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May 26, 2007

10 More Things You Might Not Know About Gardasil

Our first 10 Things You Might Not Know About Gardasil generated quite a response. It's a few months later and we're still getting comments and emails, and finding discussions about what we wrote on other blogs and websites. We're happy that we've helped to get people thinking and talking about this issue, and we can see that it isn't going away anytime soon. So we've continued following the press coverage and doing our own research, and we're back with 10 More Things You Might Not Know About Gardasil.


1. There is a controversy surrounding Gardasil in Texas.

This story has gotten a lot of press coverage so we’re not going to rehash all of the details here, but here’s a quick timeline of what happened:

~In early February, Texas Governor Rick Perry issued an executive order making Gardasil mandatory for girls entering the sixth grade. In doing so, he bypassed the state legislature and a public outcry of opposition.

~After the order was issued, it came out that Governor Perry has some ties to Merck that some people found questionable. His former chief of staff is one of Merck’s lobbyists in Texas, and the mother-in-law of his current chief of staff is the state director of Women in Government, an advocacy group that has received funds from Merck and has been a major part of Merck’s lobbying campaign for Gardasil. Merck’s political action committee also contributed to Perry’s reelection campaign.

~The situation in Texas generated a lot of discussion, debate, protest, and media coverage, which most likely contributed to Merck’s announcement in late February that it was suspending its lobbying efforts in many states to have the vaccine made mandatory for students.

~On March 14th, the Texas House of Representatives voted to overturn Governor Perry’s executive order. The bill would keep Gardasil off of the list of required vaccines for students. A similar bill is being considered by the state Senate. The issue is not just the opposition to Gardasil, but also the fact that the governor bypassed the legislature and may have overstepped his authority by issuing a binding executive order. If the bill is passed, it could still be vetoed by the governor, so lawmakers are trying to get the bill to the governor’s desk as quickly as possible so that they will have time to override a potential veto before the legislative session ends in May.

~In late April, a revised version of the bill passed both the Texas House and Senate and was sent to the governor, who then had 10 days to either sign or veto it. The legislature has enough votes to override a veto. The bill prevents state officials from requiring the vaccine for school admittance, but the ban will expire after four years so that the vaccine can be reevaluated.

~On May 8th, Governor Perry announced that he would not veto the bill. He was extremely critical of the bill and the legislature, but said that a veto would be pointless since there were enough votes to override it.

In contrast to the Texas drama, New Hampshire has largely avoided controversy by choosing not to make Gardasil mandatory, but instead to make it available free of charge to girls ages 11 to 18 through a state program for immunization of minors. One of the stated reasons for making a vaccine (especially a very expensive one like Gardasil) mandatory is that it levels the playing field, allowing people at all income levels to have the same access to the treatment. The New Hampshire approach isn't perfect either--there are waiting lists and some reports of doctors running out of the vaccine and having to wait for more--but it does provide equal access while also allowing parents more freedom to decide if and when their children should be vaccinated.

2. A variety of adverse reactions to Gardasil have been reported.

Merck has released a list of the side effects that someone could experience from Gardasil: pain, swelling, itching and redness at the injection site, fever, nausea, and dizziness.

However, the list of adverse reactions from the first dose of Gardasil that has been reported so far is more extensive. It includes:

  • loss of consciousness and syncope
  • seizures
  • dizziness, shakiness,"feeling faint"
  • loss of vision, decrease in quality of vision, dryness of eyes
  • abnormal speech
  • nausea, vomiting
  • headache
  • pallor, purple coloration of the lips
  • fever, chills
  • dyskinesia (difficulty or distortion in performing voluntary movements)
  • hypokinesia (slow or diminished movement of the body musculature)
  • difficulty swallowing
  • joint pain
  • Guillain-Barre Syndrome (an immune disorder which effects the peripheral nervous system and in extreme cases can cause paralysis)
  • hives, itching, rashes, blisters, vesicles, and skin ulcers
  • swelling of the arms, swelling of the lower extremities, swelling of the lymph nodes
  • severe pain at the site of injection.
The information on these reactions comes from the Vaccine Adverse Event Reporting System (VAERS), which is a program co-sponsored by the FDA and the CDC.

The National Vaccine Information Center has released two reports analyzing the reactions that have been reported so far: 1st Report, 2nd Report. Just to clarify—the National Vaccine Information Center is a nonprofit organization that advocates “the institution of vaccine safety and informed consent protections in the mass vaccination system”. So they’re not an objective source and their agenda has to be taken into consideration when you read their reports. But they are drawing their information on negative reactions straight from the VAERS database, which as we said above is an FDA/CDC program, making it a part of the federal Department of Health and Human Services.

One of the interesting things about this information is that quite a few of the negative reactions that were reported, including most of the cases of Guillain-Barre Syndrome, occurred in patients that had received another vaccine at the same time as Gardasil. (The meningococcal vaccine Menactra, which appears in several of the Gardasil reports, has been previously associated with Guillain-Barre warnings) As we mentioned in our first Ten Things, Gardasil was only tested for safety when administered at the same time as the Hepatitis B vaccine. No other combinations of vaccines were tested, so it is difficult to say if some of these negative reactions were caused by Gardasil, by the other vaccine involved, by the combination of the two vaccines, or by some other factors.

