How To Tick Me Off: Texas, Perry, Gardasil

Posted on 02.03.07 in Family and there are 27 comments.

This isn’t one of those posts I had to think much about writing. This is more of a cathartic entry because I’m a bit of a mad Kat.

Why?

On Friday, Texas Governor - Rick Perry, bypassed state legistlature and issued an executive order MANDATING that a brand new vaccine, Gardasil, be given to all 6th grade girls beginning in 2008.

What is the vaccine for?

Gardasil is a vaccine that prevents strains of the sexually transmitted human papillomavirus (HPV), preventing a common form of cevical cancer.

There are three main reason why I’m highly miffed:

1. Bypassing state legislature on something that directly affects children is a really lousy idea. To me, that communicates one of two things about Perry. He either thinks that the parents and lawmakers of Texas aren’t capable of caring for their kids and making wise decisions. Or he is a bit too cozy with the Merck lobbyists and has a clear personal agenda on the issue.

2. Mandating that a brand new vaccine be given to children is a really lousy idea too. Unless there is an epidemic and all children are directly at risk, then I don’t want my kids to be guinea pigs.

3. Merck, the maker of Gardasil, has doubled their lobbying budget trying to have all states mandate the administration of the vaccine. Somehow I have a feeling that their motives are not altruistic.

To me, this just smells of money and greed wrapped up in the pretend concern over the health and welfare of children. I’m sure I’ll have many more thoughts on this, but I’d love to hear yours.

What would you do if your family lived in Texas and your daughter was due to get the shot next year?

Share your thoughts.

The Comments:

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i heard this on the news yesterday...pretty crazy...i thought they said something like “you can deny the vaccine...for some reason”

sorry i couldn’t really remember why you could deny it...yeah i think it’s kind of shady to...do they really know if this vaccine is totally safe?...have they done enough tests?

shady…

and i hear the governor is connected to merck..

very shady…

Grant,
Yes, parents can opt out based on religious or philosophical reasons. You wouldn’t even want to imagine the fit I’d have if that option weren’t available.

And yes, one of Merck’s leading lobbyists was Perry’s former Chief of Staff.

I just can’t really imagine what Perry (a “conservative Republican governor") must have been smoking to think this would possibly be a wise decision. Maybe, since he was just recently re-elected, he’s hoping people will forget about it before his term is over…

I think its a bunch of hooey as well to MAKE anyone take anything.  However, I think the reason is because HPV is a bit more of an “epidemic” or “really common” than the goverment is letting on. 

It is probably because it would cause an unnessesary panic.

I guarantee people will be asking more questions now.

That makes me mad, too, especially considering the vaccine doesn’t ensure complete safety from the strains of HPV that lead to cervical cancer.  Only a few of them.  The way they’ve been advertising this gardasil thing is ridiculous.  I think some better education on the sometimes severe and long term consequences of our sexual behavior is far more in order than an overpriced brand new vaccine on the market.  That is definitely greed and I hope the public outrage is there.

I think the vaccine is a very good thing.  I think the mandate, in the way it was done especially, is a bad thing.  And I have a little girl who will be up for the needle on this one.

BTW, there is a AM radio talk show host here in Houston who calls Perry “Gov. Zoolander”, both for his apparent cluelessness and his well-maintained coiffure.

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.

i’m a cancer physician and this is fantastic.

i’m glad that he bypassed the legislature and all those crazy groups.

i don’t care that merck makes a mint, all i care about is that there will be fewer cases will need to be treated for cervical cancer…

i just treated a 34 yr old..and she will likely die..

i think this should be mandated WORLD WIDE, not just nationwide.

kudos for gardasil.
KUDOS!

Chick Pea,
Thanks so much for participating in the discussion.

To clarify, I have no qualms with the vaccine itself. My issue is with the mandating of a vaccine that is (if I understand this correctly) for something that is non-infectious except via sexual tramsmission.

I also highly disagree with the bypassing of legislature.

