Saturday, February 03, 2007

The political eye of the needle

Texas Governor Rick Perry issued an executive order requiring Merck's cervical cancer vaccine, Gardasil, be administered to all girls entering the 6th grade beginning in September 2008. Perry's bypassing of the state legislature has caused some to raise concerns about his ties to Merck Corporation, including campaign donations he received.

Merck has a huge financial incentive in seeing similar action taken in other states. According to the Baltimore Sun, "The vaccine is expected to reach $1 billion in sales next year, and state mandates could make Gardasil a mega-blockbuster drug within five years, with sales of more than $4 billion, according to Wall Street analysts."

Over a dozen states are considering legislation to make the vaccination mandatory, including Wisconsin. As the Associated Press reported,

Supporters of a mandate say it makes sense to provide the vaccine as a way to fight a cancer that kills 3,700 American women every year. But opponents say states should not push a vaccine on the assumption that young girls are or about to be sexually active.

The Food and Drug Administration approved a vaccine in June and suggested it be given to females ages 9 to 26. The CDC advised that girls be vaccinated before they become sexually active, since HPV is contracted by sexual or even skin-to-skin contact.

While that means most doctors will give the vaccination, having a state law requiring it unless a parent opts out only increases the number of girls who will get it, said Sen. Lena Taylor, D-Milwaukee, who is sponsoring the Wisconsin bill along with Sen. Robert Wirch, D- Pleasant Prairie.

Taylor said the bill -- which has three Republican co-sponsors in the Senate as well as a Republican and two Democrats in the Assembly -- is about saving lives and should find broad approval in the Legislature.

Unfortunately, this may be a case where a combination of a sexual political agenda and political cash may be pushing the science too fast. The vaccine was just approved last June, and while the American Cancer Society and the American Academy of Pediatrics are both recommending the vaccination, the Baltimore Sun reports the American Academy of Pediatrics is urging a "go slow" approach.

But some medical experts say lawmakers are moving too fast in their efforts to vaccinate all school-age girls. The American Academy of Pediatrics, for instance, is urging a go-slow approach, with an initial focus on raising public awareness of HPV and more monitoring of the safety of the vaccine, which had minimal side effects in clinical trials but hasn't been observed in larger-scale rollouts.

"A lot of us are worried it's a little early to be pushing a mandated HPV vaccine," said Dr. Martin Myers, director of the National Network for Immunization Information. "It's not that I'm not wildly enthusiastic about this vaccine. I am. But many of us are concerned a mandate may be premature, and it's important for people to realize that this isn't as clear-cut as with some previous vaccines."

He added, "It's not the vaccine community pushing for this."

Meanwhile, the Washington Times is reporting new information is coming out from the National Vaccine Information Center about potential side effects.

Negative side effects of Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that causes cervical cancer, are being reported in the District of Columbia and 20 states, including Virginia. The reactions range from loss of consciousness to seizures.

"Young girls are experiencing severe headaches, dizziness, temporary loss of vision and some girls have lost consciousness during what appear to be seizures," said Vicky Debold, health policy analyst for the National Vaccine Information Center, a nonprofit watchdog organization that was created in the early 1980s to prevent vaccine injuries.

Michigan defeated efforts to make the vaccine mandatory, and in Maryland the legislation has stalled due to the mandatory language in the bill. Before Wisconsin moves forward with a mandatory vaccination program, lawmakers may want to wait until more data comes in to make an informed decision rather than a decision based upon politics.