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.

Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -

Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?

A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.

Gardasil® has been the subject of 7,802 “adverse event” reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

Girls and women have blamed the vaccine for causing ailments from nausea to paralysis — even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.

Gardasil prevents the spread of human papillomavirus, known as HPV — a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.

The vaccine’s manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil® vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006. V

Two girls allege in court that the vaccine made them sick.

One — Jesalee Parsons of Broken Bow, Oklahoma — got the shot at age 13.

Jesalee’s lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.

Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.

“I just feel let down by the government,” Parsons said.

Merck says it could be a coincidence that the girls got sick after receiving the vaccine.

The company said in a statement that an adverse event report “does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.”

Merck said it would continue to evaluate reports of adverse reactions. It said it “updates product labels with new safety information as appropriate.”

Watch more on complications linked to Gardasil »

For Full Article and more video go to:

http://www.cnn.com/2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/

A sincere thank you to major media outlets, CNN, the Washington Post and the New York Times, for following and reporting the Gardasil® adverse events and asking probing questions about the safety and effectiveness of this aggressively-marketed Merck product.

©2012 An Inconvenient Woman. All Rights Reserved.

Addressing Questions About Gardasil

On this page:

• What is Gardasil?
• Why is Gardasil needed?
• Is Gardasil safe?
• Why have questions been raised about the vaccine’s safety?
• Should these reports worry me?
• What non-serious problems have been reported?
• What are FDA and CDC doing about the concerns?
• How is Gardasil’s safety being monitored?

Recently, questions have been raised about the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.

What is Gardasil?

Gardasil is a vaccine for use in girls and women 9 through 26 years of age. It is approved for preventing cancer of the cervix, vulva and vagina, and for preventing genital warts caused by the types of HPV contained in the vaccine.

These four HPV types (6, 11, 16, and 18) cause about 70% of cervical cancers and about 90% of genital warts. They are also known to cause some vulvar and vaginal cancers. (Percentages related to these conditions are not well defined.)

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Why is Gardasil needed?

Gardasil may benefit the health of millions of people. Each year, more than 12,000 American women are diagnosed with cervical cancer, and almost 4,000 women die from this disease. In addition, about 6.2 million Americans become infected with genital HPV each year. Worldwide, cervical cancer is the second most common cancer in women, with 233,000 deaths per year.

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Is Gardasil safe?

Based on ongoing assessments of vaccine safety information, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to find that Gardasil is a safe and effective vaccine.

Studies involving approximately 21,000 girls and women in the United States and worldwide were conducted to evaluate the safety and effectiveness of Gardasil before the vaccine was approved by FDA. Approximately half of the study participants received Gardasil, and the other half received a control.

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Why have questions been raised about the vaccine’s safety?

There have been reports of serious adverse events in girls and women that have received the vaccine. These include death and Guillain-Barre Syndrome (GBS), a rare neurological disorder that causes muscle weakness.

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Should these reports worry me?

Based on the review and assessment of vaccine safety information available, FDA and CDC continue to find that the benefits of Gardasil outweigh the risks.

Twenty deaths had been reported to the FDA- and CDC-administered Vaccine Adverse Event Reporting System (VAERS) as of June 30, 2008, in women that received Gardasil.

However, no common pattern to these deaths has been detected 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.

Given the large number of vaccine doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in a large population during the time period following vaccinations.

The manufacturer, Merck and Co., has distributed more than 16 million doses of Gardasil nationwide. As of June 30, there were 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events.

Also, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity, and potency of Gardasil.

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What non-serious problems have been reported?

• Syncope (Fainting)
• Pain at the injection site
• Headache
• Nausea
• Fever

Fainting, which may sometimes cause serious injuries from falling, is common after injections and vaccinations, especially in adolescents. FDA and CDC have reminded health care professionals that women receiving Gardasil should be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine’s prescribing information includes this as well.

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What are FDA and CDC doing about the concerns?

FDA and CDC take all concerns about vaccine safety seriously, and, as they do with all licensed vaccines, will continue to closely monitor Gardasil’s safety.

