Re: FDA Approvals

[Guest guest]

Hi, Ann,

>I know the bovine treatment is FDA approved. Please enlighten me by

>telling me what other treatments Cheney offers that do not have FDA

>approval?

>

>Please answer this question, Mark. This is quite a serious

>accusation you have made.

>

>I should think a person might be prosecuted for dispensing

>unregulated treatments. If not prosecuted, I should think a lawsuit

>(not to mention a diminished reputation) would make an

>internationally known physician think twice about dispensing

>medicines or treatments that do not meet FDA safety standards.

>

I think a lot of the confusion is that there are several different things

that can be meant by " FDA approval. "

One FDA approval is approval to market a drug. That makes it available to

anyone who has a prescription for it. This kind of approval involves the 3

phases of human testing, and takes 5yr+ and $200M+.

Another level of approval is what is available for OTC items. In this way,

" FDA approval " just means that the item has not been found to be dangerous,

and the manufacturer is not making any medical claims for it. No " safe and

effective in treatment for ... "

Then there is FDA approval for human trials. This involves getting approval

for experimental design, getting an OK from an institutional review board

(i.e. hospital's board), and getting the approval of the FDA to use a

non-approved drug on humans. At this level, " approval " means that the FDA

thinks that there is a decent chance that the drug might be useful, and a

good chance that it is not dangerous in the level being tested. Getting

approval to run a formal clinical trial usually takes only a few months. The

cost of getting the approval to run the trial is less than the cost of

running the trial, especially since most trials cannot charge the patient

anything - not even for the lab tests they will be getting.

I think that the original remark from Cheney about treatments not being

FDA=approved just means that they are not recognized prescription drugs -

have not been found to be " safe and effective " in human trials. I don't know

if Cheney is running formal clinical trials, which would have to be

FDA-approved. But he is free to prescribe any substance that can be legally

sold in the US - and that includes bovine growth factors which have been

classified as a food additive and are OTC.

Jerry

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[Guest guest]

I'll be glad to answer this.

Cheney uses a lot of drugs that are NOT FDA approved for what he uses them

for.

This is not an accusation, its true.

It's also NOT ILLEGAL, it's called " off lable use " , it is not very common

because of the liability to the DR. It IS an agggressive use of meds in a

state of the art, bleeding edge way to help paitents, which is what Cheney

does.

For example, Doxipine - Its FDA approved as a ANTI-DEPRESSENT, not a sleep

medication.

Oxytocin - FDA approved for treating woeman who have trouble lactating - NOT

Blood Brain Profusion.

Neurontin - Pain med - NOT SLEEP med.

etc

etc

etc.

So, for who ever thought this was an accusation of Cheney - get real.

Re: FDA approvals

Hi, Ann,

>I know the bovine treatment is FDA approved. Please enlighten me by

>telling me what other treatments Cheney offers that do not have FDA

>approval?

>

>Please answer this question, Mark. This is quite a serious

>accusation you have made.

>

>I should think a person might be prosecuted for dispensing

>unregulated treatments. If not prosecuted, I should think a lawsuit

>(not to mention a diminished reputation) would make an

>internationally known physician think twice about dispensing

>medicines or treatments that do not meet FDA safety standards.

>

I think a lot of the confusion is that there are several different things

that can be meant by " FDA approval. "

One FDA approval is approval to market a drug. That makes it available to

anyone who has a prescription for it. This kind of approval involves the 3

phases of human testing, and takes 5yr+ and $200M+.

Another level of approval is what is available for OTC items. In this way,

" FDA approval " just means that the item has not been found to be dangerous,

and the manufacturer is not making any medical claims for it. No " safe and

effective in treatment for ... "

Then there is FDA approval for human trials. This involves getting approval

for experimental design, getting an OK from an institutional review board

(i.e. hospital's board), and getting the approval of the FDA to use a

non-approved drug on humans. At this level, " approval " means that the FDA

thinks that there is a decent chance that the drug might be useful, and a

good chance that it is not dangerous in the level being tested. Getting

approval to run a formal clinical trial usually takes only a few months. The

cost of getting the approval to run the trial is less than the cost of

running the trial, especially since most trials cannot charge the patient

anything - not even for the lab tests they will be getting.