3. Anyone who is allergic to the ingredients of Gardasil should not receive the vaccine.

Gardasil is fermented in giant vats of yeast paste, which means that anyone with a yeast allergy should not get the vaccine. The CDC’s Vaccine Information Statement lists yeast allergy as a reason to avoid the vaccine, but the Patient Product Information on gardasil.com does not specifically mention yeast.

The listed ingredients are: “purified inactive proteins that come from HPV Types 6, 11, 16, and 18…amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.”

If you or your child have ever had even a mild negative reaction to a vaccine, or you have any allergies at all, even ones that you may not think could possibly be relevant, you should talk to your doctor and make sure you're aware of any potential complications. (Merck also recommends that you tell your doctor if you or your child have any type of bleeding disorder that would make injections difficult, a weakened immune system, a fever or other mild illness, or are taking any prescription or over-the-counter medications.)

Maybe in some circles it's common knowledge that yeast is sometimes used to develop vaccines, but we didn't know it and many of our friends didn't either. You may have a condition like a yeast allergy and not be aware of it, or your doctor may not be aware of it, and it could cause a negative reaction that you never even knew you should be looking out for. So seek out as much information as you can and talk everything through with your doctor until you feel comfortable. It's your health, so be as cautious as you want to be.

4. Women who may be pregnant, women who are breast-feeding, and women who have already been exposed to HPV should approach Gardasil with caution.

Women who may be pregnant and women who are breast-feeding should be cautious, because there are some questions about whether Gardasil could potentially affect fertility or cause harm to a fetus or a nursing infant. Full information about the testing that was conducted on pregnant and breast-feeding women can be found on the FDA's website, but we have pulled out some of the relevant quotes.

“…it is not known whether GARDASIL can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. GARDASIL should be given to a pregnant woman only if clearly needed.”

“The effect of GARDASIL on male fertility has not been studied.”

“Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received GARDASIL and subjects who received placebo.” (One note here—both Gardasil and the placebo contained aluminum, so if you are concerned about the potential harmful effects of aluminum, it’s not possible to tell whether aluminum could have been a factor in any of the complications that were experienced).

“It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GARDASIL is administered to a nursing woman.”

Also, a small number of women who used the vaccine near the time of conception gave birth to children suffering from birth defects, although there is no specific evidence that Gardasil was the cause.

Merck claims that Gardasil may still be beneficial for women who have already been exposed to HPV, since the vaccine protects against four HPV strains and it is unlikely that a woman would be exposed to all four, so the vaccine could still provide protection against the remaining strains. But it is worth noting that after reviewing the clinical trials of Gardasil last summer, the FDA did raise a concern about the potential for the vaccine to lead to "an increased number of cases of a cancer precursor" among patients already infected with one of the strains of HPV affected by Gardasil. It's important to remember that most cases of HPV show no symptoms at all and that the virus can remain in your body for months or even years.

So if you're considering Gardasil but think there's a chance you may have HPV, you may want to consider your HPV testing options before you go ahead with the vaccine.



5. A new study published by JAMA shows that only about 3.4% of women have one of the four strains of HPV that Gardasil protects against.


A study published in the February 28th issue of the
Journal of the American Medical Association has found that about 26% of women aged 14 to 59 in the U.S. have HPV. According to the study, HPV is most prevalent among women aged 20-24. About two percent have types 16 or 18, which are the types believed to cause about 70% of cervical cancer cases, and are two of the strains of HPV that Gardasil protects against. When HPV types 6 and 11 are included, it brings the number up to 3.4% of women infected with one of the four strains of HPV that Gardasil targets. Of course, this isn’t a total number of women who will ever be affected by one of these four strains, since the study included a wide age range of women and it is possible that some of the younger women will be exposed to more strains of HPV over their lifetimes. But the numbers still help to provide some perspective about the prevalence of these particular strains versus the prevalence of HPV overall.

With all of the statistics being thrown around in the media about how common HPV is and how many millions of people will get it in their lifetimes, that perspective is important. There are dozens of strains of HPV. A few of them are linked to genital warts and a few of them are linked to cervical cancer. The majority of cases of HPV will eventually clear on their own. Getting HPV does not mean you will get cancer. Gardasil protects against four specific strains of HPV. Getting vaccinated with Gardasil does not mean that you’ll never get HPV, or that you’ll never be at risk for genital warts or cervical cancer. Your risk will be greatly reduced, but not eliminated.


