

If We Told You That, We Would Have to Shoot You - ubasu
http://www.whattofix.com/blog/archives/2010/06/if-we-told-you.php

======
jdietrich
Frankly, this is an example of everything that's wrong with healthcare in the
US and much of the developed world.

The textbook OSA patient is a middle-aged man with a short, thick neck. OP is
a middle-aged man with a short, thick neck. I'll bet dollars to doughnuts that
OP is also hypertensive. In such a presentation, there is a very simple
initial prescription - lose weight, drink less alcohol, quit smoking, get some
exercise, see me in six months. In nearly all cases these simple lifestyle
changes cure the OSA, yield a huge array of other health benefits and cost
nothing. CPAP is only indicated if either the patient still has symptoms after
reducing their neck circumference, or is somehow unable to lose weight.

The only thing that went wrong in OP's case is that his primary physician
yielded to demand for a quick fix, rather than making the correct prescribing
decision. OP would rather sleep on a respirator than improve his lifestyle.
I'm not blaming him, it's a cultural problem, but it's one that will kill us
all and lumber us with an impossible burden of healthcare costs.

Consider this: The leading cause of limb loss in the developed world is type 2
diabetes. Mull that thought over for a moment, let it percolate. Most cases of
type 2 diabetes are preventable through simple lifestyle changes. Most cases
of dysvascular amputation can be prevented by better management of blood
glucose levels. People are having their feet cut off because they are unable
to appropriately manage their most basic physical needs. That thought is what
disturbs my sleep.

~~~
mynegation
Sometimes, like in this case, quick fix is sorely needed to even get started
with long fix. If you are sleep deprived and have hypertension, there is just
not enough energy to do exercise or seek or cook healthy food.

As for the weight - I can only offer anecdotal evidence: OP's problems are
likely aggravated by weight, but it may well be that there is a muscle problem
as well. My BMI (weight in kg divided by height in meters squared) during
different periods of my life hovers around 25 - just between healthy and
overweight. According to my wife, once my BMI is below 25 I stop having
episodes of snoring at night and the more my BMI goes over 25 the more snoring
I do.

------
DanBC
The system does sound incredibly frustrating. It definitely needs some fixing.

But some of what the author mentions are sensible and reasonable restrictions.

> _I can't breathe at night -- it's not being fat, although I am, it's that
> for some reason the muscle tone in my neck sucks._

How does he know? Losing weight is effective for many people with OSA.

NICE[2] have guidance for OSA and CPAP which specifically mentions obesity and
the need for lifestyle changes before CPAP is used.

([http://publications.nice.org.uk/continuous-positive-
airway-p...](http://publications.nice.org.uk/continuous-positive-airway-
pressure-for-the-treatment-of-obstructive-sleep-apnoeahypopnoea-ta139))

> _You'd think sticking a mask on your face would be fairly simple to learn_

The mask has to push air down an obstructed airway. Obviously it has to fit
correctly. As for masks being easy to fit - see almost any facemask and check
for the nose strips.[1]

> _So I went to the doc and told him my problem. Told him I needed a CPAP_

Imagine you're a doctor. You pay millions for liability insurance. Some guy
turns up and self diagnoses his illness. Do you accept that diagnosis? Or do
you follow recommended procedure for that illness? (I accept that the
recommended procedure is broken because of insurance).

> _My wife and I have been observing the symptoms for years, we're done the
> research, and now it is time for action._

See, for example, Morgellons or Chronic Fatigue or Myalgic Encephalitis or MMR
vaccinations where people have spent years doing the research and have arrived
at very wrong conclusions and want useless, or harmful, medical interventions.

[1] correct: ([http://www.molnlycke.com/us/Surgical-Products/Product-
Select...](http://www.molnlycke.com/us/Surgical-Products/Product-Selector---
Surgical-Division/Tabs/Products/Face-Mask---Extra-Comfort/?activeTab=1))
{stupid image, sorry)

incorrect: (<http://www.sciencephoto.com/media/101522/enlarge>)

[2] NICE is the organisation in the UK that assesses cost effectiveness of
treatment options. It's important not to waste money on ineffective
treatments; it's important to use a cheap treatment if it's as effective as an
expensive treatment.

