NVIC - Reasons why we should avoid the HPV vaccine.

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It's Not Just Religious Conservatives Who Oppose Mandatory HPV Vaccination The Missing Debate on the HPV VaccineOpEdNewsJuly 25, 2006 by Suzanne NelsonIt's not very often that conservative Christian organizations sound the voice of reason when it comes to the politics of women's health. Their positions on access to emergency contraception and the ability of pharmacists to refuse to fill birth-control prescriptions on ideological grounds -- not to mention their long-standing opposition to meaningful sex ed -- have provoked a strong and a persistent counter- push by those who believe their politics put ideology before the health and lives of women. So the story was already written before the Food and Drug Administration announced its approval last month of Gardasil, Merck's new vaccine against the human papillomavirus, a sexually transmitted virus linked to cervical

cancer. Most of the reporting has depicted Christian conservatives as once again playing politics with the FDA's approval process, just as they did with Plan B. Never mind that the Family Research Council and Focus on the Family, two leading social conservative groups, actually issued press releases supporting FDA approval of Gardasil. Because HPV is transmitted exclusively by sexual contact, the pervasive narrative has been that delusional religious conservatives want to deny their daughters --and everybody else's -- potentially life- saving preventative medicine on the questionable grounds that it would make girls feel immune to the dangers of pre-marital sex. Predictably, women's groups and public health advocates blasted religious ideologues as needlessly sacrificing women's lives for the foolish notion that adolescents are more likely to have sex if they believe they are protected from a sexually transmitted virus that heretofore they had probably never

heard of. Yet in the process of engaging that discussion, we're not talking about whether giving the vaccine to pre- adolescent girls makes sense in terms of their overall health, the long-term safety of the vaccine or whether it should be required to enter school -- all subjects much more controversial than news coverage would have you believe. This is about sex politics. And while that's a much easier debate to frame, it's also a sideshow. s expected, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recently put the HPV shot on its recommended childhood vaccine schedule. The shot will now become de facto required for 11- and 12- year-old girls to attend school. Some states automatically use the CDC's schedule to formulate their own requirements. If recent vaccines are any guide, most, if not all, other states will follow via legislation or regulation.But if you listen carefully to what the

largest "pro-family" groups have said, none have opposed the widespread availability of the vaccine. In fact, both FRC and Focus have advised their members of compelling reasons to give their girls the vaccine even assuming they will stay abstinent until marriage. (Some of those reasons include the very real chance their daughters' future husbands many not have abstained until marriage, as well as the possibility of rape.) Wendy Wright, executive vice president for Concerned Women for America, said she received calls from reporters who said they heard her organization was opposing the vaccine's approval but couldn't find any statement by CWFA that indicated as much. Liberals, Wright says, "kind of jumped the gun." So if cultural conservatives haven't engaged in a systemic effort to prevent the vaccine's release -- a factual point many news organizations have blurred considerably -- then why all the fuss? For all their panic about adolescent sex,

in this debate the "pro-family" groups stand for the rather fundamental belief that parents have the right to make health decisions for their children, especially as it relates to a vaccine for a virus that is not transmitted by casual contact. It would be difficult to tell from the caricatures held up on TV and online, but the real debate is much more substantive than the one we've been having about whether the vaccine will encourage sex outside of wedlock. And if discussed honestly, we would also have a much better chance of finding common ground than any battle in the culture wars. Christian conservatives -- by once again driving themselves to distraction over premarital sex -- may have actually stumbled upon a position that aligns themselves with, dare we say, choice. HPV is not a virus a kid catches by sitting next to someone at school. It is not spread by sharing juice boxes or trading germs on the bus. That makes this vaccine completely different from

the 14 others on the CDC's recommended schedule, save perhaps Hepatitis B, which is primarily (but not exclusively) transferred via intravenous drug use and sexual contact. Both vaccines aim to protect people from a virus that is basically only transmitted when a person engages in what amounts to optional behavior. (Hepatitis B can also be transmitted from mother to child if the mother is carrying the virus. Regardless of the mother's infection status, however, all babies are given that vaccine at birth.) HPV is not a public health threat in the same way, say, polio is. And that gives state governments much less of a compelling interest to mandate that children be vaccinated for it.Let's put aside for the purposes of discussion the bizarrely controversial notion that parents should be able to decide what enters their children's body via injection, especially when that shot carries the risk of harm or death. HPV does not lurk in the air, in swimming

