Paris, 23 June 2013: A three hour discussion was held during which various medical professionals, politicians, and health authorities had the opportunity to openly debate serious concerns about the HPV vaccines Gardasil and Cervarix.
Dr. Philippe de Chazournes recently sponsored an open letter to the French Minister of Health calling for the establishment of a parliamentary mission to investigate various aspects of HPV vaccination campaigns. (more information here) Over 200 medical professionals signed the letter confirming their agreement with the stated concerns about the safety, efficacy, and necessity of using Gardasil and Cervarix in national cervical cancer prevention programs.
Michele Rivasi, MEP, chaired roundtable discussions pertaining to the questions raised in Dr. de Chazournes’ letter to the French Health Ministry.
Stakeholders representing both sides of the debate were invited to attend as well as members of the French Parliament, representatives from Sanofi-Pasteur MSD, and national health authorities. Drs. G. Delepine, N. Delepine, A. Siary, Cl-Michal Teitelbaum, JP Hamon, and Mr. Coletti were in attendance along with many other interested parties.
The topics open for discussion are as follows:
What is the justification for HPV vaccination programs?
What is the risk/benefit profile of Gardasil and Cervarix?
What place do HPV vaccines have in cervical cancer prevention strategies, and at what cost?
Gardasil: Cervical Cancer or Political Cancer?
What is the level of ’ethical care’ in the new ’cancer plan’?
Member of the European Parliament, Michéle Rivasi, opened the meeting with the following speech, eloquently stating the actions necessary to protect the public health as well as public health funding.
To paraphrase her words, these vaccines are unnecessary, dangerous to many, and certainly a huge drain on precious public health funds. To halt HPV vaccination programs, pending intense investigation and proof of stated purpose could very well be the salvation of our young people.
Presentation by Michele Rivasi, European Ecology MEP
Translation by Helen Kimball Brook
It is an honor for me to receive Dr. Philippe de Chazournes today in the Parisian offices of the European Parliament. Dr. de Chazournes has fought long and hard as spokesperson for doctors in the current scandal linked to the Gardasil vaccine, the famous Sanofi-Pasteur MSD vaccine against certain strains of the human papillomavirus which can cause cancer. A large number of doctors have signed his open letter to Marisol Touraine, French Minister of Social Affairs, expressing their fears around the idea of doubling the vaccination rate of young girls with a vaccine whose effectiveness is scientifically controversial. Some of them are here today and I thank them for being here. They are demanding a parliamentary mission to clarify this question. Last April, I personally made a public demand for a moratorium, i.e. an end to mass vaccination with this vaccine until in-depth research can be performed on its benefits, risks and effectiveness.
Vaccine safety, as a general rule, is being increasingly questioned. Between 2005 and 2010, the proportion of French people in favour or very in favour of vaccination dropped from 90% to 60% (2013 INPES Peretti-Watel health barometer). The percentage of French people between the ages of 18 and 75 who are anti-vaccination increased from 8.5% in 2005 to 38.2% in 2010. In 2005, 58% of doctors questioned the usefulness of vaccines administered to children while 31% of doctors were expressing doubts about vaccine safety. These figures must surely have increased since then.
Alongside this dramatic slump in confidence, research carried out worldwide – here in France by R. – K. Gherardi and F.-J. Authier, in Canada by C. Shaw and L. Tomljenovic, in North America by S. Seneff and S.-H. Lee, in Israel by Y. Shoenfeld and in the UK by C. Exley and others – blames the toxicity of the aluminium salts used as adjuvants in vaccines.
The injection of these aluminium salts could be the cause of the considerable and unexplained increase in the number of pathologies reported because they migrate through the body until they reach and accumulate in the brain. In certain predisposed individuals, very serious adverse effects have been observed following vaccination: death, convulsions, fainting, autistic disorders, Guillain-Barre syndrome, transverse myelitis, facial paralysis, chronic fatigue syndrome, autoimmune diseases, pulmonary embolisms, macrophagic myofasciitis, pancreatitis and others.
It was the work of E3M, an organisation formed by macrophagic Myofasciitis victims, which encouraged me to bring this subject up within the European Parliament. Macrophagic myofasciitis is a little known but extremely disabling disease caused by the aluminium salts in vaccines.
Without being totally against the actual principle of vaccination, I feel that it is absolutely essential for specification of our vaccine policy to reflect the greatest of transparency and that the voices of vaccine victims be heard so that appropriate responses may be given and solutions found: in particular, urgent and abundant research financing and provision of a basic vaccine which is aluminium-free.
I therefore invited scientists and specialists in this area to come speak to us about their work on Gardasil during a press conference held at the Parisian offices of the European Parliament, last April.
Over the last seven years, nearly two million young women between the ages of 13 and 26 have received at least one dose of this vaccine, 65% of which is reimbursed by the French Social Security… but its effectiveness has still not been proven. Since then, an increasing number of young girls have been claiming that it has made them ill and the matter is becoming an issue Europe-wide.
Marisol Touraine, French Health Minister, has nonetheless just re-affirmed her attachment to this vaccination by confirming the 2014 recommendations which advise “all young girls between the ages of 11 and 14” to get the HPV vaccine. The message was apparently not heard.
Worse still, in early May, EMA (European Medicines Agency) experts recommended that the Gardasil HPV vaccine indication be lowered to age 9 for prevention of anal cancer and pre-cancerous anal lesions. One of the arguments used for this was that there are 6,800 new anal cancers in Europe every year. This feels to me like an attempt to find new justifications for the overall recommendation of Gardasil.
The French government needs to save 50 billion Euros over the next three years and ten of those billions must be saved in Health Insurance. Widespread administration of Gardasil would cost 926 million Euros (i.e. 9.3% of the needed health insurance savings) over three to four years, this for the catch-up campaign alone.
To stop this plan would be a genuine move for public health: this vaccination is worthless, clearly dangerous and a financial black hole. It serves no purpose for the European Medicines Agency to rush to the aid of Gardasil by recommending its use in the prevention of anal cancer (which causes fewer than 200 deaths every year in France, which is 0.11% of all cancer deaths).
What does Europe want? How is it that we ask the member States to reduce their deficits while simultaneously inciting them to spend more and more for the greater good of the pharmaceutical industry? How is it possible that we ask the French (and Europeans because the situation is exactly the same in many countries) to “tighten their belts” while asking them to hand over such large gifts to Big Pharma at the same time?
We must ask ourselves these questions and continue to fight against the health scandals of today and tomorrow by demanding absolute transparency in these highly sensitive issues.
The SaneVax Team would like to thank all of the participants in this debate. We sincerely hope every country in the world holds similar events. If HPV vaccines are as safe and effective as advertised, public scrutiny should be no problem.
Until such time as open and honest scientific debates are allowed in every country, medical consumers need to remember – RESEARCH BEFORE CONSENT – you can’t unvaccinate.
The 2013-2014 flu season has seen multiple lawsuits started for violating the rights of healthcare workers in refusing employment based on mandatory flu vaccinations. Now, according to a new report published by the Centers for Disease Control (CDC), the stage may be setting for mandatory flu vaccines as a condition for employment in other job sectors outside of healthcare facilities, such as food service, education, community and social services, personal care, cleaning and maintenance, and even real estate.
