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.

“In television advertisements, a cast of hip people in their 20s — artists, writers and professionals — describe why they got the shots, in the language of liberation, such as, “I chose to get vaccinated because my dreams don’t include cervical cancer.” The advertisements direct viewers to gardasil.com, which includes patients’ stories, buddy icons and downloads for holding an event at sororities.

Girls of any age who have had one dose of the vaccine can ask for text-message “reminders” from Merck to get the next two shots. The offers come with another reminder: “I understand that the information I provide will be used by Merck or those working on behalf of Merck for market research purposes.”

For such efforts, Merck last May swept the 2008 Pharmaceutical Advertising and Marketing Excellence awards, and Gardasil was named Brand of the Year by Pharmaceutical Executive magazine.

The marketing helped make Gardasil one of Merck’s best sellers, with a projected sales of $1.4 billion to $1.6 billion outside Europe this year, and more from sales in Europe, where Merck sells the vaccine through a joint venture with Sanofi Aventis.

Aggressive pharmaceutical advertising is nothing new, but the campaign was a revolution for a vaccine. Vaccines were traditionally the orphans of the pharmaceutical world because they were cheap and not particularly profitable. But the two for cervical cancer are the latest in a wave of high-priced vaccines that have come to market since 2001, opening a lucrative new field.”

Excerpted from:: 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 marketeer/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.

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 has a growing economic interest in Virginia. In December 2006, Merck announced it would invest $57 million to expand its Elkton, Va., plant to make Gardasil, helped by a $700,000 grant from a state economic development agency that is part of the executive branch. Two months later, Gov. Tim Kaine, who has been mentioned as a possible Democratic vice presidential candidate, signed legislation requiring Gardasil for schoolgirls. Four months after that, Merck pledged to invest $193 million more in the plant to make drugs and vaccines, helped by a state grant of $1.5 million.

Source: New York Times

©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.

FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

“With this proposal, FDA’s goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit,” said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. “This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women.”

There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Additionally, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

In the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding information in prescription drug labeling and began reviewing ways to improve the information. The agency held public meetings and focus groups to obtain comment on the current labeling from health care professionals and scientific experts. Current labeling uses a letter category system to describe the risks of drug use during pregnancy. Stakeholders have said the letter category system leads to an inaccurate and overly simplified view of these risks, and does not facilitate updating of labeling as new information becomes available.

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

• The first section, called the “Fetal Risk Summary,” would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: “Human data indicate that (name of drug) increases the risk of cardiac abnormalities.” This would be followed by a summary of the most important data on the drug’s effects.
• Another section, called “Clinical Considerations,” would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
• The third section, under the heading “Data,” would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.

Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.

For more information, visit: http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm

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©2012 An Inconvenient Woman. All Rights Reserved.

Canadian reporters struggle to shed light on a muddled debate that’s as much about business as it is about health.

When federal Finance Minister Jim Flaherty announced $300 million in funding for a program to vaccinate girls and young women against the virus known as human pappiloma, it was hailed as the most important development in women’s reproductive health since the Pill.

This vaccine promises to tackle more than the warts caused by certain strains of HPV. It is billed as the first-ever anti-cancer vaccine designed to prevent the vast majority of cervical cancer cases.

But it’s too early to tell whether this is just a victory for women’s health or also the triumph of an aggressive, multimillion-dollar marketing campaign that has infiltrated our living rooms and the political backrooms.

The process has been so tainted by one drug company pursuing its own commercial interests that it’s difficult to know whether financing the human pappiloma virus (HPV) vaccine is the right decision from a public health perspective. It might well be, but the heavy lobbying effort, from the prime minister’s former aide on down, muddles the debate.

In coming weeks, the Ontario government is expected to announce its financing of the vaccine, which in partnership with federal funds, is crucial to the establishment of an HPV vaccine program. The province, like Stephen Harper’s Conservatives, has come under intense drug company lobbying.

Meanwhile, we have seen health officials and women’s groups debate the merits of this vaccine on the front pages of newspapers. Many are in favour of the vaccine, calling it a revolution in health care, while others aren’t so sure it’s necessary and wonder if other health care needs are more pressing, such as reducing wait times for cancer surgery or the doctor shortage.

