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Sunday, July 06, 2008

Gardasil Reports not good - Death toll linked to vaccine rises

More evidence the Merck HPV vaccine is not ready for the public and no state funds should be used to provide access for this vaccine.

25-page report:

KP Stoller, MD
President, International Hyperbaric Medical Assoc
Medical Director, Hyperbaric Medical Center of New Mexico (and New
Mexico Aspartame Detox Center)

July 01, 2008
Complications include shock, 'foaming at mouth,' convulsions, coma
"Anaphylactic shock," "foaming at mouth," "grand mal convulsion", "coma" and "now paralyzed" are a few of the startling descriptions included in a new federal report describing the complications from Merck & Co.'s Gardasil medication for sexually transmitted human papillomavirus which has been proposed as mandatory for all schoolgirls.

The document was obtained from the U.S. Food and Drug Administration by Judicial Watch, a Washington group that investigates and prosecutes government corruption, and it has details of 10 deaths just since September.

"Given all the questions about Gardasil, the best public health policy would be to re-evaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children, said Judicial Watch President Tom Fitton.

The organization's work uncovered reports of about one death each month since last fall, bringing the total death toll from the drug to at least 18 and as many as 20. There also were 140 "serious" reports of complications including about three dozen classified as life-threatening, 10 spontaneous abortions and half a dozen cases of
Guillain-Barre Syndrome.

The document reveals the case of an 18-year-old woman who got the Gardasil vaccine, was found unconscious that evening, and died. Another woman, age 19, got the drug and the next morning was found dead in her bed.

The new documents also reveal a total of 8,864 Vaccine Adverse Event Reporting System records, up from a total of 3,461 that had been reported in a document just last fall.

WND previously has reported how Merck was lobbying state lawmakers to require the vaccination, but said it would quit the campaign after its activities were unveiled.

WND also reported when a key researcher into human papillomavirus, which is targeted by Gardasil, reported it needed more testing, and how even the Centers for Disease Control suggested the vaccine should not be mandatory.

That, however, has not diverted the building campaign to have legislatures adopt mandatory vaccination plans.

Judicial Watch said one of the reports, VAERS ID: 310262-1 (D), had this to say:
"Information has been receivedconcerning 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 afterpatient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious."

Another report said, "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"

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.

A Judicial Watch report said, "Even though Gardasil will not be fully tested for safety until 2009, physicians are already pushing it as a routine, harmless vaccine. Merck's aggressive advertisement campaign tells young girls that their lives could be 'one less' affected by cervical cancer and that, 'It's your turn to help guard
against cervical cancer.'"

The report also estimated it will cost as much as $2 billion to buy vaccinations for the nation's poorest girls.

"This vaccine will be more expensive than all other childhood vaccines put together," concluded John Schiller, a National Cancer Institute investigator.

Judicial Watch earlier uncovered reports such as this:

"Initial and follow-up information has been received from a physician concerning an 'otherwise healthy' 13 year old female who was vaccinated with her first and second doses of Gardasil. Subsequently, the patient experienced paralysis from the chest down, lesions of the optic nerveAt the time of the report, the patient had
not recovered."

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 at the time.

"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.

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.

In 2007 Merck's aggressive lobbying campaign and contributions to Women in Govern

Gardasil Vaccine - Deaths And Adverse Reactions Update
Promoting Openness, Full Disclosure, and Accountability and

Judicial Watch Gardasil Vaccine Safety Update: 18 Deaths


***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. See

Examining the FDA's HPV Vaccine Records

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.

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

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

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.


Wed, July 2nd, 2008. 01:22 pm


Associated Press
Merck slips as FDA rejects wider Gardasil use
Associated Press 06.25.08, 2:04 PM ET



Shares of Merck & Co. fell Wednesday after the Food and Drug Administration declined to expand use of the cervical cancer vaccine Gardasil to women between 27 and 45 years old.

Also, the FDA said there isn't enough data to support updating the vaccine's label to include information about cross-protection against other subtypes of the HPV virus.

Gardasil was approved in 2006 for use in girls and women ages 9 to 26 to prevent cervical cancer caused by the human papillomavirus. It is the only FDA-approved cervical cancer vaccine approved for the lucrative U.S. market, and is outselling GlaxoSmithKline PLC's rival vaccine, Cervarix, globally.

The FDA's decision bars Merck from marketing Gardasil to women ages 27-45, but does not prevent those women from getting the vaccine from their doctors. Merck said it plans to respond to the agency next month.

In afternoon trading, shares slid 24 cents to $36.79.

Cowen and Co. analyst Steve Scala described the FDA's action as only a minor setback for Merck, since the 27-to-45-year-old female population wasn't viewed as a big revenue driver for Gardasil and the vaccine remains the only one of its kind on the U.S. market.

He maintained his "Outperform" rating on Merck shares.

Deutsche Bank's Barbara Ryan also maintained her "Buy" rating and agreed the age extension indication would only add a small upside to sales. She said the bigger opportunity for Gardasil is an application to expand use to males, expected later this year.

But Goldman Sachs' James Kelly said expansion to older women actually is an important source of growth for Gardasil, since he thinks current use in other catch-up populations (notably in patients 13-18 years of age) is approaching peak levels for product growth.

He added that while the company maintained double-digit earnings per share growth through 2010, he is only forecasting mid-to-high single digit growth in 2009 and 2010.

Is Vaccine Responsible for Teen Paralysis?


From Dr. Betty Martini: Parents be educated to protect your daughter. Many more articles on this. Remember that aspartame (NutraSweet/Equal/Spoonful/Canderel, E951, etc.) interacts with vaccines. Kids are using diet pop in schools, in chewing gum,
especially Wrigley's, pediatric prescription drugs and over-the-counter drugs. Aspartame also interacts with virtually all drugs because of damage to the mitochondria or life of the cell., and
Aspartame Toxicity Center,
Aspartame Information List, scroll down to banners
Health & Nutrition Secrets to Save Your Life, Russell Blaylock, M.D.,
Vaccinations: Deception and Tragedy, page 162,
Gardasil, More Dangerous than reported, Russell Blaylock, M.D.,
Aspartame Interacts with drugs and vaccines, James Bowen, M.D.

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