Re: Re: MHRA advises Echinacea not be given to children under 12

[Guest guest]

I did look over the references briefly, but many of the articles are in vitro or with animals. I have not checked some of the more relevant articles - I will try and do that. They should be available on PubMed J Fidler, MCPP, (RH) AHGHerbalist To: ukherbal-list Sent: Wednesday, August 22, 2012 1:37 PM Subject: Re: MHRA advises Echinacea not be given to children under 12

Many thanks for all the responses. I was particularly interested to see the IMB's response below. I tend to agree with 's view (!) but as a newly qualified herbalist I felt it prudent to assume that I had missed some new evidence on safety, until proven otherwise.

If there is indeed any new evidence, the IMB letter seems to suggest it may lie in the WHO adverse events data which they were unable to share. I am, rather ironically, fighting off a respiratory infection with fever at the moment, but once I'm back at my desk I'll try and get hold of that info and share it.

Until then, back to the Echinacea

>

>

>

> I attach a link to their press release below:

>

> http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627

>

> I immediately took a look at HMPC's latest assessment documents for Echinacea angustifolia radix and Echinacea purpurea radix, dated 29/05/12 and 10/02/11 respectively. I wanted to ascertain if there was any new research that might inform our practice as herbalists in this matter. However, I couldn't find anything explicit. The MHRA have said themselves that it "is not a serious safety issue" but with the way it is being reported in the press, concerned parents are likely to ask us about it. It may be that in the context of a proper consultation with a trained herbalist, who will screen each patient for atopy, asthma, allergic tendencies etc., there is no need to change tack with regard to prescribing Echinacea to children under 12.

>

> However, if anyone knows of a reason for us as practitioners to change our approach, or knows a bit more of the background to this change in decision by MHRA and HMPC, it would be very useful to know?

>

> Many thanks,

>

>

>

[Guest guest]

I sincerely hope that the animals tested were certified to be under 12 years old.

Best regards,

Tim.

From: susan fidler

Sent: Wednesday, August 22, 2012 6:46 PM

To: ukherbal-list

Subject: Re: Re: MHRA advises Echinacea not be given to children under 12

I did look over the references briefly, but many of the articles are in vitro or with animals. I have not checked some of the more relevant articles - I will try and do that. They should be available on PubMed

J Fidler, MCPP, (RH) AHGHerbalist

To: ukherbal-list Sent: Wednesday, August 22, 2012 1:37 PMSubject: Re: MHRA advises Echinacea not be given to children under 12

Many thanks for all the responses. I was particularly interested to see the IMB's response below. I tend to agree with 's view (!) but as a newly qualified herbalist I felt it prudent to assume that I had missed some new evidence on safety, until proven otherwise.If there is indeed any new evidence, the IMB letter seems to suggest it may lie in the WHO adverse events data which they were unable to share. I am, rather ironically, fighting off a respiratory infection with fever at the moment, but once I'm back at my desk I'll try and get hold of that info and share it.Until then, back to the Echinacea > > > > I attach a link to their press release below:> > http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627> > I immediately took a look at HMPC's latest assessment documents for Echinacea angustifolia radix and Echinacea purpurea radix, dated 29/05/12 and 10/02/11 respectively. I wanted to ascertain if there was any new research that might inform our practice as herbalists in this matter. However, I couldn't find anything explicit. The MHRA have said themselves that it "is not a serious safety issue" but with the way it is being reported in the press, concerned parents are likely to ask us about it. It may be that in the context of a proper consultation with a trained herbalist, who will screen each patient for atopy, asthma, allergic tendencies etc., there is no need to change tack with regard to prescribing Echinacea to children under 12.> > However, if anyone knows of a reason for us as practitioners to change our approach, or knows a bit more of the background to this change in decision by MHRA and HMPC, it would be very useful to know?> > Many thanks,> > >

[Guest guest]

And anyway, all the under 12s can take antibiotics instead, it's not as if there's any problem with them........Sally OwenI sincerely hope that the animals tested were certified to be under 12 years old. Best regards,Tim. From: susan fidlerSent: Wednesday, August 22, 2012 6:46 PMTo: ukherbal-list Subject: Re: Re: MHRA advises Echinacea not be given to children under 12 I did look over the references briefly, but many of the articles are in vitro or with animals. I have not checked some of the more relevant articles - I will try and do that. They should be available on PubMed J Fidler, MCPP, (RH) AHGHerbalistTo: ukherbal-list Sent: Wednesday, August 22, 2012 1:37 PMSubject: Re: MHRA advises Echinacea not be given to children under 12 Many thanks for all the responses. I was particularly interested to see the IMB's response below. I tend to agree with 's view (!) but as a newly qualified herbalist I felt it prudent to assume that I had missed some new evidence on safety, until proven otherwise.If there is indeed any new evidence, the IMB letter seems to suggest it may lie in the WHO adverse events data which they were unable to share. I am, rather ironically, fighting off a respiratory infection with fever at the moment, but once I'm back at my desk I'll try and get hold of that info and share it.Until then, back to the Echinacea > > > > I attach a link to their press release below:> > http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627> > I immediately took a look at HMPC's latest assessment documents for Echinacea angustifolia radix and Echinacea purpurea radix, dated 29/05/12 and 10/02/11 respectively. I wanted to ascertain if there was any new research that might inform our practice as herbalists in this matter. However, I couldn't find anything explicit. The MHRA have said themselves that it "is not a serious safety issue" but with the way it is being reported in the press, concerned parents are likely to ask us about it. It may be that in the context of a proper consultation with a trained herbalist, who will screen each patient for atopy, asthma, allergic tendencies etc., there is no need to change tack with regard to prescribing Echinacea to children under 12.> > However, if anyone knows of a reason for us as practitioners to change our approach, or knows a bit more of the background to this change in decision by MHRA and HMPC, it would be very useful to know?> > Many thanks,> > >

[Guest guest]

Indubitably! And measuring rat gonad size is incredibly relevant to the health of the bairns we treat..... J Fidler, MCPP, (RH) AHGHerbalist To: ukherbal-list Sent: Wednesday, August 22, 2012 1:48 PM Subject: Re: Re: MHRA advises Echinacea not be given to

children under 12

I sincerely hope that the animals tested were certified to be under 12 years old.

Best regards,

Tim.

From: susan fidler

Sent: Wednesday, August 22, 2012 6:46 PM

To: ukherbal-list

Subject: Re: Re: MHRA advises Echinacea not be given to children under 12

I did look over the references briefly, but many of the articles are in vitro or with animals. I have not checked some of the more relevant articles - I will try and do that. They should be available on PubMed

J Fidler, MCPP, (RH) AHGHerbalist

To: ukherbal-list Sent: Wednesday, August 22, 2012 1:37 PMSubject: Re: MHRA advises Echinacea not be given to children under 12

