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    Saturday, February 10, 2007

    Texas Vaccine Update: The state legislature is pushing back against the Texas governor's HPV-vaccine mandate:

    Thirty-two state representatives sent a letter to Gov. Rick Perry on Thursday reiterating their plea for him to rescind his anti-cancer vaccine mandate for schoolgirls.

    The letter, signed by 31 Republicans and a Democrat, said Perry's order "usurped the legislative process."

    "While philosophic differences will dictate where our beliefs fall, no Texan would willfully abdicate their voice in the Legislature to a single office of their government," the letter said.

    ....On Tuesday, all but five state senators sent him a letter asking him to rescind the order. Lawmakers have also filed four bills aimed at superseding it.


    The governor says his royal decree mandate is justified because it will save lives. That's technically true, and it makes it difficult to argue against it. That's the advantage that all of these medically-oriented legislative pushes have - be they tax dollars for stem cell research, mandated insurance coverage for medical procedures, or mandated vaccines. It's too easy to paint a sympathetic public face for the iniatives - who wants to be against saving lives?- and too difficult to point out the cost vs. benefit without seeming a miser.

    Part of the reason for the difficulty is that someone else always pays. Imagine if the governor were telling Texans that if they want their daughters to enjoy the benefits of a public education, they must pay $360 out of their own pockets for a vaccine against a disease that most of their daughters will never get. That would be a political death sentence, would it not?

    But of course, those mandates do come out of the public's pockets - in the form of higher insurance premiums and higher taxes.

    UPDATE: Lucinda Marshall on what the legislature would do if the governor would do if he were serious about saving lives:

    It is important to note that low-income women and women who do not have health insurance are most at risk because they are less likely to get regular Pap smears. More than half of the diagnosed cases of cervical cancer are in women who have not had a Pap smear in three years. While Gov. Perry has mandated that the state of Texas foot the bill for those who can't afford the expensive HPV vaccine, it is unclear where those funds would come from either in Texas or in other states that are considering making the vaccine mandatory. And obviously the cost of the vaccine makes it prohibitive in the countries where it is most needed and would potentially do the most good.

    What is clear is that Merck has a substantial financial interest in the vaccine becoming mandatory even though the added benefit to public health is both minimal and costly. With more than 10 million girls in the U.S. between the ages of 10-14, the drug company stands to make billions of dollars preventing a disease that is already treatable in the targeted population. Since the vaccine does not eliminate the need for regular Pap smears, it would appear that a far more appropriate and cost effective first step would be to make regular gynecological healthcare available for all women regardless of income and medical insurance, particularly since this step by itself would go a long way in reducing the few cases of cervical cancer that still occur in this country.


    UPDATE II: A persuasive argument against Governor Perry at RealClear Politics:

    To the extent I have objections about this policy, they lie with the fact that Rick Perry has made a unilateral decision mandating that 11 and 12 year old girls are injected with an eight month old vaccine - and his defense that "as a pro-life governor, I will always take the side of protecting life" makes me more unsettled by his action, not less.

    Take Perry's last question, for example. Say we did have a brand spanking new, eight month old vaccine that prevented future occurrences of lung cancer. Would Perry mandate it for all children, given that he always takes "the side of protecting life?" What about a drug that prevented heart disease? Or better yet, one that reduced obesity, thereby preventing future cases of heart disease and diabetes?

    The question is, who gets to make these decisions and are they being made in a careful and methodical way?


    Exactly.

    UPDATE III: Danie makes a good point in her comment below, and probably the best argument in favor of the vaccine:

    The main benefit of this vaccine, as I see it, isn't to prevent cancer, it's to prevent the overtreatment of dysplasia. HPV is without a doubt the most widespread STD. In fact, the average 15 y.o. girl has a 77% lifetime risk of undergoing evaluation for an atypical Pap. Not because she has a serious problem, but because the bar has been set so high that any problem becomes serious. These interventions are not benign-never mind the wasted money- how many Gyns remember that they could be LEEPing away a 17 y.o. girl's fertility along with that LGSIL?

    But it is still does not justify legislative mandates.

    UPDATE IV: Alack and alas, the comment section at this Althouse post pretty much sums up the debate that we're getting rather than the debate we should be having over the vaccine mandate. Note especially the "Downtownlad" comments:

    And this is a black and white issue. You are either against cancer (pro-vaccine) or for cancer (anti-vaccine).

    It isn't a matter of pro-vaccine vs. anti-vaccine, nor is it a matter of morality. It's a matter of how much government interference in personal health decisions we're going to tolerate.

