Furor on Rush to Require Cervical Cancer Vaccine

[kurth]

Furor on Rush to Require Cervical Cancer Vaccine
By STEPHANIE SAUL and ANDREW POLLACK
Published: February 17, 2007

Racing to embrace a new vaccine, at least 20 states are considering mandatory inoculation of young girls against the sexually transmitted virus that causes cervical cancer. But a roaring backlash has some health experts worried that the proponents, including the vaccine’s maker, Merck, have pushed too far too fast, potentially undermining eventual prospects for the broadest possible immunization.

Groups wary of drug industry motives find themselves on the same side of the anti-vaccination debate with unexpected political allies: religious and cultural conservatives who oppose mandatory use of the vaccine because they say it would encourage sexual activity by young girls. Even some who support use of the vaccine question the rush and the vaccine’s high cost — about $400 for the three-shot course. “The decision to make this mandatory this early has created a significant controversy over things that have nothing to do with the vaccine,” said Dr. Joseph A. Bocchini, chairman of the committee on infectious diseases of the American Academy of Pediatrics.

Like most other public health experts, Dr. Bocchini advocates the vaccine’s use. But many say the rush toward mandatory inoculation could prove counterproductive. Most of the proposals call for vaccinating girls before they enter the 6th grade, a group that would include about two million girls nationwide annually if all states imposed the requirement. In Texas, Gov. Rick Perry recently issued an order that girls be vaccinated. But some legislators are trying to overturn the order, with some opponents complaining because the governor’s former chief of staff is now a lobbyist for Merck. State lawmakers are scheduled to hold a hearing Monday on a bill to rescind that order...

“It’s a very messy thing to be promoting right now,” said Fran Eaton, editor of the conservative blog in Illinois where one writer attacked Senator Halvorson’s morality. “If you’re a conservative, you’re going to be worried about parental rights. If you’re a liberal, you’re worried that the pharmaceutical companies are taking over the United States.” One activist who frequently criticizes pharmaceutical companies, Vera Hassner Sharav, and a co-author suggested that the H.P.V. vaccine stood for a campaign to “Help Pay for Vioxx” losses. Vioxx, the painkiller taken off the market in 2004 because it was linked to cardiovascular problems, was also made by Merck...

http://www.nytimes.com/2007/02/17/health/17vaccine.html

[aquart]

1. My confidence in Merck's testing just isn't there yet.

[depakid]

4. Merck didn't do the testing

They only hold the distribution license.

Testing was done by SCIENTISTS in Australia, the USA and Canada.

Perhaps you should get your facts straight before aligning with the anti-vaccine propagandists.

[aquart]

7. Well, if it's the better mousetrap...

Why are they pushing so hard? When Gov. Goodhair pushes a product, sorry, that makes me want all the figures rechecked.

[mhatrw]

10. So how come these "unaffiliated" scientists used three injections of a highly

pharmacologically active aluminum adjuvant as their "placebo control"?

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.

Sources -

Merck and the FDA: http://www.fda.gov/cber/label/hpvmer060806LB.htm

NY Times: http://tinyurl.com/2cyzsj

News article about alum injections causing neural death in mice: http://www.straight.com/article/vaccines-show-sinister-side

Published, peer reviewed medical paper about alum injections causing neural death in mice: http://tinyurl.com/3xhtdz

[HiFructosePronSyrup]

11. Why would you assume...

that the "pharmacologically active aluminum adjuvant" hasn't already been tested versus a blank placebo?

[mhatrw]

12. It HAS BEEN tested against a saline placebo.

It had twice the number of reported side effects. Is that a good placebo?

This highly pharmacologically active aluminum adjuvant was also shown to cause neural death in mice in a recent toxicity study:

http://www.straight.com/article/vaccines-show-sinister-side
http://tinyurl.com/3xhtdz

[madrchsod]

2. how many threads on this issue in du?

thousands? well it seemed that way...

[otherlander]

3. Oh...

I thought Limbaugh had Hitler on his show.

[Cessna Invesco Palin]

5. Ah...

I do so love it when the right wing's lunatics find common ground with the left wing's lunatics.

[NotGivingUp]

6. Medical tyranny is alive and well in the good ol' usa.

You will get many replies in these vaccine threads from trolls, nonthinkers or we-want-a-dictatorship robots.

[mhatrw]

8. GARDASIL is all about giving billions to Merck to save billions on pap smears.

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 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 ...

[JTFrog]

9. Drugmaker stops lobbying efforts for STD shots

http://www.msnbc.msn.com/id/17246920/