Big Pharma’s Dirty Little Secret: Vaccine-Induced Autoimmune Injury#Truth#Real#Pregnancy

Written By: Celeste McGovern

May 17, 2016 GreenMedInfo LLC. This work is reproduced and distributed with the permission of GreenMedInfo LLC. Want to learn more from GreenMedInfo? Sign up for the newsletter here http://www.greenmedinfo.com/greenmed/newsletter.”

Nasal flu vaccine left  energetic and happy 10-year-old Bobby Hunter with disease that makes him afraid to smile.

Scientists reveal how a hyperactivated immune system can unleash disease

Bobby Hunter was 10 years old when his mother noticed her usually energetic boy was struggling to stay awake and he looked exhausted all the time. Then he began collapsing. Eventually Bobby was diagnosed with narcolepsy, a lifelong incurable condition where victims suddenly drop into deep dream sleep, sometimes a dozen times a day or more. It can be accompanied by bizarre and terrifying symptoms: waking hallucinations of demons, insomnia, sleep paralysis and a sudden loss of muscle control or cataplexy often triggered by strong emotions. Bobby now has to be accompanied everywhere he goes in case he falls unconscious; he’ll never bathe or drive or cross a street alone. But his case is particularly cruel. Now, he is a child who is afraid to smile or laugh because it might trigger an attack.

Bobby’s mother Amanda is adamant he first became ill after he received the nasal flu vaccine at his school. But could such a small thing cause such a devastating disorder?

Narcolepsy Nightmare Explained

This month at the 10th Autoimmunity Congress in Leipzig, Germany a leading pharmaceutical researcher presented his international team’s findings suggesting that vaccination could indeed have the “unexpected” effect of inducing crippling narcolepsy, an autoimmune disease.

Sohail Ahmed, lead author of a ground breaking paper published last summer in Science Translational Medicine explained how the now-retracted Pandemrix vaccine was implicated in a narcolepsy epidemic of more than 1,300 children in several European countries and spates of cases linked to other vaccines for the 2009 swine flu pandemic that never materialized.

It turns out,  part of the influenza nucleoprotein in the swine flu vaccine looked (molecularly) just like a receptor for a neurotransmitter in the brain called orexin that regulates the sleep/wake cycle, explained, Ahmed former global head of clinical sciences at Novartis and later GlaxoSmithKline who is currently with Roche Pharmaceuticals.

When the vaccine was injected with an adjuvant to ramp up the immune response, the immune system went into overdrive. Something  — maybe chemical ingredients in the vaccine, maybe inflammation  –  breached the blood brain barrier and the immune system targeting the vaccine virus also locked in on the receptors in the brain sleep centre. Narcoleptic patients’ own immune system then destroyed a hub of 70,000 or so orexin-producing cells in their brains before their hosts started knocking out. The autoimmune reaction can’t be turned off because the immune system is programmed to relentlessly attack anything it perceives as a foreign invader. It’s a case of mistaken identity and in immunology it’s called a “cross-reaction.”

But could other vaccines still in circulation that contain the H1N1 virus trigger narcolepsy too? Could the same mechanism cause kids like Bobby Hunter to get narcolepsy from the nasal flu vaccine?

Both Ahmed and immunologist Maria Teresa Arango at Leipzig confirmed that it could indeed. Bobby probably carries the HLA-DQB1*0602 genetic marker that leaves him at a higher risk of getting narcolepsy. But so does 20% of the US population. For pharmaceutical industry dependents like Ahmed, so long as cases like Bobby’s are not epidemic as they were with Pandemrix, they are collateral damage the pharmaceutical industry is willing continue to keep flu vaccines rolling.

But what if other vaccine proteins are acting in more unexpected ways, contributing to other autoimmune diseases?

Arango said such cross-reactivity could be the underlying mechanism for widely varied and unexpected documented vaccine adverse autoimmune events affecting other parts of the brain or body. She pointed to the work of Dr. Darja Kanduc.

Massive Peptide Sharing, Massive Autoimmunity?

