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Tag: French Parliament
Free the innocent#iBelieve#repost#tmom
Just as in many posts before, I have been pondering over some thoughts that have been coming to mind. I have felt at a bit of a loss as to what justice I can do for these concerns.
As I have spent countless hours researching, I have been stunned at how vast an issue this is.
I am speaking of the Many parents, and foster parents, and others that are innocently imprisoned every year. They are wrongly accused for harming or murdering a baby or child. I cannot imagine a worse assault to one’s character. These assaults happen to innocent people, on a regular basis, and they stretch world-wide.
How does this happen to these innocent people? It happens right under our noses in our own communities, because we put our faith in man. The supposed scientific research that doctors, and nurses tell the local law enforcement, and the forthcoming pleas from these parents fall on deaf ears.
Can you imagine having your child seizure, have a fatal allergic reaction, incur brain swelling, and then be accused of murder, and sent to prison. This is what happens, and now you can grieve their loss, and have your support system torn away, and sit alone in a cell.
The research that is used is old, and faulty, and now there are talk shows that receive dollars to dramatize the events of a shaken baby.
Interestingly, the modern evidence reveals that a shaken baby cannot receive the injuries that are accepted by law enforcement in these cases. Many individuals are innocent along the way. Trusting the Superior advice of a physician.
Well, let’s not be in the dark any longer. There are those that have research, and know how these injuries take place, but it is covered up because of the tie to vaccines, and probably other prescriptions as well. How often do these injuries take place within 30 days of a vaccination?
If your child were to have these reactions in front of the doctor, then another description would be said, one being: unknown cause.
Silly isn’t it, let’s call it what it is. Every parent, babysitter, boyfriend, girlfriend, nanny, grandparent or foster parent that is caring for a child following a vaccination is at risk of being accused of shaken baby syndrome, if that child has a similar reaction above, and no one else is there to witness it. These are the extremes that pharmaceutical companies will go to protect their investments.
It makes me sick that there are individuals that walk this earth, and will hurt others to this extent, including the life of the child, just for monetary gain.
Everyday, day in and day out, our fellow man sits, and waits to be heard, and rescued.
Let’s remember the Golden Rule, and do unto others as we would have them do unto you.
Let’s be wise to this, and do all we can to free the innocent.
France: Meeting to debate HPV vaccines, Gardasil and Cervarix#vaccines#IBelieve#HPV
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.
Learn more about the issues here.
View the entire press package in French here.
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.
French Vaccine Debates: What immediate measures are required?#vaccines#health#ASD
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.
Article compliments of SaneVax.org
How the FDA responds to Gardasil Injuries#Vaccines#HPV#Family
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.”
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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:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm096052.htm
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 Robinson Subject: 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.
For more information about the VAERS program:
http://www.cdc.gov/vaccinesafety/activities/vaers.html
For more information about general vaccine safety:
http://www.fda.gov/downloads/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm298181.pdf
For more information about Gardasil vaccine safety:
http://www.cdc.gov/vaccinesafety/vaccines/HPV/index.html
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. From: Kim Robinson Sent: 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 Robinson Subject: 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.
France Debates Vaccine Safety#HPV#Vaccines#Health
France Debates Vaccine Safety
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.
My Road to Recovery Post-Gardasil#Vaccines#HPV#Health
By Kristin Clulow, Newcastle, NSW, Australia
My name is Kristin Clulow. I am 31 years old and live in Newcastle, Australia. I wrote an article a few years ago regarding my Gardasil experience. As this last post was over three years ago, I would like to take this opportunity to update you in the hope that it may be of assistance to you, or someone who you know who is suffering a similar illness.
In 2008, I received two out of three Gardasil vaccines. Soon after I lost the ability to run, skip, jump, dance, wear heels, and then struggled to walk in flat shoes, and then in a straight line. My writing disappeared; my speech followed. Any cuts and bruises would take months to heal, and would be multiplied by my increasing clumsiness and incoordination. I constantly felt sick, nauseous and suffered ‘brain fog’. The right side of my body had slumped, similar in physical manifestation to a stroke. My whole body would tremor with intention to do even the smallest task.
I was administered eight doses of Intravenous (IV) Methylprednisolone on two separate occasions (three and five doses respectively), which worsened the symptoms. The traits which were primarily limited to my right hand side now spread to the left hand side of my body, and were worsening.