Many thanks for all the responses. I was particularly interested to see the IMB's response below. I tend to agree with 's view (!) but as a newly qualified herbalist I felt it prudent to assume that I had missed some new evidence on safety, until proven otherwise.If there is indeed any new evidence, the IMB letter seems to suggest it may lie in the WHO adverse events data which they were unable to share. I am, rather ironically, fighting off a respiratory infection with fever at the moment, but once I'm back at my desk I'll try and get hold of that info and share it.Until then, back to the Echinacea > > > > I attach a link to their press release below:> > http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627> > I immediately took a look at HMPC's latest assessment documents for Echinacea angustifolia radix and Echinacea purpurea radix, dated 29/05/12 and 10/02/11 respectively. I wanted to ascertain if there was any new research that might inform our practice as herbalists in this matter. However, I couldn't find anything explicit. The MHRA have said themselves that it "is not a serious safety issue" but with the way it is being reported in the press, concerned parents are likely to ask us about it. It may be that in the context of a proper consultation with a trained herbalist, who will screen each patient for atopy, asthma, allergic tendencies etc., there is no need to change tack with regard to prescribing Echinacea to children under 12.> > However, if anyone knows of a reason for us as practitioners to change our approach, or knows a bit more of the background to this change in decision by MHRA and HMPC, it would be very useful to know?> > Many thanks,> > >

[Guest guest]

Ive emailed the WHO and asked them for the adverse reactions reports re Echinacea – so hopefully theyll get back and ill share as soon as – however not sure if I emailed the right department  – big organisation etc – we’ll see – others contact them too pleaseMy guess is the children that had adverse reactions were on a cocktail of pharma drugs and /or had chronic illness, they threw Echinacea into the mix and it go the blame (also what type of Echinacea “product†did they take –plant part? Was it a jelly sweet with aspartame and a dash of Echinacea extract? A lot of unknowns here – but the info is “classified†what a load of bullshit!gabriel From: ukherbal-list [mailto:ukherbal-list ] On Behalf Of susan fidlerSent: 22 August 2012 21:46To: ukherbal-list Subject: Re: Re: MHRA advises Echinacea not be given to children under 12 Indubitably! And measuring rat gonad size is incredibly relevant to the health of the bairns we treat..... J Fidler, MCPP, (RH) AHGHerbalistTo: ukherbal-list Sent: Wednesday, August 22, 2012 1:48 PMSubject: Re: Re: MHRA advises Echinacea not be given to children under 12 I sincerely hope that the animals tested were certified to be under 12 years old. Best regards,Tim. From: susan fidler Sent: Wednesday, August 22, 2012 6:46 PMTo: ukherbal-list Subject: Re: Re: MHRA advises Echinacea not be given to children under 12 I did look over the references briefly, but many of the articles are in vitro or with animals. I have not checked some of the more relevant articles - I will try and do that. They should be available on PubMed J Fidler, MCPP, (RH) AHGHerbalistTo: ukherbal-list Sent: Wednesday, August 22, 2012 1:37 PMSubject: Re: MHRA advises Echinacea not be given to children under 12 Many thanks for all the responses. I was particularly interested to see the IMB's response below. I tend to agree with 's view (!) but as a newly qualified herbalist I felt it prudent to assume that I had missed some new evidence on safety, until proven otherwise.If there is indeed any new evidence, the IMB letter seems to suggest it may lie in the WHO adverse events data which they were unable to share. I am, rather ironically, fighting off a respiratory infection with fever at the moment, but once I'm back at my desk I'll try and get hold of that info and share it.Until then, back to the Echinacea > > > > I attach a link to their press release below:> > http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627> > I immediately took a look at HMPC's latest assessment documents for Echinacea angustifolia radix and Echinacea purpurea radix, dated 29/05/12 and 10/02/11 respectively. I wanted to ascertain if there was any new research that might inform our practice as herbalists in this matter. However, I couldn't find anything explicit. The MHRA have said themselves that it " is not a serious safety issue " but with the way it is being reported in the press, concerned parents are likely to ask us about it. It may be that in the context of a proper consultation with a trained herbalist, who will screen each patient for atopy, asthma, allergic tendencies etc., there is no need to change tack with regard to prescribing Echinacea to children under 12.> > However, if anyone knows of a reason for us as practitioners to change our approach, or knows a bit more of the background to this change in decision by MHRA and HMPC, it would be very useful to know?> > Many thanks,> > >

[Guest guest]

Hi

The MHRA in the UK say that they took this action as a result of

advice from the European Herbal Medicinal Products Committee

(HMPC) and the UK Herbal Medicines Products Committe (HMAC). The

HMPC has 2 members for each state - the 2 UK ones are medics who

work for the MHRA and the 2 Irish ones, one medic and one

pharmacist, work for the Irish Medicines Board. None of them are

herbalists.

I am currently trying to find out from the herbal members of HMAC

what is the process by which the MHRA come to their decision. What

role does HMAC play in this as there are herbalists there.

However, the MHRA has its own people on the HMPC so there is a bit

of a circle there. Essentially, the MHRA seems to be making

decisions on proscribing herbs based on the advice of people who

are not herbalists and are not trained in herbal medicine.

Regards

 

Ive emailed

the WHO and asked them for the adverse reactions

reports re Echinacea – so hopefully theyll get back

and ill share as soon as – however not sure if I

emailed the right department  – big organisation etc –

we’ll see – others contact them too please

My guess is

the children that had adverse reactions were on a

cocktail of pharma drugs and /or had chronic illness,

they threw Echinacea into the mix and it go the blame

(also what type of Echinacea “product†did they take

–plant part? Was it a jelly sweet with aspartame and a

dash of Echinacea extract? A lot of unknowns here –

but the info is “classified†what a load of bullshit!

gabriel

 

From:

ukherbal-list

[mailto:ukherbal-list ] On

Behalf Of susan fidler

Sent: 22 August 2012 21:46

To: ukherbal-list

Subject: Re: Re: MHRA

advises Echinacea not be given to children under

12

 

 

Indubitably!

And measuring rat gonad size is incredibly

relevant to the health of the bairns we

treat.....

 

J Fidler, MCPP, (RH) AHG

Herbalist

From:

tim lane

To: ukherbal-list

Sent: Wednesday, August 22, 2012

1:48 PM

Subject: Re: Re:

MHRA advises Echinacea not be given to

children under 12

 

 

I

sincerely hope that the

animals tested were certified

to be under 12 years old.

 

Best

regards,

Tim.

 

From:

susan

fidler

Sent:

Wednesday, August 22,

2012 6:46 PM

To:

ukherbal-list

Subject:

Re: Re:

MHRA advises Echinacea

not be given to children

under 12

 

 

I did look over the references

briefly, but many of the

articles are in vitro or

with animals. I have not

checked some of the more

relevant articles - I

will try and do that.

They should be available

on PubMed

 

J Fidler, MCPP, (RH) AHG

Herbalist

From:

Shaw

To: ukherbal-list

Sent:

Wednesday, August

22, 2012 1:37 PM

Subject:

Re:

MHRA advises

Echinacea not be

given to children

under 12

 

 

Many

thanks for all

the responses.

I was

particularly

interested to

see the IMB's

response

below. I tend

to agree with

's view

(!) but as a

newly

qualified

herbalist I

felt it

prudent to

assume that I

had missed

some new

evidence on

safety, until

proven

otherwise.

If there is

indeed any new

evidence, the

IMB letter

seems to

suggest it may

lie in the WHO

adverse events

data which

they were

unable to

share. I am,

rather

ironically,

fighting off a

respiratory

infection with

fever at the

moment, but

once I'm back

at my desk

I'll try and

get hold of

that info and

share it.

Until then,

back to the

Echinacea

>

>

>

> I attach

a link to

their press

release below:

>

> http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627

>

> I

immediately

took a look at

HMPC's latest

assessment

documents for

Echinacea

angustifolia

radix and

Echinacea

purpurea

radix, dated

29/05/12 and

10/02/11

respectively.

