Since I last posted on this subject (1/15/06) the Food and Drug Administration (FDA) has approved the use of Gardasil. Gardasil is Merck's vaccine against the transmission of certain strains of the Human Papilloma Virus (HPV), and is intended for use by girls as young as nine and up to age 26. HPV is a viral infection that is transmitted ONLY via sexual activity. It is estimated to cause (between two of its several varieties) upwards of 70% of cases of cervical cancer, which can be deadly. The American Cancer Society (ACS) reports that roughly 9700 women are diagnosed with cervical cancer every year, and of that number, roughly 3,700 will die.
A few facts: Of those women who do contract HPV, 90% or more will clear the infection through natural immune response, requiring no treatment and sustaining no long-term health effects. It is important to note that the vaccine can only prevent infection by HPV (and only two types at that), and NOT treat an existing one. It also can’t protect against other strains of HPV which cause cervical cancer, which the ACS website points out: "It is important to realize that the vaccine doesn't protect against all cancer-causing types of HPV, so Pap tests are still necessary."
Clearly, regardless of what protections the vaccine does offer, monitoring of sexually active women via Pap is still critically necessary: treatment of any precancerous cells found via Pap can stop cervical cancer before it is fully developed.
When I first heard of Merck’s plan for the vaccine, I questioned the advisability of routine and blanket vaccination of very young girls against a virus that can be contracted only through sexual activity. While the FDA approved its use in girls as young as nine, the Centers for Disease Control (CDC) advisory panel, perhaps a bit more sensitive (the idea of 9-year-old girls as sexually active might upset parents!) fudged the age closer to puberty and issued its recommendation for girls 11 and up.
In the interim, Merck has been busy creating a new campaign to raise awareness about cervical cancer called "Tell Someone". Coincidentally, after years of stagnation and lack of profits in the vaccine business, drug companies such as Merck are making a major push to expand the adolescent market for vaccines, which pharma companies believe to be an area of tremendous growth opportunity. (Gardasil itself is administered in three doses over a course of six months, at a cost to the patient--or the insurer-- of $360.00, not including doctor's and other fees.) The campaign’s website should be lauded for getting out the word that this virus is connected to cancer. But it is heavy on the fear factor and just a little coy about clarifying that this particular cancer-causing virus can only be contracted through sexual contact. It takes several clicks to uncover that fact. In the meantime, a visitor might think a handshake or a sneeze could spread it.
However, the American Cancer Society is more upfront:
“You can prevent most precancers of the cervix by avoiding exposure to HPV. Delaying having sexual intercourse if you are young can help you avoid HPV. Limiting your number of sexual partners and avoiding sex with people who have had many other sexual partners lower your risk of exposure to HPV. Remember that HPV does not always cause warts or other symptoms, so a person may have the virus and pass it on without knowing it. “
Not only that, the ACS website is clear on the fact that, for the sexually active girl or woman, testing for the virus is not only possible but fairly easy:
“Doctors can now test for the types of HPV that are most likely to cause cervical cancer ("high-risk" types) by looking for pieces of their DNA in cervical cells. The test is done in a similar way to the Pap test in terms of how the sample is collected, and in some cases can even be done on the same sample. “
The CDC website makes a further point— that is, even if you contract HPV and it causes precancerous cells, you are not doomed to succumb to cervical cancer:
“Regular Pap testing and careful medical follow-up, with treatment if necessary, can help ensure that pre-cancerous changes in the cervix caused by HPV infection do not develop into life threatening cervical cancer. “
Well, that’s good news. Someone can easily keep track of their HPV status and make sure it doesn’t progress to anything more serious. So why do we need blanket vaccination? Especially when the vaccine does not prevent every type of potentially cancer-causing HPV?
Not surprisingly, two Michigan lawmakers recently proposed to make this vaccine mandatory in girls 11 and up. This is an important development as Michigan may set a trend for other states to follow, and a government program which sponsors the cost would increase both sales momentum and the “acceptability” factor of vaccinating young girls against an STD.
So I still object stubbornly to this trend, for a number of reasons. First, safety. The imprimatur of FDA and CDC approval does not make this vaccine safe. Only time will tell that, and only after it has been rolled out in a broad manner among prepubescent girls. For anyone who believes that the FDA say-so is all the reassurance they need, I’d point out that the FDA approved Vioxx and Merck had deep market penetration before that drug’s safety issues became obvious. Merck is fighting hard in court venues around the country as former patients and their families claim death and disability resulted from its use.
Second, there are reasonable options. If one can prevent HPV infections by refraining from or being very careful about sexual contact, and if HPV infections can clear up on their own or be verified by testing, and if HPV-related precancerous cells can be treated before turning cancerous, aren’t there many ways to avoid HPV-related cervical cancer without subjecting your daughter to possible side effects of the vaccine?
And finally, I object because I don’t like the social engineering aspect of it. Here's what I mean. If adult women want this protection, they should be welcome to choose it. And pharma companies have a right to want to expand their customer base. But it shouldn't be our priority to enhance their revenue stream by being obliged to buy a product for which the real need is questionable. I don’t like the effect it has on our cultural psychology: It says that to catch ‘em early, before they start having sex, we need to vaccinate at age nine. Or eleven. What happened to childhood? The medical establishment and the legislators are already buying in. When the grownups start taking this notion seriously, the children will too, no matter what sort of defensive spin you put on it. And there’s no way that can be good for children.
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