6. Questions have been raised about several of the ingredients in Gardasil.


Gardasil is made with genetically engineered materials.
Being genetically engineered doesn't automatically make Gardasil evil and harmful, but it's interesting that while many people say that the idea of genetically engineered food seems unnatural and makes them uncomfortable, a lot of those same people are putting a genetically engineered vaccine into their (or their children's) bodies without a second thought. Products made with genetically modified organisms are still controversial, and many people feel that such products should be studied more thoroughly, labeled more clearly, or even banned altogether, while others believe that they are safe and that the potential benefits of genetically engineered products outweigh the potential risks. [Nutrition Action HealthLetter] [ScienceDaily] [Greenpeace] [BBC News]

Polysorbate-80, another Gardasil ingredient, has also been linked to possible negative effects. There are some claims that polysorbate is potentially carcinogenic, and polysorbate-80 has also been linked to infertility in mice, although the amount of polysorbate in the three doses of Gardasil is thought to be too low to cause harm in humans.

Here is what the medical encyclopedia of the U.S. National Library of Medicine and the NIH has to say about sodium borate, another ingredient in Gardasil:

Sodium borate is the main ingredient in boric acid. (Powdered boric acid is often used to kill cockroaches.)

Sodium borate poisoning can be acute or chronic. Acute, accidental sodium borate poisoning usually occurs when someone swallows powdered roach-killing products that contain the chemical.

Poisoning may also occur in those who are repeatedly exposed to sodium borate. In the past, boric acid was used to disinfect and treat wounds. Patients who received such treatment over and over again got sick, and some died. Because boric acid is now known to be a dangerous poison, it is no longer commonly used in medical preparations. However, boric acid is contained in some vaginal suppositories used for yeast infections, although this is NOT a standard treatment.

Some of the symptoms listed for sodium borate poisoning are similar to those that have been reported by patients who have suffered negative effects from Gardasil.

Of course, we're not saying that every single claim about any of these ingredients being harmful is automatically 100% accurate. And we're not claiming that Gardasil equals certain doom because there are concerns. We don't think it's impossible for the benefits to outweigh the risks in some cases. We just think it's important for people to have as much information as possible about what those risks and benefits are so that they can make good decisions, and that they have the freedom to make those decisions for themselves and their families.

7. A researcher who participated in studies of Gardasil has expressed her concerns about making the vaccine mandatory.

Researcher blasts HPV marketing BY CINDY BEVINGTON Wednesday, March 14, 2007

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. 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.

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 Guillain-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.

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?"

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."


8. Men are increasingly seeking out information about HPV and Gardasil, especially in the gay community.

In our first 10 Things we wrote about the fact that Gardasil was initially approved only for women (in the U.S.), and that most of the initial testing focused on women and girls and was only expanded later to begin to include more boys and men. We found this a little concerning considering that men can get and give HPV just like women can, and men can also (to a lesser degree than women) be at risk for genital warts and certain types of cancer as a result of HPV infection.

One of the biggest problems is the fact that there is no FDA-approved HPV test for men (and the CDC claims that such a test is unnecessary, which we ranted on in our first top ten), and there have been fewer studies done on HPV in men than there have been with women. So even if a man wanted to be as responsible as possible about STD testing, his options are limited where HPV is concerned. Many men probably don't even realize that even though they are getting tested for other STDs regularly, they are still at risk for HPV and may be putting their partners at risk as well.

Some research being done now has shown that HPV may be more prevalent in men than in women, and little is known about whether transmission rates differ from men to women, women to men, men to other men, etc. This information could be critical in determining who really should be getting the vaccine, what the cost benefits are, and what the best methods of preventing HPV infection are in general.

HPV is of particular concern to gay men, because rates of anal cancer have been rising.

While rates of anal cancer are low in the general population -- and more women than men get anal cancer every year -- they're disproportionately high among gay men and people who are HIV-positive or have other immune-suppressive conditions. Part of the explanation for increased cases of anal cancer is better reporting of the disease, but Bay Area doctors say it also could be tied to HIV rates.

Studies have shown rates of anal cancer as high as 35 cases for every 100,000 people among gay men -- a figure comparable to rates of cervical cancer in women before Pap tests were introduced as a screening tool 60 years ago. Since then, rates of cervical cancer have fallen 70 percent.

Some doctors are recommending anal Pap tests for gay men as a way of catching precancerous lesions before they become anal cancer, similar to the screening process for cervical cancer. And a growing number of men are choosing to go ahead and be vaccinated with Gardasil now as a way to potentially protect themselves and their partners from any strains of HPV that they have not already been exposed to. This is an "off license" use for Gardasil since the FDA has yet to approve it for adult men, but many men and some doctors feel that the potential benefits make it worthwhile.

We don't understand why Merck hasn't incorporated this angle into their marketing campaigns. We can't think of anything that would get the conservative abstinence-only crowd on board with mandatory vaccination faster than saying ''hey, guess what? the two groups of people who benefit most from our vaccine are your precious young daughters and...gay men!'' This must have simply been an oversight that we're sure Merck is working to remedy. Expect the PSA featuring Hilary Duff and Lance Bass any day now.

9. There is a product called carrageenan that may be effective at preventing HPV infection.

Some early research has shown that carrageenan, a thickening agent derived from algae, is a powerful HPV inhibitor.