pools or on playground equipment. That makes the vaccine's public health credentials dubious at best.Yes, 3,700 women in the United States die of cervical cancer every year. But just having HPV doesn't mean you're going to get cancer. The FDA said as much in its press release: "For most women, the body's own defense system will clear the virus and infected women do not develop related health problems." Estimates of the number of people with HPV in the United States vary wildly, but perhaps up to 80 percent of women are infected with HPV at one time or another before they are 50. Yet given that high incidence, the number of women who develop cervical cancer is pretty low, about 10,000 cases each year. Pap smears usually catch abnormal cells before cancer has progressed, when women are treated with extraordinarily high rates of success. According to Dr. Herschel W. Lawson of the CDC, the greatest risk factor (60 percent) for cervical cancer in the U.S.

is not being screened or being screened at intervals greater than 5 years.So uncommon is cervical cancer in the United States that it is listed as a rare disease by the National Institutes of Health. That's not to say that it's not painful or tragic for thousands of women, but it's nonetheless relatively rare. There's a reason that just about every prediction about a reduction in cervical cancer due to the HPV vaccine is reported as a worldwide statistic. The numbers in the U.S. are just not that high as a percentage of the population.Most women in the U.S. who develop invasive cervical cancer have not had regular pap smears, according to the CDC. So to say that because 3,700 women in the United States die of cervical cancer every year, and thus there's an urgent public-health need to vaccinate every adolescent girl -- without mentioning that many if not most of those women did not have regular screenings -- is somewhat disingenuous. But even

if the vaccine proves to be successful at reducing overall HPV infection, and the reduced number of HPV infections lead to a correlating decline in cervical cancer cases -- both still assumptions at this point, as the vaccine hasn't been studied nearly long enough to determine that -- some parents still may not want to give it to their daughters. For starters, it could cause harm. All vaccines carry the risk of injury or death.Additionally, the FDA's insert reveals that nine people developed arthritis after receiving the vaccine versus three for the placebo, out of approximately 21,000 individuals in that trial. Nine kids with arthritis after receiving the vaccine might not seem like a big deal in the grand scheme of things. After all, arthritis is better than cancer, right? That depends. Given the fact that cervical cancer is relatively rare, highly preventable and most often successfully treated early on, maybe the risk of arthritis -- a painful and often

debilitating disease -- isn't a worthwhile tradeoff. Isn't that for parents to decide? And maybe we won't know the true incidence of harmful effects until the vaccine is given to millions, rather than thousands, of children and young adults. Participants in the Gardasil studies were monitored for, at most, four years and many for a considerably shorter time frame. The largest trial is scheduled to be ended early and the people who were given a placebo now will be given the vaccine, meaning it's no longer possible to study long-term differences in health between those who received the vaccine and those who received the placebo.In terms of long-term safety, one sentence in the FDA's insert is particularly revealing. "Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity," according to the insert. Yes, carcinogenicity means the ability to cause cancer. It's also not known whether the vaccine can cause chromosomal damage. We

don't know because researchers didn't look. The trials were not set up to examine that question.Additionally, five participants in the trial who were given the vaccine near the time of conception went on to give birth to babies with birth defects versus zero cases of congenital anomalies in the group that received the placebo. This is hopefully not an issue for many 11-year-olds, but it could impact teenagers and certainly young women who get the vaccine. The insert states that Gardasil is not recommended for use in pregnant women, but are pregnancy tests going to be routinely given before the vaccine is administered? Only time and widespread use will reveal whether those five babies born with birth defects reveal a pattern.As a condition for Gardasil's approval, Merck agreed to monitor the "pregnancy outcomes" of women who receive the vaccine while unknowingly pregnant, along with general safety issues. But drug companies have had a poor track record on

actually completing the post-licensure follow-up studies required by the FDA, according to the agency's own figures. The FDA announced in March that two-thirds of those promised studies had not even been started, and hundreds of trials have been pending for years. The agency has little leverage to force the companies to comply, according to a report by the Government Accountability Office. In many of those cases the companies received expedited approval from the agency on condition that the studies be carried out. Gardasil was approved on just such an expedited timeline.So if this vaccine turns out to have safety issues are we even going to know? Or is it going to remain on the states' mandatory list long after many girls suffer serious side effects or worse? What about the safety of giving Gardasil at the same time as the meningococcal and diphtheria, tetanus and pertussis vaccines, shots 11- and 12-year-olds receive during the same visit to the doctor? Merck