The increase in mandatory flu vaccines for healthcare workers began in 2012, with the implementation of Obamacare, which links federal reimbursement of Medicare and Medicaid funding to the percentage of healthcare workers vaccinated for the seasonal flu.
As we have mentioned in many other places, vaccines are products that cannot survive in a truly free market where freedom of choice exists because many people don’t want them. Medical leaders, backed by government authority, must mandate vaccines for the vaccine market to survive. They would like you to believe that they are smarter than the majority of the American public, and that those who refuse vaccines are simply uneducated and “unscientific,” but the facts actually show that there are more vaccine refusers among those with a higher education than there are among those less educated. (See: More Educated Parents Less Likely To Vaccinate and Feed Children Sugar and GMO Foods.)
Linda Morin comments: Quebec’s decision to reduce Gardasil dosage
By Norma Erickson
In 2008 Linda Morin lost her only daughter,Annabelle, 15 days after her second shot of Gardasil. It is small consolation for the Morin family that Quebec has decided to reduce the number of recommended Gardasil injections from three to two.
Linda wishes her government would concentrate more on the already proven safe and effective means of controlling cervical cancer – pap smears and good follow-up.
To this day, Linda and her family continue to fight for investigations into the causes of Annabelle’s unexplained death and all of the other mysterious deaths and disabilities after Gardasil. They do not believe in coincidence or epidemics of psychosomatic disorders. They want answers.
The SaneVax Team wholeheartedly agrees. When faced with the mysterious death of a previously healthy child, investigations and answers are not too much to ask for. The Morin family is to be congratulated for having the strength and courage to try and protect others from experiencing the dark side of Gardasil.
Gardasil: Quebec Suspends Third Dose
By Cédérick Caron in Écho de Laval, Wednesday 18th June 2014Translation provided by Helen Kimball Brooke
While Quebec is suspending administration of the third and last dose of the human papilloma virus (HPV) vaccine, Linda Morin, who remains convinced that this vaccine played a role in her daughter Annabelle’s death, feels that it would be advantageous to focus on preventive screening.
French-language newspaper Le Devoir reported on June 9th that the Health minister had taken the decision not to administer the third dose of the HPV vaccine which is part of the Canadian vaccination campaign for teenage girls in their third year of secondary school.
The reason is that according to current scientific data, a similar level of protection could be achieved with only two doses at lesser cost. This could save Quebec $8.5M.
“In my opinion”, says Linda Morin, “this decision is purely political and financial. If only the money saved could be reinvested into prevention of cervical cancer (triggered by the different strains of HPV), by encouraging sexually active girls to get regular Pap smears.”
Since her daughter Annabelle died in December of 2008, this brave woman from Laval has been leading a crusade against the Gardasil vaccine; she is convinced that it was what caused her daughter to drown in her bath.
“To stop giving the third dose will not resolve anything;” claims Mrs. Morin. “The problem is the first dose.”
Controversial Vaccine
In the death report he submitted in December 2010, Coroner Michel Ferland concluded that Annabelle Morin drowned and this was the cause of her death. He specified that she died of inexplicable natural causes but did not exclude the possibility that the vaccine could have been implicated.
The coroner also raised questions on the HPV vaccination program and advised Santé Canada, the Canadian health system, and the Health Minister to provide the population with better information on the potential adverse effects of this vaccine.
He mentioned that in the United States at the time of Annabelle’s death, the National Vaccine Information Center had already recorded 78 deaths linked to the vaccine and suggested that similar research should be conducted in Canada.
The vaccine continues to be the topic of many articles just about everywhere, including Europe where lawsuits have been filed against JV Sanofi Pasteur MSD, the pharmaceutical company which markets the product in France.
According to Mrs. Morin who is in touch with the parents of French girls who have experienced different kinds of adverse effects after receiving this vaccine,
“52 lawsuits have been filed against Gardasil in France. One of the cases is even pending in a criminal court.”
In Canada, British Columbia has already followed in the footsteps of Quebec by deciding to administer only two doses, as incidentally is the case in Switzerland also.
Merck however, the pharmaceutical company which developed the vaccine, still claims that three doses are required for optimum effectiveness of the vaccine.
The Laval Centre de Santé et de Services Sociales (Health and Social Services Department) reports that dropping the third jab will not have any impact because it was administered alongside two other vaccines.
Linda, thank you for staying so strong in the midst of such adversity, and holding the torch for others. My heart is very heavy when I think of what you and your family have been through. Annabelle is such a lovely girl, and I’m sure your efforts would make her proud.
It seems that turning around this run-away, pharmaceutical train, has to be engineered by parents. The lack of government, and medical support is inexcusable. They should have thrown on the emergency brake a long time ago, until our youth were no longer at risk. I hope that your efforts travel far and wide.
Here is a little musical gift. I hope it brings you some peace and comfort. God Bless. Your friend, jen
Turn your signature into dozens more by sharing this petition and recruiting people you know to sign.
You Your Friends Their Friends
170 10,000
avg. approx.
My name is Marie-Océane Bourguignon and I am 18 years old. I would like to have a life like other girls my age but the Gardasil vaccine has filled my life with suffering.
When I was 15, I received two injections of this vaccine prescribed to prevent cervical cancer. As a result of this, I suffer with a central nervous system disorder which has left me disabled and plagues my everyday life with fatigue, joint pains and difficulty concentrating. This makes it very hard for me to continue my studies. Due to all the adverse effects, I often miss school.
My life is not what it should be for a girl my age. I can no longer go out with friends during the day or in the evening: I am too exhausted. The trips to the beach which I used to love (we live near the sea in the Landes region of France) are now over because I can no longer tolerate heat and the sun. As a student, I would like to get a part-time or summer job, but my condition makes this impossible.
According to medical examiners, my ailments were caused by the aluminium salts in the Gardasil vaccine. More and more lawsuits are being filed against the manufacturer of this vaccine in France, an increasing number of doctors are questioning its usefulness and the French health authorities acknowledge that Pap smears are the most effective way to screen for cervical cancer, but the government is still pushing for all young girls to have this vaccine!
We must take action to prevent any more Gardasil victims. I have therefore launched this petition, backed by French vaccine victim support groups E3M, REVAHB, CNMSE and Amalyste. We call upon French Minister of Social Affairs Marisol Touraine, to declare a moratorium on the widespread use of this vaccination and to initiate impartial research into its usefulness.
The more signatures we have, the more the government will listen to us and not the pharmaceutical companies. Please sign and circulate this message.
Bordeaux: On September 18, 2013, Judge Patrick Mairé handed down a decision stating Gardasil was 50% responsible for the permanent injury of a French teenager who had received two injections of the HPV vaccine. The other 50% was attributed to a genetic pre-disposition for autoimmune disorders. Judge Mairé presides over lawsuits filed with a regional branch of the CRCI in France, which is the equivalent of the Vaccine Injury Compensation Program (VICP) court in the United States.
