Friday, January 12, 2007

The HPV Vaccine.

posted on Introibo ad altare Dei 5 December 2006

Human papilloma virus, or HPV, is a virus which causes cancer of the cervix in women. The only way HPV is transmitted is by sexual intercourse, one doesn't get it from a toilet seat or by shaking hands. Since virtually all cervical cancers are related to HPV infection, it is correct to say that cervical cancer is a sexually transmitted disease. Interestingly, those of us who used to put it in those terms were pooh-pooh'd not infrequently. Now, however, with the advent of Merk's Gardasil HPV vaccine, everybody is talking about HPV, cervical cancer, and the vaccine. Let's flesh in some details.

There are over a hundred subtypes of HPV, and over thirty of these are associated with cervical diseases including genital warts ("condylomata") in both ladies and gentlemen, cervical dysplasia (pre-cancerous cervical changes) and frank, invasive cancer. The viruses don’t cause cancer directly, they cause dysplasia. The dysplasia may, in turn, progress to cervical cancer if left untreated. The dysplasia is detected by the Pap smear and its more modern derivatives. If the Pap smear detects dysplasia, especially of the high grade variety, a biopsy of the cervix is recommended. If the biopsy confirms the high grade dysplasia, a LEEP (loop electrosurgical excision procedure) is usually performed, where a thin strip of the cervix containing the abnormal tissue is removed. This is frequently, but not always, curative. Here are some important points: first, dysplasia is not invasive cancer. It is a precursor to cancer. Secondly, a lot of dysplasia spontaneously regresses without further treatment. Thirdly, some cervical dysplasia, if untreated, progresses. Progresses to what? Invasive cervical cancer. But the important thing is this: the progression is slow, orderly, and well understood. That's why the Pap smear works so well as a screening tool for cervical cancer: it detects the precursor lesions before they become cancer. HPV infection is the most common sexually transmitted disease in the world, and prior to the widespread use of the Pap smear in the 1950's, cervical cancer was the most common cancer killer of women worldwide. It still is in parts of the world where Pap screening is not done. In the U.S., cervical dysplasia is very common. LEEP’s for high grade cervical dysplasia are very common (this procedure is done several times per day in my hospital). Cervical cancer, however, is relatively uncommon, due to the Pap smear (5000-7000 cases in the U.S. annually). Wouldn’t it be nice if there were a vaccine that would prevent all this?

Enter Merck and Gardasil. Approved for use by the FDA in June, 2006, it protects against the four most common types of high risk HPV,[1] which account for 70% of cervical cancers, and 90% of genital warts. It’s a three shot series given at 0, 2 and six months, and need for a booster is unknown at this time. A second vaccine is under development by GlaxoSmithKline. On June 29, 2006, the Advisory Council on Vaccine Practices (ACIP - the group which formulates vaccine recommendations for the CDC) voted to “recommend” universal vaccination with the HPV vaccine for all girls age 11-12, but beginning as early as age 9[2]. ACIP recommendations, once accepted by the CDC, take the de facto force of law, as local school boards and others turn the recommendations into requirements. The ACIP recommendations that all adult nonpregnant women (>19 years old) be vaccinated were published in the CDC’s publication, Mortality and Morbidity Weekly Reports (MMWR) on 13 October 2006. The recommendations for the universal childhood vaccinations are scheduled to be published in November, but are unavailable as of this writing. Not too surprisingly, the medical machine, as represented by the New England Journal of Medicine, is all for this,[3] and well funded pro-teenage contraception organs like Advocates for Youth are simply livid that those religious conservatives might not think universal HPV vaccination for children is such a swell idea.[4]

Why isn’t it a swell idea? First. The vaccine does not remove the need for Pap smears nor will it do anything for a lady already infected. Second, it doesn’t do anything about other sexually transmitted diseases, although it’s easy to imagine a 12 year old (remember, that’s the target audience) who thinks it does. For that matter, I can easily imagine a 20 year old who might think it does, but that’s neither here nor there. Thirdly, there are concerns that the FDA has "fast-tracked" licensure of Gardasil, without adequate study of its safety in little girls.[5] Fourth, and most importantly, no one knows what effect universal vaccination of 9 year olds might have on adolescent tendency to have sex. However, the data of the past forty years of social experimentation suggest that it would tend to increase sexual activity. That’s been the outcome of all the other experiments on early immersion of young children into the fetid world of “sex ed” and teenage contraception, and there’s no reason this should have a different effect. Regarding the morality of the vaccine itself, its manufacture does not involve aborted babies[6]. So the moral problems attached to, say varicella or rubella vaccines do not apply here.

HPV is a sexually transmitted disease. You don’t get it if the person next to you coughs, and you don’t get it from a water fountain or a toilet seat. Requiring HPV immunizations for young girls (and that is what ACIP “recommendations” amount to: requirements) is, in my view, no different from requiring that all school age girls be put on contraception. The decision to vaccinate one's little girl with Gardasil should reside strictly within the family. Legislating its use is inappropriately paternalistic. The National Catholic Bioethics Center has summarized it appropriately:

The NCBC considers HPV vaccination to be a morally acceptable method of protecting against this disease, but asks that civil authorities leave this decision to parents and not make such immunization mandatory.”[7]

[1] “HPV and HPV Vaccine: Information for Healthcare Providers” Centers for Disease Control, August, 2006. www.cdc.gov/std/healthcomm/fact_sheets.html
[2] “ACIP Provisional Recommendations for the Use of Quadrivalent HPV Vaccine”. available at www.cdc.gov
[3] Steinbrook, R. “The Potential of Human Papillomavirus Vaccines.” NEJM 354(11):1109-1112; 16 March 2006.
[4] “Will the Politics of Teen Sex Stop a Cancer Vaccine?” Advocates for Youth Media Brief, www.advocatesforyouth.org
[5] "Merck's Gardasil vaccine not proven safe for little girls." National Vaccine Information Center, Press Release, 27 June 2006. www.909shot.com/PressReleases/pr62706gardasil.htm
[6] Gardasil package insert, Merck & Co., 2006. Available at Institue for Vaccine Safety, www.vaccinesafety.edu/package_inserts.htm
[7] NCBC Statement on Vaccination against Human Papilloma Virus (HPV). National Catholic Bioethics Center, 11 July 2006. www.ncbcenter.org/06-07-11-hpv_vaccine.asp

9 comments:

Anonymous said...

