LEBANON, N.H. — A lead researcher who spent 20 years developing the vaccine for humanpapilloma virus says the HPV vaccine is not for younger girls, and that it is "silly" for states to be mandating it for them.
Not only that, she says it's not been tested for effectiveness in younger girls, and administering the vaccine to girls as young as 9 may not even protect them at 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.
"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 of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire.
"It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue."
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 to 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 the time of 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. Merck'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.
Merck's vaccine was approved last year by the Food and Drug Administration, and recommended in June for females ages 9 to 26 by the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP).
Glaxo has stated publicly that its vaccine, Cervarix, which protects against the two cancer-causing strains, should be on the market by 2008.
As the director of an international clinical trial for these vaccines, and as author of lead articles about the vaccines' effectiveness, Harper has been quoted widely as saying this vaccine could have enormous potential to eradicate the great majority of cervical cancers.
Not tested on young girls
Picking up on this, but before the trials were even completed, major news media and women's advocacy groups began trumpeting the vaccine as an answer to cancer of the cervix.
Once it was approved by the FDA and ACIP, Women In Government (WIG), a non-profit organization comprised of female state and federal legislators, began championing Merck's vaccine in their home states, with many of the ladies introducing legislation that would mandate the vaccine for 11- and 12-year-olds.
In Indiana, Sen. Connie Lawson, R-Danville, introduced such a bill in this year's General Assembly, but in the face of strong opposition, it was reduced to an education/information-only bill that requires data collection on any Hoosier girls who do get the vaccine. The bill is now awaiting a hearing in the Indiana House.
So far at least 26 states are reported to be considering some form of legislation requiring the new vaccine for younger girls. In February, Republican Texas Gov. Rick Perry bypassed his legislature and mandated it for all 11- and 12-year-old girls in his state. Monday, The Associated Press reported that New Mexico's governor, Democratic presidential contender Bill Richardson, is set to sign a bill requiring sixth grade girls in his state to get the vaccine.
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 mandated 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 cervical 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 the usefulness and effectiveness of this vaccine.
"But no one will print it," she said.
The rest of the story
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. "Merck has proven it has zero percent effectiveness for curing cancer," Harper said. "But it is a very, very good vaccine that prevents types of HPV responsible for half of the high-grade cervical lesions that cause about 70 percent of cervical cancers. 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)."
• It is not 100 percent effective against all HPVs. It is 100 percent effective against two types that cause 70 percent of cervical cancers.
• The vaccine only works if the woman/girl does not have a current vaccine type related infection (in other words, the vaccine only works when 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 multiple 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. The actual tests on the younger girls, ages 9 to 15, were only for safety and immune response, Harper said, and then only as a shot by itself, or in combination with only one other vaccine, Hepatitis B. It has not been tested in conjunction with any other shots a girl receives at about age 11, Harper said.
• 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 meningitis vaccine. Scientists already know that sometimes a vaccine can trigger the syndrome in a subject. "With the HPV vaccine, it is a small number but higher than is expected, and we don't know if it's the combination of the two, or the meningitis alone," Harper said.
• In the end, inoculating 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 - and 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.
Keep getting pap smears
The message to consumers, Harper said, is don't stop getting Pap smears just because you've gotten the HPV vaccine.
"This vaccine is good, and it will save a huge number of lives around the world," Harper said. "But an important point is that, if women get the vaccine and then not get their Pap smears, or decide to get them infrequently, 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.
"That's my main diatribe. We don't need mandatory vaccinations for little girls. What we do need to ask, though, is how long does it last, and when do you need a booster?"
Message for governors
For the governors of the states in this country, Harper has another message. One has to do with the fact that vaccinating little girls now is not going to protect them later. Since it can take a decade or more to even manifest itself as dysplasia, the HPVs against which this vaccine works may infect a little girl at the age she needs the vaccine most - meaning she will have to have a booster at the right point in time or she will not be protected. And, remember, it won't work at all if she was positive for the virus when she was inoculated in the first place.
Merck knows this, Harper said. "To mandate now is simply to Merck's benefit, and only to Merck's benefit," she said.
Merck was required to put together a database on the efficacy in children before Gardasil was approved, Harper said. But instead, the company put together four study sites 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 and GlaxoSmithKline pay for her HPV vaccine research, Harper doesn't know exactly how much either has 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 or Glaxo 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 influence legislation across the country, and prompt legislators to drop the mandates? 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. "My concern is still, let's get women's health better. It is still a good vaccine. But let's be honest. Don't over-promise."
" I have research on the net for 6 weeks every free minute I had and accululated from multiple sites a stack of over 12 inches of adverse information on Gardasil and 100's of personal stories, yet the CDC says none of the deaths and disability are related, they are certain without investigating half of it. Didnt they say the same about Vioxx, amd Rotateg? Its all about prestige, lies, money, and greed. Just what amount of damage, death, and or infertility is enough to get this vaccine off the market. Yet they say other vaccines have had a higher VAERS reporting number, if so thats a ver bad commentary on vaccines in general which are very dangerous as well, obviously in all Ive read. And they just keep adding more when its known unvaccinated kids are far more healthy, and also that the true stats show that these diseases were well into decline before the vaccines and they very possibly had little to do with the erradiaction. When measles vaccine is in a pushed for blanket coverage mode in a community what happens, do measles cases disapear? No, they increase, in in fully vaccinated subjects.
I have been trying to write a letter to the editor on gardasil but am having great difficulty getting that into 300 words, and without leaving something some doctor or state official can respond with that in entirety, if could cover if it all as I need to. However, getting people to investigate and educate themselves is the main goal. "
sydney Crawford wrote on Sep 27, 2008 7:10 PM:
" Wondering what are the results if two of the three shots are taken and the third is skipped.
After all the new information wondering what the reprocussions would be of not taking that final shot. Anyone have any info on this? "
Travis wrote on Jun 8, 2008 5:08 PM:
" If you're reading this you may know of a 'strong comparable' case to this possible Gardasil reaction:
" Thank you for putting this great information out there! I refused the vaccine for my daughter and my child's doctor was not happy about my decision. After reading this article I am so glad that I did not allow my daughter to become an experiment! Thank you!!! "
matt wrote on Jul 20, 2007 11:59 PM:
" I am setting up a meeting with my 14 year old daughter's ob/gyn to discuss his recommendation to my ex-wife that my girl be given this vaccine. I refused her receiving the Menactra vaccine three years ago and my ex was furious until I pointed out the incidence of Guillaine-Barre Syndrome associated with recipients of that vaccine, I at least have some credibility with her because of that and I can argue clinical trials and how they are manipukated with the best of them. My concern here, though, is not with the trials, although 14 year old girls were not a test group, but with the aggressive marketing of the drug before any peer reviewed studies appeared, almost as if Merck was in a hurry to have a fait accompli with the industry-captured FDA's approval before any firm Science could be brought to the table. I have found your series of articles an invaluable resource in preparing for meeting with the doctor who also happens to be a personal friend and who takes my concerns seriously. I do not anticipate the typical condescending speech from him but I want to be well-prepared nonetheless. Thanks again. "