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Fed's are probing into records of over 8,000 adverse events reported since the 2006 FDA approval of the Merck vaccine touted as an HPV cancer preventative. Side effects reported include paralysis, immune system disorders and a record of 18 possible deaths
"I Want To Be One Less" - the familiar slogan of the heavily advertised vaccine may prove to be more fatal that fabulous.
We're all familiar with the catchy phrases, the jump rope ads, the clever rhythmical lyrics that accompany the commercials for Gardasil. Advertised heavily across the US and abroad, Gardasil has been touted as a "must have" vaccine for girls aged 9 thru 26. TV screens and movie theatre ads have been singing the praises of the drug, claiming that it is a preventative against HPV (human papillomavirus), which is the main cause of cervical cancer.
Sold throughout the world, at an average cost of $360.00 per treatment (3 doses are required over a period of several weeks), it is estimated that over 8 million US girls and women have received the drug in the past 2 years. Security and Exchange Commission records show that Merck and Co. has profited 1.5 million last year alone from the sale of Gardasil. Immediately following it's FDA approval, Merck went on a nationwide campaign to make the vaccine mandatory, actively urging legislatures in all 50 states to pass laws requiring all school aged girls to be treated with the drug. Following heaving criticism from the media and other organizations, Merck dropped the push for state mandates in February 2006, instead concentrating on major ad campaigns urging the general female population to obtain the vaccine in order to prevent cervical cancer. Texas was the only state to pass laws mandating the vaccine before Merck withdrew it's efforts.
Lawyers in the last month have filed the first two claims on behalf of girls with ailments blamed on Gardasil under a federal program to compensate victims of vaccine-caused illness. Under the federal law passed in the late 1980s, victims of vaccines may file a claim under the Vaccine Injury Compensation Program, but cannot sue the pharmaceutical company. Last year, the government added HPV to a list of vaccines, including polio, hepatitis and measles, granted immunity from suit. A New York Post analysis of adverse event reports filed through April 30 of 2008 found that about 20 percent of such reports followed injections of Gardasil.
If victims prove a vaccine likely caused injuries, the program pays a maximum $250,000 for death. The average payment for injury has been $1 million.
Gardasil has a laundry list of reported "incidents" - 8,000 to date - which include nausea, vomiting, seizures, paralysis, autoimmune disorders and 18 deaths which are under investigation due to the timing between the receipt of the vaccine and the young women's death.
The current suits filed on behalf of two young girls reported the following adverse reactions following the vaccinations - both of which were received by the girls in their middle schools.
One is Jesalee Parsons, now 15, of Oklahoma, who began vomiting the day she got a Gardasil shot and developed pancreatitis, her claim says.
"It makes me mad because they're saying how great it is, but they never mention how many people have been hurt by it," Jesalee told The Post.
Healthy all her life, her family says, Jesalee has been hospitalized on and off for more than a year. She restricts her diet, takes pain pills and misses many school days.
"I'm pretty sick all the time," she said.
The other claim was filed for Jessica Vega of Nevada, who came down with Guillain-Barré Syndrome, an immune-system disorder, at age 14 - a week after her second Gardasil shot.
Thirty others have reported the syndrome after getting the vaccine.
Jessica's mother, Rhonda Vega, told the Post that her daughter's lower arms and legs were paralyzed as a result of the shots, but she is now learning to walk again.
13-year-old Brittany LeClaire's mother, Christina Bell, reported that her daughter suffered paralysis as well within days of receiving her last dosage of the vaccine. She began having severe headaches and lethargy immediately after the injections, and then developed paralysis in her left leg. Following weeks of having to use a walker, Brittany still walks with a limp.
Christina said her doctor "highly recommended" the vaccine. "He told me it was a cancer preventative. I thought it was the right thing to do. You see it advertised on TV every 15 minutes."
The Vaccine Adverse Event Reporting System, run by the FDA and the Centers for Disease Control and Prevention, has collected thousands of reports of health problems after Gardasil shots.
The fatalities include:
* A 17-year-old New York girl who collapsed and died on Feb. 22 this year, two days after the last of three Gardasil injections. An autopsy could not pinpoint the cause, but doctors suspect a heart-rhythm disorder.
* An 11-year-old who suffered a heart attack in May 2007, three days after a Gardasil shot. The nurse who reported it said a doctor blamed it on "an anaphylactic [severe allergic] reaction to Gardasil." The feds could not confirm the case.
