Tag: FDA

The First Six Pages of the Judicial Watch Special Report Examining the FDA’s HPV Vaccine Records

Judicial Watch, the US-based public interest group that investigates and prosecutes government corruption, obtained information about Gardasil from the U.S. Food and Drug Administration under the provisions of the Freedom of Information Act.    The first 6 pages of  the  Judicial Watch Special Report Gardasil VaccineExamining the FDA’s HPV Vaccine Records are posted below.

At the end of page 4 and on page 5 is evidence which shows that the HPV vaccine has led to outbreaks in warts in some people, which was denied as occurring by Dr Nikki Turner of the NZ Immunization Advisory Center.

Furthermore, at the end of page 5 and at the top of page 6 is mention that Gardasil was found to enhance disease in  recipients who already had “relevant HPV types” by 44.6 percent.   In spite of this Helen Petousis-Harris of the NZ Immunisation Advisory Center stated in a letter to The Whangarei Report: “There is no evidence that Gardasil increases the risk of precancerous lesions.” It states on the Gardasil insert in section 14: “Infected women may already have CIN 2/3 or AIS at vaccination onset and some will develop CIN 2/3 or AIS during followup, either related to a vaccine…”

Judicial Watch findings are summarized in an article entitled Controversial HPV Vaccine Causing One Death Per Month: FDA Report by Peter J Smith and the Judicial Watch document cited is in full here. On the 27th of March, when one clicked on this link,  a web page appeared which dissuaded people from accessing this information, by claiming the site could damage your computer, which is why I posted these 6 pages on this website.  However, since writing this post, the warning page has been removed. If it is up again when you look and you are willing to take a risk, click on “Ignore this warning” at the bottom right-hand-side of the red panel.  I did repeatedly and nothing adverse appears to have occurred to my computer.

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A Judicial Watch Special Report
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

June 30, 2008

Judicial Watch, Inc.  501 School Street, SW  Suite 500 Washington, DC 20024
Tel: 202-646-5172  Fax: 202-646-5199  www.JudicialWatch.org
Judicial Watch Special Report: Examining The FDA’s HPV Vaccine Records

Page 1 of 24
Introduction

This Judicial Watch Special Report is an analysis of records obtained from the Food and Drug Administration (FDA) concerning a recent vaccine called Gardasil.
Gardasil helps protect against four types of human papillomavirus (HPV). The vaccine was approved in May 2006 and was created and marketed by Merck & Company Incorporated.
The records 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 detailing 8,864 cases of adverse effects experienced by people after receiving the Gardasil vaccine. VAERS reports show that at least eighteen people have died after receiving Gardasil.1  Many health officials believe that adverse reactions to medications are widely underreported, therefore the actual number of adverse events occurring after vaccination with Gardasil is likely to be higher.
Judicial Watch obtained these records under the provisions of the Freedom of Information Act (FOIA), 5 U.S.C. § 552. The request, asking for documents concerning Gardasil, was originally submitted to the FDA on May 9, 2007. The FDA produced documents on May 15, 2007; September 13, 2007; February 27, 2008, and June 10, 2008.

Judicial Watch uncovered thousands of pages of material pertaining to Gardasil, which is designed to prevent cervical cancer. The controversial vaccine was fast-tracked for approval by the FDA despite concerns about Gardasil’s safety and long-term effects. The vaccine is still in the testing stages (final report due September 30, 2009), but it is already being administered to thousands of young girls and women.2  Mandatory vaccination has been opposed by the American College of Pediatrics and The New England Journal of Medicine. Legislators in 41 states and Washington, DC have introduced legislation to require, fund or educate the public about the HPV vaccine and 17 states have enacted legislation. Michigan, Texas and Virginia took steps toward mandatory vaccination for sixth grade girls; however, all three states have postponed that required mandate. 3

