Answer to Jill

March 3, 2005

Jill, while I appreciate all your good investigational research I need

to correct some discrepencies in your " science writing " .

You said:

In addition, when you get an IRB (Investigation Research) for an

item, such as 's new chamber, you are allowed to do it but not

for a profit. I am very confused about people buying 'beta test'

chambers, since a study is supposed to be totally nonprofit or even

pay the patients a bit of $ for their participation.

We do not have and do not need an IRB. We are not conducting a study,

although we do have a university willing to get an IRB and possibly do a

study involving chambers all over the country including portable

chambers. Beta does not mean study. It simply means that a product,

software or chambers is being introduced to " work out the bugs " . Most of

our bugs are worked out, however, our Beta test will include around 100

chambers to make certain we have not missed anything. Normally, an IRB

is free. A Beta is at a reduced price or is offered free without

technical support as in the case of software which uses the term beta as

a marketing tool. They introduce a beta program and then the " official "

program. The official program will have improvments that you will want

and will also have tech support so you are willing to pay for it. Our

main reason for a Beta chamber is to make certain the degree of training

and technical support is sufficient. As part of our beta program we

will be perfecting our 3 day training program. By participating in our

beta test you agree to give input on training, ease of use,

documentation and promotional literature, etc. You agree to answer

questionaires and tell us about anything that you feel may be an issue,

no matter how large or how small. Our chamber was designed to sell for

$24,900. There is not another chamber in the same category anywhere in

the world marketed at under $35,000 that will compare in quality and

strength. It is designed for commercial use. We originally considered

offering a chamber for home use at 1.3 ata under the same 510K, however,

we decided to stay with the commercial unit rather than lower the

quality. We think it was a wise decision. The company has not agreed

to offer these units to home users. However, as an associate and

willing to accept the responsibility, I may market them to those who are

willing to accept the responsibility for proper and safe use and willing

to take a professional training similar to what a CHT would take to

obtain board certification but without the " wound care " elements. We

plan on doing everything the FDA aks us to do and follow their

guidelines. The Beta edition will not be introduced until we get the

" go-ahead " from the FDA. Although, I do not agree on everything the FDA

does, they have indeed been very cooperative and the " case worker " that

was assigned to us is very knowledgable and professional in his work.

We do not try to pull any " wool " over his eyes and we keep everything

above board and go " by the book " .

As far as my meeting with Oxyhealth at the last symposium in Florida, I

did not attend that forum. As far as the IHA, International Hyperbaric

Association, it was set up to market Oxyhealth chambers and does not

have a 501©3 non-profit status. That is the reason our talks with

Oxyhealth failed. Oxyhealth produces a good high altitude sickness

chamber. They sell for aprox. $10,000, $15000, and $20,000 depending on

the model and size you choose. They serve a good purpose.

I do agree with Ken that a Scientific Writer should be provided with

enough time to obtain the knowledge and factual information needed to

properly write an article. In the future if I can assist, just let me

know.

I hope this helps clear up some confusion, although something tells me I

can expect a rebuttal. To what, I am not sure.

Hartsoe

PS: The price of the Beta edition of our chamber is now $16,800. That

is around $8,000 for helping us out.

March 3, 2005

, LOL, this post on this list is not " science writing " , it is

telling you about my conversation with Oxyhealth, in which I also

noted I was paraphrasing.

I'll forward your post on to Oxyhealth if you don't mind (it's public

anyway), I'm curious about all this now.

I will follow up with the FDA but haven't had time yet. Thanx for the

information in this post it saves me a little time.

> Jill, while I appreciate all your good investigational research I

need

> to correct some discrepencies in your " science writing " .

>

> You said:

> In addition, when you get an IRB (Investigation Research) for an

> item, such as 's new chamber, you are allowed to do it but not

> for a profit. I am very confused about people buying 'beta test'

> chambers, since a study is supposed to be totally nonprofit or even

> pay the patients a bit of $ for their participation.

>

> We do not have and do not need an IRB. We are not conducting a

study,

> although we do have a university willing to get an IRB and possibly

do a

> study involving chambers all over the country including portable

> chambers. Beta does not mean study. It simply means that a

product,

> software or chambers is being introduced to " work out the bugs " .

