Monday, February 05, 2007

HPV Vaccine Mandatory in Texas--UPDATED SCROLL DOWN

Today, Texas became the first state to mandate the HPV vaccination for girls. My peeved mom called today and asked my opinion. My first instinct is to dislike it because of the way Governor Rick Perry handled the issue--by executive order. Republicans here are NOT happy:

Several key Republican lawmakers lashed out Monday at Gov. Rick Perry's edict requiring anticancer vaccines for all Texas schoolgirls and vowed to derail the plan before it takes effect.

State Sen. Jane Nelson urged Perry to rescind the order and said she will ask Attorney General Greg Abbott to rule on its legality. Three other Republican lawmakers filed bills that would override the mandate and several others were working on similar legislation.

"The public has the right to testify on this issue and the Legislature has the constitutional duty to be involved in this decision," said Nelson, who chairs the Senate's house and human services committee.

Perry defended his decision, saying his fellow conservatives were wrong to worry that mandating the vaccine will trample parents' rights and promote premarital sex.


Here are the facts:
  • Human Papilloma Virus is a sexually transmitted disease.
  • Nearly all Cervical cancer is caused by various strains of HPV.
  • The new Gardasil vaccine protects women from the strain of HPV that causes 70% of cervical cancers. From their website:
    GARDASIL is the only vaccine that may help guard against diseases that are caused by human papillomavirus (HPV) Types 6, 11, 16, and 18:
    Cervical cancer
    Cervical abnormalities that can sometimes lead to cervical cancer
    Genital warts
    HPV Types 16 and 18 cause 70% of cervical cancer cases, and HPV Types 6 and 11 cause 90% of genital warts cases.
  • The HPV vaccine is not a guarantee of cervical cancer avoidance, it reduces a woman's risk of cancer.
  • 80% of women have HPV by age 50.
  • If a woman remains sexually inactive she has a 0% chance of getting any strain of genital forms of HPV.
  • The NIH recommends that girls get vaccinated at age 12. The website says for women ages 9-26.
There is resistance to the vaccine in some parts:

David Catania, a Washington, D.C., City Council member, says there's a simple reason [for wanting to make the vaccine mandatory]— protection against cervical cancer.

"For 14,000 women per year it means cervical cancer, and for 4,000 it means death," he said. "The district has a particular reason why this is important. It is important because we lead the nation in cases of cervical cancer. We have the highest instances of cervical cancer in the country."

But as in most states where there have been proposals to require the vaccine, Catania had to take a lot of heat. A local newspaper columnist worried that the measure suggests girls in the District of Columbia's public schools — most of whom are African American — are sexually promiscuous. Catania insists that the legislation doesn't target any particular group and the vaccination wouldn't exactly be mandatory.

The newspaper columnist reveals political correctness run amok. If D.C. has the highest rates of HPV infections, I would suggest that the girls there are promiscuous. Don't worry, though. Girls, black and white, are promiscuous or have steady sexual partner everywhere these days, so it isn't racial motivated to recommend the vaccine. Nearly 70% of girls have had sex by age 18.

I have reservations about this vaccine for a couple reason:
  1. What 9 year old is/should be sexually active?
  2. This vaccine is being marketed like it's a magic pill. The reason for this is market-driven not health-driven.
  3. How are the longitudinal safety studies? I'm a skeptic about these things. I view all new treatments like I view the new Vista operating system--with reservation. New technology takes a while to get the bugs out. Medical treatments, including vaccines, do, too.
  4. Where do parents rights/states rights begin? This is perhaps the most important issue for me. I'm not alone in this concern. The government has progressively gotten more intrusive when it comes to vaccination and health in general. I don't like this road we're on. Will the state require genetic modification (or will insurance companies?) when that becomes available for diseases like heart disease or other forms of cancer?
And here is a long-term question: Will insurance companies refuse to give treatment to a woman who refused a vaccine and then gets the cancer? That hasn't happened thus far with smoking, but premiums are certainly affected.

The LA Times discusses some other ethical concerns:
The debate highlights the balance between government's obligation to safeguard the health of its people and the rights of individuals to make their own decisions about matters affecting their health and their children's health.

All vaccine mandates pose this dilemma. But the question of an HPV vaccine presents more medical and ethical wrinkles.

"School-based laws began in the 19th century, at about the same time as mandatory education laws," says James Colgrove, a medical historian at the Columbia University Mailman School of Public Health who recently wrote an article for the New England Journal of Medicine about the ethics and politics of HPV vaccination. "People realized that schools were breeding grounds for illness." [this is still true, by the way-ed.]

Because HPV is not spread through the germ incubator of the classroom, a mandatory vaccine would lack that rationale. Further, for the first time, vaccination policies would affect only one gender. "With a compulsory HPV vaccination, we really are kind of getting into a different territory," Colgrove says.
Some libertarians like Glenn Reynolds are for this vaccine and would even include it in childhood vaccinations. He is dismissive of the science those in the alternative health profession, like chiropractors (I am a chiropractor), claim undermines vaccination benefits.

