Interesting facts about vaccinating for cervical cancer

I did a lot of research in January about cervical cancer and Merck's vaccine Gardasil for Suite101. There were some unexpected facts about the vaccine that I came across and wanted to point out.

One is that the vaccine contains an additional component called an adjuvant, even though clinical studies showed that the HPV proteins don't need one. Adjuvants usually help a vaccine activate an immune response, but they also increase side effects because they are usually salts or metals. In Gardasil there is aluminum salt! And 80% of clinical study participants had adverse reactions to the shot...even those who were given the adjuvant alone.

I expected to find that there were serious side effects covered up during the clinical trials, like has been seen with other companies, but there were no serious adverse effects from the vaccine during the trials. The study size was too small to see some of the more severe effects such as seizures, paralysis, and death, that are being seen when a larger number of girls are vaccinated. However, there were not any long term studies. These were promised as "post-marketing strategies". Which brings me to my third surprise.

The FDA approved the vaccine based on short term results in 16-26 year old women and "post-marketing" promises from the drug maker. Merck promised the FDA that long term studies on safety and efficacy would be done only after the drug was approved to be used. In other words, they want a return on their investment before they'll pay to actually test that the vaccine works in 11 year olds beyond their late teens and that it's safe.

According to the American Cancer Society, the average age of a women suffering from cervical cancer is 47. Yet we are told to vaccinate 11 year old girls with a drug that most likely only works for 5 years. So they'll still get cervical cancer in their 20s. When they would have to begin with. I'm speechless.

And finally, in the FDA summary for the drug approval it states that the vaccine does not protect against HPV infection. What it actually protects against is the development of cervical cancer caused by persistant HPV infection.

Since only about 5% of women have been shown to have the persistant HPV infections that cause cervical cancer I wonder why a vaccine that is harming 1 out of every 10,000 girls is ok, especially since there are about 16 million to vaccinate. By my calculations about 1600 can expect to have severe problems with it and it's only helping reduce about 70% cases of HPV-associated cervical cancer.

There are reports now also that Merck has filed with the FDA to seek approval for vaccinating older women. Although there are no studies in that age group, the vaccine has been shown to not work in anyone already exposed to HPV, and there are unanswered safety issues. Oh yeah and they want to give it to 11 year old boys now too! Shocking, no?!

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