Tuesday, February 06, 2007

Austin, We Have A Problem...

And it's name is Rick Perry. Corrie over at Sea of Corrie has posted on His Majesty Perry's completely over-the-line EXECUTIVE ORDER requiring all 6th grade girls to get the Guardisil HPV vaccine (more here). I posted my view over there, but I'll repost them here to get you started:

Well, I 'spose I better chime in as well. The goverment has no business MANDATING this vaccination. Offering it as an option, sure, but requiring it is an extremely dangerous proposition. Several points I would make:

1) Texas has not historically been a "Nanny-state."
2) Rick Perry does not know my kid better than I do.
3) Will Texas be able to afford the record legal bills that will occur when a girl that has been vaccinated gets HPV or cervical cancer or anyway? Or the side-effects damage or kill her?
4) What happened to "A woman has the right to chose what happens to her body?" Does this mean that Roe v. Wade is no longer valid? (A stretch, I know, but you get my point). Where does it end?
5) How insulting is that to my daughter who IS staying pure? "Oh, you've GOT to have this vaccine, because you're all dirty tramps. What's that? You're not having sex? Don't worry, you will and you're not mature to decide if you need this on your own, so we're making you take it. Next in line, please."
6) What about objections on religious grounds (ie. Jehova's Witness, etc...)?

The gov't needs to keep their hands off my daughter. If my wife, my daughter, and myself decide that it's a good idea, then she can have the vaccine. But the goverment has no right to mandate it to me.

Well, today I was thinking about this, and I've come to the realization that this is a MUCH bigger farking problem than I originally thought. Here's some reasons why:

1) We have a governor, not a king. He does not have the power to make unilateral decisions like that, even with executive order powers.

2) Executive orders are to be reserved for emergencies and for when the legislature is out of session, which they are not. They still have over 140 days left in the session.

3) Merck (the maker of Guardisil) is a contributor to Rick Perry. His former Chief of Staff is now a lobbyist working for Merck.

4) Apparently (and I need to do some checking on this), the vaccine is only effective against 4 of the 88 strains of HPV, and is only 70% effective as a cancer deterrent. Also, there's only 400 cases of cervical cancer in Texas a year. Not to diminish those 400 victims and their families, but far more people die in car accidents annually in Texas. Again, I need to double check these numbers, but I've heard them from multiple (although biased) sources.

All of this is a problem. Something is very wrong here. He never brought the issue before the legislature, probably because they would have said "No. Moron." There is already talk of a recall, which I would support at this point.

I plan on staying on top of this, so check back often for updates and news.


Whoa. Potential huge bombshell here. I was listening to the radio (570AM KLIF) at about 6:45pm, and on the John David Wells show a guy calls in saying he's a limo driver, and he drove a democratic state senator around for nearly 10 hours today. Well, the senator was listening to the Mayor Bolton show this mornging (also on 570am) when they were talking about the HPV debacle. This limo driver and the senator get to talking, and apparently the senator (who asked to remain anonymous, natch) said that Perry is getting a $6 MILLION kickback from Merck for this deal. Now, this hasn't been verified independently, but the guy DID verify (off the air) that he had the senator in his limo today. When I know more, you'll know more.


In the comments section, we've had a visit by a pediatrician (I think a friend of Justin's), and he gives some very good insights into the vaccine. Look for d. Blake's comments.


Some interesting facts about Gardasil (NOTE: Some of these are lifted from another site, but for the life of me, I lost the link where I got them. Profound apologies to whomever compiled them):

1. As mentioned before, Gardasil only reduces your risk of HPV, it does not eliminate it.

From Gardasil.com:

“HPV Types 16 and 18 cause 70% of cervical cancer cases.

GARDASIL may not fully protect everyone and does not prevent all types of cervical cancer, so it is important to continue regular cervical cancer screenings.”

Of course, you'd never know this by all the TV spots and media coverage spinning this like it's the be-all end-all of medicine. See, it's being sold as a CANCER vaccine, and it's noting of the sort.

2. Apparently, cervical cancer has been on a downward trend for the last several years.

The Gardasil commercials refer to "thousands of women" being diagnosed with cervical cancer in the U.S. each year, which is true, but they don't put that number into context.

“Cervical cancer has gone from being one of the top killers of American women to not even being on the top 10 list. This year cervical cancer will represent just 1 percent of the 679,510 new cancer cases and 1 percent of the 273,560 anticipated cancer deaths among American women. By contrast, some 40,970 women will die of breast cancer and 72,130 will die of lung cancer.

