CONGRESSMAN DAN BURTON AND AGE OF AUTISM
UK'S DR. MIRIAM AND AUTISM

FDA DELAYS APPROVING GARDASIL FOR AGES 27+

Mother_may_iThe Reuters online news is sponsored by Pfizer today. I'll be they're happy about this headline: "FDA won't clear expanded Merck cancer vaccine use."

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

Issues? Like adverse reactions, paralysis, death, girls fainting at the doctor's office?  Gardasil is still approved for girls ages 11 and older. Read more HERE.

Comments

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PJ

When are the citizens of this country going to wake up to the never ending quest for drug companies to make billions of dollars off of our bodies? Wake up America!!
Not only is our food contaminated, but now they want to inject poison into our young girls. PLEASE, check out EVERYTHING possible before you decide to inject your child. You are playing with the life of an innocent girl, unaware of the future results this NEW drug might cause.
I can't help it folks, I wonder if this is some sick way of making people sicker so the drug companies can then come up with yet more drugs to cure what they caused.
Keep 'em on drugs from time of birth until they finally die. UGH.
PJ

Sorsha

As for the birth rate - its just too early to tell what type of effect this vaccine will have on these girls' future fertility. We already know there were 5 spontaneous abortions after the administration of the vaccine, but luckily, Dr. Nancy Miller of the FDA decided these miscarriages were 'not related' to Gardasil.

And yes, receiving the vaccine during a clinical hpv infection caused the lesions to worsen. This was noted in the Merck papers submitted to the FDA for approval and noted in the FDA meeting notes. However, I don't remember reading anything about the vaccine affecting a subclinical case of hpv - as would be the case with most older women.

MacGoddess

It seems to me I remember reading a report on the testing of Gardasil (maybe it was Barbara Loe Fisher, but I can't find it at the moment) that said that Gardasil was not recommended for anyone who was already sexually active, because if they had already come in contact with HPV, the vaccine reacted negatively, maybe accelerating the HPV...or something like that...in other words, the vaccine made matters worse for anyone who had already been exposed to HPV, which was why they targeted girls who have not already been sexually active. Didn't they do something similar to this with the flu vaccine?

Diane

“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.”

Ahhh….pretty presumptive Ms. Bannister don’t ya think?? *Unless* of course, you and your buddies at Merck know something we may not?

Kelli Ann --- don't forget they're still trying to get this thing approved and recommended for BOYS. There's that other billion dollars.

mlf

Adding Gardasil to women ages 27 though 45 pretty much covers the entire population of child bearing women. Yikes.

Garbo

It's also much more difficult to hide adverse reactions in the older group. You can't paint it as paranoid parents who have desperately decided their child's illness is the result of a vaccine, especially when the vaccine is often given along with others and the underlying cause can be murky. In an older adult patient, it's more clear-cut. How many deaths is it going to take before they withdraw this vaccine????

Craig Willoughby

mlf, excellent question!

Do we have any information on whether or not women are able to become pregnant post Gardasil? I'm very curious about that.

mlf

Does Gardasil effect a population's
Birth Rate????

Sorsha

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

So, it wasn't difficult for Merck to 'prove' to the FDA that Gardasil is 100% effective against cervical cancer in an age group that doesn't get cervical cancer: young girls and teens. But its effictiveness comes under question when looking at older women who are actually at risk for cervical cancer.

Hmmm..wonder how long it will take the FDA to put 2 and 2 together here.

Kelli Ann Davis

“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.”

Ahhh….pretty presumptive Ms. Bannister don’t ya think?? *Unless* of course, you and your buddies at Merck know something we may not?

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

Can you say, “It’s-about-frickin-time”??!! Drug makers have had it wayyyy to easy for wayyyy to long.

Jeanne

John, you took the words right out of my mouth.

John Gilmore

So it's safe for a 12-year old, but not a thirty-year old. Our FDA at its best.

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