~~~
tripzilch
> it's not being fat, although I am, it's that for some reason the muscle tone
> in my neck sucks

hehe, jeez, I really wonder why "for some reason" the muscle tone in his neck
sucks ...

that said, having to repeatedly pay $2k for sleep studies that tell you
nothing new before you get any treatment is really crappy. even if the first
type of treatment should be a dietician and a personal trainer, not a fancy
machine.

and _even then_ , if you have a fancy machine that is doing important health
related tasks for you (possibly you're even trusting it with your life), I
don't think there should be _any question whatsoever_ about the user of said
machine being allowed to know _exactly_ how this machine works.

as for liability, just have people sign off on the liability if they make any
modifications or change settings to the machine since the last checkup by a
medical expert, if you make modifications it becomes your own responsibility,
that only makes sense.

------
ars
These guys can help: <http://www.apneaboard.com/>

They have info on adjusting lots of models of machine. And there is nothing
actually illegal about doing so for yourself.

You don't really need a sleep study with an APAP machine since it does it
automatically. So what you do is find a friendly doctor to write a
prescription, then go to <http://cpap.com/> and buy your own machine.

Legally any doctor can do this, you don't need a specialist. Some are willing
to prescribe based on symptoms without needed a sleep study.

And by buying the machine yourself you can research it to pick the best one
instead of what the medical supply house picks for you.

These laws are incredibly annoying, but there are ways around it - while
staying legal!

I remember once seeing a bottle of sterile water (for a humidifier) that said
"By prescription only. Only for use by, or under the advice of, a Doctor."

Apparently by writing that they can charge more money for it, and insurance
will pay for it. But if it's over the counter (remember we are talking about
water here) insurance won't pay.

------
ezyang
Suppose you have a system, but for legal liability reasons you cannot have
this system be open to users (say it's a medical system, and having untrained
people fuck around with it messes with certification.) However, you make it
reasonably easy for users to override any interlocks (i.e. put in no
protection).

A user finds out about the override, hacks their device, misprograms it, and
dies.

Is the company that manufactured this device legally liable for this death? If
they _knew_ that it was easy to override the safety interlocks, are they then
liable? How about if there was demonstrable evidence that the knew about the
_specific_ override? What if they, in an informal capacity, spread information
about how to do the override?

Here is a parallel situation: same company makes a device, and has locked it
down so hard that it's not possible to actually get anything done with it.
Nurses and other trained practitioners know that "the usual way of business"
is to override some of the safeguards, because, of course, that's the only one
anyone ever gets any work done. However, the company disclaims all legal
liability in the case that someone does such a modification. Are they allowed
to disclaim that?

It's complicated.

~~~
shabble
This has happened, to some extent:

At the Instituto Oncologico Nacional in Panama, some doctors discovered that
they could fudge things to circumvent some limitations in the software that
calculated shielding block geometry for radiotherapy patients.

In essence, the system could only handle 4 blocks, but it was possible (and
sometimes correct) to add more than one block as a single shape. If this
happened in the wrong order, however, it would screw up.

The staff in charge were brought up on civil (and possibly criminal)
negligence charges, from what I recall.

Edit: Yep, according to
[http://www.scielosp.org/scielo.php?pid=S1020-498920060008000...](http://www.scielosp.org/scielo.php?pid=S1020-49892006000800014&script=sci_arttext)

[search for "Legal actions" heading]

" _On 18 November 2004 it was announced that one of the physicists was
acquitted, but the other two were found guilty, sentenced to four years in
prison, and barred from practicing their profession for seven years (45). They
have initiated an appeal process, but they are very worried, given the
precedent established by the Costa Rica case.

The [...] Costa Rican physicist [...] was accused of negligence in 30
homicides and 59 radiation injuries. He was also accused of falsifying
documents and of using false documents. On 30 July 2001 he was absolved of the
latter two charges, but he was found guilty of 14 homicides and 50 radiation
injuries. He was sentenced to six years in prison and barred from practicing
his profession for five years._"

[1]
[https://en.wikipedia.org/wiki/Instituto_Oncologico_Nacional#...](https://en.wikipedia.org/wiki/Instituto_Oncologico_Nacional#Accident)

~~~
ars
It's quite different to do this for yourself vs for other people.

------
VBprogrammer
A lot of his complaints remind me of a situation I'm sure everyone here is
familiar with:

Client / Non-technical Manager: I looked it up on the interwebs and we should
use [MongoDB / Node.js / Java / C++ ...] for [Completely inappropriate problem
space].

You: But that technology doesn't fit our problem space and / or we have no
domain knowledge of that technology.

