People Are Clamoring to Buy Old Insulin Pumps(theatlantic.com)
theatlantic.com
People Are Clamoring to Buy Old Insulin Pumps
https://www.theatlantic.com/science/archive/2019/04/looping-created-insulin-pump-underground-market/588091/
159 comments
> once they break, it's game over
This was on my mind the entire time I read the article. People are having their lives opened up by responsive pumps; some of them are even children who will grow up without ever having to manually manage each blood sugar swing. But the entire setup depends on scavenging outdated pumps and importing unapproved devices. It's deeply scary and depressing to think of where they'll be left if those pumps fail before an approved solution hits the market - or becomes similarly affordable.
Even if closed-loop pumps are approved and affordable at that point, the loss of control will represent a real step backwards for a lot of people. I don't have easy answers, but realizing that this is how things work is chilling.
This was on my mind the entire time I read the article. People are having their lives opened up by responsive pumps; some of them are even children who will grow up without ever having to manually manage each blood sugar swing. But the entire setup depends on scavenging outdated pumps and importing unapproved devices. It's deeply scary and depressing to think of where they'll be left if those pumps fail before an approved solution hits the market - or becomes similarly affordable.
Even if closed-loop pumps are approved and affordable at that point, the loss of control will represent a real step backwards for a lot of people. I don't have easy answers, but realizing that this is how things work is chilling.
> It's deeply scary and depressing
Yes. You have no idea.
Yes. You have no idea.
What kind of effort do you think it would take to make an open-source functional copy of one that you would trust? Presumably if doing that the reverse engineering may have to be black-boxed and the designs presented as research, to create some legal cover.
Honestly, I think this should be quite doable. These guys [1] built a pump based on a stepper motor and an arduino, in order to replace expensive peristaltic laboratory pumps.
[1] https://www.instructables.com/id/Open-Source-Peristaltic-Pum...
[1] https://www.instructables.com/id/Open-Source-Peristaltic-Pum...
If you look at mikeselectricstuff’s teardown of an omnipod, its quite simple.
It can also quite easily kill you in your sleep if you mess up the implementation, so ymmv.
It can also quite easily kill you in your sleep if you mess up the implementation, so ymmv.
[flagged]
Can you please make your points substantively and not as flamebait, when posting to HN? Flamebait just leads to shitty threads.
https://news.ycombinator.com/newsguidelines.html
https://news.ycombinator.com/newsguidelines.html
It's an ongoing reminder that the Silicon Valley point of view isn't the only—or best—one.
I grew up dirt poor in the Deep South. My wife is diabetic. People need the perspective. If that's flamebait, maybe I'm not the one who's in the wrong.
Also it seems like you're ignoring your own "don't post shallow dismissals" rule.
I grew up dirt poor in the Deep South. My wife is diabetic. People need the perspective. If that's flamebait, maybe I'm not the one who's in the wrong.
Also it seems like you're ignoring your own "don't post shallow dismissals" rule.
ZhuanXia(2)
Capitalists created all of the pieces of technology in use here. Bashing them seems really out of line.
Getting devices approved by the FDA is extremely expensive and time consuming. The DIY guys are doing great work, but they have not done this. An actual company such as Medtronic could not do what they have done as they would get shut down by the FDA.
The US is the only industrialized country that does not have the English Rule, which says that if you sue someone in court and lose, you pay their court costs. As a result, trial lawyers make a lot of hay suing medical companies. There's no strong disincentive to see what happens if you go to court. This is another reason medical companies are very conservative when releasing equipment for use.
So, we have capitalists producing technology despite all of these hurdles, and yet somehow you blame them when they take a while to get things into the market?
Getting devices approved by the FDA is extremely expensive and time consuming. The DIY guys are doing great work, but they have not done this. An actual company such as Medtronic could not do what they have done as they would get shut down by the FDA.
The US is the only industrialized country that does not have the English Rule, which says that if you sue someone in court and lose, you pay their court costs. As a result, trial lawyers make a lot of hay suing medical companies. There's no strong disincentive to see what happens if you go to court. This is another reason medical companies are very conservative when releasing equipment for use.
So, we have capitalists producing technology despite all of these hurdles, and yet somehow you blame them when they take a while to get things into the market?
Contrary to your belief, the entire asset of technology known to mankind was not all invented due to capitalism. We had a lot of political systems throughout our past.
Patents, and copyright, are only in existence because of government's law. Without such, you could still live in a perfectly capable society (with capitalism as its political system, but not necessarily).
Patents, and copyright, are only in existence because of government's law. Without such, you could still live in a perfectly capable society (with capitalism as its political system, but not necessarily).
The pumps and monitors and smart phones being used by the DIYers in this case were all produced by capitalists. Without these things, the DIYers would not be able to do what they are doing.
The capitalists got these devices to market despite the regulatory processes of the FDA, which are expensive and time consuming.
What this story highlights is that the regulatory process has created a situation where only corporations with big pockets can generally play in this space legally. What the DIYers are doing is not legal. It is definitely moral, but not legal.
The capitalists got these devices to market despite the regulatory processes of the FDA, which are expensive and time consuming.
What this story highlights is that the regulatory process has created a situation where only corporations with big pockets can generally play in this space legally. What the DIYers are doing is not legal. It is definitely moral, but not legal.
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This is pure insanity and its infuriating that our corrupt political institutions are putting your life at risk.
Yup, it is infuriating. Sometimes I get so frustrated I just cry. Those aren't good days.
Most days are good days now though!
Most days are good days now though!
I'm working with a group trying to put some dent in this problem called Open Insulin (openinsulin.org). It's very legally uncertain/risky however, since the current regulatory regime is impenetrable. The problem here is not technical, its legal -- we have the technology to make this type of stuff cheaply and safely, but the status quo will not let us sell these things products without going through a multi-year, multi-million dollar regulatory process fraught with arbitrary constraints and risk of multi-million dollar patent lawsuits. Until then, the best we can hope for is feeding off scraps via loopholes, as you're forced to do.
I vote you do it underground and illegally until the law catches up. "If a law is unjust, a man is not only right to disobey it, he is obligated to do so." - Thomas Jefferson
I think the risk/reward ratio is skewed here.
That said if I had Type 1 diabetes and the skills I absolutely would do it.
Given the amazing things open source software and hardware folks have done and that you can manufacture small run electronics easier than ever it seems like a healthy underground is likely to emerge.
I'm in favour of the FDA and organisations generally (otherwise we are back to snake oil again) but it has massive issues with technology, they simply can't move fast enough to keep up.
I think a pro-tem solution is a law allowing a patient to waive all rights to sue in return for been able to use a device.
That way technology would get into the hands of the people who need it, the FDA would have a better understanding of what is going on and oversight and small manufacturers can enter the market.
Drug trials to an extent already have such legal frameworks present otherwise we wouldn't be able to perform the trials.
That said if I had Type 1 diabetes and the skills I absolutely would do it.
Given the amazing things open source software and hardware folks have done and that you can manufacture small run electronics easier than ever it seems like a healthy underground is likely to emerge.
I'm in favour of the FDA and organisations generally (otherwise we are back to snake oil again) but it has massive issues with technology, they simply can't move fast enough to keep up.
I think a pro-tem solution is a law allowing a patient to waive all rights to sue in return for been able to use a device.
That way technology would get into the hands of the people who need it, the FDA would have a better understanding of what is going on and oversight and small manufacturers can enter the market.
Drug trials to an extent already have such legal frameworks present otherwise we wouldn't be able to perform the trials.
> I think a pro-tem solution is a law allowing a patient to waive all rights to sue in return for been able to use a device.
My proposed solution is to make the FDA optional. If somebody elects to use a non-FDA approved device or substance, that's their decision to make -- not a group of faceless bureaucrats in Washington D.C. New regulatory institutions should be permitted to form, and so long as they're transparent about their process, and sellers are honest about who they've been audited b, false advertising and other species of fraud can be dealt with in the courts. People ought to be free to choose for themselves which institutions to trust and which to be skeptical of.
As soon as an institution becomes involuntary, it becomes immune to rational inquiry and revision. "Because we said so" is the ultimate axiom of any idea enforced by the FDA - if any individual disagrees with their thinking, well too bad you have to do as they say, regardless. Independent thought is the foundation of all truth, so its not really a mystery why domains where its illegal to disagree with the status quo, like medical regulation, are so fucked up.
