SANEVax – Our Daughters Should Not Be Experiments for The Drug Industry

SANEVax News Release

Parents of Daughters & Women Injured from Gardasil
React to FDA Decision

Why are medical consumers the medical experiments?
Safety and efficacy studies should be conducted for all intended age intended before market release.

On April 7, 2011 the media broke the news about the U.S. FDA’s ruling against Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil use to an older population of women.

 According to a report in MedPage Today,

‘The decision was based on a trial in 3,253 women ages 27 to 45. Although the vaccine appeared to prevent persistent HPV infection, no significant benefit was found for more important outcomes such as high-grade neoplastic lesions or cervical cancer when all participants were included irrespective of baseline HPV status.’

Within days the news of the FDA’s decision traveled across the country and across the world.  SANE Vax Inc. asked parents whose daughters have been injured by the vaccine as well as victims themselves to comment on the decision. 

Instead of protecting her life, it took her life.

I am thankful that the FDA did not give Merck a license to provide Gardasil for women over the age of 26 to 45 years.  That is only one small step when in my opinion the FDA has made many errors with this program of vaccination.  My 14 year old daughter died after having her second shot of Gardasil.  She was in perfect health until she received this vaccination.  We were told that we had to be responsible parents and that it was important that she have this vaccine.  Instead of protecting her life, it took her life.  The FDA still dares to suggest that this program is safe and effective and the benefits outweigh the risks.  That is not true in my case or in the cases of all those who have lost their daughters, and even their sons, to this vaccine; and not forgetting the many thousands who have also been injured. There can never be a benefit when there is the death of a child. 

Linda Morin, Quebec, Canada

With over 20,000 adverse injuries reported and around 100 deaths,
why is nothing being done to pull the vaccine from the market?

I am very disappointed in the FDA and CDC in general regarding Gardasil and the monitoring of adverse reactions.  The FDA recently rejected Merck’s 4th request to expand Gardasil use to women 26 years and older.  I think this was a very good decision on their part, but the fact that they have left the vaccine on the market for females 25 and below is appalling.    My 12 year old daughter was disabled by the Gardasil vaccine and missed almost an entire year of school.  2 ½ years later, she still suffers from the adverse effects of the vaccine.  With over 20,000 adverse injuries reported and around 100 deaths, why is nothing being done to pull the vaccine from the market? 

I have personally seen the damage the vaccine can do to a young, healthy girl.  I feel it is justified to not allow the vaccine to be marketed for older women.  I personally would never consider this vaccine for my 18 year old son or for myself as one who falls in the older age bracket.  I wish I had known of the adverse effects and Gardasil prior to my daughter’s vaccine injury.    

I would like the FDA to explain how Gardasil is acceptable in younger women when they say it has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.  What is the difference?  How can it be accepted as safe in the younger group but not in the older group?

Rosemary Mathis, North Carolina

U.S. FDA has rejected the use of Gardasil in women between 27-45 years old.
The problem in Spain is that the vaccine is recommended for women older than 26.
How can it be effective for women in one country and not the other?

All our suffering cannot be paid with all the money they are losing. Money is just money; they will earn or lose it. However our daughters will never recover the years they have lost suffering the side effects of a vaccine that has been on the market without enough evidence of its efficacy. The governments around the world should do something to prevent these things from ever happening again.

Health Authorities around the world should inform parents about the risks of this vaccine, so that parents can make an informed decision about their daughter´s health. I wish I had known all the dangers this vaccine had before vaccinating my daughter – but the only information I received was (1) the vaccine protects women from getting cervical cancer – not true- and (2) the vaccine may only produce local effects such as pain or swelling on the site of the injection – not true either.

When my daughter was in hospital we wrote a press release to the International Scientist Community asking for help and the answer we received from Spanish Health Authorities was that the only two cases of seizures in Spain and Europe were the Valencian girls; one is my daughter. We felt hopeless when we learned all the incidents of seizures reported to VAERS before February 2009 when my daughter received her second shot.
Now the FDA has rejected the use of Gardasil in women between 27-45 years old. The problem we have in Spain is that the vaccine is recommended for women older than 26. How can it be effective for women in one country and not the other? I do not understand how these things can happen in the world.

Alicia Capilla, Spain

Why me? I was 25 & 4 months when I received the first vaccine and became injured.
Why is my genetic make up – or whatever it was that lead to this reaction –
so different than if I was 8 months older?