Kanduc is a biochemist at the University of Bari in Italy who presented her findings in Leipzig at a one-day symposium on vaccine safety sponsored by the Children’s Medical Safety Research Institute. Bari has been looking for molecular similarities between microbial and human proteins and found that a massive, unexpected “peptide sharing” exists between human proteins and microbe proteins.

Where overlap (“peptide sharing”) occurs between a foreign protein and human protein, they have a same identical amino acid sequence (for example, SLVDTYR).  An immune response launched against SLVDTYR might hit A (the microbial protein) and also B (the human protein). In immunology terms, this is a cross-reaction between A and B — in the same way Ahmed’s team illustrated vaccine-induced narcolepsy.

Normally such cross-reactions do not occur, explains Kanduc. “In fact, the human immune system has been ‘educated’ to ignore foreign proteins and avoid cross-reactions in order not to harm the similar human ‘self’ proteins.” In immunology, this is called immunotolerance. Our immune system does not press the panic button and launch an attack on every foreign viral protein it encounters.

Tolerance Lost

Our natural immunotolerance has proved a big problem for vaccine manufacturers over the years. Simply injecting a viral or bacterial particle into our bodies does not trigger the immune storm they want. Our bodies aren’t designed to encounter pathogens via intramuscular injection, after all. Our immune system refuses to attack the injected pathogen since that would mean also attacking the look-alike human proteins. It would rather not go to war than risk the home casualties.

Imagine the immune system as a border guard. If a guard at the Canada-US border pulled every vehicle that drove up to his checkpoint aside, emptied the suitcases, called in the sniffer dogs, strip-searched the occupants and called for the SWAT team, things would get ugly pretty fast. Most of the time, border guards are alert but passive. Our immune system is the same way with foreign proteins.

So vaccine manufacturers pepper vaccines with adjuvants — crude extracts of mycobacteria, toxins such as mercury, aluminum salts, or mineral oils to force the reluctant immune system to go into attack mode – from passive border guard to hypervigilant nutter pulling a gun on a granny.  Celebrated Yale immunologist Charles Janeway called this “immunologist’s dirty little secret” underlying vaccination.

 “Adjuvants expand, potentiate, and increase immune responses,” explains Kanduc. “Such hyperactivation has a price: the loss of specificity. The hyper-stimulated immune system does not discriminate any more between foreign proteins and self-proteins…Adjuvants render the immune system blind. Human proteins that share peptide sequences will be attacked.”

Kanduc likens immunotolerance to a protective wall. “The dam is demolished by the adjuvants and the cross-reactivity flood can crush and alter human proteins.” This might also cause numerous cross-reactions, manifested as a wide variety of autoimmune attacks.

Can vaccines induce genetic disease?

Kanduc looked for peptide sharing between a single influenza A H5N1 protein and human proteins. She found that the viral protein shares 70 peptides with the human host — proteins involved in basic cell functions including proliferation, neurodevelopment, and differentiation.

Among the human proteins that could be on the firing range: reelin, a protein involved in neuron layering, neurexins, proteins that connect neurons,  syndrome 10 protein for Bardet-Biedl syndrome, a transcription factor for Williams Syndrome (a rare genetic neurodevelopmental disorder), a protein associated with amyotrophic lateral sclerosis, and so on.

When these human proteins are altered, as for example by genetic mutations, neurological disorders such as epilepsy, obesity, dystonia, amyotrophic lateral sclerosis, Sudden Infant Death Syndrome and demyelinating diseases like multiple sclerosis occur, says Kanduc.

 “The same spectrum of diseases might occur if these human proteins are attacked and altered by cross-reactions following an expanded and indiscriminate immune response induced by an adjuvant vaccine,” she adds.

With such “massive overlap” of proteins, the potential for vaccines to induce all sorts of autoimmune diseases is possible; it explains why such diverse autoimmune phenomena have been documented in the medical literature with respect to vaccination, from neurological disorders to skin afflictions to impaired fertility.

