Greed? It's not like the drug companies are writing the Government a $100 million dollar check (which, you realize, is a pittance to the US Government, who's budget is 3.8 TRILLION DOLLARS)
Yes, there are a lot of heavy, potentially onerous requirements to releasing a drug. Sometimes these requirements result in drugs taking a long time to be publicly available. But the goal of this process is public safety, not making a quick buck.
Government 'greed' may not be the best way to put it, but there is something there. This extremely high barrier to entry may not be completely necessary, and in some cases may be interpreted as deliberate suppression of competition effected by vested interests in the pharmaceutical and healthcare industries. If such a product can be proven safe using the same active ingredient and a comparable delivery mechanism, it shouldn't require millions of dollars to be approved.
The regulation is necessary because of the number of bad actors in the industry. From experimenting on people under the guise of vaccination programs through cherry picking of results, drug and technology companies have proven time and time again that they can not be trusted to put human welfare ahead of profits.
How do you prove a new product from a hostile industry safe, without having regulations covering the types of tests and acceptable reporting necessary?
The problem isn't "should we have regulation at all," but rather what is the right level of regulation. It is quite possible that the current burden of proof is too high in many cases. If drugs were made more broadly available sooner, it would likely save many lives. But also it would also likely cost some. Do we currently use the correct threshold?
There is certainly evidence that since regulatory bodies get tons of flack for letting through bad drugs, but aren't imposed on that much for slowing down the process, they incline to being risk adverse. We also have evidence of outcomes in Europe where the regulatory regimes differ and seem to approve things faster with outcomes that aren't generally worse than the US.
I highly doubt we have the optimal regulatory solution at present and could do much better. And if anything we have standards that are too high.
Perhaps it's a situation where there is no outcome where the barrier to entry is too high for bad actors while simultaneously being low for good actors.
The current solution seems to be to increase the barrier until the bad actors are gone; as this means there is less finger pointing.
Going the other way would seem to take active effort from a political representative, and the outcome will end in deaths directly attributable to them.... which would be career suicide.
There are accelerated approval processes for precisely what you're describing. Section 505(b)(2), for example, allows an applicant to rely on studies conducted for a previously-approved drug with the same active ingredient. And of course the whole ANDA generic approval process.
Part of the issue is the incentive system at work. The FDA isn't really rewarded for getting a drug to market quickly, but they are punished politically when they approve a drug that is later found to have problems.
This means that they are incentivized to be cautious, sometimes excessively so.
Okay, then expect expensive drugs for decades when it costs billions in R and D and the drug companies need to recoup the costs (in addition to the red-tape involved in releasing the drugs).
Many countries with cheap drugs never had to pay all of the research and development costs.
If it's not government greed, it's government ineptness and the inability to understand how the market actually works.
The generic company in this article, for instance, never had to pay any R&D costs for the proprietary epipen applicator and can easily charge a much lower amount of money for a generic version (which is different).
The high cost of FDA approval also creates monopolies, because it's very difficult to get anything to market. To get better and cheaper drugs, we need to change this at the government level.
The government doesn't run the clinical trials. The FDA only makes a few million per approval request which is supposedly used to expedite the approval process:
Yes but the FDA makes all the rules necessary to put barriers for new entrants, rendering the existing pharma companies as state sponsored monopolies in practice.
You're taking 'getting paid' too literally. All those FDA administrators and employees need to justify their fat budget by keeping themselves busier and busier. They're being paid by the taxpayer not the pharmaceutical industry.
It's really hard to find the sweet spot for drug approval. You want to avoid problems like this, but you also want to avoid approving the next thalidomide. (Which, incidentally, killed thousands of infants in Europe but was never sold in the US, because of the same strict FDA rules.)
This doesn't feel like the right platform for DIY. When someone needs an EpiPen, it's because they might be dying. Presumably, a large and well-capitalized organization will have tested their device extensively and can offer better guarantees about it actually working (I should stress presumably). There are a lot of ways in which the hacker mindset can be beneficial to society, but this particular application feels like an ethical gray area.
While I agree for people who can afford it, this is probably aimed to people who can totally not afford the real deal and would be left with nothing otherwise. Also it is a hack, since the best way would be to reduce the price of the good one.
Its not much of a hack
- take a medically approved auto injector
- take a medically approved needle
- put the needle on a different syringe
- put the syringe in the injector
I can't source it right now, but somewhere I read something along the lines of: "studies show 3/5 epipen usages are done improperly and are ineffective"
The premise is that $57 was the old price. and they bumped it up to $318.
And a DIY group can pull it off for $30, without economy of scale.
From wikipedia "In 2007 when Mylan acquired the rights to market the product, annual sales of all epinephrine autoinjectors were about $200M and EpiPen had around 90% of the market; in 2015 the market size was around $1.5B and Mylan still had about 90% of the market"... $1.5B annually... So if FDA testing costs them $10,000,000 anually, thats still less than 1% of their revenue.
That means that with economy of scale, and dispersing the cost of testing over several million sales, they could easily produce a product for $30. But they don't because they dont really care about saving lives, they care about getting paid. They would prefer people die than them make less money.
Completely not about "hey do it this cheap easier way" but "heres the rock solid proof that a $300 (even $60) EpiPen is stupid"
You know that's probably what they're getting at, but you have to admit it's dangerous to present their point in this way. I don't think it's a stretch to argue that if you offer an instruction manual for making something, some people will make it (and some of them will do so incorrectly).
While I agree $300 is a ripoff and takes advantage of how medicine works in the US (i.e. the cost for most users is opaque b/c insurance pays) I can also see that $30 is not likely a viable price --just like I can put a sandwich together for $3 doesn't mean I can run a profitable sandwich shop selling sandwiches at $3.
As a consumer I could see this for $75 - $100 retail (and some discount to institutional buyers) but $30 is probably not viable and of course $300 is ridiculous.
It's only profitable to sell $6 sandwiches if... 1. you use unpaid labor (family) or 2 you have 1,000+ franchisees.
If you are low volume, you're gonna have to sell at $8 - $10 to make something worthwhile.
Now, I get it, they are unquestionably overcharging for this drug and delivery system. I just don't think you can say that since I can make something at the rock bottom price of $x that someone else should be able to make a living (or run a pharma corp.) by selling at a similar price. The sweet spot is somewhere between $30 and $300, where it is is probably closer to $100.
If you have 10 customers an hour on average and you pay some guy $10 an hour to make 10 sandwiches, then your costs at $4 per sandwich. That means you have 33% headroom to pay rent for your business, which is better than what McDonald's has. McDonald's has decent pricing because they shoot for like 28% and a lot of volume (much more than 10 customers an hour and probably more hours than your business).
A soda machine is basically free money because syrup and water cost pennies. The cup is the most expensive thing you give to the customer for his $1.99 soda.
It's rent, opportunity cost, insurance, litigation, brand awareness, promotions, etc. Sure a McD can operate at that level because they have efficiencies and have bargaining power and arbitrage. A standalone shop doesn't stand a chance of being economically viable for an independent owner --you don't want a pharma which barely scrapes by. You want healthy ones but not ones which are willing to unjustly take advantage of their customers/patients.
Anyway, my main point was that ingredient cost is only one part of the cost of making/delivering something.
IIRC, restaurants aim for foodstuffs to amount to 30% or less of sales to be viable.
Well, yeah, a restaurant can buy more ingredients at a time which makes it cheaper since they get a bulk discount. While you pay $3 for that sandwich, the restaurant only pays $1.50. If the DIY EpiPen costs you $30, then a factory probably churn one out for $15.
Let's just say some number between $50 and $100 is what a company would charge for it. Someone said the old price was $57, which is right about where our back of the napkin math put it.
The cost of this project includes $28 for buying the insulin autoinjector at retail. There is no way it costs $30 to manufacture. I'd be amazed if they cost $5. Injection moulded plastic is extremely cheap once you've made the moulds.
The technology is old and should be priced competitively by now. To just come up with random numbers for a price doesn't make much sense. With your sandwich example - Subway sells $4 sandwiches because they have to, and they make plenty of profit. If they tried to sell the same sandwiches for $14, nobody would buy them and they would be out of business. The same level of competition does not exist with the epipen because of poor legislation and corruption within the FDA.
If significant competition existed, epipens would cost very close to $30 or however much they cost to make. There are many viable businesses operating at low margins.
They (including epipens) probably cost about $10 to make. That's total cost, from production to delivery to the retail outlet. They would have been handsomely profitable at the old price of $57.
Depends I guess on how you approach healthcare. If healthcare is a business then of course a considerably profitable way of producing a drug is necessary.
If healthcare is public service then profitability is not a primary concern. Data-driven decisions shows that approaching healthcare as a public service is much more effective.
The choice here is rather obvious, yet for some reason, average people who would benefit immensely from a public health system in the US seems to disregard it as socialist, paying for someone else and so forth.
Please note that drug corporations are insanely lucrative in Europe too, so a public health care system doesn't seem to harm drug companies all that much, financially speaking.
I think the choice is not that obvious if you factor in sustainability. A health system that is all about saving lives but collapses on itself (taking down a chunk of economy with it) within a year or two is not better than a less effective health system that can run sustainably for decades or more.
IMO you need to give the drug companies enough money to cover their operating expenses and R&D costs and give some margin to stay afloat. But not more than that. It's hard to do because this aspect is one that is handled well by free market - but in healthcare, you very much care about the thing free market utterly sucks at - product quality. You need regulation to ensure the product is good enough, and many of the important criteria are not immediately verifiable by the customer at the point of sale. Trying to reconcile those two issues is the hard problem.
Please note that that $27 for autoject also include wide margin in it (manufacturer, distribution, retail, etc). And epinephrine at volume is essentially free, so $30 seems to be a good estimate.
I interpret this as more of a political statement, rather than something you'd actually want to rely on.
That said, it looks like this is just reusing an existing off-the-shelf autoinjector used for insulin. If it fails, you could remove the needle and inject manually. The biggest risks I see here is making sure the epinephrine stays sterile, and that the dosage is correct. (To be clear: Either of these could have serious consequences.)
I do want to agree with you, and while watching the video I thought a lot about the risks involved. However, the realities of the world applied to ethics requires me to disagree with my knee jerk reaction. The fact is that many families are dealing with the fallout from the fact that they can't afford these life saving devices, and this option gives them a reusable $30 solution to the problem (the needles can't be reused, but the spring can). This is important given that they need to be replaced every year, apparently.
The not-so-grey ethical issue is the cost of these devices, and the fact that there are people who are too poor (medicare doesn't cover them, according to the article) to get them. Until we build a system that prevents this unjust situation, it is my opinion that there is nothing questionable about this 'hack'.
Actually, I'd rather see the system be corrected than a bifurcation in deaths due to anaphylactic shock according to income level, because Mylan decides to just accept the deadweight loss of poor DIY'ers instead of lowering their prices.
That said, USG may be too beholden to Big Pharma at this point for anything to be done.
More of a grey area than lobbying to make it illegal for schools to not stock epipens and then jacking the price up 400% and giving yourself a 671% pay raise? Not to mention the CEO is a senators daughter.
Costs should cover R&D but this is outright greed and in an industry where it's literally peoples lives at stake it can't be allowed to continue.
Oh I don't disagree at all. But that has very little to do with whether or not it's ethically responsible to propose an untested method for constructing a device that would only be needed in life-threatening situations.
There's a lot of space between the conflict of interest that arises when you lobby congress for a change that would help the company you are the CEO of while your father is a senator and not working.
