One of the early on-line responses was "maybe we can figure out how to 3D print these cases". It turns out that an Epi-pen is just a plastic safety housing around a normal syringe.
That second discussion got heated quite fast. I agree with the downvoters though. 3D printing a medical device is not something to take lightly.
Edit:
Here's why I agree.
You download this design from the internet, and 3D print the parts. You then assemble it. Awesome!
Some time later, you get an allergic reaction. You use the pen, but it fails to work correctly. Who's responsible? The designer? You (if you're alive)? The printer manufacturer? Your friend who emailed you the design? etc.
There's a reason why even getting such a simple design considered for FDA approval and certified for use on live humans is such a long and complex process. It's easy to make something that works some of the time, but it's extremely hard to make it work essentially every time, especially in life-or-death scenarios.
Of course, the price hike is terrible and the company behind it deserves punishment, but that doesn't make it OK to endanger the lives of people.
Scarcity demands innovation. I don't think its being taken lightly; more like, "a private company is gouging medical users and the government won't step in". Not left with many options when your life depends on it.
EDIT: Alternatively, a "better" temporary solution would be to arrange for the import of these from Canada, where the price is fixed by the government.
It's not merely size. It's size-relative-to-market.
Canada negotiates with drugs suppliers. Supplier says "take a hike". Canada says, "OK, you're out of the market", turns to next drug supplier.
Canada here has right-of-refusal, and can negotiate, as a single block entity, with ability to restrict market, to each. The drugs company which finds those terms acceptable has a market.
A bloc of 42 million in the US is only about 12% of the total market. The discussion there still leaves another 290M possible customers for a drugs vendor. Hence the strength is with the vendors.
If US Medicare had rights to exclusively negotiate drugs deals (it doesn't), this would change tremendously. Similarly for single payor.
Which is precisely why the entire medical services industry is so mortally opposed to it. They'd lose absolutely all market leverage. They know this.
The autoinjector provides value for people that don't do IM administration every day. It's rugged, sterile, can be used right through clothing if necessary, and provides the right amount of force to go through to the muscle. The kit might also include a practice injector for training the user.
Oh and it's probably a little hard to handle a bottle and syringe on yourself while you're suffocating.
That's an alternative, but is more complicated and the vials of epinephrine only have a shelf life of three months vice twelve to eighteen for the EpiPens.
That makes too much sence for the FDA, AMA lobby, big pharma, and very entity/persons that makes a killing off health care.
As to the simplicity the EpiPen, I once used it, and under stress didn't do it right.
When I was younger I was very interested in medicine. In college finished all pre-med courses. Interned at a Coroner's office, etc. Even spent some time in med school. Very familiar with giving a subdermal injection.
Now my father had a bad asthma attack years ago. I knew he was in poor health, so my stress level was high. He blurted out where the EpiPen was kept. I got the device, didn't have time to read the instructions, and just stuck it in his thigh. I apparently pulled it out too quick--just wasn't thinking, and nervous. I pulled it out so quick, because I was scared, felt the device was foolproof, and felt weird hurting my father. We luckey had enother one around, and injected him longer this time. If I was forced to use a syringe, their would be no assuming. "I need to get the drug into the syring. I then need to empty the syring into his thigh. Done?"
Well it didn't work, and he ended up in the emergency room. He survived.
I drove home feeling guilty, and still do today.
I always felt a kit with a single dosed bottles of epinephrine, and a syringe would make intuitive sence to a lot of people? I know I would have felt more comfortable that night.
I honestly think the powers at be underestimate the abilities of the average person, especially a person who's had an previous asthma attack. If a doctor/nurse spent a minute showing a patient how to injection themselfs with epinephrine; I don't think most would ever forget. Plus--we have all watched injections given on the boob tube? "But the average person would probally jab the syringe in the Carotid artery, or pull a Pulp fiction." They could jam it into a carotid, even with a EpiPen--with enough effort/stupidity?
