October 22, 2009

Gardasil For Boys?

The U.S. Advisory Committee on Immunization Practices (ACIP) delivered a nearly unanimous vote on Wednesday against "permissive" use of Merck & Co.'s Gardasil for boys and men, deciding instead to advise doctors that they are free to use the vaccine if they choose.

The Gardasil vaccine provides protection against the human papillomavirus (HPV), which can cause genital warts and a number of cancers.

The U.S. Centers for Disease Control and Prevention (CDC) currently recommends Gardasil for girls and women aged 11 to 26 years of age.

Earlier on Wednesday, the committee voted to recommend the use of GlaxoSmithKline Plc's Cervarix vaccine, a Gardasil rival, for routine administration among girls 11 and 12 years old.

The committee did decide to recommend Gardasil for eligible boys aged 9 to 18 in the Vaccines For Children initiative, a government-funded program that provides vaccines to children eligible for Medicaid and other uninsured children.

The U.S. Food and Drug Administration had already approved Gardasil earlier this month for preventing genital warts in boys and men ages 9 through 26.

The vaccine, which consists of a series of three shots,  was initially approved as a way to prevent cervical cancer, a disease that kills 4,000 women a year in the United States.  Some strains of HPV can also cause genital warts and cancers of the anus, penis, head and neck.

Wednesday's ACIP vote followed emotional pleas from some patients and doctors.

"We know that the later the cancer is discovered, the lower the chance of survival is," said David Hastings of the Oral Cancer Foundation, requesting the committee's recommendation to add the vaccine to the standard schedule for boys.

However, the committee limited its consideration to the vaccine's ability to prevent genital warts, saying the costs did not appear to justify a $360 vaccine.

ACIP questioned whether many insurers would cover HPV vaccines for boys.

"They are sending a, very unfortunately in my opinion, weak message to physicians," Reuters quoted Dr. William Schaffner of Vanderbilt University as saying.

However, Dr. Diane Solomon of the National Cancer Institute (NCI) said ACIP had a responsibility to exercise "responsible stewardship" of public funds.

"I think it is important to communicate to industry that we are not going to blithely indicate excessive costs," she said.

Gardasil had global sales of $1.4 billion last year, with another $865 million received through a joint venture with Sanofi-Aventis SA.

Merck said it would be launching a rebate program later this year.

"The rebate program for Gardasil enables eligible privately insured 19-26 year olds whose out-of-pocket costs are over $30 to receive a rebate from Merck for up to a maximum of $130 per dose," the company said in a statement.

The Advisory Committee on Immunization Practices (ACIP) is made up of 15 experts in fields associated with immunization.  Members are selected by the Secretary of the U. S. Department of Health and Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health and the CDC on the control of vaccine-preventable diseases.


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