Someone commented that there is consideration being given at the FDA regarding CPAP and/or APAP devices and prescription status. After searching, I found this html translation and http://www.fda.gov/ohrms/dockets/AC/04/ ... 1t1_01.pdf which are the non-pdf and pdf versions of the same document referring to a meeting held in 2004.
I also found this, which is a transcript of that meeting.
Now, I' ve read through this, and it seems that all they discussed were oral appliances and other devices of similar ilk - cervical pillows and nose thingies - not CPAP or APAP.
Some interesting points: Everyone is grinding their own axe - One dental organization made the following claims: CPAP is so poorly tolerated that there are people who believe that the first line of treatment should be oral appliances rather than CPAP. Dr. Merhan of American Academy of Sleep Disorders Dentistry (hmmm) made that claim - and also does not believe that people should fit their own appliances. His main issue is that the primary complaints (sleepiness, etc) can be caused by too many things and need a physician iinvolved in diagnosis - with then a referral to a sleep dentist, I guess, if apnea is suspected - as a primary treatment.
(Based on other dentists who had long lists of horrible side effects, I would probably not want to use such an appliance - but I tolerate CPAP well.)
AASM sent a doctor who basically said, People can't really diagnose their own sleep apnea effectively. They might even eliminate their snoring and still have OSA. These devices have all sorts of complications, like TMJ pain.
Respironics sent a representative that spoke in favor of OTC oral appliances for Sleep Apnea - but also who said that there had to be OTC devices that could be used by the patient to determine if they actually had sleep apnea (and, which, I assume, could then be used to determine if the device was successful in the treatment of their apnea).It can be difficult to differentiate between snoring and sleep apnea by symptom alone. Multiple studies have shown that thorough clinical evaluation plus objective testing, such as a sleep study, are required to establish both the presence and severity of OSA accurately.
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Our recommendations include the following. One, the presence or absence of sleep apnea must be determined before initiating treatment. Two, oral appliances should be fitted by qualified personnel who are trained and experienced in the overall care of oral health and temporomandibular joint, dental occlusion, and associated oral structures.
Oral appliances may aggravate TMJ disease and may cause dental misalignment and discomfort. Follow‑up care by dentists is necessary to assess the development in any of these complications.
The Exxon Valdez disaster might have been caused by a captain who had a sleep disorder.
Dr. Terris presents an argument that you really can't diagnose sleep apnea without a sleep study (there are always exceptions, of course) but his arguments are actually well presented.
Some of his work is criticized, validly, because many of the studies he reports on are small population stufies that are not placebo controlled. This is important - people go through surgery, say that they feel better, but then they objectively sleep just as badly.
A destist whose practice is limited to treating patients with sleep apnea points out that there is a Swedish study that fairly reliably shows that patients say that they are better and aren't.
He reports on treating patients with "boil and bite" appliances which they have gotten overseas. Some needed to have the appliances readjusted (the instructions were not good enough) and some needed surgery - some of his patients needed surgery on followup because of side effects of the appliances.
He talks about needing to fit many different types of patients into many different types of appliances and how many side effects that there are - and how it just does not work for everyone and how hard it is to tell who it won't work for if you are a layman. He talks about how some people actually get worse with the common appliances if their jaws are shaped a certain way.
One thing the FDA did ask was about cost difference. Boil and bite costs $30 from England - if it fits (small men, average woman). Lab costs can be up to $600 for a custom, plus his fees.
During the deliberation, it was brought up that reader-to-reader variation in reading a sleep study can be 30% - the "gold standard" is tarnished.
Night to night variation can also be huge.
"Compliance rates on tongue retaining devices are very very low."
The commission thought that Medicare was going to approve ambulatory sleep studies (4 leads, as I understand it, self applied). But they didn't,
There was some question as to whether you needed a government approved tennis ball to sew it into your pajamas for snoring.
Cervical pillows were approved for treating sleep apnea based on a THREE PERSON STUDY(my emphasis) where the AHI went from 14.7 to 10.5.
Supposedly there was a second study with more patients that showed the same results.
An interesting question waa asked by an FDA panel member: 40-60% of the American population snores. Do they all need to go for a sleep study to see if they have OSA?
There is something called "first night effect" in sleep studies. The military did some studies - and threw out all fitst night data out of hand. Many sleep doctors say that for real testing, many people need several nights because many people do not get deep enough into sleep in one night's test to see the full extent of their sleep disturbance.
Then there was a long discussion on what it took to have a valid study. Do you need a control group? Is it enough to simply not have the scorer of the sleep tests be part of the study? Science is important - and they discussed it in detail.
There was no significant discussion of CPAP or APAP.
In one of the discussions here, someone mentioned that the FDA was about to discuss CPAP and/or APAP as possible non-prescription devices.