My proposed solution is to make the FDA optional. If somebody elects to use a non-FDA approved device or substance, that's their decision to make -- not a group of faceless bureaucrats in Washington D.C. New regulatory institutions should be permitted to form, and so long as they're transparent about their process, and sellers are honest about who they've been audited b, false advertising and other species of fraud can be dealt with in the courts. People ought to be free to choose for themselves which institutions to trust and which to be skeptical of.
As soon as an institution becomes involuntary, it becomes immune to rational inquiry and revision. "Because we said so" is the ultimate axiom of any idea enforced by the FDA - if any individual disagrees with their thinking, well too bad you have to do as they say, regardless. Independent thought is the foundation of all truth, so its not really a mystery why domains where its illegal to disagree with the status quo, like medical regulation, are so fucked up.
> I think a pro-tem solution is a law allowing a patient to waive all rights to sue in return for been able to use a device.
I think we arrived at the same conclusion from opposite ends.
The big advantage to the FDA for the drug companies is that if they get FDA approval they top cover from that when they get sued.
Also the cost and scope of getting through the FDA makes it harder for smaller companies to get to market without either selling out to the larger companies or merging which also favours the larger companies.
It's an interesting dynamic, we definitely need some oversight of what is in the market but no so much that will stifle the market entirely.
I think we arrived at the same conclusion from opposite ends.
The big advantage to the FDA for the drug companies is that if they get FDA approval they top cover from that when they get sued.
Also the cost and scope of getting through the FDA makes it harder for smaller companies to get to market without either selling out to the larger companies or merging which also favours the larger companies.
It's an interesting dynamic, we definitely need some oversight of what is in the market but no so much that will stifle the market entirely.
"A good agorist is a jailed agorist" -- my friend
It is already legal to produce your own insulin at home and take it yourself. AFAIK its even legal to give it away for free. The problem is
1. It's expensive. The final production setup is estimated at $10k 2. The R&D non-trivial. We're still building the platform. 3. Production still must be highly self-regulated to ensure that the insulin is safe.
People need a way to fund this sort of work, but the second we try to sell anything we need to go through a multi-year, multi-million dollar FDA approval process or we'll be shut down. We're currently exploring other funding models, certainly open to ideas.
It is already legal to produce your own insulin at home and take it yourself. AFAIK its even legal to give it away for free. The problem is
1. It's expensive. The final production setup is estimated at $10k 2. The R&D non-trivial. We're still building the platform. 3. Production still must be highly self-regulated to ensure that the insulin is safe.
People need a way to fund this sort of work, but the second we try to sell anything we need to go through a multi-year, multi-million dollar FDA approval process or we'll be shut down. We're currently exploring other funding models, certainly open to ideas.
That seems like a great kickstarter you should make then.
To avoid the need to go through FDA approval, don't label it for humans. Label it for animals. Label it for lab testing.
Buy sensors from reputable names, plug them to a chip that support uPython, and make it hackable.
Even better, you may be able to recruit an engineer from one of the original providers to secure the pumping system, just for the sheer human aspect of it. Geeks are often moral driven persons.
Soon you'll have an affordable, community driven device.
There will be problems, and some people will probably pay it with their life thought. But how many lifes can be made better ?
To avoid the need to go through FDA approval, don't label it for humans. Label it for animals. Label it for lab testing.
Buy sensors from reputable names, plug them to a chip that support uPython, and make it hackable.
Even better, you may be able to recruit an engineer from one of the original providers to secure the pumping system, just for the sheer human aspect of it. Geeks are often moral driven persons.
Soon you'll have an affordable, community driven device.
There will be problems, and some people will probably pay it with their life thought. But how many lifes can be made better ?
I imagine that for a lot of people "oh well a few people died, but it's for the greater good!" is in fact not enough justification to help them sleep at night.
I get that, that's why you don't label it for humans, and you make it hackable. Just like there are people ready to die on Mars just for the sake of making the next step for humanity, there is out there a community of people ready to take the risk with their body to solve a problem that plagued their community for so long. Who knows, they may actually want it, and not be able to do it because of the lack of opportunity.
Open the door, let people volunteer. If you get a response, the ones coming will know what they are in for, and as long as you are respecting them, their action, and the community, you can be proud of what you do.
Why do you think Pasteur tested the vaccine on himself ?
The desire to help, being part of something important, is a deep human drive.
Open the door, let people volunteer. If you get a response, the ones coming will know what they are in for, and as long as you are respecting them, their action, and the community, you can be proud of what you do.
Why do you think Pasteur tested the vaccine on himself ?
The desire to help, being part of something important, is a deep human drive.
>...Why do you think Pasteur tested the vaccine on himself ?
What vaccine did Pasteur test on himself? The first human subject for the rabies vaccine was a boy who had been bit by a rabid dog.
https://en.wikipedia.org/wiki/Louis_Pasteur
What vaccine did Pasteur test on himself? The first human subject for the rabies vaccine was a boy who had been bit by a rabid dog.
https://en.wikipedia.org/wiki/Louis_Pasteur
> Why do you think Pasteur tested the vaccine on himself ?
Because he had enough of a sense of ethics to want to avoid performing a risky test on others, possibly killing them.
Because he had enough of a sense of ethics to want to avoid performing a risky test on others, possibly killing them.
That's my point. They may be people like him for a new type of insuline pump. We can't, as citizen, hope to compete against pharmaceutical companies. That doesn't mean we can't do anything.
> They may be people like him for a new type of insuline pump.
I'm sure there are -- and there is nothing stopping those people from doing the same today. The FDA cannot tell you what you can and can't do to your own body.
I'm sure there are -- and there is nothing stopping those people from doing the same today. The FDA cannot tell you what you can and can't do to your own body.
Since this is such a mission critical piece of hardware that would severely impair the user if a bug or malfunction developed, how can you completely trust the device will continue to work 99.9% of the time? I really want to recommend this to loved ones but hesitate with the liability of over/underdosing insulin and them not being as tech saavy as the HN crowd...
To answer the question you're asking, I trust that the _device_ is basically never going to fail because it's FDA approved and manufactured by Medtronic, who has a loooot on the line to make their devices fail-safe.
To answer the question I _think_ you're getting at... I trust the open source software that runs the FDA approved device because it's designed in such a way as to be as careful as possible (temp basals vs boluses). It's also open source and a lot of people contribute to it. I also only update it once a year or so when my Apple Developer certificate needs renewal.
All of that ^ helps, but honestly, it's not a guarantee. I still wear an off the shelf, FDA approved CGM with their native 1st party app installed so I still get their alerts on low/high blood sugar.
To me, it's a calculated risk and one that (so far) has been extremely worth it. My A1C went from ~7.5 to ~5.6 after using it.
To answer the question I _think_ you're getting at... I trust the open source software that runs the FDA approved device because it's designed in such a way as to be as careful as possible (temp basals vs boluses). It's also open source and a lot of people contribute to it. I also only update it once a year or so when my Apple Developer certificate needs renewal.
All of that ^ helps, but honestly, it's not a guarantee. I still wear an off the shelf, FDA approved CGM with their native 1st party app installed so I still get their alerts on low/high blood sugar.
To me, it's a calculated risk and one that (so far) has been extremely worth it. My A1C went from ~7.5 to ~5.6 after using it.
And keep in mind, "99.9% reliable" might mean it only kills you once every three years...
> how can you completely trust the device
I feel the same, however, people not having access to such an automated insulin delivery system may also suffer/die because of the consequences of a worse regulated sugar.
I feel the same, however, people not having access to such an automated insulin delivery system may also suffer/die because of the consequences of a worse regulated sugar.
Of course it is a calculated risk, however as a T1D myself, you can't ignore the fact that the current FDA approved pumps are also very dangerous. Pumps that don't respond to dropping blood sugars (most of them on the market today) and keep delivering insulin when you don't need it, compound low blood sugars, which has personally got me into serious trouble many times. Picking between a FDA approved "dumb" pump running on 10 year old software versus an open source option that explicitly has code to stop insulin delivery when blood sugars fall, seems to be an obvious choice. I've had diabetes for 31 years and this is by far, hands down, the greatest advancement I've experienced.
A valid concern, but also humans are guaranteed to make mistakes and I'm sure a high percentage of them, so anything that lowers that error rate is an improvement even if it's not perfect. My thoughts anyway
Similar to self driving cars improving car accident death rates over human drivers. Great point.
