PurSleep gone for now & why I did what I did

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
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christinequilts
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PurSleep gone for now & why I did what I did

Post by christinequilts » Wed Apr 04, 2007 12:34 pm

I'm glad to see my concerns did finally get Brett's attention and he has decided to pull his PurSleep product from the market for the time being, which should make any current users think before continued use.
SleepGuy wrote:The website (and ebay store) are closed and nothing will be available for sale pending completion of another round of R&D process. Stay posted.
And when asked 'What happened?'
SleepGuy wrote: I decided to pause the business and turn the project over to an outstanding medical product developer/consultant to revisit the R&D process (cross all the Ts etc.). That's all.
I know on the other threads, there were several very vocal people who questioned why I did what I did, some who are still vocally questioning:
Sleepy-eyes wrote:Good for you! It's a shame, but some doubt the effectiveness and safety of your product, Bret. Hope the results will put to rest the issues brought to focus by just a few on the forum.
I believe even Brett is questioning his products current safety, or he would not have taken the drastic measures he has, if he felt beyond a doubt it was a safe as he was portraying it to be. I believe his actions speak volumes more then any of his evasive answers to my questions ever did.

Anyone can think what they like about what I did, but before you all go to bed tonight, think about why I did it. I have no vested interest either way, I spent my own personal time, took insults from various posters all because I cared about the wellbeing of fellow forum members and all xPAP users who may have come across his product. Many other people on this board and other sleep boards had raised similar issues in that past that were never resolved; they only dropped the issue when they decided they did what they could and the negativity from some became apparent.

The next time a automobile manufacture takes a short cut or a drug manufacture falsifies data to obtain approval, I guess some of you are 'adult' enough to think for yourself and make your own decisions, right? Because we are all adults? Kids don't manufacture cars and drugs. Or do you want someone who is aware of what is going to question it? To not take 'everything is fine' for an answer and forget about it. Do you want that person to keep saying something until someone listens? To alert the proper authorities, if other methods of resolving the issue are not working?

I know right now, many of us are concerned about the pet food we are feeding our 'fur children', as a result events related to Menu Foods. As terrible as it seems, I lived through something much worse here in the state of Michigan in the early 1970's, which I assume Brett, as an environmental attorney, is well aware. It affected not only our animals, livestock in the case, but anyone who ate meat, poultry, or milk from contaminated animals for a period of several years. It is something I live with every single day, not only in tragic memories, but as toxic chemical within my body, as do most residents of Michigan. We unwilling became the biggest human experiment on the effects of PPB, because of lack of concern for safety.
Sometime in May or June 1973, the Michigan Chemical Co. accidentally shipped a fire retardant with the brand name of Firemaster to Farm Bureau Services, a supplier for thousands of Michigan farmers, in place of Nutrimaster, a cattle feed containing magnesium oxide. Firemaster was a brand name for PBB, a four-year-old chemical used to reduce the flammability of plastics and electrical circuits....The mistake apparently happened at a time when Michigan Chemical ran out of preprinted bags and hand-lettered the trade names of the two products in black. The similarity of product names or perhaps the smudging of the letters was all it took to make the first link in a disastrous chain of events. In October 1973, the state Department of Agriculture’s head diagnostician inspected the sickened dairy herd of Fred Halbert of Battle Creek and at first suspected lead poisoning. When tests for lead proved negative, the department sought help from Michigan State University and laboratories in Wisconsin, Iowa and New York to isolate the contaminant in the feed. Not until May 1974 did the department determine, with help from Halbert’s son Rick, a chemical engineer, that PBB was the poison. The department then tested feed and farm products across the state. By 1975 the state had quarantined more than 500 farms and condemned for slaughter over 17,000 cattle, 3,415 hogs, 1.5 million chickens, and 4.8 million eggs. PBB was removed from the market. In the 1980s, the state health department confirmed that approximately 95 per cent of Michigan’s population had residues of PBB in fat tissue.
Thirty years later: The lessons of PBBs
That doesn't tell the whole story, how it was only a small number of bags of PBB that caused such a wide spread problem. It doesn't tell how massive pits were dug, not only at the state's hastily approved land fill, and later SuperFund site, but also on farms to bury the contaminated livestock, which have contaminated ground water and water ways of Michigan. It doesn't tell how affected farms were restricted as to what they could raise for many years after. I was only a child when it happened, but I remember how it changed so many of the neighboring farming families. Some of them never seemed to recover fully, and how many did develop mysteries medical issues and cancer. We were lucky, our farms were deemed 'clean', which made it more valuable, but made us different in the eyes of our neighbors who lost everything. It was still enough for my father; all livestock was sold and we focused agriculture crops only after that.

