Thursday, March 08, 2007

HPV Vaccine: Why aren't clinics and other docs rushing to offer it?

An article in today's Metro NY talks about the lack of HPV vaccines in New York City's STD clinics and immunization centers. I'm happy to see this article on the front page, because the HPV vaccine needs to be brought to the attention of not only the public, but physicians as well. Gardasil, the quadrivalent version was only released last summer and there is still confusion and misunderstanding amongst physicians as to its use. The article, however, did not make mention of the following very crucial information for the public to be educated about the HPV vaccine:

Gardasil protects against four types of HPV (6, 11, 16, 18). HPV Types 16 and 18 cause 70% of cervical cancer cases, and HPV Types 6 and 11 cause 90% of genital warts cases.

The CDC currently recommends routine vaccination of all girls ages 11-12, although vaccination may start as early as age 9. Catch-up vaccination is recommended for girls and women ages 13 – 26 who did not receive the initial vaccine series. The vaccine cycle involves 3 doses, given at 0 months, 2 months after the first dose, and 6 months after the first dose.

Having a Positive HPV DNA result on a pap smear is NOT a contraindication to getting vaccinated. This is a misconception I have heard OB/GYNs telling their patients. The vaccine still provides some level of protection, even for someone exposed to one subtype of HPV. The HPV DNA test can only test for low-risk or high-risk. It does not distinguish which HPV type(s) were isolated in the pap smear, as this test is very costly to perform.

In addition, the HPV vaccine, which is relatively costly compared to other vaccines, brings to question some ethical issues in medicine. Each vaccine costs the provider approximately $140 to purchase. This was initially a point of hesitation for me as I'm trying to keep my costs down. Often, Merck will give discounts on mass orders, but one does not want unused vaccines sitting in the refrigerator and going to waste. With each vaccine so costly, the recommended cycle of 3 vaccines will cost $420 just for the vaccine; this is without accounting for storage and administration and overhead costs. Factor that in, and each vaccine costs $210 for a small practice, with the total cost running $630. Now you could lower the margin, but it does not help the public to not be able to meet your overhead costs. Fortunately, insurance plans are stepping up and covering the cost of the vaccine, as they rightly should. I have yet to see what they will reimburse for this, as often they pay less than it costs to purchase the vaccine. The initial creative solution for my practice to control up-front costs is to determine our vaccine requirements ahead of time by having qualified patients commit to receiving the cycle, then ordering based on that demand. One can order vaccines at VaccineShoppe.com, often with a 24 hr delivery time, which makes demand-ordering possible.

Comparative cost of commonly used vaccines on VaccineShoppe.com (other companies offer comparable rates):

Hepatitis A (Adult, single dose) $56.84
Hepatitis B (adult, single dose) $50.54
Gardasil (HPV, single dose) $141.69

Is the high cost justified, or is Merck making a hefty profit before competition hits the market? It seems that MedImmune with GlaxoSmithKline and Norvartis (separately) are racing to bring their own versions of the vaccine to the market. I have mixed feelings about Big Pharma. Even though Merck has helped the public good with its preventive vaccines, it also needs to make money off of them to meet the interests of its shareholders. Its interests are split between helping the public good and helping the pockets of its investors, as we saw with Vioxx. How much profit for Merck is ok when dealing with a matter for the public good? The good news is that competition will eventually lower the price to where it should be.

Finally, while it's true that the US population should be vaccinated for HPV no doubt, cervical cancer rates in this country have markedly dropped since the introduction of the Pap smear more than half a century ago. We should remember that cervical cancer is a more widespread and deadly disease in Africa, where many more women are dying every day from this devastating cancer. In Africa, Pap smears are not routinely done or available. Is there some obligation to make this vaccine available to Africa at a lower cost that these countries could afford to institute a nationwide vaccine program? One day our consciences will hopefully ring in compassion for those more needy.

6 Comments:

Anonymous Anonymous said...

I'd worry less about the cost of the vaccine and whether it can be marked up to break even than about the emerging concerns about safety. You should have a look at the early analyses of VAERS that have been circulated and consider sitting on this one for awhile until the safety and effectiveness issues are worked out. I talked to someone today who's kid got HSP vasculitis with renal involvement and another woman who was admitted for three days due to expressive aphasia - the neuro thinks it was the vaccine and has been working CDC and Merck to sort it out. In a year or so, the GSK product will be out and probably drive down costs and maybe the safety issues will be worked out. Also, a close look at the JAMA study isn't all that impressive - HPV-16 and 18 were 2.3%, 90% clears without intervention, leaving .23% chronically infected of which only a small proportion will get dysplasia - let alone CA. Access to routine gyne care would probably further reduce the mortality rate.

10:11 PM EST  
Blogger Andy said...

Hey Solodoc, check this article out.
http://www.aapsonline.org/brochures/irsmall.htm

7:48 PM EDT  
Blogger Andy said...

http://www.aapsonline.org/brochures/irsmall.htm

Check out this link.

7:49 PM EDT  
Blogger ObGynThoughts said...

Dear Solo Practitioner:
I was very excited when the vaccine came out and told my patients that this was a milestone in the fight against cervical cancer. By now, I am a little more modest.
In the US, no woman who takes good care of herself will ever get cervical cancer. Why? It takes 5-15 years from the first abnormal Pap to microinvasive cancer. A recent study showed a time span of 8 years between CIN 3 and microinvasive cancer. (he exception that needs to be mentioneed are HIV positive patients, who may develop this within one year). We will catch it, no doubt at all. And when we catch it, we will do a LEEP and the problem is solved. So, the vaccine really saves you a LEEP. Which is important, since even a LEEP increases your risk of preterm labor and of cervical insuficiency in pregnancy.
So, the vaccine is helpful. But it is not a sea change. It might be more valuable in developing countries, but tragically, they might not be able to afford large scale vaccinations.
The vaccine has its place in prevention and I recommend it to all teens and to all mothers of teens. I recommend that the mothers should not introduce the vaccine as having something to do with sex, since many mothers are concerned about that, but to simply say: this vaccine is good for you, it prevents cancer. Period. After all, we vaccinate young women against rubella and do not mention sex. And the value of rubella lies in prevention of malformations in pregnancy. And pregnancy, hellooo, is the result of sex.
And hopefully one day we will have tests that tell us which HPV subtypes a patient has been exposed to and we will be able to vaccinate those who have not been exposed to 16 and 18 yet.
Your Matthias Muenzer, MD

9:08 AM EDT  
Anonymous Anonymous said...

solo practitioner, i don't know how to navigate this site. but i would like to get ahold of you. are you in the nyc area? plz contact me at im.here.where@gmail.com

10:41 PM EDT  
Blogger Sharon said...

I too have had a very horrible outbreak of vasculitis since taking Gardasil. Does anyone have anymore information on how to treat this? I have been to several doctors and everyone seems to tell me that there is no treatment or cure and I am going to have to live with this forever. I have THOUSANDS of red lesions all over my body (excluding my face) which burn and are quite uncomfortable. Anyone have any advice?

8:08 AM EDT  

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