Client: The interwebs said it was the fastest hipster technology around it
would be stupid not to use it. You just want to charge your extortionate rates
analyzing the problem just to come to the same conclusion.

You: ....What?!

I'm not saying there isn't anything wrong with the medical profession, and the
US seem to have fostered a special brand of messed up in there healthcare
system but suggesting that the doctor should just agree with the patients own
diagnosis, or worse the the patient should just self medicate, seems like a
crazy thing to advocate.

~~~
ScottBurson
I think it's more complicated than that. Sometimes the patient is forced to
become the expert on his/her condition. Doctors don't always have the
expertise, and the system doesn't encourage them to spend the time required to
understand truly difficult cases.

Yes, I'm sure patients sometimes get weird ideas in their heads, but doctors
are far from perfect as well. I think patients should definitely study the
literature and bounce what they find off their doctor. Ideally the doctor is
both open to new ideas and capable of ruling out the obviously silly ones. Of
course I have to qualify that by adding that occasionally, the obviously silly
idea turns out to be right.

------
Derbasti
Very simply, the medical system can extract as much money from the patient as
they want. The worse the illness, the more the patient will pay. Because the
alternative is death. Health care is not a matter of supply and demand, it is
a matter of life and death. Patients will give you the shirt off their back to
avoid death. It's just not fair.

That is why strong government regulation for health care is a good idea.

These things run far more smoothly in countries with a public health care
system. There, doctors typically get a fixed amount of money for each kind of
illness. Hence, their incentive is to diagnose an illness as swiftly as
possible and get the patients out the door. This has its own set of downsides,
but at least the patient gets help rather more quickly and with less hassle.

~~~
codehotter
I have no idea whether to be for against government regulation in health care
because it's a complicated issue and I am nowhere near an expert. But I would
like to ask you if you think the same logic applies to food. Can the food
industry extract as much money from me as they want? I will give you the shirt
off my back in order to avoid starvation. If no, what is the magic happening
in the food industry? Could similar magic apply in health care?

~~~
jablan
There's a big difference here. Basically, anyone can grow food, while not many
people can make their own antibiotics or CPAP machines in their backyards.

------
neilk
My experience wasn't nearly as bad as the OP's - one at-home sleep study, a
tester CPAP machine for a week, and a prescription to get my own CPAP soon
after. (My health provider/insurer was Kaiser, which is more integrated, so
perhaps they have less incentive to milk it.)

It was, however, strange to need a prescription to buy a machine. The
prescription includes the settings, so when it arrives, it's already tailored
to your needs.

Even so, the machines I was given were relatively easy to understand -- I even
fiddled with the settings a bit and found what was more comfortable. The
machine I bought for myself is a DeVibliss, and part of its appeal is that
comes with software to read its data. It is proprietary and Windows only, but
likely hackable since we have readouts of what the data means. I haven't
gotten around to figuring that out.

Medical techs take a really dim view of patients fiddling with settings. I
know they did when I asked them all kinds of questions. Their assumption,
which is probably verified for them daily, is that patients have no idea what
they're doing, and conceding authority is to invite disaster. Hackers may
trust themselves to figure something out, but let's be serious -- we can be
aggressive because it's just data. We forget all the times we hose the
filesystem, corrupt the database, have catastrophic memory leaks, and so on.
Medicine is not as forgiving as computing.

Still, with CPAP, it's probably very difficult to cause yourself injury. Maybe
a more open policy would be appropriate.

~~~
raverbashing
>> It was, however, strange to need a prescription to buy a machine

Well, people need a prescription for glasses, so not that strange afterall.

I suppose if you know your prescription (only the values) they won't give you
the glasses, it has to be a proper prescription

~~~
sbierwagen
Wrong.

<http://www.eyebuydirect.com/>

~~~
raverbashing
This is not true for contact lenses

You are required to present a prescription and give the doctor's name to buy
online

e.g. <http://www.coastal.com/new-visitors.ep?ilid=lnav>

Also, the requirement of a prescription to buy glasses varies from country to
country.

------
swombat
The most valuable hack I've discovered and used when dealing with the health
system (and bear in mind this is in the UK, where the main problem is not
cost, but time) is to be great friends with a GP. I always discuss health
issues with him _before_ going to the doc, so there are no surprises
afterwards, and I know exactly what to say to expedite the process.

It turns out that there are various magic phrases you can use to speed up the
outcome, guarantee a referral, etc. If you're friends with a doctor, they'll
tell you those phrases.