In laboratory tests, carrageenan, a compound derived from red algae, prevented HPV infection by both genital wart and cancer-causing types. "We were floored by how much better it worked than anything else we have tested. It's effective at 100-fold lower concentration than the next best inhibitor we've found," said Dr. John Schiller, senior investigator at the National Cancer Institute.

Normally, HPV attacks cells by attaching to proteins on their surface and then chemically manipulating access to the cells. Carrageenan thwarts this process by attaching to HPV and preventing its entry into cells.
[Medical News Today][CBS News]

Carrageenan has also been studied for its ability to prevent herpes and HIV transmission, but it was found to be much more powerful at inhibiting HPV transmission. Carrageenan is used in a variety of commercial products, including some sexual lubricants and lubricated condoms.

Clinical trials could determine whether carrageenan could be successfully and safely used as a topical microbicide to prevent the spread of HPV. Since carageenan is already used in a variety of food, cosmetics, and sex-related products, it seems possible that a product like this could be developed. If so, it would be a powerful and relatively inexpensive tool in the fight against HPV, which would be especially beneficial in lower income countries around the world where women have limited access to health care and cervical cancer is a significant problem.

10. There is another HPV vaccine in development, which works differently than Gardasil.

GlaxoSmithKline is currently in the final stages of testing its own HPV vaccine, called Cervarix, which could be on the market as early as the end of the year. Like Gardasil, Cervarix protects against HPV types 16 and 18, which are said to cause most cases of cervical cancer. Unlike Gardasil, Cervarix does not protect against the types of HPV that cause most cases of genital warts.

Based on the information that has been released so far and the testing that is currently being done, it seems that Glaxo will try to market Cervarix as being better than Gardasil for two reasons. First, it may also protect against HPV types 45 and 31, which have also been linked to cervical cancer. Tests are underway now to determine whether this is definitely the case. And second, because Glaxo is using a special type of adjuvant that is different from the basic aluminum adjuvant used in Gardasil, they are claiming that Cervarix will provide better and longer-lasting immunity to HPV than Gardasil does, especially among girls aged 10-14.

Cervarix has also been tested on women as old as 55, which seems to indicate that Glaxo will target a wider market of women than Merck has with Gardasil. Earlier this year, Glaxo launched a study designed to directly compare the effectiveness of Cervarix and Gardasil and it will be interesting to see what the results are. Cervarix was also just recently approved for women ages 10-45 in Australia. We’ll keep researching and writing about Cervarix as it gets closer to approval in the U.S.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Our conclusion now is still the same as it was when we wrote our first 10 Things. This is a complicated issue but it also comes down to a personal choice, and everyone should be able to make that choice for themselves or for their children with as much research and information and as little guilt and manipulation as possible.

As always, we'd love to know what you think, so keep the comments and emails coming.


28 comments:

mhatrw said...

Despite the idiotic rhetoric of conservative nuts, there are a lot of good medical reasons to wait before rushing to mandate a vaccine that was approved less than a year ago based on only two years of clinical results.

For example, the most recently released clinical results are very disappointing.

To summarize this published, peer-reviewed medical journal article:

1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the only recognized precursors to cervical cancer.

2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the strongest (and many would argue only valid) precursors to cervical cancer.

3. GARDASIL’s protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer “raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18.”

4. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias — many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That’s about $60,000 per dysplasia prevented.

This is all directly from the article linked above.

I myself would add that we currently have only 3 years of follow up to go on in terms of both GARDASIL’s safety and efficacy among the 16 to 26 year female population, no data concerning its efficacy among 9 to 12 year old girls and only 18 months of follow up on less than 600 total preteen girls in terms of safety data about GARDASIL within its targeted population.

Also see : The Journal of the American Medical Association and The Wall Street Journal

It appears that the vaccinated cohort sees a 20%+ increase in high grade cervical dysplasias caused by cancer-associated HPV strains other than HPV 16 and 18. One possible explanation is that HPV 6 or HPV 11 infections are antagonistic to more dangerous HPV infections.

In addition, the use of a highly pharmacologically alum adjuvant as the sole "placebo" in both the FUTURE I & FUTURE II studies makes it impossible to accurately assess the overall risks of vaccination vs. non-vaccination in the real world. Furthermore, the fact that GARDASIL has been studied for safety in just a few hundred pre-teens (again using an alum injection as the "placebo") is highly problematic.

If HPV itself were a domestic health crisis, the analysis would be different. If the actual health risks of injecting preteens vs. the risks of not injecting were well quantified, the analysis would be different. If HPV were highly contagious without prolonged skin to skin contact, the analysis would be different. If GARDASIL were free, the analysis would be different. But as it stands, we are looking at a vaccine with a clinical effectiveness of no more than 30% against all high grade cervical lesions over a three year period. Even if we assume that HPV 16 and 18 directly cause cervical cancer, that the prevalence and carcinogenicity of current HPV strains won't change over time or in response to the limited immunity that GARDASIL confers, that vaccinated women will continue to get Pap smears at least as frequently as unvaccinated women currently do and that there will be no other improvements in tests or therapies for unvaccinated women, we are looking at saving no more than 1000 lives a year 20 to 40 years down the road, about half of which could be saved simply by assuring that all women receive regular Pap smears. That's if we vaccinate every 9 to 12 year female in the US over the next 20 years at a cost of well over 20 billion dollars. Furthermore, with only a 6% to 30% efficacy, it is now 100% clear that GARDASIL can not be utilized to save lives in any reasonably cost effective manner by allowing medical policy makers to delay the onset or reduce the frequency of recommended Pap smears.

