From the Vitamin Lawyer Health Freedom Blog
http://vitaminlawyerhealthfreedom.blogspot.com/2008/11/divesting-fda-of-food-authority.html

Updated Action eAlert posting: https://staging.drrimatruthreports.com/index.php?p=1601

Action Item: Divesting the FDA:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=26314

Wednesday, November 26, 2008
Divesting the FDA of Food Authority

It’s been a year since an official government study of the FDA said:

1) The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
2) The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
3) The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
4) FDA does not have the capacity to ensure the safety of food for the nation.
5) The development of medical products based on “new science” cannot be adequately regulated by the FDA.
6) There is insufficient capacity in modeling risk assessment and analysis.
7) The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
8) The FDA has substantial recruitment and retention challenges.
9) The FDA has an inadequate and ineffective program for scientist performance.
10) The FDA has not taken sufficient advantage of external and internal collaborations.
11) The FDA lacks the information science capability and information infrastructure to fulfill is regulatory mandate.
12) The FDA cannot provide the information infrastructure support to regulate products based on new science.

From: the November 2007 Report of the Subcommittee on Science and Technology, “FDA Science and Mission at Risk.”

The FDA is a failed agency that, in Dr. Ron Paul’s words engages in “abuse of power.”

Even the FDA’s own scientists are complaining about the corruption that pervades the agency: http://www.naturalnews.com/z024910.html

I believe that due to its focus on the drug industry (80% of its funding comes from Big Pharma “user fees”) and its failure to protect the safety of the food supply, while engaging in international “HARMonization” that degrades organic standards and allows ever-increasing levels of toxins (including antibiotic residues) in the food supply, the FDA is incapable of administering food regulations.

The FDA’s prejudice against nutrient supplementation and traditional, natural remedies means these advanced healthcare alternative competitors to pharmaceuticals are denigrated, marginalized and regulated against.

See also the Natural Solutions Foundations recent comments to the FDA condemning the agency’s latest moves against nutrients: https://staging.drrimatruthreports.com/index.php?p=1449

What is the answer? It is to, in the immortal words of John Galt, “Get out of the way.” We need to engage market forces to stimulate advanced alternatives to a medical system that is now the major source of death in our society. We need to divest the FDA of any authority over foods. Maybe then it can focus on the dangers of pharmaceuticals, including the uninsurable risks of vaccinations.

We need to free Foods (including nutrients and natural remedies) from the deadly hands of the FDA.

The FDA has implied interest in imposing a patently illegal restriction on the interstate commerce of nutrients and supplements if there has EVER been a scientific study published about the supplement.

Not only is that insane, creating a new category of dangerous substances that might be called “Anything anyone has ever studied that competes with drugs”, it is also in direct violation of US law, to say nothing of the Constitution of the United States.

The law it violates is a provision of the 2007 FDA Authorization Act that clearly states nothing in the Act shall apply to products covered by DSHEA, the 1994 Dietary Supplements Health and Education Act. Nonetheless, FDA is now questioning whether the Act’s Section 301(11) provision allowing FDA to stop interstate commerce in food substances ever studied for possible drug approval applies to dietary supplements (for details see the copy of our statement to the FDA below).

So this bizarre twist of logic, ingenious as it is, has nothing to do with legal authority by the FDA to ban supplements from interstate commerce – which it does not have.

But think about why the FDA would want to do that. Clearly, because nutrients are the single most significant economic competitor to drugs. Drugs are expensive. Nutrients are cheap. Drugs are dangerous. Nutrients are safe. Drugs kill people (23% of all adverse reactions reported to the FDA are fatalities). Nutrients do not kill people. Drug sales are reportedly off 13% in the economic downturn. Could it be that the pharmaceutical industry, which literally owns FDA decision making capacity (through permitted conflicts of interest, revolving door policies which put corporate executives in executive positions in the FDA and then the titles switch so that the same person now has a corporate executive position instead of an FDA position) and through user fees might be serving the interests of its economic masters? It certainly appears that way.

Natural Solutions Foundation is proud to have risen to the challenge because of hundreds of thousands of health freedom advocates when the FDA Authorization Act of 2007 was being debated and brought the issue squarely home to Senator Harkin (R-IL). The Senator introduced an amendment which protected all DSHEA products. Now the FDA is flagrantly ignoring the law of the land.

Health freedom advocates can go to http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=26269 to let the FDA know that this attack on supplements and other DSHEA products is illegal under US law.

You can read the formal comments of the Natural Solutions Foundation to the FDA about this issue below.

