July 7, 2008

HPV Vaccine Linked To Teen's Paralysis?

Her Father Thinks Gardasil Might Be; Drug's Maker Denies It

  •  (AP)

(CBS)  Jenny was a healthy 13-year-old living in Northern California -- until 15 months ago when, her parents say, she received the third and final shot of the vaccine designed to protect against human papillomavirus (HPV).

HPV causes a large percentage of cases of cervical cancer.

Soon after getting that third injection, her parents say, Jenny began experiencing the first signs of a degenerative muscle disease. They say she's their daughter is now almost completely paralyzed.

Did Gardasil cause Jenny's condition?

Her family told CBS News it believes "there may be a link. But, there is no medical consensus on whether this hypothesis is stronger than other possible explanations."

Merck, Gardasil's maker, disputes that, saying in a statement, "Based on the facts that we've received, the information does not suggest that this event was causally associated with vaccination."

Jenny's father hopes a blog he started will prompt other teens with similar post-vaccination problems to come forward.

U.S. News & World report says there have been other possible adverse effects associated with Gardisil, though none has been confirmed.

The New York Post also says Gardasil may be causing some medical problems.

Cervical cancer is the second most deadly cancer women's cancer.

Since the Food and Drug Administration approved Gardasil in 2006, some 8 million girls have received at least one of the three shots, with 13 million injections administered in all, the FDA says.

On The Early Show Monday, Dr. Holly Phillips of CBS station WCBS-TV in New York told substitute anchor Tracy Smith, "At this point we shouldn't be more worried than we've ever been. I think the biggest concern is -- parents want to know that, when they give the shots to their children, they're protecting them, not putting them in harm's way.

"Even though a case like Jenny's is incredibly tragic, we also have to be fair and make it very clear that it has not been linked with Gardasil. We understand the family's hypothesis, but still, the FDA, CDC (Centers for Disease Control and Prevention) have not linked her case with Gardasil."

Putting things in perspective, Phillips said, "It has been tested on thousands and thousands of women before it ever hit the market. And, already, 8 million women have gotten the shot. So, it's really a relatively small number of complaints we're looking at, but they should be taken seriously. Yet, it's not time for parents to pull the plug and say, 'This is too risky for my child.' "

Phillips said other reports of possible problems stemming from Gardisil have been received on the CDC and FDA's VAERS (Vaccine Adverse Event Reporting System), on which anyone (substantiated or not) can report side affects they feel they are having to a drug or shot.

"Anyone with any concerns whatsoever after they've had the vaccine," can report those concerns via VAERS, Phillips sais, "and they could have had the vaccine a year ago or a week ago. It really doesn't matter. Anyone with any concerns can report them to this system. ... That doesn't mean they're necessarily linked with the vaccine. It just means you have a concern and you would like it looked at thoroughly."

The feds, says Phillips, take VAERS "very seriously. Every week, they actually sit down and look at these complaints. And what they're looking is not just an individual case, but they're really looking for multiple links where several women had the same effect."

