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Merck quietly deals with conservative fears about premarital sex Months before a federal ad... Cervical cancer vaccine endorsed
Months before a federal advisory panel recommended the approval of a new cervical cancer vaccine, a delicate sales campaign was already under way.
The panel of experts unanimously recommended the vaccine, called Gardasil, in its meeting Thursday. It can protect against human papilloma virus, the cause of cervical cancer, which is spread via the skin, mostly through sexual contact.
Some social conservatives view the idea of a childhood HPV vaccine the same way they look at distributing condoms or giving out information on contraception to minors: as encouragement or at least unspoken approval of premarital sex.
"I think there has been concern in the conservative community that the wrong message will be sent," said Dr. Hal Wallis, a former obstetrician-gynecologist from Waxahachie who is part of the conservative Physician's Consortium.
Recognizing that conservative opposition could hamper its HPV vaccine, Merck & Co. quietly dispatched representatives to meet with leaders of the religious right and explain the scientific rationale for mass immunization at an early age.
More than cervical cancer lies in the balance: Many public health experts believe deliberation over the HPV vaccine is a kind of dress rehearsal for any future immunization against another sexually transmitted virus - HIV, the cause of AIDS.
"This is something we're all going to be watching," said Dr. Ruth Faden, director of the Berman Bioethics Institute at Johns Hopkins Bloomberg School of Public Health.
Most of the outright resistance to the vaccine has already softened, particularly after some of those who questioned it were publicly assailed as advocating "virginity or death." But some observers predict renewed controversy when individual states decide whether the shot should be required for school admission.
In October, Dr. Wallis appeared in a news release from the influential Focus on the Family group headlined, "Some question the ethics of universal inoculation against a sexually transmitted disease."
Other conservative Web sites posted similar concerns. A December blog on the Abstinence Clearinghouse declared: "Premarital sex is dangerous, even deadly. Let's not encourage it by vaccinating 10-year-olds so they think they're safe."
Immunization studies have found that the best candidates for vaccination are girls around age 11 or 12, for biological and social reasons. A younger immune system may respond more robustly to the shot. And because about 30 percent of girls ages 15 to 17 have had sex, public health officials want to immunize younger girls, before sexual exposure, during the time when HPV rates start to soar.
Cervical cancer prevention efforts now rely almost entirely on regular Pap smears. Thanks to the early detection of precancerous cells, cervical cancer deaths in the U.S. have plummeted to about 3,700 lives annually.
But many women, especially those who are uninsured, still don't get screened. And worldwide, the overwhelming burden of disease occurs in less developed nations. With widespread use of the vaccine, Merck predicts, global deaths from cervical cancer could drop by two-thirds.
The new vaccine won't eliminate the need for Pap smears because it does not prevent infection from all HPV strains that trigger cervical cancer and genital warts. A second vaccine, from GlaxoSmithKline, also is in development. Many strains of HPV circulate; the vast majority of infections clear up naturally, but a tiny fraction will lead to malignancy.
"They answered my questions," Dr. Wallis said, particularly the company's explanation for why the vaccination of nonsexually active young girls offers the best strategy for disease control. Despite his initial impressions, he now believes that the vaccine should be required for school registration.
The Research Council and other conservative groups, however, still do not want the vaccine to be linked to school enrollment, as other common immunizations are. Diseases like measles and whooping cough can be transmitted in classrooms; HPV does not meet that level of contagiousness, Mr. Sprigg said.
If the Food and Drug Administration approves the release of the vaccine early next month, the question of vaccine requirements is likely to be the next debate.
"I think the battleground may very well move to the 50 states, when it is up to the states to decide who will get this out to adolescents and whether school admission requirement is the best way to do that," said Cynthia Dailard of the Guttmacher Institute, which focuses on sexual and reproductive health issues.
Like other conservatives, Dr. Gene Rudd of Christian Medical & Dental Associations does not believe an HPV vaccine undermines messages about sexual abstinence, but he said vaccination should not be tied to public school admission. However, he added, "I don't think there will be that many parents who actually opt out."
Shifting the decision to parents may not be a simple compromise, said Dr. Faden of Johns Hopkins. "It's not an ethics-free path to say, " 'Let parents choose,' " she said.
"This is not going to be a cheap vaccine," Dr. Faden said. Merck has not released a price, but one research analysis estimated it at $300 per person.
In the end, parental reception to an adolescent HPV vaccine will depend on a complex mixture of information, family context and core beliefs. A study published this month in the journal Pediatrics found that, among a sample of more than 1,000 parents of adolescents, reception to the vaccine was generally positive, though not overwhelmingly so. And acceptance was not significantly better among parents who had received written information about HPV.
"What really made a difference is their underlying beliefs and their life experiences," said the study's lead author, Dr. Amanda Dempsey of the University of Michigan in Ann Arbor. When trying to educate parents, she said, "We need to be thoughtful about what type of information is important to them."
After working on the testing of the HPV vaccine, Dr. Diane Harper of Dartmouth Medical School said she has seen how even basic knowledge about HPV changes people's opinions.
"There has been a lot of misunderstanding about what the virus is," she said. About 80 percent of women will be exposed to the virus in their lifetime, most with little health consequence.
"I can understand these groups' concerns," Dr. Harper said, "but I think the most important thing is that we don't label those who are HPV positive as bad people."
That kind of stigma and the complicated biology of cervical cancer may keep HPV vaccination entangled in ethical and social issues long after its release.
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