I wanted to

ascertain if

there was any

new research

that might

inform our

practice as

herbalists in

this matter.

However, I

couldn't find

anything

explicit. The

MHRA have said

themselves

that it "is

not a serious

safety issue"

but with the

way it is

being reported

in the press,

concerned

parents are

likely to ask

us about it.

It may be that

in the context

of a proper

consultation

with a trained

herbalist, who

will screen

each patient

for atopy,

asthma,

allergic

tendencies

etc., there is

no need to

change tack

with regard to

prescribing

Echinacea to

children under

12.

>

> However,

if anyone

knows of a

reason for us

as

practitioners

to change our

approach, or

knows a bit

more of the

background to

this change in

decision by

MHRA and HMPC,

it would be

very useful to

know?

>

> Many

thanks,

>

>

>

 

 

[Guest guest]

Earlier this year the Joint Committee on Vaccination and Immunisation (JCVI), which advises the UK Government on vaccination policy, recommended the seasonal flu programme be extended to all children. The £100m scheme, which could be rolled out as early as 2014, according to the Daily Telegraph, will see all children aged two to 17 given the vaccination every autumn through a nasal spray. Could frightening parents away from echinacea be the first step to clearing the way for public acceptance of this programme?

Hi

The MHRA in the UK say that they took this action as a result of

advice from the European Herbal Medicinal Products Committee

(HMPC) and the UK Herbal Medicines Products Committe (HMAC). The

HMPC has 2 members for each state - the 2 UK ones are medics who

work for the MHRA and the 2 Irish ones, one medic and one

pharmacist, work for the Irish Medicines Board. None of them are

herbalists.

I am currently trying to find out from the herbal members of HMAC

what is the process by which the MHRA come to their decision. What

role does HMAC play in this as there are herbalists there.

However, the MHRA has its own people on the HMPC so there is a bit

of a circle there. Essentially, the MHRA seems to be making

decisions on proscribing herbs based on the advice of people who

are not herbalists and are not trained in herbal medicine.

Regards

Ive emailed

the WHO and asked them for the adverse reactions

reports re Echinacea – so hopefully theyll get back

and ill share as soon as – however not sure if I

emailed the right department – big organisation etc –

we’ll see – others contact them too pleaseMy guess is

the children that had adverse reactions were on a

cocktail of pharma drugs and /or had chronic illness,

they threw Echinacea into the mix and it go the blame

(also what type of Echinacea “product” did they take

–plant part? Was it a jelly sweet with aspartame and a

dash of Echinacea extract? A lot of unknowns here –

but the info is “classified” what a load of bullshit!gabriel

From:

ukherbal-list

[mailto:ukherbal-list ] On

Behalf Of susan fidler

Sent: 22 August 2012 21:46

To: ukherbal-list

Subject: Re: Re: MHRA

advises Echinacea not be given to children under

12

Indubitably!

And measuring rat gonad size is incredibly

relevant to the health of the bairns we

treat.....

J Fidler, MCPP, (RH) AHG

Herbalist

From:

tim lane

To: ukherbal-list

Sent: Wednesday, August 22, 2012

1:48 PM

Subject: Re: Re:

MHRA advises Echinacea not be given to

children under 12

I

sincerely hope that the

animals tested were certified

to be under 12 years old.

Best

regards,

Tim.

From:

susan

fidler

Sent:

Wednesday, August 22,

2012 6:46 PM

To:

ukherbal-list

Subject:

Re: Re:

MHRA advises Echinacea

not be given to children

under 12

I did look over the references

briefly, but many of the

articles are in vitro or

with animals. I have not

checked some of the more

relevant articles - I

will try and do that.

They should be available

on PubMed

J Fidler, MCPP, (RH) AHG

Herbalist

From:

Shaw

To: ukherbal-list

Sent:

Wednesday, August

22, 2012 1:37 PM

Subject:

Re:

MHRA advises

Echinacea not be

given to children

under 12

Many

thanks for all

the responses.

I was

particularly

interested to

see the IMB's

response

below. I tend

to agree with

's view

(!) but as a

newly

qualified

herbalist I

felt it

prudent to

assume that I

had missed

some new

evidence on

safety, until

proven

otherwise.

If there is

indeed any new

evidence, the

IMB letter

seems to

suggest it may

lie in the WHO

adverse events

data which

they were

unable to

share. I am,

rather

ironically,

fighting off a

respiratory

infection with

fever at the

moment, but

once I'm back

at my desk

I'll try and

get hold of

that info and

share it.

Until then,

back to the

Echinacea

>

>

>

> I attach

a link to

their press

release below:

>

> http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627

>

> I

immediately

took a look at

HMPC's latest

assessment

documents for

Echinacea

angustifolia

radix and

Echinacea

purpurea

radix, dated

29/05/12 and

10/02/11

respectively.

I wanted to

ascertain if

there was any

new research

that might

inform our

practice as

herbalists in

this matter.

However, I

couldn't find

anything

explicit. The

MHRA have said

themselves

that it "is

not a serious

safety issue"

but with the

way it is

being reported

in the press,

concerned

parents are

likely to ask

us about it.

It may be that

in the context

of a proper

consultation

with a trained

herbalist, who

will screen

each patient

for atopy,

asthma,

allergic

tendencies

etc., there is

no need to

change tack

with regard to

prescribing

Echinacea to

children under

12.

>

> However,

if anyone

knows of a

reason for us

as

practitioners

to change our

approach, or

knows a bit

more of the

background to

this change in

decision by

MHRA and HMPC,

it would be

very useful to

know?

>

> Many

thanks,

>

>

>

[Guest guest]

Im not sure about the process by which the MHRA come to their decision, however, there are 2 herbalists that sit on the committee with the IMB, and they were present when the ban on the sale of Echinacea for children under 12 was discussed. Part of the problem was that they were unable to present sufficient evidence for efficacy of Echinacea in children (i.e. clinical rather than anecdotal evidence ), and ultimately they were over-ruled. However, the IMB has no problem stating the fact that herbalists were on the committee, as if to imply that they were in support of the ban! We urgently need to move ahead with case study research as a profession on the efficacy of our herbs. Proof of safety is not enough any more, we need to show efficacy as well.

Hi

The MHRA in the UK say that they took this action as a result of

advice from the European Herbal Medicinal Products Committee

(HMPC) and the UK Herbal Medicines Products Committe (HMAC). The

HMPC has 2 members for each state - the 2 UK ones are medics who

work for the MHRA and the 2 Irish ones, one medic and one

pharmacist, work for the Irish Medicines Board. None of them are

herbalists.

I am currently trying to find out from the herbal members of HMAC

what is the process by which the MHRA come to their decision. What

role does HMAC play in this as there are herbalists there.

However, the MHRA has its own people on the HMPC so there is a bit

of a circle there. Essentially, the MHRA seems to be making

decisions on proscribing herbs based on the advice of people who

are not herbalists and are not trained in herbal medicine.

Regards

Ive emailed

the WHO and asked them for the adverse reactions

reports re Echinacea – so hopefully theyll get back

and ill share as soon as – however not sure if I

emailed the right department – big organisation etc –

we’ll see – others contact them too pleaseMy guess is

the children that had adverse reactions were on a

cocktail of pharma drugs and /or had chronic illness,

they threw Echinacea into the mix and it go the blame

(also what type of Echinacea “product” did they take

–plant part? Was it a jelly sweet with aspartame and a

dash of Echinacea extract? A lot of unknowns here –

but the info is “classified” what a load of bullshit!gabriel

From:

ukherbal-list

[mailto:ukherbal-list ] On

Behalf Of susan fidler

Sent: 22 August 2012 21:46

To: ukherbal-list

Subject: Re: Re: MHRA

advises Echinacea not be given to children under

12

Indubitably!

