2008 FDA Statement on Gardasil has Disturbing Data on New Medical Conditions

Leslie Carol Botha:

Gardasil doseWhat would you think of a government document on a new drug on the market that exhibited disturbing data on the development of ‘new medical conditions’?

What if that drug was for a new experimental STD vaccine? And what if the data showed that 73.3% of girls in the clinical trials developed new medical conditions?

And then lists some of those conditions?  Where is the parent’s right to be informed.  Where is the patient’s right to be informed?

 

New Medical Conditions
Merck & Co. screened eliminated male and female trial participants with any history of pre-existing medical conditions from their clinical trials. Only healthy participants without any previous history of certain medical conditions we allowed in the clinical trials.

The 2008 FDA Closing Statement on Gardasil reports that 73.3% of the ‘healthy’ girls who participated in the clinical trials developed ‘New Medical Conditions.’

The list below highlights some of the ‘New Medical Conditions’ reported in the 2008 FDA Closing Statement on Gardasil.

  • Blood & Lymphatic System Disorders 2.9% = 1 in 34
  • Gastrointestinal Disorders 13.4% = 1 in 7
  • General & Administration Site Conditions 3.8% = 1 in 33
  • Immune System Disorders 2.4% =1 in 50
  • Infections & Infestations 52.9% = 1 in 2
  • Injury, Poisoning, & Procedural Complications 8.0% =1 in 12
  • Investigations 11.8% =1 in 9
  • Musculoskeletal & Connective Tissue Disorders 6.8% =1 in 14
  • Nervous System Disorders 9.4% = 1 in 10
  • Pregnancy, Puerperium & Perinatal Conditions 2.0% = 1 in 50
  • Psychiatric Disorders 4.4% =1 in 22
  • Renal Disorders 2.7% =1 in 37
  • Reproductive & Brest Disorders 24.8 % = 1 in 14
  • Respiratory, Thoracic & Mediastinal Disorders 5.5% = 1 in 18
  • Skin & Subcutaneous Tissue Disorders 7.4% = 1 in 13
  • Surgical Procedures = Appendectomy 10.2% = 1 in 10

73.3% of the healthy participants acquired a new medical condition during the clinical trials. Considering the HPV vaccine is given to adolescents, teens and young women without consideration of pre-existing medical conditions there is a distinct possibility that  75% of the vaccinated population has subsequently been prescribed additional medication to alleviate the symptoms of the ‘new medical conditions’ without making the link that their newly acquired  illness was actually related to the HPV vaccine.

Read the document here:

September 11, 2008:  Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18.