News from Health Lover, Ilena Rosenthal
Although the Merck Flacks here on Usenet have been making industry
claims for around a year now ... how safe & effective Gardasil is ...
even the FDA disagrees now.

I for one, do not believe it should be called 'safe' nor 'effective'
for young women either!
http://ilenarose.blogspot.com

http://www.reuters.com/article/healthNews/idUSWNAS917720080625

By Lewis Krauskopf

NEW YORK (Reuters) - U.S. regulators have told Merck & Co they cannot
yet approve Merck's application to expand marketing of its cervical
cancer vaccine Gardasil to an older group of women, the drugmaker said
on Wednesday.

Merck had applied for the use of Gardasil in women ages 27 through 45.
The U.S. Food and Drug Administration said in a letter regarding the
application that it has completed its review and there are "issues"
that preclude approval within the expected review time frame, Merck
said.

"It's hard to get a feel for if this is a dead issue or if this is
delayed," said Linda Bannister, an analyst for Edward Jones. "At the
minimum, it's going to be delayed."

Merck said it also failed to win FDA approval to expand Gardasil to
protect against more strains of the Human Papillomavirus that causes
cervical cancer. The company for now is dropping plans to pursue that
expansion, a spokeswoman said.

Shares of the New Jersey-based drug maker, which also reiterated its
long-term revenue and earnings targets, fell 0.8 percent.

Gardasil, approved in June 2006 for preventing cervical cancer and
genital warts in females ages 9-26, has been one of Merck's most
successful newer products and has helped the company recover after the
2004 withdrawal of its Vioxx arthritis treatment.

The Gardasil setbacks could raise concerns about the degree of growth
that Merck can hope to achieve with the product, which is the world's
first vaccine to prevent cervical cancer.

A Merck spokeswoman said the agency has specific questions regarding
Gardasil's effectiveness in this older age group.

The company said it had already discussed the questions with the FDA
and expects to respond to the agency in July.

"Once we go back to the FDA, we'll have a better sense of what the
review timing looks like," spokeswoman Amy Rose said.

The agency's response on the application for the older group does not
affect Gardasil's current approval for females ages 9 to 26, Merck
said.

Global sales of Gardasil rose 7 percent in the first quarter to $390
million. Cowen and Co has predicted annual sales of the vaccine would
reach $1.9 billion in 2008 and jump to $3 billion by 2012.

Edward Jones' Bannister said she had expected Gardasil sales to reach
$2.6 billion by 2012, with about one-third to come from that older age
group.

Deutsche Bank analyst Barbara Ryan said failure to win approval for
the older age group could reduce her $3.8 billion estimate for 2012
sales by about $300 million.

Ryan said the most important new opportunity for the vaccine will be
for its use in males. The vaccine could help prevent males from
contracting Human Papillomavirus and spreading it to females through
sexual contact. Merck is on track to seek approval for use in males by
the end of the year, Rose said.

Gardasil has benefited from lengthy delays in approval of
GlaxoSmithKline's rival Cervarix vaccine. The FDA in December issued a
complete response letter for Cervarix, meaning it had completed its
review of the product but had further questions about it.

Bannister said the Gardasil delay reflects broader challenges facing
drug makers within the U.S. regulatory environment.

"It's not specific to Merck," Bannister said. "This is an
industry-wide issue."

Merck shares fell 29 cents to $36.74 in afternoon trading on the New
York Stock Exchange. The shares have fallen some 37 percent this year,
hurt by setbacks to its cholesterol franchise.

(Additional reporting by Ransdell Pierson and Deepa Seetharaman,
editing by Maureen Bavdek and Gerald E. McCormick)