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I am hesitant to launch into another piece on vaccine safety and efficacy. I planned on writing about Gardisil in the future, but I cannot ignore so many emails from concerned mothers asking me to comment.
The vaccine debate is treacherous. In so many ways it is worse than being the lone liberal at a table of Bush loving conservatives—an experience still fresh in my mind!
However, the EMOTIONAL debate over vaccines is SO understandable. We are talking about our children and the what ifs? What if I do not vaccinate and my child gets cancer or what if I do vaccinate and my child is permanently disabled or worse, dies? These are monumental concerns and personal dilemmas that require…DOING SOME HOMEWORK!
By the time our children are age two, they receive 20 doses of vaccines—twice the number of Japan. By age 6, they will have received 48 doses of 14 vaccines. There is no research as to the cumulative effects. Are they truly safe? No, no vaccine is truly safe. They all have risks and cannot be treated the same.
The issue is then, not a general– “to vaccinate or not,” rather, how to “pick and choose.” Which of the vaccines are most essential or necessary? Which are most effective? Which are safe enough?
THE ISSUES WITH GARDISIL
Is it Necessary?
*There are two HPV (Human Papilloma Virus) vaccines, Gardisil (Merck) and Cervarix (GSK). As only Gardisil is recommended for boys and girls, my article is limited to Gardisil. Cervarix prevents 5 cancer causing HPV strains, but does not prevent the HPV strains that lead to genital warts. It is not approved for boys. Out of the two choices, Cevarix is seen as the better vaccine. It prevents more HPV strains and provides longer immunity.
The simple answer: the vaccine is not necessary. However, the fierce debate raging on the internet clouds logic, distracting us from seeing the obvious. I wonder if is this by design? What a strategy, because when you step out of the debate and look at the facts, the answer is clear.
Gardisil, aka the anti-cancer vaccine, claims to prevent cervical cancer– the most preventable and treatable cancer. In the US, 12,000 women are diagnosed per year resulting in 4,000 deaths. Most die because they did not get their annual non-invasive, safe, Pap Smear Test (“Pap”) which is completely reliable for detecting cervical cancer. While the CDC states, cervical is the number two cancer with 470,000 worldwide affected and 233,000 deaths, these numbers reflect developing worlds with little to no gynecological care and are highly misleading. 12,000 versus a worldwide statistic of 470,000 is enormously different.
According to Dr. Diane Harper*, HPV expert and Merck insider, “95% of women who are infected with HPV never even get cervical cancer. It seemed odd to be mandating something which 95% of infections never amount to anything. Pap smear screening is far and away the biggest thing a woman can do to protect herself to prevent cervical cancer.”
*Dr. Diane Harper is a Professor and Vice-Chair of Research at the University of Missouri-Kansas City School of Medicine, HPV expert. She was also the principal investigator for clinical vaccine trials for Merck (Gardasil) and GlaxoSmithKline (Cervarix). She is often quoted in articles and I will refer to her many times. See an excellent interview and discussion about Gardisil on Huffington Post.
As for genital warts, another form of HPV the vaccine is formulated to prevent, 80% of people are infected at some point in their lifetime. However, 70% of new cases clear naturally in the first year and 90% clear within two years. “Even persistent HPV infections caused by high-risk strains generally do not lead to precursor lesions in the short term or to cervical or other cancers in the long-term.” Genital warts, while unpleasant, never lead to cancer and most of the time can be prevented with safe sex…condoms that everyone should be using anyway.
So the two things that Gardisil prevents, one was already preventable and the other, genital warts, while a nuisance, are not life threatening and generally clear up on there own. And the truth? Gardisil cannot fully prevent cervical and other HPV related cancers (vulva, vaginal, anal, penile and oropharyngeal) because the vaccine only prevents two types of HPV that lead to cancer. These two types account for 70% of cervical cancers, but 30% are caused by other strains or types. Also, while HPV is the direct cause of cervical cancer, it is not the only cause of the other related cancers. There are many contributing factors like smoking, alcohol, oral contraceptive use, multiple births, prior inflammation, etc. As for genital wart protection, it only prevents two of the forty types of HPV strains that may lead to genital warts.
Additionally, Gardisil’s package insert clearly states it does not eliminate the need for the yearly pap. Following logic, the yearly pap eliminates the need for Gardisil! When the media and the government broadcast “VACCINATE YOUR CHILDREN FOR HPV,” (if you missed it, it was the frenzy just prior to the flu), I have to wonder, why the rush to vaccinate? I also worry about all the teens who might be lulled into a false sense of security and forgo their yearly exams or the teens who feel protected from diseases and skip the condom. For those who vaccinated, I am sorry to say, you did not do your homework.
