As soon as a teenage girl walks into her pediatricianís office, he will suggest another vaccination, to be delivered through a series of shots spaced out over six months.† This time the vaccine is Gardasil, intended to protect her from being infected by the human papilloma virus, HPV, which might cause cervical cancer later in life.
On balance, is this series of vaccinations a good idea?† Is it safe; is it worth the possible side effects?
Gardasil is manufactured by Merck Vaccines.† It was fast-tracked for approval in June 2006 by the Food & Drug Administration after only two years and limited studies of only 1,200 girls for only two years.† Like all pharmaceutical products, as well as the chemicals used in all manufactured products, from skin cream to formaldehyde, the manufacturer is in charge of the studies.
When, after the two-year study, the CDC recommended that Gardasil routinely be given to all 11- to 12-year-old girls, the head of the CDC was Julie Gerberding.† With the change of administrations, she left for a job as president of Merck Vaccines.† (Just one more typical example of the revolving door between industry and the folks who are supposed to protect our health.)
Merck is the company that had known for nearly a decade before it became public knowledge that infants getting the federally-mandated multiple vaccinations were thus getting an elevated dose of mercury from the preservative in those vaccines (a dose up to 87 times higher than guidelines for the maximum daily consumption of mercury from fish), but did not disclose this information.† Gardasil is preserved with aluminum, like mercury, a toxin.
It is not clear that Gardasil is truly effective nor worth the risk.
Now that tens of thousands of girls have gotten this series of vaccinations, records kept by the Vaccine Adverse Event Reporting System (VAERS) show a high level of adverse reactions.† The reactions generally double after the second injection and quadruple after the third.† They range from headache, hair loss, dizziness and nausea, to an anaphylactic shock, seizures and even death.† Read their stories at truthaboutgardasil.org, a website founded by Marion Greene whose own daughter was injured. †In fact, there are twice as many adverse side effects from Gardasil as from flu shots (which contain mercury).† Merck, of course, reports virtually no risk.
Gardasil is approved to protect girls and women, ages 9 through 26, from the two types of HPV that are responsible for about 70 percent of cervical cancer cases (and against two other types that cause 90 percent of all cases of genital warts).† There are more than 120 types of HPV, as many as 40 of them spread through sexual contact; of these 40, 15 types have the potential to cause cancers in females and males.† The vaccineís effectiveness is very limited against these other types of HPV.† Furthermore, about 90 percent of genital HPV cases clear up on their own within two years.
Even worse, news has leaked out that Gardasil increases the risk of precancerous lesions, or worse, by 44.6 percent among people (most likely those who are sexually active) who have already been exposed to two types of the HPV virus.† This time, Merck actually told FDA about this risk, yet the agency approved the vaccine and did not even demand a warning insert in the package.
Nor is anyone sure about how long the protection will last.† As you read, above, the Merck study followed vaccinated girls and women for only two years, and in some cases even gave them booster shots.† Other clinical trials followed women ages 16 to 23 for up to four-and-a-half years after their three does of the vaccine.† But compare that to the fact that cervical cancer takes decades to develop.† Then thereís the fact that HPV exposure occurs in 10 percent of children in the first 10 years of life, before any vaccination.
The risk of adverse effects from the vaccine seems higher than the risk of getting cervical cancer in the U.S.† Thatís because women and teenage girls in our country, when they become sexually active, are likely to get regular pap smears which detect cell abnormalities before they turn into cancer, and so treatment can start long before the cancer develops.† Cervical cancer rates have dropped 74 percent since regular pap smear testing began.† Itís among the women who have not had a pap test for five years or more that most cervical cancer is found these days.† And pap smears are still required even for a girl who has been vaccinated.
Gardasil is the most expensive vaccine ever recommended for school-age children.† Merck charges $120 for each dose, and the cost for the three-shot regimen adds up to $400 to $1,000 per patient.†† Merck is now pushing to extend its market, to boys and men, to prevent genital warts, and to women up to the age of 45.†† It advertises widely, and is also pushing a campaign in at least 20 states to convince legislators to require the HPV vaccinations as a prerequisite for girls to attend school.† My state of Massachusetts actually considered such a mandate, but so far that has not succeeded.
Another HPV vaccine, Cervarix, manufactured by GlaxoSmithKline, was approved in May of this year.† It protects against only two strains of HPV virus, contains almost twice the aluminum content as well as a second adjuvant (a chemical agent added to boost the effectiveness of the active ingredient).† Higher rates of anaphylactic shock reactions have been reported after Cervarix than Gardasil in Europe, where both have been used.
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Related: To Vaccinate Your Child, Or Not?