True, but there are many people who have EpiPens that don't "need" them per se. I have one for my daughter, because her mom (my ex) pressured the doctor to prescribe them for her, even though all she had was a small rash on her face when she ate her very first egg. (the doctor said Benadryl was sufficient for that) Since then I have (with a great bit of care, and an EpiPen handy) given her increasingly large doses of eggs, never seeing a problem, till she now eats eggs like everyone else. But still her mom is fearful and gets new EpiPens prescribed every so often.
The point is, it isn't all black and white. If a kid has a severe allergy, sure, make sure you have a real EpiPen and carry it with you always. For those borderline cases, well, something like this might be fine. Having it reduces a really small risk even more.
Another interesting point: even if a kid has a severe food allergy, they are still more likely to die from a car accident than from an allergic reaction. Some people lose perspective.
The hack here is simple: this group did not get FDA approval for their device. Greedy corporations have repeatedly tried to make money by competing with Mylan with cheaper Epipens, but they've been prohibited from doing so by the US government (not so in Europe, where the unfortunate Europeans suffer eight greedy corporations trying to drive prices down).
(So all you have to do is convince your doctor to write Adrenaclick on your prescription and you can buy the generic for $145 at Walmart)
That price is interesting because it puts some kind of cap on the amount that regulation is leading to the price increase for Epipens. The regulation about substituting Adrenaclick on a prescription for Epipen can be argued, but any doctor that won't write Adrenaclick after a minute of discussion better have a good reason.
Watch the video. All described is loading epinephrine into an autoinjector. This is great because it suggests the barrier to competition is relatively low hanging fruit for those already in the drug delivery markets.
Now granted Shkreli is a controversial figure, but basically drug companies are businesses, and if you sort of detach yourself and look from a business perspective and value-based pricing, Epipen competes with the ER, and $600 is a bargain vs an ER visit.
And of course his ultimate conclusion is that maybe life saving drugs are more like water and power than cell phones and wine? Maybe the government should get involved in making generic drugs available.
Correct. Epi is a short-acting drug. Allergens can still cause anaphylaxis after the epi has broken down. Epi use should result in a call to emergency services, and/or a trip to the ED.
I feel like it's a bit of a poor comparison on the basis that an ER visit's primary purpose isn't the same as an Epipen's primary purpose. Ultimately, they can achieve the same goals, but we're not doing a direct comparison of costs.
Using all of the other costs and aspects of an ER visit to justify a price increase of Epipens feels dishonest; I do realize that ERs are largely being misused in the US as general health care, but the E is supposed to be for emergency, and the cost comes from the support required to adequately respond to emergency situations.
Given that I was under the impression that if you have a situation where you need an epipen you're supposed to seek medical care anyways [1], I'm not sure how this reasoning of "it lowers costs" really plays out, since it seems to me like it's just hiking up the price of an already bad situation. I don't see this as particularly beneficial to anyone other than the sellers of epipens.
[1] I must note, my only reference to this is my own fractured knowledge from when I had a friend that required an epipen and reading the instructions for administration. This was a long time ago though and I don't particularly trust my own memory.
> if you sort of detach yourself and look from a business perspective and value-based pricing, Epipen competes with the ER, and $600 is a bargain vs an ER visit.
This is exploitation of inelastic demand (death is a pretty high priced alternative to $600), and it's pretty clear that's exactly what government regulations and market controls are supposed to protect against.
Yes, that is the conclusion that he reached: that the government should just nationalize generics for public benefit. That's sort of the extreme version of mandated pricing.
Someone else in the comment section shared another perspective which reaches the opposite conclusion: that these regulations have created the problems in the first place, and the government should not touch this sector at all: http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...
Great talk. Chematica looks really cool, as a way to discover new ways to synthesize chemicals, just by searching a graph of possible reactions in order to reach the target chemical.
Thats like saying pirated software exposes the greed of software companies. I don't think that anybody believes that EpiPens themselves are very expensive at all - just like software, the cost comes from the cost of development, which in this market consists mostly of regulatory compliance and approval. If it were easy to bring an epinephrin injector to market, Teva would have already done so and Sanofi wouldn't have had to recall theirs. If there were more auto injectors on the market, the prices would go down.
The outrageous price of EpiPens is not a result of corporate greed so much as a failure of the FDA and Congress - but mostly Congress, the FDA is their subordinate. They failed to promogulate rules that maintained a competitive market for epinephrin auto injectors.
The cost is in the patented injector, the drug itself is cheap. Others have tried to market similar injectors, which didn't work as well as the Epipen.
As cost slowly rose, insurance paid for it, and parents didn't notice it as it was hidden in rising insurance premiums. Then deductibles skyrocketed, and suddenly insurance wasn't covering it all; parents had to pay the balance, or all of it.
If you didn't have insurance, you already watched it go up as it happened.
Finally the cost was raised arbitrarily, to cover the company's coming losses as their patent on the delivery system will expire. This, I've read recently, is common: a spike in price before generics take over.
The traffic bears this price, because parents don't want their kids to die from accidental exposure to peanuts and other allergens.
The price was raised so the CEO could escape the rigors of just scraping by on $2.5M. The board wasn't going to give her a raise without a boost in profits. That's easy to accomplish when you control 90% of the market. That is the only reason. Not production costs. Not future losses.
I bet their cheaper "generic" packaged version will see limited production to force supply shortages and drive people back to the overpriced pens.
The recent and tremendous price hike of the Epipen contradicts this line of reasoning. I don't see anything pointing to regulatory or compliance costs being behind this.
The price went up because Mylan got a monopoly on epinephrin auto injectors, they have that monopoly because regulations prevent would be competitors from swiftly and/or economically bringing competing products to market.
Nobody has to buy an auto injector. Diabetics draw insulin from a vile and inject themselves all the time, those with severe allergies can keep viles and needles too. I buy EpiPens because I don't want to do that. And before Avi-Q was recalled, I bought those instead, even though my costs were twice as high, because I liked them better.
You can say that capitalism is the wrong way to produce drugs, in which case its Congress' fault for not instituting a different way. Or you can say this is a failure of the regulated drug market to produce a result in the public interest, in which case its Congress' fault for not regulating the market differently - thats what I believe. If you're arguing that this is a moral failure of the Mylan stockholders… well I think thats a hard position to take, and no matter what demonstrating that auto injectors aren't expensive to build doesn't really try to make that argument.
I must admit that my reply was narrow-focused on Mylan not being able to pin the costs on compliance. After a re-read of your original comment, I see exactly the point you're making. You're right. The reason Mylan jacked the price up isn't directly due to their costs of compliance, it's related to the industry's cost (that is, any potential competitor), and the competition that is stifled because of it.
Your point about handling the injections the old fashioned way is a good one as well. But it's worth noting that diabetics have tons of experience self-injecting using standard needles and vials. A typical Epipen user has probably never had to do so, and when the drug is urgently needed is a bad time to get started. So for these users it's not simply a matter of convenience.
The CEO of Mylan is a Senators daughter, they lobbied to pass a law to make schools carry epipen when it passed they jacked the prices up, the CEO also gave herself an $18,000,000 raise immediately afterwards. That IS corporate greed, the very definition.
In my state, schools are required to carry them. As too are ambulances and paramedic units, despite the latter carrying epi on board (at the least the latter of which has been trained to administer Epi by drawing up, and the state is now moving to train the former, too, in light of all this).
I feel like a lot of the commenters here didn't read the article.
> Four Thieves Vinegar have created and uploaded the plans for the simple version, called the Epipencil. Also spring loaded, the parts are gathered over the counter. The epinephrine will still need to be acquired with a prescription.
This still involves an FDA-approved drug obtained through normal channels; the DIY part is the injector.
Creating DIY medical drugs would certainly be something to be concerned about, but I don't see the problem with DIY medical tools.
> Creating DIY medical drugs would certainly be something to be concerned about, but I don't see the problem with DIY medical tools.
The FDA does see a problem, though, which is why other companies have had a huge amount of difficulty trying to bring competitors to the epipen to market (in the US).
I've heard that law enforcement uses X-ray machines to look at vehicles on the road, without even asking or informing the drivers they are dosing with radiation.
Funny enough, these devices don't need FDA approval, since they aren't medical devices, and the operators don't need to know anything about radiation effects on Humans...
Self reporting. Excuse my scepticism, it doesn't have a great track record. Additionally, the users are not exactly experts on radiation safety or knowledgable about radiation dosage, and I don't see how manufacturer reporting can cover what happens in the field.
Oh, well, that's different, then. As long as the cops and TSA goons are qualified to tell when the machine is malfunctioning, miscalibrated, or otherwise going full-Therac 25 on us, we're good.
Those machines should be built to be at least as annoying as new cars - i.e. if anything breaks, any diagnostic fails, the machine should not start. They probably aren't built that way though because - unlike with cars - there isn't a profit motive to do it this way there.
If you'd said, say, 50000 times, I might be more swayed, but a thousand seems easy to hit if these are widely used. If they're used daily, just passing two on a commute is enough to go over the limit.
some aspects of regulation protects monopolies, increases burdens on businesses trying to sell life-saving products, self-justifies bureaucracy and adds cost and delay. Other aspects of regulation prevents unsafe, scam and inferior products from endangering public safety. Both positives and negatives, to varying degrees, are in play simultaneously, given a particular product or issue. We need the FDA to not be lap-dogs of industry, not block dying cancer patients from trying almost any experimental, unapproved protocols and not taking forever to approve revolutionary therapies.
To modify James Madison's quote: "If everyone were angels, no government regulation would be needed and libertarianism would be as practical of an utopian system as communism."
It's balanced, expedient and effective regulation that is the primary duty of medical regulators.
In a way, the rest of the world is indebted to the U.S. for its regulation. It's a huge and wealthy market, so manufacturers have an incentive to enter it; the regulation is hard so products often really have to improve to get through.
The rest of us can then enjoy greater safety of pharmaceuticals and medical equipment without setting up such an expensive regulatory system.
The problem is that if an auto-injector is truly needed (onset of anaphylaxis), there may not be much time to futz around with it, if it doesn't work properly.
The auto-injector apparatus is not regulated because it is dangerous; it is regulated because a failure to operate would be dangerous. It is regulated for reliability.
The hacker/maker ethos is awesome and drives a lot of innovation in our society, but sometimes there is also a need for careful engineering and rigorous testing.
I've got a heart issue going on and I've had some fascinating results from capturing my heart rate on a consumer grade chest band monitor, then uploading it to influxdb and viewing it with grafana. Total outlay a couple of hundred bucks. Invaluable to me in tracking what's going on with my heart.
Yet that whole stack would never be approved by... Anyone!
I guess it may be large. Many people have more discretionary free time than money. I surely had when I was a student; I could afford the $50 DIY contraption and assemble it myself, but no way in hell I could find a spare $300.
You pulled 90% out of the air, though. What if it's 42%?
If you think 90% is a better target than 100% for overall public health, well, fine, that's a classic kind of public health policy argument. But without a regulatory system of some kind, you won't know what the actual number is for a given product.
EDIT to add: I'm not arguing that DIY auto-injectors should be illegal to build in general. I'm in favor of people having the freedom to experiment with their own care if they want to.
I am arguing that DIY is not an adequate substitute for the general public unless the actual risks are well understood.
So folks know, there are already at least 2 EpiPen alternatives that are FDA approved.
One is the "Adrenaclick," which is another epinephrine autoinjector that (and this is key) must be specifically prescribed. You can't take an EpiPen prescription and ask for an Adrenaclick, your doctor has to specifically prescribe Adrenaclick. But right now it's a lot cheaper. A friend just switched and his copay went from $200 for EpiPen to $8 for Adrenaclick.
