Focus on the Family Publishes Confusing Piece on HPV Vaccine

| 8 Comments

Many of us trust Focus on the Family to give us family-friendly advice on our kids' well-being. It is therefore disappointing that the organization's latest mini-magazine (March, 2007) has an article on the HPV vaccine (p. 27) that contains misleading information.

The brief piece gives the impression that a girl's merely getting older will make the vaccine less effective for her and that therefore parents might want to give the vaccine to 11 and 12-year-old girls, even if they expect them to be chaste until marriage.

Of course, if you and your daughter expect fully that she will remain chaste until marriage, the earliest you would expect that she might want to get the vaccine would be prior to marrying a young man who was not a virgin and might be carrying the virus. Why not wait until then?

Ms. Klepacki tries to answer this question: "But why is this vaccine important to young girls who are not sexually active? The answer is simple: The vaccine is highly effect if given when the child is around 11 or 12 years of age, but its effectiveness decreases slightly when given at an older age."

Um, no, Ms. Klepacki, the answer is not simple, and that version of it is misleading. From this statement you'd be likely to think that there is something intrinsically biologically special about the age of 11 or 12 and that, for mysterious biological reasons, the mere passage of time makes it less effective for a young woman of, say, 21.

As far as I have been able to ascertain from the CDC's own web page on the vaccine, these implications are flatly false. Here is the CDC's answer to the same question:

"Why is the vaccine recommended for girls 11 to 12 years of age? It is important for girls to get HPV vaccine before they become sexually active. The vaccine is most effective for girls/women who get vaccinated before their first sexual contact. It does not work as well for those who were exposed to the virus before getting the vaccine. However, most women will still benefit from getting the vaccine because they will be protected against other virus types contained in the vaccine."

In other words, it is the expectation of sexual activity, not something about the girl's age by itself, that is driving the push to vaccinate girls of this age. The vaccine's effectiveness does not magically "decrease" as a girl grows older. Rather, its effectiveness is believed to be less in women already exposed to the virus, which is expected to happen when they become sexually active, which is expected to happen...when they are in their teens. Ms. Klopecki is just completely off on this when she gives decrease in effectiveness as an answer to those questioning vaccination for girls who are not sexually active.

Then, sounding disturbingly like a lobbyist for Merck, Ms. Klopecki goes on like this: "Early vaccination can protect girls from both present and future risks of infections." She alludes to the possibility that a chaste woman might marry a man who was carrying the virus.

While such exposure in marriage is certainly a possibility, the statement that early vaccination protects from far-future risks of infection is questionable. Again, the CDC states outright that it is not known how long the protectiveness of the vaccine lasts, and that so far studies have been done only up to five years. Usually, says the CDC, it is not possible to tell when a vaccine is introduced how long it will be effective. So any claim that "early vaccination" will protect a girl of 11 from being infected when she gets married in her early 20's is still very much in doubt. No one knows. If exposure is not going to occur for ten years or more, and if the vaccination has lost its effectiveness by then, there will be no value to "early vaccination." The girl will have gone through any side effects of the childhood shots for nothing.

The article then says some good things about following God's plan for abstinence. But overall, it gives the impression that Christian parents of chaste daughters should seriously consider vaccinating them at an early age when no sexual activity is expected. And it bases that near-recommendation on confusions regarding the vaccine and its effectiveness. I'm going to assume that these weren't deliberate. But in that case, Linda Klepacki didn't do her homework, and Focus--usually such a reliable organization--has let us down in researching this issue.

8 Comments

focus on the family is anything but. The MMR is made out of aborted fetal cells and they still recommend this vaccine for Christians! Someone there is paid off my big pHARMa!

In a February 28, 2007 ProLifeBlogs.com post entitled "Focus on the Family Publishes Confusing Piece on HPV Vaccine," it was stated that Focus on the Family printed misleading, simplified, false and unverified facts regarding the HPV vaccine. We appreciate your reading of Focus on the Family Magazine and assure you that our aim continues to be nurturing and defending families worldwide - and doing so with accuracy and high standards in what we publish.



At the outset, we share your concern for sexual chastity and support it wholeheartedly. Your devotion to this ideal is laudable and because we hold this in common with you, we understand the passion in your stated concerns. So, while we don't take this particular posting personally, we thought it might be helpful to clarify the facts regarding the female immune response to the vaccine. We assure you that our criticized statement is substantiated.



