The Gardasil Issue: In France You
Get A Court Hearing; In The USA You Get Garbage and An FDA Run- Around.
See Why! France: Aluminum Adjuvants and HPV Vaccines Up for Debate
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…
France:
Permanent Injury Attributed to Gardasil
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.
Gardasil changed my life
Marie –Océane’s parents, Jean-Jacques and Yveline
Bourguignon, have granted permission for their daughter’s story to be
published hoping they can help make people aware of the potential risks
involved with HPV vaccinations. They do not want anyone else to go through
what they have experienced without knowing of the possibility in advance.
In 2010, Marie-Océane Bourguignon, age 15, received two
injections of Gardasil® the first on October 11th and the second on December 13th.
Two weeks after the first injection, she experienced sensory and motor
problems in the upper limbs, lasting approximately two weeks before
spontaneously and gradually regressing.
Three months after the second injection, on the 13th of March 2011, Mlle. Bourguignon was
hospitalized at Centre
Hospitalier de Dax for
deterioration in her general health, cerebral-vestibular disturbances and
sensory-motor impairment (ataxia, vertigo). On March 15, 2011, an MRI of her
brain revealed lesions in the white matter.
The initial diagnosis was that she was suffering from
either multiple sclerosis or acute disseminated encephalomyelitis (ADEM).
After multiple subsequent hospitalizations, it was determined that
Marie had developed multiple sclerosis, a chronic, typically progressive
disease involving damage to the sheaths of nerve cells in the brain and
spinal cord, whose symptoms may include numbness, impairment of speech and of
muscular coordination, blurred vision, and severe fatigue. Marie-Océane will
live with this condition for the rest of her life.
Consequently, her parents filed for compensation on her
behalf with CRCI, Regional Medical Injury Arbitration and Compensation
Tribunal in Bordeaux on January 28, 2012. The decision was handed down on
September 18, 2013.
The decision handed down by Judge Mairé was kindly
translated into English by Helen Kimball-Brooke and is printed below in its
entirety. The Bourguignon family had been successful. They could have
accepted the compensation award from the French vaccine compensation program
and gone on to live their lives.
But this family knew they were not the only ones to have
had their lives turned upside down after using the HPV vaccine, Gardasil.
They knew that the decision by CRCI would not be widely publicized in order
to warn other families about the potential risks involved with the use of HPV
vaccines.
Consequently, they decided to turn down the award and
take their case to a traditional criminal court where the outcome of the
adjudication could be made public. They decided that a just decision for
their family was simply not good enough. They wanted justice for all victims
of adverse events after Gardasil. They wanted to have the opportunity to warn
others about the potential risks involved with consenting to the use of HPV vaccines.
They wanted the opportunity to let the public be aware of the fact that HPV
vaccines can be quite dangerous for some individuals.
The Decision
Handed Down by the French Vaccine Injury Court:
CRCI
REGIONAL MEDICAL INJURY
ARBITRATION AND COMPENSATION
TRIBUNAL
NOTICE
(Article
L.1142-8 of the French Public Health Code)
Case:
Marie-Océane Bourguignon
File Number:
12.033.C.000071
THE AQUITAINE REGION MEDICAL INJURY, IATROGENIC AILMENT
AND NOSOCOMIAL INFECTION ARBITRATION AND COMPENSATION TRIBUNAL, HELD IN
BORDEAUX ON THE 18TH SEPTEMBER 2013 AND FORMED TO REACH AN AMICABLE
SETTLEMENT
§ Considering
the French public health code, articles L. 1142-1 to L. 1142-24, D. 1142-1 to
D. 1142-3 and R. 1142-13 to R. 1142-18 in particular; modified French Law no.
2002-303 of the 4th March
2002, regarding patients’ rights and the quality of the health system; also
considering the French Order of the 4th March 2003 regarding the documentary
evidence to be included in a compensation request lodged with a regional
medical injury, iatrogenic ailment and nosocomial infection arbitration and
compensation tribunal,
§ Considering
the compensation request lodged with the secretariat of the Tribunal on the
28th of January 2012
and deemed to be complete the same day, by Mr. Jean-Jacques Bourguignon and
Mrs. Yveline Bourguignon, née Cazaux, acting as the legal representatives for
their daughter Marie-Océane Bourguignon, born on the 10th of June 1995, a claim then renewed
on the 26th of July
2013 in the names of Mme. Marie-Océane Bourguignon and as indirect victims,
Mr. and Mrs. Bourguignon, who are hereby suing:
- Dr. Fabienne
Chatelet
- SNC
Sanofi-Pasteur MSD, 8 rue Jonas Salk, 69007, Lyon 07, insured by Marsh S.A.
§ Considering
the various items of evidence included in the file,
§ Considering
that Dr. François Rouanet, neurologist, and Dr. Larbi Benali, medical
examiner, specialist in compensation for injury, had been appointed by the
presiding judge as co-examiners on the 31st of May 2012,
§ Considering
the medical examination report submitted on the 26th of June 2013,
§ Considering
the statement submitted by Attorney Coubris on behalf of Mr. and Mrs.
Bourguignon,
§ Considering
the statement submitted by Attorney Annie Berland on behalf of Dr. Chatelet,
§ Considering
the statement submitted by Attorney Cécile Derycke on behalf of
Sanofi-Pasteur,
Considering the following which was presented during the
hearing
The case presentation report by Judge Patrick Mairé,
presiding judge, the reports by Drs. Rouanet and Benali, along with the
observations made by Attorney Coubris representing Mlle. Océane Bourguignon
and her parents, Attorney Annie Berland representing Dr. Chatelet and
Attorney Cécile Derycke representing Sanofi-Pasteur.
The tribunal pronounced on:
1.
The
circumstances:
In 2010, Marie-Océane Bourguignon, age 15 at the time,
received two injections of Gardasil ®, a vaccine used to prevent cervical
cancer, the first on the 11th of
October and the second on the 13th of December that year. The
vaccines were administered by her regular doctor, Dr. Fabienne Chatelet.
Two weeks after the first injection, she experienced
sensory and motor problems in the upper limbs, lasting approximately two
weeks before spontaneously and gradually regressing.
Three months after the second injection, on the 13th of March 2011, Mlle. Bourguignon was
hospitalized at Centre
Hospitalier de Dax, the main hospital in Dax, France, for
deterioration in her general health, cerebral-vestibular disturbances and
sensory-motor impairment (ataxia, vertigo).
She was successfully treated with steroids.
An MRI of the brain was performed on the 15th of March 2011 and revealed lesions
in the white matter.
The initial diagnosis was that she was suffering from
either multiple sclerosis or acute disseminated encephalomyelitis (ADEM).
Mlle. Bourguignon was later hospitalized on several
occasions for the same cerebral-vestibular episodes and progressive flare-ups
of inflammation until multiple sclerosis was finally diagnosed after she
responded well to treatment with Tysabri ®.
On the day of the medical examination, Mlle. Bourguignon
had not recovered her health due to the progressive nature of her pathology.
Mlle. Bourguignon does not display any neurological
deficiency or functional disability but she is unable to walk more than 1
km. She takes mild analgesics for headaches and abdominal pains.
She complains that she has difficulty concentrating and suffers from vertigo.
She feels that Sanofi Pasteur MSD should compensate her
for the injury sustained which she attributes to the two injections of
Gardasil ® she received.
2. On the Jurisdiction:
Considering that Mlle. Bourguignon’s illness restricts
her to life-long clinical and radiological supervision as well as a constant
feeling of anxiety regarding the expected course of her disease, it is clear
that Mlle. Bourguignon experiences particularly serious deterioration in her
quality of life, including financial problems, and this justifies the
jurisdiction of the tribunal.
