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> 2010-01-19: Comments of Rokotusinfo in relation to Dr Eskola, THL, WHO's SAGE group and undeclared conflicts of interest.
Background: Rokotusinfo ry contacted World Health Organization in the beginning of December 2009 with regard to the conflict of interest declaration of SAGE member Dr Juhani Eskola. His declaration of conflict of interest did not disclose the 6 million euros directed from GlaxoSmithKline to THL, Dr Eskola's employer.
WHO's answer, quoted below, came January 11th, 2010.
"You recently have brought to WHO's attention that the Finnish National Institute for Health and Welfare has a research contract with GSK. This contract relates to a study of the impact of the new pneumococcal conjugate vaccine in the Finnish vaccination programme.
WHO has reviewed potential conflicts of interest concerning Dr. Juhani Eskola and his participation as a SAGE member at the October 2009 SAGE meeting and is satisfied that there were neither any with regard to the discussions on H1N1 influenza vaccines nor any relating to other topics discussed at the meeting.
WHO continues to take appropriate measures to address any perceived conflicts of interest for all experts serving on its advisory committees."
After receiving contacts from journalists in different parts of the world, Rokotusinfo has decided to publish some viewpoints on the issue. Below you will find our comments and viewpoints. We wish to thank the journalists who have contacted us for framing questions which have been a basis for viewpoints expressed; however, the nature of the international media attention also somewhat shapes the viewpoints presented below.
In our viewpoint, the central issues are things like the influence of international pharmaceutical companies on institutions like THL and WHO and the policy decisions which limit or favor the influences. While media's interest often directs itself to individuals like Dr Eskola, we should look at the big picture.
First, you will find our reply to WHO's answer with some further questions (which remain unanswered so far on Jan 19th) sent on January 12th, and after that our comments on the issue more generally.
"Dear WHO staff,
Thank you for your answer. To shed some further light on the pneumococcal conjugate vaccine trial, let me clarify that it is a part of the marketing authorization trials required post-marketing by EMEA, and at least a part worth 2 million euros of the contract was classified as commercial activity by THL instead of public-benefit research.
In the spirit of WHO's press conference statement also today ("Criticism is part of an outbreak cycle. We expect and indeed welcome criticism and the chance to discuss it," by Fadela Chaib), I trust you are able to also answer some of the specific questions relating to the issue:
1) Can Dr Eskola continue as a SAGE member despite the new disclosures?
2) Is WHO planning to publish Dr Eskola's new disclosure of conflict of interest?
3) Can you confirm or deny that Dr Eskola is a member of the secret WHO emergency committee as claimed by the Swedish news at ment.se?
4) Dr Eskola has suggested publicly, that WHO should clarify its instructions on what should be reported - is WHO planning to clarify conflict of interest reporting instructions?
5) Are there new conflict of interest disclosures from others besides Dr Eskola after October 2009 SAGE meeting?
6) In light of the change in the definition of a pandemic (omissing of disease severity in the definition), the vaccine sales contracts based on WHO declaring a pandemic, and the secret membership list of the emergency committee, criticism about the process seems well founded. Is WHO planning to make the history of pandemic declaration more open, by for example exposing the conflict of interest declarations or the membership list at the time of the pandemic decision?"
Comments of Rokotusinfo ry in relation to Dr Eskola, THL, WHO's SAGE group and undeclared conflicts of interest.
1) The role of Dr Eskola in Finland
Professor, Dr Eskola is Deputy Director General, #2 in charge of THL, National Institute for Health and Welfare in Finland. It is an institution constituted under the Finnish Ministry of Health.
THL has some governmental functions but also competes with other organizations on the international research market for research projects from pharmaceutical companies.
As an offical function is performs forensic pathological examinations. It does this even for deaths possibly caused by the products of pharmaceutical companies.
Most of the pharmaceutical research is done by the Vaccine Department of THL. A big trial brought in 6 million euros last year from GlaxoSmithKline for the Vaccine Department, which is under Dr Eskola's command. Only about 1 million came from governmental budget.
The business-like aspects are an expansion initiated by THL itself, going beyond the instutute's primary functions and authority given by legislation. These functions have recently become more important to THL. This has happened when Dr Eskola has been in top management of THL. The primary functions, for example buying vaccines for the Finnish public vaccine program, seem to have become a burden as far as THL is concerned, and THL wants vaccine buying moved away so it won't interfere with the "business-like" contract research functions.
2) Dr Eskola as a scientist
It is not our role to judge Dr Eskola as a scientist. Looking at his public CV, it seems that in the past decade, Dr Eskola's work has concentrated on management and consultation work.
Before the current position in THL, Dr Eskola was corporate vice president and senior vice president for a major European vaccine manufacturer. It looks like Dr Eskola was hired to streamline and commercialize THL's research activities to further the current THL's Director General Pekka Puska's policy of working closely together with commercial companies.
3) Connection to Finnish Goverment
THL is the #1 player in just about any matter related to vaccines in Finland, and THL has a central role in everyhing vaccine-related except marketing authorizations. As #2 man in THL, and the director under which the Vaccine Department works, Dr Eskola has a big role in steering THL's positions and via that the Government's positions in matters relating to vaccines.
