WOMEN IN GOVERNMENT COMMENDS FDA FOR APPROVING HPV VACCINE IN FIGHT AGAINST CERVICAL CANCER

Urges Access for All Recommended Age Groups; Maintains Importance of Screening


Washington, DC, June 8, 2006 --- Women In Government, a non-profit, bi-partisan organization representing women state legislators, today commended the U.S. Food and Drug Administration (FDA) for its approval of a vaccine for the human papillomavirus (HPV), the virus that causes cervical cancer. The FDA approved the vaccine, made by Merck and known as Gardasil, for girls and women between the ages of 9 and 26, in order to help prevent cervical cancer.



?The FDA?s decision marks an historic milestone in the fight against cervical cancer and should be celebrated by women and health advocates around the world,? said Susan Crosby, president of Women In Government. ?The availability of an HPV vaccine brings us one major step closer to our goal of ensuring that no more women die of this preventable disease. For the HPV vaccine to truly achieve its potential, however, it must be available to all recommended age groups, regardless of their socioeconomic status. We urge the federal Advisory Committee on Immunization Practices (ACIP) to assist in this effort. ?



The ACIP is expected to issue recommendations on who should receive the HPV vaccine and to determine if the vaccine will be included in the federal government?s Vaccines for Children Program, which provides free immunization for under-insured and uninsured children. Their guidelines are also frequently used as the basis for insurance coverage decisions, medical guidelines and inclusion in other public health programs.



Gardasil has been shown in clinical trials to be 100 percent effective in preventing infection with the two types of HPV (16 and 18) that are responsible for approximately 70 percent of all cervical cancers. Clinical data also showed the HPV vaccine to be effective in targeting HPV types 6 and 11, which can cause 90 percent of genital warts.





Ms. Crosby emphasized that, even with the availability of an HPV vaccine, screening will still be important to target cervical cancer caused by those HPV types not covered by the vaccine and to reach women who have already been exposed to high-risk HPV. ?The HPV vaccine should become a part of comprehensive cervical cancer prevention programs that also use advanced and medically appropriate screening methods, such as HPV testing,? said Ms. Crosby.



Research shows that the Pap test?s ability to detect cervical cancer or its early signs ranges from 51 to 85 percent. The FDA recently approved a new screening test for HPV, which, when used in conjunction with a Pap in women age 30 and older, increases the accuracy of the Pap to almost 100 percent.



In 2004, Women In Government launched its ?Challenge to Eliminate Cervical Cancer Campaign,? which mobilizes legislators to educate women about cervical cancer and HPV and ensure that all age-appropriate females have access to advanced and appropriate prevention technologies. To date, 45 states have introduced legislation or resolutions targeting cervical cancer prevention and 39 states have enacted such measures.



About Cervical Cancer

Worldwide, cervical cancer is the second leading cancer-killer of women, with almost a quarter-million deaths each year. In the United States, the American Cancer Society estimates 9,710 women will be diagnosed with and more than 3,700 women will die of cervical cancer. According to the U.S. Centers for Disease Control and Prevention, approximately 20 million people are currently infected with HPV, with 6.2 million new infections occurring annually and approximately 80 percent of sexually active women will be infected with HPV by age 50. For 90 percent of infected women, the virus is naturally cleared by the body and becomes undetectable within two years. However, persistent infection with ?high-risk? types of HPV is the cause of cervical cancer.


About Women In Government

Women In Government is a national, 501(c)(3), non-profit, bi-partisan organization of women state legislators providing leadership opportunities, networking, expert forums and educational resources to address and resolve complex public policy issues. For more information, visit www.womeningovernment.org.

Patient Information about GARDASIL? (pronounced ?gard-Ah-sill?)
Generic name: [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]

Read this information with care before you or your child gets GARDASIL*. You or your child will need 3 doses of the vaccine. It is important to read this leaflet when you receive each dose. This leaflet does not take the place of talking with your health care professional about GARDASIL.

What is GARDASIL and what is it used for?

GARDASIL is a vaccine (injection/shot) that helps protect against the following diseases caused by Human Papillomavirus (HPV) Types in the vaccine (6, 11, 16, and 18):

? Cervical cancer (cancer of the lower end of the uterus or womb).
? Abnormal and precancerous cervical lesions.
? Abnormal and precancerous vaginal lesions.
? Abnormal and precancerous vulvar lesions.
? Genital warts.

GARDASIL helps prevent these diseases ? but it will not treat them. You or your child cannot get these diseases from GARDASIL.

What other key information about GARDASIL should I know?

? Vaccination does not substitute for routine cervical cancer screening. Females who receive GARDASIL should continue cervical cancer screening.
? As with all vaccines, GARDASIL may not fully protect everyone who gets the vaccine.
? Gardasil will not protect against diseases due to non-vaccine HPV types. There are more than 100 HPV types; GARDASIL helps protect against 4 types (6, 11, 16, and 18). These 4 types have been selected for GARDASIL because they cause approximately 70% of cervical cancers and
90% of genital warts.
? This vaccine will not protect you against HPV types to which you may have already been
exposed.
? GARDASIL also will not protect against other diseases that are not caused by HPV.
? GARDASIL works best when given before you or your child has any contact with certain types of HPV (i.e., HPV types 6, 11, 16, and 18).

Who can receive GARDASIL?

GARDASIL is for girls and women 9 through 26 years of age. See ?Who should not receive GARDASIL?? below.

Who should not receive GARDASIL?

Anyone who:
? is allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.
? has an allergic reaction after getting a dose of the vaccine.

What should I tell my health care professional before I am vaccinated or my child is vaccinated with GARDASIL?
It is very important to tell your health care professional if you or your child:

? has had an allergic reaction to the vaccine.
? has a bleeding disorder and cannot receive injections in the arm.
? has a weakened immune system, for example, due to a genetic defect or HIV infection.
? is pregnant or is planning to get pregnant. GARDASIL is not recommended for use in pregnant women.
? has any illness with a fever more than 100?F (37.8?C).
? takes or plans to take any medicines, even those you can buy over the counter.

Your health care professional will decide if you or your child should receive the vaccine.

How is GARDASIL given?

GARDASIL is given as an injection. You or your child will receive 3 doses of the vaccine. Ideally the doses are given as:

? First dose: at a date you and your health care professional choose.
? Second dose: 2 months after the first dose.
? Third dose: 6 months after the first dose.

Make sure that you or your child gets all 3 doses. This allows you or your child to get the full benefits of GARDASIL. If you or your child misses a dose, your health care professional will decide when to give the missed dose.

What are the possible side effects of GARDASIL?

As with all vaccines, there may be some side effects with GARDASIL. GARDASIL has been shown to be generally well tolerated in women and girls as young as 9 years of age. The most commonly reported side effects included:

? pain, swelling, itching, and redness at the injection site.
? fever.
? Difficulty breathing (bronchospasm) has been reported very rarely.

If you or your child has any unusual or severe symptoms after receiving GARDASIL, contact your health care professional right away. For a more complete list of side effects, ask your health care professional.

What are the ingredients in GARDASIL?

The main ingredients are purified inactive proteins that come from HPV Types 6, 11, 16, and 18. It also contains amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.

What are cervical cancer, precancerous lesions, and genital warts?

Cancer of the cervix is a serious disease that can be life-threatening. This disease is caused by certain HPV types that can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these are not treated, they can turn cancerous.

Genital warts are caused by certain types of HPV. They often appear as skin-colored growths. They are found on the inside or outside of the genitals. They can hurt, itch, bleed, and cause discomfort. These lesions are usually not precancerous. Sometimes, it takes multiple treatments to eliminate these lesions.

What is Human Papillomavirus (HPV)?

HPV is a common virus. In 2005, the Centers for Disease Control and Prevention (CDC) estimated that 20 million people in the United States had this virus. There are many different types of HPV; some cause no harm. Others can cause diseases of the genital area. For most people the virus goes away on its own. When the virus does not go away it can develop into cervical cancer, precancerous lesions, or genital warts, depending on the HPV type. See ?What other key information about GARDASIL should I
know??

Who is at risk for Human Papillomavirus?

In 2005, the CDC estimated that at least 50% of sexually active people catch HPV during their lifetime. A male or female of any age who takes part in any kind of sexual activity that involves genital contact is at risk. Many people who have HPV may not show any signs or symptoms. This means that they can pass on the virus to others and not know it.

Will GARDASIL help me if I already have Human Papillomavirus?

You may benefit from GARDASIL if you already have HPV. This is because most people are not infected with all four types of HPV contained in the vaccine. In clinical trials, individuals with current or past infection with one or more vaccine-related HPV types prior to vaccination were protected from disease caused by the remaining vaccine HPV types. GARDASIL is not intended to be used for treatment for the above mentioned diseases. Talk to your health care professional for more information.

This leaflet is a summary of information about GARDASIL. If you would like more information, please talk
to your health care professional or visit www.gardasil.com.
Issued June 2006
Manufactured and Distributed by: MERCK & CO., Inc.
Whitehouse Station, NJ 08889, USA

I would like to say that all of this information is great!! I wish I had only heard of all of this back in my day, I wasn't the type to "sleep" around when I was young- so to find out I ended up with cervical cancer "05" was the worst news I have heard in my life....I thought I would DIE!! I'm still here I thank God everyday for my children I do have in my life, and my loving husband.
To prevent it from forming in your body is the best thing a woman can do. The after affects of cancer, chemo, radiation to your precious body is the hardest part to adjust to, so please inform as much as you can...

Pap smears -Annual check ups for females is a MUST!!!!!!

I didn't have STDs that sort of thing.....cancer just happens to most ...

in my opinion

I am 23 and I was 21 when I had my lesson on HPV. The sad part was I didn't know much about it until I was told that I had it. When I found out more about it I was terrified! I decided to go to another DR, and when I did I found that the pre cancerous cells only progressed and surgery was a must and fast. I also came to find that my grandmother had cervical cancer, Why didn't anyone fill me in on all of this???

I always went to the Dr every year and I never had any STD's either. I am just so grateful that we were able to take care of it before I had full blown cancer. I think it is so important that EVERYONE is informed of the importance of exams....had I waited I can't say that my outcome would have been the same. Vaccine is so overdue, and I am so glad this is finally being talked about!

Ashley

I had carcinoma in situ about 6 years ago and had 2 separate surgeries to have it removed. I am 38 years old. It's been nearly two years since I went for my annual= and just went 3 weeks ago. Now, I had another abnormal pap and the doc wants to do a colposcopy and ecc in 2 weeks. I was tested for HPV each time and it always came back negative. How is it that these abnormal cells keep coming back without having the virus? How far could it have gone this time since it's been two years??

I have abnormal pap after abnormal pap. It doesnt mean that I have an std or anything. I have dysplasia on my cervix and it shows as an abnormal pap. I then have to have a colposcopy as well. I have to have colposcopys every six months. So I can relate to your concern. However, if your doctor isn't giving you the anwers that you want get a second opinion, and if that doctor gives you the same answers maybe you just need to keep your appointments and go online to research if there is anything you can do to help keep those biopsies negative. Try not to worry about this too much, just stay healthy and keep your appointments. Also sex can cause abnormal paps as well.

If you have the pap too close to your menstrual period or if your are any type of antibiotic it could affect your pap results.....it did mine. I had to have mine redone and 2nd came back negative. This was after I had gone through a colposcopy and 2nd biopsy.