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Dr Diane M. Harper, a lead researcher in the development of the humanpapilloma virus vaccine, says giving the vaccine to 11 year old girls "is a great big public health experiment"  The lead researcher who spent 20 years developing the vaccine forDr Diane Harper humanpapilloma virus says the HPV vaccine is not for younger girls as it has not been tested for effectiveness in younger girls, and administering the vaccine to girls as young as 9 may not even protect them all.  And, in the worst-case scenario, instead of serving to reduce the numbers of cervical cancers within 25 years, such a vaccination crusade actually could cause the numbers to go up.

"There is not enough evidence gathered on side effects to know that safety is not an issue".

"Giving it to 11 year olds is a great big public health experiment", said Diane M. Harper, who is a scientist, physician, professor and the director the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire.

Internationally recognized as a pioneer in the field, Harper has been studying HPV and a possible vaccine for several of the more than 100 strains of HPV for 20 years - most of her adult life.

All of her trials have been with subjects ages 15-25.  In her own practice, Harper believes the ideal way of administering the new vaccine is to offer it to women ages 18 and up.  At their first inoculation, they should be tested for the presence of HPV in their system.

If the test comes back negative, then schedule the follow-up series of the three-part shots.  But if it comes back positive?

"Then we don't know squat, because medically we don't know how to respond to that" Harper said

Harper is an independent researcher whose vaccine work is funded through Dartmouth in part by both Merck & Co and GlaxoSmithKline, which means she is an employee of the university, not the drug companies.  Mercks's vaccine, Gardasil, protects against four strains of HPV, two of which cause genital warts, Nos. 6 and 11. The other two, HPV 16 and 18, are cancer-causing viruses.

Not tested on young girls

The idea is to inoculate them before they become sexually active, since HPV can be spread through sexual intercourse.  But that idea no matter how good the intentions behind it, is not the right thinking, Harper said.  The zealousness to inoculate all these younger girls may very well backfire at the very time they need protection most, she said.  "This vaccine should not be for 11 year old girls", she reiterated.  "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.

"Also the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervial cancer".  The reason she said, is because the vaccine does not protect against all HPV viruses that cause cancer - it's only effective against two that cause about 70 percent of cervical cancers.

For months, Harper said, she's been trying to convince major television and print media to listen to her and tell the facts about  this vaccine.  "But no one will print it", she said

According to Harper, the facts about the HPV vaccine are:

It is not a cancer vaccine or cure.  It is a prophylactic - preventative - vaccine for a virus that can cause cancer

It is not 100 percent effective against all HPVs.  It is 100 percent effective against two types that cause 70 per cent of cervical cancers

The vaccine only works if the woman/girl does not have HPV 6,11,16 or 18 - the viruses that Gardasil targets when she receives her first vaccine shot.

 The vaccine doesn't care if the girl/woman has been sexually active, Harper said "HPV is a skin-to-skin infection.  Although the only way to get cervical dysplasia is through an HPV infection, and HPV is most often associated with sexual activity.  HPV is not just spread through sex.  We have mulitple papers where that's documented.  We know that 3 year olds, 5 year olds, 10 year olds, and women who have never had sex have been found to be positive for the cancer-causing HPV types".

Therefore, for example, if a girl is positive for HPV 16 when she is inoculated with the vaccine at any age, she will not be protected against it later, Harper said, "That means it's a failure and those people are at risk for getting the HPV 16 and 18 cancers later".

The only way to test for the presence of HPV is through a vaginal swab- which is inappropriate for young girls, she said.

So what happens if the girls are vaccinated anyway, not knowing whether they were carrying the virus at the time of their inoculation?  "They will not be protected if they were positive for the virus at the time they are vaccinated," Harper said.

That is why it is important to note that the vaccine has not been tested for efficacy (effectiveness) in younger girls, she said.  Instead the effectiveness was "bridged" from the older girls to the younger ones - meaning that Merck assumed that because it proved effective in the older girls, it also would be effective in the younger ones.

So far more than 40 cases of Guillian-Barre syndrome - a dangerous immune disorder that causes tingling, numbness and even paralysis of the muscles have been reported in girls who have received the HPV vaccine in combination with the meningiitis vaccine.  Scientists already know that sometimes a vaccine can trigger the syndrome in a subject.  "With the HPV vaccine the number is higher than expected, and we don't know if it's the combination of two vaccines, or the meningiitis alone", Harper said.

In the end, innoculating young girls may backfire because it will give them a false sense of protection.  And, for both young girls and women, because the vaccine's purpose has been so misinterpreted - mis-marketed - Harper feels that too many girls and women who have had the vaccine will develop a false sense of security, believing they are immune to cancer when they are not, and failing to continue with their annual Pap exams, are crucial to diagnosing dysplasia before it can develop into cancer.

Merck was required to put together a database on the effectiveness in children before Gardasil was approved, Harper said.  But instead, the company put together four studies that "are not necessarily representative, and may not even have enough numbers to determine what they need to know".

Since she doesn't personally have access to the money Merck paid for her HPV vaccine research, Harper doesn't know exactly how much they paid Dartmouth for her work.

The trials are expensive, between $4,000 and $5,000 for each patient, she said.  With over 100 patients in her study, some big bucks could be in the balance, should Merck become upset with her for making these comments.

Why, then, would she risk speaking out like this - at a time when her words very well could be detrimental for Merck.  Isn't she afraid of losing her funding?

"I want to be able to sleep with myself when I go to bed at night," Harper said


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