I am wary of vaccines due to personal experience. I nearly died of anaphylactic shock reaction to the Measles part of the MMR vaccine as an infant. I had successfully been vaccinated for small pox--the public should be happy that I won't be a vector for that...or shouldn't be if it works (many vaccinations efficacy wane with time). My husband was fully vaccinated but was one of the hundreds that year that received a "bad" batch which resulted in these people thinking they had immunity, but they did not. He ended up with mumps as a teenager (along with his teenage brothers). He ended up with Measles as an adult and ended up giving that to my son (who wasn't immunized due to the family history of anyphalactic shock). So, there you go. (My son was okay, by the way. I nurse all my kids for 18 months to two years and they receive passive immunity this way. A child's immune system does not fully mature until age two.)

I have reasons to be very grateful to drug manufacturers. Glenn Reynolds does, too. His wife lives because of a hi-tech pacemaker and an exotic pharmaceutical. My son, born at 24 weeks gestation, received Bovine surfactant (Surfican) that saved his little life. (Unfortunately his twin died by being infected with a hospital-borne strain of Methicillin ResistantLink StaphylococcusAureus [MRSA] .) Without these surfactant and powerful antibiotics, my surviving son would have died, too.

I have reasons to be skeptical of drug manufacturers. There is a constant push to increase markets for medicines that are untested for that use. This is call off-label usage. Children are being medicated with drugs that have never been tested on them. Ditto vaccinations. Children are walking experiments. There has yet to be one randomized, controlled study for the efficacy of the Hep B vaccination in children and yet they are given this vaccination at birth. The studies that were done were conducted on young men. Why? Because young men are at the highest risk for the Hep B due to homosexual activity and I.V. drug use. Psychotropic medicines are given to young children--ages two and three--with not one randomized controlled trial.

Then there are the medications that did have full trials and were found much later to be worse than the disease they were purportedly treating. These include COX-2 inhibitors (a class of anti-inflamatories) and Hormone Replacement Therapy. Stroke, cardiac arrest, heart disease and cancer were the unfortunate side-effects but were only found years down the road.

Now we come to a vaccination that will only be used on women, young women, and for a disease that can be prevented (like Hepatitis B) behaviorally. Again, from the LA Times,
Proponents of mandatory vaccination are invoking the philosophy of utilitarianism, the notion that decisions should be made to provide the greatest good for the greatest number of people, Zimmerman says. That philosophy, he says, can be used to justify all sorts of ethically suspect behavior. Although he plans to have his daughter vaccinated against HPV, he says he should not be coerced to do so.

"HPV is not caught by sitting next to someone in class but by sexual contact, which often is a lifestyle choice," he says. "Using school laws, which were developed to protect children from communicable diseases like smallpox and measles, to mandate vaccination against a sexually transmitted infection, is to use the ends to justify the means."

As for other vaccine mandates, such as those for measles or whooping cough, Zimmerman says that other ethical principles justify those requirements — notably the notions of beneficence (doing good) and nonmaleficence (doing no harm), Zimmerman says. "If a person who is unvaccinated brings measles or pertussis [whooping cough] to school, their mere presence can lead to harm to other children," particularly to those children who cannot receive the vaccine for medical reasons.

While I don't want one more woman to die from cervical cancer, I don't want the government to mandate one more invasive rule, either. There is an unholy alliance between the FDA, drug manufacturers and the government--especially for vaccines. (Vaccine manufacturers get the benefit of not being liable for any side-effects secondary to their vaccines. Isn't that great? Even if they manufacture vaccines overseas, they are contaminated or worthless...no liability.) I understand how expensive it is to bring a drug to trial. I have talked before about potential solutions to the problem. In short, I think people are oversold solutions and then shocked when the "solution" doesn't work with his or her body chemistry. All interventions need to be viewed with caution--and medicines, including vaccinations are interventions.

Another thing: while vaccinations have been tested individually, the results of the substantially increased number of vaccinations at one time have not been tested. Of course, one could point to the millions of kids walking around as evidence that they don't have a deleterious effect. My personal experience suggests otherwise.

Taken together, I think all people, not just parents, should be concerned about the aggressive "it's for your own good" stance the government has progressively taken. Between eminent domain, the IRS and the local health department, citizen's rights continue to erode. For those worried about wire-tapping (and I actually view the NSA program to be for the public good), state-mandated HPV vaccination is just one more way the government controls your life and mine.

Here are some resources:
  • Nice one page summary of vaccination (Australia, but chosen for clarity).
  • Website information skeptical of vaccination and here, too.
UPDATE:

Wouldn't you know, the last thing before bed, I go looking at Anchoress and she has fantastic links on this issue. Why am I surprised? You absolutely must read these resources, too.

Happy Catholic says this about encouraging young people to have sex by making STDs seemingly unimportant:
A good friend challenged me on some of the material and also was surprised that one of the reasons I didn't like the idea of the vaccine was the possibility of the effect on adolescents' tendency to have sex (as mentioned in the excerpt above).

I guess I should have qualified it more ... mostly because I hear through Hannah and Rose how much misinformation they are told by friends "is absolutely true" and most of the time it is about half-true if that.

