HPV (“human papillomavirus”) is a common virus that can be passed from one person to another during sex. It’s the most common sexually transmitted infection in the United States. There are between 30 and 40 types of HPV that affect the genital area. Some HPV types can cause changes on a woman’s cervix that can lead to cervical cancer over time, while other types can cause genital warts. HPV is so common that most people get it at some point during their lifetime. HPV usually doesn’t cause any symptoms and typically goes away on its own without treatment. However, if it does not, there is a chance that it may cause cervical cancer. Approximately 12,000 women are diagnosed with cervical cancer each year in the United States. Of that 12,000, cervical cancer is the cause of approximately 4,000 deaths each year.
Of the 30 to 40 types of HPV, types 16 and 18 cause approximately 75% of cervical cancer cases, 70% of vaginal cancer cases and up to 50% of vulvar cancer cases. HPV types 6 and 11 cause approximately 90% of genital warts cases. Two vaccines, Gardasil and Cevarix, are currently approved by the Food & Drug Administration (“FDA”) to protect against HPV.
Gardasil, which is manufactured by Merck, is recommended for girls and young women ages 9 to 26, and purports to protect against HPV types 16, 18, 6 and 11. Cevarix is manufactured by GlaxoSmithKline, and purports to protect against HPV types 16 and 18. The Advisory Committee on Immunization Practices (ACIP) recommends immunization of girls between the ages of 11 and 12. The intent is to protect this population before they become sexually active. There are also various recommendations by the ACIP to vaccinate males between the ages of 11 and 26. The ability to implement such recommendations is a state-by-state decision.
Approximately 57 million doses of HPV vaccines were administered in the United States between June 2006 and March 2013. During that timeframe, 22,000 adverse events were reported. According to the Centers for Disease Control (“CDC”), the most frequently reported symptoms were: fainting, dizziness, nausea, headache, fever, hives, and localized pain, redness and swelling at the injection site. 8% of the adverse events were classified as “serious”. There have been 85 reports of death after receiving the Gardasil vaccine. Many of the deaths could not be verified because there was not enough information reported. 43 of the deaths were verified through a clinical review of medical records, autopsy reports and death certificates. The research did not show a pattern of death occurring with respect to time after vaccination, a consistent vaccine dose or combination of vaccines given, and a diagnosis at death that would suggest that the Gardasil vaccine caused the deaths.
Studies performed in Canada indicate that many girls who have had the Gardasil vaccination have come down with cases of multiple sclerosis and encephalitis or brain inflammation. There are also reports of girls having symptoms of Guillian-Barre Syndrome after receiving Gardasil. In addition, many girls report having seizures, muscle weakness and permanent disability. A simple Google search, results in several websites hosted by mothers of deceased young girls who are believed to have passed away due to the HPV vaccine. Although no causal link between the deaths and the use of Gardasil has been established by the CDC, many parents are questioning the safety of the vaccine.
Dr. Diane Harper, a professor at the University of Missouri-Kansas City School of Medicine, was one of the researchers that helped Gardasil obtain approval by the FDA. According to an article published by CBS, Dr. Harper says that young girls and their parents should receive a more complete warning before receiving the vaccine. She says there is no data showing that Gardasil remains effective beyond 5 years. She stated that “If we vaccinate 11 years olds and the protection doesn’t last….we’ve put them at harm from side-effects, small but real, for no benefit.” She further stated that “The benefit to the public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screening. Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women but she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks – “small but real” could occur more often than the cervical cancer itself would.
Dr. Harper also worries that the vaccine will provide women with a false sense of security and they may stop Pap screenings after being vaccinated. She fears that if women stop Pap screenings then the incidence of cervical cancer in the United States may increase.
Despite concerns and varying opinions about the HPV vaccinations safety and effectiveness, the CDC and FDA claim to have reviewed all of the safety information available for both HPV vaccines and have determined that they are both safe. The CDC continues to recommend the vaccination of 11 and 12 year old girls and women ages 13 through 26 who did not get any or all of the doses when they were younger. The vaccine is also recommended and available for boys and men, 9 through 26 years of age.
Parents are encouraged to discuss the HPV vaccine with healthcare providers. Further information and educational materials that were utilized in writing this article can be accessed by clicking on the following links:
http://www.cbsnews.com/news/gardasil-researcher-speaks-out/
http://guardianlv.com/2014/01/hpv-fda-cdc-and-merck-controversy/
http://www.cdc.gov/cancer/hpv/basic_info/
http://www.cdc.gov/vaccinesafety/Vaccines/HPV/hpv_faqs.html#one
