Gardasil®: the Paris prosecutor’s office closes the investigation without further action

Gardasil®: the Paris prosecutor’s office closes the investigation without further action

Patients accused the cervical cancer vaccine Gardasil® of having caused serious pathologies of the nervous system. The Paris prosecutor’s office concluded that there was no direct link between this vaccine and the appearance of these diseases, and closed the investigation without further action.

the Gardasil®vaccine against human papillomavirus (HPV, which can cause precancerous lesions in the cervix), was the subject of a complaint in November 2013 to a court in Seine-Saint-Denis. An 18-year-old woman estimated [1] that this treatment had caused inflammation of his central nervous system during his adolescence. Fifty women (suffering from multiple sclerosis, lupus, acute disseminated encephalomyelitis or macrophagic myofasciitis) joined this procedure.

At that date, follow-up studies of Gardasil® showed that there was no no more cases of nervous system disease in teenage girls vaccinated against HPV than in others.

The Paris public prosecutor’s office entrusted the investigations to the gendarmes specialized in attacks on the environment and public health (Oclaesp). He closed the investigation on October 26.

“No pathology has been recognized as being directly causally linked to this vaccine”explained on November 4 to AFP a judicial source.

The analysis of the prosecution echoes that of the National Medicines Safety Agency (ANSM). She assured in September that vaccines against papillomavirus (HPV) infections, themselves the main causes of cancer, did not cause “no increase in the overall risk of occurrence of autoimmune diseases”. The ANSM had conducted a study with Health Insurance on more than 2 million teenage girls[2].

Lawyers for the plaintiffs are considering an appeal

“This decision confirms that the questioning of the Gardasil® vaccine was unfounded”welcomed in a press release the Sanofi Pasteur MSD group, which markets the vaccine.

“Our fight is not over”, reacted the lawyer of 34 complainants, Jean-Christophe Coubris, to AFP. He will file a complaint with civil action to obtain the opening of a judicial investigation and the appointment of investigating judges. An appeal also considered by Mr.e Camille Kouchner, lawyer for 16 complainants, who judges the classification decision “highly questionable”. “I regret that the prosecutor did not consider it necessary to order expert opinions on each of the complainants and relied only on published studies, in particular the latest [de l’ANSM]”, he added.

According to Me Kouchner, the link between the vaccine and most of his clients’ illnesses “has not even been analyzed by the ANSM”.

[1] His complaint was based on an expertise of the Regional Commission for Conciliation and Compensation for Medical Accidents of Aquitaine, which held that the pathology was imputable to the vaccination process, but also considered that a genetic vulnerability could have come into play.

[2] On the basis of this work, the ANSM however considered “probable” an increase in the risk of Guillain-Barré syndrome, but in “limited proportions given the rarity of the disease” (1 to 2 cases per 100,000 girls vaccinated), which according to her does not call into question the risk-benefit balance. It noted that this risk was already identified in the marketing authorization (MA) for the product.

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