Anti-STD drug may become mandatory in Florida

Posted on February 7, 2007

This item first appeared at CourtZero.

I hate to post this on what seems to be National Crazy Astronaut day in the media, but in case you want something else newsworthy to think about, how about this?

In Florida, Ed Homan (Republican from the Tampa area) in the Florida House and Mike Fasano (Republican district 11) in the Florida Senate have filed HB561 and SB660, respectively (there is no need to click on both links, the language in either version is identical to the other). The bill is entitled, in part “An act relating to human papillomavirus…”

Before I get into the meat of this post, and rather than discussing the merits and demerits of the human papillomavirus (HPV) vaccine known as Gardasil, I’ll give you this link to the Centers for Disease Control for some hopefully objective facts.

Gardasil is manufactured by Merck. It is a vaccine against some strains of a virus that cause some varieties of cervical cancer in women. I don’t pretend to know whether or not the vaccine is safe and effective. Let’s presume for now that it is, even though it has only been approved since June 8, 2006. And let’s presume for now that it is, even though the National Vaccine Information Center has slogged through the Department of Health and Human Services’ Vaccine Adverse Event Reporting System to find some pretty nasty side-effects in 84 girls and 2 boys. Let’s set that aside for the moment.

What I am curious about is the rush by state governments, like that of Florida, to require nearly all children to be injected with three rounds of Gardasil. Florida papers have already begun cheerleading for the drug in emotional terms, and advertisements have become ubiquitous. Let’s look at one article and compare it to the reality one encounters when one actually reads the bills filed in the Florida legislature.

TALLAHASSEE — Top Florida lawmakers want every 11- and 12-year-old girl in the state to get a vaccination that would protect them before they risk getting a sexually transmitted virus that can cause cervical cancer.

Right off the bat we are into misinformation. First, I do not know what is meant by “top Florida lawmakers” since the Florida House bill has one sponsor, the representative who filed it, and the Florida Senate bill has only one sponsor and one co-sponsor at this time. Second, when they mention every 11 and 12-year-old girl, they leave out boys (Gardasil is FDA approved for boys as well as girls).

A casual reading of the text of the bills, however (it is not very long) shows that Florida may mandate that every “student” who is eleven or twelve get the series of vaccines. There is no distinction in the bills between boys and girls. This begs the question: if Gardasil is touted as being “100% effective” in girls who take the drug, why should boys be forced to vaccinate against something that causes cervical cancer. Does that not suggest that someone is not quite confident that what the girls are taking is completely effective?

[UPDATE and EDIT: Thanks to a helpful commenter, I note to my pleasant surprise that I'd missed the opt-out language completely the first times I'd read the bill. The bills DO allow a principal to admit a student whose parents have decided against the vaccinations. That is a good thing, but does not change the substance of the remainder of this post]. If parents object to their children getting three doses of Gardasil, the principal of his or her school is not permitted to allow them to attend school until they “prove” that parents have decided against the vaccines and after certifying that the parent or guardian has been informed of certain things regarding the vaccine (see section 1(2)(b) of the bill). This brings up additional issues of pressuring, what happens when divorced parents disagree, or when a child is in foster care, etc., but those are topics for another post.

And yes, the bills make it crystal clear that this requirement applies to private as well as public schools. Under Florida law, the definition of private schools includes parochial, religious, and denominational schools.

Under these bills, therefore, the only way to opt out, for any reason, is to homeschool.

One thing is for sure; with such sweeping scope (both boys and girls and both private and public schools), Merck’s profits in Florida are going to go through the roof at a cost of $360 per series of vaccinations. Could this possibly be part of the motivation of the sponsors of Florida’s mandatory Gardasil bills? Let me be very clear: I do not know. I do not know Representative Homan nor Senator Fasano and have no information about their motivations, only questions.

I do know, by looking at records of the campaign contributions that they have received, that both have taken contributions both from Merck itself and, in the case of Representative Homan, at least one private citizen who happens to be a Merck employee. Representative Homan ran for re-election unopposed in 2006, yet managed to raise $143,333 to campaign against no one. Much of those contributions appear to be from people with a financial stake in the medical field. That’s not shocking, since the Representative is a physician, but is at least a little interesting.

The sponsor of the Senate bill, Senator Fasano, also ran against no one in his last election in 2004, and raised $254,758. Merck made two separate $500 contributions back then. I cannot find from the FL Department of State’s website if any of the other contributors represented Merck’s interests or if Fasano has recieved other contributions from Merck since 2004.

From my reading of the Florida Department of States’ Elections website, in the 2006 campaign season, Merck contributed to 37 candidates among Florida’s 40 senate seats and 120 representatives, so it is not as if Merck has a policy of making contributions to everyone. I do not know what contributions they have made since the last election.

» Filed Under Church And State, News, Politics As Usual

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Comments

5 Responses to “Anti-STD drug may become mandatory in Florida”

Greg on February 7th, 2007 4:54 pm

Maybe if you read more than casually, you would have found the opt-out provision. Section 1(2)(b):

“A principal or any other person in charge of a public
or private school may not knowingly admit a student who is 11
years of age or 12 years of age until that student submits to
the school acceptable evidence of vaccination for the human
papillomavirus or proof that, after receiving the information
required in subsection (1), the student’s parent or guardian has
elected that the student not receive the vaccine.

