Cervical cancer vaccine bill in trouble

02/22/2007

Backers withdraw support for Minnesota mandate to inoculate girls against sexually transmitted virus


BY JEREMY OLSON
Pioneer Press


Political support is unstable at best for a proposed law that all preteen girls in Minnesota be vaccinated against the sexually transmitted virus that causes cervical cancer.

The vaccine itself has proven remarkably effective at protecting against the types of human papilloma virus, or HPV, that are responsible for 70 percent of all cervical cancers and most of the 4,000 U.S. cervical cancer deaths each year.

However, proposed vaccine requirements in Minnesota and more than 20 other states have come under heavy criticism from conservative family groups, which say they send the wrong message to preteen girls about sexual promiscuity. Other critics say a political mandate is an unscientific way to impose medical policy and are upset that the vaccine manufacturer, Merck, has been using substantial lobbying to drive the state proposals.

The Minnesota Family Council says a state vaccine requirement "undermines abstinence and excuses pre-marital sex" and that the decision should be left to parents. Executive director Tom Pritchard said the vaccine doesn't need a state mandate, because HPV isn't like other viruses that can spread through the air or casual contact.

"It's not dealing with a contagious disease that someone can get in public," he said. "It's specifically resulting from a particular behavior."

Early supporters in the Legislature are having second thoughts. Two DFL lawmakers, Reps. Sandra Peterson and Maria Ruud, have withdrawn their names from a House bill that would require all preteens to receive the vaccine before they enter sixth grade.

Peterson said she rushed to support the bill because a close friend's daughter died of cervical cancer. She now says she believes it is too soon to require the vaccine, which was only federally approved last summer.

Ruud introduced the House bill Feb. 1, but she withdrew support Feb. 12 after hearing from pediatricians who weren't convinced of the need for a state requirement.

Ruud said Merck never lobbied her to introduce the bill. She also said she hasn't even seen the company's television ads promoting its vaccine, named Gardasil.

The Senate version is written by Sen. Yvonne Prettner Solon, DFL-Duluth, who is a member of the national Women in Government caucus, which has received money from Merck.

On Tuesday, Merck said it was suspending lobbying efforts nationally because they were distracting from the real issue: the importance of the vaccine and its ability to save lives.

That leaves the proposed state mandate with few allies, at least this year. The Minnesota Medical Association opposes the legislation. The state doctors' group instead wants a scientific advisory panel in the Minnesota Department of Health to evaluate the vaccine and whether it should be required, said Dr. Edward Ehlinger, who leads the association's committee on public health and preventive medicine.

The U.S. Food and Drug Administration approved Gardasil last summer for female patients ages 9 to 26, and an advisory panel for the U.S. Centers for Disease Control and Prevention later recommended that all girls receive it by age 11 or 12. That would presumably protect them before they started engaging in sexual activity that puts them at risk for HPV infection.

While the vaccine's safety was proven through clinical trials involving thousands of patients, Ehlinger said it is possible that rare complications or other concerns might surface once the vaccine is given to millions of Americans.

"My personal belief is we'd like to have a little more experience with this vaccine before we put it into state law," he said. However, as director of Boynton Health Services at the University of Minnesota, Ehlinger said he advises college students to be vaccinated.

Other vaccine experts said the controversy over state mandates has at least raised awareness of cervical cancer, and given women more information they can use to evaluate the vaccine for themselves and their daughters.

Dr. Karl Chun, a pediatrician at the U's Children's Hospital, Fairview, said no parents have come to appointments concerned about the vaccine's moral message. Many don't know HPV is sexually transmitted, but heard of it through Merck's television ads.

"I only have to use those three letters and everybody says, 'I know what that is,' " Chun said.

The lack of information on the long-term use of the vaccine might be a reason not to require it just yet, he said, but he disagreed that it would encourage teen sex. Minnesota already requires vaccination against Hepatitis B, which is largely spread in this state through sexual contact.

As a survivor of cervical cancer, 51-year-old Sarah Rose said she plans to have her 9-year-old daughter vaccinated. She noted that a Pap smear test discovered her cancer, but previous tests didn't detect it in its earliest stages. She needed radiation to eliminate her cancer.

"I know what I went through as a cancer survivor," said Rose, of Hastings. "Had this been available to me, it would have saved me a lot of pain and suffering."

Anita Fojtik-Craggs, of Lakeland, said she'll go with a pediatrician's recommendation on whether to eventually vaccinate her daughter, who is now 8. She was uncomfortable with the idea of a state requirement for preteen girls, even though the proposals would allow parents to opt out.

"I think a state mandate would be pushing the envelope for a lot of people," she said.

The vaccine is expensive — the required three doses cost $360 — but Minnesota's health insurers provide partial or even complete coverage. The federal Vaccines for Children program also ensures full coverage for children who aren't insured or are enrolled in state-subsidized health plans.

A similar HPV vaccine is being developed by GlaxoSmithKline and might soon receive federal approval. The vaccines won't replace Pap smear screenings, though, because they don't protect against all types of cervical cancer.

Still, two studies have predicted that the vaccines will provide a cost benefit by reducing the number of expensive tests and treatments for women with cervical cancer and by keeping those women healthier and in the work force longer.

Moral concerns weren't raised at the time of the vaccine's approval, and it's hoped they won't discourage parents from having their daughters vaccinated, said Patty Stinchfield, an immunization expert for Children's Hospitals and Clinics of Minnesota. She serves on the CDC's vaccine advisory committee.

While she isn't convinced of the need for a state mandate, she criticized those who oppose the vaccine on moral grounds. The vaccine does nothing to ward off pregnancy or other sexually transmitted diseases, including HIV, so she doubted it would somehow empower teens to have more sex.

"It's hard to argue against a vaccine that prevents cervical cancer in your sisters and aunts and mothers," she said. "That's where the argument goes if you want to argue against this vaccine."

It's possible that nobody will end up arguing about the vaccine in any formal legislative session. No hearings have been scheduled by House or Senate committees on the bills. After all the early hype, Ruud said this might be a "non-issue" this year.

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WHAT IS HPV?

Human papillomavirus (HPV), a sexually transmitted infection, is the most common cause of cervical cancer.

In June 2006, the Food and Drug Administration (FDA) approved Gardasil, a vaccine that offers protection from the most dangerous types of HPV. The national Advisory Committee on Immunization Practices recommends routine vaccination for girls age 11 and 12, and girls and women ages 13 to 26 if they haven't received the vaccine already. The vaccine is most effective if given to girls before they become sexually active.

The vaccine is the first designed to prevent cancer.