“The type of autoimmune phenomenon and disease that is eventually established will depend on the molecules and organs attacked,” explains Kanduc. “For example, attacks against myelin may evoke demyelinating diseases [such as multiple sclerosis] whereas immune reactions against proteins involved in behaviour  and /or cognition may cause autism and behaviour disorders.”

Autoimmune Infertility?

Such autoimmunity may be the mechanism underlying cases of premature menopause and infertility in adolescent girls following injection with the vaccine against HPV, described in Leipzig by an Australian GP. Deirdre Little, a general practitioner in South Bellingen, first published a case study of her 16-year-old patient who developed premature ovarian insufficiency (POI) following HPV vaccination. Since then Little has encountered six more post-HPV cases of sterility in adolescents in her practice – though primary ovarian insufficiency is almost unheard of  — normally affecting one in 100,000 girls under age 20.

Little and Harvey Ward, the Australian obstetrician gynaecologist who co-authored her studies, highlighted their concerns that the HPV vaccine’s impact on fertility has not been researched.

What’s more, she said:  “The ‘saline’ placebo control for this vaccine target group was not saline.” Little discovered that even product information was misleading on this point and failed to mention that the “placebo” for the HPV contained the toxic metal aluminium and polysorbate 80 – an ingredient which has exhibited delayed ovarian toxicity to rat ovaries at all injected doses tested over a tenfold range.

Polysorbate 80 has been compared to diethylstilbestrol (DES), a cancer drug given to women until 1971 when it was shown to induce cancer. Later researchers discovered children who were exposed to DES in utero also had high risk of cervical cancer and infertility.

“The definition of a safe drug is when the children of the people who have taken it can reproduce healthy children,”

said Ward. It will be a long time yet before the HPV vaccine can be declared safe.

Contraceptive researchers have been trying to make a birth control vaccine for decades – primarily by vaccinating against female hormones such as follicle stimulating hormone and human chorionic gonadotropin. They’ve been hampered by their inability to rein in the triggered immune system; besides FSH and HcG, it attacks look-alike sequences on hormones such as thyroid and leutenizing hormone.

 “Our goal with our vaccine was to develop autoimmunity,” Bonnie Dunbar, a 20-year veteran vaccine researcher, told the 4th International Public Conference on Vaccination in 2010, according to a report from the Population Research Institute. Dunbar tried to train rabbits’ immune systems to attack proteins on their ova using pig proteins in her vaccine to “trick the rabbit into inducing antibodies against its own self proteins.”

Instead, she inadvertently launched a full-scale immune assault that completely destroyed their ovaries. “Unfortunately, we weren’t just looking at preventing fertilization now,” said Dunbar, “we generated a complete autoimmune disease, which is also known as premature ovarian failure.”

Is it possible that components of HPV vaccines share sequences with components of the reproductive system?

Do Vaccines Create New Diseases?

In 2007 cattle farmers in Europe began reporting a bizarre new disease among calves. Sometimes the new-born animals were just found dead, but others, usually less than a month old, would develop nosebleeds, black tarry stools and high fevers. Sometimes ear tagging, or the slightest scratch or knock would lead to uncontrollable bleeding. Something appeared to be destroying platelets in the blood of these animals, and post mortems revealed massive internal bleeding and almost completely decimated bone marrow.

By 2009 the disease was in the UK, and while it usually only affected one or two animals on a given farm, sometimes it affected as many as 10 percent of new-borns and it was almost always lethal. Eventually it would kill at least 4,500 calves. Vets suspected many more cases were going unreported and there was no sign of the mystery abating. Veterinary agencies were growing alarmed. The first epidemiology reports in 2009 confirmed rumours: the new disease called Bleeding Calf Syndrome, or bovine neonatal pancytopenia in academic circles, had something to do with Pfizer’s new PregSure vaccine against bovine viral diarrhea (BVD). In 2010 the vaccine was pulled from the market.

BVD spreads easily among intensively farmed animals (not so much grass-fed), and it causes diarrhea, lowers milk production and can cause stillbirths. A calf infected in utero that survives can be persistently infected throughout its lifetime and keep the disease circulating. The PregSure vaccine was given to pregnant cows to avoid BVD transmission to developing calves.