Most of

> our bugs are worked out, however, our Beta test will include around

100

> chambers to make certain we have not missed anything. Normally,

an IRB

> is free. A Beta is at a reduced price or is offered free without

> technical support as in the case of software which uses the term

beta as

> a marketing tool. They introduce a beta program and then

the " official "

> program. The official program will have improvments that you will

want

> and will also have tech support so you are willing to pay for it.

Our

> main reason for a Beta chamber is to make certain the degree of

training

> and technical support is sufficient. As part of our beta program we

> will be perfecting our 3 day training program. By participating in

our

> beta test you agree to give input on training, ease of use,

> documentation and promotional literature, etc. You agree to answer

> questionaires and tell us about anything that you feel may be an

issue,

> no matter how large or how small. Our chamber was designed to sell

for

> $24,900. There is not another chamber in the same category

anywhere in

> the world marketed at under $35,000 that will compare in quality and

> strength. It is designed for commercial use. We originally

considered

> offering a chamber for home use at 1.3 ata under the same 510K,

however,

> we decided to stay with the commercial unit rather than lower the

> quality. We think it was a wise decision. The company has not

agreed

> to offer these units to home users. However, as an associate and

> willing to accept the responsibility, I may market them to those

who are

> willing to accept the responsibility for proper and safe use and

willing

> to take a professional training similar to what a CHT would take to

> obtain board certification but without the " wound care " elements.

We

> plan on doing everything the FDA aks us to do and follow their

> guidelines. The Beta edition will not be introduced until we get

the

> " go-ahead " from the FDA. Although, I do not agree on everything

the FDA

> does, they have indeed been very cooperative and the " case worker "

that

> was assigned to us is very knowledgable and professional in his

work.

> We do not try to pull any " wool " over his eyes and we keep

everything

> above board and go " by the book " .

>

> As far as my meeting with Oxyhealth at the last symposium in

Florida, I

> did not attend that forum. As far as the IHA, International

Hyperbaric

> Association, it was set up to market Oxyhealth chambers and does not

> have a 501©3 non-profit status. That is the reason our talks with

> Oxyhealth failed. Oxyhealth produces a good high altitude sickness

> chamber. They sell for aprox. $10,000, $15000, and $20,000

depending on

> the model and size you choose. They serve a good purpose.

>

> I do agree with Ken that a Scientific Writer should be provided with

> enough time to obtain the knowledge and factual information needed

to

> properly write an article. In the future if I can assist, just let

me

> know.

>

> I hope this helps clear up some confusion, although something tells

me I

> can expect a rebuttal. To what, I am not sure.

>

> Hartsoe

> PS: The price of the Beta edition of our chamber is now $16,800.

That

> is around $8,000 for helping us out.

>

March 3, 2005

One final question:

The Beta edition will not be introduced until we get the

> " go-ahead " from the FDA. Although, I do not agree on everything

the FDA

> does, they have indeed been very cooperative and the " case worker "

that

> was assigned to us is very knowledgable and professional in his

work.

> We do not try to pull any " wool " over his eyes and we keep

everything

> above board and go " by the book " .

Have you forwarded them all your posts on this list?

Would you worry if they were forwarded?

No, I am not going to forward these posts. I just ask you to mull

that over. Re-read your posts including the soliciting of

buyers/testers of the beta chambers, and the idea of an hour a day of

hyperbaric, compared to a shower or driving a car, etc. And ponder if

your FDA caseworker would feel comfortable with all that you have

said on this list.

March 3, 2005

I really do need to answer this one.

First of all, I do not have a chamber. I do not have a chamber

company. I do not sell chambers. I promote hbot to anyone who will

listen, including the FDA. Will I sell chambers? If all testing is

positive and production begins, I have purchase the first 5 chambers

sold. I am on the Beta list. I am excited. When I say " we " , I am

friends with the producers of this company and have been an advisor.

I own no interest in the company. They are trying to do something

good for everyone here.

Go ahead and forward the posts, don't beat around the bush about your

intentions. The people on this list are not as stupid as you would

like to think. They are pretty intelligent and can make up their own

minds about things.

It is so obvious that you, along with some others, would love to stop

this chamber and let Oxyhealth have a monopoly. Go for it. Work

hard at it. You need a hobby.

Quit treating people as if they are stupid. Grow up.

By the way, Samir did offer to fly me to Florida, and I turned it

down. Then I decided to drive down. He did pay for my motel room.

