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Analysis

Challenges of independent assessment of potential harms of HPV vaccines

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3694 (Published 24 September 2018) Cite this as: BMJ 2018;362:k3694
  1. Lars Jørgensen, researcher,1,
  2. Peter Doshi, assistant professor2,
  3. Peter Gøtzsche, professor1,
  4. Tom Jefferson, researcher1
  1. 1Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark
  2. 2University of Maryland School of Pharmacy, Baltimore, Maryland, USA
  3. Correspondence to: T Jefferson tj@cochrane.dk

After three years of trying to access trial data for HPV vaccines, Lars Jørgensen and colleagues find current transparency policies unfit for their purpose

Key messages

  • 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

Since the registration of the first human papillomavirus (HPV) vaccine (Gardasil) in 2006, HPV vaccination has been rolled out across the globe.1 There are currently three registered HPV vaccines: GlaxoSmithKline’s Cervarix and Merck’s Gardasil and Gardasil 9. The vaccines are mostly given to healthy adolescents for the prevention of HPV related diseases, such as cervical cancer, making them an important public health intervention.1

In the late 2000s, reports of potential harms associated with HPV vaccines, including postural orthostatic tachycardia syndrome (POTS) and complex regional pain syndrome (CRPS), began appearing in the media (see supplementary data on bmj.com),23 followed by reports in scientific journals.456 Both syndromes are conglomerates of signs and symptoms and their diagnoses are complex.

In response to concerns about potential harms, the European Medicines Agency carried out an investigation in 2015 and concluded there was no evidence of a relation between HPV vaccination and the two syndromes.7 Independent research8910 and systematic reviews111213 drew the same conclusion. However, we believe there is reason to be cautious. EMA did not do the assessment itself …

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