EU ombudsman soft-sells safety concerns on HPV jabs
A complaint against the EMAs handling of a referral procedure related to potential side effects of Sanofi/MSDs HPV vaccine Gardasil and GSKs HPV jab Cervarix, filed by the Nordic Cochrane Centre and physicians, has been rejected by the European Ombudsman.
EU Ombudsman Emily O’Reilly announced that her findings point to no maladministration in the European Medicines Agencys (EMA) handling of questions related to HPV vaccines. In a referral procedure dating back to 2015, the Agencys PRAC Committee assessed two serious potential adverse effects – complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) – that plaintiffs alleged were caused by the marketed preventive Human Papilloma Virus (HPV) cervical cancer vaccines Gardasil and Cervarix.
The Committee looked into whether there was a causal link between the HPV vaccination and the two syndromes and concluded that there was no evidence of a correlation. The plaintiffs expressed concerns relating to a lack of transparency, and suspected lack of impartiality of the PRAC Committee. Specifically, Lars Jørgensen, head of the Cochrane Centre, and Tom Jefferson, from Oxford-based Centre for Evidence-based Medicine, suggested that the outcome of the EMAs review process was decided prior to its initiation and that the PRAC seems to have reproduced the manufacturers responses to five questions without undertaking an independent analysis of the evidence.
According to the plaintiffs, as of August 2015 there were 94 documented cases of vaccine-related reports for CRPS as well as 147 jab-associated POTS cases – 65 and 117, respectively, described as serious – following clinical testing.
Documented cases of SAEs
Saying the case series would represent a highly selected sample of patients, apparently chosen to fit a pre-specified hypothesis of vaccine-induced injury, the PRAC assessment, however, focused largely on case reports, ignored 12% of the manufacturers data set, and did not assess one quarter of the trials that contributed data to the analysis of potential CRPS and POTS cases. Furthermore, the plaintiffs allege that the PRAC sent the result of its consultation with stakeholder advisory group to the manufacturers and then reached its scientific recommendation by consensus following plenary discussion. The final 40-page assessment report, which was published online, is in large part based on the manufacturers reviews, say the plaintiffs, except where it concerns "recommendations in relation to further evaluation of CRPS and POTS.
Everything all right?
EU Ombudsman Emily OReilly now says that the Committee’s examination of the scientific evidence was complete and independent. She found the PRACs undisclosed members had no conflicts of interest and that the assessment thus was deemed to have been conducted in full independence of the relevant scientific experts." She suggested, however, that the EMA should provide as much information as possible on the scientific work of its committees.
Plaintiffs comments
he plaintiffs disagree: We found many examples of scientific maladministration, they stressed in a statement issued in November on the website of the Cochrane Centre. As long as the Ombudsman is not willing to comment on scientific maladministration, even when it is apparent to people without a scientific background, there is, in reality, no public safeguard against poor conduct by the EMA. As far as we know, there is no disciplinary committee in the European Union that can take appropriate action against EMA. We find this deeply concerning.
The five underwriters claim that the Ombudsman backed questionable practices at the EMA on many occasions.
In addition, they criticised the Ombudsman for not challenging the assessment of a possible relation between a drug or a vaccine and serious harms, provided by the vaccine producers and for not ordering an independent re-analysis of the underlying raw data and scrutiny of the methods used to reach the conclusions. "The evidence is, however, that [
] it has been documented, both to EMA and to the Ombudsman, that Sanofi Pasteur/ MSD, one of the HPV vaccine manufacturers, on two occasions, both in Sweden and Denmark, had seriously underreported neurological harms associated with its HPV vaccine to the authorities, claim the plaintiffs. It [
]appears to be acceptable to dismiss the results of independent researchers and the Uppsala WHO Monitoring Centre, which found signals that suggested neurological harms. We believe it is important for the public to know about the many problems there are with EMAs substandard approach to science, they say.
(First published in European Biotechnology, Winter Edition 2017)
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