Marie –Océane’s parents, Jean-Jacques and Yveline Bourguignon, have granted permission for their daughter’s story to be published hoping they can help make people aware of the potential risks involved with HPV vaccinations. They do not want anyone else to go through what they have experienced without knowing of the possibility in advance.
In 2010, Marie-Océane Bourguignon, age 15, received two injections of Gardasil® the first on October 11th and the second on December 13th. Two weeks after the first injection, she experienced sensory and motor problems in the upper limbs, lasting approximately two weeks before spontaneously and gradually regressing.
Three months after the second injection, on the 13th of March 2011, Mlle. Bourguignon was hospitalized at Centre Hospitalier de Dax for deterioration in her general health, cerebral-vestibular disturbances and sensory-motor impairment (ataxia, vertigo). On March 15, 2011, an MRI of her brain revealed lesions in the white matter.
The initial diagnosis was that she was suffering from either multiple sclerosis or acute disseminated encephalomyelitis (ADEM). After multiple subsequent hospitalizations, it was determined that Marie had developed multiple sclerosis, a chronic, typically progressive disease involving damage to the sheaths of nerve cells in the brain and spinal cord, whose symptoms may include numbness, impairment of speech and of muscular coordination, blurred vision, and severe fatigue. Marie-Océane will live with this condition for the rest of her life.
Consequently, her parents filed for compensation on her behalf with CRCI, Regional Medical Injury Arbitration and Compensation Tribunal in Bordeaux on January 28, 2012. The decision was handed down on September 18, 2013.
The decision handed down by Judge Mairé was kindly translated into English by Helen Kimball-Brooke and is printed below in its entirety. The Bourguignon family had been successful. They could have accepted the compensation award from the French vaccine compensation program and gone on to live their lives.
But this family knew they were not the only ones to have had their lives turned upside down after using the HPV vaccine, Gardasil. They knew that the decision by CRCI would not be widely publicized in order to warn other families about the potential risks involved with the use of HPV vaccines.
Consequently, they decided to turn down the award and take their case to a traditional criminal court where the outcome of the adjudication could be made public. They decided that a just decision for their family was simply not good enough. They wanted justice for all victims of adverse events after Gardasil. They wanted to have the opportunity to warn others about the potential risks involved with consenting to the use of HPV vaccines. They wanted the opportunity to let the public be aware of the fact that HPV vaccines can be quite dangerous for some individuals.
The Decision Handed Down by the French Vaccine Injury Court:
CRCI
REGIONAL MEDICAL INJURY
ARBITRATION AND COMPENSATION
TRIBUNAL
NOTICE
(Article L.1142-8 of the French Public Health Code)
Case: Marie-Océane Bourguignon
File Number: 12.033.C.000071
THE AQUITAINE REGION MEDICAL INJURY, IATROGENIC AILMENT AND NOSOCOMIAL INFECTION ARBITRATION AND COMPENSATION TRIBUNAL, HELD IN BORDEAUX ON THE 18TH SEPTEMBER 2013 AND FORMED TO REACH AN AMICABLE SETTLEMENT
Considering the French public health code, articles L. 1142-1 to L. 1142-24, D. 1142-1 to D. 1142-3 and R. 1142-13 to R. 1142-18 in particular; modified French Law no. 2002-303 of the 4th March 2002, regarding patients’ rights and the quality of the health system; also considering the French Order of the 4th March 2003 regarding the documentary evidence to be included in a compensation request lodged with a regional medical injury, iatrogenic ailment and nosocomial infection arbitration and compensation tribunal,
Considering the compensation request lodged with the secretariat of the Tribunal on the 28th of January 2012 and deemed to be complete the same day, by Mr. Jean-Jacques Bourguignon and Mrs. Yveline Bourguignon, née Cazaux, acting as the legal representatives for their daughter Marie-Océane Bourguignon, born on the 10th of June 1995, a claim then renewed on the 26th of July 2013 in the names of Mme. Marie-Océane Bourguignon and as indirect victims, Mr. and Mrs. Bourguignon, who are hereby suing:
– Dr. Fabienne Chatelet
– SNC Sanofi-Pasteur MSD, 8 rue Jonas Salk, 69007, Lyon 07, insured by Marsh S.A.
Considering the various items of evidence included in the file,
Considering that Dr. François Rouanet, neurologist, and Dr. Larbi Benali, medical examiner, specialist in compensation for injury, had been appointed by the presiding judge as co-examiners on the 31st of May 2012,
Considering the medical examination report submitted on the 26th of June 2013,
Considering the statement submitted by Attorney Coubris on behalf of Mr. and Mrs. Bourguignon,
Considering the statement submitted by Attorney Annie Berland on behalf of Dr. Chatelet,
Considering the statement submitted by Attorney Cécile Derycke on behalf of Sanofi-Pasteur,
Considering the following which was presented during the hearing
The case presentation report by Judge Patrick Mairé, presiding judge, the reports by Drs. Rouanet and Benali, along with the observations made by Attorney Coubris representing Mlle. Océane Bourguignon and her parents, Attorney Annie Berland representing Dr. Chatelet and Attorney Cécile Derycke representing Sanofi-Pasteur.
The tribunal pronounced on:
1. The circumstances:
In 2010, Marie-Océane Bourguignon, age 15 at the time, received two injections of Gardasil ®, a vaccine used to prevent cervical cancer, the first on the 11th of October and the second on the 13th of December that year. The vaccines were administered by her regular doctor, Dr. Fabienne Chatelet.
Two weeks after the first injection, she experienced sensory and motor problems in the upper limbs, lasting approximately two weeks before spontaneously and gradually regressing.
Three months after the second injection, on the 13th of March 2011, Mlle. Bourguignon was hospitalized at Centre Hospitalier de Dax, the main hospital in Dax, France, for deterioration in her general health, cerebral-vestibular disturbances and sensory-motor impairment (ataxia, vertigo).
She was successfully treated with steroids.
An MRI of the brain was performed on the 15th of March 2011 and revealed lesions in the white matter.
The initial diagnosis was that she was suffering from either multiple sclerosis or acute disseminated encephalomyelitis (ADEM).
Mlle. Bourguignon was later hospitalized on several occasions for the same cerebral-vestibular episodes and progressive flare-ups of inflammation until multiple sclerosis was finally diagnosed after she responded well to treatment with Tysabri ®.
On the day of the medical examination, Mlle. Bourguignon had not recovered her health due to the progressive nature of her pathology.
Mlle. Bourguignon does not display any neurological deficiency or functional disability but she is unable to walk more than 1 km. She takes mild analgesics for headaches and abdominal pains. She complains that she has difficulty concentrating and suffers from vertigo.
She feels that Sanofi Pasteur MSD should compensate her for the injury sustained which she attributes to the two injections of Gardasil ® she received.
2. On the Jurisdiction:
Considering that Mlle. Bourguignon’s illness restricts her to life-long clinical and radiological supervision as well as a constant feeling of anxiety regarding the expected course of her disease, it is clear that Mlle. Bourguignon experiences particularly serious deterioration in her quality of life, including financial problems, and this justifies the jurisdiction of the tribunal.