* A 12-year-old girl with no prior medical problems who died in her sleep on Oct. 6, 2007, three weeks after a Gardasil shot.
Dr. John Iskander, the CDC's acting director for immunization safety, says that the CDC has investigated 10 of the reported deaths and has found no conclusive evidence linking the vaccine. He went on to state that "although it is sad that young, healthy young women die for no apparent reason" there was no conclusive evidence that Gardasil had created the adverse reactions experienced by the dead women, or those suffering from seizures, paralysis and brain damage. The only common side effect of the vaccine, according Dr. Iskander, is fainting.
Merck spokeswoman Kelley Dougherty backed up Iskander's findings, and stated that the company "actively monitors" reports of side effects.
"An event report does not mean that a causal relationship between an event and vaccination has been established - just that the event occurred after vaccination," she said.
Spoken like a true government representative and pharmaceutical company spokesperson, wouldn't you agree?
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Statements of this nature always chap my arse because working in drug development, they don't TEST for adverse affects! Drugs are developed not as a way to HELP people, but as a way to fatten the pockets of a drug company.
CDC has investigated 10 of the reported deaths and has found no conclusive evidence linking the vaccine. He went on to state that "although it is sad that young, healthy young women die for no apparent reason" there was no conclusive evidence that Gardasil had created the adverse reactions experienced by the dead women, or those suffering from seizures, paralysis and brain damage. The only common side effect of the vaccine, according Dr. Iskander, is fainting.
Money isn't spent on adverse effects testing, it is spent on getting the drug to consumers. So it is no wonder that there is no apparent reason why young women are dying due to Gardasil and there was no conclusive evidence that it created adverse reactions.
I'm curious, did the vaccine undergo the FULL TWENTY YEARS OF STUDY to obtain FDA approval or was it Fast Tracked (bypassing most adverse effect testing?)
So children, not terminally ill patients, are now sick and dying in a disproportionate number due to a vaccine designed help prevent MOST cervical cancers by stopping HPV?
I'm just curious how fast this vaccine made it to market following initial phase I testing....
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I don't know how in the right mind they will sell these drugs with these type of side effects. Money overrides Conscience. The companies should be made to take it first and demonstrate it before they are allowed to sell.
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Definite "fast track" here Nikki.....
Feb. 2006: Merck & Co. Inc. and millions of women will know by June, perhaps sooner, whether a new vaccine to help prevent cervical cancer will be available this year.
The company said today that federal regulators have agreed to give fast-track review to Merck's cervical cancer vaccine, Gardasil. The faster-than-usual review is granted at a drugmaker's request for medications that address "unmet medical needs."
Although fast-track reviews can take up to six months, Merck said the FDA "has informed Merck that the review goal date is June 8."
I wouldn't let my child or anyone for that matter be injected with this poison. Thank GOD the push to make this mandatory was halted.
Yea, there will be "one less, one less" - but that means one less healthy child, not one less HPV sufferer. Evil is all that comes to my mind.
March 2008 - Merck is working to have the drug "fast tracked" for older women aged 27 to 45, and should have approval shortly. They are also working on having the vaccine approved for use in boys - as the boys give girls the HPV virus in the first place.
(might as well destroy the males too, eh?)
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The medical fields hypocrisy. Un-frikken believable! Good post, Pam...this needs as much media attention as we can give it.
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Life expectancy for most people is now nearing 80 because of the caution and attention expressed within the legal profession?
Any effort to reduce cancer in women should be distrusted?
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@ Pamela Jean (GotTheScoop)
Definite "fast track" here Nikki.....
I wouldn't let my child or anyone for that matter be injected with this poison. Thank GOD the push to make this mandatory was halted.
Yea, there will be "one less, one less" - but that means one less healthy child, not one less HPV sufferer. Evil is all that comes to my mind.
March 2008 - Merck is working to have the drug "fast tracked" for older women aged 27 to 45, and should have approval shortly. They are also working on having the vaccine approved for use in boys - as the boys give girls the HPV virus in the first place.
(might as well destroy the males too, eh?)
Thanks Pam! See? It bypassed the years of careful study (ie...adverse effects associated with) and was "Fastracked" through because the bennies outweighed the risk?!
Texas (go home state...not) mandated it as a vaccine and now, thanks Rick Perry, essentially mandated a vaccine that is un tested and NOW showing to kill kids? Hacking off their lives?
At least with HPV, one can live well into their senior years. These girls didn't even get a chance to contract HPV.
