I thought Nick’s response warranted reposting here. In the spirit of full disclosure, Nick Batik is my husband and partner in Pleiades Publishing Services and the designer of the Iconic Woman and  Holy Hormone sites.

Gardasil, By The Numbers

I view the question of Gardasil more from and economic prospective:

US 2000 Census places girls age 10-14 at 6.9% of the total female population of 151,627,727.
That would be 10,462,313 girls.

Gardasil is currently on the market for $120 per single dose. Three doses are required over a 6-month period, making the total cost for the HPV vaccine $360. On top of that, some doctors are charging office visit fees when the vaccine is given.

That would be a total expenditure of $3,766,432,680 not including office visits. In your article you state that 11,070 cases of cervical cancer were reported in the US. Assuming that 100% of those could be prevented by Gardasil (which it cannot – it only affect 4 of the 72 variations) that would be a cost per case of $340,238.

If you look at the 11,070 reported cases, 3,870 resulted in death. If you measure the cost of Gardasil based on the lives saved (again assuming 100% save rate), that would be $973,238 spent per life. It should be noted that 7,200 (65%) did not die, and that had nothing to do with Gardasil.

Recent congressional reports indicate that an increasing number of cancer related deaths are due to “lack of access” to health care, as opposed to the failures of current treatments. The relatively high cost of the vaccine is just as much a barrier to the poor and uninsured – those most at risk.

The World Health Organization states that there are a number of low-cost, highly effective diagnostic screening options (e.g. PAP test – avg. $27 USD*) and that cervical cancer is one of the most treatable (with access to health care).
*NOTE:  Using PAP Test Recommended guidelines for most women from:
http://www.womenshealth.gov/faq/pap-test.cfm#pap04

• If you are younger than 30 years old, you should get a Pap test every year.
• If you are age 30 or older and have had 3 normal Pap tests for 3 years in a row, talk to your doctor about spacing out Pap tests to every 2 or 3 years.
• If you are ages 65 to 70 and have had at least 3 normal Pap tests and no abnormal Pap tests in the last 10 years, ask your doctor if you can stop having Pap tests.

It would be a reasonable expectation for a woman to have 25 PAP test throughout her lifetime. At $27 USD per test, a woman would invest $675 USD for a life time cervical cancer prevention plan.

Lets be real clear here — even with the Gardasil HPV vaccine the current medical direction is to continued with your regular PAP test schedule. So why risk the possible side effects of the vaccine?

One great unanswered question: increasing outbreaks of diseases though to be eradicated or under control has shown that the efficacy of inoculations given to school age children diminishes over time. Since cervical cancer does not manifest in most women until after age 40, will the Gardasil treatment still be effective, or will it need to administered again?

Considering the number of high-death rate diseases, is this REALLY the best use of our limited health care resources?

Resources:
http://factfinder.census.gov/servlet/STTable?_bm=y&-geo_id=01000US&-qr_name=ACS_2007_3YR_G00_S0101&-ds_name=ACS_2007_3YR_G00_

©2012 An Inconvenient Woman. All Rights Reserved.

The Environmental Protection Agency is poised to rule that it will not set a drinking-water safety standard for perchlorate. This component of rocket fuel has been linked to thyroid problems in pregnant women, newborns and young children across the nation.

The story broke last week in a number of major newspapers; but was pushed to the back pages by the looming “debt-bomb” about to dropped on the taxpayers in the name of friendly fire from our elected representatives. No one in good conscious could refer to anyone in Washington, of any political stripe, as “leaders”, but that is another story for another day.

The EPA’s “preliminary regulatory determination” estimates that up to 16.6 million Americans are exposed to perchlorate at a level many scientists consider unsafe. Independent researchers, using federal and state data, have put the number at 20 million to 40 million.

Most perchlorate contamination in U.S. drinking water is the result of improper disposal by rocket test sites, military bases and chemical plants. A nationwide cleanup could cost hundreds of millions, if not billions, of dollars, and several defense contractors have threatened to sue the Defense Department to help pay for it if one is required. The Government Accountability Office reported this spring that the Pentagon had pressured the EPA for several years not to regulate perchlorate.

“They have distorted the science to such an extent that they can justify not regulating” the chemical, said Robert Zoeller, a University of Massachusetts professor who specializes in thyroid hormone and brain development and has a copy of the EPA proposal. “Infants and children will continue to be damaged, and that damage is significant.”

Zoeller said scientific studies have shown that a small reduction in thyroid function in infants can translate into a loss of IQ and an increase in behavioral and perception problems. “It’s absolutely irreversible,” he said. “Even small changes in thyroid functions early on have impacts on functioning through high school and even into people’s 20s.”

According to a Washington Post article, OMB officials deleted any references to those studies in the EPA’s proposal.

The current EPA document states that establishing a drinking-water standard for perchlorate “would not present a ‘meaningful opportunity for health risk reduction for persons served by public water systems,’ ” but it also reveals that many Americans will be exposed to the compound at levels higher than recommended if nothing is done to remove it. Perchlorate impedes the functioning of the thyroid gland, which produces hormones that foster mental and physical development and control metabolism. The notice indicates that the agency plans to finalize its decision by December 1st, 2008.

In response to the “dust-up” over the preliminary report, the EPA’s assistant administrator for water, Benjamin H. Grumbles, stated; “Science, not the politics of fear in an election year, will drive our final decision.”

“Until then, final numbers and strategies are mere speculation,” Grumbles added. “We know perchlorate in drinking water presents some degree of risk and we’re committed to working with states and scientists to ensure public health is protected and meaningful opportunities for reducing risk are fully considered.”

In January 2002, the EPA issued a draft risk assessment finding that 1 part per billion should be considered safe; in March 2006, the Massachusetts Department of Environmental Protection set a maximum contaminant level of 2 ppb; last year, California adopted a standard of 6 ppb.

