HPV Vaccine Distribution Stalled by 'Adverse Reactions'
Randy Hall
Staff Writer/Editor
(CNSNews.com) - Legislation requiring pre-teen girls to be vaccinated against the human papilloma virus (HPV), one of the main causes of cervical cancer, has yet to be approved by any state - the result, a conservative analyst says, of strong public reaction against the proposals as well as concerns about the drug itself.
Lawmakers in more than 25 states and the District of Columbia debated measures requiring that girls be treated with Gardasil before entering sixth grade, but an "outcry from parents and even some doctors' organizations caused legislators to take a second look" at the issue, said Wendy Wright, president of the conservative group Concerned Women for America.
"There are a few officials who really bought into the line that this vaccine is completely safe and effective, [that] it will only save lives, and [that] there is no doubt about it," Wright told Cybercast News Service on Thursday.
However, the widespread push to mandate vaccinations "caused people to say, 'Wait a minute. Why are you pushing this on us?'" she stated, describing the reaction as an "organic uproar" across the country.
"It's not like we did a mass effort to get people active to work against [the state measures]," Wright added. "There was a gut reaction among citizens and many in the medical profession who said 'mandates are wrong.'"
In addition to legislative roadblocks, Gardasil has also suffered "adverse reactions' from negative news reports.
Last week, Judicial Watch released documents obtained from the U.S. Food and Drug Administration (FDA) that "read like a catalog of horrors," according to Tom Fitton, the conservative group's president.
As of May 11, 1,637 adverse reactions to the HPV vaccine had been reported to the Vaccine Adverse Event Reporting System (VAERS), including 371 serious reactions and three deaths.
"It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug," Fitton stated.
However, Dr. John Iskander, acting director for immunization safety at the Centers for Disease Control and Prevention, told Cybercast News Service that the VAERS data "is subject to a number of limitations scientifically."
"Deaths, especially when they occur in young people, are tragic," Iskander said. However, the deaths of two of the three girls mentioned in the documents were found to be related to blood clots. "Both of the young women were taking oral contraceptives, and that's a known risk factor for developing blood clots."
In addition, "the third woman died of a heart inflammation that was caused by a viral infection unrelated to the vaccine," he stated.
Iskander said those cases "are very good examples" of the system's shortcomings. "People can report any event, so simply having an event reported doesn't necessarily mean the vaccine caused the event."
Nevertheless, a University of Michigan C.S. Mott Children's Hospital National Poll on Children's Health released on Tuesday showed that only 44 percent of parents surveyed were in favor of a school mandate for the HPV vaccine.
Gardasil manufacturer Merck did not respond to multiple requests for comment.
State actions
As Cybercast News Service previously reported, cervical cancer is the second most common type in women after breast cancer.
The FDA approved Gardasil this past July, and later that month, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted unanimously to recommend that girls receive the vaccine before they become sexually active.
The resulting controversy took a dramatic turn on Feb. 2, when Texas Gov. Rick Perry issued an executive order requiring girls entering the sixth grade to be inoculated beginning in September 2008. Texas ranks second in the U.S. in the number of women with the disease.
Perry's edict would have provided public assistance to cover the estimated $360 cost for the required series of three shots over a six-month period.
However, the Texas legislature blocked the GOP governor's initiative in late April, when the state Senate voted 30 to 1 to overturn Perry's order and the Texas House did the same with a veto-proof vote of 135-2.
Also in late April, New Mexico Gov. Bill Richardson vetoed a bill passed by the state legislature that would have required all girls entering sixth grade to be vaccinated against HPV.
"While everyone recognizes the benefits of this vaccine, there is insufficient time to educate parents, schools and health-care providers," the governor said regarding the measure, which would have taken effect on June 15. Richardson is also a candidate for the Democratic Party's 2008 presidential nominations.
Even Virginia, the first state to pass legislation regarding the HPV vaccine, does not require all children to have the Gardasil shots.
Kevin Hall, press secretary to Gov. Tim Kaine, told Cybercast News Service that the new law started out as a mandate but changed during the legislative process.
"It almost could be termed an 'opt-in' program," Hall said. Beginning in 2009, parents will be given information on the vaccination process by school divisions but will not be required to participate.
When confronted by opposition to administering the drug in schools, several states - including Washington and New Hampshire - chose to make the vaccination available for free at state-run health-care clinics, while others - such as Nevada and Illinois - are trying to require insurance companies to cover the treatment cost.
Looking at the issue from the perspective of cost, Wright suggested a less-expensive alternative.
"The amount of money spent on this vaccine would be so much better spent on pap tests, which detect pre-cancerous cells," Wright said. "Cervical cancer deaths have decreased 74 percent since pap tests became available." The tests are also far cheaper, about $60 rather than $360 for the Gardasil course.
"If the government is going to be paying for something, it ought to be the best thing and the best use of taxpayer money," she added. "If the funding went toward that, it would free up huge chunks of money to go to other kinds of health care that's necessary, rather than paying for the most expensive vaccine on the market."
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