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June 12, 2008
Our STN: BL 125126/758
Merck & Co., Inc.
Attn: Patrick Brill-Edwards, M.D.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099
Dear Dr. Brill-Edwards:
We have approved your supplement to your biologics license application (BLA) for Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (GARDASIL®), to include arthralgia, myalgia, asthenia, fatigue, and malaise in the Adverse Reactions section of the package insert to reflect reports received during post-marketing surveillance, to include corresponding changes to the patient package insert, and to include additional minor editorial changes to the package insert.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.
We will include information contained in the above-referenced supplement in your BLA file.
Sincerely yours,
/Loris McVittie, Ph.D./
Loris McVittie, Ph.D.
Acting Director
Division of Vaccines and Related Product Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Package Insert Labeling
as·the·nia
Pronunciation: as-th-n-
Function: noun
: lack or loss of strength : DEBILITY : : the quality or state of being weak, feeble, or infirm; especially : physical weakness
ar·thral·gia
Pronunciation: \är-ˈthral-j(ē-)ə\
Function: noun
Etymology: New Latin
Date: circa 1848
: pain in one or more joints
Myalgia means "muscle pain" and is a symptom of many diseases and disorders. The most common causes are overuse or over-stretching of a muscle or group of muscles. Myalgia without a traumatic history is often due to viral infections. Longer-term myalgias may be indicative of a metabolic myopathy, some nutritional deficiencies or chronic fatigue syndrome.
Merck's controversial cervical cancer vaccine, has been the subject of numerous side effects. In one case, a 14-year-old woman named Katherine Kimzey, began experiencing debilitating headaches, fainting spells, and arthritis-like stiffness. She became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Because Katherine’s symptoms began soon after she received her second shot and symptoms seemed to match many of the 5,000 reports filed through a national database that monitors vaccine safety, Katherine’s mother, Michelle, believes the problems stem from Gardasil. "When you read everybody's stories, they're too similar not to be related," Kimzey said.
Despite such anecdotes, officials with the Centers for Disease Control and Prevention (CDC) and doctors nationwide argue that concerns over the vaccine to prevent against cervical cancer—Gardasil—are unfounded and the significant side effects being reported are not related to Gardasil.
I guess Ms. Kimsey was merely suffering from " myalgia, arthralgia and asthenia" if you listen to Merck eh?!
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I've had 2 of the 3 Gardasil shots and after hearing about this I'm afraid to get the 3rd. I haven't had any side effects. Is this drug just absolutely 100% not going to work or should I risk it and get the last shot?
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@ HeatherN
I've had 2 of the 3 Gardasil shots and after hearing about this I'm afraid to get the 3rd. I haven't had any side effects. Is this drug just absolutely 100% not going to work or should I risk it and get the last shot?
I'm not able to make that determination for you Heather......but when you ask "is this drug 100% not going to work" I wonder what exactly you mean. This vaccine only protects against some of the viruses that cause HPV which can on occasion develop into cervical cancer - with that said, however, you can't get HPV if you have protected sex, or no sex, and even if you were to get HPV that is no guarantee that it will EVER become cancer. What makes me sad is the ads that have been run on TV have essentially convinced young women that they are for sure going to end up with cervical cancer if they don't get this vaccine - but, if you listen carefully, it says that it doesn't prevent the possibility of contracting HPV or cervical cancer - so what the heck is the point? With the risk of such awful side effects - is it really worth it? That is something you'll have to decide for yourself.
It is sort of like any other drug out there.......the stuff they advertise for "restless leg syndrome" or "fibromyalgia" have such horrific possible side effects I think I'd rather just have my legs kick around or my joints ache than take the chance of going blind, suffering blood clots, unusual sexual and gambling urges and the rest!!
Don't know if that helps at all Heather - but I hope you'll be OK if you do take the last injection! :-)
((hugs))
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It does, thank you :)
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I am a nurse in an OBGYN office and have given dozens of Gardasil injections.I have never had a patient report a side effect except for one patient who fainted in the office. On the other hand, I have seen a lot of patients with abnormal pap smears due to HPV, including a 24 year old who had to have a hysterectomy because she developed cervical cancer. There is a risk involved with any vaccine but people still continue to give their children the routine childhood vaccinations. This is no different. My 14 year old daughter had the vaccine with no problem. I researched the reports on the Internet before she had the shots and decided that the benefit far outweighs the risk.
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