Because available information indicates that Gardasil continues to be safe and effective, and that 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 Warnings or Precautions sections in the vaccine’s prescribing information related to safety.

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How is Gardasil’s safety being monitored?

• FDA and CDC closely monitor the safety of all vaccines through VAERS, which receives unconfirmed reports of possible side effects following the use of vaccines licensed in the United States.
• Each batch (known as a “lot”) of Gardasil is manufactured and tested for quality control according to the requirements of its FDA license. FDA verifies this, as it does with other vaccines, by performing a lot-by-lot batch review process.
• FDA’s review assures the appropriateness of manufacturing processes and confirmation of testing results. It also includes regular unannounced on-site inspections.
• No batch may be released for distribution until it has successfully completed all testing and review requirements.
• FDA analyzes possible side effects associated with individual lots to look for any unusual patterns.

CDC also has other systems in place to monitor the safety of all licensed vaccines.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

CDC and FDA Information on Gardasil’s Safety

www.fda.gov/cber/safety/gardasil071408.htm

Vaccine Adverse Event Reporting System (VAERS) Web site

www.vaers.hhs.gov

FDA Press Release (Sept. 12, 2008):

Approval of Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html

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Date Posted: September 29, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

FDA Approves Expanded Uses for Gardasil® to Include Preventing Certain Vulvar and Vaginal Cancers

The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.

“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”

The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.

HPV includes more than 100 related viruses and more than 30 types can be transmitted via sexual contact. According to the U.S. Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the United States with 6.2 million Americans becoming infected with genital HPV each year.

For most women, the body’s own defense system will clear HPV, thereby preventing serious health problems. However, some HPV types can cause abnormal cell growth in areas of the cervix, vagina, vulva, and other areas that years later may turn into cancer.

Regarding the prevention of vulvar and vaginal cancer, Gardasil’s manufacturer, Merck & Co. Inc., followed more than 15,000 participants from the original studies for about two additional years. Approximately half had received Gardasil as part of the original study—the other half did not receive Gardasil and served as a control group.

Among females who tested negative for HPV types 16 or 18 at the start of the study, Gardasil was highly effective in preventing these types of HPV-related precancerous vulvar and vaginal lesions, which are considered to be the precursors for cancer. In the control group that did not receive the vaccine, 10 individuals developed precancerous vulvar lesions and nine developed precancerous vaginal lesions, all related to HPV types 16 or 18. No one in the Gardasil group developed either kind of precancerous lesion due to HPV types 16 or 18.

There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil’s full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Gardasil’s label has been revised to note that presently available information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that Gardasil does not protect against diseases caused by HPV types not contained in the vaccine.

No vaccine is 100 percent effective, and Gardasil does not protect against HPV infections that a woman may already have at the time of vaccination. Therefore, all women should get regular Pap tests, even after they have been vaccinated. Routine Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.

Since the FDA approved Gardasil in 2006, the majority of reported adverse events have not been serious. The most commonly reported adverse events have included syncope (fainting), pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting 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. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

As part of the original approval, Merck committed to a safety surveillance study of 44,000 individuals in a managed care organization. The study is assessing short- and long-term safety for all of Gardasil’s approved uses.

As with all vaccines, the FDA and the CDC continue to closely monitor Gardasil’s safety. Updated safety information on Gardasil was published on July 22 and can be found at www.fda.gov/cber/safety/gardasil071408.htm.

Product approval information for Gardasil can be found at www.fda.gov/cber/products/gardasil.htm.

Merck & Co. Inc. is located in Whitehouse Station, N.J.

Me

©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.

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

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©2012 An Inconvenient Woman. All Rights Reserved.

 Reported by Barbara Loe Fisher

The reports of HPV vaccine reactions, injuries and deaths continue to roll in, not only to NVIC but also to the federal Vaccine Adverse Events Reporting System (Search HPV4 at: http://www.medalerts.org/vaersdb/index.html) newspapers, and television stations.

And the only response that comes from officials at the CDC, FDA and drug companies when perfectly healthy teenage girls collapse into unconsciousness, suffer a massive seizure, get paralyzed or die suddenly after being injected with GARDASIL is the buracratic mantra: “It is a coincidence.”

