So, basically someone bought the rights to the 5mg tabs, and now those are uninsured and would rack up 100s of euros per month. So instead you get the same prescription but in 2.5mg tabs, which is available as a generic brand and therefore just about free under Dutch healthcare. This may seem like a small difference, but we're talking about people with attention-deficit disorder, having to count and not get distracted twice as many pills, right at the moment the previous dose wears off. Taking them at a very precise regular schedule at the right dose really can make a huge difference in effectiveness. You don't want to get it wrong.
Sure it's not insulin, and it's mostly an inconvenience, but it's just so STUPID. I mean who the hell obtains the rights to 5mg dexamphetamine tablets? How? Why? And could the same happen to paracetamol?
I believe we need to trudge further and further because even though we are creating new therapies that are wildly expensive, we are moving closer to truly cost effective therapies and best-in-class therapies. Though, we are certainly not there yet.
If someone can explain to me that my fears are unjustified about price controls diminishing capital invested into new treatments, I'd happily join the chorus of people calling for price controls in medicine (US citizen here with a chronic disease treated by TNF inhibitor which can cost 30K+ a year but through employer insurance, I pay nothing except for a copay which the manufacturer pays for).
1. The time horizons involved don't work well with government. The US can't get anything done over a 20 year time horizon, and the highly delayed ROI means projects would always be first on the chopping block when it came to cost cutting. As a side note, currently we can't even agree to adequately fund basic research in the country, let alone drug development.
2. R&D would inevitably be politicized. Some senator would want disease X researched because their kid has it etc. Some tax payers won't want to fund disease Y.
3. It places R&D and regulatory in the same high level entity. That sets up all sorts of conflicts of interest.
4. It complicates international trade. What if the US develops most drugs. What should Europe be charged for them? Surely products can't be open sourced because one group of tax payers paid for them and would want ROI etc.
5. Similarly, who decides pricing for all the US buyers? Get ready for massively complicated procurement based on tons of different rules.
Drugs, as a whole, aren't that expensive today compared to other healthcare. They make up 9.8% of US health care expenditure, which is pretty much middle of the pack compared to OECD countries. Hospitals, largely "non profit" (but sometimes massively profitable) make up 35%. But drugs feel more expensive bc copays are typically higher for drugs than for medical care
As it stands today the drug industry spends ~$200B a year to get 20-50 new FDA approved drugs a year. Virtually no fda approved drugs are developed solely by academia. NIH budget is $30-35B and on a steady long term decline. So you'd have a massive taxpayer expense just to build out that r&d function
Then you'd have to build out manufacturing. And some sales and marketing analog -- even if you aren't trying to profit, somebody needs to go out and tell doctors about your new drug and share with them very detailed data about how the drug works, what patients it works for, compared to the competition. Doctors can't stay on top of this themselves -- they are too busy and there's too much info
Then you'd need to build out some administrative function and some way to decide what projects move forward at what stage. This is where publicly funded drug research would probably massively underperform private for profit r&d
If you are making drugs for profit, you have a strong incentive to be efficient with your research. If not you go out of business. The more these decisions are driven by politics rather than profit motive, the less productive r&d is. And r&d cost and productivity is the reason drugs are expensive
There's evidence that startups are 10x more productive at r&d than pharma and it isn't crazy to attribute a lot of that to less politics
As of now something like 30-50% of published academic findings are thought to be false. 30%+ of all NIH money goes to "overhead", i.e. Profit to universities. And yields no fda approved drugs without private company investment
Has this been successful anywhere? What purely run state enterprises that are charged with creating new and innovate things have been success stories?
I think that while private enterprise has had a jaded role in healthcare, I'm not sure what the better alternative is.
In countries where such care is provided by private insurance and not the state, I am wondering why this trade-off is not given as a choice to the consumer. Many people might be OK to get smaller premiums and better coverage throughout their life by explicitly rejecting coverage of end-of-life care.
