Alternatives do exist and they sometimes work for some folks

[Guest]

http://www.genengnews.com/news/bnitem.aspx?name=1115895XSL_NEWSML_TO_NEWSML_WEB.xml

[dizzy]

Here, let me help you out with this great find, if you don't know it, that is a PAID-for press release published by Lois Paul & Partners (LPP) a marketing and public relations firm. It is LPP's job to write crafty information and feed it to the media wires. Their Client (Restore Medical) paid for this advertisement to be published and also the makers of Pillar procedure. If you look down at the very bottom from your link and you'll see a media contact from LPP (melissa_zipin@lpp.com).

Then you see what spin LPP placed on this simple press release: "Long-Term Study of the Pillar(R) Procedure Shows Reduction of Sleep Apnea in 81 Percent of Patients and Offers New Hope to Frustrated CPAP Users:" If I wasn't afraid it would be considered a personal attack, I'd swear Rick wrote that caption, because when you get inside there is no substance

But the simple question remains: Where IS this Long-Term Study or data? they are talking about that makes up this 81%? Where can one find this data and read it for himself?

Are they talking about the Clinical_Summary_WP_approved091404.pdf ? Heck, that was done a year ago in September 2004. That was the inital short-term study!!! Where is the data or study going back to 2003 or even a year ago?

Where is the current data (from say 2003 trials until now) supposedly presented at this ENT conference last month? Or did they snucker all those ENT's as well using the same 28/36 minuscule patient data as well. If you trace it back and you come to the same conclusion I did, pretty shady

Here is the link to Lois Paul Partners Client list where you'll find Restore Medical clearly listed as a client (they are the ones that wrote the press release):
http://www.lpp.com/clients.html

Here is a copy of the same release on Restore's website:
http://www.restoremedical.com/release16.asp

Here is a link to ALL the available Pillar studies from the referenced website:
http://www.pillarprocedure.com/studies.asp

Now I encourage you do go to the website above, scroll down to Clinical Studies and download ALL the available PDF's and read all the data for yourself. You won't find any long term studies for OSA other than the one mentioned for Snoring named: LT_Clinical_Whitepaper.pdf

But all this press release stuff says is they went to conference for ENT's and tried to sell the procedure to even more ENT's then publish a press release saying that it was a "Long Term Study" presented. Then if you go to their website, there are NO such Long Term studies published or even data excerpts from one other than for snoring. Give me a break Restore.

Now if you read though ALL the studies (download them all, I did they are not that big not much substance lot of repeat info), but you'll find this procedure to be no more effective for OSA than UPPP or LAUP, then it better be mild-moderate OSA. Sure the up side is less pain, less cost, but same efficacy. There are a lot of OSA patients here that had the UPPP & LAUP and are still on CPAP.

Read on from the info on the website they dance around the insurance issue like our boys here like to do with facts, insurance doesn't pay for the procedure because it hasn't been proven effective treatment of OSA. They may have proven it to themselves but they haven't proven it to a peer reviewed group and insurance. At some point that may change as more data comes in, but in the mean time it is still considered investigational procedure (meaning insurance also wants to see more data before they will start paying for it). You would think if they have thousands of ENT's performing this procedure they would be able to convince a small panel of doctors representing insurance that it is effective for OSA.

Now my ENT is on Restore's list, and he's a top notch ENT, I may go again and see him after the first of the year about it (I was the one that told him about Pillar some 2-1/2 years ago), he is not my sleep doc, but I went to him for a 2nd opinion, he already told me back then I wasn't a good candidate for LAUP (he performs those on a regular basis in his office) and sent me back to my sleep doc for CPAP.

Now I was really disappointed to learn it didn't work for Rick's snoring. Because I looked at it much differently then they did;

Snoring triggers auto-cpap machines to respond with higher pressure, especially if its a Resmed autopap. If Pillar lessened the snoring a patient demonstrates, there should be less triggers for an autopap to pick up?

Think what it would do IF your snore and your pressure is 16cm or 19cm as a result of those snores. Deltadave would have to chime in on what he thinks about snores...

But the result should mean fewer events and LOWER mean cpap pressure. If it completely stopped snoring then the machine should not trigger on snores at all. These are inaudible snores (i.e. palatal vibrations). The theory behind this is the vibrations generated by the palate being so close to the base of the brain (Pituitary Gland, see below) are thought to be the cause of spontaneous arousals.

Now I still have to use CPAP to keep my O2 levels up and to prevent another stroke and control hypertension. But if snoring is truly the cause of spontaneous arousals seen on a EEG and you eliminate the said snoring, the arousals should also drop, who knows, a person may just screw up enough to get a good nights sleep.

[Sleepy Stoboy]

A post that essentially tells us the following:

1) Restore is in business to drive sales and profit.
2) They want to see as many people sign up for pillar implants as possible.
3) They are highly motivated to increase revenues.
4) So much so, that they will hire a partner business to help coordinate press releases.
5) That if they do have a positive study, they will highlight it as much as possible.

You make this all sound so evil. Would you prefer that a sect of nuns was marketing this procedure and supplying all of the profits to Indonesia?

They do hype the data to draw in interest. Once people do their own research, they realize what Rick, Paul and myself have said all along. That the procedure will lessen most people's apnea up to 50% and is a great start as part of a combination treatment. You could try a GA/hyoid as the second step, but we recommend dental devices due to the ZERO RDI studies we've had.

You have a lot of theories, but you haven't proven anything more than Restore has. Here's what you can't disprove- that Paul's apnea was reduced 40% and my apnea was reduced 50% (verified with sleep study data).

What I find most amazing, and perhaps is the source of your desire to research this, is that you are actually considering, and have considered this procedure.

What can be said more simply to anyone interested in pillar implants is this: These press releases are what they are- marketing for a product. No different than what you'd see on TV for Viagra, Levitra, you name it. Dizzy has one sound point- find the original research data they refer to, and draw your own conclusions. I still believe the best, unvarnished data for this procedure can be found in this forum. Most of what you'll google out there are snippets of the same Restore press release.

BOTTOM LINE: FOR THE HIGH MAJORITY OF PEOPLE WITH SLEEP APNEA, THE PILLAR PROCEDURE WILL REDUCE, BUT NOT RESOLVE YOUR APNEA BY ADDRESSING THE PALATAL COMPONENT OF YOUR OBSTRUCTION. It still stands as a great first step, but for most people will require a second level of treatment to resolve your apnea. If you are looking for a viable alternative to CPAP, consider this procedure in conjunction with a dental device or a successful surgery to advance the mandible, decrease the mass of the rear of tongue, etc.

Here's another review of the data:

http://www.surgicenteronline.com/hotnews/59h221042413314.html

This is a great link if you want to understand the business side of Restore, their motivations, and why the clinical trial data will be critical from a business standpoint:

http://www.devicelink.com/mddi/archive/05/11/018.html

[Fan of Nuns]

On a lighter side...

[dizzy]

Nah Stoby it doesn't say that, it says they take the same miniscule data and keep massaging it to come out with a better and better result.

Here, I'll make it easy for ya, this the study they took the 81% figure from, and while your at it, the data from your referenced links above, same data as in the German 16 patient study sponsored by Restore.

See Results and Discussions:
http://www.pillarprocedure.com/docs/German%20Poster%20Final%20Draft.pdf

I guess you could say 13 out of 16 saw an improvement, 3 actually got worse, much worse. They should add you 3 guys back in and they'd have 100% effectiveness.

Do those nuns ride Harleys?

[Guest]

Understand that any private company like to go public or bought out by a bigger giant. So, this company is doing anything possible in the realm of legality to make the smallest positive data outcome visible. I haven't not seen anything concrete so far only handful of neutral outcomes on this web. It is really fishy. I have heard about 3 major universities medical centers (including on in Atlanta) doing some free implants and research a year ago. It is very discouraging that we have not seen any good data or outcome for more than a year, and we have not seen extrusion results for 2+ year old cases out of Europe.
So there is a huge caution regarding this procedure.

[Sleepy Stoboy]

Nice try Dizzy. This was one of the first studies done in Europe, also funded by Restore. It is only a 16 person sample. The study they are referencing was done on approximately 100 patients across the country and presented at the ENT conference in 2005. The study you are referencing was presented at the ENT conference in 2004.

Guest- you have to remember that this procedure is only new for apnea. It has been done for snoring for a few years before that. Extrusion risk is believed to be most at risk either at the time of implantation, or shortly thereafter. RickRed had an extrusion, had it pulled, and had it replaced. The material used in the implants has been used for many years in other surgical operations. Guest, this latest study is now about the fourth study completed in the last year, and by any measure shows a substantial reduction across the mean.

Here's the caveat. The data is skewed in that the company chose those with a apnea index of less than 30 and ensured that the patients tested had optimal chances for success (long, soft palates). Because of the marketing, some apnea patients may get their hopes up only to be turned away by the ENT performing the procedure. I don't see any "huge" cautions so far, no more than any outpatient procedure that can be performed. The nature of the procedure is that the implants can be removed at any point in the future if need be. This as opposed to a UPPP where there is no reversing, a truly permanent procedure.

Let me share this again. My ENT is a practicing professor at a major university. He doesn't do this to drive a business. He is predominantly interested in seeing results positive or negative, from a research angle. He was very impressed at my results. He was skeptical that anyone over a 30 RDI would have a meaningful reduction.

Dizzy, it is mindboggling how much effort you continue to put in to misstate the facts regarding pillar. My question, that you never answer, is "what is your motivation to do so?"