And measuring rat gonad size is incredibly

relevant to the health of the bairns we

treat.....

J Fidler, MCPP, (RH) AHG

Herbalist

From:

tim lane

To: ukherbal-list

Sent: Wednesday, August 22, 2012

1:48 PM

Subject: Re: Re:

MHRA advises Echinacea not be given to

children under 12

I

sincerely hope that the

animals tested were certified

to be under 12 years old.

Best

regards,

Tim.

From:

susan

fidler

Sent:

Wednesday, August 22,

2012 6:46 PM

To:

ukherbal-list

Subject:

Re: Re:

MHRA advises Echinacea

not be given to children

under 12

I did look over the references

briefly, but many of the

articles are in vitro or

with animals. I have not

checked some of the more

relevant articles - I

will try and do that.

They should be available

on PubMed

J Fidler, MCPP, (RH) AHG

Herbalist

From:

Shaw

To: ukherbal-list

Sent:

Wednesday, August

22, 2012 1:37 PM

Subject:

Re:

MHRA advises

Echinacea not be

given to children

under 12

Many

thanks for all

the responses.

I was

particularly

interested to

see the IMB's

response

below. I tend

to agree with

's view

(!) but as a

newly

qualified

herbalist I

felt it

prudent to

assume that I

had missed

some new

evidence on

safety, until

proven

otherwise.

If there is

indeed any new

evidence, the

IMB letter

seems to

suggest it may

lie in the WHO

adverse events

data which

they were

unable to

share. I am,

rather

ironically,

fighting off a

respiratory

infection with

fever at the

moment, but

once I'm back

at my desk

I'll try and

get hold of

that info and

share it.

Until then,

back to the

Echinacea

>

>

>

> I attach

a link to

their press

release below:

>

> http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627

>

> I

immediately

took a look at

HMPC's latest

assessment

documents for

Echinacea

angustifolia

radix and

Echinacea

purpurea

radix, dated

29/05/12 and

10/02/11

respectively.

I wanted to

ascertain if

there was any

new research

that might

inform our

practice as

herbalists in

this matter.

However, I

couldn't find

anything

explicit. The

MHRA have said

themselves

that it "is

not a serious

safety issue"

but with the

way it is

being reported

in the press,

concerned

parents are

likely to ask

us about it.

It may be that

in the context

of a proper

consultation

with a trained

herbalist, who

will screen

each patient

for atopy,

asthma,

allergic

tendencies

etc., there is

no need to

change tack

with regard to

prescribing

Echinacea to

children under

12.

>

> However,

if anyone

knows of a

reason for us

as

practitioners

to change our

approach, or

knows a bit

more of the

background to

this change in

decision by

MHRA and HMPC,

it would be

very useful to

know?

>

> Many

thanks,

>

>

>

[Guest guest]

Well if it is efficacy they are looking for, at least of the kind that the IMB or MHRA are wanting, we are all done for! My understanding us that 'evidence' is not necessary. However, if I was on a committee which ignored expert opinion of a herbalist, I would resign. Why would we take part in a process which leads to our extinction? It is like turkeys buying stuffing!RegardsDr GascoigneMedical doctor, acupuncturist, herbalistClinics in Bath & Tetbury, UKTel: +44 (0) 79 88 05 92 01Also, Bandon, Co. Cork, IrelandTel: +353 (0) 87 9266234Website: www.drgascoigne.comOn 23 Aug 2012, at 18:11, Ãine Marie Reilly wrote:

Im not sure about the process by which the MHRA come to their decision, however, there are 2 herbalists that sit on the committee with the IMB, and they were present when the ban on the sale of Echinacea for children under 12 was discussed. Part of the problem was that they were unable to present sufficient evidence for efficacy of Echinacea in children (i.e. clinical rather than anecdotal evidence ), and ultimately they were over-ruled. However, the IMB has no problem stating the fact that herbalists were on the committee, as if to imply that they were in support of the ban! We urgently need to move ahead with case study research as a profession on the efficacy of our herbs. Proof of safety is not enough any more, we need to show efficacy as well.

Hi

The MHRA in the UK say that they took this action as a result of

advice from the European Herbal Medicinal Products Committee

(HMPC) and the UK Herbal Medicines Products Committe (HMAC). The

HMPC has 2 members for each state - the 2 UK ones are medics who

work for the MHRA and the 2 Irish ones, one medic and one

pharmacist, work for the Irish Medicines Board. None of them are

herbalists.

I am currently trying to find out from the herbal members of HMAC

what is the process by which the MHRA come to their decision. What

role does HMAC play in this as there are herbalists there.

However, the MHRA has its own people on the HMPC so there is a bit

of a circle there. Essentially, the MHRA seems to be making

decisions on proscribing herbs based on the advice of people who

are not herbalists and are not trained in herbal medicine.

Regards

Ive emailed

the WHO and asked them for the adverse reactions

reports re Echinacea – so hopefully theyll get back

and ill share as soon as – however not sure if I

emailed the right department – big organisation etc –

we’ll see – others contact them too pleaseMy guess is

the children that had adverse reactions were on a

cocktail of pharma drugs and /or had chronic illness,

they threw Echinacea into the mix and it go the blame

(also what type of Echinacea “product†did they take

–plant part? Was it a jelly sweet with aspartame and a

dash of Echinacea extract? A lot of unknowns here –

but the info is “classified†what a load of bullshit!gabriel

From:

ukherbal-list

[mailto:ukherbal-list ] On

Behalf Of susan fidler

Sent: 22 August 2012 21:46

To: ukherbal-list

Subject: Re: Re: MHRA

advises Echinacea not be given to children under

12

Indubitably!

And measuring rat gonad size is incredibly

relevant to the health of the bairns we

treat.....

J Fidler, MCPP, (RH) AHG

Herbalist

From:

tim lane

To: ukherbal-list

Sent: Wednesday, August 22, 2012

1:48 PM

Subject: Re: Re:

MHRA advises Echinacea not be given to

children under 12

I

sincerely hope that the

animals tested were certified

to be under 12 years old.

Best

regards,

Tim.

From:

susan

fidler

Sent:

Wednesday, August 22,

2012 6:46 PM

To:

ukherbal-list

Subject:

Re: Re:

MHRA advises Echinacea

not be given to children

under 12

I did look over the references

briefly, but many of the

articles are in vitro or

with animals. I have not

checked some of the more

relevant articles - I

will try and do that.

They should be available

on PubMed

J Fidler, MCPP, (RH) AHG

Herbalist

From:

Shaw

To: ukherbal-list

Sent:

Wednesday, August

22, 2012 1:37 PM

Subject:

Re:

MHRA advises

Echinacea not be

given to children

under 12

Many

thanks for all

the responses.

I was

particularly

interested to

see the IMB's

response

below. I tend

to agree with

's view

(!) but as a

newly

qualified

herbalist I

felt it

prudent to

assume that I

had missed

some new

evidence on

safety, until

proven

otherwise.