According to the American Cancer Society, "'Between 1955 and 1992, the number of cervical cancer deaths in the United States dropped by 74 percent.' Think about it: 74 percent.”

3. Gardasil is one of the most expensive vaccines ever, at about $360 for the series of three shots, plus the cost of doctor visits. Now, considering that cervical cancer has been on the decline for years, is it possible that Merck is "embellishing" the severity of the numbers?

"'We're seeing a fairly remarkable uptake of Gardasil,' said Rick Haupt of Merck & Co., which reported sales of the vaccine had reached $70 million, exceeding analysts' projections."

Oh, good. As long as you're making more money than you thought, it's all OK.

4. 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. That addresses one of the points I made earlier.

5. There have been no long-term studies done on the effect of the vaccine after 5-10 or more years, and testing on young girls has been extremely limited.

“Merck has tested the cervical cancer vaccine in clinical trials of more than 20,000 women (about half of them got the shot). The health of the subjects was followed for about three and a half years on average. But fewer than 1,200 girls under 16 got the shots, among them only about 100 9-year-olds, Merck officials said, and the younger girls have been followed for only 18 months."

If parents are expected to take their daughters to get a series of expensive immunizations, wouldn’t it be nice if they had any idea at all about what effects these girls might have to deal with 5 or 10 years down the line?

If you're wondering what the rush was, part of the answer could be patents. When a company's patent on a particular drug expires, that's when generic versions of the drug can be developed and released into the market, which obviously drives the price and the profits of the original drug way down. Merck's patent on the extremely profitable cholesterol drug Zocor expired in June of this year, and Gardasil is one of the new drugs being counted on to bridge Merck's financial gap. According to the FDA, Merck filed an application for a patent extension for Gardasil on December 6th.

6. It is unknown how long the immunity provided by Gardasil actually lasts.

“Public health officials want to vaccinate girls early, before they become sexually active, even though it is not known how long the immunity will last.”

“Tests show that the vaccine lasts at least four years. Long-term results aren't known yet.”

And straight from the FDA:

“The duration of immunity following a complete schedule of immunization with GARDASIL has not been established.”

So, there's always the hypothetical issue that women may have to get vaccinated again in 5 years.

7. The studies done on Gardasil were not set up to investigate whether the vaccine itself has the potential to cause cancer.

“GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.”


Matt said...

Wow...Kinky would have been better than this!

JTapp said...

I think the debate should focus solely on #1 and #2. Can we prove these points Constitutionally? If so, can we lobby our state reps to do something?
What about the Texas Supreme Court, what are they doing?

Judging from the national media, Texas is being hailed by doctors and activists all over the country for this. Perry is being applauded.

Most of the quotes I've read from state legislators (particularly democrats) have applauded Perry, calling it the "best thing he's ever done" and such. Why is the Constitutionality not being debated, or is it and I'm just not seeing it?

I don't want to focus on #4 because doctors and epidemiologists seem to think this is as necessary and beneficial to society as mandatory polio vaccination.
Maybe so. But, the ends don't justify the means in any case, which is why #1 and #2 are what I think activist groups should focus on.

The loudest complaints I'm hearing are from a purely moral standpoint ("kids will have more sex now"), but those people don't have any data to point to backing their fears, and I don't buy the logic.

But, with #1 and #2 you clearly have a written Constitution (data) to point to. Lines are clearly crossed.

Is Perry thinking about running for President in 2012?

Greatmoose said...

Personally, I don't think this will affect kids' sexual activity one way or another, but it kind of torpedoes the whole abstinence campaign by assuming that the girls are sexually active. And the whole "You have to give it to them at this age" argument is BS. The effective administration ages are 10-26 years old, IIRC. One other nasty point about the Ex.Order, is that the legislature only has 60 days to do anything about it. This will get worse before it gets better.

d blake said...

Here's the view of one (long-winded) Christian pediatrician...

1. I really don't like the idea of the state dictating that this vaccine must be given to all girls. It's a decision for parents and teens to make after being appropriately informed of the benefits and (quite limited) risks of the vaccine by a health care professional. If you are going to require the vaccine, though, 7th grade is the time to do it... you want to hit girls before they are sexually active (I've taken care of a baby born to an 11-year-old; some kids start early)

2. The vaccine is approved for girls from 9 to 26 years of age. I discuss the vaccine with every parent who brings their 9+-old-girl into the office for a check-up and provide reading materials on it. The benefit is for cervical cancer, not genital warts. As correctly noted, it covers only 4 types of HPV virus -- the ones responsible for the vast majority of cervical cancer. It is NOT 100 percent protection against cervical cancer; it is nowhere near 100 percent protection from genital warts.