Along the way people tried to speak up, to prevent the problem from happening and to alert others when it became apparent something was wrong. One of the workers at feed plant questioned his supervisor because the bags didn't look the same, but was told 'not to worry, its same stuff we always use'. He still worried and went to his supervisors boss, who told him 'not worry, its not your job'. So he didn't worry, why should he? He'd been told not to.

Next came Fred Halbert, the farmer who first noticed problems with his milk cattle herd in the Fall of 1973, mentioned above. When he contacted the State Dept of Ag, he was told 'don't worry'. He continued to hear 'don't worry', which at some point turned to 'you're doing something wrong to cause all these problems' from both the Dept of Ag & the manufacture of the contaminated feed. He heard it so much, but he never stopped worrying, realizing if it was affecting his heard, it had to be affecting others and ultimately becoming part of the human food supply. With the help of his chemical engineer son, he spent $5000 of his own money to have scientific test run that proved what the problem was. I know my 25cent allowance seemed like a lot then, and I'm sure some of you can remember what $5000 meant in 1973 dollars, and what that could have bought besides testing of a product he was told 'not to worry about', especially when his livelihood was in jeopardy. Heck, even the two companies responsible were only fined $4000 each by the government, as a result of the incident, so I guess not worrying is cheaper then worrying. At one point, after the government had finally started to worry in 1974, they feed the cattle feed to mice, which all died. You know what the feed company said, 'don't worry, of course they died, they are mice, not cattle, what did you expect if you feed them cattle feed?' Ever find a dead mouse from eating 'human food', unless it was attached to a trap?

Maybe having lived through that does make prone to worrying, to question more then others, especially when I ask very specific questions about the safety of a product and instead of reasonable answers, I'm told 'don't worry, just trust us.' How many of you are having problems now trusting what you feed your pets is truly safe, especially if it was manufactured by MenuFoods? Who knew all those trusted names didn't really make their own product, but all relied on one manufacture?

My worrying about the PurSleep In Line Diffuser is nothing compared to what Mr Halbert did, but the sentiment is the same. Yes we are all adults, yes we can make decisions for ourselves, but we do best when we have the support of each other. We can't all be experts in all things, so we have to rely on each other and look out for someone other then ourselves sometimes. We can't rely that every product we purchase is safe, but we can hope the company making worries enough to care about its consumers and not only their bottom line, and if that fails, we can hope someone will do the right thing and contact the proper regulatory authorities to address the issues.

I know I'm sleeping better at night lately. I hope Brett is able to also.

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dieselgal
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Post by dieselgal » Wed Apr 04, 2007 1:00 pm

Hey I don't have any problem with people bringing up issues about products. Sometimes only the squeaky wheel gets the grease. I happen to have the Pur-sleep system and I have used it a couple of times. Since I am so sensitive with scents I had to be very careful about not using to much so I tended not to use it, not because I didn't like it but because I am super sensitive. I can see why people love the idea and if it can be proven to be safe I am definitely for it.
Sometimes asking questions does not make you popular but you have to do what you think is right.
I hope everything works out and we find out it is harmless and those that love the product can continue to enjoy it for many years. I also hope you always feel like you can ask questions about products without being ignored or blacklisted.
After all we use to think smoking was safe.

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Post by Guest » Wed Apr 04, 2007 1:05 pm

I've been following your continuing questioning of this product for the last several days, and I think you deserve a lot of credit for bringing up these issues. I myself purchased Brets' product and have been using it for the past week, and I have to say that it does make for a peaceful nights sleep.But I also have to think that you make a valid point, and I think that Bret maybe has recognized that further testing is needed before the product is deemed totally safe. I wonder if he recommends holding off further usage until all testing is completed? I for one, will discontinue its use until "all the t's are crossed".
I commend you both for airing your differences on a civilized plateau.