Don’t forget that the Natural Solutions Foundation is supported by tax deductible donation (https://staging.drrimatruthreports.com/index.php?page_id=189) and the sales of highly recommended publications and products like Valley of the Moon(TM) (https://staging.drrimatruthreports.com/?page_id=1130) chemical-free, GMO-free, shade grown, 100 % hard bean coffee from the Natural Solutions Foundation’s Valley of the Moon(TM) Coffee Finca. Your $25 donation will bring you our thanks and a 1/2 lb. bag of what we believe to be the purest coffee anywhere. You can also find outstanding products and services at our online stores, www.Organics4U.org and www.NaturalSolutionsMarketPlace.org.

Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
www.NaturalSolutionsFoundation.org
www.Organics4U.org
www.NaturalSolutionsMarketPlace.org
www.NaturalSolutionsMedia.tv
—————–

Comments of Natural Solutions Foundation to the FDA Regarding Comments Request

Natural Solutions Foundation is a Non-Governmental Organization (NGO) consumer group organized as an exempt entity in the United States (State of Nevada) and in several other countries. Our primary web site is www.HealthFreedomUSA.org and we have over 185,000 supporters, primarily Americans.

These comments address the third question raised by FDA in its call for comments, namely how the Section 301(11) restrictions on commerce might apply to dietary supplements, thereby restricting consumer choice.

National Solutions Foundation was one of the institutions that helped educate members of Congress and other decision makers regarding the relationship of Dietary Supplements regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to the enhanced authority granted FDA by Congress in the 2007 Food and Drug Act Amendments.

Due to determined public expression, including messages to Congress by hundreds of thousands of citizens, section 1011 of the Act was included, the Rule of Construction that states, “Nothing in this title (or an amendment made by this title) shall be construed to affect– (1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417)”

The 301(11) restrictions must be interpreted under the exemption for DSHEA products intended by Section 1011. As a result, DSHEA products must be allowed in interstate commerce without interference by the provisions of section 301(11).

However, the same requirement of law does not apply to food products that contain “trace” or more amounts of extraneous hormones, pesticides, pharmaceuticals, including antibiotics, irradiation break-down products and other toxins introduced to food during its processing. Such adulterated foods should not be on the market.

In its unseemly reach for more authority to restrict consumer choice in nutrients the FDA seeks to ignore the plain Congressional intent of Section 1011 and the unanimous Congressional intent of DSHEA that Dietary Supplements are foods, deemed safe when used as directed.

In this way, FDA continues to exhibit why it is time for Congress to consider divesting FDA of its food authority. FDA has failed to protect the American food supply and is institutionally incapable of responding constructively to consumer choice in nutrition.

Ralph Fucetola JD
NSF Trustee

Gardasil is the best example of a rapid deployment, must-have quick fix for a non-emergency problem making over a billion dollars for the purveyors of illness care. How many more disasters of vaccines and drugs that kill will it take before consumers say, “NO!” to proffered absurdities like Gardasil and Vioxx when pap smears and natural anti inflammatory preparations, along with immune support and decent diet render them unnecessary.

Isn’t it time? Read the article below carefully. Then go to https://staging.drrimatruthreports.com/index.php?page_id=699 to order your copy of the Natural Solutions Foundation Vaccine Exemption eBook. It’s your body and it’s your decision!

Yours in health and freedom,
Dr. Rima
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
www.NaturalSolutionsFoundation.org
www.Organics4U.org
www.NaturalSolutionsMarketPlace.org
www.NaturalSolutionsMedia.tv

DONATE NOW https://staging.drrimatruthreports.com/index.php?page_id=189 All deductions are tax deductible if you pay taxes in the US.

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Gardasil seems to be beset with problems
Marilyn Juds
Prince George
November 2, 2008

More complications with Merck, the pharmaceutical producers of the HPV vaccine Gardasil. Uncommon knowledge, tucked away on the New York Times webpage of Feb. 21, 2007, is the promise by Merck to quit lobbying U.S. state legislatures. An angry backlash from parents, advocacy groups and public health experts across the U.S. forced Merck to back down due to possibly jeopardizing its sales.
Originally most state legislatures wanted mandatory HPV inoculations. But now that has generally been replaced. As Lawrence Gaston of Johns Hopkins University notes: “A response to the rush to mandate could backfire on us with public dissatisfaction as a deterrent to all vaccinations.” Many state legislatures are now advocating a five-year moratorium on mandatory inoculation to further review the drug’s efficacy. In any case, most states allow parental opt-out provisions.
Over an over, in medical journals, newspaper articles and health networks, the overruling question is why has Gardasil been rushed to market without proper and extensive testing techniques? (Gardasil is still in the testing stage and will not be fully evaluated for safety until September 2009.) So it begs the question: how was FDA able to OK its marketing in 2006?
In a Globe and Mail article last year entitled: “How Politics Pushed the HPV Vaccine,” was included a graph showing the rate of cervical cancer mortality in Canada between the years 1970 and 2005. By 2005 cervical cancer deaths had dropped to .003 per cent of the female population. While unfortunate, hardly a public health crisis.
Aluminum is a troubling ingredient in Gardasil. For each 0.5-ml dose, there are 225 mcg of aluminum. As one medical specialist observed: “Aluminum needs a hard look as a vaccine component as mercury does. We are learning it also causes cell death – a lot of cell death – in the brain.”
Medical practitioners can record patient reactions to vaccinations through VAERS (Vaccination Adverse Events Record System). Unfortunately, recording vaccination events is not mandatory, so VAERS only reflects about 10 per cent of patients’ distress. It cannot indicate adverse events in any accurate measure. Nevertheless, it helps to glean some idea of Gardasil’s dangers.
Judicial Watch.org is a public interest group that investigates and prosecutes government corruption. It has been regularly tracking the FDA’s HPV vaccine records. By now it has discovered more than 8,000 side-effects, as well as deaths, and has detailed its concerns.

