Panel says cervical cancer vaccine should get approval

[Guest guest]

Panel says cervical cancer vaccine should get approval

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Panel says cervical cancer vaccine should get approval

Updated 5/18/2006 3:37 PM ET

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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 on five

separate times to endorse the vaccine, known as Gardasil and made by

Merck and Co.

The vaccine could reduce by more than two-thirds the number of deaths

worldwide from the second-leading cancer in women, according to the

company.

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

believed responsible for about 70% of cervical cancer cases. The vaccine

also protects against two other virus types that cause 90% of genital

wart cases. All four virus types are sexually transmitted.

Company officials, in making their case for approval to members of a

Food and Drug Administration advisory panel, implied 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 members of the FDA's Vaccines and Related Biological Products

advisory committee.

HPV is the most common sexually transmitted disease, affecting more than

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

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

United States, where regular pap smears often detect precancerous

lesions and early cancer.

Merck said the vaccine could be used in females between the ages of 9

and 26, but would work best when given to girls before they begin having

sex.

" It will be most effective when administered prior to entry in the risk

period, and that is the age group 15 and below, " Merck's Dr. Eliav Barr

told the panel.

The FDA advisers were to decide late Thursday whether to recommend FDA

approval for the vaccine. The FDA isn't required to follow the advice of

its expert panels but usually does. A decision is expected by June 8.

Early opposition to Gardasil, based on concerns it could encourage

sexual activity in the young, largely dissipated, in part because of the

vaccine's cancer-reduction implications.

FDA reviewers said Gardasil appears safe and effective, according to

agency documents. FDA reviewer Dr. told panel members that

Merck submitted data to support the use of the vaccine in females

between the ages of 9 and 26.

cautioned that Gardasil does not necessarily protect against one

or more of the four viruses in people who already have been infected

before receiving the vaccine and even increases their risk for

precursors to cancer.

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

strains not included in the vaccine. FDA staff also highlighted five

cases where children with birth defects were born to women who had

received the vaccine around the time of conception.

Whitehouse Station, N.J.-based Merck 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. Only 250 9-year-old girls and boys received

Gardasil in trials, however, which could prove a concern for parents.

Pending FDA action, the national Advisory Committee on Immunization

Practices will decide later in June whether to endorse routine

vaccination with the vaccine. The committee's HPV vaccine workgroup is

recommending the vaccine be given to girls 11 and 12, and the committee

will consider recommendations for females 13 to 26.

Widespread vaccination could help bounce cervical cancer from its

dubious distinction as the No. 2 cancer in women worldwide. However, the

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

months, is $300 to $500 and could pose a barrier to that goal.

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

may not be published, broadcast, rewritten or redistributed.

Posted 5/18/2006 1:06 PM ET

Updated 5/18/2006 3:37 PM ET

[Guest guest]

Thanks for posting Rick - As with anything that attempts to trick mother

nature... with the good - comes the bad:

Quotes:

A vaccine that blocks infection by the four virus types

that cause most cervical cancers and genital warts appears safe and

effective, but may actually increase the chance of disease in some patients,

The second concern is that any advantage the vaccine provides in protecting

against the four virus types could be offset by infection by any of the

multiple other types of HPV that the vaccine does not cover.

FDA staff also asked that the committee examine five cases where children

with birth defects were born to women who had received the vaccine around

the time of conception.

http://www.washingtonpost.com/wp-dyn/content/article/2006/05/17/AR2006051700

931.html?sub=AR

The Washington Post

FDA: Cervical cancer vaccine safe

Gardasil prevents four types of HPV

Wednesday, May 17, 2006

WASHINGTON (AP) -- A vaccine that blocks infection by the four virus types

that cause most cervical cancers and genital warts appears safe and

effective, but may actually increase the chance of disease in some patients,

according to Food and Drug Administration documents released Wednesday.

Merck & Co. seeks FDA approval for its Gardasil vaccine against four types

of human papilloma virus, or HPV. Two of those four types are believed

responsible for about 70 percent of cervical cancer cases. The cancer kills

roughly 3,500 U.S. women a year; the other two types cause 90 percent of

genital wart cases.

An FDA panel of outside experts is to meet Thursday and discuss whether to

recommend that the agency approve the vaccine. The FDA isn't required to

follow the advice of its expert panels but usually does.

According to briefing documents released ahead of the meeting, the panel

should discuss various items of concern only if its members first agree that

studies show the vaccine is safe and effective. That suggests the FDA favors

its approval.

Merck said the vaccine has the potential to reduce the annual number of new

cervical cancers worldwide to roughly 150,000, from the current 500,000, and

cut global deaths from the cancer by more than two-thirds, to an estimated

90,000.

An FDA review of the results of studies on the vaccine found two important

concerns, according to the documents released ahead of Thursday's meeting of

the Vaccines and Related Biological Products advisory committee.

The first is that the vaccine may lead to an increased number of cases of a

cancer precursor among patients already infected by any of the four virus

types at the time they receive the vaccine, and whose immune systems have

not cleared the virus from their bodies.

The second concern is that any advantage the vaccine provides in protecting

against the four virus types could be offset by infection by any of the

multiple other types of HPV that the vaccine does not cover, according to

the FDA documents.

FDA staff also asked that the committee examine five cases where children

with birth defects were born to women who had received the vaccine around

the time of conception.

Merck developed the vaccine and tested it in both women and men, but

Thursday's discussion is expected to focus on its use in preventing

HPV-related disease in women.

An FDA decision is expected by June 8. Should it approve it, the national

Advisory Committee on Immunization Practices will decide later that month

whether to endorse routine vaccination with the vaccine.

The committee's HPV vaccine workgroup is recommending the vaccine be given

to girls 11 and 12, and the committee will consider recommendations for

females 13 to 26.

Randi Airola

517-819-5926

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From: Shuster,

Sent: Thursday, May 18, 2006 6:37 PM

Subject: Panel says cervical cancer vaccine should get approval

Panel says cervical cancer vaccine should get approval