, just google "third leading cause of death US medical errors". But, here is the original article: https://www.bmj.com/content/353/bmj.i2139
You can go to the "best hospitals", have the "best insurance", and "be able to pay for care", but you cannot evade a statistic like that. The medical error rate is on par with developing countries, by the way.
Also, 7-8% of the general population collectively has some sort of rare disease, which is theoretically treated by orphan drugs. There are now orphan drugs that cost $2 million/year per person, and the cost is so extortionate that it is literally going to screw over the US health system. Such meds have to be taken for life.: https://www.nytimes.com/2019/08/25/health/drug-prices-rare-d...
Also, life expectancy does not look so good in the US.
How healthy will we be in 2040? http://www.healthdata.org/news-release/how-healthy-will-we-b...
US was 43rd worldwide in life expectancy in 2016. In 2040, we are expected to be 64th.
Honestly, this kind of stuff is why I emigrated and I am a dual US|EU (Croatian) citizen. As an EU citizen, I have Freedom of Movement rights to live/work/retire in 30+ countries within the EU and EFTA (minus Liechtenstein--has an immigration quota).
Because of your health status, Canada, Australia, and New Zealand are off limits because they have strict medical inadmissability clauses in their immigration laws. I would stay away from the UK too, because they could implement such rules post-Brexit.
But, I have studied healthcare systems, logistics of healthcare, along with rules for acquiring citizenship, for hundreds of hours. If you want any help or advice, feel free to shoot me an email (check my profile).
Partisan gridlock is terrible, but it's even worse when the parties agree...
There are some work arounds but they're limited to things that one person decides are sufficiently budget related enough to go through the reconciliation process that prevents filibusters. And that is a thrice a year option at most.
[0] I get why since senators have all sorts of commitments to their time even counting just Senate business but it means a there's basically no cost to doing one where there was.
I mean 225,000 Americans are on it, and multiply that by 1400 x 12, and you're already way past Truvada's global annual revenue. The numbers don't work out.
Americans do subsidize European and African prices though, there's no doubt about that.
Those big monthly $$s get investors excited tho.
This is to say nothing of the public / private debate.
There are millions of people with deductibles that are in the $2000 - $8000+ range, and even higher for family plans. Those people are certainly paying $1400 for several months until their insurance kicks in. Then, in the next coverage year, they get to spend that $1400 several times again, and they continue that pattern each year.
If their insurance doesn't cover it, they're also paying $1400.
Now, is this done efficiently? I don't know. Perhaps the FDA approval process could be less costly. Or we could limit litigation in some manner. And so on.
But they're sure not gonna churn out new drugs for the cost of some generics.
Essentially, the US is footing the bill for the world. If you look at overseas pharmacies, PReP has been available (as are many drugs) at very cheap prices for quite a while now. Some countries just ignore the drug patents and go on their merry way. Our current method of accounting inside the US has people pay into insurance, which then pays out for these particular drugs.
Some non-profit pharmas do exist, but it appears that they are largely focused on generics or orphan drugs. I have seen some press-release stuff on how some of them could work in drug discovery, but it was always a team-up with someone else, and I couldn't find what new drugs had actually made it to market from non-profit pharmas.
I suppose the only way to really prove this one way or another would be to select the last thousand drugs to market globally, note the country of origin and the company, and whether or not they were for-profit or not. Perhaps build out on that -- how much did it cost to bring that to market? How many failed per pharma?
My main point is looking at this holistically profit is a huge % and a terrible incentive for both what drugs are pushed and trialed and how much they can gouge us to benefit their shareholders.
Gilead is 79%... More than 2x apple. [1]
That is ethically wrong.
Government already funds (most seems like this research article sats? [2]) early stage research e.g. discovery. Then the drug companies take the best looking candidates but they have gross incentives to pick the most potential profit, not the most benefit to society (like HIV a so far lifetime disease where our lives are dependent on this medicine) - why pay to research a prodrug or big stage 3 trial on a drug you cant make money on.
In terms of 'market incentive' on the manufacturing side manufacturing costs themselves are tiny [4] and if anything my intuition is it has a net negative effect on quality. these companies try to penny pinch and push the every lessoning government oversight to its limits & offshore production with dangerous JIT supply chains and single source failures. Plus Republicans refuse to allow the government to negotiate or 'interfere' with 'the market' in the name of 'market incentive' kudos to trump to buck the party though.
and it also seems setting up a non-profit is currently hostile by the system our government has concocted because of pharma lobby & their ad persuasion $ [3]
https://statista.com/statistics/473429/top-global-pharmaceut...
https://www.ncbi.nlm.nih.gov/books/NBK50972/
https://waxmanstrategies.com/wp-content/uploads/2020/01/Nonp...
If you wouldn't mind reviewing https://news.ycombinator.com/newsguidelines.html and taking the intended spirit of the site more to heart, we'd be grateful.
I thought it was a great idea, but issuing a bunch of scattershot EOs that never actually get implemented is not addressing anything.
The problem is that in reality he was all sending nasty tweets and no actual substance.