In the business this trust comes from the fact that they are regulated, validated devices (lots of testing and process; any change involves a lot of work). I don't think the DIY movement will address regulation or validation (and I don't know that regulation and validation is guaranteed to make a safer product than DIY can).
Both Humans and Software can malfunction. The hardware is identical. Also if the algorithm does small injections every few minutes then the risk of overdosing/underdosing is extremely low compared to a single big injection at midnight.
In Germany we have four pumps available for looping with AndroidAPS:
Roche Accu-Chek Combo and Insight
Sooil Dana R and Dana RS
From these Sooil is the only one who allows looping. Been using one for a month now and there is no going back.
I was using a used Combo last year but it broke suddenly. This time I have four years of warranty and hopefully we have more models available at that point.
Roche Accu-Chek Combo and Insight
Sooil Dana R and Dana RS
From these Sooil is the only one who allows looping. Been using one for a month now and there is no going back.
I was using a used Combo last year but it broke suddenly. This time I have four years of warranty and hopefully we have more models available at that point.
I was under the impression that there were already devices on the market that would monitor your blood sugar and dispense insulin as needed. Is that not the case? Or does this system provide some additional functionality?
There is one pump that offers looping. However, it mandates a blood sugar floor that is 1.5 times the non-diabetic. The glucose monitoring does not allow the user to control the alarms or snooze them. When these devices are connected to smart phones the user does not have ownership of their own data and the UI does not show all the data sent with the packets.
The dark side of heavy FDA regulation is it greatly slows down medical progress.
FTR: This is about the purchasing of a hackable insulin pump in order to create an artificial pancreas. Although one exists on the market, its lack of flexibility means users still prefer the hacking technique called "looping", which allows diabetics to select preferred sugar levels and monitoring engines of choice. An organization called TidePool is hoping to have official approved mechanisms working for more flexible artifical pancreases.
Side note: Did anyone else find this article difficult to read? Like it was written by an ESL writer? Christ, this is The Atlantic and it reads like it is written by a 7th grader.
Example:
> "To start looping with OpenAPS, Boss did also need to buy a mini computer called an Edison."
"..Boss did also need..." Why not just say "...Boss also needed...
>"By 2014, the hardware components of a DIY artificial pancreas—a small insulin pump that attaches via thin disposable tubing to the body and a continuous sensor for glucose, or sugar, that slips just under the skin—were available,"
This whole paragraph is confusing. Why put the parens before the "...were available,"?
>but it was impossible to connect the two.
Which two? The the sensor and the tubing? Something else?
>That’s where the security flaw came in.
Which fucking security flaw? With the DIY pancreas or the Medtronic?
edit: removed codeblocks
Example:
> "To start looping with OpenAPS, Boss did also need to buy a mini computer called an Edison."
"..Boss did also need..." Why not just say "...Boss also needed...
>"By 2014, the hardware components of a DIY artificial pancreas—a small insulin pump that attaches via thin disposable tubing to the body and a continuous sensor for glucose, or sugar, that slips just under the skin—were available,"
This whole paragraph is confusing. Why put the parens before the "...were available,"?
>but it was impossible to connect the two.
Which two? The the sensor and the tubing? Something else?
>That’s where the security flaw came in.
Which fucking security flaw? With the DIY pancreas or the Medtronic?
edit: removed codeblocks
For over a decade these publications haven't had copyeditors who review every article prior to publication and tweak the prose and correct obvious errors. It's not uncommon to have obvious spelling and grammatical errors as well in once great publications.
A few years ago the Washington Post fired ALL of its copy editors, forcing others to pick up the slack.
Memory didn't serve me well: it was over 10 years ago, not "a few," nor did the paper fire ALL of its copy editors. From a 2009 story: "Between early 2005 and mid-2008, the number of full-time copy editors dropped from about 75 to 43 through buyouts or voluntary departures. It has declined further since then, but Post managers won't provide precise figures beyond saying that six took a recent buyout offer." https://lisagoldresearch.wordpress.com/2009/07/07/the-washin...
New York Times eliminated its copy desk in 2017: https://www.chronicle.com/blogs/linguafranca/2018/06/14/new-...
It was mentioned earlier already.
What makes these outdated Medtronic pumps so desirable is, ironically, a security flaw. Boss was looking for a pump or two he could hack.
What makes these outdated Medtronic pumps so desirable is, ironically, a security flaw. Boss was looking for a pump or two he could hack.
Yes, but the syntax is off, because the author explains the diy pump and then immediately after says "that's where the security flaw is."
Why would you go into detail about the inner workings of a diy pump, follow up with an imprecise statement, and expect the reader to know what you are talking about? Because the imprecise statement immediate follows the explanation of the diy pump, it's unclear whether the author means the security flaw is in the medtronic or the diy pump that they JUST mentioned.
Sure, we can infer and assume what the author means, but it's not proper to make the reader assume, especially for a well-established publication.
Why would you go into detail about the inner workings of a diy pump, follow up with an imprecise statement, and expect the reader to know what you are talking about? Because the imprecise statement immediate follows the explanation of the diy pump, it's unclear whether the author means the security flaw is in the medtronic or the diy pump that they JUST mentioned.
Sure, we can infer and assume what the author means, but it's not proper to make the reader assume, especially for a well-established publication.
If you use code blocks for quotes you can make it more readable by introducing a few extra newlines:
"By 2014, the hardware components of a DIY artificial
pancreas—a small insulin pump that attaches via thin
disposable tubing to the body and a continuous sensor
for glucose, or sugar, that slips just under the skin—
were available,"
Android on Chrome here, I need to scroll for that. The top line gets as far as "By 2014,the hardware " before I need to scroll.
Not sure what the best option is. Just prefix with > ?
> "By 2014, the hardware components of a DIY artificial pancreas—a small insulin pump that attaches via thin disposable tubing to the body and a continuous sensor for glucose, or sugar, that slips just under the skin— were available,"
Not sure what the best option is. Just prefix with > ?
> "By 2014, the hardware components of a DIY artificial pancreas—a small insulin pump that attaches via thin disposable tubing to the body and a continuous sensor for glucose, or sugar, that slips just under the skin— were available,"
People really need to just stop using code blocks for quotes.
So what's the best way to do this? Honest question. I was looking and I didn't find good formatting help doc in less than 5min so I went with code blocks. Sorry haha :)
Use > and separate each quote with an empty line
Maybe I've missed it but I've not seen complaints about italicizing quotes by surrounding with asterisks.
Code blocks are often discouraged for quotes as they can be difficult to read on mobile.
Edit: Even with the new lines, I need to scroll.
Edit: Even with the new lines, I need to scroll.
As a type 1 diabetic, its kind of refreshing to see all these posts make it to the top of HN. Over the last few months I have seen several related to t1d tech, and others related to the ridiculous pricing of insulin.
Nothing really to say other than that, but that I appreciate all the interest the community shows towards those with chronic illnesses.
Nothing really to say other than that, but that I appreciate all the interest the community shows towards those with chronic illnesses.
I used to work for a company well known in the diabetes space that essentially automated the screenshot process Dana Lewis describes but via desktop and a webapp - we had internal protocols from most of the device manufacturers but our sticking point was training clinicians, getting physicians to buy in and dealing with Cerner and Epic (and the FDA which insisted the webapp was a medical device). The tech stack was a bit older than I would have liked. I did try to help some people bitbang their own meters on the sly but I wish I’d heard about this loop stuff before I left for grad school (mid-2014)
I looked at the OpenAPS documentation. I had no idea the preferred SoC for this system is the now discontinued Intel Edison. We have boxes of them from an IoT startup I was part of that folded a few years ago.
I see there are references to a SF looping group, but is there one for NYC? I'm happy to donate a lot gen 1/2 Edisons if there are people who need it.
I see there are references to a SF looping group, but is there one for NYC? I'm happy to donate a lot gen 1/2 Edisons if there are people who need it.
What a lovely gesture, it's hard to say that without sounding condescending (which it isn't).
I've lost family members prematurely to T1D and a simple upvote didn't seem enough :)
I've lost family members prematurely to T1D and a simple upvote didn't seem enough :)
Hey, Scott from OpenAPS.org here. That’s my email address: if you’d like to get in touch I’d be happy to arrange getting unused Edison’s to folks who need them. Or if you’d prefer, my Twitter DMs are open as well.
> The system also goes straight to an Android phone, eliminating the need for an extra device such as a RileyLink or an Edison.
