HPV vaccine Controversies


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this presentation gives insight into the recent controversies of HPV vaccine, in a VAST country like India mass vaccination at minimal cost may be the only way to tackle killer cancer cervix

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HPV vaccine Controversies

  1. 1. Controversies of HPV Vaccine<br /> Veerendrakumar C.M. MD.,DNB<br /> Associate ProfessorDept of OBG, VIMS, Bellary.<br />veerendrakumarcm@gmail.com<br />26/04/2010<br />1<br />veeru<br />
  2. 2. Human suffering <br />26/04/2010<br />veeru<br />2<br />
  3. 3. HPV has been detected in 99.7% of cervical cancers worldwide, the highest level of association identified for a specific cause of a major human cancer.<br />Walboomers JM et al, J Pathol. 1999; 189:12-9.<br />26/04/2010<br />3<br />veeru<br />
  4. 4. evidence has also been linked to cancers of the vulva, vagina, anal canal, peri-anal skin, and penis.<br />J Natl Cancer Inst. 1997; 89:1516-23. <br />GynecolOncol. 2002; 84:263-70.<br />Cancer Res. 2001; 61:1934-40.<br />Am J Med. 1997; 102:3-8.<br />26/04/2010<br />4<br />veeru<br />
  5. 5. Famous Phase III trials HPV vaccines<br />FUTURE -Females United to Unilaterally Reduce Endo/Ectocervical Disease <br />PATRICIA - Papilloma Trial Against Cancer In Young Adults .<br />26/04/2010<br />veeru<br />5<br />
  6. 6. Do we know fully about<br />The beneficial effects of medical intervention to recommend it ?or<br />The harmful effects before concluding that risks outweigh the benefits ?<br />26/04/2010<br />6<br />veeru<br />
  7. 7. Should we err on the side of caution or hope ?<br />Medical knowledge is always<br />incomplete and ambiguous<br />26/04/2010<br />7<br />veeru<br />
  8. 8. Confusion to clarity<br />26/04/2010<br />8<br />veeru<br />
  9. 9. Screening - not even tip of iceberg…<br />26/04/2010<br />veeru<br />9<br />
  10. 10. Why Ca cervix not given importance ?<br />26/04/2010<br />veeru<br />10<br />
  11. 11. Universal vaccination<br /> substantial effect in reducing the morbidity and mortality of cervical cancer in developing countries, where an organized screening program may not exist for all women.<br /> Villa LL. Vaccine. 2006; 24(suppl 1):S23-8.<br />26/04/2010<br />11<br />veeru<br />
  12. 12. What are the controversies ?.....<br />appropriate age at time of vaccination<br /> parental concerns <br />vaccination of men <br /> women age 26 years or older<br />inadequate long-term efficacy <br />safety data and <br />potential for non vaccine-related strains to emerge as prominent oncogenic serotypes.<br />26/04/2010<br />12<br />veeru<br />
  13. 13. AGE ? ACIP recommendations<br />(Advisory Committee on Immunization Practices- CDC) <br /> Girls age 11 or 12 years should receive the vaccine.<br />The vaccine is most efficacious when administered to an HPV-negative female, it is important to vaccinate patients before potential HPV exposure may occur.<br />26/04/2010<br />13<br />veeru<br />
  14. 14. ACS -Guideline for HPV Vaccine<br />administration of the quadrivalent vaccine at an early age provides an optimal opportunity to maximize protection against HPV to prevent Cervical Cancer and Its Precursors.<br />Saslow D et al. CA Cancer J Clin. 2007; 57:7-28.<br />26/04/2010<br />14<br />veeru<br />
  15. 15. Promotes Sexual promiscuity ?<br />26/04/2010<br />15<br />veeru<br />
  16. 16. illusion of invulnerability<br />An invitation to teenage sexual activity ?<br />easy access to oral contraception, distribution of condoms in schools, and increased availability of the "morning-after pill.<br />biennial national surveys conducted between 1991 and 2001 have demonstrated a gradual decline in sexual activity during that interval.<br />Monk BJ, Obstet Gynecol. 2006; 108:420-4.<br />26/04/2010<br />16<br />veeru<br />
  17. 17. What influence the sexual behavior?<br />"parental monitoring,“<br /> the influence of peers, <br />the age of the sexual partner. <br />religious beliefs and a fear of pregnancy as the main reasons for not having sex, not the fear of acquiring a sexually transmitted disease.Monk BJ, Obstet Gynecol. 2006; 108:420-4.<br />26/04/2010<br />17<br />veeru<br />
  18. 18. Men to be vaccinated ?<br />it seems reasonable that immunization of men may potentially prevent the transmission of the virus to both female and male partners.<br />preventing anogenital warts in men and indirectly preventing anogenitalneoplasia and transmission of warts to sexual partners.<br />26/04/2010<br />18<br />veeru<br />