3. On the Substance:
3.1. Responsibility of Dr. Chatelet
It is clear from the two medical examination reports and
the information which the examiners provided to the tribunal that before
administering the second injection, Dr. Chatelet performed a full clinical
examination of Mlle. Bourguignon and did not observe any residual
neurological disorder from the reaction which occurred immediately after the
first injection. She could legitimately have attributed these sensory
and motor disorders to an epicondylitis, particularly since the vaccine package
insert did not include any mention of the type of reaction her patient had
displayed.
There are therefore no grounds for claiming that she is
responsible for any fault especially as the plaintiff does not reproach her
for anything.
3.2. Responsibility of Sanofi-Pasteur
The two medical examiners were unable to agree on the
diagnosis of the first inflammatory episode so they submitted their reports
separately. Dr. Rouanet felt that it was not possible to specify with
certainty whether the first episode could be attributed to a flare-up of
multiple sclerosis or to acute disseminated encephalomyelitis (ADEM).
Dr. Benali on the other hand felt that the first episode was a kind of
pediatric ADEM. Aside from the failure to agree on this point, which
had no medical or legal impact on the case, the two medical examiners did
agree on the fact that this first episode represented the beginning of a
vaccine-induced neurological demyelinating inflammatory cascade.
They both concluded categorically that the neurological
disorders presented by Mlle Bourguignon had been triggered by the immune
decompensation of an unknown prior condition, a decompensation secondary to
the vaccination process which led to the initial vaccine-induced acute
demyelination, the prodromal physio-pathological substrate for a secondary
multiple sclerosis, which is the currently accepted diagnosis.
The medical examiners were unable to establish a direct
causal link with GARDASIL ®, stating “that there are no scientific grounds to
incriminate GARDASIL ® as the only causal factor for the demyelinating
inflammatory pathologies of the central nervous system.”
They did however feel that “the vaccine-induced
demyelinating inflammatory cascade from which the plaintiff suffers presents
all the objective characteristics of medical and legal imputability.
They concluded, after completing a conscientious
examination of all the items in the file and substantiating their
observations with information from scientific literature, that there is a
definite causal link between the first injection of the vaccine and the onset
of an acute inflammatory reaction in the central nervous system which then
later, after the second injection, led to decompensation of a latent immune
process.
They felt that total imputability of the observed damage
to the vaccination could be assessed at 50%.
It was not up to the Tribunal to make a general
pronouncement on whether the vaccine was defective since a discussion of the
public health benefits and risks of the vaccine in question was not on the
agenda but it was however expected to determine whether, given the defective
nature of the doses administered, the facts before it represented serious,
specific and corroborating evidence regarding both Mlle Bourguignon’s
personal situation and the specific circumstances (French
Court of Appeal, 1st civil, 10 July 2013. Appeal #
12-21314).
In the case in point, the medical examiners had observed
that Mlle Bourguignon presented with a family history of genetic
vulnerability making her susceptible to the potential onset of a
dysfunctional immune demyelination of the central nervous system.
Her sensory and motor disorders were triggered two weeks
after the first injection and then regressed. Later, two months after
the second injection, a cerebral-vestibular syndrome and a sensory-motor
condition appeared.
According to the medical examiners, given the substrate
of the central nervous system, the vaccination as an immunity stimulator
played a role in the onset of the dysfunctional immune and inflammatory
cascade.
Stimulation of the immune system by the antigens in
vaccines can indeed trigger an autoimmune pathology when there is a genetic
predisposition against a particular hormonal and environmental background.
What stands out from the two reports therefore is that
there is specific and corroborating serious evidence based not only on
chronological sequence but also on factors specific to Mlle
Bourguignon. This is sufficient to establish the link between the two
injections of Gardasil which Mlle. Bourguignon received and the onset of her
multiple sclerosis.