“I just kept thinking about the good outcomes rather than what could actually happen.” What happened to Crystal Olivera was arm pain so severe that it left her unconscious immediately after a Gardasil shot, something she had never experienced with her hepatitis and meningitis vaccines. “The next thing I know I am on the floor in the fetal position.” Had she known more about Gardasil – “I wish I’d waited a little until it was out in the public more and also that they did more research about the negative side effects.” – Jamie Colby, Fox News (July 11, 2008) SEE VIDEO at http://www.foxnews.com/video2/video08.html?maven_referralObject=2233990&maven_referralPlayli

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“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.” – Susan Edelman, New York Post (July 20, 2008)

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

” Katherine Kimzey got her first injection of Gardasil along with a Hepatitis-A vaccine and a chicken pox booster. She got the second injection two months later, along with the D-TaP vaccination. Six weeks after the second injection of Gardasil, Katherine passed out. “I tried to get up and my neck was stiff, and I couldn’t move it,” the teenager explained. “I couldn’t move at all.” Katherine spent five days in the hospital.

Shannon Nelson, 18, from the Chicago area, got the Gardasil shot and two other vaccines– at the same time. Within a week the soccer star could barely move. “When I went into the hospital I couldn’t walk at all. I had to have a wheelchair. It just got worse each day,” she explained. Nelson spent 23 days in the hospital and while she’s better now the teenager believes one of the vaccines she received is responsible for her illness and her neurologist says it’s certainly possible.

Katherine Kimzey is back on the soccer field in North Texas. But she still has occasional pain and doesn’t know what the future will hold. Thinking about her past experience she says she still worries and so does her mom. Michelle Kimzey says next time; she won’t be so quick to jump on the new vaccine bandwagon. “I think the connection is huge,” she said.

In a statement to CBS 11 News, Merck — the maker of Gardasil — said it has analyzed the reports of paralysis and death, and believes: no safety issue related to the vaccine has been identified.” – Ginger Allen, CBS News 11 – Dallas (July 21, 2008) http://cbs11tv.com/health/Gardasil.cervical.cancer.2.776277.html

“Consumer concerns over safety have not been assuaged by “reassurances from the government,” said Barbara Loe Fisher, cofounder of the National Vaccine Information Center (NVIC). “We have heard reassurances about safety before – for example, with the whole-cell pertussis (diphtheria- pertussis-tetanus [DPT]) vaccine in the 1980s,” she said, noting that this was subsequently withdrawn and replaced by an acellular version in the United States in the 1990s. Ms. Fisher has a son whom she believes was damaged by the DPT vaccine 28 years ago, and she has worked ever since as an activist in the vaccine safety field in various capacities, including a 4-year stint as a consumer member of the FDA Vaccines and Related Biological Products Advisory Committee.

In addition, the NVIC has been running its own private vaccine reaction registry for the past 26-years, and it currently has about 140 reports on Gardasil, Ms. Fisher said. “These include reports of injury and death, and we are seeing a pattern of what we have termed ‘atypical collapse,’ ” she commented. “These include cases where a girl suddenly passes into unconsciousness either immediately or within 24 hours of vaccination and then revives feeling weak and unable to speak properly or exhibiting other neurological signs. What we are concerned about is that girls are not aware of this possibility and could be crossing the road or driving a car and suddenly pass out.” Ms. Fisher also outlined concerns about how Gardasil has been studied. She pointed out that very few of the participants in the clinical trials were aged 11 to 12 years, which is the recommended target age for the vaccine. The New York Times reported in 2006 that of the 20,000 trial participants, 1200 were younger than 16 years.” – Zosia Chustecka, Medscape Medical News (August 8, 2008) http://www.medscape.com/viewarticle/578110

Sources:

http:://www.vaccineawakening.blogspot.com

http://www.NVIC.org

http://www.StandUpBeCounted.org

©2012 An Inconvenient Woman. All Rights Reserved.