If there is

indeed any new

evidence, the

IMB letter

seems to

suggest it may

lie in the WHO

adverse events

data which

they were

unable to

share. I am,

rather

ironically,

fighting off a

respiratory

infection with

fever at the

moment, but

once I'm back

at my desk

I'll try and

get hold of

that info and

share it.

Until then,

back to the

Echinacea

>

>

>

> I attach

a link to

their press

release below:

>

> http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627

>

> I

immediately

took a look at

HMPC's latest

assessment

documents for

Echinacea

angustifolia

radix and

Echinacea

purpurea

radix, dated

29/05/12 and

10/02/11

respectively.

I wanted to

ascertain if

there was any

new research

that might

inform our

practice as

herbalists in

this matter.

However, I

couldn't find

anything

explicit. The

MHRA have said

themselves

that it "is

not a serious

safety issue"

but with the

way it is

being reported

in the press,

concerned

parents are

likely to ask

us about it.

It may be that

in the context

of a proper

consultation

with a trained

herbalist, who

will screen

each patient

for atopy,

asthma,

allergic

tendencies

etc., there is

no need to

change tack

with regard to

prescribing

Echinacea to

children under

12.

>

> However,

if anyone

knows of a

reason for us

as

practitioners

to change our

approach, or

knows a bit

more of the

background to

this change in

decision by

MHRA and HMPC,

it would be

very useful to

know?

>

> Many

thanks,

>

>

>

[Guest guest]

You're absolutely right . However, I am (perhaps naively) hopeful that collating case study research as herbalists would offer better evidence than anecdotal reports.

Well if it is efficacy they are looking for, at least of the kind that the IMB or MHRA are wanting, we are all done for! My understanding us that 'evidence' is not necessary. However, if I was on a committee which ignored expert opinion of a herbalist, I would resign. Why would we take part in a process which leads to our extinction? It is like turkeys buying stuffing!RegardsDr GascoigneMedical doctor, acupuncturist, herbalistClinics in Bath & Tetbury, UKTel: +44 (0) 79 88 05 92 01Also, Bandon, Co. Cork, IrelandTel: +353 (0) 87 9266234Website: www.drgascoigne.comOn 23 Aug 2012, at 18:11, Áine Marie Reilly wrote:

Im not sure about the process by which the MHRA come to their decision, however, there are 2 herbalists that sit on the committee with the IMB, and they were present when the ban on the sale of Echinacea for children under 12 was discussed. Part of the problem was that they were unable to present sufficient evidence for efficacy of Echinacea in children (i.e. clinical rather than anecdotal evidence ), and ultimately they were over-ruled. However, the IMB has no problem stating the fact that herbalists were on the committee, as if to imply that they were in support of the ban! We urgently need to move ahead with case study research as a profession on the efficacy of our herbs. Proof of safety is not enough any more, we need to show efficacy as well.

Hi

The MHRA in the UK say that they took this action as a result of

advice from the European Herbal Medicinal Products Committee

(HMPC) and the UK Herbal Medicines Products Committe (HMAC). The

HMPC has 2 members for each state - the 2 UK ones are medics who

work for the MHRA and the 2 Irish ones, one medic and one

pharmacist, work for the Irish Medicines Board. None of them are

herbalists.

I am currently trying to find out from the herbal members of HMAC

what is the process by which the MHRA come to their decision. What

role does HMAC play in this as there are herbalists there.

However, the MHRA has its own people on the HMPC so there is a bit

of a circle there. Essentially, the MHRA seems to be making

decisions on proscribing herbs based on the advice of people who

are not herbalists and are not trained in herbal medicine.

Regards

Ive emailed

the WHO and asked them for the adverse reactions

reports re Echinacea – so hopefully theyll get back

and ill share as soon as – however not sure if I

emailed the right department – big organisation etc –

we’ll see – others contact them too pleaseMy guess is

the children that had adverse reactions were on a

cocktail of pharma drugs and /or had chronic illness,

they threw Echinacea into the mix and it go the blame

(also what type of Echinacea “product” did they take

–plant part? Was it a jelly sweet with aspartame and a

dash of Echinacea extract? A lot of unknowns here –

but the info is “classified” what a load of bullshit!gabriel

From:

ukherbal-list

[mailto:ukherbal-list ] On

Behalf Of susan fidler

Sent: 22 August 2012 21:46

To: ukherbal-list

Subject: Re: Re: MHRA

advises Echinacea not be given to children under

12

Indubitably!

And measuring rat gonad size is incredibly

relevant to the health of the bairns we

treat.....

J Fidler, MCPP, (RH) AHG

Herbalist

From:

tim lane

To: ukherbal-list

Sent: Wednesday, August 22, 2012

1:48 PM

Subject: Re: Re:

MHRA advises Echinacea not be given to

children under 12

I

sincerely hope that the

animals tested were certified

to be under 12 years old.

Best

regards,

Tim.

From:

susan

fidler

Sent:

Wednesday, August 22,

2012 6:46 PM

To:

ukherbal-list

Subject:

Re: Re:

MHRA advises Echinacea

not be given to children

under 12

I did look over the references

briefly, but many of the

articles are in vitro or

with animals. I have not

checked some of the more

relevant articles - I

will try and do that.

They should be available

on PubMed

J Fidler, MCPP, (RH) AHG

Herbalist

From:

Shaw

To: ukherbal-list

Sent:

Wednesday, August

22, 2012 1:37 PM

Subject:

Re:

MHRA advises

Echinacea not be

given to children

under 12

Many

thanks for all

the responses.

I was

particularly

interested to

see the IMB's

response

below. I tend

to agree with

's view

(!) but as a

newly

qualified

herbalist I

felt it

prudent to

assume that I

had missed

some new

evidence on

safety, until

proven

otherwise.

If there is

indeed any new

evidence, the

IMB letter

seems to

suggest it may

lie in the WHO

adverse events

data which

they were

unable to

share. I am,

rather

ironically,

fighting off a

respiratory

infection with

fever at the

moment, but

once I'm back

at my desk

I'll try and

get hold of

that info and

share it.

Until then,

back to the

Echinacea

>

>

>

> I attach

a link to

their press

release below:

>

> http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627

>

> I

immediately

took a look at

HMPC's latest

assessment

documents for

Echinacea

angustifolia

radix and

Echinacea

purpurea

radix, dated

29/05/12 and

10/02/11

respectively.

I wanted to

ascertain if

there was any

new research

that might

inform our

practice as

herbalists in

this matter.

However, I

couldn't find

anything

explicit. The

MHRA have said

themselves

that it "is

not a serious

safety issue"

but with the

way it is

being reported

in the press,

concerned

parents are

likely to ask

us about it.

It may be that

in the context

of a proper

consultation

with a trained

herbalist, who

will screen

each patient

for atopy,

asthma,

allergic

tendencies

etc., there is

no need to

change tack

with regard to

prescribing

Echinacea to

children under

12.

>

> However,

if anyone

knows of a

reason for us

as

practitioners

to change our

approach, or

knows a bit

more of the

background to

this change in

decision by

MHRA and HMPC,

it would be

very useful to

know?

>

> Many

thanks,

>

>

>

[Guest guest]

HiI think that would help, certainly. Anything which raises the profile of herbs is good. It won't wash though with the IMB in the current climate - or with health authorities,RegardsDr GascoigneMedical doctor, acupuncturist, herbalistClinics in Bath & Tetbury, UKTel: +44 (0) 79 88 05 92 01Also, Bandon, Co. Cork, IrelandTel: +353 (0) 87 9266234Website: www.drgascoigne.comOn 23 Aug 2012, at 19:08, Ãine Marie Reilly wrote:

You're absolutely right . However, I am (perhaps naively) hopeful that collating case study research as herbalists would offer better evidence than anecdotal reports.

