The European Medicines Agency has not lived up to the scientific standards that must be expected of such an agency. There is so much spin in its official report (3) that it could have been written by a PR agency, and some of the text is nearly identical to the assessments of the vaccines carried out by the drug companies. One of the key arguments, which appeared ten times in the official report (3), was that there was no difference between what was observed and the expected background incidence of serious neurological harms. However, as the EMA admitted that this comparison cannot confirm a causal relationship due to the inherent limitations in such research, then the EMA cannot conclude the opposite, which is that the HPV vaccines are not harmful.
The scientific approach to finding possible harms of the HPV vaccines was very insufficient. The drug companies’ searches in their own databases were grossly inadequate, and the agency allowed the companies to exclude a large number of cases diagnosed by a skilled clinician without inspecting the underlying data (10). Furthermore, the EMA allowed one-fourth of the vaccine trials to be omitted from the manufacturers’ analyses, and the search strategies for the companies’ and the EMA’s searches in the published literature were not described (10).
In all the vaccine trials apart from a very small one, the so-called placebo was not a placebo as it contained aluminium adjuvant, which is neurotoxic in high doses (11), or it was another vaccine, for example against hepatitis, which could potentially also be neurotoxic. This makes it difficult to find a difference between harms of the vaccine and the «placebo,» but the EMA failed to address this fundamental problem in its official report (3) and allowed the manufacturers to lump all the «placebo» data together. This is contrary to good scientific practice to such a degree that we consider it outright scientific misconduct.
Contrary to the EMA’s statements, the evidence was not assessed in an objective and scientifically acceptable way (8) – (10). The evidence provided by the vaccine manufacturers was generally accepted at face value, unlike the more reliable and independent publications provided for the case. The EMA’s comments about Brinth’s research were unprofessional, pejorative and misleading and came close to an accusation of scientific misconduct, and the EMA also misrepresented the facts when it stated that its scientific assessors (co-rapporteurs) did not agree with Brinth about her concerns. The EMA’s handling of the observations and concerns the Danish Health and Medicines Authority and the WHO Uppsala Monitoring Centre had raised was not acceptable either, and this was criticised by the Danish authorities in the internal report (8,10).
The EMA’s interpretations of the numerous treaties, regulations and rules the agency refers to are inconsistent and illegitimate, and not in the public interest. For example, the EMA redacted a number of important details in the documents it supplied to citizens in accordance with the right to freedom of information, which it was neither necessary nor legitimate to remove. Furthermore, the extreme secrecy, with a requirement of lifelong confidentiality, which the Agency imposed on its experts, is not legitimate and not in the public interest.