    Public health used to be concerned with protecting the public against diseases that were easily transmissible from one person to another, and from which we could not protect ourselves without the help of the community/government - clean water, sanitation, and vaccines against commonly communicable (and fatal) diseases. Now it's become about government protecting us against poor choices or any disease that might come down the pike - trans-fat, smoking, and vaccines against viruses that require intimate contact for transmission.
     

    posted by Sydney on 2/10/2007 08:30:00 AM 5 comments

    5 Comments:

    The way I see it, this vaccine is designed to prevent largely unnecessary interventions carried out to eliminate hypothetical disease.

    Cervical cancer has become a rare disease because of the (relatively) widespread use of Pap smears. However, along with that has arisen a state of hypervigilance regarding the followup of Paps. In our litigious environment almost no physician is willing to follow guideline regarding conservative followup of abnormal Paps. No patient is willing to do it either; what with the constant harping about getting Paps, patients feel that an abnormal Pap = cancer. So, those that get Paps are overtreated, and those that don't get paps (because the government would rather spend the money on vaccines?) get cancer.

    The main benefit of this vaccine, as I see it, isn't to prevent cancer, it's to prevent the overtreatment of dysplasia. HPV is without a doubt the most widespread STD. In fact, the average 15 y.o. girl has a 77% lifetime risk of undergoing evaluation for an atypical Pap. Not because she has a serious problem, but because the bar has been set so high that any problem becomes serious. These interventions are not benign-never mind the wasted money- how many Gyns remember that they could be LEEPing away a 17 y.o. girl's fertility along with that LGSIL?

    By Anonymous danie, at 11:28 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. If anyone wants the references, I can provide them.

    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 ...

    By Anonymous mhatrw, at 11:50 PM  

    Completely agree with the original post.

    Danie's argument is powerful and would convince me to have my daughter vaccinated (if I had one) or to get a vaccine myself if I had been quite a lot younger. But I have a problem with government mandating medical intervention unless there is a threat to public health from doing otherwise - as mentioned in the original post. I am not as much concerned with this specific case, but with the precedent of government's mandating medical interventions "for an individual own good", as I am worried of where such an interference might lead in future.

    I also have a problem with a politician making a medical decision without a clear recommendation to do so from the medical organizations.

    Off-topic: I find this comment by the previous poster very disturbing (especially if the author is a doctor):
    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.
    Not only this is not definite at all, but one of the tests you mentioned (urine) is not even recommended. If you are a doctor - I'd be curious to know if you flanked epidemiology.

    Not only you cannot claim that testing anybody monthly is likely to save more lives unless there are studies showing it, but contrary to popular belief, testing is neither risk- nor harm-free. False positives lead to more invasive tests which have risks. Overdiagnosis and overtreatment are even more serious risks. This is even true for recommended tests taht are shown to save life, but listing a test that USPSTF clearly recommends against because "the harms are likely to outweight the benefit" and saying it is not given every month (when it is not recommended at all) because of monetary concerns is irresponsible and ignorant.

    By Anonymous Diora, at 5:32 PM  

    mhatrw
    You've translated the medical uselessness of Gardasil into good solid economic data, and I think you're absolutely right. My graduate medical thesis on cost/utility analysis was actually published(!), so I indeed get where you're coming from.

    My point, above, was that the vaccine is basically preventing disease that is clinically insignificant because current screening methods are already quite good- and in fact are overkill as practiced. Gardasil is more of the same- but might reduce a lot of anxiety over abnormal paps- altough it is anxiety that is unwarranted. So even in the best of circumstances, it's treating the worried well. And we all know how expensive that is!

    Because, in fact, Merck advises that women continue with their routine exams, there is no cost saving there. Since the vaccine is only partially effective, I doubt ACOG or Bethesda will issue any new screening guidelines for vaccinated women, either.

    You said:
    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.

    Yet, this is the most likely outcome.

    Your point #4 about using the money to increase screening rates is the clearly most effective way to reduce the rate of cervical cancer. This is the same point that popped up when HPV testing came out. It's not all that terribly cost-effective, either. So another good question to ask your OB/GYN is this- if he/she can recall their last patient with cervical cancer, when was the last time that patient had a pap? Five years? Ten? Never?

    By Anonymous danie, at 5:46 PM  

    diora
    I agree with you. Despite my screed above, that's macroeconomics. In my little microeconomic domain, I probably will end up getting the vaccine for my daughter (if it turns out to be safe), because I know what overzealous surveillance can do. But, our revenues exceed our expenditures by a long shot (including charitable contributions, if anyone feels compelled to ask). The goverment does not have this luxury, and both goverment & private insurers have to underwrite a lot of unknown risk, which I also do not have to do.

    By Anonymous danie, at 5:52 PM  

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