FDA Postpones Decision On Wider Gardasil Use
9 CommentsBy Ed Silverman // June 16th, 2010 // 3:17 pm
Yet another setback for Merck, at least for now. The FDA has postponed a decision to broaden usage of its Gardasil HPV vaccine to women between the ages of 27 and 45. Earlier this year, the drugmaker submitted new data to the FDA and had hoped to hear by the end of June, but a Merck spokeswoman tells us the agency will now respond by the end of 2010.
The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. The vaccine is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. Gardasil is also approved to prevent genital warts in males of the same age.
Exactly two years ago, the FDA bounced its request to treat older women and early last year, the FDA again withheld approval and asked Merck to submit data when a 48-month study on a test group has been completed, which contributed to a slowdown in sales – last year, Gardasil revenue was $1.1 billion, down from $1.4 billion in 2008 and $1.48 billion in 2007.
Gardasil, in fact, has been under pressure for some time, due to cost and ongoing concerns over side effects (look here). Some parents also worry the vaccine may offer teenagers a green light for premarital sex. Meanwhile, a recent study found vaccination rates are low (see this). More recently, there is competition from GlaxoSmithKline’s Cervarix.
Justice in MI
Anyone have any data that estimates the percentage of women in this age group (say, in the U.S.) who do not already carry the four relevant strands?
Rosemary Mathis
Anyone considering this vaccine should investigate before you vaccinate. There are severe side effects, injury, and death being reported. Go to http://WWW.TRUTHABOUTGARDASIL.ORG for more information.
Stephany
Gardasil deaths:
http://www.judicialwatch.org/archive/2007/GardasilVAERSDeaths.pdf
http://www.wnd.com/?pageId=68454
Death toll linked to Gardasil vaccine rises
Complications include shock, ‘foaming at mouth,’ convulsions, coma
There is no way on God’s green Earth I will ever receive this vaccine, promoted by Merck for sales competition with Cervarix from GSK, both of which WILL eventually go head to head in sales in the U.S.
Women, STOP being a marketing target for billion dollar drug companies, research and read the fine print before you ever receive this vaccine.
The cruelist twist of fate is that the FDA approved the use for such YOUNG GIRLS and SO MANY 12-19 year olds are now DEAD as a result of receiving this marketing target BS shot@!
AnneS
This vaccine should be pulled from the market, not given approval for expanded use.
M. Black
IMHO, Gardicil is dangerous. I don’t know the reasons why, not do I necessarily care all that much why Merck has chosen this drug to be it’s new white horse. As in another post above, it only protects against 4 of (what I believe was reported, and relying on my memory alone) out of 20 strains. There are SO many more serious diseases to tackle. But, we’re working in a business atmosphere (for now, anyway). Pinheads force feeds the reps under them until they are more robotic than human.
Whether the deaths reported are attributed or not, if this cancer is aggressively vaccinated against, mutant strains will occurr. Another self serving product within it’s own self serving world.
Mandatory treatment SHOULD NEVER OCCUR. EVER.
To those who tend to be hypocondriacks, do so by getting your rump off the couch and get your checkups every 6 months. It would be caught early, problem solved). Now, as to allow this vaccine to form more aggressive strains is a HUGE issue. HPV is not Polio. I don’t care how the labs and statistician presents it’s data, there is a multitude of diseases that deserves more attention.
At least until Gardicil successfully allows these strains to mutate into something that cannot be treated.
I care not. I don’t have a vagina. But for those that do, think thrice about getting this vaccine.
~ M. Black
M. Black
… And no less for its competetors now and in the future.
MB
Stephany
Gardasil, is a profit making vaccine based on fearmongering cervical cancer to girls under age 18. Simple, another all for profit target on women, yet the girls in junior high rarely have sex to care why they are being ‘vaccinated against a sexually transmitted disease that could give you cervical cancer, and what is a cervix?’ they don’t even know.
This is a marketing promotion going up against GSK with Cervarix.
Google it, it’s not hard to find information on the vaccine.
M. Black
When in the world will “good science” comprised of “good people” push over the absolute crap that is strongly influencing it now? What kind of medical catastrophe needs to happen before we replace the suits with white coats?
It’s getting old.
MB
Stephany
It’s too late MB.