The first vaccine to protect against most cervical cancer won federal approval Thursday.
The vaccine Gardasil, approved for use in girls and women ages 9 to 26, prevents infection by four strains of the human papillomavirus, or HPV, Merck & Co. Inc. said. The virus is the most prevalent sexually transmitted disease.
Gardasil protects against the two types of HPV responsible for about 70% of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90% of genital wart cases.
Merck is expected to market Gardasil as a cancer, rather than an STD, vaccine. It remains unclear how widespread will be the use of the three-shot series, in part because of its estimated cost of $300 to $500. Conservative opposition to making the vaccine mandatory for school attendance may also curb its adoption.
The target age for receiving Gardasil is low because the vaccine works best when given to girls before they begin having sex and run the risk of HPV infection. The vaccine may not protect people already infected and may increase their risk of the kind of lesions that can lead to cervical cancer, the FDA has said.
The national Advisory Committee on Immunization Practices will decide June 29 whether to endorse routine vaccination with Gardasil. That endorsement is critical if a vaccine is to become a standard of care.
It then will be up to individual states to decide whether to add the vaccine to the list of others required before students may attend public schools.
Please read the third paragraph from the end of that block quote carefully: the vaccine is very effective before HPV infection, but can cause harm if administered to someone already infected with HPV. What do you do with that kind of information? It seems to me, if you're a loving parent who is interested in maximal effectiveness, you do what you can to get your daughters vaccinated before there is any earthly possibility that they could be exposed to HPV. (Sons, too -- while sons tend not to get cervical cancer, they could get genital warts from HPV, and they could also transmit HPV to a person with a cervix.) Since the main route of transmission for HPV seems to be sexual contact, this would mean vaccinating well before sex is even on the radar screen. Isn't this just common sense?
Not to everyone, it seems. For example:
"If people begin to market the vaccine or tout the vaccine that this makes adolescent sex safer, then that would undermine the abstinence-only message," said Reginald Finger, a member of the ACIP and a former medical adviser for the pro-abstinence Focus on the Family.
In other words, some parents may want not to have their daughters receive the HPV vaccine because then they might have sex before they get married. This assumes a lot of things. For instance:
- That the threat of cervical cancer years later will keep kids from having premarital sex.
- That teenage daughters who don't have premarital sex will all end up marrying boys who didn't have any premarital sex (and thus won't be infecting them with HPV).
- That abstinence-only education is as effective as its supporters think it is. (See Tara's recent discussion of abstinence pledges and weigh the effectiveness of this plan.)
- That a teenager who reaches an age at which her parents decide it's acceptable for her to receive the HPV vaccine will be forthcoming about whether she has already been sexually active (and thus potentially exposed to HPV).
I suppose the fact that lotteries sell tickets means that people like playing the odds. But why would you do so with your children's health?
Parenting involves all kinds of very personal choices. My choices might well differ from yours. But you'd figure that now that the HPV vaccine has federal approval, it won't take long before it's widely available and covered by insurance, right?
If FDA approves the vaccine [which it just did -- J.D.S.], decisions on its use could be influenced by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), a nongovernmental panel of experts that makes widely followed guidelines on vaccinations. The ACIP has been discussing an HPV vaccine since at least June.
Democrats worry conservatives' qualms could cause roadblocks similar to the two-year battle surrounding approval of the emergency contraceptive Plan B as an over-the-counter drug.
Conservatives say they welcome the vaccine but worry the ACIP could recommend making it mandatory for school-age children because it would violate parents' rights.
"That's something that should be left up to parents to decide," said Wendy Wright, executive vice president of conservative Concerned Women for America. ...
"I have concerns that when this administration does not like the science that they have allowed politics to enter time-tested agency practices," Rep. Tammy Baldwin (D-Wis.) told The Hill. "Our strong caution is 'Please resist any attempt to politicize what has historically been a very scientifically based process.'"
A group of 103 House members -- including five Republicans --sent a letter to ACIP Chairman Jon Abramson last month.
"Certain activists and organizations are mounting a campaign to prevent this vaccine from becoming widely available," the members wrote in a "Dear Colleague" letter circulated by Reps. Baldwin, Lois Capps (D-Calif.) and Darrell Issa (R-Calif.).
"Vaccines that can save lives should not be delayed," said Issa, a conservative who opposes abortion. "Cervical cancer takes thousands of lives, and efforts to eradicate the papilloma virus must move forward."
Other Republicans who signed the letter included Reps. Judy Biggert (Ill.), Mary Bono (Calif.), Mark Kirk (Ill.) and Jim Kolbe (R-Ariz.).
CDC spokesman Curtis Allen said neither Abramson nor the agency has seen the letter and denied a politicization of the process.
"The ACIP is first and foremost a scientific committee and bases its recommendations on the best available scientific, medical and public health information," Allen said.
