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Merck Seeks FDA Approval for Gardasil in Boys
WSJ ^ | 05 Jan 2009 | Jonathan D. Rockoff

Posted on 01/06/2009 1:40:49 PM PST by BGHater

Merck is asking federal regulators to expand the use of its human papillomavirus vaccine to boys and young men.

The company has asked the FDA to approve the Gardasil vaccine’s use in males ages 9 to 26 years to prevent genital warts and other lesions, CNBC’s Mike Huckman reported. In 2006, the FDA approved giving the vaccine to girls and women of those ages.

We talked with a Merck spokeswoman who pointed to studies showing Gardasil’s effectiveness in young males.

But the request will likely renew questions about Gardasil’s cost-effectiveness, especially with a price tag of $360 for a three-dose regimen. In August, Harvard researchers suggested the vaccine wasn’t worth the cost in older women likely to have been exposed to HPV by the time they were to get vaccinated.

Merck has also asked the FDA to expand Gardasil’s use to women ages 27 to 45 years.

(Excerpt) Read more at blogs.wsj.com ...


TOPICS: Government
KEYWORDS: boys; fda; gardasil; health; medicine; merck; pharmaceuticals; vaccines

1 posted on 01/06/2009 1:40:51 PM PST by BGHater
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To: BGHater

Just put the stuff in the condoms.............


2 posted on 01/06/2009 1:41:55 PM PST by Red Badger (I was sad because I had no shoes to throw, until I met a reporter who had no feet.....)
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To: BGHater

Makes sense from a “herd immunity” standpoint.

Other issues of this being (generally, with reasonably common exceptions) sexually trasmitted aside.


3 posted on 01/06/2009 1:43:30 PM PST by MeanWestTexan (Beware Obama's Reichstag fire.)
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To: BGHater

If they try to legally require this vaccine for girls, they better legally require it for boys because boys are often the main transmission vector of HPV.


4 posted on 01/06/2009 1:46:05 PM PST by Question_Assumptions
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To: MeanWestTexan

I have heard changing to private schools also works.


5 posted on 01/06/2009 1:46:44 PM PST by Tarpon (America's first principles, freedom, liberty, market economy and self-reliance will never fail.)
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To: Tarpon

No, I slept with girls from private schools, too.

Protestant, Roman Catholic, Jewish, didn’t seem to matter much.


6 posted on 01/06/2009 1:50:35 PM PST by MeanWestTexan (Beware Obama's Reichstag fire.)
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To: BGHater

Couldn’t get the females to buy into the pharma solution so now they will try and sucker the guys in for a nonsensical bit of chemistry that is abount 30% effective. AND best yet they will make it mandatory.


7 posted on 01/06/2009 2:07:05 PM PST by the long march
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To: BGHater
"Merck has also asked the FDA to expand Gardasil’s use to women ages 27 to 45 years."

This is interesting since the orginal reason, according to Merck's first study and subsequent presentations, for not vaccinating women over 25 was because there is 200mcg of aluminum in each vaccine. The exposure was thought to be too much over time with 3 vaccines every 3 years. I guess that whole thing is thrown out the window for more profits....

Some info on dangers of Gardasil -

http://www.newswithviews.com/Tenpenny/sherri14.htm

http://articles.mercola.com/sites/articles/archive/2007/09/27/gardasil-new-video-reveals-hidden-dangers.aspx

Shocking video on this page - http://cbs4denver.com/consumer/gardasil.danger.paralysis.2.766473.html

VAERS Report - see for yourself what girls have experienced from this miracle vaccine - www.judicialwatch.org/archive/2007/GardasilVAERSUpdatedDeaths0907.pdf

8 posted on 01/06/2009 2:26:45 PM PST by BossLady (Liberals have Stockholm Syndrome.....Conservatives have Lima Syndrome....)
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To: the long march

“for a nonsensical bit of chemistry that is abount 30% effective”

Gardasil in clinical trials has been shown to be 100% effective in preventing infection with strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains

http://www.medicalnewstoday.com/articles/67980.php


9 posted on 01/06/2009 2:31:09 PM PST by MeanWestTexan (Beware Obama's Reichstag fire.)
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To: MeanWestTexan

“According to the Journal, the vaccine has been “dogged by uncertainty” about “how effective it really is.” In clinical trials, 361 of 8,817 women who received at least one shot of Gardasil developed precancerous lesions on their cervixes within three years of vaccinations.”

This is further down in the article read more than just the propaganda


10 posted on 01/06/2009 2:51:43 PM PST by the long march
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To: the long march

I am not endorsing the product, just giving the facts.


11 posted on 01/06/2009 2:55:00 PM PST by MeanWestTexan (Beware Obama's Reichstag fire.)
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To: MeanWestTexan

Except of course that you left out some important facts which are quoted in the article. The one report looked into by WSJ is not sufficient and overlooks the multitude of studies done when the “product” was being vetted by the FDA. Not all pharma solutions are good and this is one that is particularly bad.


12 posted on 01/07/2009 8:45:05 AM PST by the long march
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To: the long march

70+% efficacy would be more than enough to generate herd immunity — by breaking contagion links.


13 posted on 01/07/2009 8:54:26 AM PST by MeanWestTexan (Beware Obama's Reichstag fire.)
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