I'd almost want an external device to do the calculations.
Imagine being killed by some Android bloatware.
Maybe devs need to start thinking of their apps as being on bio-critical devices.
I'd almost want an external device to do the calculations.
Imagine being killed by some Android bloatware.
Maybe devs need to start thinking of their apps as being on bio-critical devices.
The big innovation here is actually the CGM sensor. Having a sensor on your body that passively gives you information about how your body reacts to food, exercise and medication is amazing. I wrote a post last year on how it TOTALLY changed my life: https://medium.com/south-park-commons/the-wearable-that-chan...
Thank you for sharing this post. I enjoyed how similar the feedback loop for your experiments was to optimizing code for performance, and it makes me (someone who doesn't have diabetes) want to try CGM. However, I don't think I can get it through insurance. It costs about $42.99 for a 10-day sample, so maybe I'll try a 10-day sample to play around with it.
I presume this is the backstory for https://news.ycombinator.com/item?id=19763518 (which btw was a very engrossing read in hardware reverse engineering)?
Yes, the number of pump models that were hackable was extremely small, which made them extremely valuable to anyone looking to do this. The new work on the Omnipod should open this up to many more people who couldn't obtain an older (far out of warranty) pump.
Scott Hanselman recently posted about his experiences with the open source artificial pancreas [1]. Interesting that this article would come up so shortly after.
[1] https://www.hanselman.com/blog/OpenSourceArtificialPancrease...
[1] https://www.hanselman.com/blog/OpenSourceArtificialPancrease...
The fact that hobbyists can build this but it's not an approved medical device is a flagrant example of how the medical industry is so risk averse as to be allergic to innovation.
> the medical industry is so risk averse as to be allergic to innovation.
Is it really risk aversion? Or is it a culture whose first value is profit-by-regulatory-capture?
Is it really risk aversion? Or is it a culture whose first value is profit-by-regulatory-capture?
Ben West is cited in an article linked to from the OP article. He was hacking on that pump for the longest time since 2006 when I was living with him, and what do you know, he caused a movement.
Also check out Anthony Di Franco's open insulin project.
Also check out Anthony Di Franco's open insulin project.
Why isn't there a country in the world which would allow a wild west of medical innovation?
Then people could fly there for a brief holiday, buy the device, and bring it back to the US legally.
Then people could fly there for a brief holiday, buy the device, and bring it back to the US legally.
Is there an open source insulin pump out there? That seems like it would help the sustainability of this project.
I just texted my older brother to see if he had any of his old insulin pump models. I'd love to build him one since he only has a few years of life left since he's terrible at managing his own sugar levels.
I just texted my older brother to see if he had any of his old insulin pump models. I'd love to build him one since he only has a few years of life left since he's terrible at managing his own sugar levels.
This is a classic example of where you have to let people experiment with their own bodies. The risk tolerance lots of people have is way higher than what society is allowed to mandate as the best.
Of course paternalistic people will use the instruments of the state to restrict what we can do for ourselves. We can't just build and share "an unapproved device for managing your insulin" because the FDA will get in the way. But life would be so much better if we had the freedom to do that.
Unfortunately, the real problem is that there are a bunch of idiots who don't know how to take risks. They expect things to always work and they team up with the people who want to protect the idiots and oppress those of us who are willing to take a little risk for some reward.
Of course paternalistic people will use the instruments of the state to restrict what we can do for ourselves. We can't just build and share "an unapproved device for managing your insulin" because the FDA will get in the way. But life would be so much better if we had the freedom to do that.
Unfortunately, the real problem is that there are a bunch of idiots who don't know how to take risks. They expect things to always work and they team up with the people who want to protect the idiots and oppress those of us who are willing to take a little risk for some reward.
I would love to see more of an open source movement in medical technology. That would be such a great way to reduce costs and make healthcare more accessible.
Who knows what could be accomplished if we just had root access to more of our technology.
Who knows what could be accomplished if we just had root access to more of our technology.
Liability is a huge issue. Lots of sociopolitical changes need to take place first.
I'm fortunate to have a new pump that is a closed loop (the Medtronic Minimed 670g) and it has been a game changer for me.
Wow OpenAPS is on github https://github.com/openaps/openaps and written in Python!
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I've seen a fair number of diabetes related articles over the years that posit, for example, connections between diabetes and inflammation plus connections between insulin resistance and low protein.
I wish we would focus more on developing a better mental model for the processes involved in developing diabetes and find some way to effectively address those and prevent or reverse diabetes, at least in some cases.
But we aren't likely to because there isn't enough cool factor or profit motive. It makes me crazy.
I wish we would focus more on developing a better mental model for the processes involved in developing diabetes and find some way to effectively address those and prevent or reverse diabetes, at least in some cases.
But we aren't likely to because there isn't enough cool factor or profit motive. It makes me crazy.
One of the issues that causes confusion is there are two types of diabetes, type 2 which is developed because you don't generally take care of yourself (diet, exercise, etc.) and type 1, which is an autoimmune disease which does not 'develop' due to poor lifestyle choices.
Most people confuse the two. If only they'd chosen better names to differentiate them.
Most people confuse the two. If only they'd chosen better names to differentiate them.
One of the issues that causes confusion is there are two types of diabetes
I'm aware of a third type of diabetes that you almost never hear anything about: Cystic Fibrosis Related Diabetes (CFRD). My risk of developing it is the reason I read diabetes articles.
I have been told it is neither Type 1 nor Type 2.
My blood sugar levels are more stable than they used to be. My first-hand experience makes me skeptical of a lot of the sweeping assertions I get told we know with certainty.
I'm aware of a third type of diabetes that you almost never hear anything about: Cystic Fibrosis Related Diabetes (CFRD). My risk of developing it is the reason I read diabetes articles.
I have been told it is neither Type 1 nor Type 2.
My blood sugar levels are more stable than they used to be. My first-hand experience makes me skeptical of a lot of the sweeping assertions I get told we know with certainty.
I have never heard of Cystic Fibrosis Related Diabetes (CFRD), but I have heard of Latent Autoimmune Diabetes in Adults (LADA, sometimes called Type 1.5). It's an autoimmune type of diabetes (like type 1), but it doesn't start showing symptoms until adulthood (typically middle age or later, but I know of one case that manifested in early 20s). It is often mis-diagnosed as type 2, because of the later onset, but patients often become insulin dependent.
Thank you. This is new information for me.
There are actually a number of "diabetes" beyond Type 1 and Type 2. Some women become diabetic during pregnancy. There is also "water diabetes" which is more neurological, essentially your bladder, brain, and whatever tells your hydration level don't tall and you end up always drinking or needing to drink and not being able to tell when you need to urinate.
Not actually sure if the water diabetes effects humans. Its not too uncommon in dogs though.
Not actually sure if the water diabetes effects humans. Its not too uncommon in dogs though.
Thanks.
I need to keep gestational diabetes more in mind. I already knew of it's existence. It just never crosses my mind.
But I bet there's interesting information out there on it.
I need to keep gestational diabetes more in mind. I already knew of it's existence. It just never crosses my mind.
But I bet there's interesting information out there on it.
Diabetes is actually more of a continuum than a pair of diseases. I was diagnosed with a Type 2 variant (low insulin output and high insulin resistance) when I was in my twenties, and I was very skinny at the time. I can't tell you how offensive it is when people (including many Type 1s) blithely blame Type 2 exclusively on lifestyle choices. That said, diet and exercise do work very well to control Type 2 diabetes.
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I'd say diet is a failure on societal scale but at the same time individuals are the only ones who can fight against it. No one is going to help you because it is more profitable for corporations to ruin your health.
> and prevent or reverse diabetes
Those of us with Type 1 diabetes (which this article is about) don't love hearing that we should change our lifestyles to reverse the condition. Type 1 diabetes is an autoimmune condition that is not preventable or reversible.
Those of us with Type 1 diabetes (which this article is about) don't love hearing that we should change our lifestyles to reverse the condition. Type 1 diabetes is an autoimmune condition that is not preventable or reversible.
Eating too much and the "wrong" things proved valuable over our long trek of survival. The compulsion to eat calorie heavy foods and to over-eat, because we can, is fundamental to the animal part of us. People have a lot of conditioning as well on top of that. The solution isn't as simple as making a better mental model. You basically need people to allow themselves to be hungry and be okay with it. Like having a chain smoker stop cold turkey. It doesn't really work for any meaningful percentage of people. https://www.reddit.com/r/WatchPeopleDieInside/comments/biche...
