Sunday, February 04, 2007

Texas ORDERS all girls to be given herpes vaccine

I first thought I was on a news parody site.

But it's true. MSNBC reports, that, by executive order of Texas governor Perry,
Beginning in September 2008, girls entering the sixth grade — meaning, generally, girls ages 11 and 12 — will have to receive Gardasil, Merck & Co.’s new vaccine against strains of the human papillomavirus, or HPV.
Perry is quoted as saying
the cervical cancer vaccine is no different from the one that protects children against polio.
Why did the governor mandate the vaccine?
Merck is bankrolling efforts to pass state laws across the country mandating Gardasil for girls as young as 11 or 12. It doubled its lobbying budget in Texas and has funneled money through Women in Government, an advocacy group made up of female state legislators around the country.
So, why are just girls being targeted?
A recent study found that 90 percent of cervical cancer cases could be eliminated if boys and girls got the vaccine. If only girls get it, just more than three quarters of cases would be eliminated.
This vaccine has NOT been studied long enough, something even the manufacturer admits.
Markman acknowledged that though doctors don't know how long the vaccine will remain effective and if or when booster shots will be needed, those questions will be answered. He noted the women in the original trial are being monitored to determine if the vaccine is still working. But another area doctor, Dr. Martin Myers, said it's "a little premature" to mandate the vaccine.

"This vaccine is an incredibly important milestone and making it compulsory will definitely increase the proportion of girls who are immunized," said Myers, a professor of pediatrics at the University of Texas Medical Branch at Galveston and executive director of the National Network for Immunization Information. "But there's a difference between HPV and diseases like polio, measles and diptheria, which spread rapidly in classrooms."

Myers also cited concerns that the vaccine could cause women to stop going in for cervical screenings, which are still necessary because the vaccine doesn't cover all HPV strains.
One of the MANY troubles with this vaccine approach to protection is that the same girls who are susceptible to infection with HPV (sexually active) are also exposed to:
  • chlamydia
  • hepatitis
  • gonorrhea - many strains not curable by antibiotics
  • herpes - NOT curable
  • syphillis - many strains not curable by antibiotics
  • and PID, to just name a few
Not to mention pregnancy.

This whole situation stinks of cronyism, overkill, and over-reaching by the heavy hand of government. Parents are the ones who are in charge of their children's health, not the government. The effectiveness of this vaccine has not been studied long enough to impose it on anyone. Further, I can see that girls, who will be under the impression that they can have sex without consequences, will be more easily persuaded to engage in riskier sex practices (non-condom sex, multiple partners).

What's next, mandatory Depo-Provera shots?

But, it's (let's all chant it together)
FOR THE CHILDREN!!!!!!!!!!!

I've written about the HPV vaccinations before.

For fun, read an imaginary conversation between Lisa Simpson and the Gov.

And TailRank has a round-up of many blogger's reactions.

5 comments:

stickdog said...

There are two sides to every discussion, of course. This vaccine does appear to confer some benefits. If I were a sexually active woman who disliked condoms and liked to have multiple sex partners who had not yet been exposed to any of the four strains of HPV that this vaccine protects against, I just might sign myself up.

But that's not the same thing as making this vaccine MANDATORY for a preteen population it was not rigorously tested on a scant 8 months after its initial rush job FDA approval.

Aside from all the known risks of all vaccines, the unknown risks of this three shot regimen for preteens along with their other vaccine load, and the unknown long term risks of this vaccine for all populations, we have to look at cost vs. benefit.

7861 of the placebo subjects contracted 83 cases of HPV 6-, 11-, 16-, 18-related dysplasias during the testing period compared compared to 4 cases among the 7858 subjects who were given GARDASIL. That's after counting out every subject with any prior exposure to these strains. This includes 42 of the less serious HPV 6-, 11- related low grade dysplasias.

Merck has published no data for how many non-HPV 6-, 11-, 16-, 18-related dysplasias were contracted by these subjects over these periods, but some practitioners have commented that they expect the vaccine to protect against 40%-50% of all dysplasias.

In terms of every possible kind of dysplasia for which this vaccine confers protection, Merck's own clinical evidence suggests that this vaccine saved about 10 patients out of each 1000 injected from the painful process of having these dysplasias treated (over the entire course of follow ups which ranged from 18 months to 4 years). Note that the populations for these studies were not preteens but women at the height of their sexual activity. Further note that since the vaccine uses virus-like particles (a new vaccine technology) and is only about five years in testing now, there is no guarantee that it has any long term efficacy.

Of course, the pre-teen population is so less sexually active (and when active, so much less likely to be active with a previously contaminated partner) that I think it would be conservative to estimate that preteens are 5 times less likely to contract HPV dysplasias than the 16 to 26 year olds who were tested by Merck. So instead of saving 10 women per 1000 from painful treatments for HPV dysplasias, this vaccine would save perhaps 2 girls per 1000 from these procedures among the much younger population that Merck and Merck's politicians are targeting for mandatory vaccination.

Do we really want to pursue a public policy that costs $360,000 to vaccinate every 1000 girls while exposing each and every one of these thousand girls to the known adverse short term and largely unknown long terms side effects of three injections of a new vaccine just to save two of the more sexually active of these kids from having to have their dysplasias treated conventionally? What kind of a risk and cost vs. benefit trade off is that?

