tisdag 29 november 2016

Gardasil och framförda klagomål 2016

Please note: This complaint to the ombudsman is not about whether the HPV vaccines do more good than harm. It is about the EMA’s conduct, which we believe is an instance of maladministration. It is possible that many of the serious harms that occur after vaccination are autoimmune diseases. However, as we don’t know whether these diseases are caused by the HPV vaccines, it must be a research priority to find out. The views we express here and our conclusions are based on the facts we present; they are ours and not those of any organisation.


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Summary of our complaint to the EU ombudsman

On 26 May 2016, we complained to the European Medicines Agency (EMA) over maladministration at the EMA related to safety of the HPV vaccines. The EMA’s replies to us did not fully address our concerns. Some of our concerns were not addressed at all, and several of the EMA’s statements were either wrong or seriously misleading, or irrelevant for the criticism we had posed. We therefore now complain to the EU ombudsman over the EMA. These are our most important observations:

1. The EMA has not been open and accountable to the citizens and has not respected their rights to know about the scientific uncertainties related to the safety of HPV vaccines. The officially published 40-page report does not reflect the considerable disagreements among the EMA’s experts and others but gives the impression of a unanimous rejection of the suspected harms.

2. The EMA has not lived up to the scientific standards that must be expected of the agency when evaluating the science related to the safety of the HPV vaccines. One of the key arguments, which appeared no less than ten times in the EMA’s official report, was that there was no difference between what was observed and the expected background incidence of serious harms. However, the underlying research was of such poor quality that these observations are virtually meaningless. The EMA admitted that evidence from observed versus expected analyses cannot confirm a causal association due to the inherent limitations in such data, but then, logically, the EMA cannot provide any reassurance either for the opposite hypothesis, which is that the HPV vaccines are not harmful.

3. Contrary to the EMA’s statements, the official report does not describe the most relevant evidence. The EMA emphasized research that is highly unreliable instead of focussing on the most reliable research.

4. The amount of spin generated by EMA on its findings does not allow conclusion to be made. Its official report could have been written by a PR agency working for a drug company. It is of public interest to know who wrote or drafted the EMA’s official report, which is anonymous. The bottom line for the EMA seems to have been that the vaccine should be protected from criticism at all costs because it is believed to save lives. One pointer to this is that the text in the official report is nearly identical to the assessments of the EMA’s rapporteur and the drug companies.

5. The EMA did not treat a Danish researcher who raised concerns about possible serious harms of the HPV vaccines fairly. The EMA published pejorative comments that came close to an accusation of scientific misconduct. The EMA’s comments were unprofessional, totally inappropriate and represented unfounded criticism. If drug regulators behave like this when doctors report their observations about possible serious harms of approved products, doctors will be unlikely to alert the public to their observations in future, which would be a complete negation of one of the cornerstones of pharmacovigilance.

6. The EMA seriously misrepresented the facts when it stated that its co-rapporteurs did not agree with the Danish researcher about her concerns.

7. The EMA did not treat fairly the observations and concerns the Danish Health and Medicines Authorities and the WHO Uppsala Monitoring Centre had raised about possible serious harms of the HPV vaccines.

8. Contrary to the EMA’s statements, the evidence was not assessed in an objective and scientifically acceptable way and the evidence provided by experts was not given equal consideration. The evidence provided by the vaccine manufacturers was generally accepted at face value, unlike the more reliable and independent publications by the Danish researcher and her colleagues, the Danish Health and Medicines Agency and the WHO Uppsala Monitoring Centre.

9. The extreme secrecy, with life-long confidentiality agreements, which the EMA imposed on its working group members and scientific experts is not needed, is not legitimate and is not in the public interest.

10. Some of the redactions the EMA imposed on the documents it delivered to the citizens according to Freedom of Information requests were not needed, were not legitimate according to a 2010 ruling by the ombudsman, and were not in the public interest. The illegitimate redactions included names of contact people at the EMA and scientific assessors, case numbers of patients for which harms were reported, country names for individual cases, numbers of reported harms for individual countries, names of countries where there is an excess incidence of reported harms, and number of doses of the vaccine used in individual countries.

And it goes on and on and on.

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