This research contradicts the idea that overeating is the issue:
https://news.ycombinator.com/item?id=8748147
The existence of Cystic Fibrosis Related Diabetes (CFRD) in a population where about 90% of patients are quite underweight also contradicts the "fat" hypothesis.
https://news.ycombinator.com/item?id=8748147
The existence of Cystic Fibrosis Related Diabetes (CFRD) in a population where about 90% of patients are quite underweight also contradicts the "fat" hypothesis.
I don't know why but people seem to have an obsession with "taste" even to their own detriment. Every time I see submissions on HN about artificial meat in the top 10 comments you can find multiple people talk how this is great and how companies can use this to increase the flavor of the meat.
For companies that need to make a profit increasing flavor generally means adding additional ingredients or processing the food in a way that is as cheap as possible. Often this means adding high fructose corn syrup, sugar, carbohydrates or fat far beyond what is naturally available in the food.
Instant Ramen is an extreme example of this. Instead of just drying the noodles they deep fry them because it is cheaper and fatty foods "taste" better. Suddenly noodles made out of flour and water which should have zero fat now have 25% of their weight as fat in addition to the existing carbohydrates. I'm sure you can find less extreme examples but across the board this could result in x% more calories being consumed even if people eat the same things they did 30 years ago.
For companies that need to make a profit increasing flavor generally means adding additional ingredients or processing the food in a way that is as cheap as possible. Often this means adding high fructose corn syrup, sugar, carbohydrates or fat far beyond what is naturally available in the food.
Instant Ramen is an extreme example of this. Instead of just drying the noodles they deep fry them because it is cheaper and fatty foods "taste" better. Suddenly noodles made out of flour and water which should have zero fat now have 25% of their weight as fat in addition to the existing carbohydrates. I'm sure you can find less extreme examples but across the board this could result in x% more calories being consumed even if people eat the same things they did 30 years ago.
Surely they can be reversed engineered and some manufacturer can make them on the cheap or am I missing something ????.
You can manufacturer anything but you will not be able to commercialize it without getting approval (e.g. FDA approval in the US or CE marking in Europe)
Anything that qualifies as a 'medical device' has a plethora of processes and documentation that must be delivered to the regulatory bodies for that specific country or region.
Anything that qualifies as a 'medical device' has a plethora of processes and documentation that must be delivered to the regulatory bodies for that specific country or region.
Beta Bionics and others are trying to solve this issue. An automated pancreas. FDA process is slow & expensive though.
At this point what stopping those people from going the full DIY path and building their own insulin pump ? In those days of 3D printers and cheap electronics this seems like it should be achievable (I'm probably in full Dunning-Kruger mode here please forgive me). Or even gut one modern commercial unit to get the fluid part but replace the electronics with something more automation-friendly.
Would you trust it with your life?
The remedy for this insane injustice is to eliminate the FDA’s monopoly on medical regulation and allow the non-fraudulent production and sale of medical devices and drugs to consenting adults. No single group has ultimate authority on what constitutes efficacy and the appropriate amount of risk. So long as they are not violating our consent by lying about their regulatory process, no group has a right to conclude for us what we choose to use and consume to better our health.
Until the point that we are free to think for ourselves, we are all subject to the fumbling incompetence and cynical malfeasance of the regulatory cartel. The FDA’s mandate is morally equivalent to the mandate present on every street corner in every hood in America: “Nobody but me and my gang sells drugs on my block.” Hence nobody is surprised when their cocaine is laced with baking soda and sold at 5000% profit margins. Multiply this across all of medicine and it becomes clear why medicine in America is a schlerotic disaster. Meanwhile the political parties are only divided on whether or not the taxpayer should foot the bill...
Until the point that we are free to think for ourselves, we are all subject to the fumbling incompetence and cynical malfeasance of the regulatory cartel. The FDA’s mandate is morally equivalent to the mandate present on every street corner in every hood in America: “Nobody but me and my gang sells drugs on my block.” Hence nobody is surprised when their cocaine is laced with baking soda and sold at 5000% profit margins. Multiply this across all of medicine and it becomes clear why medicine in America is a schlerotic disaster. Meanwhile the political parties are only divided on whether or not the taxpayer should foot the bill...
How many people know enough to "think for themselves" in this area? How many are going to know anything beyond what the manufacturers' advertisements say?
> Until the point that we are free to think for ourselves, we are all subject to the fumbling incompetence and cynical malfeasance of the regulatory cartel.
I've worked for FDA-regulated medical device manufacturers twice. I didn't enjoy the experience, and no one would call them efficient, but they do not deserve the venom you are pouring on them.
> The FDA’s mandate is morally equivalent to the mandate present on every street corner in every hood in America: “Nobody but me and my gang sells drugs on my block.”
You rather badly need to re-calibrate your moral compass. Their mandate is "Nobody gets to poison people on my block. Nobody gets to create junk devices that kill people on my block." That is in no way morally equivalent to a gang of drug dealers.
> Until the point that we are free to think for ourselves, we are all subject to the fumbling incompetence and cynical malfeasance of the regulatory cartel.
I've worked for FDA-regulated medical device manufacturers twice. I didn't enjoy the experience, and no one would call them efficient, but they do not deserve the venom you are pouring on them.
> The FDA’s mandate is morally equivalent to the mandate present on every street corner in every hood in America: “Nobody but me and my gang sells drugs on my block.”
You rather badly need to re-calibrate your moral compass. Their mandate is "Nobody gets to poison people on my block. Nobody gets to create junk devices that kill people on my block." That is in no way morally equivalent to a gang of drug dealers.
> How many people know enough to "think for themselves" in this area? How many are going to know anything beyond what the manufacturers' advertisements say?
For one thing, the fact that other people might not be competent enough to think for themselves is not a justification for banning those who are from doing so. For another, I agree that we need regulatory bodies to ensure our medicine is safe and effective -- just that every individual has a right to decide for themselves which regulatory body to give authority to. Science is premised on the providing logic and evidence for one's claims; a scientific regulatory body would provide logic and evidence for why we should trust their judgement. Using threats (legislative or otherwise) to force everybody in the country to trust their judgements is anti-science -- "because I fucking said so" is not a replacement for logic and evidence.
Additionally, as I stated, the standard I'm proposing includes a justified use of force for those defrauding others via false advertising claims. If it can be transparently proven that such claims are unjustified or need further qualification, then providers can rightfully be forced to change their advertising.
> I've worked for FDA-regulated medical device manufacturers twice. I didn't enjoy the experience, and no one would call them efficient, but they do not deserve the venom you are pouring on them.
I'm speaking in broad generalities, of course in any enforced institution there will be good and bad actors, and the whole spectrum in between. What I'm railing against is the corrupt political system that allows this sort of tyranny to stifle human freedom without answering probing philosophical questions such as "why am I not allowed to disagree with your determinations?"
> You rather badly need to re-calibrate your moral compass. Their mandate is "Nobody gets to poison people on my block. Nobody gets to create junk devices that kill people on my block." That is in no way morally equivalent to a gang of drug dealers.
I've already qualified my position that such criminals should be held accountable in the court of law, and in this comment qualified it further in stating that it is reasonable to set up regulatory institutions with processes to ensure safety; they simply can't justifiably be enforced.
For one thing, the fact that other people might not be competent enough to think for themselves is not a justification for banning those who are from doing so. For another, I agree that we need regulatory bodies to ensure our medicine is safe and effective -- just that every individual has a right to decide for themselves which regulatory body to give authority to. Science is premised on the providing logic and evidence for one's claims; a scientific regulatory body would provide logic and evidence for why we should trust their judgement. Using threats (legislative or otherwise) to force everybody in the country to trust their judgements is anti-science -- "because I fucking said so" is not a replacement for logic and evidence.
Additionally, as I stated, the standard I'm proposing includes a justified use of force for those defrauding others via false advertising claims. If it can be transparently proven that such claims are unjustified or need further qualification, then providers can rightfully be forced to change their advertising.
> I've worked for FDA-regulated medical device manufacturers twice. I didn't enjoy the experience, and no one would call them efficient, but they do not deserve the venom you are pouring on them.
I'm speaking in broad generalities, of course in any enforced institution there will be good and bad actors, and the whole spectrum in between. What I'm railing against is the corrupt political system that allows this sort of tyranny to stifle human freedom without answering probing philosophical questions such as "why am I not allowed to disagree with your determinations?"