The other is to buy a bottle of epinephrine and use syringes, or buy pre-filled epinephrine syringes. Again, a doctor must specifically prescribe this, but it's a lot cheaper than EpiPen. More complicated to self-administer in an emergency, though--but better than nothing, especially for 3rd parties with access to training, like wilderness guides, teachers, etc.
Careful engineering and rigorous testing does not require FDA approval. Hackers and makers can do their own rigorous testing and publish their methodology, which can be scrutinized by peer review.
What's unlikely is that a DIY production scheme can ensure consistent manufacturing quality, since the careful, rigorous hackers are not going to be making this for everyone.
Based on the implementation of regulation in the US, I'd say the purpose of regulation is clear: To make a monopoly / oligopoly on drugs.
> It is regulated for reliability.
Then why aren't the tests and methods of testing reliability required to be published?
> it is regulated because a failure to operate would be dangerous
The risk of not having it at all far outweighs the risk of the injector failing.
Not to mention that regulated injectors fail too due to manufacturing defects.
> sometimes there is also a need for careful engineering and rigorous testing.
But should that need preclude private individuals from assembling their own life saving devices on a small scale (1-10 units)? We're not talking about someone else stealing your design, process, research, and building their own production line here.
Furthermore, careful engineering and rigorous testing is needed when you're creating a production line of these things. A competent individual can assess and test their own device. Yes, it's more time consuming, but for something as essential as a life saving drug, it's probably worth the extra time.
> Creating DIY medical drugs would certainly be something to be concerned about, but I don't see the problem with DIY medical tools.
There was a non-EpiPen epinephrine injector on the market in the US up until last year, the Auvi-Q by Sanofi, that was taken off the market because there were problems getting accurate and consistent dosing.
Sanofi is the fifth largest pharmaceutical company measured by prescription drug sales. They have annual revenue of $37 billion, and 112000 employees.
The fact that Sanofi was not able to get the mechanical aspects of this thing right leads me to suspect that these kind of things are not as easy to make as it might at first seem.
TIL that an "autoject" is an inexpensive self-injection tool commonly used by diabetics[1] that can be carried safely and used easily. It can be loaded with Insulin, or with any drug whatever. The OP article describes using it to inject epinephrine, stating that
> A 1mL vial of epinephrine costs about $2.50... Doses range from 0.01mL for babies, to 0.1mL for children, to 0.3mL for adults.
In other words, if your doctor will give you a prescription for the drug itself, you could assemble three epipen equivalents for less than $100.
Generic Adrenaclick is $145. Maybe some of the rest of the $455 difference can be explained by regulation, but a lot of it comes down to Mylan choosing to price the drug that way.
You can also look at Mylan offering $300 coupons to consumers to get them to utilize their insurance. Maybe they are just incredibly generous, but it's more likely that they are happy to net the $300 from the insurance (in other words, they profit at $300).
I mention a competitor in the first sentence of my comment!
Feel free to complain about the substitution rules surrounding Epipen prescriptions, but it's clearly a competitor in the sense you invoke with killing off any competitors. It's the same dose of the same drug intended for use in the same situations.
I seriously doubt they would be handing out 1mg doses like candy if it was as dangerous as you suggest. China has actually been quite strong with controlling potentially fatal drug distribution in the last 15 years, tightening rules for many substances. The key reason is suicide prevention. Wikipedia says "Although it is commonly believed that administration of adrenaline may cause heart failure by constricting coronary arteries, this is not the case" https://en.wikipedia.org/wiki/Epinephrine#Adverse_effects
(Edit reply to a3n below: My point was that it's not as dangerous as you are making out, not emotional appeals and cultural norms for responsible parenting. Self-administration: good enough for 3 billion+ in China/India/other developing world locations, good enough for me. The whole idea of stabbing yourself with a fat dose of adrenaline is pretty hackish anyway and shows how undeveloped our medical knowledge still is.)
If you're injecting with a traditional syringe, you can see how much you're drawing into the syringe, and presumably can create an accurate dose. Assuming you aren't untrained and panicking.
The idea behind the auto injectors is accuracy with relatively little training and skill; a parent can do it while they're watching their kid strangle. That's why you buy an auto injector instead of syringes.
Competing auto injectors have not been as accurate and simple to use, is what I've read.
I would not trust my kid's life to a hacker injector; these are medical devices that are required to go through trials. Even traditional syringes are regulated. Sure, maybe you can decide to use an unregulated injector; I wouldn't, not for my kid.
Except this isn't a purely hacker-built injector. They're using an off the shelf FDA approved injector sold as suitable for diabetics including use by children and the elderly.
The hack is putting in your own needle + medicine.
FWIW, LD50 dosage is low for intravenous injection, but very high (multiple orders of magnitude higher) for intramuscular injection. The risk is generally not getting enough of a dosage, not too little, unless you somehow manage to hit a vein.
The main problem is that, if you're carrying around EpiPens for allergic anaphylaxis, particularly for a child, dealing with syringes and bottles isn't really a practical solution for day-to-day living (and definitely not an option if you're carrying them around for yourself -- hard to carry out delicate medical procedures while being unable to breathe). There are probably a lot of people without access to autoinjectors who have had to suffer the consequences of anaphylactic shock.
Epipens come in a grand total of 2 sizes to cover everyone from small children to very large adults, I feel like the precision of the dose isn't that important...
"Mylan's efforts to maintain its market dominance were aided when Sanofi's competing product was recalled in November 2015 and further when Teva's generic competitor was rejected by the FDA in March 2016.[76]"
Yes, you can load a precise dose into a device, but the device has to actually work, reliably and consistently. This is apparently a hard problem, for at least two Epipen competitors. Since Epipen has no serious competitors for a device like this, they get to charge as much as they dare.
In Australia it costs $38 (US $29) for a twin-pack of Epipens under our Pharmaceutical Benefits Scheme. We can also buy a single pen privately without prescription for $99 (US $75).
Pretty neat. I wondered why you could just use an autoinjector like diabetics use (answer you need a larger diameter needle). Still easily doable and its all off the shelf made by medical device manufacturers and drug makers so not so much "DIY" as "repurposing existing medical gear to be more versatile".
Other big grownup companies have tried to make a precise injector, and not done nearly as well as Epipen. It's not just a needle in front of a spring. (I haven't read the article, it won't load atm.)
If the product is so expensive, and someone can make a competing product for less viably I find it hard to believe that it hasn't been done. A more fair comparison would be "medical aid which wasnt subjected to the same regulations and testing is cheaper to make and distribute" aka Corporate greed.
Not sure how that's greed as much as a case of too much regulation.
Companies exist to make a profit, why are we getting upset when they do so within the confines of law? Here, the law allows for lobbying and high regulatory burden which creates a monopoly for EpiPen.
I don't expect public shaming to reduce corporations from seeking profit. I do have great hopes for reforming laws to incentivize competition so that the desire for profit benefits us all.
Just saw more Epipen Congressional testimony. The actual unit cost of the Epipen (whether branded or "generic") is around $67 USD. Assuming that this cost were not overly inflated beyond actual overhead and unit costs, in order to be sustainable, a reasonable retail price without distributors would be $134 USD... with distributors $200-238.
That said, the more downward pressure from competitors (commercial or nonprofit projects), the better for customers; especially where a monopoly existed, it's rational to for customers to band together and attack excessive hegemony.
Enteprising folks need to jump on this to sell this as a kit (w/ or w/o the medication).
> Enteprising folks need to jump on this to sell this as a kit (w/ or w/o the medication).
Unfortunately, that's a real great way to get shut down by the FDA. Medical devices are after all subject to regulation. Others have tried making their own epipens too, but they all keep running into the slow approval process and unfavorable laws protecting Epipen: http://www.washingtonexaminer.com/fda-partly-to-blame-in-epi...
Also as we know from value based pricing, things aren't priced based on unit costs (otherwise all software should be essentially free, and the software industry is the greediest industry on earth), but rather what customers will pay. And when there are no alternatives, you get to set the price.
It may be better than having no epinephrine at hand. But other than that, there are a lot of problems: How sure are you that it will work when you need it? Can you fill the syringe cleanly enough? Will the epinephrine in the syringe degrade, or worse, develop a bacterial growth?
It may be a better Idea to look into a syringe+vial combination on hand, prescribed by a doctor. Less convenient, and you need to learn how to use it (and preferably teach those close to you), but this may be a whole lot safer. The downside of course is the problem of self-administration when in anaphylactic shock.
Ther's an abysmal difference between hacking something together an manufacturing a reliable product at scale that people can bet their lives on. Everything, from R&D to the cost of lawsuits, FDA trials and regulatory frameworks makes these comparisons dumb and ridiculous.
I've been manufacturing products for thirty years. It's never simple for good products, not even a cup of coffee at Starbucks.
Somewhat tangential: I surmise that this title will be subject to editing by HN staff, but I think that "Hacker group creates $30 DIY Epipen to expose corporate greed and save lives" is an exemplary post title for HN and want to see more like it.
Sure enough, the title was changed to "It Costs $30 to Make a DIY EpiPen," which strips out several important details: Who did it, why they did it, and what they hope the results will be.
The title could be rephrased as "Cheap guys risk the lives of thousands of people by promising savings of a few bucks".
The problem is not with the "greedy corporations", but with the poorly dedigned legislation regarding intellectual property rights.
The state created the protectionist environment in which companies can become bullies and be sure that they won't be exposed to any economic competition.
Of course, the complete lack of IP laws would deter companies from investing in research, but the same effect have too strong IP laws. Why would a company risk their money and do research once they found a cash cow which can be milked for a long time, having the state guarantee it?
> The title could be rephrased as "Cheap guys risk the lives of thousands of people by promising savings of a few bucks". The problem is not with the "greedy corporations", but with the poorly dedigned legislation regarding intellectual property rights.
Ah, so let's all just stay in line until we fix patent law. That'll work out!
The problem here is some cheap guys risking the lives of thousands of people to make a few bucks. You say it was inevitable that a company would take advantage of this cash cow; I say it was inevitable someone was going to route around this cash cow.
I also feel like no one in this comment section has taken a first aid course before. Anyone who has spent time around some epipens would start questioning the price. The thing itself does not have to be a super precise device.
Meanwhile administering epinephrine is not a big deal. Really, any idiot can administer epinephrine, and probably do about as well as people do with epipens. I would personally recommend most people who need it keep a vial and some syringes around if they need to administer it to their kid, and an epipen only for the convenience of the form factor and only if they really need it. Most of the time you can get away with benadryl.
So, hack away, cheap guys. You'll likely help a few, help a few others discover they can get away with a super cheap vial, and demonstrate to quite a few more that the prices currently listed are ludicrous.
> The title could be rephrased as "Cheap guys risk the lives of thousands of people by promising savings of a few bucks".
You say "Cheap guys".. A growing number of people cannot afford an EpiPen. What are they supposed to do? Just die when they have a reaction?
I agree that this solution is not ideal and is probably prone to error or failure. For a lot of people who no longer have the means to purchase an EpiPen it looks like a solution that could save lives.
how do you think this effort puts thousands of people at risk?
if you download the instruction packet(o) it comes with a Links.txt file that has a link to an instructions video.. which at the time of writing this comment can be found at: https://www.youtube.com/watch?v=ldFFJRdhVs8 ; i suggest you watch it
all of the components are 'off the shelf' and the drugs are prescription
from this(i) ~random site epinephrine costs 74.95$ for 30mL, the instructions call for .3mL, that is 100 uses from this 75$ vial, or 75 cents of epineprhine per epipencil
when i read the article i thought this was a great effort that could save the lives of anyone who was unable to bare the new price of the epipen, but now i am wondering what from the epipen warrants the price tag? can a loved one even sue epipen if it malfunctions and kills the intended user?