3. On the Substance:
3.1. Responsibility of Dr. Chatelet
It is clear from the two medical examination reports and the information which the examiners provided to the tribunal that before administering the second injection, Dr. Chatelet performed a full clinical examination of Mlle. Bourguignon and did not observe any residual neurological disorder from the reaction which occurred immediately after the first injection. She could legitimately have attributed these sensory and motor disorders to an epicondylitis, particularly since the vaccine package insert did not include any mention of the type of reaction her patient had displayed.
There are therefore no grounds for claiming that she is responsible for any fault especially as the plaintiff does not reproach her for anything.
3.2. Responsibility of Sanofi-Pasteur
The two medical examiners were unable to agree on the diagnosis of the first inflammatory episode so they submitted their reports separately. Dr. Rouanet felt that it was not possible to specify with certainty whether the first episode could be attributed to a flare-up of multiple sclerosis or to acute disseminated encephalomyelitis (ADEM). Dr. Benali on the other hand felt that the first episode was a kind of pediatric ADEM. Aside from the failure to agree on this point, which had no medical or legal impact on the case, the two medical examiners did agree on the fact that this first episode represented the beginning of a vaccine-induced neurological demyelinating inflammatory cascade.
They both concluded categorically that the neurological disorders presented by Mlle Bourguignon had been triggered by the immune decompensation of an unknown prior condition, a decompensation secondary to the vaccination process which led to the initial vaccine-induced acute demyelination, the prodromal physio-pathological substrate for a secondary multiple sclerosis, which is the currently accepted diagnosis.
The medical examiners were unable to establish a direct causal link with GARDASIL ®, stating “that there are no scientific grounds to incriminate GARDASIL ® as the only causal factor for the demyelinating inflammatory pathologies of the central nervous system.”
They did however feel that “the vaccine-induced demyelinating inflammatory cascade from which the plaintiff suffers presents all the objective characteristics of medical and legal imputability.
They concluded, after completing a conscientious examination of all the items in the file and substantiating their observations with information from scientific literature, that there is a definite causal link between the first injection of the vaccine and the onset of an acute inflammatory reaction in the central nervous system which then later, after the second injection, led to decompensation of a latent immune process.
They felt that total imputability of the observed damage to the vaccination could be assessed at 50%.
It was not up to the Tribunal to make a general pronouncement on whether the vaccine was defective since a discussion of the public health benefits and risks of the vaccine in question was not on the agenda but it was however expected to determine whether, given the defective nature of the doses administered, the facts before it represented serious, specific and corroborating evidence regarding both Mlle Bourguignon’s personal situation and the specific circumstances (French Court of Appeal, 1st civil, 10 July 2013. Appeal # 12-21314).
In the case in point, the medical examiners had observed that Mlle Bourguignon presented with a family history of genetic vulnerability making her susceptible to the potential onset of a dysfunctional immune demyelination of the central nervous system.
Her sensory and motor disorders were triggered two weeks after the first injection and then regressed. Later, two months after the second injection, a cerebral-vestibular syndrome and a sensory-motor condition appeared.
According to the medical examiners, given the substrate of the central nervous system, the vaccination as an immunity stimulator played a role in the onset of the dysfunctional immune and inflammatory cascade. Stimulation of the immune system by the antigens in vaccines can indeed trigger an autoimmune pathology when there is a genetic predisposition against a particular hormonal and environmental background.
What stands out from the two reports therefore is that there is specific and corroborating serious evidence based not only on chronological sequence but also on factors specific to Mlle Bourguignon. This is sufficient to establish the link between the two injections of Gardasil which Mlle. Bourguignon received and the onset of her multiple sclerosis.
The patient was not informed of the possibility of such a risk and was therefore not granted the safety she could lawfully have expected. The vaccine package insert does not mention the risk of central nervous system inflammation while this risk has been scientifically established by medical experts and was known at the time of vaccine authorization. This is an unusual risk inherent in the vaccination act itself, which does not always result in multiple sclerosis but in the case in point, the risk was real, and due to a predisposition, multiple sclerosis was triggered.
The manufacturer is therefore deemed responsible as per articles 1386-1 and 1386-4 of the French Civil Code.
Sanofi Pasteur MSD’s insurance company must therefore make an offer of compensation for the injury caused.
4. The Injury:
Mlle. Bourguignon has not recovered her health.
The injury, with the exception of her two-year absence from school, was totally and properly assessed as is by the medical examiners. The examiners formally excluded any temporary aesthetic injury.
According to the examiners, 50% of the injury sustained was due to a pre-existing condition.
Judgment:
Article 1: Sanofi-Pasteur MSD’s insurance company, Marsh S.A. must make Mlle. Bourguignon an offer of compensation amounting to 50% of her claims as specified below:
– Temporary Total Functional Disability: 73 days from 13th March to 2nd September 2011, dates as specified by the medical examiners.
– Temporary Partial Functional Disability:
Category IV: 41 days from the 22nd March to the 1st April 2011, then later from the 9th April 2011 to the 8th May 2011.
Category III: 10 days from the 27th May to the 5th June 2011
Category II: 62 days from the 1st March to the 18th August 2011, then later from the 3rd September 2011 to the 30th October 2012 which was the day of the medical examination.
– Assistance of an Unskilled Third Party Assistant (her mother):
3 hours per day during the periods of category IV temporary functional disability,
2 hours per day during the periods of category III temporary functional disability,
1 hour per day during the periods of category II temporary functional disability.
– Permanent Functional Disability at the minimum rate of 5%
– Absence from School: loss of two academic years
– Suffering experienced: assessed at the minimum rate of 4/7
Article 2: If Mlle. Marie-Océane Bourguignon does not receive an offer within four months from receipt of this notice, it will be her responsibility to request ONIAM (Office National d’Indemnisation des Accidents Médicaux, the French National Medical Injury Compensation Authority) to come up with an alternative offer.
Article 3: This notice will be sent to all interested parties, to ONIAM and to the lawyers and insurance companies concerned, by registered letter with acknowledgement of receipt.
A copy will be sent to Mlle. Marie-Océane Bourguignon’s medical team within her local Social Security unit.
Presiding Judge
Patrick Mairé
(A special thanks from the SaneVax Team to Helen Kimball-Brooke for providing the translation of this document.)
Marie –Océane, thank you to you and your parents in leading the way for so many other families affected by Gardasil/Silgard/Cervarix injuries. It is great news that French authorities have granted an award for the difficulties, and congratulations for taking the next step with a criminal court. How considerate and gracious of your family to think of others at such a challenging time, and make efforts to get the word out to other families so they do not incur these same difficulties.
Your actions speak highly of you, and I have included a video clip as a little gift. I find that uplifting entertainment is good for the soul. I hope you and your family enjoy the following clip.
By Attorney Philippe Vanlangendonck, guest author from Belgium
Translated by Helen Brooke Kimball, European Forum for Vaccine Vigilance (EFVV)
The Colloquium and public hearing on the aluminium in vaccines, held in Paris on the 22nd May 2014: What immediate measures are required? Mandatory genetic tests before any aluminium-containing vaccine, or immediate moratorium on these aluminium-containing vaccines?
