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How the FDA responds to Gardasil Injuries#Vaccines#HPV#Family

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Correspondence between Gardasil Parents and the FDA

Gardasil: Precaution or Promotion?

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.fda.gov/biologicsbloodvaccines/safetyavailability/reportaproblem/vaccineadverseevents/overview/default.htm

http://www.cdc.gov/vaccinesafety/activities/vaers.html

https://vaers.hhs.gov/index

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

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France Debates Vaccine Safety

SaneVax-FeaturedBy Norma Erickson, President

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.

Vaccine Debates in French Parliament

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.

This article is courtesy of SaneVax Inc.

Dr. Jodie A. Dashore – Featured Doctors Week#vaccines#ASD#Lyme

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Dr. Jodie A. Dashore OTD, MS (Neurology), OTR/L, SIC, NDTC, TLPC, BOMC

Board Certified Doctor of Occupational Therapy

Member International Lyme and Associated Diseases Society

Clinical Director

11 Burlington Drive, Marlboro, NJ 07746

Phone: 732 772 1989; Fax 732 333 4526

Autism and Stealth Infections: Emerging Concepts, Treatment Strategies and New Hope!

A change

An epic journey through the quagmire of spectrum issues and infections with my own son inspired me to change my practice, my outlook, and pretty much turned my entire personal and professional life in a new direction. Being a clinician and seeing my child ravaged by unknown infections was devastating, daunting, and emotionally challenging for the whole family. I have had blessed opportunities to train with and learn from world renowned physicians like Dietrich Klinghardt, Charles Ray Jones, Kendal Stewart, Sergej Dorochov, Thomas Rau, Donna Embree, Ritchie Shoemaker, Jeffrey Bradstreet , and Robert Bransfield. The information has been overwhelmingly complex and hard to grasp; however, once understood, it is truly empowering, enriching, and life-changing, not only my son but also for the many children and families I’ve been able to help in the last few years.

I learned how to blend the modern, cutting-edge, research-based treatments with age old wisdom of bio energetic and biomedical natural approaches to healthcare. The amazing concept of bio individuality- the physiological and biochemical uniqueness of each child treated – is the single most pivotal factor upon which treatment decisions are based. Being able to hand select a synergistic combination of treatment approaches for each patient and to witness the wondrous, often life-changing improvements seen in these children is a blessing and privilege to witness.

Today, bio energetic and functional medicine are the cornerstone of my practice. Homotoxicology, homeopathy, herbal therapies, autonomic response testing, neuro biofeedback, sensory Integration, methylation and nutrigenomics are modalities I employ every day to help children and their families negotiate through the complex world of Autism Spectrum Disorders (ASD). These same modalities and treatments have simultaneously greatly improved many of the multiple underlying chronic infections – an extremely welcome additional benefit!

Success stories:

I would like to start off with a few case studies: stories of hope, recovery, and the blossoming of many little lives after the underlying infections lurking in their bodies and brains had been discovered and treated.

Aidan:

Aidan’s mom called me frantic with worry, looking for answers and for hope that her 6 year old son did not simply develop Asperger’s syndrome at this age, all of a sudden and out of the blue. Upon further inquiry, she informed me that Aidan was always smart, funny, sweet, kind, creative, and talented and had many friends. Then one day he woke up a completely different child: a new, unseen cough that happened every few seconds, a shoulder shrug that also happened every few seconds, and a little eye roll as well. Aidan went on to become mean, angry (complete with full blown rages), depressed, uncaring, deteriorating handwriting, steady loss of math skills, socially withdrawn (losing most all friends), and, in general, failing academically. She found him trying to kill his little brother with a hammer and to her horror she caught him trying to eat the cleaning chemicals under the sink, trying to kill himself as he thought nobody liked him and everybody hated him at home and at school.

The pediatrician suggested ADHD and referred them to a psychiatrist for appropriate medication. The neurologist diagnosed him with Asperger’s syndrome and suggested behavioral therapy. Aidan had developed severe OCD with rituals for many routine things like going to the bathroom or leaving the house. It would sometimes take two hours for him to go complete all his compulsive steps before they could leave for an appointment. School was next to impossible, and the school sent home a tutor to help Aidan. This went on for two years.