Interesting enough the one thread that the folks pushing that concept picked out was a provision that paid doctors for consulting with people about what kind of end of life care they would like. That's all it was. There had been strides that showed individuals chose all on their own to refuse some of the most expensive late stage life care after having talked to a doctor about it. The result also meant there was significant cost savings, reduced stress for those dying and their families.
Sadly the BS surrounding "death panels" meant that provision was left out of Obamacare.
I don't know if there is an afterlife with any sort of destination based on people's choices, but I like to think if there is there's a special room in hell for folks who used that provision to score political points, and likely meant that some folks may have suffered more because of it.
Unfortunately the trade-offs don't go away, and we haven't figured out a way of making these trade offs that doesn't feel horribly statist (so called "death panels") or callous (private insurance denying care).
This never works out. Right now many people buy low quality high deductible health insurance expecting never to get sick and then balk when they suddenly get ill and end up paying a huge deductible. People don't assess correctly what they need later in life. When people are denied the health care later due to these decisions, the death panel rhetoric will be brought up.
* Drug companies have profit margins of 15% on average indicating there is room. * many recent 'orphan drugs' were not newly developed, but off-label uses registered with the FDA for a whole new patent. * these drugs rely heavily on research done by universities through public funding. It stands to reason the public should get to benefit. * there is something morally wrong about setting the price of drugs purely based on demand. It is essentially blackmail: pay me or die / suffer.
It puts quite a dent in public health care resources.
People who are in this business to actually help the sick hate this system with a passion, and some national governments are now willing to allow hospitals and pharmacists to experiment with creating their own medicine again as a result.
There are maybe 15 pharma companies that commercialize a large portion of the drugs developed in the world. The vast vast majority of drug companies never make a penny in profit. They sell their products or companies to bigger, commercial companies
So the profits in the industry all accrue to a few big players, and the losses largely accrue to companies you've never heard of
Something like 65% of FDA approved drugs are developed by small companies that will never generate revenue. Bigger companies buy these drugs and plug them into their established sales forces
Virtually (probably literally in the last few years) no drugs emerge fully formed from academia. For profit companies bear the brunt of the r&d costs. 30% of public r&d goes to academic "overhead" and much goes to research that will never come close to informing drug r&d. The NIH spends $30-35B a year, the top 15 pharma companies spend $75B in r&d
http://rooseveltinstitute.org/wp-content/uploads/2019/02/RI_....
Large sum of that money is wasted because incentives are perverse.
Developing new molecular entities (NME) that do the same thing as already approved new chemical entity (NCE) just for competitive reasons is wasted R&D from the public health perspective.
Evergreening and pay-for-delay costs additional billons for pharma companies and it's just zero-sum game between manufacturers.
I see a lot of expensive looking ads on TV. Those ads were made legal in my lifetime. Maybe it’s time to ban prescription ads again?
What is just one more reason for the government to bear that risk, from research up to distribution.
This seems to contradict itself. 15% profit margin is not that great compared to the opportunity cost. Someone working at a drug company could in theory switch (retraining etc.) to working at, say, Google which has a 22% profit margin. I realize it’s not apples to apples, but that’s not a huge, monopoly level profit.
There is only one producer of an approved formulation and they are charging too much.
The article mentions that the compound (lutetium octreotate) has been in use for a long time, suggesting that any patent term on the compound has lapsed. Novartis’ specific preparation has been approved for this use by the EMA. Compounding pharmacies have the right to prepare the drug without this approval, which they could not do if the compound was subject to a patent.
Theoretically another company could make a generic version of this but the market is probably too small to justify the approval costs.
https://www.kff.org/news-summary/india-brazil-launch-trade-d...
Then, I read your link and had another WTF moment: why is a shipment from India to Brazil travelling through the Netherlands and thus subject to their customs? India->Netherlands->Brazil seems like an incredibly inefficient trade route.
Source: my wife is a pharmacist and could have worked in the UK after only completing 1/3rd of her study.
