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HPV vaccine nearing approval: political/religious controversy
  FDA likely to OK immunizer that may eliminate most cases of cervical cancer
By Jonathan Bor
Baltimore Sun reporter
Originally published May 11, 2006
Although the FDA delighted conservatives when it refused to act on its own advisors' recommendation to make emergency contraception available without a prescription, most observers say the agency probably will approve the HPV vaccine.
Once the FDA rules on Merck's application, a group that advises the Centers for Disease Control and Prevention will make specific recommendations about who should be vaccinated. LA Times
With conservative opposition softening, scientists say a vaccine that could eliminate most cases of cervical cancer appears headed toward government approval for girls as young as 9.
The Food and Drug Administration is expected to decide next month whether to grant a license to Merck & Co., which hopes to market the vaccine against the human papilloma virus (HPV). The sexually transmitted virus triggers both cervical cancer and genital warts.
If approved, it would become the first vaccine designed specifically to prevent a form of cancer. Because the virus spreads rapidly among teenagers once they become sexually active, proponents argue that the vaccine should be offered to preteen girls - and possibly boys.
"I don't know how you argue against a vaccine that prevents cancer," Dr. David I. Bernstein, a pediatrician from the Cincinnati Children's Hospital Medical Center, said after addressing the National Foundation for Infectious Diseases in Baltimore on Tuesday.
The possibility of administering the vaccine to youths had raised concerns among social conservatives that it could send a message that teen sex is safe and acceptable.. But many conservative groups, including some on the Christian right, say they support FDA approval as long as vaccination is not required for school admission - a decision typically left to states.
"We're health professionals," said Dr. Gene Rudd, a Tennessee obstetrician-gynecologist who is associate director of the Christian Medical and Dental Associations. "Where there are diseases out there, the only reasonable way you can protect individuals and society is to be immunized."
100% protection
After a two-year trial involving 12,000 sexually active women in 13 countries, Merck reported last year that the vaccine provided 100 percent protection against the two strains of the human papilloma virus responsible for 70 percent of all cervical cancers.
The vaccine is not likely to replace routine Pap smears because it doesn't fight all strains. Pap smears can detect precancerous cells that can be removed to prevent deadly tumors.
"This is a huge step," said Dr. Karen L. Kotloff, a professor of infectious disease at the University of Maryland's Center for Vaccine Development. "They tackled a virus that is known to be required to produce cervical cancer, and the data I've read suggests that it's one of the most effective vaccines available."
While Merck has applied for FDA approval, GlaxoSmithKline is expected to ask permission later this year to market its own HPV vaccine. The Merck vaccine targets two strains responsible for cervical cancer and two that trigger genital warts, while SmithKline's targets the cancer strains only.
Although the FDA delighted conservatives when it refused to act on its own advisers' recommendation to make emergency contraception available without a prescription, most observers say the agency is likely to approve the HPV vaccine.
"It appears the FDA is doing the right thing, that they're looking at the science, and the science is good there," said Deborah Arrindell, vice president for health policy at the American Social Health Association. "The politics seem to have settled down for the moment."
Once the FDA rules on Merck's application, a group that advises the Centers for Disease Control and Prevention will make specific recommendations about whom should be vaccinated, including optimal age groups.
At a meeting in February, the Advisory Committee on Immunization Practices outlined the options. One was routine vaccinations for girls ages 11 and 12, while another was to include the vaccine in a "platform" of vaccinations that are typically given to youths of that age.
The committee's final recommendation could play a big role in whether government and private insurers agree to reimburse the cost of the vaccination. It could also influence whether low-income families can obtain free HPV vaccine through the federal Vaccines For Children program.
Dr. Gene Rudd of the Christian Medical and Dental Associations said in an interview that he would want his daughter and granddaughter vaccinated.
His group advocates abstinence before marriage and argues that promoting condom use among teenagers amounts to a tacit approval - if not an endorsement - of sexual activity. But like seat belts, he said, the vaccine isn't a license to engage in risky behavior but protects people against known dangers.
"Whether you're pro-condom or anti-condom, or pro-moral issues or anti-moral values, the issue is that the vaccine is not reasonably linked with any kind of risk-taking choices," Rudd said.
Another Christian organization, Focus on the Family, says on its Web site that it supports "universal" availability of the HPV vaccine but believes that parents should decide whether to vaccinate a minor.
Peter S. Sprigg, vice president for policy at the Family Research Council, said the group supports vaccinating adolescents as long as doctors warn that it doesn't protect against all strains - and does nothing to guard against HIV and other sexually transmitted diseases.
"We feel the administration of this vaccine to [adolescents] should be taken as an opportunity for the health care community to communicate with young people about their sexual health in general," he said.
Deaths from cervical cancer have dropped drastically in the U.S. because of routine Pap smears. Worldwide, however, cervical cancer is the second-leading cause of cancer mortality among women, with 300,000 deaths annually. The disease is most common in developing nations where Pap smears are not widely available.
Researchers are working on a variety of vaccines designed to treat cancers once they are diagnosed. But the HPV vaccine would prevent cancer by arming the immune system to defeat a virus before it triggers a malignancy.
A vaccine against hepatitis B also protects against the liver cancer it can cause. But the HPV vaccine is the first whose main purpose is to prevent cancer.
Dr. Carol J. Baker, who heads the pediatric infectious disease section at the Baylor College of Medicine in Houston, said the Merck vaccine is likely to be approved for use among girls. But she said she expects some doctors to recommend it also for boys to prevent genital warts and further interrupt the chain of transmission. "The main education piece is not that your child will have sex at 13, but there is always a risk, and stuff happens," Baker said.
A survey by the Cincinnati Children's Hospital found that 75 percent of pediatricians would recommend the vaccine to patients between 9 and 17.
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