My quick read on the situation: if vaccination against HPV is not recommended as the "standard of care" -- if it doesn't join measles, mumps, rubella, diptheria, various strains of hepatitus, varicella, etc., in the parade of standard childhood vaccinations -- medical insurance won't cover it. This means folks without the money for the vaccinations won't get them -- even if they would have elected to vaccinate their kids against HPV. None of this has anything to do with the safety of HPV.
(I'm also guessing, although Tara would probably know better than I, that the size of the U.S. market for the vaccine might have an effect on how widely available Merck can make the HPV vaccine in poorer countries where women are more likely to die from cervical cancer because detection and treatment is more likely to be later rather than sooner.)
As for the claim that the ACIP is "first and foremost a scientific committee", please read the account of Dr. Reginald Finger (quoted above) as to how he came to be on the ACIP (pdf):
My appointment came about because a little over a year ago, Focus on the Family was asked -- along with a number of other organizations -- to line up a list of qualified scientists to suggest to Secretary Thompson for service on various federal boards. My bosses here gave the assignment to me and kindly suggested that I put my own name on the list. So I did -- and this spring HHS called and asked if I would serve on the ACIP! ...
[I]t's true that most ACIP members work at academic medical centers, and some at state health departments or private medical practices. But through the years, Focus on the Family has gotten many questions from the public about medical issues, and lots of those concern public health. The two other MDs here see a big need to have someone with my background do research and analysis on medical and public health policy questions. So I have found a good fit here at Focus. This ministry is very pro-immunization and can be a great influence in helping parents resolve their concerns about vaccines. In addition, Focus on the Family wants to have good relationships at CDC -- and I can help make those happen.
I'm a little curious to know what other groups were asked by HHS to put together lists of "qualified scientists", and how many of these groups were primarily religious (or business oriented, or whatever) as opposed to, say, being places where scientists do science. Also, if Focus on the Family is loosking for "good relationships" with the CDC, can we assume, for the sake of consistency, that they won't be screwing with the CDC? Or, is that just what they'll tell us if we ask?
(Hat tip: Feministing)
One promising note: Finger's position on the ACIP expires in three weeks, according his wiki entry, anyway.
The anti-vaccination crowd is making two more mistaken assumptions. First: They seem to assume that withholding the vaccine will actually prevent people from having sex. The model, it seems, is that there are young women out there who, after weighing the risks and rewards of sex, have *just barely* decided that it's the right choice---but than fear of HPV will push them back over the precipice. If we vaccinate against HPV, the logic goes, society has lost one more inch of anti-sex leverage against these "marginal actors". That's stupid: the marginal actor doesn't exist.
Second, I think, there are some conservative parents who terrified that they'll have to talk to their kids about sex. "Sweetheart, this injection will sting a little bit, but it'll protect you from an STD someday when you become sexually active." It's a fundamentalist mom's worst nightmare; they'd rather slip an abstinence-education pamplet under the door and shut up forever. As shortsighted as that is, won't the vaccine just be one in an array of forgettable booster shots? There's no one forcing the parents to map out the birds-bees-sex-HPV-cancer connection; they can just tell the kids they're getting shots for MMR, tetanus, and cervical cancer.
Hey, I have a brilliant idea: why don't we quit giving kids tetanus shots? After all, withholding tetanus shots may give children pause and cause them to play more carefully and avoid activities that could lead to puncture wounds. Seriously, though, this mom's daughter will be first in line when the vials of vaccine arrive in southwestern Virginia. There is absolutely no way of forseeing whether my daughter's future sexual partner(s) will be uninfected, and that applies whether she experiences intercourse within or without marriage. Given that, vaccination seems like a no-brainer.
I've been a member of a hysterectomy support group since 2003. I was fortunate in that my own surgery was because of endometriosis rather than cancer, but several of the women I met there have battled invasive cervical cancer that was past being curable. One of them was a young wife and mother who always went out of her way to cheer up other women who were coping with surgery or chemotherapy. After being terribly, painfully ill for several years, she died of her disease at age 41, and we still miss her.
Now that cervical cancer is about to become a preventable disease, there is no excuse for any yahoos to pre-empt that prevention. There will be no excuse for a woman to have to suffer and possibly die young from a preventable malignancy. There will be no excuse for other children to lose their mother this way, as this wonderful woman's two kids did.
If there were a vaccine that prevented lung cancer, would we deny it to kids because we were afraid they might smoke? Unbelievable.
Another issue to keep in mind - I only learned this year (at the age of 25) that you could get cancer this way. By the time your gyno thinks to mention it, it's usually too late. I'm pretty up on health issues normally, and believe me when I say this one caught me by surprise. By the time this becomes availible, it will be too late for most of my generation. If it were availible tomorrow, I'd be the first one in line (I've already had one false alarm). Maybe my abstinance-only school should taught us a little more about sex.