Parents have weighed in, admitting they don’t know whether they want their preteens and teens vaccinated.

Many people are confused. No wonder. This isn’t just a health story, it’s a business story, and when we look at it in that light, the urgency around the issue makes more sense.

The multinational drug giant Merck Frosst makes Gardasil, the only approved HPV vaccine available, and it has a lot riding on a successful launch of the vaccine.

According to last week’s Wall Street Journal, Merck faces patent expirations on other best-sellers and legal costs related to Vioxx, the withdrawn painkiller linked to heart attacks and strokes. Some analysts believe Gardasil’s annual sales could reach $2 billion U.S. or more by 2010.

Until its competitors can get their own versions of an HPV vaccine approved (GlaxoSmith Kline has one in the pipe), Gardasil is the only girl in the pageant. And that makes Merck quite keen to see a government program to finance wide-scale vaccination while it has the only vaccine on the market.

But in order to create a public appetite for the vaccine, it must convince us our daughters need this vaccine. It also has to deal with our lapses in medical knowledge (who knew a virus caused cancer?), as well as our squeamishness around an issue most of us don’t want to think about — our preteen girls one day having unprotected sex.

Sheila Murphy, spokeswoman for Merck, explained in an e-mail how difficult it is to explain Gardasil to the masses.

“The fact that a virus causes cancer, in this case anogenital cancers, is a big paradigm shift for many people,” she wrote, adding, “When I started working on the Gardasil team, I didn’t know that HPV was the reason I

was having a Pap test.”

She said it’s equally challenging to communicate to people that a vaccine exists to prevent those cancers.

“We are working with individuals and groups who share our desire to improve the wellness of Canadian women by communicating information on HPV.

“We are using all the channels of communication open to us to get the message about our cancer-preventing vaccine out.”

Gardasil is a three-course vaccination that prevents four strains of the human pappiloma virus, including HPV 16 and 18, thought to cause 70 per cent of cervical-cancer cases. While cervical cancer is common in developing countries, it’s relatively rare in North America. About 400 women will die of cervical cancer each year in Canada. Women already have a very effective method of prevention — regular Pap tests. During the past five decades, this exam has contributed to an 80 per cent reduction in cervical-cancer deaths. However, some critics argue the $300 million would be better spent ensuring Pap tests for immigrants, aboriginals and women who live in poverty — all disproportionately represented among cervical cancer cases.

It’s expected the vaccine will not only reduce cancer deaths but the number of actual infections, the developments of precancerous lesions and the need for biopsies. In Canada and the U.S., even before the vaccine was approved, Merck financed information campaigns that linked the little-talked-about human pappiloma virus with cancer.

Last April in the U.S., Merck began the “Tell Someone” advertising campaign featuring girls (actresses), in interview style, expressing surprise about the cause of cervical cancer and promising to tell other women.

These ads didn’t mention the vaccine — Merck wasn’t allowed because it hadn’t been approved by the Food and Drug Administration — but represented a first step in linking cancer with a virus. At the time, a Merck spokesperson denied the campaign had anything to do with the vaccine.

In Canada, women can consult www.tellsomeone.ca, which describes the link. It also tells viewers about a vaccine against HPV but, of course, Merck’s name isn’t mentioned because direct-to-consumer advertising for cancer therapies is not allowed.

Once the FDA granted approval in the U.S. last June, a full-scale ad campaign began which Canadians are generally exposed to because these advertisements show up in our homes on American TV channels.

In one TV spot, girls skipping ripe on a sidewalk are chanting: “O-N-E-L-E-S-S.

I want to be one less. One less.” In another, a young women skateboarder faces the camera and says, “I could be one less. One less statistic.” The ads are poignant and gripping.

In Canada, we won’t be seeing the “One Less” type advertising. While direct-to-consumer advertising is generally allowed for vaccines, in the case of Gardasil, Merck cannot mention cancer in any ads. This has to do with the classification of the disease.

In the absence of the TV ads, Merck has to rely on various doctors and women’s groups to promote the product. It hasn’t been difficult.

A spokeswoman for the Society of Obstetricians and Gynecologists of Canada told the Citizen that Merck gave the doctors’ group a $1.5-million grant to educate people about HPV. The SOGC’s website on the issue (www.hpvinfo.ca) does not mention Merck, but serves the larger purpose of educating people about the cancer/viral link.

The society, which has come out strongly in favour of the vaccine, was only too happy to oblige when asked by Merck to educate the public about HPV. One of their main mandates is public education, said SOGC spokeswoman Kelly Nolan. Dr. Vyta Senikas, the executive vice president of the SOGC, said that aggressive marketing of products is a fact of life. She likened Merck’s marketing of Gardasil to Microsoft’s marketing of the video game system Xbox. She said physicians are smart enough to withstand any undue pressure and believes Canadians will receive unbiased information about a new product she thinks is revolutionary. She stressed that, despite Merck financing, all information coming from the SOGC is peer-reviewed and fact based.

Merck has also had to convince lawmakers of the vaccine’s value, which has been particularly difficult in some parts of the U.S., where the Christian right feared protection from a sexually transmitted disease might lead to promiscuity.

Still, with the U.S. Centers for Disease Control and Prevention recommending the vaccine for females between the ages of nine and 26, Merck, which has lobbied state-by-state to get vaccination laws passed, has had many successes. Twenty states are considering mandatory vaccination, while Texas* and Virginia required it for girls entering sixth grade.

In February, Merck halted its lobbying when it was learned that at least some of the lawmakers had accepted donations from the company. The Associated Press reported the Texas governor’s chief of staff met with key aides about the vaccine the same day its manufacturer donated $5,000 to the governor’s campaign. An organization backed by the company continues to push for similar laws.

In Canada, the campaign to make the vaccine a must-have for every preteen is more of a backroom affair.

Shortly before Flaherty announced funding for vaccination in the budget, Merck hired Ken Boessenkool, a former aide to Prime Minister Stephen Harper, to lobby the federal government. Boessenkool works for Hill & Knowlton, a giant public relations and lobbying firm. After his hiring was revealed by the Citizen, a Merck spokesperson said Hill & Knowlton

would help explain the importance of the new vaccine to policy makers.

Now, with the federal money committed, Merck is lobbying the individual provinces for matching funding and the establishment of vaccination programs.

Last month in Ontario, two lobbyists registered on behalf of Merck to lobby the health minister and others on “the proposed policy decision to support a childhood immunization program for HPV and funding related thereto.” Both men work for Hill & Knowlton. One of them, Jason Grier, was the former executive assistant to Health Minister George Smitherman.

Merck has also courted other groups with the power and potential to lobby the Ontario government. The seemingly innocuous health committee of the Ontario Chamber of Commerce, for example, is considering a resolution that, once passed, would urge the Ontario government to expedite funding of vaccines.

Why would this group have much interest — except as parents — in the funding of Gardasil? In fact, the committee counts as members representatives of the pharmaceutical industry, including one from Merck.

Another pharmaceutical industry representative on the committee — Jeff Connell, who works for the Canadian Generic Pharmaceutical Association — told the Citizen he has complained about Merck’s involvement in the resolution.

“Once I found out that the OCC Health Resolution was part of Merck Frosst’s international campaign to get governments to pay for Gardasil, I raised concerns with the OCC Health Committee,” he said.

Prior to this resolution, he said the issue of immunization had never been raised at the committee.

He said he told the committee, “I just can’t seem to shake the feeling that the immunization funding resolution represents the voice of Merck Frosst far more than the voice of Ontario business.”

Connell wrote to the group, asking them to reconsider the resolution, although he acknowledged it would still be passed.

So there you have it: A very small glimpse into the lengths Merck has gone in order to convince politicians and the people that millions of Canadian girls and young women need this vaccine.

Reprinted With Permission: Ottawa Citizen

©2012 An Inconvenient Woman. All Rights Reserved.