Our daughter has a life threatening condition that I’ve posted a lot about on, a complication from spina bifida where she holds her breath when she gets upset. Many kids die from the condition.
There’s a medication, piracetam, that a child with the same complication uses in the UK. It’s safe and has greatly helped the little girl in the UK. When we mentioned it to doctors we were immediately shut down and told it was impossible to get in the US.
Any chance of the Mark Cuban Cost Plus Drug Company seeking FDA approval for piracetam and drugs like it?
But I had a similar condition in my childhood. Many doctors thought it was some form of complicated asthama or something but couldn't figure out what exactly was it.
Then my parents put me in an breathing camp (yoga retreat kind of thing). I was there for six months and we were convinced there that breathing is life. Breathing is the most important thing in and for life. And slowly, the condition disappeared.
The condition was more of an impediment in the brain blocking the breathing command when I got upset unlike some incurable damage to the lungs. Just teaching and reminding us to breath every second for six months made things a lot better.
If there's no such camp/retreat in your country, you could try India.
The tyranny of prescription required isn't worth it.
From the reddit discussion https://www.reddit.com/r/Nootropics/comments/hkn7v2/piraceta...
Articles like this one are driving their actions. https://jamanetwork.com/journals/jamainternalmedicine/articl...
From my very limited understanding of the regulations, a company would have to spend the million+ dollars it costs to get FDA approval, but then wouldn’t be able to recoup that cost by selling the drug exclusively because the patent has long since expired. The US has this class of drugs that just never got approved and no drug company will ever pay to get approved, even if they are commonplace in other nations.
[0] https://en.m.wikipedia.org/wiki/Piracetam
[1] https://medcraveonline.com/JPNC/peac-prolonged-expiratory-ap...
[0] https://www.fda.gov/patients/learn-about-expanded-access-and...
A few times we’ve missed a day and it’s not a fun experience. Something as innocuous as a diaper change can mean giving her getting upset, turning blue, pulling out the a bag and mask, and giving her oxygen and hoping she’ll come to. Then she’ll sleep for hours. If it’s especially bad, like it was before, she’ll forget words which is super scary.
I'm not sure drug importation will work though, not because it's a bad policy per se, but I'm not sure that other countries will let the US import their low-cost medicines if US law changes in order to protect their domestic supplies.
There's Canada as an example case. We have ~10x the population of Canada, and California alone could use up all of Canada's medicines. Not sure Canada would go for it.
Think it's worth a shot though. I know there are some trial programs going into place in Colorado and Florida around allowing drug importation. Will be cool to follow and see how they play out.
Cross-border drug buying works well in the EU, where any European country can buy drugs from any other European country, so whoever has the lowest price usually wins the market.
As a private company, your incentive is to maximize profit for shareholders. Since all you have to do is undercut high drug prices a little, what will stop you from the same price gouging that all other US drug companies perform?
On the technical level, we incorporated as a public benefit corporation, so we are judged not only on how profitable we are for shareholders, but how well be maintain our social mission. That is actually in our charter documents and is a legal requirement.
On a practical level, Mark Cuban is our lead investor and his interest is very much focused on helping people and fixing system issues in healthcare. We also did some screening to ensure our other investors are socially minded and prioritize social benefit as well as profits.
My mindset is that we need to be profitable to be sustainable and grow enough to help the overall system, but we won't be extortionate.
Also he got to write his name on it
Cost of advertising is a serious problem for generic drug makers. There are a lot of drugs where there exists an identical, cheaper, generic version, but the more expensive one gets sold because neither the doctors nor the patients have any idea that it exists. Hence all the "ask your doctor for x" ads, but the problem is that advertising on that scale, especially for low-incidence conditions, is very expensive compared to the amount of money you make, an so will result in just another expensive drug.
A celebrity putting their name on a drug company and then maybe mentioning it a few times publicly in places where normal people hear about it may make people who are facing very expensive drug bills look up the site and see if they make something useful for them.
If it’s the case where there’s an older generic and a newer product still under patent, that’s a discussion with your doctor: Is the newer product worth the money, or should I stick with the older thing?
