Monday, February 05, 2007

What's the hurry?

From
The Washington Times
Negative side effects of Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that causes cervical cancer, are being reported in the District of Columbia and 20 states, including Virginia. The reactions range from loss of consciousness to seizures.
"Young girls are experiencing severe headaches, dizziness, temporary loss of vision and some girls have lost consciousness during what appear to be seizures," said Vicky Debold, health policy analyst for the National Vaccine Information Center, a nonprofit watchdog organization that was created in the early 1980s to prevent vaccine injuries.
Following federal approval of the vaccine in July 2006, a storm of legislation was introduced across the nation that would make the vaccine mandatory in schools.
The same article is reporting lower stats than other sites – I'm generally reading 11K+ cases of invasive cervical cancer projected for 2007. That's a major jump, especially since the incidence of cervical cancer (US) has been declining for years.
The American Cancer Society estimates there were 9,710 new cases of cervical cancer in the United States in 2006.

I'm particularly unnerved about this:
Merck spokesman Chris Loder said the vaccine is effective for five years and the Whitehouse Station, N.J., drug maker is not sure how long afterward the vaccine will work. Critics point out that an additional booster shot may be necessary.
So, are they suggesting that a booster may be necessary? From my reckoning, it will need to be updated just when the girls are hitting the 16-18 year range – precisely when they are more likely to be having sex.

Therefore, vaccinate them early, because some girls are having sex at ages when their partners could be charged with stat rape. However, at the ages girls are more likely to have consensual sex, the vaccine MAY NOT WORK!

From the Merck site:http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf
As with all vaccines, GARDASIL may not fully protect everyone who gets the vaccine.
Merck says that, even if previously infected with HPV, women should get the vaccine, since there's no way to know precisely which strain caused the positive response. On the Women to Women site, http://www.womentowomen.com/sexualityandfertility/gardasil-landing.asp
in contrast, they found that
trial subjects who had already had exposure to the four strains showed higher rates of cervical neoplasia (abnormal cancer cell precursors), raising questions as to whether the vaccine impairs immune response under such circumstances, or whether there were demographic factors at play, or both.
The evolutionary issue has to be considered – remember that old maxim, Nature abhors a vacuum?
How long will protection last? Will boosters be needed? Or worse, will elimination of just four out of over 100 viral strains create a niche for other strains to fill? Swimming in its own vast gene pool and with billions of human hosts at hand, HPV has quite a survival advantage. What will happen to the niche currently occupied by strains # 16, 18, 6 and 11, if they are eliminated through vaccination? Microorganisms enjoy an extremely short life-cycle relative to ours, giving them the evolutionary edge when it comes to developing resistance against the very drugs and vaccines (and pesticides) we employ to annihilate them.
Further, I don't entirely agree with adding the 2 strains of genital warts to the package. Wouldn't it have been more useful to protect against the remainder of the HPV strains that are said to be responsible for about 30% of cancers?
Where have all the young men gone? On another note, if our desire to protect women from cervical cancer is genuine, when would such a vaccine be ready for administration to men and, for that matter, when will boys and men be lined up to receive it? Some speculate that the reason protection is afforded against two genital wart strains by the vaccine is not simply because, as the company describes it, the presence of infection from the two strains can be a confounding factor in determining exposure to oncogenic strains, but because men worry most of all about the cosmetic impact of contracting genital warts, so having resistance to warts would lend cachet to having the vaccination.
Yeah, the unsightliness of those warts on the penis does inhibit women from rushing the guys into the sack. You have to look at the warts and say, wow, if he has that, what ELSE does he have?

The American College of Pediatricians opposes forcing HPV vaccination as a requirement for school attendance.
The American College of Pediatricians applauds the availability of HPV vaccine. We strongly oppose requiring students to obtain the Human Papilloma Virus (HPV) vaccine as a requirement for public school attendance.
HPV is spread only by intercourse. Keeping children out of school because they have not been vaccinated with the HPV vaccine is a serious, precedent-setting action. It replaces parental medical decision-making with government regulation which should be reserved for the improvement of the general public health. HPV cannot innocently be “caught” in a classroom as measles or other vaccine preventable diseases can.
The College also addresses the need for boosters
Waning protection is an issue with almost every vaccine in existence.
From Merck's own site, something new. I know I've not seen this information before
GARDASIL* is a non-infectious recombinant, quadrivalent vaccine
Given many people's reaction to manipulating DNA, I think the public should be aware of this.

1 comment:

stickdog said...

The Facts About GARDASIL

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 test subjects was 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.

8) GARDASIL is the most expensive vaccine ever marketed. It requires three vaccinations at $120 a pop for a total price tag of $360. It is expected to be Merck’s biggest cash cow of this and the next decade.

These are simply the facts of the situation as presented by Merck and the FDA.