After months of infighting and latterly outright war in the scientific community - and particularly within the Cochrane Group, formerly Collaboration - British Medical Journal have finally published a paper questioning the safety of HPV vaccines. This represents a major step forward, because they had previously backed away from publishing a review by the same authors of European Medical Agency data, preferring in May to report the official Cochrane whitewash of the products by Aubyn et al, and only reluctantly reported the paper in July by three of the present authors in its cadet journal BMJ Evidence Based Medicine criticising their Cochrane colleagues - also now defended. All the present authors are historically associated with Cochrane but matters came to a head the weekend before last when the Group sacked one of the co-authors, a founder member board member of Cochrane - Peter Gøtzsche - on the basis of vague and unsubstantiated allegations of bad behaviour, followed by the resignation of four other board members.
While the Cochrane Group is now widely considered to be a sinking ship, it has been frustrating to see weeks of politics overshadowing the incredibly serious criticisms of HPV vaccine safety made in BMJ EBM in July, and this is now somewhat rectified by the new paper which documents the painful and unsatisfactory process of extracting vaccine data from the European Medicines Agency: -
Challenges of independent assessment of potential harms of HPV vaccines
After three years of trying to access trial data for HPV vaccines, Lars Jørgensen and colleagues find current transparency policies unfit for their purpose
Lars Jørgensen, Peter Doshi, Peter Gøtzsche, Tom Jefferson
Public confidence in interventions such as vaccines relies on comprehensive, independent, and accurate assessments
Clinical study reports contain more information than journal publications but are harder to access
Only half of potentially eligible reports for a systematic review of HPV vaccines had been obtained after three years, and these were incomplete and contained redactions
Regulators did not have the full data and the manufacturers place restrictions on the dissemination of data
The process for releasing clinical study reports should be improved to make it faster and more complete
Though it is disappointing not to have finally published the authors' full assessment of the EMA data, and the paper is not perhaps as dramatic as the one published by BMJ EBM in July, the issue of whether these vaccines are safe is finally presented to the assembled British medical profession in a way that may be difficult to avoid.
Also, of a great interest, is Peter Doshi's new report "Pandemrix: why was the public not told of the early warning signs?", which is presently open access.
John Stone is UK and European Editor of Age of Autism