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What is HPV

HPV is a virus that is believed to be transmitted by skin to skin or genital to genital contact during sexual activity. It commonly causes genital warts, although infection may occur completely out of view on the cervix, where it is not apparent and does not show any symptoms. There are some 150 named HPV types. Newer testing methods that detect the DNA sequence of viruses demonstrate that there is actually a lot more variation in viral types than this 150, with some suggesting that there are thousands of distinct viral types.

What is the Gardasil HPV Vaccine?
The Merck Gardasil vaccine contains recombinant-generated Virus Like Particles from four strains of human papillomavirus (HPV), numbered 6, 11, 16 and 18. It is approved for females age 9 to 26. It is given in 3 doses over 6 months, at a drug cost of $360.

Are There Other Ways Besides a Vaccine to Prevent HPV?
Condom use dramatically reduces chance of infection from all types of HP viruses, by as much as 70%.

Are There Treatments for HPV?
There is no specific anti-viral treatment for infection, but the majority of infections are cleared by the immune system anyway. Of women who contract HPV infection, 90% will clear the infection through the body’s natural immune processes. The younger the patient the more rapidly they naturally clear infection.

What is Cervical Cancer?
Cervical cancer is cancerous growth on the lower portion of the womb, the part that extends into the vagina.

Are There Treatments for HPV?
There is no specific anti-viral treatment for infection, but the majority of infections are cleared by the immune system anyway. Of women who contract HPV infection, 90% will clear the infection through the body’s natural immune processes. The younger the patient the more rapidly they naturally clear infection.

Is Cervical Cancer a Growing Concern?
Between 1955 and 1992, the number of cervical cancer deaths in the United States dropped by 74%. The death rate continues to go down by about 4% per year. The HPV vaccine is coming out at a time when cervical cancer is already on the decline. This is similar to the polio vaccine, which came out when polio was already rapidly going away on its own.

What Age Group Gets Cervical Cancer?
Half of the cases of cervical cancer occur between the ages of 35 and 45. It is rare under age 20. U.S. statistics show 3-4 cervical cancer cases per year per 100,000 women age 9-26. These are the ages on which the new vaccine was tested.

Of All Cancer Deaths in the US, How Many Are From Cervical Cancer?
The American Cancer Society reports that cervical cancer is responsible for about 1% of cancer deaths per year. Some claim that this low number is due to effectiveness of routine Pap screening, which results in the detection and treatment of pre-cancerous lesions so that they never get to the cancer stage. However the big drop in cervical cancer also coincides with an increased use of condoms, so it is more likely a combination of the two factors.

Has HPV Actually Been Proved to Cause Cervical Cancer?
HPV infection is highly associated with cervical cancer, yet there remains debate as to whether the virus actually causes cancer. There are no published studies in the medical literature that demonstrate HPV actually causes cancer. The alternate explanation (raised by an FDA scientist) is that the theory that “HPV causes cancer” could be backwards. It could be that HPV is just a so-called “opportunistic infection” that is allowed to flourish un-checked in the vicinity of cancer cells.

What Else May Cause Cervical Cancer Besides HPV?
Nutritional deficiencies, especially vitamin A and folate, mineral deficiency (zinc, selenium, calcium and iron), smoking, birth control use and douching have been shown to be associated with cervical cancer. Increase in number of sex partners is a major risk factor for cervical cancer.

Does an Abnormal Pap = Cancer?
The vast majority of abnormal Pap tests do not equate to cancer. Even abnormal Pap tests showing pre-cancerous cells of the CIN II grade clear by themselves with no treatment 40% of the time. Treatment of pre-cancers has limited the progression to cancer to only 1%.

How is HPV Infection Related to Cervical Cancer?
30 types of HPV have been found in association with cervical cancer. HPV type 16 is currently found in 50% of cases of cervical cancer, and type 18 is found in 20% of cases of cervical cancer. Some cervical cancers don’t have associated HPV, and most people infected with HPV do not get cancer, so HPV cannot be the full cause of cancer. Some researchers and FDA scientists wonder if the abnormal cells (cancerous or pre-cancerous) may simply be a friendly environment for viruses to grow around, so the virus infection may occur after the changes that cause cancer rather than the other way around.

