DC Department of Health Budget Committee Hearing – May 5, 2011
Submitted by Emily Tarsell
My name is Emily Tarsell and I am here again this year as a mother, consumer and concerned citizen to oppose mandatory vaccination of children with the HPV vaccine Gardasil. In fact, I would argue that all sales of Gardasil should be suspended based on testimony presented today.
My 21 year old daughter, Christina, my only child, died in June 2008, 18 days after her third injection with Gardasil. We have expert opinion that Chris died from an autoimmune response to Gardasil.
You may recall I previously testified that we were deceived by false advertising touting Gardasil as a vaccine that was safe and effective and would prevent cervical cancer. We were also not told of possible serious side effects. This knowledge would have prevented her death.
So now almost three years later, are consumers being adequately educated to make informed decisions regarding Gardasil? The answer is NO.
The DC Information statement for qHPV (1) and the CDC information sheet on Gardasil (2) both allege that Gardasil “can prevent most cases of cervical cancer” as well as “vaginal and vulvar cancer” and that “the vaccine is expected to be long-lasting.” These are not true statements. We just heard Dr. Lee’s well documented testimony that the duration of HPV effectiveness is about 4 years and there is no evidence Gardasil will prevent cervical cancer.
With regard to risk, information sheets say that the risk of a serious injury is very small and would occur “within a few minutes to a few hours after vaccination.” This is untrue and misleading. Dr.Yehuda Shoenfeld reports in The Journal of Autoimmunity that “vaccines can induce….inflammatory condition and overt autoimmune disease.” Furthermore, he reports such events were documented “weeks and even months and years following vaccination.” (3) We heard Dr. Lee testify that anaphylaxis following HPV vaccinations were reported to be 5 to 20 times greater than those occurring from other childhood vaccines (4). Additionally, the FDA has reported that there are three times as many Adverse Event (AE) reports for Gardasil than there are for all other vaccines combined (5). And even though only about a tenth of the cases get reported, there are now 21,000 AEs including almost 9,000 ER visits, over 2,000 hospitalizations and 94 deaths.(6)
But there is more reason for concern. In June 2009, the FDA approved the addition of “Respiratory, thoracic and mediastinal disorders” including “pulmonary embolus” and “seizure-like activity” to the package insert Warnings and Precautions section for HPV vaccine (Gardasil) (7). Current information sheets and ads about Gardasil do not disclose these risks to consumers. (2).
The truth is out in France though. In August of 2010, the Director General for Safety of Health Products found Merck’s claims of efficacy to be unproven and the claims that it will prevent cervical cancer to be unfounded. The French have forbidden Gardasil ads in their country (8).
They are also onto the truth in India. Following reports of serious illness and death and reports of unethical marketing practices, Gardasil was pulled from the market in India in April 2010. (9,10)
In February, 2011, the FDA finally denied approval of Gardasil for women over the age of 26 because the efficacy of the vaccine was not studied in this group (11). However, as Dr. Lee has testified, they have not yet acted responsibly regarding young girls because the efficacy and safety of Gardasil were not studied for those under the age of 15 either.
Consumers are not adequately informed perhaps because the evidence is clear. The risks of HPV vaccination with Gardasil outweigh the benefits (12). There is no justifiable reason to continue to mandate Gardasil for school children. It is expensive, unnecessary and potentially dangerous. We now know there are less costly, more effective, less invasive and far safer ways to prevent cervical cancer. No one ever died from a pap smear.
1. Government of the District of Columbia Department of Health. Human Papillomavirus (HPV) Information Statement. January 2011.
2. CDC. Vaccine Information Sheet: HPV Vaccine- Gardasil. March 30, 2010. http://cdc.gov/vaccines/pub/vis/downloads/vis-hpv-gardasil.pdf. Accessed April 30,2010
3. Shoenfeld Y,Agmon-Levin N. ‘ASIA’ – Autoimmune/inflammatory syndrome induced by adjuvants. Journal of Autoimmunity (2010), doi:10.1016/j.jaut.2010.07.003.
4. Brotherton JML, Gold MS, Kemp AS, et al. Anaphylaxis following quadrivalent human papillomavirus vaccination. CMAJ. September 9, 2008; 179 (6): 525-533.
5. Slade BA, Leidel L, Vellozzi C, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009; 302 (7): 750-757.
6. Updated VAERS Reports – HPV Vaccines. http://www.SaneVax.org. Accessed April 30, 2011.
7. Vaccines, Blood and Biologics, Division of Vaccines and Related Products Applications. Approval Lettter-Gardasil. June 9, 2009. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165132.htm. Accessed April 30, 2011.
8. Legifrance gouv.Le Service Public De La Diffusion Du Droit. Decision du 31 aout 2010 interdisant une publicite pour un medicament mentionnee a l’article L. 5122-1, premier alinea, du code de la sante publique destinee aux personnes habilitees a prescrire ou delivrer ces medicaments ou a les utiliser dans l’exercice de leur art.
9. Dhar A. Groups write to Azad on HPV vaccine trial. The Hindu. April 8, 2010. http://beta.thehindu.com/news/national/article392111.ece. Accessed April 30, 2011.
10. Sarojini NB, Srinivasan S, Madhavi Y, et al. The HPV vaccine: science, ethics and regulation. Econom Polit Weekly. 2010; 45 (48): 27034.
11. Teichert E. FDA rejects Merck’s Gardasil for women over 26. Fierce Vaccines. April 7, 2011. http://www.fiercevaccines.com/story/fda-rejects-mercks-gardasil-women-over-27/2011-04-07. Accessed April 30.2011.
12. Attkisson S.Gardasil Researcher Speaks Out. CBS News. August 19,2009. http://www.cbsnews.com/stories/2009/08/19/cbsnews_investigates/main5243431.shtml. Accessed April 30, 2011.