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'''Gardasil''', the recently-available HPV vaccine, protects against types 6, 11, 16 and 18 of the human papillomavirus (HPV).

The '''HPV vaccine''' is a product developed by [[Merck]] under the brand name Gardasil, and it protects against a few strains of a sexually transmitted disease.  Specifically, this vaccine protects against types 6, 11, 16 and 18 of the human papillomavirus  

(HPV), which is transmitted only by sexual contact with a promiscuous partner.

These strains of HPV are [[sexually transmitted diseases]] endemic among [[promiscuous]] people, with 80% of those who have sex outside of marriage suffering from the disease.<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 without reviewing any epidemiological studies and merely monitoring for a brief period elevated [[antibody]] levels in recipients of the vaccine.<ref> http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm</ref>

Only about 3% of women are infected in their lifetime by these four types of HPV (Types 6, 11, 16, 18) targeted by the vaccine.<ref>This was confirmed by 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>

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.

There have been 3,461 adverse reactions, including eleven deaths, reportedly due to the HPV vaccine since the FDA approval in June 2006.<ref>http://www.judicialwatch.org/6428.shtml</ref>

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.

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

The HPV vaccine is being promoted as protection against cervical cancer, but Merck itself does not ensure protection in its package insert.<ref>http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf</ref> Rather, this claim is based on research showing that 70% of cervical cancer cases also have prevalence of these four strains of HPV, but correlation is not necessarily causation.<ref>http://www.cancer.gov/cancertopics/factsheet/Risk/HPV</ref>  Cervical cancer has been quickly declining in the United States ''without'' the vaccine.

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.

The FDA approved this HPV vaccine without reviewing any epidemiological studies and after monitoring for only a brief period elevated [[antibody]] levels in recipients of the vaccine.<ref> http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm</ref>  No tests were done, for example, to see if the vaccine causes cancer or birth defects in rats, though such tests would be easy for the FDA to require, if it weren't for the possibility that it might cause disapproval of the vaccine.<ref>http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf</ref>

 

The long-term consequences of the HPV vaccine are not known.  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, such as infertility or cancer.

 

Merck sells Gardasil for $360 ($120 per shot in a three-shot series).  Adding administrative costs, the overall cost to the public is $400-500 per child vaccinated. Doing the math, the cost of vaccinating 100 children will be at least $40,000, 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 effective cost is $13,000 per child to possibly protect her against a cancer over 30 years in the future. But the vaccine is not known to be effective for more than five years!

 

A 100% effective means of protection against the same disease is freely available, and it is abstinence.

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.

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."  

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."  

Many girls who receive the shot say that it is the most painful of all injections they get, and that the vaccine itself burns, unlike the "other shots [that] tend to hurt only at the moment of the needle stick, and not after the vaccine plunges in." Many girls have been known to pass out from the pain.<ref>http://www.msnbc.msn.com/id/22492557/</ref>

In addition to the above referenced injuries and deaths, many girls who receive the HPV vaccine say that it is the most painful of all injections they get, and that the vaccine itself burns, unlike the "other shots [that] tend to hurt only at the moment of the needle stick, and not after the vaccine plunges in." Many girls have been known to pass out from the pain.<ref>http://www.msnbc.msn.com/id/22492557/</ref>

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

Parents can best decide whether to give this untested vaccine to their own children, most of whom are never likely to benefit from it.

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[[category:pharmaceuticals]]

[[category:pharmaceuticals]]