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> Press release 16.3.2009: Vaccine trial violates ethical code
The vaccine in the trial is known by the names Synflorix, PhiD-CV, Streptorix, GSK1024850A, GSK1024850.
Finnish NGO: GlaxoSmithKline pneumococcal vaccine trial in Finland violates ethical code
According to the Finnish NGO "Rokotusinfo ry" (Vaccination Information Association), the London-based pharmaceutical company Glaxosmithkline's vaccine study in Finland does not comply with the World Medical Association's Declaration of Helsinki, a central ethical code for medical trials. (1). GlaxoSmithKline is contracting with University of Tampere and the National Institute for Health and Welfare (formerly known as National Public Health Institute on Finland, Kansanterveyslaitos, KTL) vaccine department, and the municipalities' health care centers. The trial is aiming to recruit one hundred thousand 2-18 months old Finnish children. Vaccination Info association works to promote the dissemination of information regarding vaccination and the promote patient's rights.
Violations of the Declaration of Helsinki
Vaccination Info says GlaxoSmithKline's pneumococcal vaccine trial seriously violations a central point of the ethical code. According to Declaration of Helsinki, the drug under investigation in the trial should normally be compared to the current best evidence-based treatment or prevention.
However, in the pneumococcal vaccine trial to be done in Finland, one third of subjects (control group) is to be left without any pneumococcal vaccine. There's a pneumococcal vaccine on the market which has been approved in 2001 and has been recommended by NPHI's own task force to be included in the taxpayer-funded vaccine schedule. Instead of the pneumococcal vaccine, the comparison group receives the hepatitis A or B vaccine. These vaccines are not targeted against pneumococcal disease and are normally not considered necessary in Finland for the agegroup.
The NGO compares the design to a test of new antibiotic against bacteria-induced pneumonia, where one third of patients would only receive malaria medication and no antibiotic, despite an antibiotic medicine on the market with prove effectiveness against pneumonia. Malaria drug does not give any benefit in the treatment of pneumonia, and it has adverse effects, sometimes serious.
From the view of research ethics, the design of the pneumoccan vaccine trial is the same as the hypotethical antibiotic trial. Hepatitis vaccines are not effective against pneumococcal disease combat, and the package insert of the hepatitis B vaccine lists serious adverse effects, for example neurological effects such as the polio-like Guillain-Barré syndrome, optical nerve inflammation and multiple sclerosis (2).
According to Rokotusinfo, the vaccine trial also violates other parts of the ethical code. (3).
Does drug company funding influence vaccine schedule?
The NGO suspects that pneumococcal vaccine is not included in the vaccine schedule due to the National Public Health Instute's Vaccine Department's aim to seek and acquire funding from pharmaceutical companies. For example, in 2007, NPHI's Vaccine Department received more funding for the pharmaceutical companies as the governmental budget funding. GlaxoSmithKline has been a big source of income for the Finnish NPHI - in both 2006 and 2007, the biggest funding by far came from GlaxoSmithKline. In 2006, GSK funding was 95 percent of the funding from drug manufacturers and 53 percent of the total outside funding for NPHI's vaccine department. (4)
National Public Health Institute set in January 2007 two working groups to evaluate whether the rotavirus vaccine and the pneumococcal vaccine should be included in the Finnish taxpayer-funded vaccination schedule. The working groups recommended that both vaccines should be included. Rotavirus vaccine is going to be included in the vaccine schedule in autumn 2009, pneumococcal vaccine is not.
