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WHITE PAPER: Gardasil, the Cervical Cancer Vaccine: Carefree Cure or Cause for Caution? By Larry Scherwitz, PhD

 
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On June 8, 2008, the Food and Drug Administration (FDA) approved Gardasil, a vaccine created by the pharmaceutical giant, Merck, to protect girls and young women from specific human papillomavirus (HPV) strains that can lead to 70% of cervical cancer cases.(1) Since receiving approval in America and many European countries, tens of millions of females between ages 11 to 26 have been vaccinated with Gardasil. At this time, state legislators are considering campaigns to make Gardasil widely available if not mandatory.(2) While most who have received the vaccine are symptom-free, a growing number of desperate mothers believe in their heart and soul that Gardasil has caused their daughters’ serious, chronic—and sometimes life-threatening—adverse reactions.

Committed to helping and de-coding the contradictions between Merck’s scientific studies and those who are suffering serious side effects that seem to be linked to the vaccination, EmpowHer is presenting this white paper. The intention of EmpowHer is to act as a lightening rod and advocate for action if there are enough adverse cases reported. With this in mind, we are inviting you to let us know of young girls and women whose health has suffered following Gardasil injections.

This white paper will give you a glimpse into both sides of the story, plus related links and references to a wealth of media, personal stories, scientific studies, and governmental agencies. In this way, we are inviting you to be empowered, and to get informed, connected, and involved.

Victoria’s Story
“I can’t believe you’re calling me,” Jodi Speakman told Michelle Robson, founder of EmpowHer.

Michelle had called Jodi in response to a comment Jodi posted on EmpowHer on April 13, 2009.

”I’m desperate for information about the Gardasil vaccine and my daughter’s many adverse reactions to it,” Jodi said. “We’re searching. We’re trying to figure this out.”

What Jodi was trying to figure out was a litany of symptoms her now 17-year-old daughter, Victoria, had been experiencing since receiving her second injection of Gardasil two years prior. These ranged from diarrhea, nausea, non-epileptic seizures, tingling, and migraines, to joint and back pain, memory loss, intermittent leg and facial paralysis, and chronic fatigue. Formerly a healthy, happy, involved teenager, “she has not been in school since April 2008,” wrote Jodi. “My daughter can never be left home alone. She can't go to school, go out with her friends or work. She has very few good days and always says she doesn't feel good. Help!(3)

Victoria isn’t the only teenager to experience serious adverse reactions following a Gardasil vaccination. In fact, her mother, Jodi, has been in close contact with 13 other mothers whose daughters have reportedly acquired symptoms after injections of Gardasil that seriously impaired them.

Even more confounding are the results of many medical and diagnostic tests the girls have undergone, all of which ruled out a variety of diseases; at the same time, no common cause was found that could explain why these young ladies got so sick following an injection of Gardasil. In the same light, after experts at the Centers of Disease Control (CDC) examined adverse reactions across the country, it reported no evidence of a pattern that links Gardasil to adverse events.(4)

Knowns, Unknowns

The development of the first vaccine to prevent cancer is believed to be a medical, scientific, and technological breakthrough. Before the Gardasil vaccine was provided for public use, nine clinical trials were conducted to test it. In total, the studies included more than 20,000 subjects in at least 13 countries and 90 clinical testing sites, and the results were consistently positive in terms of efficacy and safety. Indeed, Gardasil has shown an amazing degree of value, particularly for reducing HPV infection rates (for four strains), as well as eliminating genital warts.(5, 6) The research designs were simple and straightforward; statistical methods were well-chosen; articles published in top medical journals were well-written; and the results were convincing enough to obtain approval from the FDA and CDC.

Because of such excellent evidence, those who are certain that Gardasil is the cause of their, or their daughters’ adverse reactions, and who, in turn, want to protect other girls from a similar fate, have their work cut out for them—especially given the vaccine’s widespread dissemination and acceptance by many medical professionals.(2)

While Gardasil is viewed as an encouraging breakthrough for preventing specific types of cervical cancer, there are several reasons to remain skeptical about its unlimited and universal use: First, most (about 65%) of HPV infections are successfully fought off by the body’s immune system within a year of exposure.(7) Secondly, Gardasil prevents infection from only four of some 30 to 40 strains of the HPV virus. While the four strains for which Gardasil is effective account for the majority of cervical cancers (and genital warts), there is no guarantee that the 30 to 40 other strains will not manifest and perhaps “compensate” by becoming more prevalent.

As worrisome, we do not know whether the vaccine will remain effective for more than 10 years; nor do we know the long-term side effects of this vaccination. In response, the Centers for Disease Control (CDC) is keeping close tabs, while the FDA has an “Adverse Reactions” site so it can collect data on girls and women who have received the vaccination.(8)

EmpowHer Support: Next-Step Considerations

Is turning Gardasil into a “must-have injection” for millions of young females more than a marketing coup for Merck? As we’ve seen, proponents laud its merits: a bright light has been shed on cervical cancer and prevention; it can prevent genital warts caused by other viral strains; and it is the first vaccine that may, indeed, prevent certain viruses from manifesting as cervical cancer, a dreadful disease that is global killer. Critics, however, have a different a perspective. A sampling:

• How long will the protection last? If it wanes after, say, three to five years, will a 12-year-old who has been vaccinated need to receive a booster?

• Is the vaccine really necessary in the West, where cervical cancer is almost always preventable through regular pap smears?

• With a clinical trial on the vaccine that lasted five years, Merck didn’t take the time to test for possible side effects that could become apparent—both short-term and over a longer period of time.

“With so many essential questions still unanswered…we should concentrate on finding more solid answers through research…rather than base…decisions on yet unproven assumptions,” states The New England Journal of Medicine.(9)

EmpowHer agrees. So, too, do Jodi Speakman, who is leaving no stone unturned to help her daughter, and Michelle Robson.

“Jodi’s article gave me the opportunity to pick up the phone and I wasn’t going to pass it up.”

With this in mind, we are inviting you to share your stories and experiences with Gardasil as a way to support women and girls who have experienced adverse symptoms since receiving the vaccination. Here are some options:

1. Post some basic facts on EmpowHer, such as dates of injections and symptoms, whether the problem has resolved, what has been helpful, and your ideas about why you think you or your daughter were susceptible to the vaccine.

2. Below, post insights into both the physical and emotional impact Gardasil has had on you and your family and how you have sought and found support that could be helpful to others.

3. If the adverse effects have been severe, consider submitting an on-line report to the FDA.

4. In these ways, you can help EmpowHer help you solve the mystery of why so many young and healthy girls and women suddenly get severely and chronically ill after receiving injections of Gardasil.(10)

The “Links and Resources” section that follows can give you yet more information about the growing group of those radically opposed to Gardasil, particularly in response to the new state statutes that are making it mandatory.

References, Notes, Links
1. Z.G. issue, "Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions." N Engl J Med. 356, 19 (2007): 1915-27.
2. http://www.ncsl.org/IssuesResearch/Health/HPVVaccineStateLegislation/tabid/14381/Default.aspx
3. Jodi’s story of Victoria has been reported in other media and she has been a leader in a Yahoo Group of several mothers with daughters having similar serious neurotoxic adverse reactions following injections of Gardasil. I have reviewed 11 cases and see sufficient similarities to justify further efforts to get a consistent core of facts on each case and see if we can find a pattern that would explain the cause of illness.
4. The justifications for Gardasil’s continued use are contrasted with petitions signed by impassioned true believers it caused all the unexplained adverse reactions; they want it taken off the market. The jury is still out on whether to halt further use. Most of all we urge you to report any cases in your family where a young woman was vaccinated with Gardasil and had an adverse reaction. We need the number of cases to get the Center for Disease Control to review the evidence.
5. L.A. Koutsky, K.A. Ault, C.M. Wheeler, D.R. Brown, E. Barr, F.B. Alvarez, L.M. Chiacchierini, and K.U. Jansen, "A controlled trial of a human papillomavirus type 16 vaccine." N Engl J Med. 347, 21 (2002): 1645-51.
6. L.L. Villa, R.L. Costa, C.A. Petta, R.P. Andrade, J. Paavonen, O.E. Iversen, S.E. Olsson, J. Hoye, M. Steinwall, G. Riis-Johannessen, A. Andersson-Ellstrom, K. Elfgren, G. Krogh, M. Lehtinen, C. Malm, G.M. Tamms, K. Giacoletti, L. Lupinacci, R. Railkar, F.J. Taddeo, J. Bryan, M.T. Esser, H.L. Sings, A.J. Saah, and E. Barr, "High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 l1 virus-like particle vaccine through 5 years of follow-up." Br J Cancer. 95, 11 (2006): 1459-66.
7. E.L. Franco, L.L. Villa, J.P. Sobrinho, J.M. Prado, M.C. Rousseau, M. Desy, and T.E. Rohan, "Epidemiology of acquisition and clearance of cervical human papillomavirus infection in women from a high-risk area for cervical cancer." J Infect Dis. 180, 5 (1999): 1415-23.
8. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm?s_cid=rr5602a1_e
9. http://content.nejm.org/cgi/content/full/356/19/1991
10. Please share with us your experiences. It is only through numbers that we can convince the epidemiologists at the CDC that there is a problem with Gardasil. Conversely, it is only by the lack of numbers and the likelihood of coincidence that we can know whether Gardasil is safe. Presently, Gardasil’s use is widespread and it is being advocated for boys, which may be alarming to some, but it makes sense if it can stamp out the epidemic.