In the longer term, success in the health space could add prestige to his name, ala the Nobel prize.
> The results show that the average annual price of top-selling cancer drugs in 2006, adjusted for inflation and secular changes in drug prices, have increased by US$154 and US$235 for branded and competitive brand drugs, respectively, following the 2010 ACA; however, generic oncology drug prices showed no significant changes.
Depends on the country. For example India is the largest generic drug manufacturer and has a population of over 1 billion, and they already export their drugs to many countries.
Couldn't Canadian drug companies increase supply if the demand was there? In the short term, sure, they would not be able to handle our level of demand, but unless there's some constraint I'm not aware of they could always just scale up and make more animal insulin or whatever.
The history is that Canada used to have "compulsory licensing" for patented drugs. Anyone could manufacture a patented drug in Canada and pay a ?6?% or whatever royalty to the patent owner and they just had to deal with it.
Over the years, first 4, then 10 years of exclusivity were provided to the patent owner.
Then the WTO came along, and presently, everyone has agreed to ~20y exclusivity and charge/pay the median price of OECD countries before it's a royalty-free free-for-all.
http://publications.gc.ca/Collection-R/LoPBdP/BP/prb9946-e.h...
Canadian generic drugs today aren't usually cheaper than US generics, except where patent exclusivity mismatches.
Re-importation shouldn't be illegal, but it shouldn't be necessary - it's really kinda dumb. Other countries have solved this problem by making healthcare universal, and forming a bulk purchasing group which strong-arms providers into charging something the system can bear. The end user doesn't have to care how much that is, because most developed countries simply pay for the drugs people need in the first place.
The ideal way to obsolete this problem is to follow their lead - get Medicare for All to happen and restore Medicare's ability to negotiate the price of drugs directly with manufacturers.
Then nobody has to pay for the drugs directly in the first place.
Can't or won't?
I doubt the American people (or American industry) would ever allow such a truly free market system to transpire, but I know for a fact it can work.
Labor is cheaper in Tanzania obviously, but even if you adjusted for the more expensive labor, a free market system (vs the crony capitalist system we have now) would probably be 10-100x cheaper.
Also, even controlling for median wage, the drugs are vastly cheaper in Tanzania vs America. A median worker there might make around $5-10 in wage, so most drugs for a month supply would be only a day of work. Median hourly wage in America of $15 would correspond to drug prices between $60-120 dollars, much cheaper than most medications without insurance. In reality, it should be much cheaper, as the marginal cost can be reduced a lot through online pharmacies (remember that $5-10 cost in Tanzania not only factors in product cost and labor cost, but a staggeringly inefficient distribution network).
In short, I don't believe there's any theoretical reason why generic drugs couldn't be dirt cheap and affordable by all in a free market system. After all, capitalism has done a stellar job at reducing the cost of consumer goods over time, and medication should be no different.
If everyone could buy lightly regulated pills from alibaba, it would definitely be a win from a utility standpoint. But of course such a thing would never fly, as maximizing total utility doesn't get people elected. Everyone might win except one guy who died from bad pills and the whole gig would be up, even though the total utility function of every citizen in aggregate was being correctly maximized.
The strong needs of the few always trumps the weak needs of the many. If everyone paid one $1 dollar per day in order to prevent one death, I'm sure some politician would call it a massive win, even though that's an aggregate loss of 100bn dollars annually and the money saved generated more utility than the utility lost by that one guy dying.
Unfortunately, human beings are unable to make correct statistical/utilitarian decisions and support so many policies that are a net negative utility wise.
Aligning prices with purchasing power allows pharmaceutical companies to get _something_ out of the markets they'd get nothing out of. And with large numbers, that something might turn out to be a bit more.
Sure production cost is usually low and that technically allows to sell to poor countries essentially at cost plus a tiny margin.
But that's only half the story. Drugs need to be developed. From idea to market only a tiny fraction of medication makes it. You need studies ovet studies, and most of the time a drug does not make it through that process because it's ineffective or dangerous or both. The few that make it need to compensate for the cost of this process, not just their own but all of those that didn't make it.