It probably won't help with all the waste in the process, though. And it
definitely won't help with closed hardware.

~~~
nollidge
Good advice, but don't abuse that friendship. They're getting questions from
every friend/family member with a cough.

~~~
richieb
Isn't this the same as having everyone of your friends and family calling you
to fix their Windows box?

------
Eliezer
I tried to schedule a sleep study, was told it would be a month, tried to
price a sleep study somewhere else, was told it would be over $2000...

...gave up and bought an automatic CPAP machine off Craigslist for $650 from
someone who knew how to access doctor mode (hold down button X for 10 seconds
after turning the power on), set it to adjust automatically...

...and stopped after a month because the mask was preventing me from sleeping
well, but at least I didn't spend more than $650.

~~~
ars
Try a different mask. There are a huge number of types, and different people
like different ones.

Nasal, dental, full face, nasal prong, nasal pillow. And the straps attach in
many different ways as well.

~~~
Tichy
Maybe had he done the sleep study they would have fitted the right mask to
begin with :-)

~~~
dsr_
Probably not. The sleep study measures the number of events per hour and your
blood oxygenation, and in the followup (which can be in the same night, at no
extra cost) discovers the necessary pressure. It doesn't check for mask
comfort or fit. (Should it? Probably.)

------
munin
"If this situation existed anywhere else where we paid tens of thousands of
dollars, people would be outraged."

oh you mean like your iphone? or how about your android? or the software that
runs your television? or how about your car?

you're locked out of software products _all_ _the_ _time_ and (almost) no one
is outraged. the people who care diligently go to work to jailbreak the device
and everyone else enjoys something that "just works"...

~~~
jamesaguilar
If you paid tens of thousands of dollars for your Android phone, you might
want to check out the better prices available at
<http://www.google.com/nexus/>.

Also, to answer your real question and not the hyperbole: you aren't locked
out of your iphone or Android with anything like the security of the device
he's describing. No one cares about installing software on their TV -- mine
doesn't even have an obvious port by which this could be accomplished -- and
cars share the same liability structure as medical devices, probably. Plus
many of them are actually quite easily programmable.

~~~
TeHCrAzY
My TV has a USB port for firmware updates ;)

------
snitko
I think this is a perfect opportunity for businesses from other countries to
step in. Say, some company in a less regulated country starts selling ones.
Would it be actually cheaper to hop on a plain and get yourself one, instead
of taking a couple of $2000 sleep studies? I bet it would.

To generalize, basically any kind of business could profit from less
regulation. You just have to find the market big and desperate enough to
travel far for that.

~~~
ttt_
>> _To generalize, basically any kind of business could profit from less
regulation._

I think the point is made that the health-care business is doing quite well.

Now how about the actual patient? Would you say he would benefit from more or
less regulation?

Seems to me that competition on this front would only be between the companies
that can manage to better extort patients.

I say more regulation works best in the health-care area. Authority is called
for to oversee practices and audit business decisions to make sure that the
patient is first priority and profit second.

Taking an example from Brazil. A while ago the private health insurances were
regulated into not enforcing grace periods of users who had already gone
through them and were migrating from a different plan from the same or another
insurer. Isn't that perfectly valid policy that focuses on the patient for
what they really need (health-care)? Would unregulated business agree to this
on their own?

~~~
snitko
Good point, however it is, I think, still unclear wether a patient would
benefit from less or more regulation. It, again, looks like a more general
discussion of left vs right. While people tend to take sides, we still have
about equal numbers of economists in favor of either free market or
regulations.

One might argue, that competition is in the best interest of the patient. And
that what is currently regulated, should rather be advised. This looks
reasonable, however I wouldn't advocate it until this is actually tested.

I once saw a TED-talk by an economist who said that it is trial and error that
politicians should advocate, not particular strategies that they "know" are
the right ones. That is, I believe, an ultimate solution to many problems,
including the medical market.

------
powera
Definitely sounds like a bit of a racket. There doesn't seem to be any reason
to need all these studies to get diagnosed here.

However, if you go too far the other way, you end up with Kevin Trudeau and
other scam artists selling you snake oil to cure whatever ails you. There are
reasons why people can't just say anything will cure any medical ailment.

~~~
steamer25
> too far the other way

You're obviously allowing for nuance but it seems like many people have the
argument that, "unless we put all our eggs in the single basket of a central
'impartial/trustworthy/infallible' evaluation and enforcement agency such as
the FDA, people will get taken advantage of".