I hope in the future we have over the counter life saving medications over the counter, including naloxone.
Demand passing a basic test if worried about consumers hurting themselfs? Something like a CPR certification? If the patient can pass, they can buy cheap medications over the counter? They don't need fancy propriatiatry drug delivery gadgets in so many cases.
I really think the only way to bring down medicine costs will be to make many drugs OTC, and demand basic competency exams if worried about ineptitude? There will always be people out there that will find a way to abuse/overdose/screw up dosesages on medication. Let's just try it for a year? Especially with certain life saving drugs. How many diabetics die each year because they don't have a prescription for insulin, and couldn't get to a hospital?
I used to have so much respect for any sector of the health care; now I look at most of them with utter discontent.
Sure... but then there is the problem of the end user.
Is there 3D printer correctly calibrated? will miscalibration effect its end use? how can you test to make sure the printed design is working as intended?
Can the printed plastic withstand direct sunlight for days on end? Some printed plastics become brittle over time in sunlight (PLA for instance).
When the difference is $1 vs $600, I think a lot of people would be willing to take that risk, especially for something that is basically an unexpected expense; I doubt any allergic people are getting stung by bees on purpose.
Most people I know couldn't handle a sudden $600 expense
like a car repair without help from someone like their parents (I'm mid-20s living in JP).
> When the difference is $1 vs $600, I think a lot of people would be willing to take that risk, especially for something that is basically an unexpected expense; I doubt any allergic people are getting stung by bees on purpose.
What probabilities are you assigning to needing the printed epipen to survive, and to it functioning correctly, such that it's worth that risk?
Dying because you can't afford a device you need is also not something to take lightly. It may not be a good idea, but blame should lie with the manufacturer for raising the price to such ridiculous levels.
Yes; this is why using the free market to set prices in health care is always such a troubling thing. People don't like the idea of putting a price on their health.
Please don't blame the free market for these high prices. This is a highly regulated medical device market with patent protections and insurance market complications.
The price hikes would immediately attract lower-cost competitors if this were truly a free market.
> The price hikes would immediately attract lower-cost competitors if this were truly a free market.
Any participants in a free market for a product with inelastic demand (e.g. something you need to stay alive) and non-trivial entry costs immediately implements price fixing in the absence of regulation.
When life-saving devices that require a significant supply chain to manufacture capture the bulk of consumer surplus from the majority of potential customers (and the poorest are left to die), the free market is working as intended, efficiently allocating resources to maximize profits.
Yes, but in other countries everyone gets the same access to health care and people don't die on the street because they can't afford a commodity like an epipen! Though you might die in a hospital bed because the government wont spend a million euros a week on medication that may or may not give you a year more to live.
Of course. This case is particularly interesting because the device/drug combo is so commonly needed. But you'll find many other stories of manufacturers hiking the price of drugs people need to live, and the resulting backlash. Look up Martin Shkreli for a couple of recent examples that got attention.
We also see drug shortages because the lone manufacturer temporarily or permanently stops manufacturing. For example, there's an ongoing injectable estrogen shortage because the manufacturer has an issue sourcing a key ingredient [0] [1]. (Thankfully, other forms and dosages are not impacted.)
Then why are they making hundreds of thousands of epipens? Sounds like they should make like 100 a year and auction those suckers off. Less material and capital to manufacture, same profits.
doubtful that an auction that would demand those profits would be 1) easy to facilitate 2) stable and predictable.
Also, the individual price per unit would rise to the point that there would be another competitor to the market.
My point is that you can't cry about government controlled health care, and high prices of "free-market" items at the same time.
So either we have a gene pool cleansing and accept that people die, or a controlling entity uses force to coerce the manufacturers to adopt practices that will make it available at "reasonable" prices to the populous.
The manufacturer is obligated to (1) obey the law, and (2) maximize profits for shareholders. If you have a problem with the current situation, blame the government/laws[1], not the company.
