When a Placebo isn’t a Placebo - Episode 1

The PRAC review of GSK and Merck HPV vaccines

We arrived late on the case of the Human Papillomavirus (HPV) vaccines. We were busy with Tamiflu and declined a request to review evidence from a public source, as the vaccines were undergoing licensing.

Bad mistake, but we cannot clone ourselves. Maybe Matt can, but certainly not us.

Anyway, we got there in the end (or at least we thought so).

From September 2014, the European Medicines Agency (EMA) began sending us batches of clinical study reports for HPV vaccine trials. Over 3 years, we received 35,000 pages for the 18 clinical study reports in 61 batches.

It was challenging to keep track of what was what and piecing the reports together.

The reports also had some redacted parts. Narratives of serious events and case report forms were missing (these are like doctors’ notes, containing everything known about a case).

Vaccine batch numbers were missing, as were the vital anonymised identifiers, which could allow us to follow or thread a trial participant from page to page: from harms to …