Steve.

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jennie_len
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Hmmm...

Post by jennie_len » Wed Apr 04, 2007 2:03 pm

I cannot help but agree with what has been said here. I am a brand new CPAP user, and sure the idea of the essential oils sounds fantastic, but I really want to make sure that it is approved for use. Even if it is considered non-harmful to use...the machines are way too expensive to be playing with!

Just because the product made some feel better and was enjoyable, does not mean it was safe. And that the site has been taken down and all sales have been suspended....this makes me feel even stronger about this.

Hopefully this will lead to an approved version of the product, and we can all jump in!

*Jennie Len*
myspace.com/jennie
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"I love sleep. My life has the tendency to fall apart when I'm awake, you know?" --Ernest Hemingway

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Post by -SWS » Wed Apr 04, 2007 2:25 pm

Christine, is it my imagination or has that ASV REALLY increased your vigor lately?
Anonymous wrote:I've been following your continuing questioning of this product for the last several days, and I think you deserve a lot of credit for bringing up these issues. I myself purchased Brets' product and have been using it for the past week, and I have to say that it does make for a peaceful nights sleep.But I also have to think that you make a valid point, and I think that Bret maybe has recognized that further testing is needed before the product is deemed totally safe. I wonder if he recommends holding off further usage until all testing is completed? I for one, will discontinue its use until "all the t's are crossed".
I commend you both for airing your differences on a civilized plateau.

Steve.
Dunno which Steve the above guest happened to be... but that particular Steve wasn't me. Very kind words about Christine and Bret, to Steve-guest's credit.

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Sleepless_in_LM
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Post by Sleepless_in_LM » Wed Apr 04, 2007 2:26 pm

To borrow a saying from old Col. Potter "Horse Hockey!" Please don't take this as a personal attack. It is not meant as such, but I think you have made this personal against Brett.

You have have every right to question this product and air your concerns. Good discussion is what this board is about. But for you to compare this to "automobile manufacturers taking short cuts" or "a drug manufacturer that falsifies data" is over the line. To question his integrity and put him in the same boat as lying/cheating companies is just unfair and unwarranted. Brett spent a lot of time and money to come up with a product that he thought was safe and would help people. I know it is a product that he used personally for a long time before he offered it for sale, so that is maybe where actions speak louder than words. I personally feel his intentions were above board and to personally attack him is just plain wrong.

Then to compare this to the pet food problem or the Michigan beef problem is also unfair. Those are cases where there was evidence of something being wrong. Then it makes sense to keep questioning until you figure out what is wrong. In this case, all evidence, so far, was pointing to this being a product that was helping people cope with their therapy. Were there some possible risks? Yeah. Is it good to make people aware of those risks? Yeah. But to make it a personal crusade to shut him down, calling the FDA to "turn him in"... that also strikes me as bit much for something that had no evidence of causing problems. There is a big difference between fighting a known problem, and fighting the possibility that there might be a problem.

Lastly, to claim that your successful crusade to shut him down proves he has safety concerns about his own product is an assumption I doubt is true. It is my guess that you have forced Brett to play an expensive game of CYA. I work for an educational institution, and I can't tell you how many plain stupid things we do, or good things we have stopped doing, just because of the minute risk that puts in the CYA mode. It drives me nuts.

So, you are certainly welcome and encouraged to question products and have healthy discussion. It is good to point out risks. It is good to point out possible problems. Then "adults" can weigh the risk and benefits and make informed decisions. It might turn out that there are some risks with Bret's product. It might also turnout that it is 100% safe. It might also turnout that a product that could have helped countless OSA sufferers will never be available to them because the expense to prove "100%" safe will make it beyond affordable to offer.

I am glad you are sleeping better, but the fact that you were losing sleep over this and the fact that you chose to post such a lengthy claim of victory and explanation of your reasons, would indicate to me that this issue became much too personal.

