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Tuesday, June 24, 2008

NJCVC Member Responds to Opinion Letter.

After reading the vituperative letters in response to Assemblywoman Vandervalk's excellent OpEd piece on vaccination (June 17), I am devastated that we are shutting down the dialogue with vicious name calling. It's through debate that facts are disclosed, beliefs are challenged, alternatives are examined, change and progress occur. Until big questions regarding universal vaccination can be adequately addressed, Ms. Vandervalk is fighting for New Jersey’s right to have a choice. Too many people feel entitled to summarize topics of great complexity without offering a balanced assessment nor admitting where science has not kept up with our desire to believe in this last sacred cow of public health policy.

Is it possible that we do not fully understand every mechanism of the miraculous human body and that we therefore have not foreseen all the ramifications of our expanding decision to inject entire generations of children with more pathogens and toxins than ever before in the history of the world? Do not think for one moment that vaccination is a simple medical procedure. It is entwined into our medical, societal, political, state and federal governmental and industry systems with billions of dollars at stake. But please don't worry about the man behind the curtain. It's much easier to believe you are protecting your precious babies with every vaccine that modern man can concoct. So hang on for the ride, because there are 70 shots on the CDC schedule and 350+ vaccines under development.

If Jill Stoller traced disease rates since the 1800s, she would find that deaths fell substantially, nearly disappearing before mass immunization was even introduced. Disease was spread by overcrowding, malnutrition and raw sewage in the streets. Disease was halted through improved sanitation and hygiene. And yes, Irwin Berkowitz, these diseases are prevalent in other parts of the world, but only because developing countries do not benefit from the health and sanitation infrastructure that we take for granted in America.

As for Dr. Stoller’s assertions that vaccines don’t cause autism, she should have called Dr. Julie Gerberding, who admitted last week that the methodology used in CDC safety studies was flawed design_b_108398.html or Dr. Bernadine Healy, former head of the NIH and current IOM member who said last month that our government fails to study vaccine-injured populations because they are afraid of what they might find.

Dr. Stoller further asserts that 85% of children must be vaccinated or diseases will return. Why aren’t there raging epidemics among adults who are notoriously undervaccinated? We have forgotten that measles and chickenpox were never deadly. Many adults get shingles today because chickenpox is no longer prevalent and we aren’t naturally boosted through periodic, benign exposure. Good thing there’s now a herpes zoster shot, 14x stronger than Varivax and, incidentally, recommended by the CDC. Until we do the long-term, controlled studies, we will never have the answers we need. Gardasil was fast-tracked through the FDA so quickly that they didn’t do efficacy testing for 11-year-olds. We don't even know how long its immunity lasts. Let’s admit that the system is not protecting our children.

I ran marketing for a top global investment firm. As someone who commissioned market research, I know that data can be manipulated to tell a story. There are no short cuts in life. We have to roll up our sleeves and do the work. Today, we no longer hear that "More Doctors Smoke Camels Than Any Other Cigarette." It took our government thirty years to stand up to Big Tobacco. Our children don't have thirty years.

Louise Kuo Habakus
Middletown, New Jersey
June 24, 2008

Wednesday, June 18, 2008

Free public lectures and Q&A by David Kirby on Vaccine / Autism link

Calling All Vaccine-Autism Critics**

David Kirby, Huffington Post

In the next two weeks, I will give three public lectures and Q&A sessions, free and open to the public, at Brown University in Providence, NYU Law School in Manhattan, and Northeastern University in Boston. (Other events are to be announced soon for New Jersey, Long Island and Southern California).

I sincerely encourage any and all vaccine-autism skeptics, critics, agnostics and cynics living in the northeastern US to please consider attending one of these talks, armed with all of your most pointed, difficult and critical questions.

For my part, I will present slides showing evidence to support and refute the link between autism, vaccines, mercury & heavy metals, air pollution and other environmental factors.

My only arguments will be that the evidence is NOT conclusive against a link, and it is premature to declare that vaccines and their ingredients have been 100% exonerated as environmental contributors to autism.

I hope to have a reasoned and enlightening public discussion with members of the audience. Among the subjects we will tackle are:

1) The Poling Case - in which the government conceded that vaccines induced autism in one little girl, and updates on other court cases.

2) Brand New Evidence - of a link between mitochondrial dysfunction and autistic regression, and evidence of mitochondrial issues in many ASD kids.

3) Research Underway - at top universities on the connection between environmental toxins, oxidative stress, glutathione depletion, neuro-inflammation and autistic encephalopathy.

4) Declarations - By the US Presidential candidates and the former NIH director that autism is epidemic and calling for more research into vaccines and mercury as possible causes.

5) Recent Studies - Linking autism spectrum disorder with heavy metals and contaminants in air pollution.

Here are the times and locations:

PROVIDENCE: Thursday, June 19 - 6:30-9:00PM
Brown University, Salomon Center, Room 101
On the Campus Green
Hosted By Wendy Fournier, President of the National Autism Association

NEW YORK CITY: Thursday, June 26 - 6:30-9:00PM
NYU School of Law, 40 Washington Square South
Vanderbilt Hall, Room 204
Hosted By Mary Holland, NYU Law School

BOSTON: Friday, June 27 - 6:30-9:00PM
Northeastern University
Behrakis Health Science Building (Bldg #26) - Room 10
Hosted by Dr. Richard Deth, Northeastern University Professor of Pharmacology

This series was made possible by Generation Rescue, Autism Research Institute, National Autism Association, Coalition for SAFE MINDS, and Talk About Curing Autism.

Announcements for each event can be downloaded at - please feel free to circulate these electronically and otherwise to all interested parties.



Coalition Member Response to July 2008 Article in PARENTS Magazine

I am usually one to use PARENTS magazine as a decent resource. I was horrified to see the article in the magazine issue I received today. The article is named, "Why Babies Need Shots." It is a a completely biased article that literally begins with the following statement "Your infant really does need all those vaccines she's scheduled for in her first year. We'll tell you what she's getting and why each one is vital to her health." Need I say more about the rest of the article? Well, I will anyway.

The article "explains" how there is no vaccine-autism link and how the the shots 'prevent'epidemics etc. One statement reads, "You can limit the number of jabs your baby receives by requesting combination vaccines, which protect your child against multiple diseases with a single shot." (PARENTS, July 2008, p. 36)

The article adds a Q&A section explaining that the vaccines are safe because they are researched "extensively" before and after approval. When delving into the issue of mercury and autism, the article actually states that, "The truth is that a baby typically is exposed to 25 times more mercury by breastfeeding for six months...than by a flu shot...Methyl mercury, found in fish, takes almost two months to break down and leave the body. Thimerisol, which is ethyl mercury, is rapidly eliminated--within a week."

Another horrible coommentary was in response to vaccine overload. Their response was "Your infant is already exposed to thousands of germs on a daily basis (whether or not he's in child care). Even if your baby got 11 shots at the same time, he would need to use only 0.1 percent of his immune system to respond." (PARENTS, July 2008, p. 39).

Finally, they "address" the vaccine court cases and try to debunk Hannah Poling's win by reporting that the court "...did not concede that vaccines caused autism. Turns out Hannah was born with a rare mitochondrial disorder...and the court ruled that the stress of immunizations may have aggravated her condition, leading to autistic-like symptoms." (PARENTS, July 2008 p. 39). They then continue their argument: "If she had gotten a vaccine-preventable disease like the flu or chicken pox, she could have suffered far worse health consequences. Experts recommend that these children, especially, get vaccinated."

I wrote a letter to their "Mailbag" section to request a fair article on "our" side of the vaccine issue (copy below). If anyone else wants to do the same the email is". Since the article is brand new, take a look inside next time you are in the store (no one says you have to purchase it). My only problem is that I have my opinions, but I do not feel I have the proper qualifications and facts to respond sufficiently. Any help with multiple emails to them would help.

