Apr 24, 2008 11:46 pm US/Eastern
CBS4 I-Team: Vaccine Concern Part 1
MIAMI (CBS4) ―
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. 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. Just weeks later, 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 doll's. 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? 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.
(© MMIX, CBS Broadcasting Inc. All Rights Reserved.)
Presidential Inauguration 2009
Click to enlarge
Stumble It!
Reporting