A National Academy of Sciences panel prepared a risk analysis in 2005 that, according to the EPA’s traditional models, would produce a protective standard of 1 to 6 ppb. The academy’s study came under attack because two of the committee’s members had financial ties to defense contractors that face legal liability because of perchlorate disposal.

The EPA’s proposed ruling assumes that perchlorate contamination of 15 ppb is safe. But its regulatory document states that “between 16,000 and 28,000 pregnant women” and 900,000 to 2 million Americans could be exposed to higher levels.

The EPA document also finds that bottle-fed infants would be exposed to more than five times the level the National Academy of Sciences deemed safe — 700 nanograms per kilogram of body weight per day — if parents mix formula with drinking water containing perchlorate levels of 15 ppb.

OMB officials said during the drafting process that there was “no need” for detailed data to flesh out a table suggesting that infants would be exposed to perchlorate levels above the academy’s recommendation.

To determine safe levels of exposure, the OBM opted not to use the academy’s “reference dose,” a formula that includes a tenfold safety factor to protect children and vulnerable populations, and instead used a computer model developed by the Chemical Industry Institute of Toxicology. EPA officials initially inserted language in the document calling this a “novel approach,” but the OMB deleted that language.

Federal officials have yet to determine the extent of perchlorate contamination nationwide, but it is known to be widespread. The GAO, which produced a 2005 report calling for a better federal tracking system for perchlorate, found that limited EPA data show the chemical compound has polluted the soil, groundwater and drinking water in 35 states and the District and has contaminated 153 public water systems in 26 states.

Stay tuned, and don’t drink the water, or swallow the Kool-Aid.

©2012 An Inconvenient Woman. All Rights Reserved.

But 55-percent of all strokes and 60-percent of stroke deaths occur in women.

About 100,000 women die annually of stroke, 40,000 more than the number of men who die from it. The fact that risk goes up with age and women live longer account for a large portion of that difference.

Strokes can affect younger women as well, including after childbirth when the blood is more likely to clot — probably an evolutionary adaptation so new mothers don’t bleed to death, says Dr. David Sherman, chief of neurology at the University of Texas Health Science Center.

And for women who have migraine headaches — about 18 percent of women do — and those who smoke and take oral contraceptives, there is more risk of stroke.

Twice as many women die from stroke every year than from breast cancer

That is why I’ve posted the following Harvard Medical report. LEARN the early warning signs of stroke. Inconvenient Women know their bodies and are proactive about their health. For more information go to ‘Stoke Facts In America‘

		September 23, 2008

3 warning signs of stroke You know the signs of a stroke. Or do you? You’d probably recognize the classic symptoms, such as sudden weakness on one side of the body or blurred vision, but often the signs are much less obvious. A crushing headache may come on without warning. Your face may feel numb. You may have inexplicable trouble speaking or following what people say. How to tell when someone’s having a stroke Crooked smile. Have the person smile or show his or her teeth. If one side doesn’t move as well as the other or seems to droop, that could be sign of a stroke. Arm drift. Have the person close his or her eyes and hold his or her arms straight out in front for about 10 seconds. If one arm does not move, or one arm winds up drifting down more than the other, they may be having a stroke. Slurred speech. Have the person say, “You can’t teach an old dog new tricks,” or some other simple, familiar saying. If the person slurs the words, gets some words wrong, or is unable to speak, that could be sign of a stroke. Knowing all the warning signs of a stroke may one day save your life and well-being. That’s because the faster you recognize the symptoms, the sooner you can get medical help. And prompt treatment is the key to shielding your brain from a stroke’s damage and sparing you serious disabilities such as paralysis, speech impairment, and dementia. Every 45 seconds, someone in the United States has a stroke. Stroke is the third leading cause of death in the United States and other industrial countries, trailing only heart disease and cancer. In the United States, about 700,000 people have a stroke each year. If you have a stroke, the risk of dying from it increases with age: 88% of deaths from stroke are in people 65 and older. About two-thirds of people who have a stroke have some resulting disability and require rehabilitation. The odds of having a stroke more than double for each decade after age 55. Two-thirds of strokes involve people over 65. Men and women are about equally likely to have a stroke, but women have a greater risk of dying from one. Race is another risk factor. African-Americans, for example, are almost twice as likely to suffer a stroke as are whites. Although you can’t change your age or race, you can take steps to reduce other risk factors for stroke, especially ischemic stroke. The most common risk factors for both ischemic stroke and TIAs (transient ischemic attacks, or “mini strokes”) are high blood pressure (hypertension), diabetes, unhealthy cholesterol levels, and obesity. All of these factors affect the health of your blood vessels — increasing the risk not only of stroke, but also of heart disease. That’s why medications and other steps you take to reduce the risk of an ischemic stroke will also benefit your heart. Some types of hemorrhagic strokes are more likely to occur in people with chronic high blood pressure. But other types of hemorrhagic strokes seemingly strike out of the blue. Although abnormal blood vessel conditions such as an aneurysm (a bubble in the blood vessel wall that could rupture) or an arteriovenous malformation (an abnormal tangle of blood vessels) increase the risk, these conditions may only be discovered inadvertently while you are undergoing testing for something else or may not be discovered until a stroke occurs. Fortunately, medicine has made considerable strides in understanding how to treat and prevent strokes. Medical imaging devices now enable medical teams to begin to diagnose a stroke accurately within minutes. Large studies have clarified which medications and other treatments are best for which patients. For those who need rehabilitation, experimental techniques are showing promise in helping patients make better progress than was possible even just a few years ago.

FEATURED CONTENT: What is a stroke? How the brain works Subtypes and causes of stroke Diagnosing a stroke Treating ischemic stroke Treating hemorrhagic stroke Stroke rehabilitation Preventing stroke Reprinted from Stroke: Preventing and treating “brain attack” — A Special Health Report from Harvard Medical School, Copyright © 2008 by Harvard University. All rights reserved.

