- A recent study analyzed how doctors communicate with their patients about the HPV vaccine.
- The study authors concluded doctors are not effectively promoting HPV vaccine to increase use by adolescents.
- The study does not address issues of public concern regarding the safety of the HPV vaccine; need for informed consent and conflicts of interest between vaccine researchers and the pharmaceutical industry.
Human Papillomavirus (HPV) vaccination rates in the United States continues to remain low in comparison to other adolescent vaccinations1 2—approximately 38% of adolescent girls and 14% of adolescent boys complete the entire three-doses of HPV vaccine.2 As identified by the U.S. Centers for Disease Control and Prevention (CDC), a key strategy in increasing HPV vaccination coverage is to modify the manner in which healthcare providers communicate information about the vaccine to parents.2
As a result, the CDC has introduced a national campaign, “You Are the Key” to coach vaccine providers on how to successfully recommend the HPV vaccine in order to increase vaccine use by adolescents targeted by the CDC.2 3
In response to the government’s efforts to raise HPV vaccination rates, a study published in Cancer Epidemiology, Biomarkers and Prevention assess the communication methods used by primary care physicians and pediatricians in recommending the HPV vaccine. The study also evaluates whether communication methods used by healthcare providers are consistent with the five communication practices outlined by the CDC to ensure adolescent patients are fully vaccinated.2 4
With an overarching goal to “to inform efforts to target interventions to the specific communication practices and provider populations that could benefit most,”2 the study’s findings conclude that many primary care physicians and pediatricians are not effectively communicating the importance of the HPV vaccination to parents of adolescents.2 5
The findings highlight the following communication patterns:
• 59% of physicians only recommend the HPV vaccine to those patients believe to be “at risk”5
• 26% and 39% do not provide timely HPV vaccination recommendations for girls and boys, respectively5
• 27% do not strongly endorse the HPV vaccine5
• 44% do not recommend same-day HPV vaccination at the time of visit5
An author of the study, Melissa B. Gilkey, PhD, assistant professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston, reports:
Physicians have a lot of influence on whether adolescents receive the HPV vaccine. Our findings suggest that physicians can improve their recommendations in three ways: by recommending HPV vaccination for all 11- to 12-year-olds and not just those who appear to be at risk; by saying the HPV vaccine is very important; and by suggesting vaccination on the day of the visit rather than at a later date.5
The implications of the study raise broader contextual issues reflecting public concerns about the safety of the HPV vaccine, informed consent and conflict of interest.
International Investigations on the Safety of the HPV Vaccine
The HPV vaccine has been entangled in controversy from the very beginning when it was fast tracked to licensure in the U.S. in 2006.6 Over the last few years, numerous reports of young girls experiencing adverse effects after receiving the vaccine has resulted in several countries calling investigations into the safety of vaccine.7
• In July of this year, the European Medicines Agency (EMA) launched an investigation into the safety of three HPV vaccines after reports of severe reactions.
• In 2014, similar reports of reactions to the vaccine prompted Columbian Inspector General, Alejandro Ordoñez, to ask “the Columbian National Institutes of Health to disclose the technical and scientific studies relating to HPV vaccine safety and approval for use in Colombia along with all details regarding the guidelines for the management of Gardasil doses from manufacture through administration.”8
• In 2013, Japan’s Ministry of Health, Labor and Welfare publically announced that it had decided to withdraw its recommendation for the HPV vaccine after recipients reported devastating side effects.
The irony here is that while the international community is raising important questions regarding vaccine safety, ethics and informed consent, public health officials in the United States continue to turn a blind eye to this matter.7 What is even more unsettling is that studies such as this one not only disregard these issues entirely but many study authors also strongly endorse use of HPV vaccine. It is quite apparent that the recent study examining communication techniques used by HPV vaccine providers carries an underlying message strongly promoting adolescent use of the HPV vaccine by claiming that it has “an excellent safety profile”2 and that there exists “mounting evidence of effectiveness.”2
Attributing physician attitudes and poor communication as evidence of “missed opportunity” to increase HPV vaccination rates seems like a rather rigid outlook when analyzing the issue in a larger context.2 Could it possibly be that HPV vaccine coverage rates are low due to serious, adverse reactions experienced by vaccine recipients and reported in VAERS? Could be it possibly be due to the fact that a number of countries are calling for probes into the safety and effectiveness of the vaccine and that some have gone as far as withdrawing HPV vaccine recommendations?
