People Are Clamoring to Buy Old Insulin Pumps
theatlantic.com
theatlantic.com
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.
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 But the entire setup depends on scavenging outdated pumps and importing unapproved devices.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.
Yes. You have no idea.
[1] https://www.instructables.com/id/Open-Source-Peristaltic-Pum...
It can also quite easily kill you in your sleep if you mess up the implementation, so ymmv.
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.
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?
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 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 fact that no one has done so speaks volumes.
Most days are good days now though!
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.
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 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.
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.
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 ?
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.
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.
Because he had enough of a sense of ethics to want to avoid performing a risky test on others, possibly killing them.
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.
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.
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.
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.
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
What makes these outdated Medtronic pumps so desirable is, ironically, a security flaw. Boss was looking for a pump or two he could hack.
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.
"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,"
Edit: Even with the new lines, I need to scroll.
Nothing really to say other than that, but that I appreciate all the interest the community shows towards those with chronic illnesses.
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've lost family members prematurely to T1D and a simple upvote didn't seem enough :)
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.
[1] https://www.hanselman.com/blog/OpenSourceArtificialPancrease...
Is it really risk aversion? Or is it a culture whose first value is profit-by-regulatory-capture?
Also check out Anthony Di Franco's open insulin project.
Then people could fly there for a brief holiday, buy the device, and bring it back to the US legally.
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.
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.
Who knows what could be accomplished if we just had root access to more of our technology.
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.
Most people confuse the two. If only they'd chosen better names to differentiate them.
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.
Not actually sure if the water diabetes effects humans. Its not too uncommon in dogs though.
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.
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.
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.
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.
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.
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.
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.
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.
Who is banning anyone from doing their own research or thinking? Not the FDA, as near as I can tell.
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.
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.
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.
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
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
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 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.
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.
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.
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).
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.
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.
It allows the gullible to avoid seeking real medical care by propping up delusional notions about how to treat an illness.
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.
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.
Are the products mentioned, vitamins, cupping, and ear candling, significant contributors to death anywhere in the world? How many are being killed?
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.
> 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.
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...