** Get your copy of Stroke: Preventing and treating “brain attack” Stroke: Preventing and treating “brain attack” provides up-to-the-minute information about stroke symptoms, diagnosis, stroke treatment, and rehabilitation. This report discusses stroke prevention and common signs of stroke. It also contains helpful illustrations, an extensive glossary, and an informative resource guide. Click here to read more or buy online. To order online, click one of the following links: Purchase printed version ($18.00) Purchase electronic download (PDF) ($18.00) Purchase print + electronic download (PDF) ($26.00) Or to order by mail, print and mail the order form below:

Harvard Medical School offers special reports on over 50 health topics. Visit our Web site at http://www.health.harvard.edu to find reports of interest to you and your family. Copyright 2008 by Harvard University.

©2012 An Inconvenient Woman. All Rights Reserved.

By JARED A. FAVOLE

WSJ.com, September 5, 2008 8:07 p.m.

WASHINGTON — The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.

The list includes a wide array of drugs, from Eli Lilly & Co.’s antidepressant Cymbalta to Purdue Pharma LP’s painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (See the FDA’s list of drugs that are under investigation.)

The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers — such as Johnson & Johnson’s Remicade — as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn’s.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp.’s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn’t previously said it was investigating the drug for this side effect.

The list, which the FDA will start issuing quarterly, is aimed at giving consumers and health-care professionals early indications of what the FDA is investigating, but it might end up creating more confusion. Indeed, the agency is concerned “that people will stop taking a drug inappropriately” because it is on the list, said Paul Seligman, associate director of safety policy at the agency.

The FDA said it alerted companies whose drugs appeared on the list prior to it being made public — several companies said they received word late Thursday — and intends to give drug makers a heads-up in the future as well.

Drug makers said they support the FDA’s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.

“It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,” said Tony Jewell, a spokesman for AstraZeneca PLC, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.

Companies also cautioned that just because a drug is posted on the site doesn’t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.

The FDA’s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn’t represent a comprehensive list of drugs the FDA is investigating, the FDA’s Mr. Seligman said.

The report is generated from the agency’s adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.

Mr. Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.

Write to Jared A. Favole at jared.favole@dowjones.com

©2012 An Inconvenient Woman. All Rights Reserved.

Pap Smear

A Pap smear is a microscopic examination of cells scraped from the cervix that is used to detect cancerous or precancerous conditions of the cervix and other medical conditions. If detected, precancerous conditions can be treated before they become malignant. Between 1975 and 2001 use of the Pap smear is credited with cutting the age adjusted cervical cancer incidence in half, from 14.8 to 7.9 cases per 100,000 women; and with reducing the age adjusted cervical cancer death rate from 5.6 to 2.7 deaths per 100,000 women (1).

In 2002 cervical cancer was the reported cause of death for 4,000 women in the United States (2).

The U.S. Preventive Services Task Force, the American

Cancer Society, and the American College of Obstetricians and Gynecologists all recommend regular Pap smear screening for cervical cancer, although recommendations vary as to the frequency, timing, risk factors, and age of women to be screened (3–5).

Between 1987 and 2003 the percent of women 18 years of age and over with a Pap smear within the past 3 years increased from 74 percent to 79 percent, with increases occurring among women of all race and ethnic groups (figure 22). However, Pap smear screening rates vary considerably by race and ethnicity. In 2003 non-Hispanic black women had the highest rate of screening, 84 percent.

Both non-Hispanic black and non-Hispanic white women were considerably more likely to report having a recent Pap smear than Asian and Hispanic women in 2003. Screening rates for both Asian and Hispanic women increased between 1987 and 1993, but have remained fairly stable through 2003. Pap smear screening rates remained lower for Asian and Hispanic women than for non-Hispanic black and non-Hispanic white women. Several studies have examined barriers to cervical cancer screening for Hispanic and Asian women. Demographic and socioeconomic variables were found to be important predictors of Pap smear screening for Hispanic and Asian women, as they are for the general U.S. population (6). In addition, language and acculturation has been shown to predict Pap smear utilization among Hispanic and Asian women, with more recent immigrants and those with English language barriers, fatalistic views on cancer, and culturally-based embarrassment reporting less frequent receipt of Pap smear (7–9).

Incidence rates of cervical cancer were highest for Hispanic women and rates for black women were also higher than the average for all women (10). Despite their high Pap smear screening rates, black women had the highest death rates from cervical cancer in 1997–2001, 5.6 deaths per 100,000 women. Hispanic women also had cervical cancer death rates higher than that of non-Hispanic white and Asian women. In contrast, both the incidence rate of cervical cancer and the death rate for Asian women—who had the lowest screening level—were in line with the average rates for women of all races and ethnicities combined. The reasons for the higher death rates among black women despite their high screening rates are not fully understood. This higher mortality among black women may be in part due to diagnosis at more advanced cancer stages and lower socioeconomic status (11).

For women in whom precancerous lesions have been detected through Pap smears, the likelihood of survival is nearly 100 percent with appropriate evaluation, treatment, and followup (12).

The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and other initiatives help low income, uninsured, and underserved women to obtain access to both screening and follow-up care for cervical cancer.

1. Ries LAG, Eisner MP, Kosary CL, et al. (eds). SEER Cancer

Statistics Review, 1975–2001. Table V-3. National Cancer

Institute. Bethesda, MD. 2004. Available at seer.cancer.gov/csr/

1975_2001/ accessed on January 5, 2005.

2. Kochanek KD, Murphy SL, Anderson RN, Scott C. Deaths: Final data for 2002. National vital statistics reports; vol 53 no

5. Hyattsville, MD: National Center for Health Statistics. 2004.

Available at www.cdc.gov/nchs/data/nvsr/nvsr53/nvsr53_05.pdf accessed on February 18, 2005.