We stated: "The vaccine is highly effect if given when the child is around 11 or 12 years of age, but its effectiveness decreases slightly when given at an older age." This is true, and not for the mere reason of teen sexual debut. It is documented in original research that the antibody response to this vaccine is clearly more robust in younger girls than in older girls or women.*


*[See: Block, S. L., Nolan, T., Sattler C., et al, "Comparison of the Immunogenicity and Reactogenicity of a Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine in Male and Female Adolescents and Young Adult Women," Pediatrics, 2006, p. 2140 (accessed 3/2/07.)]


*[See: Merck & Co, Inc., "Gardasil: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine" October 2006, p. 7, Table 5 (accessed 3/2/07.)]


Please be assured, our article's wording was carefully chosen and aimed at empowering parents in their own decision-making process. In order to assist parents in making informed decisions, we believe it's imperative to avoid withholding or distorting the pertinent verifiable data on the topic.


However, let us be clear, neither HPV vaccine nor any other medical intervention supersedes our belief in God's plan for sexuality. God, in His perfection, created male and female and gifted us with marriage for sexual expression. God gave us boundaries for our sexuality not only for blessing but also for protection from consequences such as sexually transmitted infections.


If you care to see a more comprehensive view of the parent-equipping resources we have offered to date and with to fully understand our statements, I invite you to visit www.citizenlink.org/hpv. In short, we respect parents' rights and the family's values amid this important issue and hope to equip moms and dads with the information they need to make decisions that are best for their particular child.


We stand arm and arm with you in the cause and call of Christ to defend and protect children and families. Thank you for this opportunity for clarification.


Linda Klepacki

Analyst for Sexual Health

Focus on the Family

Dear Linda,

I appreciate your attention to the post. I also appreciate the additional information. What you cite regarding immune response from your first citation does seem to support the claim you made in the article, and I accept the correction thus far.

The second citation, to the Gerdasil flyer, I am more doubtful about. I accessed the flyer and went over it at the following address:

http://www.cdc.gov/nip/acip/slides/oct06/08_HPV_Vaccine/hpv-2-barr.pdf

I did not find on p. 7 or anywhere else a table that addressed specifically the question of age as opposed to lack of previous exposure to HPV. It's possible that I missed it, though.

Though I admit that you have provided some evidence for your assertion, even there, questions remain. I can't help wondering why this greater immune response and its alleged independence from sexual experience and prior exposure have not been more widely publicized either by Merck or by the CDC. The Washington Times just had an article on this very subject in which this claim was not brought up. Also, was sexual activity controlled for in the study you cite from Nolan and Sattler? The summary I was able to find did not say. While it's not implausible that as a general rule children's immune systems are more robust than adults' and a greater reaction was simply the result of age, it would be interesting to know whether there was a similar effect in older young women (say, ages 19-22) who were virgins and had not been previously exposed to the virus.

Moreover, you have not addressed the entirely relevant and legitimate concern regarding the vaccine's wearing off. No one seems to know--including Merck!--whether it would last for the approximately 10 years or more from age 11 until a normal marriage age in American society. The entire matter of a robust immune response is moot if the vaccine will wear off in that long of a time. So the girl has a robust immune response to the vaccine when she _isn't_ going to be exposed, then it wears off by the time she is. That's pointless. I'm not saying that this will happen. The point is that since this is unknown, the supposed advantages of a child's robust immune response may be irrelevant to the case at issue.

I have to point out here, what I left out of the main post, your rather...unpleasant reference in the original article to hand-to-genital contact in early adolescents. You need to realize that the people who are going to be hardest to convince here are those of us who absolutely do not expect any such behavior from our children and who reject an approach that expects it and seeks to "protect" against it. While I appreciate very much your commitment to parental rights and to helping parents make the right decision, I'm pointing out here that the toughies in your audience are going to be put off rather than being drawn toward the vaccine by your reference to mutual masturbation among children. For some of us, this is as irrelevant a consideration as the possibility of penetrative intercourse.

I've been reading the back-and-forth here. I hope you don't mind if I offer some facts and my personal outlook into the mix. Thanks for giving me the chance to do so.


First, the immune response in younger women is indeed stronger per the studies cited. No question about it. Table 5 on page 7 at this address (http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf)notes this. You will see that the GMT numbers (that is, the antibody titer measures) are higher for the younger age group. The same is shown on Table 2, p. 2140 in the Pediatrics journal. (General summary at: http://www.pediatrics.org/cgi/content/full/118/5/2135)


I may be "slow" here, but this says to me that immune response is at least a small factor for a parent to consider -- even w/ kids like mine who I trust will be abstinent before marriage. Some parents of abstinent kids, like myself, *do* still want their child vaccinated because of the unpredicatable event of rape (and, of course, the possibility of marriage to a previously infected person.)


