Thread: They are wanting to make the HPV vaccine mandatory in schools

killbarney - I just had to post the article in it's entirety.

Gardasil First childhood vaccine for sexually transmitted disease
By MARIAN JEFFERSON
The Dallas Examiner

Side-stepping the legislature, Governor Rick Perry recently mandated that all Texas schoolgirls entering the sixth grade receive vaccination for the Human Papillomavirus. That mandate is causing quite a stir, but Perry asserts that the mandate is necessary. "Requiring young girls to get vaccinated before they come into contact with HPV is responsible health and fiscal policy that has the potential to significantly reduce cases of cervical cancer and mitigate future medical costs,’’ said Governor Perry.

Governor Perry also directed state health authorities to make the vaccine available free to girls 9 to 18 who are uninsured, enrolled in Medicaid or the Children’s Health Insurance Program or whose insurance does not cover vaccines. In addition, he ordered that Medicaid offer Gardasil to women ages 19 to 21.

And Dallas County Health and Human Services has been prompt to respond to the Governor’s orders. DCHHS currently offers the Human Papillomavirus vaccine through its adult immunization clinic. “DCHHS wants to provide the vaccine as a weapon against this deadly form of cancer,” said Zachary Thompson, DCHHS Director. “According to the Texas Cancer Registry, there were approximately 1,169 new cases and 391 deaths from cervical cancer in Texas in 2006. DCHHS is awaiting shipment of the HPV vaccine for children through the Texas Vaccine for Children program and will make a formal announcement when it becomes available…”

HPV infection, in most cases, is harmless.

Many know that the vaccine has been tested for safeness and effectiveness against HPV. But what many do not know is that, according to the Center for Disease Control, the HPV infection, in most cases, is harmless. In fact, 90 percent of infections are fought off by the bodies own immune system, rendering the infection inactive or causing it to dissolve on its own. But, there are other strains of HPV that are deemed as “high-risk” because the virus may, in rare cases, develop into persistent infection that can progress to cervical cancer if left untreated (There are more than 100 known strains of HPV, 30 of these are sexually transmitted and are defined as genital HPV). It is estimated that fewer than 4000 Americans die from HPV related cervical cancer yearly.

So, why the need for an executive order which is used in times of crisis and emergency?

Justification

According to Sherbert v. Verner (1963) three questions must be considered to justify actions of this nature:

During The April 2005 State Affairs meeting regarding HOUSE BILL NO. 195, which stated, “An Act requiring governmental entities to meet certain requirements before placing a burden on a person’s free exercise of religion.” REPRESENTATIVE DYSON “noted that when the standard was established in 1963, the court said three questions must be asked.” He said, “The first of those was, does the government create an infringement on a constitutional right to practice religion? That is, has a government action somehow impaired someone’s practice of religion?


“… the second question is whether the government has a compelling state interest that justifies burdening the religious activity in question. The term “compelling” means “very important, or of the highest magnitude,” he explained.


“…the third question is, “If a compelling interest does exist, are there alternative means by which the government can achieve its goal and thus not burden the religious action?”


According to the Supreme Court: It is basic that no showing merely of a rational relationship to some colorable state interest would suffice; in this highly sensitive constitutional area, “[o]nly the gravest abuses, endangering paramount interests, give occasion for permissible limitation,” Thomas v. Collins, 323 U.S. 516, 530.


The question is, has the government determined this infection cannot be avoided by behavioral change and has chosen to shift the focus toward vaccination? And, if so, is mandatory vaccination against a disease that is largely sexually transmissible really the answer or is there a larger problem?


Adverse reactions reported during Gardasil’s testing phase In initial clinical trials, Merck tested over 20,000 females, giving half of them placeboes and the other half the Gardasil. The subjects were followed for approximately four years. More noteworthy, a little more than 1000 subjects, ages ranging from 9 to 16 year old were a part of the trials and they were followed for only 18 months. Both in the placebo and in the vaccine groups, there are reports of adverse reactions. Gardasil’s own package insert sites as some of the adverse reactions reports of arthritis, headaches, dizziness, nausea, and pain at the injection site. Page 12 of Merck package insert also cites 102 incidents of serious, adverse reactions such as headaches, dizziness, juvenile arthritis, gastroenteritis, headaches, appendicitis, pelvic inflammatory disease and includes 17 deaths out of 21, 464 subjects. Merck concluded these deaths have nothing to do with their product.


The test group was only followed for a period of four years, raising doubts as to whether Gardasil prevents anything, especially since the incubation period for the infection is about 20 years and usually presents in women in their late thirties and forties. The only thing known with certainty is the short-term effects of this vaccine. Additionally, the study did not address carcinogens (any potentially cancer causing agent) or genotoxicity (a chemical or agent that causes damage to cellular DNA which can result in mutations or cancer).


The maker of Gardasil’s troubled past

Gardasil is made by Merck, a giant pharmaceutical manufacturer. Merck received licensing for Gardasil from the Food and Drug Administration in June of 2006, while the vaccine was still in clinical trials.

In Gardasil’s own package insert, it asserts that HPV types 16 and 18 are the cause for 70 percent of cervical cancer and Gardasil is reported to be effective against these with implications for types 11 and 6. Merck’s package insert goes on to explain that women will continue to need regular cervical cancer screenings and that the vaccine may not protect everyone, raising the question as to whether this vaccine really is 100 percent effective.

Merck is the same manufacturer of the drugs Fosomax and Vioxx, pharmaceutical nightmares for Merck and Company that have left the company reeling from lawsuit settlements. It is estimated between 88,000 to 139,000 have suffered heart-attacks or strokes as a result of taking the drug Vioxx and more than 55,000 have died.

Merck continued to defend Vioxx even after it had been pulled from shelves, better than four years from when they knew there were problems.


Doesn’t FDA approval mean it’s safe?

According to The San Fransico Chronicle, Dr. David Graham, the scientist and 20 year FDA veteran, that blew the whistle on Merck & Co., said at a Senate hearing in 2004 that policies by the FDA had left the American public “virtually defenseless” against the kind of safety problems that led to Vioxx’ abrupt withdrawal in September 2004.

FoxNews.com reported that in his testimony, Graham said, “the FDA’s Office of New Drugs unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not. That rule does not protect consumers, Graham told the Senate committee. “What it does is it protects the drug,” he said.

Additionally, Graham told the Senate Finance Committee, “I would argue the FDA, as currently configured, is incapable of protecting America against another Vioxx.”

According to Reuters, in the same hearing, Committee Chairman Charles Grassley, an Iowa Republican also raised concerns regarding the reliability of the FDA, saying, he feared the FDA had become too intimately involved with drug companies and thought an independent office of drug safety might be needed.

In an interview with CBS News Correspondent, Sharyl Attkison, Dr. Graham characterized the FDA fostering as a work environment where supervisors intimidate employees when they bring attention to products that have questions with regard to safety. In the interview, he discussed problems not only with Vioxx and Fosomax, but also Bextra, Meridia, Crestor, Accutane, and Serevent.

Were Gardasil to prove to be another Merck disaster, Governor Perry’s mandate requiring Gardasil be offered under the vaccine for children’s law which will create total immunity from lawsuits from those who take Gardasil and experience adverse or even life threatening reactions. This is because the Federal Vaccine Liability program shields pharmaceuticals that develop vaccines.

( continued )



One hand left to play. Selling the public.

“We were first introduced to the Gardasil vaccine through what is commonly known as direct-to-consumer marketing,” says a mother with her young child in the background, in a Merck commercial. “O-N-E-L-E-S-S! I want to be one less, one less…” is chanted by children while skipping rope and playing. “Who wouldn’t want to vaccinate their children against cervical cancer.” It is a manufacturer’s way of first, raising awareness about its newest product and secondly, encouraging consumers, when visiting the doctor’s office, to ask for their product and to ask for it by name.

If this were a game of poker, one might say it was the only hand that Merck had left to play if it were going to stay afloat financially. In a 2005 interview with Jim Lehrer of NPR, a representative from Merck Pharmaceuticals reported that because of financial hardships (largely attributed to trade mark expiration of Zocor, a cholesterol medication, and lawsuits from Fosomax and Vioxx), Merck, by 2008, would be closing seven manufacturing sites and laying off approximately 11 percent of its workforce. Ironically, 2008 is when the Governor’s mandate is to take affect. There is no word yet on whether sale of the Gardasil vaccine will off-set the financial disparities experienced by Merck & Co.

Gardasil is given in a series of three shots at $140.00 per shot ($420 in total). Some private doctors are already offering the vaccine, others are not stocking for reasons such as: too expensive to store and refrigerate or they have to charge a surcharge in case the insurance company does not pay.


Gardasil is currently covered by some insurance companies, but others are waiting until there is more information about the drug (USA Today). But if the vaccine is indeed mandated under the Childhood Vaccination Program, this will guarantee profits for Merck both immediately and in the future as there is “…sure to be a need for a booster. After all, it is a vaccine,” said Dr. Edwards of the Texas Association of Ob-Gyns. This is a fact that has had little to no discussion in the public arena.


