Tuesday, September 27, 2011

How to be "ONE LESS": The Truth About Gardasil

Thanks to Michelle Bachmann and her giving Rick Perry the ole "one-two" during the Republican Debate, the Gardasil HPV vaccine has been pretty big in the news lately. Rick Perry, the Governor of Texas, is attempting to run for POTUS 2012.

So what's the real deal on the HPV vaccine?

There are two different HPV vaccines. The one most known to myself, Gardasil, is manufactured by the pharmaceutical company Merck and is distributed in the United States. According to official product information, “Gardasil is the only cervical cancer vaccine that helps protect against four types of human papillomavirus (HPV): two types (16 and 18) that cause 70 percent of cervical cancer cases, and two more types (6 and 11) that cause 90 percent of genital warts cases.” The manufacturer states that Gardasil is for girls and young women ages 9 to 26. It is also being used on boys and young men ages 9 to 26 for the "prevention" of anal cancer and genital warts. {from fda.gov}

The other HPV vaccine, Cervarix, is manufactured by the pharmaceutical company GlaxoSmithKline and is distributed in Europe, Austraila, and the Phillipines. It is indicated for the prevention of cervical cancer caused by HPV types 16 and 18. It is approved for the use in females ages 9 to 25 years. It is not administered to males. {from us.gsk.com}



Let me introduce you to Dr. Diane Harper. She holds a Masters Degree in Public Health, Harper is a Professor and Vice-Chair of Research at the University of Missouri-Kansas City School of Medicine, specializing in Community and Family Medicine, Obstetrics and Gynecology, Bioinformatics and Personalized Medicine. She is also a "principal investigator (PI) for clinical vaccine trials" for both Merck and GlaxoSmithKline.

In an interview published in Dec. 2009 with Marcia G. Yerman, Dr. Harper explains what her role as the PI for both pharmaceutical companies entailed.
“Principal investigator means that I was responsible for assembling a research team to recruit participants, deliver the health care during the study, collect biological specimens at the correct time, and retain subjects over the entire time frame of the study. After the data collection is complete, I have a professional/medical/clinical obligation to review the data for interpretation, comment and publication. There are instances when industry will exclude a PI from participating in the data publication process. In total, for Merck and GSK, our team enrolled and followed nearly 3000 women in these studies. We have been participating in these trials as early as 1997 when the first protocols were written.” {from empowher.com}
This lady was basically the big fat cherry on top of my research sundae. She is an international expert in HPV science, vaccines, clinical disease and treatment. She has had women come from all over the world to consult with her and has personally seen tens of thousands of women with abnormal Pap smears. If anyone knows their stuff it is Dr. Harper.

Let's take a look at what statistics Merck cite that cause a fear of HPV and cervical cancer and entice a person to use Gardasil. {from Gardasil.com}
  • Each day in the United States, 30 women are diagnosed with cervical cancer (about 11,000 women per year) and 11 women die from it. 
  • Essentially all cervical cancer is caused by HPV.
  • HPV also causes genital warts and other types of cancers. 
  • 75-80% of men and women will be infected with HPV sometime in their life. 
  • Gardasil protects against 2 types of HPV that cause 75% of cervical cancer. 
  • Gardasil protects against 2 types of HPV that cause 90% of genital warts. 
  • Due to no mention of boosters or limited protection Merck infers that Gardasil will last a lifetime. 
The first three bullets are absolutely true. The fourth statistic while true, is misleading because there are over 150 types of HPV. Over 100 of these are completely harmless types that cause typical warts on the hands and feet. Twelve (12) are "low-risk" because they are not known to cause cervical cancer but do cause genital warts or very minor cell changes of the cervix. Thirteen (13) others are considered "high-risk" because they cause abnormal cells which may gradually develop into cervical cancer if not removed. {from hpv information.com} In addition to this, 95% of HPV cases are cleared naturally by the body with no treatment whatsoever. {from Dr. Diane Harper} Included in those that naturally clear the body are the great majority of high-risk HPV infections. {from National Cancer Institute} This means that in all only 5% of HPV infections will progress to precancer.

After all this, Merck would still have you believe that Gardasil is the best way to prevent cervical cancer. It is true that types 16 and 18 cause cervical cancer and that types 6 and 11 cause genital warts, but does the vaccine provide adequate protection against those types? Diane Harper's studies on Gardasil's efficacy reveal that the vaccine ONLY protects against HPV 16 and ONLY for 5 years!! {from Dr. Diane Harper}
"Even if a person receives the Gardasil vaccination at a young age, it has not been shown that this will prevent development of cervical cancer during adulthood. Even though girls and women of ages 9 to 26 can receive the vaccine, cervical cancer is rare in females younger than 30 years of age, as shown in Figure 3; the median age of cervical cancer diagnosis is 47 years (Centers for Disease Control and Prevention, "Cervical Cancer Rates by Race and Ethnicity"). However, Merck has not of yet demonstrated whether receiving Gardasil at an age between 9 and 26 can reduce cervical cancer rates in women of that age group. Furthermore, of the 79% of women who will be infected with HPV, about 90% of women will not develop cervical cancer due to the strength of their natural immune response; as of now, it has not been determined who will actually benefit from the Gardasil vaccination, making it necessary to conduct clinical studies that involve a long-term follow up with those who get vaccinated." {Centers for Disease Control and Prevention, "Genital HPV Infection – Fact Sheet"; Haug, 2009}

