interesting blog:http://evilslutopia.blogspot.com/2007/05/gardasil-2.html1. 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.