Pharmaceutical company representatives have publicly indicated (5), that the initiative for the trial has come from researchers at the National Public Health Institue's (NPHI) vaccine department. Vaccination Info has at September 2008 pointed out NPHI's press release at that time as a sign of the NPHI "coupling" NPHI's research funding and the inclusion of new vaccines in the taxpayer-funded vaccine schedule. (6)
Participation as trial subject not recommended by NGO
The NGO does not recommend that Finnish families participate in the trial as trial subjects. If the family is seeking protection against pneumococcal disease, they can consider a vaccine which was approved for sale eight years ago. GlaxoSmithKline has also announced that their vaccine is expected to be approved in the coming months. The association however points out that there's not as much information on the adverse effects of drugs recently come onto the market as there's for drugs used for a longer period. If the parents want to help advance medical research, they could choose a trial being done ethically. The checklist for parents considering participating in vaccine trial published by the NGO can be used to help. (7)
Background, sources and more information(parts in Finnish for the moment)
(1) The Declaration of Helsinki is an ethical code first approved in World Medical Association's meeting in Helsinki in 1964. It is one of the cornerstones of medical research ethics. The declaration has been updated several times since the approval, the latest time was in 2008.
Adhering to the principles of the Declaration of Helsinki is required by the European Commission's medical product directive, the Finnish National Public Health Institute's "Hyvä tutkimustapa Kansanterveyslaitoksessa" code sekä useiden eettisten toimikuntien ohjeistus. Helsingin julistus soveltaa paljolti samoja periaatteita kuin vuonna 1947 Nürnbergin lääkärioikeudenkäynnissä epäeettisesti ihmisillä tehtyjen kokeilujen ehkäisemiseksi vahvistettu ensimmäinen nykyaikainen lääketieteellinen tutkimuseettinen säännöstö, Nürnbergin säännöstö.
Declaration of Helsinki in Finnish: http://www.laakariliitto.fi/etiikka/helsinginjulistus.html
Declaration of Helsinki in English: http://www.wma.net/e/policy/b3.htm
(2) Hepatitis B vaccine package insert (in Finnish): http://spc.nam.fi/indox/nam/html/nam/humpil/5/988095.pdf
(3) Rokotusinfo: Ethical review of vaccine trials, comparison between the principles of Declarationof Helsinki and the pneumococcial trial(s) ongoing and to be done in Finland
(4) Funding for NPHI of Finland for years 2006 and 2007: http://www.rokotusinfo.fi/tekstit/ktl_roko_rahoitus_2007_html
(5) Hufvudstasbladet 16.9.2009, Petteri Knudsen & Taneli Puumalainen
"Både den planerade pneumokock- och den pågående HPV-vaccinundersökningen är initierade av Folkhälsoinstitutets forskare som behöver beslutsunderlag för en nationell vaccinationsstrategi."
(6) Rokotusinfo ry: release 28.9.2009, "KTL:n rokoteosasto lääkeyhtiöiden leivissä - tiedotus uusista rokotteista ei perustu näyttöön", http://www.rokotusinfo.fi/yhd/tiedotteet/tiedote_080928_html
(7) Rokotusinfo: A checklist for persons considering to become trial subjects, http://www.rokotusinfo.fi/rokotetutkimus/muistilista_html
Information on organizations and persons resposible for design out, carrying out, approving and supervising the trial(s)
Persons responsible for the trial as per Finnish research legislation
Head of vaccine department Terhi Kilpi, The National Institute for Health and Welfare
Professor Timo Vesikari, University of Tampere, head of the vaccine research center at University of Tampere Medical School
Oversight of vaccine trials: National Agency for Medicines
Hospital district of Helsinki and Uusimaa coordinating ethical review board (Helsingin ja Uudenmaan sairaanhoitopiiri, koordinoiva eettinen toimikunta)
Hospital district of Helsinki and Uusimaa ethical review boards: http://www.hus.fi/default.asp?path=1,28,2530,15595,2540
Pirkanmaa hospital district ethical review board (Pirkanmaan sairaanhoitopiirin eettinen toimikunta)
Medical director Petteri Knudsen (GlaxoSmithKline)
Taneli Puumalainen, medical advisor (GlaxoSmithKline, also researcher at National Institute for Health and Welfare, source: personnel search of the Institute)
The topic is also covered in releases:
Information about the trial available elsewhere: