A vaccine to prevent cervical cancer looks set to be a blockbuster -- but resistance from parents and patient advocates could trip it up.

[Guest guest]

Good article.The more I read the wackier this vaccine is. They want to

vaccinate 9 year olds, but that is 6 years before the average girl has a

sexual encounter, and the vaccine only lasts 5 years!

C

Merck's $4 billion PR problem

A vaccine to prevent cervical cancer looks set to be a blockbuster -- but

resistance from parents and patient advocates could trip it up.

By Simons, FORTUNE writer

June 5, 2006: 8:13 AM EDT

NEW YORK (FORTUNE) - Merck has already angered Christian conservatives by

pushing to make its yet-to-be approved cervical cancer vaccine, Gardasil,

mandatory for girls as young as nine. But that could be the least of the

company's worries regarding the projected $4 billion-a-year vaccine.

More mainstream resistance from parents and patient advocates could emerge

as the medicine's FDA approval draws closer.

Merck's Gardasil, a vaccine designed to prevent the sexually-transmitted

human papillomavirus (HPV), is in its final stages of FDA review and could

receive the agency's blessing as soon as June 8th. In May, a federal

advisory panel unanimously recommended the agency approve the vaccine to

combat HPV - a virus that can lead to cervical cancer.

Merck (Research) is appealing to states to make the vaccine mandatory for

all children who attend public schools. A mandate from the states, which

control vaccination policies, would make Gardasil a guaranteed blockbuster.

That's crucial for the nation's fourth-largest drugmaker, which is still

struggling to replace revenues lost after the 2004 withdrawal of its

blockbuster arthritis medicine, Vioxx, in addition to shrinking sales of its

cholesterol drug Zocor, as it faces generic competition this summer.

Gardasil is almost certain to be approved by the FDA, say analysts, who

place the medicine's annual peak revenue potential in the $2 to $4 billion

range. Those estimates assume states will make Gardasil mandatory. The shots

are given three times over a six month period, and will cost anywhere

between $300 and $500. The vaccine lasts for up to five years.

Merck's strongest data point: Studies that show the vaccine to be 100

percent effective against strains of HPV, which are responsible for some 70

percent of cervical cancers. In the United States, 14,000 women are

diagnosed with cervical cancer each year, and 3,900 die from it, according

the U.S. Centers for Disease Control.

Inoculating pre-adolescent girls for a sexually-transmitted virus raises

concerns for many parents - not just Christian conservatives. A survey of

1,600 mothers and fathers published in the journal Pediatrics found that 35

percent are against having their child inoculated.

Is it necessary?

Barbara Loe Fisher, president and co-founder of the National Vaccine

Information Center, questions the need for a mandatory HPV vaccine in the

United States, where most women receive regular annual pap smear exams.

Those exams usually catch HPV early, before it develops into cancer. As a

result of pap smear campaigns, Fisher observes, the instance of cervical

cancer fell 74 percent between 1955 and 1992.

Fisher says mainstream parental opposition to Gardasil is easy to explain.

" Parents are becoming more concerned about the shear number of vaccines kids

are getting these days, " she says. " In the 1980s, U.S. children got 23 doses

of seven vaccines by age six. Today, they get 48 doses of 14 vaccines in the

same period. "

" And during the time that vaccines doses have doubled, " she says, " there's

been an increase in the number of children with autism, attention deficit

and hyperactive disorder, learning disabilities, asthma, and diabetes, in

which vaccines could be a contributing factor. "

Fisher is strongly opposed to Merck's proposals to inoculate girls at age 9,

which is six years before the average age of first sexual experience in the

United States " It's just profit-making on the backs of 9-year-old girls, "

charges Fisher.

The proposal has also drawn widely publicized ire from groups like the

Family Research Council and Focus on the Family, both Christian conservative

organizations generally opposed to anything they believe promotes premarital

sex.

Merck insists it has good reason to start young. " The best time to

administer any preventative vaccine is before individuals are exposed to the

virus in question. Additionally, preteens have very robust immune responses

to vaccines, " says Merck spokesperson, Kelley Dougherty.

Requirements that students get a vaccine to enroll in school, says Merck's

Dougherty, " have proven effective in preventing infectious diseases and help

to decrease racial and ethnic disparities in vaccine utilization. "

Before states make Gardasil mandatory, a committee at the Centers for

Disease Control needs to give its own go-ahead. That committee is scheduled

to meet on June 29.

In addition, the American Academy of Pediatricians would need to recommend

to doctors that they add Gardasil to the battery of vaccines already

administered to U.S. schoolchildren. From there, each U.S. state would have

to decide whether to make Gardasil compulsory for school children.