(If you want, you can stop reading. Enough said. Clearly no need for Gardisil. Just get a Pap test and assume genital warts will clear on their own. However, based on the length of this article, obviously there is more worth knowing…even if it is just to prove my point: “do your homework”!!)
I hate to assume that money wins out over integrity, but it often feels this way when the monetary stakes are so high. Did anyone question Merck’s initial fear mongering, “one less” campaign on TV? One less girl getting cervical cancer… What mother would not drag her daughter to the closest pediatrician? Who wants to be one more?
Dr. Diane Harper, said it best, “Yes, the marketing campaign was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine. If parents and girls were told the benefits and harms of Pap screening and HPV vaccines, an informed and valued decision would have been able to be made.” How manipulative and deceptive!
A Washington Post article echoed critics of Merck’s aggressive marketing efforts– “the latest evidence that the company is pushing the vaccine inappropriately.” In a report by Sheila M. Rothman of Columbia University’s Mailman School of Public Health in New York, and David J. Rothman, Columbia’s Center for the Study of Society and Medicine, they write, “They seem to be repeating the marketing message of Merck. If the societies are just repeating the drug companies’ message they are not really educating. They are blurring the line between educating and marketing.” By societies, they mean the doctors and medical associations!
What makes Gardisil more egregious is that with each year, like politicians, they keep changing the talking points. It seems each year they do not sell enough of the vaccine, they drum up one more reason you should be vaccinated. They add more cancers the vaccine may prevent and a whole new market– boys! It is true HPV 16 and 18, the two types in Gardisil, can lead to vulva, vaginal, anal, penile and some head and neck cancers (mostly throat), but these numbers are still very small in the scheme of things. Look at these incredibly low CDC numbers for these cancers per year:
- 1,500 women who get HPV-associated vulvar cancer
- 500 women who get HPV-associated vaginal cancer
- 400 men who get HPV-associated penile cancer
- 2,700 women and 1,500 men who get HPV-associated anal cancer
- 1,500 women and 5,600 men who get HPV-associated oropharyngeal cancers (cancers of the back of throat including base of tongue and tonsils) [Note: Many of these cancers may also be related to tobacco and alcohol use.]
And again, while Gardisil prevents HPV types 16 and 18, which are the most prevalent, it is no way full proof against preventing cervical or HPV related cancers…not even close. The other HPV types are still out there and there is no proof it is effective. Most HPV related cancers take 20-40 years from infection to tumor. Let’s say, for arguments sake, 10-20 years. If the vaccine came out in 2006, it seems like we still have a way to go to see if it has truly prevented any cancers… a good gauge of effectiveness!
Is it Effective?
So instead of effectiveness tests, Gardisil trials relied on “efficacy.” Big difference! Efficacy measures the vaccines ability to stimulate a certain number of measurable antibodies.
The clinical trials proved efficacy, antibodies were produced, but for how long? How long does immunity last? Diane Harper says, only 4-5 years in girls and maybe only 2.9 years in boys, necessitating the need for booster shots and presuming people will get them. So far, Merck has not conducted any studies to evaluate the long-term immunogenicity and efficacy of needed booster shots, nor are any planned. It also means that we could all be vaccinating our children at ages 11 or 12, or as young as 9, to protect them sexually in the future, but by the time they are sexual, they are no longer immune! By the time they get the booster, it may or may not be proven effective or efficacious.
Also, the vaccine has no medicinal benefits in cases of existing HPV and shockingly, information from Merck presented to the FDA prior to approval states that “if you have been exposed to HPV 16 or 18 prior to injection and take the vaccine, you increase your risk of precancerous lesions, or worse, by 44.6%” Yet, there is no pre-screening required by the FDA and CDC!! The shot is not just for 11 and 12 year olds, but recommended for ages 13-26 as well and in 2011, the FDA approved the vaccine for women ages 27-45!!! If 80% of the population is infected at any given time with HPV, pre-screening seems essential particularly in these age groups. It appears this anti-cancer vaccine may very well increase the rate of HPV related cancers!!!! I am curious if any doctors discuss this “tidbit” prior to injection?
“If you have been exposed to HPV 16 or 18 prior to injection and take the vaccine, you increase your risk of precancerous lesions, or worse, by 44.6%”
Based on logic, seriously, why vaccinate? Why don’t the FDA and CDC, at the very least, just make a pap test mandatory instead of a vaccine? It would certainly alleviate all the fear, anger and frenzy generated by this vaccine. But oh, that would eliminate a chance to make money. The big bucks!
Gardisil is the MOST EXPENSIVE vaccine on the market. $400 for 3 shots and do not forget all the boosters at $120 a pop. The very first year, Merck made $1 billion on the Gardisil vaccine. Since 2010, even more, thanks to ACIP, the Advisory Committee on Immunization Practices, when they approved Gardisil for use in boys.
