[Pflienews] PharmFacts E-News Update: HPV Vaccine Updates

Tue Jul 1 12:10:25 MDT 2008

*PharmFacts E-News Update -- 1 Jul 2008 AD #2

NB: GSK announced yesterday that their HPV vaccine, Cervarix, will be 
delayed in the US until sometime in late 2009 due to less than stellar 
results submitted to the FDA...

http://www.google.com/news/url?sa=t&ct=us/0-0&fp=486aa268c1550cc7&ei=TnJqSJupMIfsyATvnJjHAw&url=http%3A//online.wsj.com/article/SB121484151326916113.html%3Fmod%3Dgooglenews_wsj&cid=1224229756&usg=AFQjCNG82std0P5cNCHVdx7gG2XXK_ascg
*

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

FYI

***Though approved for marketing by the FDA in May 2006, Merck's HPV 
vaccine, Gardasil, is still in the testing stages, and will not be fully 
evaluated for safety until September 2009.

Gardasil gained FDA approval under a fast track process--within 6 months 
of testing. Fast-track approval is a process reserved for life-saving 
products with the potential to fill an unmet medical need, such as, new 
cancer treatments or AIDS drugs.

A special report issued by Judicial Watch, "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" is (June 30, 2008) shows that aggressive lobbying by 
Merck--rather than medical need backed by scientific data--led the FDA 
to approve Gardasil before adequate testing for safety had been completed.

The report is a MUST READ for every parent considering vaccinating a 
daughter with Merck's papillomavirus (HPV) vaccine, Gardasil. The report 
should be required reading for every public health official and policy 
maker.
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf

Thousands of documents were obtained by Judicial Watch after filing a 
lawsuit against the FDA.  The documents include Merck's patent and drug 
information submitted to the
FDA, transcripts and briefing material from approval meetings, and 
reports documenting health, safety, and efficacy test results, as well 
as Vaccine Adverse Event Reporting System (VAERS) documents.

VAERS reports provide details about 8,864 cases of adverse effects 
experienced by girls and women after receiving the Gardasil vaccine.  
Since January 2008, the FDA identified 140  as "serious" reports (27 
were categorized as "life threatening"), 10 spontaneous abortions and 6 
cases of Guillain-Barre Syndrome .  VAERS reports show that at least 
eighteen people have died after receiving Gardasil.  See adverse effect 
reports submitted to VAERS: http://www.judicialwatch.org/gardasil

*Adverse report excerpts include:
*
    * Information has been received...concerning a 20 year old female 
with no medical history reported, who on 01-APR-2008 was vaccinated with 
a dose of Gardasil....The patient died four days after...patient sought 
unspecified medical attention. An autopsy was performed which ruled out 
suicide and anything suspicious. The cause of death is currently 
unknown. VAERS ID: 310262-1 (D)

    * Information has been received.concerning a 23-year-old female.who 
on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil...the 
patient experienced anaphylactic shock 2 minutes after vaccination 
characterized by a brief loss of consciousness...respiratory arrest, 
eyes rolled upwards, blurred vision and greyish skin tone...Anaphylactic 
shock was considered to be immediately life-threatening. VAERS ID: 
304739-1 (S)

    * Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, 
Immediate post-injection reaction....Pt [patient, 14-year-old female] 
received vaccine, took 6 steps, fell to the ground unconscious and had a 
60 sec grand mal seizure then regained consciousness. [Blood pressure] 
after seizure 60/40 pale clammy skin. [Patient] had bit her tongue and 
had foam around her mouth. VAERS ID: 305259-1 (S)

    * Information has been received from a physician concerning a female 
patient who on an unknown date was vaccinated with a dose of Gardasil. 
Subsequently, the patient experienced a coma and is now paralyzed. At 
the time of this report, the patient's outcome was unknown. VAERS ID: 
303188-1

Most health officials believe that adverse reactions to medications are 
vastly underreported, as they are optional. Safety experts estimate that 
only between 1% and 10% of adverse effects are reported. Therefore the 
actual number of adverse events occurring after vaccination with 
Gardasil is likely to be much higher.

Based on the reports submitted to the VAERS database, Gardasil is 
demonstrably a risk-laden vaccine.

Even without Gardasil, cervical cancer deaths have decreased drastically 
in the past several decades. The American Cancer Society estimates that 
deaths from cervical cancer declined 74% between 1955 and 1992, and that 
the rate continues to decrease by about 4% each year.

Since condoms are indisputably a safe, non-invasive, cost-effect method 
for protecting boys and girls / men and women against ALL sexually 
transmitted diseases -- Why are we exposing American girls and young 
women to a public health experiment whose benefits are unclear while its 
risks include death ?

Below is the Executive Summary of Judicial Watch's special report.

Contact: Vera Hassner Sharav
veracare at ahrp.org
212-595-8974

*Judicial Watch Special Report: Examining The FDA's HPV Vaccine Records*

*Executive Summary*

(See full report at:

http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf)

In May 2007, Judicial Watch submitted a request to the FDA under the 
Freedom of Information Act for all records concerning Merck's new 
anti-HPV vaccine, Gardasil.

After Judicial Watch filed a lawsuit in October 2007 to compel record 
production, the FDA finally released four sets of documents, the last in 
June 2008. These records detail the development and expedited approval 
of Gardasil. The documents include patent and licensing memoranda, test 
reports for the vaccine, and the final briefing document on Gardasil 
submitted to the FDA in April 2006, one month before the vaccine was 
approved. The FDA also produced 8,864 VAERS reports. Judicial Watch 
uncovered a transcript of Merck's May 18, 2006, meeting with the 
Vaccines and Related Biological
Products Advisory Committee (VRBPAC), at which the vaccine received a 
unanimous vote of approval.

*Analysis of the records shows:
*
. Gardasil is a prophylactic, preventative vaccine and will not treat 
pre-existing HPV infection. It is not a cancer vaccine or cure.

. Gardasil is marketed as a vaccine that prevents cancer, but it " . . . 
has not been evaluated for the potential to cause carcinogenicity or 
genotoxicity."

. Gardasil is not 100% effective against all HPVs. It is designed to 
protect against only four strains of HPV, even though there are over 
thirty strains including at least fifteen that can cause cancer.

. While Gardasil is the most expensive vaccine ever to be recommended by 
the FDA, its long-term effectiveness is unknown and could be as brief as 
only two to three years.

. During testing, an aluminum-containing placebo was used. Aluminum can 
cause permanent cell damage and is a reactive placebo, unlike most 
standard saline placebos. This means that tests of Gardasil may not have 
given an accurate picture of safety levels.

. Although some states are considering making it mandatory for young 
girls to get the Gardasil vaccine, it has only been tested with one 
other vaccine commonly given to children. There are ten commonly 
administered adolescent vaccines.

. Gardasil is still in the testing stages, and will not be fully 
evaluated for safety
until September 2009. VAERS reports show that as many as eighteen people 
have died after receiving Gardasil.

*See full report:
*http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf

------------------------------------------------------------------------

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