> You rather badly need to re-calibrate your moral compass. Their mandate is "Nobody gets to poison people on my block. Nobody gets to create junk devices that kill people on my block." That is in no way morally equivalent to a gang of drug dealers.
I've already qualified my position that such criminals should be held accountable in the court of law, and in this comment qualified it further in stating that it is reasonable to set up regulatory institutions with processes to ensure safety; they simply can't justifiably be enforced.
> For one thing, the fact that other people might not be competent enough to think for themselves is not a justification for banning those who are from doing so.
Who is banning anyone from doing their own research or thinking? Not the FDA, as near as I can tell.
Who is banning anyone from doing their own research or thinking? Not the FDA, as near as I can tell.
ibeckermayer(1)
I'm going to argue against this. Safe food and medicine have been an enormous benefit to everybody: we don't have to risk having food poisoning if we choose the wrong grocery store. Besides that, if we don't regulate the oligopolistic markets we have in everything today (how many pharma companies are there?) we are in enormous danger of everyone losing confidence in food and medicine supplies. Nobody wants that.
Instead, I'm going to argue that the entire problem here is a combination of regulatory capture and monopoly power. The onerous regulation is bad for innovation, sure, but it's also great for any participants already in an oligopolistic market. The participants don't have to worry about innovators, who can't possible comply with ridiculous procedures, entering the market and decreasing profits. This is not unlike the defence industry. Boeing, Lockheed-Martin and Raytheon dominate. The bizarre security clearance and DoD procurement process keep out everybody else.
Instead, I'm going to argue that the entire problem here is a combination of regulatory capture and monopoly power. The onerous regulation is bad for innovation, sure, but it's also great for any participants already in an oligopolistic market. The participants don't have to worry about innovators, who can't possible comply with ridiculous procedures, entering the market and decreasing profits. This is not unlike the defence industry. Boeing, Lockheed-Martin and Raytheon dominate. The bizarre security clearance and DoD procurement process keep out everybody else.
> we don't have to risk having food poisoning if we choose the wrong grocery store
Yet we still have food poisoning outbreaks. So this is false, no single institution is omnipotent and without error. This is a soluble problem - force institutions to justify their existence, rather than forcing individuals to abide by their rulings.
> if we don't regulate the oligopolistic markets we have in everything today (how many pharma companies are there?) we are in enormous danger of everyone losing confidence in food and medicine supplies. Nobody wants that.
Indeed it is an oligopoly, because of the enforced regulatory regime. So your argument is circular - we need enforced regulation because of the oligopoly caused by enforced regulation.
Pragmatically, I agree that it would be mayhem if the FDA was simply abolished tomorrow. My solution is to abolish their enforced regulatory power and allow individuals to decide for themselves whether they want to give authority to the FDA exclusively or instead heed the judgements of other bodies that might be more competent.
Yet we still have food poisoning outbreaks. So this is false, no single institution is omnipotent and without error. This is a soluble problem - force institutions to justify their existence, rather than forcing individuals to abide by their rulings.
> if we don't regulate the oligopolistic markets we have in everything today (how many pharma companies are there?) we are in enormous danger of everyone losing confidence in food and medicine supplies. Nobody wants that.
Indeed it is an oligopoly, because of the enforced regulatory regime. So your argument is circular - we need enforced regulation because of the oligopoly caused by enforced regulation.
Pragmatically, I agree that it would be mayhem if the FDA was simply abolished tomorrow. My solution is to abolish their enforced regulatory power and allow individuals to decide for themselves whether they want to give authority to the FDA exclusively or instead heed the judgements of other bodies that might be more competent.
Yes, we still have food poisoning outbreaks. No institution is all-powerful or all-knowing. I'm 100% positive we have fewer food poisonings with the FDA than we'd have without it. Your "this is false" assertion is, while technically true, fairly obviously a case of asking for perfection before doing anything.
Given that the Trump administration is scaling regulation of pork products way back (https://www.specialtyfood.com/news/article/trump-administrat...) we get to be part of an experimental test of this!
I disagree with you about oligopoly because of regulations. If we enforced sensible anti-trust laws as we did from about 1900-1960, we wouldn't be in the dilemma of having 3 pharma companies, or 3 grocery store companies, or 1 ISP. Yes, the regulatory environment is a result of capture and oligopoly, but without the regulation, the oligopolies, which have close to zero market forces to check them, would really abuse the consumers. Asserting that this is circular is kind of like saying that without ticks, rabbits wouldn't have need of blood. Ticks, (and/or similar blood suckers) co-evolve with their hosts. Regulatory environments, particularly when the agency has been captured, and I'm sure we can agree that the FDA has been captured, co-evolve.
Given that the Trump administration is scaling regulation of pork products way back (https://www.specialtyfood.com/news/article/trump-administrat...) we get to be part of an experimental test of this!
I disagree with you about oligopoly because of regulations. If we enforced sensible anti-trust laws as we did from about 1900-1960, we wouldn't be in the dilemma of having 3 pharma companies, or 3 grocery store companies, or 1 ISP. Yes, the regulatory environment is a result of capture and oligopoly, but without the regulation, the oligopolies, which have close to zero market forces to check them, would really abuse the consumers. Asserting that this is circular is kind of like saying that without ticks, rabbits wouldn't have need of blood. Ticks, (and/or similar blood suckers) co-evolve with their hosts. Regulatory environments, particularly when the agency has been captured, and I'm sure we can agree that the FDA has been captured, co-evolve.
We tried this and got snake oil and Bayer heroin.
If somebody is fraudulently selling snake oil then prove it transparently in court. If somebody is using heroin then its none of your business.
> If somebody is fraudulently selling snake oil then prove it transparently in court.
I'd rather not live in a society where it takes hundreds, thousands or millions of people becoming sick, injured or dead to eventually bring a class action lawsuit against an entity that was allowed to openly sell snake oil to sick and desperate people for long periods of time.
> If somebody is using heroin then its none of your business.
It's society's business when a drug with a relatively low LD50 that has fatal interactions with alcohol and many common prescription drugs is sold on drug store shelves as a panacea.
Again, we tried this and got Radithor[1] and children's laudanum[2].
[1] https://en.wikipedia.org/wiki/Radithor
[2] https://wellcomecollection.org/articles/WckzzigAACe3DJPD
I'd rather not live in a society where it takes hundreds, thousands or millions of people becoming sick, injured or dead to eventually bring a class action lawsuit against an entity that was allowed to openly sell snake oil to sick and desperate people for long periods of time.
> If somebody is using heroin then its none of your business.
It's society's business when a drug with a relatively low LD50 that has fatal interactions with alcohol and many common prescription drugs is sold on drug store shelves as a panacea.
Again, we tried this and got Radithor[1] and children's laudanum[2].
[1] https://en.wikipedia.org/wiki/Radithor
[2] https://wellcomecollection.org/articles/WckzzigAACe3DJPD
Anti-vax is what happens when people "think for themselves". Medical regulation doesn't solve every problem, but it solves many problems that we would have in addition to our current ones.
I agree with you here, and go much further to include any drug that is not a systemic risk. A systemic risk might be things like antibiotics, because antibiotic resistant bacteria are a systemic risk. My daughter's asthma inhaler and grandma's heart medication are certainly not. Let me buy these things off the shelf without anyone's permission. Hopefully once we get pot legalized everywhere for recreational use, we can move on to everything else.
Sure, there are difficult cases in this domain that require more complex moral reasoning. But as you say, for drugs that are simply an individual putting something into their own body without infringing on others, there is no justification for one group having monopoly authority to decide whether that's "safe".
While the FDA has gotten slightly better in recent years it still suffers from a lack of consumer feedback. They need to be willing to embrace a "move fast and break things" approach with highly-informed consenting patients. They're afraid of another thalidomide but they're willing to let an unlimited number of people die so long as it was disease and not treatment that killed them, which is such utter cowardice.
I don't trust the "move fast and break things" approach with for-profit healthcare.
With open source stuff like this, it works because nobody is pushing this tech for any reason other than it works. But if commercial products were able to move at this rate, we might see a lot of snake oil because companies can be pretty effective at producing misinformation.
This isn't a critique of commercialized healthcare because I think it works, but you do certainly need regulation for it to continue to work
With open source stuff like this, it works because nobody is pushing this tech for any reason other than it works. But if commercial products were able to move at this rate, we might see a lot of snake oil because companies can be pretty effective at producing misinformation.
