Human papillomavirus (HPV) vaccine policy and evidence-basedmedicine: Are they at odds?
& Christopher A. Shaw
Neural Dynamics Research Group, Department of Ophthalmology and Visual Sciences, University of British Columbia, 828 W. 10th Ave,Vancouver, BC, V5Z 1L8, Canada and
Program in Experimental Medicine and the Graduate Program in Neuroscience, University of BritishColumbia, Vancouver, BC, Canada
In the US Food and Drug Administration (FDA) stated that vaccines represent a special category o drugs aimed mostly athealthy individuals and or prophylaxis against diseases to whichan individual may never be exposed (). Tis, according to theFDA,places signifcant emphasis on vaccine saety (). In otherwords, contrary to conventional drug treatments aimed at man-agement o existing, oentimes severe and/or advanced diseaseconditions, in preventative vaccination a compromise in e cacy or the beneft o saety should not be seen as an unreasonableexpectation. Furthermore, physicians are ethically obliged toprovide an accurate explanation o vaccine risks and benefts to theirpatients and, where applicable, a description o alternative courseso treatment. Tis in turn enables patients to make a ully inormeddecision with regard to vaccination. For example, the Australianguidelines or vaccination emphasize that or a consent to belegally valid, the ollowing element
be satisfed: ‘it [consent]can
be given aer the relevant vaccine (s) and their potentialrisks and benefts have been explained to the individual’ (empha-sis added) (). Likewise, the United Kingdom (UK) guidelinespertaining to vaccination practices state that subjects must be given
Annals of Medicine
, 2011; Early Online,
© 2011 Informa UK, Ltd.ISSN 0785-3890 print/ISSN 1365-2060 onlineDOI: 10.3109/07853890.2011.645353
o date, the e cacy o HPV vaccines in preventing
cervical cancer has not been demonstrated, while vaccine risks remain to be ully evaluated.Current worldwide HPV immunization practices with
either o the two HPV vaccines appear to be neither justifed by long-term health benefts nor economically viable, nor is there any evidence that HPV vaccination(even
proven eective against cervical cancer) wouldreduce the rate o cervical cancer beyond what Papscreening has already achieved.Cumulatively, the list o serious adverse reactions
related to HPV vaccination worldwide includes deaths,convulsions, paraesthesia, paralysis, Guillain–Barrésyndrome (GBS), transverse myelitis, acial palsy,chronic atigue syndrome, anaphylaxis, autoimmunedisorders, deep vein thrombosis, pulmonary embolisms,and cervical cancers.Because the HPV vaccination programme has global
coverage, the long-term health o many women may beat risk against still unknown vaccine benefts.Physicians should adopt a more rigorous evidence-based
medicine approach, in order to provide a balanced andobjective evaluation o vaccine risks and benefts to theirpatients.
All drugs are associated with some risks o adverse reactions. Be-cause vaccines represent a special category o drugs, generallygiven to healthy individuals, uncertain benefts mean that onlya small level o risk or adverse reactions is acceptable. Further-more, medical ethics demand that vaccination should be carriedout with the participant’s ull and inormed consent. This neces-sitates an objective disclosure o the known or oreseeable vac-cination benefts and risks. The way in which HPV vaccines areoten promoted to women indicates that such disclosure is notalways given rom the basis o the best available knowledge. Forexample, while the world’s leading medical authorities state thatHPV vaccines are an important cervical cancer prevention tool,clinical trials show no evidence that HPV vaccination can protectagainst cervical cancer. Similarly, contrary to claims that cervicalcancer is the second most common cancer in women worldwide,existing data show that this only applies to developing countries.In the Western world cervical cancer is a rare disease with mor-tality rates that are several times lower than the rate o reportedserious adverse reactions (including deaths) rom HPV vaccina-tion. Future vaccination policies should adhere more rigorouslyto evidence-based medicine and ethical guidelines or inormedconsent.Key words:
Cervarix, cervical cancer, Gardasil, HPV vaccines,
informed consent, vaccine adverse reactions
Lucija omljenovic, Neural Dynamics Research Group, Department o Ophthalmology and Visual Sciences, University o British Columbia,828 W. 10th Ave, Vancouver, BC, V5Z 1L8, Canada. E-mail: firstname.lastname@example.org
(Received 24 May 2011; accepted 31 October 2011)
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