The Implications for Informed Consent
The right to informed consent to accepting or refusing a medical intervention is a human right.9 Since vaccination is a medical intervention that involves use of a pharmaceutical products that carries the risk of potential injury, everyone has the right to become fully informed and educated about the risks associated with the vaccine prior to making a decision about receiving it.9
The recommendations provided in this study calling on doctors to improve HPV vaccine rates among adolescent patients carries an underlying implication that presents an interesting paradox with regard to doctors adhering to the ethical principle of informed consent. For instance, the study found that…
On urgency, about half of physicians reported recommending HPV vaccination for a later visit or giving a choice about when to vaccinate, rather than recommending same-day vaccination for patients in the target age range. These deficiencies in recommendation timeliness and urgency likely lead to avoidable delays in vaccination, thereby contributing to under-immunization among younger adolescents.2
Furthermore, the authors state that HPV vaccine recommendation…
quality was higher among physicians who began conversations about HPV vaccine by saying that the child was due versus giving information or eliciting questions. This approach may correspond with a more directive, or “presumptive,” communication style that research in early childhood vaccination suggests is associated with higher vaccine acceptance when compared with an open-ended, “participatory” style.2
The implication here is that physicians must use authoritarian styles of communication when recommending the vaccine. It discourages them from using open-ended, two-way methods of communication with parents but instead encourages directive, one-way communication when recommending the vaccine. Doesn’t this conflict with providing patients with the right to informed consent?
Conflicts of Interest
Financial interests between academic researchers and industry are becoming all too common particularly with pharmaceutical companies. Conflict of interest disclosure for this study states:
This work was funded via an unrestricted educational grant from Pfizer (to N.T. Brewer)… N.T. Brewer reports receiving commercial research grants from Merck, Pfizer, and GSK, received speaker honoraria from Merck, and is a consultant/advisory board member for Merck. No potential conflicts of interest were disclosed by the other authors.2
Two of the pharmaceuticals mentioned above manufacture HPV vaccines—Merck manufactures Gardasil and GlaxoSmithKline (GSK) produces Cervarix.
We know that Big Pharma does not just throw away its money. By no means did this highly profitable business gain its success by donating funds and certainly not to people that threaten its interests. Can we trust the legitimacy and credibility of this study in light of Dr. Noel Brewer’s strong financial ties to Merck and GSK?
1 National Cancer Institute. President’s Cancer Panel Annual Report. Accelerating HPV vaccine uptake urgency for action to prevent cancer. A report to the President of the United States from the President’s Cancer Panel. National Institutes of Health 2014.
2 Gilkey M, Malo T, Shah P, Hall M, Brewer N. Quality of Physician Communication about Human Papillomavirus Vaccine: Findings From A National Survey. Cancer Epidemiology, Biomarkers and Prevention 2015; 24(11): 1-7.
3 U.S. Centers for Disease Control and Prevention. You Are The Key to HPV Cancer Prevention. National Center for Immunization and Respiratory Diseases Feb. 28, 2014.
4 U.S. Centers for Disease Control and Prevention. Preteen and Teen Vaccines: What Can You Do To Ensure that Your Patients Get Fully Vaccinated? National Center for Immunization and Respiratory Diseases Oct. 7, 2015.
5 The American Association for Cancer Research. Many U.S. Physicians Communicate With Parents in Ways That May Discourage HPV Vaccination. News Release Oct. 22, 2015.
6 National Vaccine Information Center. Merck’s Gardasil Vaccine Not Proven Safe for Little Girls: NVIC Criticizes FDA for Fast Tracking Licensure. NVIC June 27, 2006.
7 Jaxen J. Nearly Half of the Doctors in the U.S. Not Routinely Recommending the HPV Vaccine. Health Impact News Nov. 6, 2015.
8 Erickson N. HPV Vaccine Controversy in Columbia Continues. InfoWars Jan. 12, 2015.
9 National Vaccine Information Center. Informed Consent. National Vaccine Information Center.