MMVIII, CBS Interactive Inc. All Rights Reserved.
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by sceptic11 July 9, 2008 4:36 PM EDT
I agree with pbxb, that most vaccines are worth the risk, and didn''t mean to imply that we should all stop taking them. But after reading so much about Vioxx and Gardasil, it seems clear to me that the pharmaceutical industry has gotten to a dangerous place... where the financial/marketing side is making decisions better left to scientists. In theory, an independent nurse practitioner or doctor should have no motivation to push one drug over another, but the same cannot be said (without a healthy dose of cynicism) of the marketing side of big pharma. The goal of marketing is to SELL... as soon and as much as possible... which is well and good, but the tactics used toward that goal need to be reigned in and STRICTLY monitored. Otherwise, beneficial but potentially dangerous drugs can be released before certain risks are discovered, or the risks that ARE known are allowed to be underplayed and buried in the fine print. Science should be dictating the timetable... not the shareholders or the scientists being highly paid as consultants to marketing.
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by pbxb2 July 9, 2008 12:05 PM EDT
I''m a nurse practitioner and highly recommend the vaccine, I don''t force the vaccine on anyone and I give the parents the information on the vaccine to make a rational decison for themselves. I have boys and will vaccinate them when it is approved for them. I have seen 12, 13, 15, 16 18-28 year olds having cervical dysplasia which leads to cancer. They have to have colposcopies yearly, pap smears every 3 months for 1-2 years and even Leep procedures at a young age. If you have never seen or had a leep procedure done it''s terrible for such a young child to go through. I wouldn''t wish that on my worst enemy. They may come up with something better in the future, but for now if I can prevent something I will try. All of our vaccines have risks, but the benefits on most out way the risks. The CDC and FDA have not put any warnings out on this yet. I have had numerous girls get the vaccine without any side effects. The only try way to prevent this disease (and others) is total abstinence (no touching of genital parts at all). I''m sorry to say this will never happen in today''s society.
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by sceptic11 July 9, 2008 7:55 AM EDT
I never would have known about Gardasil at all if I hadn''t had a heart attack while taking Vioxx. That event started me reading everything I could find out about the Vioxx situation, during which I learned about Gardasil. My initial concern was the amazing lengths to which Merck would go in order to virtually force Gardasil on trusting consumers. Attempts, through political connections, to have the use of Gardasil MANDATED, one state at a time. I really hate having become so cynical, but after reading about it for so many months, it''s impossible to not be suspicious of the "humanitarian" slant Merck has put on the entire Gardasil campaign. Especially since the primary customers are children. What better way to sell a product than to so brazenly play on a parent''s desire to do what is right for their child? Talk about cynical. And is it merely a coincidence that the aggressive, multi-tiered promotional campaign (born of concern, of course) came during a time when Merck was looking for a way to pay for an enormous Vioxx litigation?
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by sceptic11 July 9, 2008 7:54 AM EDT
I never would have known about Gardasil at all if I hadn''t had a heart attack while taking Vioxx. That event started me reading everything I could find out about the Vioxx situation, during which I learned about Gardasil. My initial concern was the amazing lengths to which Merck would go in order to virtually force Gardasil on trusting consumers. Attempts, through political connections, to have the use of Gardasil MANDATED, one state at a time. I really hate having become so cynical, but after reading about it for so many months, it''s impossible to not be suspicious of the "humanitarian" slant Merck has put on the entire Gardasil campaign. Especially since the primary customers are children. What better way to sell a product than to so brazenly play on a parent''s desire to do what is right for their child? Talk about cynical. And is it merely a coincidence that the aggressive, multi-tiered promotional campaign (born of concern, of course) came during a time when Merck was looking for a way to pay for an enormous Vioxx litigation?
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by mellownnv July 9, 2008 6:00 AM EDT
It is sickening to see how dr''s and nurses blindly recommend this vaccine to impressionable young girls and their parents who do not have all the information about the possible side effects. Yet another example of pharmaceutical companies buying off these professionals!
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by mellownnv July 9, 2008 5:51 AM EDT
It would be ridiculous to think that vaccines don''t have possibly horrible consequences for some who get them. I would never get an unnecessary vaccine or advise others to do so, knowing that there is such uncertainty as to who may have these serious reactions! How about advising girls to protect themselves by not having casual *** and to get regular Pap Smears when they are sexually active to detect cervical changes.
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by llk2901 July 9, 2008 1:50 AM EDT
As a registered nurse and a mom, I too will not allow my daugher nor son, (boys will be the next target since they are HPV carriers) to get this shot. As I tell people that the old nurse in me sees the value of some vaccines, but the more informed mom questions the the risks and need for others. Up until this point both kids have had all vaccines, but if I had it to do over I certainly would refuse at least the Hepatitis B and chickenpox vaccine and as I said, the HPV vaccine. And when I say they have had all vaccines that is everything except flu and pneumonia vaccines. I am an RN and have never had nor will I ever have a flu shot!
I have very strong opinions about the politics of Gardasil as well as several other vaccines, but all you have to do is read the valid scientific information, (NOT PROVIDED BY GOVERNMENT OR DRUG COMPANY), and the proof is there that this is a dangerous, dangerous vaccine.
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by 4marlene July 8, 2008 11:19 PM EDT
Type this in your search engine and see what Judical Watch uncovered via the Freedom of Information Act... FDA Hides Eight More Gardasil Deaths
October 25 2007 and you can also find other adverse vaccine events from Gardisil including more reports of paralysis. This is not an isolated incident. I''ve advised my son''s to not get this shot for their daughters. Investigate before you vaccinate!!!
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by toldyouso12 July 8, 2008 5:40 PM EDT
Hundreds of thousands die every year from cervical cancer. It''''s sad to think that many of them could have been saved, and that some of those now may not due to fear from one singular coincidence.

