More Gardasil Worries

We have talked a lot in the last year about the dangers of Gardasil and whether it's a good idea to give young girls the shot that protects against HPV-which can lead to cervical cancer. It seems more doctors are deciding not to administer it. Here are some comments from readers on their decision whether or not to vaccinate.

"My daughter is 14 and suffering from a severe reaction to the HPV and Meningitis vaccines which she received in October of 2007, three days before her 14th birthday. She had 2 sets of seizures at the time she received the vaccines and now she suffers from chronic joint pain in her knees and periodic numbness on her left side (hand, arm, face, etc.) She has always been an accelerated learner with an outstanding memory and straight A student in honors classes with little effort. She did not have t study often as she picked things up right away when they were introduced to her. After her vaccinations we have noticed a change in her short term memory, it is just not as sharp as it has always been."

"My daughter has had 2 doses of the vaccine and has had no problems. Cervical cancer runs in our family and if there is a remote chance that we can prevent it for her we will. I think the risks in vaccines out weighs the potential outcome."

FROM ABC: The CDC recommends that all girls starting at 11 or 12 years old get vaccinated against cervical cancer. It's a disease that kills four thousand women each year, but now two studies just published in the Journal of the American Medical Association are raising new questions about the safety of this vaccine. ABC’s John Mckenzie has the details in tonight's medical minute. It is a dilemma for millions of parents across the country: Whether to vaccinate their daughters against a sexually transmitted virus, that can cause cervical cancer.

SOT Mother: "This is a difficult decision but we decided to do it (OR) not do it because, etc" Gardasil, a series of three shots, given over six months has been promoted heavily. “So far, more than 7 million Americans have received Gardasil injections. The study identifies 12–thousand (12,424) medical problems after vaccination most are mild: dizziness, headache, and fainting." But there are more than 700 reports (772) of SERIOUS medical problems, including blood clots, autoimmune disorders... and 32 cases of death.

(Dr. Sarah Feldman) (Brigham & Howard Jones)"These are initial reports. We can't assume a cause and effect relationship as many of these women had other, underlying medical conditions that may have contributed or caused their deaths or adverse outcomes." (Dr. Moritz)"Most doctors I know have stopped giving the vaccine because of questions of safety." As a gynecologist... Dr. Jacques Moritz sees the deadly effects of cervical cancer. He is also... the father of an 11–year–old daughter.

(Dr. Jacques Moritz) (St. Luke's / Roosevelt Hospital) "I have decided not to have her vaccinated." JMK: "Why not? Dr:"Until I know more I just don't think it's worth the risk. Cervical cancer is a terrible disease, but if a woman gets a PAP smear once a year her risk of getting cervical cancer is virtually zero. But I just don't know this vaccine." Making the decision to vaccinate... all the more difficult, for many parents and pediatricians(Dr. Sarah Feldman) (Brigham & Women's Hospital)"I feel that we don't have enough information or data yet to be able to persuasively say that this will "prevent" cervical cancer."

-NewsAnchorMom Jen

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Gardasil Worries?

I am looking for a parent/child to interview who is thinking about getting the Gardasil vaccine to protect against HPV.

I am also looking for some parents who give their children vitamin D supplements each day. If you live in Central Illinois, please contact me at newsanchormom (at) gmail (dot) com.

Thanks a ton!

-NewsAnchorMom Jen

4.0 Cheerleader dying from Gardasil?

Warning: This is sad, but important.

FROM ABC: It's a drug that is supposed to help prevent the virus that causes cervical cancer, but one Wichita teen wants Gardasil pulled from the market because of what she says are dangerous side effects. 16 year old Gabi Swank and her mother are on a mission. They want the government to pull the popular Gardasil vaccine from the market. Gabi along with many other girls are dying.

Gabi's mother Shannon Schrag said, "We do have bad days, we do, we can't change what happened to Gabi" Her home is filled with support from friends and family, but the once four point oh cheerleader, so full of energy now is home bound she has seizures, swelling throughout her body and migraines she's suffered two mini strokes. She's surrounded by a dozen different medications as she tries to make it through each day. Last year 16 year old Gabi Swank and her mother Shannon decided the Gardasil vaccine was important.

The family has a history of cervical cancer. Gabi Swank said, "It was a preventative for when I do when i am married" Gardasil is the vaccine recommended for girls and young women ages 9-26 . It 's approved by the FDA for preventing the HPV virus that causes cervical cancer. But after the first shot, Gabi started feeling different. Schrag said, "Her muscles were sore, her joints were hurting, by the time she had the third shot last August. Schrag said, "It was Sept 12 of 08 and she collapsed we thought she was having a heart attack."

Doctors couldn't figure it out, but after months of testing, a Wichita neurologist diagnosed Gabi with Cerebral Vasculatis, a terminal disease, and he blames it on Gardasil complications. Swank said,"Oh, I'm sorry. Don't cry." Gabi's mom said, "I made the choice for her to get the shots, so I deal with the guilt." The FDA has received reports of 28 deaths in the U.S. from Gardasil, but it continues to find that the benefits of Gardasil outweigh the risks.

Gabi knows she's dying, but she is on a mission. Her mom said, "She looked at me with the most somber face and she said if I have to die to save other girls than I am prepared to do that." Swank said,"I want this drug off the market, I want it off the market."

A group called the National Vaccine Information Center is studying the side effects of Gardasil and is reporting to the FDA. The makers of Gardasil still maintain the drug is safe and are now hoping to vaccinate boys with it as well.

-NewsAnchorMom Jen

Gardasil Haulted

There are a lot parents who are worried the Gardasil vaccine can cause serious side effects. Merck has said time and again the drug was tested and does not pose any severe dangers like paralysis and death. Spain seems to think at least one batch of Gardasil did cause some girls to become ill. Was it just a bad batch?

Reuters: MADRID, Feb 10 - Spain's Health Ministry has ordered hospitals and chemists to temporarily halt the use of a batch of cervical cancer vaccine Gardasil, produced by drugmaker Merck & Co (MRK.N), after two girls became ill after a shot. Spain's health ministry said health services would continue to administer shots of the vaccine but ordered that the use of batch NH52670 be suspended after health authorities in Valencia region reported on Feb. 6 that two girls had become ill after receiving the injection. Merck markets the vaccine in Europe with Sanofi-Aventis SA (SASY.PA). It competes with GlaxoSmithKline Plc's (GSK.L) rival product Cervarix.

Both vaccines are designed to be given to girls and young women to protect against cancer-causing strains of the sexually transmitted human papillomavirus (HPV). Sanofi Pasteur MSD, the Sanofi-Merck partnership that sells Gardasil in Europe, said it and health authorities were investigating what happened, but it added that an adverse event after vaccination did not mean the vaccination had caused it. "In both cases, other medical conditions (in the girls) have been observed and are being investigated which could be the cause of the reported events," said Sanofi Pasteur MSD, adding that 40 million doses of Gardasil had been distributed worldwide since its launch in 2006, without showing evidence of concerns. Simon Mather, analyst at bank WestLB, told clients the news was mildly positive for Glaxo, though in any case, Glaxo's Cervarix shot had been chosen in 80 percent of recent tenders. "

Although millions of doses have been administered worldwide without any side effects, it could strengthen Glaxo's claims for winning future tender bids with its rival cervical vaccine Cervarix if it transpires that batches or Gardasil are found to be contaminated," he said in a note. According to the health ministry, 76,000 shots from the affected batch have already been distributed to regional authorities and chemists, who have been told to halt its sale. On Feb 3, Merck reported a 16 percent decline in quarterly sales of Gardasil and cut its expectation for the product's sales this year [ID:nN034901126]. (Reporting by Raquel Castillo; translating by Ben Harding, editing by Will Waterman)

-NewsAnchorMom Jen

No Gardasil Mandate

Medical -News Net:Vaccinating girls against the human papilloma virus (HPV) before they are sexually active appears to be successful in protecting them against cervical cancer, however, a Johns Hopkins University researcher and health policy expert warns it would be ill-advised to mandate vaccinations at this time.

Gail Javitt, JD, MPH, is a Research Scholar at the Johns Hopkins Berman Institute of Bioethics and the Law and Policy Director at the Institute's Genetics and Public Policy Center. In a recently published paper in the Summer 2008 issue of the Journal of Law, Medicine & Ethics , Javitt and her co-authors argue state-mandates requiring girls to be vaccinated for HPV as a condition for school attendance would not currently be supported by legal and ethical justifications.

The HPV vaccine, sold as Gardasil in the U.S., is intended to prevent 4 strains of the human papillomavirus. HPV is the most common sexually transmitted infection in the world. Two strains are known to cause 70% of cervical cancer cases and two other strains are associated with 90% of genital warts cases.