If you are going to get the Gardasil vaccine you should get it within the first year of sexual activity (and at least within the first 6 years) to provide the most protection. Studies show that "if vaccination occurs within one year of the onset of sexual activity, there will be 57/1000 cases of all [precancer and cancer] types and persistent HPV 16/18 infections prevented, as compared to only 17/1000 cases prevented if virgins are vaccinated." {ibid}

Not only is Gardasil not as effective as they would have you believe, but it is also more dangerous than they would have you believe. Gardasil was introduced in 2006. That was only FIVE years ago. We know little to nothing about this vaccine. Not only is it so so new, but Merck has only done ONE study before handing these shots out when they are supposed to have at least THREE studies on adults before administering a drug to children. This one study states "from June 2002 through May 2003, we enrolled 12,167 women between the ages of 15 and 26 years at 90 study sites in 13 countries in our ongoing double-blind, placebo-controlled, randomized trial." {from nejm.com} Half of those were given the Gardasil vaccine and the other half were given placebos (*note: the placebo itself contained aluminum). Additional studies were preformed by the FDA with approximately 17,000 participates.

The CDC states that as of June 2011 approximately 35 million doses of Gardasil have been administered. {from cdc.gov} Let it be known that each person is supposed to receive 3 shots to complete the series, though not every person finishes the series. With a total of 3,166 serious adverse events (SAEs) to date the incidence rate is 9/100,000. According to the National Cancer Institute there are expected to be over 12,000 cases of cervical cancer in 2011 which makes the incidence rate 11.7/100,000. That may or may not seem like a fair trade to you, but there are some other things you need to know.

The incidence rate of cervical cancer found in those who get pap-screening is 7/100,000. The incidence rate of cervical cancer in those who are only vaccinated with Gardasil is double - 14/100,000. {from Dr. Diane Harper} Add on top of this the fact that cervical cancer typically develops very slowly and can be detected as a precancer, known as dysplasia. Dysplasia can be detected with a pap smear and is 100% treatable. {National Library of Medicine}

What type of vaccine injuries can occur with Gardasil? "The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program that collects information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States." It is important to know that events reported to VAERS may not be directly related to a vaccine, but you should also know that "'underreporting' is one of the main limitations of passive surveillance systems, including VAERS. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. {from VAERS} The CDC considers severe adverse reactions to include hospitalization, permanent disability, life-threatening illness, congenital anomaly or death. As of June 2011 there have been 18,727 reports of adverse events; of those 3,166 are considered severe. Those events break down as follows:

70 Deaths
330 Life Threatening (which includes many deaths that are not reported as such)
552 Permanently Disabled
972 Hospitalized
197 Hospital Prolonged
1,045 Emergency Room Visits

This may seem like a small number compared to the 4,000 women who die every year from cervical cancer, but according to the American Cancer Society regular pap screening is a proven solution to cervical cancer, and the only absolutely sure way to be "one less." Not to mention that you, or your child, can also be one less vaccine injury.


After everything you have now read it is understandable why Michelle Bachmann was creating such a stink about the vaccine. In 2007, Perry issued an executive order mandating that Texas girls receive the HPV vaccine. One would like to think that this would be because he genuinely cares about the health and welfare of Texan girls. One would also think that he would take the time to learn any and everything he can about the vaccine he is trying to mandate, or maybe he has a hidden agenda. Let's see here, as usual there seems to be a connection between Merck (the pharmaceutical company who manufactures Gardasil) and Rick Perry (just another dirty politician). What is the link you may ask?

History shows that pharmaceutical companies are continuously bankrolling efforts to press more and more vaccines. Merck was (and still is) "bankrolling efforts to pass state laws across the country mandating Gardasil for girls as young as 11 or 12. It doubled its lobbying budget in Texas and has funneled money through Women in Government, an advocacy group made up of female state legislators around the country." {from the Washington Post}

Well wouldn't you know it, "Perry has ties to Merck and Women in Government. One of the drug company's three lobbyists in Texas is Mike Toomey, Perry's former chief of staff. His current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government. The governor also received $6,000 from Merck's political action committee during his re-election campaign." {ibid} So far, Merck's political action committee has contributed $28,500 since 2001 to Perry's campaign. {from latimes.com}


Now, you have a decision to make. There is so much more about the Gardasil vaccine that I couldn't even fit into this blog. So much more that we still have yet to even discover. What will you do? Is it worth the risk?