Clinical Trials, Historical Use, Efficacy, Placebo Effect, Etc

[Guest guest]

I just want to make a really quick point. I've seen some discussion here

about clinical trials, historical use of things, (the lack of historical

use of things), proven efficacy, placebo effect, etc ...

 

As far as the FDA and other bodies similar to it are concerned ... even

if an herb has been in use for thousands of years, with positive results

by millions of folks over time, etc, etc ... it is still worthless, only

works by placebo effect, has no proven efficacy, is potentially

dangerous, and is not to be bothered with if it hasn't gone through

their routine of clinical trials ...

 

Just something to think about since this pertains to not only essential

oils being able to be called unproven substances, but also pertains to

everything including herbs and vitamins, and many and almost any other

" supplements " (and even most, if not all, Traditional s

which are actually patent medicines and prescriptions in other parts of

the world).

 

Everything except the marketed drugs that are " FDA approved " is pretty

much considered to be unproven and potentially dangerous in Western

Medicine philosophy, so really the use of any herbs or oils or

" alternative " procedure, is risky and/or worthless according to some

 

I do hope that one day we will advance to embrace and truly study all

varieties of treatments and treatment substances available to us, and

not just use one single, tunnel vision method of proving efficacy (and

even find a way to harness the power of the mind and " placebo effect " ).

 

Have a healthy and happy MLK Day.

 

*Smile*

Chris (list mom)

http://www.alittleolfactory.com

 

 

 

 

 

 

 

[Guest guest]

At 12:23 PM 1/19/2004 -0600, you wrote:

 

>As far as the FDA and other bodies similar to it are concerned ... even

>if an herb has been in use for thousands of years, with positive results

>by millions of folks over time, etc, etc ... it is still worthless, only

>works by placebo effect, has no proven efficacy, is potentially

>dangerous, and is not to be bothered with if it hasn't gone through

>their routine of clinical trials ...

 

I'm not sure if I agree with your definition of how the FDA 'and other

bodies' view herbs, supplements and other stuff, Chris, not debating the

point, just not very sure of the wording :-> I think it is wonderful how

the FDA backed down and is allowing a disclaimer on the same substances

now. They were working towards banning many, if not all substances, IIRC,

and then got a new director, some new lawsuits, and here is a brief bit of

the info, copied from the herbalgram.com site:

 

>HerbalGram

>The Journal of the American Botanical Council

>Issue: 59 Page: 50-56, 67

>

>The Slow Demise of FDA Censorship

>

>HerbalGram. 2003;59:50-56, 67 © American Botanical Council

 

>Recent Court Cases on Health Claims that Define the Scope of Speech Rights

for the Manufacturers and Distributors of Herbs and Other Dietary Supplements

>by Jonathan W. Emord

>Summary: Certain herbs, like saw palmetto, have physiological effects upon

the body that are useful in mitigating or preventing disease and

health-related conditions. Even in the presence of credible scientific

evidence supporting claims for such products, the Food and Drug

Administration has often censored them, denying manufacturers of such

products the right to inform consumers of truthful and nonmisleading health

information. The loss of that information harms consumers. Indeed, in

certain instances it may be responsible for the worsening of human health.

This article provides a detailed history of recent federal court decisions

that spell a new day for those who wish to communicate on dietary

supplement product labels and in labeling truthful and nonmisleading health

information concerning the effects of herbs and other nutrients upon disease.

>[Editor's note: Just before presstime, on July 11, 2003, the U.S. Food and

Drug Administration announced plans to allow " qualified health claims " for

foods and dietary supplements under the Nutrition Labeling and Education

Act of 1990, the subject of much of the article below. HerbalGram will

cover the new FDA policy in a future issue.]

>For decades the U.S. Food and Drug Administration (FDA) censored

nutrient-disease relationship claims (so-called " health claims " ) with

impunity. Agency scientists and officials have long believed it was FDA's

unique role to determine for Americans what is in their own best interest

and to deny them access to information on how nutrients, and foods in

general, could affect disease, reasoning that less-than-certain information

of this kind could result in dangerous self-medication by consumers. The

era of censorship with impunity is now coming to a close. A new era of

agency respect for the First Amendment* appears in the offing.1

 

I also have the German Commission E monographs, and, AFAIK, that is a

generally acceptable list of herbs (that have been used for centuries :-)

Some herbs are approved by them, others are still under study. I know some

herbalists disagree with some of the findings of the ComE (even the

favorable ones!) but that may be more a function of their belief system and

educational background -- there is disagreement amongst herbalists, of

course :-)

 

The Euro community has, individually, banned some herbs (often due to

widely ranging factors, including the ill-thought-out kava ban due to the

importation of kava shavings that caused liver problems note: the

centuries-old use of kava never included the shavings, but a greedy

supplier in Europe decided not to throw them away, people used the product,

got very sick, kava got banned <sigh>.) That is just one example of a

government reacting to piecemeal or incorrect information, but overall, I

think things are improving. If we can stop irresponsible selling of

unproven stuff. Heh.