But a host of studies conducted by European agriculture ministries and veterinary researchers revealed the underlying mechanism: the vaccine caused the dams to produce aggressive anti-viral antibodies, present in their colostrum, which also attacked the newborn calves’ blood cells when they drank them.

Today, six years after PregSure was discontinued, previously vaccinated dams are still producing bleeding calves.

Vaccines In Pregnancy

Bleeding Calf Syndrome raises a host of questions: What do these findings suggest for humans? What happens when pregnant women are vaccinated against foreign proteins? The CDC advises women to get vaccinated before, during and after pregnancy. Do these women pass on potentially cross-reactive antibodies to their babies as well?

It seems the industry is aware of the enormous implications of the phenomenon. A study published two months ago in the journal Vaccine states that,

“Although maternal vaccination is generally considered to be safe, the occurrence of Bovine Neonatal Pancytopenia (BNP) in cattle shows that maternal vaccination may pose a risk to the offspring.”

“The occurrence of BNP years after last PregSure© BVD vaccination indicates that alloantibody levels may remain high in dams,” it adds. Alloantibodies are immune system components that recognize and attack proteins with genetic differences within species – as between a host and a tissue transplant graft, for example. “Since pregnancy induces alloantibodies we hypothesized that pregnancy boosts the vaccine-induced alloantibody response,” explain the researchers from the Department of Infectious Diseases and Immunology, Faculty of Veterinary Medicine at Utrecht University in The Netherlands.

Pregnancy seems to reactivate the immune system and relaunch antibody production – in calf after calf. It also suggests that pregnancy is a particularly vulnerable window for launching autoimmune disease.

Subclinical Disease

You may be reassured to think only several thousand calves died from the PregSure vaccine, but recent veterinary studies have demonstrated that the bleeding calves are not all of the affected newborns. A 2014 study found that while only three percent of offspring expressed clinical bleeding calf syndrome, 15 percent of the clinically normal calves had “profoundly altered hematology.” Though they were not ill before they were sold, the researchers could not say if they would become so later or in different conditions.

What happens to the subclinical cows? Do they carry these alloantibodies for life and do they become clinically diseased with a stress trigger years later as per Autoimmune/inflammatory Syndrome Induced by Adjuvants?  Are they already experiencing subtle symptoms of disease? I contacted Zoetis Inc. the animal health company that Pfizer spun off in 2013, to ask these questions. They said they would get back to me. I’m still waiting.

Again, the questions about subclinical disease in animals are important for humans. Is it possible that there are subclinical manifestations of other vaccine adverse events?   Scientists have wondered if generalized anxiety and panic disorders might not be subclinical manifestations of narcolepsy, for example, because they also share symptoms of narcolepsy, such as cataplexy. Is it possible that H1N1 antibodies act subtly at lower levels but still have an effect on the brain? Is it possible that other vaccine proteins induce other autoimmune diseases in people with different susceptibilities?

These are questions that haven’t yet registered with public health vaccine advocates who sit in closed-door policy meetings and hold shares in the drugs they mandate. Bleeding calves won’t be on their radar for years, if ever. They still refuse to acknowledge that Pandemrix was linked to narcolepsy – though the industry does. And cases like Bobby Hunter?  Forget it.

Public health regulators’ main interest is preserving the notion that vaccines help more than they harm. Anything else is blasphemous.

For the rest of us, though, a recent review in immunology literature should give pause. It states: “To date, more than 80 systemic and organ-specific autoimmune diseases have been defined, and their cumulative burden is substantial, both medically and financially. Furthermore, the burden of autoimmune and autoinflammatory diseases is rising, making these diseases a ubiquitous global phenomenon that is predicted to further increase in the coming decades.”

An autoimmune storm is rising. The role of vaccines in it is emerging and will one day be crystal clear. The question is, how far off is that day, and who is going to pay while we wait for it?