As an attorney registered with the Brussels Bar and defending vaccine victims, I was honored to be able to attend these two important scientific meetings held on the 22nd of May 2014 at the French National Assembly in Paris. It is at present too early to grasp the full extent and impact of these discussions, the scope of which was vast.
Vaccine Safety Debates
In the morning, E3M (Macrophagic myofasciitis sufferer support group) had invited internationally renowned medical consultants to take part in a colloquium called “Aluminium and Vaccines: International expertise requires action;” and in the afternoon, OPECST, the Office parlementaire des choix scientifiques et technologies, the equivalent of the British House of Commons Science and Technology Committee, had organized a public hearing, open to the press and called “Vaccine Adjuvants: A Controversial Question”.
When one attends a scientific meeting in a political setting such as this and the presence of a minister is announced, the said minister often sends a replacement at the last minute, due to his busy schedule, but on the 22nd of May, it was the exact opposite which happened and this is remarkable enough to be highlighted. In fact, a correction had been included in the introductory section of the OPECST public hearing programme, informing those attending that Mme. Marisol Touraine, French Social Affairs and Health Minister would be present.
So the French Health Minister attended this public hearing, the profile of which was raised by her presence. The consequences of this for her, as political figure responsible for the proceedings, are clear because by attending this public hearing she cannot later claim not to be aware of what took place.
In fact, any decision in the field of health must take the latest scientific advances and knowledge into consideration.
On the 22nd of May 2014, the latest scientific and technical knowledge in the field of health were presented:
Professor Yehuda Shoenfeld, director of the Zabludowicz Centre for autoimmune diseases and international specialist on immunity, pointed out that certain individuals have a genetic predisposition to much greater and more serious reaction to immune system stimulation in the form of aluminium salt-containing vaccines.
Professor Yehuda Shoenfeld also informed those attending that we already have genetic ‘tests’ which can determine, before any vaccine is administered, whether an individual’s genetic makeup is such that he may be susceptible in the long term to a potentially very serious auto-immune reaction.
Now that the matter has been so clearly outlined in a political setting, the only valid criterion to take into account is that of current scientific knowledge and progress.
As of today, current scientific knowledge and progress has revealed that aluminium is responsible (as an isolated triggering factor or combined with other factors, including the presence of an antigen) for what can be called vaccine-induced illness, or, depending on the case, illnesses which did not naturally exist pre-vaccination and which the individual therefore contracted through aluminium toxicity; as such, he or she would NEVER in his/her life have contracted this disease since without the presence of aluminium, his/her genetic predisposition to serious reactions when exposed to aluminium COULD NOT have caused this illness, e.g. macrophagic myofasciitis.
In other words, no individual even genetically predisposed would ever contract such an illness unless he or she were exposed to the aluminium in a vaccine.
What all this means is that either a genetic ‘test’ would need to be performed before any vaccination (particularly if the vaccine contains aluminium) or no vaccine containing aluminium could ever be mandated.
Professors Exley and Gherardi had also made the same observations regarding the toxicity of aluminium.
On another matter, the fact that Mme. Marisol Touraine, French Health Minister, had taken a public stance during the French presidential campaign in favour of freedom of choice for families faced with aluminium salt-containing vaccines for their children, shows that she is fully aware of the problem and the urgent need to take concrete measures as soon as possible.
Against this background, lack of immediate action, no action or delaying the adoption of the essential measures required would inevitably result in a scandal similar to that of contaminated blood.
The problem is also that the presence of unknown disease makes it very difficult to recognize the disease and treat people suffering from vaccine-induced ailments.
As far as Belgium is concerned, I am working on a letter which I will send to the head of ONE (Office de la Naissance et de l’Enfance), the Belgian Birth and Childhood Authority.
Correspondence between Gardasil Parents and the FDA
Gardasil and the FDA: Precaution or Promotion?
Kim and Chad Robinson’s nightmare began on September 2, 2010. That was the day their daughter, Katie, received her first and only injection of Gardasil. Katie’s health began to deteriorate almost immediately. Like so many others, she developed Dysautonomia (POTS), food sensitivities/allergies, autoimmune disorders and a host of other health problems. By April 2011, she was totally disabled. To this day, Katie suffers daily pain and a number of other debilitating symptoms with no end in sight.
Katie had a single injection of Gardasil in September of 2010. Her parents are still fighting to recover her health. Like many other parents, research has become a part of their everyday life.
In Kim’s own words:
I know Gardasil injured my child and I will forever be angry about that. We have been forced to learn more about individual health, healthcare in general, food production and environmental factors that influence health than we ever dreamed. These are all things we’ve been learning about along the way that we never gave a second thought to before Katie’s illness – so it is one positive outcome to her vaccine injury. I believe our family as a whole will be healthier for it in the long run once we figure Katie’s way out of this nightmare!!!!
Kim and Chad ultimately felt compelled to contact the FDA about their daughter’s situation. They have kindly allowed the SaneVax Team to publish their letters to the agency responsible for approving Gardasil along with the responses they received. They sincerely hope their correspondence with the FDA will help other parents who are living the “Gardasil Nightmare.”
.
From: Kim Robinson Sent: Thursday, May 01, 2014 11:58 AM To: CBER OCOD Consumer Account Subject: Gardasil information
After reading the following on this website, we felt compelled to contact your office to let you know that your office is clearly misinforming the public with the following Information:
Are there any possible adverse reactions associated with the use of Gardasil?
More than 10,500 females who received Gardasil were evaluated for adverse reactions. Most of the reactions experienced by the study participants were not serious and included mild or moderate local reactions, such as pain or tenderness at the site of the injection. It is always possible, that unexpected and rare adverse events can occur when a vaccine is used more widely. The manufacturer has committed to FDA to performing additional studies of the safety of Gardasil. In addition, FDA and CDC carefully monitor the safety of approved vaccines through the Vaccine Adverse Event Reporting System (VAERS) in order to detect any problems.
We were shocked to read this garbage in a place that is supposed to serve and protect the health and welfare of the American people. By now, your office must be well aware that there are many, many individuals that have experienced much more than what is described above. To state “unexpected and rare adverse events can occur” is perpetuating a blatant lie. Too many individuals have been adversely affected post-Gardasil vaccine with serious health problems, disability and death.
Our daughter has-been chronically ill since September 2010 after receiving only one injection of Gardasil. She continues to suffer with daily pain and a number of debilitating symptoms with no end in sight. This is not a RARE occurrence as there are so many more like her. Like so many, she developed Dysautonomia (POTS), food sensitivities/allergies, autoimmune disease and much, much more. THESE MEDICAL ISSUES ARE A COMMON THEME FOR THOSE THAT HAVE BECOME CHRONICALLY ILL POST GARDASIL VACCINE.
Whatever your office is doing this at this point with regards to monitoring adverse events post Gardasil vaccine, is ineffective clearly and absolutely not in the best interest of the American people.