 

>Everything except the marketed drugs that are " FDA approved " is pretty

>much considered to be unproven and potentially dangerous in Western

>Medicine philosophy, so really the use of any herbs or oils or

> " alternative " procedure, is risky and/or worthless according to some

 

Yes, but it is allowed, and a simple disclaimer like " This product has not

be tested or approved by the FDA for the claims made on the label " is a

helluva big step in them recognizing people have the right to choose.

 

>I do hope that one day we will advance to embrace and truly study all

>varieties of treatments and treatment substances available to us, and

>not just use one single, tunnel vision method of proving efficacy (and

>even find a way to harness the power of the mind and " placebo effect " ).

 

I'm an optomist. That day is coming. And I agree, the placebo effect is a

powerful element of our psyches. Fascinating subject.

 

http://member.newsguy.com/~herblady

[Guest guest]

Hi Anya,

 

Thanks so much for posting " The Slow Demise of FDA Censorship " . I

remember when that legislation about allowing the disclaimer on herbs

and supplements as opposed to banning everything passed. I was working

at a health food store in NYC at the time and there were a lot of happy

folks that I was in contact with

 

What I meant about the FDA and similar bodies, is that they won't

acknowledge the value of or give a stamp of approval to anything except

drugs that have gone through the clinical testing method, and that has

proven in many ways to be a flawed system.

 

Also, I was more referring to American organizations and their

practitioners, not European ones. I have more than once in my lifetime

mentioned an herb or what have you to doctors here in the US and they

say things like they can't be bothered with silly things like herbs, etc

as they use " real " medicines, or patronize and practically pat you on

the head while going " there there you ridiculous little person you " ;-p

 

I do hope that a better system for health care in general will evolve

some day.

 

*Smile*

Chris (list mom)

http://www.alittleolfactory.com

 

 

 

 

Anya [mccoy]

Monday, January 19, 2004 3:16 PM

 

Re: Clinical Trials, Historical Use, Efficacy,

Placebo Effect, Etc

 

 

At 12:23 PM 1/19/2004 -0600, you wrote:

 

>As far as the FDA and other bodies similar to it are concerned ... even

>if an herb has been in use for thousands of years, with positive

results

>by millions of folks over time, etc, etc ... it is still worthless,

only

>works by placebo effect, has no proven efficacy, is potentially

>dangerous, and is not to be bothered with if it hasn't gone through

>their routine of clinical trials ...

 

I'm not sure if I agree with your definition of how the FDA 'and other

bodies' view herbs, supplements and other stuff, Chris, not debating the

point, just not very sure of the wording :-> I think it is wonderful

how

the FDA backed down and is allowing a disclaimer on the same substances

now. They were working towards banning many, if not all substances,

IIRC,

and then got a new director, some new lawsuits, and here is a brief bit

of

the info, copied from the herbalgram.com site:

 

>HerbalGram

>The Journal of the American Botanical Council

>Issue: 59 Page: 50-56, 67

>

>The Slow Demise of FDA Censorship

>

>HerbalGram. 2003;59:50-56, 67 C American Botanical Council

 

>Recent Court Cases on Health Claims that Define the Scope of Speech

Rights

for the Manufacturers and Distributors of Herbs and Other Dietary

Supplements

>by Jonathan W. Emord

>Summary: Certain herbs, like saw palmetto, have physiological effects

upon

the body that are useful in mitigating or preventing disease and

health-related conditions. Even in the presence of credible scientific

evidence supporting claims for such products, the Food and Drug

Administration has often censored them, denying manufacturers of such

products the right to inform consumers of truthful and nonmisleading

health

information. The loss of that information harms consumers. Indeed, in

certain instances it may be responsible for the worsening of human

health.

This article provides a detailed history of recent federal court

decisions

that spell a new day for those who wish to communicate on dietary

supplement product labels and in labeling truthful and nonmisleading

health

information concerning the effects of herbs and other nutrients upon

disease.

>[Editor's note: Just before presstime, on July 11, 2003, the U.S. Food

and

Drug Administration announced plans to allow " qualified health claims "

for

foods and dietary supplements under the Nutrition Labeling and Education

Act of 1990, the subject of much of the article below. HerbalGram will

cover the new FDA policy in a future issue.]

>For decades the U.S. Food and Drug Administration (FDA) censored

nutrient-disease relationship claims (so-called " health claims " ) with

impunity. Agency scientists and officials have long believed it was

FDA's

unique role to determine for Americans what is in their own best

interest

and to deny them access to information on how nutrients, and foods in

general, could affect disease, reasoning that less-than-certain

information

of this kind could result in dangerous self-medication by consumers. The

era of censorship with impunity is now coming to a close. A new era of

agency respect for the First Amendment* appears in the offing.1

 

I also have the German Commission E monographs, and, AFAIK, that is a

generally acceptable list of herbs (that have been used for centuries

:-)

Some herbs are approved by them, others are still under study. I know

some

herbalists disagree with some of the findings of the ComE (even the

favorable ones!) but that may be more a function of their belief system

and

educational background -- there is disagreement amongst herbalists, of

course :-)

 

The Euro community has, individually, banned some herbs (often due to

widely ranging factors, including the ill-thought-out kava ban due to

the

importation of kava shavings that caused liver problems note: the

centuries-old use of kava never included the shavings, but a greedy

supplier in Europe decided not to throw them away, people used the

product,

got very sick, kava got banned <sigh>.) That is just one example of a

government reacting to piecemeal or incorrect information, but overall,

I

think things are improving. If we can stop irresponsible selling of

unproven stuff. Heh.