Corporate Greed and the FDA’s Failure to Protect

Reported by Barbara Loe Fisher

The vaccine reaction reports keep coming into the National Vaccine Information Center (NVIC) from mothers describing how they took their healthy teenage girls into a pediatrician or gynecologist’s office where they were given a GARDASIL shot and, then, nothing was ever the same again.

The reports of HPV vaccine reactions, injuries and deaths continue to roll in, not only to NVIC but also to the federal Vaccine Adverse Events Reporting System (Search HPV4 at: http://www.medalerts.org/vaersdb/index.html) newspapers, and television stations.

 And the only response that comes from officials at the CDC, FDA and drug companies when perfectly healthy teenage girls collapse into unconsciousness, suffer a massive seizure, get paralyzed or die suddenly after being injected with GARDASIL is the zombie mantra: “It is a coincidence.”

Last week a nurse who is an administrator in the outpatient department for a group of hospitals in California called and asked if NVIC had been getting reports of unusual collapse after GARDASIL vaccination. I said, yes, we are getting those reports and she said “A lot of our patients are collapsing after the shot is given. It happens with GARDASIL more frequently than with any other vaccine we give.” That same week, NVIC received a report from the mother of a 15-year old daughter who got her first GARDASIIL shot last month. Within 10 minutes of being injected, she collapsed and had her first grand mal seizure, became incontinent, temporarily lost vision in her right eye, suffered uncontrolled vomiting and had to be taken by ambulance to the hospital. Another report to NVIC that week also involved first-time seizures in a 15-year old girl after she got a GARDASIL shot.

Through June 30, 2008, there have been reports that at least 17 to 20 deaths have occurred following GARDASIL and were filed with the federal Vaccine Adverse Events Reporting System (VAERS), although the FDA has yet to admit even one death is causally related to the vaccine, suggesting that the girls would have died that day even if no vaccine had been given.

Many of the teenage girls, who die suddenly after vaccination without explanation, were among the brightest and the best and in top physicial condition. This was true for 17-year old Jessica Ericzon, a New York softball player, snowboarder and honor roll student who dropped dead within 48 hours of getting a GARDASIL shot. A coroner could find no cause for her death after an autopsy.

There have been so many reports of reactions, injuries and deaths following GARDASIL vaccination (20-25 percent of all vaccine adverse event reports being filed with VAERS are for GARDASIL vaccine reactions) that the FDA and CDC issued a statement defending the vaccine’s safety on July 22, 2008.

But one of the vaccine’s developers has urged caution and offers practical advice about the need for continued use of Pap screening to prevent cervical cancer rather than relying on the vaccine to do the job. ” If you are at all concerned, then don’t have the vaccine – have regular Pap smears and you will be equally protected from cervical cancer….Pap screening is still the only proven method we have for cervical cancer prevention,” said Professor Diane Harper, Ph.D. “We don’t know how long the vaccine will protect a woman from HPV infection, and the vaccine does not protect against all types of HPV infection that cause cervical cancer.”

The “coincidence” defense mounted by doctors and drug-company officials every time a vaccination is followed by injury and death is as old as it is unscientific.

It is amazing that they have been able to get away with it for so long. Babies can’t talk and babies can’t walk so who they will become is still a dream. But young girls and women have already become much of who they will be and, on the cusp of fulfilling the dream, their vaccine deaths and injuries are much more difficult to sweep under the carpet.

It is immoral for doctors in government and industry to continue to look away from the damage done when vaccines cut down the brightest and most physically fit among us. The suggestion that these healthy, high functioning girls were biologically compromised and would have died or been injured that day even if no vaccine had been given is ludicrous. If those in government responsible for protecting the public health and safety look the other way when healthy individuals die and are injured by pharmaceutical products pronounced by government as “safe” for public use, then we cannot be assured that any licensed drug or vaccine is safe.

Last year, the head of the FDA in China was executed for allowing toxic pharmaceutical products to be licensed and released for public use that ended up killing and crippling people.

Sources: http://www.vaccineawakening.blogspot.com

http://www.NVIC.org

http://www.StandUpBeCounted.org

©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.

It’s a question many families are asking after reports last week that a chemical used to make baby bottles, water bottles and food containers is facing increasing scrutiny by health officials in Canada and the United States.

