aaps hpv: Judicial Watch reports on the Gardasil public health experiment

[Guest guest]

Judicial Watch reports on the Gardasil public health experiment

August 25th, 2008

http://www.aapsonline.org/newsoftheday/0046

Based on records obtained under a May 2007 Freedom of Information Act

(FOIA) request, Judicial Watch 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. "

One of the most startling findings is 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.

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% (that's a

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.

Most tests with Gardasil were done against an adjuvant-containing

" placebo, " rather than a nonreactive saline base, possibly making the

vaccine seem safer than it actually is.

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.

Nonetheless, intensive marketing continues.

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.

The entire Judicial Report is available.

<http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf>

[pdf via link]

Mandating HPV vaccine is a matter of the public good vs. private rights,

states andra M. , J.D., who worked under contract from Merck

with the Washington University Medical Center to study Medicaid

coverage for HPV vaccine. The intimate mode of transmission is " a

distinction without a meaningful difference " ; therefore, legal

precedents justifying mandates should apply to Gardasil, she writes (/N

Engl J Med/ 2007;356:1998-1999).

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.

The FDA and CDC issued a joint statement reassuring the public and

physicians of the vaccine's safety.

/MedScape/ was accused of " germ theory denialism " (apparently for

suggesting that it might be fruitful to investigate how most patients

successfully fight off HPV) and " antivaccination myths. " It was also

criticized for having the " chutzpah " to run a poll on how physicians

were reacting to the reports about adverse events and the FDA/CDC

advisory, and the poll has apparently been pulled also.

*Additional information:*

* " The Case Against Gardasil, " by AAPS Director Hilton P. Terrell,

M.D., /AzMedicine/, Spring 2008.

<http://www.azmedassn.org/publications/2008_01-Spring.pdf>

* " Serious Reactions Attributed to HPV Vaccine, " AAPS News of the

Day 5/24/07. <http://www.aapsonline.org/nod/newsofday429.php>

* " Hands Off Our Kids, " /AAPS News/, March 2007.

<http://www.aapsonline.org/newsletters/mar07.php>