Wednesday March 14, 2007
New Mexico Close to Mandating HPV Vaccine for 6th Grade Girls Despite Lingering Questions about Safety
By Peter J. Smith
SANTA FE, New Mexico, March 14, 2007 (LifeSiteNews.com) – New Mexico Gov. Bill Richardson intends to sign legislation within the week mandating the immunization of young girls entering the 6th grade with Gardasil, a vaccine against the sexually transmitted human papilloma virus (HPV), which causes cervical cancer in women.
"It's a public health issue, and I believe it's an important step," Gov. Richardson said Monday. "New Mexico has always been progressive on these issues... We've got to find ways for young women to be protected."
The measure passed Sunday in the Legislature and would take effect June 15. However, the law permits parents to decline having their daughters vaccinated, and would not prevent them from attending school.
Gardasil is a three-dose vaccine by Merck & Co. released last June for young girls and women ages 9 to 26 protecting against HPV 16 and HPV 18 strains that cause 70% of cervical, vulvar and vaginal cancers and genital warts.
However, many are concerned that politicians may be mandating the drug without giving sufficient thought to the potential side-effects or benefits of Gardasil in young girls.
“The last time Merck was in the news was for Vioxx, which appeared safe in trials but later showed serious health hazards,” said Wendy Wright, President of Concerned Women for America, who called mandating the vaccine for schoolgirls “an overreach.”
Merck, which lobbied extensively for mandating the vaccine tends to make an enormous profit from its most expensive vaccine costing $120 per shot for 3 shots. Profits from Gardasil reached $155 million for the fourth quarter of 2006 and $255 million for the entire year.
Wright pointed out that Merck will enjoy protection from medical liability under the National Childhood Vaccine Injury Act, which will protect it from the class action lawsuits it has endured from Vioxx, a prescription drug.
However, CWA documents that Merck sacrificed adequate data testing involving pre-adolescent children (its target group). Merck utilized adult data to “predict” the immune response in children, meaning it has no evidence the vaccine prevents anything when given to children ages 9-12. Also, the maximum median follow up in any of its studies was 4 years, while sexually-transmitted HPV requires 10-15 years from time of infection to the development of cervical cancer.
However, the Washington Times reports Merck’s target age for girls’ to receive the vaccine is too low: Girls inoculated with Gardasil will be no older than 18 when they reach the end of the vaccine’s proven 5 year effectiveness. Given the CDC’s assumption the vaccine may be 10 years effective, it still leaves them vulnerable in their 20s to early 30s, while the typical cervical cancer patient (age 47) acquires the virus in her 30s.
"Nobody at Merck, the CDC or FDA knows if the injection of Gardasil into all pre-teen girls - especially simultaneously with hepatitis B vaccine - will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults,” said Barbara Loe Fisher, president of the National Vaccine Information Center.
The NVIC has asked states to address growing reports of mild to severe adverse affects involving Gardasil including severe headaches, dizziness, temporary loss of vision, some lost consciousness during what appear to be seizures, and temporary paralysis.
Fisher said, "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria-acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome.”
“With cervical cancer causing about one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group."
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