Posted by SusanHelit at 03:49 PM : Jul 07, 2008

Gee, Susan, according to the stats less than 5,000 die from cervical cancer each year. Others may be prone to some exaggeration--but honey--you just shot the entire wad of your credibility in one big hit. HUNDREDS OF THOUSANDS DIE FROM CERVICAL CANCER EACH YEAR? Where? Susan? On "pulling the numbers out of your azz planet? LMAO

ACS :: What Are the Key Statistics About Cervical Cancer?
About 3870 women will die from cervical cancer in the United States during 2008. Cervical cancer was once one of the most common causes of cancer death for ...
www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_cervical_cancer_8.asp - 36k - Cached - Similar pages
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by toldyouso12 July 8, 2008 5:34 PM EDT
Posters that decry this vaccine as dangerous are those that have similar opinions of vaccines in general.

Polio was killing thousands of people a year, a plague among the young. Should we have just let nature run its course and take out those that could not fight the virus? That is a tough call and would like to see it made by a reasonable individual.

To some, 5 years is not enough for testing. Millions of young woman are now protected from cancer...and this is a bad thing?


Posted by mecury69 at 04:07 PM : Jul 07, 2008


I am against this vaccine. I have had many vaccines in my lifetime (I worked in Biologics--human and veterinary) and all my kids have had all of their shots--but not this vaccine, and based on what I have read --they won''t be getting this one. Many who are familiar with the literature and testing data of this product are not letting members of their family near this product--the main reason is that the data is skewed and controversial information is not answered by ignored. This product appears to have been fast tracked--in the old days, the only way that was done was by bribing the FDA.
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by toldyouso12 July 8, 2008 5:30 PM EDT
Well obviously medical personal are in a different category. I don%u2019t get flu shots but I would if I was a doctor/nurse. I would try to get a shot for every communicable disease if I was a doctor/nurse.

