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Science Forum Index » Immunology Forum » Did Gardasil Vaccine Cause a 12-yr-old Girl's Paralysis
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| JOHN |
 Posted: Thu Nov 15, 2007 2:48 am |
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Did Gardasil Vaccine Cause a 12-yr-old Girl's Paralysis
Posted by Jane Akre
Wednesday, November 14, 2007 3:33 PM EST
http://www.injuryboard.com/national-news/did-gardasil-vaccine-cause-a-12-yr-olds-paralysis.aspx?googleid=28460
There isn't a single person who watches television that hasn't seen the ads.
"One Less" is the campaign theme created by drug maker Merck to promote
Gardasil. Approved by the FDA in June, 2006, Gardasil is being aggressively
marketed to parents of pre-teen girls as young as nine as a way to "guard"
against cervical cancer and genital warts caused by Human Papillomavirus
(HPV) type 6, 11, 16 and 18.
The Merck campaign has been tremendously effective.
The Centers for Disease Control (CDC) recommends all 11 and 12-year-old
girls receive a Gardasil injection.
By September 2006, the state of Michigan approved a measure requiring girls
about to enter the sixth grade be vaccinated with Gardasil.
And beginning next fall, all Texas girls ages 11 and 12 will be required to
receive the three Gardasil injections according to a February, 2007
executive order signed by conservative Republican Texas Gov. Rick Perry.
Parents groups and lawmakers had objected to the order in the belief the
mandated vaccine condones premarital sex and supersedes a parent's authority
in raising their own children.
Christina Bell says she had seen ads for the vaccine so after consulting
with her doctor she agreed to have her 12-year-old daughter, Brittany
vaccinated.
Two months ago the Florida girl suddenly collapsed.
Her mother says Brittany used to play softball and run cross country.
Now she can't feel her legs.
Kelley Dougherty of Merck tells IB News that paralysis is not one of the
recognized side effects of Gardasil use and is not even on the warning label
in the product insert.
What Christina Bell didn't know was the Gardasil has been linked to
thousands of adverse reports including paralysis and 11 deaths reported to
the Vaccine Adverse Event Reporting System, (VAERS) a joint project of the
CDC and FDA where raw data is gathered before it is vetted for accuracy by
the CDC.
In August, the non-profit Washington, D.C. government watchdog group,
Judicial Watch filed a request asking the FDA for all adverse events reports
linked to Gardasil injections.
By September, Judicial Watch had an additional 1,800 reports of suspected
reactions to Gardasil, bringing the adverse report total to 3,461 and 11
deaths. Among them:
.. "20-Jun-2007: Information has been received.concerning a 17 year old
female who in June 2007.was vaccinated with a first dose of Gardasil.During
the evening of the same day, the patient was found unconscious (lifeless) by
the mother. Resuscitation was performed by the emergency physician but was
unsuccessful. The patient subsequently died."
.. "12-Jun-2007: Information has been received.concerning a 12 year old
female with a history of aortic and mitral valve insufficiency.who on
01-MAR-2007 was vaccinated IM into the left arm with a first does of
Gardasil.On 01-MAR-2007 the patient presented to the ED with ventricular
tachycardia and died."
.. "28-Aug-2007: Initial and follow-up information has been received from a
physician concerning an "otherwise healthy" 13 year old female who was
vaccinated with her first and second doses of Gardasil. Subsequently, the
patient experienced.paralysis from the chest down, lesions of the optic
nerve.At the time of the report, the patient had not recovered."
In August, the National Vaccine Information Center, a clearinghouse for
information on vaccines, reported that Gardasil given with the meningococcal
vaccine could put patients at risk for Guillain-Barre syndrome (GBS). GBS
allows the body's immune system to attack the nervous system causing
paralysis and muscle weakness.
There is other information that Christina Bell didn't have.
No one can really say if the drug is effective over time. It is supposed to
be given before girls are sexually active. What if that doesn't happen for
five or 10 years. Does Gardasil still work? No one knows.
Then there is the moral question- does giving Gardasil send the wrong
message to our young girls that they can be promiscuous without
consequences? New partners are associated with an increased risk of HPV and
Gardasil doesn't protect against HIV.
There is also concern that women may opt out of an annual PAP screen,
considered the most effective test for cervical cancer.
Numerous studies find that HPV is transmitted through skin contact, not
through bodily fluids. A report in the New England Journal of Medicine finds
using condoms is effective in preventing HPV.
Are parents about to discuss condom use with their 12-year-olds? Is getting
another inoculation just easier?
Christina Bell didn't hear these arguments. Now she has filed an injury
claim with the government, not drug maker Merck.
It turns out that Merck put Gardasil on the National Vaccine Injury
Compensation Fund about six months after it hit the market.
Bells' attorney, Sean Cronin tells First Coast News that, "The Federal
government would not put it on the list without medical scientific
justification."
But Dougherty tells IB News that most or all childhood vaccines are
automatically added to the list as well as all of Merck's new drugs as a
standard practice.
"There is no special criteria, it's a legislative process and has little or
nothing to do with the data," she tells IB News.
What we do know is that there are 100 different strains of HPV. Gardasil
protects against four of them.
At $360 for the three-vaccine regimen is one of the most costly vaccinations
ever marketed. For those without private health insurance, Gardasil was
added to the Vaccines for Children (VFC) Program on November 1, 2006.
Already about 10 million Gardasil vaccinations have been distributed. At
last count, 3,461 adverse reports have been sent to the government reporting
system, Vaccine Adverse Event Reporting System (VAERS). Brittany is not
among them.
Merck is seeking FDA approval for the use of Gardasil in women up to the age
of 45, even though studies show about 80 percent of women that age already
have HPV which is largely kept in check by the body's immune system.
Gardasil is being marketed aggressively outside the U.S.. So far 85
countries have approved it.
GlaxoSmithKline is poised push its version of the HPV vaccine, Ceravix into
the U.S. market. It's already available in Europe. Glaxo is confident it
will eventually capture half of the market, $365 million as of June, 2007,
for Gardasil. # |
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