3. U.S. Preventive Services Task Force. Screening for cervical cancer: Recommendations and rationale. AHRQ pub no

03–515A. January 2003. Agency for Healthcare Research and

Quality. Rockville, MD. Available at www.ahrq.gov/clinic/

3rduspstf/cervicalcan/cervcanrr.htm accessed on January 3,

2005.

4. Saslow D, Runowicz CD, Solomon D, et al. American Cancer

Society guideline for the early detection of cervical neoplasia and cancer. CA Cancer J Clin 52(6):342–62. 2002.

5. The American College of Obstetricians and Gynecologists.

ACOG News Release: Revised cervical cancer screening guidelines require reeducation of women and physicians.

Available at:

www.acog.org/from_home/publications/press_releases/nr05–04-04–1.cfm accessed on January 5,

2005.

6. Swan J, Breen N, Coates RJ, et al. Progress in cancer screening practices in the United States: Results from the 2000 National Health Interview Survey. Cancer 97(6):1528–40.

2003.

7. Chaudhry S, Fink A, Gelberg L, Brook R. Utilization of

Papanicolaou smears by South Asian women living in the

United States. J Gen Intern Med 18:377–84. 2003.

8. Alba D, Sweningson JM, Chandy C, Hubbell FA. Impact of

English language proficiency on receipt of Pap smears among

Hispanics. J Gen Intern Med 19(9):967–70. 2004.

9. Austin LT, Ahmad F, McNally MJ, Stewart DE. Breast and cervical cancer screening in Hispanic women: A literature review using the health belief model. Women’s Health Issues

12(3):122–8. 2002.

10. Ries LAG, Eisner MP, Kosary CL, et al. (eds). SEER Cancer

Statistics Review, 1975–2001. Table V-7. National Cancer

Institute. Bethesda, MD. 2004. Available at:

seer.cancer.gov/csr/1975_2001/results_merged/topic_race_ethnicity.pdf accessed on January 6, 2005.

11. Schwartz KL, Crossley-May H, Vigneau, FD, et al. Race, socioeconomic status and stage at diagnosis for five common malignancies. Cancer Causes Control 14:761–6. 2003.

12. Lawson HW, Henson R, recommendations for the early detection of breast and cervical cancer among low-income women. MMWR Recomm Rep. 49(RR-2):37–55. 2000.

Available at www.cdc.gov/mmwr/PDF/RR/RR4902.pdf accessed on January 26, 2005.

When quoting from this source, use the following citation:

National Center for Health Statistics

Health, United States, 2005

With Chartbook on Trends in the Health of Americans

Hyattsville, Maryland: 2005

Library of Congress Catalog Number 76–641496

For sale by Superintendent of Documents

U.S. Government Printing Office

Washington, DC 20402

©2012 An Inconvenient Woman. All Rights Reserved.

Between 1975 and 2001 use of the Pap smear is credited with cutting the age adjusted cervical cancer incidence in half, from 14.8 to 7.9 cases per 100,000 women; and with reducing the age adjusted cervical cancer death rate from 5.6 to 2.7 deaths per 100,000 women. By 2002, cervical cancer was the reported cause of death of less than 4,000 women in the United States.

— American Cancer Society

Most of those deaths were the direct results of lack of access to preventive health care — in this case, an inexpensive, safe PAP Test. Due to wider access to multilingual health education, and public health clinics the number of cervical cancer deaths continues to decline. MERCK wants billions of dollars for solving a health issue that was well on its way to being eradicated; and in my personal opinion, endangering the lives of our daughters and granddaughters in their rush to make a profit before too many lawsuits forces them to pull the vaccine from the market… the ghost of VIOXX past…

Below is a description of the PAP Test.

Inconvenient Women make informed decisions.

Get educated, form an opinion and act on it.

Silence is for lambs

What is a Pap test?

The Pap test, also called a Pap smear, checks for changes in the cells of your cervix. The cervix is the lower part of the uterus (womb) that opens into the vagina (birth canal). The Pap test can tell if you have an infection, abnormal (unhealthy) cervical cells, or cervical cancer.

Why do I need a Pap test?

A Pap test can save your life. It can find the earliest signs of cervical cancer – a common cancer in women. If caught early, the chance of curing cervical cancer is very high. Pap tests also can find infections and abnormal cervical cells that can turn into cancer cells. Treatment can prevent most cases of cervical cancer from developing.

Getting regular Pap tests is the best thing you can do to prevent cervical cancer. About 13,000 women in America will find out they have cervical cancer this year. And in 2004, 3,500 women died from cervical cancer in the United States.

Do all women need Pap tests?

It is important for all women to have pap tests, along with pelvic exams, as part of their routine health care. You need a Pap test if you are:

• 21 years or older
• under 21 years old and have been sexually active for three years or more

There is no age limit for the Pap test. Even women who have gone through menopause (when a woman’s periods stop) need regular Pap tests.

How often do I need to get a Pap test?

It depends on your age and health history. Talk with your doctor about what is best for you. The American College of Obstetricians and Gynecologists recommends the following:

• If you are younger than 30 years old, you should get a Pap test every year.
• If you are age 30 or older and have had three normal Pap tests for three years in a row, talk to your doctor about spacing out Pap tests to every two or three years.
• If you are ages 65 to 70 and have had at least three normal Pap tests and no abnormal Pap tests in the last 10 years, ask your doctor if you can stop having Pap tests.

You should have a Pap test every year no matter how old you are if:

• You have a weakened immune system because of organ transplant, chemotherapy or steroid use
• Your mother was exposed to diethylstilbestrol (DES) while pregnant
• You are HIV-positive

Women who are living with HIV, the virus that causes AIDS, are at a higher risk of cervical cancer and other cervical diseases. The U.S. Centers for Disease Control and Prevention recommends that all HIV positive women get an initial Pap test, and get re-tested 6 months later. If both Pap tests are normal, then these women can get yearly Pap tests in the future.