http://www.princegeorgecitizen.com/20081102159354/opinion/letters/gardasil-seems-to-be-beset-with-problems.html

The two articles listed below make horrifying and compelling reading. They document the fraud upon which Gardasil rests, its dangers and its astonishing profitability: vaccination with Gardasil is more expensive than all other childhood vaccinations combined.

I do not believe anyone should be vaccinated for anything. I believe no one should be vaccinated with Gardasil. And I certainly do not believe that anyone should ever, EVER, be vaccinated or drugged involuntarily. Children, drugged or vaccinated by State mandate against their parents’ wishes? I have no words to describe how strongly I oppose any such measure.

The issue is not cervical cancer or even vaccination. The issue is freedom. Who owns your body, your daughter’s body and who decides what goes into them?

It is our responsibility to alter both laws and social forces by social action to make sure that the answer to those questions is a resounding “I DO!” Please visit Natural Solutions Foundation at www.HealthFreedomUSA.org and sign up for the Health Freedom eAlerts (https://staging.drrimatruthreports.com/index.php?page_id=187) so you can be part of that resounding cry of freedom.

Yours in health and freedom,
Dr. Rima
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
www.NaturalSolutionsFoundation.org
www.Organics4U.org
www.NaturalSolutionsMarketPlace.org
www.NaturalSolutionsMedia.tv

DONATE NOW https://staging.drrimatruthreports.com/index.php?page_id=189 All deductions are tax deductible if you pay taxes in the US.

For donations in multiples of $25, we’ll say “Thanks” with a 1/2 lb bag of our full bodied Valley of the Moon(TM) Coffee: Shade Grown, GMO and Chemical Free Coffee from the Chiriqui Highlands of Panama, it’s Friendly Food Certified: Friendly to Your Health, Friendly to the Workers and Friendly to the Environment https://staging.drrimatruthreports.com/?page_id=1130

HUMAN PAPILLOMA VIRUS VACCINE FRAUD

By Dr. James Howenstine, MD.
November 3, 2008

For several years the pharmaceutical firm has made aggressive efforts to market the Gardasil human papilloma virus vaccine as a prevention for cervical cancer. The governor of the state of Texas made the administration of this vaccine to young girls mandatory.

What is the truth about this vaccine?

Natural News reporter Mike Adams has uncovered some interesting facts about this vaccine. The FDA has been aware since 2003 that Human Papillloma Virus [1] does not cause cervical cancer. The Gardasil vaccine is unable to eradicate HPV virus from women who have been exposed to HPV(nearly all sexually active women). This makes vaccinating all young women in Texas against HPV virus a very questionable decision.

To make matters even worse it has now been learned that vaccinating women with Gardasil may actually increase the risk that those women harboring a benign cervical HPV viral infection have a 44.6 percent increased risk of having their benign HPV infection converted into a precancerous state by the HPV vaccine administration. Thus women vaccinated with Gardasil not only receive no benefit those who were sexually active before the vaccine administration have become at increased risk for developing cervical cancer.

To summarize some of the facts about HPV and this vaccine:

• HPV vaccine increases the risk of developing a precancerous cervical lesion by 44.6% in women .previously infected with a HPV viral type found in the vaccine.
• HPV virus does not cause cervical cancer.
• HPV viral infections are self limiting and are not a health threat to healthy females.
• This valuable information about the etiology of HPV viral infections has been suppressed from public knowledge.
• Allowing untruths about Gardasil to be disseminated in public hearings and planting fear have been used to promote sales of this worthless vaccine.

The Evidence for the Gardasil Fraud

HiFi DNA Tech was involved in manufacturing a portable device for testing for HPV viral infection. This company, to improve sales, needed to have their product reclassified as Class II instead of Class III because Class III category products are not able to be sold to the public whereas Class II products can be sold to the public because they are deemed safe enough for public release.

