The Gardasil Issue: In France You Get A Court Hearing; In The USA You Get Garbage and An FDA Run- Around.
Paris, France: The use of aluminum adjuvants and HPV vaccines’ benefit versus risk profile will be under intense scrutiny and open scientific debate on May 22, 2014. Stakeholders from both sides of the vaccine debate will have an opportunity to present their case to members of the French Parliament, French Senate, health authorities, medical professionals and the public due to massive efforts on the part of E3M, a non-governmental organization of patients with MMF (macrophagic myofasciitis), and OPECST, Parliamentary Office for Evaluation of Scientific and Technological Choices.
Obviously, the French government cares enough about the health and well-being of their citizens to listen to both sides of the vaccine debate – the very same ‘debate’ that government health officials in other countries claim doesn’t exist.
French government officials are willing to listen to the victims of adverse events after vaccination. They are willing to listen to scientists and medical professionals who have been conducting research to find out why some people are prone to experiencing adverse reactions after vaccination.
Not only is the French government willing to listen to the survivors of vaccine injury and scientists; they are willing to facilitate open debates with the press in attendance…
By Norma Erickson
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:
REGIONAL MEDICAL INJURY
ARBITRATION AND COMPENSATION
(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.
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.
(A special thanks from the SaneVax Team to Helen Kimball-Brooke for providing the translation of this document.)
Declare a moratorium on the generalization of the vaccine Gardasil
My name is Marie-Ocean Bourguignon and I'm 18. I wish I could live like other girls my age, but
At the age of 15, I received two injections of the prescribed against cancer cervical vaccine. Following vaccination, I suffer an attack the central nervous system that handicaps me in everyday life because of fatigue, joint pain and impaired concentration.
This is really problematic for my studies. I often miss my course because of these side effects.
I do not live the life of a young girl that I should have. Outputs with friends during the day or evening, it's over, I'm exhausted.
The trips to the beach I love so much (I live near the sea, in the Landes region), it's over: I can not stand the heat and sun. I am a student and I want to work, doing summer jobs, it is not possible for me given my condition.
, as more and more doctors are skeptical of its usefulness, that the health authorities recognize that generalization is effective smear to screen for cervical cancer,
With the support of associations E3M, REVAHB, CNMSE Amalyste and so I launched this petition to
We will be many for the government to hear us instead of listening to the pharmaceutical industry. Thank you sign and circulate this call.
AND HERE IS WHAT GOES ON IN THE GOOD OLD US of A
Top Senate Recipients Funded
Contributions shown for the last six years of available data, Jan 1, 2008 - Dec 31, 2013, including contributions to presidential campaigns.
Top House Recipients Funded
Contributions shown for the last two years of available data, Jan 1, 2012 - Dec 31, 2013, including contributions to presidential campaigns.
“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. “
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?
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.
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.
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:
For more information about general vaccine safety:
For more information about Gardasil vaccine safety:
.. 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 cannot 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.
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.
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.
Please take a little time to listen to Tracy tell her story about what life has been like since Alexis her lovely daughter was vaccinated with Gardasil. This is totally heartbreaking.