Vicky Debold Testimony
April 21, 2010
Public Oversight Hearing by Committee on Health on
Proposed Fiscal Year 2011 Budget for Dept. of Health
Council of the District of Columbia
John A. Wilson Building, Washington, D.C.
April 21, 2010
VICKY DEBOLD, PHD, RN
Director of Research and Patient Safety
National Vaccine Information Center
Chairman Catania and Members of the Committee:
My name is Vicky Debold. I am the Director or Research and Patient Safety for the National Vaccine Information Center. I am also a Research Scientist at George Mason University and serve as the consumer representative on the FDA’s vaccine licensing committee. My doctorate is in public health. I’ve been a nurse for more than 30 years and I’ve vaccinated hundreds of children and adults and cared for infants who died from infectious diseases.
All lives are valuable and should be protected. While cervical cancer can be deadly if left undetected and untreated, there are also cases of death and disability from HPV vaccination.
Merck’s HPV vaccine, Gardasil, was licensed on June 8, 2006. One month later, a 16-year-old Illinois girl was vaccinated and developed a life-threatening paralyzing condition, Guillain-Barre Syndrome. Four days later, a 14-year-old District of Columbia girl was vaccinated, developed severe pain, fainted for 10-15 seconds, fell off the examining table, developed speech problems and was hospitalized. Her report was the first in the nation filed with the federal Vaccine Adverse Events Reporting System for a Gardasil injury. This case was described in the first of four analyses of Gardasil-related adverse events published by the National Vaccine Information Center between 2007 and 2009. , ,
Whether HPV vaccine is safe or necessary has been debated intensely by state and federal policymakers; federal advisory and scientific committees; and by the American public. Last August, federal health officials at the Centers for Disease Control and Prevention (CDC) published a paper in the Journal of the American Medical Association showing that Gardasil was associated with blood clots and fainting just like the reaction reported by the 14-year-old DC girl. CDC officials also concluded that Gardasil was not associated with any other reactions including Guillain-Barre Syndrome. I wrote a Letter to the Editor of the Journal disputing some of the CDC’s conclusions, including pointing out that finding a vaccine safe at a population level does not mean that the vaccine is safe for all individuals.
Policy and lawmakers, including the DC City Council, should make sure that all citizens are informed about the individual benefits and risks and are able to work with their doctors to make individual vaccine decisions. We know that vaccine reactions are under-reported. Please consider using the $150,000 appropriated under the 2007 law to help DC citizens make informed health decisions and learn how to recognize and report HPV vaccine reactions.
VAERS ID 259545, 14.0 DC Female, MedAlerts, National Vaccine Information Center. Accessed 4/20/10 at http://www.medalerts.org/vaersdb/findfield.php?IDNUMBER=259545
National Vaccine Information Center (Debold V, Fisher B). (2007). NVIC Report on VAERS and GARDASIL, Human Papilloma Virus Vaccine Safety, Analysis of Vaccine Adverse Events Reporting System Reports: Adverse Reactions, Concerns and Implications (undated). http://www.nvic.org/Diseases/HPV/HPVHOME.htm (Accessed on June 22, 2008).
National Vaccine Information Center (Debold V, Fisher B). (2007). NVIC Report on VAERS and GARDASIL: Part II, Human Papilloma Virus Vaccine Safety, Analysis of Vaccine Adverse Events Reporting System Reports: Part II (February 21, 2007). http://www.nvic.org/Diseases/HPV/HPVHOME.htm (Accessed on June 22, 2008).
National Vaccine Information Center (Debold V, Downey C, Fisher B). (2007). NVIC Analysis of Vaccine Adverse Events Reporting System Reports: Part III, Human Papilloma Virus Vaccine Safety, Analysis of Vaccine Adverse Events Reporting System Reports: Part III (August 15, 2007). http://www.nvic.org/Diseases/HPV/HPVHOME.htm (Accessed on June 22, 2008).
Slade BA, Leidel L, Vellozzi C, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302(7):750-757.
Debold, V, Hurwitz, E. (2009). Adverse events and quadrivalent human papillomavirus recombinant vaccine (letter to the editor), JAMA, 302(24):2657.