It is common knowledge VAERS that has many inherent flaws. We can quickly name two: # 1 Most American doctors are unable to diagnose a vaccine injury; and, # 2 Most American doctors, assuming they could actually diagnose a vaccine injury, are not aware of their obligation to report adverse events post vaccine to VAERS. Rather than simply monitoring VAERS, perhaps your office should put together a voluntary survey of those vaccinated with Gardasil. This would allow the public to provide relevant information about medical issues acquired post-vaccination. While I am well aware that most individuals do not experience medical issues post vaccination, I am very aware that Gardasil has adversely affected a broad sub-set of individuals post-vaccine and that no one has provided answers for why this might be.
Leaving this misinformation on your website is a true travesty. How many-have to be seriously injured by this vaccine before the adverse reactions to Gardasil are truly investigated in a meaningful way?
Kim and Chad Robinson Red Hill, PA 18076 . . From: CBER OCOD Consumer Account [mailto: cberocod@fda.hhs.gov ] Sent: Friday, May 02, 2014 3:36 PM To: Kim RobinsonSubject: RE: 9190: Gardasil information
Dear Mrs. and Mr. Kim and Chad Robinson:
Thank you for your email to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) requesting changes to the website’s information on Gardasil.
We are truly sorry to hear about your daughter’s medical circumstances and we understand your concerns. Your email describes your daughter’s symptoms have including Dysautonomia, food allergies, and autoimmune disease. The FDA takes this kind of adverse event report very seriously. We cannot imagine the pain and frustration which your family has gone through and we recognize that no amount of information we provide can make your daughter feel better. We only hope that the information which we are able to provide will more fully express the close scrutiny and monitoring by both the FDA and the Centers for Disease Control and Prevention (CDC) of the Gardasil vaccine.
In your letter you mention the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety database. The information from this system is evaluated on an ongoing basis evaluated by the FDA, CDC and others in order to identify safety concerns, trends of adverse events, or possible side effects. Reports to VAERS can be made by anyone including vaccine recipients, parents and caregivers, vaccine manufacturers, and physicians, so it can capture the voluntary information that you describe. Health professionals and vaccine manufacturers are required by the National Childhood Vaccine Injury Act (NCVIA) of 1986 to report adverse events occurring after the administration of the routinely recommended vaccines to the U.S. Department of Health and Human Services (HHS).
The reports submitted to VAERS are carefully monitored and analyzed through in-depth medical review, statistical data mining techniques (the process of discovering patterns in large data sets,: such as VAERS reports), and analysis of reporting rates (number of adverse events per number of doses distributed) in order to detect serious events that occur at rates greater than expected. VAERS receives reports of many events that occur following immunization. Some of these events may occur coincidentally during on the time period following vaccination, while others may actually be caused by vaccination. The report of an adverse event to VAERS is not proof that a vaccine has caused the event, however if the VAERS data suggests a link between an adverse event and vaccination, the relationship may be further studied in a controlled fashion.
The most common adverse events reported about in VAERS for Gardasil are syncope (fainting), local reactions at the injection site (i.e. pain, redness and swelling), dizziness, nausea, headache, fever and urticaria (hives).
In addition to VAERS, CDC has two other systems in place to monitor the safety of all licensed vaccines. The Vaccine Safety Datalink (VSD) and the Clinical Immunization Safety Assessment (CISA) Network.
The VSD Allows scientists to monitor adverse events and health conditions among vaccinated people. In 2011, the VSD studied the occurrence of specific adverse events following more than 600,000 doses of Gardasil. Adverse events in the HPV Vaccinated population were compared to another appropriate population (such as teenagers vaccinated with vaccines other than HPV) and included Guillain-Barré Syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope (fainting) , allergic reactions, and a potentially life-threatening allergic reaction called anaphylaxis. None of these adverse events were found to be any more common after HPV vaccination than among the comparison groups.
When the FDA originally approved Gardasil on June 8, 2006, its safety and effectiveness were supported by studies that included approximately 21,000 girls and women. Approximately half of the study participants received the vaccine and the other half received a control product for comparison. Most adverse experiences in the study participants who received Gardasil or the control product involved mild or moderate local reactions, such as pain at the site of injection. In these studies there were a few participants who experienced the onset of new medical conditions potentially indicative of a systematic autoimmune disorder such as juvenile arthritis, but were assessed by the FDA as unlikely to be related to Gardasil.
Although it was determined to be unlikely that these medical conditions were related to Gardasil, FDA wanted to be more certain that these conditions were not linked to the vaccine. To accomplish this, the FDA requested the manufacturer of Gardasil, Merck and Co., to conduct an additional study after the vaccine was approved for use. This type of study, known as a post – marketing study, is often conducted for vaccines FDA approved vaccines. The FDA evaluated the results of this study, which included 189.629 females ages 9 to 26 years, 51% of whom were 9 to 15 years of age, to assess the risk for onset of new autoimmune diseases after vaccination with Gardasil. Examples of these types of diseases include juvenile rheumatoid arthritis, lupus, multiple sclerosis, etc… The results of this study showed that there is no elevated risk for onset of new autoimmune disease associated with the use of Gardasil. Additionally, as reported by the CDC, continued post-licensure safety monitoring from June 2006 through March 2013 continues to show no new adverse events or HPV vaccine to suggest a safety concern.
The safety of vaccines in the United States continues to be one of our highest priorities and we absolutely take any and all reports of adverse events very seriously. As described above, we have multiple systems for monitoring vaccine safety. Based on the scientific information available to FDA and our evaluation of these multiple monitoring systems, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks. The information contained on the FDA’s website regarding Gardasil reflects this assessment. If you would like additional information pertaining to Gardasil, please visit the FDA and CDC linked pages at the end of this letter.
Again, we are truly sorry to hear about your daughter’s medical conditions and we encourage you to report this through VAERS if you-have not done so already. Information submitted this way is a key component in the continued monitoring of the safety of Gardasil.
Sincerely, Rachael Conklin Consumer Safety Officer Consumer Affairs Branch Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research U.S. Food and Drug Administration Follow us on Twitter: FDACBER
This informal communication represents my best judgment at this time. It does not constitute an advisory opinion in accordance with 21 CFR 10.85, and does not necessarily represent the formal position of FDA or otherwise obligate the agency to the views expressed.
. From: Kim RobinsonSent: Wednesday, 14 May 2014 To: CBER OCOD Consumer Account
Dear Ms. Conklin:
Thank you for taking the time to read our prior e-mail and for your prompt response.
While we described some of our daughter’s symptoms/diagnoses, please know that our daughter suffers many more symptoms than those associated with Dysautonomia, food allergies and autoimmune disease. She has suffered daily since September 2, 2010, which was the day she received the Gardasil vaccination. By April 2011, she was totally disabled by this vaccine, no longer able to attend school. She continues to be disabled and suffers daily with the after effects of the Gardasil injury. For the HPV vaccine injured, it is typical to suffer daily with a gamut of symptoms, receive multiple diagnoses and most still remain unsuccessfully treated many years after receiving this vaccine.
Is the FDA aware of the fact that of the 75 + vaccines approved for use in the United States, that ‘HPV vaccines accounted for the following percentages of the VAERS database as of October 2011?
24% of all life threatening events
26% of all emergency room visits
25% of all hospitalizations
33% of all extended hospital stays
36% of all disabling events
Since the FDA Closely scrutinize these reports, why have these percentages not resulted in intense investigations into the safety of HPV vaccines?
While the VASERS database is monitored and evaluated on an ongoing basis by the FDA, CDC and others in order to identify safety concerns, it is widely accepted that there is a gross under-reporting problem so the data that is being evaluated is strongly skewed. Perhaps this is a reason why the FDA and CDC are not recognizing trends of adverse events and possible side effects while the Gardasil injured and their families can readily identify the “common trends of adverse events” experienced by the HPV vaccine injured as they suffer an abrupt health decline eventually leading to chronic illness and disability. While we understand that healthcare professionals and vaccine manufacturers are required by the National Childhood Vaccine Injury Act (NCVIA) of 1986 to report specific adverse events occurring after the administration of routinely recommended vaccines to the U.S. Department of Health and Human Services (HHS), there is no penalty for failure to do so. Doesn’t this make the VAERS system somewhat of a joke?
You indicate that the reports submitted to VAERS are carefully monitored and analyzed through in-depth medical review, statistical data mining techniques and analysis of reporting rates (number of adverse events per number of doses distributed) in order to detect serious events that occur at rates greater than expected. But the number of adverse events reported per number of doses distributed means absolutely nothing. A relevant analysis would be the number of adverse events reported per number of doses actually administered (divided by the three recommended doses). This analysis would make the reporting rates comparison more meaningful. Even then, there would be a problem without instituting and enforcing a penalty for failure to report suspected adverse events.
If the VAERS data suggests a possible link between an adverse event and vaccination, the relationship may be further studied in a controlled fashion. According to the information provided by the FDA, the most common adverse events reported to VAERS for Gardasil are syncope (fainting), local reactions at the injection site (i.e. pain, redness, and swelling), dizziness, nausea, headache, fever, and urticarial (hives). However aaccording to VAERS data, there has been an 8100% increase of Acute Disseminated Encephalomyelitis (ADEM), a 442.4% increase in Postural Orthostatic Tachycardia Syndrome (POTS) and a 790% increase in infertility reports since HPV vaccines were approved by the FDA. Does this not adequately demonstrate the safety signals the FDA claims to be looking for? The rates of increase listed above should not be assumed as mere coincidences. It is our contention that any serious event reported after vaccination should be investigated thoroughly as a potential adverse reaction.
The Vaccine Safety Datalink (VSD) and The Clinical Immunization Safety Assessment (CISA) Network are administered by the CDC, an organization which according to a 2007 report prepared by Senator Tom Coburn’s office has a questionable track record, at best. See the report here: http://www.coburn.senate.gov/public/index.cfm?a=Files.Serve&File_id=f016bd58-8e45-45d4-951a-b6b4d1ef3e70 . Adding to this is the fact that the U.S. government holds patents on HPV vaccine technology and receives income from each dose administered. This is not a situation that instills confidence in the voracity of any reports generated by systems under control of the CDC.
You indicated that in 2011, the VSD studied the occurrence of specific adverse events following more than 600,000 doses of Gardasil and that the adverse events studied included Guillain–Barré syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope (fainting), allergic reactions, and a potentially life-threatening allergic reaction called anaphylaxis. Those studies found that none of these adverse events were found to be any more common after HPV vaccination than among the comparison groups. One has to question why these particular adverse events were chosen for analysis instead of events such as ADEM and POTS for which there were such large increases in VAERS reports after HPV vaccine approval. Why not analyze these adverse events versus the prevalence in the general population?
We are aware that the FDA originally approved Gardasil based on its safety and effectiveness supported by studies that included approximately 21,000 girls and women. We also know that approximately half of the study participants received the vaccine while the other half received a control product for comparison. However, the “control product” contained a known neurotoxin (aluminum) plus unknown (proprietary) ingredients in the so-called carrier solution. All this proved was that Gardasil was no less dangerous than the carrier solution. Perhaps the FDA should rethink the policy of allowing vaccine manufacturers to use “placebos” which are not inert….particularly in vaccines such as Gardasil, where there was NO COMPARABLE VACCINE ALREADY ON THE MARKET TO COMPARE IT AGAINST. Further, over 70% of the participants in Gardasil clinical trials reported new medical conditions after injections – please check your own VRBPAC documentation. Considering the fact that an inert placebo was not used for the vast majority of the clinical trials, why didn’t this fact raise any red flags?
Considering Merck’s track record with other medications (VIOXX) and vaccines (isn’t Merck currently in court over allegedly falsifying data on Dtap efficacy, which potentially bilked US taxpayers out of millions of dollars?), how could the FDA possibly place any value on the post-marketing studies reported by this particular manufacturer? Despite whatever is being reported by Merck in its “self-monitoring studies,” when is there going to be enough growing evidence to warrant concern so that the FDA takes a closer look into how the HPV vaccine is seriously injuring, and sometimes killing, a sub-set of the HPV vaccine recipients?
The FDA has been informed of multiple problems with HPV vaccine approval and safety but it has not responded with scientific data. The FDA has responded with platitudes and no scientific documentation to back up its claims. How is the average medical consumer supposed to trust the FDA when so many medications are pulled from the market after extensive damage to the public health – all of which were approved by the FDA as “safe and effective” at one time?
We are working on reporting our daughter’s vaccine injury to VAERS. Unfortunately, her Children’s Hospital affiliated Pediatrician at the time was not capable of recognizing or diagnosing a vaccine injury even though the onset of symptoms clearly began after administering the Gardasil vaccine to a child that was healthy and thriving pre-vaccine. Instead this Pediatrician referred us to many different specialists, all of whom looked at the subset of symptoms related to their specialties and were also unable to diagnose the post-Gardasil vaccine injury. This is despite the fact that we continued to ask if her illness was caused by Gardasil since it so clearly marked the onset of her symptoms. If most healthcare professionals can not recognize or diagnose a vaccine injury, how is it realistically possible for healthcare professionals to report vaccine injuries to VAERS? Three and a half years later after reviewing our daughter’s vaccine records, pre-vaccine medical records and post-vaccine medical records, our daughter’s primary care physician and a treating specialist have agreed that our daughter was injured by the Gardasil vaccine. The inability of healthcare professionals to diagnose vaccine injuries ultimately leaves the burden of reporting vaccine injuries on the family or the vaccine injured recipient, who in most cases are not healthcare professionals and may struggle with being able to submit a complete and accurate VAERS report.
Because the FDA and the CDC have not truly investigated the serious injuries reported by many of the Gardasil injured, the misinformation contained on the FDA website continues to be travesty and surely is destined to insure that there will be many more of our country’s youth sustaining serious injuries from HPV vaccines. Again, how many have to be seriously injured by this vaccine before the adverse reactions to HPV vaccines are investigated in a truly meaningful way?
Please share this e-mail with any other Departments within the FDA that may be relevant to addressing our concerns and that of the growing number of HPV vaccine injured victims and their families.