After a truly horrible day and at the end of her rope, she came across my information on Facebook and called me. I saw Aidan and his mother in my office, where she informed me he was a mere shadow of his former self. Aidan pleaded with me to help him. Upon further inquiry, I found out that Aidan had a tick attached to his scalp immediately behind his ear at around 3.5 years of age. The tick was engorged, and he was seen by his pediatrician for removal. The tick was duly identified as a “dog” tick and hence deemed “ok” and the matter was never mentioned again until the day I asked mom the question that she says no physician has ever asked her.

I started Aidan on comprehensive biomedical protocols and also referred Aidan to a pediatric Lyme disease specialist. Just as I suspected Aidan tested positive for tick borne infections- namely Borrelia Burgdorferi, Bartonella Henselae, and Babesia Microti. Aidan’s labwork also came back positive for streptococcus antibodies being very high. The diagnosis of PANDAS was added on to his medical concerns.

Treatment Strategies: Aidan’s mom chose to go the antibiotic route along with Klinghardt Neurotoxin elimination protocol, Klinghardt KPU (KryptoPyrole Urea) protocol, Neuro biofeedback, Homoeopathic Pleomorphic organ support and Detox.

Today Aidan, after 22 months of treatment is back to being his old self. He is getting straight A’s in school again, has many friends, feels strong and calm overall. 14 months in Aidan came up to me and said “Thank you Dr. Jodie. I am able to make friends again!”

Olivia and her brothers:

Olivia was diagnosed with mild Autism Spectrum Disorder at age 3 and ADHD at age 6. A bright and happy child, Olivia did well in school with her special education. She loved to play basketball and soccer with her brothers, and the athletic little girl would give her two older brothers a run for their money any day! Olivia had been a little sickly that year and as flu season approached her mom decided to vaccinate her. Olivia received the flu mist along with her neuro-typical brothers James and Logan.

About a week later, Olivia started gagging at meal times and developed several sensory issues around food. Soon after, 8 year old James started bedwetting and would awaken with night terrors. Around the same time 11 year old Logan developed coordination challenges with basketball and his writing skills in school. Their symptoms continued to get worse as days turned to weeks of Olivia barely able to eat, having sleep difficulties, rapid eye blinking motor tics, and development of OCD around personal hygiene routines. James had started having bladder and bowel accidents during the day along with having difficulty remembering things and poor grades in school. Logan, on the other hand, had started limping with severe leg muscle cramps, episodes of dizziness when standing up, back pain, tingling and numbness in his hands and doing poorly in school.

The entire family was devastated at this sudden and rapidly deteriorating change of events. Their mother called me a month into her ordeal with her three children having seen four different doctors – without any definitive answers. The potential vaccine connection was very obvious, and upon further investigation in the right direction, all three were diagnosed with PANDAS. Additionally, based on the fact that the family had multiple pets for many years, lived in a rural setting, and loved to hike through the woods, camp etc., I had them tested for Lyme disease. The entire family- the parents, children, and even the two family dogs – tested positive for Lyme disease and other-tick borne infections!

Treatment areas: The parents chose to pursue a combination protocol of antibiotics for the various infections and biomedical holistic protocol for detox, drainage support, herbals for hypercoagulability, homotoxicology for leaky gut and food allergies, and neurobiofeedback for help with brain fog/executive function challenges and Zyto EVOX for perceptual and emotional reframing. Today, the children are off all antibiotics, on an herbal maintenance protocol, and are doing very well academically and socially. The parents now have the time to work on their infections and healing.

Jake:

Jake was only 16 months old when I first saw him. His parents reported a sudden change in his behavior, eating difficulties, and regression in language and social skills. They were terrified he might be turning Autistic. They were determined to avoid labelling their child until after a thorough biomedical assessment and intervention. Jake had experienced chronic sinusitis since eighteen months of age and multiple ear infections. He also had a history of being colicky as an infant. When I saw Jake he was hyperactive, with low muscle tone, poor focus, was only able to say “no”, poor eye contact, visual stimming, making continuous moaning sounds and hand flapping. His mom informed me he also banged his head at home for no apparent reason.