For 20 years the FDA had classified the HPV test as a test for cervical cancer. In 2003 the FDA changed its position advising that HPV virus was not associated with cervical cancer. On Oct12, 2007 HiFi DNA Tech sued the FDA to get their testing device reclassified as Class II based on the knowledge that cervical cancer was not caused by HPV infection .and therefore did not need to be restricted from public sales. The fact that the FDA had already acknowledged in a policy statement on March 31, 2003 that “most infections by HPV are shortlived and not associated with cervical cancer. Most women who become infected with HPV are able to eradicate the virus and suffer no apparent long term consequences to their health.” It is not the HPV virus itself that causes cervical cancer but rather a persistent state of ill health on the part of the patient that makes her vulnerable to cervical cancer. Repeated transient HPV infections even when caused by high risk types of HPVs are characteristically not associated with an increased risk of developing squamous intraepithelial lesions, the precursor lesion of cervical cancer.

This was not revealed when the public hearings over the need for mandatory HPV vaccinations was pushed by manufacturer of Gardasil. The FDA had known for many years that HPV was unrelated to cervical cancer but to have this knowledge disseminated during the hearings would have instantly made the HPV vaccine worthless.

The main push from the drug company has been that we “must save these young girls from losing their lives to cervical cancers.” The FDA knew when these hearings were held that this argument was phony but said nothing.!!!

Does the HPV Vaccine Actually Increase the Risk of Cervical Cancer?

Gardasil vaccine actually increases the risk for a sexually active woman to develop cervical cancer (nearly all sexually active women have been exposed to HPV virus). Women who have already been exposed to HPV from sexual activity and have positive serologies for HPV viral types found in the HPV vaccine have a 44.6% increased risk [2] for developing high grade precancerous cervical lesions after they have received Gardasil vaccine injections. This means that young women carrying a harmless form of HPV viral infection often get converted after HPV vaccine, into a more dangerous precancerous cervical condition. that can lead to cervical cancer.

These patients were made worse by exposure to a vaccine that contained a virus that had already infected them. Thus this evidence reveals that Gardasil increases disease in 44.6 % of patients who already been exposed to the same serotype found in the vaccine. This strongly suggests that sexually active women can become more likely to develop cervical cancer after taking Gardasil vaccine.

This information puts the state of Texas in the position where theoretically the Gardasil should be given only to young females who are virgins (sexually active females have existing HPV infections that may become more dangerous if given the vaccine). Questioning these young women about sexual activity may lead to sexually active girls denying sexual activity in the presence of parents or physician thus leading to HPV viral administration to a female with previous HPV infection who does have an increased risk of developing pre-invasive cervical lesions because of exposure to the vaccine. Thus females denying sexual activity will have an increased risk of getting pre-cancerous cervical lesions which can lead to cervical cancer.

To make this situation even worse the health officials that will be involved in screening candidates for HPV vaccine are heavily involved in promoting vaccine administration (They almost certainly have no idea the vaccine is worthless and capable of causing precancerous cervical lesions). Therefore the truth about the danger of cervical cancer resulting from the vaccine given to sexually active girls will not be given to these young women. This will probably cause an unnecessary increase in cervical cancer.

The FDA Is A Badly Flawed Agency

The FDA is administered by 12 officials. Three of these 12 persons are automatic appointments given to the pharmaceutical industry. If there ever was a situation where the fox is in charge of the chicken house this is it. It is common knowledge among these 9 selected officials that if they play ball with the drug industry they will be moved up to high paying positions with drug companies for their final working years. Very few appointed officials will have the character, with these temptations placed in front of them, .to make honest decisions. One can be certain that no one who had a healthy skepticism about the pharmaceutical industry would ever get appointed to the FDA.

It needs to be understood by the general public that the FDA is an effective arm of the pharmaceutical industry and has nothing at all to do with public health. [Emphasis added – REL] Anyone who doubts this statement need only look at the record of scams condoned by the FDA:

1 – The original director of the FDA, Dr.Harvey W. Wiley, resigned in disgust when he realized in 1912 that pressure from the food and pharmaceutical industries was preventing him from abolishing nutritionally worthless white flour.

2 – Fluoride was added to the water in both Germany under Adolf Hitler and Russia under Josef Stalin to keep the populace “dumbed down and easy to control.” There is scientific evidence that fluoride actually increases cavity formation [3] so the cover story about the virtue of fluoride decreasing cavity formation is fraud. Most US cities place fluoride in their water and this does increase the incidence of cancer by 10% when compared to cities not using fluoride in their water. The U.S. Environmental Protection Agency has classified fluoride as more toxic than lead but less toxic than arsenic. U.S. Congressmen placed spring water in their offices when faced with the danger they might be forced to drink fluoride containing water.

3 – Aspartame excites and kills neurons along with causing seizures.. This toxic substance is now found in most packaged foods and beverages. Aspartame causes neurologic symptoms that mimic Multiple Sclerosis and brain tumors. These symptoms disappear when aspartame intake ceases. FDA approval for this dangerous substance was obtained despite some serious health concerns. by responsible health oriented experts.