I was given the first dose of Gardasil by my GP in Australia in May 2008. I advised him that I had recently separated from my husband (in March 2008), and was convinced of his infidelity. As such, I requested a pap smear and full women’s wellness test, which to my knowledge, included blood samples to be taken for STI’s. The first dose of Gardasil had been administered prior to receiving the results which were negative. My GP was also aware that my immune system was severely lowered due not only to my separation, but moving house and changing employment. Exactly two weeks after receiving the vaccine, I fell and snapped a bone in my foot. Once I was off crutches, I went to the GP as recommended to receive my second shot. I advised them that my walking was a bit funny due to getting off crutches. No warning was given, I was administered the shot, and not required to wait the mandatory waiting time. I was allowed to leave and drive. A few weeks later, everything started to deteriorate. This led to paralysis and my cerebellum to shut down. Prior to this, I was fit and healthy and had no health concerns. My question is: Why me? I was 25 & 4 months when I received the first vaccine. Why is my genetic make up – or whatever it was that lead to this reaction – so different than if I was 8 months older? It does not make sense. If there is something in an individual’s genetic make up, should they not receive some sort of screening or testing prior to being vaccinated? We need to fill out pages of information to give blood (i.e. specimen coming out of our bodies), but this is not the same for something that goes into our body’s, and may stay there for a lifetime. Furthermore, it may change our lives forever. I struggle every single day to accomplish seemingly simple every day tasks, and there is no saying that this will change. And I am one of the lucky ones.

We are guinea pigs. We place our lives in the hands of those who we believe are there to protect our health, and that sense of trust seems to be overwritten by money. Furthermore, not only was I a victim of Gardasil, the treatment to save my life – which is supplied by CSL Laboratories – was ultimately purchased by my parents to save my life as CSL would not donate it.

Kristin Clulow, Australia

What the heck is the difference in approving it for those who are one year younger!

As a parent dealing with a 20 year old daughter badly damaged by Gardasil I can say whilst it is pleasing to see that the FDA has not approved Gardasil for women over 26, I guess the question that everyone  would now be asking is, what the heck is the difference in approving it for those one year younger!

Stephen Tunley, Australia

SANE Vax Inc., believes that if Gardasil has not been demonstrated to prevent CIN 2/3 or worse in older women the same applies for women younger than 26 years of age. Clinical trials used an endpoint insufficient to clearly demonstrate efficacy in this arena. Therefore, we believe that Gardasil needs to be taken off the market until an independent study on the vaccine’s safety and efficacy is conducted.  

  • The SaneVax Team and medical consumers around the world demand scientific proof that Gardasil® is safe, effective and necessary for the approved age groups.
  • The SaneVax Team and medical consumers around the world, once again request the FDA rescind their approval of Gardasil® until studies are conducted with appropriate endpoints.

The FDA has opened the door of doubt confirming our worst fears; Gardasil is a potentially dangerous vaccine fast-tracked into the medical consumer market without adequate testing. Medical consumers should never become medical experiments for the profit of the pharmaceutical industry or the government.  SANE Vax, Inc. will continue our global campaign on behalf of the parents whose daughters and sons have been injured or who have died post-vaccination, until the vaccine is taken off the market.

 

Leslie Carol Botha,
Vice-President Public Relations, SANE Vax, Inc.
Health Educator, Broadcast Journalist

Internationally Recognized Expert on Women’s Hormone Cycles
Holy Hormones Honey -The Greatest Story Never Told!
http://holyhormones.com/
http://sanevax.org
 

Amazing US News Report – Part III – Autism’s Causes: How Close Are We to Solving the Puzzle?

Part III of this six part PBS series by reporter Robert MacNeil is disappointing.  Preview tonight’s episode – watch it below online, listen on a download mp3 file or read the transcript. 

This episode fails to touch on what we already know.  Vaccines have been admitted by US Government officials and agencies and the US Federal Court to cause autistic conditions.  If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines.

One thing seems clear – if it is left to the medical doctors MacNeil interviews in this broadcast, no one will ever “find” the “causes of autism”.

Watch Video

Listen to MP3 Download

Autism’s Causes: How Close Are We to Solving the Puzzle?

Visit PBS Web Page

Autism’s Causes: How Close Are We to Solving the Puzzle?

Read Transcript

Live Chat: Join a discussion about autism Wednesday at 1 p.m. ET

ROBERT MACNEIL: As we’ve reported, autism now affects one American child in a 110. Last month, a committee convened by public health officials in Washington called it a national health emergency. The dramatic rise in official figures over the last decade has generated a surge of scientific research to find what is causing autism.

Among the centers for such research is here, the University of California, Davis MIND Institute in Sacramento. Here and around the country, we’ve talked to leading researchers about where that effort now stands. Among them is the director of research at the MIND Institute, Dr. David Amaral.

DR. DAVID AMARAL, MIND Institute: Well, I think we’re close to finding several causes for autism. But there’s — I don’t think there’s going to be a single cause.

