HPV vaccine a big public health experiment

[Guest guest]

http://www.ahrp.org/cms/content/view/503/27/HPV Vaccine Researcher Blasts Mandatory Marketing PWednesday, 14 March 2007Dr. Diane M. Harper, a lead researcher in the development of the humanpapillomavirus vaccine, who says giving the drug to 11-year-old girls "is a great bigpublic health experiment."AHRP's stated rationale for objecting to a policy mandating Merck's HPV vaccinein 11 year old girlshttp://ahrp.blogspot.com/2007/03/nyt-vital-discussion-clouded-mandatory.html isvalidated by an internationally recognized expert in the field who tested thevaccine in clinical trials.Dr. Harper, a scientist, physician, professor and the director of theGynecologic Cancer Prevention

Research Group at the Norris Cotton Cancer Centerat Dartmouth Medical School in New Hampshire, said: "It is silly to mandatevaccination of 11- to 12-year-old girls There also is not enough evidencegathered on side effects to know that safety is not an issue."All of her trials have been with subjects ages 15 to 25."This vaccine has not been tested in little girls for efficacy. At 11, thesegirls don't get cervical cancer - they won't know for 25 years if they will getcervical cancer."Dr. Harper said, Merck was required to put together a database on the efficacyin children before Gardasil was approved. But instead, the company put togetherfour study sites that "are not necessarily representative, and may not even haveenough numbers to determine what they need to know."She believes the ideal way of administering the new vaccine is to offer it towomen ages 18 and up. At the time of their first

inoculation, they should betested 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 tothat," Harper said.She said 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, theHPVs against which this vaccine works may infect a little girl at the age sheneeds the vaccine most - meaning she will have to have a booster at the rightpoint in time or she will not be protected. And, remember, it won't work at allif 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, andonly to Merck's benefit," she said.Dr. Harper said, she's

been trying for months to convince major television andprint media to listen to her and tell the facts about the usefulness andeffectiveness of this vaccine. "But no one will print it," she said.Something is very wrong with this commerically driven frenzied marketing whichall those who shape public policy and public opinion were caught shilling forMerck.Independent advocates need to take to the streets to protect our children fromirresponsible pharmaceutical companies whose financial largesse buys publicofficials, government agencies that are supposed to protect us from potentiallyharmful drugs and vaccines, and the uncritical transcribers of hype in thepress!What role did the FDA play in this Gardisal promotion debacle?Today the FDA orderd manufactures of 13 sleeping pills to add warning labelsthat sleeping do indeed cause sleep driving!! Imagine 13 different sleepingpills and all of

them put pedestrians and drivers at risk of a sleeping driverbehind th wheel!!With the current regime in command, the FDA is lending the governmen seal ofapproval to the creation of chemically induced disasters.Contact: Vera Hassner Sharav212-595-8974veracare email address is being protected from spam bots, you needJavascript enabled to view it < This email address is being protected from spambots, you need Javascript enabled to view it '; document.write( '' );document.write( addy_text90969 ); document.write( '<\/a>' ); //-->\n This emailaddress is being protected from spam bots, you need Javascript enabled to viewit >http://www.kpcnews.com/articles/2007/03/14/online_features/hpv_vaccine/hpv01.txtResearcher blasts HPV marketingBY CINDY BEVINGTON cindyb email address is being protected fromspam bots, you need Javascript enabled to view itWednesday, March 14, 2007Diane M. Harper, a lead researcher in the development of the humanpapillomavirus vaccine, says giving the drug to 11-year-old girls "is a great big publichealth experiment." (Photo contributed)LEBANON, N.H.  A lead researcher who spent 20 years developing the vaccinefor humanpapilloma virus says the HPV vaccine is not for younger girls, and thatit 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 themat all. And, in the worst-case scenario, instead of serving to reduce thenumbers of cervical cancers within 25 years, such a vaccination crusade actuallycould cause the numbers to go up."Giving it to 11-year-olds is a great big public health experiment," said DianeM. Harper, who is a scientist, physician, professor and the director of theGynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Centerat Dartmouth Medical School in New Hampshire."It is silly to mandate vaccination of 11- to 12-year-old girls There also isnot enough evidence gathered on side effects to know that safety is not anissue."Internationally recognized as a pioneer in the field, Harper has been

studyingHPV and a possible vaccine for several of the more than 100 strains of HPV for20 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 towomen ages 18 and up. At the time of their first inoculation, they should betested for the presence of HPV in their system.If the test comes back negative, then schedule the follow-up series of thethree-part shots. But if it comes back positive?"Then we don't know squat, because medically we don't know how to respond tothat," Harper said.Harper is an independent researcher whose vaccine work is funded throughDartmouth in part by both Merck & Co. and GlaxoSmithKline, which means she is anemployee of the university, not the drug companies. Merck's vaccine, Gardasil,protects against four strains of HPV, two of

which cause genital warts, Nos. 6and 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, andrecommended in June for females ages 9 to 26 by the Centers for DiseaseControl's Advisory Committee on Immunization Practices (ACIP).Glaxo has stated publicly that its vaccine, Cervarix, which protects against thetwo cancer-causing strains, should be on the market by 2008.As the director of an international clinical trial for these vaccines, and asauthor of lead articles about the vaccines' effectiveness, Harper has beenquoted widely as saying this vaccine could have enormous potential to eradicatethe great majority of cervical cancers.Not tested on young girlsPicking up on this, but before the trials were even completed, major news mediaand women's advocacy groups began trumpeting the vaccine as an answer to

cancerof the cervix.Once it was approved by the FDA and ACIP, Women In Government (WIG), anon-profit organization comprised of female state and federal legislators, beganchampioning Merck's vaccine in their home states, with many of the ladiesintroducing legislation that would mandate the vaccine for 11- and 12-year-olds.In Indiana, Sen. Connie Lawson, R-Danville, introduced such a bill in thisyear's General Assembly, but in the face of strong opposition, it was reduced toan education/information-only bill that requires data collection on any Hoosiergirls who do get the vaccine. The bill is now awaiting a hearing in the IndianaHouse.So far at least 26 states are reported to be considering some form oflegislation requiring the new vaccine for younger girls. In February, RepublicanTexas Gov. Rick Perry bypassed his legislature and mandated it for all 11- and12-year-old girls in his state.