[Less Sleepy]

Many of the studies confirming the efficacy of CPAP were funded by ResMed and Respironics. I certainly hope that doesn't mean CPAP is no good.

[dizzy]

I don't know why you even bother Stoby, you don't have ANY accurate answers and make up every thing you respond with.

I stated the FACTS. I know you have trouble dealing with facts but they are above for EVERYONE to check it out and READ it for themselves.

When you don't have any answers you start quoting from a non-existent study that is not publicly available (if one even exists). Your studies always turn out to be some marketing literature white paper someone created from all the hodge-podge piece meal studies with a dozen patients.

[Gazing North]

We may need to get a petition going to resurrect the "Three Bed Vancouver Study".

You can throw plenty of beds and research dollars at an issue like this, but only three-bed Vancouverites can even begin to make a dent in an unwieldy issue like this.

[Sleepy Stoboy]

No Dizzy, you consistently mis-state the facts to fulfill your argument that this is a fraudulent procedure, being touted by representatives of Restore (myself and anyone else who rebutts you), and part of a plan for this fraudulent company to sell itself off at the first opportunity.

The clinical studies, whether funded by Restore or not, say the same thing that RickRed, PaulY and myself have confirmed through sleep studies. That the pillar procedure effectively addresses the palatal component of our apnea, which has reduced our total apnea index from 40-50%. Some people in the study achieved a greater result, some less, but the mean average is exactly where our personal data is.

Those are the facts, and yes, they are there for everyone to check out. So is the sleep study data pre and post pillar for PaulY and myself. That's not made up. Those aren't marketing literature, nor white paper.

The bigger question is why you bother? What's the motivation Dizzy? To stop just one more person who may need help? Would you rather have those that struggle with CPAP compliance simply give up altogether? Three of us have been treated. That number can become 300. Or 3000. In many cases, these are people who would slip through the cracks after CPAP non-compliance.

I know you like facts, so here are some. Let's pretend that someone didn't want the dental device that we say is a critical second step. Let's pretend that they are swayed by all the marketing hype and believe that this procedure is the cure all, and that they have no intention of doing anything else afterwards. In my case, in cut my events in HALF and raised by oxygen levels by a full 5 percentage points. Not bad for the out of pocket costs they'll incur. Definitely a healthier situation, if not a fully treated one.

Reputable universities, and practicing ENT/professors are using and exploring pillar as a viable surgical option. Without their support, Restore dies on the vine. You can argue all day that this clinical data is meaningless, but the medical world isn't calling up Dizzy to ask what he thinks. They're reviewing these "piece meal" studies as you call them, and using their education to make their own qualified decisions to present this to their patients.

Fortunately we live in a capitalist society that encourages innovation and advancement, especially in the medical field. People line up for new treatments every day and assume certain risks when long term study is not available. Why would apnea be any different? Apnea is simply a far more silent and insidious killer. We need advances here. CPAP cannot, and hasn't proven that it can effectively treat 100% of the apnea population.

The data on hyoid and genioglossus advancement is just as limited, yet I haven't heard you weigh in there. Is it because there is no parent company marketing it?

My passion for this topic is born out of the relief it has brought me. The same can be said for PaulY and Rick. Your motivation is still a mystery to me.

[dizzy]

Gazing North wrote:

[Sleepy Stoboy]

Ah, Dizzy, in your mind this will go on forever. Meaningless ramblings, piece meal studies, fraudulent companies, suspect posters on this forum. So much to fear, so little time.

Your railings against pillar haven't changed a thing, and in fact lose ground one year after the procedure was approved by the FDA for sleep apnea. Studies continue to reinforce, people continue to try the procedure and experience relief, and insurance companies like mine come to the front and pay for the procedure.

Good luck in your continued attempts to keep people from CPAP alternatives. We will work equally vigilantly to ensure that the information continues to be shared, both on the dental forum and on this one.

[Less Sleepy]

Most of the drugs on the market today are available as a result of studies conducted by the manufacturers. Who else is going to invest the money? Just because the manufacturer funded the studies doesn't mean they are invalid. The original CPAP studies were done by the inventor - a man named Sullivan - whose company ultimately became ResMed. The same is true for implanted pace-makers, replacement joints, and any medical device - the studies are almost always conducted or paid for by the manufacturers. Granted, there have been a few difficulties with this system, but overall, with policing by the FDA, it works pretty well.

Since the FDA doesn't generally police medical procedures, the ultimate proof-of-the-pudding will be when a study of palatal pillar implants comes out in a peer-reviewed journal. Just understand that, as with any medical procedure or medical device, even that will be paid for by the inventor or manufacturer.

[Sleepy Stoboy]

Less Sleepy,

You would think from Dizzy's comments that his primary issue with palatal implants is the lack of/and or depth of clinical research validating their effectiveness.

Yet this is the same Dizzy that advocated the use of melatonin for someone in another post today. Here is his quote: