WHO/GSK conflict of interest and trial practices, updated

[Guest guest]

New addition to the info:

To WHO:

....

Judging from the Danish newspaper Information (original at

http://www.information.dk/218247 apparently machine translated below

to English so it might have errors), it seem WHO may have incorrect or

misleading information on the nature of the GlaxoKline pneumococcal

trial which is contracted to professor Eskola's employer. The trial is

one required for marketing authorization by the European medicines

authority EMEA, i.e. is part of GlaxoKline's product development.

It may be pertinent for WHO to also know professor Eskola's involvment in

National Institute of Health and Welfare's research policies as the

second-in-charge of the Institute. The National Institute of Health and

Welfare has been repeatedly reprimanded by the Finnish oversight

officials due to failures in upholding the Finnish law and informed

consent in clinical trials; recently on a trial funded by

GlaxoKline. A few years back the institute was reprimanded for

failures in proper procedures in a trial funded by an infant formula

manufacturer and done on Finnish newborns (the FinDia trial, see for

example

http://en.wikinews.org/wiki/Finnish_parliamentary_ombudsman_faults_infant_formula_study

). The Institute's apparent response has been, instead of mending their

procedures, to campaign for a law which would take away the parental

consent requirement altogether, in direct contradiction of medical

research ethical principles and the EU directive.

In the infant formula study, the institute did not tell infant's parents

that the primary funding came from an infant formula company; thus the

parents were not able to give informed consent. Professor Eskola was

involved in correspondence regarding publication of an article partly

based on the Findia trial's results. Professor Eskola's answer to the

editor of the journal claimed there were no issues with the trial, in

direct contradiction to the Parliamentary Ombudsman's findings described

in the abovementioned news article. The Institute was reprimanded in 2006

also for not getting permission from both parents as required by Finnish

law.

In the marketing authorization -related vaccine trial funded by

GlaxoKline, the trial staff did not seek permission from both

parents, despite the Finnish law and the earlier reprimand. Thus they got

a new reprimand in 2009, in which it was also found that the information

given to participants was insufficient to result in an informed consent.

We have contacted the European medicines agence EMEA and provided them

with information on the trial.

You can find more information on the recent (2009) reprimand at

http://www.rokotusinfo.fi/en/draft_091211_html

Thank you for taking the issue seriously,

with kind regards

< signature & contact info removed >

" Men i en mail skriver talsmand Härtl følgende:

»WHO har for nylig erfaret, at det finske Nationale Institut for Sundhed

og Velfærd har en forskerkontrakt med GSK. Kontrakten drejer sig om et

forskningsprojekt om pneumokokvaccine i det finske vaccinationsprogram.

WHO vil træffe passende foranstaltninger i forhold til alt, hvad der

måtte opfattes som interessekonflikter i denne sag.« "

" But in an e-mail, spokesman Hartl writes the

following:

WHO has recently discovered that the Finnish National Institute of Health

and Welfare has a research contract with GSK. The contract is a research

project on pneumococcal vaccine within the Finnish vaccination programme.

WHO will take appropriate action in relation to anything that might be

perceived as conflicts of interest in this matter. "

**********

Correspondence with WHO on conflict of interest, December 2009

For contact info, see Rokotusinfo ry

at http://www.rokotusinfo.fi

(in English) and

World Health Organization at

http://www.who.int

Correspondence with WHO, December 2009 is enclosed below. For some news

coverage on the conflict of interest issue on WHO's pandemic declaration

and vaccine expert groups, see

Dagbladet Information

(Denmark),

Svenska Dagbladet (Sweden) and

Kauppalehti (Finland). For WHO instructions on what experts are

required to report, see quote below. For exact financial information from

money transactions from GlaxoKline to professor Eskola's employer

THL (Finnish National Institute for Health and Welfare), see

http://www.rokotusinfo.fi/tiedostot/thl-laskutus-091207_html.

