Unnecessary vaccine Gardasil is KILLING, Paralyzing, comas, nerve disorder,

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It's worse:

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FDA clears Merck's Gardasil against 2 new cancers

 

http://www.forbes.com/feeds/ap/2008/09/12/ap5419015.html

 

by MATTHEW PERRONE 09.12.08, 5:09 PM ET

WASHINGTON -The Food and Drug Administration has updated the label of

Merck's cervical cancer vaccine Gardasil, adding new information about

its protective effects against two other gynecological cancers.

 

The new labeling indicates the vaccine also protects against cancers

of the vagina and vulva, which affect more than 5,000 women in the

U.S. each year, according to Merck.

 

The vaccine works by defending against four strains of the human

papillomavirus, which cause the majority of cervical cancers. A Merck

scientists said the virus accounts for a smaller portion of vaginal

and vulvar cancers, though he added it plays a role in more than half

of them.

 

" Anytime we have evidence of additional cancer protection, that's a

really important piece of information, " said Merck's Rick Haupt,

executive director for HPV vaccines.

 

It was not immediately clear what the additional indication would mean

for sales of the vaccine, which have fallen short of the company

expectations.

 

Merck has already scaled back full-year sales estimates for Gardasil

from between $1.9 billion and $2.1 billion to between $1.4 billion and

$1.6 billion, following regulatory setbacks and challenges making

inroads with young adult patients.

 

First approved in 2006, Gardasil is the only cervical cancer vaccine

approved for the lucrative U.S. market, though Merck has had limited

success expanding use.

 

The FDA rejected Merck's proposal in June to begin marketing the

vaccine to women ages 27 to 45. It is currently approved for ages 9 to

26. The company's expansion effort seems even less likely after a

government-funded study released last month concluded the roughly $375

vaccine is not cost-effective for women in their 20s and older.

 

Gardasil is outselling rival GlaxoSmithKline's Cervarix vaccine

abroad. The Glaxo injection is still pending review at the FDA.

 

The positive announcement Friday breaks a string of FDA rejections for

the Whitehouse Station, N.J.-based company. Earlier this year the

agency denied applications to sell two new experimental cholesterol

drugs and what would have been the first nonprescription cholesterol drug.

 

Shares of Merck & Co. Inc. fell 17 cents Friday to close at $33.82.

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-Talmer

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