This isn't a critique of commercialized healthcare because I think it works, but you do certainly need regulation for it to continue to work
> I don't trust the "move fast and break things" approach with for-profit healthcare.
This a million times. At the end of the day, tying money to people's lives instantly means people are willing to do anything (it's basic survival instinct, the most basic of all). Free market absolutely does not work when the customer is "willing to do anything at any price".
This a million times. At the end of the day, tying money to people's lives instantly means people are willing to do anything (it's basic survival instinct, the most basic of all). Free market absolutely does not work when the customer is "willing to do anything at any price".
> I don't trust the "move fast and break things" approach with for-profit healthcare.
This is a non-sequitur. Why is it relevant what you trust or don't trust? You should can be free to conclude for yourself what methodologies you trust, while allowing others to disagree with your judgement given their personal risk tolerance, scientific disagreements, etc. It's one thing to have an opinion on a scientific matter, its quite another to enforce it on an entire nation-state.
> With open source stuff like this, it works because nobody is pushing this tech for any reason other than it works. But if commercial products were able to move at this rate, we might see a lot of snake oil because companies can be pretty effective at producing misinformation.
A company also wants to produce tech that works -- people tend to buy tech that works. If they are lying about their evidence then we already have laws against fraud/false-advertising/tort-law which should be enforced.
This is a non-sequitur. Why is it relevant what you trust or don't trust? You should can be free to conclude for yourself what methodologies you trust, while allowing others to disagree with your judgement given their personal risk tolerance, scientific disagreements, etc. It's one thing to have an opinion on a scientific matter, its quite another to enforce it on an entire nation-state.
> With open source stuff like this, it works because nobody is pushing this tech for any reason other than it works. But if commercial products were able to move at this rate, we might see a lot of snake oil because companies can be pretty effective at producing misinformation.
A company also wants to produce tech that works -- people tend to buy tech that works. If they are lying about their evidence then we already have laws against fraud/false-advertising/tort-law which should be enforced.
Why don't those laws against fraud apply to those companies that sell "power bracelets" or "healing crystals"? Or like 80% of the supplement industry?
Snake oil is sold with regularity under our current false-advertising laws. The impact of that happening in the medical industry would obviously be drastic.
With regards to forcing my opinion onto others- I'll concede that point. This is certainly an infringement of people's liberty and you're right that it's difficult to justify. I think that in this case (medical industry), the ends justify the means. But we certainly need to be concerned of overregulation.
Snake oil is sold with regularity under our current false-advertising laws. The impact of that happening in the medical industry would obviously be drastic.
With regards to forcing my opinion onto others- I'll concede that point. This is certainly an infringement of people's liberty and you're right that it's difficult to justify. I think that in this case (medical industry), the ends justify the means. But we certainly need to be concerned of overregulation.
How do you know "the ends justify the means"? What if I disagree?
Then by all means, disagree. That's just my opinion man.
Any amount of law or regulation will have some amount of citizens who disagree with it. For me, I think that the average citizen should be able to trust the medical community, and I think that the best way to accomplish that is to require the medical community to meet safety standards, and to support their claims of effectiveness with science. And I think that the less regulated parts of the health industry (supplements and fitness) have proven that many businesses will not back their claims with science if not required by law to do so. And that uneducated americans aren't able to see through that sort of nonsense and will purchase from those businesses anyways. This isn't a big deal with something relatively harmless like supplements, but when it comes to medical treatment you could potentially cause a lot of harm.
Any amount of law or regulation will have some amount of citizens who disagree with it. For me, I think that the average citizen should be able to trust the medical community, and I think that the best way to accomplish that is to require the medical community to meet safety standards, and to support their claims of effectiveness with science. And I think that the less regulated parts of the health industry (supplements and fitness) have proven that many businesses will not back their claims with science if not required by law to do so. And that uneducated americans aren't able to see through that sort of nonsense and will purchase from those businesses anyways. This isn't a big deal with something relatively harmless like supplements, but when it comes to medical treatment you could potentially cause a lot of harm.
> Then by all means, disagree. That's just my opinion man.
But it's not just your opinion, because I'm forced to go along with it. If it was just your opinion then we'd have a more just world, where disagreements are reconciled by argument or agreement to go our separate ways, rather than by force.
> I think that the average citizen should be able to trust the medical community, and I think that the best way to accomplish that is to require the medical community to meet safety standards, and to support their claims of effectiveness with science.
Trust is a two way street. In order to justifiably trust some person or institution, I need to know their reasoning for their decisions and decide for myself whether I agree. There can be no trust (and no science) where reasoning is enforced.
> when it comes to medical treatment you could potentially cause a lot of harm
This can be dealt with via non-enforced regulatory bodies that people consent to trusting, and through the court of law if those fail (with basic institutions like innocence until proven guilty, the opposite standard of what the FDA enforces).
But it's not just your opinion, because I'm forced to go along with it. If it was just your opinion then we'd have a more just world, where disagreements are reconciled by argument or agreement to go our separate ways, rather than by force.
> I think that the average citizen should be able to trust the medical community, and I think that the best way to accomplish that is to require the medical community to meet safety standards, and to support their claims of effectiveness with science.
Trust is a two way street. In order to justifiably trust some person or institution, I need to know their reasoning for their decisions and decide for myself whether I agree. There can be no trust (and no science) where reasoning is enforced.
> when it comes to medical treatment you could potentially cause a lot of harm
This can be dealt with via non-enforced regulatory bodies that people consent to trusting, and through the court of law if those fail (with basic institutions like innocence until proven guilty, the opposite standard of what the FDA enforces).
> But it's not just your opinion, because I'm forced to go along with it
Welcome to society? I don't like speed limits so I feel your pain.
> There can be no trust (and no science) where reasoning is enforced.
I'm not sure what your point is here. Is there no science in the current medical community?
>through the court of law if those fail
Unless the judicial system learns how to resurrect dead people, I'm not sure that suing after the damage is done is really going to help victims of malpractice.
In the event of those who aren't killed, only injured, how do you prove malpractice if there are no legal standards of care by which to judge? Even good doctors (or good medical tech companies) can have bad outcomes, so it can't be results driven.
Welcome to society? I don't like speed limits so I feel your pain.
> There can be no trust (and no science) where reasoning is enforced.
I'm not sure what your point is here. Is there no science in the current medical community?
>through the court of law if those fail
Unless the judicial system learns how to resurrect dead people, I'm not sure that suing after the damage is done is really going to help victims of malpractice.
In the event of those who aren't killed, only injured, how do you prove malpractice if there are no legal standards of care by which to judge? Even good doctors (or good medical tech companies) can have bad outcomes, so it can't be results driven.
As the article points out, there's another OSS solution, Loop (an iOS app with a hardware dongle that talks to a few kinds of pumps), that a company is putting through the FDA approval process (https://www.tidepool.org/loop). This seems like OSS working as intended, would be awesome to have the choice of a fast-moving DIY solution (for techies, early adopters, people without insurance) or a warrantied supported option (for everyone else).
The problem isn't that you don't trust it. The problem is you don't trust me to trust it.
I have no problem with you avoiding this. I have no problem with you requiring a certification program to get a little marker that says FDA approved. Then you can go shop those. I can take the risks I want to take.
All I want is for me, a person with a different risk tolerance from you, to choose for myself something higher risk than you would choose for yourself. Instead you choose your risk tolerance as the best mode and impose it upon me.
There are no externalities. I alone will suffer.
Please, for the love of god. All I ask for is 0.07 cubic metres of autonomy. Give me that one freedom. All else is Caesar's. I'll wear a black sash. Or tattoo a red A to my forehead. Just give me freedom over myself, my body.
I have no problem with you avoiding this. I have no problem with you requiring a certification program to get a little marker that says FDA approved. Then you can go shop those. I can take the risks I want to take.
All I want is for me, a person with a different risk tolerance from you, to choose for myself something higher risk than you would choose for yourself. Instead you choose your risk tolerance as the best mode and impose it upon me.
There are no externalities. I alone will suffer.
Please, for the love of god. All I ask for is 0.07 cubic metres of autonomy. Give me that one freedom. All else is Caesar's. I'll wear a black sash. Or tattoo a red A to my forehead. Just give me freedom over myself, my body.