Jake was started on a comprehensive biomedical protocol almost right away. He truly surprised everybody and almost immediately he started making fantastic progress. His digestion, bowel habits, sleep, and appetite all improved within four weeks. His eye contact, focus, and activity level made small but significant gains in a month, and in two months he had gained 65 new words according to his month’s observations! Upon further testing, lab work showed underlying infections with Streptococcus, Epstein Barr Virus, and Lyme disease. Intestinal parasites tested positive with stool tests, as did Candida.

Treatment Strategies: Heavy metals, Methylation- CBS and SHMT homozygous mutations, COMT and MTHFR A1298 heterozygous mutations, homeopathic and German Biological remedies for organ support, PANDAS, and Lymphatic drainage. Herbal remedies for candida, Lyme and parasites.

Latest update: Jake’s mom wrote:

“Speech has been the biggest change during this past month with the Lyme and parasite herbs.  He started them on March 19th and I am amazed on how much it has helped him in such a short time. Because of the increase in speech, the temper tantrums have decreased drastically. Jake is able to focus more and when he needs or wants something, he no longer screams. His new phrase is “Nope. No Thanks!” and “I need a help”. He can count backwards from 10, and has started to arrange letters in alphabetical order. He has started to follow along with the characters on his favorite TV shows instead of just “zoning out” watching TV.”

Understanding about underlying infections in children with ASD

Chronic underlying infections (Viral, bacterial, fungal, parasitic) could be the cause of the illness, or could be a cofactor with other factors (Methylation, heavy metals, leaky gut) as the cause of the illness. Many of these infections are immune suppressing. ASD is now being studies as a possible neuro immune syndrome and not just a neuropsychiatric illness. Genetic predisposition, environmental exposure to epigenetic triggers (vaccines, food allergens, pesticides), and immune suppression often go hand in hand in most children diagnosed with ASD.

Symptoms associated with neuro-immune syndromes are severe food allergies and chemical sensitivity, low muscle tone, and poor healing from physical and emotional events. Testing will frequently reveal heavy metal toxicity, neurochemical deficiency, hormone deficiency, immune dysfunction, aggressive inflammation, infectious overgrowth, poor toxic clearance, and mitochondrial weakness.

Infections seen and Mechanism of Action

Some of the co-infections seen are Lyme Borrelioisis and Neuro-Borreliosis, Bartonella Henselae, Babesia Microti, Babesia Duncani, Streptococcus, mold exposure and biotoxin illness, Mycoplasma Pneumonias and more. Streptococcus infections with Group A Beta Hemolytic streptococcus have been studied to sometimes trigger an autoimmune illness called PANDAS – Pediatric Autoimmune Neuropsychiatric Disorders associated with strep. Subsequently it was observed that other infections like tick borne diseases can induce molecular mimicry in the brain and cause neuro psych symptoms too and PANDAS was then renamed as PANS – Pediatric Autoimmune Neurological Syndromes.

Research reveals that tick borne infections like Lyme disease can contribute to ASD directly by their immune suppressing characteristics, and also by promoting other infections and immune dysfunction during fetal development and infancy. Shockingly, supporting data includes multiple cases of mothers with Lyme disease and children with ASD!

The Diagnosis of Lyme Disease

The good News: There are various tests that can detect Lyme disease antibodies in blood samples

The bad news: The Lyme bacteria can seriously disable the immune system, and hence many tests that do rely on an immune response can show up false negative.

The bottom line:

· Diagnosis should not be made on lab results alone

· Testing MUST be interpreted by trained clinicians and in conjunction with clinical picture

· False negative doesn’t necessarily rule out Lyme Disease

· A positive Diagnosis can often be: Just 1 or more Borrelia specific bands positive plus clinical symptoms.

