Proposed HPV Vaccine Mandates Draws Fire

From the National Vaccine Information Center

"Even ignoring the limited incidence of cervical cancer, we are troubled by the newness of the vaccine, the small sample of preteen girls studied and the disturbingly short guarantee of immunity. The vaccine has been on the market for only eight months, not nearly enough time to discover the range of adverse effects before administering it to tens of thousands of girls in a statewide mandate. More than 25,000 patients were part of a clinical trial of Gardasil, but only 1,184 of them were preteen girls. “That’s a thin base of testing upon which to make a vaccine mandatory,” Barbara Loe Fisher, co- founder of the National Vaccine Information Center, said in a Feb. 7 Wall Street Journal article. The center lobbies for safer vaccines." - Editorial, Rockford Register Star, Illinois

"We're really not lining one company's pockets with this," said Dr. Colleen Kraft, president of the Virginia chapter of the American Academy of Pediatrics, which supports the mandate....."We should proceed down this road very carefully," said Del. Robert Marshall, R-Prince William. "The company that is producing this is the same company that produced Vioxx." - Kimball Payne, Hampton Roads Daily Press

"Even some watchdog groups like the Center for Public Policy Priorities believe Perry's move is unconstitutional. "What can't happen is for the governor to just wake up one morning and say, 'we're going to have a new law in the state of Texas. I just wrote it. You have to have a whole rule-making proceeding where the public gets notice, the public gets an opportunity to come and comment, the executive commissioner has to consider their comments, and then develop a rule based on those comments," CPPP Executive Director Scott McCown said. Twenty-six senators from both parties even signed a letter asking Perry to withdraw the order. Now it's up to the governor to decide if the controversy will continue." - News 8, Austin, Texas


It’s premature to mandate cancer vaccine

Editorial

Rockford Register Star, IL
Published: February 12, 2007
http://www.rrstar.com/apps/pbcs.dll/article?AID=/20070212/OPINION03/102120005

One argument against mandating a cervical cancer vaccine for preteen girls revolves around morality: Will the vaccine encourage girls to have sex?

That isn’t our concern. We don’t believe the vaccine should be mandatory for a host of reasons having nothing to do with whether the vaccine would condone early sex and spawn a generation of promiscuous 11- and 12-year-olds. That’s a bogus issue.

Set aside cervical cancer and there are still plenty of frightening things for girls about having sex — getting AIDS, getting pregnant, getting a sexually transmitted disease.

Illinois Senate President Emil Jones has introduced a bill that would mandate all 11- and 12- year-old girls to receive a vaccination against the human papillomavirus (HPV) that causes cervical cancer. Beginning Aug. 1, 2009, girls would not be allowed to enter any grade of a public, private, or parochial school unless they present to the school proof of having received the vaccine. There is an opt- out clause if parents object.

Jones is not a pioneer in the mandate effort; already, some 20 states are considering or have passed similar measures. We believe they are being hasty, and they may be feeling the pressure of intense lobbying by Merck, the manufacturer of Gardasil, the only vaccine available on the market.

We encourage them to slow down and look at the facts. Courage to face down misguided moralists to protect women’s health is one thing; ignoring troubling medical questions is another.

Texas Gov. Rick Perry, who signed an executive order Feb. 2 mandating the vaccine, wrote on the editorial page of USA TODAY: “Some are focused on the cause of this cancer, but I remain focused on the cure. And if I err, I will always err on the side of protecting life ...

“If we could stop lung cancer, would some shy away claiming it might encourage tobacco use? This is a rare opportunity to act, and as a pro-life governor, I will always take the side of protecting life.”

But how many lives? How much protection? And at what cost?

According to the Centers for Disease Control and Prevention, 12,085 women in the United States were diagnosed with cervical cancer in 2002. The same year, 3,952 women died of the disease. The incidence of cervical cancer has gone down dramatically in the last four decades because of widespread use of the Pap test to detect problems.

In contrast, one of the most common cancers to attack women — breast cancer — claims 41,619 women’s lives a year and is responsible for 181,646 annual diagnoses.

Even ignoring the limited incidence of cervical cancer, we are troubled by the newness of the vaccine, the small sample of preteen girls studied and the disturbingly short guarantee of immunity.

The vaccine has been on the market for only eight months, not nearly enough time to discover the range of adverse effects before administering it to tens of thousands of girls in a statewide mandate.

More than 25,000 patients were part of a clinical trial of Gardasil, but only 1,184 of them were preteen girls. “That’s a thin base of testing upon which to make a vaccine mandatory,” Barbara Loe Fisher, co- founder of the National Vaccine Information Center, said in a Feb. 7 Wall Street Journal article. The center lobbies for safer vaccines.

The vaccine guarantees immunity, but only for five years and only against HPV strains that cause 70 percent of cervical cancer cases. Worst-case scenario, a child vaccinated at 12 might lose her immunity at just the time she needs it: at 17, when the chances of her having sex increase.

All of these questions should be considered against the backdrop of Merck’s financial position. The Wall Street Journal says mandatory vaccination would be an “automatic blockbuster” for the pharmaceutical company, at a time when its patents on other bestselling drugs are expiring.

The vaccine might very well be the right choice for many girls, an appropriate balance of risk and benefit. That only can be determined after consultation with your doctor and in the context of your family.