4 – Monosodium glutamate MSG (Accent) is an excitogen that increases the appetite leading to repeat food sales and weight gain. This substance is added to a multitude of foods with no labeling. MSG causes Chinese Restaurant Syndrome, mimics neurologic diseases (M.S.,. A,L.S., Parkinson’s Disease, headaches, and seizures), hypoglycemia, learning disorders, hyperactivity, and Attention Deficit Disorder

5 – Nitrogen, phosphorus, and potassium fertilizer has made North American soil the poorest of all the seven continents. Poor quality foods grown from these depleted soils obviously damage the health and mental capability of the unfortunate citizens living in North America. This fertilizer was approved over strenuous objections by knowledgeable academic agricultural experts. Much US soil no longer contains the critical element selenium (cancer risk increases, infections spread).

6 – Genetically modified food has never before been consumed by humans. World famous geneticist Dr. Mae-Wan Ho states that “insertion of foreign genes into the human gene pool has long been known to have many harmful effects including cancer in the recipient organism” The results of safety testing on GMO foods have never been released to authorities and the FDA does not require GMO foods to be labeled so the public is unable to avoid eating these dangerous foods..

7 – Salk polio vaccine was given to 10,000,000 persons even though FDA leaders knew that the vaccine contained Simian Virus 40 and other dangerous viruses which can cause leukemia, lymphoma, HIV and other significant health problems. Sloppy animal isolation techniques .were the probable cause for this problem. The whistle blower was admonished for discovering this important contamination because “it was beyond the scope of her job description.”

8 – Federally mandated nitrogen, phosphorus and potassium fertilizer has resulted in making North American soil the most depleted soil of the 7 continents tested. The critical elements selenium and sulfur are now missing from large amounts of U.S. soil.

9 – Codex Alimentaris, now implemented in parts of Europe (Norway, Germany), will probably soon become law in the USA. This will change valuable nutrients like vitamin C, alpha lipoic acid, and CoQ 10 into drugs requiring prescriptions which will raise the cost of these valuable substances. This impending lack of less expensive supplements will damage the health of the American people. Supplement makers may be forced to sell their companies to take it or leave it type pharmaceutical company offers. [See www.HealthFreedomUSA.org for a more comprehensive discussion of Codex Alimentarius. Enter “Codex” in search bar. REL]

10 – Vaccines cause major health problems(autism, 4000 deaths in children admitted in the first year of Hepatitis B vaccine{only 10 % of adverse reactions get reported. etc.}. Pharmaceutical firms have been exempted from lawsuits by Congress for vaccine damages which are common.

Health problems created by a malfunctioning FDA are wonderful for the pharmaceutical industry because they increase the sale of drugs.

The drug company involved in the sale of Gardasil is caught in a torrent of lawsuits caused by the failure to warn the public that a widely used arthritis drug they had marketed was known to commonly cause deaths from heart attacks. This company has a sordid history of price fixing, tax avoidance, biopiracy, collusion with the FDA on how to discredit critics, purchasing negative evidence for its drugs and other activities that could be considered criminal in nature. Their product Gardasil should obviously never be given to any woman.

Thanks to Dr. James Howenstine for this excellent review of the Gardasil and related issues – REL

Footnotes:

1, FDA News Release March 31, 2003
2, FDA VRBPAC Background Document: Gardasil HPV Quadrivalent Vaccine May 18, 2006 VRBPAC Meeting
3, Howenstine, James A Physicians Guide To Natural Health Products That Work pg 76. 2008 Source www.mynaturalhealthteam.com Phone 1-800-416-2806

EIGHTEEN DEATHS LINKED TO GARDASIL VACCINE REPORT CLAIMS

By NWV Staff Writer, Sarah Foster

July 17, 2008

A recent publication by a conservative watchdog group has rekindled media interest in a controversial anti-virus vaccine and sent Big Pharma and federal health agency officials into damage control mode.

In a 25-page special report released June 30, Judicial Watch — a Washington DC-based nonprofit organization that promotes “transparency and accountability in government” – presents evidence based on government documents that in the two years since being licensed by the Food and Drug Administration, Merck & Co’s Gardasil, heavily promoted as a safe and effective vaccine against cervical cancer, has been connected with nearly 9,000 “adverse events,” including the deaths of 18 – perhaps 20 – girls and young women.

In addition, there were 140 “serious” events reported (27 categorized as “life-threatening”), with 10 spontaneous abortions and six cases of Guillain-Barre Syndrome – all since January 2008.