So, in "rich" countries, a pill that costs $0.10 to produce can easily cost $1000. That's a necessity to finance the whole process of getting there.
After that is all done and established, sure, you may get that same pill for $1 since it's either that or no sale. But that does not mean the whole system would work for $1 per pill everywhere in the world. Then the pill would not exist in the first place.
In effect, it's about 're-importation' of drugs, not so much regular import.
The Government of Ontario negotiates drug prices for it's citizens, as to other entities elsewhere.
By selling to XYZ regime at ABC price, drug companies create a situation wherein 'the resulting price will be the lowest price we sell to any regime' - because of course everyone will want to import from there.
In many cases, the price sold to XYA regime isn't quite a very good measure of net market prices.
Ergo, it's a weird law, but it's rational on a level.
To start - there could be a slew of laws requiring transparency on pricing for everything in the medical domain. That would be a good start.
More challenging - Americans could actually get together and start negotiating hard on prices. This may require some legislation.
So the 're-importation' issue is an artifact of an odd system, not in and of itself the issue.
OHIP negotiates the prices of all drugs on behalf of Ontarians by being the sole purchaser, and then drugs are sold at that rate (cost plus, I believe) in pharmacies. Further, the cost of all services is listed on the OHIP website. [1] Not that anyone needs to worry about that as they are fully covered for everyone - not the drugs (yet, fingers crossed), the procedures.
[1] http://www.health.gov.on.ca/en/pro/programs/ohip/sob/physser...
Almost all expensive drugs end up being on a special permission list, where you must to beg the government for access.
Not any different than dealing with an insurance company, really. At least you can sue an insurer.
However of course consider delays in getting a drug to market aren’t always provincial; Health Canada has their own timelines and schedules for approvals, sometimes it’s faster than in America and sometimes it’s slower.
The difference is frequently you’re forced to sue insurers as they have a profit motive to screw you. The province only cares about getting you healthy within their means.
Ambien is not available in Canada for example.
One of the things about hard negotiations is that sometimes the other side will call the bluff and walk away.
And of course in rationed systems you don't get things that 'the masters' decide you don't need, like Ambien.
In the case of Ambien, I don't care, I question the real medical value of it, but you can see how that could get out of hand with other things.
It would better to solve the 're-import' problem with better regulation - and of course, initiatives such as the the MC Company here.
I think the Cleveland Clinic and some others like it are technically non-profits, there are models that work.
I've heard the argument that Americans effectively subsidize drugs for everybody else. While it may be true, it still seems like a terrible situation to me, even as a non-american. There's got to be a fairer way to work this out.
Lot of drugs are manufactured and exported from India.
How is the example cost of Albendazole right? Technically, it's a generic drug, and the cost is 10c (locally in India, atleast). What marks this up 130x in the US?
This is a misconception. There are dozens of different drugs people refer to as Insulin, some new insulin analogs are better, and expensive. You can still get old synthetic formulations very cheaply. Walmart famously sells them for $25.
https://www.medicalnewstoday.com/articles/311300#drugs-for-t...
The newer, better insulin costs around €7 (~$8.50) per pen in Europe. That same pen costs $180+ in the US. The markup these companies charge is criminal.
The status quo isn't criminal: changing it to make things cheaper and more efficient is.
Sometimes I'm so happy to live in Ireland, I know we have our faults. But at least with some things, we seem to get it right.
Diabetics in Ireland have 0 cost associated with it. They can go to any pharmacy, and get anything related to Diabetes for free, and as much of it as they need.
This should be the case for any life long illness - or any illness for that matter, in any country; in my opinion. Healthcare should be free for all, it amazes me that this is not yet the case. I do know deep down that it will be eventually though.
Why are you amazed? It's impossible to provide a valuable product or service for free without institutionalizing either slavery or robbery, and not everyone agrees on that trade-off.
