The European Medicines Agency is accused of misjudging the side effects of the HPV vaccine. She is the subject of a complaint from the Nordic Cochrane Center.
The European Medicines Agency (EMA) is in turmoil. The very serious Nordic Cochrane Center has filed a complaint against her. At issue: his management of the papillomavirus vaccine file. Scandinavian researchers blame the Agency for failing in its homework by dismissing the risk of rare, but serious, injection-related side effects. The complaint, brought to the European Ombudsman, was declared admissible on December 5, reveals The world. The document is consistent, to say the least. It spans 99 pages.
Dubious precedents
These reproaches are the conclusion of an exchange provided between the two parties. From July 2015, the Danish health and medicines authority was alerted by hospital staff. They noticed a progression of several complex syndromes after vaccination (chronic fatigue, regional pain, postural orthostatic tachycardia, etc.). The authority forwards and asks the EMA to reassess the possibility of rare side effects.
A report emerges from this analysis. The Agency “neither denies nor excludes” a link between the two phenomena. The Nordic Cochrane Center disagrees. It calls into question the work of the EMA. The document remained inaccessible for a long time and the procedures raise doubts.
No independent analysis has been carried out. “Several statements from the EMA are either false or seriously misleading”, accuses the center in his complaint. In his eyes, the file is simply a case of mismanagement. Especially since this is not a first: twice in the past, the attitude of the EMA has been singled out. Treatments for obesity have been poorly evaluated.
Silent complications
The problem is not just with the instructions. The authors of the complaint are alarmed by an underestimation of the victims of these side effects, a direct consequence of this silence. The syndromes in question are difficult to diagnose, they point out. They are nonetheless treatable. But for this, young women must be informed of the risks.
This position, Japan already adopted in June 2013. A media storm was unleashed after the revelation of several serious side effects. The Land of the Rising Sun has decided to no longer recommend the vaccine. He is currently carrying out epidemiological studies in order to raise suspicion. In last september, researchers called on the government to re-advise the vaccine.
Because the benefits of the vaccine against papillomavirus are real. It reduces precancerous lesions of the cervix and effectively fights genital warts, a milder symptom of papillomavirus infection.
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