USA Today Article---'Panel says Cervical Cancer Vaccine should get approval'

[Guest guest]

Panel says cervical cancer vaccine should get approval Updated

5/18/2006 7:05 PM ET

WASHINGTON (AP) — A vaccine that blocks infection by the two types of viruses

that cause most cases of cervical cancer is safe and effective and should be

approved, a federal panel recommended 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% of cervical cancer cases. It also protects against two

other virus types that cause 90% 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%

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 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 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

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.

, 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 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.

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

not be published, broadcast, rewritten or redistributed.

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

Messenger with Voice. PC-to-Phone calls for ridiculously low rates.