Who does not need regular Pap tests?

The only women who do not need regular Pap tests are:

• Women over age 65 who have had a number of normal Pap tests and have been told by their doctors that they don’t need to be tested anymore.
• Women who do not have a cervix and are at low risk for cervical cancer. These women should speak to their doctor before stopping regular Pap tests.

I had a hysterectomy. Do I still need Pap tests?

It depends on the type of hysterectomy (surgery to remove the uterus) you had and your health history. Women who have had a hysterectomy should talk with their doctor about whether they need routine Pap tests.

Usually during a hysterectomy, the cervix is removed with the uterus. This is called a total hysterectomy. Women who have had a total hysterectomy for reasons other than cancer may not need regular Pap tests. Women who have had a total hysterectomy because of abnormal cells or cancer should be tested yearly for vaginal cancer until they have three normal test results. Women who have had only their uterus removed but still have a cervix need regular Pap tests. Even women who have had hysterectomies should see their doctors yearly for pelvic exams.

How can I reduce my chances of getting cervical cancer?

Aside from getting Pap tests, the best way to avoid cervical cancer is by steering clear of the human papilloma virus (HPV). HPV is a major cause of cervical cancer. HPV infection is also one of the most common sexually transmitted diseases (STD). So, a woman boosts her chances of getting cervical cancer if she:

• Starts having sex before age 18
• Has many sex partners
• Has sex partners who have other sex partners
• Has or has had a sexually transmitted disease (STD)

What should I know about human papilloma viruses (HPV)?

Human papilloma viruses are a group of more than 100 different viruses.

• About 40 types of HPV are spread during sex.
• Some types of HPVs can cause cervical cancer when not treated.
• HPV infection is one of the most common sexually transmitted diseases.
• About 75 percent of sexually active people will get HPV sometime in their life.
• Most women with untreated HPV do NOT get cervical cancer.
• Some HPVs cause genital warts but these HPVs do not cause cervical cancer.
• Since HPV rarely causes symptoms, most people don’t know they have the infection.

How would I know if I had human papilloma virus (HPV)?

Most women never know they have HPV. It usually stays hidden and doesn’t cause symptoms like warts. When HPV doesn’t go away on its own, it can cause changes in the cells of the cervix. Pap tests usually find these changes.

How do I prepare for a Pap test?

Many things can cause wrong test results by washing away or hiding abnormal cells of the cervix. So, doctors suggest that for two days before the test you avoid:

• Douching
• Using tampons
• Using vaginal creams, suppositories, and medicines
• Using vaginal deodorant sprays or powders
• Having sex

Should I get a Pap test when I have my period?

No. Doctors suggest you schedule a Pap test when you do not have your period. The best time to be tested is 10 to 20 days after the first day of your last period.

How is a Pap test done?

Your doctor can do a Pap test during a pelvic exam. It is a simple and quick test. While you lie on an exam table, the doctor puts an instrument called a speculum into your vagina, opening it to see the cervix. She will then use a special stick or brush to take a few cells from inside and around the cervix. The cells are placed on a glass slide and sent to a lab for examination. While usually painless, a Pap test is uncomfortable for some women.

When will I get the results of my Pap test?

Usually it takes three weeks to get Pap test results. Most of the time, test results are normal. If the test shows that something might be wrong, your doctor will contact you to schedule more tests. There are many reasons for abnormal Pap test results. It usually does NOT mean you have cancer.

What do abnormal Pap test results mean?

It is scary to hear that your Pap test results are “abnormal.” But abnormal Pap test results usually do NOT mean you have cancer. Most often there is a small problem with the cervix.

Some abnormal cells will turn into cancer. But most of the time, these unhealthy cells will go away on their own. By treating these unhealthy cells, almost all cases of cervical cancer can be prevented. If you have abnormal results, to talk with your doctor about what they mean.

My Pap test was “abnormal,” what happens now?

There are many reasons for “abnormal” Pap test results. If results of the Pap test are unclear or show a small change in the cells of the cervix, your doctor will probably repeat the Pap test.

If the test finds more serious changes in the cells of the cervix, the doctor will suggest more powerful tests. Results of these tests will help your doctor decide on the best treatment. These include:

• Colposcopy: The doctor uses a tool called a colposcope to see the cells of the vagina and cervix in detail.
• Endocervical curettage: The doctor takes a sample of cells from the endocervical canal with a small spoon-shaped tool called a curette.
• Biopsy: The doctor removes a small sample of cervical tissue. The sample is sent to a lab to be studied under a microscope.

The FDA recently approved the LUMA Cervical Imaging System. The doctor uses this device right after a colposcopy. This system can help doctors see areas on the cervix that are likely to contain precancerous cells. The doctor uses this device right after a colposcopy. This system shines a light on the cervix and looks at how different areas of the cervix respond to this light. It gives a score to tiny areas of the cervix. It then makes a color map that helps the doctor decide where to further test the tissue with a biopsy. The colors and patterns on the map help the doctor tell between healthy tissue and tissue that might be diseased.

My Pap test result was a “false positive.” What does this mean?

Pap tests are not always 100 percent correct. False positive and false negative results can happen. This can be upsetting and confusing. A false positive Pap test is when a woman is told she has abnormal cervical cells, but the cells are really normal. If your doctor says your Pap results were a false positive, there is no problem.

A false negative Pap test is when a woman is told her cells are normal, but in fact, there is a problem with the cervical cells that was missed. False negatives delay the discovery and treatment of unhealthy cells of the cervix. But, having regular Pap tests boosts your chances of finding any problems. If abnormal cells are missed at one time, they will probably be found on your next Pap test.

I don’t have health insurance, how can I get a free or low-cost Pap test?

