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Editorials

Safety of the quadrivalent human papillomavirus vaccine

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5631 (Published 09 October 2013) Cite this as: BMJ 2013;347:f5631

Poor quality of scientific journalism about the human papillomavirus vaccine: open letter to Colombian news media

Dear Editor,

I read with interest this and other articles published in The BMJ about the safety and effectiveness of the human papillomavirus vaccine.

During the last month the coverage of alleged massive adverse events caused by this vaccine has received a high coverage by the Colombian news media (national and regional newspapers, radio, television). The overall quality of scientific journalism in Colombia is very poor and there are many more examples about this phenomenon. It's interesting that the quality of news media reports about human papillomavirus vaccine does not appear to be improving, the population still very confused, distressed, and concerned about "disastrous" adverse events caused by this prophylactic intervention. This phenomenon is spreading to social networks, people seek answers and receive responses by healthcare professionals which surprisingly (with a few exceptions) are a reflection of the poor quality of Colombian scientific journalism.

ClinicalTrials.gov registries of human papilloma vaccine were analyzed 3 days before the submission of this letter (Figure 1). (1)

Results are very surprising:

- 23 out of 25 of industry sponsored studies completed before January 1st, 2011 are published (92%).
- The 2 unpublished studies (8%) sponsored by the industry have results available at ClinicalTrials.gov
- 70% (n=16) of industry sponsored studies have at least one journal article reporting results and this data is also available at ClinicalTrials.gov.
- Only 1 out of 14 studies receiving funds from non-industry sources (e.g., Universities, NIH, Hospitals) is published. None of this studies have results available at ClinicalTrials.gov
- Human papillomavirus vaccine overall disclosure of study results: 64%

I have been analyzing clinical trial registries during the last months to understand how much clinical trial results are disclosed considering of different variables (e.g., geographical region, type of intervention, source of registry, novel drugs approved by regulatory agencies, among other variables). I am very surprised by this case because: (1) This is the first time in which I found more than 50% in the overall disclosure of trial results; (2) This is evidence that it is possible for industry to share the results of 100% of human studies; (3) This is also evidence that the source of withheld information is not only the pharmaceutical industry and those results must also be shared with the scientific and medical community; (4) It is unfair that interventions in which the sponsors have complied with their duties of disclosing the results of their studies are now being questioned by reports of very poor quality scientific journalism in Colombia, as well as many other countries in the past; (5) I have shared information about AllTrials and the BMJ Open Data Campaign with the Colombian news media; however, I had no success to obtain their attention.

I decided to write an open letter to Colombian news media about the news media coverage of the human papillomavirus vaccine. This letter is available in English and Spanish. (2)

Yours sincerely,
Jorge Ramírez

References

1. Ramirez, Jorge H (2014): Results disclosure of papilloma vaccine studies in humans completed before January 1st, 2011.. figshare.
http://dx.doi.org/10.6084/m9.figshare.1158703

2. Ramirez, Jorge H (2014): Mala calidad de periodismo científico en discusiones sobre los supuestos efectos adversos asociados a vacuna contra el virus del papiloma humano: carta abierta a los medios de comunicación Colombianos. figshare.
http://dx.doi.org/10.6084/m9.figshare.1158943

Competing interests: I support open data and transparency in research

04 September 2014
Jorge H Ramirez
Professor of Pharmacology
Universidad del Valle
Cll 4B 36-00 Univalle sede San. Fdo. Edificio 116.