Despite extensive physiotherapy and exercise as well as full-time work, my body continued to deteriorate to the point where in June 2009, my primary Neurologist stated ‘We have missed something’.
I underwent a Positron Emission Tomography (PET) Scan. A PET scan is similar to a Magnetic Resonance Imaging (MRI) Scan, but is more minute in results. The individual is injected with a glucose resin, which highlights parts of the body of concern. In my case, it showed up that my cerebellum had switched off. I was diagnosed with a condition called Acute Disseminated Encephalomyelitis (ADEM), which is an immune mediated disease of the brain, and may appear following a vaccination.
At this point, I was at my worse. I could not walk; I could not write; I could barely speak and could barely eat (as I could not find my mouth to ingest food). My nervous system, my immune system and myelin sheath surrounding my nerves were dissolved. I was given little hope of any improvement.
When faced with a situation such as this, there are two options: fight, or flight. Running away from this was not going to make it better. Fighting was the only chance I had – the harder option, but I do not shy away from challenges.
This one moment in time made me re-evaluate my life – my goals, my values, and the importance of relationships, material possessions, and overall issues. What I’ve realized is that without your health, you are helpless. And I also realized that out of great fear, comes great faith.
I researched neurosciences and neuroplasticity and believed that the brain could repair itself. I gave up full-time work at my doctor’s instructions for two years.
Instead of just concentrating on Gardasil, I returned to University to obtain another degree in Masters of Teaching (Secondary). Every day, I undertook extensive physiotherapy, speech therapy, occupational therapy and hydrotherapy, as well as hours of study, exercise and countless other activities.
Every 28 days, I was admitted to hospital to receive IV Immunoglobulin (IVIG). This was warranted due to my diagnosis of ADEM.
IVIG is a drug in limited quantity– its demand is much higher than stock in supply. CSL, the licensee of Gardasil in Australia refused to honor my claim on three separate occasions for this drug, although having access to it.
Ultimately, my family purchased this from a different supplier, had it flown to Newcastle and administered to me. I have no doubt that this played a huge role in saving my life. IVIG is wonderful medication. I suffered major headaches, but saw improvements in my motor skills.
There are issues however:
- It is not cheap. A lot of females suffering Gardasil cannot afford to have a PET scan or obtain this highly sought after drug. Nor can they get access to the top medical professionals that I had working on my case. Unfortunately, money and contacts go a long way in a case of this caliber.
- IVIG will not work for everyone, and;
- For a cheaper option, I would try homeopathy.
I class myself as a guinea pig for Gardasil. I have tried both Eastern and Western remedies. Some have worked, many have not worked.
For me, IVIG worked in western medicine. After trying just about everything in eastern medicine, I would recommend homeopathy in the first instance.
Approximately six months ago, I received word from another Gardasil Girl that there was a doctor, Dr. Isaac Golden, in Melbourne, Australia that was ‘fixing’ girls affected by Gardasil with his own personal remedy. This remedy does not reverse the effects of Gardasil. Instead, it helps the body in breaking down the barrier that Gardasil has created, allowing the body to recover itself.
At the time of receiving this advice, I had reached a plateau. Regardless of how much exercise I did, I could only see limited improvement, so I went to see Dr. Golden.
What he administers is completely natural. He is a homeopath, specializing in vaccination injuries. For me, I started on dose #1. All it took was placing two small tablets under the tongue every few days and allowing them to dissolve. I report back any progress and/or side effects to Dr. Golden every few weeks, and then it is decided if my dosage should be increased. At present, I am on #6. The price of these tablets is small and affordable.
Since beginning to take these tablets, I have noticed a decrease in my tremors, an improvement in my walking (I am starting to wear heels again), and the tone and speed of my voice has improved.
The side effects are that I get pain in my head on occasions. This pain is limited to the cerebellum area. I do get tired on occasions, but this could be due to the busy lifestyle that I choose to live.
I am still continuing to take these tablets and plan to do so indefinitely, as I believe they are assisting.
Approximately two months ago, I had a hair mineral analysis test conducted. This required taking a small portion of untreated hair out and sending it to a lab for testing. This test showed up that my body was high in Aluminum (a major ingredient in Gardasil), and that my body was not absorbing the nutrients from food. As such, I have booked in to see a dietician to resolve this issue.
