Thread by @RecheckHealth

1/9 Has #Gardasil approval ushered in an era of #overprevention? @RecheckHealth’s @CatherineRiva published on @thejospi an intriguing, original research piece co-signed by MD Jean-Pierre Spinosa: jospi.org/article/18180-… #HPV

2/9 The article tracks back the approval history of the first vaccine to have been granted the FDA’s accelerated approval and fast track. @CatherineRiva and MD @gipispinosa combined published documents with DAPs and correspondence obtained with a #FOIA #Gardasil #HPV

3/9 The authors of @thejospi piece sought to understand how the evaluation criteria were selected during #Gardasil approval and the impact of the FDA experts’ choices on the quality of the available evidence about the vaccine’s efficacy. #Gardasil #HPV

4/9 The article shows that, under the pressure of the fast-track procedure, U.S. regulatory authorities failed to comply with the methodological guidelines supposed to be applied during drugs and vaccines approval (ICH guidelines ich.org). #HPV #Gardasil

5/9 @thejospi published analysis shows that in the approval process of #Gardasil the FDA experts made problematic methodological choices (endpoints, primary and exploratory analysis criteria, etc.) that could only lead to inconclusive results on its efficacy and safety. #EBM

6/9 Gardasil accelerated approval created a new situation in countries where, prior to the introduction of this vaccination, cervical cancer was already prevented by screening with Pap smear. Screening must be maintained because vaccines do not target all high-risk HPV strains.

7/9 Gardasil’s approval has thus inaugurated a new form of medical overuse #overmedicalisation: introduction of a low-value primary prevention measure (vaccination) whose effectiveness can’t be fully assessed, since the secondary prevention measure (screening) cannot be removed.

8/9 This inextricable #overprevention situation allowed Merck to escape the burden of proof while generating huge profits. Health authorities promote the product and the society bears the costs of both vaccination campaigns and potential health risks. #HPV

9/9 Lay person’s summary of findings: re-check.ch/wordpress/en/g…
PDF in open access: jospi.org/article/18180-…