While the HPV vaccine represents a significant public health advance, the article argues it is inappropriate at this time to mandate the vaccine for the following reasons: the vaccine is relatively new, and long-term safety and effectiveness in the general population is unknown; outcomes of those voluntarily vaccinated should be followed for several years before mandates are imposed; the HPV vaccine does not represent a public health necessity of the type that has justified previous vaccine mandates; the economic consequences of mandating HPV are significant and could have a negative impact on financial support for other vaccines as well as other public health programs.

Javitt and her colleagues argue that during the current climate regarding vaccines and their effects on children, state-mandated vaccinations are under a higher degree of scrutiny from parents, especially the HPV vaccine.

The paper argues that state lawmakers' push to mandate HPV has led to significant concern that the government is overreaching its police powers and authority, and unduly interfering with parental rights to make health care decisions for their children. At this time, Javitt warns a mandate could actually do more harm than good, "It could not only pose Constitutional concerns, but could also lead to public backlash, undermining both HPV vaccines and existing vaccine programs."

Gardasil is the first vaccine developed for a disease that is not easily communicable (i.e. airborne) or immediately life-threatening. "There will likely be other vaccines available in the future that don't fit the traditional conditions that have justified state mandates," says Javitt, "and we need to figure out a legally and ethically appropriate way to provide such vaccines to the public."

IMHO: I would be shocked if the government ever mandates a vaccine that is for something that is not easily communicable or immediately life-threatening. Why would that even be an option? Will there be a mandate that all girls go on birth control until they're 18 years old too? I think parents are smart enough to make their own decisions about this vaccine, especially since it's so controversial! What are your thoughts? Is there good reason to mandate the HPV vaccine?

-NewsAnchorMom Jen

Methodist Medical Center's new online healthcare program, MyMethodist eHealth, is a proud sponsor of this blog post. MyMethodist eHealth is the secure link to your doctor's office that lets you request appointments, order prescription refills, update your personal health record, and more. Sign up for MyMethodist eHealth here.

CDC says Gardasil needs more study

From CNN:

Major concerns about a vaccine given to many teen girls. The Centers for Disease Control says Gardasil helps prevent certain types of cervical cancer. But since Gardasil hit the market two and a half years ago - there's been an alarming number of serious adverse reactions and even deaths that some say are linked to the vaccineand as more girls come forward alleging the vaccine made them sick, the more confusion and mystery there is surrounding Gardasil and its manufacturer Merck.

According to a federal tracking system - called Vaers - there have been 9,749 adverse reactions following the vaccination -- and 21 reported deaths since 2006. But Merck - Gardasil's maker - points out these are anecdotal cases.

In a statement, Merck officials say quote: "An adverse experience report describes an event that occurred after vaccination and does not necessarily mean that the vaccine caused or contributed to the event."

The acting immunization safety director for the Centers for Disease Control - says Vaers does not provide enough information for researchers to prove whether Gardasil caused any of the side effects reported, and that the majority of the 8 million girls who have gotten the vaccine have had no problems.

While the CDC believes Gardasil is safe - a conservative watchdog group called Judicial Watch, which has been studying Gardasil safety, says parents' concerns about the vaccine are valid.

The CDC says it's working on a comprehensive study right now that will determine whether or not there is a pattern that links Gardasil to some of these serious side effects. That study is expected to be released in October.

-NewsAnchorMom Jen

Methodist Medical Center's new online healthcare program, MyMethodist eHealth, is a proud sponsor of this blog post. MyMethodist eHealth is the secure link to your doctor's office that lets you request appointments, order prescription refills, update your personal health record, and more. Sign up for MyMethodist eHealth here.

More Gardasil Woes

From ABC:

Gardasil, the vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems. Girls and women have blamed the vaccine for causing ailments from nausea to paralysis to even death.

15 deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The maker of the vaccine, Merck & Company incorporated says it has distributed more than 26 million gardasil vaccines worldwide, including nearly 16 million in the United States.

Merck says while it continues to evaluate reports of adverse reactions to the vaccine, it could just be a coincidence that some women have fallen ill after receiving the shot.

Many people who have really studied this vaccine are crying foul, saying it wasn't tested appropriately and should be taken off the market. How are we as parents supposed to know who to believe? Here are the past links on Gardasil that talk about the controversy.

Gardasil Vaccine Warning

New HPV Article

-NewsAnchorMom Jen

Methodist Medical Center's new online healthcare program, MyMethodist eHealth, is a proud sponsor of this blog post. MyMethodist eHealth is the secure link to your doctor's office that lets you request appointments, order prescription refills, update your personal health record, and more. Sign up for MyMethodist eHealth here.