Cynthia A. Janak
Why VAERS is a passive reporting system that the FDA loves to quote
By Cynthia A. Janak
I have been researching a specific vaccine since February of 2007 and I have learned so much about how the FDA, CDC and the other organizations like the ACIP like to skew the data for their own purposes. It has gotten to the point that you can no longer trust or believe in what they say. They have gotten to the point where they will intentionally underreport the adverse events of any drug or vaccine to suit the purpose of God knows who. Here are the facts in their own words. At the end I will show you the impact this underreporting has on our youth with the HPV vaccine. I will underscore the parts I feel are important for you to remember.
"Aside from adverse events associated with specified vaccines (listed in the National Childhood Vaccine Injury Act), most reporting by health providers is voluntary." (1)
"Although the FDA receives many adverse event reports, these probably represent only a fraction of the serious adverse events encountered by providers. A recent review article found that between 2% and 11% of hospital admissions could be attributed to adverse drug reactions. Only about 1% of serious events are reported to the FDA, according to one study." (1)
"There are probably several reasons why some serious events are not reported to either the FDA or the manufacturer. First, when confronted with an unexpected outcome of treatment, physicians may not consider drug-induced or device-induced disease, but rather consider the event to be related to the course of the disease." (1)
"Unfortunately, this may be due to the limited training medical students receive in clinical pharmacology and therapeutics. A 1985 survey of US medical schools found that only 14% of them had required courses in core skills and principles of therapeutic decision making and clinical pharmacology. Of the remainder, 87% taught only a few hours of clinical pharmacology, and most of the teaching occurred in the early years of medical training." (1)
"Another factor inhibiting physician reporting is that it is not an ingrained practice – it is not in the culture of US medicine to notify the FDA about adverse events or product problems." (1)
"On the other hand, the FDA does not want providers to report every adverse reaction observed; this would not be practical for the practitioner or useful to the FDA. The FDA's goal is to increase reporting of serious events, not all adverse events. What should be reported are those cases in which the physician suspects that an FDA – regulated product was associated with a serious outcome – death, a life-threatening condition, initial or prolonged hospitalization, disability, or congenital anomaly, or when intervention was required to prevent permanent impairment or damage." (1)
Accuracy of reports
"VAERS is a passive surveillance system, and the large number of reports to VAERS increases the likelihood that some reports may not be adequately checked for accuracy, especially the less serious ones. Some reports to VAERS do not include full medical record documentation and may contain errors. The VAERS forms often have missing or incorrect data, including age, sex, vaccines administered, and adverse events." (2)
Underreporting
"Since VAERS is a passive system, it is inherently subject to underreporting. For example, a confidential study conducted by Connaught Laboratories, a vaccine manufacturer, indication that "a fifty-fold underreporting of adverse events" is likely. According to David Kessler, former commissioner of the FDA, "only about one percent of serious events [adverse drug reactions] are reported." Less serious vaccine adverse events (e.g., swelling, fever, or redness at the vaccination site) are more underreported than more serious vaccine adverse events (e.g., hospitalizations and death). The current analysis made no attempt to quantify underreporting due to age, type of adverse event, or other factor since only relative trends were utilized." (2)
"Approximately 85% of the variation in mean hospitalization rates for children aged 0.1–0.5 years was accounted for on the basis of the number of vaccine doses. If the quantity and severity of adverse vaccine events is, in fact, related to the accumulated total number of vaccine doses, then methodology that includes the complete age-specific vaccination history of the patient might enhance the analysis. Furthermore, while vaccines may appear to be the causal factor leading to adverse vaccine events, other underlying patient medical conditions, including latent mitochondrial disease or vitamin deficiencies, may ultimately play a role. Some reports have postulated that environmental factors, including vaccine administration, can trigger an adverse reaction due to its various components or agents that depleted body resources and/or cause immune insults." (2)
"Studies have not been conducted to determine the safety (or efficacy) of administering multiple vaccine doses in a variety of combinations as recommended by CDC guidelines. Our findings show a positive correlation between the number of vaccine doses administered and the percentage of hospitalizations and deaths reported to VAERS. In addition, younger infants were significantly more likely than older infants to be hospitalized or die after receiving vaccines. Since vaccines are administered to millions of infants every year, it is imperative that health authorities have scientific data from synergistic toxicity studies on all combinations of vaccines that infants are likely to receive; universal vaccine recommendation must be supported by such studies." (2)
What does all this mean to you?