As far as I understand: a regular bubble of air, while undesirable, won't kill you. That's part of what the lungs are for, and in fact it happens in hospitals all the time.
A very large bubble can kill you, but you need to put some serious effort [1].
sure, but concerns like that are why the epipen`cil came to be
in emergencies you are stressed and on a time constraint
if one takes the time to prepare for such an emergency by constructing the epipencil i would hope thae would follow the instructions given carefully, which notes:
7) Inspect carefully to make sure there are no air bubbles, and remove them if present.
i sent them an email requesting that they explicitly describe in the instructions and verbally describe in the video how to ensure the syringe is bubble free
The Hackers groups are doing what they can to expose Mylan's (EpiPen makers) Greed which is laudable. What is really needed is also an explainer on why a bit of govt. leverage (socialism if you will) is good in Medicine Pricing as well.
Mylan is a really great user of buying legislation.
They leveraged their 90% market ownership of the epinephrine auto-injector market such that
[1] It lobbied hard to ensure that all parents of school going kids (or tax payers) paid for EpiPens by making it into a bill that politicians could easily justify.
Once the bill passed and schools all over the country purchased these by the boatloads, then they just kept raising the price over and over and milking the profits.
When it got too much and they could not ignore the patient backlash they have turned again to purchasing legislation..
[2] Now they want to make it so that the patients do not see the copays - instead every one suffers by paying more for health insurance.
the challenge is that ~40% of healthcare spend is even plausibly directed by the patient. the majority is not elective, a result of an acute situation, etc. The concept of free market, unfortunately, doesn't work. It's easy to confuse this because most people on HN are (relatively) healthy. 15% of the population consumes 80% of total healthcare spend. These are the ones that we need to solve for
Sources: lots of research I could link to but don't have handy and, with great dismay/frustration, I've spent a decade analyzing the root causes of US healthcare spend.
How much does the government have to intervene in this market before it is at least partially culpable for the problems? Will government be blamed for any systemic problems even when there is a single-payer system, or will the problems then be attributed to underfunding?
Monopolies can dictate terms, which is why monopolistic companies are regulated. But if that monopoly is the state, then it actually works in the citizens favour if the monopoly presses down costs.
So the question that comes up with this, if there is no free market like the US medical system, would it kill the incentive for biomedical startups and pharmaceutical research in general (which is largely based on the US now).
Also, it's important to distinguish between true R&D aimed at developing actual cures and iterative R&D aimed at developing medicine that will get you hooked on long-term courses that maximise profits.
And R&D aimed at developing replacements for perfectly-fine drugs that are soon to go out of patent, or R&D that is put on a back burner until some other drug is about to go out of patent etc.
I think its clear that the US medical system is specifically not a free market. It has become (and is continuing to become) increasingly subjected to regulatory capture.
Corporate capture, not regulatory. Plain old corruption. Regulation just increases the barrier to enter for competition, which is beneficial to the status quo who can afford it.
My question is similar...is the US fitting most of the bill for R&D currently, since apparently we get ripped off for prescription drugs? (or are we getting ripped off? maybe it costs that much to develop the drugs dunno)
Just to clarify, the medical system in the US is far from a free market... the pharmaceutical industry itself is the opposite of a free market, inundated with incumbents and very strong patent protections without anything to force open generic production and licensing at a reasonable cost.
Beyond the pharmaceuticals, is that the most expensive healthcare services are provided by hospitals that are mostly locked in by proximity.
Yes, assuming the monopoly actually wants to keep its costs low. In the US, corporate-funded legislators made it so that Medicare is not allowed to negotiate drug prices. It willy-nilly pays whatever the private drug companies prices its drugs at.[1]
This is why it's so profitable for companies to "purchase legislation". The return on investment is 10x or something insanely high, like in this case. Spend $10 million "donating" to the campaigns of a few unconscientious politicians, and soon you are milking an extra $100 million in profits from unwitting taxpayers.
Bugs me to bits. I'm very glad I live in a much 'cleaner' country i.e. Sweden.
Transparency could strip off lobbying. If we know who gets what money, and we know how people vote, a bit of clustering etc ought reveal patterns...
What's needed is something gimmicky that gets popular appeal and covered on mainstream media for fifteen minute fame...
E.g. an iphone app that you point at the live news on your TV and it OCRs the senator's name and queries opensecrets.org or something bigger and better and tells you how much money they got, from whom, and how this correlates with their voting record etc.
Something that makes politicians accepting money very counterproductive.
Don't underestimate the complacency of the public.. Most of this information (campaign funding information) is publicly available in the US as well... it's just that most of the population doesn't care... they're more worried about one of those damned (insert other party here) getting into office.
I'm from Poland, where we have 100% national healthcare, and it's literally illegal for people or companies to donate to politicians to do anything. Or fund their campaigns, or pay for their holidays, or whatever - politicians are straight up forbidden from taking money from companies/people no matter what reason. So basically, our healthcare system plays hardball with suppliers, basically saying that we can pay X, or we won't buy your product at all - because it simply can't afford to pay any more.
These strategies can allow governments to bargain down the cost of products to the marginal cost of production; the only problem is that if every buyer does the same thing, the supplier goes bankrupt (as it can't cover its fixed costs). This strategy also doesn't allow for any earnings to be retained for product development, and discourages investment in the field but those are separate issues.
They can, but that is not what all of them are doing.
They realize that if they only cover marginal cost, and don't allow for development, they will only get the right product for a limited amount of time.
What often happens is that they agree on a more realistic price that will allow for that.
In many cases the company will go low to still be the supplier for a whole country - especially as they can still keep their margins in other countries, like US.
I think we agree on this, but the strategy of bargaining down to near marginal cost is dependent on the US customers paying for the fixed costs. The 'internationals' don't have to worry about doing safety studies or drug development either, so they can just take advantage of US companies doing the expensive work. For their part, the US government seems to know what they are doing too; they know they pay more for the drugs than anyone else, and do so to retain the industry.
I'd compare it to a 'tragedy of the commons' scenario where one farmer keeps paying his son to re-turf the meadow, so the boy can have a job (and thereby feeds everyone else's sheep).
Do you mean the monopsonist? I am not sure that I would define the governments who provide drugs to their citizens as monopsonists or monopolists outside of being monopoly suppliers to their own subjects.
I agree that the 'internationals' who control domestic drug consumption have little incentive to set up their own drug production systems, but if my supposition is correct, they need the US to keep paying higher prices for the same drugs.
> the only problem is that if every buyer does the same thing, the supplier goes bankrupt (as it can't cover its fixed costs).
The government is responsible for using a fair price, both for itself and the supplier.
His non-profit nature ensure that it will not try to lower the price too far.
If a politician is dumb enough to make companies go bankrupt, it's the responsibility of the people to vote him out of office.
That's the only way to have a fair price on drugs. A free market cannot exist in these industries and the inelasticity of the demand will always, always distort the prices.
Yes, America will have to face its demons and trust its government. The alternative is to continue paying exhorbitant prices to greedy scumbags and let fellow citizens die as a result.
This sounds like capitalism. This is the inverse of the anti-marketplace argument that capitalism leads to monopolies, which then price-gouge consumers.
In this scenario, consumers drive the prices too low and put suppliers out of business. It's the same argument coming from the other direction.
Markets don't seem to work like that. Prices get driven down, but not to the point where suppliers go out of business, because they won't sell at that price. Sometimes if margins are too low new players will find efficiencies or new inventions that allows them more profit for awhile.
For this to happen you need a balance of power between buyer and seller. It's obvious to me that such a balance is radically absent in the US system right now.
Putting governments into the role of buyers is not anti-market - it's pro market because it allows an informed, more powerful buyer that balances the market forces and allows the market to work. (It's certainly possible that other entities, such as insurance companies, could fill the same role.)
A worry comes because of the label "single buyer" which is the inverse of a monopoly and is anti-market. But in practice drug companies are global and there are many governments.
All this would lead to much lower profits for drug companies, of course, but that's not a pro-market argument, that's a pro-monopoly concern.
>This is the inverse of the anti-marketplace argument that capitalism leads to monopolies
I don't think I have heard such an argument, and I understand the parent comment just fine.
What he means is that, since pharmaceutical and medical supplies companies have large upfront research costs coupled with negligible marginal costs, they face a falling average-cost curve. However, a firm operating under competition has it output at the point where marginal and average costs are equal. The point is that for a firm who profits off research, reaching this point is unfeasible. What all this economic gobbledygook is that, in order to survive, firms have to charge above what would be otherwise the "warranted" price (like the price of the components and labor that go into a kit).
This is more obvious in the case of software, since the cost of copying any piece of software is pretty much zero, anyone trying to sell it for it's marginal price won't ever get what he put in by having written it in the first place. In such markets the socially efficient outcome, the one which makes both consumer and producer better off, is actually to have a single or few firms regulated firms operating under imperfect competition. And all this happens because of the cost structure of the firms, not because of the market itself.
Though I'm rather skeptic that pressing on the suppliers will push them near their marginal costs in this particular case.
From a quick read, it seems that this article does not talk about Pharmacy Benefits Managers such as Express Scripts. The latter are certainly not a full-fledged solution but another country-specific attempt to privatize for the sake of privatization. I agree that it is sad that the elected representatives in the US have worked so hard against the people they serve by hampering Medicare in this manner.
I live in Hungary and we're often fed up with the corruption we see here, but as I learn more and more about American corruption I'm not so sure we're that bad in the end.
Monopsonies pressing down costs by exerting their sole-buyer power causes deadweight losses (compared to the free-market clearing price). Really the question is whether or not the redistribution from health care providers to the general population is worthwhile -- and if it is, you have to compare the monopsony against levying a specific tax to accomplish the same goal.
Not too much, but too little. A monopsonist that buys at a lower price than where the market naturally clears will remove more producer surplus than the extra consumer surplus it extracts.
In concrete terms, this means something like "the price of a doctors visit is low enough that a nearby clinic closes down. Even though you were happy to pay the higher price for the convenience, and they were happy to provide service at that price, we no longer get to have that experience."
"Universal"-ness is just one dimension of health care costs. What about the malpractice liability environment in other countries, for example? What about the attitudes towards end-of-life medicine? What about medical tourism to America for advanced care? How much of the cost savings for universal health care is a result of saying no to procedures?
Insisting that moving to a single-payer system is the only solution is very one-dimensional thinking.
It can also be said that drug companies use Americans to make their profits and sell to other countries for the best they can get, we could well be paying for an unfair portion of the "real" cost and other countries are only doing better because we're paying the bill.
---
I'll switch to talking about something entirely different to expand on the last point. You'll often see people arguing about how the US has the highest military budget, higher than the next N countries combined.
The thing is, we're providing security for those next N countries, and the world as a whole. Many of those N countries are NATO allies who would have to spend a whole lot more if the US didn't. And also by making real war outside regional and civil conflicts impossible for the whole world with military dominance.
In other words, in an American military spending blackout, the game would change and everyone else would be spending a whole lot more. We couldn't simply reduce our defense spending to something comparable without significant consequences.
> How much of the cost savings for universal health care is a result of saying no to procedures?
My personal opinion is that we should absolutely say no to a lot of scenarios when it comes to single payer. That and we should absolutely stop providing care in the worst cases if there is a strong likelihood that the patient will not make it out alive. We spend way too much in the last six months of a patient's life holding on to every last bit of hope grasping to keep their heart beating. I've heard doctors express frustration about this as well.