ROBERT MACNEIL: The science director of the Simons Foundation in New York, Dr. Gerald Fishbach; Dr. Martha Herbert, professor of neurology at Harvard Medical School; and Dr. Craig Newschaffer, professor of epidemiology and biostatistics at Drexel University in Philadelphia. First, I asked, how close are we to discovering the cause of autism?

DR. GERALD FISHBACH, Simons Foundation: I think we’re much closer now than we were five years ago. There’s been a tremendous amount of new information and discoveries. But with any disorder as complicated, as multifaceted as autism, I’m reluctant to say how close.

DR. DAVID AMARAL: Everything we know about autism is that there are multiple genes that confer risk. The children have various co-morbid problems. And everything we know looks like this is a multitude of disorders all under the umbrella that we call autism spectrum disorders.

DR. CRAIG NEWSCHAFFER, Drexel University: To begin with, I think there probably is no cause of autism. We’re probably talking about multiple causes. And I think we already have identified some causal components on the genetics front. But if I can interpret your question as complete understanding of all of these complex causes of autism, I think we’re still quite a ways away.

ROBERT MACNEIL: Some people we’ve talked to say we are on the verge of big discoveries. Others say we’re just scratching the surface. Where do you think we are?

DR. GERALD FISHBACH: I think we’re scratching the surface of big discoveries.

RELATED INFORMATION

(LAUGHTER)

DR. MARTHA HERBERT, Harvard Medical School: I think it’s somewhere in between. At the brain level, I think in the last five years, we’ve figured out that there’s a coordination problem of the different parts of the brain not hooking up in as synchronized of a fashion. The question for me is why is that happening?

ROBERT MACNEIL: The autism puzzle is proving to be immensely complex. But I asked what hunches they have on where the answer will be found.

DR. DAVID AMARAL: Clearly, 30 years ago, we didn’t know any genes that conferred risk of autism. Now, we know that there’s at least 20 or more that seem to be associated with autism. The interesting thing, though, is that any particular gene that you might find that is related to autism is only related to about 1 to 2 percent of the cases of autism. So there — I think what’s clear now is that there’s not going be a single autism gene. But there are many, many.

DR. GERALD FISHBACH: Well, I think many people feel that autism is a problem in communication between cells in the brain. Now that’s saying an obvious truth. The brain is a communicating organ. We take in sensory information. We put out motor actions. And in between, there’s the whole phenomena of perception, understanding and digestion of that information. It’s the phenomenon of synaptic transmission. And my belief is we will find root causes of autism at particular synapses in the brain.

DR. CRAIG NEWSCHAFFER: Well, I think it’s going to be a combination of continued good work on the genetic side of things. I also believe, however, that there are going be causal components that are nonheritable genetics, things that we refer to as environmental causes, with a capital E, environment-encompassing lifestyle factors — exposures, things of that nature. And those were, by the way, we’re still at the very beginning stages.

DR. MARTHA HERBERT: I don’t think there’s any one cause of autism. I would lay money that we will not find one thing. We certainly haven’t found one gene; we’re finding hundreds of genes. We’re finding boutique genes. We’re finding genes that kids have and the parents don’t have — their own parents. I think that there are a lot of things environmentally that are overwhelming our ability to cope, metabolically, that are overwhelming our immune system. And the synergy — the collective impact of that is to deplete our protective systems. And I think that’s what’s causing autism.

DR. CRAIG NEWSCHAFFER: But I think the emphasis on genetics probably has been correct, at least as we think about the unfolding of our understanding of what causes autism. And I think over time, we realized that in addition to these genetic components, there is room for and probably just cause for investigating the environmental. So we’re swinging around.

DR. GERALD FISHBACH:  First, there’s no question that autism is a genetic disorder. That does not mean the environment is not tremendously important, because it is also clear that the genetics are complex. We’re looking at the Simons Foundation for what are called de novo mutations — mutations that arise anew in the germ cells of one or the other parent, sperm or egg. Because it appears that these de novo mutations have a very big effect, a very profound effect. If you have the mutation, you have a great risk of developing autism.

DR. MARTHA HERBERT: I think that what you have is, yes, definitely a question of toxics and toxics in our environment, that some of them act like our own molecules, like hormones, for example. That’s called endocrine disruption. Some of them get confused with neurotransmitters. Some of them damage our cell membranes. Many, many of them damage our mitochondria, our energy factories in our cells.

DR. CRAIG NEWSCHAFFER: Something that I think is important in thinking about these complex causes is thinking about the window of vulnerability. When are these causes most likely to act? And again, I believe that that prenatal, intrauterine period is going be very, very important. So things from maternal diet, infections that mothers may be exposed to in pregnancy, exogenous chemicals, chemicals in the environment that could be neuro-developmentally significant. All these are things — I think these things are likely to play a role. How large, how small, I think, is yet to be determined.