looked at the safety of administering the HPV vaccine at the same time as Hepatitis B, but what about the safety of concurrent vaccination with DPT, or any other combination of vaccines the kids could be "caught up" on during that visit?The CDC's vaccine advisory committee also said the vaccine could be given to girls as young as nine, at the direction of the physician. The rationale for doing so is that the vaccine is only effective prior to exposure to HPV and actually leads to increased risk of precursors to cervical cancer in those previously infected, so it's best to catch girls as early as possible. Yet only 250 9-year-olds received Gardasil in trials, adding to the unknowns about administering a vaccine on still developing bodies. Shouldn't parents be permitted to weigh such considerations when making health decisions for their children? Merck had an enormous amount at stake in making the shots mandatory. A place on states' required lists means

a steady and exponentially larger revenue stream. Financial analysts predict Gardasil could be Merck's most important pipeline contributor to top- line growth, with peak sales of at least $2 billion -- revenue Merck badly needs after the Vioxx scandals. That revenue figure assumes that states will make Gardasil mandatory. The CDC's support also all but guarantees insurance reimbursement, as well as state and federal funding. Perhaps more importantly, it also gives Merck coverage under a federally funded vaccine liability program. If Gardasil turns out to have devastating or deadly consequences, Merck isn't liable. "It's a stockholders dream," said Barbara Loe Fisher, president of the NVIC, a nonprofit that promotes right to informed consent on

vaccine decisions. Fisher sat on the FDA's committee that reviews vaccines in 2001, when the vaccine underwent early reviews. "This has nothing to do with kids and whether they are going to have sex," Fisher added. "It has to do with whether they are going to be set up for chronic inflammatory disease" from yet another vaccine being added to the litany of those they already receive. "I would want more data on long-term effects of autoimmunity on certain genotypes," she said in an interview, "and whether this vaccine is going to harm far more girls than it is going to protect." In a recent study published in the journal Pediatrics, 35 percent of parents surveyed were against having their children vaccinated for HPV. Safety was their primary concern. Although the study didn't specifically look at whether that resistance was tied to a fear that the shot would make their kids more likely to have sex, are we really going to deny parents the right to make

an informed choice?Beyond touting the misleading public-health argument, many progressive organizations have asserted that leaving HPV off the CDC's recommended schedule means that the resulting lack of public funds will prevent many poor kids from having access to it. If that's the only objection, then another public funding avenue could be devised to get the vaccines to those who want them and couldn't otherwise afford the $360 price tag.Yet, at its core, the argument for mandatory use is really about something else. It was recently summed up aptly, if inadvertently, by Joe Kernan, anchor of CNBC's Squawk Box. He moderated a segment last month on whether Gardasil should be mandated. He said: "Parents aren't necessarily going to do the right thing. They might not even ... they might space. They might not take the time to get this done. There's a lot of reasons this wouldn't be done. Shouldn't we just do it with the kids, get it out of the way, no one gets

cervical cancer?" If only it were that simple. His essential point -- that parents are too stupid or too lazy to figure out this issue for themselves and thus the government should step in -- highlights a consistent criticism conservatives have about liberals. So perhaps it's not surprising that conservative groups have argued that mandating the HPV vaccine isn't the government's place. But looked at another way, ultimately this is about an intrusive government versus one that doesn't meddle in the affairs of women's bodies. That's a principle progressives usually fall all over themselves to support.The protracted debate about whether the HPV vaccine will make adolescent kids more likely to have sex is largely irrelevant. If some parents decide that possibility is reason enough to forgo the shot, however, isn't such their right -- regardless how foolish others may think their reasoning? Linda Klepacki of Focus on the Family replied to Kernan's remarks

with a simple statement: "Parents have the right to be the decision-makers for their children, especially when it comes to medicine."Indeed. Click here for the URL: NVIC E-News is a free service of the National Vaccine Information Center "Our ideal is not the spirituality that withdraws from life but the conquest of life by the power of the spirit." - Aurobindo.

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