So I looked at this and thought of the girls who come into their freshman year of high school pregnant because "everybody knows" that you can't get pregnant when you're on the pill or using condoms or without full penetration ... or whatever the myth is that they've been told. And this just looked like a silver bullet for people to start saying that it works on all STDs.

Here's an important point I didn't mention via Evil Slutopia (you know us crazy chiropractors, we're conspiracy nuts and all):
While we're on the subject of liability, lawsuits, and profits, there's another angle to consider. If Merck can get state governments to put Gardasil on their lists of vaccines that are required for schoolchildren, it can become a part of a federal vaccine liability program. Meaning that Merck will not be liable if Gardasil turns out to be harmful some time in the future. [5] [6] [7]

If I felt like being cynical again, I might think that this is one of the reasons why a vaccine for a sexually transmitted disease is being marketed not just to young women who are having sex or are going to become sexually active soon, but also to girls as young as nine. There’s a hell of a lot more stability and profitability in a required childhood vaccine than there would be in an optional vaccine meant only for young women.

It's important to remember that no matter how many feel-good, we're all in this fight together and we're just doing this out of the goodness of our hearts ad campaigns they run, drug companies are not non-profit organizations. They are in this to make money and a lot of it, and while that doesn't mean that all prescription drugs are harmful and horrible or that all doctors are evil, it does mean that when it comes to our health, we probably shouldn't take anything at face value.

Evil also brings up the sexism of only giving women and girls this vaccine (this is longish but worth it):

I think both men and women can take issue with this. Men, because their sexual health is really not being addressed here. They don't even have a test that can tell them whether they have HPV or not, so even if they want to be responsible about it there is only so much they can do. And women, because they are being asked to take full responsibility for HPV prevention. Women and girls are expected to take on all of the costs and the risks of this vaccine, and even if they do get vaccinated they could still be infected with HPV by a male partner who has been told that HPV isn't something that he needs to worry about.

From the Centers for Disease Control and Prevention website:

"There is no clear health benefit to knowing you have this virus—since HPV is unlikely to affect your health and cannot be treated. For most men, there would be no need to treat HPV, even if treatment were available— since it usually goes away on its own." [18]

Isn't it a little irresponsible (and sexist) to say there is no benefit to a male HPV test? Regardless of the possible health issues such as penile or anal cancer, isn't not infecting your unsuspecting partner also considered a benefit? Men are reassured that tests and treatment are unnecessary because their HPV infections will likely go away on their own, while the fact is that most women's HPV infections will go away on their own as well. [19]

Apparently, when Gardasil went before an FDA panel for approval, Merck asked the panel to approve the vaccine for boys also, even though they have not done the same amount of testing on boys as they have on girls.

"Merck asked the committee to endorse vaccination of boys age 9 to 15, too. Urging them not to wait for ongoing studies to end, it said evidence shows Gardasil can prevent some male cancers and may slow the spread of sexually transmitted HPV.
'By delaying three-plus years, we could have an additional 100,000 [cancer] cases that could have otherwise been avoided,' Barr told the committee. But panel members didn't vote on the request, calling the idea compelling but unproven."[20]

It seems to me that we need to spend more time researching HPV in men and boys, not less time. And it would be nice to feel like Merck was taking this issue seriously and not just tacking it on as a "me too" measure in order to get approval more quickly. On the flip side, it's a positive step that more research on HPV in men is now being done. Maybe they'll even change their minds and decide that it is worthwhile to develop a male HPV test after all. They could probably share a lab with the researchers who are hard at work on that male birth control pill we've been hearing about for years.

This vaccine was fast-tracked, if state-sponsored Merck avoids liability, it's a behaviorally avoidable disease, and it's only for girls. To top it all off, the government can mandate this. No choice.

There are many very logical, ethical, moral, and health reasons to avoid this vaccine.

4 comments:

kman said...

Unfortunately not many people are interested in controlling their behavior these days.

To quote Homer (Simpson) when he ran for Sanitation Commissioner... "Can't someone else do it".

The saddest part of this story is when you mention the 3 year olds on psychotropic drugs. I can attest that it's real and it happens a LOT. My wife runs across this all the time in her non-profit and when I say all the time I mean just about every single kid in the foster care system.

Here is the quick version of how the sausage is made... Children are taken from their parents (the most common cause for removal is neglect IE being poor), the kids act out or are difficult for the foster parents, most of the foster kids go to a handful of doctors, the drug companies have the psychiatrists in their pockets, the psychiatrists prescribe certain cocktails the drug companies need tested, and Medicare (er.. make that our tax dollars) pays for it. There is no liability on the drug companies part and there is no parent to say no since the state "owns" these kids. It makes me sick thinking about all the toddlers taking experimental psychotropic drugs for mental illnesses that you can't even diagnose until the children get older.

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.

For a more complete discussion on GARDASIL with sources, click on my name.

Dr. Melissa said...

Good information Stickdog,

Thanks!

Nancy Kathlene said...

HPV has been implicated in cancer of the cervix, vulva, vagina, anus, penis and oropharynx (tonsils and tongue). One hundred percent (100%) of cervical cancer cases worldwide what is a wart