  19. 19. Limitations to assess the efficacy men<br /> problems associated with the collection of cells required for detection of HPV DNA and discomfort in patients during a peniscopy with biopsy.<br /> Weaver BA, J Infect Dis. 2004; 189:677-85.<br />26/04/2010<br />19<br />veeru<br />
  20. 20. FDA Approves HPV Vaccine for Men and Boys - Oct 2009<br />26/04/2010<br />20<br />veeru<br />
  21. 21. Vaccination of Women Older Than 26 Years ?<br />FDA denied request for the approval of the quadrivalent vaccine for use in women 27-45 years of age based on cost-effectiveness.<br />(Data collected by the Harvard School of Public Health)<br />26/04/2010<br />21<br />veeru<br />
  22. 22. Vaccine efficacy in older women<br />the efficacy of the vaccine against cervical disease was reduced among women who were HPV seropositive at the time of vaccine administration<br /> N Engl J Med. 2007; 356:1915-27.<br />26/04/2010<br />22<br />veeru<br />
  23. 23. Long-term Efficacy ?<br />Of the five Phase II and III clinical trials published to date, the longest extended follow-up was 4.5-5 years.<br />26/04/2010<br />23<br />veeru<br />
  24. 24. Long term surveillance and follow up required. <br />Will prophylactic vaccination still provide benefit against the development of cervical cancer, which usually takes decades?<br /> Will a booster injection be required to maintain efficacy?<br />30 years required to know the efficacy !<br />26/04/2010<br />24<br />veeru<br />
  25. 25. Safety ?<br />26/04/2010<br />veeru<br />25<br />
  26. 26. VAERS received<br />12,424 adverse reactions out of <br />23, 051, 336 doses distributed <br />Vaccine Adverse Event Reporting System<br />26/04/2010<br />26<br />veeru<br />
  27. 27. 54 / 1 lakh vaccines distributed<br />772 /12,424 were serious events including 32 deaths<br />Only 6 % of the reactions were serious<br />26/04/2010<br />27<br />veeru<br />
  28. 28. Relative risks per 1 lakh vaccine dose<br />8.2 syncope<br />7.5 local site reactions <br />6.8 dizziness<br />5 nausea<br />4 head ache<br />3.1 hypersensitivity reactions<br />0.2thromboembolic event<br />0.1 anaphylaxis and death<br />0.04 GB Syndrome<br />0.009 Motor Neuron Disease<br />26/04/2010<br />28<br />veeru<br />
  29. 29. Disproportionate reporting of Syncope and thromboembolic events <br />26/04/2010<br />29<br />veeru<br />
  30. 30. timesonline.co.uk<br />Natalie Morton died after receiving a shot for cervical cancerat her school in Coventry. Sept 2009<br />She reportedly died from a large malignant tumor in her chest. Natalie's condition was reportedly so severe that she could have died at any point:<br />26/04/2010<br />30<br />veeru<br />
  31. 31. Media accused of scaremongering on cancer jab death• <br />"irresponsible" coverage of the death of a girl<br /> Guardian <br />26/04/2010<br />31<br />veeru<br />
  32. 32. 26/04/2010<br />32<br />veeru<br />
  33. 33. 8th April 10<br />Centre halts HPV vaccine project <br /> following the death of four girls, who were given this vaccine in AP.<br />26/04/2010<br />veeru<br />33<br />
  34. 34. Four deaths not due to flawed cervical cancer vaccine trial 9th April 2010<br />26/04/2010<br />veeru<br />34<br />
  35. 35. 2 deaths due to poisoning, 1 due to drowning and 1 due to PUO - Dr.V.M.Katoch, DG of ICMR<br />"I decided to suspend the trials because I wanted to first prove to the public that the allegations are false. I also want the general public to know that all ethical guidelines would be followed in this trial," Katoch said. <br />26/04/2010<br />veeru<br />35<br />
  36. 36. Ethical violation ?<br />The “demonstration project” had no follow-up system in place to deal with the after-effects of the vaccination, the report said. It found that in many schools, only the verbal consent was taken from the hostel warden/ teacher-in-charge to vaccinate girls residing in the hostels and the parents had not been informed about it.<br />26/04/2010<br />veeru<br />36<br />
  37. 37. Vaccine ? Screening ? <br />Holistic approach required, Women health not to be viewed in bits<br />Research and ethical values must be respected .<br />If safety well established -HPV vaccine may be the immediate answer for cancer especially in India.<br />26/04/2010<br />veeru<br />37<br />
  38. 38. Thank you<br />26/04/2010<br />veeru<br />38<br />