Simply stated is that the VAERS (Vaccine Adverse Event Reporting System) is a passive system and the physicians are not even trained properly or at any intensity as to the importance of sending a report of you or a loved one's adverse event to a drug or vaccine. It is not promoted to become an integral part of their practice. This is something that I believe any conscientious physician would want for their patients that rely on their knowledge with regards to the effectiveness of the medications and vaccines that they administer. I feel that because of this lack of training and promotion we have the reporting rate of only 1% of the physicians reporting into a system that would be instrumental in the safety of all vaccine functionality.
The next interesting item that I found was that the FDA which is the agency that we trust to want the most accurate information possible to protect the safety of our loved ones does not even want all the adverse events to be reported. Now, I understand that some are mild like a slight fever, flulike symptoms that go away in a short period of time but what about all the other adverse events. They only want incidents "associated with a serious outcome – death, a life-threatening condition, initial or prolonged hospitalization, disability, or congenital anomaly, or when intervention was required to prevent permanent impairment or damage." (1) When researching the different adverse events reported to the VAERS database it seems like the list goes on forever. When you read all the different events reported you would think that over half would be considered serious but as you can see they are not worth the time of the FDA.
What I believe has been promoted by the FDA is a system that is grossly inadequate to ascertain the safety of any drug, vaccine or medical device. This has led to so many products that have been touted to be safe left on the market where I feel in reality are highly dangerous.
This is how this applies to the HPV vaccines. I am going to reference the information about the Gardasil vaccine as the prime example of this underreporting and how it is used to promote the vaccine.
In their documents they will use the present numbers as to how many individuals reported an adverse event to the VAERS data base. Presently, as of October 13, 2013, there have been 32,179 reports. They will insinuate this number as fact per the whole population of vaccines distributed. What they do not bring up is that this could only be 1% as they attest to as the amount that really reports. So what this gives us if you multiply this by 100% is in realty 3,217,900 has suffered an adverse event from the vaccine. This could also be on the low end because from my conversations with hundreds of parents and individuals over the years I can safely say that I believe that this is only the tip of the iceberg.
They will also downplay the deaths that have been reported. Presently there have been 148 young people who have died with relation to this vaccine. If you use what they stated of 1% you really have 14,800 have died. The only problem that I see in this is that all the parents that I have spoken with have told me that the autopsy reports were inconclusive as to a cause so I believe that this number has the real possibility to be double if not triple the amount I have stated above. This in itself should be cause to remove this vaccine from distribution. I cringe and wonder and pray that when I read a news report of some young person suddenly dying for some unknown reason did not receive the HPV vaccine.
Another way they will skew the real numbers is what they did for the reports to the FDA. You will hear often that the percentage of adverse events reported for the vaccine compared to the placebo was comparable. In the report to the FDA on September 11th, 2008 this is what the reporter wrote. "Reviewer's Comment: The proportions of subjects in each System Organ Class were comparable. The most common conditions reported were pharyngitis, upper respiratory infections, and influenza. There was a higher proportion of subjects with abdominal pain in the Gardasil group (5.0%) as compared to the saline placebo group (2.7%)." (3)
The reality of this statement with relation to table 79, New Medical Conditions After Day 1..., it is referencing is this. Out of 11,778 participants that received the Gardasil vaccination 8,628 (73.3%) reported a new medical history during the study. In the placebo group out of 9,686 participants 7,390 (76.3%) reported a new medical history during the study. So what the FDA says to you is that there was only a 3.0% difference between the vaccine group and the placebo group. If you look at this that is a small margin but if you look at the real numbers reported which is the 73.3% that is huge. Can you imagine that 3 out of 4 young people receiving this vaccine are expected to have a new medical condition when the real numbers are known and this is acceptable to the FDA, CDC and all the other organizations that use this data?
It is because of what these organizations tell us that I can safely say that the HPV vaccine has the potential to be the worse vaccine ever created because by their own admission they promote the under reporting of adverse events, do not encourage doctors to report and omit vital statistics when promoting the safety of this vaccine to the public. How can this make you feel confident in the practices of the FDA? From what I have learned over the years I have a '0%' confidence level in regards to anything that they do.
