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Slide 1: HPV Vaccine: Arguing the Case Kathy Mayhue Nursing 512 1
Slide 2: Objectives • 1. Provide background information on Human Papillomavirus. • 2. Provide background information on Human Papillomavirus vaccine. • 3. Identify controversies surrounding the Human Papillomavirus Vaccine • 4. Identify talking points for healthcare providers and professionals regarding the HPV vaccine. 2
Slide 3: Introduction “In 1999, the Morbidity and Mortality Weekly Report identified the ten most significant health achievements of the the last 100 years. First on the list of accomplishments was vaccination, a biomedical and public health success story responsible for saving millions of lives and preventing untold misery from infectious diseases”. (Daley and McDermott, 2007) 3
Slide 4: Introduction (cont.) • HPV vaccine prevents cervical cancer. • Cervical cancer is the second leading cause of cancer deaths in women. • HPV vaccine marketed under the name Gardasil or Cervarix. 4
Slide 5: Background on HPV • HPV is the most commonly acquired sexually transmitted infection in the United States for females ages 16-24 (CDC, 2009). • HPV is transmitted through skin-to-skin contact during sexual foreplay and through anal, vaginal, or oral intercourse (Thomas, 2008). 5
Slide 6: Background on HPV (cont.) • HPV- 40 known strains • HPV- Strains #6,11, 16, 18 linked to: 70% of cervical cancers 90% of genital warts 6
Slide 7: HPV Vaccine • Protects against HPV strains 6,11,16,18 • 6.2 million HPV infections occur annually • 11,070 new cases of cervical cancer in 2008 • 3,700 cases end in death 7
Slide 8: HPV Vaccine (cont.) • Administer in a series of 3 doses over 6 months • Recommended age for vaccine is 11-12 • Questionable long-term efficacy • Vaccine does not exclude routine HPV screenings and cervical screenings, including a PAP smear. 8
Slide 9: HPV Vaccine Controversies • 1. Safety • 2. Cost • 3. Mandatory HPV vaccination • 4. Increase sexual promiscuity 9
Slide 10: Controversy #1 Safety • FDA clinical trials • 7 clinical trials/21,000 participants • Are clinical trials representative of the general population? 10
Slide 11: Safety Monitoring • FDA and CDC monitor safety via 3 systems: • The Vaccine Adverse Event Reporting System. • The Vaccine Datalink (VSD) Project. • The Clinical Immunization Safety Assessment (CISA) Network. 11
Slide 12: Safety Reports • 10, 326 VAERS reports of adverse event (CDC,2009). • 94% Non-serious Events: fainting, swelling and pain at injection site, headache, nausea, fever. • 6% Serious Events: Guillain-Barre syndrome, anaphylaxis, embolic events, death. 12
Slide 13: Safety Reported reactions require further investigation. 13
Slide 14: Safety Proponent’s Views • FDA and CDC consider safety their priority • Ongoing monitoring • Both agencies “continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women….” (CDC, 2008). 14
Slide 15: Controversy #2: Costs HPV vaccine is the most expensive vaccine ever marketed. 15
Slide 16: Costs • 2 fold problem: 1. Patient Costs 2. Provider Costs 16
Slide 17: Cost to Patient • $360 for series of 3 injections Revaccination-costs will exceed $1000/patient) • Costs for all childhood vaccines in 1995: $155 • Costs for all childhood vaccines today: $834 (exclusive of HPV vaccine) 17
Slide 18: Costs to Health Care Provider • Costs to stock and administer vaccine: • Slow reimbursement of charges • Refrigerated storage • Expiration costs • Accidental wastes 18
Slide 19: Cost Effectiveness Proponent’s Views • $5 billion dollars spent annually in US for routine screening and management of lowgrade cervical abnormalities (Vamos, McDermott, & Daly, 2008). • HPV vaccine cost effective in the long term 19
Slide 20: Controversy #3 Mandatory HPV Vaccine? • Does not eliminate the disease • Decreases a person’s chance of contracting the disease. • Why vaccinate? 20
Slide 21: Mandatory HPV Vaccine? Proponent’s View • It does not “violate rights” because of the opt out clause. • Assures coverage by Medicaid and other payers. • You must take time to do it. • Allows all the opportunity to receive the vaccine. 21
Slide 22: Controversy #4 Promotion of Sexual Promiscuity • Cervical cancer is not a national health concern? • Prevention through abstinence and marital fidelity • Consistent message to adolescents • Over generalization of protection to other STDs 22
Slide 23: Promotion of Sexual Promiscuity Proponent’s View • Sexual risk taking decreased from 19922002 prior to the vaccine’s release. • Eradicate cervical cancer 23
Slide 24: Conclusion • Controversy continues to swirl • CDC stands firm that the vaccine is effective and safe • Sort the truths from the misconceptions • Provide parents with factual information ADVOCATE 24
Slide 25: “First is the danger of futility; the belief there is nothing one man or one woman can do against the enormous array of the world’s ills-against misery, against ignorance, or injustice and violence. It is from numberless diverse acts of courage and belief that human history is shaped. Each time a man stands up for an ideal, or acts to improve the lot of others, or strikes out against injustice, he sends forth a tiny ripple of hope, and crossing each other from a million different centers of energy and daring those ripples to build a current which can sweep down the mightiest walls of oppression and resistance.” -Robert F. Kennedy South Africa, June 6, 1966 25
Slide 26: Thank You 26
Slide 27: References 27
Slide 28: Brotherton, J., Gold, M., Kemp, A., McIntyre, P., Burgess, M., & Campbell, S. (2008). Anaphylaxis following quadrivalent human papillomavirus vaccination. Canadian Medical Association Journal, 179(6), 525-533. Carey, D., & Palermo, J. (2008). Should nurse practitioners support the use of gardasil as a mandatory vaccine? The Journal of Nurse Practitioners, 3(4), 192-193. http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm http://www.hli.org/mission.html Daley, E., McDermott, R. (2007). The hpv vaccine: Separating politics from science-A commentary. American Journal of Health Education, 38(3), 177-179. Fisher,R.,Darrow, D., Tranter, M., & Williams, J. (2008). Human papillomavirus vaccine: Recommendations, issues and controversies. Current Opinions in Pediatrics, 20(4), 441-445. Forman, S., & Woods, E., (2007). Human papillomavirus vaccine: A new frontier or political controversy? Current Opinion in Pediatrics, 19(4), 387-388. 28
Slide 29: Marlow, L., Forster, A., Wardle, J., & Waller, J. (2008). Mothers’ and adolescents’beliefs about risk compensation following hpv vaccination. Journal of Adolescent Health, 43(6), 1-6. Myers, E. (2008). The economic impact of hpv vaccines: Not just cervical cancer. American Journal of Obstetrics & Gynecology, 198(5), 487-488. Savage, L. (2007). Proposed hpv vaccine mandates rile health experts across the country. Journal of the National Cancer Institute, 99(9), 665-666. Suivante, F. (2008). Juman papillomavirus vacine risk and reality. Canadian Medical Association Journal, 179(6), 503-505. Thomas, T. (2008). The new human papillomavirus (hpv) vaccine: Pros and cons for pediatric and adolescent health. Pediatric Nursing, 34(5), 429-431. Vamos, C., McDermott, R.,& Daly, E. (2008). The hpv vaccine: Framing the arguments for and against mandatory vaccination of all middle school girls. The Jorunal of School Health, 78(6), 302-309. 29