Beatriz Serrano, Laia Alemany, Sara Tous, Laia Bruni, Gary M Clifford, Thomas Weiss, Francesc X Bosch and Silvia de Sanjosé*
Corresponding author: Silvia de Sanjosé firstname.lastname@example.org
Infectious Agents and Cancer 2012, 7:38 doi:10.1186/1750-9378-7-38
(2013-05-08 16:40) SaneVax Inc
Dear Editors In Chief:
The article entitled 'Potential impact of a nine-valent vaccine in human papillomavirus
related cervical disease'  lists Silvia de Sanjose as its corresponding author.
This same author wrote a companion Editorial entitled 'HPV Prevention Series' 
in the Journal.
Since a scientific report published in conjunction with an Editorial traditionally
represents an opinion endorsed by the Editorial Board of a peer-reviewed medical journal
which in turn carries considerable weight in influencing health care policy making
in various countries, we feel obligated to comment on this article.  Both the Editorial
 and the subsequent article  list Dr. Sanjose as the corresponding author who
was financially supported by the vaccine manufacturer as disclosed; the article was
also co-authored by an employee of the vaccine manufacturer and several consultants
paid by the vaccine manufacturer. The publications are quite obviously promoting a
new HPV vaccine.
The conclusion of the article states, 'If the nine-valent vaccine achieves the same
degree of efficacy as has been shown for HPV 16 and 18, and vaccination programs are
effectively implemented, almost 90% of ICC cases worldwide could be prevented' 
is blatantly misleading. The fact is that there is no evidence that HPV vaccination
has prevented a single case of invasive cervical cancer.
The endpoint used in the HPV vaccine clinical trials was CIN2/CIN3 lesions.  The
lesions are often self-reversing and in most cases never progress to invasive cervical
cancer.[4, 5] In contrast, invasive cervical cancer has been reported in at least
two young women shortly after receiving a full course of HPV vaccination, and at least
one of them was a subject enrolled in an HPV vaccine clinical trial project.
A more appropriate conclusion of the article  would have been 'If the nine-valent
vaccine achieves the same degree of efficacy as the current HPV vaccines in use, it
may or may not prevent any ICC cases'.
The authors' estimation of the relative contribution to invasive cervical cancer (ICC)
and precancerous cervical lesions of the nine HPV types was based on using 'PCR with
SPF-10 broad-spectrum primers followed by DNA enzyme immunoassay and genotyping with
a reverse hybridization line probe assay.'
A recent WHO survey has shown that 9 of the 12 (9/12) laboratories using the SPF-10
test were found to be 'not proficient' in detecting the HPV types.  Therefore,
the data presented in the article  are analytically unreliable, based on a 'not
proficient' testing method with an uncomfortably high 75% error rate.
In developed countries cervical cancer death is rare, occurring among women at a rate
of 1.4-1.7 per 100,000 in countries like the USA, New Zealand and Australia  at
an average age after 54, and can be further reduced by better care through improved
cervical screening, which is less invasive, cost effective and has no serious adverse
outcomes. The current proposed policy of mass vaccination of young women age 9-12
at the cost of ~$40-100 million per 100,000 women, to prevent 1 or 2 cervical cancer
deaths, is therefore not supported by either risk/benefit, or cost effectiveness analyses.
Numerous factors other than vaccination in a woman's life may be more important in
determining the risk of developing invasive cervical cancer. 
Promoting an HPV vaccine at a very young age to possibly prevent cervical cancer death
45 years down the road must wait until more research is conducted to prove that the
benefit of the HPV vaccine in cervical cancer prevention in fact outweighs its risk
which is substantial to the young girls who are being vaccinated. 
Norma Erickson, President
The SaneVax mission is to promote only Safe, Affordable, Necessary and Effective vaccines
and vaccination practices.
 Serrano B, Alemany L, Tous S, Bruni L, Clifford GM, Weiss T, Bosch FX, de Sanjose
S. Potential impact of a nine-valent vaccine in human papillomavirus related cervical
disease. Infect Agent Canc 2012, 7:38.
 de Sanjose S: HPV Prevention Series. Editorial. Infect Agent and Canc 2012, 7:37.
 FUTURE II Study Group: Quadrivalent vaccine against human papillomavirus to prevent
high-grade cervical lesions. N Engl J Med 2007, 356: 1915-27.
 Castle PE, Stoler MH, Solomon D, Schiffman M: The relationship of community biopsy-diagnosed
cervical intraepithelial neoplasia grade 2 to the quality control pathology-reviewed
diagnoses: an ALTS report. Am J Clin Pathol 2007, 127: 805-15.
 Arends MJ, Buckley CH, Wells M: Aetiology, pathogenesis, and pathology of cervical
neoplasia. J Clin Pathol 1998, 51:96-103.
 Beller U, Abu-Rustum NR: Cervical cancers after human papillomavirus vaccination.
Obstet Gynecol 2009, 113:550-2.
 Eklund C, Forslund O, Wallin KL, Zhou T, Dillner J; WHO Human Papillomavirus Laboratory
Network: The 2010 global proficiency study of human papillomavirus genotyping in vaccinology.
J Clin Microbiol 2012, 50:2289-98.
 Lee NC: Testimony before the House Committee on Commerce, Subcommittee on Health
and Environment. http://www.hhs.gov/asl/testify/t990316b.html
 Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball
R, Miller N, Braun MM, Markowitz LE, Iskander J: Postlicensure safety surveillance
for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009, 302: 750-7.
President of SaneVax Inc.
BioMed Central Ltd unless otherwise stated. Part of Springer Science+Business Media.