Difference between revisions of "Gardasil"

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'''Gardasil''', the recently-available HPV vaccine, protects against types 6, 11, 16 and 18 of the human papillomavirus (HPV), which are sexually transmitted diseases.  These strains of HPV have been associated with 70% of cervical cancer cases and may also play a role in the development of other types of cancer <ref>[http://www.cancer.gov/cancertopics/factsheet/Risk/HPV]</ref>. In June 2006, the U.S. Food and Drug Administration approved the first HPV vaccine based on observance of elevated [[antibody]] levels in a few thousand patients who had received the vaccine (including perhaps only a few hundred or less young girls).
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'''Gardasil''', the recently-available HPV vaccine, protects against types 6, 11, 16 and 18 of the human papillomavirus (HPV), which are sexually transmitted diseases that are endemic in the human population and which approximately 80% of sexually active adults carry <ref>http://www.hopkinsmedicine.org/hnf/hnf_6403.htm</ref>.  These strains of HPV have been associated with 70% of cervical cancer cases and may also play a role in the development of other types of cancer <ref>[http://www.cancer.gov/cancertopics/factsheet/Risk/HPV]</ref>. In June 2006, the U.S. Food and Drug Administration approved the first HPV vaccine based on observance of elevated [[antibody]] levels in a double blind clinical trial involving over 20,000 subjects. <ref> http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm</ref>
  
 
The HPV vaccine does not protect against other sexually transmitted diseases (e.g., chlamydia, herpes, hepatitis, trichomoniasis, gonorrhea, syphilis, [[HIV]], [[AIDS]], etc.).  The vaccine is not recommended for use in pregnant women or girls.[http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf]
 
The HPV vaccine does not protect against other sexually transmitted diseases (e.g., chlamydia, herpes, hepatitis, trichomoniasis, gonorrhea, syphilis, [[HIV]], [[AIDS]], etc.).  The vaccine is not recommended for use in pregnant women or girls.[http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf]
  
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The long-term consequences of the HPV vaccine are not known and there have not been any long-term studies.  Children in the 9-year-old age group have been monitored for 18 months, and there have been no studies of possible longer-term risks of the vaccine.  Between July 2006 and January 2007, there were 82 reports of adverse events filed with the Vaccine Adverse Event Reporting System ([[VAERS]]) following the receipt of the vaccine.
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The long-term consequences of the HPV vaccine are not known and there have not been any long-term studies.  Children in the 9-year-old age group have been monitored for 18 months, and there have been no studies of possible longer-term risks of the vaccine.  Between July 2006 and January 2007, there were 82 reports of adverse events filed with the Vaccine Adverse Event Reporting System ([[VAERS]]) following the receipt of the vaccine.  Under clinical trial conditions, the reports of adverse or severe reactions were not any higher for those receiving the vaccine versus those receiving a placebo.
  
 
A study published February 28, 2007 in the Journal of the American Medical Association (JAMA) <ref>JAMA 297(8):813-819, February 28, 2007</ref> disclosed that about 3% of women are infected in their lifetime by the particular types of HPV (Types 6, 11, 16, 18) targeted by the vaccine.
 
A study published February 28, 2007 in the Journal of the American Medical Association (JAMA) <ref>JAMA 297(8):813-819, February 28, 2007</ref> disclosed that about 3% of women are infected in their lifetime by the particular types of HPV (Types 6, 11, 16, 18) targeted by the vaccine.
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Merck manufactures the HPV vaccine ("Gardasil") and sells it for $360 ($120 per shot in a three-shot series).  Its package insert explains the limitations of the vaccine and describes its testing for safety and efficacy.<ref>http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf</ref>
 
Merck manufactures the HPV vaccine ("Gardasil") and sells it for $360 ($120 per shot in a three-shot series).  Its package insert explains the limitations of the vaccine and describes its testing for safety and efficacy.<ref>http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf</ref>
  
