At least three deaths and more than 1,600 adverse reactions including spontaneous abortion and paralysis have been connected to Merck & Co.’s new vaccine for the human papillomavirus, a treatment the company has lobbied state lawmakers to make mandatory for young girls across the nation.
The report comes from Judicial Watch, the Washington-based public interest group that investigates and prosecutes government corruption.
“The FDA adverse event reports on the HPV vaccine read like a catalog of horrors,” said Tom Fitton, Judicial Watch president. “Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports. It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug.”
One report, No. 275438-1, describes the reaction as coronary artery thrombosis, sudden cardiac death. “Given Gardasil vaccine dose #1 3/12/07. Collapsed and died on 3/26/07… Echocardiogram revealed very enlarged right ventricle, small left ventricle as well as large blood clots within both the right atrium & right ventricle.”
A second report noted that the woman was vaccinated and “died of a blood clot 8 hours after getting the Gardasil vaccine.”
It was being facilitated by donations from Merck to Women in Government, whose members are women state lawmakers across the country, who in turn often were introducing legislation that would require young girls to be given the brand new vaccine in order to be enrolled in school.
Judicial Watch said documents it obtained from the U.S. Food and Drug Administration under the provisions of the Freedom of Information provided information on 1,637 reports of adverse reactions.
The reports of the deaths cited myocarditis, coronary artery thrombosis and pulmonary embolism as causes for the deaths.
Besides the only hours-long lapse between vaccination and death, two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting, the Judicial Watch analysis said.
Jill Farrell, a spokeswoman with Judicial Watch, said its own tabulation uncovered 371 serious reactions among the 1,637 total reported. She said JW found more cases of serious situations than did the official government report, because of the way reactions were classified.
“Stopped breathing later revived. … 13-year-old developed pain, sought physical therapy, later could not tolerate therapy due to pain. … Hives, sent home, found unresponsive by mother, who called 911, revived at ER…” Farrell noted. “You decide. If these were your children, would you consider these non-serious?”
Of the 42 women who got the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities, the report said.
“Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Indeed, 77 percent of the adverse reactions reported are typical side effects to vaccinations. But other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre syndrome (a disorder in which the body’s immune system attacks part of the peripheral nervous system), and seizures,” Judicial Watch said.
Merck declined an opportunity to respond to WND requests for comment on the report.
WND also reported earlier a researcher who worked on a vaccine for HPV is warning it hasn’t been tested on young girls, is “silly” for states to mandate, and in a worst-case scenario even could increase cervical cancer rates.
Researcher Diane M. Harper said giving such a vaccine to 11-year-olds “is a great big public health experiment.”
The target of the vaccine is cervical cancer, since studies show that those who have HPV have a higher chance of later developing cervical cancer. However, opponents note that such cancers develop most often in older women, while the plan is to require girls as young as 11 or 12 years old to be inoculated. They cite the lack of evidence that the vaccine would have an impact later in life.
They also question the imposition of a vaccine against a condition that is spread only by sexual contact.
Merck’s vaccine was approved last year by the Food and Drug Administration, but a doctor at the Centers for Disease Control’s advisory committee on immunizations has reported that while the vaccine may be helpful, it should not be mandatory.
Merck has lobbied for its product by contributing financially to Women in Government, an organization for women state lawmakers, and at least partly because of that effort, almost three dozen state legislatures have been given proposals regarding Gardasil.
Harper noted that the vaccine is not a cancer vaccine or cure – it just is thought to prevent development of a virus that could lead to cancer.
She earlier had warned that Guillian-Barre syndrome had been reported among those who got the vaccine.
The National Conference of State Legislatures set up a special website just to track and update the various campaigns.
That site confirms that about three dozen states have had such plans introduced. But it shows slow progress in many locations.
Officials with the Abstinence Clearinghouse noted in a position paper that groups including the Texas Medical Association, the American Academy of Pediatrics, the Association of American Physicians and Surgeons, and the American Academy of Environmental Medicine have come out publicly against mandatory vaccination.
“The reasoning of these medical associations is clear. They are not opposed to medical progress, and certainly support all efforts to combat life-threatening diseases. The problem, as these organizations see it, lies in the fact that the drug only went through three and a half years of testing, leaving the medical community somewhat in the dark as to what serious adverse effects might result in the long term,” the group said.
“Along with the potential of serious adverse effects is the question of efficacy. There is evidence that after approximately four years, the vaccine’s potency significantly declines. The long-term value of the vaccine has yet to be determined; if it wears off within six years, will girls and women need to repeat the battery of injections they originally received?” the organization wondered.
“It is negligent to require any person, especially a child, to receive a treatment which might in the future prove to be dangerous,” the group said. “It is pertinent to note that by mandating a vaccine, the state assumes all liability. If it causes harm to patients, to whatever extent, Merck is immune to legal retribution. No state ought to be so ethically or fiscally irresponsible as to mandate this vaccine.”
Leslee Unruh, chief of the Abstinence Clearinghouse, told WND her organization’s research shows that such vaccines actually can increase cervical cancer rates, because women believe they are “protected” by the vaccine, and fail to follow up with their physicians for routine exams.
She also said Merck’s campaign has extended far beyond state lawmakers, reaching into school districts and other organizations that are pressured to advocate for the vaccines.
“They come in and shame these poor teachers and schools into sending out letters that make it sound like the best thing since sliced bread,” she said.
The NCSL said federal studies show HPV infects about 20 million people in the U.S. and 10,000 women are diagnosed with cervical cancer annually.
Texas Gov. Rick Perry in February issued an executive order requiring those vaccinations, but the state legislature rescinded it, citing those concerns. Perry’s reaction was to describe the lawmakers’ policy as “social Darwinism.”
“Banning widespread access to a vaccine that can prevent cancer is short-sighted policy,” he said.
Michigan was the first state to introduce a plan to require the vaccine to be given to young girls, but the proposal failed. Ohio also considered a failed plan in 2006.
Then in 2007, after Merck’s aggressive lobbying campaign and contributions to WIG, lawmakers in at least 39 states and the District of Columbia worked on sponsoring such plans.
The Merck campaign’s results so far include New Hampshire and South Dakota, which have announced they will provide the vaccine on a voluntary basis, and Virginia’s requirement for the vaccine, although that was heavily marked up with exceptions.
The NCSL also confirms that Colorado also set up a fund to provide the vaccine, Indiana set up a plan to require the vaccinations and New Mexico is requiring that insurance plans cover the costs. A plan there to require the inoculations was vetoed.
In Maryland a plan to require the vaccine was withdrawn, and a similar proposal was killed Mississippi. Utah has approved an awareness campaign.
In California, the requirement is being set up for girls as young as 11. Lawmakers, instead of setting the requirement in the law, decided that an administrator shall adopt federal recommendations to impose the HPV vaccine.
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