To assure the highest integrity, and hence public confidence, in its

activities, WHO policies require that all experts serving in an advisory

role agree to disclose any circumstances which could give rise to a

potential conflict of interest (i.e., any interest which may affect, or

may reasonably be perceived to affect, the expert's objectivity and

independence). Since you have been selected as a WHO expert in the

activity described below, you are requested to disclose in this

Declaration of Interest (DoI) form any financial, professional or other

interest relevant to the subject of the work or meeting in which you will

be involved and any interest that could be significantly affected by the

outcome of the meeting or work. You are also asked to declare relevant

interests of others who may, or may be perceived to, unduly influence

your judgment (such as immediate family members, employers, close

professional associates or any others with whom you have a substantial

common personal, financial or professional interest.)

source: WHO,

http://www.who.int/entity/immunization/sage/SAGE_TORs_Full_21_11_08.pdf

To WHO:

Dear WHO staff,

I was very surprised to see at

http://www.who.int/immunization/sage/Final_LOP_DOI_16_Nov_09.pdf that

professor Juhani Eskola, a SAGE member, has not disclosed the conflict of

interest resulting from GlaxoKlines funding of an estimated 6

million euros at year 2009. The funding of 6 million euros (estimated by

National Institute for Health and Welfare, Dr Terhi Kilpi, working under

professor Eskola) is awarded to the National Institute for Health and

Welfare, Eskola's employer. The conflict of interest resulting from the 6

million euros of funding and ordering of the GlaxoKline Pandemrix

vaccine by National Institute for Health and Welfare for 37 million euros

has received quite a lot of publicity in Finland. Even the Minister of

Health has decided that things have to be changed because of the

conflicts of interest have become untolerable, see for example

http://www.mtv3.fi/uutiset/sika/index.shtml/arkistot/kotimaa/2009/11/1003417

I trust you will take approriate action as you tell to the public in

http://www.who.int/csr/disease/swineflu/notes/briefing_20091203/en/index.html

< signature & contact info removed >

From WHO:

....

Thank-you for your important message. The responsible officer for the

SAGE Committee is Dr Duclos, who I have copied on this message,

for further action. I have also copied Drs Okwo-bele and Kieny who have

senior line management responsibilities for the Committee.

Please be assured that WHO takes the issue of conflicts of interest very

seriously, and we will revert to you as soon as possible on the issue you

have highlighted.

Regards

< signature & contact info removed >

Update: According to a Swedish business news site

Ment.se, professor Eskola belongs to the secret WHO expert group with

a key role in declaring a swine influenza pandemic. It is not clear from

the news article what Ment.se is basing the claim on.

Source of this document:

http://www.rokotusinfo.fi/yhd/kirjeenvaihtoa/who_0912_html

Sheri Nakken, R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://www.nccn.net/~wwithin/vaccine.htm or

http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start January 6 & 7

http://www.wellwithin1.com/vaccineclass.htm or

http://www.wellwithin1.com/homeo.htm

[Guest guest]

New addition to the info:

To WHO:

....

Judging from the Danish newspaper Information (original at

http://www.information.dk/218247 apparently machine translated below

to English so it might have errors), it seem WHO may have incorrect or

misleading information on the nature of the GlaxoKline pneumococcal

trial which is contracted to professor Eskola's employer. The trial is

one required for marketing authorization by the European medicines

authority EMEA, i.e. is part of GlaxoKline's product development.

It may be pertinent for WHO to also know professor Eskola's involvment in

National Institute of Health and Welfare's research policies as the

second-in-charge of the Institute. The National Institute of Health and

Welfare has been repeatedly reprimanded by the Finnish oversight

officials due to failures in upholding the Finnish law and informed

consent in clinical trials; recently on a trial funded by

GlaxoKline. A few years back the institute was reprimanded for

failures in proper procedures in a trial funded by an infant formula

manufacturer and done on Finnish newborns (the FinDia trial, see for

example

http://en.wikinews.org/wiki/Finnish_parliamentary_ombudsman_faults_infant_formula_study

). The Institute's apparent response has been, instead of mending their

procedures, to campaign for a law which would take away the parental

consent requirement altogether, in direct contradiction of medical

research ethical principles and the EU directive.

In the infant formula study, the institute did not tell infant's parents

that the primary funding came from an infant formula company; thus the

parents were not able to give informed consent. Professor Eskola was

involved in correspondence regarding publication of an article partly

based on the Findia trial's results. Professor Eskola's answer to the

editor of the journal claimed there were no issues with the trial, in

direct contradiction to the Parliamentary Ombudsman's findings described

in the abovementioned news article. The Institute was reprimanded in 2006

also for not getting permission from both parents as required by Finnish

law.

In the marketing authorization -related vaccine trial funded by

GlaxoKline, the trial staff did not seek permission from both

parents, despite the Finnish law and the earlier reprimand. Thus they got

a new reprimand in 2009, in which it was also found that the information

given to participants was insufficient to result in an informed consent.

We have contacted the European medicines agence EMEA and provided them

with information on the trial.

