CDC doctor (vaccine chairman) opposes law for vaccine (GARDASIL)

[mhatrw]

http://washingtontimes.com/functions/print.php?StoryID=20070226-115014-2031r

The chairman of the federal panel that recommended the new cervical-cancer vaccine for pre-teen girls says lawmakers should not make the inoculation mandatory, as the District and more than 20 states, including Virginia, are considering.

Dr. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices (ACIP), also said he and panel members told Merck & Co., the drug Gardasil's maker, not to lobby state lawmakers to require the vaccine for school attendance.

"I told Merck my personal opinion that it shouldn't be mandated," Dr. Abramson told The Washington Times. "And they heard it from other committee members."

Dr. Abramson said he opposes mandating Gardasil, which prevents the cervical-cancer-causing human papillomavirus (HPV), because the sexually transmitted HPV is not a contagious disease like measles and he is not sure states can afford to inoculate all students. "The vaccines out there now are for very communicable diseases. A child in school is not at an increased risk for HPV like he is measles," Dr. Abramson said.

[terip64]

1. Common sense, how refreshing...n/t

[MADem]

2. Geez, I got a major chewing here for suggesting the exact same course of action. NT

[Caution]

3. But , but he's the vaccine chairman! He's evil! Mercury! Autism!

Gee look, how shocking, a doctor who cares about the rights and health of other people.

And here I thought they were all controlled by <cue scary music>big pharma</cue scary music> and were trying to hide from everyone the ASTOUNDING BENEFITS of homeopathy, aromatherapy and THE SECRETS OF ANCIENT EASTERN MEDICINE!!!!

As long as people can choose to opt out (which all of the currently proposed "mandatory" inoculation laws suggest, I see no reason not to make it available.

[mhatrw]

4. Why then do you suppose that this doctor does not support "opt out" mandates?

I mean, since you were lauding this doctor for his independence from the Merckanaries who have been pushing so hard to mandate this vaccine for all 11 and 12 year old girls less than 9 months after the FDA approved it, I was wondering why you disagree with him about mandatory GARDASIL vaccinations?

[PLF]

5. Mischaracterizing the opposition to this stupid mandate is all you have left.

but you know that already.

give it up, you Merck apologists have been overly strident and owe alot of people an apology.

[depakid]

6. One should also note that school districts require Hep B vaccinations

Which clearly flies in the face of this doctor's reasoning.

While cost is an issue- it seems to me that protecting our children from preventable diseases is a very worthwhile investment.

[mhatrw]

7. At well over $2000 per year of life gained, hundreds of therapies,

medicines and procedures are far batter investments.

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 21, 22, 23, 25 or 27) 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 advertising the fact (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 ...

[Kagemusha]

8. The cost argument is a lot more believable than the other hysteria.

My two cents.

[mhatrw]

9. The cost argument is the heart of the argument.

The "hysteria" would disappear if the Merckenaries would stop their full court press to mandate this vaccine for all preteen girls until the data on GARDASIL's long term side effects on little girls, long term efficacy and actual effectiveness in reducing cervical cancer contraction rates exist.

[Lobster Martini]

10. A somewhat different perspective

This is a terrible analogy, but it's all I can think of right now. Follow me down my yellow brick road.

The number of Americans that have died in Iraq since 2003 is roughly 3,700. (I'm including civilian contractors.) There are some reasonably sane people who want to impeach the President.

Roughly 3,700 women die from cervical cancer every year. Even if Gardasil is only 70% effective, that's still about 2,600 preventable deaths per year. No one wants to impeach the President for failing to prevent these deaths. Some otherwise reasonable people are opposed to the vaccine that could prevent them.

Forget the cost. The GAO says that something like $9 billion has been wasted in Iraq. That could have paid for some vaccinations, had there been any oversight.

