By World Mercury Project Team
In May 2018,
Cochrane, the research organization that bills itself as the
“international gold standard for high quality, trusted information,” released a flattering
review of human papillomavirus (HPV) vaccines. The Cochrane review methodology involves pulling together data from clinical trials and reviewing the assembled evidence in what is supposed to
be a standardized, systematic and neutral manner.
In
June, we reported that Cochrane’s sources of funding—agencies and foundations that are unwilling to brook any questions about vaccine safety—raise reasonable doubts about Cochrane’s conflicts of interest and ability to remain independent from its funders’ agendas. Now, researchers affiliated with one of Cochrane’s regional member centers (the Nordic Cochrane Centre) and with the Oxford-based Centre for Evidence Based Medicine (OCEBM) have come out with an exhaustive
critique of Cochrane’s HPV review, published in BMJ Evidence-Based Medicine. Not mincing their words, the authors state,
“We believe that the Cochrane [HPV vaccine] review does not meet the standards for Cochrane reviews or the needs of the citizens or healthcare providers that consult Cochrane reviews to make ‘Informed decisions,’ which…is part of Cochrane’s motto” [emphasis added].
- The Nordic Cochrane Centre and OCEBM authors dress down Cochrane’s review on seven counts:
- The Cochrane review missed nearly half of the eligible trials.
- No included trial in the Cochrane review used a placebo comparator.
- The included HPV vaccine trials used composite surrogate outcomes for cervical cancer.
- The Cochrane review incompletely assessed serious and systemic adverse events.
- The Cochrane review did not assess HPV vaccine-related safety signals.
- The review ignored industry trial funding and other conflicts of interest.
- Cochrane’s public relations of the review were uncritical.
For example, using the Cochrane review’s own inclusion criteria, 42 clinical trials (involving 121,704 randomized participants) were eligible to be included in the HPV vaccine review, but the reviewers only included 26 trials (with 73,428 participants). One of the studies that they
“inappropriately excluded” was a trial of Gardasil-9—the newest HPV vaccine that includes nine types of HPV rather than the four or two in Gardasil and Cervarix—even though many countries are now shifting to Gardasil-9. Because
the nine-strain Gardasil-9 contains more than twice the amount of neurotoxic aluminum adjuvant as Gardasil, assessments of its safety are vital.
