intellectual property vs safety?
I sent the following letter to the FDA and a similar one to the EFF. Many of you may not realize that insulin pumps that ship with a radio have a suite of commands that we can use to fix bugs in the therapeutic software and share/download data and logs with ease. Medtronic and the other vendors refuse to give us access to knowledge we need to make our therapy safe.
Please join me in contacting the FDA, who recently acknowledged the dangers of not having enough information to manage therapy, along with your pump vendor in order to demand access to the data we need on an ethical basis. Medtronic has told me that I will need lawyers in order to get the information we need. I am beginning to become convinced that a class action suite is indeed necessary.
TL;DR: Insulin pumps ship with features supported by the manufacturer to reduce the adverse events you've been facing, but refuses to let you have access to the information needed.
Here is the letter I sent.
-bewest
https://github.com/bewest/insulaudit/blob/master/questions/fda.mark...
-----------%<-------------------- Howdy, My name is Ben West, I'm a type 1 diabetic using an insulin pump and other gear made by Medtronic. The insulin pump infuses me with insulin using suggestions generated by special therapeutic software whenever I manually intervene, and on an ongoing basis.
The pump automatically keeps logs of its behavior I need in order to monitor and manage my ongoing therapy. In the process of setting out to reverse engineer the protocol https://github.com/bewest/insulaudit in order to audit my logs, I discovered that the protocol includes a suite of commands that can be used to control the pump's primitives.
The pump's therapeutic software has bugs that require me to use folk-lore passed to me to manually override the suggestions with newer "safe" suggestions without the support of science or software. Without constant action to manually over-ride the pump, the pump will give me the incorrect amount of insulin, causing insulin reactions and in some cases even contributing to severe hyperglycemia requiring hospitalization.
The FDA recently acknowledged the safety problems involved in pump therapy: http://www.fda.gov/ForHealthProfessionals/ArticlesofInterest/ucm295... Many patients are actively harmed by lack of access to epistemic certainty of what to expect from their therapy. Eg, the fidelity of their care is poor because they are prevented from empirically understanding their own therapy or ensuring its safety. This lack of access provides the largest vendors with a market absent of competitors, ensuring they can always sell new pumps and other products in ways they can control. The priorities giving them this position in the market also create dangerous and unethical scenarios that I and other patients could fix or work around if only we had access to the right information.
I need the ability to inspect the device for bugs, to monitor it's ongoing behavior, and to use the primitive capabilities of the device as recommended by my doctor. Without this, I'm constantly suffering from incorrect dosages of insulin. There are some well known examples of this that many doctors will be familiar with, such as the life time of active insulin. The variable representing this value was hardcoded into early production models, ensuring an incorrect bolus. Software using the remote diagnostic protocol could circumvent the on board therapeutic dosage generator without modifying the device in any way, using commands they support with their remote control product to generate safer suggestions on demand, and could allow patients to audit logs without vendor software.
I've called Medtronic and repeatedly asked for access to documentation of the remote diagnostic protocol, and for access to the firmware so that I can analyze it for safety and provide tools to verify expected therapy outcomes. They have denied my request every time without arguing the merits of my request, simply admitting that it's proprietary. I want to make clear I am not talking about servicing or modifying my insulin pump. I am talking about the ability to correctly calibrate and fill my syringe, something Medtronic has expressly prevented me from doing. The vendor is preventing access to information necessary for safe therapy, and has employed bundling and misinformation on the technology in order to shape the market place in their favor at the cost of safety.
Originally I believed I only needed access to my own medical data and ended up discovering that the device has the capability to work around faults in the on board therapeutic software. I'm sick of suffering from insulin reactions and need access to the protocol in order to safely administer my therapy. Can anyone help? The FDA report http://www.fda.gov/ForHealthProfessionals/ArticlesofInterest/ucm295... confirms that lack of epistemic certainty regarding therapy results in harming patients. It is a reflection on Medtronic that they refuse to share the knowledge needed to prevent these adverse events.
I shouldn't have to reverse engineer my own medical data. I don't understand how they can get away with doing harm to people this way. I believe it is their intent to work with industry groups to allow read-only access to filtered feeds, and few people will even know that bugs in the device can be mediated using capabilities the manufacturer supports. I cannot abide allowing someone to give insulin to me without empirically investigating their methods, it's just too dangerous.
-bewest
Ben West
San Francisco
http://openaccess.city.ac.uk/1069/1/1oo2-revised-13apr11.pdf
Replies to This Discussion
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Permalink Reply by Bradford on -
I'm still struggling to understand how having access to a bunch of code, or even more, access to a bunch of zeros and ones, is going to help me make better judgments in my diabetes management.