Deputy Press Secretary for Governor Perry, Krista Moody, declined to respond to questions about the vaccine mandated by the Governor, stating, “I believe your attached questions should be directed to the CDC, FDA or Merck, as they relate to specifics for drug research and testing.”


Both Christopher Loder, Media Relations Officer for Merck & Co. and Heidi Robello, FDA Media Relations agreed to answer questions presented to them in writing, but to date neither has responded.

Keeping it in perspective

The public is being told that the Gardasil vaccine should be hailed as a cure for cervical cancer, but this vaccination is not a cure for cancer. It is a vaccination purported to protect against two of over 100 different strains of HPV, with implications for two more. Furthermore, sexually active men and women, boys and girls can still continue to transmit other forms of HPV infections even after vaccination.

http://209.85.165.104/search?q=cache...lnk&cd=1&gl=us

You know, someone posed a wonderful question I'd love to see answered.

If

Using new and improved statistical models, CDC scientists estimate that an average of 36,000 people (up from 20,000 in previous estimates) die from influenza-related complications each year in the United States

is true, then why isn't the flu vaccine mandatory? It kills THOUSANDS more than cervical cancer.

Merck lobby fiasco obscures vaccine's benefits
Tucson, Arizona | Published: 03.02.2007

BOSTON - Hasn't anyone ever told drug companies to put a warning label on their lobbying? You know, the kind you find on every little prescription bottle? Caution: Too much lobbying may result in an overdose of suspicion. Push too hard and you may experience political acid reflux.

As it is, Merck seems to have rolled a million — or many millions — into a shoestring. And the real losers may be girls and women who need access to the vaccine against cervical cancer.

Let's return to that magical moment when clinical trials proved that a new vaccine was nearly 100 percent effective in preventing two strains of the HPV virus that causes most cervical cancer. This is the second-leading cancer killer of women in the world. In America, about 9,700 women are diagnosed with it every year and 3,700 die.

In October 2005, Eliav Barr of Merck said exuberantly, "This is it. This is the Holy Grail." Merck, barely recovering from its Vioxx troubles, was the first of two companies to develop a vaccine. There were hosannas all around. Or, well, almost all around.

The response from the abstinence-only crowd was less enthusiastic. Family Research Council's Tony Perkins said that "it sends the wrong message." After all, HPV had been almost as useful in the scare tactics of abstinence-only education as had HIV. There were fanciful charges that preventing cancer would encourage promiscuity. But it was bad PR to be against cancer prevention. So the right-wing groups dropped back from opposing the vaccine itself to opposing mandatory school vaccination.

All of this might have just simmered along, but something happened on the way to gradual acceptance. After FDA approval, the folks at Merck saw Gardasil as their anti-Vioxx, the drug that would help them do well by doing good.

Let us say that the lobbying and advertising that ensued were not heavy-handed by drug company standards. Let us not say much about drug company standards.

Nineteen states introduced legislation to add Gardasil to the list of school vaccines. But the plans blew up when Rick Perry, the governor of Texas and a conservative darling, issued an executive order mandating vaccines. His order allowed parents to opt out on religious or philosophical grounds, the same all-purpose loophole that has worked with other vaccines.

But it turned out that Perry's former chief of staff is now a lobbyist for Merck. Did that look bad? Whoa, Nellie. Did it look bad that Merck had funded an organization of women legislators backing similar bills? Whoa, Merck.

With a JetBlue-style fiasco on its hands, Merck suspended all flights, uh, lobbying and advertising. But now some very strange bedfellows are going to the mattresses against Gardasil.

There are the abstinence-only folks who believe that cancer prevention sends the "wrong message." There are the routine opponents of all vaccines and the libertarian opponents of the "nanny state," not to mention some doctors who thought the vaccine was being rushed and was too expensive.

I hold no brief for Merck. They won their setback the old fashioned way: They earned it. There's every reason to assume that Merck wanted its drug approved before the competitor from GlaxoSmithKline comes down the pike. At $400 for a three-shot regimen, there's a lot of money at stake.

Nor am I surprised to find that parents are queasy. It's not easy for any parent to accept that their middle-schooler should get protection from a sexually transmitted disease, even with the risk of cancer. But the parents among these strange bedfellows may remember that the enemy of your enemy is not necessarily your friend.