DR. GERALD FISHBACH: I don’t think this is an either-or effort. The issue is ideas and hypotheses. The genetics will facilitate work on the environment.

ROBERT MACNEIL: One issue science considered settled for years won’t go away: the parental belief that vaccines cause autism. Public health officials have steadily maintained there is no valid, scientific evidence of such a connection; all epidemiological studies have proved negative.  But now, bowing to public opinion, the body that sets priorities in autism research, The Inter Agency Coordinating Committee, has recommended studies to determine whether small subgroups might be more susceptible to environmental exposures, including vaccines.

DR. GERALD FISHBACH: Despite many, many, many epidemiological studies, no evidence that current vaccines in their present form have triggered autism. There are two prevalent things going on here: vaccination and autism. But trying to correlate those two have failed to date.

DR. DAVID AMARAL: So I think it’s pretty clear that, in general, vaccines are not the culprit. If you look at children that receive the standard childhood vaccines. If anything those children are at are at slightly less risk of having autism than children that aren’t immunized. It’s not to say, however, that there is a small subset of children who may be particularly vulnerable to vaccines if the child was ill, if the child had a precondition, like a mitochondrial defect. Vaccinations for those children actually may be the environmental factor that tipped them over the edge of autism. And I think it’s — it is incredibly important still to try and figure out what, if any, vulnerabilities in a small subset of children might make them at risk for having certain vaccinations.

DR. MARTHA HERBERT: I think it’s possible that you could have a genetic subgroup. You also might have an immune subgroup. There are a variety of subgroups. But the problem with the population studies is they don’t they aren’t necessarily designed to have the statistical power to find subgroups like that if the subgroups are small.

DR. DAVID AMARAL: I think more importantly what the whole vaccine issue has done is has opened our eyes again to the idea that the immune system is an important component of autism.

DR. MARTHA HERBERT: The brain and the immune system and the gut are intimately related. The cells in those systems have common features. They work together seamlessly, and when you disregulate one, you disregulate all the others. And systems biology is a way of looking at how we work as an integrated whole. I think that’s 21st century biology. Is the brain miswired, or is it misregulated? And I’ve come to think the brain is misregulated. And there are several reasons for that. Short-term, dramatic changes in the functional level of people with autism. One of them is the improvements you see with fever. A child who gets a fever will start to make eye contact, be interactive, will relate. A child who would have been really out of touch will become connected, and then it will go away.

DR. DAVID AMARAL: You know, vaccines are only one of the things that we do to ourselves. But there are myriad other kinds of– toxic chemicals that we’re putting into the environment.

I don’t think there’s enough research on environmental factors. Frankly, I think it’s very expensive. It’s difficult research to do. Because again, you start trying to develop a list of how many new things there are in the environment now, from 30 years ago. And it’ll be a very long list.

DR. MARTHA HERBERT: When we were having this explosion of our chemical revolution, we didn’t have any way of knowing the subtle impacts on cellular function. We thought if it doesn’t kill you, it’s probably okay. But now we’re learning that it can alter your regulation way before it kills you.

ROBERT MACNEIL: There are many other areas of focus that researchers are pursuing.

DR. GERALD FISHBACH: Parents are having children at later ages. And there is a lot of evidence that children born of parents in the late 30’s and 40’s have a higher likelihood of developing autism.

DR. DAVID AMARAL: We’re trying to chart the course of the — of brain development in autism. And what we’ve found is that there are certain parts of the brain — the frontal lobe, right behind the forehead, in particular — as well as a small structure that’s about two inches in from your ear, called the amygdala. Both of these structures actually grow too quickly. They get to the adult size too quickly in children with autism.

There’s a bunch of kids who probably have autism right from the get-go. Right– you know, right from conception or — very early on. There’s another group of kids who, at 12 months old, they look fine. They’re communicating, they’re having — engaging socially. But then sometime between 18 and 24 months, they lose social behavior. They lose language. And they regress back into autism. But now we’re showing that the kids who regress into autism, for whatever reason, are the ones who have the rapidly growing brains. So that’s a clue.

I mean, it — it doesn’t tell us all that much. And it doesn’t tell us how to treat those two kids differently, but it’s beginning to provide evidence that there really are biologically different subsets of kids with autism. And I think once we actually define that there are different subsets, we can start going after the causes of each one of those subsets.

ROBERT MACNEIL: Are you at all discouraged that after so much effort, investment, some of the best minds in the world on this, that — that autism is still so baffling?

DR. GERALD FISHBACH: I’m not discouraged at all about that. I think we’re addressing one of the most profound problems in not only all of medicine but in all of human existence. We’re talking about the ability to relate to other people, to empathize in a certain way and to comprehend. And I think it’s the most worthwhile, most challenging effort in science that I’ve ever been involved in. So I’m not discouraged at all.