Celeste McGovern is a national award-winning investigative journalist in the United Kingdom.

To view the scientific presentations from the 4th International Symposium on Vaccines, go to www.cmsri.org.

To explore more research related to the unintended, adverse effects of vaccination use the GreenMedInfo.com Vaccine Research portal.

Continue to the Article Here

Is Your Unborn Baby Part of a Vaccine Experiment?#android#iPad#retweet

by Christina England
Health Impact News

When a woman becomes pregnant, naturally, she would want to protect her unborn child above all else. Therefore, when offered a series of vaccinations said to protect her newborn baby against disease in the first few weeks of life, she will probably accept the vaccinations without a moment’s hesitation.

However, would she accept those vaccinations so readily if she knew that her unborn child was going to be used as part of a vaccine experiment being conducted by the Centers for Disease Control and Prevention (CDC) and the vaccine manufacturers?

The Growing Fetus Marked as Big Pharmas Latest Guinea Pig

According to CDC paperwork, both the Tdap and the Dtap are vaccinations offered to pregnant women during pregnancy, supposedly to protect their newborn infant from contracting pertussis (whooping cough) in the first few weeks of life.

However, despite recommending these vaccinations to all pregnant women, the CDC readily admits in their own documentation that neither vaccine has ever been tested during pregnancy for vaccine safety and that they have no idea whether the vaccines could harm a growing fetus.

In other words, by recommending these vaccinations to pregnant women, the CDC is fully prepared to use unborn babies as part of a massive vaccine experiment. What is even more worrying is the fact that, in doing this, they are potentially risking the lives of millions of unborn babies.

Why would the CDC do this?…

Continue to the Article Here

http://healthimpactnews.com/

 

Hundreds Claim Swine Flu Vaccine Injury From 2009 Push#android#iPad#retweet

 by

An investigation I conducted in 2009 revealed that the H1N1 swine flu epidemic was far less than the U.S. government had made it out to be. I exclusively obtained lab test results from 50 states when the Centers for Disease Control refused to produce them. The results showed that most of the supposed cases of swine flu were not swine flu at all. In fact, they weren’t any type of flu.

That reality makes it all the more difficult for those who were brain damaged by the vaccine they took to try to prevent swine flu…

…“There has never been a case like this before. The victims of this vaccine have an incurable and lifelong condition and will require extensive medication,” said Peter Todd, a lawyer who represented many of the claimants, in a Sunday Times article.

The number of brain-damaged victims who filed claims is a tiny fraction…

  Continue to the Article Here

http://sharylattkisson.com

The Scary Facts Most Parents Don’t Know About Vaccine Injury Compensation#Family#Android#iPad

by Missy Fleugge

Vaccine injures and adverse reactions are massively under-reported, as admitted by the Centers for Disease Control. Estimates show that only one to ten percent of vaccine injuries and deaths are actually filed with the government.

In the United States, the government has created a database to keep track of hundreds of kinds of reactions to vaccinations, including fevers, soreness, seizures, swelling of the brain, arthritis, and death. Since its inception, this program has awarded over $2.5 billion to individuals and families who have suffered vaccine injury and death. These awards are funded by taxes on vaccines.  [1]

Even though health care providers are required by law to report vaccine injuries, most of these adverse events are not made public in this database, known as the Vaccine Adverse Event Reporting System (VAERS). Parents may not know that common reactions to vaccines, including fevers, long bouts of crying, or rashes following vaccination should be reported to their child’s doctor. When a more serious adverse event occurs, parents may be too overwhelmed to make sure a report is filed.

Unfortunately, rather than educating doctors and parents about the importance of reporting all adverse reactions to vaccines to the VAERS database, the US government has just tightened the requirements for reporting an adverse reaction, making the process even more difficult…

Continue to the www.vactruth.com article here

Judges demand answers after children die in controversial cancer vaccine trial in India#cdcwhistleblower#HearThisWell#Vaccines

There have been over 37,000. adverse events and 214 deaths from the Gardasil/Cervarix vaccines with no evidence of any benefit from the vaccine.  These figures are off of the November 2014 VAERS report and estimated to be only 1-10% of actual cases.  