Here is another tasty tidbit. "Postlicensure safety data from the Vaccine Safety Datalink study, including data from >600,000 HPV4 doses administered, showed no statistically significant increased risk for the outcomes studied, including Guillain-Barré syndrome, stroke, venous thromboembolism, appendicitis, seizures, syncope, allergic reactions, and anaphylaxis (15). Postlicensure safety data from a manufacturer-sponsored study found no increased risk for outcomes such as anaphylaxis and venous thromboembolism; however, persons who were vaccinated with HPV4 were more likely to faint on the day they were vaccinated than another period in which vaccine was not administered (16)." (4)
Once again they are referencing the differences between the vaccine and the placebo. So in essence what they are stating is correct that there is "no statistically significant increased risk." The real numbers tell the truth and this is what they do not want you to know. They also do not tell you what the other outcomes they studied were. This is how they skew the numbers to say what they want and technically they are not lying.
The last item of interest is this. "Studies have not been conducted to determine the safety (or efficacy) of administering multiple vaccine doses in a variety of combinations as recommended by CDC guidelines." (2) This sentence needs absolutely no explanation. So when you go to your doctor for your next well baby visit and he tells you they need this, this and this vaccine that day, you can safely tell them that in doing so they are violating recommended CDC guidelines where multiple vaccine studies have not been conducted. Also, if your school has a vaccine clinic and they decide to administer multiple vaccines to the children at once you can tell them the same thing and reference the document this came from.
Now you know why so many children are suffering from various diseases and have Autism. The doctors are not trained and a study was not performed as to the safety of multiple vaccinations per recommended by the CDC guidelines.
Will you be one more or one less individual hurt by the underreporting of adverse events which is promoted by the FDA? Think about it. I plan on being one less and will educate myself since it is not an ingrained practice for our doctors to do so. This is very sad.
(1) Jama, June 2, 1993 – Vol 269, No. 21, page 2765 Introducing MEDWatch – Kessler
(2) Human and Experimental Toxicology, 31(10) 1012–1021, DOI: 10.1177/0960327112440111, Relative trends in hospitalizations and mortality among infants by the number of vaccine doses and age, based on the Vaccine Adverse Event Reporting System (VAERS), 1990–2010
(3) http://www.renewamerica.com/columns/janak/081204 Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18. Dated September 11, 2008,
(4) Centers for Disease Control – Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males – Advisory Committee on Immunization Practices (ACIP), 2011, Weekly, December 23, 2011 / 60(50);1705-1708
© Cynthia A. Janak
November 17, 2013
I have been researching a specific vaccine since February of 2007 and I have learned so much about how the FDA, CDC and the other organizations like the ACIP like to skew the data for their own purposes. It has gotten to the point that you can no longer trust or believe in what they say. They have gotten to the point where they will intentionally underreport the adverse events of any drug or vaccine to suit the purpose of God knows who. Here are the facts in their own words. At the end I will show you the impact this underreporting has on our youth with the HPV vaccine. I will underscore the parts I feel are important for you to remember.
"Aside from adverse events associated with specified vaccines (listed in the National Childhood Vaccine Injury Act), most reporting by health providers is voluntary." (1)
"Although the FDA receives many adverse event reports, these probably represent only a fraction of the serious adverse events encountered by providers. A recent review article found that between 2% and 11% of hospital admissions could be attributed to adverse drug reactions. Only about 1% of serious events are reported to the FDA, according to one study." (1)
"There are probably several reasons why some serious events are not reported to either the FDA or the manufacturer. First, when confronted with an unexpected outcome of treatment, physicians may not consider drug-induced or device-induced disease, but rather consider the event to be related to the course of the disease." (1)
"Unfortunately, this may be due to the limited training medical students receive in clinical pharmacology and therapeutics. A 1985 survey of US medical schools found that only 14% of them had required courses in core skills and principles of therapeutic decision making and clinical pharmacology. Of the remainder, 87% taught only a few hours of clinical pharmacology, and most of the teaching occurred in the early years of medical training." (1)
"Another factor inhibiting physician reporting is that it is not an ingrained practice – it is not in the culture of US medicine to notify the FDA about adverse events or product problems." (1)
"On the other hand, the FDA does not want providers to report every adverse reaction observed; this would not be practical for the practitioner or useful to the FDA. The FDA's goal is to increase reporting of serious events, not all adverse events. What should be reported are those cases in which the physician suspects that an FDA – regulated product was associated with a serious outcome – death, a life-threatening condition, initial or prolonged hospitalization, disability, or congenital anomaly, or when intervention was required to prevent permanent impairment or damage." (1)
