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Federal Advisers Back Cervical Cancer Vaccine

Posted on: Thursday, 18 May 2006, 21:00 CDT

By Diedtra Henderson, The Boston Globe

May 19--GAITHERSBURG, Md. -- A federal advisory panel voted unanimously yesterday to recommend approval of the world's first vaccine against the sexually transmitted virus that causes cervical cancer and said girls as young as 9 years old can be inoculated.

The Food and Drug and Administration, which usually follows the advice of such panels, is expected to decide by June 8 whether to approve the vaccine, called Gardasil. Its manufacturer, Merck & Co., said the product could be made available by the end of June.

Advisers yesterday called Gardasil an important advance in the fight against cervical cancer, which affects 10,000 American women annually and results in nearly 4,000 deaths. Analysts who follow Merck estimated tens of millions of women and girls will receive the vaccine, which is administered in a series of three shots over six months and costs about $500.

But panel members and women's health advocates said Gardasil does not reduce the importance of the routine screenings that are responsible for cutting cervical cancer rates in the United States by 75 percent. Gardasil protects against two high-risk strains of human papillomavirus that cause most of the infections that lead to cervical cancer.

"You're preventing the bulk of these infections, but not all of them," said Bruce Gellin, one of the 15 panel members. "Even if you're vaccinated, it doesn't mean that you're absolutely prevented from developing these infections," said Gellin, director of the National Vaccine Program Office.

While Merck highlighted the estimated $4 billion to $6 billion spent each year on cervical cancer screening, a company executive said it would promote the vaccine as complementing, not competing with, annual Pap tests.

"This company is absolutely committed to cervical cancer screening," Dr. Eliav Barr, Merck's senior director of clinical vaccine and biologics research, told the panel. "This vaccine is not a replacement for cervical cancer screening."

The company also wants to market Gardasil to boys as young as 9, though the panel did not vote on that issue. Monica Farley, an infectious disease specialist who served as the panel's acting chairwoman, said the question of whether to sell the vaccine to boys was not on a list of items to be voted on prepared by the FDA. Males spread the human papillomavirus to women through sexual contact. Barr said Merck proposes a label for the vaccine that would permit "gender-neutral" vaccination.

Lauri Markowitz, a Centers for Disease Control epidemiologist, cautioned others on the panel not to read too much into Merck estimates that vaccinating boys could prevent thousands of infections among women.

Markowitz said the potential to prevent disease by inoculating boys was "very exciting" but that "a lot of assumptions" went into Merck's models, including widespread use of an expensive treatment.

Analysts project Gardasil could become a blockbuster, with up to $3 billion in annual sales.

The vaccine also protects against genital warts, which, like cervical cancer, are caused by the human papillomavirus. American women and men have a one in eight lifetime risk of becoming infected with genital warts.

Routine screening has reduced American women's risk for developing cervical cancer from 1 in 30 to 1 in 120, Barr said. Still, 10 American women, on average, die from cervical cancer each day.

Worldwide, cervical cancer has the second-highest mortality rate among women who develop cancer.

Merck's vaccine can prevent 100 percent of infections for the two strains of human papillomavirus that later cause 70 percent of cervical cancers for women inoculated before they begin having sex. It is much less effective for women already infected with the virus.

Bonnie Word, a pediatric infectious disease specialist, worried about teenage girls who might get vaccinated without mentioning they have a pre-existing infection.

"Adolescents don't tell the truth all the time," said Word, assistant professor of pediatrics at Baylor College of Medicine.

Five of the nine women's health advocates who spoke in favor of Gardasil during the public hearing said they had received Merck funding.

Three members of the advisory panel, including its chairwoman, recused themselves from yesterday's vote due to financial conflicts of interest.

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MRK,

Source: The Boston Globe

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