Merck Submits Data To Widen Gardasil Use
12 CommentsBy Ed Silverman // January 14th, 2010 // 7:53 am
The Gardasil grope continues. Merck gave the FDA new data to win approval to market its HPV vaccine to women between the ages of 27 and 45. Gardasil 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. The vaccine is also approved to prevent genital warts in males of the same age.
Merck has been trying for some time to win FDA approval to market Gardasil to more women, but has so far been frustrated. In June 2008, the agency bounced its request to treat women between ages of 27 and 45, which contributed to a slowdown in sales (background here). 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.
Approved in 2006, Gardasil sales rose quickly, but Merck’s push for mandatory vaccination generated controversy. And the price tag and safety concerns slowed sales. For the nine months ended Sept. 30, Gardasil sales were $841 million, a 25 percent drop. And now, Merck faces competition from Glaxo’s Cervarix. Whether women will get vaccinated remains unclear. An analysis in the New England Journal of Medicine predicted life expectancy gained by giving Gardasil to women older than 18 doesn’t outweigh the expense (see here). The vaccine costs about $360 for a three-dose regimen.
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Laurie
This vaccine is poison and is not worth the risk!! Annual pap smears can safely detect the strains of HPV and treatments can cure them. The side effects of Gardasil leaves a life change in young girls that, so far, is undetectable and irreversable. My daughter, like thousands of others, is now one less. One less normal child…that vomits every day of her life and has to have pap smears almost monthly because of the PID (Pelvic Inflammatory Disease) that she got from this vaccine. We have to watch her closely now so that she can be treated for her flare ups because the possiblity of sterility and tubal pregnancies are what is caused by this disease.
Google gardasil side effects and THEN decide if you want to take that risk! My guess is that you won’t…I wish we hadn’t!
Robert
I agree with Laurie. I think it’s better to instruct young people to practice safe sex rather than give a vaccine that protects against one strain of one disease.
Gaynell
My daughter was also injured by this vaccine. It has been 9 months since her first vaccine (we did not get the rest!), and she is still suffering from side effects. I wish I had done my research before allowing this vaccine to be given to her. Please do your research before you allow this vaccine to be given to your healthy daughters!
Justice in MI
I’ll quote one of my students who was in the first age group that Merck decided to target to expand Gardasil sales (18-26 yr olds). She described being “bludgeoned” by university health services hcps to consider the vaccination.
Whatever is or is not good or bad about this vaccine, Merck’s marketing strategies, and their use of of various front organizations (including college health services personnel), have been repulsive.
Justice in MI
re: above, see JAMA. 2009;302(7):781-786.
Not surprising, the American College Health Association no longer has the Merck-created materials on their website.
vince
So how will much will Julie effect the FDA.
informed
The mis information above is appalling
The PID you state was from the vaccine is impossible, you are only getting VLPs ( virus like particles) in the vaccine. Not the virus at all, just mimics the virus to produce antibodies.
The vaccine has 4 strains that cover 70% of Cervical Cancer in US & 90% of Genital Warts.
The CDC has recommended this vaccine & been reviewed by thousands of physicians that recommend it.
Why do you thin there is no polio in North America? Vaccines!
Here we have something trying to prevent CANCER & you are throwing around misinformation & possibly lies!
Please don’t do this for the health of out children. get informed!!!
patrons99
Gardasil may end up being the poster child for all or most of what is wrong with a global vaccination policy which is seriously misguided. It is a great example of a “toxic cocktail” for which little if any valid data support either efficacy or safety. It is a perfect example of “The Arrrogance of Preventive Medicine”. No one should be forced to take ANY vaccine and no one should have them forced upon their sons, daughters, or parents. Schools, nursing homes, and governments should not be allowed to mandate them. They are very similar to the “magical” concoctions that were once sold in covered wagons. Nothing has really changed. Disclaimer: this comment is solely opinion and is not in any way intended to be medical advice. Any reliance placed on this comment is solely at your own risk.
Informed in NJ
I continue to be amazed and terrified by the mindset of the American public with respect to medicine. We have created/are creating a sentiment that medical interventions are free of ANY risk. The reality is that EVERY medical intervention (even taking a simple aspirin) carries BOTH benefit and risk.
Vaccines are perhaps the single most effective public health innovation ever! The US has eradicated many diseases that still yield death to infants/children in other parts of the world - and vaccines are the reason! According to the most reputable public health experts worldwide, the benefit of these products far out way the risk, however, for those few patients who experience side affects the risk ends up being 100%…the challenge is that we cannot predict who will have side effects and who will not.
In the end, our society benefits enormously from these innovations and educating the public about the benefits and risks would go a long way to eradicating the pervasive ignorance that exists around vaccine safety.
…it is very sad to see people dying of vaccine preventable diseases- including cervical cancer. For those choosing not to vaccinate their children against measles, mumps, rubella, HiB, varicella, H1N1, meningicoccal, HPV, etc. - I HOPE you made the right decision….
pharmavet
For those who take comfort in Pap smears, these days, depending on the institution, Pap smears are no longer read by a qualified cytologist or Pathologist. They are read by a computer, without the aid of a trained eye. For myself, I would not put my daughters health re a serious disease such as cervical cancer in the hands of a machine. I am more reassured by the combination of Gardisil AND Pap smears.
patrons99
Mercifully, even Ian Frazer, the co-inventor of the HPV vaccine, and Diane Harper, a clinical investigator at the Dartmouth Medical School, favor choice, not mandates. Though I find it very hard to stomach the appalling lack of credible safety (both short term and long term) and efficacy data, behind the HPV vaccines, I draw the line at mandates. Let the public inform themselves and choose. The interests of the WHO and CDC are thoroughly conflicted as to vaccines in general.
punter
Informed,
Are you informed of the fact that Merck used poison in their so-called control recipients to make it look like the side effects were no big deal? They gave the vast majority of the controls an aluminium based solution so it was impossible to tell what the side effects of the vaccine were relative to the vaccine itself. But don’t believe me, get it straight from the horse’s mouth. See specifically tables 5 and 6 on page 7. http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
You should also be informed that nobody from either the control group or the vaccine recipient group got cancer and therefore Merck has absolutely no justification to claim that this will reduce cervical cancer. But I suspect that no amount of information will make you change your mind.