You can find more information on the recent (2009) reprimand at

http://www.rokotusinfo.fi/en/draft_091211_html

Thank you for taking the issue seriously,

with kind regards

< signature & contact info removed >

" Men i en mail skriver talsmand Härtl følgende:

»WHO har for nylig erfaret, at det finske Nationale Institut for Sundhed

og Velfærd har en forskerkontrakt med GSK. Kontrakten drejer sig om et

forskningsprojekt om pneumokokvaccine i det finske vaccinationsprogram.

WHO vil træffe passende foranstaltninger i forhold til alt, hvad der

måtte opfattes som interessekonflikter i denne sag.« "

" But in an e-mail, spokesman Hartl writes the

following:

WHO has recently discovered that the Finnish National Institute of Health

and Welfare has a research contract with GSK. The contract is a research

project on pneumococcal vaccine within the Finnish vaccination programme.

WHO will take appropriate action in relation to anything that might be

perceived as conflicts of interest in this matter. "

**********

Correspondence with WHO on conflict of interest, December 2009

For contact info, see Rokotusinfo ry

at http://www.rokotusinfo.fi

(in English) and

World Health Organization at

http://www.who.int

Correspondence with WHO, December 2009 is enclosed below. For some news

coverage on the conflict of interest issue on WHO's pandemic declaration

and vaccine expert groups, see

Dagbladet Information

(Denmark),

Svenska Dagbladet (Sweden) and

Kauppalehti (Finland). For WHO instructions on what experts are

required to report, see quote below. For exact financial information from

money transactions from GlaxoKline to professor Eskola's employer

THL (Finnish National Institute for Health and Welfare), see

http://www.rokotusinfo.fi/tiedostot/thl-laskutus-091207_html.

To assure the highest integrity, and hence public confidence, in its

activities, WHO policies require that all experts serving in an advisory

role agree to disclose any circumstances which could give rise to a

potential conflict of interest (i.e., any interest which may affect, or

may reasonably be perceived to affect, the expert's objectivity and

independence). Since you have been selected as a WHO expert in the

activity described below, you are requested to disclose in this

Declaration of Interest (DoI) form any financial, professional or other

interest relevant to the subject of the work or meeting in which you will

be involved and any interest that could be significantly affected by the

outcome of the meeting or work. You are also asked to declare relevant

interests of others who may, or may be perceived to, unduly influence

your judgment (such as immediate family members, employers, close

professional associates or any others with whom you have a substantial

common personal, financial or professional interest.)

source: WHO,

http://www.who.int/entity/immunization/sage/SAGE_TORs_Full_21_11_08.pdf

To WHO:

Dear WHO staff,

I was very surprised to see at

http://www.who.int/immunization/sage/Final_LOP_DOI_16_Nov_09.pdf that

professor Juhani Eskola, a SAGE member, has not disclosed the conflict of

interest resulting from GlaxoKlines funding of an estimated 6

million euros at year 2009. The funding of 6 million euros (estimated by

National Institute for Health and Welfare, Dr Terhi Kilpi, working under

professor Eskola) is awarded to the National Institute for Health and

Welfare, Eskola's employer. The conflict of interest resulting from the 6

million euros of funding and ordering of the GlaxoKline Pandemrix

vaccine by National Institute for Health and Welfare for 37 million euros

has received quite a lot of publicity in Finland. Even the Minister of

Health has decided that things have to be changed because of the

conflicts of interest have become untolerable, see for example

http://www.mtv3.fi/uutiset/sika/index.shtml/arkistot/kotimaa/2009/11/1003417

I trust you will take approriate action as you tell to the public in

http://www.who.int/csr/disease/swineflu/notes/briefing_20091203/en/index.html

< signature & contact info removed >

From WHO:

....

Thank-you for your important message. The responsible officer for the

SAGE Committee is Dr Duclos, who I have copied on this message,

for further action. I have also copied Drs Okwo-bele and Kieny who have

senior line management responsibilities for the Committee.

Please be assured that WHO takes the issue of conflicts of interest very

seriously, and we will revert to you as soon as possible on the issue you

have highlighted.

Regards

< signature & contact info removed >

Update: According to a Swedish business news site

Ment.se, professor Eskola belongs to the secret WHO expert group with

a key role in declaring a swine influenza pandemic. It is not clear from

the news article what Ment.se is basing the claim on.

Source of this document:

http://www.rokotusinfo.fi/yhd/kirjeenvaihtoa/who_0912_html

Sheri Nakken, R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://www.nccn.net/~wwithin/vaccine.htm or

http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start January 6 & 7

http://www.wellwithin1.com/vaccineclass.htm or

http://www.wellwithin1.com/homeo.htm