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The cost for buying and administering the three-dose vaccine is about $500 per child. Accordingly, the cost of vaccinating 100 children will be about $50,000, but only 3 out of that 100 will ever be exposed to the HPV types targeted by the vaccine. The average age of diagnosis of cervical cancer is 48 years old. Accordingly, the cost is $15,000 to $50,000 per child to possibly protect her against a cancer over 30 years in the future. There is not yet a clear plan in place for funding this vaccine.
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Alternative means of protection against cervical cancer include abstinence, and condom use, which does not provide absolute protection, but does significantly reduce the likelihood of HPV transmission.<ref>http://content.nejm.org/cgi/content/full/354/25/2645</ref><ref> Report to Congress 2004: Prevention of Genital Human Papillomavirus Infection, Centers for Disease Control and Prevention, Gerberding, J.L., M.D., M.P.H. (January 2004): pp. 3-4. http://www.cdc.gov/std/HPV/2004HPV%20Report.pdf</ref> HPV infection can be detected by pap smear which is effective if done regularly, but does not ''prevent'' infection, only allows for treatment to prevent progression from infection to cancer. <ref>http://www.cdc.gov/std/HPV/STDFact-HPV.htm#cancer</ref>. Condoms are not a safeguard against  infection
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Alternative means of protection against cervical cancer include abstinence (most effective), and early detection via pap smear (effective if done regularly, but only ''detects'' infection or precancerous changes.  It does not ''prevent'' infection, but can prevent progression from infection to cancer). <ref>http://www.cdc.gov/std/HPV/STDFact-HPV.htm#cancer</ref>. Condoms are not a safeguard against  infection<ref>http://content.nejm.org/cgi/content/full/354/25/2645</ref> <ref> Report to Congress 2004: Prevention of Genital Human Papillomavirus Infection, Centers for Disease Control and Prevention, Gerberding, J.L., M.D., M.P.H. (January 2004): pp. 3-4. </ref>
 
 
The [[Association of American Physicians and Surgeons]], the Texas Medical Association and the American Academy of Pediatrics do not support making this vaccine mandatory.
 
The [[Association of American Physicians and Surgeons]], the Texas Medical Association and the American Academy of Pediatrics do not support making this vaccine mandatory.
  

Revision as of 20:39, May 27, 2007

Gardasil, the recently-available HPV vaccine, protects against types 6, 11, 16 and 18 of the human papillomavirus (HPV), which are sexually transmitted diseases that are endemic in the human population and which approximately 80% of sexually active adults carry [1]. These strains of HPV have been associated with 70% of cervical cancer cases and may also play a role in the development of other types of cancer [2]. In June 2006, the U.S. Food and Drug Administration approved the first HPV vaccine based on observance of elevated antibody levels in a double blind clinical trial involving over 20,000 subjects. [3]

The HPV vaccine does not protect against other sexually transmitted diseases (e.g., chlamydia, herpes, hepatitis, trichomoniasis, gonorrhea, syphilis, HIV, AIDS, etc.). The vaccine is not recommended for use in pregnant women or girls.[2]

The long-term consequences of the HPV vaccine are not known and there have not been any long-term studies. Children in the 9-year-old age group have been monitored for 18 months, and there have been no studies of possible longer-term risks of the vaccine. Between July 2006 and January 2007, there were 82 reports of adverse events filed with the Vaccine Adverse Event Reporting System (VAERS) following the receipt of the vaccine. Under clinical trial conditions, the reports of adverse or severe reactions were not any higher for those receiving the vaccine versus those receiving a placebo.

A study published February 28, 2007 in the Journal of the American Medical Association (JAMA) [4] disclosed that about 3% of women are infected in their lifetime by the particular types of HPV (Types 6, 11, 16, 18) targeted by the vaccine.

Merck manufactures the HPV vaccine ("Gardasil") and sells it for $360 ($120 per shot in a three-shot series). Its package insert explains the limitations of the vaccine and describes its testing for safety and efficacy.[5]

Alternative means of protection against cervical cancer include abstinence, and condom use, which does not provide absolute protection, but does significantly reduce the likelihood of HPV transmission.[6][7] HPV infection can be detected by pap smear which is effective if done regularly, but does not prevent infection, only allows for treatment to prevent progression from infection to cancer. [8]. Condoms are not a safeguard against infection The Association of American Physicians and Surgeons, the Texas Medical Association and the American Academy of Pediatrics do not support making this vaccine mandatory.

Dr. Jon Abramson, a member of the CDC's advisory committee on immunization practices, said in a report published in the Washington Times that "I told Merck my personal opinion that it shouldn't be mandated. And they heard it from other committee members."

A list of pending statutes in NJ for the HPV vaccine is here.

  1. ↑ http://www.hopkinsmedicine.org/hnf/hnf_6403.htm
  2. ↑ [1]
  3. ↑ http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm
  4. ↑ JAMA 297(8):813-819, February 28, 2007
  5. ↑ http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
  6. ↑ http://content.nejm.org/cgi/content/full/354/25/2645
  7. ↑ Report to Congress 2004: Prevention of Genital Human Papillomavirus Infection, Centers for Disease Control and Prevention, Gerberding, J.L., M.D., M.P.H. (January 2004): pp. 3-4. http://www.cdc.gov/std/HPV/2004HPV%20Report.pdf
  8. ↑ http://www.cdc.gov/std/HPV/STDFact-HPV.htm#cancer
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