Regardless of where you fall on the spectrum of opinion regarding this, it shouldn't come as a surprise that there are some people with philosophical objections to encoding nonconsensual interactions like slavery or robbery into the fabric of our society.
Many reasonable people agree that providing healthcare (or other important services) for "free" to all people is more important than not having the government rob people to pay for it.
Many reasonable people agree that that is a bridge too far, and that we shouldn't be robbing people, regardless of what the stolen money is used to do.
Both are sincere positions held by sane, reasonable, intelligent, empathetic people.
For example, one thing most other developed countries do is have a central state agency negotiate prices for drugs for the whole country at once, which exerts a lot of buying power to drive costs down.
The idea of Medicare in the US doing that has been proposed several times, but has been blocked, most famously during the initial ObamaCare debate.
The stated reason for blocking that is that decreasing reimbursements would decrease the profit motive for pharma companies to innovate and create new drugs. The more practical reason is.... probably just that lobbyists exist.
But that is just one policy among many. We are simple folk here at the MCCPDC, we just charge less. :-)
I’m the Founder of mailmyprescriptions.com (now rebranded as geniusrx.com) the second online pharmacy / first wholesale online pharmacy (similar cost plus model) - just sent you an email. Love what you guys are doing, would love to help. Keep driving those prices down!!
If so, would that include manufacturing the active pharmaceutical ingredients or will you be sourcing them from generic manufacturers and then making the final drugs at your plant?
Our initial drugs are supplied on "private label" arrangements where other companies actually do the manufacturing, and we just add our labels and our own NDC code so we can set the price. Since we don't go through middlemen, that price can often times be a lot lower.
We'll have to source API (active pharmaceutical ingredients) elsewhere for now. At some point, would like to completely internalize our supply chain, but one step at a time. :-)
He planned to pre-fund several coronavirus vaccine manufacturing plans _prior to FDA approval_ just to speed up vaccine production. He expected several of those would end up being wasted money. [1]
Perhaps he would find this valuable too?
[1] https://www.weforum.org/agenda/2020/04/bill-gates-7-potentia...
1) The FDA grants a single company the exclusive right to manufacture, distribute, market and sell a generic version of a drug. In this case, the price will be lower than the brand drug, but not by much, since there's only one maker and no competition.
2) Several drug companies are allowed to design their own versions of the brand drug. Because there are several competing brands with essentially the same product in the marketplace, competition causes the prices drop.
If your company targets the first type, you replace another company as the sole producer of the generic, and there's still no competition to drive the price down.
If you target the second type, you become an additional competitor to the other generic drug makers, so the market gets a bit more competitive, but the prices in theory were already competitive because of the number of makers. For example, the Lexapro generic Escitalopram has many makers, so you can get it for as low as $10.
So in terms of generics, the options are either single source agreements where pricing won't be competitive by design, or multiple makers, where the pricing is likely already competitive. Having said that, which of those does your company want to target, and how do they plan to tackle it?
I suspect their intended mission is to cover their costs with only a modest profit and thereby drive down prices where they are most inflated.
Given the proliferation of people like Martin Shkreli and companies like Purdue, there's a lot of pharmaceutical fruit out there to be pulled down and made low hanging once more.
I'm assuming most drugs are priced high to start due to the R&D costs, and (I hope) they eventually decrease their costs over time as that's recouped.
If Cost Plus comes in and reduces the costs significantly, then the original manufacturer has no incentive to create these medicines to start.
Or is that not at all how this works :-)
Basically, there's is an international shortage for one of the most effective treatment for severe depression because of an unfortunate series of events, the drug's long history as a generic and the manufacturers' willingness to replace the drug class, and constantly produce new patented molecules with chemical tricks(ex. just taking one isomer in the citalopram->escitalopram case, or even metabolites in the case of venlafaxine -> desvenlafaxine case) like they are 'annual smartphone model releases', except efficacy even goes down.
You can read more about it the drug itself on the blog of Scott Alexander (the rationalist/Bayesian psychiatrist guy) as well: https://slatestarcodex.com/2015/04/30/prescriptions-paradoxe... And now some years down the line after his observation, the price has exploded, very few new patients get a prescription due to uncertainty and there's no alternative. Your options are either taking taking an atypical antidepressant like vortioxetine or an experimental ketamine.
