Vaccine for cervical cancer $300 to $500

[Guest guest]

3 shots over 6 months = $300-500

They do have gall.

But people will line up to pay it

Sheri

http://abcnews.go.com/Health/wireStory?id=1978530 & CMP=OTC-RSSFeeds0312+

By ANDREW BRIDGES

WASHINGTON May 18, 2006 (AP)— A vaccine with the potential to slash

worldwide deaths from cervical cancer, the No. 2 cancer killer in women,

should be approved for sales in the United States, a federal panel said

Thursday.

A Food and Drug Administration advisory committee voted 13-0 to endorse the

safety and effectiveness of Merck and Co.'s Gardasil, which blocks viruses

that cause cervical cancer. The company said the vaccine could cut

worldwide deaths from the disease by two-thirds.

However, the anticipated cost of the vaccine, administered in three shots

over six months, is $300 to $500 a possible impediment to widespread

vaccination campaigns.

The drug protects against the two types of human papillomavirus (HPV)

believed responsible for about 70 percent of cervical cancer cases. It also

protects against two other virus types that cause 90 percent of genital

wart cases. All four virus types are sexually transmitted.

The FDA is not required to follow the recommendations of its outside panels

of experts, but usually does. An agency decision is expected by June 8.

HPV is the most common sexually transmitted disease. It affects more than

50 percent of sexually active adults. The cervical cancer it can cause

kills about 290,000 women worldwide each year, including 3,500 in the

United States where regular pap smears often detect precancerous lesions

and early cancer.

" This is certainly a wonderful, good step in addition to our screening

processes " in helping eradicate cervical cancer, said Dr. Farley,

who heads the advisory panel. She is a bacterial infectious disease expert

at the Emory University School of Medicine in Atlanta.

Early opposition to Gardasil was based on concerns it could encourage

sexual activity in preteens and teens. But that largely faded away because

of the vaccine's potential for reducing cancer.

Making their case for approval, Merck officials suggested that Gardasil

could be the biggest advance in preventing cervical cancer since the pap

test.

" Gardasil has the potential to meet an unmet medical need as the first

vaccine to prevent cervical cancer, " Merck's Dr. Brill- told

the Vaccine and Related Biological Products advisory committee.

Several speakers said the vaccine should not replace screening. Merck said

the vaccine was not intended to do that but that it could eliminate many of

the abnormalities the tests turn up.

" We would like to see the FDA mandate some sort of labeling or other

mechanism to communicate to health care providers and patients the

continued need for regular cervical screening, " said Amy Allina, program

director of the National Women's Health Network.

Merck said the vaccine could be used in females age 9 to 26, but would work

best when given to girls before they begin having sex.

The company is seeking to license Gardasil in more than 50 countries, said

Dr. Eliav Barr, who headed the vaccine program at Merck.

Pending action by the FDA, the national Advisory Committee on Immunization

Practices will decide in June whether to endorse routine vaccination with

the vaccine.

The committee's HPV vaccine group is recommending giving the vaccine to

girls 11 and 12. The 15-member committee of experts who advise the

government will consider recommendations for females 13 to 26. Merck seeks

use of the vaccine in girls as young as 9.

Dr. , an FDA reviewer, cautioned that Gardasil does not

necessarily protect against one or more of the four viruses in people

already infected before they get the vaccine, and can increase their risk

for precursors to cervical cancer.

Also, the drug does not protect against infection from the many other virus

strains not included in the vaccine. In addition, FDA staff highlighted in

briefing documents five cases where children with birth defects were born

to women who received the vaccine around the time of conception. Merck said

it was " highly unlikely " they were related to Gardasil.

Merck, based in Whitehouse Station, N.J., developed the vaccine and tested

it in more than 27,000 females and males.

Thursday's discussion focused on its use in preventing HPV-related disease

in girls and women, including those as young as 9. But only 250 9-year-old

girls and boys received Gardasil in trials.

The anticipated cost of the vaccine, administered in three shots over six

months, is $300 to $500. That could pose a barrier to widespread

vaccination campaigns.

" The vaccine community will see this as an opportunity to prevent cancer.

They will also see issues of availability and cost, " said Dr. Bruce Gellin,

a committee member and head of the federal vaccine policy office.

Analysts believe Gardasil sales could top $1 billion a year for Merck,

which is battling thousands of lawsuits over its withdrawn painkiller Vioxx.

On the Net:

Food and Drug Administration: http://www.fda.gov

Copyright 2006 The Associated Press. All rights reserved. This material may

not be published, broadcast, rewritten, or redistributed.

--------------------------------------------------------

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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