Vaccine maker fills war chests

Campaign coffers get a boost from Merck, whose anti- cancer shot is being weighed by legislators as a requirement for girls

Hampton Roads Daily Press
February 11, 2007

BY KIMBALL PAYNE
http://www.dailypress.com/news/local/dp-52313sy0feb11,0,4664322.story?coll=dp-news-local-final

RICHMOND -- Virginia is poised to require schoolgirls be given a controversial new cancer-blocking vaccination produced solely by a drug company generous with campaign cash for key state lawmakers.

Merck & Co. has given nearly $197,000 in contributions to dozens of Virginia politicians and campaign committees since 1997 and is touting the vaccine in a national push.

Among those who've received Merck money over the past decade are two of the General Assembly's biggest proponents of the vaccines this session.

The pharmaceutical giant has given $10,000 to Del. Phil Hamilton, R-Newport News, and $4,100 to Sen. Janet Howell, D-Fairfax, according to the Virginia Public Access Project, a nonprofit campaign finance watchdog.

Hamilton and Howell pushed vaccination mandates through the state Senate and House of Delegates. Final approval on the legislation is expected in the next few weeks. The bills would require shots for all girls entering sixth grade in the 2009 school year. Hamilton said that what's at issue is fighting cancer, not political fundraising.

"It's not about the manufacturer," said Hamilton, who chairs the House Health, Welfare and Institutions Committee. "It's about one thing and one thing only - anti-cancer. When you're leading the pack, people are going to criticize you."

Howell could not be reached for comment.

In June, the Food and Drug Administration signed off on the vaccine called Gardasil that blocks strains of the human papillomavirus, a sexually transmitted disease which infects 80 percent of women by the time they turn 50 years old, according to the Centers for Disease Control and Prevention.

Several strains of the virus can lead to cervical cancer, which kills about 3,700 women a year in the United States.

Texas became the first state to require schoolgirls get the vaccine. Republican Gov. Rick Perry bypassed the legislature and signed an executive order Feb. 2 requiring shots for sixth-grade girls in September 2008.

More than a dozen states are considering adding the vaccine to the list of required immunizations already given to schoolgirls.

A competing pharmaceutical company - GlaxoSmithKline Inc. - is pushing for federal approval for a nearly identical vaccine.

Either set of shots would fulfill the proposed requirement in Virginia.

"We're really not lining one company's pockets with this," said Dr. Colleen Kraft, president of the Virginia chapter of the American Academy of Pediatrics, which supports the mandate.

During a recent debate, one staunch House conservative openly questioned Merck's track record.

"We should proceed down this road very carefully," said Del. Robert Marshall, R-Prince William. "The company that is producing this is the same company that produced Vioxx."

Merck had to pull Vioxx - a profitable painkiller and anti-inflammatory - from the market in 2004, after further research found it increased the risk of heart attacks and strokes.

That's why vaccine side effects are tracked in a national database, Kraft said, noting that in 1999 the side effects directory identified problems with a vaccine against rotavirus that was immediately pulled from the market.

Hamilton's bill would give schools 30 months to prepare for the program and allow health care professionals to further track research about the injections.

The series of shots would cost roughly $360.

"It's not like were rushing into something that's going to be mandated tomorrow," Hamilton said.

Parents can seek medical or religious exemptions from the vaccinations.

The House version allows parents who review information about the virus to decline injections. The Senate passed the vaccine mandate without the additional exemption, so the two chambers will have to negotiate a compromise.

Expanding the list of required injections and broadening exemptions could erode parents' confidence in all vaccines, said Dr. Louis Cooper of the National Network of Immunization Information, which does not weigh in on policy debates.

"Mandating a vaccine is a big step," Cooper said. "It runs the risk of pouring gasoline on the whole mandate issue."

Reduced confidence in vaccinations, he said, could undermine the required vaccines that stamp out contagious diseases such as measles and mumps that "could spread through a school like wildfire."


Controversy heats up over HPV executive order

News 8 Austin, TX
February 8, 2007
By Bob Robuck

http://www.news8austin.com/content/headlines/?ArID=178886&SecID=2

The heat is almost to the boiling point over Gov. Rick Perry's executive order regarding the HPV vaccine. Perry bypassed the legislative process and ordered a law that mandates mandatory vaccination against HPV for girls entering the sixth grade.

"Although I support the governor in the action he's trying to propose, it has created such a firestorm because the legislators think they're being cut out of the process," bill author Sen. Leticia Van de Putte said.

Sen. Jane Nelson, chair of the Health and Human Services Commission, is the one carrying most of the burden since she will have to carry out the governor's order. Nelson has asked for help from the state attorney general's office. It won't offer an opinion for 180 days.

Even some watchdog groups like the Center for Public Policy Priorities believe Perry's move is unconstitutional.

"What can't happen is for the governor to just wake up one morning and say, 'we're going to have a new law in the state of Texas. I just wrote it. You have to have a whole rule-making proceeding where the public gets notice, the public gets an opportunity to come and comment, the executive commissioner has to consider their comments, and then develop a rule based on those comments," CPPP Executive Director Scott McCown said.

Twenty-six senators from both parties even signed a letter asking Perry to withdraw the order. Now it's up to the governor to decide if the controversy will continue.

"I would prefer, for the good of the safety of the process and also so that we can get this really good public policy, that the legislature should decide this and not by executive order," Van de Putte said.

Perry is also being criticized because the vaccine's manufacturer contributed to his re-election campaign.

Even if the governor doesn't withdraw the order on his own, some watchdog groups believe he'll have to do it at some point. They feel the attorney general's office will side with pulling the measure. Either that, or it could wind up in the courts.


From the National Vaccine Information Center

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