Scientific Advisory Group for Emergencies (Sage) Glaxo SmithKline Conflict of interest WHO
WHO ADVISER CONCEALS A DONATION OF MILLIONS FROM A PHARMACEUTICAL COMPANY
Written by Louise Voller & Kristian Villesen for the Danish daily newspaper, “Information”
10.12. 2009
A Finnish member of the WHO board, an advisor on vaccines, has received 46 million crowns (6 million euros) for his research centre from the vaccine manufactures, GlaxoSmithKline. WHO promises transparency, but this conflict of interests is not available for the public to see at WHO’s homepage.
Another ‘WHO’ vaccine advisor is withholding information concerning financial support from the pharmaceutical industry.
Professor Juhani Eskola is the director of the Finnish research vaccine programme (THL) and a new member of the WHO group, ‘Strategic Advisory Group of Experts’ (SAGE), which gives advice to the WHO Director-General, Margaret Chan. ‘SAGE’ also recommend which vaccines - and how many - member countries should purchase for the pandemic.
According to documents acquired through the Danish ‘Freedom of Information Act,’ Professor Juhani Eskola’s Finnish institute, THL, received almost 6.3 million Euro from GlaxoSmithKline (GSK) for research on vaccines during 2009.
This amount of money qualifies GlaxoSmithKline as THL’s main source of income.
GlaxoSmithKline produces the H1N1-vaccine ‘Pandemrix,’ which the Finnish government following recommendations from THL and WHO purchased for a national pandemic reserve stockpile.
These facts bring Professor Juhani Eskola in line with several other ‘WHO ’experts who play a double role by having financial ties to the pharmaceutical industry – a double role which notably is not published by WHO.
During November, the Danish daily, ‘Information’ has informed the public that several members of WHO’s expert group have also been secretly working for the pharmaceutical industry. Since revealing this information, a record of meetings and the conflict of interests of some of the experts have become accessible, but not all, including Juhani Eskola.
CONFLICT OF INTEREST
In Finland, Professor Juhani Eskola is at the centre of a national conflict of interest. The Finnish Minister of Health has become involved in this case and has asked for transparency concerning the researcher’s financial ties to the pharmaceutical industry. However, Professor Eskola doesn’t agree that there is a problem. He secures and protects his ‘WHO’ status, by offering a minor ‘consultative payment’ to the pharmaceutical company, ‘Novartis.’
“Why haven’t you informed the public about a research grant of six million Euros from GlaxoSmithKline?” Professor Eskola comments, “It is a contract my chief and GSK have made, and I am not a part of the study, which receives the money.”
Regarding ‘WHO’s declaration on conflicts of interest, ‘SAGE’ experts are obliged to inform on all kinds of financial research support, scholarships, payment for collaboration and sponsor support for the research unit, during the past three years. “We have 1,400 researchers at ‘THL’ and if I declare every economic transaction I am a involved in then it gets complicated.
My interpretation of the WHO-declaration was that I didn’t have to declare the agreement of collaboration with GSK, as I neither receive the money personally nor do my research team. ‘WHO’ has asked me, and now I wait to be informed, whether they agree with my interpretation. If they don’t, they should make their declaration more clear.”
You are chair of the department and during 2009, GSK is your greatest contributor. Don’t you see a conflict of interests in this matter?
“It is a discussion we have had with the Finnish Minister of Health during the past few weeks but it is the ministry, who has bought the vaccines, not our institute. Pandemrix was chosen as the best vaccine and could be available soon at the Finnish market. The decision had to be made at the beginning of June and in my mind, the ministry of health chose the right solution, namely Pandemrix.”
But do you recognize a conflict of interest? - “We are aware that there appears to be a conflict of interest” he says.
“VERY SERIOUS”
According to WHO, all SAGE-members are obliged to inform about all financial interests, inclusive financing from the pharmaceutical industry, consulting payments and other forms of professional employment. Meanwhile, WHO has rejected an invitation to be interviewed about why not all financial interests of the WH -experts has been declared.
But in a mail WHO spokesman Gregory Hartl writes as follows:
“WHO has recently learned, that the Finnish National Institute for Health and Welfare has a research contract with GSK. The contract concerns a research project about pneumococcal-vaccine in the Finnish vaccination programme. WHO will take suitable action according to everything, which must be considered as conflicts of interests in this case.”
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The Danish journalists have reported on other cases involving SAGE experts with financial links to pharmaceutical companies, many of which have not been declared.
Dr. Peter Figueroa, Professor, Public Health, Epidemiology & AIDS, Department of Community Health & Psychiatry, Faculty of Medical Sciences, University of the West Indies, Jamaica, received money from Merck.
Dr. Neil Ferguson has received funding Baxter, GlaxoSmithKline und Roche as well as insurance companies that he advised about pandemics but this was only revealed after publicity.
Professor Malik Peiris, Department of Microbiology, the University of Hong Kong, Faculty of Medicine, Hong Kong has received money from Baxter GSK und Sanofi Pasteur.This is not declared on the Who website.
Dr. Arnold Monto, advisor to Chiron, GlaxoSmithKline, MedImmune, Roche, Novartis, Baxter und Sanofi Pasteur.
Dr. Friedrich Hayden, consultant to MedImmune in 2006 and Sanofi Pasteur, in 2007. He has also got money from Roche, RW Johnson und SmithKline Beecham. The interests are not declared on WHO website.
Dr. Albert Osterhaus, head of the European Scientists Fighting Influenza, financed by Baxter, Crucell, Novartis, Hoffmann-La Roche, MedImmune, Nobilon, Sanofi Pasteur, MSD, Glaxo SmithKline und Solvay.
In a new development, Finnish Ministry of Social and Welfare has authorized the National Institute of Health and Welfare (THL) to purchace another 5.3 million H1N1 pre-pandemic vaccines for the whole population of Finland, adding to the existing stockpile of 5.3 million H5N1 vaccines and a contract to purchase another 5.3 million vaccines.
Below is a correspondence with WHO on the conflict of interest of Eskola by a Finnish citizen, revealing staff of WHO scrambling to whitewash their failure to declare Eskola's conflict of interest:
Correspondence with WHO on conflict of interest, December 2009
For contact info, see Rokotusinfory 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
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 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
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
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 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 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
"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. "
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