 

>Everything except the marketed drugs that are " FDA approved " is pretty

>much considered to be unproven and potentially dangerous in Western

>Medicine philosophy, so really the use of any herbs or oils or

> " alternative " procedure, is risky and/or worthless according to some

 

Yes, but it is allowed, and a simple disclaimer like " This product has

not

be tested or approved by the FDA for the claims made on the label " is a

helluva big step in them recognizing people have the right to choose.

 

>I do hope that one day we will advance to embrace and truly study all

>varieties of treatments and treatment substances available to us, and

>not just use one single, tunnel vision method of proving efficacy (and

>even find a way to harness the power of the mind and " placebo effect " ).

 

I'm an optomist. That day is coming. And I agree, the placebo effect is

a

powerful element of our psyches. Fascinating subject.

 

http://member.newsguy.com/~herblady

 

 

 

 

[Guest guest]

At 04:12 PM 1/19/2004 -0600, you wrote:

>Hi Anya,

>

>Thanks so much for posting " The Slow Demise of FDA Censorship " . I

>remember when that legislation about allowing the disclaimer on herbs

>and supplements as opposed to banning everything passed. I was working

>at a health food store in NYC at the time and there were a lot of happy

>folks that I was in contact with

 

Chris, maybe you're confused? It just happend last summer. Soon after, all

the labels started popping up with the disclaimer. It's very recent.

Previously, all herbs and supplements couldn's have stuff on the labels

like 'helps lower HBP', or 'reduces nasal congestion'. Now they can put

that on the label. Before, a layperson would go into a store, and have to

*know* what hawthorne berries did, or that MSM helped with 'this and that'.

Now it says it on the label.

>

>What I meant about the FDA and similar bodies, is that they won't

>acknowledge the value of or give a stamp of approval to anything except

>drugs that have gone through the clinical testing method, and that has

>proven in many ways to be a flawed system.

 

I agree, but I really believe it is changing. The Age of Keller is over,

and consumer awareness and demands will change the FDA in regards to

natural supplements.

 

>Also, I was more referring to American organizations and their

>practitioners, not European ones. I have more than once in my lifetime

>mentioned an herb or what have you to doctors here in the US and they

>say things like they can't be bothered with silly things like herbs, etc

>as they use " real " medicines, or patronize and practically pat you on

>the head while going " there there you ridiculous little person you " ;-p

 

The German ComE reports are helping to change the American system, IMHO.

And the paternalistic, 'deify me' attitude of American doctors seems to be

going the way of the horse buggy. My review of the literature and lay

articles shows they are *having* to become more aware of the billions of $$

of supplements their patients are ingesting, since may interact/interfere,

in some cases, with the drugs they prescribe. A few years ago, I got my

mother's doc in PA, over the phone, to discuss SJW with me before we got

her on Zoloft. He knew all the protocols for weaning from one to the other,

etc. Another of her doctors down here agreed to let me put her on an herb

and garlic regimine for her high cholesterol, and it worked. Things are

changing, and some med schools now have courses in natural thingies :-)

 

I'm working with several medical schools/centers here in SoFla with several

different clinical studies I'm funding. Not pricey on my part, but a

time-consumer. A little mix of herbal and EO stuff being looked at. Pain

and immune system concerns are right up in the stuff patients want natural

help with, and the doctors are coming around (especially when they see good

results!).

 

>I do hope that a better system for health care in general will evolve

>some day.

 

You're an optimist like me, and we will prevail.

http://member.newsguy.com/~herblady

[Guest guest]

Hi again Anya

 

Yep, I hadn't heard about this recent passage of legislation. I guess

between having the baby and moving - 2003 was a semi news fog for me

*lol*

 

Thanks for the info!

 

*Smile*

Chris (list mom)

 

 

http://www.alittleolfactory.com

 

 

 

 

Anya [mccoy]

 

>Thanks so much for posting " The Slow Demise of FDA Censorship " . I

>remember when that legislation about allowing the disclaimer on herbs

>and supplements as opposed to banning everything passed. I was working

>at a health food store in NYC at the time and there were a lot of happy

>folks that I was in contact with

 

Chris, maybe you're confused? It just happend last summer. Soon after,

all

the labels started popping up with the disclaimer. It's very recent.

Previously, all herbs and supplements couldn's have stuff on the labels

like 'helps lower HBP', or 'reduces nasal congestion'. Now they can put

that on the label. Before, a layperson would go into a store, and have

to

*know* what hawthorne berries did, or that MSM helped with 'this and

that'.

Now it says it on the label.

 

<snipped>