By GETHIN CHAMBERLAIN IN INDORE, INDIA,

  •  Tribal girls were given shots of cervical cancer vaccines during trial
  • Children given Merck’s Gardasil and Cervarix vaccines
  • Petitioners also asked judges to investigate trials of new drug Gardasil 9
  • Drug has allegedly caused side-effects in children as young as nine
  • Investigation claims children were used as unwitting human guinea pigs
  • Supreme Court has given the government one month to provide answers

Judges in India’s Supreme Court have demanded answers after children died during a controversial cervical cancer vaccine trial.

Young tribal girls received shots of pharmaceutical company Merck’s Gardasil vaccine and Cervarix, manufactured by GlaxoSmithKline.

The vaccines are given to girls as young as nine in many countries – including the UK and the US – to protect against the human papilloma virus, one of the major causes of cervical cancer.

But the Indian court yesterday heard a challenge by campaigners who claim the study – funded by the Bill & Melinda Gates Foundation – failed to obtain the informed consent of the children or their parents.

They say that a ‘study’ carried out for the foundation by a US organisation was in fact an illegal drugs trial.

Continue to the Article Here

http://www.dailymail.co.uk/

Spain: First case filed against HPV vaccine manufacturers and health authorities#Vaccines#HPV#Health

By Alicia Capilla (President of AAVP)

AAVP-logo-Spain-smallAAVP, together with law firm Almodóvar & Jara, filed the first of a long series of lawsuits for damages caused by HPV vaccines. The complaint is filed in the High Court against health authorities and vaccine manufacturers.

The process of trying to find justice now begins for one of the Valencian girls who suffered an adverse reaction after the second shot of Gardasil in 2009. Spanish families whose lives have been adversely impacted by HPV vaccines have organized as the Association of Affected People by HPV Vaccine (AAVP www.aavp.es) to assist others in similar circumstances.

The well documented lawsuit is based on violations of the fundamental right to informed consent prior to medical interventions which all citizens have.

Parents whose daughters are vaccinated with Gardasil are not informed beforehand of the possible risks their daughters may suffer, despite the fact there are numerous reports in Spanish, European and American databases. Furthermore, most of the adverse reactions these girls suffered are included in the brochure/leaflet of the product.

The introduction of HPV vaccines into the market without their real effectiveness being known is another issue. The effectiveness has not sufficiently been proven and will not be demonstrated for decades.

Much of the damage these vaccines are producing is being hidden, despite the fact that pharmacovigilance systems around the world are collecting numerous reports of similar reactions.

Moreover, the Spanish Health Ministry withheld information from affected families by denying that the damage the girls suffered was legitimate and previously known via similar cases being reported to health authorities in various countries.

The  Spanish Ministry of Health, Sanofi Pasteur, and Merck, Sharp and Dohme (MSD), producers of Gardasil®, human papillomavirus vaccine, have a responsibility to report accurately and in a timely manner all data available at the time.

Health authorities around the world are trying to deny any causal relationship between HPV vaccines and adverse events occurring after vaccine use. In some cases, authorities say that the new medical conditions are psychological. This is a paradox because if people in different times and different places suffer a similar adverse reaction, it is undeniable that the cause is the vaccine.

The damage these girls have suffered and many continue to suffer were not all included in the leaflet at the time of injection. Some of them were included later. Others continue without being warned.

Based on data that the AAVP has examined, the number of suspected deaths and serious sequelae left behind after human papillomavirus vaccines is completely unacceptable.

As stated in the case filed, health authorities do not investigate the facts and their attitude is favoring manufacturers. They even accused the victims of suffering psychological disorders, which is not true.

This first case will be followed by another four within two months. The firm will continue to file additional cases, not only against Gardasil® but also Cervarix®, the other brand of the HPV vaccinemanufactured by GlaxoSmithKline.

www.aavp.es

This article, in it’s entirety, is compliments of SaneVax.org.