------
mtraven
Here's a start:

[http://www.kickstarter.com/projects/1342192419/pulse-
sensor-...](http://www.kickstarter.com/projects/1342192419/pulse-sensor-an-
open-source-heart-rate-sensor-that)

CPAPs aren't exactly super hi-tech either, and since they are fairly
noninvasive as medical tech goes I can easily imagine some people
experimenting with homebrews...

~~~
ars
CPAP can be dangerous actually. First if the power goes out the person can
suffocate. The masks have small holes in them for this reason (basically a
permanent leak).

A MUCH MUCH more dangerous hazard is re-breathing. In a properly designed
machine if it fails (power outage or mechanical) it will have a strong
resistance to air flow - this lets the small holes take over.

But if air flow is not blocked then the person will breath the same air over
and over in the tube (the same air will flow back and forth) and will
eventually asphyxiate.

Another hazard is if the pressure goes up too high, this can cause injuries.

The fact that you are not even aware of these hazards is probably a good
reason not to try building one. And there may be more hazards I have not
thought of.

~~~
shrike
All masks come equipped with an anti asphyxia valve. They are a very simple
flap that fails open in the case of a power outage or other failure, a
(C|A)PAP mask cannot asphyxiate you.

[1]
[https://encrypted.google.com/search?hl=en&q=anti%20asphy...](https://encrypted.google.com/search?hl=en&q=anti%20asphyxia%20valve)

~~~
ars
Only full face masks do. The nasal ones don't.

Technically you could breath through your mouth if there was a problem, but
some people have issues keeping themself from breathing through their mouth,
so they use a chip strap to prevent it. And then this hazard comes into play.

And you entirely missed my point. The masks are safe because someone thought
of the hazard and designed against it. If you are making things homebrew you
better make sure you are aware of all the hazards.

------
tibbon
For everyone hyper-focused on him being overweight- that sometimes isn't the
only problem (or the problem at all).

I'm relatively thin/average build, and was having troubles sleeping, breathing
and I was snoring a ton. I complained to my GP about this, and he prescribed
some nasal spray which didn't help at all. Went to an ENT and of course had to
have a sleep study.

The entire time I was telling them, I think my tonsils are fucking huge and I
have sleep apnea due to it. Only after seeing two doctors and having an $800
sleep study did they agree and I was able to get my tonsils removed. Afterward
they wanted to do another sleep study to find if it fixed it; I said no
thanks.

Sometimes- just sometimes the patient actually knows what they need. Now I
have a new GP, who is much more helpful in providing what I actually need
without random expensive tests.

------
arvidj
Of course, doctors should just give the patient whatever he asks for. What
does all those years of medical school matter, this guys runs a blog and he
has done research before going to the doctor!

------
vinc
I wrote a small program named Oximon a few months ago to extract data from
CMS-50x pulse oximeters and generate Gnuplot graphs. I use it to detect REM
sleep and it does the job with a nice accuracy so maybe it could help someone
suffering from sleep apnea as well: <https://github.com/vinc/oximon>

------
TamDenholm
While this sort of policy has its place, like for stopping people overriding
their morphine machine to skip its limit, I honestly don't see the problem for
things like this, primarily diagnostic based equipment.

I wonder if there might be a market for open source medical hardware with open
source software to go with it. This could provide people with a very
inexpensive option to look after themselves and also by perhaps uploading
their data anonymously to an open database, help others too in diagnosing
their problems too.

Obviously you when you get into things like this people get a bit scared
because the medical industry is proprietary by nature which makes it scary
because you don't want to mess with something you are told to go to a
professional about, I think ubiuiquity might solve the problem. The more
information out there, the more people are educated and the less scared they
are.

~~~
jreeve
One of the common jokes between my wife and I is to setup a "home surgery kit"
for some point in some horrible dystopian future.

However, we were thinking it out and were moved to wonder why there isn't more
straightforward "how-tos" as far as medicine is concerned: how-to relocate
joints, how-to suture, how-to collect appropriate equipment, how-to operate in
a sane and sanitary manner.

This is, of course as lay people... for all we know all the information is
available to whoever is willing to look for it and take the risks involved
with amateur medicine.