Sincerely, Kim and Chad Robinson Red Hill, PA 18076 . . From: CBER OCOD Consumer Account [mailto: cberocod@fda.hhs.gov ] Sent: Friday, 16 May 2014 To: Kim RobinsonSubject: RE: 9190: Gardasil information
Dear Mrs. and Mr. Kim and Chad Robinson:
Thank you for taking the time to share the information that you have found with the FDA.
We can only hope that you are able to accept our assurance that FDA and CDC monitoring of vaccine safety takes all relevant data into account and that decisions are made based on the absolute best available information. Patient safety is, beyond all other things, the priority for the FDA.
We will be certain to pass the information which you have provided along to the appropriate entities within the organization.
Again, thank you for the time and energy that you have put into making your concerns heard. The pain and suffering which your daughter and your family have experienced is not something which we take lightly. Submitting the VAERS report, which you indicated that you are working on, will be a valuable piece in the continued monitoring of Gardasil safety.
Sincerely, Rachael Conklin Consumer Safety Officer Consumer Affairs Branch Division of Communication and Consume r Affairs Center for Biologics Evaluation and Research U.S. Food and Drug Administration . .
Note from SaneVax: These are quite typical of responses from the FDA when a citizen expresses concern or asks questions about HPV vaccine safety. Notice that there was absolutely no scientific data to back up any of the assertions made by the FDA. Like so many others, Kim and Chad Robinson received a pat on the head and empty platitudes – no REAL answers to any of their questions or concerns. One has to wonder exactly who the FDA is working for as it is apparently not the parents of HPV vaccine survivors!
Dr. Sin Hang Lee, put the issue in a nutshell when he stated:
HPV vaccination is unnecessary and potentially dangerous to some recipients. This is the first vaccine invented by the government, patented by the government, approved by the government, regulated by the government and promoted by the government to prevent an already preventable disease (cervical cancer) 30 years down the road based on using a poorly demarcated, self-reversible surrogate end-point (CIN2/CIN3 lesions) for evaluation of vaccine efficacy, a big scientific fraud. There are no cervical cancer epidemics in any developed countries.
On May 22, two conferences were held at the National Assembly on the subject of aluminum adjuvants in vaccines and the safety of HPV vaccines. (View the announcement here.)
Organized by E3M and hosted by Virginia Belle, the morning conference was entitled, “Aluminum and Vaccines: International Expertise Demands Action.” (View schedule here.) Scientists and medical professionals from various countries around the world were invited to present their research in an open forum to members of the French Parliament and French National Health Authorities with journalists and television cameras present.
Professors Romain Gherardi and Jerome Authier informed the audience of the preliminary results of their research which was funded by MSNA (the French Medicines Agency) which indicated a causal link between aluminum adjuvants and adverse events experienced after vaccination stating:
We injected normal mice, without any particular background, with either PBS as a control serum, or the hepatitis B vaccine, Engerix. We did cognitive and motor testing at various intervals. We have the results of the first two times. At 45 days, there is no difference between the control group and the vaccinated group. By contrast, at 135 days (4 ½ months), three tests are significantly altered in the vaccinated mice only. What are these tests? Tests of anxiety, decreased activity, decreased stamina (including motor endurance), that is to say a series of symptoms resembling that exactly described by patients of chronic macrophagic myofasciitis.
Dr. Sin Hang Lee, described his Gardasil research to date, stating:
I have tested 16 samples of the HPV vaccine Gardasil, each of different lot number, from 9 countries, and found that they all contained fragments of residual HPV DNA, namely viral DNA which was used to manufacture the HPV vaccine antigens by a genetic engineering technology.
Furthermore, the viral DNA fragments in a non-B conformation were firmly bound to the aluminum adjuvant in the vaccine by ligand exchange, an inadvertently created chemical compound containing viral DNA which can be transfected into the host cells, namely the human phagocytes and macrophages.
Based on established research, this viral DNA can activate the innate immune system of the macrophages to generate and release cytokines, including tumor necrosis factor in the vaccine recipients.
In certain genetically predisposed individuals, the level of tumor necrosis factor may be high enough to cause hypotension, fainting, tachycardia, unexpected sudden death and acute disseminated encephalomyelitis, namely adverse reactions which have been documented following Gardasil vaccination.
Professor Belec, head of the Laboratory of Virology, Hospital European Georges Pompidou, confirmed the work of Dr. Lee on Gardasil, stating:
We found residual viral DNA fragments, which should not be there. This is true residual contamination, probably related to the manufacturing process. Between 200 and 400 fragments of residual DNA in Gardasil. This is not normal.
What is the meaning? I do not know. Dr. Lee showed us in his work that this fragment was associated with aluminum hydroxyphosphate. This is not any normal way.
This is but a sample of the information presented during the conferences held in Paris on the 22nd of May. The schedule for the day with a list of speakers is available here. All 16 presentations and the two very informative debates can be viewed in their entirety on the OPECST site.
At the conclusion of the morning session as a direct result of having the opportunity to hear both sides of the vaccine debate, the parliamentarians who were present (Jean-Louis Roumegas Danielle Auroi, Laurence Cohen, Jean Lassalle, and Sophie Errante) called upon the French government to:
Massively support rapid research so that the consequences of the accumulation of aluminum in the brain are established quickly and comprehensively
Make vaccines available without aluminum adjuvants
Not promote any campaign of mass vaccination with vaccines containing aluminum, as research has not provided satisfactory answers to safety questions
Recognize the group Action on Health
For the first time in France, open public debates have been held with arguments being heard from both vaccine promoters and vaccine safety advocates. These historic events need to be duplicated in every country around the globe.
Dr. Izard, himself a victim of macrophagic myofaciitis, stated it quite succinctly during his presentation when he said:
Pending the results of this work, the precautionary principle should apply. The population must have access to vaccines without aluminum adjuvants. The widespread vaccination against HPV should be put under immediate moratorium.
Senator and co-chair of the debate sponsored by OPECST, Corinne Bouchoux, proposed research be funded to discover treatment protocols for those suffering adverse events post-vaccination.
The debates in France were about more than HPV vaccines, but one has to remember HPV vaccines are a prime example of what can go wrong with a hastily instituted vaccination program.
As a society, we are injecting a healthy population of young people hoping that eliminating one of the risk factors for the development of cancer will make an impact on the disease prevalence – albeit decades down the road. Contamination with a new chemical compound that has completely unknown health consequences has been discovered and documented by two separate independent laboratories. Said contamination has been swept under the FDA/CDC carpet. Victims of adverse events are told it is all in their mind, coincidence, etc…
HPV vaccines are not the first time this type of scenario has played out. The time has come to stop discrediting those who discover something not quite right with any particular vaccine. The time has come to look at their findings and investigate to see if there is indeed a problem.
The time has come for government health authorities to meet the survivors of adverse reactions after HPV vaccinations face to face. The time has come to acknowledge vaccine injuries and find out how and why they happen. The time has come for open scientific investigation and debate.
Given all of the facts, perhaps more governments would choose precaution over promotion. Given all of the facts, perhaps more governments would choose science over psychosomatic.
Given all of the facts, medical consumers would actually be allowed to exercise their right to make informed choices.
