FDA Adverse Reports on Gardasil Made Public

According to Judicial Watch, a so-called conservative Washington D.C.- based public interest group, there have been nearly 9,000 adverse health events reported to the government concerning the Merck & Co drug, Gardasil.  That number likely is underreported, says the group.

Using the Freedom of Information Act to obtain detailed reports from the Food and Drug Administration's Vaccine Adverse Event Reporting System (VAERS), Judicial Watch gathered reactions following administration of Gardasil, the vaccine approved for young girls to prevent human papillomavirus (HPV).

The reports were released in set of documents, the last delivered in June 2008.  They are the best record so far of the widespread use of the drug by the public. 

Included in the documents was a June 2006 memo to the FDA from Merck that described the clinical testing done for Gardasil.  Four placebo-controlled double-blind tests evaluating 20,541 women ages 16 to 26 were included. 

The Vaccine Adverse Event Reporting System (VAERS) system generally takes input from medical personnel, but anyone can report an adverse reaction to a drug.  VAERS includes:

• 78 separate cases, patients experience an outbreak of warts in the groin and genital area, even among girls who tested negative for HPV.  Other outbreaks of warts were found on the face, hands, and feet and were all caused by strains of the papilloma virus.
  
  
• There are 10 deaths reported since September 2007, and at least 18 deaths total.  Of those 18, eleven occurred less than one week after receiving the vaccine and seven in less than two days. The young women were diagnosed with blood clotting as the cause, which was cited as the cause in almost a fourth of all deaths involving Gardasil. One girl died from inflammation of the heart, one from arrhythmia and one from meningitis. An 11-year-old died from anaphylactic reaction.
  
  
• The FDA also reported 140 “serious” reports of injury. The FDA considers reports only that are life threatening in that category; genital warts on one’s face would not qualify
  
  
• There were 10 spontaneous abortions 
  
  
• Six cases of Guillain-Barre Syndrome (the body’s immune system attacks the nervous system) since January 2008 
  
  
• 25.4 percent experienced swelling after receiving Gardasil, and 15.8 percent reported the same thing after receiving an aluminum placebo. Gardasil contains 225 mcg of aluminum. The FDA allowed Merck to use an aluminum-based placebo, while most are saline based.

“Using a reactive aluminum-containing placebo instead of a non-reactive saline base can make vaccines seem safer than they may actually be” reports Judicial Watch.  
 

Reports look like this:

• Information has been received...concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil....The patient died four days after...patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious. The cause of death is currently unknown. VAERS ID: 310262-1 (D)
  
• Information has been received…concerning a 23-year-old female…who on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil...the patient experienced anaphylactic shock 2 minutes after vaccination characterized by a brief loss of consciousness...respiratory arrest, eyes rolled upwards, blurred vision and greyish skin tone...Anaphylactic shock was considered to be immediately life-threatening. VAERS ID: 304739-1 (S)
  
• Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, Immediate post-injection reaction....Pt [patient, 14-year-old female] received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness. [Blood pressure] after seizure 60/40 pale clammy skin. [Patient] had bit her tongue and had foam around her mouth. VAERS ID: 305259-1 (S)
  
• Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a coma and is now paralyzed. At the time of this report, the patient's outcome was unknown. VAERS ID: 303188-1
  
  

Background

The FDA approved Gardasil June 8, 2006 as a vaccine against certain types of human papillomavirus (HPV) which causes cervical cancer. 

Merck obtained FDA approval for the drug to be used on children as young as nine  but the drug was never tested on nine-year-olds and only on a couple hundred 11 and 12-year olds.  

The vaccine works best in someone who has never been exposed to HPV.

The effectiveness of Gardasil is unknown.

HPV is spread through sexual contact. There are more than 100 different types of HPV and some low risk varieties can cause genital warts. Most people do not develop cancer from HPV which can be detected with a PAP smear.  

Chris Farrell, director of research at Judicial Watch tells IB News that the race to have 11-year-olds vaccinated with Gardasil is not good public health.  Judicial Watch is not encouraging the drug be removed from the market, he says, just that minor children under the age of 18 not be forced to have the vaccine.

“We need a greater public health dialogue on this between parents, politicians, and health care officials. There should be as much effort to ask questions as political lobbying and advertising,” he tells IB News.

Merck launched an aggressive advertising campaign, “One Less” on television and in print. 

Three states - Texas, Michigan, and Virginia all began moving toward mandating Gardasil immunizations for school girls entering the 6th grade, but all three states stopped the mandatory immunization push because of public pressure.

17 states have passed some legislation encouraging education and making information available about HPV. Mandatory vaccination has been opposed by The New England Journal of Medicine and the American College of Pediatrics.

Dr. Diane Harper, a specialist on HPV who helped develop the Gardasil vaccine, has spoken out against making the vaccine mandatory. “The vaccine has not been out long enough for us to have post-marketing surveillance to really understand what all of the potential side effects are going to be,” she says in an interview to FWdailynews.com.

Dr. Harper believe the vaccine will be beneficial in the long run but says it is unacceptable “to mandate any vaccine without first testing it for effectiveness, safety, and long-term side effects.”  

The final safety evaluation tests should be concluded on Gardasil by September 2009.

Judicial Watch president, Thomas Fitton says that “Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, the governments should rethink any efforts to mandate or promote this vaccine for children.  #