Well if it is efficacy they are looking for, at least of the kind that the IMB or MHRA are wanting, we are all done for! My understanding us that 'evidence' is not necessary. However, if I was on a committee which ignored expert opinion of a herbalist, I would resign. Why would we take part in a process which leads to our extinction? It is like turkeys buying stuffing!RegardsDr GascoigneMedical doctor, acupuncturist, herbalistClinics in Bath & Tetbury, UKTel: +44 (0) 79 88 05 92 01Also, Bandon, Co. Cork, IrelandTel: +353 (0) 87 9266234Website: www.drgascoigne.comOn 23 Aug 2012, at 18:11, Ãine Marie Reilly wrote:

Im not sure about the process by which the MHRA come to their decision, however, there are 2 herbalists that sit on the committee with the IMB, and they were present when the ban on the sale of Echinacea for children under 12 was discussed. Part of the problem was that they were unable to present sufficient evidence for efficacy of Echinacea in children (i.e. clinical rather than anecdotal evidence ), and ultimately they were over-ruled. However, the IMB has no problem stating the fact that herbalists were on the committee, as if to imply that they were in support of the ban! We urgently need to move ahead with case study research as a profession on the efficacy of our herbs. Proof of safety is not enough any more, we need to show efficacy as well.

Hi

The MHRA in the UK say that they took this action as a result of

advice from the European Herbal Medicinal Products Committee

(HMPC) and the UK Herbal Medicines Products Committe (HMAC). The

HMPC has 2 members for each state - the 2 UK ones are medics who

work for the MHRA and the 2 Irish ones, one medic and one

pharmacist, work for the Irish Medicines Board. None of them are

herbalists.

I am currently trying to find out from the herbal members of HMAC

what is the process by which the MHRA come to their decision. What

role does HMAC play in this as there are herbalists there.

However, the MHRA has its own people on the HMPC so there is a bit

of a circle there. Essentially, the MHRA seems to be making

decisions on proscribing herbs based on the advice of people who

are not herbalists and are not trained in herbal medicine.

Regards

Ive emailed

the WHO and asked them for the adverse reactions

reports re Echinacea – so hopefully theyll get back

and ill share as soon as – however not sure if I

emailed the right department – big organisation etc –

we’ll see – others contact them too pleaseMy guess is

the children that had adverse reactions were on a

cocktail of pharma drugs and /or had chronic illness,

they threw Echinacea into the mix and it go the blame

(also what type of Echinacea “product†did they take

–plant part? Was it a jelly sweet with aspartame and a

dash of Echinacea extract? A lot of unknowns here –

but the info is “classified†what a load of bullshit!gabriel

From:

ukherbal-list

[mailto:ukherbal-list ] On

Behalf Of susan fidler

Sent: 22 August 2012 21:46

To: ukherbal-list

Subject: Re: Re: MHRA

advises Echinacea not be given to children under

12

Indubitably!

And measuring rat gonad size is incredibly

relevant to the health of the bairns we

treat.....

J Fidler, MCPP, (RH) AHG

Herbalist

From:

tim lane

To: ukherbal-list

Sent: Wednesday, August 22, 2012

1:48 PM

Subject: Re: Re:

MHRA advises Echinacea not be given to

children under 12

I

sincerely hope that the

animals tested were certified

to be under 12 years old.

Best

regards,

Tim.

From:

susan

fidler

Sent:

Wednesday, August 22,

2012 6:46 PM

To:

ukherbal-list

Subject:

Re: Re:

MHRA advises Echinacea

not be given to children

under 12

I did look over the references

briefly, but many of the

articles are in vitro or

with animals. I have not

checked some of the more

relevant articles - I

will try and do that.

They should be available

on PubMed

J Fidler, MCPP, (RH) AHG

Herbalist

From:

Shaw

To: ukherbal-list

Sent:

Wednesday, August

22, 2012 1:37 PM

Subject:

Re:

MHRA advises

Echinacea not be

given to children

under 12

Many

thanks for all

the responses.

I was

particularly

interested to

see the IMB's

response

below. I tend

to agree with

's view

(!) but as a

newly

qualified

herbalist I

felt it

prudent to

assume that I

had missed

some new

evidence on

safety, until

proven

otherwise.

If there is

indeed any new

evidence, the

IMB letter

seems to

suggest it may

lie in the WHO

adverse events

data which

they were

unable to

share. I am,

rather

ironically,

fighting off a

respiratory

infection with

fever at the

moment, but

once I'm back

at my desk

I'll try and

get hold of

that info and

share it.

Until then,

back to the

Echinacea

>

>

>

> I attach

a link to

their press

release below:

>

> http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627

>

> I

immediately

took a look at

HMPC's latest

assessment

documents for

Echinacea

angustifolia

radix and

Echinacea

purpurea

radix, dated

29/05/12 and

10/02/11

respectively.

I wanted to

ascertain if

there was any

new research

that might

inform our

practice as

herbalists in

this matter.

However, I

couldn't find

anything

explicit. The

MHRA have said

themselves

that it "is

not a serious

safety issue"

but with the

way it is

being reported

in the press,

concerned

parents are

likely to ask

us about it.

It may be that

in the context

of a proper

consultation

with a trained

herbalist, who

will screen

each patient

for atopy,

asthma,

allergic

tendencies

etc., there is

no need to

change tack

with regard to

prescribing

Echinacea to

children under

12.

>

> However,

if anyone

knows of a

reason for us

as

practitioners

to change our

approach, or

knows a bit

more of the

background to

this change in

decision by

MHRA and HMPC,

it would be

very useful to

know?

>

> Many

thanks,

>

>

>

[Guest guest]

Hi Ainne Marieyou wrote..... However, I am (perhaps naively) hopeful that collating case study research as herbalists would offer better evidence than anecdotal reports.No, not naive - essential. And advocated in the regulatory consultation report.I note that one of the optional modules in the UCLAN MSc is to develop a practice based research project. - really encouraging. I've long believed this is the best way forward, and have been advocating the idea to my students enthusiastically for some time. And with the growth in the mainstream interest iand respect for Comparative Effectiveness Research (CER), now is a really good time to insist on respect for collated information if we can just get it together to produce it...... It (CER) has come to prominence precisely because of the recognition of the severe limitations of "gold standard" RCTs.... If anybody out there has a favourite condition to treat -PLEASE start collating case histories - I know we are all busy, but..... I'd be interested in brainstorming on the matter with other practitioners. (Especially after the middle of September, when part of my family are moving abroad and I could do with some distraction ;-) )I'm not in the least surprised by this development - saddened, but not surprised. I've noticed that the direction of current research in HM seems to be mainly following just two directions - new methods for analysing constituents, and a search for possible contra-indications or side-effects. There is all too little research exploring possible clinical usefulness. And if there is a Systematic Review showing a benefit, one will shortly follow "showing" that there is no real benefit.The most prestigious clinical trial for efficacy of Echinacea was published in the New England Journal of Medicine, and is an impressive and impeccably carried out piece of research * ..............except for the dosages of echinacea which were completely inadequate for effective treatment. *( - if you ignore the possibility of a "nocebo" effect - the subjects received either echinacea or placebo, but no orthodox medicine. If they harboured a prejudice against HM, they would believe either way they were receiving an ineffective intervention. If I had designed the trial, I would have considered another treatment arm with an orthodox Rx that patients and prescribers may have faith in, then with adequate dosages, it would have been a reasonable trial.)Sally Owen MNIMHVisiting Lecturer UEL