[1] Blame is justifiably attributed to the government whether you believe the fix is a freer market (to reduce the costs associated with bringing suitable competitors to market) or you believe regulation should prevent this from happening. Apart from the requirements codified into law, we should have no expectation of altruism by companies, especially when their existence is intrinsically related to profit-seeking motives.
(1) seems like a total cop-out to me. By that logic, you can blame everything on the government. Some guy murders his family in a fit of rage? Government should have done a better job preventing it.
Also, part of the point of this kind of outrage is to punish these companies for their behavior so that the evil choice is not the most profitable one.
If corporations don't have an obligation to maximize profits for shareholders, then you'd better try and take that argument to shareholders rather than believe someone's opinion piece on the matter.
I didn't say corporations are legally required to seek profits, but they do have profit-seeking obligations in most cases. Without investors' expectations of future profits, those companies wouldn't exist in the first place.
And last I checked, murder is illegal, so no, I can't expect the government to do anything beyond that (as long as that law is enforced).
There is no inherent obligation to maximize profits. Most companies have that as their goal because that's what their shareholders want. But then saying that the manufacturer is obligated to maximize profits is a really bizarre and rather disingenuous way of saying that the people who actually own the manufacturer prioritize profits over lives. They don't have to do that, they just do. There's no "obligation" anywhere in there, just people's preferences. Saying that companies are obligated to maximize profits is just a way of saying that it's OK for people to value money above all else, even the well-being of their fellow humans, as long as there's enough indirection in the process.
Fiduciary obligation is complicated and jacking up prices in the short term result in lower profit than keeping prices lower -- if this company wanted to keep the price of the product low, they could easily justify it by arguing that indiscriminately raising the price would invite government regulation and price control (or invite more competition), which would reduce profits in the long run.
Shareholders already know that companies don't have an obligation to maximize profits. Tim Cook among others has made this point forcefully fairly recently.
Shareholders make investment decisions based on their own opinions of which companies are most likely to generate the highest return over their preferred time span. That is not the same thing as believing in an obligation.
Company misbehaves, government nationalizes them. It's a perfectly valid approach often used in the US, which places the blame on the company not the government as it should be.
Sure, we mostly stopped doing this for various stupid reasons, but legally it's sill an option.
It's surprisingly frequent, though generally short lived.
Legal and profitable mob run businesses are taken over vs shut down then resold once the books are clean. During World War II, Washington seized dozens of companies including railroads, coal mines and, briefly, the Montgomery Ward department store chain.http://www.nytimes.com/2008/10/13/business/worldbusiness/13i... Banks are probably the most common but it can also happen in bankruptcy.
Companies have those obligations, and others too. We all have many obligations, including to our communities/society. If most businesses didn't meet those other obligations for the last several hundred years, there would be no community, no market, no technology, and nobody rich enough to buy epipens. You'll notice that most companies are responsible members of their communities to some extent, but there are a few leaches of course who live off everyone else's contributions.
Thanks for this summary comment. This is backed in the literature by people who are systems / usability engineers:
tldr: Reliable design is HUGELY important. You can't just put these things together haphazardly.
"The fact that less than 50% of participants across all devices could follow the labeled instructions without committing a single error provides confirmation that the need for training on the use of epinephrine autoinjectors is still important...The user-centered device design may have a significant impact on correct epinephrine autoinjector use and patient preference."
In the study below, moms of kids with severe allergies were trained to use the EpiPen. Six weeks later in a simulated test, only about two out of five were able to successfully deliver a lifesaving dose of adrenaline.
Shouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose?
They should allow reasonably safe products that are among the best available options.
So if people can use an Epipen more reliably than they can prepare an injection, allow it to be marketed. If someone with a history of anaphylaxis is better off with an Epipen than they are with no treatment at all, allow it to be marketed.