Remember

Lyme Disease is called “The Great Imitator”. It’s a MULTI system illness and based on which system if affects first in the body it can mimic

· MS

· ALS

· Autism

· Fibromyalgia

· Chronic Fatigue syndrome

Co-infections to look for

· Bartonella

· Babesia

· Mycoplasmas

· Parasites

· Viruses

· Protozoa

· Strep

Some symptoms of Lyme disease in ASD

· Obsessive Compulsive Disorder

· Fatigue

· Rash

· Achy Joints and muscles

· Sleep issues

· Delayed development, even physical growth sometimes

· Poor balance

· Frequent ear or sinus infections

· Brain fog

· Irritability

· Aggression and rage

· Extreme “growing pains”

· Extreme sensory issues

· Anxiety or Depression

Additional considerations in treatment

· Heavy metals

· Intracellular infections

· Immune dysfunction

· Disruption of the Blood-Brain barrier

· Chronic inflammation –often in the gut and the brain

· Environmental Toxins and allergens

· Dietary allergies

· Biofilm

· Electro Magnetic Radiation (EMR) and Frequencies (EMF)

· Emotional and physical stress

· Mold exposure

A mom’s advice

· DON”T leave any stone unturned when you hear the Diagnosis of ASD for your child.

· Get support from positive people and filter out energy-draining, negative people

· Be aggressive with your child’s treatment

· Don’t leave yourself behind. Get treatment. Many mothers are infected too and don’t know it. Borrelia bacteria can stay dormant in a cyst form for many years.

· There is a large body of epidemiological data linking maternal infections before and during pregnancy to neurodevelopmental disorders in offspring including Autism, and schizophrenia

· Your child’s Autism may be treatable. Never lose HOPE!

· New research is emerging rapidly. Stay current!

All the very best!

Dr. Dashore

2014

BIO

 

Dr. Jodie A. Dashore OTD, MS(Pediatric Neurology),HHP.

Clinical Director

Integrative Neuro-Sensory Associates, LLC

Marlboro, New Jersey. USA.

Member International Lyme and Associated Diseases Society (ILADS)

Member North American Association of Homeopaths

Member American Association of Drugless Physicians

Office 732 772-1989

Dr. Dashore completed her specialization in Neurology in 1991 from King Edward Memorial Hospital and Medical school in Bombay, India.  In 1992, she went on to complete research collaboration on Stroke and Cognitive deficits and working as a consultant for the NHS in London. Subsequently she immigrated to the United States to earn her Doctorate in Occupational Therapy- Evidence Based Medicine and Neurology from Rocky Mountain University in 2004. She went on to complete her Post- Doctoral dissertation in Sensory Integration from University of Southern California.

Dr. Dashore is currently a Board Certified Doctor of Occupational Therapy, specializing in Neurology. Dr. Dashore is also Board Certified in Sensory Integration, Holistic and Energy Medicine and Homotoxicology. She has obtained additional training in the areas of Tick Borne Diseases, Nutrigenomics, Herbalism, and Neuro -Immune Syndromes. She is currently training to be a Board Certified Herbalist.

She is an esteemed member of the International Lyme and Associated Diseases Society (ILADS), and The North American Association of Homeopaths (NASH). She has trained intensively and continues to stay current and mentored by Dr. Charles Ray Jones, MD, and Dr. Dietrich Klinghardt, MD, PhD. Dr. Dashore is the founder and Medical Director of Integrative Neuro-Sensory Associates, LLC , a functional medicine and Sensory Integration practice in Marlboro, NJ. She works with children and adults from across the country with  Autism, Lyme Disease, PANDAS, Methylation Dysfunction, Mitochondrial Disorders, IBS, chronic fatigue, Neuro- Degenerative Diseases, Allergies, Autoimmune Disease, and more.

Recently Published:

http://www.pageturnpro.com/Autism-Media-Channel/56399-AF54_AutismFile_FebMar2014/index.html#2

Upcoming:

  • June 4th: Interview at Functional Forums Media, New York City. To be broadcast live.
  • June 7th:Invited to Lecture At Harvard “Hidden Causes to consider with delayed recovery in Tick Borne Diseases”
  • Autism File International Magazine June/July Issue: “Autonomic Dysfunction: Behavioral Implications and Treatment Strategies in Children with ASD”.

