Gardasil And Tetanus Shots Leave Girl Paralysed
CBS 4 - Miami
CBS4 I-Team: Vaccine Concern Part 1 http://cbs4.com/iteam/vaccine.gardasil.i.2.708105.html
April 24, 2008
Reporting by Michele Gillen
If you are the parent of a young girl you most likely have heard of a first of its kind vaccine named GARDASIL, developed to protect against the viruses which can cause cervical cancer.
The FDA's approval of the vaccine triggered efforts in Florida and across the nation to mandate its use for 11 and 12 year old girls, who are believed to see the most benefit from its use. However CBS4 Chief Investigative Reporter Michele Gillen has learned there is an increasing concern over the use of the vaccine.
Christina Bell's daughter Brittney was one of the young girls who recieved the vaccine. She was healthy at the time, but six months ago, her life took a radical turn for the worse.
Seemingly, in a moment's time, Brittney's left leg became paralyzed, her ankle swinging like a rag dolls'. Even with a shoe brace, she walks with a limp.
"It's hard for me to lift it up," Brittney told Gillen.
Brittney's limb paralysis occurred shortly after the 12 year old went to the doctor for a routine tetanus shot for school. That is when Bell says the doctor suggested Brittney also have the GARDASIL vaccine on the same day. And she did.
GARDASIL is a first-of-its-kind vaccine approved by the U.S. Food and Drug Administration (FDA) for girls as young as nine. The vaccine is profiled on the FDA website with the headline, "New vaccine prevents cervical cancer."
In trials, the vaccine was shown to prevent pre-cancerous lesions due to certain types of Human Papillomavirus (HPV).
In searching for answers as to why her daughter now suffers from a limb paralysis, Christina Bell says she couldn't shake the idea that it might somehow be tied to the HPV vaccine. She hasn't found a doctor to agree with her, including the pediatrician who recommended the shot.
"He doesn't believe it has anything to do with the shot at all," said Bell.
She says he stopped returning her calls. When the CBS4 I-Team tried calling him, he didn't return the calls.
Bell began to research the vaccine herself and what she found startled her - government-compiled reports, filed from around the country, of adverse events that occurred sometimes within hours, other times within weeks, of a GARDASIL vaccination.
While they don't prove a link, they do document that in some cases an adverse event occurred following an injection. These types of events have been reported to VAERS, a federal vaccine reporting system.
"We've seen reports of paralysis, convulsions, seizures in young girls. It's very, very, scary and very unfortunate," said Irene Garcia, spokesperson for Judicial Watch, a government watchdog group that obtained the VAERS records from the FDA through the Freedom of Information Act and posted them on the Internet.
When the data was finally released, Garcia said she felt outraged.
"It was outrage because all that I had seen publicly in the media and on television and from pediatricians was positive," said Garcia.
Last February, the FDA told CBS4 that it was investigating reports of 13 deaths following an HPV vaccination. At the time, the agency said it was confident that none were tied to the vaccine and that reports of adverse events were under review but not considered anything out of the ordinary.
An FDA spokeswoman told CBS4 this week that she could not provide an update on the number of reported events, including deaths.
"I haven't seen updated numbers for several months. We monitor on a daily basis but we don't total it up. We are not seeing a problem," said Susan Cruzan, spokesperson for the FDA.
In some states across the U.S., it is mandatory to report a suspected reaction to VAERS. But in others, it isn't.
"It varies by state and there is no blanket federal law,unfortunately," said Garcia.
Brittney's mom said she can't find a doctor willing to report an adverse reaction following the administration of her daughter's vaccines. CBS4 informed her that parents, just like doctors, can report an adverse event and the Bell family has done just that.
"It might always be that people will say you can't prove that this is linked," Gillen told Bell.
"I am still going to speak and tell everybody what I think. I tell everybody," replied Bell. "What do I want today, " asked Gillen? I want my daughter back to normal," said Bell.
In a response to this report Merck, which makes the GARDASIL vaccine, issued the following statement:
Merck actively monitors adverse event databases throughout the world, including the U.S. Vaccine Adverse Event Reporting System (VAERS). An event report does not mean that a causal relationship between an event and vaccination has been established - just that the event occurred after vaccination.
The labeling for GARDASIL reflects the extensive data available from our clinical trials. The data, including safety information, have been thoroughly reviewed and discussed by medical experts.
Since its FDA approval in June 2006 through March 31, 2008, Merck has distributed more than 26 million doses of GARDASIL worldwide.
Merck will continue to evaluate all reports in the context of our own post-marketing adverse experience database and our clinical trial database. Post-marketing adverse event reports received by the Company are sent to regulatory authorities worldwide in accordance with regulatory requirements, and Merck updates its product labels with new safety information as appropriate.
Merck encourages healthcare providers and consumers to report any potential adverse experiences following vaccination with GARDASIL to the Company and to adverse event reporting systems.