Material Weakness in European Pharmacovigilance - Wouter Aukema (summary interview)

Potkaars Podcast - Interviews en reportages

In a series of interview recorded early 2023 by Rico Brouwer for Potkaars, Dutch data and pattern analyst Wouter Aukema makes concerning observations with regards to the functioning of the European medicine adverse events registration system Eudravigilance.
hundreds of thousands of reports retroactively got modified (age group changed to unspecified)
filed individual case safety reports about reported deaths are being removed from public view
a significant uptick in adverse medicine effects has been happening in recent months
These and other observations were derived from a year long of weekly download of records from EMA, followed by a months long investigation into all Eudravigilance adverse effects database records such as they are available to the public. Upon completion of the series of interviews mr. Aukema requested publication be postponed. The open data that was collected from EMA in the mean time was made accessible through https://docs.openema.org/ as was first discussed July 10 2023 with Dutch programmer Milo van der Linden; https://potkaars.nl/blog/2023/7/18/openema-milo-van-der-linden .
On Potkaars: https://potkaars.nl/blog/2023/4/14/eudravigilance-wouter-aukema