Speaking for myself, if my child was molested or raped (God forbid) and I had not taken the very easy step of giving this vaccine, then I would feel doubly terrible! And, if giving this vaccine offers my child a "mixed ethical message" or double message, then I have a larger problem in my parenting practices. My kids will know our family standards and God's plan -- this is not the same as handing them a condom, which is a terrible pratice. And if a judicious use of this vaccine throws my parenting off course, then I wasn't doing too good of a job in the first place.


Now, admittedly, from a public health standpoint: giving the vaccine to large #'s of 12-year-olds also has a higher chance of pre-dating sexual activity (at least when looking at the population as a whole). And, yes, public health officials do unapologetically consider that a factor when they "push" for this vaccine. I still don't think this fact should make it mandatory for school entry -- I just think parents need to be informed so they can make a decision for their own child at the right age.


As for the possiblity of needing a booster shot:
This indeed appears likely w/ the HPV vaccine. (Virtually all other vaccines require a booster at some point...this one for HPV is probably no exception). However, studies haven't proven when that booster is needed for the HPV shot yet. Since Merck has only had 5 years to track the HPV vaccine data thus far, they can only say FOR SURE that the vaccine is good for 5 years. But, that is mostly because we can't "fast forward" time. We have to study data with each passing year and learn. We can only say what we know -- and for now we know we have a solid five year immune response.


I am not certain on this, but it would seem to me that an early innoculation (getting the proven stronger immune response) would perhaps help make the future "booster" shot more effective as well... That is, if a baseline (or initial) immune response has any influence on efficacy of a later-in-life booster shot. We will just have to keep watching the data and see.


Let me say: I'm an advocate for sexual purity, for sure. But I also advocate for fair, objective accuracy as we look at the information and try to make truly informed decisions as parents. While we can't trust the character of drug companies any further than we can throw them -- we also can't "throw the baby out with the bath water" when it comes to looking at the professional journals and all the data.


That's the approach I am taking as a parent.


Oh, and since sexual acting out does unfortuneately happen for many Christian teens, I think that parents should at least be aware (as Linda Klepacki pointed out in her article) that HPV transmission can occur through hand-to-genital contact. Informing parents of facts is not tantamount to "promoting" use of the vaccine -- it's just giving them full information. Every child is different in their personality and risk facotrs. As I see it, Klepacki is not trying to "sell" anyone on the vaccine, she is just giving info to a wide audience and you are perhaps interpreting it a bit too defensively.


The resources I have read from http://www.citizenlink.org/hpv seem fair and equipping to me.

Hi, Colin,

Thanks so much for stopping by and commenting. I see the titer number differences in the tables, now. Thanks for pointing that out. I was looking at a different version of the pamphlet with different page numbers.

As far as I know, the studies of the older women were not controlled for sexual experience and, hence, probable previous exposure to HPV. Do you know of evidence that they were? I would genuinely be interested. One question here is this: Is the immune system response higher in the younger girls merely because they are younger per se, or is it because in fact that group had not ever been exposed to the virus before, due to absence of sexual activity yet? You see the point I'm raising. All such studies need controls before causation can be claimed. And since no one I know of in any article _except for_ this one in Focus claims that the difference in titer response is due to age all by itself (as opposed to lack of previous exposure to the virus), and since Merck itself and the CDC emphasize previous exposure to the virus as a factor lowering immune response, it seems to me possible that this is really what is being measured. Maybe the difference is due solely to age. But without studies controlling for sexual experience in the older group of women, and knowing that there is likely to be less sexual experience among the younger girls, we aren't in a position to draw the inference that Linda Klepacki is drawing.

The fact that a booster shot is required for most vaccines isn't really relevant. You would not normally give the first shot at all if you had every reason to believe your child _wouldn't_ be exposed now but _would_ be exposed later. There wouldn't be any reason to, if the exposure wasn't expected to take place until ten years down the line, if at all. Again, I'd be interested in evidence that a woman who received the full shot dosage just before marriage was significantly less protected than one who had been vaccinated at age 11 and then again with a booster more than ten years later. So far, no such evidence is forthcoming. And I'll be honest and say that the conjecture sounds fairly weak to me.

As for the possibility of rape, I have to ask: Would most parents give their children a vaccination against syphilis, if there were one, because they _might_ be raped? That just seems such a low-probability event to be vaccinating kids for STD's for.

I don't think I'm being defensive here in response to the stuff about mutual sexual touching so much as pointing out that, for some parents, that just isn't an issue. "Sexual acting out" doesn't just "happen." It's a choice the kid makes, and I think there are parents who would not consider it significantly more probable for their children than full-fledged intercourse. This is especially the case with home-schooling parents whose kids aren't being exposed to classmates--not to mention teachers--who tell them about such things and arouse their interest.