> You use the pen, but it fails to work correctly. Who's responsible?
You are responsible for making decisions for yourself. If you think a 3D printed pen is not safe, buy the more expensive one. Don't hedge every decision you make against who you'd be able to sue if it goes wrong.
I rather dislike the (frequently American) immediate viewpoint of assigning blame/responsibility in the case of a failure, and thus who can someone sue. This isn't an uncommon viewpoint at all, rather it seems to be the first that many go to.
Consider this: every time you get into a car, you are putting yourself into life-or-death scenarios that greatly depend on the class and quality of car you've chosen. The government enforces some minimum safety standards for any registered car on the road, but above that, you pay for safety - quite literally.
Does the government prevent the sale of cheaper, inferior cars just because higher-priced cars are substantially safer?
Why should medical devices be any different? If the barriers to entry (e.g., costs associated with FDA approval) were lower, then we'd absolutely have some inferior EpiPens on the market. But we'd also have a lot more options, and all of them (even the best) would be ridiculously cheap compared to what we're seeing now. Wouldn't that be better overall for people who might not be able to afford one at all in the current system?
> The government enforces some minimum safety standards
I think this understates the safety regulations for automobiles by quite a bit. Maybe there's an example of an industry which makes lightly regulated, dangerous products, but I don't think cars are it.
True - the government's automobile safety standards are far from trivial, but there's no denying that the difference in safety between the cheapest smart car on the road and the safest car on the road is huge. In a head-on collision between the two, there's absolutely no contest.
Asking why the government should allow an EpiPen competitor with a 0.1% higher failure rate is akin to asking why the government should allow people to purchase small, cheap cars.
As a road user (walker, cyclist, occasional runner) I consider small vehicles that are easy to see around and above far safer than heavy, bulky vehicles.
Cars aren't designed for the safety of anyone but their occupants, though.
> Cars aren't designed for the safety of anyone but their occupants, though.
This is not the case. Part of the reason that all new cars from large manufacturers are as bulky looking as they are is to conform with US pedestrian collision regulations.
While I applaud this initiative, I'd like to be able to buy a smaller, nimbler car and simply avoid hitting pedestrians.
> there's no denying that the difference in safety between the cheapest smart car on the road and the safest car on the road is huge. In a head-on collision between the two, there's absolutely no contest.
I don't think that's true. Certainly expensive cars have new safety features, but ...
I read a study of empirical data on what, in practice, made cars more survivable in accidents. It was awhile ago but here is my vague memory:
The data was hard to analyze - they were trying to untangle cause and effect from wrecks - but the conclusion was that the most important factor was the relative location of hard points: If their hard point (e.g., bumper) lines up with your soft spot (e.g., driver-side door/window), it's bad for you. That's something that doesn't depend on cost.
Otherwise, I would assume safety depends heavily on weight and structural integrity, and certainly some cheaper vehicles, such as pickup trucks, would be much safer by those measures than much more expensive sedans.
It also might depend on center of gravity, roll-over potential, breaking ability, etc.
I once read someone stating that "The safest car on the road is the one with a ten-inch razor-sharp metal spike fixed to the centre of the steering wheel.".
Yes, but that's mostly because the safest car is more like a suburban tank while the smart car is more like an urban mobility device. If there were no suburban tanks around, the smart car would instantly be much safer.
Firstly, the standards and regulations a manufacturer needs to meet to get even a single car on the road are staggering - probably comparable to FDA approval in complexity. Also, the testing of single components and complete vehicles is extremely comprehensive.
Secondly, there's a huge difference between the two cases that you're not considering: medical devices are designed to interact directly with the human body and alter it from within.
Even though there are cars with a 5-star safety rating, you can still get ones with a 4-star or even 3-star ratings. So I would say the answer to the original question "Does the government prevent you from buying less safe cars" is "No".
In both situations, the government sets a minimum permissible safety standard to sell the product. Medications and medical devices are allowed to kill/injure, but only to a point. Same with cars.