Finally, even though we don't have any decent quantitative numbers concerning GARDASIL's safety (especially on a pre-teen population), we must consider that vaccines in general are not 100% safe. They can cause juvenile arthritis, Guillain-Barre syndrome and other major complications (such as temporary paralysis, fainting, and persistent pain, swelling and itching) in a small subset of the population. Vaccines are not like other medicines in that they are given to a lot of healthy people who would not otherwise contract any disease with or without vaccination. So vaccines must be reasonably effective for their benefits to outweigh their associated risks.

tal said...

Merck and much of the MSM together have limited the discussion of Gardasil to the objections of religious fundamentalists, relegating all dissenters to the same anti-science, anti-progress, anti-sex backwaters thereby de-legitimising any inconvenient facts which might otherwise squeeze through the pre-programmed script.

We have been habituated to the handing-over of our brains to the experts but we need to take them back in order to examine the un-stated facts that are too often conveniently left out of the discussions:

CancerMonthly
quotes the text Cancer: Principles & Practice of Oncology, "In most studies, HPV status was not a strong independent prognosticator of outcome in cervical cancer patients; however there appears to be a trend for HPV-negative tumors to do worse �those tumors containing HPV DNA tend to be of an early stage and low grade."4 This suggests that if the goal is to reduce deaths from cervical cancer the target should not be HPV at all because the tumors without HPV actually "do worse."




One of the FDA concerns about Gardasil™ is that "any advantage provided by the vaccine in protecting against the four targeted HPV types could be offset by infection by the numerous other HPV types that aren't affected by the vaccine. as happened in the U.K. with the Meningitis C vaccination, resulting in more deaths.

Cervarix, under development by GlaxoSmithKline, is formulated with
a lipid-based adjuvant ( monophosphoryl lipid A) whose precursors have been linked to severe autoimmune disorders.


A Glimpse into the Scary World of Vaccine Adjuvants


See also:

Armed with New Vaccines, Drug Makers Target Teenagers

Facts Behind Merck's Mandatory Vaccine Campaign to Help Pay for Vioxx

Shultzy said...

Thanks so much for your info on Gardasil. I'm 25 and almost at the cut off and have been debating if I should get it or not - I've been trying to get as much info as possible!

All medical experts now say thet cervical cancer is always caused by the HPV virus - so I think Gardasil is a step in the right direction. BUT I'm really concerned about all the negative side effects and the fact that it doesn't prevent ALL high risk types of HPV.

My mother died of cervical cancer when I was a teenager - EVEN THOUGH she had regular pap tests. The Dr told us Pap smears have a high rate of 'false negatives' which was exactly what happened to my Mum. So to rely solely on Pap's doesn't seem the best way to go in my opinion and because of my experience - I've never been confident with Pap smears.
If HPV causes cancer - then we should focus on that predominantly.

I asked my Dr to do an HPV test along with my paps and she said they don't do HPV tests in Australia as a general rule - but in many other countries they use it instead of Paps as the first screen for cervical cancer.
She also thought this was where the medical industry was heading and alerted me to a new test you can do at home called Tam-Pap. www.tampap.com
It's a DNA test so almost 100% accurate - and the best thing is YOU CAN TEST AT HOME!!! By yourself - no uncomportable prodding! All you do is use a normal tampon when you do not have your period and take it out after 10 secs. Then you send it to the pathologists in a reply paid special specimen bag! How easy is that? My results go directly to her so we can discuss all the options etc if it's positive for high strain HPV. If not she recommended I do the test once or twice a year.
She said she has recommended that all her patients who are having the Gardasil vaccine do this Tampap test first. NO POINT HAVING A VACCINE FOR SOMETHING YOU ALREADY HAVE?

So I ordered it the other day (Tampap - 1300 850 434) and am waiting for the kit to arrive - and will keep you posted! Hopefully its as simple as it sounds... cross fingers!

PS - I'm still deciding whether or not to have the Gardasil - if I do go ahead - I'll keep getting hpv tests to see if it works!!

BlueBerry Pick'n said...

“There is no Dypraxa, never was, never will be. I know of no wonder-cure for TB that has recently been launched on the African market or any other - or is about to be - so with Luck I shall not be spending the rest of my life in the law courts or worse, though nowadays you can never be sure.

But I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.”
- John Le Carré, The Constant Gardener, Author's Note, 2001.

Flu Shot: an Epidemic of Mercury?: Thimerosal & US Campaign funds...