The patient was not informed of the possibility of such
a risk and was therefore not granted the safety she could lawfully have
expected. The vaccine package insert does not mention the risk of
central nervous system inflammation while this risk has been scientifically
established by medical experts and was known at the time of vaccine
authorization. This is an unusual risk inherent in the vaccination act
itself, which does not always result in multiple sclerosis but in the case in
point, the risk was real, and due to a predisposition, multiple sclerosis was
triggered.
The manufacturer is therefore deemed responsible as per
articles 1386-1 and 1386-4 of the French Civil Code.
Sanofi Pasteur MSD’s insurance company must therefore
make an offer of compensation for the injury caused.
4. The Injury:
Mlle. Bourguignon has not recovered her health.
The injury, with the exception of her two-year absence
from school, was totally and properly assessed as is by the medical
examiners. The examiners formally excluded any temporary aesthetic
injury.
According to the examiners, 50% of the injury sustained
was due to a pre-existing condition.
Judgment:
Article 1: Sanofi-Pasteur MSD’s insurance company, Marsh S.A. must
make Mlle. Bourguignon an offer of compensation amounting to 50% of her
claims as specified below:
- Temporary Total Functional Disability: 73 days from 13th March to 2nd September 2011, dates as specified
by the medical examiners.
- Temporary Partial Functional Disability:
§ Category
IV: 41 days from the 22nd March
to the 1st April
2011, then later from the 9th April
2011 to the 8th May
2011.
§ Category
III: 10 days from the 27th May
to the 5th June 2011
§ Category
II: 62 days from the 1st March
to the 18th August
2011, then later from the 3rd September
2011 to the 30th October
2012 which was the day of the medical examination.
- Assistance of an Unskilled Third
Party Assistant (her mother):
§ 3 hours per
day during the periods of category IV temporary functional disability,
§ 2 hours per
day during the periods of category III temporary functional disability,
§ 1 hour per
day during the periods of category II temporary functional disability.
- Permanent Functional Disability at the minimum rate of
5%
- Absence from School: loss of two academic years
- Suffering experienced: assessed at the minimum rate of
4/7
Article 2: If Mlle. Marie-Océane Bourguignon does not receive
an offer within four months from receipt of this notice, it will be her
responsibility to request ONIAM (Office National d’Indemnisation des Accidents
Médicaux, the French National Medical Injury Compensation
Authority) to come up with an alternative offer.
Article 3:
This notice will be sent to all interested parties, to ONIAM and to the lawyers
and insurance companies concerned, by registered letter with acknowledgement
of receipt.
A copy will be sent to Mlle. Marie-Océane Bourguignon’s
medical team within her local Social Security unit.
Presiding Judge
Patrick Mairé
(A special thanks from the SaneVax Team to Helen
Kimball-Brooke for providing the translation of this document.)
Declare
a moratorium on the generalization of the vaccine Gardasil
Petition
Ocean
Bourguignon France
My name is Marie-Ocean
Bourguignon and I'm 18. I wish
I could live like other girls my age, but the
Gardasil vaccine has filled my life with suffering.
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.
It is
urgent that the Gardasil not new victims. With the support of associations
E3M, REVAHB, CNMSE Amalyste and so I launched this petition to call the Minister of Social
Affairs Marisol Touraine to declare a moratorium on
the widespread vaccination and the establishment of an impartial study on its
usefulness.
We will be many for the government to hear us
instead of listening to the pharmaceutical industry. Thank you sign and circulate this
call.
More information www.moratoire-gardasil.fr
AND HERE IS WHAT GOES ON IN THE
GOOD OLD US of A
Pharmaceutical manufacturing
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.
How the FDA responds to Gardasil Injuries
“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
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:
.
.
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?
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.
How Closely
Does The CDC Monitor HPV Vaccine Safety?
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.
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Thursday, June 19, 2014
The Gardasil Issue: In France You Get A Court Hearing; In The USA You Get Garbage and An FDA Run- Around. See Why!
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