Guillain-Barre Syndrome (GBS) is a rare, potentially devastating autoimmune disorder that attacks the peripheral nervous system and can lead to paralysis and, occasionally, death. There is no known cure or cause, but a fact sheet from the National Institute of Health says it’s sometimes triggered by surgery or vaccinations. Judicial Watch uncovered a total of 38 cases of GBS have been filed with the FDA since June 2006 (six since January) among girls who had received at least one dose of the three-dose vaccine.

The records indicate 10 deaths since last September, bringing the total number of Gardasil-connected death reports in the United States to at least 18 – four of these were from blood clots, nine from unknown or unidentifiable causes.

The fatalities include:

* A 20-year-old woman with no medical history reported, who was vaccinated April 1, 2008, with Gardasil and died four days later, seeking medical attention. An autopsy was performed which ruled out suicide or anything suspicious. The cause of death is currently unknown. [VAERS ID 310262-1 (D)]
* A 12-year-old girl with no reported medical problems, who died in her sleep of known causes on Oct. 6, 2007, three weeks after receiving a Gardasil shot. [VAERS ID: 297528-1 (D)]
* An 11-year-old girl, vaccinated in May 2007 with a first dose of Gardasil, who died three days later after going to an emergency room. A physician at the hospital said “death was due to an anaphylactic [severe allergic] reaction to Gardasil.”[VAERS ID 280163-1 (D)]

Because adverse reactions to medication tend to be under reported, Judicial Watch believes the actual number is likely to be higher.

“I think we’ve uncovered a lot of disturbing things about Gardasil,” said Judicial Watch president Tom Fitton. “All we’re asking for is further investigation of its safety. We’re not convinced they’re taking these reports seriously.”

Gardasil is the first vaccine on the market that targets the four strains of sexually transmitted human papillomavirus (HPV) believed to account for most cases of cervical cancer and genital warts infections.

HPV is not contagious in the way tuberculosis or measles or the common cold is. You don’t become HPV-infected by being in a crowd or sitting near someone, but through skin-to-skin contact. There are over 100 strains of HPV, 30 of which are sexually transmitted – and of these 30, 15 can cause cervical lesions and other abnormalities that may develop into cervical cancer, while about 12 can cause genital warts. Two of the strains targeted by Gardasil (HPV 16 and 18) are believed responsible for 70 percent of the cancer cases, the other two (HPV 6 and 11) cause 90 percent of the genital warts infections.

The FDA approved Gardasil on June 8, 2006, for girls and women ages nine to 26. Less than a month later the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended vaccination for all girls, ages 11 to 12. The committee’s first report on Gardasil was published the following March.

Gardasil was fast-tracked and received FDA approval before testing was complete and its final safety evaluation trials won’t be concluded until Sept. 2009. Despite this, the drug is being aggressively mass-marketed on TV and at the movies in ads pitched to young girls, including preteens, and state legislators were heavily lobbied to make the drug mandatory for school girls ages 11 up. Sold worldwide, Merck reports over 16 million doses of the vaccine have been distributed in the U.S. , and eight million women and girls have received at least one shot of the three-dose regimen.

The special report – its complete title is 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 — continues work Judicial Watch began in 2007 when it published two analyses (the first in May of that year, the second in Oct.) of Gardasil-related documents it had received in sets from the FDA, after making requests through the Freedom of Information Act.

As in its earlier reports, the group raises serious questions about the vaccine’s effectiveness, safety, long-range effects and overall costs — which are astronomical. At $120 a shot ($360 for the requisite three-doses), Gardasil is the most expensive vaccine on the market. [Emphasis added – REL]

The VAERS Reports

Using FOIA, Judicial Watch obtained thousands of pages from the FDA, including 8,864 reports filed by doctors, nurses, parents and others with the Vaccine Adverse Events Reporting System [VAERS] – a database shared by the CDC and FDA — detailing reactions experienced by girls and women after receiving at least one shot of the vaccine.

Besides the deaths, the VAERS reports reveal a gamut of reactions – from trivial to terrifying — including vomiting, dizziness, seizures, paralysis and Guillain-Barre Syndrome, swelling at the injection site and in lymph nodes in the neck and groin, fevers, hives, shortness of breath, nausea and flu-like symptoms.

There were reports of a sudden appearance of blisters on a 20-year-old’s upper arms and back and ano-genital warts on a 12-year-old. A 15-year-old reported blisters that appeared in her vaginal area within two days of receiving the vaccine and spread to her upper body and behind her ears and knees. These lasted five to seven days, then developed scabs.

Judicial Watch’s use and dissemination of VAERS reports have drawn criticism from the FDA, the CDC, Merck and other advocates of the vaccine, in part because anyone can file a VAERS report — physicians, nurses, family members and patients — so the accounts tend to be dismissed as “anecdotal” and lacking-in-evidence. More important, they don’t prove the vaccine caused the event.

In the wake of the Judicial Watch report, Merck issued a press statement downplaying the findings.