In that link to the other forum you say, "I happen to be using a MM522, which has both adjustable sensitivity and duration. However, I still observe lows due to incorrectly calibrated bolus corrections. The FDA report I've linked to mentions user error as the reason for the majority of adverse events. I don't know how medicine works, but in software, we don't blame users whenwe give them difficult tasks, we figure out a way to make the impossible possible and the difficult easy."
I do not see how just using the pump as it is currently configured is not the root cause. I think that's your perspective too which is why you want to change it, but I'm struggling to understand your method of trying to correct that functionality.
For example exercise is a HUGE mitigator in the context of insulin sensitivity and perhaps even duration. If I go ride my bike for 4 hours and get in a 75 or 80 mile ride of pretty hard effort, my sensitivity is going to be through the roof. Additionally, if I were to wear my canula in my thigh or upper butt, directly near the muscles that I just used heavily for 4 hours, then I'm going to have not only increased insulin sensitivity, but also perhaps a shorter duration of action b/c the insulin will be actively taken up through the muscles much quicker b/c of the proximity to the canula (as upposed to the stomach or upper arm that were less used, for example).
Yes the same formula that I used the day before to calculate insulin doses (that the pump uses all the time) is going to "over bolus" for me if I decide to eat x amount of carbs after my ride, and bolus for x amount of carbs as well. It is inherently flawed b/c there is NO way for that pump to know that I'm more insulin sensitive. It's not a pancreas. It's a pump. That is outside of its capability because of the endless number of factors that may come into play.
But to say that we as consumers should have the ability to rewrite the code each and every time we feel like it seems a bit far fetched. We aren't typically well versed in how to speak/write in code (unless you have formal training, which most don't) so just "giving us the keys" to the shiny convertible stick shift in the driveway when we have never driven a car of that type or with that much horsepower is clearly a bad idea (even though we know how to drive our old clunker car and they're "pretty much the same thing"...we both know they're not).I get the concept that using the same formula all the time has its potential down sides. However, until newer technology is developed that allows for an understanding of things like exercise, GI load of food, other hormone levels (for example the time leading up to menstruation for females each month causes a huge influx in other hormones that can change the insulin sensitivity/effectiveness), etc, then we must learn to work with the system we have. So on days when I go ride 80 miles, I look at the plate of food afterwards and I decide not to bolus for the entire amount that it suggests. I also decrease my basal rates to help with my increased sensitivity, not only during the ride but also for hours afterwards.
I think if you would like to work on that next generation of pump (the one that allows for additional factors to be considered, over and above insulin duration, insulin sensitivity, I:C ratios, etc) then perhaps it would be best to seek a job with a current pump manufacturer (or perhaps invest in your own start up company?) so that you can work on those things.
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Permalink Reply by acidrock23 on -
Changes due to activity are one reason I'm not thinking an artificial pancreas is entirely realistic. It seems likely to get "calibrated" in a "medical setting" which seems, in turn, to be unlikely to accomodate DP, exercise, stress, hormones and other factors that can push BG up and down. Or simply "changes" that occur from time to time.
In my experience, doctors faced with a "problem", whether it's too many lows or highs or whatever, will first look to check the data to see to what degree there's a "user error" involved. If there's a user error, I think many doctors/ CDE/ etc. may "default" to "my plan was correct, they just aren't sticking to it" and send me off to the CDE to talk about eating more carbs. I, like Bradford and a lot of other users have discussed, find it pretty easy to adjust my pump based on numbers with the buttons involved. Duration, sensitivity, ratios and rates are about the only "controls" we need. Access to the data isn't going to give you any more "tools" with which to adjust your BG. I don't see Medtronics making their code available. Re the "I have an older model pump" issue, their business model will support them but it's not really set up that way, they want you with their most current pump as, I presume, it will cost them less to support it?
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Permalink Reply by Brunetta on -
. It's not a pancreas. It's a pump.
Well said, Bradford, and the absolute truth.
There is no way the pump will automatically always give us accurate dosages, even if we manually override the" bolus wizard" suggestion; or whatever your pump's bolus system is called. We have to do as both you (Bradford)and Acidrock have suggested,and take into consideration the multiple variables that ultimately effect current glucose sensitivity and response to carbs.
Ben, those on the pump ALL "observe lows due to incorrectly calibrated bolus calculations". It happens. Happens to me. I treat, adjust basals if necessary, taking into consideration years of prior experience,remembering logging info, Carelink data, CGMS trends: We treat/bolus/adjust, and keep on going. I do not know if you are recently diagnosed or hypo-unaware. As I am neither, I do not mean to sound callous nor misunderstanding . But just Live with it, hon.. Access to the data isn't going to give you any more "tools" with which to adjust your BG , wrote Acid. The pump is a pump and we, as users, are not automatrons who will always make the "right" dosing decisions that will never send us low. It is just, as I mentioned before in this thread, "Living it up in the Hotel Diabetes". We LIVE with it, do not fret, and keep moving.God Bless,
Brunetta
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Permalink Reply by Brunetta on
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Ben, I just read your link to the SWP site. I now think I understand your motivation. You really are capable and have designed a device(s) that will access the data and allow you to make many of the changes you desire.. you just want to have access to some of the more specific controls that MM has "proprietary' restrictions on. Am I correct in stating this? You are a self-avowed "hacker" and LOVE doing that. All good as long as no one else's systems are being maligned, and I am sure you are not doing that.