Accuracy of reports
"VAERS is a passive surveillance system, and the large number of reports to VAERS increases the likelihood that some reports may not be adequately checked for accuracy, especially the less serious ones. Some reports to VAERS do not include full medical record documentation and may contain errors. The VAERS forms often have missing or incorrect data, including age, sex, vaccines administered, and adverse events." (2)
Underreporting
"Since VAERS is a passive system, it is inherently subject to underreporting. For example, a confidential study conducted by Connaught Laboratories, a vaccine manufacturer, indication that "a fifty-fold underreporting of adverse events" is likely. According to David Kessler, former commissioner of the FDA, "only about one percent of serious events [adverse drug reactions] are reported." Less serious vaccine adverse events (e.g., swelling, fever, or redness at the vaccination site) are more underreported than more serious vaccine adverse events (e.g., hospitalizations and death). The current analysis made no attempt to quantify underreporting due to age, type of adverse event, or other factor since only relative trends were utilized." (2)
"Approximately 85% of the variation in mean hospitalization rates for children aged 0.1–0.5 years was accounted for on the basis of the number of vaccine doses. If the quantity and severity of adverse vaccine events is, in fact, related to the accumulated total number of vaccine doses, then methodology that includes the complete age-specific vaccination history of the patient might enhance the analysis. Furthermore, while vaccines may appear to be the causal factor leading to adverse vaccine events, other underlying patient medical conditions, including latent mitochondrial disease or vitamin deficiencies, may ultimately play a role. Some reports have postulated that environmental factors, including vaccine administration, can trigger an adverse reaction due to its various components or agents that depleted body resources and/or cause immune insults." (2)
"Studies have not been conducted to determine the safety (or efficacy) of administering multiple vaccine doses in a variety of combinations as recommended by CDC guidelines. Our findings show a positive correlation between the number of vaccine doses administered and the percentage of hospitalizations and deaths reported to VAERS. In addition, younger infants were significantly more likely than older infants to be hospitalized or die after receiving vaccines. Since vaccines are administered to millions of infants every year, it is imperative that health authorities have scientific data from synergistic toxicity studies on all combinations of vaccines that infants are likely to receive; universal vaccine recommendation must be supported by such studies." (2)
What does all this mean to you?
Simply stated is that the VAERS (Vaccine Adverse Event Reporting System) is a passive system and the physicians are not even trained properly or at any intensity as to the importance of sending a report of you or a loved one's adverse event to a drug or vaccine. It is not promoted to become an integral part of their practice. This is something that I believe any conscientious physician would want for their patients that rely on their knowledge with regards to the effectiveness of the medications and vaccines that they administer. I feel that because of this lack of training and promotion we have the reporting rate of only 1% of the physicians reporting into a system that would be instrumental in the safety of all vaccine functionality.
The next interesting item that I found was that the FDA which is the agency that we trust to want the most accurate information possible to protect the safety of our loved ones does not even want all the adverse events to be reported. Now, I understand that some are mild like a slight fever, flulike symptoms that go away in a short period of time but what about all the other adverse events. They only want incidents "associated with a serious outcome – death, a life-threatening condition, initial or prolonged hospitalization, disability, or congenital anomaly, or when intervention was required to prevent permanent impairment or damage." (1) When researching the different adverse events reported to the VAERS database it seems like the list goes on forever. When you read all the different events reported you would think that over half would be considered serious but as you can see they are not worth the time of the FDA.
What I believe has been promoted by the FDA is a system that is grossly inadequate to ascertain the safety of any drug, vaccine or medical device. This has led to so many products that have been touted to be safe left on the market where I feel in reality are highly dangerous.
This is how this applies to the HPV vaccines. I am going to reference the information about the Gardasil vaccine as the prime example of this underreporting and how it is used to promote the vaccine.
In their documents they will use the present numbers as to how many individuals reported an adverse event to the VAERS data base. Presently, as of October 13, 2013, there have been 32,179 reports. They will insinuate this number as fact per the whole population of vaccines distributed. What they do not bring up is that this could only be 1% as they attest to as the amount that really reports. So what this gives us if you multiply this by 100% is in realty 3,217,900 has suffered an adverse event from the vaccine. This could also be on the low end because from my conversations with hundreds of parents and individuals over the years I can safely say that I believe that this is only the tip of the iceberg.