> In other words, in an American military spending blackout, the game would change and everyone else would be spending a whole lot more. We couldn't simply reduce our defense spending to something comparable without significant consequences.
Consequences for us too. We have to keep spending to maintain the status quo.
I mean I get that there are certain common goal costs that we contribute perhaps a little more than our tab but it isn't nice to point it out like this. At the end of the day, we aren't spending on our military prowess to be charitable. I'm not an expert so it is likely that some cost saving would be possible. I'd welcome efforts to do that.
With medicine, I think a single payer should be able to negotiate with manufacturers and suppliers to keep costs low.
We have to rethink end of life care for humans. I'm very willing to sign a medical release form that says pull the plugs if my treatment will cost over $10M regardless of who pays for it.
But that's a different topic. This current issue with epippen is a simple issue of rent seeking. There is no way anyone could side with the company of this one. I hope that the spotlight means their efforts will fail.
Are you suggesting we spend more than we can get away with hoping the slimeball companies will reinvest their profits into R&D?
>My personal opinion is that we should absolutely say no
We don't disagree that there's a problem: medically fighting to the last breath should be replaced by gracefully accepting the end at the appropriate time (for both cost reasons and for the quality of life at the end for the patient, etc.)
We do disagree on how. If you want to make progress on that front we should have education and cultural growth around accepting death and doing what's best at the end for doctors, patients, and families. We shouldn't have a bureaucrat forcing the decision on anyone.
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>This current issue with epipen is a simple issue of rent seeking
It's not an issue of rent seeking specifically, but abusing government granted monopolies (patent protection, trademark protection, forcing schools to buy, etc)
> Are you suggesting we spend more than we can get away with hoping the slimeball companies will reinvest their profits into R&D?
No, the high cost of R&D and slimeball behavior are often intermixed, but separate issues. I'm suggesting that a whole lot of the money for expensive drugs is actually going towards R&D. Lots of foreign countries are getting steep discounts and not paying equal shares because the drug companies are taking the path of least resistance. They can get funded in America more easily so they don't fight as much in places that are more difficult to win.
America couldn't magically get the foreign prices because the R&D money wouldn't appear from anywhere else. America's prices go down but the rest of the world's prices go up to meet in the middle ... or a lot less drug research happens (or a bit of both)
There are lots of things happening, and a lot of the problems are due to lacking regulation. What can get patented and for how long is wrong; more research should be publicly funded with stipulations that the results are free to society; drug approval mechanisms need to be more efficient; some barriers between national drug markets need to be broken down (you should be able to sell across borders between economically equal nations)
There are a lot of things which could lead to a healthier medical environment which aren't being done. We've got some small reforms out of the way, but there are still huge inefficiencies.
If you're scared about being told "no", don't be - you're more than welcome to purchase additional private insurance in a single-payer system to cover whatever you want. It's not a particularly uncommon job perk in the UK.
Our single-payer system covers a pile of things that low-end insurance often doesn't in the US as it is, so most people are happy with it.
I don't think we can generalize from Wikipedia lists for complex issues when the lists contain very diverse countries. I have spent some time in Europe and in India. I have a couple of chronic conditions that requires daily medications. One of those conditions have generics available worldwide, the other one does not. My medication costed 5 times my montly European insurance premium in Europe. In India, insurance providers don't cover much beyond hospitalization and cancer. In India, the same non-generic medicine used to cost me about half of my European insurance cost, but I had to foot the bill myself. Now, there are generics of that available here, and I pay about one fifth of my European insurance premium for a month's worth of medication. I have to pay for doctors' visits off-pocket too, and the specialists I visit charge me about 3€ per visit. If I visit a local GP, they'd charge me about 1.5€ per visit. I pay for tests out-of-pocket too, but most of them cost in the range of single-euro-digit per test. Sorry about being vague, I don't want to give away too much about myself.
Looking at per capita healthcare costs in India would be pointless, as the vast majority of people go without proper healthcare.
No, the US healthcare is in serious trouble. My point was about a line of approach for the problem. In fact, India can give a few good pointers here, which you can see from how little I pay for my own, rather excellent, healthcare.
Indian healthcare has its own can of worms, but since we are not talking about that, I won't open it.
I think the problem is that the US healthcare system is a perfectly miscalibrated non-free market coupled with aggressive corporations pursuing unrealistic profit margins and hyper-growth, coupled with corporatism in government, coupled with a poorly design public system, employer-provided health insurance, and a general lack of information about real costs.
What you're talking about is a monopsony and those are bad too. They undermine investment in a market because market participants can't get a normal ROI.
What you're missing is that those countries can (and do) use market mechanisms.
I have direct experience with the French system, so I'll use that as an example. When you go to the doctor for an outpatient visit, you pay the whole bill right then and there. Your insurance company will then reimburse you for some significant percentage of the "reasonable and customary" cost of that visit. Do you need a shot as part of that visit? Guess what -- you have to go next door to the pharmacist and buy the dose. The doctor will then administer it.
Inpatient is different (fully covered and no billing) and indigent patients are given a special card that directs the doctor to bill insurance directly.
We could do that here in the US without universal health care and it would make a significant dent in our spend without a corresponding decrease in outcomes.
People vote with their wallets (and their feet) on matters of life and death all the time. People choose what car they buy (with crash ratings and cost being significant factors), what dentist they go to (in places where they pay for dental), and many (but not all) Canadians choose to pay for medical care to avoid long waits. People also choose what neighborhood they live in (both safety and pollution are significant concerns), what job they do, how much to spend on food, what airplane to fly on (, the DC-10 was doomed by its safety record), and any number of other health-critical, financial decisions.
I thought it was obvious, but I'm sure OP meant that if you have an accident, you can't shop for providers - an ambulance or a helicopter takes you to a hospital, and you wake up with a gigantic bill. Not exactly "voting with your wallet", is it?
Perhaps there is some misunderstanding, but that (parent to my comment) was responding to a comment which indicated that there is too much government intervention, which is not allowing people to feel the direct financial impact of their medical decisions. People using epipens are not buying them 'just-in-time', they are planning ahead.
The great grandparent comment also seemed to be speaking to the way the government has incentivized employer-provided health insurance, which insulates people from making cost/benefit decisions. I think that if individuals had to pay $100 per juice box their insurer gets billed, they would likely find a way to cut costs.
Wait, how is the state trying to achieve "free healthcare" in the US? .... or is your comment not about the US?
If it's in regards to Obamacare, that's pretty recent compared to the trend of the medical lobbying getting one over on Americans... and definitely not "free healthcare" by really any measure.
Voting with your wallet is very short sighted. Some examples:
A manager replaces free coffee in the office with a paid vending machine to save expenses. Moral goes down. Production goes down.
A team member is fired because she has the worst production level of the team. What they did not know is that this team member was holding the team together.
So there are a lot of side effects to every decision. And therefore I think voting with your wallet is a bad idea.
A manager sees that workers work better when well caffeinated, but that they are sucking up time with starbucks runs. So she installs a Keurig machine, an investment that saves money and time in the long run.
Voting with your wallet is short-sighted if you are short-sighted.
Alternatively, we might have a manager who buys a coffee machine to give the employees free coffee, as the former sees the latter will be happier and more productive for a low price; this the manager buys productivity cheaply.
That's not even what "voting with your wallet" means. It has nothing to do with saving costs. It's about depriving an organization/person of money to stop supporting them.
For example, you might choose a higher airfare with a carrier that has better customer service than the cheapest. This is voting with your wallet and it has nothing to do with cutting costs.
By American ideology I meant that everyone can become anything they want if only they work hard. Everyone can be a hero and defy their fate. Therefore if someone is in need, it's their fault for not working hard enough. If they don't have the money to afford medicine, then they don't deserve it, end of story.
And additionally, a gut-level fear of government and way too much trust in corporations.
Alan Watts mentions somewhere that USSR was essentially a single corporation (can this be said of China ?) - a disgrace to human creativity. Killing of competition using Gov. regulation and red-tape is not much different in function.
This is why the US is where it is. Anything pointing towards any social programs - something that benefits not only you but also your neighbor - gets shot down using the Red Scare.
Europe's social welfare programs, universal healthcare and free education don't make these countries "socialist" or "communist". These countries are still capitalist market economies with a few critical aspects about people's livelihood regulated for accessibility.
As long as the response to these ideas is always "but that's communism", it won't ever improve.
>This is why the US is where it is. Anything pointing towards any social programs - something that benefits not only you but also your neighbor - gets shot down using the Red Scare.
This is why the US has one of the smallest militaries, the smallest public road system, unsafe aviation due to no air traffic control, no public schools for children, and unsubsidized farming and food purchases. /s
I know you're just using it as an off-hand metaphor but fire is actually one of the most useful tools in preventing and fighting large fires (e.g. forest fires).
> But liberals will blame capitalism anyway, not government.
The "no true capitalism" of the libertarians ? Communists also claim USSR was "no true communism". A doctrine or ideology is never "pure" or "perfect" in practice since men aren't.
The only difference being that places with more liberty are more prosperous, and places with more socialism are less prosperous. There doesn't seem to be an optimal 'middle-ground'.
Socialism isn't the answer. In fact over government caused the epipen debacle by reducing competition. If an epipen costs $5 to produce, competition means that the price would eventually approach $5 -- it would commoditize it. Doing things like price caps only result in shortages: see Venezuela's economy for a case study.
Look at the FDA process: you reform that and drug costs will decrease dramatically.
What would be better would be FRAND-style licensing requirements on prescription medications and the application of patents on medical devices.
Beyond this would be a requirement of two sources for ALL medical prescriptions and devices in order to sell them in the U.S. (or whatever country you, the reader, are in).
This would ensure at least competition, even though there's still greed there can be momentum for competition.
Hope I'm not out of line helping you out with this, but laudable probably doesn't mean what you think it does, unless you wanted to praise Mylan's greed? But that didn't seem like something you wanted to do.
Hope I'm not out of line helping you out with this, but laudable probably doesn't mean what you think it does, unless you wanted to praise Mylan's greed? But that didn't seem like something you wanted to do.
411 comments
[ 1.8 ms ] story [ 290 ms ] threadEdit: something is very wrong in the HN community, when I get downvoted for making an intelligent and thought-out point.
I'm always disappointed at the lack of discourse here and pure emotion-based reactions to comments.
Yes, there are a lot of heavy, potentially onerous requirements to releasing a drug. Sometimes these requirements result in drugs taking a long time to be publicly available. But the goal of this process is public safety, not making a quick buck.
How do you prove a new product from a hostile industry safe, without having regulations covering the types of tests and acceptable reporting necessary?
There is certainly evidence that since regulatory bodies get tons of flack for letting through bad drugs, but aren't imposed on that much for slowing down the process, they incline to being risk adverse. We also have evidence of outcomes in Europe where the regulatory regimes differ and seem to approve things faster with outcomes that aren't generally worse than the US.
I highly doubt we have the optimal regulatory solution at present and could do much better. And if anything we have standards that are too high.
The current solution seems to be to increase the barrier until the bad actors are gone; as this means there is less finger pointing.
Going the other way would seem to take active effort from a political representative, and the outcome will end in deaths directly attributable to them.... which would be career suicide.
This means that they are incentivized to be cautious, sometimes excessively so.
Many countries with cheap drugs never had to pay all of the research and development costs.
If it's not government greed, it's government ineptness and the inability to understand how the market actually works.
The generic company in this article, for instance, never had to pay any R&D costs for the proprietary epipen applicator and can easily charge a much lower amount of money for a generic version (which is different).
