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Saturday, September 6, 2008

Gardasil®

Gardasil®, Is it a massive public health experiment?

I have been telling the parents of my teenage patients to be wary of Gardasil® ever since its maker, Merck, tried to strong arm the Texas legislators to mandate it two year ago. My concerns about its safety proved to be warranted. A recent report published by Judicial Watch has summarized the approval process, side effects, safety concerns, and marketing practices related to the human papillomavirus (HPV) vaccine Gardasil based on records obtained under a May 2007 Freedom of Information Act (FOIA). The organization calls the approval of Gardasil as a vaccine as a “large-scale public health experiment.” Here are some of the report’s findings:·

78 cases of outbreaks of warts following the vaccine in women already infected without knowing it. Besides genital warts, some patients experienced massive outbreaks on the face, hands, or feet, sometimes caused by strains not included in the vaccine.·

The vaccine increases the incidence of CIN 2/3 (cervical endothelial neoplasia in moderate stage) in women who had persistent infection with “vaccine-relevant” HPV strains at baseline. · A chart in a report of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) showed an efficacy rate of –44.6% (that’s a minus sign) in subjects already exposed to “relevant HPV types.”·

Most tests with Gardasil were done against an adjuvant-containing “placebo,” rather than a nonreactive saline base, possibly making the vaccine appear safer than it actually is.· It reported that 27% of pregnant women experienced an adverse reaction upon receiving the vaccine, and the Vaccine Adverse Event Reporting System (VAERS) contains 45 cases of spontaneous abortion following Gardasil.·

A total of 8,864 VAERS reports have been filed, including 38 of Guillain-Barre syndrome and 18 deaths, 11 occurring within one week of receiving the vaccine. Association, of course, does not prove causality.

Diane Harper, M.D., a principal chief investigator in clinical HPV trials, was quoted in a Medscape article as saying, “The side effects that have been reported are real and they cannot be brushed aside.” She suggested that physicians not vaccinate patients with personal or family histories of the more serious complications, which have included neurologic disorders, thromboembolism, and autoimmune conditions.

Gynecologist Christiane Northrup, M.D., said on an Oprah show that she wouldn’t advocate vaccinating her daughters, and that medical dollars were better spent elsewhere. Of course her view is opposed by many vaccine front groups masquerading as consumer advocacy such as the National Cervical Cancer and HPV Coalition. In addition to that, The FDA and CDC issued a joint statement reassuring the public and physicians of the vaccine’s safety.

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