Diane M. Harper

A researcher who worked on a vaccine for the human papillomavirus is warning that it hasn’t been tested on young girls, is “silly” for states to mandate the vaccination, and in a worst-case scenario could even increase cervical cancer rates.

In a report published by the Indiana-based Daily News, researcher Diane M. Harper said giving such a vaccine to 11-year-olds “is a great big public health experiment.”

Further, she said, requiring vaccinations now “is simply to Merck’s benefit.”

Harper is a professor and director at the Gynecologic Cancer Prevention Research Group at Dartmouth, and told the publication that there “is not enough evidence gathered on side effects to know that safety is not an issue.”

Harper, who has spent much of the last 20 years studying dozens of strains of HPV, said all of her trials have been with subjects ages 15 to 25, and personally she believes the new vaccine could offer help to women ages 18 and up.

The new vaccine, Gardasil, made by Merck and Co., has been an issue recently because of Merck’s aggressive lobbying at the state level to have lawmakers require that all schoolgirls at about age 11 or 12 be vaccinated with its product – at a cost estimated at about $360-$400 per child.

Texas Gov. Rick Perry in February issued an executive order requiring those vaccinations, but the state House of Representatives in Texas has approved by a 6-1 margin a plan to rescind that.

The issue that has rippled across the country as nearly three dozen state legislatures have considered the situation has not been the validity of the vaccine or the goal of reducing cervical cancer, but requiring schoolgirls to be vaccinated against a disease that is transmitted by sexual contact.

Harper said on women 18 and older, a test should be done to test for the presence of HPV, and if it’s negative, the series of three shots could be helpful. But if the test is positive?

“Then we don’t know squat, because medically we don’t know how to respond to that,” Harper said.

Her work has been funded through Dartmouth in part by Merck and GlaxoSmithKline, but technically she’s a university employee, not a researcher for the drug companies.

Merck’s vaccine was approved last year by the Food and Drug Administration and recommended for females ages 9-26. But a doctor at the Centers for Disease Control’s advisory committee on immunizations has reported that while the vaccine may be helpful, it should not be mandatory.

Merck has lobbied for its product by contributing financially to Women in Government, an organization for women state lawmakers, and at least partly because of that effort, almost three dozen state legislatures have been given proposals regarding Gardasil.

“This vaccine should not be mandated for 11-year-old girls,” Harper said. “It’s not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer – they won’t know for 25 years if they will get cervical cancer.”

She said the vaccine is not a cancer vaccine or cure – it just prevents development of a virus that could lead to cancer.

“For the U.S. what that means is the vaccine will prevent about half of high-grade precursors of cancer but half will still occur, so hundreds of thousands of women who are vaccinated with Gardasil and get yearly Pap testing will still get a high-grade dysplasia (cell abnormality),” she said.

Harper also reported that the drug company “bridged” the studies to apply to young girls. That means that Merck assumed that because it proved effective in the older girls, it also would be effective in the younger girls.

And she warned more than 40 cases of Guillian-Barre syndrome – an immune disorder that results in tingling, numbness and even paralysis of the muscles – have been reported in girls who got the HPV vaccine in combination with a meningitis vaccine.

She said the vaccine’s purpose has been misinterpreted and mis-marketed so that too many may believe if they’ve had the vaccine they are immune to cancer – when they are not.

While calling the vaccine “good” Harper said it is important to realize that if women get the vaccine, but not an routine Pap smear, “what will happen in the U.S. is that we will have an increase in cervical cancer, because the Pap screening does a very good job.”

Harper told the publication she’s attempted to publicize her opinion for months, “but no one will print it.”

The National Conference of State Legislatures set up a special website just to track and update the various campaigns.

That site confirms that about three dozen states have had such plans introduced. But it shows slow progress in many locations.

U.S. Rep. Phil Gingrey, R-Ga., also has introduced in Congress a plan to discourage states from requiring parents to have their underage daughters – those heading into sixth grade – vaccinated for the STD. His effort would ban the use of federal money for mandatory programs, but allow it for voluntary programs.

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