They will also downplay the deaths that have been reported. Presently there have been 148 young people who have died with relation to this vaccine. If you use what they stated of 1% you really have 14,800 have died. The only problem that I see in this is that all the parents that I have spoken with have told me that the autopsy reports were inconclusive as to a cause so I believe that this number has the real possibility to be double if not triple the amount I have stated above. This in itself should be cause to remove this vaccine from distribution. I cringe and wonder and pray that when I read a news report of some young person suddenly dying for some unknown reason did not receive the HPV vaccine.
Another way they will skew the real numbers is what they did for the reports to the FDA. You will hear often that the percentage of adverse events reported for the vaccine compared to the placebo was comparable. In the report to the FDA on September 11th, 2008 this is what the reporter wrote. "Reviewer's Comment: The proportions of subjects in each System Organ Class were comparable. The most common conditions reported were pharyngitis, upper respiratory infections, and influenza. There was a higher proportion of subjects with abdominal pain in the Gardasil group (5.0%) as compared to the saline placebo group (2.7%)." (3)
The reality of this statement with relation to table 79, New Medical Conditions After Day 1..., it is referencing is this. Out of 11,778 participants that received the Gardasil vaccination 8,628 (73.3%) reported a new medical history during the study. In the placebo group out of 9,686 participants 7,390 (76.3%) reported a new medical history during the study. So what the FDA says to you is that there was only a 3.0% difference between the vaccine group and the placebo group. If you look at this that is a small margin but if you look at the real numbers reported which is the 73.3% that is huge. Can you imagine that 3 out of 4 young people receiving this vaccine are expected to have a new medical condition when the real numbers are known and this is acceptable to the FDA, CDC and all the other organizations that use this data?
It is because of what these organizations tell us that I can safely say that the HPV vaccine has the potential to be the worse vaccine ever created because by their own admission they promote the under reporting of adverse events, do not encourage doctors to report and omit vital statistics when promoting the safety of this vaccine to the public. How can this make you feel confident in the practices of the FDA? From what I have learned over the years I have a '0%' confidence level in regards to anything that they do.
Here is another tasty tidbit. "Postlicensure safety data from the Vaccine Safety Datalink study, including data from >600,000 HPV4 doses administered, showed no statistically significant increased risk for the outcomes studied, including Guillain-Barré syndrome, stroke, venous thromboembolism, appendicitis, seizures, syncope, allergic reactions, and anaphylaxis (15). Postlicensure safety data from a manufacturer-sponsored study found no increased risk for outcomes such as anaphylaxis and venous thromboembolism; however, persons who were vaccinated with HPV4 were more likely to faint on the day they were vaccinated than another period in which vaccine was not administered (16)." (4)
Once again they are referencing the differences between the vaccine and the placebo. So in essence what they are stating is correct that there is "no statistically significant increased risk." The real numbers tell the truth and this is what they do not want you to know. They also do not tell you what the other outcomes they studied were. This is how they skew the numbers to say what they want and technically they are not lying.
The last item of interest is this. "Studies have not been conducted to determine the safety (or efficacy) of administering multiple vaccine doses in a variety of combinations as recommended by CDC guidelines." (2) This sentence needs absolutely no explanation. So when you go to your doctor for your next well baby visit and he tells you they need this, this and this vaccine that day, you can safely tell them that in doing so they are violating recommended CDC guidelines where multiple vaccine studies have not been conducted. Also, if your school has a vaccine clinic and they decide to administer multiple vaccines to the children at once you can tell them the same thing and reference the document this came from.
Now you know why so many children are suffering from various diseases and have Autism. The doctors are not trained and a study was not performed as to the safety of multiple vaccinations per recommended by the CDC guidelines.
Will you be one more or one less individual hurt by the underreporting of adverse events which is promoted by the FDA? Think about it. I plan on being one less and will educate myself since it is not an ingrained practice for our doctors to do so. This is very sad.
(1) Jama, June 2, 1993 – Vol 269, No. 21, page 2765 Introducing MEDWatch – Kessler
(2) Human and Experimental Toxicology, 31(10) 1012–1021, DOI: 10.1177/0960327112440111, Relative trends in hospitalizations and mortality among infants by the number of vaccine doses and age, based on the Vaccine Adverse Event Reporting System (VAERS), 1990–2010
(3) http://www.renewamerica.com/columns/janak/081204 Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18. Dated September 11, 2008,
(4) Centers for Disease Control – Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males – Advisory Committee on Immunization Practices (ACIP), 2011, Weekly, December 23, 2011 / 60(50);1705-1708
© Cynthia A. Janak
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