A lawsuit filed in the U.S. Federal Court of Claims this week alleges that the HPV vaccine Gardasil caused the death of a 16-year-old Missouri girl. Gardasil is a vaccine used to prevent the transmission of a sexually transmitted disease called human papillomavirus (HPV). Controversy regarding the safety of Gardasil surrounded the vaccine since its FDA approval in 2006 and continues to be the subject of intense debate.
Safety and efficacy of Gardasil in question
As on December 31, 2008 there were 12,424 reports of injuries related to Gardasil in the Vaccine Adverse Event Reporting System (VAERS) (1). These reports are used by the FDA to monitor the safety of vaccines and it is well known that injuries are underreported (1). Of note, 68% of the 12,424 reports of injury where written employees of Merck (1). While there is risk of injury with every drug, including vaccines, at least one report questions whether or not Gardasil provides enough protection to counterbalance the risk of injury.
In a report issued by Judicial Watch, it was found that Gardasil was not tested thoroughly enough to know whether it will be safe or effective in the long term (2). The report goes on to state that it is still unknown how long any protection provided by the vaccine lasts (2).
Influence of Merck’s money on doctor recommendations
Merck’s campaign, directed at every adolescent-aged female instead of those populations at greatest risk, combined with the generous education grants for professional medical associations like the American Medical Society (3). These grants were made with the primary goal of obtaining physician encouragement of Gardasil vaccinations and proved successful as sales in 2008 were $1.4 billion worldwide (3). However, the relationship between professional medical associations and Merck raises questions concerning Merck’s aggressive anticancer campaign’s influence on the responsibilities these associations have to be impartial advocates for vaccinations (3).
The death of a 16-year-old girl two days after receiving her last Gardasil shot
Two days after receiving her third and final Gardasil shot, the 16 year old girl collapsed in seizure while walking through a parking lot. She was rushed to the hospital and passed away a short time later. â€œI think we can all agree that its not normal for a healthy 16-year-old girl to suddenly suffer a seizure and dies” said attorney Mark Sadaka, MSPH who represents the family of the girl. “What makes the case against Gardasil compelling is that the seizure happened within two days of her last shot.”
The lawsuit is pending in the vaccine injury compensation program located in the U.S. Federal Court of Claims in Washington, DC.
About Mark Sadaka, MSPH
Mark Sadaka is an attorney and public health advocate. Mr. Sadaka is the founding partner of the Law Offices of Sadaka Associates LLC and can be contacted at 1-800-810-3457 or by visiting www.VaccineInjuryHelpCenter.com.
(1) Slade et al. Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine. JAMA: The Journal of the American Medical Association (2009) vol. 302 (7) pp. 750-757.
(2) Judicial Watch, Examining the FDA’s HPV Vaccine Records (June 30, 2008).
(3) Rothman and Rothman. Marketing HPV Vaccine: Implications for Adolescent Health and Medical Professionalism. JAMA: The Journal of the American Medical Association (2009) vol. 302 (7) pp. 781-786.
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