GARDASIL® for PROFIT: Health Ontario & "CorpWatch: Merck's Murky Dealings: HPV Vaccine Lobby Backfires"

everybody worried about WHO sticks WHAT in their daughters... but not worried about whether or not the shot may permanently fuck over an entire generation of women...

you see enough of this freaky, fucked up shit & you start getting bent in the head, you know... is the EndGame or goal to kill off those of us who *aren't* freaky sex-"a-feared" religious nutjobs?

I mean... you look at how the US freaks out over any 'Muslim' country & calls them "terrorists!!"... but then turns around & says, "SWATH YOUR DAUGHTERS! modesty! modesty! its the ONLY PROTECTION for your WOMEN!"

I mean, either we're told NOBODY should get the shot, because it *encourages sex* or that *EVERYBODY* should get it.

... freaky.
I tell ya, freaky. Look @ the freaky Khristians... then look @ the Taliban...

'nuff said, there!

its enough to make you wanna just start a commune & hole up somewhere... no wonder people end up starting cults in the forest...

nobody is willing to LIVE & LET LIVE... everybody's gotta tell everybody how to live...


say what you will about paranoia... is it paranoid to think that BigPharma is out to make a bizarre profit...


Spread Love...
... but wear the Glove!


BlueBerry Pick'n
can be found @
ThisCanadian.com
~~~
"We, two, form a Multitude" ~ Ovid.
~~~
"Silent Freedom is Freedom Silenced"

Anonymous said...

My daughter (age 12) had only first dose of HPV gardasil and after reading all of this I don't plan on having her get the remaining 2 doese. Genetically engineered was the kicker for me.
I wonder if just having the first dose and not the remaining two, will let her flush it out? She has no allergies, and has had no reactions thus far.

Anonymous said...

Firstly, well done to whoever wrote this, it must've taken ages to put something like this together. And while i don't necessarily agree with all of the things said here, I can appreciate why people are so concerned, and it's a very thought-provoking read.

I know alot of people who are freaking out about the whole genetically engineered thing, but seriously, it's some revolutionary stuff they're working with here. Vaccines used to be manufactured by culturing the virus (or a part of the virus) in eggs, which is why people with allergies to eggs could not recieve the vaccine. Gardasil is done pretty differently - rather than injecting dead virus particles or small particles of the virus, it involves injecting just the protein coating of the virus, so the risk of getting hpv from the injection is seriously diminshed. And people who are allergic to egg can also recieve the vaccine.

Historically, think of the smallpox vaccine - it works by injecting the patient with the pus from a cowpox pustule - kind of disgusting. And even though there was so much public outcry in the early stages of the vaccine, immunization against smallpox has lead to the complete eradication (save for a few cultures being kept for future research) of this disease! So maybe, after this vaccine is refined, altered or improved however it may need to be, and is convincingly safe (although there will always be some risk), it will eventually lead to the eradication of these four strains of HPV.

I would also just like to add, that while i strongly support gardasil, and have myself recently recieved all three doses, i don't believe that the mandatory vaccination of all girls in grade six was a good idea. People still deserve the right to choose what injections they recieve.

Anonymous said...

i know there has been a lot of debate about the side effects of gardasil. Here in australia, many schools aren't even offering gardasil as they fear it may make the girls "promiscuous" (i don't know whether that's strictly a side effect, but still related). A while ago, when a victorian school recieved the first dose of vaccines (i think) seven girls were taken to hospital suffering severe side effects, inlcuding paralysis.

Australia was assured that this was not a result of the vaccine, but rather a result of the girls becoming worked up over the vaccine. Maybe it was, maybe it wasn't. But seriously, there are sure to be side effects from all vaccines. Take, for example, the meningococcal vaccine. When we recieved this vaccine at school, half of my class went home because they were dizzy, fainting, and i know someone who even had a panic attack.

So yes, while the vaccine does have side effects (as just about all vaccines do) the risk is fairly minimal, and often not even associated with the vaccine, but rather girls working themselves up over it.

THE EVIL SLUT CLIQUE said...

So girls who experience side effects from Gardasil are actually not having any kind of real medical issue, and are really just getting themselves "worked up" over nothing? How very...antiquated. Kinda reminds me of some other fun theories, like penis envy, or PMS symptoms being imaginary side effects of feminine 'hysteria'. Good to know that women are being taken as seriously as ever.

SassyInkPen said...

Wow - thanks so much for both of your very well informed and reasonably presented articles about this.

You've just helped one very concerned mother make an informed decision. I chose to wait and see, and to discuss all this information with my about to be 12 year old daughter so she can start to be informed about it herself.

Sassy

BlueBerry Pick'n said...

anonymous said... "REVOLUTIONARY"

ThisCanadian says, WTF?!?


yeah. say "revolutionary" to the the *victims* of BigPharma's other little oopsie mistakes.

you know. they DO make mistakes.

I'm sure you've heard of them, "Anonymous"

cuz when they screw up... they really, really screw up.

show some freaking *judgement*, people.

shmexynursey said...

these two articles were an awesome read. i'm a nursing student and I recently got into an arguement with my teacher about gardasil, because she was all for it.

so do u think those 1637 reports of adverse effects and deaths are true? if so, how come nobody has sued anyone yet?