The mega-drug company claimed to have “analyzed the adverse events reported for Gardasil … and based on the data available to Merck, believes that no safety issue related to the vaccine has been identified. … An adverse experience report describes an event that occurred after vaccination and does not necessarily mean that the vaccine caused or contributed to the event. The vast majority of adverse events that have been reported to Merck are non-serious and the most common include dizziness and syncope (fainting).”

In a similar vein, FDA spokeswoman Kelly Riley told the Sydney Morning Herald, an Australian newspaper, that there was nothing in the VAERS reports to cause a review of the usefulness of the vaccine. “These adverse reaction reports have not been analyzed. If there’s a death after someone received a vaccine, and long after they had a car crash, a bee sting … these would be filled out. It does not mean Gardasil caused it.”

The FDA and CDC said that safety data reviewed in approving Gardasil showed only mild side effects, like pain at the injection site or fainting.

But Tegan Millspaw, the report’s lead researcher and principal author, says these critics are missing the point.

“Judicial Watch was not and is not interested in proving causality,” she writes. ”Only science can do that. And that is why we asked for more investigation of the VAERS reports to ensure there was no causality between Gardasil and the serious reported adverse reactions”

There were 18 deaths, she points out – and of those, 11 occurred less than a week after the girl had received the vaccine, seven in less than two days.

“Perhaps all these deaths are simply coincidence, but given the unknowns about Gardasil and its overall safety, it is far too important an issue to simply ignore,” Millspaw states.

Making Bad Symptoms Worse

Attracting less attention from the media are the cases of groin and genital warts – 78 VAERS-reported cases — which weren’t supposed to happen considering that Gardasil is a vaccine against the two strains of HPV that cause 90 percent of such outbreaks. But Gardasil is not a cure, it is a preventative medication – and in some instances it seems to have triggered outbreaks or made existing conditions worse, for there are reports of warts suddenly appearing after vaccination on the face, hands, feet and chest.

“Not only will Gardasil not cure pre-existing HPV, it can also make symptoms worse,” warns Millspaw in the report. “Women who already have the virus without knowing it could suffer massive outbreaks of genital warts or abnormal precancerous lesions, both of which require extensive treatment.”

“The outcomes that can result from pre-exposure are disconcerting and deserve far more attention.”

Contacted by telephone, Millspaw told NewsWithViews of her concern that Merck did not screen women prior to vaccination for possible HPV exposure or infection.

“The reason they target very young girls is it’s easier to assume they don’t have the viruses – but the women are not screened to see if they’ve been exposed. The FDA allows that, which I find very disturbing.”

Asked whether the drug could cause sterility, Millspaw told NewsWithViews there’s “no indication” of this – “but they’re now vaccinating very young girls, so it will be years before long-term effects are known. They haven’t done enough tests to know at this point.” [Emphasis added -REL]

Millspaw brought up another long-range possibility. “A lot of scientists are worried that preventing these four strains may just cause other HPV viruses to take their place,” she said. “That could be serious, particularly because while the vaccine protects against two main forms of cervical cancer the other [13] strains are usually more severe.”

“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,” said Tom Fitton in a press release. “In the least, governments should rethink any efforts to mandate or promote this vaccine for children.” [Emphasis added – REL]

Backlash

Fitton was referring particularly to the action that sparked the most controversy about the vaccine and unleashed a furious backlash against it: Merck’s aggressive lobbying aimed at state legislatures.

The company began marketing the drug even before the FDA gave the green light. Not by name – that would be illegal — but through a sophisticated, high-pressure public relations campaign using TV and Internet ads designed to frighten young girls about cervical cancer and HPV, so that they would accept – and demand – the drug once it became available.

But Merck was not content merely to advertise the vaccine and make it accessible to those who wanted it; as soon as it got the high-sign from the FDA it funded a huge lobbying effort to persuade state lawmakers to mandate Gardasil vaccination of young girls, including preteens, as a condition for attending public or private school.

The campaign has been fairly successful. To date: 41 states have introduced legislation to require, fund or educate the public about the HPV vaccine and 17 enacted legislation. Three considered making vaccination mandatory.

It was too much. Parents and consumer advocates from all points across the political spectrum were outraged, and in Feb. 2007 Merck announced it was dropping its lobbying campaign – though its TV advertising continues. But the lobbying was so intense, many former supporters were inspired to take a closer look at Merck and to question its motives for mass-marketing a drug before it’s been fully tested and evaluated for safety and efficacy.

A ‘Wonder Drug’ for Merck?