3. I think the vacccine is a good idea. I tell parents I think it's a good idea... including Christian parents in the Upstate of S. Carolina, which is one of the most churched areas in the US. Here's why... 80 percent of women have been exposed to HPV by the time they are 50. Your daughter may very well be a chaste woman looking for a chaste man. But men lie (as women do)... even "Christian" men. More than once I've seen notes on charts stating that new Moms don't want their previous STD's (which can impact the health of their baby) discussed in front of the father because the father thinks the Mom was a virgin before they were married.

4. I put little stock in the "it will make kids more sexually active" argument. Kids generally aren't thinking about STD's when they're thinking about sex. One quality of adolescents = sense of indestructability ("It won't happen to me").

5. To deny teen sexual activity is to put your head in the sand. On occasion, to get to the bottom of a teen girl's health problems, I have to kick the parents out of the room and pull out this speech: "I know this is uncomfortable to talk about, but I have to ask about your sexual activity. Your answers are between you and me, and I won't share them with your parents. If you're not honest with me, though, and I don't make the right diagnosis, there can be serious consequences... you may not even be able to have children in the future [a very true statement]. So the question is... are you having sex now or have you had it in the past?" Honestly, I've never had a teenage girl say "no" (but keep in mind that teenage girls with abdominal pain is a highly-biased group (NOT a random sample as J. Tapp would surely point out)).

6. Just for the record, I strongly support abstinence and think it should be strongly encouraged, particularly within the church. Our culture. though, is so geared toward sexual titilation that Christian teens have to wage full-out war to remain sexually pure. What hope do teens living without the power of Christ have to remain sexually pure???

(Oh, yeah, if you think I'm a bad person for not telling parents about their daughter's sexual activity, I'm ok with that.)

Greatmoose said...

Dr. Blake,

Wow! Thank you so much for your comments and insight. It really helps a lot to get information from the medical profession. I'm in agreement with you, the vaccine is a very good idea. I just do not like that we're being told we have to do it. A little honesty from the Perry camp would be greatly appreciated, you know. Feel free to stop by any time and comment. Thanks!

d blake said...

feel free to call me dave. :)

Leesa said...

I got to this site from Patriot Action's site.

I would think this should be viewed like other vaccinations. People can refuse to get other vaccinations based on religious or other grounds, and this information is normally documented in the medical record. You mentioned something about a 6 million dollar kickback. I cannot comment on this, but I do know that many vaccinations are not huge moneymakers for drug manufacturers. The government sometimes puts a ceiling on what the manufacturer can charge, which makes these deals far less lucrative than you might imagine. Just think of the flu vaccine and the number of companies that no longer wish to participate because of economic reasons.

And I loved reading the pediatrician's comments.

Greatmoose said...

Welcome, Leesa!

I haven't been able to confirm the kickback yet (although, it would NOT surprise me). I agree on the government caps, but apparently, that's not the case here. For example, most flu vaccines are $5-$10 (or free in a lot of cases), but the HPV vaccine is $365 (IIRC) for the course of 3 shots. $365 time however many hundreds of thousands (maybe millions?) of middle school+ aged girls in Texas there are, and that's real money. I've heard that there may be provisions for religious refusals, but if it had been brought before the legislature like it should have been, then there probably would have been multiple options for this. I'm still of the opinion that while the vaccine is a good idea, it should NOT be mandatory. Anyway, hopefully we'll get some more information this week. Come back anytime!

JTapp said...

$365 is no joke. Can we get a source on that? Plenty of parents won't be able to afford that. And Texas, after all, leads the nation in people without health insurance.

One of my professors has taken to calling him "Hugo Perry."

Greatmoose said...

Sorry, it's actually $360, via MSNBC (http://www.msnbc.msn.com/id/16948093/).

HA! Hugo Perry. I am impressed.

d blake said...

The wholesale price our practice pays is $120/dose = $360 for the series.

We charge patients $180/dose (to cover overhead, etc) = $540 for the series.

Greatmoose said...

Whoa, so does insurance pay for any of it, or, since it's optional, is it all on the patient? Thanks, Dr. Dave.

d blake said...

Most insurances are picking up the cost of the vaccine. If you're paying out-of-pocket, though, it's ridiculously expensive.

Greatmoose said...

Well, that's good news, at least. I assume that there will now be some new government assistance for those without insurance.

Matthew J. said...

Don't blame me, I voted for one of the other guys!

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 virus. It is not contagious without prolonged skin to skin contact. 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.

Greatmoose said...

Thanks, stickdog. I knew I'd seen that somewhere before. Great post!