Judicial Watch, using records obtained under a May 2007 Freedom of Information Act
(FOIA) request, has summarized the approval process, side effects, safety concerns,
and marketing practices related to the human papillomavirus (HPV) vaccine Gardasil.
It calls these a "large-scale public health experiment."
As noted in a release by the The Asssociation of American Physicians and Surgeons
(AAPS) one of the most troubling findings is 78 cases of outbreaks of warts
following the vaccine in women already infected without knowing it. In addition to
genital warts, some patients experienced massive outbreaks on the face, hands, or
feet, sometimes caused by strains not included in the vaccine.
Additionally, the vaccine could increase 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% (minus sign) in subjects already exposed to "relevant HPV types."
On June 25, 2008, the FDA denied Merck's application to expand marketing of
Gardasil to women aged 27 through 45. The FDA refused Judicial Watch's request for
a copy of the letter to Merck, stating that it may be available under FOIA.
Merck also failed to win approval to expand the vaccine to more strains and has
reportedly dropped plans to do so.
In its report to the FDA, Merck noted that "it is not known whether Gardasil can
cause fetal harm when administered to a pregnant woman." 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 pre-condition for fast-tracking Gardasil was a requirement for a safety
surveillance study, which will not be complete until June, 2009. Not to be deterrred
intensive marketing continues by Merck.
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. It
should be noted that association does not prove causality.
In an article that appeared in MedScape on July 26, and was quickly taken off the
website, Diane Harper, M.D., a principal chief investigator in clinical HPV trials,
was quoted 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.
"The cause of recent complications remains a mystery and it is difficult to know
whether they are linked to vaccines," the article stated.
Two physicians, a cardiologist and a rheumatologist, say they regret their decision
to immunize their 17-year-old daughter and will not encourage his younger daughters
to receive the vaccine. After being vaccinated, their eldest went from being a
healthy athlete to a chronically ill patient. He worries that other girls may be
struggling with immune damage, feeling achy and unwell, but going undiagnosed and
unreported.
Gynecologist Christiane Northrup, M.D., appearing on the Oprah Winfrey Show, told
viewers that she wouldn't advocate vaccinating her daughters, and that medical
dollars were better spent elsewhere.
To add more future fear to the folly the FDA and CDC issued a joint statement
reassuring the public and physicians of the vaccine's safety.
What were they thinking?
