Ah, Perry, You Ol’ Dog…
By txmed • Feb 2nd, 2007 • Category: UncategorizedTexas is the first state to require the HPV vaccine! (I’m really into exclamation marks right now).
Texas on Friday became the first state to require all 11- and 12-year-old girls entering the sixth grade to be vaccinated against a sexually transmitted virus that causes cervical cancer.
Averting a potentially divisive debate in the Legislature, Gov. Rick Perry, a Republican, signed an executive order mandating shots of the Merck vaccine Gardasil as protection against the human papillomavirus, or HPV, starting in September 2008.
The order won’t live up to all public health pundits’ expectations, seeing as those who object can opt out. I think that is the right move personally. With that provision I applaud the move by my Governor.
Opposition has centered not only around the age old question of the rights of parents to keep their children from being vaccinated but also around the vaccine, given to such young girls, being a form of acceptance of sexual activity at a young age.
The governor’s executive order directing his Health and Human Services Commission to adopt rules mandating the HPV inoculations along with others required for schoolchildren saved legislators from having to go on record for or against a bill involving child sexuality.
Some parents have voiced concern that the plan could send a message that sexual activity was condoned or that vaccinations made it safe. On the whole, however, conservative and religious groups have not come out strongly against the vaccinations as long as families can opt out.
It is of note that Merck is represented in Austin by a powerful lobbying group headed by Governor Perry’s former Chief-of-Staff.
Merck is manufacturer of the HPV vaccine.
A Merck spokesman, Raymond F. Kerins Jr., declined to discuss the company’s lobbying efforts in Austin, part of a nationwide campaign that has enlisted women in state legislatures to advance the program.
“Merck’s goal is to support efforts to implement policies that ensure that Gardasil is used to achieve what it was designed to do: help reduce the burden of cervical cancer,†Mr. Kerins said.
I’m proud of Texas.
txmed is a fourth year medical student with a strong interest in health care policy and politics. In addition to From Medskool, he writes for Medscape and helps run the popular medical blog carnival Grand Rounds.
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So I’ve been watching all these ads on TV telling people to find out about GARDASIL. And then I read that Merck was lobbying for this vaccine to become mandatory. Then I saw that the Texas governor is making this vaccine mandatory in Texas for preteens. So I finally decided to look into it.
Here’s the scoop:
1) GARDASIL is a vaccine for 4 strains of the human papillomavirus (HPV), two strains that are strongly associated (and probably cause) genital warts and two strains that are typically associated (and may cause) cervical cancer. About 90% of people with genital warts show exposure to one of the two HPV strains strongly suspected to cause genital warts. About 70% of women with cervical cancer show exposure to one of the other two HPV strains that the vaccine is designed to confer resistance to.
2) HPV is a sexually communicable (not an infectious) virus. When you consider all strains of HPV, over 70% of sexually active males and females have been exposed. A condom helps a lot (70% less likely to get it), but has not been shown to stop transmission in all cases (only one study of 82 college girls who self-reported about condom use has been done). For the vast majority of women, exposure to HPV strains (even the four “bad ones” protected for in GARDASIL) results in no known health complications of any kind.
3) Cervical cancer is not a deadly nor prevalent cancer in the US or any other first world nation. Cervical cancer rates have declined sharply over the last 30 years and are still declining. Cervical cancer accounts for less than 1% of of all female cancer cases and deaths in the US. Cervical cancer is typically very treatable and the prognosis for a healthy outcome is good. The typical exceptions to this case are old women, women who are already unhealthy and women who don’t get pap smears until after the cancer has existed for many years.
4) Merck’s clinical studies for GARDASIL were problematic in several ways. Only 20,541 women were used (half got the “placebo”) and their health was followed up for only four years at maximum and typically 1-3 years only. More critically, only 1,121 of these subjects were less than 16. The younger subjects were only followed up for a maximum of 18 months. Furthermore, less than 10% of these subjects received true placebo injections. The others were given injections containing an aluminum salt adjuvant (vaccine enhancer) that is also a component of GARDASIL. This is scientifically preposterous, especially when you consider that similar alum adjuvants are suspected to be responsible for Gulf War disease and other possible vaccination related complications.
5) Both the “placebo” groups and the vaccination groups reported a myriad of short term and medium term health problems over the course of their evaluations. The majority of both groups reported minor health complications near the injection site or near the time of the injection. Among the vaccination group, reports of such complications were slightly higher. The small sample that was given a real placebo reported far fewer complications — as in less than half. Furthermore, most if not all longer term complications were written off as not being potentially vaccine caused for all subjects.
6) Because the pool of subjects were so small and the rates of cervical cancer are so low, NOT A SINGLE CONTROL SUBJECT ACTUALLY CONTRACTED CERVICAL CANCER IN ANY WAY, SHAPE OR FORM — MUCH LESS DIED OF IT. Instead, this vaccine’s supposed efficacy is based on the fact that the vaccinated group ended up with far fewer cases (5 vs. about 200) of genital warts and “precancerous lesions” (dysplasias) than the alum injected “control” subjects.
7) Because the tests included just four years of follow up at most, the long term effects and efficacy of this vaccine are completely unknown for anyone. All but the shortest term effects are completely unknown for little girls. Considering the tiny size of youngster study, the data about the shortest terms side effects for girls are also dubious.
These are simply the facts of the situation as presented by Merck and the FDA. This vaccine was just approved in June, 2006. It was never tested on pre-teens except in a tiny trial run with at most 18 months of follow up. Even if we subscribe to the theory that HPV causes cervical cancer, there is ZERO hard data showing that this vaccine reduces cervical cancer rates or cervical cancer mortality rates, which are both already very low in the US and getting lower every year. Now Texas has already made this vaccine mandatory for middle school with all sorts of useful idiots and Big Pharma operatives clamoring for more states to make this vaccine COMPULSORY immediately.
Has everyone gotten the picture or should I continue?