I just do not want you to stress about it....
God bless,
BrunettaPS. I have found No problems with access to the Carelink Software on my current or prior computers.
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Permalink Reply by bewest on -
You are correct. I am able to dramatically improve therapeutic outcomes by applying simple technology that already exists today. I can allow other vendors to bring better solutions to market. I can even help advertise Medtronic's solution as the safest, if the facts support this. However, I can only do that if I can get access to the data.
Currently, if I die from an adverse event, it will be called user error even though I don't really have any control over the device and am not able to debug problems with my therapy. I'm actively prevented from doing this, but any problem will be labeled a user error. People are currently dying, and as our friends mentioned earlier have problems every single week.
The solutions I'm trying to advocate put the user of the pump up front and center and in control with explicit confirmations and opt-ins along every step of the way. Currently, it feels like the vendor is intervening in the clinical loop between me and my doctor without really explaining what they are doing or allowing me to debug it or inspect it properly.
At work I help implement a sophisticated dashboard to monitor real time stats and behavior of routers, switches, and wireless end points. I'm intimately familiar with what is possible in controlling and managing our therapy with utmost precision, but only if I can get access to the controls. I'm not whining about the poor state of the current technology, I'm simply arguing for an opportunity to manage my own medical data. It's my data!
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Permalink Reply by bewest on
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There is a well known trend when evaluating technical solutions to blame the users when something goes wrong.
http://www.infodesign.com.au/articles/themythofthestupiduser
The situation we find ourselves in is one which the FDA has identified regular usability problems. My claim is that this is due to the controls being secret, and that it appears to be a deliberate choice.
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Permalink Reply by bewest on
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The more data we have, the better we can understand our therapy. The data will show which parts of our therapy can be improved and which parts are going as expected. I think that's a pretty simple premise.
Right now, we have no access to our own data without using proprietary software. This has nothing to do with new features, just with getting access to my own medical data.
For those of you who grow your own food, would you buy the produce you grow at the gas station, or would you go to your garden? I happen to grow my own software and information instead of food. Why should I be blocked from accessing my own data? It's my data and I need independent access to it in order to better understand my therapy.
It's a reflection on the vendors that they refuse to share such critical information while people suffer. The two are directly related. The opacity of their intervention in the clinical loop between my doctor and me is causing harm.
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Permalink Reply by coldsoup on -
Great idea! Having open communication between the pump's history and current activities and any other device would be a great feature for grabbing logs for a doctor and cross-referencing with other things such as a calendar and credit card bill to see what exactly causes highs and lows. I'm also a software and hardware geek and would be able to make some apps to do this if only there was an easy-to-get source of data.
I have a family member who has a pump and we tried to install the Carelink software on my computer-- it doesn't work for me either!
Medtronic (and other manufacturers) don't actually need to create useful apps if they would do what other hardware manufacturers do and give users access to an open device interface.
For those that still don't seem to understand, here's an anology... Consider an iPhone. The request here is for an interface that allows people to create apps that work with the device, not peprogramming the device. Phone manufacturers are all about this kind of thing! I'm more of a hardware guy and I can attest to the fact that really useful products happen when hardware manufacturers make it easy to work with the hardware. I've done some tinkering with BGMs and can attest to the difficulty of working with them (from a technical standpoint).