4) The influence of pharmaceutical companies on govermental organization THL
It is very alarming that the Finnish politicians have allowed THL to drift more and more into the influence or even control of medical companies, while at the same time adding official governmental roles - like forensic exams - to THL. Due to the major funding from international drug companies, it looks like a form of the Finnish government outsources offical government decision-making to pharmaceutical companies.
It is proposed THL would also have the authority to give out the health records of every Finn to pharmaceutical companies.
Even more alarming, THL is backing a law which would erase the parents' right to decide if their children are subjects in THL's vaccine trials it performs for pharmaceutical companies. The child herself could decide, with no age limit, if a THL researcher judges the child competent, and parents would not be told about the trial.
With Europe-wide pharmaceutical marketing authorizations, the decisions in Finland also shape what happens in the rest of Europe. Vaccine trials from Finland are used for Europe-wide marketing authorizations. If the THL people cut corners in medical issues like they have repeatedly done with informed consent and legal consent issues as witnessed by two separate reprimands from Parliamentary Ombudsman, the result can be devastating to the safety of vaccines on the market.
5) Discussion in Finland
In 2009, the six million euros funding to THL has been in the public eye and awakened critisism and plans by the Minister of Health to change things.
Also, the most disturbing initiative of THL, taking children as vaccine trial subjects without parents' knowledge has gained media attention. However, the discussion has been about THL in general, not Dr Eskola specifically. That said, the WHO role of Dr Eskola and lack of disclosure has not really been covered in Finnish news as of 19th January, 2010.
6) Role of Dr Eskola in WHO and SAGE group
In October, Dr Eskola started as a member of SAGE, an expert group advising WHO on vaccines. We have no information on the internal functions of SAGE, so we can't say if his role in SAGE is different from other members. However, a Swedish news site (ment.se) has claimed that Dr Eskola is also a member of another, secret WHO advisory group. We don't know if he is, or whether the membership was active when WHO general secretary declared the pandemic in summer 2009 after advise from the secret, emergency group.
7) Financing from GlaxoSmithKline
The more than six million euros has been paid by GlaxoSmithKline for a pneumococcal vaccine trial. The trial is part of GSK's product development, and a requirement for granting of marketing authorization. The trial has some quite questionable practices from the viewpoint of Finnish law and medical research ethics. Despite two separate reprimands from the Parliamentary Ombudsman's Office, THL continues the practice not adhering to Finnish law when getting consent.
An ethical problem is also that the trial is being done in municipal health care centers, where families may feel dependent on the health care personnel and may feel pressure to consent. In contrary to the principles of Declaration of Helsinki, a previously approved pneumoccal vaccine is not used as a comparison vaccine, but instead a hepatitis A or B vaccine is used which is normally not recommended to the age group in Finland. That's what the 6 million is for.
8) Undeclared conflict of interest during the October meeting
Dr Eskola has failed to inform WHO of the significant GlaxoSmithKline funding directed to THL, to the vaccine department working under Dr Eskola. Despite this conflict of interest, Dr Eskola has participated in SAGE in the October 2009 meeting, when WHO had no knowledge of GlaxoSmithKline funding to the department under Dr Eskola.
9) Financial influence on THL
Pharmaceutical companies are a very significant funder of Dr Eskola's place of employment, THL. With money comes power to influence. Our association Rokotusinfo ry is very worried about vaccine manufacturer's financial influence on THL, and the transfer of public functions relating to people's health to an instutution that from a funding viewpoint seems like a daughter company of a large vaccine manufacturer.
From news in other countries, it seems information has surfaced which hints that the same thing happening with THL in Finland might be happening with WHO, too.
10) Conflict of interests
In THL and Finnish vaccine policies, there are huge conflicts of interest, as THL's vaccine department received the majority of its funding from vaccine manufacturers in 2009, and has a central role in almost everything relating to vaccines in Finland. The conflicts expand to adverse event reporting vaccine schedule, vaccine buying and so on.
#1 WHO maintains that its procedures require experts to declare conflicts of interest. The agency however does not publish all of the declared conflicts of interest, thus the policies do not make things transparent.
The comment WHO has published in relation to Dr Eskola's unreported 6 million euros funding looks at the concept of conflict very narrowly. WHO has not really answered any of the questions we have asked them after we reported Dr Eskola's undeclared THL funding to WHO.
#2, There's the problem of vaccine sales contras being tied to WHO pandemic declaration, and WHO changing the description of what a pandemic is. There's the secret, unaccountable decision-making in WHO with regard to declaration of the pandemic. The identities of the emergency group members who had an important role in declaring the pandemic are secret, and the conflicts of interest have not been made public.
According to a Swedish news site, Dr Eskola belongs to the secret group.
#3, There have been reports that also other members in central role at decision-making in WHO have close ties with vaccine manufacturers, and that vaccine manufacturer representatives are present in WHO's decision making. Hopefully the Council of Europe will find out more about the details.
Some more releases and news relating to Rokotusinfo ry
Information about the trial mentioned available elsewhere:
Source of this document: http://www.rokotusinfo.fi/en/memo_100119_htmlContact info: