FDA Approves Merck's,GARDASIL. First and Only Cervical Cancer

[cal04]

FDA Approves Merck's GARDASIL(R), the World's First and Only Cervical Cancer Vaccine
Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) approved GARDASIL® (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine), the first and only vaccine to prevent cervical cancer and vulvar and vaginal precancers caused by HPV types 16 and 18 and to prevent low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18. In the United States, approximately 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease.

The FDA approved GARDASIL for the prevention of cervical cancer; cervical pre-cancers (cervical intraepithelial neoplasia (CIN) 2/3 and adenocarcinoma in situ (AIS)); vulvar pre-cancers (vulvar intraepithelial neoplasia (VIN) 2/3); and vaginal pre-cancers (vaginal intraepithelial neoplasia (VaIN) 2/3)) caused by HPV types 16 and 18. GARDASIL is also approved for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. GARDASIL is approved for 9- to 26-year-old girls and women.

"Merck is proud to be the leader in cervical cancer vaccine research and development," said Richard T. Clark, chief executive officer and president, Merck & Co., Inc. "Bringing forward this life-saving scientific advance is yet another testament to Merck's long-standing mission to research and develop novel vaccines and medicines that can greatly improve public health."

GARDASIL is designed to prevent the majority of HPV-related clinical diseases, those caused by HPV 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, AIS (non-invasive cervical cancer), CIN 3, VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases.

http://biz.yahoo.com/bw/060608/20060608005597.html?.v=1

[ChairmanAgnostic]

1. IFF the religious reichists don't try to ban it.

bet you three crucifixes (never used, and still in the original packaging) that they do, and that they pack the committee that will change he FDA's decision.

[OzarkDem]

3. Another vaccine is awaiting approval

Glaxo Smith Kline also has one called Cervarix that works in a different way and can be administered at a later age.

[rocktivity]

2. Is this the drug that the Bush monarchy thinks will start teen sex cults?

if so, CUE THE VONAGE THEME!

:woohoo:
rocknation

[YDogg]

4. About time.

[Viva_La_Revolution]

5. as a survivor of cervical cancer, this is what I have to say...

:woohoo: :bounce: :7 :party: :bounce: :thumbsup: :loveya: :applause: :bounce:
:woohoo: :bounce: :7 :party: :bounce: :thumbsup: :loveya: :applause: :bounce:
:woohoo: :bounce: :7 :party: :bounce: :thumbsup: :loveya: :applause: :bounce:
:woohoo: :bounce: :7 :party: :bounce: :thumbsup: :loveya: :applause: :bounce:
:woohoo: :bounce: :7 :party: :bounce: :thumbsup: :loveya: :applause: :bounce:
:woohoo: :bounce: :7 :party: :bounce: :thumbsup: :loveya: :applause: :bounce:

[myrna minx]

6. This makes me so happy, I can't even type.

:bounce: :bounce: :bounce:

[DixieBlue]

7. Thank god

someone with a brain got it through. I was worried it wasn't going to make it.

[truthisfreedom]

8. too bad it doesn't work if you've already been exposed.

so many of us have. what do they estimate, over 80%?

on edit: quote from article:

These studies also showed that administration of GARDASIL to women who are already infected with one or more vaccine related HPV types prior to vaccination protects them from clinical disease caused by the remaining vaccine types but may not alter the course of an infection that is already present.

i guess guys can't receive the innoculation at all. rats.

[AllyCat]

9. That's too bad, isn't it?

Since men carry it but don't have any manifestations of the disease unless they have obvious warts, it would be nice if they could get the vaccine too. I wonder if the Fundies would say it was okay for boys and not for girls since they seem to approve of anything that encourages procreation.

My GYN told me that girls can get HPV from their mothers during birth.

[knitter4democracy]

10. Get it fast.

I should call my ped for my daughter and see if she can get a hold of any before they ban it.

[nodehopper]

11. FDA Licenses New Vaccine for Prevention of Cervical Cancer!!!!

the vaccine got approved

The Food and Drug Administration (FDA) today announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is approved for use in females 9-26 years of age. Gardasil was evaluated and approved in six months under FDA's priority review process--a process for products with potential to provide significant health benefits.

"Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer," said Alex Azar, Deputy Secretary, U.S. Department of Health and Human Services (HHS). "HHS is committed to advancing critical health measures such as the development of new and promising vaccines to protect and advance the health of all Americans."

HPV is the most common sexually-transmitted infection in the United States. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives. On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year. Worldwide, cervical cancer is the second most common cancer in women; and is estimated to cause over 470,000 new cases and 233,000 deaths each year.

For most women, the body's own defense system will clear the virus and infected women do not develop related health problems. However, some HPV types can cause abnormal cells on the lining of the cervix that years later can turn into cancer. Other HPV types can cause genital warts. The vaccine is effective against HPV types 16 and 18, which cause approximately 70 percent of cervical cancers and against HPV types 6 and 11, which cause approximately 90 percent of genital warts.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html

[Gman]

12. Why does the FDA hate God and America?

it's gonna start.

[bumponalog]

13. Dubyafundies are distracted by the most-recent big death,

and this will get little if any news coverage, but it represents a serious repudiation of religious dogma's influence over science and health policy. Lester Crawford and Pat Robertson's other friends over at FDA have been smacked down well.

[hogwyld]

14. I only hope that the FDA

TEsted this drug to death. I would really hate for some side effect to "pop" up after 5 or so years. Such as some of the arthritis medicines causing heart damage, etc. But I applaud the drug companies efforts to try to help people. Here on DU, it's popular to bash the drug giants, but where would we be without their expensive investments?

[Telly Savalas]

17. Actually it's the drug companies that are supposed to test the drug

to death.

The FDA just reviews their studies to try to ensure that they're not bullshitting everybody.

[wicket]

15. The cut off is 26

I missed the cutoff by 1 year :(

[bedazzled]

16. you folks trust merck after vioxx? you're more trusting than i am

my husband worked there several years ago and said they were going downhill. vioxx is enough evidence to me that i wouldn't take one of their drugs under any circumstance