Oh yes and most of the advertisers are either pharmaceutical companies or for medicines...BIG HUGE SHOCK ON THAT ONE! There's a time and a place for everything, but please...


PS here's the letter i sent:

"Normally, I refer to PARENTS magazine for many baby issues and usually enjoy the
magazine. However, I was very disappointed to read the "Why Babies Need Shots" and "Hot Topic: Vaccines and Autism" in the July 2008 issue. There were many misconceptions in these writings and it was a very biased, one-sided pair of articles.

The original intent of vaccines was to eradicate horrible communicable diseases, however, your articles neglected to show the evolution of the contents of vaccines. Mercury, aluminum, formaldehyde, and antifreeze are just a few components that the companies themselves list as ingredients in their immunizations. Pregnant mothers are asked to avoid fish because of the mercury content, yet the shots have far greater amounts in them. Aluminum is one of an array of metals that have horrific effects on the human body as seen in the plethora of people contaminated with heavy metal poisoning. Formaldehyde used to be used in classrooms as a preservative in activities such as frog dissection. This substance is now banned and prohibited because it is a toxic poison. Finally, antifreeze is a toxic liquid used in cars and can be fatal if swallowed. All of these ingredients are toxic, yet parents are supposed to be blindly accepting of them being put in a baby's bloodstream? These ingredients were not always used in vaccinations.

Additionally, there are a multitude of other studies that show the common and dangerous side effects of those injections, and yet other studies that show groups that choose not to vaccinate that have no autism among their people and none of the communicable diseases either. One such study involved the observation of the Amish people.

As a scientist, I would like to know what studies are the basis of these articles, especially the statement about breastfeeding over six months gives a baby 25 times more mercury than a flu shot (PARENTS, July 2008, p. 38). Think of this, if this statement is accurate, the article is equating ONE SHOT given at ONE TIME to SIX MONTHS of exposure to the same contaminate...This statement alone should make one think about inoculations. One shot equals six months of mercury? How should that make a parent feel BETTER about the injection?

Another resource that I would have liked to have been cited is the one that states that. "Even if your baby got 11 shots at the same time, he would need to use only about 0.1% of his immune system to respond." This does not sound right. If this was, then why is this not the recommended schedule?

Also, consider this, pharmaceutical companies back medical textbooks, doctor incentives, and provide almost a million dollars per MINUTE to advertising their product...THEY have a lot to lose if their products do not sell. They are not going to sit with a child that has a reaction to their product, nor are they going to pay or apologize for any side effects they may suffer from either.

Please check the facts: There have been several products on the market, including
vaccines, that have been taken off the shelves for recalls despite their "extensive" research before and after the product was approved.

Please understand, vaccines have their place, but there needs to be an understanding that they are not perfect solutions and need much more research by outside groups with nothing to gain from them. How is it that the side effects are far worse now than in years before? "Cleaner" vaccines need to be considered and produced as well as other alternatives to keeping the communicable diseases out of our children. There are two sides to every story and being fully informed can help parents make educated decisions about the subject rather than being forced into a situation with scare tactics that some in the medical community use to get children vaccinated. This is not an exaggeration, this is the truth and I have experienced this first-hand. Parents need to have the right to decide for themselves what is put into their child/ren not big corporations.

I would love to see some real research into the other side of the vaccine issue and a follow up article. There are wonderful groups, (such as NJ Alliance for Informed Choice in Vaccination, New Jersey Coalition for Vaccination Choice, and the Holistic Moms Network) out there that are simply looking for a "fair shake" within this issue. They do not have the money that big corporations have to shed light on their perspectives, which deserve a look.

Respectfully yours,

MK in NJ"

Tuesday, June 17, 2008

A260/S1071 on the Gary Null Radio Show

Tomorrow, Wednesday, June 18, between 12 and 1pm, Gary Null will be discussing the Conscientious Exemption to Mandatory Vaccinations bill, A260/S1071 on his radio show. We invite you to tune into radio station, 91.5 FM, as Gary will be featuring Lawrence Palevsky, MD FAAP ABHM, Mayer Eisenstein MD JD, and Sue Collins, of NJ Coalition for Vaccination Choice, to discuss the issues surrounding New Jersey's mandatory vaccine schedule and the need for the Conscientious Exemption to Mandatory Vaccinations. Dr. Palevsky and Sue Collins gave testimony at our recent Senate Health Committee hearing.

If you are in the NY Metropolitan area, you may access the show on 91.5 FM, starting at noon, or you may listen to the broadcast anywhere via your computer, by clicking this link: (and then accessing the button "Click here to listen to PRN" on the upper left of the webpage). If you are not able to listen to the live show, you may access an archive of the show within a day or so via this webpage:

We thank the legislators who have researched the critical issues surrounding the one-size-fits-all vaccine mandate policy and are sponsoring this important bill; we invite all legislators to continue to learn more about the risks involved with mandatory vaccinations by tuning into tomorrow's show.

If you have any questions, please feel free to contact us: We hope you will join us for this lively and informative discussion!

Best regards,
NJ Coalition for Vaccination Choice

Vandervalk: Vaccines - shots in the dark?

Vandervalk: Vaccines - shots in the dark?
Tuesday, June 17, 2008

The lack of safety studies has been at the core of what has been terrifying many parents who have been researching the issue of compulsory vaccinations for children.

AHMED SOLIMAN'S column ("Don't let parents opt out of children's inoculations," Other Views, June 12) decries the parents who oppose compulsory vaccinations.

He laments the suffering of a family whose child did not have the benefit of a particular vaccine. Does he also lament the suffering of the more than 4,800 families who are now in the process of suing in a special federal court because they believe their children were seriously damaged by a vaccine?

Does he lament the many deaths caused by vaccines? Does he know that the compensation for a dead child in such instances has been established at $250,000?

Does he know that in New Jersey there are 60 doses of vaccines mandated by the state Department of Health by the time a child is 6 years old?

It must be pointed out that appropriate safety studies have not been done — no double-blind studies and no studies about the safety of combining several vaccines into a multiple dose.
The lack of safety studies has been at the core of what has been terrifying many parents who have been researching this issue.

Unfortunately, it is the extent to which children have been damaged that is driving this concern.
The public and the media are rightly concerned about pollutants in our waterways, on our recreation fields and in the environment in general. Some of these same pollutants are being injected directly into the bloodstreams of our babies by way of vaccines, in quantities larger than permitted by federal law for our environment.

If you check the package inserts of vaccines, which are written by the vaccine manufacturers, you will find aluminum, mercury, formaldehyde, latex rubber and a variety of potentially cancer-causing chemicals.

These package inserts also warn of serious side affects, such as encephalitis, myelitis, seizure, Guillain-Barre syndrome, multiple sclerosis, even sudden death.

Unvaccinated and risk

Do unvaccinated people cause a risk to the rest of society? No. Just look at the older generation of Americans who grew up prior to vaccine proliferation. We are not spreading epidemics.

On the contrary, some vaccines are made from live viruses, and they can spread the disease to those in close contact with the vaccinated person. There are 19 states that allow a type of philosophical exemption, and their residents have not had epidemics.

There has been a recent report of eight cases of measles in California, to which a mother responded in the press, "I'll take measles any day over autism."

Look at the Amish people in Pennsylvania. They do not vaccinate, and they do not have any outbreak of autism. Most European countries as well as Canada, Australia and Japan have rescinded their vaccination requirements.

In 1975, Japan stopped vaccinating babies under 2 years old, and it went to the top of the charts worldwide for low infant mortality. It had previously ranked somewhere in the middle.