[Guest guest]

Well, it really should - cutting edge orthodox clinical research is turning towards CER. - because RCTs aren't up to the job. Very interesting article in the scientific American last year -http://www.scientificamerican.com/article.cfm?id=the-best-medicine-july-11A very interesting read.Sally Owen MNIMHVisiting lecturer UEL HiI think that would help, certainly. Anything which raises the profile of herbs is good. It won't wash though with the IMB in the current climate - or with health authorities,RegardsDr GascoigneMedical doctor, acupuncturist, herbalistClinics in Bath & Tetbury, UKTel: +44 (0) 79 88 05 92 01Also, Bandon, Co. Cork, IrelandTel: +353 (0) 87 9266234Website: www.drgascoigne.comOn 23 Aug 2012, at 19:08, Áine Marie Reilly wrote:You're absolutely right . However, I am (perhaps naively) hopeful that collating case study research as herbalists would offer better evidence than anecdotal reports. Well if it is efficacy they are looking for, at least of the kind that the IMB or MHRA are wanting, we are all done for! My understanding us that 'evidence' is not necessary. However, if I was on a committee which ignored expert opinion of a herbalist, I would resign. Why would we take part in a process which leads to our extinction? It is like turkeys buying stuffing!RegardsDr GascoigneMedical doctor, acupuncturist, herbalistClinics in Bath & Tetbury, UKTel: +44 (0) 79 88 05 92 01Also, Bandon, Co. Cork, IrelandTel: +353 (0) 87 9266234Website: www.drgascoigne.comOn 23 Aug 2012, at 18:11, Áine Marie Reilly wrote: Im not sure about the process by which the MHRA come to their decision, however, there are 2 herbalists that sit on the committee with the IMB, and they were present when the ban on the sale of Echinacea for children under 12 was discussed. Part of the problem was that they were unable to present sufficient evidence for efficacy of Echinacea in children (i.e. clinical rather than anecdotal evidence ), and ultimately they were over-ruled. However, the IMB has no problem stating the fact that herbalists were on the committee, as if to imply that they were in support of the ban! We urgently need to move ahead with case study research as a profession on the efficacy of our herbs. Proof of safety is not enough any more, we need to show efficacy as well. HiThe MHRA in the UK say that they took this action as a result of advice from the European Herbal Medicinal Products Committee (HMPC) and the UK Herbal Medicines Products Committe (HMAC). The HMPC has 2 members for each state - the 2 UK ones are medics who work for the MHRA and the 2 Irish ones, one medic and one pharmacist, work for the Irish Medicines Board. None of them are herbalists.I am currently trying to find out from the herbal members of HMAC what is the process by which the MHRA come to their decision. What role does HMAC play in this as there are herbalists there. However, the MHRA has its own people on the HMPC so there is a bit of a circle there. Essentially, the MHRA seems to be making decisions on proscribing herbs based on the advice of people who are not herbalists and are not trained in herbal medicine.Regards Ive emailed the WHO and asked them for the adverse reactions reports re Echinacea – so hopefully theyll get back and ill share as soon as – however not sure if I emailed the right department – big organisation etc – we’ll see – others contact them too pleaseMy guess is the children that had adverse reactions were on a cocktail of pharma drugs and /or had chronic illness, they threw Echinacea into the mix and it go the blame (also what type of Echinacea “product” did they take –plant part? Was it a jelly sweet with aspartame and a dash of Echinacea extract? A lot of unknowns here – but the info is “classified” what a load of bullshit!gabriel From: ukherbal-list [mailto:ukherbal-list ] On Behalf Of susan fidlerSent: 22 August 2012 21:46To: ukherbal-list Subject: Re: Re: MHRA advises Echinacea not be given to children under 12 Indubitably! And measuring rat gonad size is incredibly relevant to the health of the bairns we treat..... J Fidler, MCPP, (RH) AHGHerbalistTo: ukherbal-list Sent: Wednesday, August 22, 2012 1:48 PMSubject: Re: Re: MHRA advises Echinacea not be given to children under 12 I sincerely hope that the animals tested were certified to be under 12 years old. Best regards,Tim. From: susan fidlerSent: Wednesday, August 22, 2012 6:46 PMTo: ukherbal-list Subject: Re: Re: MHRA advises Echinacea not be given to children under 12 I did look over the references briefly, but many of the articles are in vitro or with animals. I have not checked some of the more relevant articles - I will try and do that. They should be available on PubMed J Fidler, MCPP, (RH) AHGHerbalistTo: ukherbal-list Sent: Wednesday, August 22, 2012 1:37 PMSubject: Re: MHRA advises Echinacea not be given to children under 12 Many thanks for all the responses. I was particularly interested to see the IMB's response below. I tend to agree with 's view (!) but as a newly qualified herbalist I felt it prudent to assume that I had missed some new evidence on safety, until proven otherwise.If there is indeed any new evidence, the IMB letter seems to suggest it may lie in the WHO adverse events data which they were unable to share. I am, rather ironically, fighting off a respiratory infection with fever at the moment, but once I'm back at my desk I'll try and get hold of that info and share it.Until then, back to the Echinacea > > > > I attach a link to their press release below:> > http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627> > I immediately took a look at HMPC's latest assessment documents for Echinacea angustifolia radix and Echinacea purpurea radix, dated 29/05/12 and 10/02/11 respectively. I wanted to ascertain if there was any new research that might inform our practice as herbalists in this matter. However, I couldn't find anything explicit. The MHRA have said themselves that it "is not a serious safety issue" but with the way it is being reported in the press, concerned parents are likely to ask us about it. It may be that in the context of a proper consultation with a trained herbalist, who will screen each patient for atopy, asthma, allergic tendencies etc., there is no need to change tack with regard to prescribing Echinacea to children under 12.> > However, if anyone knows of a reason for us as practitioners to change our approach, or knows a bit more of the background to this change in decision by MHRA and HMPC, it would be very useful to know?> > Many thanks,> > >

[Guest guest]

When herbalists (or other "complementary" practitioners) talk about their experience of treating patients it's "anecdotal" but when medics do the same it's a "case study", go figure!CheersGraham White, B.Sc. (Herb. Med.)

Medical Herbalist

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

Phone: 01438 213284

Mobile: 07740 766335

Ive emailed

the WHO and asked them for the adverse reactions

reports re Echinacea – so hopefully theyll get back

and ill share as soon as – however not sure if I

emailed the right department – big organisation etc –

we’ll see – others contact them too pleaseMy guess is

the children that had adverse reactions were on a

cocktail of pharma drugs and /or had chronic illness,

they threw Echinacea into the mix and it go the blame

(also what type of Echinacea “product†did they take

–plant part? Was it a jelly sweet with aspartame and a

dash of Echinacea extract? A lot of unknowns here –

but the info is “classified†what a load of bullshit!gabriel

From:

ukherbal-list

[mailto:ukherbal-list ] On

Behalf Of susan fidler

Sent: 22 August 2012 21:46

To: ukherbal-list

Subject: Re: Re: MHRA

advises Echinacea not be given to children under

12

Indubitably!