 Dr. Dashore, thank you for taking the time to share these success stories with us.  It is an honor to feature you on the blog.  Thank you for your example of open-mindedness, and taking the time to get to the root cause of the illness.  You are making a considerable difference in the health, and well-being among youth, and their families the world over.  Enough cannot be said of the work you are doing.  I look forward to watching your interview on the Functional Forums in New York this week.

Functionalforum.com

Dr. Dashore will be a panelist at the Functional Forum this Wednesday at 8pm EST, and anyone can watch, and ask questions for free using #functionalforum on Twitter. 

 

 

 

Guard Yourself: Gardasil Documentary Short#HPV#Vaccines#Health

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A documentary short that exposes the unsafe nature of the Gardasil vaccine, by Joe Ferdman.

The SaneVax Team would like to express their sincere appreciation to Joe Ferdman for producing this wonderful film documenting the impact Gardasil has made on four families. Emily Tarsell, Lisa Ericzon, Tim Hall, the Mosher family and the Evans family speak for thousands of families around the world suffering adverse events after HPV vaccinations. A special thanks to Amy and Kirstie for telling their personal stories to try and save others from going through what they have experienced after HPV vaccination.

Please, do your research before you decide whether HPV vaccines are right for you.

To all those in the world, that I care so much about,  please watch this video.  Let’s have this be the end, of the catastrophic misery that these children are enduring, and those that have passed on.

SaneVax.org

Thimerosal and Autism Timeline#vaccines#ASD#autism

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How did the idea that a mercury-based preservative (thimerosal) causes autism come to be?

This timeline is the historical account of an unbelievable, but true, story.

It’s the story of parents who knew something was wrong and never gave up. The story of brave scientists who told the scientific truth. And a story of unsung heroes – the child victims whose lives were devastated and forever changed by vaccines.

To the heroes who have sacrificed so much: this timeline is to honor you with the hope that our nation will have a true understanding of your suffering.

Continue reading timeline here

Genetically Engineered HIV Vaccine INCREASED Risk of HIV Infection#Vaccines#HIV#Health

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by Sayer Li

A new study published in Lancet reveals that an experimental vaccine manufactured by Merck using a genetically modified adenovirus actually increased the risk of contracting HIV infection in recipients.

Titled, “Recombinant adenovirus type 5 HIV gag/pol/nef vaccine in South Africa: unblinded, long-term follow-up of the phase 2b HVTN 503/Phambili study,” researchers randomly assigned a total of 801 HIV-1 uninfected, sexually active adults aged 18—35 years from five sites in South Africa to receive either the vaccine (400) or a placebo (401).  216 (27%) received only one injection, 529 (66%) received only two injections, and 56 (7%) received three injections.

The results were reported as follows:

At a median follow-up of 42 months (IQR 31—42), 63 vaccine recipients (16%) had HIV-1 infection compared with 37 placebo recipients (9%; adjusted HR 1·70, 95% CI 1·13—2·55; p=0·01). Risk for HIV-1 infection did not differ according to the number of vaccinations received, sex, circumcision, or adenovirus type 5 (Ad5) serostatus.

Differences in risk behaviour at baseline or during the study, or annualised dropout rate (7·7% [95% CI 6·2—9·5] for vaccine recipients vs 8·8% [7·1—10·7] for placebo recipients; p=0·40) are unlikely explanations for the increased rate of HIV-1 infections seen in vaccine recipients.

In other words, those receiving vaccines had a 70% increased risk [HR 1·70] of contracting HIV versus those receiving the placebo.  The researchers concluded:

The increased risk of HIV-1 acquisition in vaccine recipients, irrespective of number of doses received, warrants further investigation to understand the biological mechanism. We caution against further use of the Ad5 vector for HIV vaccines.

Read Entire Post Here

Activistpost.com