The Government doesn't forbid you, the consumer, from buying questionable cars. It's the manufacturer who is restricted by Government regarding what cars they can sell.
Well, if I can print 3 of them for 1/100th the price of a single one from said manufacturer, if the design is even adequate I'm probably still better off.
What doesn't seem to be represented in the discussion is that if you source and build your own epi pen, you might not have that initial discussion with your doctor and you certainly don't get any medical guidance leaflet with it.
Using an epi pen is a dangerous business and can cause considerable complications. It is absolutely not to be taken lightly and is literally for life-or-death situations. I fear that those making their own (or heaven forbid somebody else's) pen will not know this.
Source: my doctor when I bought my first epi pen (beekeeper).
Semi-yes, semi-no. The epi-pen case is specially made to try and get people to shoot it into themselves/other people correctly. They are super color coded and once triggered can't be untriggered
Other than that, they could be 3-d printed or whatever is cheapest by many providers
Consider also reliability: What if some 3D-printed part breaks? What if it sticks when it gets hot or cold, or after a few hot/cold cycles, or after some flexing in a pocket?
The first 90% of quality is easy ... Think of the difference between the quality needed for a mobile game app and the software that flies airplanes.
If they're significantly cheaper, carry 2 or 3. If you're at a 90% level, you will be almost assured of cheaply having one work, assuming the error/failures are random.
Yes, this is sub-optimal in a life or death situation, but it's a reasonable counter to unreasonably high EpiPen pricing. Moreover, if this becomes common practice or if it's even feared as plausible, it could help reduce EpiPen pricing.
I am allergic to bee stings, myself and, to be honest, I don't agree with you.
The best solution is the one you can actually carry with you – if you can't afford the EpiPen, this system would be far, far better than nothing.
Further, while anaphylaxis is a life threatening situation, it isn't a situation where, if recognized in a timely manner, 10 seconds more to pull out the second or even 3rd home-brew auto-injector would kill the patient.
Next, the widespread existence and feasibility of a home-brew option would itself exert significant pricing pressure on the original EpiPen thereby making it more affordable for everyone and thus less likely that I would even need to actually make one.
Lastly, I would, in fact, use the above hypothesized home-brew option for my kids or wife (if they were alergic), if we couldn't afford an EpiPen or as a way of making sure we always had one available.
As I argued, having multiple devices cheaply on hand makes failure of one an okay thing. If they have a 10% failure rate (which itself is a high failure rate even for this scenario), having 3 on hand would mean you'd have one-tenth of one percent odds of all three failing. Add a 4th and you get down to 0.01% – get the individual reliability down to 5% failure rate and 3 devices would give you 0.0125% odds of failure. Those are actually pretty good odds. Moreover, I'm not sure what the traditional EpiPen's reliability is, but I'd bet it's not that much better than a 0.000125 failure rate.
Liability isn't (shouldn't be) the first concern in health discussions. Presuming an individual cannot afford the $600 version, surely the chance that a printed version might work is purely an improvement in their situation.
On the other hand, it doesn't have to work 100% of the time to be viewed as a threat, economically. Make it widespread, make it reasonably effective and you will likely succeed in driving the price of the certified EpiPen.
Edit:
Here's why I agree.
You download this design from the internet, and 3D print the parts. You then assemble it. Awesome!
Some time later, you get an allergic reaction. You use the pen, but it fails to work correctly. Who's responsible? The designer? You (if you're alive)? The printer manufacturer? Your friend who emailed you the design? etc.
There's a reason why even getting such a simple design considered for FDA approval and certified for use on live humans is such a long and complex process. It's easy to make something that works some of the time, but it's extremely hard to make it work essentially every time, especially in life-or-death scenarios.
Of course, the price hike is terrible and the company behind it deserves punishment, but that doesn't make it OK to endanger the lives of people.