Programs funded by the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) offer free or low-cost Pap tests to women in need. These and other programs are available throughout the United States. To find contact information for a program near you, visit the NBCCEDP website at http://www.cdc.gov/cancer/nbccedp/ or call 1-888-842-6355 (select option 7). Also, your state or local health department can direct you to places that offer free or low-cost Pap tests.

Planned Parenthood offers low-cost Pap tests as well. To find the Planned Parenthood office in your area, call 1-800-230-7526 or visit their website at: http://www.ppfa.org

For more information . . .

You can find out more about Pap tests by contacting the National Women’s Health Information Center (NWHIC) at 1-800-994-9662 or the following organizations:

Cancer Information Service, NCI, NIH, HHS

Phone Number: (800) 422-6237

Internet Address: http://cis.nci.nih.gov/

American College of Obstetricians and Gynecologists (ACOG) Resource Center

Phone Number: (800) 762-2264 x 192 (for publications requests only)

Internet Address: http://www.acog.org/

American Cancer Society

Phone Number: 1-800-227-2345

Internet Address: http://www.cancer.org

National Cervical Cancer Coalition (NCCC)

Phone Number: (800) 685-5531

Internet Address: http://www.nccc-online.org/

Planned Parenthood Federation of America

Phone Number: (800) 230-7526

Internet Address: http://www.ppfa.org

Centers for Disease Control

National Breast and Cervical Cancer Early Detection Program

Phone Number: (888) 842-6355

Internet Address: http://www.cdc.gov/cancer/nbccedp/

All PAP SMEAR (TEST) material contained in the FAQs is free of copyright restrictions, and may be copied, reproduced, or duplicated without permission of the Office on Women’s Health in the Department of Health and Human Services; citation of the sources is appreciated.

This FAQ was reviewed by Edward L. Trimble, MD, MPH

Head, Gynecologic Cancer Therapeutics & Quality of Cancer Care Therapeutics

Clinical Investigations Branch

Cancer Therapy Evaluation Program

Division of Cancer Treatment and Diagnosis

National Cancer Institute

©2012 An Inconvenient Woman. All Rights Reserved.

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now.”

— Dr. Diane Harper, a professor of medicine at Dartmouth Medical School

Those who follow BIG PHARM have noticed some interesting trend-lines lurking in the infamous ‘9-point Helvetica, grey ink’ Corporate 10-K, Annual Reports. Over the past several years, research budgets trended downward, while “Marketing” expenditures accelerated.

What would be considered a BIG PHARMA marketing expense?

Marketing expenses would include clever print and electronic media ads, along with brochures for health professionals. This print material is usually given to Doctors at “Sponsored” events, “Educational” resort-based retreats, private dinners, and that basic and most appreciated pharmaceutical freebee, the “Free Lunch”! On any given day an army of pharmaceutical reps drop off Lunches and other “Goodie packages” to busy practices with free drug samples and good cheer.

Speaking of “good cheer” Marketing expenses also include BIG PHARMA lobbyists spending largest amongst the very representatives “we the people” sent to our local, state, and federal to look after our interest. The amount of cash laid down by MERCK in 2005-2006 to grease the skids for one of the fastest new drug roll outs yet witnessed is staggering. Whoever said you couldn’t buy happiness, hasn’t talked to a MERCK stockholder.

Go to: THE EVIDENCE GAP; Drug Makers’ Push Leads to Cancer Vaccines’ Rise

August 20, 2008 – By ELISABETH ROSENTHAL (NYT) – Front Page –

… DRUG MAKERS’ BIG PUSH A marketing campaign in the United States and Europe by Merck has made Gardasil, its cervical cancer vaccine, a best seller. Cervarix, a similar vaccine from GlaxoSmithKline, has also proved popular, and profitable.

Read the full article and send the link out to anyone who cares about the health issues of women and girls!

Inconvenient Women do not get angry…We get ACTIVE!!

The lobbyist/legislator ‘hook-up’ only works if no one is looking. Make sure your representatives know you are watching them and are holding them accountable for the health and wellfare of the nations’ women and girls.

©2012 An Inconvenient Woman. All Rights Reserved.

In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time from the clinical trials and the FDA approval; which in our opinion precluded a reasonable amount of time to follow-up for adverse reaction to the injection.

The RUSH-TO-APPROVAL, combined with MERCK’s, MEGA-Money State and Federal legislative-lobbying efforts, made us very nervous. Anytime a State or Federal agency mandates the use of a vaccine, the manufacturer is essentially, held harmless. That means adverse reaction victims cannot sue them directly. MERCK gets hide behind the shield of the very government agencies WE pay to protect us.

In our articles, Leslie and I cited European researchers who questioned not only the efficacy of the HPV vaccination plan, but the cost effectiveness of what could be one of the largest transfers of public money to private industry in history. With early detection, cervical cancer can be successfully treated; and the best early detection tool is the inexpensive, easily attainable PAP test.

“In developed countries, Pap smear screening and treatment have effectively reduced cervical cancer death rates to very low levels already. There are 3,600 deaths annually from cervical cancer in the United States, 1,000 in France and 400 in Britain.”

Each of those women were mothers, daughters and sisters, and very dear to their families. Most of the deaths were a result of lack of access to preventive medical care. The poor and uninsured can’t get a $30 PAP test, but our public heath officials think its justifiable to mandate BILLIONS of dollars to inoculate young girls with a vaccine that could do more harm than good.

MERCK has sold $1.5 BILLION worth of Gardasil® vaccine in less than two years. Those Gardasil® sales are saving their Vioxx-ravaged balance sheet. How many PAP tests would that amount provide women who have limited, or no, access to preventative care? If the safety of young girls doesn’t make you want to take action and stop this madness, how about cost-effect, use of limited health care resources?

Breast cancer kills hundreds of thousands of women every year…and the numbers are rising. Would 1.5 BILLION dollars be better spent on breast cancer research? We think so.

Spending 1.5 billion on Gardasil®, chasing the ghost of “possible cancer” in the distant future, is not good stewardship of time, talent and treasure — unless you own MERCK stock.