As a doctor, what are you thoughts about stickdog’s facts? Are they accurate? If so, they don’t seem to justify something so drastic as an mandate via executive order.

Finally, what studies have been done to prove that the vaccine is safer than the risk developing cervical cancer?

I appreciate your input here and I hope other doctors will chime in as well (That’s a hint, John...).

CDC says that the vaccine is recommended for up to age 26.  Perry should order that young, female teachers be injected.  They are just as much “at risk” as students.

It wouldn’t take 24 hours for the teachers’ unions to file a law suit.

it is in clinical trials at this point for those over 26 yrs of age..

bypassing the legislature was a smart move.. why? it would’ve taken EONS before it would ever get passed (if it would get passed), tx is a crazy conservative state, and sometimes they are unreasonable..

it is safe, it can prevent hpv 16 80% of the time..

i didn’t read that other guys comments, he posted on my blog tooo, i deleted it.. seems like he is hitting all the blog with cut and paste action.. (WHATEVER!)

go on the website for more info…

bottom line:
gardasil for all.
cost wise, it sucks, but those over 26 can get it if you pay out of pocket (which i will do).

now if i can only get people quit smoking…

i see dollar signs every time someone lights up… they are contributing to my beach house fund.  thank you for smoking.
*(super sarcams)*

So you didn’t read my comments, but you still deleted them, chickpea? Why don’t you just stick your fingers in your ears and shout? That would be about as mature and balanced. I guess you already know everything, right, chick pea?

Tell me, chickpea, how many women did GARDASIL save from getting cervical cancer in the trials? The answer is ZERO. Now tell me why Merck used a shot of alum as its “control placebo.” Is that best medical practice as far as you are concerned?

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.

My first thought when I heard this (after I said, “He did WHAT???!") was that they don’t give teenagers the credit that they deserve.  Why don’t they try telling them that if they behave like little you-know-whats then they might get cancer and die??  I think vaccines are great, but, like you, I don’t agree with Perry’s mandate (especially since he’s in bed with Merck).  I think it’s sad that instead of teaching kids to not have sex until marriage, they’re teaching kids to just get a vaccine and have safe sex.  They need to know that there is no such thing as safe sex unless neither partner has ever had sex with anyone else!  That being said, I wouldn’t want my daughter to make a big mistake and then die of cancer because I didn’t allow her to get a vaccine.  I’ll have to do a lot more research on this vaccine though.  Thank goodness I won’t have to worry about it for 8-9 years.

So you didn’t read my comments, but you still deleted them, chickpea? Why don’t you just stick your fingers in your ears and shout? That would be about as mature and balanced. I guess you already know everything, right, chick pea?

sickdog… you went on every fricking blog with gardasil and wrote the same damm thing.  sorry charlie.  my blog is my world.  some people are welcome and others are kicked out, including you.

suzanne:
i understand the promiscuity issues surrounding it.. but that aside, family values, religious values aside, if you look at the bigger picture, it is a good vaccine. 

in the end, its about saving lives...whether you agree with the prior activities or not.

in medicine you cannot judge but only hope that some people change their habits, aka stop smoking, drinking,etc.. esp in the oncology field.

Chick Pea,

I can see how you would support it considering that you are a cancer physician.  Do you think it should be mandated though?  Making it very accessible and easily available seems a better route to me.

i think it should be mandated...it’s just being ‘smart’ about cancer prevention...should polio vaccines be mandated?  i mean the argument could go on and on until the cows come home.

in the end, it’s about protection.
just like seatbelts
better safe than sorry…

no it’s not foolproof, but what the heck in the world is 100% foolproof? 

thats right: NOTHING.

Chick Pea, I disagree.  I’m not sure that I disagree with the vaccine, yet, but I disagree with your argument and your logic.  If this is a good idea, it has to be a good idea for a different reason.  HPV isn’t infectious.  It’s an STD.  Polio is highly contagious.  They’re not at all the same thing.  You have to be sexually active to get HPV.  By your reasoning, we should also mandate that pre-teens go on birth control to prevent unwanted pregnancies.  Is there another way of looking at it?