Monday, The Associated Press reported that NewMexico's governor, Democratic presidential contender Bill Richardson, is set tosign 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 canbe spread through sexual intercourse.But that idea, no matter how good the intentions behind it, is not the rightthinking, Harper said. The zealousness to inoculate all these younger girls mayvery 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 getcervical 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 stillget Pap smears (which test for abnormal cells that

can lead to cancer), some ofthem will still get cervical cancer."The reason, she said, is because the vaccine does not protect against all HPVviruses that cause cancer - it's only effective against two that cause about 70percent of cervical cancers.For months, Harper said, she's been trying to convince major television andprint media to listen to her and tell the facts about the usefulness andeffectiveness of 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. "Merck has proven it has zero percenteffectiveness for curing cancer," Harper said. "But it is a very, very goodvaccine that prevents types of HPV responsible for half of the high-gradecervical 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 precursorsof cancer but half will still occur, so hundreds of thousands of women who arevaccinated with Gardasil and get yearly Pap testing will still get a high-gradedysplasia (cell abnormality)."• It is not 100 percent effective against all HPVs. It is 100 percenteffective against two types that cause 70 percent of cervical cancers.• The vaccine only works if the woman/girl does not have a current vaccinetype related infection (in other words, the vaccine only works when thewoman/girl does not have HPV 6, 11, 16 or 18 - the viruses that Gardasil targetswhen she receives her first vaccine shot).• The vaccine doesn't care if the girl/woman has been sexually active, Harpersaid. "HPV is a skin-to-skin infection. Although the only way to get cervicaldysplasia is through an HPV infection, and HPV is

most often associated withsexual activity, HPV is not just spread through sex. We have multiple paperswhere 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 thecancer-causing HPV types."• Therefore, for example, if a girl is positive for HPV 16 when she isinoculated with the vaccine at any age, she will not be protected against itlater, Harper said. "That means it's a failure and those people are at risk forgetting 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 theywere carrying the virus at the time of their inoculation? "They will not beprotected 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 forefficacy (effectiveness) in younger girls, she said. Instead, the effectivenesswas "bridged" from the older girls to the younger ones - meaning that Merckassumed that because it proved effective in the older girls, it also would beeffective in the younger ones. The actual tests on the younger girls, ages 9 to15, were only for safety and immune response, Harper said, and then only as ashot by itself, or in combination with only one other vaccine, Hepatitis B. Ithas not been tested in conjunction with any other shots a girl receives at aboutage 11, Harper said.• So far more than 40 cases of Guillian-Barre syndrome - a dangerous immunedisorder that causes tingling, numbness and even paralysis of the muscles havebeen reported in girls who have received the HPV vaccine in combination

with themeningitis vaccine. Scientists already know that sometimes a vaccine can triggerthe syndrome in a subject. "With the HPV vaccine, it is a small number buthigher 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 afalse sense of protection. And, for both young girls and women, because thevaccine's purpose has been so misinterpreted - and mis-marketed - Harper feelsthat too many girls and women who have had the vaccine will develop a falsesense of security, believing they are immune to cancer when they are not, andfailing to continue with their annual Pap exams, are crucial to diagnosingdysplasia before it can develop into cancer.Keep getting pap smearsThe message to consumers, Harper said, is don't stop getting Pap smears justbecause you've

gotten the HPV vaccine."This vaccine is good, and it will save a huge number of lives around theworld," Harper said. "But an important point is that, if women get the vaccineand then not get their Pap smears, or decide to get them infrequently, what willhappen in the U.S. is that we will have an increase in cervical cancer, becausethe 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 abooster?"Message for governorsFor the governors of the states in this country, Harper has another message. Onehas to do with the fact that vaccinating little girls now is not going toprotect them later. Since it can take a decade or more to even manifest itselfas dysplasia, the HPVs against which this vaccine works may infect a little girlat the age she needs the

vaccine most - meaning she will have to have a boosterat the right point in time or she will not be protected. And, remember, it won'twork at all if she was positive for the virus when she was inoculated in thefirst place.Merck knows this, Harper said. "To mandate now is simply to Merck's benefit, andonly to Merck's benefit," she said.Merck was required to put together a database on the efficacy in children beforeGardasil was approved, Harper said. But instead, the company put together fourstudy sites that "are not necessarily representative, and may not even haveenough numbers to determine what they need to know."Since she doesn't personally have access to the money Merck and GlaxoSmithKlinepay for her HPV vaccine research, Harper doesn't know exactly how much eitherhas 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 verywell could influence legislation across the country, and prompt legislators todrop 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 goodvaccine. But let's be honest. Don't over-promise."For more stories on this topic, see the HPV Vaccine Series<http://www.kpcnews.com/online_features/hpv_vaccine/>FAIR USE NOTICE: This may contain copyrighted (© ) material the use of whichhas not always been specifically authorized by the

copyright owner. Suchmaterial is made available for educational purposes, to advance understanding ofhuman rights, democracy, scientific, moral, ethical, and social justice issues,etc. It is believed that this constitutes a 'fair use' of any such copyrightedmaterial as provided for in Title 17 U.S.C. section 107 of the US Copyright Law.This material is distributed without profit.

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