And measuring rat gonad size is incredibly

relevant to the health of the bairns we

treat.....

J Fidler, MCPP, (RH) AHG

Herbalist

From:

tim lane

To: ukherbal-list

Sent: Wednesday, August 22, 2012

1:48 PM

Subject: Re: Re:

MHRA advises Echinacea not be given to

children under 12

I

sincerely hope that the

animals tested were certified

to be under 12 years old.

Best

regards,

Tim.

[Guest guest]

HiThere are many 'rationales' for vaccine policy, very few of them medical. Who knows why they decided to proscribe echinacea for kids. Adults next? However, as the MHRA, IMB and pharmaceutical companies are in bed together it may be naive to think that policy is not influenced by such interconnectionsRegardsDr GascoigneMedical doctor, acupuncturist, herbalistClinics in Bath & Tetbury, UKTel: +44 (0) 79 88 05 92 01Also, Bandon, Co. Cork, IrelandTel: +353 (0) 87 9266234Website: www.drgascoigne.comOn 24 Aug 2012, at 00:12, charles rodgers wrote:

Hello Aine,

I don't believe any flu vaccination policy would ever consider

Echinacea as a factor in vaccination uptake.

The rationale for this policy is to increase vaccination rates in

interpandemic years, and is just one part of the global six part WHO

position agenda for pandemic influenza preparedness. The WHO position

paper (following the avian H5N1 outbreak from 2003 and again

highlighted from the lack of preparedness in the 2009 H1N1 'swine' flu

pandemic) has finally filtered down through various EU projects and

bodies (VENICE project, European Centre for Disease Prevention and

Control, and of course the European Commission!).

This part of the policy has a twofold aim, i.) to increase industrial

capacity for vaccine production in a pandemic, and ii.) to increase

the poor take up rates within the population as a whole (especially

risk groups). If it wasn't for the current economic situation I could

see us following the U.S. policy of annual vaccination for ALL over 6

months of age.

Kind regards,

[Guest guest]

Dearest , thank you, thank you, thank you - how unexpected, considering this sorry state of affairs, a fantastically spontaneous and joyous burst of laughter. You have brightened my day

xxx therri

From: Gascoigne (IRL)

Sent: Thursday, August 23, 2012 7:03 PM

To: ukherbal-list

Subject: Re: Re: MHRA advises Echinacea not be given to children under 12

Well if it is efficacy they are looking for, at least of the kind that the IMB or MHRA are wanting, we are all done for! My understanding us that 'evidence' is not necessary. However, if I was on a committee which ignored expert opinion of a herbalist, I would resign. Why would we take part in a process which leads to our extinction? It is like turkeys buying stuffing!

Regards

Dr Gascoigne

Medical doctor, acupuncturist, herbalist

Clinics in Bath & Tetbury, UK

Tel: +44 (0) 79 88 05 92 01

Also, Bandon, Co. Cork, Ireland

Tel: +353 (0) 87 9266234

Website: www.drgascoigne.com

Im not sure about the process by which the MHRA come to their decision, however, there are 2 herbalists that sit on the committee with the IMB, and they were present when the ban on the sale of Echinacea for children under 12 was discussed. Part of the problem was that they were unable to present sufficient evidence for efficacy of Echinacea in children (i.e. clinical rather than anecdotal evidence ), and ultimately they were over-ruled. However, the IMB has no problem stating the fact that herbalists were on the committee, as if to imply that they were in support of the ban!

We urgently need to move ahead with case study research as a profession on the efficacy of our herbs. Proof of safety is not enough any more, we need to show efficacy as well.

HiThe MHRA in the UK say that they took this action as a result of advice from the European Herbal Medicinal Products Committee (HMPC) and the UK Herbal Medicines Products Committe (HMAC). The HMPC has 2 members for each state - the 2 UK ones are medics who work for the MHRA and the 2 Irish ones, one medic and one pharmacist, work for the Irish Medicines Board. None of them are herbalists.I am currently trying to find out from the herbal members of HMAC what is the process by which the MHRA come to their decision. What role does HMAC play in this as there are herbalists there. However, the MHRA has its own people on the HMPC so there is a bit of a circle there. Essentially, the MHRA seems to be making decisions on proscribing herbs based on the advice of people who are not herbalists and are not trained in herbal medicine.Regards

Ive emailed the WHO and asked them for the adverse reactions reports re Echinacea – so hopefully theyll get back and ill share as soon as – however not sure if I emailed the right department – big organisation etc – we’ll see – others contact them too please

My guess is the children that had adverse reactions were on a cocktail of pharma drugs and /or had chronic illness, they threw Echinacea into the mix and it go the blame (also what type of Echinacea “product†did they take –plant part? Was it a jelly sweet with aspartame and a dash of Echinacea extract? A lot of unknowns here – but the info is “classified†what a load of bullshit!

gabriel

From: ukherbal-list [mailto:ukherbal-list ] On Behalf Of susan fidlerSent: 22 August 2012 21:46To: ukherbal-list Subject: Re: Re: MHRA advises Echinacea not be given to children under 12

Indubitably! And measuring rat gonad size is incredibly relevant to the health of the bairns we treat.....

J Fidler, MCPP, (RH) AHGHerbalist

To: ukherbal-list Sent: Wednesday, August 22, 2012 1:48 PMSubject: Re: Re: MHRA advises Echinacea not be given to children under 12

I sincerely hope that the animals tested were certified to be under 12 years old.

Best regards,

Tim.

From: susan fidler

Sent: Wednesday, August 22, 2012 6:46 PM

To: ukherbal-list

Subject: Re: Re: MHRA advises Echinacea not be given to children under 12

I did look over the references briefly, but many of the articles are in vitro or with animals. I have not checked some of the more relevant articles - I will try and do that. They should be available on PubMed

J Fidler, MCPP, (RH) AHGHerbalist

To: ukherbal-list Sent: Wednesday, August 22, 2012 1:37 PMSubject: Re: MHRA advises Echinacea not be given to children under 12

Many thanks for all the responses. I was particularly interested to see the IMB's response below. I tend to agree with 's view (!) but as a newly qualified herbalist I felt it prudent to assume that I had missed some new evidence on safety, until proven otherwise.If there is indeed any new evidence, the IMB letter seems to suggest it may lie in the WHO adverse events data which they were unable to share. I am, rather ironically, fighting off a respiratory infection with fever at the moment, but once I'm back at my desk I'll try and get hold of that info and share it.Until then, back to the Echinacea > > > > I attach a link to their press release below:> > http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627> > I immediately took a look at HMPC's latest assessment documents for Echinacea angustifolia radix and Echinacea purpurea radix, dated 29/05/12 and 10/02/11 respectively. I wanted to ascertain if there was any new research that might inform our practice as herbalists in this matter. However, I couldn't find anything explicit. The MHRA have said themselves that it "is not a serious safety issue" but with the way it is being reported in the press, concerned parents are likely to ask us about it. It may be that in the context of a proper consultation with a trained herbalist, who will screen each patient for atopy, asthma, allergic tendencies etc., there is no need to change tack with regard to prescribing Echinacea to children under 12.> > However, if anyone knows of a reason for us as practitioners to change our approach, or knows a bit more of the background to this change in decision by MHRA and HMPC, it would be very useful to know?> > Many thanks,> > >