Two years ago Leslie and I sent information to major media outlets, asking that they at least investigate the possibility that HPV vaccines might not be effective or safe for young girls.

We felt like the mythical Cassandra…no one was interested in the news.

To date, there have been 17-deaths and thousands of reported hospitalizations of previously healthy young women and girls. As adverse reactions started to be recorded to the NVIC database, investigative reporters began questioning the HPV vaccine’s safety and cost-effectiveness. Harvard just published a “Follow the Money” report delineating the cost benefit of the mostly, publicly, funded HPV-vaccination initiative.

In the fall of 2006, using published US census data, Leslie and I estimated the number of targeted girls and women (nine to twenty-six year old) and the reported cost of the series of three of the Gardasil® inoculation and estimated the cost to public health budgets. I was sure some bean counter in the bowls of MERCK had preformed the same calculations, with far better resources, when determining the Lobbying budget that got Gardasil® approved.

I wish I could say, we are please to report that with about 20-hrs work, an old calculator and a new MAC laptop we came within a $60K of the Harvard study; but it is actually kind of depressing. All it proves is that we need more inconvenient women, asking more questions, more often, with greater insistence.

Excerpt of Harvard Study

“The vaccines, which require three shots for a complete series, cost about $400 to about $1,000, depending on the country and the fees for doctors’ visits. Unlike older vaccines that save money by preventing costly disease, these vaccines cost health systems money.

The Harvard study concluded that giving the vaccine to 12-year-olds would cost $43,600 for every “quality adjusted year of life” it saved by preventing a cancer death; that price would often be considered acceptable by health officials in wealthy countries, experts say.

But if the vaccine were given to all girls and women up to age 21, the cost per year of life saved would be far higher — $120,400, the Harvard study concluded. And if the vaccines prove to require a booster shot, as many critics believe, that cost rises to $140,000. In such cases it might make more economic sense to rely on Pap smear screening alone, the researchers said.”

Read the full text of following NY Times article.

Email the links to as many women, and health professions as you can.

Inconvenient Women take ACTION!

Click here for the full ELISABETH ROSENTHAL’s NY Times article on Gardasil®, Published: August 20, 2008

“Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease, two articles in this week’s New England Journal of Medicine conclude.”

“The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by GlaxoSmithKline, target two strains of the virus that together cause an estimated 70 percent of cervical cancers. Gardasil also prevents infection with two other strains that cause some proportion of genital warts. Both vaccines have become quick best sellers since they were licensed two years ago in the United States and Europe, given to tens of millions of girls and women.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” Dr. Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, wrote in an editorial in Thursday’s issue of The New England Journal. “With so many essential questions still unanswered, there is good reason to be cautious.”

In her article, Dr. Haug points out the vaccines have been studied for a relatively short period — both were licensed in 2006 and have been studied in clinical trails for at most six and a half years. Researchers have not yet demonstrated how long the immunity will last, or whether eliminating some strains of cancer-causing virus will decrease the body’s natural immunity to other strains.

More to the point, because cervical cancer develops only after years of chronic infection with HPV, Dr. Haug said there was not yet absolute proof that protection against these two strains of the virus would ultimately reduce rates of cervical cancer — although in theory it should do so.

Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer”

For more information read:

The Evidence Gap: Drug Makers’ Push Leads to Cancer Vaccines’ Rise (August 20, 2008)

Send these links out to anyone who cares about the health issues of women and girls!

Inconvenient Women do not get angry…We get ACTIVE!!

©2012 An Inconvenient Woman. All Rights Reserved.

In the July 20, 2008 edition of the, New York Post, SUSAN EDELMAN told Jessica Ericzon’s story. It serves as a cautionary tale for girls, their mothers and guardians. In my opinion it should be required reading for every state official who controls public health policy, every school nurse and every pediatrician, gynecologist and family practice physician. Email it to your local, state and congressional representatives. Bring it to PTA meetings. Send it to anyone who loves his or her daughters, sister, mother, and wife. Jessica’s chance to be a wife, a mom, and a grandmother has been taken from her by a system more focused on profi,t than patient safety. It is past time we stand up to the lobbyist that grease the wheels of government with cash and favors and the representatives more concerned with the next campaign donation than the health and welfare of their most vulnerable constituents.

TRAGIC: Jessica Ericzon collapsed dead days after receiving a shot of the cervical-cancer vaccine Gardasil.

She loved SpaghettiO’s, pepperoni, lilies, listening to her iPod and making her pals laugh.

In her senior yearbook, she wrote, “The best things in life aren’t things, they’re friends.”

Now that’s the quote chiseled into her gravestone.

Jessica Ericzon, 17, was “an all-American teenager,” as described by one of her upstate LaFargeville teachers.

Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother.

Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom.

It started with a pain in the back of her head. On the advice of her family doctor, Jessie had taken a series of three Gardasil shots. The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer.

Jessie got the first injection in July 2007. After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa.

On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine.The next night, “she told me the spot on the back of her head was bothering her again,” her mom said. The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep.

Jessie never showed up for the class she was taking at Jefferson Community College.

When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot.

Jefferson County Medical Examiner Samuel Livingstone is stumped. “She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous,” Livingstone said. His autopsy found no cause. He speculates she suffered a cardiac arrhythmia, or irregular heartbeat, extremely rare in young people.

Jessie had been on birth-control pills for a year to treat acne, records show.

Livingstone reported Jessie’s death to the federal Vaccine Adverse Events Reporting System. Run by the FDA and the Centers for Disease Control and Prevention, it has collected 8,000 reports of problems after Gardasil shots, including paralysis, seizures and miscarriages.

Seventeen other deaths following the vaccine have been reported since Merck & Co. introduced it in 2006.

Officials have confirmed 11 of the reported deaths so far, said CDC spokesman Curtis Allen.They have found “no pattern or connection” to Gardasil in eight deaths and are still reviewing three, he said.

