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> Draft 2009-12-11: GlaxoSmithKline HPV vaccine trial in Finland reprimanded - no proper informed consent

GlaxoSmithKline HPV vaccine trial in Finland reprimanded - no proper informed consent

Both major vaccine trial contractors in Finland were reprimanded for failing to get informed consent in a GlaxoSmithKline-funded vaccine trial as required by Finnish law. The decision came from the Parliamentary Ombudsman's office - the Parliamentary Ombudsman is the supreme governmental oversight official in Finland. The vaccine trial was contracted by GlaxoSmithKline and done in public schools.

In a decision dated August 14, 2009, it is resolved that University of Tampere and National Public Health Institute of Finland did not follow proper consent procedures as Finnish law requires. Parental consent was not seeked from both parents as the law requires, and there were also problems with informing parents, with the result that no valid informed consent could be given. Furthermore, informed consent was not received by a doctor qualified to answer possible questions as is the norm in medical research ethics, but instead the parent was requested to mail in the consent form.

University of Tampere and National Public Health Institute of Finland do vaccine trials as subcontractors for many major international vaccine manufacturers - for example GlaxoSmithKline, Sanofi Pasteur, Novartis and Baxter.

For National Public Health Institute, this is already the second time the institute is reprimanded for failures in proper procedures in getting informed consent in a medical trial. In 2006 the Institute was conducting a trial on newborns with the funding of an infant formula company, but neglected to tell the funding of the trial to the parents, and also neglected to gain the consent of both parents as required by law. There were also other shortcomings. In both cases, the Institute's head responsible for and who has accepted the Institute's conduct in the trials is Pekka Puska, who has worked as a medical expert for the World Health Organization (WHO) in the 1990's and was the Finnish candidate for the director-general post of the World Health Organization in 2006. Rokotusinfo ry, a Finnish NGO dedicated to advancing patient's rights with regard to vaccines and vaccine information, will be contacting European and U.S. vaccine licensing authorities regarding the shortcomings in the trial, and possibly other vaccine trials. According to Rokotusinfo, many of the same problems as in the HPV trial are also present in some other studies by the same institutions - for example a pneumococcal vaccine study on Synflorix currently in progress, also funded by GlaxoSmithKline.

The issue can potentially have international consequences, because the results from many of the trials done in Finland have been used in vaccine license applications in Europe and USA. A GCP inspection might be useful to find out what is the impact of incorrect procedures in the HPV vaccine trial as well as possibly other trials contracted to National Public Health Institute of Finland and University of Tampere for various international vaccine manufacturers.

According to Rokotusinfo, there are also other ethical problems relating to the use of Finnish public sector institutes in product development of vaccine manufacturers. Schools and municipal health care centers are used by the vaccine manufacturing companies as testing ground. The parents or pupils in public schools can feel dependent for municipal health care and can feel pressured to give consent to the trials.

Serious conflicts of interests are not controlled for in the Finnish vaccine policies. National Public Health Institute's vaccine department gets more money from the contracts with the vaccine manufacturers than it gets from the governmental budget. At the same time the institute acts as the Finnish government's acquirer of vaccines and an expert body with a central role in decision making regarding the vaccines funded by tax-payers. The conflicts of interest are obvious.

National Public Health Institute has ordered the swine flu (H1N1) vaccine from the Institute's biggest company funder, GlaxoSmithKline, without a public tender. National Audit Office of Finland has urged the policies for vaccine buying decisions to be changed due to conflicts of interest.

Rokotusinfo ry has contacted EMEA (European Medicines Agency) and reported the failures to EMEA.

Decision from the Parliamentary Ombudsman's office (Google translation to English):

google translation

Decision from the Parliamentary Ombudsman's office (original + index page):

The topic is also covered in releases:

Information about the trial available elsewhere: