As physicians, we play a unique role in medicine. Drawing on research data, we provide a gateway of information to patients and families. Governing agencies use that data to make recommendations so that we can promote treatment with confidence. But we also have a responsibility if there is an ill outcome, so being well versed on vaccines and treatments is imperative.
Since the human papillomavirus (HPV) vaccines (Gardasil, Cervarix) were approved for the prevention of HPV, there has been controversy. Despite the ongoing reports of the vaccine’s success in lowering cervical cancer rates, many parents still feel that it puts their children at risk.
A 2012 study – a systematic review of parents’ knowledge of HPV – showed a decline from 2001 to 2011, with a rise in parents’ safety concerns, and fewer parents opting to have their children vaccinated (Obstet Gynecol Int. 2012. doi: 10.1155/2012/921236).
Dr. Francine Pearce
Several studies have shown the overwhelming decline in cervical cancer that is directly related to the implementation of the HPV vaccines. But there has been growing concern, as postural orthostatic hypotension (POTS), complex regional pain syndrome (CRPS), and sudden death have been cited as side effects of theses vaccines. POTS and CRPS have been in the headlines recently, since a report came out linking the vaccine to these syndromes. Although a review by the European Medicines Agency found that the evidence does not support the notion of the HPV vaccine causing POTS or CRPS, many groups still promote a ban of the vaccine.
In 2013, Japan withdrew its recommendation for administration of the HPV vaccine after reports that many girls had been seriously harmed by it, and now calls for follow-up for patients who believe they are having side effects. Researchers argue that the basis for this action is poorly founded, and that many young women are being deprived of a vaccine that would be protective. But just as many say that more investigation needs to be done before the recommendation can be reinstated, given the number of reports about women being seriously injured from the vaccine. The Japan Society of Obstetrics and Gynecology is pleading with the Japanese Health Ministry to commence recommending the HPV cancer-preventing vaccineonce again.
An Internet search of this topic shows there are several articles questioning the safety of the vaccine, and throughout the world, concerns are forcing more research to be done to ensure its safety. Although the research overwhelmingly shows that the risk-to-benefit ratio is in favor of the HPV vaccine, several sites are reporting injury.
In a study of 997,585 girls aged 10-17 years in Denmark and Sweden, among whom 296,826 received a total of 696,420 quadrivalent HPV vaccine doses, 1,043 (less than 1%) were found to have adverse reactions, compared with 11,944 (2%) of unvaccinated girls (BMJ 2013;347:f5906). Although some relationship between HPV vaccine and autoimmune disorders such as Behçet’s syndrome, Raynaud’s disease, and type 1 diabetes was apparent, no consistent evidence for a causal association was found.
“Analysis of data reported to the Vaccine Adverse Event Reporting System revealed disproportionate reporting of venous thromboembolism,” noted Dr. Lisen Arnheim-Dahlström of the Karolinska Institutet, Stockholm, lead author of the BMJ study, and associates. “A study by the Vaccine Safety Datalink, which involved eight outcomes, identified a nonsignificantly increased relative risk (1.98) of venous thromboembolism; medical record review could confirm five of the eight cases identified from databases using international classification of diseases codes, and all five had known risk factors for venous thromboembolism. In our analysis, based on 21 vaccine exposed cases, there was no significant association with venous thromboembolism within 90 days after exposure to [quadrivalent] HPV vaccine.”
These rising concerns are resulting in more parents declining the HPV vaccine, and more questions for the primary care physician to answer. Not only are parents alarmed, but so are the physicians who make the recommendations. Being aware of the most current research and reports for and against the vaccine’s use, and being able to discuss with the family the validity of this information, will help to dispel much of the anxiety.
Dr. Pearce is a pediatrician in Frankfort, Ill. To contact her, send email to pdnews@frontlinemedcom.com.