Judicial Watch is concerned by the facts detailed in the FDA’s adverse event
reporting associated with Gardasil. Merck has waged an aggressive lobbying campaign with state governments to mandate this HPV vaccine for young girls. Given all the questions about Gardasil, the best public health policy would be to reevaluate 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.
Thomas Fitton
President
Christopher J. Farrell Tegan N. Millspaw
Director of Investigations & Research Lead Researcher & Principal Author
Judicial Watch Special Report: Examining The FDA’s HPV Vaccine Records

Page 2 of 24

Executive Summary
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 aluminium-containing placebo was used. Aluminium 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.
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FDA Says No To Labels On Food From Genetically Engineered Animals

http://medheadlines.com/2009/01/23/fda-says-no-to-labels-on-food-from-genetically-engineered-animals/

In a recent announcement, the US Food and Drug Administration (FDA) says there is no reason to require labels for foods made from animals that were genetically engineered and sold to American consumers.  The animals themselves will require labels designating them as genetically engineered, once such an animal is created that passes the FDA approval process.  Thus far, no such animals have met approval for marketing.

The announcement was met with controversy.  Those in favor of genetic engineering of animals intended as part of the agricultural industry say the genetic manipulation will create livestock that grows faster, produces less toxic waste, and is more resistant to disease.  They also claim the foods derived from these animals will be healthier for the consumer.

Against using genetically modified animals in the nation’s food supply are those who think altering the molecular structure of these animals comes with the risk of unintended or unimagined long-term consequences.  Many opponents of the FDA decision say the consumer should know which food products come from genetically altered animals in order to make wiser choices of their own.

A Victory for Health – FDA Forced to Admit That Mercury Fillings are Hazardous

http://articles.mercola.com/sites/articles/archive/2008/06/26/a-victory-for-health-fda-forced-to-admit-that-mercury-fillings-are-hazardous.aspx?source=nl

The U.S. Food and Drug Administration (FDA) has finally admitted that metal dental fillings containing mercury can cause health problems in pregnant women, children and fetuses.

As part of the settlement of a lawsuit filed by several consumer advocacy groups, the FDA agreed to alert consumers about the potential risks on its Web site and to issue a more specific rule next year for fillings that contain mercury.

The FDA’s Web site now states that: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.”

Charles Brown, a lawyer for advocacy group Consumers for Dental Choice, said the agency’s move represented an about-face. According to Brown, “Gone, gone, gone are all of FDA’s claims that no science exists that amalgam is unsafe … The impact of the re-writing of its position on amalgam can hardly be understated. FDA’s website will no longer be cited by the American Dental Association in public hearings.”
Sources:

* eMax Health

* Reuters June 4, 2008

Dr. Mercola Dr. Mercola’s Comments:
This is indeed an authentic health victory.

Finally, the FDA has owned up to the fact that permanently installing a toxic substance like mercury inside of your mouth is not such a good idea, at least for those most at risk:

* Pregnant and nursing women
* Children
* Fetuses
* People with already high levels of mercury bioburden
* Those who are sensitive to mercury exposure

Dental amalgam fillings — which are made from about 50 percent mercury and the rest an amalgam of silver, tin, copper, zinc and other metals — have been used for more than 150 years, in an estimated 100 million fillings each year in the United States alone.

I don’t know how it’s gone on that long.

Mercury is a potent toxin that can damage your brain, central nervous system and kidneys. Children and fetuses, whose brains are still developing, are most at risk, but really anyone can be impacted. I find it quite ironic, not to mention unsettling, that the metallic mercury used by dentists to manufacture dental amalgam is shipped as a hazardous material to the dental office. Any amalgam leftover is also treated as hazardous and requires special precautions to dispose of.

Yet, most dentists will readily implant this hazardous material directly into your mouth, with assurances that it’s perfectly safe and harmless.

Now, at least the FDA has admitted the obvious: mercury fillings are dangerous.