Merck’s doctors argued it was important that boys be included so that there was no appearance of discrimination. They were also concerned that not enough girls were being vaccinated…they needed to spread the responsibility of curtailing HPV, and ACIP agreed! Dr. Schudat, the director of the National Center for Immunization and Respiratory Diseases at a CDC press conference stated,
“There’s been a disappointing uptake among teen girls we reported earlier this summer. HPV vaccination of males offers an opportunity to decrease the burden of HPV related disease in both males and females. So in addition to providing direct benefit to boys by preventing future genital warts or anal cancer there is also the potential that vaccinating boys will reduce the spread of HPV from males to females and reduce some of the HPV–related burden that women suffer from.”
Or perhaps boys are an opportunity to sell off an incredible surplus of vaccines? If only 27% of girls are opting to vaccinate, sales are definitely lagging!
Yes, arguably for boys, the vaccine might prevent genital warts or the spread of warts, which will most likely clear up on their own. The vaccine might prevent HPV cancer-associated infections, which also may clear up on their own or may in some rare instances develop into cancer. However, for some perspective, Dr. Christiane Northrup, has a great point:
“It is not HPV per se that causes the cancer. It’s the immune system’s inability to fight the virus that is the issue. The rapid, widespread, and unquestioning acceptance of the HPV vaccine as “the answer” speaks volumes about our cultural misunderstanding of the root causes of health and disease.”
Without even addressing the monumental issue of safety (keep reading), I do not understand why doctors, who guide our decision making, are pushing this unnecessary vaccine for girls and now, boys?!!!!! It seems doctors need to do a little homework of their own!!!
Is it Safe?
To learn more about what the government calls “supposed” serious reactions to Gardisil, go to the truthaboutgardisil.org website. Take a look and be prepared for heart-wrenching stories and a laundry list of life altering complications. VAERs is the government agency in charge of monitoring adverse reactions or ADRs. According to VAERs, and its counterparts in England and Australia, HPV vaccines are the highest reported ADRs out of all the vaccines. In the US alone, 18,000 injuries and by some reports 68 deaths. Others claim 26 deaths just in 2010. The truthaboutgardisil.org says, 103 deaths and 21,000 injuries and counting. The big problem is VAERs is a passive reporting system. Maybe only 10% of ADRs are reported.
Also at issue– our country makes causality so hard to prove. Criteria for causality is poorly defined. Neurological outcomes or disorders take considerable time to manifest and symptoms can be individualistic. It is not one size fits all! Officially, the CDC, FDA and Merck have dismissed all significant reactions. No causal relationship was found, but unofficially, a research report by Lucija Tomljenovic, PhD of the University of British Columbia says otherwise. Dr. Tomljenovic and Dr. Diane Harper seem to be the most forward in their thoughts about Gardisil.
Dr. Tomljenovic conducted a post mortem study of two teen girls who received the HPV vaccines and died within months of injection. Her conclusion–“Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies.” Although, the CDC argued technicalities involving some research methods, the report is still quite alarming. As a parent, it is hard to dismiss, particularly when our kids begin healthy.
Interestingly, a just-released study conducted by Kaiser Permanente Vaccine Study Center seems to be in response to the growing number of adverse reactions. The study tracked 190,000 girls for only 60 days. Some received one shot, and only 44,000 received all three.
The study concluded there were no significant adverse reactions to the vaccine, only pain, swelling at site, redness, itching, headaches, nausea and an increased chance of fainting… so make sure your child who receives a vaccine is monitored for 15 minutes. They also reported that fainting generally happens in those who smoke, are obese or use oral contraception.
Merck thrilled with this news, hopes to bury the horror stories for good. For some, they did. Some are breathing a sigh of relief and accept the official findings that there is no causal link between deaths/complications and the vaccine. However, so many fail to mention this study was completely funded by Merck. It was a post licensing requirement. While it did have an independent safety review team, the study is not immune from criticism.
In an article on Bloomberg, Diane Harper is quoted as saying,“I think they truncated their conclusions. The biggest concern of all of these is neurologic that are most rare and most hard to define.” In a study she authored, “Independent scientists are publishing reports of patients who have had autoimmune demyelinating neurologic sequelae after Gardasil administration, resulting in blindness, paralysis, and death.” She singled out a rare condition known as Guillain-Barre Syndrome, in which the immune system attacks the nerves leading to paralysis. She continued, “It doesn’t rule out that any of these effects could still be coming.”
Also, I am curious as to why the study only covered adverse reactions and for only 60 days? Why not assess efficacy or effectiveness?! Isn’t that the bigger question? If it is not effective, then the vaccine isn’t necessary and the debate about safety is moot.