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Last edited by Sleepless_in_LM on Wed Apr 04, 2007 2:57 pm, edited 1 time in total.

SleepGuy
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Post by SleepGuy » Wed Apr 04, 2007 2:27 pm

While I certainly don't appreciate the personal nature of some of the comments on this and other threads (such as being compared to a person who lies and falsifies information to make money on a product--disclaimer aside), I've said all along that all questions as to safety and effectiveness are completely fair and deserve to be asked, evaluated, answered, and resolved.

Truth be told, SnoreDog's questions and recommendations on the other thread (about product bench testing and the like) resulted in the current pause in marketing (in fact, I'm using the people SnoreDog recommended to do that work). The pause was completely, 100% voluntary and did not result from any direct or indirect inquiry, regulatory action, safety complaint, problem, or anything of that nature. The intent is to have another set of qualified people scrutinize all aspects of the products (design, quality controls, material selection, manufacturing, bench testing, compatibility testing, regulatory issues, etc.) and to fully document that process.

I'm confident that these products will come back to market in the next few months, documented testing and everything else needed in hand, better than ever. The scientific case for linking compliance and olfaction--and plastic smells and non-compliance--is just too compelling to be overlooked.

And by the way, I'm sleeping just as well now as before--all night, every night, ready for the day at 6:30 a.m.--never felt better!
Last edited by SleepGuy on Wed Apr 04, 2007 2:44 pm, edited 2 times in total.

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SleepingBeauty
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Post by SleepingBeauty » Wed Apr 04, 2007 2:37 pm

I just received my Pur-Sleep about a week or so ago. I did find it very nice to use, but I am also going to remove it until we hear that it is 100% safe.

I think making sure it is safe benefits everyone involved and I appreciate the efforts of those that questioned it as well as the actions of SleepGuy for getting more testing done.

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dieselgal
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Post by dieselgal » Wed Apr 04, 2007 3:17 pm

I wouldn't like to make this a tit for tat thing on the board. I think questions were raised by a few people that made some sense and sleepguy was listening. After all, he isn't a dummy. I love the idea of the pur-sleep and certainly don't intend to throw mine out. He is wise to cover all the bases and get the air clear so we can all enjoy the product without concern.

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Sleepy-eyes
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Post by Sleepy-eyes » Wed Apr 04, 2007 3:38 pm

Just to put in my two cents worth........................

I have the Pur-Sleep system. Love the Pur-Sleep system. Don't think there is anything dangerous about the Pur-Sleep sytem. Don't plan on stopping the use of the Pur-Sleep system. I personally think all the negative statements are just a pile of Horse Puckies. Any of you who plan on stopping the use of the system are just missing some good night's sleep, in my opinion.

I spent 40 years in the plastic manufacturing business, dealing with more inventors than I can possibly remember, and think Bret has gone to great lengths to produce and provide a good and safe product. I think much of what has transpired has been a personal attack, based on a true lack of understanding of the product. He's receiving even more of my respect for responding in all the ways he has...............especially the latest response of further testing.

Now why can't we just let it rest, for heavens sake?
Chris

I'm not a Doctor, nor am I associated with the medical profession in any way. Any comments I make are just personal opinions. Take them or leave them. (justa don't gripe at me if ya donna like 'em!)

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Post by DreamStalker » Wed Apr 04, 2007 4:39 pm

Oh now there is no need to spin this into a superfund level of hazard … I have worked on a federal superfund site remediation project and Pur-Sleep is nowhere near that level of danger. Having said that, I also meant no offense to Christine in my prior posts (nor this one) and do apologize if I have. As I said before, I think it is great that there are people caring enough to look out for the less fortunate and the health and welfare of all.

I agree that Bret has gotten some great feedback from all of the great members of this forum … mixed in with a little grief too I suppose … and I do wish him the best in alleviating the concerns of some and fulfilling the expectations of everyone else.

Remember, life is hazardous to your health!
President-pretender, J. Biden, said "the DNC has built the largest voter fraud organization in US history". Too bad they didn’t build the smartest voter fraud organization and got caught.

