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GARDASIL/CERVARIX
ANNOUNCEMENT and Why VAERS
Is A Passive Reporting System That The FDA Loves To Quote
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  
For years we’ve been bombarded with
multimillion dollar advertisements promoting the HPV vaccine known as
Gardasil. Commercial after commercial, whole page magazine ads and
posters at subway stations sent more fear than facts to the public about the
human papilloma virus (HPV) and its role in cervical cancer.
Like every vaccine that came before these two, reactions post-vaccination were documented and reported in the VAERS database (Vaccine Adverse Event Reporting System). Currently, almost 32,000 adverse reactions have been reported as well as 144 deaths. Despite growing concerns about Gardasil and Cerivax, and about the increasingly serious and fatal reactions young girls have had from them, it was suggested in 2011 that boys as young as 11-years old also receive the 3-shot series. During the campaign to sell, sell, sell this product, we were told that the HPV vaccine would be an answer—an answer to help prevent cervical cancer. We were told those who got the vaccine would be One Less: One Less to chance it. One Less to catch the disease. One Less cancer victim. We were also told that 3 doses were recommended for the series to be effective. Reports are now saying 3 vaccines may be two too many though. Good news for less jabs, right? What, then, should we tell the girls, and now possibly the boys, who got sick from their 2nd dose of the vaccine? Who tells them, “Oops, sorry.” What do we tell the families of those who died after continuing the series with their 2nd or 3rd doses? Does anyone say, “Well, were wrong. We should have said two less; two less vaccines, that is.” I highly doubt that anyone will utter that kind of apology. Those promoting and inflicting the most damage, including death, will likely get to walk away. They do not have to handle the irreparable harm done. They will not witness adverse reactions that lead to future health problems. They are not left with a lesson to be learned either, unless that lesson is to publicly continue to herald their own efforts while hiding behind the protection they’ve been granted by the government. What irks me when I read articles like the one suggesting that only one HPV vaccine is needed, besides the fact that that this vaccine was made out to be the vaccine that would save the most lives, is that our nation’s children have once again become pin-cushioned guinea pigs. With all safety cast aside, our children have become part of an experiment and not a solution. If ever there was a reason for someone to learn how to educate themselves before choosing to vaccinate, this ‘whoops, two less vaccines’ discovery is more than reason enough. Being fully informed before opting for any unavoidably unsafe product like a vaccine is better than finding out too little too late. Fortunately, being informed is something anyone, including my pre-teen daughter, and the girls she is talking to, can do. First, start learning the facts, all of the facts. Learn as much as you can about vaccines and particularly the ones you’re opting for. Look at the track record of each. Listen to what your doctor or provider has to say about them, and then, research what they’ve shared. Research what they didn’t share also. Read more than just the Vaccine Information Sheet the medical staff is required by law to give you, too. Instead, request, read and study (or download) the 30 pages of each vaccine insert: Gardasil and Cervarix. Look up what’s being reported in the news about the growing list of negative side effects making sure the news comes from a reputable source. Read as much as you can, and continue to read some more. Know that this vaccine proposes to protect only 4 out of the 40 known strains of cervical cancer. Realize, too, that this vaccine hasn’t been around all that long. Long-term studies don’t happen overnight; they take years to be conducted and only after gathering hundreds of pieces of data—data gotten from those who received the vaccine, including from the ones who escaped vaccine injury to the ones who succumbed from it. Remember that while some side effects from vaccines can be seen immediately (fainting, nausea, dizzy spells and seizures), others take time to be discovered and subsequently reported. Understand that through the National Vaccine Injury Compensation Fund, the US government has awarded $6 billion toward 49 cases of HPV vaccine injury and death. (Keep in mind that while 49 may not sound like a lot, over 200 claims have been filed and that all of them have yet to be processed.) And finally, remember that you have a choice; a choice to say yes, no, or not right now until you know as much as you need to know. Vaccine choice is a benefit, but being fully informed about a vaccine can have a much more lasting effect. I’ve come to realize that the best way to be avoid vaccine injury or death resulting from vaccines is to abstain from vaccinations. My daughter, and now her middle school friends are well aware of this too. My daughter will continue to use her recess time to talk about vaccines, particularly the HPV vaccine. She does this not because she’ll be getting it, but because she personally knows girls who have received it, and she is genuinely concerned about their future health. I don’t blame her for wanting to stay as informed as I do or for attempting to educate others. With how things have gone for so many HPV vaccine recipients, one more conversation on the playground could very well lead to one less tragedy. Cathy Jameson is a Contributing Editor for Age of Autism.   |
Tuesday, November 19, 2013
GARDASIL/CERVARIX ANNOUNCEMENT and Why VAERS Is A Passive Reporting System That The FDA Loves To Quote
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