He only did this to distract from COVID and even when he wrote the EOs everyone said they were going to get jammed up in the courts forever.
I'm not going to play pretend about things trump really truly wanted to do but waited 3.5 years until the middle of a pandemic, and then never implemented.
I don't preclude Trump from having actually done something meaningful, but a lot of what he does is vain and self-promoting, so I could easily see this being a case where he tried to put something into effect that looks good on the surface but doesn't actually accomplish anything, or doesn't accomplish it in a sustainable way and thus would need to be revoked to prevent prices going up in the long term.
https://www.gaytimes.co.uk/life/prep-is-finally-available-on...
http://www.pmlive.com/pharma_news/nhs_england_will_make_prep...
So it seems that your claim is (thankfully) outdated.
8 dollars is what the user pays in co-pay at a pharmacy. Taxes paid for others shoulder the rest, via a subsidy mechanism.
Reference from the first google search: https://www.chemistwarehouse.com.au/buy/78769/truvada-300-20...
Private prescription means you forgo the govt subsidy. Truvada is apparently no longer on the subsidized (PBS) list: https://www.starobserver.com.au/news/national-news/no-more-s...
Even now, United is making it clear that they don't intend to cover new PrEP medication like Descovy even though the medication doesn't cause as much renal damage and failure as Truvada does: https://www.beckershospitalreview.com/payer-issues/unitedhea...
If you have a high deductible insurance plan, it is not going to be fun to pay for your first few months of PrEP entirely out of pocket. Many people are priced out of PrEP because of that, as are the uninsured and underinsured.
https://www.fda.gov/about-fda/fda-basics/it-legal-me-persona...
>In most circumstances, it is illegal for individuals to import drugs into the United States for personal use.
The drug is for use for a serious condition for which effective treatment is not available in the United States; There is no commercialization or promotion of the drug to U.S. residents; The drug is considered not to represent an unreasonable risk; The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country;and Generally, not more than a 3-month supply of the drug is imported. >> And even if the drug could save your life and it's not available in the US you still have to play this stupid traveling game every three months. I'm sure most people with chronic illnesses love to burn their money being forced to travel due to some arbitrary regulation
Holy shit fuck the fda
Many seem to think that the use of a condom turns transmission risk from 99% to 0% or something along those lines.
The reality is more so that it changes 1% to 0.3%, and it heavily depends on the sex act and direction of transmission as well.
Another not so often sung fact is that the transmission rate from patients who take blockers properly, and thus have an undetectable viral load is 0%.
https://www.aidsmap.com/about-hiv/estimated-hiv-risk-exposur...
Correct condom use will make you as an individual much safer. But as a public health strategy, telling people to use condoms has a significant but limited effect.
More info here: https://www.aidsmap.com/about-hiv/do-condoms-work
The difference a condom makes is quite comparable to being the receiver or penetrator in penio-vaginal sex, in fact.
As others begin producing it market pressure will hopefully drive those costs down.
It’s also worth noting that some insurance companies have recently begun classifying it as preventative medicine (as it should’ve been this whole time) and covering it at 100%.
That's the idea, but it doesn't really work that way.
https://hbr.org/2017/04/how-pharma-companies-game-the-system...
> One of the ways branded drug manufacturers prevent competition is simple: cash. In so-called “pay for delay” agreements, a brand drug company simply pays a generic company not to launch a version of a drug. The Federal Trade Commission estimates these pacts cost U.S. consumers and taxpayers $3.5 billion in higher drug costs each year.
and this fun one...
> Another way pharmaceutical firms are thwarting generics is by restricting access to samples for testing. Generic drug makers need to be able to purchase a sample of a brand-name product to conduct bioequivalence testing. That’s because they have to prove they can make a bioequivalent product following the current good manufacturing practices (CGMP) standard. These manufacturers don’t need to conduct clinical trials like the original drug company did.
> But the original drug developer often declines to sell drug samples to generics manufacturers by citing “FDA requirements,” by which they mean the agency’s Risk Evaluation and Mitigation Strategies program. The idea behind this program is a good one: give access to patients who will benefit from these personalized medicines, and bar access for patients who won’t benefit and could be seriously harmed. However, brand drug makers are citing these requirements for the sole purpose of keeping generics from coming to market.
And if one generic manufacturer was able to get approved, then the flood gates are open. It won't limit anything if all those additional patents were found invalid (which they would need to be for the 1st generic to be approved).
1. Gilead owns 3 of 4 top HIV drugs. GSK owns the #2, Triumeq.
2. GSK, Merk, J&J are all megacap, viable competitors with their own HIV products. Yes, its true that Merk and Gilead are in cahoots, but this was out of fear of GSKs dominance.
3. Some other US-listed names who are developing HIV drugs: ViiV (GSK subsidiary), Bristol Myers Squibb, Janssen, Mylan, Genentech, Abbvie.
Yes, the US is currently dominated by one company, but that does not mean there are heavy incentives for competitors--who are already well invested in the space--to break in.
[0]: https://www.statista.com/statistics/273434/revenue-of-the-wo...
https://www.hiv.gov/hiv-basics/overview/data-and-trends/stat...