What's been lost in the debate about school-mandated vaccines is that this one is extraordinarily safe and effective against a lethal disease.
It's wise to keep one eye on the costs and another on alternative vaccines. It's savvy to give parents a way to opt out.

But allow me to add one last label on this sorry tale of public relations and public health. This warning is for parents. Caution: Too much suspicion can be bad for your daughters' health.

http://www.azstarnet.com/sn/opinion/171531.php


My opinion : Ellen Goodman
Contact Ellen Goodman of the Boston Globe at ellengoodman@globe.com.


I think this person finds too many excuses for Merck and completely dismisses the concerns and issues involved in undertesting and no idea what the long term effects may be. It is ALL about the money for Merck and they are willing to risk an entire generation of women if it will line their pockets.

The incidents of Cervical Cancer are decreasing in the more modern world while increasing in Third World countries where they do not have access to regular Pap smears. Why doesn' Merck release a supply to them ( Oh yeah - they can't afford it... )

Taking some points from this woman's article, she needs a HEAVY reality check and needs to practice responsible journalism. She's full of poo


Let's return to that magical moment when clinical trials proved that a new vaccine was nearly 100 percent effective in preventing two strains of the HPV virus that causes most cervical cancer. PROVEN??? right, in biased trials


This is the second-leading cancer killer of women in the world. In America, about 9,700 women are diagnosed with it every year and 3,700 die.

This is downright a LIE as from the CDC's website doesn't even put cervical cancer in the top of any cancers for women=Breast cancer is the leading cancer among women of all races in the United States ( you know what's funny? this isn't true, it's lung cancer and has been for years) ;
Among white women, lung cancer is the second most common cancer and colorectal is the third most common cancer. Among black and Asian/Pacific Islander women, colorectal cancer and lung cancer are the second and third most common cancers, respectively;
The fourth leading cancer among women of all races in the United States is cancer of the uterus, not including cervical cancer;

I can say that ingrown toenails are the leading cause of hair loss but it doesn't make it true. Cervical cancer had NEVER been a leading cause of cancer death in women.



What's been lost in the debate about school-mandated vaccines is that this one is extraordinarily safe and effective against a lethal disease. Says WHO-there were a LOT of adverse reactions, and in the 6 months of "reporting"(ha that's a big JOKE) there have been hundreds of reported adverse reactions)

This warning is for parents. Caution: Too much suspicion can be bad for your daughters' health. And too much trust can cripple and kill them.

(I have to admit, I didn't feel like reading 7 pages so im just putting my ideas on it since im actually in the age group for it, so many things that im saying may have already been said so... yeah)

I'm kinda blah, on the whole thing. Yes it sounds great, yes lets all do it for the good of us, but ... how can we even get all of that stuff that its fighting for... uh... I don't feel like being a guinie pig.. however you spell that. and I don't think that they should be telling us it's perfectly alright to go and get this disease, because, oh we're protected anyway. and what if it dont work huh? (wow I'm not at all formal...)

N.M. lawmakers approve cancer vaccine
By MATT MYGATT, Associated Press Writer
Tue Mar 13, 6:15 PM ET

ALBUQUERQUE, N.M. - New Mexico is on the verge of becoming the latest state to require sixth-grade girls to be vaccinated against a sexually transmitted virus that can cause cervical cancer, a spokesman for the governor said Monday.

The state House approved the bill Sunday, and Gov. Bill Richardson will sign it once he receives the legislation, spokesman Gilbert Gallegos said. "It's a public health issue, and I believe it's an important step," Richardson said Monday. "New Mexico has always been progressive on these issues. ... We've got to find ways for young women to be protected."

The measure would take effect June 15 — 90 days after the adjournment of the Legislature.

Texas is the only state to require the vaccine so far, but other states are considering doing the same. While federal regulators have approved the vaccine, the issue of making it a requirement for girls has been surrounded by controversy.

Merck & Co., the vaccine's maker, said last month that it would suspend a behind-the-scenes lobbying campaign to get states to require it for school-age girls because of pressure from parents and medical groups.

Texas Gov. Rick Perry sidestepped his state's Legislature when he ordered the shots for girls entering the sixth grade there starting in September 2008. He has since had to defend his relationship with Merck; The Associated Press reported Perry's chief of staff met with key aides about the vaccine on the same day Merck's political action committee donated money to the governor's campaign.

It wasn't known if Merck had lobbied New Mexico officials.