Manufacturers have been exempted from liability in producing vaccines. Therefore, when a court decides a child has been seriously damaged by a vaccine, it is the taxpayers who will foot the bill.

New Jersey allows both a religious exemption and a medical exemption; however, the medical exemption is worthless. I have seen firsthand how a doctor's letter explaining the medical risk to a particular child was overruled by officials. That family is moving to Pennsylvania.

The American Association of Physicians and Surgeons has called for a halt to mandated vaccines until appropriate safety studies are done. In the meantime, parents should have the right to decide about vaccines for their children.

Charlotte Vandervalk, R-Westwood, is an assemblywoman serving the 39th Legislative District. Send comments about this column to

The "Other" Heavy Metal, Aluminum, in Vaccines
The Doctor's Corner
National Vaccine Information Center

Aluminum and Vaccine Ingredients: What Do We Know? What Don’t We Know?
by Lawrence B. Palevsky, MD, FAAP

Thimerosal, which contains the organic compound ethyl mercury, is a known neurotoxin and used to be a major ingredient in childhood vaccines. There are over 15,000 articles in the medical literature describing the adverse health effects on the human body with exposure to varying amounts and forms of mercury.

In 1999 the American Academy of Pediatrics (AAP) urged government agencies to work rapidly toward reducing children's exposure to mercury from all sources. Because any potential risk was of concern, the AAP and the USPHS (United States Public Health Service) agreed that the use of thimerosal-containing vaccines should be reduced or eliminated. [1] The AAP recommended that it would be a good idea to remove thimerosal from vaccines, even though according to them, there was no evidence linking childhood health issues to thimerosal exposure from vaccines. In 2008, children are still being injected with thimerosal-containing vaccines, and old stocks of thimerosal-containing vaccines manufactured by 1999 continued to be administered to children up to 2003.

However, a growing number of physicians, scientists and parents maintain that thimerosal has played, and continues to play a large role in contributing to the emergence of multiple chronic illnesses in children and adults, including the neurological spectrum disorders. Aluminum, which is present in the environment and in many childhood vaccines, may be affecting the health of our children in ways that we have yet to understand.

Aluminum is a heavy metal with known neurotoxic effects on human and animal nervous systems. It can be found in the following childhood vaccines – DTaP, Pediarix (DTaP-Hepatitis B-Polio combination), Pentacel (DTaP-HIB-Polio combination), Hepatitis A, Hepatitis B, Haemophilus influenzae B (HIB), Human Papilloma Virus (HPV), and Pneumococcal vaccines. [2]
In 1996, the American Academy of Pediatrics issued a position paper on Aluminum Toxicity in Infants and Children which stated in the first paragraph, “Aluminum is now being implicated as interfering with a variety of cellular and metabolic processes in the nervous system and in other tissues. [3]

A review of the medical literature on aluminum reveals a surprising lack of scientific evidence that injected aluminum is safe. There is limited understanding of what happens to children when aluminum is injected into their bodies, including whether or not it accumulates in tissues and organs or is properly eliminated from the body. It is also unknown if genetic factors affect long term adverse health outcomes for those injected with aluminum containing vaccines.

One in 6 children under the age of 18 in this country has developmental/learning disabilities, although the numbers may be higher since this 1994 report was published. [4] Ten percent of all children have asthma. [5] Growing numbers of children are living with different types of allergies. That means they have impairment, or even irreversible damage to their nervous and immune systems. Isn’t it possible that injected aluminum plays a role in affecting the health of our children’s nervous and immune systems, as the science we do have seems to suggest?

What is even more concerning is the lack of accepted scientific data explaining whether injected aluminum interacts with other vaccine ingredients to cause harm to our children. Boyd Haley, PhD, Professor Emeritus of Chemistry at the University of Kentucky completed lab experiments showing the damaging effects on nerve cells when he exposed them to aluminum, especially in the presence of other vaccine ingredients like mercury, formaldehyde, and the antibiotic neomycin. [6] [7] His data, however, have been ignored by the scientific, medical and governmental institutions making vaccine policies. [8] The scientific community needs to be doing these experiments in the lab before shooting kids with these ingredients and declaring unequivocal vaccine safety for all children.

Aluminum is added to vaccines as an adjuvant so vaccines will produce a stronger antibody response and be more protective. It is this role as an adjuvant that may reveal to us the most significant relationship between aluminum in vaccines and the damage it imparts on the long term health of our children’s nervous and immune systems.

A Little Science Review

Children are born with a cellular mediated immune system (TH1 cells – T-helper 1), a humoral immune system (TH2 cells – T-helper 2), and a regulator immune system (TH3 cells – T-helper 3) as major pieces of their overall immune systems. These three arms are immature when babies are born, and begin to mature as children are exposed to their environments through their nervous systems, skin, airways and intestines. Antibiotics, poor nutrition, stress, exposure to heavy metals and other environmental toxins, and the use of vaccines, may interfere with the proper maturing process of these three arms of children’s immune systems. In theory, if the TH system is allowed to mature, and is not interfered with, children will develop a mature, balanced TH1, TH2 and TH3 immune system by age three.

TH1 and TH2 develop to protect children from the outside world, producing inflammation and anti-inflammation responses to foreign particles from the natural environment. TH3 immune cells develop to keep the TH1/TH2 arms of the immune system in check so the body only produces the amount of inflammation and anti-inflammation that is needed to protect itself from exposures in the natural environment.

When TH2 cells are activated properly, either directly via the natural environment, or through a direct signal from the TH1 system, the B cell arm of the immune system is then stimulated, leading to the production of the desired protective antibodies. [9] [10]

It’s important for the reader to know that the hallmark of a healthy, mature immune system in children is demonstrated by an equal and balanced TH1, TH2 and TH3 immune response to the natural environment. TH1, TH2 & TH3 do not work independently, and require a very important synergistic relationship to function properly in our bodies. As soon as one or more of these three arms begins to over or under work in relation to the other, chronic illness begins to express itself.

More on Aluminum

Aluminum is placed in the vaccines to selectively target the up-regulation of the humoral arm (TH2 cells) of children’s immune systems, to drive the production of antibodies. The medical community leads us to believe that this production of antibodies is what imparts for children a protective nature against vaccine-preventable illnesses. Yet, this outcome may come at a cost.
There are multiple articles in the medical literature demonstrating how chronic illnesses like allergies, [11] [12] asthma, [13] [14] [15] eczema, [16] lupus, [17] inflammatory bowel disease, [18] ADD/ADHD [19] and autism [20] all exhibit a skewed production and over-activity of the TH2 arm of the immune system.

Similarly, chronic illnesses like juvenile diabetes mellitus [21] [22] and rheumatoid arthritis, [23] multiple sclerosis, [24] uveits, [25] inflammatory bowel disease, [26] and autism [27] [28] all exhibit skewed production and over-activity of the TH1 arm of the immune system.
While aluminum in the vaccines is specifically targeting the over-activation of TH2 to encourage the body to produce antibodies, any direct or indirect effect of aluminum on the health or maturation of the TH1 or TH3 system is unknown. Yet, in many of these TH2 dominant chronic illnesses, TH1 and TH3 have also been shown to exhibit an impaired immune response to the environment. [29]

Any direct or indirect effect on the health or maturation of the TH1, TH2 and TH3 arms of children’s immune systems from any of the injected vaccine ingredients, either due to their individual action, or due to their combined interaction, is unknown as well.

The important synergistic, balanced activity of TH1, TH2 and TH3, in response to the environment is dysfunctional and impaired in all chronic illnesses. Children are not necessarily born with this dysfunction or impairment, although they may inherit the susceptibility from their parents. How then, do children develop the expression of these TH1, TH2, TH3 impairments, into what we describe as chronic illness?

