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

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.

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