I’m a physician as well, and I second what ChickPea has said.  I am very glad to see that Governor Perry has required young girls to get vaccinated with Gardasil.

My family has been directly affected by cervical cancer.  A female relative of mine, who was not a poor or promiscuous woman, contracted HPV.  Unfortunately, her husband did sleep around, and likely that’s who she contracted it from.

HPV isn’t just a disease of promiscuity.  You only need one sexual partner to get HPV and ultimately develop cervical cancer.

VeganDoc,
Thanks for commenting. I understand that your job and chickpea’s job is to make sure people live and live well. So I get where you’re coming from regarding the vaccine - if it will save someone’s life - it’s worth it. I think that’s exactly the perspective that I’d want my doctor to have…

Here’s my 2 cents as a citizen of Texas and a parent of 2 daughters:
“On a yearly average, over 1100 Texas women will be diagnosed with cervical cancer and approximately 390 are expected to die.” Source: Texas Department of Health Services

Gardasil has only been proven to be 80% effective, so 312 deaths will be prevented yearly by this mandate.

(Before I go on...PLEASE UNDERSTAND: I am not attempting to put a value on human life.)

What I do want to communicate is that I think that the political power and billions of dollars that will be spent on this program (Gardasil is $360 per vaccine and is only proven effective for 5 years, boosters may be needed) could be spent far more wisely elsewhere.

Perhaps for a far more aggresive campaign promoting (and funding) a regular pap smear. Cervical Cancer is highly treatable if caught early. Could not the money and political power behind this mandate be used more effectively elsewhere to save women’s lives?

Or perhaps, skip the mandate and use Merck’s doubled lobbying funds to promote the vaccine among those most at risk (Asian, African American and Latina women. Source)?

I have nothing against the vaccine itself. It’s great. My problem is with the misuse of power and funds that ultimately appear to benefit Merck and certain political figures more than the women of Texas.

Finally, my other concern is that this vaccine was just approved by the FDA in June. Merck is no stranger to drug recalls and I don’t think that cervical cancer is a great enough risk to my daughters for me to allow them to be guinea pigs for an unknown drug with unknown side effects that is only 80% effective for 5 years.

It just doesn’t make sense to me.

"Finally, my other concern is that this vaccine was just approved by the FDA in June. Merck is no stranger to drug recalls and I don’t think that cervical cancer is a great enough risk to my daughters for me to allow them to be guinea pigs for an unknown drug with unknown side effects that is only 80% effective for 5 years.”

This summarizes my concerns with the mandate best.  I am the father of a little girl.  I would want her to have this vaccine.  I do not expect her, as she gets older, to be promiscuous but that is not the point to me.  I love the fact that there is now a vaccine for serveral (but not all) forms of HPV.

My problem comes from the mandating of a drug whose long-term efficacy is completely unknown to treat a disease that is not readily communicable (I’m with cachinnator: this is no polio or small pox to be transmitted casually).  Will it provide a false sense of security and then have less benefit in 20 years?  What, then, for all those who had to take the vaccine and then felt impervious to this disease?  This would be no small population.  Will it have side effects that are not apparent for 10 or 20 years?  Perhaps that sounds a little naïve or a little paranoid and reactionary, but that is not where I’m coming from.  I’m coming from the stance of a seasoned scientist who has seen first hand the differences between short-term and long-term behaviors in chemical, engineering, and medical products.  It’s caution that speaks here, to stamp down hubris.

I’m all for the vaccine being on the market.  And I’ve talked with my wife and we agree that, when she is a little older, our girl should get this vaccination.  But there is a big difference between our personal choice in using a product that may fail us later and in mandating everyone to buy that product.

Wow, Kat.  It looks like you hit a sensitive vein on this one!  It’s good to see healthy debate on controversial topics like this.