What is clear is aluminum pushes the TH2 immune system to over perform, and multiple chronic illnesses in children show immune systems where the TH2 immune response over performs, while TH1 and TH3 responses are also impaired. Is there a connection? By having this type of effect on the TH2 system, is aluminum in any way contributing to the development of these chronic illnesses in children; especially in those children from families with a genetic history of the above mentioned chronic illnesses?

Does aluminum also affect the TH1 immune response, unbeknownst to scientists, clinicians and parents? Does aluminum play a role in impairing the overall synergistic, balanced activity of TH1, TH2 and TH3, which is a requirement for a healthy immune system response to the natural environment? There is no scientific evidence to clarify our understanding one way or the other, but the evidence may be right in front of us to conclude otherwise.

Aluminum forces the undeveloped and immature immune system of infants and children to produce greater amounts of humoral immune cells (TH2) and antibodies, before their immune systems have a chance to adapt to the world in which they’ve barely had a chance to live in.

Under these circumstances, the activity of aluminum appears to play a vital role in disrupting the maturation of the immune system in infants and children through its effects on TH2 and therefore, on TH1 and TH3.

What effect this has on their overall health in the short or long term is unknown, but this model appears to help us understand how we may be contributing to the development of chronic illness in infants and children with the use of aluminum in vaccines. We also have little understanding of what might happen to the overall health of their immune systems if parents wait until later in life to expose them to vaccines containing aluminum, or if they’re exposed in smaller doses one at a time.

How much of a role does injected aluminum play, either acting alone, or in conjunction with other vaccine ingredients and environmental toxins, in the selection and subsequent development of chronic illnesses, in a susceptible population of children, through the disruption of TH1, TH2, TH3? There is no science to answer this question because no one has investigated this issue.
We have no scientific studies in infants, children or adults to help us understand the nature of the progression of TH1, TH2 and TH3 immune responses to any of the injected materials in vaccines.

You cannot do research on questions that enough people don’t believe is worth asking, or are afraid of what the answers might show if the proper studies were done.

It is unfortunate that we continue to drag out this dialogue by singling out each individual vaccine ingredient as a detriment to the health of our children. First thimerosal needed to be removed, despite contentions from the medical community that there were any real medical reasons to do so, and now aluminum. According to Environmental Defense [30] (formerly known as the Environmental Defense fund), all the vaccine ingredients are poisonous, carcinogenic or potentially harmful to the skin, gastrointestinal, pulmonary, immune and neurological systems in our bodies.

What about formaldehyde? Are we going to wait until another brave physician or scientist writes about the damaging effects of injected vaccine-containing formaldehyde on our children’s brains before we are called to demand that formaldehyde be removed? Or about the problems associated with having Polysorbate-80 in the vaccines?

Polysorbate-80 is used in pharmacology to assist in the delivery of certain drugs or chemotherapeutic agents across the blood-brain-barrier. What viral, bacterial, yeast, heavy metal or other vaccine containing ingredient need to pass into the brains of our children? Do they belong in the brain? Is that part of the needed immune response to protect our children from disease? Do vaccine materials pass across the blood-brain barrier with the help of Polysorbate-80? If so, are there complications from being in the brains of our children? Is this another connection to help us get an understanding of why 1 in 150 [31] children have autism, or 1 in 6 children has developmental/learning disabilities?

If we’re going to do justice to the topic of vaccine ingredients, we need to look at the potential harm of all the vaccine ingredients at once, and examine their individual effects on our children’s immune and nervous systems. Then, we can examine the interactive effects of the vaccine ingredients on human tissue, and evaluate the potential for harm, as Dr. Haley has already successfully done.

How many more children need to be potentially harmed before we invoke the precautionary principle and the Hippocratic Oath – First, Do No Harm? If there’s no adequate science, and we have positive evidence of toxicity from aluminum, injected alone or in conjunction with other ingredients, and we have a potential model to understand why certain chronic conditions may be developing in a susceptible population of children, then injecting aluminum containing vaccines into anyone should stop right now until we have the proper scientific proof we need to say otherwise. We need the same scientific proof of safety for all vaccine ingredients and their interactions, and we need parents, scientists and practitioners to stand up and demand nothing less before we make matters worse.

Lawrence B. Palevsky, MD, FAAP
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7 [ Return]
8 [Return]
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30 [ Return]
31 [ Return]

Sunday, June 15, 2008

CDC Under Attack for "Losing" Negative Vaccine Data

Tuesday, April 08, 2008
Byron Richards, CCN

The Centers for Disease Control and Prevention (CDC) is coming under a microscope for its inept handling of vaccine data that likely showed a link between mercury in vaccines and autism. The CDC insists publicly that there is no link between mercury in vaccines and autism, based on several studies with numerous flaws in design. It appears the CDC has tampered with data to slant results to its favor – a common trick of Big Pharma when trying to hide poor results and cover its rear end.

Central to the controversy is a four-year analysis by the CDC of a large US database called the Vaccine Safety Datalink (VSD). The original results of the study showed a significant correlation between mercury and autism (as discovered by FOI requests). By the time the CDC was done massaging the data the study showed no correlation; and now the CDC has apparently lost the data the original results were based on.

Here is the link to the CDC’s mercury studies. Here is a link to a detailed article explaining what is wrong with CDC’s thimerosal studies, including a link to various Congressional leaders speaking out on CDC incompetence.

While it is unlikely, in my opinion, that thimerosal in vaccines is the only issue relating to vaccine injury – I do believe there is enough data to label thimerosal in vaccines as highly problematic and a toxin that is a significant risk for increase in vaccine injury that may trigger autism.
It will require congressional oversight to get to the bottom of the CDC’s vaccine cover-up. Judging by the lack of results Congress has had in recent months getting to the bottom of various FDA scandals; it will be a struggle for parents to get the truth from unelected bureaucrats protected by a pro Big Pharma Bush administration. I would like to know how McCain, Clinton, or Obama would actually solve this very real problem.



Deirdre Imus' Response to Recent Article in Time Magazine

A Timely Truth Untold… Again
Posted June 2, 2008 05:13 PM (EST)

This week Time magazine’s cover story “The Truth About Vaccines” carries an ominous suggestion… “worried about autism, many parents are opting out of immunizations. How they’re putting the rest of us at risk.” (June 2, 2008). Finally, a major periodical puts a spotlight on the most emotionally charged and inaccurately reported medical controversy in modern history. And what does Time do? Blame parents for a crisis in confidence created by public health officials. If you were hoping to learn the “truth” about vaccinations, you are not going to find it in this issue of Time.

In her article, “How Safe Are Vaccines?” Alice Park attempts to address growing concerns about vaccines and asks the million-dollar question that parents around the country really want to know. Unfortunately, Park’s version of the “truth” does a disservice to readers when it falls into the same trap that has plagued similar reports; gross inaccuracies, reliance on industry-funded spokesmen whose conflicts are not disclosed, and the all too familiar and constant beat of immunization dogma suggesting doomsday disease scenarios.

Those of you who have read my postings before know that I am very skeptical of both the public health officials and the mainstream media’s ability to objectively and forthrightly cover this issue. The Time article does nothing to change that opinion. If anything, it confirms it.

At the heart of Park’s report, however, is the question about parental rights. Should parents be forced to vaccinate their children given the growing concerns about vaccine safety?

For over a year now, there has been a steady stream of articles about school districts and health departments’ heavy-handed actions towards parents who choose not to vaccine their children. Intimidation tactics that included monetary fines, expulsion from school, even threats to call in child protection agencies were used to try and coerce parents into compliance with the current immunization recommendations.