Now let me ask you a question? Who appointed you God? Who appointed

you judge? In fact, who appointed you anything? Quite simply, it

has nothing to do with this group or the purpose of this group. If

you have a bone to pick with me, email me directly without threats

this time. The people on this list should not be subjected to this

crap.

I'm done

Hartsoe

>

> One final question:

>

> The Beta edition will not be introduced until we get the

> > " go-ahead " from the FDA. Although, I do not agree on everything

> the FDA

> > does, they have indeed been very cooperative and the " case worker "

> that

> > was assigned to us is very knowledgable and professional in his

> work.

> > We do not try to pull any " wool " over his eyes and we keep

> everything

> > above board and go " by the book " .

>

> Have you forwarded them all your posts on this list?

>

> Would you worry if they were forwarded?

>

> No, I am not going to forward these posts. I just ask you to mull

> that over. Re-read your posts including the soliciting of

> buyers/testers of the beta chambers, and the idea of an hour a day of

> hyperbaric, compared to a shower or driving a car, etc. And ponder if

> your FDA caseworker would feel comfortable with all that you have

> said on this list.

March 3, 2005

No, if I were going to forward your posts I would do it and never say

anything in advance. I suggested you re-read them yourself with a

more careful eye and look at all your claims and, dare I say,

contradictions.

As for, " the people on this list are not as stupid as you like to

think " --I definitely don't think they're stupid, it's an excellent

list, where I learned much about two very helpful modalities,

hyperbaric (it was on this list, somebody wrote me privately about

Lance Brubaker, portables and lyme, or I would never have found out

about it) and ozone....as well as other generally useful information.

>> It is so obvious that you, along with some others, would love to

stop

> this chamber and let Oxyhealth have a monopoly.

Why is that so obvious? I think and have stated that competition

would be good for the industry and hopefully bring prices down for

those who need chambers.

There was some guy in Hawaii making chambers, or claiming to, that

went to a somewhat higher PSI if I recall and were cheaper than

oxyhealth, but he did not have FDA approval so you had to ship it

overseas, I believe. This is my memory from a woman who was ill and

at a high altitude in Colorado, she called me and some others who

were using portables. She was debating whether to save the $. The

problem was she would have had an illegal chamber and no recourse to

repair if it broke. I don't know whatever happened to that guy, or

whether he is still trying.

I do think oxyhealth has done a good job, and an innovative one.

Obviously portables are becoming increasingly popular with innovative

doctors. When I was in Santa Fe there were three docs who had them.

Perhaps if a 1.5 portable gets approved--I'm not sure for *what* use,

and it is competitive with oxyhealth, doctors will consider it. Who

knows. The saturation curve of 1.3 is very close to 1.5. I'm not sure

the clinical difference would be meaningful. Pressure itself, and the

slight increase in oxygen resulting in pressurized ambient air, if I

recall, helped CP kids...in that double blind study that mystified

people a while back. So 1.3 with oxygen from a concentrator is very

effective, even more so from a tank.

I suspect it'll be a long while if/before anything happens with any

other competitors. There's really no point in continuing the

argument, I agree. I'm glad the portables are out there, for my sake

and all those they have helped. I myself had to fend off lots of

negativity before I tried and got a portable. There was tremendous

negeativity about them on your list, as well as from one doctor who

treated me at a clinic at 2.4 ata previously. It took a lot of

sifting through attacks, aggressiveness, etc, to decide to fly down

to Atlanta and try it. All I had to do was try it once--and felt so

different from one hour--that I knew it worked. In addition, it was

roomy and I wasn't claustrophobic. I know I posted the benefits of

the mild chamber on my lyme disease on your list and people had the

nerve to call it a placebo effect because it was 1.3 ata.

March 3, 2005

WOW Jill! You always have to get the last word. Your typing speed certainly

must win many an argument.

As I go through the progress of these posts, nothing, absolutely nothing

constructive has been achieved by any of it.

Can you just not let people decide for themselves. We really do not need

someone watching out for every little possible contradiction to save us from

ourselves. Thanks for your enthusiasm but your aggressive, argumentative

approach truly becomes painful. Please just stop! Thanks.

Best wishes and much love, Ken

Ken Gullan

Institute for Research Integration (IRI), San Diego, CA 92106-2424

IRI is a 501C(3) non-profit corporation established to help children with

developmental difficulties.

To contact me off-list use kengullan@... or call 619-222-1104

Re: Answer to Jill