Helpful Resources

1. The Centers for the Disease Control and Prevention (CDCP) is the national agency responsible for monitoring and evaluating diseases and conditions. CDCP’s task is to collect data and generate statistics on adverse events related to Gardasil and other vaccinations. Its website, www.cdc.gov, contains much useful information and credible reporting of research.

2. To search for more information on Gardasil, enter “Gardasil Adverse Reactions” on the CDCP Web site, and follow the links.

3. Here’s a Web site with good general information on Gardasil. The CDCP claims it is monitoring the adverse reactions and that their last review showed no pattern linking adverse events to Gardasil.

4. Judicial Watch is a conservative, non-partisan educational foundation that performed considerable digging on the Gardasil issue and issued a report that you can find by clicking this link.
The links share documents that Judicial Watch uncovered after invoking the Freedom of Information Act. This includes a copy of individuals’ adverse events. The site also provides links to news stories, and even a full text of the Phase 3 clinical trial published in the New England Journal of Medicine.

5. Rick Fontana, a concerned father of two young daughters, wrote an informed letter of passionate concern to the regional immunization leader in British Columbia, Canada, when he found out that it would be launching a Gardasil vaccination campaign. He did considerable research and provides a linkable biography with many sources, including second thoughts about the widespread use of Gardasil.

Larry Scherwitz, PhD, is a behavioral scientist who specializes in mind-body medicine and reversing heart disease and obesity through lifestyle changes. He has conducted research on studies published in prestigious medical journals, ranging from The Journal of the American Medical Association to The Lancet; he is also co-author of The Enlightened Diet: 7 Weight Loss Solutions That Nourish Body, Mind, and Soul. Call him at 415.810.7874, or visit him at www.Enlightened-Diet.com to learn more about his Whole Person Nutrition Program for wellness, weight loss, and heart-health; and his coaching programs and books.

Add a Comment32 Comments

Comments were directly specifically to me in the prior post and since people choose to keep posting as anonymous it can become unclear as to the thread of the conversation in instances such as this. Obviously there are others viewing this site, it just makes it much easier to carry on a thread when people are willing to register and become part of the group.

August 20, 2009 - 10:28am
EmpowHER Guest
Anonymous

Bonnie, not all comments are directed to you. Link is demonstrative of what has been in the news for the last two days. You are not the only one who read this article.

August 20, 2009 - 9:41am

Not sure what the purpose of the link is other than as informative for other readers. There is nothing new in this article than what has already been said. What is reiterated however, is that parents need to do the research and become informed. Frankly, this is true of any vaccine your child receives and not just Gardasil. I wonder how many people now questioning Gardasil investigated the other vaccines their children received.

August 19, 2009 - 6:12pm
EmpowHER Guest
Anonymous

http://abcnews.go.com/Health/CancerPreventionAndTreatment/story?id=8356717

August 19, 2009 - 5:58pm

It is so very unfortunate that anyone have to experience these symptoms. As a number of these posts are listed as anonymous I have no idea if I am responding to one or several people so I will make my statements general.

Most parents would like to believe that their daughters are not having intimate relationships at such an early age but many are. This is why the vaccine is recommended to begin at 9 in the hopes that the protection would be "in place" once beginning intimate relations. Unfortunately too much information is not provided which leads to assumptions and further dissemination of incorrect information.

One of you said "many won't be having sex for another 5 years". This is another misconception. You do not have to engage in sex to contract HPV. What we (back in the day) would refer to as "petting" with skin to skin contact is all that is required for transmission of the virus. There is also increasing research showing that foamites (inert objects) are capable of transmitting the virus. One study has not ruled out kissing as the means of transmission of HPV induced oral cancers.

It was also stated that cervical cancer occurs in a woman's 60's. This is not true. The peak incidence of CC is in between 34 to 54. However larger numbers of younger women in their 20' and 30's are now getting CC. And it's not just cervical cancer. HPV also causes vaginal, vulvar, anal, lung, head/neck and oral cancers. The more research being done the more cancers are being linked to this virus and it has moved past the "sex" arena.

It was also mentioned that women get CC without HPV, true, about 0.3%. 99.7% of cervical cancers ARE caused by HPV. As for the comment that Gardasil is to prevent HPV and not cervical cancer is a moot point. If HPV causes 99.7% of cervical cancers and Gardasil can help prevent against the strains that cause 70% of those, then yes it does prevent (indirectly) cervical cancer and every other cancer those two strains may cause.