In March, the New York Times ran two separate articles on the subject of parents deciding not to vaccinate their children (”More Families Are Shunning Inoculations” [March 2], “Public Health Risk Seen as Parents Reject Vaccines” [March 21]). Other news organizations around the country ran similar stories.

Throughout the article, Park implies parents are too “confused” to do their own homework on this subject or lack the good sense to make an informed decision. In reality, parents are deciding to opt out of vaccinations because they are concerned that vaccines may put their children at risk for adverse reactions that they feel are more threatening than the diseases the vaccines are purported to prevent. Chief among these concerns is the possible association between vaccines and autism.

As the Time article details, concerns about thimerosal-containing vaccines is one of several concerns that continues to weigh on the conscience of many parents. In one sentence Ms. Park states, “Thimerosal can do serious damage to brain tissue, especially in children, whose brains are still developing” and then dismissively trivializes parental concerns about a possible link between the developmental neurotoxin and autism by saying “that link could be merely temporal, of course; babies also get their first teeth after they get their first vaccines, but that doesn’t mean one causes the other.” The absurdly of this analogy ranks with one of the most nonsensical comments I think I have ever read. This “temporal” association has been reported by literally thousands of parents across the country who have documented evidence of their normally developing child regressing into a world of silence and isolation. To consider these vaccines containing neurotoxins like mercury and aluminum, along with other toxins, would seem to be reasonable, absent any other logical explanation.

The article also inaccurately reports that thimerosal-containing vaccines were “replaced” with thimerosal-free formulas in 2001. Thimerosal-containing vaccines were not recalled as the article suggests and remained on clinic shelves well into 2003, according to government communications. In addition, the majority of flu shots, given to pregnant women and babies as young as six months, still contain 25 micrograms of thimerosal.

According to the article, “In the first four months of this year, 64 confirmed cases of measles were reported in the U.S., scattered across 11 hot spots…the most by this date for any year since 2001; 54 cases had links to other countries, an only one of the 64 patients had been vaccinated.” Interestingly, the map denoting the location where the outbreaks occurred show that in four of the 11 “hot spots” only 1 case of measles was reported and only three states had more than 10 cases.

So let’s put the reports about the recent measles outbreak into some sensible perspective.Out of the approximately 40 million children born in the last ten years, hundreds of thousands of which are not vaccinated, there have only been 64 cases of measles reported nationwide, all of whom recovered although 14 did require hospitalization.

Now let’s compare this statistic with the one that really has parents frightened, the 1 in 150 children who have been diagnosed with autism for which the health agencies have no logical explanation.

Like other articles on this subject, Time attempts to reassure parents about the safety of vaccines based on very selective information from conflicted sources and fails to cite recent published research and independent voices that support parental concerns. Nowhere did we read about the study that suggests delaying vaccinations for just two months might reduce the risk of developing asthma by half.

The article cites a 2003 Institute of Medicine (IOM) report as showing “no scientific evidence to support the link” between vaccines and autism. Actually it was 2004, and the same report also said the committee could not rule out an association in a small susceptible sub-group of children. In addition, it has been four years since that report was released and there have been dozens of published, peer-reviewed studies to suggest there could be an association. Those studies did not make into the Time article.

Having spoken to literally thousands of moms, I know many parents are terrified of the dozens of vaccines given to babies today. They want to do what is right for their children and want to protect them from diseases. Ms. Park notes that 77% of children are fully vaccinated and therefore supposedly protected from the childhood diseases, the author fails to acknowledge that these same children are among the sickest children in the world in spite of being the most vaccinated. They may not get the chicken pox, measles or mumps but they are beleaguered with serious developmental and autoimmune disorders that last a lifetime.

This is where Time fails to really explore the reasons and the truth about why parents are opting out of vaccinations and examine the mindset behind a modern day medical dictatorship that will go to any lengths, including school expulsion and threats of taking children away from parents in order to carry out their mission.

Suggesting that the reason parents don’t vaccinate is because “the illnesses kids are being inoculated against are rarely seen anymore,” Ms. Park opines, “Once you’ve seen your neighbor’s toddler become paralyzed, you’re a lot more likely to worry that the same thing will happen to yours.” There may be some truth to this but many parents would look at this suggestion another way. Once you see your healthy, normal toddler, or your neighbor’s healthy toddler develop autism following a series of vaccinations, you are a lot more likely to worry that the same thing could happen to your child.

Parents are not “confused,” Ms. Park…they are concerned and have every reason to be concerned.

It isn’t parents that created this crisis in confidence; it is the government and medical establishment for dismissing parental concerns and failing to make vaccine safety a priority. It is Congress’ fault for failing to do proper oversight.

Parents who chose to vaccinate their children should have nothing to fear from the relatively few who are not vaccinated. But ultimately, the choice of whether or not to vaccine a child must be made by the parent who will live with the life-long consequences.

The government bears the burden of proving vaccines are safe. Not parents. And the government has not proven the number of vaccines given to children today are safe, or that injecting our babies with mercury, aluminum and formaldehyde is safe.

Bucco: Parents Should Have Choice on Children's Health

June 5, 2008

Contact: Andy Pratt / 609-292-5199
Senator Anthony R. Bucco (R-25)
Bucco: Parents Should Have Choice on Children’s Health

Senator Anthony Bucco, R-District 25, made the following comments after members of the Senate Health, Human Services and Senior Citizens Committee debated the merits of Senate Bill S-1071, which allows exemptions from mandatory immunizations for children if parents object on conscientious grounds. Bucco and Senator Gerald Cardinale, R-District 39, are co-sponsors of the bill:

“This legislation reaffirms the fundamental right of parents to decide what’s best for their children,” Bucco said. “The decisions of families who have religious or medical reasons for rejecting mandatory immunizations should be respected by the state.

“This measure provides safeguards to both students who reject immunizations and their classmates. For example, students who register as not having immunizations will be required to stay away from school during disease outbreaks, and the state Health Commissioner could suspend exemptions to immunization rules in a health emergency.

“I urge quick consideration of this bill, which I am pleased to say has bipartisan support.”

North Jersey - Parents Challenge Vaccination Requirement

(by Rebecca Scanlon - Staff Writer - May 21, 2008)

Suburban Trends Full Story with comments:

NORTH JERSEY - Vaccinations have long been accepted as the answer to preventing disease – but could they pose other dangers for some children?

This is the question more and more parents are beginning to ask, especially now that the state is set to add two more vaccines to the required list, bringing the total to 13 vaccines over a person’s lifetime.

And now, parents who have found that their answer is “Yes, vaccinations can be dangerous” are asking lawmakers to lift some requirements and urging parents to research before vaccinating.
“I wish I had asked questions,” said Mary DeLaosa, a former long-time Bloomingdale resident and mother of two boys, ages 11 and 10, who believes that vaccines led to one of her son’s autism-like symptoms.

One mother’s experienceDeLaosa is a member of New Jersey Coalition for Vaccination Choice (NJCVC), a group of parents, physicians, holistic organizations and autism support groups concerned with the growing number of mandated vaccinations.

DeLaosa said that she was late on vaccinating her older son but vaccinated her younger son at the doctor-recommended ages. After his vaccinations, her younger son’s behavior and development changed, she said.

“He was developing fine, but then be became a different kid. He lost everything,” she said.
DeLaosa’s younger son developed autism, she said. The link between vaccines and autism has been debated for a long time.

While the Center for Disease Control (CDC) acknowledges on its web site that a 1998 study of autistic children raised the question of a connection between the measles, mumps and rubella (MMR) vaccine and autism, the CDC says additional scientific studies have found no relationship between the vaccine and autism.

The incidence rate of autism in New Jersey children is about one in 94. In boys, it is about one in 60 and for girls it’s one in 250.

