A recent publication by a conservative watchdog group has rekindled media interest in a controversial anti-virus vaccine and sent Big Pharma and federal health agency officials into damage control mode.

In a 25-page special report released June 30, Judicial Watch -- a Washington DC-based nonprofit organization that promotes “transparency and accountability in government” – presents evidence based on government documents that in the two years since being licensed by the Food and Drug Administration, Merck & Co’s Gardasil, heavily promoted as a safe and effective vaccine against cervical cancer, has been connected with nearly 9,000 “adverse events,” including the deaths of 18 – perhaps 20 – girls and young women.

In addition, there were 140 “serious” events reported (27 categorized as “life-threatening”), with 10 spontaneous abortions and six cases of Guillain-Barre Syndrome – all since January 2008.

Guillain-Barre Syndrome (GBS) is a rare, potentially devastating autoimmune disorder that attacks the peripheral nervous system and can lead to paralysis and, occasionally, death. There is no known cure or cause, but a fact sheet from the National Institute of Health says it’s sometimes triggered by surgery or vaccinations. Judicial Watch uncovered a total of 38 cases of GBS have been filed with the FDA since June 2006 (six since January) among girls who had received at least one dose of the three-dose vaccine.

The records indicate 10 deaths since last September, bringing the total number of Gardasil-connected death reports in the United States to at least 18 – four of these were from blood clots, nine from unknown or unidentifiable causes.

The fatalities include:

• A 20-year-old woman with no medical history reported, who was vaccinated April 1, 2008, with Gardasil and died four days later, seeking medical attention. An autopsy was performed which ruled out suicide or anything suspicious. The cause of death is currently unknown. [VAERS ID 310262-1 (D)]
  
• A 12-year-old girl with no reported medical problems, who died in her sleep of known causes on Oct. 6, 2007, three weeks after receiving a Gardasil shot. [VAERS ID: 297528-1 (D)]
  
• An 11-year-old girl, vaccinated in May 2007 with a first dose of Gardasil, who died three days later after going to an emergency room. A physician at the hospital said “death was due to an anaphylactic [severe allergic] reaction to Gardasil.”[VAERS ID 280163-1 (D)]

Because adverse reactions to medication tend to be underreported, Judicial Watch believes the actual number is likely to be higher.

“I think we’ve uncovered a lot of disturbing things about Gardasil,” said Judicial Watch president Tom Fitton. “All we’re asking for is further investigation of its safety. We’re not convinced they’re taking these reports seriously.”

Gardasil is the first vaccine on the market that targets the four strains of sexually transmitted human papillomavirus (HPV) believed to account for most cases of cervical cancer and genital warts infections.

HPV is not contagious in the way tuberculosis or measles or the common cold is. You don’t become HPV-infected by being in a crowd or sitting near someone, but through skin-to-skin contact. There are over 100 strains of HPV, 30 of which are sexually transmitted – and of these 30, 15 can cause cervical lesions and other abnormalities that may develop into cervical cancer, while about 12 can cause genital warts. Two of the strains targeted by Gardasil (HPV 16 and 18) are believed responsible for 70 percent of the cancer cases, the other two (HPV 6 and 11) cause 90 percent of the genital warts infections.

The FDA approved Gardasil on June 8, 2006, for girls and women ages nine to 26. Less than a month later the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended vaccination for all girls, ages 11 to 12. The committee’s first report on Gardasil was published the following March.

Gardasil was fast-tracked and received FDA approval before testing was complete and its final safety evaluation trials won’t be concluded until Sept. 2009. Despite this, the drug is being aggressively mass-marketed on TV and at the movies in ads pitched to young girls, including preteens, and state legislators were heavily lobbied to make the drug mandatory for school girls ages 11 up. Sold worldwide, Merck reports over 16 million doses of the vaccine have been distributed in the U.S. , and eight million women and girls have received at least one shot of the three-dose regimen.

The special report – its complete title is Examining the FDA’s HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment -- continues work Judicial Watch began in 2007 when it published two analyses (the first in May of that year, the second in Oct.) of Gardasil-related documents it had received in sets from the FDA, after making requests through the Freedom of Information Act.

As in its earlier reports, the group raises serious questions about the vaccine’s effectiveness, safety, long-range effects and overall costs -- which are astronomical. At $120 a shot ($360 for the requisite three-doses), Gardasil is the most expensive vaccine on the market.

The VAERS Reports

Using FOIA, Judicial Watch obtained thousands of pages from the FDA, including 8,864 reports filed by doctors, nurses, parents and others with the Vaccine Adverse Events Reporting System [VAERS] – a database shared by the CDC and FDA -- detailing reactions experienced by girls and women after receiving at least one shot of the vaccine.

Besides the deaths, the VAERS reports reveal a gamut of reactions – from trivial to terrifying -- including vomiting, dizziness, seizures, paralysis and Guillain-Barre Syndrome, swelling at the injection site and in lymph nodes in the neck and groin, fevers, hives, shortness of breath, nausea and flu-like symptoms.

There were reports of a sudden appearance of blisters on a 20-year-old's upper arms and back and ano-genital warts on a 12-year-old. A 15-year-old reported blisters that appeared in her vaginal area within two days of receiving the vaccine and spread to her upper body and behind her ears and knees. These lasted five to seven days, then developed scabs.

Judicial Watch’s use and dissemination of VAERS reports have drawn criticism from the FDA, the CDC, Merck and other advocates of the vaccine, in part because anyone can file a VAERS report -- physicians, nurses, family members and patients -- so the accounts tend to be dismissed as “anecdotal” and lacking-in-evidence. More important, they don’t prove the vaccine caused the event.

In the wake of the Judicial Watch report, Merck issued a press statement downplaying the findings.

The mega-drug company claimed to have “analyzed the adverse events reported for Gardasil … and based on the data available to Merck, believes that no safety issue related to the vaccine has been identified. … An adverse experience report describes an event that occurred after vaccination and does not necessarily mean that the vaccine caused or contributed to the event. The vast majority of adverse events that have been reported to Merck are non-serious and the most common include dizziness and syncope (fainting).”

In a similar vein, FDA spokeswoman Kelly Riley told the Sydney Morning Herald, an Australian newspaper, that there was nothing in the VAERS reports to cause a review of the usefulness of the vaccine. “These adverse reaction reports have not been analyzed. If there’s a death after someone received a vaccine, and long after they had a car crash, a bee sting … these would be filled out. It does not mean Gardasil caused it.”

The FDA and CDC said that safety data reviewed in approving Gardasil showed only mild side effects, like pain at the injection site or fainting.

But Tegan Millspaw, the report’s lead researcher and principal author, says these critics are missing the point.

“Judicial Watch was not and is not interested in proving causality,” she writes. ”Only science can do that. And that is why we asked for more investigation of the VAERS reports to ensure there was no causality between Gardasil and the serious reported adverse reactions”

There were 18 deaths, she points out – and of those, 11 occurred less than a week after the girl had received the vaccine, seven in less than two days.

“Perhaps all these deaths are simply coincidence, but given the unknowns about Gardasil and its overall safety, it is far too important an issue to simply ignore,” Millspaw states.