Anonymous said...

You forgot an 11th thing: there is always the possibility of vaccine recall; as in, for example, this very recent headline: http://news.yahoo.com/s/ap/20071213/ap_on_bi_ge/vaccine_recall;_ylt=Akj85.QXoqUrxdu6TS0I9LWb.HQA, or "Merck recalls common children's vaccine". If they have to recall Hib vaccines due to a bad batch, why can't this happen with the HPV vaccine? And what of the women and girls who may have already received a possibly tainted vaccine prior to a recall? Or conversely, those who may not recieve their 'booster' shots on time because of potential production delays? (9 months on this Hib vaccine, for example MAY be too long a wait.) Just another point to ponder....

Anonymous said...

I'm basically a pro-abortion rights, bleeding heart liberal, father of two pre-teen girls.

I had Guillain Barre. Mine was caught early when I could still walk. I spent a week completely paralyzed and spent $50,000 in the ICU. It took me six months to completely recover. That's about 18 months shorter than average.

My physician tells me not to get any vaccine I absolutely do not need.

I am not against vaccinations. I am for informed vaccination programs and my wife and I discussed the various issues with our daughters physicians when vaccinations became necessary for school.

I want to thank you for both of these lists of yours. I wish it appeared higher on google's current list.

And I can't tell you how angry I am that various feminists that for a long time would say "keep the government off of our bodies" have now turned that around to demand mandatory injection programs.

I absolutely believe in "keep the government off our bodies" not just to protect abortion rights, but to protect people from mistakes like this, and from worse.

Thanks again.

Kamily said...

My 11 year old daughter is having health problems from getting the series of shots.

We have been going thru this since August:

*Flu like symptoms
*low grade fever
*fatigue
*abdominal pain
*kidney issues
*headaches
*thyroid problems
*weight gain
*no period in over a year
*rash on her face, neck and chest
*a seizure

She was a healthy and happy before getting the shots. Now she is too tired to do anything.


Shes had all kinds of blood work, EKG, EEG and an MRI. She has been
seen by 2 Pediatricians, a Nephrologist, Endocrinologist and has an
appointment with a Neurologist at the end of this month.


Every test is coming back normal. The doctors dont know what is the matter with her.

There are lots of others that are experiencing the same side effects. I wish that I had known this before she got the shots.

My younger daughter sure wont get them!!!!

BlueBerry Pick'n said...