As Usual, the American Dental Association Stands Its Ground

When asked whether silver mercury fillings are safe, the American Dental Association (ADA) states on its Web site:

“Yes. Dental amalgam has been used in tooth restorations worldwide for more than 100 years. Studies have failed to find any link between amalgam restorations and any medical disorder. Amalgam continues to be a safe restorative material for dental patients.”

So clearly they are not ready to admit they’re wrong. The economic consequences of all those lawsuits would devastate the profession. If they ever decided to agree with the new research and become more open-minded, my guess is that they would have to be bailed out by the U.S. Congress, which would shift the financial burden to the U.S. taxpayer, NOT the ADA.

They maintain that mercury fillings are “highly resistant to wear,” but what they don’t tell you is that when amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. More importantly, every time you chew food or brush your teeth, these fillings also release toxic mercury vapor.

Just How Much Mercury Do These Fillings Release?

Remember, any kind of stimulation can cause these fillings to release mercury. Eating, drinking, brushing your teeth, grinding your teeth, chewing gum, anything. If you want to see the vapors released for yourself, watch this shocking video.

Mercury vapor from the amalgams passes readily through cell membranes, across the blood-brain barrier, and into your central nervous system, where it causes psychological, neurological, and immunological problems.

For an interesting comparison, consider that scientists recently made a wise warning about eating mercury-contaminated seafood. Well, eating such seafood will expose you to about 2.3 micrograms of mercury a day. A single dental amalgam filling, meanwhile, releases as much as 15 micrograms of mercury per day.

But that’s not all. The average person has eight amalgam fillings and could absorb up to 120 micrograms of mercury per day. Clearly this is cause for urgent action to be taken. I was NO different. I had 16 fillings by the time I was in college.

What to Do if You Have Mercury Fillings

I do not believe that pregnant women and children are the only ones who need to worry about the mercury in silver dental fillings. I highly suggest that if you need to get a filling, you see a biological dentist who can recommend a truly inert material that will not harm your health.

I also recommend that you have any existing amalgam fillings removed … but avoid making the mistake I did 20 years ago by having it done by a non-biological dentist. You see, when you have these fillings removed you can be exposed to significant amounts of mercury vapors if the dentist doesn’t know what he or she is doing.

Although they may be more than technically competent and one of the most skilled dentists the earth has ever seen, if they haven’t received training in how to remove mercury safely let me strongly assure you they will harm you.

My mercury exposure from having this done improperly nearly caused me to lose both my kidneys and go on dialysis. Fortunately, I have access to some of the best medical minds on the planet and I was able to have the problem reversed.

For this reason, I suggest you get healthy BEFORE having your fillings removed, as you want your detoxification mechanisms optimized prior to removal.

Once you’re ready to go ahead with it, I’d say only about 5 percent of dentists know how to remove these fillings safely, so do your research and seek out a highly qualified biological dentist. Some things that need to be done to keep you (and your dentist) safe during the procedure include:

* Providing you with an alternative air source and instructing you not to breath through your mouth
* Using a cold-water spray to minimize mercury vapors
* Putting a rubber dam in your mouth so you don’t swallow or inhale any toxins
* Using a high-volume evacuator near the tooth at all times to evacuate the mercury vapor
* Washing your mouth out immediately after the fillings have been removed (the dentist should also change gloves after the removal)
* Immediately cleaning your protective wear and face once the fillings are removed
* Using room air purifiers

Meanwhile, if you’re concerned about the mercury burden in your body, I highly recommend reviewing my Mercury Detoxification Protocol, which details the things you can do right now to help detoxify your body of this toxic substance.

Related Articles:

Are “Silver” Dental Fillings Safe?

Is Toxic Mercury Exposure Ruining Your Life?

Mercury Toxicity and Systemic Elimination Agents

Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine

“Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormalities.”

Link
Event Reports Obtained from FDA Detail 1,637 Adverse Reactions to Gardasil

(Washington, DC) — Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. Three deaths were related to the vaccine. One physician’s assistant reported that a female patient “died of a blood clot three hours after getting the Gardasil vaccine.” Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.
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