The high cost of FDA approval also creates monopolies, because it's very difficult to get anything to market. To get better and cheaper drugs, we need to change this at the government level.
http://blogs.plos.org/workinprogress/2012/01/25/how-much-mon...
It's still all medical grade parts isn't it?
The premise is that $57 was the old price. and they bumped it up to $318.
And a DIY group can pull it off for $30, without economy of scale.
From wikipedia "In 2007 when Mylan acquired the rights to market the product, annual sales of all epinephrine autoinjectors were about $200M and EpiPen had around 90% of the market; in 2015 the market size was around $1.5B and Mylan still had about 90% of the market"... $1.5B annually... So if FDA testing costs them $10,000,000 anually, thats still less than 1% of their revenue.
That means that with economy of scale, and dispersing the cost of testing over several million sales, they could easily produce a product for $30. But they don't because they dont really care about saving lives, they care about getting paid. They would prefer people die than them make less money.
Completely not about "hey do it this cheap easier way" but "heres the rock solid proof that a $300 (even $60) EpiPen is stupid"
As a consumer I could see this for $75 - $100 retail (and some discount to institutional buyers) but $30 is probably not viable and of course $300 is ridiculous.
If you are low volume, you're gonna have to sell at $8 - $10 to make something worthwhile.
Now, I get it, they are unquestionably overcharging for this drug and delivery system. I just don't think you can say that since I can make something at the rock bottom price of $x that someone else should be able to make a living (or run a pharma corp.) by selling at a similar price. The sweet spot is somewhere between $30 and $300, where it is is probably closer to $100.
A soda machine is basically free money because syrup and water cost pennies. The cup is the most expensive thing you give to the customer for his $1.99 soda.
Anyway, my main point was that ingredient cost is only one part of the cost of making/delivering something.
IIRC, restaurants aim for foodstuffs to amount to 30% or less of sales to be viable.
If significant competition existed, epipens would cost very close to $30 or however much they cost to make. There are many viable businesses operating at low margins.
They (including epipens) probably cost about $10 to make. That's total cost, from production to delivery to the retail outlet. They would have been handsomely profitable at the old price of $57.
They cost $35 to the NHS in the UK.
If healthcare is public service then profitability is not a primary concern. Data-driven decisions shows that approaching healthcare as a public service is much more effective.
The choice here is rather obvious, yet for some reason, average people who would benefit immensely from a public health system in the US seems to disregard it as socialist, paying for someone else and so forth.
Please note that drug corporations are insanely lucrative in Europe too, so a public health care system doesn't seem to harm drug companies all that much, financially speaking.
IMO you need to give the drug companies enough money to cover their operating expenses and R&D costs and give some margin to stay afloat. But not more than that. It's hard to do because this aspect is one that is handled well by free market - but in healthcare, you very much care about the thing free market utterly sucks at - product quality. You need regulation to ensure the product is good enough, and many of the important criteria are not immediately verifiable by the customer at the point of sale. Trying to reconcile those two issues is the hard problem.
That said, it looks like this is just reusing an existing off-the-shelf autoinjector used for insulin. If it fails, you could remove the needle and inject manually. The biggest risks I see here is making sure the epinephrine stays sterile, and that the dosage is correct. (To be clear: Either of these could have serious consequences.)
The not-so-grey ethical issue is the cost of these devices, and the fact that there are people who are too poor (medicare doesn't cover them, according to the article) to get them. Until we build a system that prevents this unjust situation, it is my opinion that there is nothing questionable about this 'hack'.
That said, USG may be too beholden to Big Pharma at this point for anything to be done.
Costs should cover R&D but this is outright greed and in an industry where it's literally peoples lives at stake it can't be allowed to continue.
http://www.bloomberg.com/politics/articles/2016-08-24/the-se... https://www.theguardian.com/business/2016/aug/24/epipen-ceo-...
So? Is she just not supposed to work?
You are basically saying that she needs to be kept below a glass ceiling because of who her father is.
The point is, it isn't all black and white. If a kid has a severe allergy, sure, make sure you have a real EpiPen and carry it with you always. For those borderline cases, well, something like this might be fine. Having it reduces a really small risk even more.
Another interesting point: even if a kid has a severe food allergy, they are still more likely to die from a car accident than from an allergic reaction. Some people lose perspective.
http://well.blogs.nytimes.com/2013/12/06/food-allergies-less...
http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...
(So all you have to do is convince your doctor to write Adrenaclick on your prescription and you can buy the generic for $145 at Walmart)
That price is interesting because it puts some kind of cap on the amount that regulation is leading to the price increase for Epipens. The regulation about substituting Adrenaclick on a prescription for Epipen can be argued, but any doctor that won't write Adrenaclick after a minute of discussion better have a good reason.
Also: screw mylan
Now granted Shkreli is a controversial figure, but basically drug companies are businesses, and if you sort of detach yourself and look from a business perspective and value-based pricing, Epipen competes with the ER, and $600 is a bargain vs an ER visit.
And of course his ultimate conclusion is that maybe life saving drugs are more like water and power than cell phones and wine? Maybe the government should get involved in making generic drugs available.
Mrs. Bresch justified the increase of cost on the Epipen.
(Just making a note so that there is no confusion over who is responsible)
At least according to my last first aid course in Australia. At best you skip needing an ambulance
Using all of the other costs and aspects of an ER visit to justify a price increase of Epipens feels dishonest; I do realize that ERs are largely being misused in the US as general health care, but the E is supposed to be for emergency, and the cost comes from the support required to adequately respond to emergency situations.
Given that I was under the impression that if you have a situation where you need an epipen you're supposed to seek medical care anyways [1], I'm not sure how this reasoning of "it lowers costs" really plays out, since it seems to me like it's just hiking up the price of an already bad situation. I don't see this as particularly beneficial to anyone other than the sellers of epipens.
[1] I must note, my only reference to this is my own fractured knowledge from when I had a friend that required an epipen and reading the instructions for administration. This was a long time ago though and I don't particularly trust my own memory.
This is exploitation of inelastic demand (death is a pretty high priced alternative to $600), and it's pretty clear that's exactly what government regulations and market controls are supposed to protect against.
Someone else in the comment section shared another perspective which reaches the opposite conclusion: that these regulations have created the problems in the first place, and the government should not touch this sector at all: http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...
The outrageous price of EpiPens is not a result of corporate greed so much as a failure of the FDA and Congress - but mostly Congress, the FDA is their subordinate. They failed to promogulate rules that maintained a competitive market for epinephrin auto injectors.
The cost is in the patented injector, the drug itself is cheap. Others have tried to market similar injectors, which didn't work as well as the Epipen.
As cost slowly rose, insurance paid for it, and parents didn't notice it as it was hidden in rising insurance premiums. Then deductibles skyrocketed, and suddenly insurance wasn't covering it all; parents had to pay the balance, or all of it.
If you didn't have insurance, you already watched it go up as it happened.
Finally the cost was raised arbitrarily, to cover the company's coming losses as their patent on the delivery system will expire. This, I've read recently, is common: a spike in price before generics take over.
The traffic bears this price, because parents don't want their kids to die from accidental exposure to peanuts and other allergens.
I bet their cheaper "generic" packaged version will see limited production to force supply shortages and drive people back to the overpriced pens.
I think you have a very liberal definition of "slowly."
http://www.cnbc.com/2016/08/23/this-chart-shows-you-why-a-lo...
Nobody has to buy an auto injector. Diabetics draw insulin from a vile and inject themselves all the time, those with severe allergies can keep viles and needles too. I buy EpiPens because I don't want to do that. And before Avi-Q was recalled, I bought those instead, even though my costs were twice as high, because I liked them better.
You can say that capitalism is the wrong way to produce drugs, in which case its Congress' fault for not instituting a different way. Or you can say this is a failure of the regulated drug market to produce a result in the public interest, in which case its Congress' fault for not regulating the market differently - thats what I believe. If you're arguing that this is a moral failure of the Mylan stockholders… well I think thats a hard position to take, and no matter what demonstrating that auto injectors aren't expensive to build doesn't really try to make that argument.
Your point about handling the injections the old fashioned way is a good one as well. But it's worth noting that diabetics have tons of experience self-injecting using standard needles and vials. A typical Epipen user has probably never had to do so, and when the drug is urgently needed is a bad time to get started. So for these users it's not simply a matter of convenience.
> Four Thieves Vinegar have created and uploaded the plans for the simple version, called the Epipencil. Also spring loaded, the parts are gathered over the counter. The epinephrine will still need to be acquired with a prescription.
This still involves an FDA-approved drug obtained through normal channels; the DIY part is the injector.
Creating DIY medical drugs would certainly be something to be concerned about, but I don't see the problem with DIY medical tools.
A lot of thought goes into achieving dosage that is reliably correct and consistent between applications, not to mention when applied by non-pros.
Not to say that I know whether this design achieves this, but administering the drug properly seems almost as important as the drug itself.
And you don't f with severe allergic reactions.
The FDA does see a problem, though, which is why other companies have had a huge amount of difficulty trying to bring competitors to the epipen to market (in the US).
That stuff does go through FDA approval in the US, right? It's not all for nothing.
Funny enough, these devices don't need FDA approval, since they aren't medical devices, and the operators don't need to know anything about radiation effects on Humans...
http://www.fda.gov/Radiation-EmittingProducts/RadiationEmitt...
Everyone, that is, but law enforcement.
Thanks, FDA. Good job.
"A person would have to be screened more than a thousand times in one year in order to exceed the annual radiation dose limit"
some aspects of regulation protects monopolies, increases burdens on businesses trying to sell life-saving products, self-justifies bureaucracy and adds cost and delay. Other aspects of regulation prevents unsafe, scam and inferior products from endangering public safety. Both positives and negatives, to varying degrees, are in play simultaneously, given a particular product or issue. We need the FDA to not be lap-dogs of industry, not block dying cancer patients from trying almost any experimental, unapproved protocols and not taking forever to approve revolutionary therapies.
To modify James Madison's quote: "If everyone were angels, no government regulation would be needed and libertarianism would be as practical of an utopian system as communism."
It's balanced, expedient and effective regulation that is the primary duty of medical regulators.
The rest of us can then enjoy greater safety of pharmaceuticals and medical equipment without setting up such an expensive regulatory system.
The auto-injector apparatus is not regulated because it is dangerous; it is regulated because a failure to operate would be dangerous. It is regulated for reliability.
The hacker/maker ethos is awesome and drives a lot of innovation in our society, but sometimes there is also a need for careful engineering and rigorous testing.
I've got a heart issue going on and I've had some fascinating results from capturing my heart rate on a consumer grade chest band monitor, then uploading it to influxdb and viewing it with grafana. Total outlay a couple of hundred bucks. Invaluable to me in tracking what's going on with my heart.
Yet that whole stack would never be approved by... Anyone!
What is the cross section of america can carefully construct a DYI Epi-Pen, but can't afford the actual Epi-Pen?
If you think 90% is a better target than 100% for overall public health, well, fine, that's a classic kind of public health policy argument. But without a regulatory system of some kind, you won't know what the actual number is for a given product.
EDIT to add: I'm not arguing that DIY auto-injectors should be illegal to build in general. I'm in favor of people having the freedom to experiment with their own care if they want to.
I am arguing that DIY is not an adequate substitute for the general public unless the actual risks are well understood.
I'm just saying it's better than nothing.
Think of it as the best that can be achieved within a broken and unchangeable system.
