June 8, 2006 — -- The U.S. Food and Drug Administration announced today that it has approved Gardasil, a vaccine that prevents infection by some strains of the human papillomavirus, which can cause cervical cancer if left untreated.
"It marks a very important step forward in women's health," said Dr. John O. Agwunobi, the assistant secretary for health at the Department of Health and Human Services.
"It will be the first vaccine licensed by the FDA that can prevent a cancer that kills a large number of women each year," said Dr. Michael Keefer, an associate professor in the infectious disease division at the University of Rochester School of Medicine in New York. "If that's not a breakthrough, I don't know what is."
Gardasil is made by Merck & Co. Inc., a global pharmaceutical company. It's a series of 3 shots given over six months.
There are about 100 strains of human papillomaviruses, which can cause warts on different parts of the body. At least 30 strains are sexually transmitted, and about 10 of those can also cause cellular abnormalities that lead to cervical cancer, according to the Centers for Disease Control and Prevention.
Gardasil will protect against at least four of the 10 known cancer-causing strains, Merck said. About 270,000 women worldwide die from cervical cancer each year; about 4,000 die in the United States.
"The potential for vaccines, including Gardasil, to wipe out the major cause of death from cancer for women in the developing world ranks this as one of the most significant moments in the history of cancer treatment," said Dr. Joanna Cain, the director at the Center for Women's Health at the Oregon Health and Science University.
HPV is the most common sexually transmitted infection in the United States, with about 20 million people currently estimated to have it, according to the National Institute of Allergy and Infectious Diseases.
More than half of sexually active men will become infected with HPV at some point in their lives, and by age 50, as many as 80 percent of women will have had HPV, according to the CDC.
If left untreated, the virus can invade the cervical cells of the uterus and cause cancer. This is especially problematic in areas where women don't have access to the current treatments, such as cryotherapy, which removes abnormal cervical cells.
Now that the FDA has approved Gardasil, the next step "is the critical meeting of the CDC's Advisory Committee (ACIP), where they come out with recommendations about how the vaccine should be used," Dr. Tim Johnson, ABC News' medical editor, said today on "Good Morning America."
Which is more complex than it sounds: Even though many doctors support this new vaccine, it carries some controversy. For it to be effective, it needs to be given before a person becomes sexually active.
That means preteens would be the ideal candidates for the vaccine.
"There is a great debate because medically speaking, it is clear it would best be given to very young girls before they become sexually active, even if they intend to be abstinent," Johnson said.
The ACIP will make a recommendation for the age requirement of Gardasil after the FDA licenses the vaccine for certain age groups.
"The state decides whether it should be a school entry law, [so] these laws will vary state to state," said Curtis Allen, spokesperson for the CDC.
The recommendations of the ACIP are important since doctors practicing in the U.S. should follow them.
However, "no law says that they have to," Allen said.
Dr. Cynthia Rand, assistant professor of pediatrics at the University of Rochester, interviewed about 30 parents about HPV vaccines, such as Gardasil (other drug companies have similar vaccines in development).
Even though most supported these vaccines for adolescents, Rand said "a few parents, the minority, were completely against the vaccines [for their children]. A few parents felt that their children were raised in a Christian manner and would not be having sex until they were married."
In response to such concerns, Dr. Mark Groshek, a pediatrician in the department of pediatrics and health Connect at Kaiser Permanente Colorado, said, "My approach with parents will be to say upfront to them, and to their daughters, that we are not suggesting girls should become sexually active at a young age."
Not all parents or faith groups feel as strongly as those select parents from Rand's study. The Family Research Council, an organization that "promotes the Judeo-Christian world view as the basis for a just, free and stable society," welcomes the news of such vaccines as Gardasil.
"We strongly encourage the health care community to clearly communicate the medically accurate fact that only abstaining from sexual contact with infected individuals can fully protect someone from the wide range of sexually transmitted diseases," said Moira Gaul, a policy analyst for the Family Research Council in Washington, D.C.
Some doctors also said they agreed with the practice of abstinence to avoid exposure to sexually transmitted diseases and infections.
"I will encourage parents to be involved with their [kids], and to encourage their delaying sexual debut. That is the best way to prevent STIs [sexually transmitted infections], including HPV," said Dr. J. Zanga, professor of pediatrics at Brody School of Medicine at East Carolina University.
In the end, the vaccine may prove more useful in poorer nations where cervical cancer is still a big problem because most women don't have access to preventive health care like Pap smears -- the main way to detect cervical cancer.
"In many developing countries, the burden exceeds, by far, the approximately 4,000 annual deaths from cervical cancer in the U.S.," said Dr. Samuel Katz, of the department of pediatrics at Duke University Medical Center.
These countries "do not have the screening programs … to detect and eliminate early infections and their cytological changes that reveal HPV infection."