DeLaosa said after she stopped vaccinating and her son went through three to four years of therapy and an applied behavior analysis, he recovered from his autistic tendencies.

“We were able to pull him out of it,” DeLaosa said.

DeLaosa also noticed that her older son, after he received his five-year vaccinations, became much more ill. He had strep throat several times that year and developed pneumonia and asthma.

“He was never asthmatic before that,” DeLaosa said.

When her younger son’s behavior started changing, DeLaosa conducted research on the link between vaccines and autism and came to believe that she should have questioned doctor immunization recommendations, even as early as the Hepatitis B vaccination newborns are given while still in the hospital. The disease is transmitted through bodily fluids and all mothers are checked for it before delivery.

“They don’t tell you why. I didn’t even think to question. I just figured doctors know,” she said.
DeLaosa has opted to have some vaccinations administered to her children but believes that the schedule on which vaccinations are given is not optimal for all children, and caused her children harm.

“With whatever makeup my kids have, the shots just didn’t agree,” she said. “When they do vaccinate, it should agree with the child… There’s no need to rush everything.”

Vaccines in New JerseyNew Jersey’s Public Health Council, a voluntary advisory panel appointed by the governor, has voted to add the flu and meningococcal vaccines to the immunization schedule, to start in the fall. New Jersey would be the first state to require these vaccines.

When the two vaccines are added, New Jersey will require 13 vaccines for various diseases, to be given in 35 doses.

The NJCVC is urging lawmakers to support the Conscientious Exemption to Vaccination bill (A260/S1071) that would make it easier for parents to exercise a choice as to how they vaccinate their children. The bill would allow for conscientious exemptions, which 20 other states allow, the NJCVC said.

Parents may avoid required vaccinations via a religious exemption, but it’s getting harder for parents to utilize the religious exemption, according to the NJCVC.

DeLaosa takes the religious exemption to get her kids into school while she utilizes “tighter” tests, which analyze her children’s antibodies so that she can decide when vaccines are appropriate.

NJ’s required immunizationsThe following are diseases for which vaccines are required in New Jersey:
—Diphtheria - Disease spread by bacteria or germs. Can make it impossible to
breathe and cause heart problems.
—Tetanus - Caused by a toxin produced by a
germ that enters through a wound. Causes serious, painful spasms of all muscles
and can lead to lockjaw. Three of 10 people die.
—Pertussis (whooping cough)
- Caused by bacteria. Causes spells of violent coughing and choking. Can last
for weeks.
—Polio - Caused by a virus spread by contact with feces of an
infected person. Sudden fever, sore throat, headache, muscle weakness and pain;
can cause paralysis and death.
—Measles - Virus is spread very easily.
Symptoms include a rash, fever, cough and watery eyes. Can also cause pneumonia,
brain damage, seizures or death. Of every 1,000 children who get measles, one or
two will die.
—Mumps - Causes fever, headaches and swollen salivary glands.
Children may develop a mild meningitis and sometimes encephalitis. Can also
result in permanent hearing loss.
—Rubella (German measles) - Usually causes
a mild sickness with fever, swollen glands and a rash that lasts about three
days. A pregnant woman can lose her unborn baby, or the baby can be born with
serious problems.
—Hib Disease - Haemophilus influenzae type B (Hib) bacteria
causes meningitis; can also cause pneumonia and infection of the blood, joints,
bone, throat and heart covering.
—Hepatitis B - An infection of the liver.
Spreads through contact with blood or other body fluids. Causes a flu-like
illness. Stays in the liver and can result in severe liver diseases or
—Varicella (chickenpox) - Causes a rash, itching, tiredness and
fever. Can lead to pneumonia, brain infection or death.
To be added in the fall:


Jersey Mothers Gather Forces Against Mandatory Vaccinations
By Susan Avedissian

Barbara Flynn speaks to mothers May 13 in West Cape May about her coalition lobbying legislators to create a conscientious objection to mandatory vaccines.

WEST CAPE MAY - When Melanie Gargiole of Court House entered Cape Regional Medical Center ready to give birth she had a birthing plan. That plan did not include her baby getting what, since 1999, has become a routine vaccination for Hepatitis B.

But she was groggy and the birth was difficult, and, as she describes it, she was verbally “attacked” by hospital personnel in an attempt to persuade her otherwise.

Gargiole was one of approximately 25 mothers, some from as far as Harleysville, Pa., who gathered at the Bella Vida Café here May 13 to learn more about two bills, Assembly Bill 260 and Senate Bill 1071 (A260/S1071), pending before the New Jersey Legislature which provide parents with a way to opt out of mandatory vaccinations by creating a conscientious exemption.
A new coalition has formed to support the bills, New Jersey Coalition for Vaccination Choice,

Mothers listened to Barbara Flynn, of Summit, speak about what her own group, C.H.E.R.U.B.S., which stands for Children Having Everybody Really Upset ‘Bout Shots, considers the dangers of vaccines.

Flynn has personal experience from which to draw. Eighteen years ago her older child suffered what she calls a classic case of “post-vaccinal encephalitis” and was diagnosed with serious “incurable” neurological disorders. He was eventually cured exclusively through natural healing therapies.

Flynn, married and the mother of two children aged 18 and 13 holds a BS in Math Education from Loyola University of Chicago and an MBA in Finance from Rutgers University. She is formerly an EDP (Electronic Data Processing) Auditor with Citibank and a Banking Consultant with the accounting firm of Peat, Marwick and Mitchell, both in New York City.
C.H.E.R.U.B.S. provides support for New Jersey parents filing religious exemptions to vaccinations, which the group claims anyone can assert. It was formed in 1999 as a support group for vaccine-injured New Jersey families seeking natural medical alternatives. The mission was expanded to help all NJ families realize informed consent, file religious and medical vaccination exemptions as provided by law and advocate for Conscientious Exemption legislation.

With a slate of new mandatory vaccinations slated for September, 2008, some families believe their rights to make choices for their family’s health are being trampled.

This was the first meeting in South Jersey, Flynn said, for her group, and she was pleased at the turnout.

See next week’s Herald for the full story.

For more information, see, or a newly formed coalition of organizations opposing mandatory vaccinations in New Jersey,

Contact Avedissian at (609) 886-8600 Ext 27 or at: .

HPV Scientist Speaks Out

CBS4 - Miami
May 7, 2008
Michele Gillen reporting

(CBS4 - Miami)
Gardasil. It is a first of its kind vaccine designed to prevent cervical cancer and approved by the Food and Drug Administration on June 8, 2006 for use in females aged 9 to 26. Within weeks the vaccine was unanimously approved by the CDC’s Advisory Committee on Immunization Practices for 11 and 12- year old girls. What followed was a cascade of calls by legislators around the country, including in Florida, pushing for this new to the market vaccine to be mandated for scores of young girls.

“This is a real danger zone, ” says Dr. Diane Harper.

Why might you care about what she says? Dr. Harper is one of the world’s top experts on the Human Papilloma virus, HPV, which can lead to cervical cancer. In fact, she’s one of the leading scientists the pharmaceutical industries turned to for help to conduct clinical trials - including those that led to approval by the US Food and Drug Administration of Gardasil - and the recommendations that followed.

Speaking out in her first such television interview with WFOR-TV Chief Investigative Reporter Michele Gillen, Dr. Harper expresses concerns over what she considers a rush to recommend and mandate the vaccination of very young girls with the vaccine. “It went too fast, it went too fast without any breaks,” says Harper, who devoted nearly two decades of her career to research on HPV.

Dr. Harper says she believes the vaccine is safe but cautions that time is needed to study potential side effects in larger numbers of young girls before any consideration should be given to mandating such a vaccine.