One is the "Adrenaclick," which is another epinephrine autoinjector that (and this is key) must be specifically prescribed. You can't take an EpiPen prescription and ask for an Adrenaclick, your doctor has to specifically prescribe Adrenaclick. But right now it's a lot cheaper. A friend just switched and his copay went from $200 for EpiPen to $8 for Adrenaclick.
The other is to buy a bottle of epinephrine and use syringes, or buy pre-filled epinephrine syringes. Again, a doctor must specifically prescribe this, but it's a lot cheaper than EpiPen. More complicated to self-administer in an emergency, though--but better than nothing, especially for 3rd parties with access to training, like wilderness guides, teachers, etc.
(search for Adamis)
What's unlikely is that a DIY production scheme can ensure consistent manufacturing quality, since the careful, rigorous hackers are not going to be making this for everyone.
> It is regulated for reliability.
Then why aren't the tests and methods of testing reliability required to be published?
> it is regulated because a failure to operate would be dangerous
The risk of not having it at all far outweighs the risk of the injector failing.
Not to mention that regulated injectors fail too due to manufacturing defects.
> sometimes there is also a need for careful engineering and rigorous testing.
But should that need preclude private individuals from assembling their own life saving devices on a small scale (1-10 units)? We're not talking about someone else stealing your design, process, research, and building their own production line here.
Furthermore, careful engineering and rigorous testing is needed when you're creating a production line of these things. A competent individual can assess and test their own device. Yes, it's more time consuming, but for something as essential as a life saving drug, it's probably worth the extra time.
There was a non-EpiPen epinephrine injector on the market in the US up until last year, the Auvi-Q by Sanofi, that was taken off the market because there were problems getting accurate and consistent dosing.
Sanofi is the fifth largest pharmaceutical company measured by prescription drug sales. They have annual revenue of $37 billion, and 112000 employees.
The fact that Sanofi was not able to get the mechanical aspects of this thing right leads me to suspect that these kind of things are not as easy to make as it might at first seem.
> A 1mL vial of epinephrine costs about $2.50... Doses range from 0.01mL for babies, to 0.1mL for children, to 0.3mL for adults.
In other words, if your doctor will give you a prescription for the drug itself, you could assemble three epipen equivalents for less than $100.
[1] https://smile.amazon.com/AJ-1311-Autoject-Injection-Removabl...
Can we please give blame where it's due? http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...
You can also look at Mylan offering $300 coupons to consumers to get them to utilize their insurance. Maybe they are just incredibly generous, but it's more likely that they are happy to net the $300 from the insurance (in other words, they profit at $300).
Because the FDA is killing off any competitors. Did you read the link?
Feel free to complain about the substitution rules surrounding Epipen prescriptions, but it's clearly a competitor in the sense you invoke with killing off any competitors. It's the same dose of the same drug intended for use in the same situations.
That means the epinephrine (adrenalin) itself is essentially free. What do they charge in the US/Europe/Australia?
(Edit reply to a3n below: My point was that it's not as dangerous as you are making out, not emotional appeals and cultural norms for responsible parenting. Self-administration: good enough for 3 billion+ in China/India/other developing world locations, good enough for me. The whole idea of stabbing yourself with a fat dose of adrenaline is pretty hackish anyway and shows how undeveloped our medical knowledge still is.)
The idea behind the auto injectors is accuracy with relatively little training and skill; a parent can do it while they're watching their kid strangle. That's why you buy an auto injector instead of syringes.
Competing auto injectors have not been as accurate and simple to use, is what I've read.
I would not trust my kid's life to a hacker injector; these are medical devices that are required to go through trials. Even traditional syringes are regulated. Sure, maybe you can decide to use an unregulated injector; I wouldn't, not for my kid.
The hack is putting in your own needle + medicine.
Also legally EpiPen must be fulfilled by a brandname version instead of alternatives, and alternatives are scarce due to the difficulty of passing regulatory approval: http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...
The main problem is that, if you're carrying around EpiPens for allergic anaphylaxis, particularly for a child, dealing with syringes and bottles isn't really a practical solution for day-to-day living (and definitely not an option if you're carrying them around for yourself -- hard to carry out delicate medical procedures while being unable to breathe). There are probably a lot of people without access to autoinjectors who have had to suffer the consequences of anaphylactic shock.
That means for an average human, LD50 = ~10 x 70 = 700mg... or perhaps more for typically overweight Americans.
Conclusion: Scare factor is being used to justify the market... you have been had.
"Mylan's efforts to maintain its market dominance were aided when Sanofi's competing product was recalled in November 2015 and further when Teva's generic competitor was rejected by the FDA in March 2016.[76]"
http://www.fiercepharma.com/sales-and-marketing/fda-swats-do...
Yes, you can load a precise dose into a device, but the device has to actually work, reliably and consistently. This is apparently a hard problem, for at least two Epipen competitors. Since Epipen has no serious competitors for a device like this, they get to charge as much as they dare.
They get to charge as much as the market will bare.
The precise and reliable dosing mechanism is out of patent.
Companies exist to make a profit, why are we getting upset when they do so within the confines of law? Here, the law allows for lobbying and high regulatory burden which creates a monopoly for EpiPen.
I don't expect public shaming to reduce corporations from seeking profit. I do have great hopes for reforming laws to incentivize competition so that the desire for profit benefits us all.
That said, the more downward pressure from competitors (commercial or nonprofit projects), the better for customers; especially where a monopoly existed, it's rational to for customers to band together and attack excessive hegemony.
Enteprising folks need to jump on this to sell this as a kit (w/ or w/o the medication).
Unfortunately, that's a real great way to get shut down by the FDA. Medical devices are after all subject to regulation. Others have tried making their own epipens too, but they all keep running into the slow approval process and unfavorable laws protecting Epipen: http://www.washingtonexaminer.com/fda-partly-to-blame-in-epi...
Also as we know from value based pricing, things aren't priced based on unit costs (otherwise all software should be essentially free, and the software industry is the greediest industry on earth), but rather what customers will pay. And when there are no alternatives, you get to set the price.
It may be a better Idea to look into a syringe+vial combination on hand, prescribed by a doctor. Less convenient, and you need to learn how to use it (and preferably teach those close to you), but this may be a whole lot safer. The downside of course is the problem of self-administration when in anaphylactic shock.
I've been manufacturing products for thirty years. It's never simple for good products, not even a cup of coffee at Starbucks.
I'm sure this is an interesting article but the only way we will stop this practice is if we stop giving user-hostile publications our eyeballs.
https://www.facebook.com/barbara.k.hollinger/posts/128523673...
The problem is not with the "greedy corporations", but with the poorly dedigned legislation regarding intellectual property rights.
The state created the protectionist environment in which companies can become bullies and be sure that they won't be exposed to any economic competition.
Of course, the complete lack of IP laws would deter companies from investing in research, but the same effect have too strong IP laws. Why would a company risk their money and do research once they found a cash cow which can be milked for a long time, having the state guarantee it?
Ah, so let's all just stay in line until we fix patent law. That'll work out!
The problem here is some cheap guys risking the lives of thousands of people to make a few bucks. You say it was inevitable that a company would take advantage of this cash cow; I say it was inevitable someone was going to route around this cash cow.
I also feel like no one in this comment section has taken a first aid course before. Anyone who has spent time around some epipens would start questioning the price. The thing itself does not have to be a super precise device.
Meanwhile administering epinephrine is not a big deal. Really, any idiot can administer epinephrine, and probably do about as well as people do with epipens. I would personally recommend most people who need it keep a vial and some syringes around if they need to administer it to their kid, and an epipen only for the convenience of the form factor and only if they really need it. Most of the time you can get away with benadryl.
So, hack away, cheap guys. You'll likely help a few, help a few others discover they can get away with a super cheap vial, and demonstrate to quite a few more that the prices currently listed are ludicrous.
You say "Cheap guys".. A growing number of people cannot afford an EpiPen. What are they supposed to do? Just die when they have a reaction?
I agree that this solution is not ideal and is probably prone to error or failure. For a lot of people who no longer have the means to purchase an EpiPen it looks like a solution that could save lives.
It's not poorly designed. It's designed very carefully and very well for the purposes of those who bought the legislation.
how do you think this effort puts thousands of people at risk?
if you download the instruction packet(o) it comes with a Links.txt file that has a link to an instructions video.. which at the time of writing this comment can be found at: https://www.youtube.com/watch?v=ldFFJRdhVs8 ; i suggest you watch it
all of the components are 'off the shelf' and the drugs are prescription
from this(i) ~random site epinephrine costs 74.95$ for 30mL, the instructions call for .3mL, that is 100 uses from this 75$ vial, or 75 cents of epineprhine per epipencil
when i read the article i thought this was a great effort that could save the lives of anyone who was unable to bare the new price of the epipen, but now i am wondering what from the epipen warrants the price tag? can a loved one even sue epipen if it malfunctions and kills the intended user?
(o) https://fourthievesvinegar.org/download/#epipencil
(i) http://www.buyemp.com/product/epinephrine-vial
IANAMD, but I suppose air bubbles in the injector could cause problems (?)
A very large bubble can kill you, but you need to put some serious effort [1].
[1] http://www.straightdope.com/columns/read/2866/can-air-inject...
in emergencies you are stressed and on a time constraint
if one takes the time to prepare for such an emergency by constructing the epipencil i would hope thae would follow the instructions given carefully, which notes:
7) Inspect carefully to make sure there are no air bubbles, and remove them if present.
i sent them an email requesting that they explicitly describe in the instructions and verbally describe in the video how to ensure the syringe is bubble free
Mylan is a really great user of buying legislation. They leveraged their 90% market ownership of the epinephrine auto-injector market such that
[1] It lobbied hard to ensure that all parents of school going kids (or tax payers) paid for EpiPens by making it into a bill that politicians could easily justify.
Once the bill passed and schools all over the country purchased these by the boatloads, then they just kept raising the price over and over and milking the profits.
When it got too much and they could not ignore the patient backlash they have turned again to purchasing legislation..
[2] Now they want to make it so that the patients do not see the copays - instead every one suffers by paying more for health insurance.
[1] https://www.opensecrets.org/lobby/billsum.php?id=hr2094-113
[2] http://www.nytimes.com/2016/09/16/business/epipen-maker-myla...
With scumbags like these, is it any wonder that the USA has the most expensive healthcare system in the world?
When people don't have to pay for something straight from their pocket, they're not feeling the ripoff so strongly, so they don't revolt.
That's why I personally think that the systems where people vote with their wallets are much more efficient.
Sources: lots of research I could link to but don't have handy and, with great dismay/frustration, I've spent a decade analyzing the root causes of US healthcare spend.
Monopolies can dictate terms, which is why monopolistic companies are regulated. But if that monopoly is the state, then it actually works in the citizens favour if the monopoly presses down costs.
Also, it's important to distinguish between true R&D aimed at developing actual cures and iterative R&D aimed at developing medicine that will get you hooked on long-term courses that maximise profits.
As far as I understand it, yes. http://www.xconomy.com/seattle/2014/09/02/which-countries-ex...
As far as your claim about most drugs being a scam, I can't speak to that as I'm not familiar enough with the industry.
Uh, that's precisely the point of regulatory capture. Ensure nobody else can compete but you.
Beyond the pharmaceuticals, is that the most expensive healthcare services are provided by hospitals that are mostly locked in by proximity.
http://www.bizjournals.com/triangle/news/2016/07/19/where-gs...
Yes, assuming the monopoly actually wants to keep its costs low. In the US, corporate-funded legislators made it so that Medicare is not allowed to negotiate drug prices. It willy-nilly pays whatever the private drug companies prices its drugs at.[1]
This is why it's so profitable for companies to "purchase legislation". The return on investment is 10x or something insanely high, like in this case. Spend $10 million "donating" to the campaigns of a few unconscientious politicians, and soon you are milking an extra $100 million in profits from unwitting taxpayers.