Lines 36-42.
Lorraine on February 7th, 2007 6:17 pm

We have the same bill under consideration here in Colorado. However, they do have the usual opt-out available. My objection is that all of the other vaccines required for students are for communicable diseases that can be spread in schools. Unless sex in hallways is rampant in middle school, the government has no business mandating this vaccine, especially when it’s so new. Talk about intruding on parental rights!
Dethanial on February 7th, 2007 7:33 pm

The state of Texas is also trying this BS instead of sending
the girls to church.
ArrMatey on February 8th, 2007 9:20 am

Greg, I thank you for catching that, in spite of the somewhat unpleasant tone. I’ve made the correction.
mhatrw on February 11th, 2007 2:31 am

In medical cost vs. benefit modeling (which strongly informs national medical public policy making and far too strongly informs the medical policies of HMOs), the most critical component is a value called “cost per life year gained.”

If the cost per life year gained is under $50,000, that is generally considered a decent investment by US medical policy makers. If “cost per life year” gained is over $100,000, that is generally considered a wasteful medical policy because that money could surely be put to much better use elsewhere. Yes, this is cruel and heartless to some degree, but wide scale medical cost allocations do need to be made and, more relevantly, are continually made using these cost plus risk vs. benefit analyses. Think HMOs. Now consider why pap smears, blood tests and urine tests aren’t recommended every month for everyone. Testing monthly could definitely save more than a few lives, and there is no measurable associated medical risk. But the cost would be astronomical versus the benefit over the entire US population when comparing these monthly tests to other therapies, procedures and medicines.

Now on to GARDASIL. By the time you pay doctors a small fee to inventory and deliver GARDASIL in three doses, you are talking about paying about $500 for this vaccine. And because even in the best case scenario GARDASIL can confer protection against only 70% of cervical cancer cases, GARDASIL cannot ever obsolete the HPV screening test that today is a major component of most US women’s annually recommended pap smears. These tests screen for 36 nasty strains of HPV, while GARDASIL confers protection against just four strains of HPV.

Now let’s consider GARDASIL’s best case scenario at the moment — about $500 per vaccine, 100% lifetime protection against all four HPV strains (we currently have no evidence for any protection over five years), and no risk of any medical complications for any subset of the population (Merck’s GARADSIL studies were too small and short to make this determination for adults, these studies used potentially dangerous alum injections as their “placebo control” and GARDASIL was hardly even tested on little kids). Now, using these best case scenario assumptions for GARDASIL, let’s compare the projected situation of a woman who gets a yearly HPV screening test starting at age 18 to a woman who gets a yearly HPV screening test starting at age 18 plus the three GARDASIL injections at age 11 to 12. Even if you include all of the potential medical cost savings from the projected reduction in genital wart and HPV dysplasia removal procedures and expensive cervical cancer procedures, medicines and therapies plus all of the indirect medical costs associated with all these ailments and net all of these savings against GARDASIL’s costs, the best case numbers for these analyses come out to well over $200,000 per life year gained — no matter how far the hopeful pro-GARDASIL assumptions that underpin these projections are tweaked in GARDASIL’s favor.

Several studies have been done, and they have been published in several prestigious medical journals:

http://dx.doi.org/10.1001/jama.290.6.781
http://tinyurl.com/2ovy95
http://tinyurl.com/2tbuma

None of these studies even so much as consider a strategy of GARDASIL plus a regimen of annual HPV screenings starting at age 18 to be worth mentioning (except to note how ridiculously expensive this would be compared to other currently recommended life extending procedures, medicines and therapies) because the cost per life year gained is simply far too high. What these studies instead show is that a regimen of GARDASIL plus delayed (to age 22, 25 or 28) biennial or triennial HPV screening tests may — depending on what hopeful assumptions about GARDASIL’s long term efficacy and risks are used — hopefully result in a modest cost per life year savings compared to annual HPV screening tests starting at age 18.

If you don’t believe me about this, just ask any responsible OB-GYN or medical model expert. Now, why do I think all of this is problematic?

1) Nobody is coming clean (except to the small segment of the US population that understands medical modeling) that the push for widespread mandatory HPV vaccination is based on assuming that we can use the partial protection against cervical cancer that these vaccines hopefully confer for hopefully a long, long time period to back off from recommending annual HPV screening tests starting at age 18 — in order to save money, not lives.

2) Even in the best case scenario, the net effect is to give billions in tax dollars to Merck so HMOs and PPOs can save billions on HPV screening tests in the future.

3) These studies don’t consider any potential costs associated with any potential GARDASIL risks. Even the slightest direct or indirect medical costs associated with any potential GARDASIL risks increase the cost per life year gained TREMENDOUSLY and can even easily change the entire analysis to cost per life year lost. Remember that unlike most medicines and therapies, vaccines are administered to a huge number of otherwise healthy people — and, at least in this case, 99.99% of whom would never contract cervical cancer even without its protection.

4) These studies don’t take in account the fact that better and more regular HPV screening tests have reduced the US cervical cancer rate by about 25% a decade over the last three decades and that there is no reason to believe that this trend would not continue in the future, especially if we used a small portion of the money we are planning on spending on GARDASIL to promote free annual HPV screening tests for all low income uninsured US women.

5) The studies assume that any constant cervical cancer death rate (rather than the downward trending cervical cancer death rate we have today) that results in a reduced cost per life year gained equates to sound medical public policy.

As I said before, if any of you don’t believe me about this, please simply ask your OB-GYN how the $500 cost of GARDASIL can be justified on a cost per life year gained basis if we don’t delay the onset of HPV screening tests and back off from annual HPV screening tests to biennial or triennial HPV screening tests.

The recommendations are already in: http://tinyurl.com/33p9q6

The USPSTF strongly recommends … beginning screening within 3 years of onset of sexual activity or age 21 (whichever comes first) and screening at least every 3 years …