Update! See http://www.rokotusinfo.fi/en/memo_100119_html - 2010-01-19: Comments of Rokotusinfo in relation to Dr Eskola, THL, WHO's SAGE group and undeclared conflicts of interest.

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 GlaxoSmithKline 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

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 GlaxoSmithKlines 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 GlaxoSmithKline 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

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From WHO:

Thank-you for your important message. The responsible officer for the SAGE Committee is Dr Phillip 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

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...

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 seems WHO may have incorrect or misleading information on the nature of the GlaxoSmithKline 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 GlaxoSmithKline'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 GlaxoSmithKline. 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 GlaxoSmithKline, 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 agency 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

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"Men i en mail skriver talsmand Gregory 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 Gregory 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. "