Friday, June 09, 2006

The FDA...does something right?

How can that be? (thanks Kacey)

FDA Approves Vaccine That Should Prevent Most Cervical Cancers

By Marc Kaufman
Washington Post Staff Writer
Friday, June 9, 2006; Page A01

In what officials called a major public health breakthrough, the Food and Drug Administration yesterday approved the first vaccine developed to protect women against cervical cancer.

The vaccine, which works by building immunity against the sexually transmitted human papillomavirus, was found to be effective in preventing almost three-quarters of all cervical cancers.

"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," said FDA Acting Commissioner Andrew von Eschenbach.

He predicted that the vaccine -- the first ever designed specifically to prevent a cancer -- will have a "dramatic effect" on the health of women worldwide.

The vaccine, called Gardisil and developed by Merck & Co., was approved for girls and women ages 9 and 26. It is most useful if given to younger girls, because the vaccine is ineffective once the virus -- which is very common among sexually active people -- is already present.

The prospect of young girls receiving the vaccine has disturbed some social conservatives, who adamantly oppose efforts to make the vaccination mandatory. They say that sexual abstinence is the best way to avoid getting the virus.

But women's and public health groups are pressing hard for early and mandatory vaccinations, saying they will potentially save thousands of lives.

"The most effective vaccination programs are either given to young children or are mandated for attending school," said Jeffrey Waldman, senior director for clinical affairs for Planned Parenthood Federation of America. "Clearly, to have the greatest benefit, this vaccine would be given to all girls -- and in the future, maybe boys -- before they become sexually active."

Merck said in a statement yesterday that the vaccine can be ordered immediately, but the company was not specific on when the drug might be available for use. Doctors will be free to administer the vaccine as soon as it is distributed.

A Centers for Disease Control and Prevention advisory committee will decide June 29 whether the vaccine should be incorporated into routine vaccination schedules, in effect determining whether it will become the standard of care. If the CDC does, as expected, give the vaccine strong support, each state would have to determine whether the vaccine will be mandatory for school attendance. The federal government and states will also have to decide whether to subsidize its price.

On its Web site, the company said the catalogue price for Gardisil will be $120 per dose, and protection will require three doses over six months. That price has raised concerns that the vaccine will not be widely available to poor women or in less developed nations, where incidence of cervical cancer is considerably higher than in the United States.

Posted by crimnos @ 10:31 AM