It seems every step of the way, so many are trying to paint this vaccine as the big “break through” in the world of cancer prevention. On the surface, if we all listen to the CDC, the FDA and our doctors, run and do not walk…go vaccinate. However, I beg you, use common sense. Why would you vaccinate? Is it effective? Debatable. Is it safe? Definitely debatable. The official/unofficial ADRs, 18,000 or 21,000, seem to compete with the approximate, 33,000 cases in men and women (according to the CDC) of HPV cancers per year! I am not a gambler, but you calculate the odds and the risk/reward ratio.
Finally, I am saving the best for last. The INGREDIENTS! Perhaps I should have started here as they are a toxic cesspool and a “conversation ender!” Aluminum, sodium chloride, polysorbate 80 (remember the one that causes infertility) L’histidine and the other glaringly alarming, sodium borate also known as roach killer. Remember, Gardisil requires 3 shots or a triple whammy of toxic ingredients!
Amorphous aluminum hydroxyphosphate.sulfate, 225mcg: used as an adjuvant to stimulates the body’s immune response to the antigens in the vaccine. Requires less antigen, making vaccine less expensive to make. Aluminum is a well-known neurotoxin that may lead to long-term brain inflammation—MS, Alzheimer’s, Parkinson, ALS. It also greatly increases the toxicity of mercury.
Sodium chloride–9.56 mcg: Raises blood pressure and inhibits muscle contraction.
Yeast protein–make sure you are not allergic to yeast!
L-histidine–seemingly innocuous, but read an article by someone like me, that raises serious, substantiated questions.
Polysorbate 80—50 mcg: A solubilizing agent that has shown to cause infertility in mice. When injected into rats it caused a rapid growth of reproductive organs, growth was abnormal and the rats were sterile, unable to reproduce. When Polysorbate 80 was used intravenously with vitamins, it has been known to cause anaphylactic shock.
Sodium borate—a common roach killer!!!!! Considered harmful to development.
On top of this toxic brew, Merck did something really shady in their clinical trials. According to the National Vaccine Information Centers, the FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo. Simply, they compared those vaccinated versus a control group who received a placebo, mixed with aluminum.
There were reactions…duh, but since the reactions in both groups were near similar, they concluded that the vaccine was safe. Side effects were simply because of injecting a needle and not because aluminum can make you sick. They dismissed 102 adverse events in 21,514 women and children who received the vaccine or the aluminum containing placebo. (Aluminum is a huge toxin and warrants a whole separate post–one for my “to do” pile!!)
Also, please be aware, according to the 2012 Gardisil package insert, “Gardisil has not been evaluated for the potential to cause carcinogenity or genotoxicity.” A.K.A.–Gardasil is marketed as a vaccine that prevents cancer, but the drug has not been evaluated for the potential to cause cancer or genotoxicity (damage to the DNA)!! Not to be repetitive from my previous article on the influenza vaccine, but WTF??? So we are to believe it is an anti-cancer vaccine, but it is not known whether the anti-cancer vaccine can cause…cancer? How horrifically ironic!! This is so typical of western medicine. Rather than look at the whole body, doctors treat one issue with a pill that may resolve that issue, but then create a whole set of other issues!!! However, we are not talking about medicinal treatments, rather preventative treatments in otherwise healthy children!
For the best scholarly review of Gardisil, read the paper by Lucija Tomljenovic, PhD, and Christopher Shaw of the University of British Columbia entitled, “HPV Vaccine Policy and Evidence-Based Medicine: Are they at Odds?”
They make one think about–
Australia and Britain both require informed consent. The United States does not. How can the FDA or Merck not mandate that everyone be pre-screened for HPV? Remember, for those already infected, the vaccine does nothing to help, but could hurt by increasing the risk of cancer. Why do our doctors not pre-screen us for any family histories of ADRs, sensitivities, or reactions to different substances that may be triggered by the vaccine? How can states like California enact laws allowing Gardasil to be administered to children 12 years old and up without parental consent? Why is there no Federal mandate for annual Pap screen tests? Why the rush to vaccinate?
I hope people are starting to realize the need to question. By relying on our government and doctors, which most of us do, the Gardisil vaccine seems safe and effective. But, obviously there is controversy, and controversy should NEVER be ignored. In fact, it should raise all antennae that there is likely much more!
So picking and choosing in the world of vaccines becomes an exercise in discernment– that little feeling in the gut that acts as a beacon guiding us toward the truth. Yes, it is a matter of trusting, but it is so much easier to trust your instincts when you have gathered enough information.
Thanks for your patience. You made it to the end! I promise future posts will be shorter for your sake and mine!!!
UPDATE JUNE 2013:
Japan Withdraws HPV Vaccine Recommendation for Girls due to high rates of severe adverse reactions.