Re: SynchroMeter and Frequency generator

[Guest guest]

And what exactly makes your line of reasoning acceptable?

jalyons@... wrote:

>

> > Trust me

> > ... the FDA is acutely aware that this is a homeopathic device.

>

> On what basis do you say that?

>

> > There is nothing

> > unethical about the marketing of this device,

>

> For homeopathic evaluations?

>

> What makes that line of reasoning acceptable?

>

> JALyons

>

> Learn more from:

> http://home.online.no/~dusan/gallstones/

> http://home.online.no/~huldakli/

> http://www..net/

> http://home.online.no/~dusan/

>

>

[Guest guest]

> Sorry , this is registered as a NON-COGNITIVE bio-feedback

machine. Now go do your

> homework and figure out what this means. Also, wrong number!

Woops!

-------------------

I'm not , but I am confused about some other stuff above.

I just finished reading the FDA letter to phazx and it seems pretty

clear to me what they found issue with.

Registered where as a " NON-COGNITIVE " bio-feedback machine? Because

they wrote that on their FDA application maybe? That did not seem to

be the issue in the rather strongly worded (and documented) warning

letter. It doesn't seem that the FDA think they registered it as a

NON-COGNITIVE bio-feedback machine.... Mmmmm...

And what number is the " wrong number? "

Could you be more clear in your response?

Thanks,

JALyons

[Guest guest]

<snip>

LB > > > There is nothing

> > > unethical about the marketing of this device,

JL > > For homeopathic evaluations?

> >

JL > > What makes that line of reasoning acceptable?

> >

I was wondering how ethical it is to get a machine registered with

the FDA as a bio-feedback machine -- assuming one understands what

the definitions and limitations and usages are legally for bio-

feedback machines -- when in fact the machine is intended to be used

in a [questionable] diagnosis and presciptive manner.

And the " NON-COGNITVE " use/claim of this machine imputes/implies

power to both the machine and the " patient " (as well as, I suppose,

the practitioner) which would seem to imply that the machine itself

is involved in the healing / diagnosis / prescription /reading

(whatever the words one might use are).

That for sure isn't covered in the FDA devices registration, now is

it?

So back to the ethics question: Is it ethical to present a machine

to the FDA for approval as a biofeedback machine when the marketeers

know full well that they are not going to be using it for those

purposes as understood and defined by the FDA? This is not a guess.

This is a result of examining the website (and others of similar

design and purpose.) I realize (I think) that you are not personally

responsible for these actions, but you don't seem to be having any

trouble with it.

If my " line of reasoning " is " acceptable " you have an ethical

problem. So the solution (although there are others) has to be to

trash the reasoning, or trash the ethics questions, or appeal to the

higher ground (*Big* ???) of " the end justifies the means. "

The proverbial slippery slope if ever there is one.

JALyons

[Guest guest]

Sorry to see you're still so confused JAL. Hopefully one of these days you'll

figure it

out. Best wishes,

jalyons@... wrote:

>

>

> <snip>

>

> LB > > > There is nothing

> > > > unethical about the marketing of this device,

>

> JL > > For homeopathic evaluations?

> > >

> JL > > What makes that line of reasoning acceptable?

> > >

>

> I was wondering how ethical it is to get a machine registered with

> the FDA as a bio-feedback machine -- assuming one understands what

> the definitions and limitations and usages are legally for bio-

> feedback machines -- when in fact the machine is intended to be used

> in a [questionable] diagnosis and presciptive manner.

>

> And the " NON-COGNITVE " use/claim of this machine imputes/implies

> power to both the machine and the " patient " (as well as, I suppose,

> the practitioner) which would seem to imply that the machine itself

> is involved in the healing / diagnosis / prescription /reading

> (whatever the words one might use are).

>

> That for sure isn't covered in the FDA devices registration, now is

> it?

>

> So back to the ethics question: Is it ethical to present a machine

> to the FDA for approval as a biofeedback machine when the marketeers

> know full well that they are not going to be using it for those

> purposes as understood and defined by the FDA? This is not a guess.

> This is a result of examining the website (and others of similar

> design and purpose.) I realize (I think) that you are not personally

> responsible for these actions, but you don't seem to be having any

> trouble with it.

>

> If my " line of reasoning " is " acceptable " you have an ethical

> problem. So the solution (although there are others) has to be to

> trash the reasoning, or trash the ethics questions, or appeal to the

> higher ground (*Big* ???) of " the end justifies the means. "

>

> The proverbial slippery slope if ever there is one.

>

> JALyons

>

> Learn more from:

> http://home.online.no/~dusan/gallstones/

> http://home.online.no/~huldakli/

> http://www..net/

> http://home.online.no/~dusan/

>

>

[Guest guest]

>Sorry , this is registered as a NON-COGNITIVE bio-feedback

>machine. Now go do your homework and figure out what this means.

>Also, wrong number! Woops!

No , it's time for you to do YOUR homework and look at the

actual official FDA documents which are up on the web at the site I

mentioned, rather than what you have been told. What I quoted were

not my own words -- they came directly from an official FDA document

that I got at their own website, so if you have a problem with that

and think the FDA is in error, I suggest you contact the FDA. Note

that it is NOT at all approved for curing cancer or any other disease

and there is no research that shows that it does this.

Pignotti