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I have done more web searches than just this one and I can't find any evidence that the FDA is deliberating whether APAP should leave prescription status at all. This rather interesting discussion was the closest I could find - I present it partially because it is interesting, partially because these dental devices are effective treatments for apnea for some (not for me, I think, I hate that sort of mouth device) and partially because I think this sort of proves that if there were such discussions on the FDA site that I would have found them with my searches.
Now, were APAP to go non-prescription, I think there would be issues. While the cost of a machine might go down, it is quite likely that many insurance plans would simply quit covering them. My general experience is that my private insurance simply would not cover any medication that I could buy OTC. For example, they would not cover H2 pump inhibitors in non-prescription strengths - and they were just as expensive as they had been in prescription strengths. They would cover the same pills in prescription strengths if the doctor happened to prescribe them in those strengths.
But if one could get a first class machine which also could function as a tester for $300-$400 cash, well, I think many more people could afford treatment. And, well, based on reading this discussion, I am not sure what the remaining objections could be.
You can't tell whether you have sleep apnea - but supposing the machine could? That whole issue goes away. There are some lung problems which you can't have when using CPAP - but they can handle that with labeling.
You can't tell if the machine is treating your sleep apnea - but supposing that the machine can?
After reading the above document, I think that there has to be the ability to test for Sleep Apnea as well. For example, supposing Respironics sold a machine - you would pay initially $200 for it and they would have your credit card - no credit card? They need a cash deposit.
It would be able to operate for, say, 100 hours. During that time, it would evaluate you - it might even connect to the Internet or via modem and send the data to someone who would double check the evaluation.
This machine would then confirm or deny your diagnosis. If it confirmed the diagnosis, it would then allow you to spend, say, another $200 to buy a key that would allow the machine to keep running, and if it did not confirm your diagnosis, you would have to return the machine within a month in pre-supplied packaging - or you would be charged the same $200. Keep the mask if you want it.
The issues that the panel was looking at were a numerous. They were looking at outcomes - suppose you could buy a device to treat your snoring but you have Apnea? Can you make a diagnosis? The general feeling on the panel was that no one, not even a doctor, could make a putative diagnosis of sleep apnea without a sleep study. One doctor who spoke disagreed.
We know that APAPs do something that is very close to a dynamic sleep study. With a oximeter channel and, maybe, an eeg channel, they would be pretty much as good as a sleep study. You might only need to hook those leads up a couple times during the initial period. Heck, if you had an extra diagnostic package, an attachment to the machine, you could plug the APAP into the thing that had the extra memory and modem in it and have that sent in separately. It could even have a cellphone in it.
So we are almost there. CPAPs cost more than the numbers I am quoting above, but not that much more. Supposing you could sell millions of machines - and sell them fast - supposing you were not limited by the cost and accessability of a sleep study? Supposing the machine was available in designer colors - but the diagnostic piece was dirty orange?
And you still have masks, hoses and supplies to sell.
I'll bet you could get those numbers down to where this would be accessable to almost everyone - and if a doctor had to be involved at all, it might only be the family physician.
One of the main issues for approving oral appliances for treating snoring was, as I understood it, "You have a snorer. Is it a good idea to treat the snoring by itself when the person might also have sleep apnea? What if you treat the snoring and leave the apnea and all that it involves untreated? If the person goes to a doctor, they have a better chance of telling the differnece. A non-apneic snorer might not want to hire a physician to just treat snoring."
There was also the issue that the oral appliances had a ton of side effects - you wear them longer than a couple months and they could make permanent changes to your appearance, for example. Or cause you bite problems or worse.
Anyway, a scheme where you combine an APAP with an Apnea tester allows you to get past most of those issues. The limit might be seeing a family doctor so that you could be asked the questions about lung problems - the three or four lung issues that disqualify you from using CPAP at all.
Maybe instead of non-prescription, they require that you see a family doctor - cut the specialist out of the loop.
Anyway, the guy from Respironics who testified made sense - if you have a home test of some sort, you pass two important hurdles - does the patient have OSA and is the patient helped by this treatment. It might even be able to say, "No matter what this machine does, it can't treat your apnea effectively. You do have apnea and you need to see a doctor. Print the charts at this web site." This might be the case when someone had Central Sleep Apnea, for example and could not be treated with CPAP or APAP.
As pointed out by many, the gold standard is tarnished - not only is there the 15%-30% reading and night-night variation but it is just plain too expensive to be accessable to many people. These people are concerned enough about this to at least mention it in their discussions. They are considering approving those boil-and-bite mouthpieces despite all the issues with them. Automatic titrating PAP probably has fewer issues - while compliance is an issue, non-compliance only leaves you poorer, not less healthy than you were before you were treated.
So, summary:
- Can anyone point me to specific evidence that APAP is being considered for non-prescription status by the FDA?
- Is it a good idea?