I haven't seen any "scare tactics" utilized regarding the vaccine and would be interested to know where they can be found. Just as dangerous as potential side effects can be with any vaccination, what is just as dangerous in my opinion, is the dissemination of erroneous non-fact based information spread for the purpose of alarming people. Many of the comments above do just that. CC is STILL the second leading cause of death worldwide among women.

Someone questioned me about Merck continuing testing on the vaccine and that they're not sure that's true. Why don't you do some research and find out the true information. Merck has all of these reports available and all you have to do is contact them. You can look at the statistics, when these studies were performed and where and a host of other information. Then make your decisions, but not based on what someone thinks is true. You have to know it to be true, or not. Becoming educated and your own best advocate is my primary purpose regarding HPV. Sometimes it means taking the time to research these things ourselves since many physicians are ill equiped to provide accurate information either.

Whoever said HPV is preventable in other ways simply does not have the facts, yet is presenting this as such in her post. If she is referring to celibacy, men asymptomatically transmit HPV to women, this is how we get it. There is no test for men and so how do you determine if you celibate daughters future husband has HPV or not? You can't. And given the fact that 80% of sexually active adults will have acquired HPV it's more than likely he WILL have it and pass it along to your daughter even if she remained celibate. As for condoms, they can reduce but not prevent transmission of HPV. The most appauling comment above is "many women who get cervical cancer do not have HPV" These "many women" only equate to, as mentioned earlier, 0.3%. This is misleading without providing the true and accurate facts.

And while CC may not be an epidemic in this country it is not only an epidemic but the #1 cause of death in many under developed countries throughout the world. In the US, new cases of dysplasia/cancer occur at rate of approximately 300,000 a year. That is more than the number of lung cancers diagnosed annually in this country.

I understand peoples upsetment, especially as a parent of a young daughter myself. However, having dealt with the ravages of HPV and what it can do to a person it is all about weighing the risks after becoming informed. I just completed radiation therapy, brachtherapy (two days ago) which is radiation seed implants and have another course of chemo to go. I certainly would not want my daughter to experience any of THIS!

August 19, 2009 - 1:10pm

Oh Anon, girls that age are sexually active.

The thing is that it doesn't protect against all strains, just like flu shots.

August 19, 2009 - 11:35am
EmpowHER Guest
Anonymous

Bonnie, you mentioned in a previous post that Merck continues to test Gardasil. I'm not sure that that's true. I've heard that they stopped the medical studies. I don't believe they tested long enough. They should have tested Gardasil for many, many years before giving it to our daughters. I'd like to find out for sure if they are doing medical studies. It seems to me that they're only interested in making big bucks, so I'd be surprised if they're still studying things like side effects of Gardasil.

Also, why the rush to get 11 and 12 year olds vaccinated? Many won't be having sex for another 5+ years, and we don't even know if Gardasil is effective for that long.

There are still so many questions about this drug. I don't see why we're rushing to give it to our young girls. I don't even know for sure if it causes infertility. Does anyone?

August 19, 2009 - 11:28am
(reply to Anonymous)

I agree with Charlotte - and it's really appalling, in my opinion, that girls are becoming sexually active as young as 11.

On the other hand, I also don't like to see us rushing to vaccinate our young girls, preferring better parenting and sex education. It's as though we're telling our girls that we'll vaccinate them so that it would be okay to go ahead and have sex so early on - okay, maybe an exaggeration. But, that's how it looks to me, and I'm simply opposed to 1) vaccination this young, and 2) sex this young (it's an act that carries a great deal of responsibility, after all!).

August 22, 2009 - 3:39am
EmpowHER Guest
Anonymous

Thank you all for your thoughts and information. I received the 1st injection in mid July and have not experienced unusual side effects. I pray that I never do. My heart goes out to the families with daughters who've experienced such awful side effects. I felt as though my gynecologist practically forced me to have the 1st injection at my yearly exam; she was so adamant that I get it before I turn 26. On this site alone, I've read enough to decide I will refuse the next 2 injections. I appreciate that I found comments from both sides here. Thank you all so very much.

August 19, 2009 - 11:16am
EmpowHER Guest
Anonymous (reply to Anonymous)

There have been quite a bit of reports of precancerous lesions and positive HPV results on girls who have had the Gardasil. Even on those who had not experienced any side effects initially. Some were positive soon after vaccination and others learned of it 2 or 3 years later. Something to watch out for.

September 26, 2009 - 8:01pm
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