Virginia lawmakers passed a similar law, which Gov. Timothy M. Kaine has said he would sign. Massachusetts Gov. Deval Patrick's budget proposal calls for providing the vaccine for free to all girls 9 to 18 who want it.

Other states have considered legislation as well. In Colorado, lawmakers are debating a bill that would make the cervical cancer vaccine mandatory for girls entering sixth grade unless their parents sign a form refusing it.

The federal government approved Gardasil, a three-dose vaccine that protects against the human papilloma virus, or HPV, in June for females ages 9 to 26. The vaccine protects against HPV strains that cause cervical, vulvar and vaginal cancers and genital warts.

More than 500 cases of mostly minor side effects have been reported in girls and women who got the vaccine. Government health officials said last month that no additional warning labels are needed.

Also Monday, two Texas lawmakers said that state health officials are not required to follow Perry's order.

Their announcement was made after meeting with Texas Attorney General Greg Abbott, who told them the order "was more like a suggestion to the head of the agency," according to state Sen. Jane Nelson.

Abbott spokesman Jerry Strickland said the attorney general's office does not discuss the content or substance of its discussions with lawmakers.

The governor's office says the order is consistent with current law, although Perry has acknowledged that the Legislature can supersede it. The Texas House is to vote Tuesday on a bill that would bar state officials from requiring the vaccine.

http://news.yahoo.com/s/ap/20070313/...tfsc2ylKWs0NUE

(( Thanks Mesue ))

Wednesday, March 14, 2007 9:04 AM EDT
Researcher blasts HPV marketing
BY CINDY BEVINGTON

Diane M. Harper, a lead researcher in the development of the humanpapilloma virus vaccine, says giving the drug to 11-year-old girls "is a great big public health experiment."

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.

( continues ... )

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."

http://www.kpcnews.com/articles/2007...cine/hpv01.prt

For more stories on this topic, see the HPV Vaccine Series
http://www.kpcnews.com/online_features/hpv_vaccine/

Ten reasons why HPV vaccine is 'murky' issue
Sunday, February 4, 2007

The word "cancer" triggers emotions ranging from fear to empathy to panic. But we cannot let our emotions cause us to spend money or create mandates without careful research. We need to evaluate claims of drugmakers, lobbyists and lawmakers when they seek money for cancer prevention efforts.

Here are 10 reasons why we are skeptical about efforts to mandate for school girls the HPV vaccine against the sexually transmitted cervical-cancer virus.

10. Merck and Co. (the manufacturer of the vaccine) has funneled money through Women in Government, an advocacy group made up of female state legislators around the country.

9. Sen. Connie Lawson, the General Assembly's No. 1 advocate for the vaccine, is a member of Women in Government.

8. A top official from Merck's vaccine division sits on Women in Government's business council.

7. Women in Government President Susan Crosby, a former Indiana state legislator, said the vaccine could "eliminate a cancer." Yet Gardasil, is NOT a cancer vaccine. It is a vaccine for a virus; specifically for four of the more than 100 types of HPV, two of which cause 70 percent of cervical cancer in women, and two that cause 90 percent of genital warts.

6. Merck could generate billions in sales if Gardasil - at $360 for the three-shot regimen - were made mandatory across the country. Depending on how many girls are Medicaid-eligible in each state, much of that money could come from Medicaid dollars - even if the vaccine is recommended, not mandated.

5. The top 10 leading killers of women in the U.S. are heart disease, stroke, lung cancer (more than 70,000 deaths of women per year), respiratory diseases, Alzheimer's, breast cancer, diabetes, accidents, flu/pneumonia and colon cancer. About 3,700 U.S. women die of cervical cancer each year; that is about 1/8th of the number of women who die from colon cancer, the No. 10 killer of U.S. women.

4. Because the vaccine was only studied for 3 1/2 years, the long-term effectiveness and safety of this vaccine has yet to be determined. It took years for thalidomide and Vioxx (also a Merck product) to demonstrate their most negative side effects.

3. Pap smears have dramatically reduced cervical cancer deaths in the U.S. But Gardasil does not protect against all cancers of the cervix. If the number of Pap smears go down because of women's false sense of security, the number of cervical cancer deaths could go UP!

2. Scarce health care dollars should be spent in the most effective way possible. We believe an investment of billions could be better spent in efforts to battle the top 10 killers of women. (See No. 6 and No. 5.)

1. With an issue as "murky" as this, our little girls should not be guinea pigs

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I am 25 years old and I have several friends with HPV. If they would have had this vaccine when I was younger they wouldn't have to be going through all this now.....and for the record, three of them got it from their husbands!