According to Dr. Harper, “the vaccine has not been out long enough for us to have post marketing surveillance to really understand what all the potential side effects are going to be. We feel it is very safe.” However, she adds, “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in process a place that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.”

Barbara Loe Fisher agrees. She took to the streets a grass roots fight credited with derailing many efforts around the country to mandate the vaccine. “It was the quickest effort I have ever seen in 25 years for a vaccine to be mandated,” says Fisher. A mother of a son who she say was left with learning disabilities following a routine vaccination in the 1980’s, Fisher is President and Co Founder of the National Vaccine Information Center. It is a non-profit independent clearinghouse for information on vaccines and disease.

Fisher says her organization has been contacted by nearly 100 parents claiming their daughters have suffered some type of adverse reaction following a Gardasil shot - at times given in combination with other vaccines. She says many parents are frustrated in their search for answers and that they don’t know where to turn. She tells Gillen “the National Vaccine Information Center is getting reports every week, mostly mothers, of what is happening to their 11-year old girls after receiving Gardasil.”

Fisher says she has heard from parents upset that their doctors are refusing to report reactions potentially tied to this vaccine they recommended, if not aggressively pushed.

“I think that this has caused a real crisis of trust in the hearts and minds of parents who are being more educated about vaccines and all types of products they give their children,” says Fisher.

Harper says parents need to be armed with as much information as possible. She believes the vaccine should be an educated choice. She explained that many parents do not realize or are not being told by physicians, that their daughters might end up needing a booster shot. She says what can be considered key study trials lasted at most 5 years and that there is no way to know exactly how long the vaccine will be effective.

“I think the thought is that there probably will be efficacy for longer than 5 years but its probably not going to be lifetime efficacy. There probably will be some need for a booster. There will be some need for understanding when we going to need to be able to revaccinate those women. Those are all open questions,” says Dr.Harper.

Given that it is unknown for how long the vaccine will be effective, Dr. Harper says she can’t stress enough the need for pap tests throughout a woman’s lifetime, even if she has received an HPV vaccine.

Dr. Harper understands why some parents are left wondering how young might be too young?
Gillen asked Dr. Harper what she thought the optimum age of a girl should be to receive the shot.

“I would have started at 15, and not at 12,” explained they physican.

Fisher says she applauds Dr. Harper for being willing to address controversial questions regarding HPV vaccines and concerns by parents who say they want more information before deciding if the shot is right for their daughters.

“I think that Dr. Harper has done a tremendous public service to stand up,” says Fisher.
Dr. Harper says she is convinced HPV vaccines can help prevent cancers in the long run. But that parents and women should have a choice. Dr. Harper has also served as a consulting researcher for study trials for another HPV vaccine named Cervarix, being developed by GlacoSmith Kline, GSK. “I am the first author on two of the GSK papers,” she noted.
But again she expressed her disapproval for any potential effort to mandate a Cervex vaccine for young girls. As Dr. Harper explains ” It’s still like-wise with Gardasil. They haven’t been out long enough , there isn’t enough information to have a mandate that you can’t go to school until you have this vaccine. It does not make any sense.”

Dr. Harper served as a researcher on study trials for Gardasil and Cervarix while employed as a professor at Dartmouth College. The University was contracted by both Merck and Co.. and Glaxo Smith Kline for the HPV studies who paid for the studies. Dr. Harper has disclosed receiving speaking fees from both Merck and from GSK for speaking about the HPV vaccines, and has received consultation fees from both Merck and GSK for consulting about trial development and data interpretation, in addition to the monies paid to Dartmouth to conduct the trials.

In asking a representative from Merck. for a response to the WFOR-TV interview with Dr. Harper and the types of concerns she raised a Merck representative provided WFOR-TV with the following statement:

Merck’s research program for GARDASILĂ‚® [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18) Vaccine, Recombinant] spans more than 10 years of rigorous study of more than 25,000 individuals around the world and the labeling for GARDASIL reflects the extensive data available from our clinical trials.

In addition, the data from our clinical trials have been discussed in public settings by leading medical and policy experts, including an FDA Advisory Committee meeting in May 2006, publications in The New England Journal of Medicine and The Lancet and meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In February of 2006 the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for GARDASIL and designated the file for priority review. A priority designation is intended for products that address unmet medical needs and under the prescription Drug User Fee Act (PDUFA), the FDA’s goal is to review and act on BLAs designated as priority review within six months of receipt.

GARDASIL received its U.S. FDA approval on June 8, 2006 and on June 29, 2006 received a universal ACIP recommendation for use in 9-26 year old girls and young women.

We began discussions of data from the clinical trials with the ACIP’s HPV Working Group as early as 2004. It is important to note that the three week time period between FDA licensure and the ACIP recommendation in June of 2006 does not represent the total amount of time the ACIP Working Group and full ACIP membership actually discussed the data and potential recommendation for GARDASIL - this time period was more than two years.

Since FDA licensure in June 2006 GARDASIL has been approved in 101 countries around the world and through March 31, 2008 more than 26 million doses have been distributed globally.
We are very confident in GARDASIL, and look forward to continuing to lead in the fight against cervical cancer. Here are some additional milestones you may be interested in as you complete your story.

· By 1996, Merck started production of the HPV-16 targeted prototype of GARDASIL.
· Merck filed an Investigational New Drug Application and started Phase I clinical trials of the HPV-16 prototype in 1997.
· Phase II trials of the prototype began in 1998.
· In 2000, Merck conducted the first dose-ranging trial of a vaccine to protect against HPV types 6, 11, 16 and 18.
· The first pivotal Phase III trial of GARDASIL, FUTURE 1, started in 2001.
· November 2001: An FDA Advisory Committee agreed on clinical trial design.
· The results from the first phase II trials of the HPV-16 prototype were published in NEJM in 2002.
· Merck presented results from the pivotal Phase III trials of GARDASIL at the Infectious Diseases Society of America (IDSA) meeting in October 2005.
· In December, 2005, Merck submitted its first license application for GARDASIL to the FDA. FDA later grants priority review. Merck also begins to file regulatory applications worldwide.
· May 2006: An U.S. FDA Advisory Committee unanimously agrees that the clinical data support the efficacy and safety of GARDASIL.
· June 8: U.S. FDA approves GARDASIL.
· June 29, 2006: In the U.S., the Center’s for Disease Control (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously recommended broad vaccination with GARDASIL - routine for girls and women ages 11-26, with 9- and 10-year-old girls vaccinated at their physicians’ discretion.
· Since July 2006: GARDASIL receives approval in more than 70 countries worldwide, including Canada, those in the European Union, Australia, New Zealand, Brazil, Peru, Taiwan and two countries in Africa.
· Nov. 1, 2006 - GARDASIL is added to the CDC’s Vaccines for Children (VFC) Program
· In January 2007, GARDASIL was added to 2007 U.S. Childhood and Adolescent Immunization Schedules released jointly by the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).
· Recommendations have since been made by health agencies in other countries (i.e. Canada’s National Advisory Committee on Immunization (NACI) on Jan. 30, 2007 and by the Australian Government in November 2006) and funding and reimbursement for GARDASIL is also becoming available in additional countries as well (i.e. Austria, Germany).
· In March 2007 the CDC finalized the provisional recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of GARDASIL. These vaccination guidelines were published in the March 23, 2007, issue of the CDC’s Morbidity and Mortality Weekly Report (MMWR).

CBS4 I-Team: Vaccine Concern Part 2

April 25, 2008
Michele Gillen Reporting

MIAMI (CBS4)The Gardasil television commercial is a popular one which markets a vaccine that is considered a major breakthrough in a fight the U.S. federal government is convinced can prevent cervical cancer. Within weeks of approval by the FDA, the Centers for Disease Control immediately recommended it for every 11 and 12-year-old girl.