I think that the original remark from Cheney about treatments not being

FDA=approved just means that they are not recognized prescription drugs -

have not been found to be " safe and effective " in human trials. I don't know

if Cheney is running formal clinical trials, which would have to be

FDA-approved. But he is free to prescribe any substance that can be legally

sold in the US - and that includes bovine growth factors which have been

classified as a food additive and are OTC.

Jerry

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other, not to give medical advice. If you are interested in any treatment

discussed here, please consult your doctor.

[Guest guest]

> I'll be glad to answer this.

> Cheney uses a lot of drugs that are NOT FDA approved for what he

uses them

> for.

Thank you for your clarification, Mark.

In your first post you came out with precisely this statement ...

*His treatments are not FDA approved*.

I am sure I should not have questioned your statement if you had been

as clear in your first post as you were in your second.

Regards,

Ann

[Guest guest]

> Cheney uses a lot of drugs that are NOT FDA approved for what he uses them

for. This is not an accusation, its true.

It's also NOT ILLEGAL, it's called " off label use " , it is not very common

I think you'd be surprised at how common off-label use of drugs is, and

always has been. I have been prescribed off-label use of drugs by very

traditional, conservative docs in a large family practice/internal medicine

group since as early as the mid-80's - long before any of us realized I had

CFIDS. Prednisone and other steroids were long ago used for off-label

purposes, which in some instances has proven to be a sad mistake. Using

tricyclics for migraine pain relief is off-label. Tricyclics too are

antidepressants, but it has been common practice to use them for controlling

pain - even by regular docs. There is so much off-label use of drugs the FDA

is now trying to get a handle on it. A Dr. Seastrunk, psychiatrist,

pioneered the use of high doses of Neurontin, doses Cheney does not like and

won't use, for the treaatment of CFS and MCS. This is where Cheney got his

info from, and probably several other docs that use high dose Neurontin. It

has many off-label uses. Guaifenisen is currently being used off-label, and

the list goes on. I think the neurologist at the big medical center that did

my brain MRI and said I was in a state of status migrainous and prescribed

400 mg B-2 daily (as I didn't seem to be truly helped my any meds I had

used) would be accused of off-label use of the " supplement " , but drug, if

the FDA gets its wishes, would be considered off-label for that particular

Vitamin. Funny thing is, it seems to be helping.

Cheney is by no means the only one, but the tone of your message comes

acrosss as very hostile towards him, particularly in your first message, for

doing this. I don't think very highly of the FDA, as I think they are in bed

with both the insurance companies, and certainly the pharmaceutical

companies, when you see that most of the FDA's advisory board have financial

connections to the pharmaceutical industry, so I don't have a problem taking

something as off-label use as long as I feel fairly safe about it. IMHO, of

course.

Donna in NC

[Guest guest]

I take exception to " it is not very common. " Off label use is extremely

common. In fact I read something recently that drugs were used more often

off-label than for what they were FDA approved.

Cindi

" Mark Werner " <bwentdg@...>

05/14/01 07:36 PM

Please respond to

< >

cc:

Subject: RE: Re: FDA approvals

I'll be glad to answer this.

Cheney uses a lot of drugs that are NOT FDA approved for what he uses them

for.

This is not an accusation, its true.

It's also NOT ILLEGAL, it's called " off lable use " , it is not very common

because of the liability to the DR. It IS an agggressive use of meds in a

state of the art, bleeding edge way to help paitents, which is what Cheney

does.

For example, Doxipine - Its FDA approved as a ANTI-DEPRESSENT, not a sleep

medication.

Oxytocin - FDA approved for treating woeman who have trouble lactating -

NOT

Blood Brain Profusion.

Neurontin - Pain med - NOT SLEEP med.

etc

etc

etc.

So, for who ever thought this was an accusation of Cheney - get real.

[Guest guest]

http://www.drugs.com/pro/naltrexone.html

http://www.jointogether.org/news/research/summaries/2006/naltrexone-drug-wins-initial.html (re: Vivitrol)

http://drugabuse.gov/MeetSum/naltrexone.html

" Naltrexone was approved by the FDA in 1984 on the basis of its pharmacological efficacy as a narcotic antagonist and its safety profile. "

Re: [low dose naltrexone] Re: Doctors who are willing to prescribe LDN

IT IS FDA APPROVED, SINCE 1984

Off Label use of other harmful misused drugs are OKAY, Off Label use for a lower dose is just Fine.