Note that nowhere are we discussing actual incidences of cervical cancer because there is no clinical evidence whatsoever that GARDASIL reduces cervical cancer rates, and even if we place our hope in the the fact that it might, cervical cancer is simply not a meaningful health risk for any girl in the target vaccination population who is getting an annual pap smear.

stickdog said...

While it is a widely accepted medical theory that HPV "causes" cervical cancer, it's not close to being a fact. Although the vast majority do, many cases of cervical cancer don't show any association with HPV. It's a very good guess that certain strains of HPV are necessary co-factors for certain highly prevalent types of cervical cancer to emerge. The two really bad strains protected for in GARDASIL go hand in hand with 70% of CURRENT cervical cancer cases. My point is that there are 36 nasty strains of HPV screened for currently, and the human body is an ecology. We have no idea how protection against the two strains of HPV that are CURRENTLY most prevalently associated with cervical cancer (typically decades after initial exposure) will affect overall cervical cancer rates far in the future.

What we instead DO know is that current practices of annual pap smears and screening for ALL bad strains of HPV continue to reduce rates of cervical cancer among the US population annually. If all US women received a pap smear every year and were then promptly treated for any abnormal growths encountered, both the cervical cancer contraction and mortality rates would plummet even further to the point where HPV-associated cervical cancer would kill no more than a handful of US women a year. Yes, that is a guess as well, but it's a far better guess than assuming that conferring protection against four of the myriad of current and future strains of harmful HPV will somehow do the trick.

Certainly GARDASIL's benefit data against the four strains of HPV it targets are compelling. HOWEVER, the benefit data against ALL forms of HPV are not published by Merck and estimated by OP-GYNs to be a mixed bag. The benefit data against cervical cancer itself are nonexistent. The long term risk data for any population are nonexistent. There are almost no risk data at all for pre-teens. The fact that the "placebo control" was a shot of alum that was recently shown to cause neural death in mice is particularly problematic in terms of interpreting the small amount of risk data that were gathered.

Studies of the long-term benefits of a new drug or vaccine take a long time. It would take several decades to prove conclusively that this vaccine prevents cervical cancer deaths. So why the rush to make these three injections COMPULSORY for pre-teens?

Perhaps this would be excusable if GARDASIL conferred protection against HPV generally, but it does not. We have absolutely no way of even guessing how conferring protection against four strains of HPV will affect cervical cancer rates decades down the line. If you think you do, then please quantify the expected benefits in terms of the expected reduction of cervical cancer contraction and mortality rates for the population of US women who get annual pap smears. The only thing you can say about these numbers are that they are both unknown and tiny.

*****

I am not trying to stop anyone from signing up themselves or their kids for this. If you want to pay $360 to make your little girl one of Merck's test subjects, please do. As I said, the vaccine shows promise. It may be a life saver for a small segment of the population (especially those too poor or uninformed to get annual pap smears), and it offers protection against most genital warts and a good percentage of HPV dysplasias. The procedures to remove these warts and dysplasias are very painful, so these benefits are compelling. However, the risk and cost vs. benefit profile of this vaccine is not such that it is good public policy to mandate it -- especially not for a pre-teen population on which it has never been sufficiently tested -- even with an "opt out" clause. If Merck wants to make sure that women and parents who want it and can't afford it can get it, they should offer it to low income individuals and families on a sliding scale rather than lobbying state and federal governments to pony up the billions.

This is hope-based medical policy. We are hoping the vaccine will have benefits against cervical cancer, and we are hoping that three injections of this vaccine (along with its alum adjuvant) will have no meaningful long term effects. We are talking about forcing a vaccine with a completely unknown period of efficacy on a pre-teen population it was not tested on -- most of whom already get annual pap smears despite no or limited sexual activity! How many among the population of 9 to 26 year old women who get annual pap smears die of cervical cancer? This number is TINY and always getting smaller as we screen for more and strains of HPV.

You know who could really use this vaccine? Places where you can't go down to the women's needs center to get your annual pap smear. Places where they can't afford to effectively treat dysplasias. Places like the third world. But Merck needs money after its VIOXX disaster, so our daughters are being made into the guinea pigs for this vaccine so Merck can rob our public coffers.

In terms of genital warts, that's actually what this vaccine has been shown to be highly effective against. If Merck wants to sell it to women and men that way, I have no problem with that. But you should have to opt in rather than have it forced on your kids by Big Brother as a condition of sending them middle school! Now we see that all these commercials had little to do with actually selling the product to us, but were instead all about selling the idea to us that it would be a good thing to make this vaccine mandatory.

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Depo-Provera Prescription Information said...

My name is Janice Still and i would like to show you my personal experience with Depo-Provera.

I am 24 years old. I have been on Depo for 9 years and did not realize that the symptoms I experienced might be related to the shot. I am now facing thousands of dollars in dental work due to bone density loss, and will probably end up with osteoporosis. I am getting off Depo and will never touch it again!

I have experienced some of these side effects-
Low libido, joint pain, bone density loss, dental problems, headaches, fatigue, out of control eating, gained 40 lbs., depression

I hope this information will be useful to others,
Janice Still