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Permalink Reply by Todd Foster on -
Bewest, I have tried to make since of your request and it seems that you are blaming the pump companies for your problems. But after reading the fda report it seems that they point the problems to pt being placed on the pump by their ENDO when the pt has no understanding of the pump, carb counting and proper diet. I could be wrong but can you imagine the liability of the pump companies if they gave out the information you are requesting to everyone. What if someone made a change and they died from that? What if they give you the information and you make a mistake that ends up causing you more trouble. Then you would be blaming them for giving you the option of being able to make the changes? But here is a portion of the FDA report that I gather they are blaming the problems on lack of training and misunderstanding. If you are unhappy with the pump my advise is to stop using and go back to the MDI. Just saying
CDRH and AACE's assessments indicate patient errors in the use of insulin pumps appear to be the cause of the adverse events associated with these devices. Prior to pursuing insulin pump therapy, patients must master and understand the use of insulin in basal/bolus therapy, carbohydrate counting and logging, interpreting numbers and trends, etc. in order to optimize the treatment regimen. Insulin pump users must be well trained in the use of the pump, both initially and throughout their pump treatment and receive continued education in balancing food, insulin and activity levels. Proper extended follow up care by the health care provider is necessary in order for diabetes management goals to be achieved and sustained. Additionally, the provider of the insulin pump should be well educated and trained on the benefits and limitations of the device. (1, 2)
Patient selection should be based on numerous factors such as maturity, psychological and behavioral factors, which play a vital role in the patient's ability to adhere to the medical treatment regimen. Most of the current seven pump manufacturers appear to actively engage with health professionals in providing patient education, guidelines for patient selection, patient and provider support for their products. The pump manufacturers, Animus Ping, Accu-Check Spirit, DANA Diabecare, Deltee Cozmo, Insulet Omnipod, Minimed Paradigm, and Nipro Amigo provide important phone support, but it is limited since the support personnel neither prescribe the insulin doses nor are directly involved in the patients' care. (3-9)
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Permalink Reply by bewest on
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Thanks for mentioning user error again. This is a common mistake people without technical experience make. Most engineers are forced to take ethics classes that cover this material.
I don't know about medicine, but in software we value the humanity of our users above our investment in our technology. The report communicates that many users of the pump find it easy to make dangerous mistakes, agreed?
The previous posters have already mentioned their own struggles taming the pump while writing "loopy" messages, while shopping, exercising, and even every weekend. I haven't mentioned these problems, the dear community here has volunteered them for me.
Here are some facts that may not be well understood:
* Pump manufacturers are currently protected from liability.
* People have already died and continue to be harmed because insulin therapy is inherently dangerous.
* Pump manufacturers, syringe manufacturers, and other medical "business associates" are protected from liability because of FDA approval, regardless of how I use their equipment. Having technical information or independently reading logs doesn't change this.
* The logs of your therapy, how, when and how much insulin was given, are not considered part of the therapy by the vendors. This claim historically has put the data out of scope for the FDA regulation.This last bit turns out to be the reason the vendor is allowed deny us access to the logs. However, what doctor would prescribe tweaks to an insulin regiment without looking at the past results? Would you dose insulin without doing a glucose test? Of course the data is part of the therapy. Brandon and others have done an excellent job of explaining how we need to independently consider all aspects of our therapy before making changes and while making therapeutic decisions.
I believe HIPAA grants me access to independently reading my pump's logs. The logs are necessary to better understand and control therapy. It's a violation of my human rights to deny me access to my own logs on my own device originating from my therapy.
One of the first things I will do with the access is write a program to upload the data into the government's own open-source EHR system for free. This will be done shortly after uploading the data to glucosurfer.org and similar sites to help my doctor and I share the same view of my therapy. These are things the vendors have no incentive to do. Innovating ways to visualize our therapy and communicate its details with caregivers can only help us, but it's only possible if we have the ability to independently read the data.
This isn't about blaming anyone for anything, it's about engaging therapy to the best of my abilities. If the vendor is preventing me from using my ability to make therapy better, I think that's a rather shocking reflection on them, especially when so many people clearly suffer from a dearth of knowledge created by them.
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Permalink Reply by Brunetta on
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Ben, you wrote: "The previous posters have already mentioned their own struggles taming the pump while writing "loopy" messages," HAHA.. I have never tried to "tame" my pump; adjust it, but not tame it. NOT that "wild" to me...And I probably cannot be "tamed" either-LOL I was "loopy" when moderately low while on MDI, as well.. Sweetie, I know what you are trying to do .. You love doing that kind of technical stuff; and an app for pump-generated data that is user-friendly would probably be VERY cool for some. But I am not a tech-head and could probably take it or leave it. If it was low-cost,simple to use, and if I had a smartphone, I would go for it. But I prefer the simple life and can get good control by following the basics.. My low "loopies" do not bother me as long I am safe.. and I am 95% of the time.
Keep up your work..It will benefit those who choose to take advantage of the possibilities..
Take care,
God Bless,
Brunetta
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Permalink Reply by HPNpilot on -
Look guys, bewest's mumbo jumbo about safety is simply a pretext to get the FDA to force the manufacturer to document the radio APIs. He's obviously an engineer or programmer and wants to use the interfaces so he can control the pump remotely from a computer.
If you have access to the API's (programming interfaces , or "commands", if you will) you can write your own control software on a phone or laptop, etc . This would allow one to develop/experiment with artificial pancreas algorithms (if you choose to integrate with a CGM , etc) just like other researchers do. it would also let one choose one's own algorithms instead of the pump algorithms, etc.
For example, you could create a non-linear IOB calculation that more closely matches the insulin response in your own body to a specific type of insulin, rather than the simple-minded "duration" parameter most pumps gives you.
In short, he is using the argument of safety to get access so he can do what he wants with the pump.
I personally think it is a great idea.
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