Christina Bell, like many mothers, found her pediatrician recommending it for her daughter.
CBS4 Chief Investigative Reporter Michele Gillen asked Bell if it seemed like a no-brainer.

“I thought so,” Bell told Gillen.

However, Bell says she now finds herself on a search for answers as to what happened to her daughter, Brittney, just weeks following an injection of Gardasil and a tetanus shot. The former cheerleader and runner’s left leg was mysteriously affected by paralysis. The family wants to know if the condition could have been triggered by the vaccines she received that day.

Reported adverse events following vaccine injections, including Gardasil, have come under increasing scrutiny by parents reviewing them on the U.S. Vaccine Adverse Event Reporting System (VAERS).

“I think it’s a marvelous addition to the scope of therapy I can offer kids,” said Dr. Lorena Siqueira, Director of Adolescent Medicine at Miami Children’s Hospital.

She says she believes the vaccine is safe and well worth prescribing for adolescents.

“Fortunately, I have no reports of serious reactions. I have seen occasional fainting episodes,” Dr. Siqueira told Gillen.

Dr. Siqueira says she believes the fainting episodes are not tied to just the Gardasil vaccine but is the reaction of certain adolescents to an injection. Because of concerns over some girls who have reportedly fainted and injured themselves falling, the National Vaccine Information Center recommends that girls receive the shot lying down and that they be observed for 15 minutes after the injection.

“Brittany’s case is at a quandary,” said Sean Cronin, attorney for the Bell family.

Cronin says it is an uphill battle trying to investigate whether the Gardasil shot played any role in what has happened to Brittney. Christina Bell says Brittney’s pediatrician does not believe there is a link.

Now the Bell family has learned that Merck can’t be sued over its Gardasil vaccine because it has been added to a federal list of vaccines recommended by the government. The vaccine manufacturers are insulated from liability.It’s a fact many parents, and even some doctors, may not be aware of.

“You can’t sue Merck over Gardasil,” Gillen told Dr. Siqueira. She replied, “It’s because vaccines are protected.”——————

Statement from Merck regarding the GARDASIL vaccine:

Merck actively monitors adverse event databases throughout the world,
including the U.S. Vaccine Adverse Event Reporting System (VAERS). An event
report does not mean that a causal relationship between an event and vaccination
has been established - just that the event occurred after vaccination.

The labeling for GARDASIL reflects the extensive data available from
our clinical trials. The data, including safety information, have been
thoroughly reviewed and discussed by medical experts.

Since its FDA approval in June 2006 through March 31, 2008, Merck has
distributed more than 26 million doses of GARDASIL worldwide.

Merck will continue to evaluate all reports in the context of our own
post-marketing adverse experience database and our clinical trial database.
Post- marketing adverse event reports received by the Company are sent to
regulatory authorities worldwide in accordance with regulatory requirements, and
Merck updates its product labels with new safety information as

Merck encourages healthcare providers and consumers to report any
potential adverse experiences following vaccination with GARDASIL to the Company
and to adverse event reporting systems.

CBS4 I-Team: Vaccine Concern Part 1

April 24, 2008
Michelle Gillen Reporting 105.html

If you are the parent of a young girl you most likely have heard of a first of its kind vaccine named GARDASIL, developed to protect against the viruses which can cause cervical cancer.
The FDA’s approval of the vaccine triggered efforts in Florida and across the nation to mandate its use for 11 and 12 year old girls. CBS4 Chief Investigative Reporter Michele Gillen has learned there is an increasing concern over the use of the vaccine.

Christina Bell’s daughter, Brittney, was one of the young girls who recieved the vaccine. Just weeks later, her life took a radical turn for the worse.

Seemingly, in a moment’s time, Brittney’s left leg became paralyzed, her ankle swinging like a rag doll’s. Even with a shoe brace, she walks with a limp.

“It’s hard for me to lift it up,” Brittney told Gillen.

Brittney’s limb paralysis occurred shortly after the 12 year old went to the doctor for a routine tetanus shot for school. That is when Bell says the doctor suggested Brittney also have the GARDASIL vaccine on the same day. And she did.

GARDASIL is a first-of-its-kind vaccine approved by the U.S. Food and Drug Administration (FDA) for girls as young as nine. The vaccine is profiled on the FDA website with the headline, “New vaccine prevents cervical cancer.”

In trials, the vaccine was shown to prevent pre- cancerous lesions due to certain types of Human Papillomavirus (HPV).

In searching for answers as to why her daughter now suffers from a limb paralysis, Christina Bell says she couldn’t shake the idea that it might somehow be tied to the HPV vaccine. She hasn’t found a doctor to agree with her, including the pediatrician who recommended the shot.
“He doesn’t believe it has anything to do with the shot at all,” said Bell.

She says he stopped returning her calls. When the CBS4 I-Team tried calling him, he didn’t return the calls.

Bell began to research the vaccine herself and what she found startled her - government-compiled reports, filed from around the country, of adverse events that occurred sometimes within hours, other times within weeks, of a GARDASIL vaccination.

While they don’t prove a link, they do document that in some cases an adverse event occurred following an injection. These types of events have been reported to VAERS, a federal vaccine reporting system.

“We’ve seen reports of] paralysis, convulsions, seizures in young girls. It’s very, very, scary and very unfortunate,” said Irene Garcia, spokesperson for Judicial Watch, a government watchdog group that obtained the VAERS records from the FDA through the Freedom of Information Act and posted them on the Internet.

When the data was finally released, Garcia said she felt outraged.

“It was outrage because all that I had seen publicly in the media and on television and from pediatricians was positive,” said Garcia.

Last February, the FDA told CBS4 that it was investigating reports of 13 deaths following an HPV vaccination. At the time, the agency said it was confident that none were tied to the vaccine and that reports of adverse events were under review but not considered anything out of the ordinary.

An FDA spokeswoman told CBS4 this week that she could not provide an update on the number of reported events, including deaths.

“I haven’t seen updated numbers for several months. We monitor on a daily basis but we don’t total it up. We are not seeing a problem,” said Susan Cruzan, spokesperson for the FDA.
In some states across the U.S., it is mandatory to report a suspected reaction to VAERS. But in others, it isn’t.

“It varies by state and there is no blanket federal law, unfortunately,” said Garcia.
Brittney’s mom said she can’t find a doctor willing to report an adverse reaction following the administration of her daughter’s vaccines. CBS4 informed her that parents, just like doctors, can report an adverse event and the Bell family has done just that.

“It might always be that people will say you can’t prove that this is linked,” Gillen told Bell.
“I am still going to speak and tell everybody what I think. I tell everybody,” replied Bell.
“What do I want today? I want my daughter back to normal,” said Bell.

In a response to this report Merck, which makes the GARDASIL vaccine, issued the following statement:

Merck actively monitors adverse event databases throughout the world,
including the U.S. Vaccine Adverse Event Reporting System (VAERS). An event
report does not mean that a causal relationship between an event and vaccination
has been established - just that the event occurred after vaccination.

The labeling for GARDASIL reflects the extensive data available from
our clinical trials. The data, including safety information, have been
thoroughly reviewed and discussed by medical experts.

Since its FDA approval in June 2006 through March 31, 2008, Merck has
distributed more than 26 million doses of GARDASIL worldwide.

Merck will continue to evaluate all reports in the context of our own
post-marketing adverse experience database and our clinical trial database.
Post-marketing adverse event reports received by the Company are sent to
regulatory authorities worldwide in accordance with regulatory requirements, and
Merck updates its product labels with new safety information as

Merck encourages healthcare providers and consumers to report any
potential adverse experiences following vaccination with GARDASIL to the Company
and to adverse event reporting systems.