Is Smoking a Risk for Developing Cervical Cancer?
Smoking has more to do with the progression of HPV infection to cervical cancer than any other single factor. Smokers with HPV go on to develop cervical cancer much more frequently than infected non-smokers.

Does HPV Cause Warts or Cervical Abnormalities?
According to the Centers for Disease Control and Prevention, it has been estimated that up to 80% of adults have had genital HPV at some point during their life. Although many people are exposed to genital HPV types, only a small number will develop problems as a result of exposure. It has been estimated that less than 5% of people with genital HPV will develop warts, and about 5% of women with genital HPV will develop cervical abnormalities. Most people who have genital HPV but have no warts will have the HPV resolve spontaneously without any treatment.

Do I Need to Do Something for an Abnormal Pap Smear?
HPV infection is often eliminated by the body’s natural immune mechanisms. Abnormal Pap tests often return to normal on their own.

Does a Positive HPV Test Mean I Have Cancer?
If a Pap is atypical or you test positive for HPV, the chances you have a high-grade lesion are about 10-20%. But even a high grade lesion does not mean you have or will develop cancer. With proper medical follow-up, chances of developing cervical cancer will be very close to 0%.

Does HPV Lead to Cancer?
Even though HPV is considered a cause of cervical cancer, only one out of 1,000 women with HPV will develop invasive cervical cancer (ACOG, 2000). Most HPV infection never leads to the development of cervical cancer — even in the absence of medical intervention.

Can a Positive HPV Test Become Negative?
Most young women with a positive HPV test will become negative within a 24-month period.

What About Persistently Positive HPV Tests?
Persistent positive tests with HPV types associated with cervical cancer represent a significant risk for the development of HSIL (High-Grade Squamous Intraepithelial Lesion. However, the document referred to below found that most young women with persistent positive HPV tests did not have cytologically perceptible HSIL over a 2-year period. Factors thought to be associated with the development of HSIL were found not to be important in HPV regression.

Is There an HPV Test for Men?
Currently, there is no medical standard for HPV testing in men. Men are tested for research purposes only by analyzing HPV DNA in swab samples taken from the penis and other sites. However, finding “HPV DNA” is not the same as finding actual HPV (the virus itself).

If There’s No HPV Test for Men, How Are Men Screened for HPV?
Men are typically screened clinically with a visual inspection to check for lesions (such as warts). There is no specific way to test directly for HPV in men that is approved for clinical use.

Do Independent Studies Show the HPV Vaccine Works?
No. It is a crucial part of full informed consent to let patients know that all human studies submitted to the FDA were done by or financed by the drug manufacturers. It cannot be brushed aside that these studies have limited to no independent scientific review. In fact, it takes a formal Freedom Of Information Act request to obtain the exact study reports and statistical analyses that the drug manufacturer gave to the FDA.

Is the HPV Vaccine Proved to Prevent Cervical Cancer?
No. Since HPV is found in connection with most cervical cancers, the theory was that a vaccine against HPV would prevent cervical cancer. However the vaccine studies couldn’t demonstrate this simply because there were no cases of cervical cancer in the vaccinated group, or in the group that got dummy shots. Instead, Gardasil makers used a substitute measure (or surrogate marker) for cancer. They compared abnormal pre-cancerous Pap results in people who were vaccinated versus not vaccinated.

Does the Vaccine Reduce Pre-Cancerous Paps Results?
HPV vaccine studies show that pre-cancerous Paps only went down by 12% to 45%, depending on which population was studied.

How Many Young Women in America Get Cervical Cancer?
U.S. statistics show there are 30 to 40 cervical cancer cases per year per one million women age 9-26, the ages the vaccine was tested on.