Aside from the important issues that you raised, the evidence as noted in the federal Vaccine Adverse Events Reporting System suggests that there may be problems with Gardasil's safety http://tinyurl.com/yflfb9 . The vaccine was approved six months ago and already there are 82 reaction reports filed. Of these, 21 document syncopal or fainting episodes sometimes combined with seizures. Two reports document a close temporal association between Gardasil vaccination with series neurological problems including Guillain Barre Syndrome.

Anonymous said...

As a Catholic family physician as well as the mother of a daughter, I have been following this topic closely and wrote about it most recently here. I completely agree that the decision to vaccinate is a morally acceptable decision for a parent to make, however, the state has no business requiring such a vaccination. The precedent for such a requirement was set with the Hepatitis B vaccine. This is a disease spread by sexual transmission, IV drug abuse, tainted tattoo equipment and other blood borne vehicles. It is certainly not a public health risk in the school setting. (one would hope) Yet it has joined the ever expanding list of mandatory vaccinations.

Anonymous said...

But Catholic Mom---

Hepatitis B vaccine --and the subsequent prevention of Hepatitis B infection-- prevents liver cancer. If we have the capacity to safely prevent cancers, don't we have a moral responsibility to relieve and prevent human suffering?

Anonymous said...

I am quite torn on this. I personally would not want to be required to vaccinate my daughter for an STD, but spend a day doing check-ups at an inner-city school where the fifth grade girls have STD's in their throats because of what goes on and it makes you stop to think (and cry). The parents of those girls are not doing things to help their daughters and are very unlikely to take them to get the vaccine on their own. Who is going to help those girls when their parents are not willing or do not know how?

jmjtina said...

Where are the pro-choice people when you need them?

Invading girls bodies like that!

Anonymous said...

Some additional points about HPV should be discussed in the article. First, the virus can reside and does exist under the fingernails which does allow hand to hand transmission.(Japan has the custom of a bow when greeting someone; and it also has the lowedst incidence of cervical cancer.) Other means of transmission are not discussed including the presence of the virus on pubic hair which is an area not covered by a condom. Second, HPV treatments does include the removal of the cervix or in some cases an hysterectomy is the only answer. Third, in some cases especially in the undeveloped world, HPV avoids reporting because the virus or cancer has moved to another area of the body especially the lungs. Fourth, HPV when in the presence of some viral infections or cancers, it's presence is some times not reported to the patient. (HPV is not a reported disease to the CDC which further limits testing). For example, nasal cavity is almost never related to tobacco but to the presence of Epstein-Barr and HPV being present. These two viruses may be the cause of about 20% of all bladder cancers. Some brain tumors in children under three years of age are due to HPV. HPV when in the presence of melanoma cancer will aid the rapid development of this cancer. Fifth, HPV causes lesions of different types but all will aid entry to allow other viral infections. HPV is a double strain DNA that is larger than most single strain DNA viral infections. Single strain Hepatitis C and HIV can gain entry. HIV is a difficult virus to transfer sexually; but this is not so when HPV or herpes viral infection is present. Almost all cases of HIV infected individuals have HPV which is not a coincidence. Six, the pap smear which was approved in 1942 long before the virus was ever seen under it was ever seen under an electron microscope. It is an observation of skin and not a test for HPV. Strain testing for HPV is very important. Strains not only have a high and low risk for the probable development of cancer or for warts; but many other causes including a smell and large amounts of vaginal discarge. In Afganistan, females married to much older men have HPV infections with discharge so bad that many leave trails when walking and inner leg sores is very common. Seventh, the vaccine Gardasil is approved and is being given to boys in the Europe Union. Males develop penile cancer and anal cancer. All anal cancer are due to HPV. The gay population reports large number of anal cancers; but women still report the largest number of anal cancers.

I hope this information is helpful.

"Are You at Risk for Cancer from HPV?"---the book.

Jessica said...

As a catholic pediatrician and sibling to a 12yo sister, I very much agree with advocating for the vaccine, even if you do not think your child is sexually actvive. For one thing, you can never say 100% that you know what your child is doing all the time (even if they're not having sex, they could be engaging in many other forms of intimacy which could risk transmission of virus). In addition, God forbid a child is raped or molested, but these things happen. Wouldn't you want to know that you did the best you could to protect your child? I agree with earlier posts which recommend that the vaccine be required. I think that it should be mandated precisely for those children whose parents are not as involved and not as concerned about their welfare - kids I see every day, and kids who are much more likely to engage in risky behaviors. This is where the real target audience is for a mandatory vaccine - those who need protection. Obviously, parents who are strongly against the vaccine may refuse, just like any other vaccine, but I truly believe receiving the HPV vaccine is in the best interest of our children.

Cammy said...

Does the vaccine work if you get it right before you get married?

Anonymous said...

I would like to add that while HPV is primarily sexually transmitted, that sexual contact is not always consensual. I would hate to anyone's child forced to deal with a lifelong consequences of being infected with HPV on top of already living with the trauma of being raped. For that reason, though I will teach my daughters to abstain until marriage, I will also protect them by getting them this vaccine.