NewsThu Jul 3, 2008 - 12:15 pm EST
Controversial HPV Vaccine Causing One Death Per Month: FDA Report
By Peter J. Smith
WASHINGTON, D.C., July 3, 2008 (LifeSiteNews.com) - One death per month is the average loss of life associated with the cervical cancer vaccine Gardasil according to an FDA report obtained by a government watchdog agency.
Merck, the makers of Gardasil, are poised to make profits in the billions from the vaccine, which protects against some cancer-causing forms of the sexually transmitted human papilloma virus (HPV), but the pharmaceutical giant has come under heavy criticism for fast-tracking the drug onto the market without adequate testing in order to beat out its rivals.
Judicial Watch, a public interest group that campaigns against government corruption, uncovered documents through the Freedom of Information Act that show the US Food and Drug Administration (FDA) received reports of 10 deaths associated with Gardasil since September 2007, and 140 "serious" reports of adverse reactions, including 27 "life threatening" cases, 10 spontaneous abortions, and 6 cases of the debilitating Guillain-Barre Syndrome since January 2008.
Judicial Watch also found 8,864 Vaccine Adverse Event Reporting System (VAERS) records associated with Gardasil, more than double the 3,461 events that had been reported with the HPV vaccine in Fall 2007. Many experienced outbreaks of genital warts from the HPV vaccine.
The watchdog group says the number of deaths associated with the vaccine is at least 18 and possibly as many as 20.
Eleven deaths occurred less than a week after receiving the vaccine. Seven women died in less than two days. The most common diagnosed cause was blood clotting. One woman died from a clot within 3 hours of the vaccine. One 20-year-old woman, with no medical history reported, died April 4, 2008 just four days after receiving Gardasil.
The serious adverse events include anaphylactic shock, grand mal convulsion, foaming at mouth, coma, paralysis, and death.
Another 23 year-old woman was vaccinated with her first dose of Gardasil on January 31, 2008 and thereupon went into anaphylactic shock. The report says, "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."
A 14 year-old girl took six steps after being injected with the vaccine before she collapsed to the floor unconscious and foaming at the mouth. The girl regained consciousness after "a 60 second grand mal seizure" and had "pale clammy skin" and blood pressure of 60/40.
A VAERS report from a physician stated a female patient was inoculated with a dose of Gardasil and, "Subsequently, the patient experienced a coma and is now paralyzed."
Merck & Co. has invested heavily in getting US states to mandate Gardasil to schoolgirls as young as 11 for sexually transmitted HPV in order to beat out rival GlaxoSmithKline’s vaccine Cervarix. Merck successfully lobbied the FDA to fast track Gardasil to the market, which critics have charged essentially makes US women part of a massive testing experiment.
JPMorgan Analyst Chris Schott told Forbes.com that since GlaxoSmithKline PLC was delaying submitting more information to the FDA on its cervical cancer treatment Cervarix until the first half of 2009, he projects Merck to dominate the market, while Cervarix will manage only 25% market share by 2012.
"Given all the questions about Gardasil, the best public health policy would be to re-evaluate its safety and to prohibit its distribution to minors," said Judicial Watch President Tom Fitton. "In the least, governments should rethink any efforts to mandate or promote this vaccine for children."
Read the special report by Judicial Watch: