At a Wall Street briefing last month, Peter Loescher, president of global human health at Merck, said he emphasizes "speed, speed, speed" in a product launch. Already, he noted, 80 percent of cities and states - including Maryland - have ordered Gardasil to be distributed through Vaccines for Children. The federally funded program provides free vaccines to doctors who serve children with little or no insurance.
Which explains the rush for Gardasil mandates:
The vaccine is expected to reach $1 billion in sales next year, and state mandates could make Gardasil a mega-blockbuster drug within five years, with sales of more than $4 billion, according to Wall Street analysts.
Merck, which has been arming its lobbyists across the country with information on the vaccine, has been getting an assist from Women in Government, a nonpartisan organization of female legislators whose agenda includes cervical cancer prevention. The group, like breast-cancer activists before it, works through political channels. It also takes corporate donations from Merck.
They've been very successful in promoting mandated vaccines among governors and legislators. Not so much among medical professionals:
The American Academy of Pediatrics, for instance, is urging a go-slow approach, with an initial focus on raising public awareness of HPV and more monitoring of the safety of the vaccine, which had minimal side effects in clinical trials but hasn't been observed in larger-scale rollouts.
"A lot of us are worried it's a little early to be pushing a mandated HPV vaccine," said Dr. Martin Myers, director of the National Network for Immunization Information. "It's not that I'm not wildly enthusiastic about this vaccine. I am. But many of us are concerned a mandate may be premature, and it's important for people to realize that this isn't as clear-cut as with some previous vaccines."
He added, "It's not the vaccine community pushing for this."
The Jan. 7, 2007 WSJ has some interesting insights into this issue. Chief among them was that only 1,184 preteen girls were part of the sample. Cervical cancer accounts for less than 1% (0.77) of diagnosed cancers, and less than 1% (0.65) of cancer deaths.
I do not wish to demean or minimize those people suffering with this terrible disease, but do we wish to set a precedent of population wide vaccination for such low numbers of incidents with no guarantee that this will offer life time protection. There is talk of a second round of vaccinations five years after the first.
A secondary consideration is: Do we wish our schools to become the instrument of commercial enterprise at the direction of one company? We are not talking about a class of drugs, but a specific drug with no competition on the horizon. Giving kids yet another hoop to jump through to go to school does not help the kids.
If states were really interested in providing this drug they would purchase it and supply it to various health providers removing the initial inventory investment and handling the paper work. This along with a publicity campaign to inform the public when and where the vaccine will be available would provide a more common sense approach to this problem.
library-gryffon That's lawyer-speak. They're never going to guarantee anything, because of the risk someone will get cancer anyway, and sue them.
This is also why they still insist women get Paps after having been vaccinated.
But it does account fo the four most likely strains that add up to 70% of cervical cancer cases, and 90% of genital warts. Still not an earth-shattering protective effect, IMHO, and not nearly as good as the advice you gave your daughter.
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:
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 ...