How the FDA responds to Gardasil Injuries

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
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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
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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 
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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.

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