However, I wonder if what trained people think about the ethics of making
professional medical techniques and equipment available to lay folks.

~~~
DanBC
There are strict laws about practicing medicine.

Legally, anything more than first-aid and getting someone to a qualified
doctor is going to cause problems (unless you're in exceptional
circumstances.)

> _One of the common jokes between my wife and I is to setup a "home surgery
> kit" for some point in some horrible dystopian future._

It's a funny joke. I had similar thought about "Backstreet dentists" in the
UK. A few years ago there was a problem getting NHS dentists, and many people
didn't have any insurance. You could have made money by trafficking East
European dentists into the UK and setting up a secret dentist.

(<http://news.bbc.co.uk/1/hi/magazine/3502813.stm>)

([http://news.bbc.co.uk/1/hi/england/gloucestershire/4506013.s...](http://news.bbc.co.uk/1/hi/england/gloucestershire/4506013.stm))

(<http://news.bbc.co.uk/1/hi/7041291.stm>)

~~~
justincormack
It was easier to fly to Eastern Europe and use them legally there. Medical
tourism is fairly big business.

------
TamDenholm
I think open source medical hardware is an industry ripe for exploding, which
is helped by 3D printers becoming more common and affordable. Need a new
prosthetic leg? Let's print you a specifically custom fit one for next to
nothing compared with getting one made the traditional way.

~~~
Torn
How do you propose modelling and tailoring a custom leg attachment for "next
to nothing"?

~~~
brohee
Imprint in Play-Doh, 3D scan, 3D print?

------
spullara
I blame lawyers more than doctors for this situation we've gotten ourselves
into.

------
sbierwagen
This site smells like a SEO scam. Look in the "related sites" sidebar: lots of
links to common search keywords like "treating neuropathy in feet" and
"facebook login help", in a small, light gray text.

------
pepijndevos
Would it be possible to reverse-engineer such a device?

I have been messing with some stepper motor drivers, that had at least a few
pages of spanish or incorrect documentation, or a very simple circuit,
however, I wonder what you do when there is no documentation. How do you learn
reverse-engeneering?

~~~
pmjordan
For USB devices, where you have access to both the device and some proprietary
software that can drive it, this isn't so difficult: you can intercept the USB
commands quite easily, then it's a matter of spotting patterns for each
activity.

For intercepting the USB traffic, you have a few options:

\- software USB Snooping; this hooks into your OS's USB subsystem and
intercepts data. The Linux USB debug stuff works well for this, I've had less
luck on Windows.

\- using a virtual machine and forwarding it the USB device. I've had success
with this for intercepting the USB traffic for a device with only proprietary
Windows drivers, but where snooping in Windows directly failed. Boot up in
Linux, set up a Windows virtual machine, forward the USB device to the VM,
install the Windows drivers in the VM and use Linux' USB debug interface.

\- Hardware USB snooping devices. You physically insert them between your USB
device and the PC, and they log the data flowing through. Obviously, this is a
bit more expensive, but will basically always work.

------
antihero
Are there exercises you can do to improve the muscle tone in your neck?

~~~
archangel_one
Seems to me like a sensible option would be to try losing weight, since sleep
apnea is strongly linked to obesity. And yeah, he says it's his muscles that
are the problem, but it seems rather convenient to blame that when he admits
he's overweight and suffering from this complaint where that's known to be a
huge factor. I guess you could say that a hidden silver lining of the medical
industry taking so long to fix his problem is that it'd give him time to
explore that alternative...

~~~
antihero
Aye, becoming healthy is a better start than drugs or equipment to help you
breathe.

------
gosub
The "True Hacker™" way: step1, reverse engineer the pulse ox usb protocol,
step2, build a DIY CPAP machine, step3, release everything as open source/open
schematics.

------
steamer25
Does anybody know what the medical risks of a non-OSA sufferer using an
APAP/CPAP are?

~~~
steamer25
Let me Google that for myself:
[http://www.nhlbi.nih.gov/health//dci/Diseases/cpap/cpap_risk...](http://www.nhlbi.nih.gov/health//dci/Diseases/cpap/cpap_risks.html)

------
Daniel_Newby
This isn't about FDA regulations[1] or tort law[2]. It's about the American
medical system being a corrupt racket.

1\. The FDA will approve nearly anything. For example, very flexible user-
managed insulin pumps.

2\. A jury of retards will convict if the plaintiff is sufficiently pathetic.
Assuming you have reasonably good intentions and reasonably clear
documentation, tort liability is just a roll of the dice.

