TIME: Cancer Vaccine Gardasil under fire.

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http://www.time.com/time/health/article/0,8599,1816507,00html?xid=rss-healthAnti-Vaccine Activists vs. Gardasil Thursday, Jun. 19, 2008 By HILARY HYLTON/AUSTIN Gardasil has been a shot in the arm for pharmaceutical giant Merck. Thecompany had been reeling from the withdrawal of its anti-arthritis drugVioxx because of increased risk of heart attacks and resulting lawsuits. Now however, Merck's new vaccine against the human papilloma virus (HPV) —aimed at combating cervical cancer — has been deployed worldwide, earning anestimated $1.5 billion in sales. But the drug is coming under increasingfire from anti-vaccine activists. Already very vocal about childhoodinnoculations,

now they are expressing concern about the effects of Merck'sdrug on young girls, a primary focus of the company's big ad campaign. The movement's efforts and propaganda are particularly viral on the web. Onestory that has been making the rounds for the past week, starting with areport in the Dallas Morning News, concerns Dallas mother Michelle Kimzey,who said that her 14-year-old daughter Katherine, after receiving her secondshot of the three-dose vaccine battery in November, experienced headaches,fainting and stiff joints. A few weeks later, she suffered a seizure andlater was diagnosed with epilepsy, according to her mother. Kimzey said thatshe reviewed 5,000 reports filed by the public on a government databasewebsite that monitors vaccine safety and became convinced that her daughters health problems were related to the Gardasil shot. "When you readeverybody's stories, they're too similar not to be related," Kimzey told theNews. The story has been picked up by over a hundred mainstream mediawebsites and by blogs and chatrooms like vaccinationnews.com.The government website Kimzey was referring to is VAERS — the VaccineAdverse Event Reporting System — a program run by the Centers for DiseaseControl (CDC) and the Federal Drug Administration (FDA). Drug companies arerequired to report any adverse reactions to VAERS, according to CDCspokesman Curtis Allen, while doctors, patients and parents are encouragedto do so. The CDC regards the VAERS as "an early warning system," Allen said that allows them to pick up any statistical trend that might indicate aproblem. For health professionals, the VAERS system provides some of

thebest data related to vaccine safety, beyond that provided by themanufacturer, according to Jessica Kahn, M.D., a pediatrician, HPVresearcher and teacher at Cincinnati Children's Hospital Medical Center. Thedanger is that such uninterpreted raw data can also be misused. "It is veryimportant to note," says Dr. Kahn, "that anyone can report a side effect toVAERS, and just because it is reported does not mean it was caused by avaccine."For example, a study of VAERS reports of fainting among Gardasil recipients— the medical term is syncope — published in the Journal of the AmericanMedical Association this month did lead to a recommendation that patientsshould be kept seated or lying down for 15 minutes following the shot. ButAllen says reports of other serious side effects, instigated by VAERS datas,have been investigated and the CDC has not found any causal link to GardasilNevertheless,

stories like Kimzey's on Gardasil and other vaccines — manypicked up from VAERS reports — continue to fly around the web. "This issueis not going away as more and more vaccines are brought to the market,"Barbara Loe Fisher, president of the National Vaccine Information Center(NVIC) who became an activist after a serious reaction in her son to a DPTvaccine (a combined innoculation against Diptheria, Whooping Cough —pertussis — and Tetanus). Fisher, who has served on an Federal DrugAdministration consumer advisory committee on vaccines, takes issue with theCDC's read of the

VAERS Gardasil reports. Her organization, NVIC, has calledon the CDC and FDA to warn the public that Gardasil has been associated withat least 15 cases of Guillain-Barre Syndrome (GBS), an autoimmune disorder;and it says there is an increased risk for GBS when Gardasil isco-administered with other vaccines, particularly Menactra, a meningitisvaccine.But Dr. Kahn says there no evidence to suggests that the GBS cases reportedwere caused by vaccination. "Because GBS occurs, though rarely, in youngwomen, it is inevitable that some cases will occur after vaccination bychance and are not caused by vaccination," Dr. Kahn said. "Among 9 to 26year-olds, the number of reports of GBS received by VAERS are within therange that could be expected to occur by chance alone after a vaccination."Fisher calls that argument a "utilitarian rationale" and said too often thenumbers are dismissed as a small sacrifice necessary for the greater good. How many is too many?" she asks.NVIC is concerned about the growing number of vaccinations required byschools and the push, in some public health quarters, to mandate morevaccines. The political fight

has been taken to New York and New Jersey. NewYork state public health officials have endorsed state legislation thatwould take the CDC's recommended vaccine list for children and declare it tobe mandatory, Fisher says, and she sees that as a move that should alarmparents. Vaccinations should be voluntary, Fisher says, and be made with informed consent" by parents. Dr. Kuhn agrees on that point. "Parents shouldask any questions that they wish in order to feel comfortable that they haveenough information to make a decision about vaccinating their child," shesays. "They should bring up any concerns that they have and make sure thatall of their questions are answered before agreeing to any vaccine for theirchild.It is now 30 years since I have been confining myself to the treatment ofchronic diseases. During those 30 years I have run

against so many histories of littlechildren who had never seen a sick day until they were vaccinated and who, in the severalyears that have followed, have never seen a well day since. I couldn't put my finger onthe disease they have. They just weren't strong. Their resistance was gone. They wereperfectly well before they were vaccinated. They have never been well since. "---Dr. William Howard Hay

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My daughter tells me that 15 girls died in or shortly after the initial clinical trials - Merck denied responsibility for these deaths claiming that they were not related to the vaccine, however there were stringent checks that all participants were completely healthy prior to the trials

 

Jane