The substance is bisphenol-a, or BPA, widely used in the making of the hard, clear and nearly unbreakable plastic called polycarbonate. Studies and tests show that trace amounts of BPA are leaching from polycarbonate containers into foods and liquids.

While most of the focus is on products for children, including clear plastic bottles and canned infant formula, the chemical is also used in food-storage containers, some clear plastic pitchers used for filtered water, refillable water bottles and the lining of soft-drink and food cans.

While there is debate about how much of a health worry BPA really is, retailers including Wal-Mart have said they are withdrawing baby products made with it. Nalgene, the maker of a popular sports bottle, and the baby-products maker Playtex have announced they will stop using it.

Here are answers to some common questions about BPA.

What is the evidence that BPA is harmful?

It all comes from animal studies. Rat pups exposed to BPA, through injection or food, showed changes in mammary and prostate tissue, suggesting a potential cancer risk. In some tests of female mice, exposure appeared to accelerate puberty.

A draft report from the National Toxicology Program, part of the Department of Health and Human Services, notes that there is no direct evidence that human exposure to BPA harms reproduction or infant development. “I don’t think there’s anything in this brief that should lead to alarm,” said Dr. Michael D. Shelby, director of the Center for the Evaluation of Risks to Human Reproduction, who oversaw the report. “It means we’ve got a limited amount of evidence from some studies that were done in laboratory animals.”

The main concern is the possible risk to infants and pregnant women, although Canada has begun a study to monitor BPA exposure among about 5,000 people to assess any danger to adults.

How much BPA are we exposed to?

BPA migrates into food from polycarbonate plastic bottles or the epoxy resin coatings that line canned food. The typical adult ingests an estimated 1 microgram of BPA for every kilogram (2.2 pounds) of body weight. Babies who use polycarbonate bottles and formula from cans get more, an estimated 10 micrograms per kilogram of body weight. A microgram represents a trace amount. Consider this: a single M&M is about a gram. If you cut it into 100,000 slices, one slice would equal about 10 micrograms.

The 2003-4 National Health and Nutrition Examination Survey by the Centers for Disease Control and Prevention found detectable levels of BPA in 93 percent of urine samples collected from more than 2,500 adults and children over six.

How do I know if the plastic containers in my home contain BPA?

Any product made of hard, clear plastic is probably made from polycarbonate unless the manufacturer specifically states that it’s BPA-free. One way to check is to look for the triangle stamp on or near the bottom: polycarbonate plastics should have the numeral 7 in the triangle, sometimes with the letters PC.

Unfortunately, 7 is a catchall “other” category for a variety of plastics. In my own kitchen, I found just one product with a 7 — plastic fruit cups my daughter takes to school. But the plastic is soft and pliable, so it is probably not made with BPA.

I also found refillable water bottles without a stamp. Because they are hard, shatterproof and clear, it’s reasonable to assume they are made from polycarbonate.

What about canned food and drinks?

While much of the focus is on plastic bottles, most human exposure occurs through the lining of canned foods. Canned beverages appear to contain less of the chemical than canned foods like soup, pasta, fruits and vegetables, which are often processed at high temperatures. Virtually every canned product, even those labeled organic, has a liner with BPA. One brand, Eden Organic Baked Beans, says it uses a BPA-free can.

How do I lower my exposure?

Switch to frozen or fresh vegetables. Use glass, porcelain and stainless-steel containers, particularly for hot foods and liquids. If you don’t want to use a glass baby bottle, several companies, including the popular brand Born Free, now sell BPA-free baby bottles and sippy cups. For formula-fed babies, you can switch to powdered formula rather than liquid.

Although many plastic products claim to be microwave safe, some scientists warn against putting any plastic in the microwave. “There is such a wide variety now, from disposable containers to actual Tupperware,” says Dr. Anila Jacob, a senior scientist for the Environmental Working Group, a Washington-based advocacy group. “I don’t know of anyone who has done definitive testing of all these different types of plastic containers to see what is leaching into food.

Source:  Tara Parker-Pope, New York Times

©2012 An Inconvenient Woman. All Rights Reserved.