Man, we have to *hope* that pharmaceutical products simply functions according to claims & disclaimers.




~~~
Spread Love...

BlueBerry Pick'n
can be found @
ThisCanadian com
~~~
"We, two, form a Multitude" ~ Ovid.
~~~
"Silent Freedom is Freedom Silenced"
"do no harm"

Anonymous said...

The 11th thing that people may want to know is at

http://jenjensfamily.blogspot.com/

If anyone knows of ANY cases that are comparable to this suspected Gardasil reaction, PLEASE contact the family before time runs out for Jenny.

Anonymous said...

One bad oyster? or one bad vaccine shot?

I experienced what I thought was a really bad allergic reaction on my face and neck the morning after my first time eating oysters. Now I've been eating seafood for years and never ever had a negative response. But after reading through this article - I also am reminded of how only 2 weeks prior to this awful reaction where my face and neck swelled with red, itchy welts - I had received my first Gardasil shot.

I have since been back for my 2nd shot and questioned the nurse about this random, yet serious reaction and it's possible link to the Gardasil vaccine. She left the room to consult a doctor and upon returning shared that any negative reaction to the vaccine would have occurred 24 - 72 hours after receiving the shot.

Yeah right. I can't believe I so blindly followed along with what the media and several friends encouraged me to do with little research (minus the pamphlets that the drug company conviently provided).

I will Not be receiving the third shot and hope that I can continue to live a long and healthy life with no reprecussions of this ill informed health decision. My heart goes out to all females and families that are suffering from negative symptoms with no concrete answers.

jneubs said...

2 of my 3 daughters are of age and I believe their pediatrician told them to get it and no one did any reseach. Their mom didn't have the 3rd dose done from that Dr. as she didn't want to pay $300 being charged. Meanwhile, the Dr. today wouldn't talk to me about Gardisil until I paid him for my outstanding $135 we owe him!

I can only imagine how much money his practice has made on Gardisil!

Anyway...my question...if anyone knows where I can find info is this...My girls didn't get there 3rd does until 11 months after the first @ $197 rather than $300 (still ridiculous!) and Gardisil says 2 months and 6 months as a schedule but to "ask your Dr if you missed a dose".

After much research I wouldn't get any doses, but no one asked me my opinion...just to pay the bill!

Thanks for the great info and site...can't wait to turn my daughters on to it!

Anonymous said...

Ever hear of Phen Phen?

Anonymous said...

My 17 yr old daughter has had to see her doctor this summer for un-related issues to this topic; however, EACH time we are there we are both treated to very heavy tactics trying to start her innoculations with Gardasil. She and I already did the homework and decided against it. In her words she didn't want to be the guinea pig generation for this vaccine and who knows what is in store 5 or 10 years from now? She didn't want to be someone who may be infertile or another problem that just isn't cropping up yet because there isn't enough research. That being said, she may decide to get her own daughter (when and if) vaccinated-she/we are not against this vaccination, just that there isn't enough research to justify the risk to her health at this time. Paps have been very successfully used-I was diagnosed in my early 30's with a pre-cancerous growth which was easily removed before it turned "bad"-thats what Paps do.

If you choose to do without this vacine, be prepared to fight off the doctors and nurses around you-geez, it was almost like they got a kickback it was so intense!

youareallcrazy2 said...

I've been doing some research on Gardasil and I was wondering if anyone knew what was in each dose? For example, does the 1st dose protect against the strains 6 & 11 and the 2nd against strain 16, etc. Or...are they all just mixed together?

nina said...

To the last Commenter, all subtypes are mixed in, and most people will be protected from just one dose, but to increase protection level further they repeat doses. Many other vaccines do that, such as HepB vaccine.

Now, I have just gotten my 2nd dose of Gardasil, and it hurt like hell. But two of my mom's friends have had cervical cancer, and although sucessefully treated, it was a huge ordeal for them and their family. I don't want that, that's why in September I will get my last dose, and will continue to go for papsmear every year. It's just another thing I can do to protect myself.

Yes, vaccines have side effects. Actually any and EVERY drug has side effects. That's why you always have to analyze whether the side effects are worth it, and that's what I always do, whether taking Benadryl, Aspirin, or Tylenol. To me 3 days of pain from Gardasil will reduce chances of cervical cancer by 70%. I'll endure those 3 days. (Just one more, after my arm stops hurting today. YAY!)

Always evaluate benefit vs. side effects. But don't choose cancer over temporary pain. Because trust me, the pain will go away on it's own.

BlueBerry Pick'n said...

nina:

good luck.
if your uterus rots & falls out in 20 years, don't expect a refund from the drug pusher!

kelly said...

I wished I found your blog earlier! You made pertinent info of Gardasil and Cevarix, and I would have linked to it!

They are not gonna say Gardasil is unsafe because they've spent a lot of time and money to test it, and yet the tests were filmsy!

I will be blogging more about Gardasil next and tracking back to this link. Feel free to comment in "10 facts you need to know of cancer" (one of the commenters seem to be some kind of Gardasil supporter) and also at http://www.bloggersbase.com/articles/lifestyle/sports-and-fitness/the-vaccine-dilemma-h1n1-and-others-part-1

Take care!

Anonymous said...

The sudden emergence and push of the vaccine raised red flags for me and I refused to accept the vaccine. Why are we developing vaccines if we still don't have a fully functioning HPV test? When researching the lack of an HPV test for men, a web site of one of the female HPV tests stated that men shouldn't be concerned about HPV because it will likely pass and disappear with time. A life threatening virus for women but a minor inconvenience in men? What a crock. How about instead of once again burdening women (in the case of Gardasil, young girls) with the cost and hazards of birth control and STD prevention, the pharmaceutial companies develop an HPV test for men. When I'm ready to marry I'd like to know if my future husband is infected with the virus or not. But apparently Merck and other pharmaceutical companies don't think that kind of information is important.

Anna said...

These two posts confirmed my decision about receiving the Gardasil vaccine! I'm 17 and I have always had my suspicions about Gardasil. I can't believe so few long-term studies have been done! Thank you for all the great information.

Christine said...

VAERS is a reporting system.
It catalogues the reports. it does not investigate the veracity thereof, nevermind any actual causal relationships.
Someone pulled a very entertaining stunt a while back - reported the the Flu shot had turned him into the Incredible Hulk. The report went into the database, and stayed there until someone called him to request permission to remove it. if he had not given that permission, it would still be there as a possible side-effect of the flu shot.

If you're allergic to the ingredients, don't get the vaccine. Also, if you're allergic to peanut butter, stay away from that. And while we're at it maybe people who can't drive should refrain from speeding through city streets in an eighteen-wheeler. Use a little sense, people. I actually don't get the yeast warning at all: if you have an allergy either a) you know it, in which case I hope you've done your bloody research, and anyway your doctor should be warning you about this b) you don't know it, and you're dead, because there's yeast all over the place c) you don't know it because it's relatively mild, and thus probably not worth causing panic over.

I'm with your researcher, on an even broader basis. HPV is an STI. STIs are not considered STIs if they are passed through casual contact, so you're not going to infect anyone else by accident. that makes it a private, not a public health issue, and the government has no business mandating it (as opposed to something like varicella, which could result in an entire class of children being infected or taken out of school until the infection is past.)

Nancy Kathlene said...

Ideally females should get the vaccine before they become sexually active and exposed to HPV. Females who are sexually active may also benefit from vaccination, but they may get less benefit.