Monday, May 3, 2010

Should Our Daughter Get the HPV Vaccine?

Tough Decisions
I have had many parents ask me this question lately. They typically have heard from their doctor and from the adds on TV that they should. At the same time they have heard that HPV is a sexually transmitted disease, the vaccine is potentially harmful, and that it may not be as effective as they say. Who should you believe? See how informed you are about the HPV and the vaccine by answering the following questions.

True or False?
HPV is the most common sexually-transmitted infection in the U.S.
True. HPV is a sexually transmitted disease. It is spread through body fluids. It is therefore spread through sexual means, IV drug use, and blood transfusions (screened out in the USA).
True or False?
According to the National Institutes of Health National Cancer institute, in more than 90% of the cases, HPV infections are harmless and go away without treatment
True. The majority of women clear the HPV virus from their bodies naturally but women with risk factors, such as HIV infection, smoking, long-time use of oral contraceptives, and co-infection with herpes simplex virus or chlamydia, are at higher risk for chronic HPV infection.

Between 1955 and 1992, cervical cancer deaths in American women dropped by __?__ percent due to routine pap smears.

75%. Survival for women with pre-invasive cervical cancer lesions is nearly 100% with early diagnosis and appropriate treatment.

Cervical Cancer makes up what percentage of all cases of cancer diagnosed each year in the USA?

1% There are about 9,800 new cases of cervical cancer annually diagnosed in the U.S., which represents .007 percent out of the approximately 1,372,000 new cancer cases of all types diagnosed.
There are about ___?____ deaths due to cervical cancer in the USA.

There are about 3,700 deaths, in mostly older American women, annually attributed to HPV-related cervical cancer, which is about .006 percent of the approximately 570,000 cancer deaths that occur in the U.S.
As of January 31, 2010, there were ____?___VAERS reports of adverse events following Gardasil vaccination in the United States?





16,000 As of January 1, 2010, approximately 28 million doses of Gardasil were distributed in the United States.
As of January 31, 2010, there were 15,829 VAERS reports of adverse events following Gardasil vaccination in the United States. Of these reports, 92% were reports of events considered to be non-serious, and 8% were reports of events considered serious.

Other Facts:

  • Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein.

  • Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, and water for injection.

    CIN 2/3 and AIS are the immediate and necessary precursors of squamous cell carcinoma and adenocarcinoma of the cervix, respectively. Their detection and removal has been shown to prevent cancer; thus, they serve as surrogate markers for prevention of cervical cancer.
    HPV package insert

  • GARDASIL was efficacious against HPV disease caused by each of the 4 vaccine HPV types.

  • In a pre-defined analysis, the efficacy of GARDASIL against HPV 16/18-related disease was 100% (95% CI: 87.9%, 100.0%) for CIN 3 or AIS and 100% (95% CI: 55.5%, 100.0%) for VIN 2/3 or VaIN 2/3. The efficacy of GARDASIL against HPV 6-, 11-, 16-, and 18-related VIN 1 or VaIN 1 was 100% (95% CI: 75.8%, 100.0%).

  • When Cancer Monthly began looking at the research that enabled this "cervical cancer vaccine" to receive FDA approval we were astounded to find that this approval was not based on the vaccine's actual prevention of cervical cancer. Instead a surrogate was used - precancerous lesions. We were pleased to see a recent article in the Wall Street Journal (WSJ) that echoed these same issues - "Questions on Efficacy Cloud a Cancer Vaccine" April 16, 2007; Page A1. The WSJ stated, "The Food and Drug Administration didn't ask its panel of experts advising on Gardasil to rule on whether the vaccine specifically prevented the cancer itself.“
    ¨How effective is Gardasil in decreasing the incidence of cervical cancer? 100%? 50%? No one really knows because this question has not yet been answered. As of today, the Gardasil vaccine has never been proven to decrease the actual incidence of cervical cancer"

  • The large-scale implementation of human papilloma virus (HPV) immunization will be followed by cases of autoimmune diseases occurring in temporal association with immunizations.

  • If HPV immunization had been used with 80% coverage, 3 per 100,000 adolescents would have required emergency care for asthma/allergy within 24 hours and 2 per 100,000 for diabetes within 1 week of an injection. The risks of hospitalization in temporal association with immunization are 4 times higher for thyroiditis than for multiple sclerosis or Guillain-Barre's syndrome, and more than 20 times higher in young women than in adolescents.

  • November 2007, 26:11 > Human Papilloma Virus Immunization...The Pediatric Infectious Disease Journal (C) 2007 Lippincott Williams & Wilkins, Inc.

  • "The overall message, in my mind, is that among susceptible young women, the vaccine was highly effective in preventing HPV-16 or -18 precancerous cervical lesions," Koutsky said. When the researchers included all the women enrolled in the study, the vaccine reduced the risk of lesions caused by types 16 and 18 by 44%.

  • But when Koutsky and her colleagues considered lesions caused by all strains of the virus, the vaccine reduced the risk by only 17%.

  • Dr. Diane M. Harper of Dartmouth University, who helped design a related Merck-funded HPV study in the journal.She is still in favor of giving Gardasil to girls because it is safe and it "protects against the main HPV bad actors," but she argued that neither doctors nor women should be lulled into a false sense of security by the shots. "I don't think this is the gun that is going to take cervical cancer off the map," she said.

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