HPV Vaccine Trials in India: Is Merck above the law?#vaccines#iBelieve#HPV

By Norma Erickson            

3 July 2014: As a result of continued investigations regarding clinical trials involving HPV vaccines in India, more allegations of unethical conduct have been lodged against Merck. These allegations pertain to Merck’s recent trials of the new V503 HPV vaccine, a proposed nine valent HPV vaccine. A complete report of the investigation results written by Dr. Anand Rai, Kelly O’Connor, Amoli Tuli, and Anisha Bhattacharya is now a matter of public record. (Link to report)

The additional allegations of multiple ethics violations were added to a currently ongoing Supreme Court Case via an affidavit added as an addendum to the brief previously prepared regarding the ’demonstration projects’ conducted by a U.S NGO PATH in India beginning in 2009. The deaths of subjects during the ’demonstration projects’ resulted in a government-ordered enquiry and  suspension of all HPV vaccine trials in India pending further investigation. This suspension was effective as of April 2010 and is still in effect.

Ultimately, the suspension and subsequent investigations allowed advocates in India to take their case all the way to the Supreme Court. The petition for the case was formally admitted by the judges on January 7, 2013. By September 2013, the court had issued notices to all participants involved while the Indian Parliament issued a scathing comment condemning all organizations involved in the so-called ’demonstration projects’ calling them a case of child abuse expressly carried out to create a market for the two companies – Merck and GlaxoSmithKline.

According to new allegations, Merck ignored the suspension of HPV-related clinical trials and continued with a phase III trial of the yet-to-be-approved investigational HPV vaccine called V503, which theoretically adds protection against 5 types of HPV to the ones already included in their current HPV vaccine, Gardasil.

Allegations of Merck’s Misconduct

The supplemental affidavit submitted to the Supreme Court of India states that Merck and/or their representatives committed the following violations of basic human rights:

1. Respondent No. 8, MSD Pharmaceuticals Pvt. Ltd.  and its affiliate companies in respect of pre-licensure trials with investigational HPV vaccine V-503.

2. Pre-licensure Phase III trials were carried out at many centres in India. One of these centres was Indore. In Indore this vaccine was administered to 44 children, boys and girls. A field study with the participants was carried out by Dr. Anand Rai and others and is detailed in the Annexure.

3. The timing of this trial was such that vaccination was carried out during the same period when Respondent no. 1, The Ministry of Health and Family Welfare, had asked all HPV related studies to suspend vaccination. As such then this was a violation of the government orders.

4. The Annexure also lists in detail all the problems with this trial on a case by case basis, some of them are summarized below:

a) This clinical trial was not preceded by any trial among adults thereby violating the Drugs and Cosmetics Act. This trial had the approval of the Respondent No. 2, The Drugs Controller General of India (DCGI), who violated the law that his job specifically asked him to uphold. The petitioners have complained to the court that is the second time regarding HPV vaccines the DCGI bestowed this favour on Merck and its associates.

b) The trial used middle men and women acting as agents of the investigator who went around residential areas recruiting subjects in complete violation of all national and international guidelines.

c) The trial was carried out at a government hospital using government stationery and seal even though this was a privately sponsored trial of the company thereby misusing the trust parents place in the governmental vaccination programmes.

d) The parents and children were told that they were getting a successful vaccine from abroad free which would otherwise cost Rs 10,000. This was a blatant lie as this vaccine was not approved for marketing anywhere in the world. Also this constituted undue inducement to recruit children to this trial.

e) None of the participants were informed that they were participating in a clinical trial.

f) Economically vulnerable sections and those from scheduled castes and minorities were recruited for the trial, those who would not be able to afford the vaccine if and when it is marketed; thereby the trial further violated all laws and guidelines in this regard.

g) Merck listed history of allergic reaction that required medical intervention, currently enrolled in another clinical trial, subject is pregnant, subject is immunocompromised or has taken immunosuppressants in the last year, subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial and subject has history of positive test for HPV as exclusion criteria for this clinical trial. No examinations of the children who were selected for participation were undertaken prior to administration of the V503 vaccine.