Granted, the long-term effectiveness of Gardasil isn't known yet, and Merck's lobbying has been as effective as whacking a beehive with a stick, but every argument I have heard against Gardasil has focused on its cost, whether or not vaccinations should be mandatory, whether Merck is lobbying too aggressively...the only thing that isn't being discussed is the potential benefit, like saving a life or 2,600. I could care less whether Merck is overcharging or lobbying too aggressively. Since the treatments for cervical cancer are external beam radiation therapy, brachytherapy and chemotherapy--three really unappealing alternatives--I'll take my chances with the vaccinations.

[mhatrw]

11. These lives will be saved 20+ years down the road, if ever.

Almost all of them could be saved by giving every woman an annual HPV screening test and by promoting condom use.

Yes, GARDASIL's initial clinical results look good in terms of HPV 16 and 18 protection. But we have no evidence how this will play out in terms of cervical cancer protection. We are just hoping for 70% efficacy against cervical cancer contraction and mortality rates based on, well, hope. Just like we are hoping that there are no long term side effects and we are hoping GARDASIL's protection lasts long enough to make vaccinating preteens reasonable.

Nobody is trying to stop any state or organization from offering this vaccine free, educating the public on its potential benefits and encouraging as many youngsters as possible to be vaccinated. It's just that the push to make GARDASIL mandatory is coming too soon for the data we currently have.

http://www.vaccineinfo.net/immunization/vaccine/hpv/doc_against_HPV.shtml

OBGYN Questions HPV Vaccine Gardasil

Editorial Office
Obstetrics and Gynecology
The American College of Obstetricians and Gynecologists
409 12th Street, SW
Washington, DC 20024-2188

I am writing in response to the recent Committee Opinion 344 Published in the September issue of Obstetrics and Gynecology. I have several concerns regarding Gardasil. First, the Gardasil’s product insert states their endpoint is the prevention of "High Grade Disease", this encompasses CIN II-III and adenocarcinoma in situ (AIS) which are "immediate and necessary precursors" for squamous cell and adenocarcinoma of the cervix.1 The MAXIMUM median follow up in any of their studies is FOUR years. However, the time course from CIN III to invasive cancer averages between 8.1 to 12.6 years.2 Claiming this vaccine prevents cervical cancer, with the longest median study subject being 4 years, is inappropriate. The vaccine only "protects" against 4 high risk HPV subtypes. We are currently screening for 15 "high risk" HPV subtypes. This may lead to an increase in infection with other and possibly more aggressive subtypes.

According to ACOG, “The vast majority of women clear or suppress HPV to levels not associated with CIN II or III and for most women this occurs promptly. The duration of HPV positivity (which is directly related to the likelihood of developing a high grade lesion or cervical cancer) is shorter, and the likelihood of clearance is higher, in younger women.”3 Seventy percent of women clear the virus spontaneously after 18 months and 90% clear the virus after 2 years.4 Vaccinating children against HPV with a vaccine that is of unknown duration of efficacy may only postpone their exposure to an age which they are less likely clear the infection on their own and be subject to more severe disease, including the cervical cancer which the vaccine is supposedly preventing. This would require an unknown number of boosters and is a setup for complacency in the older population that is a recipe for disaster.

The likelihood for regression to a normal pap from CIN II with expectant management is 40%.5 This beats Gardasil’s reduction of CIN II-III of only 39% in the “general population impact group” which is where most people would currently fall.6 This includes “all subjects who received at least one vaccination (regardless of baseline HPV status at Day 1.”7 Since ACOG does not currently recommend serologic testing for HPV before vaccination this will be the endpoint from here out. In this case, "first do no harm” rules.

The study of the vaccine in children and adolescents is limited to only measuring the development of antibodies to the HPV subtypes in the vaccine. There is absolutely no evidence that the vaccine prevents anything when administered at this young age. Merck expects you to extrapolate their adult data to the immune response in children. If they were really interested in vaccine efficacy in children, should it not be studied properly in children? Vaccinating children for this or any other sexually transmitted infection is not without risk. There are over 30,000 immunization reactions reported to the Vaccine Adverse Events Reporting System (VAERS) annually 8, and it has been estimated that only 10% or less of vaccine reactions are reported.9 ...

[xchrom]

12. you can get the hpv virus from fingers.