God I hate myself for being that guy, but neither of the drugs you’ve listed are actually MAOIs. I’m sure the point still stands though.
I'll edit my parent comment to make it clearer.
How good is it, I cannot say as not a lot of people prescribe it anymore. The problem with it is that a risk of hypertensive crisis, especially in combination with tyramine in aged foods, or inducing an overload in combination w/ any other drug that raises monoamine neurotransmitter levels, i.e. SSRI's etc. It's become kind of a bogeyman. So the original source seems to be trying to fight that particular "meme" in medical education. I'm not about to wade into pubmed regarding how often hypertensive crisis happens in a 60 or 70 year old drug, but there may be a point in that as medical students, we memorize the "quick bites" of some of these things as our time and attention is extremely limited in figuring out what to study for the boards. and if we do want to prescribe it, we have a pharmacist pushing back on the other end of the phone because it has this thing as a big scary Black Box Warning on the drug.
I will say, MAO-B inhibitors (at least those studied in anti-parkinsonian trials and doses) don't seem to do anything. No hypertensive crisis, but we haven't been able to see a huge therapeutic effect either. The psych people dose them at 6 times the parkinsonian dose though...<shrug>
The other potential angle on that post is...this may reflect on some aspect of an unregulated generics market. Aside from phenelzine, I seem to see weird swings in availability and pricing of generics in the past few years.
What is the stack, what kind of developers are you looking for?
Maybe post a link to your job listings.
Would be looking for folks to help make a more robust consumer facing site as we add products and different types of customers.
We've been focusing mostly on filling roles for the sterile fill-finish facility we are constructing in Dallas (QA, formulation specialists, etc.) and have put building out the dev team for the web sit kind of on the backburner with me just kind of personally managing it at the moment.
While Hacker News is looking though... :-)
Compare it to JSON:API or GRPC.
With Apollo it also solves a lot of frontend caching and state management problems so you can somewhat use it as an alternative to Redux.
Thank you!
Here's a brief video that breaks down some of it though: https://www.youtube.com/watch?v=15IQO_jTMUM
And can you export the drugs to other countries (for sale)?
https://www.lexology.com/library/detail.aspx?g=fcf817fe-192b...
> Ultimately, scientists traced the contamination back to a change in valsartan’s synthesis. The antihypertensive drug contains a tetrazole ring, which is an aromatic five-membered ring with one carbon atom and four nitrogens. For many years, the synthesis for this compound, developed by Novartis, used tributyltin azide to form the tetrazole, with xylene as a solvent. However, in 2014, China’s Zhejiang Huahai Pharmaceutical, which makes valsartan for some companies, filed a patent for an improved method for forming the tetrazole ring.
https://cen.acs.org/pharmaceuticals/pharmaceutical-chemicals...
It's all blood pressure medications like Valsartan, losartan and irbesartan, and metformin the diabetes drug.
These are just the ones that have been tracked. Sometimes the drugs come in with higher doses than they should, or less than they should. Or sometimes the pills are mislabeled.
Honestly, something that's advertised as ruby/python and HTML will probably put a lot of devs off that used to happily do that all day, and so a company might have to pay higher for good talent, or put up with worse talent applying for the same salary.
You might actually be worth more not knowing react. Communicating that to prospective employers might be hard though.
In other words, you can probably make really good money slinging COBOL if you know it and can communicate your talent sufficiently for the same reason, but more extreme.
(I'm not saying React is as useful as a hammer, but if it genuinely makes building and maintaining websites faster, it's a skill worth paying for).
We're planning to introduce a lot more drugs with transparent prices later this year, cutting out monopolistic middlemen in the supply chain and alleviating pharma drug shortages, particularly for rare and orphan disease conditions.
We are looking for a few devs (fullstack, frontend, and backend). If anybody is interested, drop me a line at [email protected]
In the meantime, happy to answer questions if anyone is interested!