Lydia,

From Merck's studies, it is clear that immune response (antibody titers) is greater in females given the HPV vaccine at ages 9 to 16, compared to those given the vaccine in their 20s. There are two main reasons to conclude that the difference is due to innate age-related differences in immune response and not to the older women's prior experience with HPV. First, this pattern is typical of immune responses to other antigens. We know that a number of the functions of the immune system peak at around age 12 and decline progressively into adulthood. Second, while the overall population of women in their 20's would certainly have a higher prevalence of exposure to HPV than would a population of teens or pre-teens, the women eligible for this study, regardless of age, were serologically confirmed to have no evidence of exposure to HPV in order to participate. Thus the antibody response measured was in HPV-naive individuals, not some who had prior exposure and some who did not.

This is not an argument against abstinence, nor is it an argument for mandated use of HPV vaccine. It does support the case, however, that if a female is a candidate for HPV vaccine at any point in her life, then she is likely to benefit more from having received the vaccine at an earlier age. The vaccine has not been in use enough years to have long-term outcome data. But the early results at least support, without confirming, that at age 30 a women who was vaccinated at age 15 may well have a higher degree of protection than a 30-year-old who was vaccinated at 25.

Don,

Thanks for the comment. I pored over the tables again just now, and I certainly see where the populations are defined as naive in several of them in specific places, but I can't see that it actually says this on the specifically relevant table (7, I believe). But I may just be missing an indicator on that specific table. And it would make most sense that, since they had all the other statistics for naive subjects, they would have reported them for this table on naive subjects as well.

If the comparison is done on naive populations, this essentially amounts to controlling for previous exposure and does address my point there. You are also quite right to say that children often have stronger immune responses than adults. So this is relevant evidence.

I'm not sure I follow you, though, regarding a hypothetical woman first vaccinated at 25. Do we have evidence from other shots that require boosters (tetanus, for example) that a person who receives such shot for the first time before age 12 and then gets a booster in his twenties is better protected than a person who gets the same shot for the first time in his twenties? This would seem to argue some degree of "holdover" effect from the childhood shot which is then only supplemented by the booster, bringing the person to a higher level of protectedness than if he'd first been vaccinated in his twenties. I'm not saying I know that this is not the case, but I wonder what the evidence is for guessing that it is the case with the HPV vaccine. If this were known to be true for many other vaccines (and the requirement for a booster is not unknown), that would be some evidence. But my understanding is that children are primarily vaccinated for something like tetanus in childhood because they may be _exposed_ to tetanus in childhood. And would the difference there be great enough to be worth exposing the child to side effects, etc., in childhood, when no exposure is expected for such a long time, if then?

After all, we don't go vaccinating everybody who *might* go to a foreign country at some time in his whole life for every illness he might be exposed to there, if it isn't a regular part of the regimen here in the U.S. with plausible exposure here in the U.S. We don't say, "Well, yes, you wouldn't be going to Africa [or wherever] until in your twenties, if ever. But we're just going to give you all the possible shots you might ever need in your whole life right now before you reach 12, so you'll have overall more protection later, _if_ you should be exposed, even if you need a booster." It would be massively wasteful to do this.

Don,

I've gone over the Merck pamphlet again in as much detail as I can just now. Actually, Merck's own study had 73% naive subjects and 27% who were not, as I understand their claim. They separate out the responses of naive and non-naive in different tables. But in any event, Table 5, the crucial one for this purpose (p. 7), has not been clearly taken from Merck's own study. They state "A clinical study compared..." My best guess at this time is that they are referring to a different study described by Nolan, Satler, et. al. and mentioned by Linda above. I do not have subscriber privileges to get their full article, but the abstract does not say that all subjects were naive, nor what percentage were naive. If Merck is referring on p. 7 and in table 5 to Nolan, et. al.'s, study, this might explain why it's hard to see anywhere that the question is addressed as to whether the subject's in table 5 are naive for the virus. Again, I may merely be missing something, but Merck's own tables from its own study(ies) are explicit and clear about this question everywhere else in the pamphlet.

If you can show definitely something that I'm just missing, or if you have access to the full text of the journal article and can show from there that the subjects in the Table 5 comparison in Merck's pamphlet were all definitely naive for the virus, I will post an update to this post on that subject as a correction regarding the evidence on this subject.

I'm afraid I still remain unconvinced regarding the timing issue, though, given the very long probable time before exposure in chaste, unmarried pre-teens. I doubt this subject would even be under discussion if the disease were not sexual.




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