Gardasil, the controversial drug that took the early Republican presidential debates by storm, is back in the news as newly unearthed documents reveal 26 additional deaths associated with the shot designed to help prevent young women from getting a sexually transmitted disease that can lead to cervical cancer.
by Joe Kovacs
World Net Daily
The public-interest group Judicial Watch has obtained the documents through the Freedom of Information Act from the Food and Drug Administration detailing reports of harmful reactions to the vaccination for human papillomavirus, also known as HPV.
“The adverse-reaction reports detail 26 new deaths reported between Sept. 1, 2010, and Sept. 15, 2011, as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short-term memory loss and Guillain-Barré Syndrome,” Judicial Watch said.
According to the documents, adverse Gardasil events reported to the FDA include:
- The information was received from the patient’s mother… concerning her healthy 14-year-old daughter who in August 2007, January 2008, and June 2008, was vaccinated with a first, second and third dose of Gardasil … It was reported that the patient experienced several symptoms including numbness and tingling in her fingers and toes, fatigue, a really hard time falling asleep, urinary tract infections, ovarian cyst, moody, trouble getting out of bed and seizures. The patient had had upwards of 150 seizures following her third shot in June 2008. During her seizures she stopped breathing for periods of 30 to 40 seconds. The patient was diagnosed with Neurocardiogenic syndrome and seizures. It was reported that the patient died due to ovarian cyst. The reporter felt that the patient’s symptoms were related to vaccination with Gardasil.
- Additional information was received from a newspaper article concerning a 18-year-old female …who on 10-MAY-2007 was vaccinated with Gardasil … in the right arm … The patient who was a college freshman traveled on 05-OCT-2007 to visit her family for the weekend. The patient reportedly felt “slightly ill” upon her arrival and subsequently took an aspirin and went to bed awakening at 1:30 PM the following afternoon “appearing refreshed.” The patient became feverish again that night and woke at 1:00 a.m. the morning of 07-OCT-2007 with chills and a severe headache complaining that “my headache is about to explode.” The patient was taken to a local hospital, where a brain computed axial tomography (CAT) scan was performed and the brain revealed meningococcal disease in her brain and brain stem. The patient was immediately transferred to another hospital and died the evening of 07-OCT-2007 due to complications of meningitis.
- Information has been received from a physician regarding a 15-year-old female who on 26-SEP-2007 was vaccinated with her second dose of Gardasil for prevention of HPV … Thirty minutes after the vaccination, the patient experienced a headache and that night went home and slept until the next morning. The patient woke up the next day and went to school. The school nurse called the patient’s mother and informed her that the patient felt tingling in both hands. Later that day, the patient was again sent to the nurse’s office due to a shaking sensation all over. Later that evening, things became worse and the patient started crying from the pain and burning in her back. The patient was taken to the emergency room by her parents. In the emergency room, the patient collapsed and was not able to walk; she was paralyzed from the waist down. It was reported that the patient was hospitalized for two months.
In response to the concern about death reports among those who received Gardasil, the Centers for Disease Control insists “there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine.”
“These reports raise additional concerns about Gardasil’s questionable safety and provide ample reason to end the push to give it young girls and boys. And the CDC’s continued caginess on reported deaths is disturbing,” said Judicial Watch President Tom Fitton. “Federal, state and local officials need to stop promoting this vaccine for children.”
The Gardasil controversy received national attention during the presidential debates, as candidates hammered Texas Gov. Rick Perry over his 2007 executive order to vaccinate schoolgirls in the Lone Star State against HPV.
“To have innocent little 12-year-old girls to be forced to have government injections through an executive order is just flat-out wrong,” Michele Bachmann said during the Sept. 12 tea-party debate in Tampa, Fla. (video)
Former Pennsylvania Sen. Rick Santorum also took aim at Perry’s inoculation push.
“This is big government run amok,” Santorum said, receiving applause from those in attendance. “It is bad policy and it should not have been done.”
Perry said he regretted his decision to push for the vaccine using an executive order, but said he was standing up against cancer.
“At the end of the day I am always going to err on the side of life,” Perry said. “At the end of the day this was about trying to solve cancer.”
The mandated shots never actually took place after the Texas Legislature halted the plan.
As WND previously reported, one expert on Gardasil claims the drug is not only dangerous, but actually useless in fighting cervical cancer.
Dr. Christian Fiala, who successfully fought the use of the drug in Austria, told WND “there is no proof of a causal relationship of HPV and cervical cancer (correlation is not necessarily causation) and there is no evidence that HPV vaccine reduces the overall number of cervical cancer (cases).”
Judicial Watch launched a comprehensive investigation of Gardasil’s safety record in 2008 after the drug’s manufacturer, Merck & Co., began a major effort to lobby in state legislatures to impose requirements that girls be given their product.
It was in 2008 when Judicial Watch obtained documents from the FDA documenting “anaphylactic shock,” “foaming at mouth,” “grand mal convulsion,” “coma” and “now paralyzed” descriptions of the complications from Gardasil. The company wanted it to be mandatory for all schoolgirls.
Previous federal reports documented some three dozen deaths in the United States, although an activist organization claimed there had been almost 70 deaths, nearly 800 “serious” reactions and thousands of minor reactions.
According to a Reuters report today, as of this past June, about 35 million doses of Gardasil had been dispensed in the U.S., and about 18,700 “adverse events” – which may or may not be caused by the vaccine – had been reported.
Of those, 92 percent were considered mild – meaning they were not life threatening and caused no persistent damage. The rest were serious, and included blood clots and 56 deaths. If the 26 new deaths are added to the official figure, it would put the official fatality count at 82.
Reuters says the CDC estimates that in 2010, 48 percent of girls between 13 and 17 received at least one dose of the HPV vaccine, which is given in three doses over six months. That rate is higher than in the two previous years, but still too low, according to the agency.
Merck spokeswoman Jennifer Allen Woodruff told WND that the drug addresses a medical need, that of reducing the rates of HPV.
She said it has been approved widely around the world, with 120 countries having examined and approved its use.
“Nothing is more important to Merck than the safety of our vaccines and those who use them,” she said. “The facts about Gardasil are clear and its efficacy and safety … were established.”
She declined to say that Merck had not lobbied state lawmakers for laws that would force the vaccine on children and families, instead offering that the company focused on lobbying efforts regarding the “potential school requirements” in some states.
She said the company’s goal was simply to provide information to those who made such decisions.
However, the vaccine has had a few bumps. Agence France-Presse reported in 2009 that Spanish authorities withdrew tens of thousands of doses of the vaccine when two teen girls were hospitalized.
In the United Kingdom, an investigation was launched after two young girls died following their injections of the drug.
And the Daily News and Analysis from India said the Indian Council of Medical Research suspended a cervical cancer control vaccination program for girls after four deaths and complications for 120 more.