Merck’s Gardasil Not Linked To Side Effects: CDC
4 CommentsBy Ed Silverman // October 23rd, 2008 // 12:47 pm
Amid ongoing controversy over the safety and effectiveness of the HPV vaccine, the Centers for Disease Control and Prevention yesterday declared that Gardasil is not likely the cause of numerous adverse events. “Based on all of the information we have today, the CDC and FDA have determined that Gardasil is safe to use and effective in preventing 4 types of HPV,” the CDC says.
The decision came after both adverse event reports and data from the first post-marketing safety study was presented to a CDC panel. The study looked at 375,000 doses of the vaccine from August 20, 2006, the year Gardasil was approved, to July 20, 2008, in girls and women ages 9 to 26 (here is the statement).
As of August 31, there were 10,326 adverse events reported in the US, of which 94 percent were considered not to be serious. The remaining 6 percent included cases of Guillan-Barré Syndrome, blood clots and deaths. Of the 27 deaths, five are still being evaluated and another is under review.
The CDC conclusion is good news for Merck, because Gardasil sales fell 4 percent in this year’s third quarter, reflecting debate over safety and effectiveness (if the CDC doesn’t stop the bleeding, maybe the Gardasil band-aids in the photo can help). Twice last year, a conservative group, Judicial Watch, trumpeted side-effect reports showing thousands of adverse reactions and several deaths.
And a recent study in the New England Journal of Medicine found the vaccine, which is approved for girls and young women ages 9 to 26, isn’t cost effectiveness for those older than 18. The benefit depends on how long Gardasil’s protection will last, although Merck contends the vaccine is cost effective for women through age 24. Gardasil costs about $360 for a three-dose regimen.
LILLI
Every medication may be harmful–Pharmaceuticals and doctors must treat patients as indivituals—Patients react differently to medications, I am allergic and if a take the smallest amount of a sulpher drug immediately I break out with bumps all over—from my head to my toes.
CDC is not reliable or OfficE and learn that the general public can not depend upon CDC for favorable honest data. Pharmaceuticals should realize that we are all different, some are born wil blue, or brwon and maybe hazel eyes—.It is after the drug is on the market and precribed that doctors and pharmaceuticals must honestly monitor and report serious side side—which of cours is not reported—because of the greed of Big PHarma.
Adam
I don’t care what you say, I don’t care if you had “proof” that Gardasil has no adverse effects on women, all I know is my girlfriend is laying in her bed with the worst pain of her life thanks to this shot. Yes it prevents cervical cancer, but it has made my girlfriend so miserable!!! YES IT DOES HAS ADVERSE EFFECTS!!! Merck says it doesnt so there arent any lawsuits so they can keep their precious money, which is obviously more important than human lives to them!!!
Cynthia Janak
There are side effects and a lot of them, Adam. I would suggest that your girlfriend go to my side and check out the tab on Gardasil. Then I would suggest that she goes to my contact page and join the group Let’s talk about Gardasil. There is alot of information that she will need to help her get through all this. Over 11,900 girls have had some type of side effect from this vaccine already and the numbers keep climbing.
I am sorry to hear that she is going through all this. At least she has your support. That will mean a lot for her to recover.
Cynthia Janak
Just a PS. My website did not come up so I am going to put it here.
http://www.cynthiajanak.com