I am not a doctor or a scientist.  I do have a daughter, but she is still a baby and I’m sure legislation will change before I have to deal with this.  For the better? I don’t know.  With the arguments that have been so eloquently made, I am a bit intimidated to post, but all I can do is give is my opinion.

I agree with so much that has been said.  The vaccine is a product of good, worthwhile medical research and I am truly glad it is available.  I also agree that with the potential to save lives, it is worthy of recognition and marketing.  I also agree that no matter who is profiting from all this, if it saves lives, it is worth it all. 

That said, my problem is more that the government is, once again, stepping in where common sense and wisdom should play a part in society.  Example: I agree that we should all wear seatbelts.  Common sense.  They save lives.  I cannot control other drivers so I better control what I can.  Put your seatbelt on.  However, do I put it on because there is a law about it or do I put it on because it is smart?  Yes, I know, not all people are smart.  But by forcing them to take action that they themselves should take the intiative on...is that helping, really?  In a societal sense, are we advancing?  Saving lives, perhaps.  But are we wiser in the long run?  I don’t think so.  In education, people complain that teachers “dumb down” curriculum so that the kids can pass.  Are we not “dumbing down” society by forcing people to do things that seem like they should be common sense?  (I’m sure the analogies are not perfect, but you get what I am trying to say.) I know that not all girls will abstain from sex before marriage which, to me, is wisdom.  But instead of requiring a vaccine we know scant information about regarding long term effects, wouldn’t it be better to address the root issues of sexual behavior?  The Texas governor is assuming that my daughter will be sexually active and therefore must be vaccinated.  While I don’t necessarily take personal offense at this, it burns me that there is not more done to educate and assist parents and young people regarding the issues related to this entire problem.

There’s my two cents, Kat!  I’m sure there are probably holes in my argument and I’m sure someone out there will point them out to me. 

Have a great day, everybody!

Kim,
Thanks for chiming in! I like what you had to say about getting to the root of the issue.

Good stuff.

I was thinking about my previous post and felt the need to clarify something. 

I am not anti-government.  In fact, I am so thankful for the government that we have; especially in comparison to other countries.  However, I don’t like it when legislation is passed and laws are created simply because people are not educated enough to do the right things for themselves.  That said, I realize people have different interpretations of what “the right thing” is when it comes to many issues.  I don’t really know what the answer is.  Just wanted to throw that in there.

Why isn’t this mandatory for boys, chickpea?  I mean it **is** a vaccine for HPV that is ***one of the causes*** for cervical cancer.  Why not vaccinate the herd?

Hello:  I’m from N.H. (the motto for the State is Live Free or Die but the whole state is in the process of going over to the enemy and pretty soon, the people with any common sense might be totally gone from even N.H.) So , why am I on this blog?  Because those with a heart to stop the Govenor in his track can use the film “Direct Order” for their argument!  Take a look at this http://www.directorder.org/site/about-direct-order.html Good luck!  If I had a little girl she would not get a mandatory vaccine !  Period.
Carlene

To those who think this should be mandatory is an idiot. Do any of you shooting out statistics have any concrete data to back that up? you people cant back something that’s been tested what, 8 months, before being released to the public? what will you guys be saying if this vaccine causes some typ of long term disorder when you’re 60? common people think with your heads! you people should read up on TGN1412. that might make some of you people wake up and start using the old noodle.

Interesting discussion.  Interesting subject.  Given the fact that there are several unknowns here, I really question the wisdom of slapping this vaccination on every girl across the board.  What will the state require next? 
Make it available, give us the facts about the virus, the cancer and about what other options there might be (prevention/treatment) and let us make a concious choice for it. 
While they are currently allowing parents to opt out, this is but a step away from saying “the state always knows what’s best for your children.” Generally speaking, this is not a good thing.  While I/you/we might be okay with THIS mandate (and some are definitely not), you never know when some nutty political leader you disagree with will mandate something you believe is absolutely not beneficial.  Just like the birth control pill someone alluded to.  Yikes!

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