Baum Hedlund Aristei & Goldman Trial Lawyers
The Gardasil vaccine, manufactured by Merck & Co., was approved by the U.S. Food and Drug Administration (FDA) in 2006 for use in preventing infection from only a few of the hundreds of types of human papillomavirus (HPV). Since hitting the market, however, thousands of adolescents and adults have reported serious and disabling Gardasil side effects after receiving the HPV vaccine, including death.
Gardasil was fast-tracked to the market, achieving FDA approval in six months, which usually takes three years. Even one of the principal investigators of the Gardasil clinical trials (the human testing that precedes FDA approval) said the process “went too fast.”
The clinical trials for the Gardasil HPV vaccine reveal several disturbing side effects that were not disclosed on the package insert:
- The miscarriage rate for subjects who were injected with Gardasil was 25%. The miscarriage rate for women under 30 in the U.S. is 12.5%.
- In the Gardasil group, 5 babies were born with congenital abnormalities. There were none in the control group (the group that does not receive treatment).
- 10.9% of women who took Gardasil reported reproductive and breast disorders within 7 months. In the Protocol 18 placebo group, that figure was 1.2% (through 12 months).
- The rate of Gardasil deaths in the clinical trials was 8.5 per 10,000, nearly double the background U.S. death rate for young women ages 15 to 24.
There are more than 64,000 case reports of HPV vaccine adverse reactions in the Vaccine Adverse Events Reporting System database.
It is estimated that only 1% of serious adverse events are actually reported to VAERS.
Researcher Peter C. Gøtzsche in his book Vaccines: Truth, Lies, and Controversy noted some of the research inadequacies in the HPV vaccine clinical trials
“It is a requirement for registration of drugs that randomized trials have been carried out where one group received the drug and the control group received placebo or nothing. This allows assessment of both the benefits and harms of drugs. I have done research on non-vaccine drugs for decades and was shocked when I learned through my work with vaccines against human papilloma virus (HPV) that the regulatory requirements are much less for vaccines. Almost all the HPV vaccine trials have a control group receiving a hepatitis vaccine or a strongly immunogenic adjuvant, which makes it impossible to find out what the harms of the HPV vaccines are.”
Today, the Gardasil shot has left many young women and men suffering (FDA also approved Gardasil for boys), and it has been a living nightmare for parents whose children have experienced severe adverse reactions to the vaccine. They all trusted Gardasil, never suspecting the grave illnesses and disabilities that could follow. […]
What is the Gardasil Controversy?
Underlying the entire Gardasil controversy are clinical trials (human testing) that victims allege were fraudulently conducted and reported. Preliminary evidence compiled by a team of Gardasil attorneys and investigators suggests that the clinical trials Merck conducted for the Gardasil HPV vaccine were flagrantly deceptive and unscientific.
According to Mary Holland and Kim Mack Rosenberg, and Eileen Iorio, co-authors of the book, The HPV Vaccine On Trial: Seeking Justice For a Generation Betrayed, “none of the participants in the [Gardasil] clinical trials received a true saline placebo,” which means the clinical trials failed to measure the effects of Gardasil against a true control. Instead of receiving a placebo, some clinical trial subjects received aluminum-containing adjuvants, chemical mixtures, and other vaccines, which masked adverse events and made Gardasil seem safer than it would have otherwise.
According to Holland, Mack Rosenberg, and Iorio, “HPV vaccines have never been proven to prevent against cervical or other cancer.” … Full article