EXCERPT ON COMPLAINTS ON HOW THE AGENCY IS HANDLING VACCINE APPROVALS/RECOMMENDATIONS:
- experts who had declared current direct interests in a pharmaceutical company or for a particular medicinal product were allowed to participate in the Scientific Advisory Group meeting.”
- We don’t have confidence that the agency [EMA] has interpreted these documents in a way that ensures openness, gives the administration legitimacy, makes it accountable to the citizens, and respects fundamental rights of access to information that is important for the citizens when they make decisions about healthcare…”
- internal report and all other documents related to this case should therefore be made publicly available, without redactions.”
- The EMA’s procedures for evaluating the safety of medical interventions need to be fundamentally reworked and made transparent to the public.
- “I have come into possession of documentation which leads me to believe multiple individuals and organizations deliberately set out to mislead Japanese authorities regarding the safety of the human papillomavirus (HPV) vaccines, Gardasil® and Cervarix®”