I have heard that many Gardasil Girls suffer from food intolerances. I also suffered from this. I try to eat fresh food, limit processed food, and try and eat as much gluten free, lactose free and sugar free products as possible. I try not to eat takeaway foods, as well as trying to limit artificial colors and preservatives.
If you are having food allergies, I would recommend trying the ‘Elimination diet’. This is a slow process, but affordable, whereby you go back to basics (phase one is rice, chicken, beans and pears etc.) and then you add in different foods. You record your progress and find out which ones you have a reaction to.
This was conducted under the assistance of a dietician who was able to give me advice as I proceeded. I also had a gluten and lactose blood test, which showed that there was a level of intolerance, and also resulted in headaches, nausea, cramping and bloating.
Further, I attend Chiropractic care twice per week. My Chiropractor is a doctor with extensive experience and serves to readjust my spine and stimulate the nervous system and the cerebellum.
I try and attend the gym three to four times per week and undertake over an hour of cardio, weights and stretching. I am now able to interval run, however my right foot still lacks coordination. My strength and tone is improving. I also do additional exercise to challenge my body and brain. In the last few months I have tried surfing, stand up paddle boarding, dancing (many forms), yoga, Pilates – and the list goes on. Although I am not the best, I have shifted my mindset to ‘giving things a go’. Any form of exercise is beneficial and works out different muscles of your body.
As for my hands, my right hand was more affected than my left. Being right handed, I have relied heavily on the use of technology to aid in communication. I practice my handwriting; however still find it quicker and easier to type.
As a teacher, I am very grateful that our school uses electronic whiteboards, which limits the amount of writing. The staff and students are also extremely supportive of my present inability.
I was also a good pianist pre-Gardasil, and this has resulted in me going back to basics. I still know the notes and theory, but I was unable to play due to the tremors in my hands. Thankfully, this is slowly improving due to constant practice of technical work (e.g. scales).
I have suffered insomnia since Gardasil. Some nights I can sleep well, others, I average three to four hours sleep. I still suffer pain, primarily leg pain. For this, I take Panadeine. I try and exhaust my body as much as I can, as this often means I get a better sleep.
My life now is about 85% compared to before – if I had to put a quantitative measure on it. I say this simply because there are still things which I struggle to do – to walk, speak and write.
My friends see me as being completely normal, which is uplifting. I, however, am much harder on myself because I know what I was like before.
I have learned so much from my experiences after Gardasil. The happiness I experience daily because of this, far exceeds any feeling before. If I could change the past, I would not change a thing – as this experience has made me who I am today, and I truly believe that everything happens for a reason.
I trust that this, in some way, can be of assistance to you. Everyone is going to have different symptoms and different things work for different people.
If you have a daughter or a loved one going through this, my advice is this: they need you. They are too tired and too sick to fight for help to make it through. They need support. They need someone to go to doctor’s appointments with them. When you have brain fog, you do not recall much. Make sure they keep a diary, or have someone who can record everything that happens. I know this is painful, but if you need to refer back to anything, it is easier to track it this way. Have a video/photo database.
This is something that I did not do, and I wish I had. But, I was so sick and tired (and looked terrible!) that I did not want photos being taken. But do it. If this ever escalates, you will need proof.
Listen to advice, try things that you think will work, and always stay positive. Having a bad attitude does not help (and gives you frown lines!).
Lastly, never give up. You will have times when you want to, when it seems pointless, hopeless, unfair etc. I have been there. I have felt all of those emotions – and more. But I am living proof that you can improve and that you can, once again, enjoy a quality of life.
If you would like any more information, I can be contacted via Facebook (Kristin Clulow) or via email: kristinclulow@live.com.au. I am in contact with hundreds of Gardasil girls and families all around the world and can put you in contact with the relevant people. We are all here for each other, and can help you.
Thank you and kind regards,
Kristin Clulow
Article courtesy of SaneVax
Kristin, I loved reading every word. You are a shining example of determination, endurance, and having a positive attitude. You are undoubtedly forging a path for many others to follow. I hope your insights, and formula for success travel far and wide. I am sure that many and many more to come will find refuge from trying circumstances, and reassurance in their future within your company. Thank you for all you do.
I have included a musical clip that has given me hope, lifted my spirit, and I hope you will also enjoy. Your friend, jen 🙂