[1] http://healthaffairs.org/blog/2016/09/19/the-politics-of-med...
Transparency could strip off lobbying. If we know who gets what money, and we know how people vote, a bit of clustering etc ought reveal patterns...
What's needed is something gimmicky that gets popular appeal and covered on mainstream media for fifteen minute fame...
E.g. an iphone app that you point at the live news on your TV and it OCRs the senator's name and queries opensecrets.org or something bigger and better and tells you how much money they got, from whom, and how this correlates with their voting record etc.
Something that makes politicians accepting money very counterproductive.
They realize that if they only cover marginal cost, and don't allow for development, they will only get the right product for a limited amount of time.
What often happens is that they agree on a more realistic price that will allow for that.
In many cases the company will go low to still be the supplier for a whole country - especially as they can still keep their margins in other countries, like US.
I'd compare it to a 'tragedy of the commons' scenario where one farmer keeps paying his son to re-turf the meadow, so the boy can have a job (and thereby feeds everyone else's sheep).
They can set up non-profit-driven suppliers, but it seems probable that normal for-profit suppliers will flourish.
I agree that the 'internationals' who control domestic drug consumption have little incentive to set up their own drug production systems, but if my supposition is correct, they need the US to keep paying higher prices for the same drugs.
http://www.bizjournals.com/triangle/news/2016/07/19/where-gs...
The government is responsible for using a fair price, both for itself and the supplier.
His non-profit nature ensure that it will not try to lower the price too far.
If a politician is dumb enough to make companies go bankrupt, it's the responsibility of the people to vote him out of office.
That's the only way to have a fair price on drugs. A free market cannot exist in these industries and the inelasticity of the demand will always, always distort the prices.
Yes, America will have to face its demons and trust its government. The alternative is to continue paying exhorbitant prices to greedy scumbags and let fellow citizens die as a result.
In this scenario, consumers drive the prices too low and put suppliers out of business. It's the same argument coming from the other direction.
Markets don't seem to work like that. Prices get driven down, but not to the point where suppliers go out of business, because they won't sell at that price. Sometimes if margins are too low new players will find efficiencies or new inventions that allows them more profit for awhile.
For this to happen you need a balance of power between buyer and seller. It's obvious to me that such a balance is radically absent in the US system right now.
Putting governments into the role of buyers is not anti-market - it's pro market because it allows an informed, more powerful buyer that balances the market forces and allows the market to work. (It's certainly possible that other entities, such as insurance companies, could fill the same role.)
A worry comes because of the label "single buyer" which is the inverse of a monopoly and is anti-market. But in practice drug companies are global and there are many governments.
All this would lead to much lower profits for drug companies, of course, but that's not a pro-market argument, that's a pro-monopoly concern.
I don't think I have heard such an argument, and I understand the parent comment just fine.
What he means is that, since pharmaceutical and medical supplies companies have large upfront research costs coupled with negligible marginal costs, they face a falling average-cost curve. However, a firm operating under competition has it output at the point where marginal and average costs are equal. The point is that for a firm who profits off research, reaching this point is unfeasible. What all this economic gobbledygook is that, in order to survive, firms have to charge above what would be otherwise the "warranted" price (like the price of the components and labor that go into a kit).
This is more obvious in the case of software, since the cost of copying any piece of software is pretty much zero, anyone trying to sell it for it's marginal price won't ever get what he put in by having written it in the first place. In such markets the socially efficient outcome, the one which makes both consumer and producer better off, is actually to have a single or few firms regulated firms operating under imperfect competition. And all this happens because of the cost structure of the firms, not because of the market itself.
Though I'm rather skeptic that pressing on the suppliers will push them near their marginal costs in this particular case.
https://en.wikipedia.org/wiki/Cost_curve
Deadweight losses are a joke, if the sole buyer buys too much, they are at a loss. It just does not happen in this sector.
In concrete terms, this means something like "the price of a doctors visit is low enough that a nearby clinic closes down. Even though you were happy to pay the higher price for the convenience, and they were happy to provide service at that price, we no longer get to have that experience."
Insisting that moving to a single-payer system is the only solution is very one-dimensional thinking.
It can also be said that drug companies use Americans to make their profits and sell to other countries for the best they can get, we could well be paying for an unfair portion of the "real" cost and other countries are only doing better because we're paying the bill.
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I'll switch to talking about something entirely different to expand on the last point. You'll often see people arguing about how the US has the highest military budget, higher than the next N countries combined.
The thing is, we're providing security for those next N countries, and the world as a whole. Many of those N countries are NATO allies who would have to spend a whole lot more if the US didn't. And also by making real war outside regional and civil conflicts impossible for the whole world with military dominance.
In other words, in an American military spending blackout, the game would change and everyone else would be spending a whole lot more. We couldn't simply reduce our defense spending to something comparable without significant consequences.
My personal opinion is that we should absolutely say no to a lot of scenarios when it comes to single payer. That and we should absolutely stop providing care in the worst cases if there is a strong likelihood that the patient will not make it out alive. We spend way too much in the last six months of a patient's life holding on to every last bit of hope grasping to keep their heart beating. I've heard doctors express frustration about this as well.
> In other words, in an American military spending blackout, the game would change and everyone else would be spending a whole lot more. We couldn't simply reduce our defense spending to something comparable without significant consequences.
Consequences for us too. We have to keep spending to maintain the status quo.
I mean I get that there are certain common goal costs that we contribute perhaps a little more than our tab but it isn't nice to point it out like this. At the end of the day, we aren't spending on our military prowess to be charitable. I'm not an expert so it is likely that some cost saving would be possible. I'd welcome efforts to do that.
With medicine, I think a single payer should be able to negotiate with manufacturers and suppliers to keep costs low.
We have to rethink end of life care for humans. I'm very willing to sign a medical release form that says pull the plugs if my treatment will cost over $10M regardless of who pays for it.
But that's a different topic. This current issue with epippen is a simple issue of rent seeking. There is no way anyone could side with the company of this one. I hope that the spotlight means their efforts will fail.
Are you suggesting we spend more than we can get away with hoping the slimeball companies will reinvest their profits into R&D?
We don't disagree that there's a problem: medically fighting to the last breath should be replaced by gracefully accepting the end at the appropriate time (for both cost reasons and for the quality of life at the end for the patient, etc.)
We do disagree on how. If you want to make progress on that front we should have education and cultural growth around accepting death and doing what's best at the end for doctors, patients, and families. We shouldn't have a bureaucrat forcing the decision on anyone.
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>This current issue with epipen is a simple issue of rent seeking
It's not an issue of rent seeking specifically, but abusing government granted monopolies (patent protection, trademark protection, forcing schools to buy, etc)
> Are you suggesting we spend more than we can get away with hoping the slimeball companies will reinvest their profits into R&D?
No, the high cost of R&D and slimeball behavior are often intermixed, but separate issues. I'm suggesting that a whole lot of the money for expensive drugs is actually going towards R&D. Lots of foreign countries are getting steep discounts and not paying equal shares because the drug companies are taking the path of least resistance. They can get funded in America more easily so they don't fight as much in places that are more difficult to win.
America couldn't magically get the foreign prices because the R&D money wouldn't appear from anywhere else. America's prices go down but the rest of the world's prices go up to meet in the middle ... or a lot less drug research happens (or a bit of both)
There are lots of things happening, and a lot of the problems are due to lacking regulation. What can get patented and for how long is wrong; more research should be publicly funded with stipulations that the results are free to society; drug approval mechanisms need to be more efficient; some barriers between national drug markets need to be broken down (you should be able to sell across borders between economically equal nations)
There are a lot of things which could lead to a healthier medical environment which aren't being done. We've got some small reforms out of the way, but there are still huge inefficiencies.
Our single-payer system covers a pile of things that low-end insurance often doesn't in the US as it is, so most people are happy with it.
Looking at per capita healthcare costs in India would be pointless, as the vast majority of people go without proper healthcare.
Here's a generalisation for you: The US has lower life expectancy than most of the 'developed' world and yet spends twice as much (OECD 2007).
See Meeker's USA Inc. slide 111 https://s3.amazonaws.com/kpcbweb/files/USA_Inc.pdf
Indian healthcare has its own can of worms, but since we are not talking about that, I won't open it.
I have direct experience with the French system, so I'll use that as an example. When you go to the doctor for an outpatient visit, you pay the whole bill right then and there. Your insurance company will then reimburse you for some significant percentage of the "reasonable and customary" cost of that visit. Do you need a shot as part of that visit? Guess what -- you have to go next door to the pharmacist and buy the dose. The doctor will then administer it.
Inpatient is different (fully covered and no billing) and indigent patients are given a special card that directs the doctor to bill insurance directly.
We could do that here in the US without universal health care and it would make a significant dent in our spend without a corresponding decrease in outcomes.
The great grandparent comment also seemed to be speaking to the way the government has incentivized employer-provided health insurance, which insulates people from making cost/benefit decisions. I think that if individuals had to pay $100 per juice box their insurer gets billed, they would likely find a way to cut costs.
If it's in regards to Obamacare, that's pretty recent compared to the trend of the medical lobbying getting one over on Americans... and definitely not "free healthcare" by really any measure.
A manager replaces free coffee in the office with a paid vending machine to save expenses. Moral goes down. Production goes down.
A team member is fired because she has the worst production level of the team. What they did not know is that this team member was holding the team together.
So there are a lot of side effects to every decision. And therefore I think voting with your wallet is a bad idea.
A manager sees that workers work better when well caffeinated, but that they are sucking up time with starbucks runs. So she installs a Keurig machine, an investment that saves money and time in the long run.
Alternatively, we might have a manager who buys a coffee machine to give the employees free coffee, as the former sees the latter will be happier and more productive for a low price; this the manager buys productivity cheaply.
For example, you might choose a higher airfare with a carrier that has better customer service than the cheapest. This is voting with your wallet and it has nothing to do with cutting costs.
The manager hasn't "voted with their wallet" in your example.
The US would need different regulations. But the American ideology will probably not allow that.
Ah, the old strawman. Let's bring it out and beat it around a bit.
That's the "American ideology" in the same way the "European ideology" is to not work and collect a check from the government.
And additionally, a gut-level fear of government and way too much trust in corporations.
Europe's social welfare programs, universal healthcare and free education don't make these countries "socialist" or "communist". These countries are still capitalist market economies with a few critical aspects about people's livelihood regulated for accessibility.
As long as the response to these ideas is always "but that's communism", it won't ever improve.
This is why the US has one of the smallest militaries, the smallest public road system, unsafe aviation due to no air traffic control, no public schools for children, and unsubsidized farming and food purchases. /s
https://en.wikipedia.org/wiki/Natural_monopoly
http://thelibertarianrepublic.com/epipen-monopoly-hint-not-r...
The "no true capitalism" of the libertarians ? Communists also claim USSR was "no true communism". A doctrine or ideology is never "pure" or "perfect" in practice since men aren't.
Socialism is the collectivized ownership of the means of production and a centralized plan-based economy with fixed production quotas and prices.
Scandinavia isn't socialist. The Eastern Bloc in Cold War times was socialist.
Social democracy != socialism.
Look at the FDA process: you reform that and drug costs will decrease dramatically.
Beyond this would be a requirement of two sources for ALL medical prescriptions and devices in order to sell them in the U.S. (or whatever country you, the reader, are in).
This would ensure at least competition, even though there's still greed there can be momentum for competition.