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Post by Snoredog » Wed Apr 04, 2007 5:06 pm

SleepGuy wrote:While I certainly don't appreciate the personal nature of some of the comments on this and other threads (such as being compared to a person who lies and falsifies information to make money on a product--disclaimer aside), I've said all along that all questions as to safety and effectiveness are completely fair and deserve to be asked, evaluated, answered, and resolved.

Truth be told, SnoreDog's questions and recommendations on the other thread (about product bench testing and the like) resulted in the current pause in marketing (in fact, I'm using the people SnoreDog recommended to do that work). The pause was completely, 100% voluntary and did not result from any direct or indirect inquiry, regulatory action, safety complaint, problem, or anything of that nature. The intent is to have another set of qualified people scrutinize all aspects of the products (design, quality controls, material selection, manufacturing, bench testing, compatibility testing, regulatory issues, etc.) and to fully document that process.

I'm confident that these products will come back to market in the next few months, documented testing and everything else needed in hand, better than ever. The scientific case for linking compliance and olfaction--and plastic smells and non-compliance--is just too compelling to be overlooked.

And by the way, I'm sleeping just as well now as before--all night, every night, ready for the day at 6:30 a.m.--never felt better!
Hey I'm really sorry to learn you took the drastic step to pull your product from market, that was never my intent for asking those questions. I know how difficult it can be for a small business to launch a new product. It is not like I seen you were ripping anyone off, in fact I thought your product was priced very reasonable.

In fact, I don't think I ever mentioned the essential oils aspect at all. There are so many products made from oil extracts today that we consume every day, that was never even a concern for me. My only concern was with the diffuser somehow impacting the ability of the machine to respond, that was it.

While I had seen pictures of the device on the website, I didn't have to see the device up close to know that was a possibility. I only questioned the diffuser because I suspected it had some sort of a grate or screen to prevent objects from traveling down the hose and being swallowed by the patient. I know how it is, they dig out a M&M from their lung and blame it on your device. Even after the grate was mentioned (which confirmed my suspicion it had one) I never said anything else after that.

Hopefully those iron lung guys can test your device out behind the simulator and give you a certified report with not too much expense. Then once you have that documentation you can use it to your advantage. Then legally, should anything happen in the future it would be very difficult for anyone to then claim neglegence on your part as you have gone through the necessary steps and expense to have an independent lab test the product for those virtues.

Even if you could test the product yourself, those findings would be thrown out, the independent lab findings would out weigh any testing you could have possibly ever done on your own.

Hope your back in business soon, as mentioned there are other ways to delivery the product, the inlet filter on the machine is one way. While it would require different devices for every brand machine, it is doable. I'd have no problem putting a drop of oil on my inlet foam filter, I'm not recommending it to anyone only saying what I would do. If you seen what I do now with my inlet filters you would say that is nothing. I make my own fine filters for use on my own machines, I use .3 micron polyester filter media used to make industrial dust collection filters. Food processors like General Mills, Proctor & Gamble etc., all use it in their mfg plants.

someday science will catch up to what I'm saying...

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Sleepy Dog Lover
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Post by Sleepy Dog Lover » Wed Apr 04, 2007 5:44 pm

I think doing the R&D is a great idea, it will make marketing the product much easier for Brett. I love my pur-sleep too, and will not stop using it, but I think it a good thing for all of us. Thanks Brett.

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Wistful
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Post by Wistful » Wed Apr 04, 2007 5:45 pm

I was surprised to here that Bret closed the store for now but completely respect him for doing so. He has continually shown an openness for people's feedback as well as genuine concern for other's well being.

I love my pur-sleep and intend to keep using it unless it is proved unsafe. Having seen and used it however, I don't see how that can be.
Infact, I was just considering posting that thanks to 'fresh', I was finally able to sleep through the night.
Pressure 7-9 C-Flex 3 AHI 1.6
Mirage Swift
Marine Mask Seal so my mask doesn't leak
Polygrip Strips so my mouth doesn't leak
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Pur-Sleep so I can fall asleep despite all of the above.

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dudley_doright
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Hope all the best to you Brett.....

Post by dudley_doright » Wed Apr 04, 2007 6:29 pm

....and that the additional expenses you incurred will not make the cost of the pur-sleep system to go up.