FDA Rejects Gardasil For Use In Most Adult Women
4 CommentsBy Ed Silverman // April 6th, 2011 // 5:11 pm
In a setback to Merck, the FDA has refused to approve the use of the Gardasil vaccine for preventing HPV in women ages 27 to 45, a market the drugmaker has been counting on to boost sorely needed vaccine revenue. In a brief statement, Merck says prescribing info was updated to indicate Gardasil has not demonstrated to prevent HPV-related cervical cancer in women older than 26.
The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story).
The vaccine is already approved to protect against the 6, 11, 16 and 18 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, anal cancer, anal dysplasias and precancerous lesions in males of the same age. Nonetheless, Gardasil sales have slowed considerably, from $1.4 billion in 2008 to $988 million last year (see page 6 of this SEC filing).
The sales slide is 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 study last year found Gardasil vaccination rates are low, although a government study found teenage vaccination rates are starting to creep up (see this and this). More recently, there is competition from GlaxoSmithKline’s Cervarix.
ocnaturaldoc
Progress…..YAY! Now, if FDA would ban mercury from all dental practices and fluoride from all water sources…..
Mom
After what Gardasil has done to my daughter I am thrilled that the FDA has denied this request. Maybe they will eventually get it off the market altogether!
Mindano Iha
This is very good news!
I can’t see that EMEA has refused the use of Gardasil for older women, so maybe it will not apply for Europe or Scandinavia. http://vactruth.com/2010/06/28/merck-paying-experts-gardasil/
In Norway there are such close connections between the health authorities and the pharmaceutical industry, (see link), that it is doubtful that there will be any change in the present situation, which is that it may be used for all above 9 years.
MaryClare
The elephant in the room is the 675 mcgs. of reactive aluminum in the 3-shot series. 1 mcg is considered neuro-toxic and babies are receiving 250 mcgs. of aluminum in the hepB shot within hrs. of birth. Even Shaquille O’Neal cannot handle this much aluminum. Crazy!!
I asked Dr. Diane Harper, lead researcher for Gardasil at the NVIC convention in D. C. about the fact that the aluminum in the Gardasil vaccine is causing neurological damage such as myalgia, seizures, loss of consciousness, convulsions, juvenile/rheumatoid arthritis, asthma, Guillain-Barre, etc. and if she indeed thought this adjuvant (aluminum) was a contributing factor to the 22,000+ adverse reactions and over 94 deaths of young women, which represents less than 10% of vaccine reactions.
She totally ignored the question and her transparent response was evident to the 800+ members in the audience that she was stonewalling and did not want to go on record as admitting this was the case.
Btw, HPV does not cause cervical cancer, however, the Gardasil vaccine does by over 44%. Dr. Christiane Northrup, among other doctors, has gone on record to state that HPV does not cause cervical cancer.
Merck spent over $4 million to fund ‘Women in Gov’t', an advocacy group of women legislators in order to grease the wheels for mandating this vaccine, which fortunately did not succeed. Every women legislator who joined this group had to shell out $100 to Merck in order to join this ‘exclusive’ club, which turned out not to be so exclusive at all, as these women legislators were then seen as being partial to Merck, therefore, having no objectivity, but being assured that their campaign coffers would be padded when up for re-election.
Business as usual…