For instance, last July Judith Siers-Poisson, editor of PR Watch, authored a devastating four-part series for CounterPunch, a leftist biweekly newsletter, titled “The Politics and PR of Cervical Cancer,” in which she took a hard look at HPV and Gardasil – “the facts, the hype, and what Merck stands to gain, the marketing campaigns … and the media’s lack of attention to concerns about the rush to mandate vaccination…”

“Gardasil is being touted as a “wonder drug” for women. Might it also be a wonder drug for Merck?” Siers-Poisson asked then answered:

“In the world of drugs, vaccines for use by the whole population are close to corporate nirvana since they ensure a mass market for prevention instead of having to wait to identify the smaller number of people who actually develop a particular disease. In addition, mandating vaccination helps ensure a mass market and gets the government involved in what would otherwise be left to market forces.” [Emphasis added -REL]

The drug could likely go far in replenishing the pockets of the firm as it recovers from the Vioxx recall, in which Merck’s pain medication was held to be responsible for 27,000 heart attacks and sudden cardiac deaths. Analysts estimate that the Vioxx recall decreased Merck’s stock value, and could cost Merck up to $20 billion in legal settlements.

At $360 for the three-shot regimen, Gardasil is the most expensive vaccine the FDA has ever approved. A measles-mumps-rubella combo costs $42.85. The New York Times estimates that making the vaccine mandatory would double the cost of existing vaccine programs. And John Schiller, a senior investigator for the National Institute, told the Times “This vaccine will be more expensive than all childhood vaccines put together.”

But whether paid for by insurance, tax dollars, or individual parents – at $360 a patient Merck is guaranteed billions of dollars.

It’s already paying off. Even without Gardasil being mandated, the incessant campaign has persuaded millions of young women to be vaccinated – and netted Merck $1.5 billion in sales revenue in 2007, according to the Securities and Exchange Commission.

How Serious a Threat?

But how serious a threat is the disease which is already costing millions of dollars to vaccinate against?

Cervical cancer is a major killer of women in non-industrial nations – as it once was in this country. Worldwide it affects 470,000 women and kills 233,000 each year. This is not the case in the United States thanks to widespread Pap screening. This is a medical screening test involving the examination of cells taken from the cervix to detect pre-malignant and malignant cervical cancer cells. It is named after its inventor, Dr. George Papanicolaou, who developed it over 60 years ago.

As a result of routine Pap tests and early, follow-up treatment when necessary, the deaths from cervical cancer plummeted 74 percent between 1955 and 1992, according to the American Cancer Society, and that rate continues downward by about four percent a year.

Today in the United States cervical cancer is so rare that it is not on the National Cancer Institute’s list of 13 most common cancers. To qualify as a common cancer, the estimated annual incidence for 2008 had to be 35,000 cases or more.

Nor is it among the top 10 deadliest diseases for women, which are heart disease and stroke, followed by lung cancer (third place, with 71,030 deaths), breast cancer (6th, with 40,480 deaths) and colon cancer (10th with 25,700 deaths), according to the American Cancer Society.

The American Cancer Society estimates that in 2008, about 11,070 women in the United States will be diagnosed with invasive cervical cancer in the United States and 3,870 women will die from it. The tragedy behind those deaths is that they could likely have been prevented had the women received regular Pap tests and treatment.

Millspaw concludes: “With these statistics in mind, one must ask whether Gardasil vaccination is absolutely necessary, especially for children. At this point in time, we do not know if it will prevent cancer, or whether it will have unforeseen consequences. The American public must ask themselves if Gardasil is really worth the risk. Fast-tracking drugs and vaccines before their safety has been fully evaluated is unethical and dangerous, and until more tests have been completed on Gardasil no vaccination mandates should be established.” [Emphasis added – REL]

Below is a list from the special report summarizing objections to the vaccine

* Gardasil has not been tested thoroughly enough to know whether it will be safe or effective in the long term.
* Even if it is shown that the Gardasil vaccine is effective, it is still unknown how long the vaccine lasts or if there will be a need for booster shots.
* Regardless of its potential to help prevent HPV and cancer, Gardasil should never be administered without a prescreening for HPV since it has the potential to make existing cases worsen.
* It is important that people remember that this vaccine will not eliminate the need for regular PAP screening. No vaccine is 100 percent effective, and Gardasil is designed to protect against only four strains of HPV.
* While Gardasil may be an important medical advance, it is unwise to compromise the health and safety of the American public, especially children, by mandating or marketing it before sufficient tests are concluded.

Links for Further Reading

1. Judicial Watch has posted its earlier publications, VAERS reports and other documents on its website: http://www.judicialwatch.org/gardasil

2. George F. Sawaya, M.D., and Karen Smith-McCune, M.D., Ph.D: “HPV Vaccination: More Answers, More Questions,” New England Journal of Medicine, May 10, 2007

3. Judith Siers-Poisson: “The Politics and PR of Cervical Cancer”four parts), posted at PR Watch.

4. Cindy Bevington: “Researcher blasts HPV Marketing.” An interview with Diane Harper, Fort Wayne Daily News.