WHO/GSK conflict of interest and trial practices, updated

[Guest guest]

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 >

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. "

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