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Digest Number 1635

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To be simplistic as far as the Food and Drug Administration goes, if

it's a food then you would prove harm to be banned, drugs have to prove

there is no harm in its use. The trade-off is that we continue to lose

out on that elusive insurance money and the use of herbs in hospitals.

doug

 

>

> In other words, as soon as one embraces a scientific approach to the

> problem of iatrogenesis from CHM, a multitude of problematic issues

> arise. There is considerable risk in all this that herbs will be

> banned or their use restricted beyond a level that we would consider

> to be appropriate, there would be strong pressure for CM to define

> itself in line with the type of scientific research that was being

> conducted. etc. And where would the funds for all this research come

> from? When a new drug is licensed, a high percentage of the

> development costs (which may be in the region of $300,000,000) go into

> clinical trials.

>

> This is a very complex area, and that if we wish Chinese medicine as

> we know it to survive, an important task is for us to exert political

> pressure to NOT subject CM to any type of systematic scientific

> investigation, or at the very least, to preserve a high measure of

> autonomy for CM in the process.

>

>

>

> Wainwright

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To be simplistic as far as the Food and Drug Administration goes, if

it's a food then you would prove harm to be banned, drugs have to prove

there is no harm in its use. The trade-off is that we continue to lose

out on that elusive insurance money and the use of herbs in hospitals.

doug

>>>No foods must be shown to have no toxic effects, drugs can have them

alon

 

 

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Doug,

 

You lose out on more than insurance money. You lose out on the opportunity to

spend $500 million per herb or formula to develop " new drug " status. Wainwright

was being overly modest in his estimates. Since there's no possibility of

patents, then who ever makes the investment will be doing so purely as a public

service. Any volunteers?

 

Emmanuel Segmen

To be simplistic as far as the Food and Drug Administration goes, if

it's a food then you would prove harm to be banned, drugs have to prove

there is no harm in its use. The trade-off is that we continue to lose

out on that elusive insurance money and the use of herbs in hospitals.

doug

 

>

> In other words, as soon as one embraces a scientific approach to the

> problem of iatrogenesis from CHM, a multitude of problematic issues

> arise. There is considerable risk in all this that herbs will be

> banned or their use restricted beyond a level that we would consider

> to be appropriate, there would be strong pressure for CM to define

> itself in line with the type of scientific research that was being

> conducted. etc. And where would the funds for all this research come

> from? When a new drug is licensed, a high percentage of the

> development costs (which may be in the region of $300,000,000) go into

> clinical trials.

>

> This is a very complex area, and that if we wish Chinese medicine as

> we know it to survive, an important task is for us to exert political

> pressure to NOT subject CM to any type of systematic scientific

> investigation, or at the very least, to preserve a high measure of

> autonomy for CM in the process.

>

>

>

> Wainwright

 

 

 

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Emmanuel,

 

Gees, has the price of an IND dropped so low?

 

I researched the herbal medicine/FDA interface

from top to bottom for a Chinese traditional

pharmaceutical company back in 96/97 and

an IND could easily cost $1 billion back then.

 

Ken

 

, " Emmanuel Segmen " <

susegmen@i...> wrote:

> Doug,

>

> You lose out on more than insurance money. You lose out on the

opportunity to spend $500 million per herb or formula to develop " new drug "

status.

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