Does a Mandatory HPV Vaccine For Young Girls Make Good Sense?
Gardasil’s reduction of pre-cancers by 12.2% to 16.5% in the general population of 9-26 year old females—the age range for which the vaccine is recommended—would mean that instead of 30 to 40 cases of cancer, there would only be 26 – 35 cancers. In other words, it would take vaccination of a million girls to prevent cancer in 4 to 5 girls. Since about 37% die from cervical cancer, the vaccine would prevent 1 to 2 deaths. So $360 million in vaccine would prevent 1 to 2 deaths.

Is Gardasil Proved to Prevent Cervical Cancer?
All claimed benefits for Gardasil in preventing cervical cancer are unproved speculation. In Merck studies of its HPV vaccine, the follow up was too short and the numbers too few to prove prevention of cervical cancer.

How Were Results from the HPV Vaccine Studies Analyzed?
The vaccine studies were analyzed in several different ways. One analysis looked only at girls whose pre-vaccine testing did not show any evidence of current or past infection with the HPV types that are in the vaccine. In people who did not already have one of the four types of HPV, the vaccine was 91 – 100% effective in preventing pre-cancers that were associated with the four vaccine HPV types. They still got pre-cancer associated with non-vaccine HPV types at the same rate as un-vaccinated girls.

The only way to know if you are going to get this response is if you have never had sex before the vaccine, or you have been tested for evidence of prior infection. The HPV test is recommended by the American Cancer Society as part of cancer screening every three years in women older than 30, but it is not yet widely covered by insurance plans outside of these recommendations.

The more useful analysis was called “the general population.” This is all study participants analyzed together, without separating out the ones who had tests showing current or prior infection with vaccine-type HPV. The results for the general population are much different. Because most women are not getting pre-vaccine HPV tests, these numbers apply to all but virgins. In the general population there was little over 12% reduction in pre-cancer associated with any type of HPV.

Is the HPV Vaccine Safe? Can the Vaccine Make HPV Infection Worse?
The study showed an increase in pre-cancer related to the vaccine types in the people who already had these infections before they got the vaccine. It is possible that when infected girls whose immune systems have not cleared the virus from their bodies are vaccinated, the vaccine may lead to an increased number of cases of a pre-cancer. This is very concerning because there is no routine test you can get in your doctor’s office that will tell if you are already infected by a vaccine type HPV before you get the vaccine.

Can Gardasil HPV Vaccine Cause Birth Defects?
Five subjects who got the Merck Gardasil vaccine around the time of conception had babies with birth defects, whereas no birth defects occurred in this time period in the subjects who got dummy shots.

Can the HPV Vaccine Cause Cancer?
The manufacturer of Gardasil specifies that the vaccine has not been tested to see whether it could cause cancer.

What If a Woman is Pregnant or Nursing?
It is not known if the HPV vaccine virus-like proteins or the antibodies pass into the breast milk. Merck says Gardasil should not be given to pregnant women.

Does the HPV Vaccine Affect Fertility?
The longest portion of the study only lasted just under four years. Thus there is no long-term data on how it affects the ability to become pregnant (fertility). This is especially concerning because the FDA has approved the vaccine for as young as 9 year old girls.

Can the HPV Vaccine Harm Young Girls’ Immune Systems?
The effect of artificially influencing the immune system during a time of tremendous hormone shifts of puberty is unknown.

Can the HPV Vaccine Cause Genetic Mutations?
The package insert for the Gardasil HPV vaccine specifies that it has not been tested for altering genes in the patient or her future children (genotoxicity).

How Does Gardasil Compare to Other Vaccines for Safety?
Hepatitis B vaccine was rushed to the market and broadly administered to young people in the absence of adequate human safety testing. It is now one of the most common vaccines reported to the Vaccine Adverse Effect Reporting System, particularly for gastrointestinal problems, arthritis and multiple sclerosis. The new HPV vaccine uses aluminum and polysorbate, two substances known to cause cancer in laboratory animals and to alter immune responses.

What About Long Term Safety of Gardasil?
The long term safety and effectiveness of Gardasil is unknown. Effects on causing cancer, infertility, gene mutations, birth defects and effects in breast milk have not been adequately studied in humans.

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