Lisa Ericzon now feels her daughter was “a guinea pig” for Gardasil, and is urging parents to research the vaccine before letting their daughters get it.

“I want other mothers to know,” said Lisa, the first parent of a girl who died after Gardasil to speak publicly.

“I don’t want them to go through what I went through.”

Jessie planned to major in psychology at SUNY Plattsburgh and pursue her greatest ambition – to become a New York state trooper. Just six days before she died, she got to ride along with a trooper canine unit. She was ecstatic.

The full article can be found at:

http://www.nypost.com/seven/07202008/news/regionalnews/my_girl_died_as_guinea_pig_for_gardasil_120737.htm

Read it. Become an Inconvenient Woman — Don’t Get Angry — Get Active!

Send this article link to every mom you know.

©2012 An Inconvenient Woman. All Rights Reserved.

	CDC HPV and HPV Disease Information
	CDC HPV Vaccine Information
	CDC Vaccine Safety Information
	HPV Questions and Answers
	FDA Center for Biologics Evaluation and Research
	To Report an Adverse Event in VAERS
	Related Information on Guillain-Barré Syndrome

Information from FDA and CDC on Gardasil and its Safety

July 22, 2008

Consumers, parents, health care professionals and others have raised questions regarding the safety of the human papillomavirus (HPV) vaccine, Gardasil. FDA and CDC take all concerns about vaccine safety seriously, and have been closely monitoring the safety of Gardasil.

Below is a summary of Gardasil vaccine safety monitoring activities and findings.  Based on ongoing assessments of vaccine safety information, FDA and CDC continue to find that Gardasil is a safe and effective vaccine.  FDA and CDC continue to monitor the safety of this vaccine, with the public’s health and safety our top priority.

Gardasil Background

FDA approved Gardasil vaccine on June 8, 2006 for use in girls and women 9 through 26 years of age. This vaccine prevents infection with the types of HPV that cause most cases of cervical cancer and genital warts. CDC’s Advisory Committee on Immunization Practices (ACIP) recommended routine 3-dose vaccination of girls aged 11 and 12 years. The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or who have not received all 3 doses.

Gardasil was tested in over 11,000 women in the United States and around the world, and found to be safe and effective in preventing serious HPV-related diseases.  These studies showed that in women who have never been infected by HPV types 6, 11, 16 or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina, and vulva, and in preventing genital warts often caused by these HPV types.

This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.

Monitoring  the Safety of Gardasil 

Vaccine Safety Overview

FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS).  VAERS receives unconfirmed reports of possible side effects following the use of Gardasil and all vaccines licensed in the U.S.  VAERS reports are regularly reviewed for safety concerns or trends of adverse events (possible side effects).

Vaccines are manufactured in batches called lots.  All vaccine lots are routinely tested and must pass all tests before they can be used, and vaccine manufacturers must comply with strict manufacturing standards.  FDA also analyzes adverse events (possible side effects) associated with individual lots to look for any unusual patterns.  No such patterns have been observed in FDA’s review of HPV vaccine lots since the vaccine was licensed.

In addition to VAERS, CDC has two other systems in place to monitor the safety of all licensed vaccines.  The Vaccine Safety Datalink (VSD) Project is a collaborative effort between CDC and eight managed care organizations that monitors vaccine safety and addresses the gaps in scientific knowledge about rare and serious side effects following immunization. The Clinical Immunization Safety Assessment (CISA) Network is a collaboration with six academic centers in the United States to conduct clinical research on vaccine-associated adverse events.

Adverse Event Reports following Gardasil

To date, the manufacturer, Merck and Co., has distributed over 16 million doses of Gardasil in the United States.  Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations. Our monitoring and analysis of reports, including in-depth medical review, are designed to detect serious events that occur at rates greater than expected, compared to what would be expected by chance alone.

VAERS receives reports of many events that occur following immunization. Some of these events may occur coincidentally during the time period following vaccination, while others may actually be caused by vaccination. In our analysis of VAERS data, we look for patterns of adverse events that may be plausibly linked to a vaccine. Such patterns of adverse events may require further study.

As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events, and 6% as serious events.

Non-Serious Reports (94% of total reports)

Since Gardasil was approved, the great majority (94%) of adverse events reported to VAERS after receiving this vaccine have not been serious. These reports include syncope (fainting), pain at the injection site, headache, nausea and fever.  Fainting is common after injections and vaccinations, especially in adolescents.  Falls after syncope may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. FDA and CDC have taken steps to remind immunization providers about the recommendation that individuals be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine’s prescribing information was changed to include this information.

Serious Reports (6% of total reports)

Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil.  As of June 30, 2008, 20 deaths had been reported to VAERS.  There was not a common pattern to the deaths that would suggest they were caused by the vaccine.  In cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.

Guillain-Barré Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil.  GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections.  FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS.  To date, there is no evidence that Gardasil has increased the rate of GBS above that expected in the population.  While we continue to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS.

Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots such as use of oral contraceptives which are known to increase the risk of clotting. Thromboembolic disorders as well as other medical events are being studied through the VSD in previously planned controlled studies.  The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety.

Summary

Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks. 

CDC has not changed its recommendations for use of Gardasil. FDA has not made any changes to the prescribing information for how the vaccine is used or to the vaccine’s Precautions.  In addition, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity and potency of Gardasil.

Public health and safety are priorities for FDA and CDC. As with all licensed vaccines, we will continue to closely monitor the safety of Gardasil. FDA and CDC continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women by providing protection against the types of HPV that cause the majority of cervical cancer, genital warts, and other HPV-related diseases.

Page last reviewed: July 22, 2008

Page last updated: July 22, 2008

Content source: Immunization Safety Office, Office of the Chief Science Officer

©2012 An Inconvenient Woman. All Rights Reserved.