This snake oil market already exists. Supplements. Cupping. Ear candling. Everything sold by Goop. Essential oils. The market exists and it's already killing people like the toxic baby food from a couple years ago.
The difference is that Goop-care, by and large, doesn't really do anything, and the iatrogenic problems are mostly second-order (like, you might get an infection by putting something they recommend --- excuse me for saying this --- up your butt). An artificial pancreas is a very serious, active medical intervention. It has to work, reliably; you can't just hope it will help and that all its bases are covered.
> ... doesn't really do anything
It allows the gullible to avoid seeking real medical care by propping up delusional notions about how to treat an illness.
It allows the gullible to avoid seeking real medical care by propping up delusional notions about how to treat an illness.
Not just the gullible, but the desperate, too.
There's another class of people that fall for this stuff, and I am not sure what label (if any) could apply, but I think of people like Steve Jobs.
Arguably, his diagnoses was essentially a death sentence, because few live long from what he had. That said, I don't think he was necessarily gullible. Desperate? Maybe - who wouldn't be? But he had immense resources at hand, but squandered them on treatments known for being snake oil at best.
Maybe fearful would be proper - perhaps coupled with desperation - leading to easier to take, but less effective (where "less" could equal or be very, very close to zero) treatments, vs the conventional ones?
I could see that, and emphasize on that choice as well.
There's another class of people that fall for this stuff, and I am not sure what label (if any) could apply, but I think of people like Steve Jobs.
Arguably, his diagnoses was essentially a death sentence, because few live long from what he had. That said, I don't think he was necessarily gullible. Desperate? Maybe - who wouldn't be? But he had immense resources at hand, but squandered them on treatments known for being snake oil at best.
Maybe fearful would be proper - perhaps coupled with desperation - leading to easier to take, but less effective (where "less" could equal or be very, very close to zero) treatments, vs the conventional ones?
I could see that, and emphasize on that choice as well.
This is a good point, and very true of Goop-style products. But I have to say, it's hard for me to reserve much charity for the way US medical regulation operates.
Homeopathic medicine got a special exemption from FDA coverage, freeing them from basic standards like filing new-drug applications and testing finished preparations for strength and purity. Most of them are just water, but some retain enough strength and toxicity to do serious first-order harm, and many are marketed for treating serious conditions that absolutely need real treatment. It took 80 years to start making progress on that ludicrous exemption, while snake venom applied and antibiotics forgone inflicted untold harm.
At the far end of the spectrum, medical devices are intensely regulated but medical procedures aren't. A mobility-assist for putting socks on has to be marketed with goofy infomercials to steer clear of FDA burdens, but a new approach to treating fibroid tumors can be deployed with no long-term studies - and then turn out to rapidly progress minor cancers to metastatic ones, and then stay in regular use with no informed consent while doctors debate.
None of this means drug regulation lacks merit, or should be pared back without serious planning and study. But the current state of affairs is so absurdly arbitrary, and so covered in the scars of ancient political squabbles, that major improvements look not only possible but obvious.
Homeopathic medicine got a special exemption from FDA coverage, freeing them from basic standards like filing new-drug applications and testing finished preparations for strength and purity. Most of them are just water, but some retain enough strength and toxicity to do serious first-order harm, and many are marketed for treating serious conditions that absolutely need real treatment. It took 80 years to start making progress on that ludicrous exemption, while snake venom applied and antibiotics forgone inflicted untold harm.
At the far end of the spectrum, medical devices are intensely regulated but medical procedures aren't. A mobility-assist for putting socks on has to be marketed with goofy infomercials to steer clear of FDA burdens, but a new approach to treating fibroid tumors can be deployed with no long-term studies - and then turn out to rapidly progress minor cancers to metastatic ones, and then stay in regular use with no informed consent while doctors debate.
None of this means drug regulation lacks merit, or should be pared back without serious planning and study. But the current state of affairs is so absurdly arbitrary, and so covered in the scars of ancient political squabbles, that major improvements look not only possible but obvious.
Those are markets with much less regulation than the medical market. If we deregulate medical tech we risk our medical tech market reaching similar levels of degeneracy.
That, to me, is a pretty solid argument in support of the parent -- that deregulating medical devices will strongly benefit the scammers you mentioned, rather than benefiting patients desperate for something to help.
> it's already killing people
Are the products mentioned, vitamins, cupping, and ear candling, significant contributors to death anywhere in the world? How many are being killed?
Are the products mentioned, vitamins, cupping, and ear candling, significant contributors to death anywhere in the world? How many are being killed?
Cupping and ear candling almost certainly aren't killing people directly. Alternative-medicine vitamin use has a significant death toll, but not an active one; high-dose vitamin regimes are commonly pushed as a cancer treatment, keeping people from effective treatments during early stages.
Homeopathy mostly kills people in the same negative sense of effective treatments skipped, but every so often it does actively cause a bunch of deaths. Several different companies have sold homeopathic medicines for infants with potentially-lethal levels of belladonna in them; the sort of thing which might be prevented if homeopathic drugs didn't have a special exemption from FDA rules around testing purity and strength. More commonly, homeopathic medicines for adults like ear and eyedrops end up causing deafness and blindness.
These things aren't especially common killers, and if the comment above was implying that alternative medicine's existence means the FDA doesn't serve a purpose, that's absurd. But the narrower point is a good one: in a country where there are special legal protections for people who peddle neurotoxins to cancer patients, it's not so wild to suggest that our regulations could be greatly improved by obvious changes.
Homeopathy mostly kills people in the same negative sense of effective treatments skipped, but every so often it does actively cause a bunch of deaths. Several different companies have sold homeopathic medicines for infants with potentially-lethal levels of belladonna in them; the sort of thing which might be prevented if homeopathic drugs didn't have a special exemption from FDA rules around testing purity and strength. More commonly, homeopathic medicines for adults like ear and eyedrops end up causing deafness and blindness.
These things aren't especially common killers, and if the comment above was implying that alternative medicine's existence means the FDA doesn't serve a purpose, that's absurd. But the narrower point is a good one: in a country where there are special legal protections for people who peddle neurotoxins to cancer patients, it's not so wild to suggest that our regulations could be greatly improved by obvious changes.
> homeopathic medicines for infants with potentially-lethal levels of belladonna
> More commonly, homeopathic medicines for adults like ear and eyedrops end up causing deafness and blindness
Homeopathic, or "natural medecines"? I'd have trouble believing that literal water was making people blind, or that literal water had lethal level of belladonna in it.
> More commonly, homeopathic medicines for adults like ear and eyedrops end up causing deafness and blindness
Homeopathic, or "natural medecines"? I'd have trouble believing that literal water was making people blind, or that literal water had lethal level of belladonna in it.
Homeopathic. I was shocked too. Hyland's homeopathic teething tablets contained belladonna, and the strength of different batches varied from placebo to lethal.
Most homeopathy is literal water, but there's a section of the market offering low-dilution preparations ranging from 1:10,000 to 1:100. Given the "like treats like" logic, some of the active ingredients are sufficiently nasty to do real harm at 1:100 or lower. And given the exemption from batch-strength testing, some preparations are substantially stronger than intended. (As far as the ear drops, that seems to mostly be a matter of contamination or infection. Which is a secondary harm, but again one that can occur because those companies are exempt from many standard testing practices.)
https://www.fda.gov/news-events/press-announcements/fda-conf...
https://www.fda.gov/news-events/press-announcements/fda-warn...
Most homeopathy is literal water, but there's a section of the market offering low-dilution preparations ranging from 1:10,000 to 1:100. Given the "like treats like" logic, some of the active ingredients are sufficiently nasty to do real harm at 1:100 or lower. And given the exemption from batch-strength testing, some preparations are substantially stronger than intended. (As far as the ear drops, that seems to mostly be a matter of contamination or infection. Which is a secondary harm, but again one that can occur because those companies are exempt from many standard testing practices.)
https://www.fda.gov/news-events/press-announcements/fda-conf...
https://www.fda.gov/news-events/press-announcements/fda-warn...
k, makes sense! There's so many people who think homeopathy and naturopathy is one and the same that I thought its what was happening here. Fascinating (and horrifying!) situation you describe, though!
About 6 months ago I realized that as more and more people found out about this (and Atlantic publishes articles about it...) these pumps were going to be harder to find. I immediately scoured craigslists across the county and spent an inordinate amount of money to buy three of these pumps, because once they break, it's game over.
I can't imagine having to go back to the old way, it actually scares me.