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Did Gardasil Vaccine Cause a 12-yr-old Girl's Paralysis

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. #