* 4 years undergrad, of which 90 credit hours must be a specific series of courses * 4 years PharmD, doctorate program * 1800 hours of internship
At this point a student has met all requirements to sit for the two license exams (NAPLEX and MPJE[^1]):).
Many students will elect for an additional period of education due to the competitive nature of pharmacist jobs in the USA. Those two extra opportunities are:
* 2 years of residency; followed by, * 2-3 years of fellowship
Most pharmacists at a common drug store will not have the last 4 or 5 years of study. However most pharmacists in research or synthesis (including at both manufacturers and pharmacies) will have these two final steps of education due to just how competitive these jobs are.
Briefly there was also a 6 year accelerated pharmacy track (BS+) however this is no longer allowed and any practicing pharmacists with these credentials have to take a non-degree PharmD program to meet the new requirements. At this point in time I don't know if any practicing pharmacists still only hold the accelerated credentials.
[^1]: AK, CA, and VA have their own jurisprudence exams and do not accept the Multistate Pharmacy Jurisprudence Exam
Source: apotheek.nl e.a.
A doctorate* (nl: doctorandus) which takes 6 years to earn (3-4 years BSc then 1-2 years MSc to use the English terms) followed by a 1 year specialization for public pharmacist. Exactly the same as the MDs (also doctorandus) have to do.
It's not a PhD; although I assume that you'd want to go that route if you're more interested in the research (I'm assuming that a PhD in Pharmacology is a thing). I tried convincing my wife to do it but she feels that she helps others more by being more hands on.
I think the confusion comes because a doctorate and a PhD are different things and different countries and disciplines use different terminology. I just about understand the Dutch system now but I'll never understand the German system.
That doesn't seem to be true? This page says you need an MSc, in the UK, to register and be a licensed pharmacist: https://www.healthcareers.nhs.uk/explore-roles/pharmacy/stud...
Who funds this and what kind of shit lawyers and economists draw up the funding schemes that give away full intellectual property, only with a (historic) backstop for individual preparation?
We need risked based co-funding, co-profiting (irregardless of wether it's governments or, say, insurers investing), a backstop on prices via qualy-s, relatively short patents, no gaming of patents via arbitrarily small changes, governments creating generics, ... And now I wake up.
It says so in the first few paragraphs: Novartis licensed (bought) the right to sell the drug in Europe. The patents remain with the hospital.
The hospital that developed the drug is a public hospital associated with a public university. So the government paid for development, and (indirectly) to government is benefitting from the license fees paid by Novartis. That is co-profiting.
“Novartis bought the rights to Lutathera with a $3.9-billion-euro takeover of French company AAA last year.”
Where exactly does it say that the patents have remained with the hospital?
While it may sound strange put that way, most universities spend a lot of time thinking about how spin off profitable companies from their research. It's a huge deal and public spending on research is often motivated like this. Universities and R&D companies have a codependent relationship and this is generally regarded as a good thing.
The morally dubious outcome of this is that a lot of research ends up locked away as intellectual property of some private entity, but it's not easy to question.
Is it? At best, I'd say it's seen as a "necessary evil," where "evil" is much more certain than "necessary."
Drugs don't emerge fully formed from academia, just waiting for pharma to patent them and jack up the price. Pharma spends more on r&d than academia
This, so much. I'd add no gaming of orphan drug patents. It's through the patent system that pharmaceuticals get their pricing power.
http://sourceonhealthcare.org/orphan-drug-act-fostering-inno...
https://philanthropynewsdigest.org/news/cystic-fibrosis-foun...
They helped fund the development of the new CF drug by Vertex, which Vertex sells for $300k. Because of the success of the drug, they were able to resell their royalty rights to another investor for $3.3 billion.
Funds which they will use to drive massive amounts of additional R&D to make even better treatments at lower costs. In the process they have created therapies which did not previously exist, saving and improving people’s lives.
You can debate the profit motive (as your link mentions) but the Foundation considers this a massive win for their ability to fight CF and make CF sufferers lives better.