h) There was no placebo involved in this trial, simply three different lots of V503, despite the fact that one purpose of the trials was to detect potential safety issues.

i) From the beginning to end, there was no examination of the children for their health status, and even though the trial was supposedly carried out to determine the safety of the vaccine not even fever post vaccination was recorded.

j) No medical care was provided for the health problems of the children nor were they provided any compensation. The study found many children who continue to suffer new medical problems even as late as 2013. Out of the 12 individuals interviewed, 4 have experienced health problems after the vaccine, such as mood swings, persistent stomach aches, dizziness, late onset of periods and severe anaemia. One boy whose family was interviewed has suffered extreme weight loss.

k) Though the investigation covered only the trial centre at Indore the entire list of trial centres is placed in the supplemental affidavit for information. In all hundreds of children have been affected in India.

One would think all of the complaints filed against PATH and Merck during the ’demonstration projects’ for Gardasil would have caused them to be on their best behavior. But apparently, when the government officials in India called a halt to any trials relating to HPV, Merck thought the decree did not apply to them. Either that, or they believed themselves powerful enough to be above the law.

Whatever the motivation, it appears hundreds more economically disadvantaged children and their families were put at risk by their participation in a clinical trial they were not told they were taking part in.

Compound this disregard for informed consent with participants being told they were priviledged to receive a successful and very expensive vaccine from overseas. Nevermind the fact that this ’successful vaccine’ had not been approved for use in any country in the world.

The people of India are not the only ones who may suffer the effects of this particular set of clinical trials. What ’results’ will Merck report to the rest of the world on this set of trials where the exclusion criteria was apparently ignored?

What ’results’ will Merck report to the rest of the world when no adverse events were recorded? One can certainly assume the adverse events which apparently were not recorded will no longer exist.

Will pretending these new medical conditions did not happen allow Merck to report their new V503 HPV vaccine is safe?

Is Merck above the law?

Will Merck be allowed to ignore the international laws protecting the basic right of informed consent prior to participation in clinical trials? Will Merck be allowed to continue to exploit economically disadvantaged people then extrapolate the resulting ’conclusions’ to the entire population of the world?

One can only hope the Supreme Court in India decides to protect the health and well-being of their young people by responding to the complaints of the organizations who put forth the allegations in a manner which will stop these types of abuses from ever happening in their country again.

By doing so, India’s Supreme Court Judges could help protect all of the world’s young people.

The Supreme Court of India has scheduled the final hearing of this case for August 12, 2014. The Court’s decision should be rendered on that date.

Whatever the ultimate outcome, advocates around the world will be watching.

Article in it’s entirety, compliments of SaneVax.org

Report: Girl Falls Asleep Up To 30 Times A Day After Getting Flu Shot #Narcolepsy #Flu Shot #Adverse Reactions To Vaccines

EDINBURGH, U.K. (CBS Atlanta) — A 15-year-old girl is reportedly falling asleep up to 30 times a day after getting a flu shot.

Australia’s News Limited reports Chloe Glasson began suffering from narcolepsy four months after being injected with Pandemrix, a vaccine to combat against swine flu, in November 2009. She is one of at least 100 people to suffer from the sleeping disorder after getting vaccinated with Pandemrix.

“She has gone from being a bright, outgoing girl to one who cannot go out on her own,” Rebecca Glasson, Chloe’s mother, told News Limited. “She doesn’t doze for more than a couple of hours at a time, but she can have disturbing dreams.”…

CBS Atlanta Reports: Girl falls asleep up to 30 times a day after getting flu shot

Please click on the above link to continue reading this article.  This is one of many reports surfacing world-wide over the past few months, reporting on the narcolepsy effect after the flu shot with children. 

I think parents as well as other loved ones need to insure to make informed decisions prior to any shot.  The CDC, VAERS, FDA and the Vaccine court do not have the same concern and connection with your children.  Oftentimes, the response time for help can seem endless and hopeless for those injured. 

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