Cervical cancer vaccine gets okay
Gardasil, approved by the FDA on Thursday, brings hope and new challenges to the health care industry.
By ASSOCIATED PRESS
Published June 9, 2006
WASHINGTON - Three jabs of a needle could give women an excellent shot at avoiding cervical cancer.
A vaccine approved Thursday by the Food and Drug Administration is the first to protect against the No. 2 cancer killer in women. The three-shot, $360 series should be available by the end of the month.
Its manufacturer, Merck & Co. Inc., eventually hopes to win worldwide approval to sell the vaccine, called Gardasil. The company says Gardasil could cut by two-thirds the 240,000 cervical cancer deaths estimated to occur around the world each year.
"FDA approval of the HPV vaccine, the first vaccine targeted specifically to preventing cancer, is one of the most important advances in women's health in recent years," said Dr. Carolyn Runowicz, president of the American Cancer Society. The vaccine developed for hepatitis B has been shown to protect against liver cancer.
The FDA licensed Gardasil for use in girls and women ages 9 to 26. The vaccine works best when given to girls before they begin having sex and become infected by human papillomavirus, or HPV.
The vaccine works by preventing infection by four of the dozens of strains of HPV. The virus is the most prevalent sexually transmitted disease. It's so common that by age 50, 80 percent of women have been infected.
Gardasil protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases.
Early vaccination is key; Gardasil does not protect those already infected.
In women not previously infected, clinical trials showed Gardasil prevented 100 percent of cervical cancer related to the two HPV strains, Merck said. It also prevented 99 percent of the cases of genital warts caused by the two other strains.
"Fortunately, we can now include the worst types of HPV and most cervical cancer in the list of diseases that no one need suffer or die from ever again," said Alex Azar, deputy Health and Human Services secretary.
The vaccine comes with an apparent bonus: Research suggests Gardasil also protects against vaginal and vulvar cancers linked to the four types of HPV.
The FDA said that Gardasil appeared very safe but that it can't vouch for how long its effect may last. Merck plans to study its long-term effectiveness and continues to study if it can be given to males.
Merck intends to market Gardasil as a cancer, rather than an STD, vaccine. It has rolled out an ad campaign to build awareness of HPV.
Conservative opposition to making Gardasil vaccination a prerequisite for school attendance could limit its widespread use, as may its cost. Merck plans to provide it free to the poor and uninsured.
The national Advisory Committee on Immunization Practices will decide June 29 whether to endorse routine vaccination with Gardasil. That endorsement is critical if the vaccine is to become routine.
Sen. Frank Lautenberg, D-N.J., urged the panel to put "science and women's health ahead of ideological opposition" in considering a recommendation. It then will be up to individual states to decide whether to add the vaccine to the list of others required before students may attend public schools.
Conservative groups such as Focus on the Family support availability of the vaccine but oppose making it mandatory, saying the decision to vaccinate should be up to a child's parents or guardians. It promotes abstinence as the best way to prevent infection by HPV and other STDs.
Inda Blatch-Geib, an Akron, Ohio, mother of four, said she would consider vaccinating her daughters, ages 9 and 16. Blatch-Geib, 41, doesn't think it would signal a parental okay for her girls to have sex.
"Fortunately, we can now include the worst types of HPV and most cervical cancer in the list of diseases that no one need suffer or die from ever again."
- Alex Azar, deputy Health and Human Services secretary.
"Giving the vaccine goes with a conversation. We are pretty open with our children, so it wouldn't be an issue. It would lead to conversations," Blatch-Geib said.
The vaccine does not eliminate the need for the regular Pap tests that can detect precancerous lesions and early cancer. Merck has said Gardasil could cut the number of abnormal Pap results due to HPV infection, saving women both money and worry.
Analysts believe Gardasil sales could top $1-billion a year for Merck. The Whitehouse Station, N.J., company is battling thousands of lawsuits over its withdrawn painkiller Vioxx. Eventually, it could face competition from GlaxoSmithKline PLC, which is developing its own HPV vaccine.
The cost of Gardasil and the difficulty of getting young girls in to see a doctor three times in six months to receive the vaccine could pose problems, said Cynthia Dailard, senior public policy analyst at the Guttmacher Institute, which focuses on sexual and reproductive health. Ensuring its availability to poor and minority girls and women - and others less likely to receive regular Pap exams - also will be difficult.
"This is an incredibly exciting breakthrough, but at the same time, it presents some major challenges, some the likes of which we have never confronted before," she said.
By the Numbers
The cost for a three-shot inoculation series.
The percentage of women over age 50 who have been infected by the human papillomavirus, which causes cervical cancer.
The number of cervical cancer deaths worldwide annually.
The number of deaths Gardasil may prevent.
9 to 26
The ages between which the vaccine is to be administered.$
Expected annual sales.
[Last modified June 9, 2006, 05:42:58]
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