Posted by kindrox at 11:34 AM : Jul 08, 2008


Silly. The Influenza virus is not one virus but can be one or a combo of over a hundred different strains. Every year based on epidemiology, the CDC tracks the different strains and takes a gamble on which one will likely hit America or effect it most severely. Then two or 3 different viral strains are mixed in a cocktail. If they are right or the strain that actually strikes the country is not that virulent, the deaths are down--if they are wrong then your flu shot will do you no good. Either way, over 100 thousand Americans die of the flu each year--that is about the same number that die in hospital due to poor or wrong care, each year.
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by wantanswers July 8, 2008 4:15 PM EDT
My daughter received her first shot of gardasil at age 14 on April 08. Since then she is suffering side effects: dizziness, stomach pain, headaches, body pain, trouble breathing, ets. At home she suffered a seizure and was taken to the emergency room they said it was a migraine Upon follow up tests were done that came back normal. Physician%u2019s advice was to see how it goes. I have a daughter whom is different like night and day now. She was so energetic riding her horses and showing them at the fair now too exhausted and weak with muscle and stomach pain and headaches and dizziness. I only wanted to do the right thing. I read all the information they gave to me at the Drs. office on the vaccine but did not see any of these serious side effects mentioned If I had read these I would never have agreed to the shot. My Dr. does not want to help me in finding out what to do with her as she doesn''t think it is from the vaccine. I am taking her to another children%u2019s hospital Dr. to try to get some help for her. I know in my heart and so does my daughter that this shot caused her symptoms. I appeal to all physicians to give us help instead of being blasi%u2019 about this we only want our precious daughters to get better. Also if Merck continues to push this poison they should at least update the brochure and state the severe side effects that could happen from receiving the vaccine and maybe more people could make a better decision about whether to risk with this vaccine.
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by krisw52003 July 8, 2008 3:56 PM EDT
People are blind about health care decisions. Start educating yourselves. Vaccines are a billion dollar industry and pharmaceutical companies are exempt from lawsuits from vaccines thanks to the 1986 vaccine compensation act. Where is the incentive to make safe, effective vaccines if there are no repercussions from injury or death. People need to be proactive in there health care choices, they are CHOICES.
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by chiromom54 July 8, 2008 2:43 PM EDT
I have a completed a 5 page literature search on HPV and HPV vaccinations...highlights: Gardasil study involved 2,392 women 16 to 23 y/o, some participants had to be eliminated leaving only 1,533 participants: serious side effects reported included paralysis, Bells Palsy, Guillain-Barre Syndrome & seizures, long term effects of the vaccine remain unknown, 3 deaths related to vaccine, including two 12 y/o & a 19 y/o relating to heart problems &/or blood clotting
Another product made by GlaxoSmith Kline,Inc is in third phase of studies (Gardasil was stopped in 2nd phase and rushed to market), 18,644 women ages 15-25 in study, 98% seropositivity maintained for HPV 16/18 antibodies with Cervarix (GlaxoSmithKline) also evidence of cross protection (HPV 45 & HPV 31) Cerarvix also partly protected women from 2 other strains of HPV, HPV-45 and HPV-31, which are the third and fourth most common HPV types asoc with cervical cancer. A vaccine adjuvant, monophosphoryl lipid A, (MPL) is a substance that is added to vaccines to improve their effectiveness by boosting the immune system. MPL is used in Cervarix as well in GSK vaccine for hepatitis B. No side effects from the Cervarix have been reported.
Cervarix is due to hit market in 2008, is it''s release being politically stopped?! I have a 16 y/o, not sexually active, daughter and am waiting for this vaccination to be available.
I can fax or e-mail literature search if requested.
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by kindrox July 8, 2008 2:34 PM EDT
Well obviously medical personal are in a different category. I don%u2019t get flu shots but I would if I was a doctor/nurse. I would try to get a shot for every communicable disease if I was a doctor/nurse.
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by pedsnurse50 July 8, 2008 2:27 PM EDT
Being a Pediatric Nurse and having been someone who was diagnosed with HPV and having to have a Colposcopy and Leep procedures towards this viral infection I''d been told I have a 50/50 chance of not getting cervical cancer. Since this minor operation, all my paps have been negative. But who''s to say I won''t get cervical cancer later since this infection is in my body and will never leave, according to all the publications I have read. I wish there would have been an injection for me to take to avoid this HPV. And furthermore, this HPV is known to be prevalent in 99% of society now and all these woman and men who have it are still spreading it around and some do not even know they have it!!!
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by kindrox July 8, 2008 2:25 PM EDT
I don''t get it. Don''t screw around and you don''t NEED this shot. Don''t screw around and you won''t get a whole host of diseases. It%u2019s unbelievable to me that one out of four have genital herpes.
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by deepperppl July 8, 2008 2:18 PM EDT
I''ve always been careful when getting my daughter vaccinated, asking every time if the shots had Thimerosal in them. (My son has Asperger''s Syndrome. When he was born, Thimerosal was still being used routinely as a preservative in baby immunizations.) My daughter was fine - no signs of Autsim - until one week after she got her first flu shot. During that week, she began flapping her arms when upset and she also began to lose her verbal skills. I figured it was just now showing up, since some kids get diagnosed later than others. I thought maybe she was just going through what my son did: being normal until suddenly changing. I began the therapy with her that helped my son. When I found out a month later that all the flu shots still had Thimerosal, I blew a gasket. Why on earth the nurse or pediatrician didn''t tell me, I''ll never know. Maybe they thought the Thimerosal scare would prevent kids from getting the flu shot. It''s the only time I didn''t check to make sure Thimerosal wasn''t in the shot. And now my daughter isn''t "normal" anymore. People in hospitals and doctor''s offices ROUTINELY skip the flu shot. hmm I wonder why?
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by Meg003 July 8, 2008 11:33 AM EDT
After reading the Judicial Watch report, Examining the FDA%u2019s HPV Vaccine Records, dated June 30, 2008, I am concerned that the vaccine''s benefits are overstated and the risks understated. Girls are dying at a rate of one per month from the vaccine, and it only protects against a fraction of the harmful types of HPV.

Most types of HPV infection are not prevented by this vaccination, so how much protection are the girls getting for this risk?



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by tootall10142 July 8, 2008 11:17 AM EDT
my primary medical doctor is nuerosurgeon and rehabilitation doctor he died recently but exspressed to me on sevral occassions not to take synthetic drugs unless they have been out on the market at least five years, unless it is a case of life or death and with no alternatives left.he believed if it doesnt come from the mother earth it should not be TAKEN lightly.
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